Zeenat Jamal Siddiqui v. Sahara Hospital

evening because of which the heart rate, pulse rate and respiratory rate became abnormal and the doctors could not give any satisfactory explanation for the same. The callousness of the hospital authorities is clearly exhibited from the fact that on 16.5.2010 blood was transfused which made the patient shiver for quite long but when this thing was brought to hospital authorities notice, a flat reply was given to the complainant from the nursing staff and doctors that she is not a doctor and she should not interferein the functioning of the doctors. Although, when the complainant's late husband was admitted, all his organs were functioning normally and his blood sugar level was also normal but suddenly on 17.5.2010, Dr. Sunil Verma advised dialysis and when the reason for this sudden requirement was sought he was not in a position to give any plausible answer. The complainant's late husband was given over medication just to inflate themedical/hospital bills and because of this over treatment, his condition kept deteriorating and the hospital authorities could not provide any plausible explanation for the same.

Though the complainant was told that her late husband is being treated under the guidance of Dr. R.K. Sharma and whose fee was also charged but he never came to see or examine complainant's late husband. From the above narrated facts it comes out that the complainant's husband was victim of medical negligence as he was given that treatment which was not required or which caused reaction in his body metabolism. In fact, the opposite party failed in its duty to diagnose the disease of the complainant's husband, thereafter they committed negligence in administering the correct treatment which led to occurrence of complications and ultimately the condition of multiple organ failure. The complainant's husband was drawing salary of Rs.47,910.00 as President of the District Consumer Forum, Lucknow and he would have continued in that capacity till 27.2.2012 had he not been a victim of medical negligence and apathy in the respondent hospital. Apart from this fact, the complainant's husband was also saddled with the responsibility of the marriage of his 3 daughters as also getting his son settled and before he could fulfill all his responsibilities/obligations, he was made to leave for his heavenly abode thanks to the faulty treatment so given in the respondent hospital.

The complainant has suffered an irreparable loss, which can not be compensated in any manner but still in monitory terms considering the length of service of the complainant's husband as also his loss though immeasurable comes to about Rs.70 lacs which includes the cost of mental agony and trauma suffered by the complainant. The complainant had instructed her lawyer to serve a notice upon the respondent demanding the above noted compensation. On the basis on instructions, her lawyer had served notice vide letter dated 13.11.2010. However, the respondent has neither responded to the notice nor it has paid any compensation in terms of the notice. Therefore the present complaint has been filed for the above mentioned reliefs. The opposite party no.1 has filed their written statement wherein it is stated that Mr. A.J. Siddiqui, aged about 63 years, as informed, had reported to Sahara Hospital Respondent on 27.04.2010 at 15.20 p.m. as a case of Parkinsonism with high grade fever having been brought by his attendants. Mr. Siddiqui, the aforesaid patient was found to have high fever with pneumonitis left lower zone with breathlessness.Medical consultant, Neuro Physician, Uro

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Surgeon, Pulmonologist, Cardiologist, General Surgeon and latter G.I. Surgeon collectively worked on appropriate investigations and treatment of the said patient. The neuro Physician noted low general condition and features of septicemia on 28.04.2010.Urologist found that patient gave history of acute retention of urine and indwelling catheter was in situ since one month. He had urinary tract infection (UTI) and showed pus cells in urine and culture had grown E. Coli (Culture done from outside and brought by the attendant).The Patient, Mr. Siddiqui was found to have multiple fistulae in ano feculent discharge from each fistulous opening noted while doing per rectal examination. These could only develop if perineal abscess is neglected for prolonged period. It was the combined effect of severe UTI, pneumonia and perineal cellulitis that the septicemia must have developed and got aggravated. Fever persisted and patient's oxygen saturation fell as a result he was put on ventilator support and later developed featured of MODS (Multiple Organ Dysfunction Syndrome) too.MRI revealed multiple sinuses in the perineal area which can only develop when a perineal area which can only develop when a perineal abscess is neglected for prolonged period (may be months or more).The GI surgeon latter, having examined the patient, recommended conservative treatment for multiple fistulae in ano. The patient, Mr. Siddiqui was actually victim of his own negligence in which he kept the catheter in situ for a month after acute retention and neglected the perineal abscess leading to perineal sinuses due to which probably he developed fever and pneumonitis which forced him to report to Hospital. Apart from the above he also continued to neglect parkinsonism as a disease as recorded by the Neuro physician.

The Hospital could not be blamed for the sequelae of prolonged catheterization (severe UTI) and neglected multiple fistulae in ano (which takes months to develop) and the high fever and pneumonia with which he reported. Apart from the above parkinsonism for which the patient took no treatment for a long period as noted by the Neuro physician. Patients of Parkinsonism are prone to develop serious life threatening infections especially respiratory tract infections.It is to be noted that during the pre-hospitalization period the patient was already suffering from Parkinsonism (for which he had discontinued treatment) and multiple fistulae in ano. The patient was admitted at Sahara Hospital with high grade fever and breathlessness and his general condition was poor as he was in septicemia. In septicemia, the major organs of the body are at risk of getting damage although pathology reports may show a normal trend initially.

Patients with infections may initially respond to antibiotics but deterioration in condition may occur if the given antibiotics become resistant to organism causing the infection, which is a known phenomena.The patient was already on noninvasive ventilation (Bi PAP) since 01.05.2010 but when patient's condition did not improve on non invasiveventilation he was put on invasive ventilator support on 05.05.2010. Ventilator can only be removed once its need does not arise. Patient might have improved transiently on ventilator support but since the patient's own respiratory efforts were too weak, without ventilator support he would not have carried on. Therefore as elaborated above, it can be said that at no point of time was any assurance could have been offered to the attendant regarding removal of the all given implanted ventilator support.

There was a persistent fall in Hemoglobin of the patient and the blood reports of Hb fell to 7.2

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gm% (on 16.05.2010). Hence there was a need for blood transfusion to improve the Oxygen Carrying Capacity of the patient. Since fever was persisting, an increase in heart rate/pulse rate can be explained. Respiratory rate was governed by the ventilator. There was no transfusion reaction observed as per the records.Hence the claim that there was no need of blood transfusion is totally baseless and is layman's assumption.

Once the blood is drawn for donation testing of blood has to be done which takes time. Blood components have to be made as transfusion has to be given according to the clinical requirement of the component and this also takes time. As the patient was immuno- compromised we cannot give siblings or 1^stdegree relative's blood. However, an explanation of the above phenomenon is given below.

Minor shivers can occur due to transfusion of any kind of blood product, i.v. medication and i.v. fluid. Had there been a major transfusion reaction, patient would not have survived till 18.05.2010.Also it is been mentioned in the case notes that adequate precaution was taken for such an eventually. Along with general condition, patient's kidney function was along going downhill-part of multiple organ dysfunctions. It was only advised to the relatives that patient may need dialysis support in future if the condition did not improve. An expert opinion with nephrologists, Dr. Muffazal Ahmad was also sought regarding this.

As the patient was admitted in the C.C.U. as per the Hospital protocol of super specialty treatment, reference of specialists is taken.A patient who is admitted in critical care unit like CCU and is seen by Physician, Neurologist, Pulmonologist, Nephrologist, Cardiologist daily, cannot fall in the ambit of medical negligence from the treatment point of view. On regular basis patient's daughter, son, wife were briefed about the prognosis and clinical condition of the patient.Despite a concerted scientific approach and dedicated efforts by the treating team of specialists, the patient kept deteriorating due to the multiple factors as also contained in his clinical profile. The said patient Mr. A.J. Siddiqui succumbed to death before he was shifted to S.G.P.G.I. where the attendant wished to take him.

The documents annexed as Annexures Nos.1 and 2 with the complaint shall be subject to its verification from the record. At no point of time, any kind of assurances were given to the attendants including to the complainant as alleged.No assurance was given for the removal of ventilator support. Rest as alleged its wrong and denied.The documents relating to the treatment of Mr. Ashraf Jamal Siddiqui, his bills etc. are being filed and the allegations made in the paragraphs under reference contrary to the said records are wrong and denied. Mr. A.J. Siddiqui was provided the appropriate treatment and was never victim of any medical negligence as alleged. The treatment so provided to him was medically sound and his death was the result of the ailment he suffered. Inspite of the best possible medical treatment having been provided to the said patient he could not survive. There was no case of any medical negligence on the part of the doctors in the Respondent's Hospital while treating the said patient and providing treatment. Rest denied.

It is submitted that the answering Respondent is not aware of the monthly salary of Mr. A.J. Siddiqui, at the time of his death. The Respondent is also not aware with respect to the status and conditions of his family members. The patient died due to his serious ailment as mentioned above despite the appropriate and best treatment provided to him by the doctors in the Respondents Hospital. The Complainant is not legally entitled to any damages against the

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respondent's Hospital due to the death of the patient, Mr. A.J. Siddiqui in view of the facts and circumstances mentioned hereinabove. Rest denied.The complainant was not entitled to any compensation pursuant to the said notice which was illegal. The complainant is required to the strict proof of the allegations made in the paragraphs including to the proof with respect to the notice.

The complainant is not legally entitled to the reliefs claimed which are frivolous in nature. The complainant is guilty of filing the present complaint on this basis of concocted allegations and the same has resulted into causing harassment to the Respondent.

The opposite party no.2 has filed its written statement whereinit is submitted at the outset that the complainant had not furnished the copy of the complete complaint with affidavit and all annexures to the answering opposite Party, due to which, the answering opposite Party could not file the written statement earlier. Upon the facts, gathered from the present documents, it is submitted at the outset that the complainant has not been the "consumer" of the answering opposite party at any point of time. The Complainant has never sought any services from the answering Opposite party nor has claimed any relief therefrom. Thus, the name of the answering opposite party is liable to be deleted from the array of parties and the present complaint is liable to be rejected as against the answering opposite party with heavy costs. It is further submitted that allegedly, the matter pertains to medical negligence of several doctors who treated the deceased at the Sahara Hospital during his lifetime. Hence, it does not related to the answering opposite party in any manner whatsoever. It is submitted that as there is no relationship/link between the complainant and the answering opposite party the complainant has not received any sort of services from the answering opposite party, hence, there can be no question of deficiency in service on the part of the answering opposite party in any manner.

It is specified here that the instant matter is a case of alleged composite negligence of several doctors and staff, who treated/assisted during the treatment of the deceased at Sahara Hospital. Hence, the instant matter is not entertainable by this Hon'ble Commission.Without prejudice to the aforesaid, it is emphatically pointed out here that the amount claimed by the Complainant towards "mental, emotional, physical and financial loss suffered by the Complainant" has been mentioned as Rs 70 lacs. No logic, calculation or reason has been assigned by the Complainant for seeking the said amount in any manner whatsoever. Thus, the prayer itself is utterly vague and baseless, and as such, the instant matter is not entertainable by this Hon'ble Commission at all.

It is reiterated here that the amount claimed by the Complainant by mode of the Prayer Clause in the Complaint is not substantiated at all, it is utterly vague and whimsical and grossly devoid of any calculation, reasoning or logic.

From the aforesaid, it is evident that the Complainant has claimed highly exaggerated and baseless amounts towards compensation, mental agony and damages etc, to somehow bring this matter within the domain of pecuniary jurisdiction of this Hon'ble Commission, which is utterly impermissible as well as illegal.It is emphatically submitted here that in the circumstances of the case, there is no privity of contract between the Complainant and the answering opposite party.

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The answering opposite party is not in a position to furnish a complete and comprehensive reply at this stage. However, the answering opposite party reserves its rights to file additional written statement after the complainant furnishes the details of insurance policy, if any.It is submitted that the entire aforesaid aspect of composite negligence of several doctors/staff of Sahara Hospital altogether is not covered under the complaint in question nor can it be adjudicated in the present case.It is submitted that the complainant has not adduced any expert opinion or any other technical document/certificate to prove the allegations of medical negligence, alleged to have been committed by all the doctors of Sahara Hospital. It is reiterated here that in the light of the aforesaid facts and circumstances, the Complainant has neither been able to establish any sort of a link with the answering Opposite Party or any services received therefrom, and has also not been able to establish privity of contract or any other grounds for impleading the answering Opposite Party in the present case. Thus, the answering Opposite Party's name is liable to be deleted at the inception stage itself.It is submitted that the answering Opposite Party craves leave of this Hon'ble Commission to file a separate application to this effect. However, it is submitted that the present complaint is liable to be dismissed against the answering Opposite Party on this preliminary ground itself.In view of the aforesaid facts and circumstances, the present Complaint is completely devoid of merits, it contains highly exaggerated amounts, and as such, is liable to be rejected even upon merits. We have heard ld. Counsel for the complainant Sri Vikas Agarwal & Ms. Farhat Jamal Siddiqui. Ld. counsel for the opposite party no.1 Sri B.K. Tripahti, Sri R.N. Singh & Sri Alok Kumar, Ld. counsel for the opposite Party no.2 Sri IPS Chaddha, Ld. counsel for Opposite Party no.3 Ms. Rehana Khan and Ld. counsel for Opposite Party no.5 Sri A.K. Rai. None appeared for opposite Party no.4. We have perused the entire record. It has been said that the patient was admitted in the Sahara Hospital on 27.04.2010 at 3:20 PM. The counsel of the opposite parties have filed the medical documents with clear eligible copies. On 27 April 2010, the provisional diagnosis was parkinsonism and the final diagnosis is of Parkinsonism with an LRTI with UTI with septicaemia with MODS with multiple fistula in Ano. In the history column it has been written, "Fever high-grade since last three days. Breathlessness since morning. Abdominal pain due to unable to pass urine. Known case of parkinsonism since last five years. He was taking medicine from physician since the last three days, he was having fever and breathlessness. He was brought to our hospital for further treatment. On the same day that is 27.04.2010 it has been written in the case history of the patient, "seen by Dr Sunil Verma . Patient k/c ? Parkinsonism presented with high-grade fever with breathlessness x 3-4 days. BP - 160/90 mmHg, chest B/L/Crepts L R, CVS S1 & S2 (N), drowsy, RBS- 117 mg%. In the same case history Dr Sandeep Agarwal has written h/o parkinsonism - not taking treatment regularly. Seen extrapyramidal rigidity & no focal neurological deficit." Some medicines were prescribed.

On 28.04.2010, the progress sheet says k/c/o parkinsonism, RLZ pneumonia. What is RLZ pneumonia. It is Right Lower Zone. What is this?

Airspace consolidation is seen within the posterior and lateral segments of the right lower lobe. This is associated with a small pleural effusion. The right upper and middle lobes, and the entire left lung, are clear. There is minor mediastinal lymphadenopathy, which in this setting may be reactive. The most common cause of bacterial pneumonia in the U.S. is Streptococcus

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pneumoniae. This type of pneumonia can occur on its own or after you've had a cold or the flu. It may affect one part (lobe) of the lung, a condition called lobar pneumonia. Is lower lobe pneumonia serious?

It is a serious infection in which the air sacs fill with pus and other liquid. Lobar pneumonia affects one or more sections (lobes) of the lungs. Bronchial pneumonia (also known as bronchopneumonia) affects patches throughout both lungs.

What is the right lower zone?

The right lower lobe (RLL) is one of three lobes in the right lung. It is separated from the right upper lobe superiorly and the middle lobe anteriorly by the right oblique fissure and is subdivided into five bronchopulmonary segments.

On which basis this right lower Zone pneumonia has been written, nothing has been given in the history sheet but at 7:15 PM advice is chest x-ray PA view, CBC, Na+ /K+. Here it has also been written that parkinsonism symptom reduced. As far as the medicines are concerned, injection Falcigo 120 mg, i/v has been prescribed OD for eight days. Falcigo 120mg Injection is an antiparasitic medication. It is used in the treatment of malaria. It is not used to prevent malaria or to treat severe malaria (where it has affected the brain, lungs, or kidneys).

Falcigo 120mg Injection is administered as an injection by a healthcare professional. Kindly do not self-administer. It is given in cases where oral administration is not possible.

Some people may experience a headache, dizziness, weakness, and loss of appetite, as the side effects of this medicine. You may also notice some injection site reactions like pain, swelling, or redness. Please consult your doctor if these side effects persist for a longer duration. You may be monitored with blood tests once a week for 4 weeks to detect the presence of malarial parasites.

BENEFITS OF FALCIGO INJECTION

In Malaria Falcigo 120 mg Injection is an antimalarial medicine and is used alone or with other medications to treat malaria (a serious or life-threatening illness that is spread by a parasite that enters the human body by the bite of infected mosquitoes). This medicine is given by a doctor or nurse and should not be self-administered. Refrain from taking any other medicines or antacids along with this medicine (unless advised by the doctor) as they may affect the absorption of this medicine. Do not use this medicine for treating any other condition without consulting your doctor.

SIDE EFFECTS OF FALCIGO INJECTION

Most side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you're worried about them Common side

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effects of Falcigo Headache•

Dizziness•

Weakness•

Loss of appetite• Injection site reactions (pain, swelling, redness)• What does Falcigo mean?•

Falcigo 120 MG Injection is an anti-malarial medicine used for the treatment ofsevere malaria. It is caused by parasites (organisms living in another organism and causing harm), namely Plasmodium falciparum.

This medicine has been prescribed for eight days. It means that the opposite parties have full knowledge or anticipated that the patient is suffering from malaria. In the history sheet filed before us there no entry of malaria. On 29.04.2010 , tablet Lariago- BD has been added. This tablet is also a medicine for the treatment of malaria.

Lariago 250 mg Tablet is an antiparasitic medicine, used for the prevention and treatment of malaria. It works by killing the malaria-causing parasite and stops the infection from spreading. Lariago 250 mg Tablet should be used in the dose and duration as advised by your doctor. Take it with food to decrease the risk of stomach upset. Do not skip any doses and finish the full course of treatment even if you feel better. Stopping it early can result in treatment failure and increase the side effects too. Do not take a double dose to make up for a missed dose. Simply take the next dose as planned. Take measures to reduce the chance of being bitten by mosquitoes like using insect repellent creams on parts of your body, not covered by clothing. Spray mosquito repellent to kill any mosquitoes that may have entered rooms in spite of screening. Wear light-colored and covered clothing when you are outside after sunset.

Some people may experience rash, headache, dizziness, and vomiting as side effects of this medicine.It may also cause stomach pain, diarrhea, loss of appetite, and nausea. Please consult your doctor if these side effects persist for a longer duration.

Inform your doctor if you have diabetes as it can lower the sugar levels in the blood. If you are diabetic, you should monitor your blood sugar regularly. It may cause blurring of vision. Therefore, regular eye examinations are recommended while on treatment with this medicine. When used long-term, your doctor may monitor the amounts of the different types of blood cells in your blood regularly. Inform your doctor if you have unexplained bruising or bleeding, sore throat, fever, or a general feeling of tiredness.

BENEFITS OF LARIAGO TABLET

In Treatment of Malaria Lariago 250mg Tablet is used to treat malaria, a serious or life-threatening illness that is spread by a parasite that enters the human body by the bite of infected mosquitoes. It kills the infection causing parasite and stops further spread of the infection. Take it only as prescribed and refrain from taking any other medicines along with this medicine (unless advised by the doctor) as they

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may affect the absorption of this medicine. Do not use this medicine for treating any other condition without consulting your doctor.

SIDE EFFECTS OF LARIAGO TABLET

Most side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you're worried about them Common side effects of Lariago

Rash•

Headache•

Dizziness•

Vomiting•

Nausea•

Stomach pain•

Loss of appetite•

Diarrhea•

HOW LARIAGO TABLET WORKS

Lariago 250mg Tablet is an antiparasitic medication that treats malaria. It works by increasing the levels of haeme in the blood, a substance toxic to the malarial parasite. This kills the parasite and stops the infection from spreading.

Now we have seen that the opposite parties prescribed Inj. Falcigo 120 mg for 08 days on 28.04.2010 and thereafter added Tab. Lariago on 29.04.2010. Both these medicines are for the treatment of Maria and still there is no confirmation of Malaria till 29.04.10. Now the question arises as to whether test of Maria takes a long time are it can be tested within the short duration. The following article deals with the malaria regarding its tests.

How long do malaria test results take?

Various test kits are available to detect antigens derived from malaria parasites. Such immunologic ("immunochromatographic") tests most often use a dipstick or cassette format,

and provide results in 2-15 minutes. What are malaria tests?

Malaria is a serious disease caused by a parasite. Parasites are tiny plants or animals that get nutrients by living off another creature. Parasites that cause malaria are passed to humans through the bite of infected mosquitos. At first, malaria symptoms may be similar to those of the flu. Later on, malaria can lead to life-threatening complications. Malaria is not contagious like a cold or flu, but it can be spread from person to person by mosquitos. If a mosquito bites an infected person, it will spread the parasite to anyone it bites afterward. If you are bitten by an infected mosquito, the parasites will travel into your

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bloodstream. The parasites will multiply inside your red blood cells and cause illness. Malaria tests look for signs of a malaria infection in the blood.

Malaria is common in tropical and subtropical areas. Every year, millions of people are infected with malaria, and hundreds of thousands of people die from the disease. Most people who die from malaria are young children in Africa. While malaria is found in more than 87 countries, most infections and deaths happen in Africa. Malaria is rare in the United States. But U.S. citizens who travel to Africa and other tropical countries are at risk for getting infected. Other names: malaria blood smear, malaria rapid diagnostic test, malaria by PCR.

What are they used for?

Malaria tests are used to diagnose malaria. If malaria is diagnosed and treated early, it can usually be cured. Left untreated, malaria can lead to life-threatening complications, including kidney failure, liver failure, and internal bleeding.

Why do I need a malaria test?

You may need this test if you live or have recently traveled to an area where malaria is common and you have symptoms of malaria. Most people will have symptoms within 14 days of being bitten by an infected mosquito. But symptoms can show up as soon as seven days afterward or can take as long as a year to appear. In the early stages of infection, malaria symptoms are similar to the flu, and may include:

Fever•

Chills•

Fatigue•

Headache•

Body aches•

Nausea and vomiting•

In the later stages of infection, symptoms are more serious and may include:

High fever•

Shivering and chills•

Convulsions•

Bloody stools•

Jaundice (yellowing of the skin and eyes)•

Seizures•

Mental confusion•

What happens during a malaria test?

Your health care provider will probably ask about your symptoms and for details on your recent travels. If an infection is suspected, your blood will be tested to check for signs of a malaria infection.

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During a blood test, a health care professional will take a blood sample from a vein in your arm, using a small needle. After the needle is inserted, a small amount of blood will be collected into a test tube or vial. You may feel a little sting when the needle goes in or out. This usually takes less than five minutes.

Your blood sample may be tested in one or both of the following ways.

Blood smear test. In a blood smear, a drop of blood is put on a specially treated slide. A laboratory professional will examine the slide under a microscope and look for parasites.

•

Rapid diagnostic test. This test looks for proteins known as antigens, which are released by malaria parasites. It can provide faster results than a blood smear, but a blood smear is usually needed to confirm a diagnosis.

•

Will I need to do anything to prepare for the test?

You don't any special preparations for a malaria test.

Are there any risks to the test?

There is very little risk to having a blood test. You may have slight pain or bruising at the spot where the needle was put in, but most symptoms go away quickly.

What do the results mean?

If your results were negative, but you still have malaria symptoms, you may need retesting. The number of malaria parasites can vary at times. So your provider may order blood smears every 12-24 hours over a period of two to three days. It's important to find out whether you have malaria so you can get treated quickly.

If your results were positive, your health care provider will prescribe medicine to treat the disease. The type of medicine will depend on your age, how serious your malaria symptoms are, and whether you are pregnant. When treated early, most cases of malaria can be cured.

Medication to Prevent Malaria (Prophylaxis)

These drugs are chosen by geographic region, since there are different patterns of infection and drug resistance depending on your area of travel.

You'll need to take your prophylaxis for the recommended duration before, during, and after your time in an area with widespread malaria transmission.

Your need for malaria prophylaxis is still the same if you used to live in the area or if you've had malaria before.

A Malaria Vaccine: Progressand Challenges

No medication provides 100 percent protection against malaria, so it's still important to take other steps to reduce your risk of exposure to parasite-carrying mosquitoes.

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Your options for malaria prophylaxis may include:

Atovaquone and Proguanil (Malarone) This drug combination tends to be well tolerated, with few side effects. It cannot be used by women who are pregnant or breast- feeding. Malarone should be started for prophylaxis one to two days before potential malaria exposure. It is taken daily, and must be continued for seven days after your trip.

Chloroquine (Aralen Phosphate) This drug is considered safe during pregnancy, but it's not an option in certain areas because of drug resistance. Chloroquine should be started for prophylaxis one to two weeks before potential exposure, is taken weekly, and must be continued for four weeks after your trip.

Doxycycline (Vibramycin) This drug is an antibiotic that can also help prevent certain other infections. It's not an option for pregnant women or young children, and side effects may include increased sun sensitivity, stomach upset, or vaginal yeast infections in women. Doxycycline should be started for prophylaxis one to two days before potential exposure, is taken daily, and must be continued for four weeks after your trip.

Mefloquine (Lariam) This drug is considered safe during pregnancy, but it's not compatible with certain psychiatric, seizure, and cardiac disorders. Lariam should be started for prophylaxis at least two weeks before potential exposure, is taken weekly, and must be continued for four weeks after your trip.

Primaquine This drug is the most effective option for the Plasmodium vivax malaria parasite, but it's not for pregnant women and may cause stomach upset. It also requires a test for a genetic defect called G6PD deficiency, and cannot be used in people who test positive. Primaquine should be started for prophylaxis one to two days before potential exposure, is taken daily, and must be continued for seven days after your trip. (1)

Deciding on a Treatment Plan

Which drug or combination of drugs you take to treat malaria, and the length of your treatment, will be based on several factors:

Geographic Location of Infection Malaria parasites commonly become resistant to drugs, with different patterns of drug resistance seen in different areas of the world. Your doctor will choose a drug regimen that's known to be effective against malaria parasites where you acquired the infection.

Symptom Severity Severe malaria requires intravenous (IV) medication and hospitalization, rather than the oral drugs given for uncomplicated malaria.

Severe malaria can be caused by any parasite species, but it's most often caused by Plasmodium falciparum, the most common species in sub-Saharan Africa.

Species of Malaria Parasite Malaria attacks red blood cells, and most drugs for malaria fight

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the parasite in your bloodstream. Infections with P. vivax or Plasmodium ovale species require additional medication to kill immature parasites that may be dormant in your liver. This is necessary to prevent a recurrence of the infection.

Age Children will need smaller drug doses than adults, based on their weight.

Pregnancy Some malaria drugs aren't safe to take during pregnancy, or their safety in pregnancy is unknown. But it's crucial for pregnant women to be treated for malaria.

G6PD Deficiency Some malaria drugs can't be taken by people who lack an enzyme called G6PD, so your doctor may test you for this deficiency before prescribing certain drugs. (1,2,3)

Drug Availability Where you are located geographically when seeking treatment might limit the drugs readily available to you.

Medication to Treat Malaria

To reduce the risk of drug resistance, drugs for malaria are often given in combination. This helps kill off the parasite by targeting it in more than one way.

It's important to take the full course of your drugs as prescribed, and to acquire them from a reputable source. (2)

Common side effects from various malaria drugs include:

Nausea• Blurred vision• Headache•

Mouth sores• Ringing in your ears• Sensitivity to sunlight (4)• In the United States, guidelines for treating both uncomplicated and severe malaria include the following drugs:

Artemisinin Combination Therapies (ACTs) This group of combination drugs, which includes artemether and lumefantrine (Coartem), is key to the current treatment of malaria caused by P. falciparum, the deadliest form.

Artemisinin is derived from the "sweet wormwood" plant Artemisia annua, but synthetic variants of this chemical are often used instead.

Chloroquine and Hydroxychloroquine (Plaquenil)

Chloroquine and hydroxychloroquine are the first-line treatment for uncomplicated malaria without known drug resistance from Central America west of the Panama Canal, Haiti, the Dominican Republic, and most of the Middle East.

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Quinine (Qualaquin) This drug is used to treat chloroquine-resistant malaria. Quinine is derived from the cinchona tree of South America.

Primaquine This drug is given to people with malaria caused by P. vivax or P. ovale to kill immature parasites in their liver. Primaquine is not an option for people with G6PD deficiency.

Mefloquine This drug has been shown to cause potentially severe psychiatric symptoms in rare cases, and is contraindicated in those with a previous history of seizures or a recent history of psychiatric disorders.

Atovarone and Proguanil This drug combination can cause stomach upset and should be taken with food or milk.

Doxycycline, Tetracyline, and Clindamycin Doxycycline, tretracycline, and clindamycin are all antibiotics that are usually given for bacterial infections, but they also help disrupt the reproduction of malaria parasites. (1,3)

Additional drugs approved to treat severe malaria in the United States include:

Artesunate This is a first-line medication given by IV to people with severe malaria. In absence of malaria how one can prescribed drugs for malaria for such a long period with combination of another medicine. Injection Facigo has been prescribed on 01.05.2010 also. It means that this injection has been given from the date of admission till 1 May 2010. We should not find any report regarding positive malaria. On 03/04-05.2010 Falcigo injection has been stopped. We have seen the side effects of these two drugs. If there is no malaria why these drugs have been given for such a long period in combination? As far as malaria test is concerned, it takes less than one day. Why did the opposite party not advice for malaria test on the very first day? Without confirmation of malaria ,drugs have been given to the patient knowing that the patient has so many ailments so the course of medication applied by the opposite party no 1 are nonetheless a glaring example of negligence and deficiency of service. So we see the first negligence and on the part of the opposite parties by prescribing the drug for malaria in the absence of malaria.

There are many medicines which can be helpful in reducing the high fever. No need to give any special drug which is meant for any specific diseases like malaria or typhoid unless it is so detected in the pathology report.

When you or your child has a fever, you want something that works quickly and works well. But with so many over-the-counter (OTC) medications available, it can be tough to know which one is best for you.

You can choose between two main types of OTC fever reducers: Acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include ibuprofen, aspirin, and naproxen. In general, no particular one of these fever-reducing drugs is better than the others. Instead, you should compare the drug forms, side effects, and other factors to choose a fever reducer that will work well for you or your child. Here's what you need to know to make an informed decision.

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Acetaminophen (Tylenol) is a fever reducer and a pain reliever. It's not fully understood how this drug works. Acetaminophen doesn't decrease swelling or inflammation. Instead, it likely changes the way your body senses pain. It also helps cool your body to bring your fever down. Now we come to the other aspect of the patient which has been mentioned on the date of admission in opposite parties hospital that is Parkinsonism with LRTI with UTI with septicaemia with MODS with multiple fistula in ano.

First we see the Parkinson's disease, its causes, symptoms and treatment. The opposite parties diagnosed in the final diagnosis on 27 April 2010, Parkinson with LRTI (Lower Respiratory Tract Infections).

We have seen the first history sheet of the patient in which it has been written "Parkinsonism with LRTI" first we should know about the Parkinson's disease.

Parkinson's Disease: Causes, Symptoms, and Treatments

Parkinson's disease is a brain disorder that causes unintended or uncontrollable movements, such as shaking, stiffness, and difficulty with balance and coordination. Symptoms usually begin gradually and worsen over time. As the disease progresses, people may have difficulty walking and talking. They may also have mental and behavioral changes, sleep problems, depression, memory difficulties, and fatigue.

While virtually anyone could be at risk for developing Parkinson's, some research studies suggest this disease affects more men than women. It's unclear why, but studies are underway to understand factors that may increase a person's risk. One clear risk is age: Although most people with Parkinson's first develop the disease after age 60, about 5% to 10% experience onset before the age of 50. Early-onset forms of Parkinson's are often, but not always, inherited, and some forms have been linked to specific alterations in genes.

What causes Parkinson's disease?

The most prominent signs and symptoms of Parkinson's disease occur when nerve cells in the basal ganglia, an area of the brain that controls movement, become impaired and/or die. Normally, these nerve cells, or neurons, produce an important brain chemical known as dopamine. When the neurons die or become impaired, they produce less dopamine, which causes the movement problems associated with the disease. Scientists still do not know what causes the neurons to die.

People with Parkinson's disease also lose the nerve endings that produce norepinephrine, the main chemical messenger of the sympathetic nervous system, which controls many functions of the body, such as heart rate and blood pressure. The loss of norepinephrine might help explain some of the non-movement features of Parkinson's, such as fatigue, irregular blood pressure, decreased movement of food through the digestive tract, and sudden drop in blood pressure when a person stands up from a sitting or lying position.

Many brain cells of people with Parkinson's disease contain Lewy bodies, unusual clumps of the protein alpha-synuclein. Scientists are trying to better understand the normal and abnormal

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functions of alpha-synuclein and its relationship to genetic variants that impact Parkinson's and Lewy body dementia.

Some cases of Parkinson's disease appear to be hereditary, and a few cases can be traced to specific genetic variants. While genetics is thought to play a role in Parkinson's, in most cases the disease does not seem to run in families. Many researchers now believe that Parkinson's results from a combination of genetic and environmental factors, such as exposure to toxins.

Symptoms of Parkinson's disease

Parkinson's has four main symptoms:

Tremor in hands, arms, legs, jaw, or head• Muscle stiffness, where muscle remains contracted for a long time• Slowness of movement•

Impaired balance and coordination, sometimes leading to falls• Other symptoms may include:

Depression and other emotional changes•

Difficulty swallowing, chewing, and speaking•

Urinary problems or constipation•

Skin problems•

The symptoms of Parkinson's and the rate of progression differ among individuals. Early symptoms of this disease are subtle and occur gradually. For example, people may feel mild tremors or have difficulty getting out of a chair. They may notice that they speak too softly, or that their handwriting is slow and looks cramped or small. Friends or family members may be the first to notice changes in someone with early Parkinson's. They may see that the person's face lacks expression and animation, or that the person does not move an arm or leg normally. People with Parkinson's disease often develop a parkinsonian gait that includes a tendency to lean forward; take small, quick steps; and reduce swinging their arms. They also may have trouble initiating or continuing movement.

Symptoms often begin on one side of the body or even in one limb on one side of the body. As the disease progresses, it eventually affects both sides. However, the symptoms may still be more severe on one side than on the other.

Many people with Parkinson's disease note that prior to experiencing stiffness and tremor, they had sleep problems, constipation, loss of smell, and restless legs. While some of these symptoms may also occur with normal aging, talk with your doctor if these symptoms worsen or begin to interfere with daily living.

Changes in cognition and Parkinson's disease

Some people with Parkinson's may experience changes in their cognitive function, including problems with memory, attention, and the ability to plan and accomplish tasks. Stress,

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depression, and some medications may also contribute to these changes in cognition. Over time, as the disease progresses, some people may develop dementia and be diagnosed with Parkinson's dementia, a type of Lewy body dementia. People with Parkinson's dementia may have severe memory and thinking problems that affect daily living. Talk with your doctor if you or a loved one is diagnosed with Parkinson's disease and is experiencing problems with thinking or memory.

Diagnosis of Parkinson's disease There are currently no blood or laboratory tests to diagnose non-genetic cases of Parkinson's. Doctors usually diagnose the disease by taking a person's medical history and performing a neurological examination. If symptoms improve after starting to take medication, it's another indicator that the person has Parkinson's.

A number of disorders can cause symptoms similar to those of Parkinson's disease. People with Parkinson's-like symptoms that result from other causes, such as multiple system atrophy and dementia with Lewy bodies, are sometimes said to have parkinsonism. While these disorders initially may be misdiagnosed as Parkinson's, certain medical tests, as well as response to drug treatment, may help to better evaluate the cause. Many other diseases have similar features but require different treatments, so it is important to get an accurate diagnosis as soon as possible.

Treatments for Parkinson's disease

Although there is no cure for Parkinson's disease, medicines, surgical treatment, and other therapies can often relieve some symptoms.

Medicines for Parkinson's disease Medicines can help treat the symptoms of Parkinson's by:

Increasing the level of dopamine in the brain•

Having an effect on other brain chemicals, such as neurotransmitters, which transfer information between brain cells

•

Helping control non-movement symptoms•

The main therapy for Parkinson's is levodopa. Nerve cells use levodopa to make dopamine to replenish the brain's dwindling supply. Usually, people take levodopa along with another medication called carbidopa. Carbidopa prevents or reduces some of the side effects of levodopa therapy — such as nausea, vomiting, low blood pressure, and restlessness — and reduces the amount of levodopa needed to improve symptoms.

People living with Parkinson's disease should never stop taking levodopa without telling their doctor. Suddenly stopping the drug may have serious side effects, like being unable to move or having difficulty breathing.

The doctor may prescribe other medicines to treat Parkinson's symptoms, including:

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Dopamine agonists to stimulate the production of dopamine in the brain• Enzyme inhibitors (e.g., MAO-B inhibitors, COMT inhibitors) to increase the amount of dopamine by slowing down the enzymes that break down dopamine in the brain

• Amantadine to help reduce involuntary movements• Anticholinergic drugs to reduce tremors and muscle rigidity•

Deep brain stimulation

For people with Parkinson's disease who do not respond well to medications, the doctor may recommend deep brain stimulation. During a surgical procedure, a doctor implants electrodes into part of the brain and connects them to a small electrical device implanted in the chest. The device and electrodes painlessly stimulate specific areas in the brain that control movement in a way that may help stop many of the movement-related symptoms of Parkinson's, such as tremor, slowness of movement, and rigidity.

Other therapies

Other therapies that may help manage Parkinson's symptoms include:

Physical, occupational, and speech therapies, which may help with gait and voice disorders, tremors and rigidity, and decline in mental functions

• A healthy diet to support overall wellness• Exercises to strengthen muscles and improve balance, flexibility, and coordination• Massage therapy to reduce tension•

Yoga and tai chi to increase stretching and flexibility•

Support for people living with Parkinson's disease

While the progression of Parkinson's is usually slow, eventually a person's daily routines may be affected. Activities such as working, taking care of a home, and participating in social activities with friends may become challenging. Experiencing these changes can be difficult, but support groups can help people cope. These groups can provide information, advice, and connections to resources for those living with Parkinson's disease, their families, and caregivers. The organizations listed below can help people find local support groups and other resources in their communities.

The main drug for the treatment of Parkinson's disease is Levodopa. Levodopa works by being converted to dopamine, a chemical messenger that is needed to control the movement through transmission of signals in the brain.

Common side effects of Levodopa Nausea, Vomiting, Dizziness, Loss of appetite, Orthostatic hypotension (sudden lowering of blood pressure on standing), Akathisia (inability to stay still) When we perused the treatment sheet of the patient, we could not find any medical like

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dopamine or Levodopa . It should be there.levodopa, orL-dopa, Organic compound (L-3,4- dihydroxyphenylalanine) from which the body makes dopamine, a neurotransmitter deficient in persons with parkinsonism. When given orally in large daily doses, levodopa can lessen the effects of the disease. However, it becomes less effective over time and causes abnormal involuntary movements (dyskinesia). During argument the case, the parties did not mention any mixing for the treatment of Parkinson's disease. We have seen the difference between Parkinson's disease and parkinsonism. The opposite parties have written in the history sheet of the patient on 27 April 2010 that the patient is not taking the treatment of parkinsonism regularly. This medicine was prescribed by the opposite party has not been mentioned in the history sheet. How did they come to know that the patient is not taking the medicines regularly. During argument the consul of the opposite parties stated that the patient Mr. AJ Siddiqui was a judicial officer and he worked as chairman, District Consumer Forum. So being a judge it cannot be presumed that he did not take medicines regularly.

In the case history, parkinsonism is written. During argument when we quaried regarding difference in Parkinson's disease and parkinsonism, the counsel for the opposite parties stated that there is no difference between Parkinson's disease and parkinsonism. But when we searched on the net, we find the following article.

What is Parkinsonism?

Symptoms• Causes• Diagnosis• Treatment• Outlook• Parkinsonism is a disease that occurs when a person has symptoms and brain dysfunction commonly associated with Parkinson's disease but also has other symptoms related to an additional condition or cause.

A person who has Parkinsonism will also have another disorder that causes additional neurological symptoms, ranging from dementia to the inability to look up and down. Parkinson's disease itself refers to dysfunction and cell death of the portion of the brain that produces dopamine. Dopamine is a neurotransmitter — a chemical that transmits signals between brain and nerve cells. It is partially responsible for making controlled movements in the body.

In this article, we take a look at the symptoms of Parkinsonism, how the disease is diagnosed, and what can be done to treat it.

Fast facts on Parkinsonism:

Doctors call this disease Parkinsonism plus or atypical Parkinsonism.• When a person has Parkinson's disease, their movements are significantly affected.•

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In the disease's later stages, a person will have difficulty walking and have very stiff, spastic muscles.

• Treatment will aim to reduce Parkinson's symptoms while also treating the accompanying disorder.

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Symptoms

A person with Parkinsonism usually starts developing symptoms at anywhere from age 50 to 80, according to the University of Texas Southwestern Medical Center. Parkinson's disease can cause varying and progressive symptoms throughout its course. Some of the most common symptoms associated with the disease include:

difficulty showing facial expressions•

muscle stiffness•

slowed, affected movements•

speech changes•

tremor, especially of one hand•

A person with Parkinsonism may have some, but not all, of the symptoms listed above. This is because they also have an additional disorder that affects the brain's functioning.

For example, people with Parkinsonism often do not have the hand tremor that affects many people with Parkinson's disease.

Other symptoms associated with Parkinsonism include:

dementia•

issues with the autonomic nervous system, such as problems with controlled movements or spasms

• early problems with balance• rapid onset and progression of symptoms• Each underlying cause of Parkinsonism, such as dementia with Lewy bodies, also has its own unique set of symptoms.

Causes

Parkinsonism can be caused by Parkinson's disease itself as well as another underlying condition.

Other causes associated with Parkinsonism include:

Corticobasal degeneration: This condition causes dementia as well as affected movements, usually on one side. A person may also be unable to make controlled muscle movements.

•

Dementia with Lewy bodies: This condition causes changes in overall alertness as well •

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as visual hallucinations. This condition is the second most common cause of dementia after Alzheimer's disease, according to Johns Hopkins Medicine.

Multiple system atrophy: This condition affects coordination and autonomic dysfunction, including bowel and bladder incontinence.

•

Progressive supranuclear palsy: This condition causes dementia, frequent backward falls, and problems moving the eyes up and down in addition to Parkinson's disease symptoms.

• The conditions above are the four most common causes of Parkinsonism, according to University of Texas Southwestern Medical Center. The number of people with these conditions is about one-fourth of the amount of people who have Parkinson's disease itself. Another, less common condition called vascular Parkinsonism also exists. This condition causes multiple, small strokes that can affect a person's balance, walking, and memory. Parkinsonism is also sometimes the result of taking certain medications. Doctors call this condition drug-induced Parkinsonism. Examples of drugs that could cause it include aripiprazole (Abilify), haloperidol (Haldol), and metoclopramide (Reglan). Ideally, if a person has drug-induced Parkinsonism, they can slowly reduce the dosages of these medicines. However, that may not always be possible, and a person should not stop taking a medication without their doctor's approval.

How do doctors diagnose Parkinsonism?

No single test exists for doctors to diagnose Parkinsonism. A doctor will start by taking a person's health history and review their current symptoms. They will ask for a medication list to determine if any medicines could be causing the symptoms. A doctor will likely also order blood testing to check for underlying potential causes, such as thyroid or liver problems. A doctor will also order imaging scans to examine the brain and body for other causes, such as a brain tumor.

Doctors can perform a test that tracks the movement of dopamine in the brain. This is known as the DaT-SPECT test.

The test uses radioactive markers designed to track dopamine in the brain. This allows a doctor to watch the release of dopamine in a person's brain and identify the areas of the brain that do or do not receive it.

Because Parkinsonism does not respond to typical treatments and can have a variety of symptoms, doctors can have difficulty coming to a quick diagnosis. It may take time for doctors to rule out other conditions and begin to make treatment recommendations.

Treatments

One of the most commonly prescribed medications to treat Parkinson's disease is levodopa. This medication is related to dopamine and can increase the amount of dopamine available in

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the brain. However, people with Parkinsonism not only have problems producing dopamine, but they also have damaged or destroyed cells that cannot respond to dopamine. As a result, levodopa may not work as well to reduce their symptoms.

Doctors can find Parkinsonism challenging to treat because the symptoms of the condition do not always respond as well or at all to medications that boost dopamine. As a result, treatments for Parkinsonism depend upon the "plus" disease that a person has. For example, if a person has corticobasal degeneration and related muscle spasms, a doctor may prescribe antidepressants and botulinum toxin A (BOTOX) injections. Treatments for Parkinsonism usually aim to help reduce a person's symptoms whenever possible to help them maintain independence. Doctors often recommend physical and occupational therapy because they can help a person keep their muscles strong and improve balance.

To discover more evidence-based information and resources for Parkinson's disease, visit our dedicated hub.

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Outlook

The outlook for Parkinsonism depends upon the type of Parkinsonism a person has and how quickly it affects them.

According to the Parkinson's Disease Clinic and Research Center at the University of California, San Francisco, the survival rate for a person who has multiple system atrophy is about 6 years from clinical diagnosis. People with other types of Parkinsonism may have longer or shorter life expectancies.

The onset and symptom progression of Parkinsonism tend to be much faster than that of Parkinson's disease alone. However, researchers are working every day to find treatments for Parkinson's disease and Parkinsonism in hopes of improving quality of life and symptoms reduction.

What are the main types of parkinsonism?

There are 3 main forms of parkinsonism, as well as other related conditions.

Idiopathic Parkinson's

Most people with parkinsonism have idiopathic Parkinson's, also known as Parkinson's. Idiopathic means the cause is unknown.

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The most common symptoms of idiopathic Parkinson's are tremor, rigidity and slowness of movement.

Vascular parkinsonism

Vascular parkinsonism (also known as arteriosclerotic parkinsonism) affects people with restricted blood supply to the brain. Sometimes people who have had a mild stroke may develop this form of parkinsonism.

Common symptoms include problems with memory, sleep, mood and movement.

Drug-induced parkinsonism

Some drugs can cause parkinsonism. Neuroleptic drugs (used to treat schizophrenia and other psychotic disorders), which block the action of the chemical dopamine in the brain, are thought to be the biggest cause of drug- induced parkinsonism.

The symptoms of drug-induced parkinsonism tend to stay the same - only in rare cases do they progress in the way that Parkinson's symptoms do.

Drug-induced parkinsonism only affects a small number of people, and most will recover within months - and often within days or weeks - of stopping the drug that's causing it.

How is parkinsonism diagnosed?

You should be referred to a Parkinson's specialist for the diagnosis of any parkinsonism. They may wish to explore different things before giving you a diagnosis. Your specialist will look at your medical history, ask you about your symptoms and do a medical examination.

Telling the difference between types of parkinsonism isn't always easy, for the following reasons:

The first symptoms of the different forms of parkinsonism are so similar.• In many cases, parkinsonism develops gradually. Symptoms that allow your doctor to make a specific diagnosis may only appear as your condition progresses.

• Everyone with parkinsonism is different and has different symptoms.•

Understanding the differences between Parkinsonism and Parkinson Plus syndromes

"Parkinsonism" means "looks like Parkinson's disease." To neurologists this means that the

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person has a somewhat flexed posture, moves slowly, is stiff and usually walks slowly, with small steps and reduced or no arm swing. We call the syndromes "atypical" because they usually differ from Parkinson's Disease in a few ways:

there is usually no tremor1.

the two sides are usually affected about equally2.

the response to L-Dopa and the other medications used in Parkinson's Disease is not very good

3.

deep brain stimulation surgery is of no value4. Very often when the condition is mild, at the earliest stages, we can't tell whether it is Parkinson's Disease or atypical Parkinson's Disease (APD) and we treat it as if it is Parkinson's Disease because we don't have treatments for the atypical Parkinson disorders. Sometimes they respond to the usual Parkinson's Disease medications, but usually they don't. And when they do, the response is not as good as it is with PD.

"Parkinson plus" syndromes refer to syndromes which look like atypical PD, but also include additional abnormalities that are not seen in PD. These include: abnormalities of eye movements, gait "ataxia" (wide based walking that looks like the walk of someone who is drunk or walking on a boat), dystonia (abnormal postures), severe problems with low blood pressure on standing, or changes on the neurological exam that are only detected by the neurologist in the form of abnormal reflexes.

The problems caused by APD are the same as those caused by PD: slowness, difficulty with movements, balance problems, speech problems and falls. There are many of these disorders and it is often difficult, or even impossible to be sure of the correct name to attach to the condition until autopsy. The reasons for this are that the disorders often share many of the same features, and that they occasionally lack certain symptoms that we count on for the clinical diagnosis.

Is Parkinsonism the Same as Parkinson's Disease?

Parkinsonism is a group of neurological conditions that manifest as movement problems such as tremors, slowness of movement and rigidity. It is particularly identified by the presence of bradykinesia, both a slowness of and decrease in movement resulting in fatigue. Parkinsonisms result in part because of a loss of dopamine in the brain.

A complex disease process, it can be difficult to differentiate because of idiopathic, unknown, origins. Often there is not enough information about the hallmark symptoms to accurately diagnose a specific disorder.¹

Parkinsonism vs. Parkinson's disease

Often confused as one and the same, Parkinson's disease (PD) is actually the most common kind of Parkinsonism, accounting for nearly 80% of all cases.²PD is a progressive neurodegenerative disorder characterized by the same motor conditions as Parkinsonisms including tremor, rigidity, bradykinesia, and impaired balance. Other contributing causes of Parkinsonism include multiple system atrophy, progressive supranuclear palsy, and corticobasal

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degeneration. PD has no directly attributable cause or cure.

Types of Parkinsonisms

Parkinsonisms look like Parkinson's disease. Sometimes called atypical Parkinsonism or Parkinson-plus syndromes, it is hard to definitively distinguish between them. A neurologist would need to conduct a thorough medical history and may request several kinds of physical tests to identify and rule out the specific conditions. Definitive diagnoses for both Parkinsonisms and Parkinson's disease can only be done via an autopsy. Drug-induced Parkinsonism is the most common secondary cause, followed by vascular Parkinsonism (arteriosclerotic pseudoparkinsonism) which generally affects the lower body and involves gait disturbance and cognitive impairment.

Atypical Parkinsonisms are generally more difficult to treat than PD. Syndromes include:^4,5

Drug-Induced Parkinsonism (DIP)

Sometimes called secondary Parksinsonism, DIP can be caused by drugs, especially those affecting dopamine levels including antipsychotics or anti-depressive and antiemetic medications. Once the contributory medications have been stopped, Parkinsonism symptoms should gradually disappear over time.

Progressive Supranuclear Palsy (PSP)

PSP generally progresses more rapidly than PD. Falling is a hallmark of PSP and as the condition progresses people may experience limitations in eye movements, swallowing (dysphagia), speech (dysarthria), sleep, memory and other cognitive functions including dementia.

Multiple System Atrophy (MSA)

MSA typically develops in people in their 50s. It is characterized by slowness, stiffness, imbalance and the deterioration of one or more body systems. There is no specific treatment for MSA and people tend to respond poorly to PD medications. Treatment is focused on alleviating symptoms. Sometimes increased doses of medication are prescribed, often however with limited benefits.

Corticobasal Syndrome (CBS)

The least common form of Parkinsonism, it also develops after age 60 and progresses more rapidly than PD. Symptoms generally start in one extremity and can progress to include dystonia, myoclonus and apraxia. Some people have found Botox® to be an effective treatment for dystonia. Others find antidepressants, as well as speech and physical therapy to be useful. Dopamine medications tend not to be effective.

A progressive, neurodegenerative disorder, LBD is close behind Alzheimer's as a cause for

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degenerative dementia. Like Parkinson's, it is associated with clumping deposits of alpha- synuclein proteins in the substantia nigra area of the brain. Along with cognitive change, LBD can cause slowness, stiffness and other symptoms similar to PD. People with LBD often experience memory issues, cognitive problems, and visual hallucinations.

Vascular Parkinsonism (VP)

Small strokes in specific areas of the brain may contribute to the development of Parkinsonisms. There are no distinct clinical features or diagnostic tests which can differentiate PD and vascular Parkinsonism. VP may be more likely if symptoms occur after having had a stroke. The presence of vascular disease in the brain combined with other hallmark Parkinsonisms like early cognitive change, lower body, gait, and balance problems are other indicators. Treatment with medications has shown some improvement.

Parkinson's disease

PD is generally thought of as a condition characterized by a loss of motor control including resting tremors, stiffness, balance issues and slowness of movements. There is also a wide range of non-motor symptoms including mood disorders like depression, a change in basic body functions like digestion and sleep patterns, as well as cognitive change.¹Motor symptoms most frequently appear in people in their 60s, although young onset Parkinson's can develop in people in their 30s or 40s.

Underlying pathological changes in Parkinson's may appear up to 30 years before the appearance or recognition of clinical signs of disease. Factors contributing to Parkinson's include a hereditary predisposition, environmental toxins, and aging.

Treatments

The most effective approach to Parkinson's is to treat the symptoms that most affect a person's quality of life. Levodopa is the most efficacious drug available for treating Parkinson's symptoms. It has resulted in significant improvement since its debut on the market in the

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especially the doctor, no the difference between these two. The opposite parties have also mentioned septicaemia with MODS .Despite major advances in the knowledge of the pathophysiologic mechanisms responsible of the development of sepsis and its related consequences, namely Multiple Organ Dysfunction Syndrome (MODS) and Failure (MOF), the mortality rate of septic patients remains high. Although this can be attributed to a number of factors, including the underlying diseases, a more advanced age of the affected patients, the appearance of antibiotic-resistant bacterial strains, etc., nevertheless it is surprising and somewhat disappointing that the clinical applications of the basic researches carried results far below the expectations . Then, it appears rather logical to wonder

a) if the measures developed to contrast sepsis, MODS and MOF on the basis of these experimental results are effective and

b) if the main indicator used to assess the effectiveness of these approaches (namely the survival at a predetermined interval of time) is fully appropriate.

Multiple organ dysfunction syndrome (MODS), also known as multiorgan failure, is a disorder in which two or more organ systems are not working correctly, usually because of a complex cascade of events initiatedby an illness, injury, or severe infection.¹MODS is a severe illness in which someone can die if the dysfunction is not treated immediately. Due to a high risk of death, people with MODS are typically cared for in an intensive care unit where healthcare providers can potentially reverse the organ damage.

This article discusses multiple organ dysfunction syndrome, including its causes, symptoms, treatment, and prevention.

Causes any significant illness, injury, or infection can result in MODS. While the exact mechanisms that lead to MODS are not well understood, experts think widespread inflammation and decreased blood flow work together to cause organ damage. People suffer multiple "hits" during a severe illness. The first is the inciting event, such as a major motor vehicle accident or massive heart attack. The second is when the immune system overreacts to fix the problem. Finally, a third hit can occur if a person needs major surgery or develops an infection after the initial insult.

Specific disorders are more likely to lead to this dangerous cascade of events and eventual organ dysfunction. Examples of these severe illnesses include:²

Sepsis (a bacterial infection in the blood that leads to widespread inflammation)• Major physical trauma, like a motor vehicle accident•

Severe burns•

Pancreatitis•

A massive heart attack•

Liver failure•

Acute respiratory distress syndrome (ARDS)•

Severe heat illness•

Eclampsia (a severe illness during or shortly after pregnancy)•

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Certain poisonings or toxic ingestions• These conditions lead to significant changes within the immune and hematologic systems that affect other organs.

MODS is not only due to the initial hit itself but also results from a cascade of events involving many or all organ systems. People experience decreased blood flow and oxygen, leading to damage.¹

An overwhelming immune response that leads to free radical generation is also involved.¹Free radicals are reactive molecules generated in the body and can alter fats, proteins, and DNA to trigger disease.³

Other individual factors that affect the development of MODS include:² Genetics•

Other underlying illnesses, like chronic kidney disease• Current medications•

People without other health problems often survive MODS.

Risk of Death From MODS During a severe illness, if a person has two failing organ systems, their likelihood of dying can be 20% to 50%. If a person has dysfunction of four organ systems, their likelihood of death can be 60% to 100%.⁴

Symptoms The severity of MODS is determined by the amount of dysfunction in six main organ systems. These systems include:⁴

Respiratory system•

Cardiovascular system•

Renal system•

Hepatic system•

Hematologic system•

Neurologic system•

There are several different scoring systems used to determine the severity of MODS.¹To create a severity score, each organ system is evaluated and used to predict a person's likelihood of recovery vs. death. Healthcare providers monitor an organ system through a person's symptoms and laboratory testing.

Respiratory (Lungs)

People with MODS can develop difficulty breathing due to lung damage. Often people need to be placed on a ventilator to help them breathe.

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However, although mechanical ventilation helps treat lung problems, it can sometimes cause lung injury, worsening the overall disease process.⁴As lung dysfunction continues, the lungs fill up with fluid and start to develop scar tissue.

The worst type of lung injury found in people with MODS is acute respiratory distress syndrome (ARDS).¹Once ARDS sets in, people have difficulty maintaining oxygen in the blood and have a higher risk of dying.

Cardiovascular (Heart)

The widespread inflammation associated with MODS dilates the blood vessels, slowing blood flow to tissues. This process becomes evident when a person has low blood pressure with a severe illness or injury. The vessels also become leaky, allowing fluid to collect in the tissues and skin, known as edema.⁴

Slowed blood flow leads to clotting in some body areas, worsening the function of already damaged organs. These cumulative effects are particularly concerning when the organ affected by the decreased blood flow is the heart.

In this scenario, the heart will not function appropriately to continue to push blood to the rest of the organ systems and body.¹This can be considered a "silent heart attack," which compounds the overall problem and leads to the failure of other organ systems. Higher Risk of Death With Cardiac Dysfunction

Unfortunately, people with MODS who develop cardiac dysfunction often have a higher likelihood of dying.¹

Renal (Kidneys)

The renal system includes the kidneys, which help excrete toxins and fluids from the body.⁴ Decreased blood flow can lead to kidney dysfunction. In addition, people may need dialysis to get rid of toxins and extra fluid.⁴

The primary sign of renal dysfunction is decreased urine output.

Kidney function can also be made worse by certain medications used during the treatment of

MODS.

Hepatic (Liver) The liver's function is to get rid of toxins. It makes specific proteins necessary for other organ systems to function correctly.

People with MODS and decreased blood flow can develop liver failure. People may look yellow from hepatic dysfunction. Liver failure can lead to further imbalance inside the body.

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Hematologic (Blood) MODS is associated with a complex cascade of events that disrupt the balance of specific proteins and slow blood flow. This imbalance can simultaneously lead to bleeding and clotting.⁴

Parts of the body are affected differently depending on the severity of MODS, the presence of previous illnesses, and the person's genetics. The person can develop bruising and color changes to the skin. They might start bleeding inside the stomach. The most severe problem of hematologic system failure is disseminated intravascular coagulation (DIC).⁵The syndrome becomes evident when people spontaneously bleed around catheter sites (the tubes placed for a person's resuscitation). People with DIC have a poor prognosis. Only about half of people with DIC survive.⁵ Neurologic (Brain)

Widespread inflammation and problems with the hematologic system lead to decreased blood flow to the brain. This, in conjunction with blood clotting, can lead to brain damage, which may cause people with MODS to have a reduced level of consciousness or be confused.⁴ These changes can also cause various other problems, including stroke-like symptoms.

Treatment

MODS treatment is multifactorial and depends on the inciting event and type of organ damage. People with widespread infection and sepsis need antibiotics.¹•

People who develop respiratory failure need to be placed on a ventilator and sedated to rest the lungs.¹

• Medications called vasopressors are often required to maintain a person's blood pressure and tissue perfusion.

• People are typically treated with intravenous fluids, but healthcare providers need to delicately balance a person's acid-base status and electrolytes when using intravenous fluids.¹

• Problems with the hematologic system need to be treated based on whether a person is bleeding too much or clotting too much. Sometimes people require blood or platelet transfusions.

• People with severe injuries may need surgery.• A more complex and high-tech treatment is extracorporeal organ support (ECOS).¹ECOS involves using a machine to extract blood from the body and process it with medications before replacing it.⁶These systems can bypass different organs depending on the needed treatment. The most common of these systems is a hemodialysis machine that bypasses the kidneys.¹ Extracorporeal membrane oxygenation (ECMO) involves a machine that functions as an

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artificial lung.⁶It is increasingly used as a treatment to rest the lungs and heart. A molecular absorbent recirculating system (MARS) can support the liver.⁶ Prevention

There is no particular medication that helps to prevent MODS. Researchers have investigated ways to treat early MODS to prevent worsening illness, but interventions can be controversial. However, there is good evidence that healthcare providers can avoid worsening organ dysfunction by:⁴

Minimizing trauma to the lungs during ventilatory support•

Restricting blood transfusions until absolutely necessary•

Avoiding medications that are toxic to the kidneys•

Giving medications to prevent ulcers and bleeding in the stomach• Giving people good nutrition•

Preventing hematologic complications by thinning the blood•

Summary

Multiple organ system dysfunction (MODS) is a severe illness defined as dysfunction of at least two organ systems. MODS can affect any organ, but the primary players are the lungs, heart, kidneys, liver, brain, and blood.

There are many causes of MODS, but the general categories include major trauma, severe illness, and widespread infection. Treatment is multifaceted but centers around treating the initial insult and working to prevent severe injury to other organ systems. So it is clear that there is difference between Parkinson's disease and parkinsonism as reported in the above-mentioned article. When we have seen the case history sheet of the patient, on 27 April 2010, it has been written that it is a known case of parkinsonism since last five years and he was taking medicine from physician since last three days he was having fever and breathlessness. So here it has been written that the patient is taking the medicines for parkinsonism from his physician. Now the case history sheet dated 27 April 2010 and by doctor Sandeep Agarwal that the patient is not taking treatment regularly for parkinsonism. It means different doctors are writing different things about the medication of parkinsonism. Who told them that the patient was not taking the medicines of parkinsonism regularly before coming to the opposite parties. On 28 April 2010 it has built and that parkinsonism symptom reduced but no details have been given. So here we can see the negligent in letting the history sheet of the patient.

Now we have seen the history sheet dated 29 April 2010 in which it has made in that patient is suffering from infection of E.Coli . What is this disease? This unique culture was done from outside as written in the case history of the patient. First we should know what these bacteria is and how its treatment is done.

E. coli (Escherichia coli), is a type of bacteria that normally lives in your intestines. It's also found in the gut of some animals.

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Most types of E. coli are harmless and even help keep your digestive tract healthy. But some strains can cause diarrhea if you eat contaminated food or drink fouled water. While many of us associate E. coli with food poisoning, you can also get pneumonia and urinary tract infections from different types of the bacteria. In fact, 75% to 95% of urinary tract infections are caused by E. coli. E.coli is a normal resident of the bowel, which is how it makes it way to the urinary tract.

Some versions of E. coli make you sick by making a toxin called Shiga. This toxin damages the lining of your intestine. The strains of E. coli that make the toxin are sometimes called STEC, which is short for "Shiga toxin-producing E. coli."

One especially bad strain, O157:H7, can make you very sick. It causes abdominal cramps, vomiting, and bloody diarrhea. It is the leading cause of acute kidney failure in children. It can also cause life-threatening symptoms such as:

Adult kidney failure•

Fever•

Bleeding•

Confusion•

Seizures•

You should get emergency help if you have any of these symptoms.

How Do You Get Infected?

You can become infected when you swallow even a small amount of E. coli bacteria. Among the ways this can happen:

Ground meat: You eat ground meat that carries E. coli, and the meat wasn't cooked enough to kill the bacteria. When meat is processed, sometimes bacteria from the animals' intestines make their way into the meat. This happens more with ground meat because it comes from more than one animal.

•

Untreated milk: You drink unpasteurized milk, which hasn't been heated to kill bacteria. E. coli can get into the milk from the cow's udder or from milking equipment.

•

Vegetables and fruit: You might eat fresh vegetables or fruit that's been tainted by water that has the bacteria. This happens most often when manure from nearby animals mixes with the water supply.

•

Other foods and beverages: You might also get E. coli from unpasteurized fruit juices and yogurt and cheese made from raw milk.

•

Water: You swallow water that contains E. coli, perhaps while swimming in a pool, lake, or pond.

•

Other people: You might get E. coli from another person who has it, such as a child. The bacteria can be passed to you if you clean up after an infected person and then don't wash your hands really well before you touch your mouth.

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Animals: It can be found at petting zoos or animal exhibits at fairs.• You can also contaminate food in your own kitchen if you allow a knife or cutting board that has touched uncooked meat (like chicken) to come into contact with food that will be eaten raw (like a salad).

Symptoms

You'll probably start to feel ill 2 to 5 days after you've taken in the E. coli bacteria. The most common symptoms are:

Abdominal cramps•

Diarrhea, which may be bloody•

Nausea•

Constant fatigue•

You may not have a fever. If you do, it may be slight.

Healthy people infected with E. coli usually feel better within a week. But some people have a serious complication called hemolytic uremic syndrome, which affects the kidneys. This is more likely to happen to older people and children.

Treatments

The only way your doctor can know for sure if you have an E. coli infection is to send a sample of your stool to a lab to be analyzed.

Fortunately, the infection usually goes away on its own.

For some types of E.coli associated with diarrhea, such as the watery travelers' diarrhea, antibiotics can shorten the length of time you have symptoms and might be used in moderately severe cases.

But if you have fever or bloody diarrhea or if your doctor suspects Shiga toxin-producing E. coli, antibiotics should not be taken. They can actually increase the production of Shiga toxin and worsen your symptoms.

It's important to rest and get plenty of fluids to replace what your body is losing through vomiting or diarrhea.

Don't take over-the-counter medications that fight diarrhea. You don't want to slow down your digestive system, because that will delay your body's shedding of the infection. When you start to feel better, stick to low-fiber foods at first such as:

Crackers•

Toast•

Eggs•

Rice•

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Dairy products and foods that are high in fat or fiber can make your symptoms worse.

Prevention

One of the most important things you can do to protect yourself and your family against E. coli is wash your hands, particularly in these situations:

Before you prepare food•

Before preparing bottles or food for infants or toddlers•

Before touching anything, such as a pacifier, that goes into a small child's mouth.• After you've used the bathroom or changed a diaper•

After you've had contact with animals, even your own pets•

After handling raw meat•

You can also prevent E. coli infections by being careful about the foods that carry the greatest chance of contamination:

Cook hamburgers until they're 160 F inside.•

Drink only pasteurized milk, juice, and cider.•

Wash all of your produce before you eat it. Be especially careful to get dirt off leafy greens such as lettuce and spinach.

• In your kitchen, a couple of simple rules will help keep you safe:

Wash: Clean knives, counters, and cutting boards with hot, soapy water after raw meat has touched them.

Keep raw and cooked separate: Use different cutting boards for food that you eat raw, such as vegetables and fruit. Don't put cooked meat back on the same plate you used for raw meat without washing the plate first.

When you're swimming, try not to swallow the water, whether it's a pool, a lake, or the ocean. It may be tainted with E. coli from feces.

Now in this case, no precautions are prescriptions have been written to treat this bacterial infection. Advice has been given for urine and blood culture. This advice has been given on 29 April 2010. We did not find this report of urine and blood culture on the case history sheet of patient till 2 May 2010. On the following dates we do not find any comment regarding this bacterial infection in the case history of the patient on 06.05.2010 and we find the patient on ventilatory support. What about the treatment of the E.coli ?

First of all we have to see the doctor - patient relationship (DPR). This relationship is very important for all types of treatment of a patient by a doctor.

"Medicine is an art whose magic and creative ability have long been recognized as residing in the interpersonal aspects of patient-physician relationship." Hall et al.,1981

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A doctor-patient relationship (DPR) is considered to be the core element in the ethical principles of medicine. DPR is usually developed when a physician tends to a patient's medical needs via check-up, diagnosis, and treatment in an agreeable manner. Due to the relationship, the doctor owes a responsibility to the patient to proceed toward the ailment or conclude the relationship successfully. In particular, it is essential that primary care physicians develop a satisfactory DPR in order to deliver prime health care to patients. The physician-patient relationship is a foundation of clinical care. Physician-patient relationships can have profound positive and negative implications on clinical care. Ultimately, the overarching goal of the physician-patient relationship is to improve patient health outcomes and their medical care. Stronger physician-patient relationships are correlated with improved patient outcomes. As the relationship between physicians and patients becomes more important, it is essential to understand the factors that influence this relationship.

Frameworks for Physician-Patient Relationships

Throughout history there has been much debate regarding the "ideal" physician-patient relationship. In 1992, Ezekiel and Linda Emanuel proposed four models for the physician- patient relationship: the paternalistic model, the interpretive model, the deliberative model, and the informative model. These models differ based on their understanding of four key principles: the goals of physician-patient interactions, the physician's obligations, the role of patient values, and the concept of patient autonomy.

Factors that Influence the Physician-Patient Relationship

Although there are several factors that influence physician-patient relationships, the dynamic shared and sense of trust between physicians and patients are two critical components to their overall relationship.

Dynamic Between Physicians and Patients

The dynamic between physicians and patients refers to the communication patterns and the extent to which decision making is shared between both parties. Effective physician-patient communication is an integral part of clinical practice and serves as the keystone of physician- patient relationships. Studies have shown the approach taken by physicians to communicate information is equally important as the actual information that is being communicated. This type of communication incorporates both verbal and nonverbal interactions between physicians and patients. Effective communication has been shown to influence a wide array of outcomes including: emotional health, symptoms resolution, function, pain control, and physiologic measures such as blood pressure levels. When miscommunication occurs, it can have severe negative implications in clinical caresuch as impeding patient understanding, expectations of treatment, treatment planning, decreasing patient satisfaction of medical care, and reducing levels of patient hopefulness.

In addition to having effective communication, it is important that medical decisions stem from a collaborative process between physicians and patients. Decision making is a process in which patients should be involved from the very beginning, and the result is a decision which reflects the physician's medical knowledge as well as the patient's values and beliefs. Collaborative

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communication and decision making have been correlated with greater patient satisfaction and loyalty. Working from a collaborative framework along with effective physician-patient communication can also strengthen a physician's ability to utilize a personalized health care model through patient empowerment.^v

Trust Between Physician and Patients

"….'patients must be able to trust doctors with their lives and health,' and that maintaining trust is one core guidance for physicians…"

Birkhäuer et al, 2017

Trust is a fundamental characteristic of the physician-patient relationship. Patients must trust that their physicians will work in their best interests to achieve optimal health outcomes. Patients' trust in their physicians has been demonstrated to be more important than treatment satisfaction in predictions of patient adherence to recommendations and their overall satisfaction with care. Studies have also shown that trust is additionally a strong predictor of a patient continuing with their provider. Trust extends to many different aspects of the physician- relationships including, but not limited to: physicians' willingness to listen to patients, patients' believing that physicians value patient autonomy and ability to make informed decisions, and patients feeling comfortable enough to express and engage in dialogue related to their health concerns.

Physician-Patient Relationships Influence on the Future of Healthcare

The idea of viewing physician-patient relationships as a core element of quality health care is not something new, however understanding and assessing the factors that influence this relationship is just beginning. Effective physician-patient communication has been shown to positively influence health outcomes by increasing patient satisfaction, leading to greater patient understanding of health problems and treatments available, contributing to better adherence to treatment plans, and providing support and reassurance to patients. Collaborative decision making enables physicians and patients to work as partners in order to achieve a mutual health goal. Trust within all areas of the physician-patient relationship is a critical factor that influences communication between both parties. As health care transforms into a more personalized and patient-centered model, the physician-patient relationship will significantly shape health outcomes. The personalized health care model encourages collaboration among physicians and patients in order to create shared health goals and the cultivation of a health plan to address identified problems. By understanding the factors that influence patient-physician relationships, in the future, health care providers will be able to address some of the barriers that prevent the adoption of more personalized approaches to health care. The primary responsibility of a doctor is to ensure they can provide their patients with the best level of care. A talented doctor can perform these tasks efficiently while practising a range of soft skills, such as effective communication. When considering a career in medicine, it may be helpful to know the basic duties a doctor performs daily.

What are a doctor's responsibilities?

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There are seven key tasks that make up a doctor's responsibilities that most perform as part of their daily working routine. The duties of a doctor may vary depending on where they work, the type of doctor they are and the conditions of the patients they treat that day. While there may be some differences in a doctor's primary tasks, outlined below are seven common duties that doctors within any speciality can typically perform. These include the following:

Diagnosing any illness and other conditions

A Dr is qualified to diagnose a range of illness, injuries, diseases or pains that a patient may be experiencing. The made in several tests on a patient before they reach their final diagnosis to ensure their decision is accurate. They also want to ensure that they can rule other illnesses out the time it takes for a Dr to make a diagnosis depends on what the ailment is and the severity of symptoms that the patient showing. For injuries, doctors can usually make an accurate diagnosis straightaway, whereas diseases or chronic illness may take a few weeks to doctor to detect.

Planning and conducting a patient's course of treatment

following a diagnosis, a doctor may then plan and prepare a course of treatment for the patient. Individuals in this profession use their technical knowledge and medical research skills to find the quickest and most effective form of treatment. This process may include finding suitable medication, providing care for any external wounds or referring the patient to be more specialised doctor.

A doctor typically discusses their recommended treatment course with the patient to ensure that the individual is happy to proceed. If the doctor is treating a child, they may require the parents permission to conduct the treatment plan.

Any stream follow-up care for patients if necessary

if a doctor feels they cannot treat a patient effectively, they may refer the patient to a specialist organisation or healthcare provider. This may occur if a patient is experiencing problems with their teeth, eyes or mental health because a dentist, optometrist or psychiatrist is more likely to find the root of the issue.

The doctor may also ask the patient to make a follow-up appointment with them for a variety of reasons. The reasons may be to check the progress of symptoms, run further tests and administer higher or lower doses of medication. They may also ask patients to arrange a further appointment to discuss any blood test or laboratory results. For the Bulls, the doctor may want to redress bandages and thoroughly cleanse the cut to prevent infection.

Consulting with other healthcare professionals

during their working day, a doctor may consult with other healthcare professionals that work at their organisation or a specialist unit. A doctor may ask a nurse practitioner to assist them with running tests or consult with a fellow doctor to gain a second expert opinion on the patient's case. If they wish to have a patient admitted to hospital they may communicate with hospital staff via telephone to arrange an appointment on behalf of the patient.

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If a patient is experiencing symptoms that are associated with a specific area in medicine, a doctor may contact a specialist unit to consult with a specialist Dr. For example if a patient is complaining of frequent chest pains, a doctor may consult with cardiologist to discuss a suitable treatment plan.

Prescribing medication

a doctor is also responsible for prescribing the most effective medicine for a patient's symptoms. They may write a prescription for the patient to take with them to a pharmacy or contact the pharmacy directly. Doctors can prescribe medication to either cure illness or offer relief from symptoms. This medication can take various forms, including tablets, gels, creams and liquids.

To ensure the prescribed medication is effective, the doctor may ask the patient to schedule a follow-up appointment. If the medicine has made no improvements to the patient's illness, the doctor can then consider other medications or alternative forms of treatment. It is crucial that a doctor is aware of the patient's allergies or intolerances before prescribing medication.

Staying updated with medical research

a skilled doctor requires a wealth of technical knowledge to identify and treat ailments. As technological and medicinal research progresses, it is responsible to offer doctor to show that they are up to date on the latest advancements in the healthcare industry. This includes researching new diseases, understanding the risks and benefits of new medications and learning how to conduct new procedures.

The primary responsibility of a doctor is to ensure they can provide their patients with the best level of care. A talented doctor can perform these tasks efficiently while practising a range of soft skills, such as effective communication. When considering a career in medicine, it may be helpful to know the basic duties a doctor performs daily.

What are a doctor's responsibilities?

There are seven key tasks that make up a doctor's responsibilities that most perform as part of their daily working routine. The duties of a doctor may vary depending on where they work, the type of doctor they are and the conditions of the patients they treat that day. While there may be some differences in a doctor's primary tasks, outlined below are seven common duties that doctors within any speciality can typically perform. These include the following:

Diagnosing any illness and other conditions

A Dr is qualified to diagnose a range of illness, injuries, diseases or pains that a patient may be experiencing. The made in several tests on a patient before they reach their final diagnosis to ensure their decision is accurate. They also want to ensure that they can rule other illnesses outthe time it takes for a Dr to make a diagnosis depends on what the ailment is and the severity of symptoms that the patient showing. For injuries, doctors can usually make an accurate diagnosis straightaway, whereas diseases or chronic illness may take a few weeks to dpctor to detect.

40

Planning and conducting a patient's course of treatment

following a diagnosis, a doctor may then plan and prepare a course of treatment for the patient. Individuals in this profession use their technical knowledge and medical research skills to find the quickest and most effective form of treatment. This process may include finding suitable medication, providing care for any external wounds or referring the patient to be more specialised doctor.

A doctor typically discusses their recommended treatment course with the patient to ensure that the individual is happy to proceed. If the doctor is treating a child, they may require the parents permission to conduct the treatment plan.

Any stream follow-up care for patients if necessary

if a doctor feels they cannot treat a patient effectively, they may refer the patient to a specialist organization or healthcare provider. This may occur if a patient is experiencing problems with their teeth, eyes or mental health because a dentist, optometrist or psychiatrist is more likely to find the root of the issue.

The doctor may also ask the patient to make a follow-up appointment with them for a variety of reasons. The reasons may be to check the progress of symptoms, run further tests and administer higher or lower doses of medication. They may also ask patients to arrange a further appointment to discuss any blood test or laboratory results. For the Bulls, the doctor may want to redress bandages and thoroughly cleanse the cut to prevent infection.

Consulting with other healthcare professionals

during their working day, a doctor may consult with other healthcare professionals that work at their organisation or a specialist unit. A doctor may ask a nurse practitioner to assist them with running tests or consult with a fellow doctor to gain a second expert opinion on the patient's case. If they wish to have a patient admitted to hospital they may communicate with hospital staff via telephone to arrange an appointment on behalf of the patient. If a patient is experiencing symptoms that are associated with a specific area in medicine, a doctor may contact a specialist unit to consult with a specialist Dr. For example if a patient is complaining of frequent chest pains, a doctor may consult with cardiologist to discuss a suitable treatment plan.

Prescribing medication A doctor is also responsible for prescribing the most effective medicine for a patient's symptoms. They may write a prescription for the patient to take with them to a pharmacy or contact the pharmacy directly. Doctors can prescribe medication to either cure illness or offer relief from symptoms. This medication can take various forms, including tablets, gels, creams and liquids.

To ensure the prescribed medication is effective, the doctor may ask the patient to schedule a follow-up appointment. If the medicine has made no improvements to the patient's illness, the doctor can then consider other medications or alternative forms of treatment. It is crucial that a

41

doctor is aware of the patient's allergies or intolerances before prescribing medication.

Staying updated with medical research

a skilled doctor requires a wealth of technical knowledge to identify and treat ailments. As technological and medicinal research progresses, it is responsible to offer doctor to show that they are up to date on the latest advancements in the healthcare industry. This includes researching new diseases, understanding the risks and benefits of new medications and learning how to conduct new procedures.

Therefore it is clear that it is the duty of the doctor to update with all the medication regarding the diseases and also to tell his patient or his wards about the diagnosis, treatment and if any complication is there, he should also tell either the patient or is attendant about this. We have seen thatA doctor is also responsible for prescribing the most effective medicine for a patient's symptoms. But in this case the medicines prescribed for malaria without being affected by malaria. Thereafter the report shows that the patient was suffering from bacteria E.Coli and prescription has been written for urine and blood cultures test but on the following days we did not find any report regarding urine / blood culture . The question arises that what are the treatment prescribed for eradication of this bacteria. Any alkaline medium solution or injection or tablets have been given to the patient to counter the infection of E.Coli ? Further it is the duty of Dr to consult other senior and specialised doctors of particular fields either on video conferencing or on any other electronic devices. In this case no such video conferencing took place between the doctors of Sara hospital and some senior and learned doctors of specialised hospitals or SGPGI or IIMS . Why did they hesitate to take opinion to consult the well established doctors of these fields?

Now let us see the oath taken be a doctor before entering the nobel profession of the Medical World. The tradition in medical school includes taking the Hippocratic Oath usually at graduation. The purpose of this review is to examine what that oath has been, what forms it currently has, and the implications for physicians in today's healthcare environment. The changes in health economics affect physicians as they try to follow the oath's allegiance to the individual patient's needs. At times, this goal conflicts with the perspective of the financial world's controls of insurance companies and medical groups and institutions. This difference of the physicians' ethical perspectives from the business leaders regarding the philosophy of the value of the individual's health and life may be related to some aspect of physician burnout. Many populations in the world know of the Hippocratic Oath for physicians as they begin the journey to care for patients. In this current era of medicine the frequency of students' taking the oath has increased to nearly every one compared to the early twentieth century; however, few medical students and physicians actually know that the translations of the ancient words have become less complete, as well as quite varied from the classical translations. With more and more medical students taking an oath, the content actually has been simultaneously thinned. Certainly, the part addressed to faith in the Greek deities, in whom the ancient physicians believed, does not exactly apply for different locations and religions. It does honor the history of medicine and the bond with principles of the selfless tradition of healing. Now the act of saying the oath with peers has been viewed as a process of getting the diploma from medical school rather than a devoted allegiance to the purpose of medical education, namely, the best care of each patient by a competent physician. A true physician focuses his or her care of each

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patient not only on the use of skilful and current techniques but also on the recognition of the unique needs and welfare of the patient. This professional devotion of the compassionate physician to the patient may be eroded as the concept of the oath faces challenges from the increasing demands and restrictions by corporate entities. The years of education and training lead to the agreement with a code of ethics in medicine that emphasizes behavior to earn the trust of patients. Some of the burnout of physicians may indicate the loss of autonomy and the need to free physicians to return to the core content of the oath, i.e., to uphold the highest standards of care for the safety and health of each patient.

As per guidelines of MCI, Every member should get it framed in his or her office it should never be violated in its letter and spirit.

"I solemnly pledge myself to consecrate my life to service of humanity. Even under threat, I will not use my medical knowledge contrary to the laws of Humanity.• I will maintain the utmost respect for human life from the time of conception.• I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient.

• I will practice my profession with conscience and dignity.• The health of my patient will be my first consideration.• I will respect the secrets which are confined in me.• I will give to my teachers the respect and gratitude which is their due.• I will maintain by all means in my power, the honour and noble traditions of medical profession.

• I will treat my colleagues with all respect and dignity.• I shall abide by the code of medical ethics as enunciated in the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002.

• I make these promises solemnly, freely and upon my honour." Whether this oath has been complied with properly by the doctor. We know that the human body is a very complex body. The doctor spent years to study the course of MBBS/MD/MS and any other specialized fields. Despite of all the facts they should be cautious during treatment of a patient because it is the patient who paid them for their livelihood. It is the utmost and noble duty of a doctor to adhere with the oath taken by him.

So it is very important to maintain trust between the patient and the concerned Doctor. The doctors should also adhere to their oath taken by them when entering into this noble profession. If you have taken an oath, you have to stick on your oath but we not find any such adherence in this case from the very beginning.

Now we see the case history sheet of 6 May 2010 when the patient was put on ventilatory support. During argument this fact came to our knowledge and also clear from the case history sheet of the patient that the patient was on ventilator till his sad demise. On 6 May 2010 at 10:45 AM the patient was put on ventilator support but there is no reason for putting the patient on ventilatory support. Nothing has been written about oxygen level or about breathlessness. On 07.05.2010 it has been written in the case history SpO2 100% with 35 % FiO2 . What does it

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mean ? The same issue has been depicted on 09.05.2010 also. The SpO2/FiO2 ratio may be a reliable tool for hypoxemia screening among patients admitted to the ED. But nothing has been said or described by the opposite parties regarding this ratio. It shows that they are playing a game of hide and seek with the patient.

The fraction of inspired oxygen, FiO2, is an estimation of the oxygen content a person inhales and is thus involved in gas exchange at the alveolar level. Understanding oxygen delivery and interpreting FiO2 values are imperative for the proper treatment of patients with hypoxemia. Hypoxemia, especially in the critically ill, has been shown to increase all-cause mortality. When oxygen consumption and supply are mismatched, cell damage and death occur.[5] The key is recognizing the cause and, thus, the appropriate route of treatment. Inhaled atmospheric gas is 21% oxygen. The amount of oxygen inhaled, i.e., FiO2 is not equivalent to the oxygen which participates in gas exchange at the alveolar level. Several factors need merit consideration and are summarized by the alveolar gas equation. The equation takes into account the barometric pressure (P), water vapor pressure (P), and gas exchange ratio (Rq). The partial pressure of alveolar oxygen (PAo2)= [ P(ATM) - P(H2O FiO2] - [PaCO2/Rq]. What can be assumed from this direct relationship is that as FiO2 increases, so should Pao2. An alternative surrogate for alveolar oxygen saturation is SpO2, oxygen saturation obtained with pulse oximetry.

FiO2 can be adjusted based on Spo2; however, when to start supplemental oxygen is widely contested. In patients with COPD, there have been suggestions to begin supplemental oxygen when the SpO2 drops below 88%. In patients without pulmonary disease but with myocardial infarction or stroke, the minimum recommended SpO2 is 93%. Studies show there is increased mortality with high levels of SpO2 above 96%. The severity of hypoxemia will determine the best mode of supplemental oxygen.

Oxygen delivery devices such as a nasal cannula, venturi mask, and high-flow nasal cannula can deliver varying FiO2. A patient breathing ambient air is inhaling a FiO2 of 21%. Oxygen delivery devices determine the flow rate and FiO2 based on predicted equipment algorithms. The conventional prediction model states that for every liter of oxygen supplied, the FiO2 increases by 4%. Therefore, a nasal cannula set at a 1 L/min flow rate can increase FiO2 to 24%, 2 L/min to 28%, 3 L/min to 32%, 4 L/min to 36%, 5 L/min to 40%, and 6 L/min to 44%. Recent studies have shown, however, that at low-flow oxygen (particularly below 5 L/min), this conventional prediction is not accurate. The patient receives a mixture of pure oxygen supplied by a nasal cannula and room air, which at low-flow rates does not equal 4% per liter. In vitro testing with a mechanical test lung demonstrated that inspiratory flow has a major impact on FiO2 delivery at low-flow rates. A new prediction formula was proposed by the authors during this study accounting for the effect of inspiratory flow in patients breathing spontaneously on low-flow supplemental oxygen. The proposed prediction model states that the fraction of oxygen delivered is 0.21 + (1/(4 x minute ventilation)) x L/min of O2.[6] This equation applies when the inspiratory time to total inspiratory-expiratory time ratio was 0.33. The fraction of oxygen delivered formula changes to 0.21 + (1/(2.5 x minute ventilation)) x L/min of O2 when the inspiratory time to total inspiratory expiratory time ratio changes to 0.5. The authors reported that this prediction formula had greater good accuracy for predicting the fraction of oxygen delivered at low flow rates via supplemental oxygenation through a heat-and-moisture

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exchanger in patients who breathe spontaneously. A venturi mask can provide a 1 to 15 L/min flow rate, and FiO2 is titrated based on the valve. The valves are categorized by color, with the blue valve providing the lowest flow rate and FiO2, 2 to 4 L/min, and FiO2 24%, respectively. The green valve allows the maximum 12 to 15 L/min flow rate with 60% FiO2. A nonrebreather can provide a 10 to 15 L/min flow rate; FiO2 varies from 60 to 90%. Lastly, there is a high-flow nasal cannula. This method can provide flow rates up to 60 L/min and FiO2 of 21% to 100%, irrespective of the flow rate. As mentioned above, oxygen devices can provide much higher flow rates than a normal patient's inspiratory flow. However, the reported FiO2 that is delivered is not always accurate. Based on previous studies, the understanding is that the delivered flow rates are lower than the predicted FiO2.[8] Studies have shown FiO2 provided via nasal cannula increased by 2.5% per 1 L/min.[8] HFNC, with a setting of 30 L/min flow rate, delivered the most accurate FiO2. Another factor that can alter FiO2 is humidity. Dry air, aside from being uncomfortable for patients, has the potential to increase airway resistance by inducing acute damage and inflammation. Dry air can also cause increased water loss and decreased mucociliary clearance. Interestingly even having a patient's mouth open can increase the delivered Fio2. In the setting of critically ill patients, FiO2 is routinely used to assess the lungs' capacity for gas exchange., using the PaO2/FiO2 (P/F) ratio, where PaO2 represents the partial pressure of oxygen. The most notable use of this metric is in the Berlin criteria, which categorizes ARDS as mild (201 to 300 mmHg), moderate (101 to 200 mmHg), and severe (less than 100 mmHg). While cardiac output, hemoglobin concentration, and barometric pressure can affect the P/F ratio, it remains a reasonable assessment of pulmonary function.

Lastly, there has been much debate as to the use of high FiO2 during surgery. Previously it was suggested perioperative oxygen would decrease the risk of surgical site infections, rate of atelectasis, myocardial infarction, and ICU admission. The World Health Organization, in addition to several meta-analyses, has shown no benefit in perioperative hyperoxia. But in this case it is not clear that why did this remark has been entered into the case history of the patient. This issue has been mentioned on 07.05.2010 and thereafter again on 09.05.2010 and thereafter on the subsequent dates there is no mention of this ratio in the case history sheet of the patient. It shows again negligence on the part of the appeal parties because they take a thing for one or two days and thereafter forget it. By these history sheets of the patient, it is not clear why the ventilator was given to him ?

A ventilator is a medical device that helps you breathe when you have trouble breathing on your own. A ventilator may be needed when an injury or an illness like COVID-19 impairs your lung function. Ventilators are also used to help you breathe during surgery.

Ventilators work by gently pushing air into the lungs and allowing it to come back out like the lungs would typically do in normal breathing.

This article explains when and why a ventilator is needed and details the process by which a person is connected and removed from mechanical ventilation.

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When Is a Ventilator Needed?

A ventilator helps support a person with impaired lung function during the recovery process. It delivers oxygen through a tube inserted through the mouth and into the windpipe. A ventilator may be needed when certain illnesses like COVID-19 progress to a condition known as acute respiratory distress syndrome (ARDS). In people with ARDS, the air sacs in the lungs fill with fluid, making breathing difficult.

A ventilator may also be required when a COVID-19 patient is breathing too slow, too fast, or stops breathing altogether.

COVID-19 patients may need supplemental oxygen when their oxygen saturation falls below 90%. This does not always mean mechanical ventilation. Often, the supplemental oxygen is delivered non-invasively through small tubes inserted into the nostrils.¹Mechanical ventilation is reserved for patients with severe breathing difficulties.

During Surgery

General anesthesia lowers the level of a patient's consciousness during surgery. A paralytic that paralyzes the muscles of the body temporarily may be necessary depending on the patient's respiratory needs or the needs of the operation. This includes the muscles that allow us to inhale and exhale. Without a ventilator, breathing during general anesthesia would not be possible. Most people are on the ventilator while the surgery is taking place. A drug is given after the operation is complete to stop the effects of the anesthesia. Once the anesthesia stops, the person is able to breathe on their own and is removed from the ventilator.

After Surgery

A ventilator is necessary when a person who has undergone surgery is unable to breathe well enough to provide oxygen to the brain and body.

Some people, due to injury or illness, cannot breathe well enough after surgery to be removed from the ventilator. This may be due to poor lung function prior to surgery, which can happen when patients have damage to their lungs caused by things like chronic obstructive pulmonary disease (COPD).²

This can also happen due to trauma, infection, or another serious medical problem. A person who is on the ventilator prior to surgery will likely remain on the ventilator after surgery until they recover enough to breathe well on their own.

Some surgeries require a person to be on a ventilator for a short time after surgery. For example, people having open heart surgery are typically maintained on a ventilator until they wake up enough to lift their head off their pillow and follow simple commands. They are not given a drug to stop the anesthesia; rather, the anesthesia is allowed to wear off on its own.

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Intubation In order to be placed on a ventilator, the person must be intubated. Intubation means having an endotracheal tube placed in the mouth or nose and threaded down into the airway. This tube has a small inflatable gasket that is inflated to hold the tube in place. The ventilator is attached to the tube and provides "breaths" to the person needing respiratory assistance.³ If a ventilator is needed after surgery, a sedative may be used to relax the person. This is done because it can be upsetting to have an endotracheal tube in place and feel the ventilator pushing air into the lungs.

The goal is to keep the person calm and comfortable without sedating them so much that they cannot breathe on their own or be removed from the ventilator.

Patient Care During Ventilation

Patient care consists of preventing infection and skin irritation while a person is on a ventilator. These individuals are almost always in an intensive care unit (ICU) and require constant monitoring and attention.

Tape or a strap is used to keep the endotracheal tube in place. This is changed when dirty, and the tube is regularly moved from one side of the mouth to the other to prevent sores or ulcers.

Mouth care is also frequently performed. The mouth is often dry, so it needs to be cleaned and moistened to protect the teeth and reduce harmful bacteria that can make their way into the lungs and cause pneumonia. Oral secretions are also suctioned from the mouth to prevent them from draining into the lungs and causing pneumonia.³

People who require a ventilator often find it hard to reposition themselves because they are sedated, so frequent turning is also part of routine care.

Extubation

Extubation is the process of having the endotracheal tube removed. During this process, the nurse removes the air from the inflated gasket on the tube and releases the ties or tape that holds the tube in place. The tube is then gently pulled from the person's mouth or nose. Once the tube is removed, the person is able to breathe on their own. Many, however, are given oxygen through a mask or nasal cannula to help transition to normal breathing. Extubation may cause coughing or sore throat but is not typically painful. Weaning

Weaning is the term used for the process of decreasing ventilatory support. Most surgery patients are removed from the ventilator quickly and easily. Those who cannot be may require weaning.

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During weaning, the ventilator setting levels are gradually reduced to allow the person to attempt to breathe on their own. This may take place over the course of days or even weeks. The continuous positive airway pressure (CPAP) setting is one in which the ventilator adjusts the level of support according to the strength of a person's breath.³ People who have been on a ventilator for a long time may only be on CPAP during the day and on full ventilator support at night. This allows the person to rest comfortably at night without having to work to breathe.

CPAP is also the setting that allows doctors to determine if a person no longer needs mechanical ventilation. This trial period is often referred to as the CPAP trial. Long-Term Care

An endotracheal tube should not be left in place for more than a few weeks as it can eventually cause permanent damage to the vocal cords or windpipe. It can also make ventilator weaning more difficult.

For people who are unable to be weaned from the ventilator or are expected to require long- term mechanical ventilation, a surgical procedure called a tracheostomy may be used to create an opening in the neck to bypass the mouth or nose. One end of the tube is inserted through the opening, while the other is connected to a ventilator.

People who require long-term mechanical ventilation are often transferred to a long-term acute care facility. These facilities specialize in ventilator weaning and can help a person relearn how to breathe effectively once a ventilator is no longer needed.⁴

Summary

A ventilator is used to support breathing during surgeries that require general anesthesia as well as after surgery for those who need longer respiratory support. The process of inserting the breathing tube through the mouth or nose is called intubation, while the removal of the tube is called extubation.

People who require long-term respiratory support may undergo a tracheostomy in which an opening is created in the neck so that the tube can bypass the mouth or nose.

Complications of Ventilator Use

Written by Paul Frysh Medically Reviewed by Dan Brennan, MD on December 26, 2022

IN THIS ARTICLE

Why You Might Need a Ventilator• Ventilator Complications: Infection• Ventilator Complications: Lung Damage• Ventilator Complications: Other Risks•

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A ventilator is a machine that helps you breathe when you're sick, injured, or sedated for an operation. It pumps oxygen-rich air into your lungs. It also helps you breathe out carbon dioxide, a harmful waste gas your body needs to get rid of.

Even while they help you breathe, ventilators sometimes lead to complications. These problems can result from the ventilator itself, or from things that are more likely to happen when you're on a ventilator.

Why You Might Need a Ventilator

You may need to be on a ventilator for days, weeks, or more if you have an injury or illness that makes it hard to breathe.

A ventilator also may help you breathe during surgery where you are asleep (general anesthesia), but this is usually for no more than a few hours. Doctors sometimes use ventilators for operations because anesthesia drugs can interfere with your breathing. To put you on a ventilator, your doctor sedates you. Then, they put a tube down your throat and into your windpipe. This makes it easier to get air into and out of your lungs. The process is called intubation.

Ventilator Complications: Infection

The breathing tube in your airway could let in bacteria that infect the tiny air sacs in the walls of your lungs. Plus, the tube makes it harder to cough away debris that could irritate your lungs and cause an infection.

This type of infection is called ventilator-associated pneumonia, or VAP. It's especially risky because you may already be quite sick when you're put on a ventilator. VAP can make it harder to treat your other illness.

Doctors treat it with antibiotics. In some cases, VAP might require special types that can fight antibiotic-resistant bacteria.

Even if you already have an infection, like a viral infection of your lungs, you can get VAP on top of that. Doctors call this a "superinfection."

Ventilation also increases your risk of infections in other areas, like your sinuses.

Ventilator Complications: Lung Damage

Medical staff members carefully measure the amount, type, speed, and force of the air the ventilator pushes into and pulls out of your lungs. Too much oxygen in the mix for too long can be bad for your lungs. If the force or amount of air is too much, or if your lungs are too weak, it can damage your lung tissue. Your doctor might call this ventilator-associated lung injury (VALI).

Among the conditions VALI can lead to are:

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Pneumothorax: A hole or holes in your lungs that release air into the opening between your lungs and the wall of your chest. This can cause pain and loss of oxygen. It might also cause your lungs to collapse, which is an emergency.

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Pulmonary edema: The buildup of liquid in your lungs. Your lungs may collect more liquid if you already have pneumonia.

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Hypoxemia: Too little oxygen in your blood. Damage to your lungs can cause this. Medical staff will notice it if your blood oxygen levels start to drop and you are short of breath.

•

RELATED

Ventilator Complications: Other Risks Delirium: You're usually unconscious or heavily sedated when you're on a ventilator. Either way, you take strong medications. Sometimes, these drugs may take some time to wear off even after the tube is removed from your airway.

You may have a hard time reading, writing, or thinking clearly. You also might notice a poor memory, have trouble sleeping, feel anxious, or have unusual emotions like paranoia. Talk to your doctor about these effects, which should fade over time.

Immobility: Because you're sedated, you don't move much when you're on a ventilator. That can lead to bedsores, which may turn into skin infections. You're more likely to get blood clots for the same reason. Your muscles, including those that normally help you breathe for yourself, may get weak. You might need rehab with a physical or respiratory therapist.

Vocal cord problems: When your doctor removes the breathing tube to take you off the ventilator, it can damage your vocal cords. Expect some soreness and a raspy voice at first. But let your doctor know if it's hard to breathe or speak after the tube comes out. The family members of the patient were against the ventilator from the very been but they were not told why was it necessary? As we know it is the duty of Dr to inform all the circumstances to the patient or his family members. There were so many doctors visiting the patient but everything was not made clear to the patient or his family members. The opposite party no.1 has stated in his written statement that the patient was already on non- invasive ventilation ( Bi PAP) since 01.05.2010 but when patient is a condition did not improve on non-invasive ventilation, he was put on invasive ventilator support on 05.5.2010 . The complainant has stated that after two days, there was no need of ventilatory support but the opposite party did not remove the ventilator. First we have to see as to what is non-invasive international and what is invasive ventilator support.

Noninvasive Ventilation

Manuel PardoJr. MD, in Critical Care Secrets (Fourth Edition), 2007

1 What is noninvasive ventilation?

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Noninvasive ventilation is mechanical ventilation without the use of an endotracheal tube or tracheotomy.

2 What are the main types of noninvasive ventilation?

The two main types are positive-pressure and negative-pressure noninvasive ventilation. With the former, positive pressure is applied to the airway to inflate the lungs directly. With negative-pressure ventilation, negative pressure is applied to the abdomen and thorax to draw air into the lungs through the upper airway. This chapter deals mainly with positive-pressure ventilation, the most commonly used noninvasive ventilator mode in the intensive care unit

(ICU).

3 When did noninvasive ventilation first become widely used? For what disease?

Noninvasive ventilation became widely used during the poliomyelitis epidemics of the 1920s through the 1950s. The ventilators used included the rocking bed, various types of tank respirators or "iron lungs," and body-wrapping cuirass respirators. Patients with chronic respiratory failure after polio could be supported for years with these forms of negative-pressure noninvasive ventilation.

4 Why did the use of noninvasive ventilation decrease in the 1950s and 1960s?

The success of the polio vaccines led to the control of the epidemic. In addition, the use of positive-pressure ventilation became more widely used. The success of this form of "invasive"

positive-pressure ventilation was described during the Copenhagen polio epidemic of 1952. At the start of the epidemic, the Blegdam Hospital had only seven ventilators, yet up to 70 patients required ventilatory support simultaneously. Lassen and Ibsen developed the technique of tracheotomy and manual intermittent positive-pressure ventilation and described their success in 1953.

Woollam CH: The development of apparatus for intermittent negative pressure respiration. (2) 1919-1976, with special reference to the development and uses of cuirass respirators. Anaesthesia 31:666-685, 1976.

5 Why has the use of noninvasive positive-pressure ventilation (NIPPV) increased in recent years?

Several developments have led to its increased use. The use of continuous positive airway pressure for obstructive sleep apnea was described in the early 1980s. The development of a more comfortable nasal mask was important to the success of this therapy. These masks became widely available in the 1980s and were found to be effective in delivering NIPPV. Inexpensive portable ventilators have been developed specifically for NIPPV (Fig. 8-1). As physicians have gained experience with this mode of ventilation, it has been used in many different forms of acute and chronic respiratory failure. In the past 5-10 years, randomized clinical trials have evaluated NIPPV in a variety of patient populations in the ICU setting.

6 What are the advantages of NIPPV compared with conventional mechanical ventilation with an endotracheal tube?

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In most studies of NIPPV in the ICU setting, the main outcome measure has been the need for tracheal intubation. For those patients who avoid intubation, the main advantage is the avoidance of artificial airway complications. Several studies document a lower infection rate (e.g., nosocomial pneumonia and sinusitis) with NIPPV, which may be related to the maintenance of the protective glottic barrier. Other advantages include reduced need for sedative medications. Some NIPPV trials have demonstrated reductions in ICU length of stay, ICU mortality, or in-hospital mortality.

7 What are the disadvantages and contraindications of NIPPV?

Patient selection is crucial to ensuring success with noninvasive ventilation. Patients who are uncooperative, need immediate intubation, have upper airway pathology, are hemodynamically unstable, or have excessive secretions are not likely to succeed. NIPPV should be contraindicated in these patients. In practical terms, NIPPV can initially require significant attention from a respiratory therapist, ICU nurse, or both. Early generations of noninvasive ventilators had limitations on the amount of oxygen that could be delivered.

8 Has noninvasive ventilation been used for chronic respiratory failure? For what disorders?

As previously described for the polio epidemics, negative-pressure ventilation has a long history of success for chronic respiratory failure. Similar benefits have also been shown in uncontrolled studies for NIPPV. The disorders for which it has been used include thoracic restrictive diseases (e.g., kyphoscoliosis, chest wall deformities), central hypoventilatory disorders, and slowly progressive neuromuscular diseases (e.g., amyotrophic lateral sclerosis, muscular dystrophy). If the patient is able to maintain only brief periods of spontaneous breathing, tracheotomy along with positive-pressure ventilation is usually a better option. Otherwise, intermittent (usually nocturnal) noninvasive ventilation may be successful in controlling hypercarbia and promoting daytime independence.

9 Can noninvasive ventilation be used for patients with acute respiratory failure?

Noninvasive ventilation has been used for acute respiratory failure of diverse causes. Patient selection is important because clinical trials have not demonstrated uniform benefit for all causes of acute respiratory failure. The earliest studies involved patients with acute exacerbations of chronic obstructive pulmonary disease (COPD).

10 Which patients with acute respiratory failure are most likely to benefit from NIPPV?

Patients with acute exacerbations of COPD are most likely to benefit, in terms of reduction in the need for tracheal intubation and decreased mortality. The benefits in this patient population may be limited to those with more severe exacerbations. Other populations likely to have a decreased intubation rate with NIPPV include patients with immune compromise from solid organ transplants or hematologic malignancies, cardiogenic pulmonary edema, respiratory failure after lung resection, and respiratory failure immediately after elective abdominal surgery. If NIPPV is used for patients who do not fit in these categories, consider limiting the time to 2 hours unless clear improvement is evident.

11 Which patients with acute respiratory failure are not likely to benefit from NIPPV?

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Patients with contraindications to NIPPV (see question 7) are inappropriate candidates. Unselected patients with postextubation respiratory failure are not likely to benefit and may even have a higher mortality rate. Patients with hypoxemic respiratory failure of various causes may have a reduced need for intubation with NIPPV, but there may be no survival advantage. The exception may be patients with a high risk of mortality with prolonged mechanical ventilation, such as an immunocompromised patient with multiple organ dysfunction. There are few data on NIPPV in patients with acute lung injury or acute respiratory distress syndrome. Esteban A, Frutos-Vivar F, Ferguson ND, et al: Noninvasive positive-pressure ventilation for respiratory failure after extubation. N Engl J Med 350:2452-2460, 2004.

12 What are the complications of noninvasive ventilation?

The main complication of negative-pressure ventilation is development of upper airway obstruction and hypoxemia during sleep. This complication may be caused by changes in the upper airway muscle activation when exposed to ventilator breaths. Complications of NIPPV include pressure necrosis of the skin, aerophagia, and intolerance of the mask. The incidence of mask intolerance can be as high as 25%.

Key Points: Noninvasive Ventilation

1 For patients with acute exacerbations of COPD, noninvasive ventilation is associated with decreased need for tracheal intubation and improved survival.

2 For patients with hypoxemic acute respiratory failure, noninvasive ventilation may decrease the need for tracheal intubation but may not improve survival.

3 Do not use noninvasive ventilation for patients with an urgent need for tracheal intubation.

4 Noninvasive ventilation can be effective long-term management for some patients with chronic respiratory failure.

13 What ventilator settings can be used for NIPPV?

A range of ventilator settings and modes may be effective for a given patient. The most common setting is inspiratory pressure support ventilation. A typical setting for a patient with acute exacerbation of COPD is inspiratory pressure of 10-20 cm H2O and expiratory pressure of 0-2 cm H2O. Some ventilators incorporate a backup ventilator rate so that patients are given a mandatory breath if their respiratory rate is less than the desired rate. The pressure level is adjusted by subjective comfort or by measurement of the exhaled tidal volume. An exhaled tidal volume of 6-8 mL/kg is appropriate for most patients. The method of oxygen enrichment depends on the specific ventilator.

14 What type of masks can be used for NIPPV?

The most common type is a full face mask or nasal mask. Full face masks provide a better seal but are generally considered less comfortable than nasal masks. Other devices include nasal

"pillows" and "helmet" masks that seal around the neck.

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So it is clear that in, non-invasive ventilation there is no need of anyendotracheal tube or tracheotomy. No such separate marketing have been seen in the history sheet of the patient. The next mechanism is invasive mechanical ventilation as stated by the opposite party no 1 . By the following article we can know more about the invasive Mechanical Ventilation. Invasive Mechanical Ventilation

James M. Walter, MD, Thomas C. Corbridge, MD, and Benjamin D. Singer, MD Author information Copyright and License information Disclaimer

Abstract

Invasive mechanical ventilation is a potentially lifesaving intervention for acutely ill patients. The goal of this review was to provide a concise, clinically focused overview of basic invasive mechanical ventilation for the many clinicians who care for mechanically ventilated patients. Attention is given to how common ventilator modes differ in delivering a mechanical breath, evaluation of respiratory system mechanics, how to approach acute changes in airway pressure, and the diagnosis of auto-positive end-expiratory pressure. Waveform interpretation is emphasized throughout the review.

Invasive mechanical ventilation is a lifesaving tool commonly used in the care of hospitalized patients. Because of a variety of factors, including an aging population, the number of patients who receive mechanical ventilation is increasing.^1,2Despite the increasing prevalence of invasive mechanical ventilation, providers in a variety of care settings report inadequate education on the use of mechanical ventilation.^3,4

Components of Invasive Mechanical Ventilation

Invasive mechanical ventilation includes an endotracheal tube (ETT) and a mechanical ventilator (as opposed to noninvasive ventilation in which the interface is a face mask). In addition to serving as the conduit for delivery of mechanical breaths, the ETT protects the airway, allows for suctioning of secretions, and facilitates select procedures, including bronchoscopy. Invasive mechanical ventilation helps stabilize patients with hypoxemic and hypercapnic respiratory failure, decreases inspiratory work of breathing, redistributes blood flow from exercising respiratory muscles to other tissues in patients with shock, and allows for the implementation of lung-protective (low tidal volume) ventilation in patients with acute respiratory distress syndrome (ARDS).

Ventilators are inspiratory assist devices that integrate volume, pressure, time, and flow (each as dependent or independent variables) to deliver a tidal breath under positive pressure. How the clinician sets these variables determines the mode. If a tidal volume is set and the pressure that results from delivering that volume is not, then the patient is receiving volume-controlled (VC) ventilation. Conversely, if a pressure is set and the tidal volume is not, then the patient is receiving pressure-controlled (PC) ventilation. Within VC there are two common strategies of breath sequencing: assist control (AC) and synchronized intermittent mandatory ventilation (SIMV). In PC, we discuss AC, pressure support (PS), SIMV, and pressure-regulated volume controlled (PRVC). A discussion of advanced modes of ventilation including airway pressure

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release ventilation and BiLevel are beyond the scope of this article, but have been reviewed elsewhere.⁸

To understand differences among available modes, it is important to be familiar with three terms: trigger, target, and cycle. "Trigger" refers to the stimulus that initiates a breath. Breaths initiated by a patient's effort are patient triggered. The ventilator senses effort through changes in airway pressure (pressure triggered) or inspiratory flow (flow triggered). The pressure or flow threshold required to trigger a breath is adjustable and termed the trigger sensitivity. Alternatively, breaths can be time triggered if the patient does not initiate a breath in the time required to achieve a set respiratory rate (RR). For example, if the RR is set at 12 breaths per minute, absent patient efforts, the ventilator delivers a breath every 5 seconds to ensure that the target RR is achieved. "Target" refers to the breath delivery strategy—a parameter that is set, achieved, and maintained throughout inspiration. This can be a set inspiratory flow rate and pattern or pressure, depending on the mode. "Cycle" describes how the breath is terminated. This can be a delivered tidal volume (VT), the end of a set inspiratory time (Ti), or a change in inspiratory flow rate.

AC

The most common mode of mechanical ventilation in intensive care units is the AC mode (also referred to as continuous mandatory/mechanical ventilation on some models).⁹A key feature of AC is that the patient receives a supported breath with both patient-triggered (assisted) and time-triggered (controlled) breaths. Positive end-expiratory pressure (PEEP), RR, and the fraction of inspired oxygen (FiO2) also are set. AC is available in VC and PC. AC-VC

In AC-VC, breaths may be patient triggered or time triggered. The patient triggers the breath by generating a requisite change in airway pressure or inspiratory flow. Patients receive a time- triggered breath if they do not trigger a breath in the time required to meet the set RR. AC-VC is flow targeted, as a set flow rate and pattern drive breath delivery. Both the flow rate in liters per minute (LPM) and the flow pattern (either a square/constant flow or a ramp/decelerating flow) are set. It is important to recognize that in AC-VC, the patient receives the set flow rate and pattern with every breath. Clinicians should choose settings that approximate the patient's needs and optimize patient-ventilator synchrony. In general, decelerating waveforms are better tolerated and are the default choice by many intensivists. A square/constant waveform reduces inspiratory time and thus often is used to help prolong expiratory time in patients at risk for gas trapping and auto-PEEP (eg, patients with severe asthma).¹⁰With a constant flow, the tidal volume is delivered more rapidly than with a decelerating waveform, thus maximizing the time a patient is able to exhale. Recommended average flow rates range between 30 and 60 LPM. With a square flow pattern, flow is constant. With a ramp pattern, the initial flow rate is set and the machine linearly decelerates flow to near zero during breath delivery. As such, the average flow rate in a patient set to receive 80 LPM by a ramp pattern is approximately 40 LPM on most ventilators.

Breaths in AC-VC are volume cycled. Inspiratory flow continues until a set VT is achieved, after which an exhalation valve opens and airway pressure drops to the set PEEP. AC-VC is therefore patient or time triggered, flow targeted, and volume cycled (Fig. 1A).

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Fig. 1.

(A) Pressure, volume, and time waveforms in assist-control volume control (AC-VC) mode using a decelerating flow strategy. Note the second breath is patient triggered as evidenced by a negative deflection of the pressure waveform. The flow rate set on the ventilator represents the peak flow rate (solid black arrow), which linearly decelerates to near zero with each breath. Inspiration ends after a preset tidal volume is achieved. Peak airway pressure is not set by the clinician but rather a consequence of respiratory system mechanics, tidal volume, inspiratory flow rate and pattern, and patient effort. Note that during the second and third breaths, airway pressure decreases while flow rate and tidal volume remain unchanged reflecting a favorable change in respiratory system mechanics. Expiratory flow (arrowhead) is not controlled by the ventilator but is instead dependent on patient effort and respiratory system mechanics. (B) Pressure, volume, and time waveforms in the assist-control pressure control (AC-PC) mode. Note that the second breath is patient triggered as evidenced by a negative deflection of the pressure waveform. With each breath, a preset inspiratory pressure above positive end- expiratory pressure is delivered for a set inspiratory time, after which the breath is cycled off. Tidal volume is determined by the patient's respiratory system mechanics, inspiratory effort, inspiratory pressure, and inspiratory time. Note that during the second and third breaths, tidal volume increases despite an unchanged inspiratory pressure and inspiratory time, reflecting a favorable change in respiratory system mechanics or increased patient effort. (C) Pressure, volume, and time waveforms in pressure-regulated volume control (PRVC) mode. During a test breath (gray box), the ventilator estimates the inspiratory pressure and flow rate needed to achieve a preset goal tidal volume in a preset inspiratory time. Inspiratory pressure is continually adjusted to correct discrepancies between the goal and delivered tidal volume. Note during the fifth breath the delivered tidal volume exceeds the goal tidal volume (solid arrow). Inspiratory pressure is decreased by the machine on subsequent breaths to bring the delivered tidal volume closer to the goal tidal volume.

In AC-VC, airway pressure is not under direct control of the clinician but is rather a function of the compliance and resistance of the respiratory system and patient effort. When changing a patient's VT or flow settings, attention should be paid to how these changes affect airway pressure, in particular the pressure obtained during an inspiratory hold maneuver termed the plateau pressure (Pplt), which measures the distending pressure of the respiratory system (discussed further below). Maintaining a Pplt 30 cm H2O has been associated with improved mortality for patients with ARDS and should be closely monitored for all patients on mechanical ventilation.⁵For patients ventilated in AC-VC, changes in clinical status (eg, worsening ARDS, pneumothorax) will be reflected by changes in airway pressure as VT remains fixed with each breath.

AC-PC

As in AC-VC, breaths in AC-PC may be patient or time triggered. Inspiration in AC-PC is pressure targeted. The clinician chooses an inspiratory pressure (also known as the driving pressure) to be given above PEEP and maintained throughout inspiration. These pressures are additive so that the peak pressure maintained during breath delivery is the sum of the set PEEP and set inspiratory pressure (eg, a PEEP of 5 cm H2O and an inspiratory pressure of 15 cm H2O will result in a constant peak pressure of 20 cm H2O during breath delivery). As in AC-VC, clinicians should aim to achieve a Pplt measured during an end-inspiratory hold of 30 cm H2O

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to reduce the risk of barotrauma. In contrast to AC-VC, in which the clinician chooses the flow rate and pattern, in AC-PC the ventilator delivers flow in a decelerating pattern to achieve the preset constant pressure.

AC-PC is time cycled. The preset inspiratory pressure is provided for a set Ti, after which the exhalation valve opens and airway pressure returns to PEEP. AC-PC is therefore patient or time triggered, pressure targeted, and time cycled (Fig. 1B). Because Ti can be directly adjusted, the clinician can easily increase the time that a patient spends in inspiration. Inverse ratio ventilation refers to a strategy in which the ratio of inspiratory time to expiratory time exceeds

1. Because mean airway pressure is directly proportional to inspiratory time, inverse ratio ventilation has been proposed as a way to improve alveolar recruitment and oxygenation for patients with ARDS. Data supporting the superiority of this strategy are lacking, however, and there is concern that it may increase the risk of barotrauma.¹¹

Unlike in AC-VC in which VT is set by the clinician, in AC-PC VT is determined by the patient's respiratory system mechanics, effort, the set inspiratory pressure, and the set Ti. Tidal volume should therefore be monitored after changes in ventilator settings. Similarly, as a set inspiratory pressure is achieved with every breath, changes in a patient's lung mechanics will be primarily reflected by changes in VT.

PRVC

Many ventilators include an AC mode termed PRVC, also known as VC⁺or adaptive pressure ventilation on some models. In this mode, Ti and a goal VT are set by the clinician. The ventilator delivers a constant inspiratory pressure with decelerating flow for the duration of the Ti, after which the breath is cycled off. This mode is therefore patient or time triggered, pressure targeted, and time cycled as in AC-PC (Fig. 1C). The unique aspect of PRVC is that the ventilator adjusts inspiratory pressure to correct discrepancies between the delivered and goal VT. For example, if the set VT is 500 mL and the actual delivered VT for a given breath is 600 mL, the ventilator will decrease inspiratory pressure on subsequent breaths to bring the achieved VT closer to the goal VT.

Because flow is neither set by the clinician nor fixed, PRVC may improve patient-ventilator synchrony and reduce the potential for inappropriately low flow settings. Conversely, although a goal VT is set by the clinician, VT will fluctuate based on changes in effort and mechanics. As such, PRVC may decrease adherence to a lung-protective ventilation strategy and should be used with caution in patients with ARDS. It also may increase the work of breathing because increasing patient efforts will be met with decreasing ventilator support to ensure that the goal VT is achieved. As such, this mode may be most appropriate for patients who are clinically improving and moving toward liberation from mechanical ventilation.

VC vs PC

Evidence does not support the superiority of one AC mode over another.¹²In general, the lack of a fixed flow rate in AC-PC may improve patient-ventilator synchrony, but it is unclear whether this translates into improved outcomes.¹³

PS

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PS is a spontaneous mode of ventilation used most commonly during spontaneous breathing trials. In PS, there is no set RR and all breaths are patient triggered. In the absence of a backup mode that takes over during apnea, an apneic patient will not receive any breaths if he or she is ventilated using PS. Once a breath is triggered, an inspiratory pressure above the set PEEP is maintained throughout inspiration. PS is therefore pressure targeted. PS is flow cycled, as inspiration is cycled off by a drop in inspiratory flow. This variable can be adjusted by the clinician and is typically set as a percentage of peak inspiratory flow (eg, when inspiratory flow falls to 25% of peak inspiratory flow). PS is therefore patient triggered, pressure targeted, and flow cycled (Fig. 2A).

Fig. 2.

(A) Pressure, volume, and time waveforms in pressure support (PS) ventilation. All breaths are patient triggered as evidenced by the negative deflections in the pressure waveform (gray circles). With each breath, a set inspiratory pressure is delivered above positive end-expiratory pressure. Per the equation of motion, constant pressure waveforms require decelerating inspiratory flow, and when this inspiratory flow falls to a preset percentage of peak inspiratory flow (solid arrow), the machine cycles off. Tidal volume will vary based on respiratory system mechanics and patient effort. (B) Pressure, volume, and time waveforms in SIMV-VC with pressure support. Flow-targeted volume-cycled mandatory breaths are given at a rate set by the clinician (gray box). These breaths are "synchronized" to patient effort (and thereby assisted) if a patient attempts to trigger a breath near the time of set breath delivery (gray circle). Between synchronized and mandatory breaths, the patient may take spontaneous breaths which are generally supported with pressure support (middle two breaths).

SIMV

SIMV is a frequently used mode of mechanical ventilation.⁹In SIMV, supported (mandatory) ventilator breaths are given at a set rate. If a patient attempts to trigger a breath in a preset time interval before the next IMV breath, the machine will deliver a supported breath (the mandatory breaths are therefore synchronized to patient effort). Mandatory breaths can be delivered with a VC (flow targeted, volume cycled), PC (pressure targeted, time cycled), or PRVC (pressure targeted, time cycled) strategy as in the AC mode.

The key difference between SIMV and AC is that patients ventilated in SIMV may take unassisted spontaneous breaths between mandatory machine breaths (Fig. 2B). Often, a small amount of pressure support is added to these breaths to overcome the resistive load of the ETT and augment VT. The VT achieved with these breaths is not controlled by the clinician but rather a function of patient effort and respiratory system mechanics. Use of SIMV in a spontaneously breathing patient often results in two unique ventilator waveforms: supported mandatory breaths and spontaneous pressure-supported breaths. In patients without spontaneous efforts (eg, because of neuromuscular blockade), SIMV is identical to AC, as the patient will receive only time-triggered machine breaths.

SIMV has been purported to reduce respiratory muscle disuse atrophy, improve ventilator

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synchrony, and prevent respiratory alkalosis¹⁴; however, in patients whose spontaneous RR is significantly higher than the set IMV rate, SIMV may promote respiratory muscle fatigue.¹⁵Although there is a lack of convincing evidence to support or discourage the use of SIMV as the primary mode of mechanical ventilation in acutely ill patients, several well- conducted trials have found SIMV inferior to other methods during ventilator weaning. 16,17 Ventilator Settings: Getting Started

Initial ventilator settings for patients placed on invasive mechanical ventilation should be guided by the cause of respiratory failure, the goals of mechanical ventilation, and the patient's comorbidities. In general, ventilation is manipulated by changes in VT and RR. To improve oxygenation, FiO2 and/or PEEP can be increased. PEEP improves oxygenation by recruiting collapsed alveoli and decreasing intrapulmonary shunt.¹⁸Below, we provide an overview of ventilator strategies for three common scenarios encountered in clinical practice. Normal Minute Ventilation

Some patients who require mechanical ventilation will have a normal minute ventilation (≈6-8 L/min). These include patients intubated for upper airway

obstruction (eg, angioedema), altered mental status (eg, ethanol intoxication), and those undergoing surgery. In these cases, the following settings are likely to achieve an adequate PaO2 (eg,

PaO2 60-80 mm Hg, SpO2 88%) and acceptable PaCO2 (eg, 30-50 mm Hg) in most adult patients:

Mode: AC-VC•

RR: 14 breaths per minute•

VT: 7 to 8 mL/kg ideal body weight (IBW, based on a patient's height and sex)• FiO2: 0.4 to 1.0, depending on the clinical scenario•

PEEP: 5 cm H2O•

Inspiratory flow rate and pattern: 80 LPM using a decelerating/ramp flow• Alternatively, in patients with normal lungs and an intact mental status, PS can be used. Reasonable initial settings include a PEEP of 5 cm H2O, Pi of 15 cm H2O, and an FiO2 of 0.4.^A Subsequent adjustments to Pi should target an RR of roughly 14 breaths per minute and a VT of 8 to 10 mL/kg IBW.

ARDS

For patients with ARDS, a ventilator strategy that prioritizes low-tidal volumes and low plateau pressures, termed "lung-protective ventilation," has been shown to improve mortality.⁵Reasonable initial settings for a patient with ARDS include the following:

Mode: AC-VC•

RR: 20 breaths per minute•

VT: 7 to 8 mL/kg IBW•

FiO2: 1.0•

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PEEP: 5 cm H2O• Inspiratory flow rate and pattern: 80 LPM using a decelerating/ramp flow• Note the higher initial RR that is needed to match the high minute ventilation of patients with ARDS. The VT should be decreased over several hours to a goal of 6 mL/kg IBW. The RR is increased in parallel with the decrease in VT to maintain an adequate minute ventilation and avoid progressive hypercapnia and acidemia. Tidal volume should be decreased further if necessary to achieve a Pplt 30 cm H2O. PEEP and FiO2 are adjusted in stepwise fashion to maintain a PaO2 of 55-80 mm Hg.⁵

Severe Obstructive Lung Disease

For patients with status asthmaticus or chronic obstructive pulmonary disease, ventilation should allow for complete exhalation to prevent the development of auto-PEEP (discussed further below). This is most effectively accomplished by limiting RR and VT.¹⁰Reasonable initial settings include the following:

Mode: AC-VC•

RR: 10 to 14 breaths per minute•

VT: 7 to 8 mL/kg IBW•

FiO2: 1.0•

PEEP: 5 cm H2O•

Inspiratory flow rate and pattern: 60 LPM using a square waveform• For patients with severe bronchospasm, clinicians should target a minute ventilation of 6 to 8 L/minute to prevent auto-PEEP. Deep sedation and neuromuscular blocking agents may be required to achieve this goal.¹⁰Elevations in PaCO2 are tolerated to facilitate the reduction in minute ventilation provided the pH does not drop below 7.15. The set flow rate can be increased above 60 LPM to further shorten inspiratory time, although this strategy provides only marginal additional benefit when minute ventilation is low. High flow rates will increase peak pressure because of an increase in airway resistive pressure. Because these changes do not increase the distending pressure of the lung (as measured by Pplt), isolated elevations in peak pressures are not necessarily harmful.

Respiratory System Mechanics

Once a patient is placed on invasive mechanical ventilation, the ventilator can be used to measure plateau pressure, airway resistance, and the static compliance of the respiratory system, collectively referred to as respiratory system mechanics. Knowledge of how to obtain and interpret these values is essential for optimal care.¹⁹

Equation of Motion

The equation of motion relates the pressure at the airway opening (Pao) to lung volume, flow, respiratory system mechanics, and patient effort, as follows:

Pao=VCstrs+(V˙×R)−Pmus

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where V is lung volume above functional residual capacity, Cstrs is the static compliance of the respiratory system, V˙ is inspiratory flow rate, R is inspiratory resistance, and Pmus is the pressure generated by the patient's respiratory muscles. The

product V˙×R reflects the pressure required to overcome the frictional forces generated by flow through the ETT and airways (otherwise known as resistive pressure). Under zero flow conditions (V˙×R=0), in a passive patient without spontaneous respiratory effort (Pmus = 0), the distending pressure of the respiratory system or Pplt is determined by VT and Cstrs, as follows:

Pplt=VtCstrs+PEEP

The equation of motion predicts that as distending pressure increases with a tidal breath, resistive pressure must decrease to maintain a constant inspiratory pressure. Constant pressure waveforms therefore mandate a decelerating inspiratory flow pattern (Fig. 3A). Conversely, use of a constant flow pattern (where resistive pressure remains constant during a tidal breath) produces a steady rise in airway pressure with lung inflation (visualized as a "shark fin"

pressure waveform).

Fig. 3.

(A) Pressure and flow waveforms for constant (left) and decelerating (right) inspiratory flow patterns. Note the "shark fin" appearance of the pressure waveform with constant inspiratory flow caused by the steady increase in distending pressure (shaded area) coupled with a constant resistive pressure (unshaded area). With decelerating inspiratory flow, a square pressure waveform is observed as decreasing flow causes a decline in resistive pressure during breath delivery. (B) Pressure and flow waveforms during an inspiratory hold maneuver. During inspiration, airway pressure rises from positive end-expiratory pressure (PEEP) to peak inspiratory pressure. Inspiratory flow is then stopped, eliminating resistive pressure and causing airway pressure to fall to a plateau pressure (Pplt). The difference between peak inspiration pressure and Pplt represents airway resistive pressure. The difference between Pplt and PEEP is determined by tidal volume and respiratory system compliance. (C) Diagnostic approach to elevated peak pressures on a mechanical ventilator. ETT, endotracheal tube. Resistance and Compliance

Pressures generated during breath delivery are determined by the compliance of the respiratory system and airway resistance. It is not possible to determine the respective contributions of each of these components without performing an inspiratory hold maneuver (Fig. 3B). A valid inspiratory hold maneuver requires minimal or no effort on the part of the patient. Compliance measurements do not depend upon the flow delivery strategy because they are obtained under zero flow conditions. Because compliance is the differential change in volume for a given change in pressure (ΔVΔP), the Cstrs is calculated by

Cstrs=VTPplat−PEEPtotal

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Normal compliance in a ventilated patient is 60 to 80 mL/cm H2O. Causes of decreased compliance include pulmonary edema, interstitial lung disease, auto-PEEP, pleural disease, chest wall deformity, obesity, and ascites. In patients with low Cstrs, Pplt is higher for any given

VT.

Resistance is pressure divided by flow. As such, airway resistance is calculated by the following:

Raw=PIP−Pplatflow

Normal airway resistance on a mechanical ventilator is 15 cm H2O/L/second, assuming a normal-sized ETT. If the patient is receiving a decelerating flow pattern, this should be switched to constant flow (at 60 LPM, which is 1 L/s, thus making the calculation simpler) to obtain valid resistance measurements. Increased airway resistance suggests a kinked or plugged endotracheal tube, intraluminal mucus, or bronchospasm. Many ventilators will calculate and display airway resistance and compliance when an inspiratory hold is performed. Evaluating Changes in Airway Pressure

A frequent diagnostic challenge when caring for mechanically ventilated patients is responding to sudden changes in airway pressure. Assessing respiratory system compliance and airway resistance facilitates the development of a focused differential diagnosis and helps guide initial management (Fig. 3C). Sudden changes in airway pressure that result in hemodynamic instability should be managed by disconnecting the patient from the mechanical ventilator and ventilating them with a bag valve mask device connected to the ETT at a rate of 8 to 10 breaths per minute. Outside this scenario, the initial diagnostic step should be to perform an inspiratory hold maneuver. Increased peak airway pressure coupled with an elevated Pplt suggests decreased lung compliance. When this change occurs acutely, pneumothorax and auto-PEEP should be rapidly excluded.

An increase in peak pressure with a low Pplt suggests increased large-airway resistance. The ETT should be examined to ensure that it is not kinked or occluded by the patient's teeth, tube patency should be confirmed with the passage of a suction catheter, and the patient's chest should be auscultated for evidence of bronchospasm.

Sudden decreases in airway pressure suggest that air is escaping from the ventilator circuit. This can be caused by a defect in the ETT, a malfunctioning ETT balloon, or a large air leak in the setting of chest tube drainage.

Auto-PEEP

As noted above, clinicians should monitor for the development of auto-PEEP, which is defined by an EEP above machine-set PEEP. 20,21 Auto-PEEP results from incomplete exhalation of the delivered breath, which leads to increased end-expiratory lung volumes. This is most commonly seen in conditions with increased airway resistance and reduced expiratory flow rates (eg, severe asthma, chronic obstructive pulmonary disease). The resulting increase in intrathoracic pressure decreases the gradient for venous return, increases right ventricular afterload, and increases the work of breathing because the patient must overcome this pressure to trigger a

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breath. In severe cases, these physiologic changes can be life threatening.¹⁰Auto-PEEP can be estimated in several ways. Persistent expiratory flow at the start of inspiration (noted either by auscultation or observing an expiratory flow tracing that does not return to zero by the start of the next breath) suggests the presence of auto-PEEP (Fig. 4). An end-expiratory occlusion maneuver also can be performed whereby flow is stopped at the end of expiration and an occlusion pressure that approximates a patient's intrinsic PEEP is recorded. This measurement can only be reliably obtained in patients without spontaneous respiratory effort. Finally, in the absence of other known causes of decreased respiratory system compliance, an elevated Pplt in an at-risk patient strongly suggests the presence of auto-PEEP. In addition to treating the underlying lung disease, strategies that prolong expiratory time such as decreased RR, low VT, and increased inspiratory flow rates decrease auto-PEEP. If progressive auto-PEEP is believed to be the cause of hemodynamic instability, the patient should be disconnected from the ventilator and the chest manually decompressed.

Fig. 4.

Pressure and flow waveforms in a patient with autopositive end-expiratory pressure. Note that expiratory flow does not return to zero before the start of the next breath (arrows). Conclusions

Invasive mechanical ventilation is a powerful therapeutic and diagnostic tool in critically ill patients. Understanding modes and settings, measuring respiratory system mechanics, and paying attention to pressure and flow waveforms are essential components of delivering high- quality critical care.

Key Points

Modes of ventilation can be described by three key variables: "trigger" (the stimulus that initiates a mechanical breath), "target" (the breath-delivery strategy), and "cycle" (how the breath is terminated).

• Measuring respiratory system mechanics facilitates the development of a differential diagnosis and helps guide initial management for mechanically ventilated patients who experience sudden changes in airway pressure.

• Acknowledgments This work was supported by Northwestern University's Lung Sciences Training Program (5T32HL076139-14), the National Institutes of Health (grant HL128867), and the Parker B. Francis Research Opportunity Award.

References

1. Carson SS, Cox CE, Holmes GM, et al. The changing epidemiology of mechanical ventilation: a population-based study. J Intensive Care Med 2006;21:173-182. [PubMed] [Google Scholar]

63

2. Halpern NA, Goldman DA, Tan KS, et al. Trends in critical care beds and use among population groups and Medicare and Medicaid beneficiaries in the United States:

2000-2010. Crit Care Med 2016;44:1490-1499. [PMC free article] [PubMed] [Google Scholar]

3. Cox CE, Carson SS, Ely EW, et al. Effectiveness of medical resident education in mechanical ventilation. Am J Respir Crit Care Med 2003;167:32-38. [PubMed] [Google Scholar]

4. Wilcox SR, Strout TD, Schneider JI, et al. Academic emergency medicine physicians' knowledge of mechanical ventilation. West J Emerg Med 2016;17:271-279. [PMC free article] [PubMed] [Google Scholar]

5. Acute Respiratory Distress Syndrome Network, Brower RG, Matthay MA, et al. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 2000;342:1301-1308. [PubMed] [Google Scholar]

6. Cinnella G, Conti G, Lofaso F, et al. Effects of assisted ventilation on the work of breathing:

volume-controlled versus pressure-controlled ventilation. Am J Respir Crit Care Med 1996;153:1025-1033. [PubMed] [Google Scholar]

7. Kapitan KS. Ventilatory failure. Can you sustain what you need? Ann Am Thorac Soc 2013;10:396-399. [PubMed] [Google Scholar]

8. Singer BD, Corbridge TC. Pressure modes of invasive mechanical ventilation. South Med J 2011;104:701-709. [PubMed] [Google Scholar]

9. Esteban A, Anzueto A, Alia I, et al. How is mechanical ventilation employed in the intensive care unit? An international utilization review. Am J Respir Crit Care Med 2000;161:1450-1458. [PubMed] [Google Scholar]

10. Leatherman J Mechanical ventilation for severe asthma. Chest 2015;147:1671-1680. [PubMed] [Google Scholar]

11. Shanholtz C, Brower R. Should inverse ratio ventilation be used in adult respiratory distress syndrome? Am J Respir Crit Care Med 1994;149:1354-1358. [PubMed] [Google Scholar]

12. Chacko B, Peter JV, Tharyan P, et al. Pressure-controlled versus volume-controlled ventilation for acute respiratory failure due to acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). Cochrane Database Syst Rev 2015;1:CD008807. [PMC free article] [PubMed] [Google Scholar]

13. MacIntyre NR, McConnell R, Cheng KC, et al. Patient-ventilator flow dyssynchrony: flow- limited versus pressure-limited breaths. Crit Care Med 1997;25:1671-1677. [PubMed] [Google Scholar]

14. Kacmarek RM, Branson RD. Should intermittent mandatory ventilation be abolished? Respir Care 2016;61:854-866. [PubMed] [Google Scholar]

64

15. Marini JJ, Smith TC, Lamb VJ. External work output and force generation during synchronized intermittent mechanical ventilation. Effect of machine assistance on breathing effort. Am Rev Respir Dis 1988;138:1169-1179. [PubMed] [Google Scholar]

16. Brochard L, Rauss A, Benito S, et al. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med 1994;150:896-903. [PubMed] [Google Scholar]

17. Esteban A, Frutos F, Tobin MJ, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med 1995;332:345-350. [PubMed] [Google Scholar]

18. Sahetya SK, Goligher EC, Brower RG. Fifty years of research in ARDS. Setting positive end-expiratory pressure in acute respiratory distress syndrome. Am J Respir Crit Care Med 2017;195:1429-1438. [PMC free article] [PubMed] [Google Scholar]

19. Stansbury RC, Long JL, Petsonk EL. Respiratory mechanics in a patient requiring neuromuscular blockade. Ann Am Thorac Soc 2017;14:288-292. [PubMed] [Google Scholar]

20. Tobin MJ, Lodato RF. PEEP, auto-PEEP, and waterfalls. Chest 1989;96:449-451. [PubMed] [Google Scholar]

21. Marini JJ. Dynamic hyperinflation and auto-positive end-expiratory pressure: lessons learned over 30 years. Am J Respir Crit Care Med 2011;184:756-762. [PubMed] [Google Scholar]

now it's clear that Invasive mechanical ventilation includes an endotracheal tube (ETT) and a mechanical ventilator (as opposed to noninvasive ventilation in which the interface is a face mask). In addition to serving as the conduit for delivery of mechanical breaths, the ETT protects the airway, allows for suctioning of secretions, and facilitates select procedures, including bronchoscopy. But from the perusal of the history sheet will not find any such differentiation between two and also we did not find any emergency to put the patient on Invasive Mechanical Ventilator.

When we are going through the hospital nurses beside records, we have seen that on 6 May 2010, there is a remark of bedsore dressing BD. When this bedsore developed and what was the intention to this bedsore, has not been made clear. At the time of admission to the hospital, there are no bedsore recorded in the history sheet made by that when the patient was brought to the opposite parties, he had no bedsore.

Your doctor will likely look closely at your skin to decide if you have a pressure ulcer and, if so, to assign a stage to the wound. Staging helps determine what treatment is best for you. You might need blood tests to assess your general health.

Questions from the doctor

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Your doctor might ask questions such as:

When did the pressure sore first appear?• What is the degree of pain?•

Have you had pressure ulcer in the past?• How were they managed, and what was the outcome of treatment?• What kind of care assistance is available to you?• What is your routine for changing positions?• What medical conditions have you been diagnosed with, and what is your current treatment?

• What is your normal daily diet and fluid intake?• Treatment

Treating pressure ulcers involves reducing pressure on the affected skin, caring for wounds, controlling pain, preventing infection and maintaining good nutrition.

Treatment team

Members of your care team might include:

A primary care physician who oversees the treatment plan• A physician or nurse specializing in wound care• Nurses or medical assistants who provide both care and education for managing wounds• A social worker who helps you or your family access resources and who addresses emotional concerns related to long-term recovery

• A physical therapist who helps with improving mobility• An occupational therapist who helps to ensure appropriate seating surfaces• A dietitian who monitors your nutritional needs and recommends a good diet• A doctor who specializes in conditions of the skin (dermatologist)• A neurosurgeon, vascular surgeon, orthopedic surgeon or plastic surgeon•

Reducing pressure

The first step in treating a bedsore is reducing the pressure and friction that caused it. Strategies include:

Repositioning. If you have a bedsore, turn and change your position often. How often you reposition depends on your condition and the quality of the surface you are on.

•

Using support surfaces. Use a mattress, bed and special cushions that help you sit or lie in a way that protects vulnerable skin.

•

Cleaning and dressing wounds

Care for pressure ulcers depends on how deep the wound is. Generally, cleaning and dressing a wound includes the following:

Cleaning. If the affected skin isn't broken, wash it with a gentle cleanser and pat dry. Clean open sores with water or a saltwater (saline) solution each time the dressing is

•

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changed.

Putting on a bandage. A bandage speeds healing by keeping the wound moist. It also creates a barrier against infection and keeps skin around it dry. Bandage choices include films, gauzes, gels, foams and treated coverings. You might need a combination of dressings.

•

Removing damaged tissue

To heal properly, wounds need to be free of damaged, dead or infected tissue. The doctor or nurse may remove damaged tissue (debride) by gently flushing the wound with water or cutting out damaged tissue.

Other interventions

Other interventions include:

Drugs to control pain. Nonsteroidal anti-inflammatory drugs — such as ibuprofen (Advil, Motrin IB, others) and naproxen sodium (Aleve) — might reduce pain. These can be very helpful before or after repositioning and wound care. Topical pain medications also can be helpful during wound care.

•

A healthy diet. Good nutrition promotes wound healing.•

Surgery

A large bedsore that fails to heal might require surgery. One method of surgical repair is to use a pad of your muscle, skin or other tissue to cover the wound and cushion the affected bone (flap surgery).

When a person develops a bedsore during longer-term confined to bed, the attending doctor dresses the bedsore regularly after rubbing with the cotton gauze so that blood oozes from the bedsore which helps in early healing of the bedsores. As we have seen in so many cases that to avoid a bedsore, the patient was given water mattresses or air mattresses having change of air columns every three minutes or six minutes by a pump so adjusted with the air mattress so that the pressure on the back of the patient changes every 3 to 6 minutes and it helps in not developing the bedsores. We have not seen any such precaution in the history sheet of the patient. Is it not a negligent on the part of the opposite party no 1 ? The bedsores developed in the hospital so the opposite party no 1 is answerable for the bedsores. The opposite parties in their written statement has stated that the Urologist found that patient gave history of acute retention of urine and in dwelling catheter was in situ since one month. During argument the counsel of the complainant vehemently denied this fact and stated that catheter has already been removed before coming to the opposite party hospital. If it was there, what steps were taken to remove this catheter by the opposite party ? The opposite party in their written statement has stated that it was the combined effect of severe UTI, pneumonia and perennial cellulitis that the septicaemia must have developed and got aggravated. It is a speculation and not confirmation. Nothing has been said in the written statement regarding removal of the catheter so this supports the case of the complainant's counsel that the catheter has already been removed before coming to the opposite parties hospital.

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The opposite parties has also stated that Mr. Siddiqui was actually victim of his own negligence in which he kept the catheter in situ for a month after acute retention and neglected the perennial access leading to perennial sinuses due to which probably he developed fever and pneumonitis which forced him to report to hospital. Apart from the above he also continued to neglect parkinsonism as a disease as recorded by the Neuro physician. It has been stated only on surmises and speculation by the opposite party. Opposite party has a team of super doctors and they could diagnose the ailments of the patient with full determination and confirmation and not only on speculation. The opposite party has said that it was patients own negligence. After seeing the records it is clear that the patient was judicial officer of so many years of service and after his retirement he joined the post of chairman, District Forum Lucknow. So the statement that Mr. Siddiqui, the judge was a victim of his own negligence is far from the truth and it shows the attitude of the opposite party who failed to save the life of the patient. The opposite parties have also stated that Mr Siddiqui was found to have multiple fistulae are in ano . In the history sheet dated 27 April 2010 the attending doctor has written about final diagnosis that the patient is suffering multiple fistula in Ano.

What is an anal fistula?

An anal fistula is a small tunnel that connects an abscess, an infected cavity in the anus, to an opening on the skin around the anus.

The anus is the external opening through which feces are expelled from the body. Just inside the anus are a number of small glands that make mucus. Occasionally, these glands get clogged and can become infected, leading to an abscess. About half of these abscesses may develop into a fistula.

SYMPTOMS AND CAUSES

What causes an anal fistula?

The leading causes of an anal fistula are clogged anal glands and anal abscesses. Other, much less common, conditions that can cause an anal fistula include:

Crohn's disease (an inflammatory disease of the intestine)•

Radiation (treatment for cancer)•

Trauma•

Sexually transmitted diseases•

Tuberculosis•

Diverticulitis (a disease in which small pouches form in the large intestine and become inflamed)

• Cancer•

What are the symptoms of an anal fistula?

The signs and symptoms of an anal fistula include:

Frequent anal abscesses•

Pain and swelling around the anus•

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Bloody or foul-smelling drainage (pus) from an opening around the anus. The pain may decrease after the fistula drains.

• Irritation of the skin around the anus from drainage• Pain with bowel movements•

Bleeding•

Fever, chills and a general feeling of fatigue• You should see your doctor if you notice any of these symptoms.

DIAGNOSIS AND TESTS

Anal Fistula: Diagnosis and Treatment

How is an anal fistula diagnosed?

Your doctor can usually diagnose an anal fistula by examining the area around the anus. He or she will look for an opening (the fistula tract) on the skin. The doctor will then try to determine how deep the tract is, and the direction in which it is going. In many cases, there will be drainage from the external opening.

Some fistulas may not be visible on the skin's surface. In this case, your physician may need to perform additional tests:

An anoscopy is a procedure in which a special instrument is used to see inside your anus and rectum.

• Your physician may also order an ultrasound or MRI of the anal area to get a better view of the fistula tract.

• Sometimes your surgeon will need to examine you in the operating room (called exam under anesthesia) to diagnose the fistula.

• If a fistula is found, your physician may also want to do further tests to see if the condition is related to Crohn's disease, an inflammatory disease of the intestine. About 25% of people with Crohn's disease develop fistulas. Among these studies are blood tests, X-rays and colonoscopy. A colonoscopy is a procedure in which a flexible, lighted instrument is inserted into the colon via the anus. It is performed under conscious sedation, a type of light anesthetic.

MANAGEMENT AND TREATMENT

What are the treatments for an anal fistula?

Surgery is almost always necessary to cure an anal fistula. The surgery is performed by a colon and rectal surgeon. The goal of the surgery is a balance between getting rid of the fistula while protecting the anal sphincter muscles, which could cause incontinence if damaged. Fistulas in which there is no or little sphincter muscle involved are treated with a fistulotomy. In this procedure, the skin and muscle over the tunnel are cut open to convert it from a tunnel to an open groove. This allows the fistula tract to heal from the bottom up. In the case of a more complex fistula, the surgeon may have to place a special drain called a

69

seton, which remains in place for at least 6 weeks. After a seton is placed, a second operation is almost always performed:

A fistulotomy, or•

An advancement flap procedure (the fistula is covered with a flap, or piece of tissue, taken from the rectum, like a trap door), or

• A lift procedure (the skin above the fistula is opened up, the sphincter muscles are spread, and the fistula is tied off).

• A new treatment for Crohn's disease fistulas is to inject stem cells into the fistula. Your colorectal surgeon will discuss all of your options before the surgery. Fistula surgery is usually done on an outpatient basis, which means the patient can go home the same day. Patients who have very large or deep fistula tunnels may have to stay in the hospital for a short time after the surgery. Some fistulas may require several operations to get rid of the fistula.

Is any follow-up treatment necessary for an anal fistula?

Most fistulas respond well to surgery. After the surgery, your surgeon may recommend that you soak the affected area in a warm bath, known as a sitz bath, and that you take stool softeners or laxatives for a week.

Since you may also have some pain or discomfort in the area after surgery, your physician will usually inject local anesthetic such as lidocaine to decrease your discomfort, and may prescribe pain pills. If opioids are prescribed, they are usually used for a very short period. If the abscess and fistula are treated properly and heal, they will probably not come back.

Anal fistula is a chronic abnormal communication between the anal canal and usually the perianal skin.^[1]An anAal fistula can be described as a narrow tunnel with its internal opening in the anal canal and its external opening in the skin near the anus.^[2]Anal fistulae commonly occur in people with a history of anal abscesses. They can form when anal abscesses do not heal properly.

Anal fistulae originate from the anal glands, which are located between the internal and external anal sphincter and drain into the anal canal.^[4]If the outlet of these glands becomes blocked, an abscess can form which can eventually extend to the skin surface. The tract formed by this process is a fistula.

Abscesses can recur if the fistula seals over, allowing the accumulation of pus. It can then extend to the surface again - repeating the process.

Anal fistulae per se do not generally harm, but can be very painful, and can be irritating because of the drainage of pus (it is also possible for formed stools to be passed through the fistula). Additionally, recurrent abscesses may lead to significant short term morbidity from pain and, importantly, create a starting point for systemic infection.

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Treatment, in the form of surgery, is considered essential to allow drainage and prevent infection. Repair of the fistula itself is considered an elective procedure which many patients opt for due to the discomfort and inconvenience associated with an actively draining fistula. Signs and symptoms

Anal fistulae can present with the following symptoms:skin maceration pus, serous fluid and/or (rarely) feces discharge — can be bloody or purulent• pruritus ani — itching•

depending on presence and severity of infection:•

pain•

swelling•

tenderness•

fever•

unpleasant odor•

Thick discharge, which keeps the area wet•

Diagnosis

Diagnosis is by examination, either in an outpatient setting or under anaesthesia (referred to as EUA or Examination Under Anaesthesia). The fistula may be explored by using a fistula probe (a narrow instrument). In this way, it may be possible to find both openings. The examination can be an anoscopy. Diagnosis may be aided by performing a fistulogram, proctoscopy and/or sigmoidoscopy.

Possible findings:

The opening of the fistula onto the skin may be observed•

The area may be painful on examination•

There may be redness•

An area of induration may be felt; thickening due to chronic infection• A discharge may be seen•

•

Classification

Park's classification: This was done by Parks et al. from the UK in 1976, before MRI or endoanal ultrasound was available. It classified the fistula in four grades:

St James University Hospital Classification: This was done by Morris et al. in the year 2000.This classification was improvement over Parks classification as it was based on MRI studies. It classified the fistula in five grades.

• Garg classification: This was done by Pankaj Garg in 2017. This classification is improvement over both Parks and St James University Hospital Classification. This was

•

71

based on MRI studies and operative findings in 440 patients. It classified the fistula in five grades. The grades of this classification correlate quite well with the severity of the disease. Grade I & II are simpler fistulas and can be managed by Fistulotomy whereas Grade III-V are complex fistulas in which fistulotomy should be not be done. They should be managed by Fistula experts. Unlike Park's and St James University Hospital Classification, this correlation is quite accurate with Garg's classification. Therefore this new classification is useful to both surgeons and radiologists.

Types

Depending on their relationship with the internal and external sphincter muscles, fistulae are classified into five types:

Extrasphincteric fistulae begin at the rectum or sigmoid colon and proceed downward, through the levator ani muscle and open into the skin surrounding the anus. Note that this type does not arise from the dentate line (where the anal glands are located). Causes of this type could be from a rectal, pelvic or supralevator origin, usually secondary to Crohn's disease or an inflammatory process such

as appendiceal or diverticular abscesses.

• Suprasphincteric fistulae begin between the internal and external sphincter muscles, extend above and cross the puborectalis muscle, proceed downward between the puborectalis and levator ani muscles, and open an inch or more away from the anus.

• Transphincteric fistulae begin between the internal and external sphincter muscles or behind the anus, cross the external sphincter muscle and open an inch or more away from the anus. These may take a 'U' shape and form multiple external openings. This is sometimes termed a 'horseshoe fistula.

• Intersphincteric fistulae begin between the internal and external sphincter muscles, pass through the internal sphincter muscle, and open very close to the anus.

• Submucosal fistulae pass superficially beneath the submucosa and do not cross either sphincter muscle.^[10]

•

Differential diagnosis

Other conditions in which infected perianal "holes" or openings may include pilonidal cyst. Treatment

There are several stages to treating an anal fistula:

Definitive treatment of A fistula aims to stop it recurring. Treatment depends on where the fistula lies, and which parts of the internal and external anal sphincters it crosses.

Lay-open of fistula-in-ano - this option involves an operation to cut the fistula open. Once the fistula has been laid open it will be packed on a daily basis for a short period of time to ensure that the wound heals from the inside out. This option leaves behind a scar, and depending on the position of the fistula in relation to the sphincter muscle, can cause problems with incontinence. This option is not suitable for fistulae that cross the entire internal and external anal sphincter.

•

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Cutting seton - if the fistula is in a high position and it passes through a significant portion of the sphincter muscle, a cutting seton (from the Latin seta, "bristle") may be used. This involves inserting a thin tube through the fistula tract and tying the ends together outside of the body. The seton is tightened over time, gradually cutting through the sphincter muscle and healing as it goes. This option minimizes scarring but can cause incontinence in a small number of cases, mainly of flatus. Once the fistula tract is in a low enough position it may be laid open to speed up the process, or the seton can remain in place until the fistula is completely cured. This was the traditional modality used by physicians in Ancient Egypt and formally codified by Hippocrates, who used horsehair and linen.

•

Seton stitch - a length of suture material looped through the fistula which keeps it open and allows pus to drain out. In this situation, the seton is referred to as a draining seton. The stitch is placed close to the ano-rectal ring - which encourages healing and makes further surgery easy.

• Fistulotomy - till anorectal ring•

Colostomy - to allow healing•

Fibrin glue injection is a method explored in recent years, with variable success. It involves injecting the fistula with a biodegradable glue which should, in theory, close the fistula from the inside out, and let it heal naturally. This method is perhaps best tried before all others since, if successful, it avoids the risk of incontinence, and creates minimal stress for the patient.

•

Fistula plug involves plugging the fistula with a device made from small intestinal submucosa. The fistula plug is positioned from the inside of the anus with suture. According to some sources, the success rate with this method is as high as 80%. As opposed to the staged operations, which may require multiple hospitalizations, the fistula plug procedure requires hospitalization for only about 24 hours. Currently, there are two different anal fistula plugs cleared by the FDA for treating ano-rectal fistulae in the United States. This treatment option does not carry any risk of bowel incontinence. In the systematic review published by Dr Pankaj Garg, the success rate of the fistula plug is 65-75%.

•

Endorectal advancement flap is a procedure in which the internal opening of the fistula is identified and a flap of mucosal tissue is cut around the opening. The flap is lifted to expose the fistula, which is then cleaned and the internal opening is sewn shut. After cutting the end of the flap on which the internal opening was, the flap is pulled down over the sewn internal opening and sutured in place. The external opening is cleaned and sutured. Success rates are variable and high recurrence rates are directly related to previous attempts to correct the fistula.

• Japan: A man with an anal fistula. From the Yamai no Soshi, late 12th century.

LIFT Technique is a novel modified approach through the intersphincteric plane for the treatment of fistula-in-ano, known as LIFT (ligation of intersphincteric fistula tract) procedure. LIFT procedure is based on secure closure of the internal opening and removal of infected cryptoglandular tissue through the intersphincteric approach. Essential steps of the procedure include, incision at the intersphincteric groove, identification of the intersphincteric tract, ligation of intersphincteric tract close to the internal opening and removal of intersphincteric tract, scraping out all granulation tissue in the rest of the

•

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fistulous tract, and suturing of the defect at the external sphincter muscle. The procedure was developed by Thai colorectal surgeon, Arun Rojanasakul, The first reports of preliminary healing result from the procedure were 94% in 2007. Additional ligation of the intersphincteric fistula tract did not improve the outcome after endorectal advancement flap.

Fistula clip closure (OTSC Proctology) is a recent surgical development, which involves the closure of the internal fistula opening with a superelastic clip made of nitinol (OTSC). During surgery, the fistula tract is debrided with a special fistula brush and the clip is transanally applied with the aid of a preloaded clip applicator. The surgical principle of this technique relies on the dynamic compression and permanent closure of the internal fistula opening by the superelastic clip. Consequently, the fistula tract dries out and heals instead of being kept open by continuous feeding with stool and fecal organisms. This minimally-invasive sphincter-preserving technique has been developed and clinically implemented by the German surgeon Ruediger Prosst. First clinical data of the clip closure technique demonstrate a success rate of 90% for previously untreated fistulae and a success rate of 70% for recurrent fistulae.

•

VAAFT is a surgical kit for treating anal fistulae. The system comprises:

A video telescope (fistuloscope) to allow surgeons to see inside the fistula tract.1. A unipolar electrode for diathermy of the internal tract. This is connected to a high frequency generator.

2.

A fistula brush and forceps for cleaning the tract and clearing any granulation tissue.3.

• The VAAFT procedure is done in 2 phases, diagnostic and operative. Before the procedure, the patient is given a spinal or general anaesthetic and is placed in the lithotomy position (legs in stirrups with the perineum at the edge of the table). In the diagnostic phase, the fistuloscope is inserted into the fistula to locate the internal opening in the anus and to identify any secondary tracts or abscess cavities. The anal canal is held open using a speculum and irrigation solution is used to give a clear view of the fistula tract. Light from the fistuloscope can be seen from inside the anal canal at the location of the internal opening of the fistula, which helps to locate the internal opening. In the operative phase of the procedure, the fistula tract is cleaned and the internal opening of the fistula is sealed. To do this, the surgeon uses the unipolar electrode, under video guidance, to cauterise material in the fistula tract. Necrotic material is removed at the same time using the fistula brush and forceps, as well as by continuous irrigation. The surgeon then closes the internal opening from inside the anal canal using stitches and staples.

Infection

Some people will have an active infection when they present with a fistula, and this requires clearing up before definitive treatment can be decided.

Antibiotics can be used as with other infections, but the best way of healing infection is to prevent the buildup of pus in the fistula, which leads to abscess formation. This can be done with a seton.

Epidemiology

A literature review published in 2018 showed an incidence as high as 21 people per

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100,000. "Anal fistulas are 2-6 times more prevalent in males than females, with the condition occurring most frequently in patients in their 30s and 40s."

So it is not very difficult to treat the anal fistula. Surgery is almost always necessary to cure an anal fistula. In the present case as per final diagnosis dated 27.04.2010 , the opposite parties came to know that there is multiple fistula in Ano of the patient. Whether any surgery has been performed on the patient for the treatment of this multiple fistula? The case history sheet of the patient has not disclosed anything regarding treatment of this multiple fistula till 30 April 2010. We have perused the affidavit as evidence filed by Dr Sandeep Agarwal on behalf of opposite party no 1 . He has stated that GI surgeon recommended conservative treatment for multiple fistulae in ano. But he did not disclose as to when this conservative treatment started and what was the result of this conservative treatment in relation to multiple fistulae in ano. In this case one doctor Ashok Singh has submitted his affidavit from the complainant aside. He has stated that on 28.04.2010 Dr Sunil Verma diagnosed the patient to be suffering from septicaemia without resorting to pus culture and blood culture investigation. Definite diagnosisabout septicaemia cannot be made without resorting to pus culture investigation. He has also said that on 29 April 200 and the urine culture report showed the sensitivity of the patient to certain drugs, however medicines were not prescribed as per the said report. The patient's blood, urea and creatinine levels showed no signs of abnormality till 10 May 2010 and his vital parameters were found to be normal after 2 May 2010. The anti-tuberculosis drugs were started on 11 May 2010 without resorting to any investigation for the purpose. We have seen the prescription of medicines as per history case sheet of 10 and 11 May 2010 at 4:30 PM in which Forcox-2 -OD has been mentioned. Forecox Tablet is a combination of medicines that is used to treat tuberculosis, an infectious disease that mainly affects the lungs but can affect other parts of the body as well. It kills as well as stops the growth of infection causing bacteria and helps in treating the infection. Take it in the dose and duration advised by the doctor. Your symptoms may improve before the infection is completely cured. Do not stop taking it without consulting your doctor as doing so may cause the infection to return or worsen.

SIDE EFFECTS OF FORECOX TABLET

Most side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you're worried about them Common side effects of Forecox

Nausea•

Vomiting•

Rash•

Fever•

Dark colored urine•

Sweating•

Increased sputum production•

Salivation•

Watery eyes•

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Peripheral neuropathy (tingling and numbness of feet and hand)• Increased liver enzymes•

Jaundice•

Increased uric acid level in blood•

Visual impairment•

We do not find any test report showing the disease of tuberculosis. So it is not clear why this particular medicine was prescribed to the patient. So we have seen that medicines were prescribed for malaria but no malaria was detected and now medicine was prescribed for tuberculosis but no report regarding tuberculosis has been submitted. In a very common understanding the common men understand that when there is no disease, there should be no medicine for that particular disease but in this case the medicine were prescribed for the disease which was not there altogether. It can attribute negligence on the part of the opposite parties. We have seen the history sheet of the patient dated 4 May 2010 in which it has been written

"Bronchoscopy planned". But till 6 May 2010 there is nothing written about bronchoscopy in the history sheet of the patient, instead on 6 May 2010 the patient was put on ventilatory support. On 14 May 2010 we find the entry of grade-II bedsores. When a pressure ulcer reaches the second stage, the sore has broken through the top layer of the skin and part of the layer below. This typically results in a shallow, open wound.

A stage 2 pressure ulcer may appear as a shallow, crater-like wound or a blister containing a clear or yellow fluid.

Some symptoms associated with stage 2 pressure ulcers include:

pain•

an ulcer containing pus or liquid•

swelling and discoloration around the sore•

When the patient was in the hospital how did the bedsore from grade-I reached grade -II ? It shows that the internal atmosphere of the ICU was not perfect and it was not totally germfree or bacteria free or infection free.

We have seen the case history of the patient dated 17 May 2010 where it has been written "no indication of Dialytic support at present but if septicaemia is not controlled he may need Dialytic Support". On 18^thMay 210 the patient was referred to SGPGI. We have seen the patient's bill which includes the fee for bronchoscopy of ₹ 3500. It means that bronchoscopy was done on the patient. Before going further it would be better to see that what is bronchoscopy and what happens during bronchoscopy. What is bronchoscopy?

Bronchoscopy is a procedure to look directly at the airways in the lungs using a thin, lighted tube (bronchoscope). The bronchoscope is put in the nose or mouth. It is moved down the throat

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and windpipe (trachea), and into the airways. A healthcare provider can then see the voice box (larynx), trachea, large airways to the lungs (bronchi), and smaller branches of the bronchi (bronchioles).

There are 2 types of bronchoscope: flexible and rigid. Both types come in different widths. A rigid bronchoscope is a straight tube. It's only used to view the larger airways. It may be used within the bronchi to:

Remove a large amount of secretions or blood•

Control bleeding•

Remove foreign objects•

Remove diseased tissue (lesions)•

Do procedures, such as stents and other treatments•

A flexible bronchoscope is used more often. Unlike the rigid scope, it can be moved down into the smaller airways (bronchioles). The flexible bronchoscope may be used to:

Place a breathing tube in the airway to help give oxygen•

Suction out secretions•

Take tissue samples (biopsy)•

Put medicine into the lungs•

Why might I need bronchoscopy?

A bronchoscopy may be done to diagnose and treat lung problems such as:

Tumors or bronchial cancer•

Airway blockage (obstruction)•

Narrowed areas in airways (strictures)•

Inflammation and infections such as tuberculosis (TB), pneumonia, and fungal or parasitic lung infections

• Interstitial pulmonary disease• Causes of persistent cough• Causes of coughing up blood• Spots seen on chest X-rays• Vocal cord paralysis•

Diagnostic procedures or treatments that are done with bronchoscopy include:

Biopsy of tissue•

Collection of sputum•

Fluid put into the lungs and then removed (bronchoalveolar lavage or BAL) to diagnose lung disorders

• Removal of secretions, blood, mucus plugs, or growths (polyps) to clear airways• Control of bleeding in the bronchi•

Removing foreign objects or other blockages•

Laser therapy or radiation treatment for bronchial tumors• Placement of a small tube (stent) to keep an airway open (stent placement)•

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Draining an area of pus (abscess)• Your healthcare provider may also have other reasons to advise a bronchoscopy. What are the risks of bronchoscopy?

In most cases, the flexible bronchoscope is used, not the rigid bronchoscope. This is because the flexible type has less risk of damaging the tissue. People can also handle the flexible type better. And it provides better access to smaller areas of the lung tissue. All procedures have some risks. The risks of this procedure may include:

Bleeding•

Infection•

Hole in the airway (bronchial perforation)•

Irritation of the airways (bronchospasm)•

Irritation of the vocal cords (laryngospasm)•

Air in the space between the lung covering (pleural space) that causes the lung to collapse (pneumothorax)

• Your risks may vary depending on your general health and other factors. Ask your healthcare provider which risks apply most to you. Talk about any concerns you have. In some cases, a person may not be able to have a bronchoscopy. Reasons for this can include:

Severe narrowing or blockage of the trachea (tracheal stenosis)•

High blood pressure in the lungs' blood vessels (pulmonary hypertension)• Severe coughing or gagging•

Low oxygen levels•

If you have high levels of carbon dioxide in the blood (hypercapnia) or severe shortness of breath, you may need to be on a breathing machine before the procedure. This is done so oxygen can be sent right into your lungs while the bronchoscope is in place. How do I get ready for bronchoscopy?

Give your healthcare provider a list of all of the medicines you take. This includes prescription and over-the-counter medications, vitamins, herbs, and supplements. You may need to stop certain medicines before the procedure.

You will be asked to sign an informed consent document. This document explains the benefits and risks of the procedure. Make sure all of your questions are answered before you sign it. If the procedure is being done on an outpatient basis, arrange to have someone drive you home. What happens during bronchoscopy?

You may have your procedure as an outpatient. This means you go home the same day. Or it may be done as part of a longer stay in the hospital. The way the procedure is done may vary. It

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depends on your condition and your healthcare provider's methods. In most cases, a bronchoscopy will follow this process:

You may be asked to remove your clothes. If so, you will be given a hospital gown to wear. You may be asked to remove jewelry or other objects.

1.

You will sit on a procedure table with the head raised like a chair.2. An IV (intravenous) line may be put into your arm or hand.3. You may be given antibiotics before and after the procedure.4. You will be awake during the procedure. You will be given medicine to help you relax (sedative). You will also be given a liquid medicine to numb your nose and throat. For a rigid bronchoscopy, you will be given general anesthesia. This is medicine that prevents pain and lets you sleep through the procedure.

5.

You may be given oxygen through a nasal tube or face mask. Your heart rate, blood pressure, and breathing will be watched during the procedure.

6.

Numbing medicine will be sprayed into the back of your throat. This is to prevent gagging as the bronchoscope is passed down your throat. The spray may have a bitter taste to it. Once the tube passes down your throat the gagging feeling will go away.

7.

You won't be able to talk or swallow saliva during the procedure. Saliva will be suctioned from your mouth as needed.

8.

The healthcare provider will move the bronchoscope down your throat and into the airways. You may have some mild pain. Your airway will not be blocked. You can breathe around the bronchoscope. You will be given extra oxygen if needed.

9.

As the bronchoscope is moved down, the lungs will be examined. Tissue samples or mucus may be taken for testing. Other procedures may be done as needed. This may include giving medicine or stopping bleeding.

10.

When the exam and other procedures are done, the bronchoscope will be taken out.11. What happens after bronchoscopy?

After the procedure, you will spend some time in a recovery room. You may be sleepy and confused when you wake up from general anesthesia or sedation. Your healthcare team will watch your vital signs, such as your heart rate and breathing. A chest X-ray may be done right after the procedure. This is to make sure your lungs are okay. You may be told to gently cough up and spit your saliva into a basin. This is so a nurse can check your secretions for blood.

You may have some mild pain in your throat. You will not be allowed to eat or drink until your gag reflex has returned. You may notice some throat soreness and pain with swallowing for a few days. This is normal. Using throat lozenges or gargle may help. If you had an outpatient procedure, you will go home when your healthcare provider says it's OK. Someone will need to drive you home.

At home, you can go back to your normal diet and activities if instructed by your healthcare provider. You may need to not do strenuous physical activity for a few days. Call your healthcare provider if you have any of the below:

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Fever of 100.4°F (38°C) or higher, or as advised by your provider• Redness or swelling of the IV site•

Blood or other fluid leaking from the IV site• Coughing up significant amounts of blood•

Chest pain•

Severe hoarseness•

Trouble breathing•

Your healthcare provider may give you other instructions after the procedure.

Risks and Side Effects

A bronchoscopy is usually safe, but there are a few risks. If your oxygen levels drop during the procedure, the doctor may give you oxygen.

Afterward, you could get a fever or pneumonia. Or you might notice some bleeding. It's rare, but a bronchoscopy can cause a collapsed lung. This is treatable, but you'll have to stay in the hospital. Your doctor may order a chest X-ray after a bronchoscopy to check for any problems. For bronchoscopy, you should be asked to sign an informed consent document. This document explains the benefits and risks of the procedure. We did not find any such consent document. The opposite parties also did not mention any such consent document for bronchoscopy. In the evidence filed by the opposite party we did not find the procedure of bronchoscopy and the consent document taken before bronchoscopy either from the patient or from the attendants of the patient. It is not clear as to what was the emergency situation to perform bronchoscopy. The complainant has said that due to this bronchoscopy the deceased went unconscious and laryngeal edema developed. So as we have seen the patient was on ventilator and his condition was not very sound despite of it bronchoscopy was performed, so this treatment was not in accordance with medical protocol for such patient.

On 18 May, 2010 it has been written in the case history of the patient "patient attendant grant to shift patient to SGPGI , formalities being done". On the same date at 7:10 PM it has been written "no pulse/no BP/no heartbeat/pupil dilated and fixed, non-reacting". On the same date it has also been written "patient is being referred to SGPGI for further management". Now it has become clear that the patient was with the opposite parties till his last breath. The opposite party no.1 could not manage the treatment as per medical protocol and ultimately when they came to know that the patient will die, they referred him to SGPGI . Now the question arises that if they were failed to manage the patient treatment, why did they not refer the patient to SGPGI earlier. A number of tests have been performed by the opposite party no1 of no result. The patient was put on ventilator for so many days without any specific report. They also suggested for dialysis but before they could put him on dialysis , he breathed his last. The complexity of the human body and the uncertainty involved in the medical procedure are of such great magnitude that it is impossible for a Doctor to guarantee a successful result; and the only assurance that he can give, or can be understood to have given by implication is that he is possessed of requisite skill in that branch of profession which he is practising and while

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undertaking the performance of the task entrusted to him, he would be exercising his skills with reasonable competence. An ordinary physician or surgeon is not expected to be either a clodhopper or feckless practitioner of profession, as much as, he is not expected to be a paragon, combining qualities of polymath or prophet as in the realm of diagnosis and treatment, there is ample scope for genuine difference of opinion; and a Doctor cannot be treated as negligent merely because his conclusion differs from that of other persons in the profession, or because he has displayed less skill or knowledge than others would have shown. The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of, if acting with ordinary care.

Furthermore, a golden principle of law has been laid down by the Hon'ble Apex Court in Jacob Mathew Vs. State of Punjab, (AIR 2005 SC 3180) that no sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient as the professional reputation of the person is at stake. A single failure may cost him dear in his career. Even in civil jurisdiction, the rule of res ipsa loquitor is not an universal application and has to be applied with extreme care and caution to the cases of professional negligence and in particular that of the doctors, else it would be counter productive. Simply because a patient has not favourably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per-se by applying the doctrine of res ipsa loquitor. Yet, another golden principle of law has been laid down by the Hon'ble Apex Court in Indian Medical Association Vs. V.P. Santha's III (1995) CPJ 1 (SC) at para 37 that "it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiencyrendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the out patient card containing the warning or use of wrong gas during the course of an anaesthetic or leaving inside the patient swabs or other items of operating equipment after surgery.

Furthermore, it has been observed in Malay Kumar Ganguli's case (AIR 2010 SC 1162) that"

charge of professional negligence on a medical person is a serious one as it affects his professional statusand reputation and as such, the burden of proof would be more onerous. A doctor cannot be held negligent only because something has gone wrong. He also cannot be held liable for mischance or misadventure or for an error in judgment in making a choice when two options are available. The mistake in diagnosis is not necessarily a negligent diagnosis." In the instant matter, thus a simple test, in the light of aforesaid observations, needs to be conducted in order to ascertain whether the Doctor is guilty of any tortious act of negligence/battery amounting to deficiency in conducting a surgery in the delivery of child and not properly attending the patient, the complainant and consequently, liable to pay damages for leaving cotton mass in the abdomen / stomach due to failure in surgery and deteriorating condition of the patient.

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Now, it is required to be seen whether an expert report is necessary in each and every case relating to medical negligence or not ?

It has been observed by the Hon'ble Apex Court in Indian Medical Association Vs. V.P. Santha III (1995) CPJ 1 (SC) at para 37 that "it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency rendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the out patient card containing the warning or use of wrong gas during the course of an anaesthetic or leaving inside the patient swabs or other items of operating equipment after surgery.

Furthermore, in B. Krishna Rao Vs. Nikhil Super Speciality Hospital 2010 (V) SCC513 at para 40 the Hon'ble Apex Court was pleased to hold that it is not necessary to have opinion of the expert in each and every case of medical negligence.

The Hon'ble Apex Court was pleased to further hold in Nizam Institute of Medical Sciences Vs. Prashant S. Dhananka and others 2009 (VI) SCC 1 that "in a case of medical negligence, once initial burden has been discharged by the complainant by making of a case of negligence on the part of the hospital or the doctor concerned, the owner then shifts on the hospital or to the attending doctors and it is for the hospital to satisfy the court that there was no lack of care or diligence".

A doctrine or rule of evidence in tort law that permits an inference or presumption that a defendant was negligent in an accident injuring the plaintiff on the basis of circumstantial evidence if the accident was of a kind that does not ordinarily occur in the absence of negligence a plaintiff who establishes the elements of res ipsa loquitur can withstand a motion for summary judgment and reach the jury without direct proof of negligence— Cox v. May Dept. Store Co., 903 P.2d 1119 (1995).

In Byrne vs Boadle, this maxim was used for the first time where the complainant was injured by a barrel that dropped from the window of the defendant. In the abovementioned case, Pollock, C. B., said "here are many incidents from which no presumption of negligence can arise, but this is not true in every case. It is the duty of persons who keep barrels in a warehouse to take care that they do not roll out and I think that such a case will, beyond all doubt, afford prima facie proof of negligence."

This doctrine intends to help direct the court proceedings to a conclusion, especially if it is established through the implication of this doctrine's rule that the injury caused to the claimant would not have occurred or taken place if the defendant wasn't negligent. This also gives enough cause and evidence to hold the defendant liable for his negligent actions. The thing speaks for itself is the gist of the maxim Res Ipsa Loquitur Maxim. What are the essentials of this maxim.

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The injury caused to the plaintiff shall be a result of an act of negligence.1. There is a lack of evidence, or the evidence presented before the court is insufficient to establish the possibilities of the fault of the plaintiff or third party.

2.

The defendant owes a duty of care towards the plaintiff, which he has breached.3. There is a significant degree of injury caused to the plaintiff.4.

Applicability of Doctrine of Res Ipsa Loquitur.

The maxim of res ipsa loquitur came into force to benefit the plaintiff as he can use circumstantial evidence to establish negligence.

Consequently, it shifts the burden of proof on the defendant, logic being, where there is an event of unexplained cause, usually, the one that does not occur without the defendant's negligence in controlling the action which has caused the injury to the claimant or destroyed his goods.

In this scenario, the court shall presume negligence on the part of the defendant in such a case unless it includes an appropriate explanation compatible with his taking reasonable care. In Achutrao Haribhau Khodwa and Others vs. State of Maharashtra and Others, it was considered that the maxim should not be applied in the case of general incidences of neglect and shall only be reflected when there is a significant degree of injury caused.

Section 106 of the Indian Evidence Act

Section 106 of the Act provides that when any fact is especially within the knowledge of any person, the burden of proving that fact is upon him.

Res ipsa loquitur is a Latin phrase that means "the thing speaks for itself." In personal injury law, the concept of res ipsa loquitur (or just "res ipsa" for short) operates as an evidentiary rule that allows plaintiffs to establish a rebuttable presumption of negligence on the part of the defendant through the use of circumstantial evidence.

This means that while plaintiffs typically have to prove that the defendant acted with a negligent state of mind, through res ipsa loquitur, if the plaintiff puts forth certain circumstantial facts, it becomes the defendant's burden to prove he or she was not negligent. Res Ipsa Loquitur and Evidence Law

Accidents happen all the time, and the mere fact that an accident has occurred doesn't necessarily mean that someone's negligence caused it. In order to prove negligence in a personal injury lawsuit, a plaintiff must present evidence to demonstrate that the defendant's negligence resulted in the plaintiff's injury. Sometimes, direct evidence of the defendant's negligence doesn't exist, but plaintiffs can still use circumstantial evidence in order to establish negligence.

Circumstantial evidence consists of facts that point to negligence as a logical conclusion rather than demonstrating it outright. This allows judges and juries to infer negligence based on the totality of the circumstances and the shared knowledge that arises out of human experience. Res

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ipsa is one type of circumstantial evidence that allows a reasonable fact finder to determine that the defendant's negligence caused an unusual event that subsequently caused injury to the plaintiff.

This doctrine arose out of a case where the plaintiff suffered injuries from a falling barrel of flour while walking by a warehouse. At the trial, the plaintiff's attorney argued that the facts spoke for themselves and demonstrated the warehouse's negligence since no other explanation could account for the cause of the plaintiff's injuries.

As it has developed since then, res ipsa allows judges and juries to apply common sense to a situation in order to determine whether or not the defendant acted negligently. Since the laws of personal injury and evidence are determined at the state level, the law regarding res ipsa loquitur varies slightly between states. That said, a general consensus has emerged, and most states follow one basic formulation of res ipsa.

Under this model for res ipsa, there are three requirements that the plaintiff must meet before a jury can infer that the defendant's negligence caused the harm in question:

The event doesn't normally occur unless someone has acted negligently;• The evidence rules out the possibility that the actions of the plaintiff or a third party caused the injury; and

• The type of negligence in question falls with the scope of the defendant's duty to the plaintiff.

• As mentioned above, not all accidents occur because of someone else's negligence. Some accidents, on the other hand, almost never occur unless someone has acted negligently. Going back to the old case of the falling flour-barrel, it's a piece of shared human knowledge that things don't generally fall out of warehouse windows unless someone hasn't taken care to block the window or hasn't ensured that items on the warehouse floor are properly stored. When something does fall out of a warehouse window, the law will assume that it happened because someone was negligent.The second component of a res ipsa case hinges on whether the defendant carries sole responsibility for the injury. If the plaintiff can't prove by a preponderance of the evidence that the defendant's negligence cause the injury, then they will not be able to recover under res ipsa.

States sometimes examine whether the defendant had exclusive control over the specific instrumentality that caused the accident in order to determine if the defendant's negligence caused the injury. For example, if a surgeon leaves a sponge inside the body of a patient, a jury can infer that the surgeon's negligence caused the injury since he had exclusive control over the sponges during the operation.

In addition to the first two elements, the defendant must also owe a duty of care to protect the plaintiff from the type of injury at issue in the suit. If the defendant does not have such a duty, or if the type of injury doesn't fall within the scope of that duty, then there is no liability.

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For example, in many states, landowners don't owe trespassers any duty to protect them against certain types of dangers on their property. Thus, even if a trespasser suffers an injury that was caused by the defendant's action or inaction and that wouldn't normally occur in the absence of negligence, res ipsa loquitur won't establish negligence since the landowner never had any responsibility to prevent injury to the trespasser in the first place. Res ipsa only allows plaintiffs to establish the inference of the defendant's negligence, not to prove the negligence completely. Defendants can still rebut the presumption of negligence that res ipsa creates by refuting one of the elements listed above.

For example, the defendant could prove by a preponderance of the evidence that the injury could occur even if reasonable care took place to prevent it. An earthquake could shake an item loose and it could fall out of the warehouse window, for instance.

A defendant could also demonstrate that the plaintiff's own negligence contributed to the injury. To go back to the flour-barrel example, if the defendant shows that the plaintiff was standing in an area marked as dangerous it could rebut the presumption of negligence created by res ipsa. Finally, the defendant could establish that he did not owe the plaintiff a duty of care under the law, or that the injury did not fall within the scope of the duty owed. For example, if the law only imposes a limited duty on the defendant not to behave recklessly, then res ipsa will not help the plaintiff by creating an inference of negligence since a negligent action would not violate the duty owed to the plaintiff.

According to the Blacks Law Dictionary the maxim is defined as the doctrine providing that, in some circumstances, the mere fact of accidents occurrence raises an inference of negligence so as to establish a prima facie (at first sight) case. It is a symbol for that rule that the fact of the occurrence of an injury taken with the surrounding circumstances may permit an inference or recipes omission of negligence, or make out a plaintiff's prima facie case and present a question of fact for defendant to meet with and explanation. It is merely a short way of saying that the circumstances attendant on the accident are of such a nature to justify a jury in light of common sense and past experience in inferring that the accident was probably the result of the defendant's negligence, in the absence of explanation or other evidence which the jury believes. Its use in clinical negligence gained some traction before Bolam and Bolitho. Mahon v Osborne [1939] 1 All ER 535, is an early example of the application of res ipsa loquitur in a case where a surgical swab had been left inside a patient's body.

In Clarke v Worboys (1952) Times, 18 March, CA, a patient noticed burns on her buttock shortly after surgical excision of a breast tumour. The surgery involved cauterisation. The Court of Appeal held that this was a case where res ipsa loquitur applied. The outcome was not one that would ordinarily occur in the absence of negligence, and the surgical team were unable to explain how the injury was caused.

In Cassidy v Ministry of Health [1951] 2 KB 343, Denning LJ succinctly summarised the maxim's application to clinical negligence cases: "I went into hospital to be cured of two stiff

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fingers. I have come out with four stiff fingers and my hand is useless. That should not happen if due care had been used. Explain it if you can."

Ng Chun Pui Vs Lee Chuen Tat, the first defendant was driving a coach owned by the second defendant westwards in the outer lane of dual carriageway in Hong Kong. Suddenly the course across the central reservation and collided with a public bus travelling in the inner lane of the other carriageway, killing one passenger in the bus and injuring the driver and three others on the bus. The plaintiff could not prove that the defendants were negligent and had caused the accident. They however proceeded on the basis of Res Ipsa Loquitur and shifted the onus on the defendants to prove that they were not negligent. However, they failed to do so. And the judicial committee of the Privy Council held the defendants liable for the plaintiffs injuries. MarkLuney and Ken Opliphant, Tort Law Text And Materials (Oxford University Press, New York, 2000) pp 173-175

In A.S. Mittal &Anr Vs State Of UP &Ors , AIR 1979 SC 1570 , the defendants had organised an eye camp at Khurja along with the Lions Club. 88 low risk cataract operations were undertaken during the period of the camp. It was however, disastrous as many of those who had been operated upon lost their eyesight due to post medical treatment. Proceedings against the government initiated for negligence of the doctors. Damages worth Rs.12,500/- were paid as interim belief to each of the aggrieved. The decision was on the basis of Res Ipsa Loquitur as the injury would not ave occurred had the doctors not been negligent in not having followed up with post-operation treatment. Res Ipsa Loquitur can be applied in matters where are the procedures have not been followed and is not just limited to the commission of an act. We can define 'Medical negligence' as the improper or unskilled treatment of a patient by a medical practitioner. This includes negligence in taking care from a nurse, physician, surgeon, pharmacist, or any other medical practitioner. Medical negligence leads to 'Medical malpractices' where the victims suffer some sort of injury from the treatment given by a doctor or any other medical practitioner or health care professional.

Medical negligence can occur in different ways. Generally, it occurs when a medical professional deviates from the standard of care that is required.

So, we can say that any kind of deviation from the accepted standards of medication and care is considered to be medical negligence and if it causes injury to a patient then the doctor who operated on him, other staff and/or hospital may be held liable for this. Some of the common categories of medical negligence are as follows:

Wrong diagnosis - When someone goes to a hospital, clinic or medical room, etc. the first step after admittance is the diagnosis. Diagnosing symptoms correctly is critical and important to provide medical care to any patient. However, if a patient is not treated properly due to any mistake in diagnosis, the doctor can be made liable for any further injury or damages caused as a result of the wrong diagnosis.

•

Delay in diagnosis - A delayed diagnosis is treated as medical negligence if another doctor would have reasonably diagnosed the same condition in a timely fashion. A delay in diagnosis can cause undue injury to the patient if the illness or injury is left to worsen with time rather than being treated. Obviously, any delay in the identification and

•

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treatment of an injury can reduce the chance of recovery for the patient.

Error in surgery - Surgical operations require an enormous level of skill and it should be done with due care and caution because even the slightest mistakes can have profound effects on the patient. The wrong-site surgery, lacerations of any internal organ, severe blood loss, or a foreign object being left in the body of the patients, all this comes under Surgical error.

•

Unnecessary surgery - Unnecessary surgery is usually associated with the misdiagnosis of patient symptoms or a medical decision without proper consideration of other options or risks. Alternatively, sometimes surgery is chosen over conventional treatments for their expediency and ease compared to other alternatives.

•

Errors in the administration of anesthesia - Anesthesia is a risky part of any major medical operation and requires a specialist (anesthesiologist) to administer and monitor its effect on the patient. Prior to any medical procedure requiring anesthesia, the anesthesiologist has to review the patient's condition, history, medications, etc. to determine the most suitable of all the medicine to use. Anesthesia malpractice can happen even during the pre-operation medical review or during the procedure itself.

•

Childbirth and labor malpractice - Childbirth is a difficult event for a woman and it becomes worse if not handled properly by the doctors and nurses. There are many instances of medical negligence during childbirth including the mishandling of a difficult birth, complications with induced labor, misdiagnosis of a newborn medical condition, etc.

•

Long-Term negligent treatment - Medical negligence can also occur in subtle ways over the course of a long treatment period. Usually, the negligence can take the shape of a failure to follow up with treatment, or a doctor's failure to monitor the effects of the treatment properly.

• A standard of care specifies the appropriate treatment and medication procedure as per the requirements that should be taken into account by a doctor while providing the treatment to his patients. The care should not be of the highest degree nor the lowest. Here, the degree means the level of care an ordinary health care professional, with the same training and experience, would render in similar circumstances in the same community. This is the critical question in medical malpractice cases and if the answer is "no," and you suffered injury as a result of the poor treatment, you may file a suit for medical malpractice.

In the case of Dr. Laxman Balkrishna Joshi Vs. Dr. Trimbak Bapu Godbole and Anr.[ 1969 AIR 128], the Supreme Court held that a doctor has certain aforesaid duties and a breach of any of those duties can make him liable for medical negligence. A doctor is required to exercise a reasonable degree of care that is set for this profession.

Dr. Kunal Saha vs Dr. Sukumar Mukherjee on 21 October, 2011 ( NC) original petition number 240 OF 1999 is one of the most important case regarding medical negligence. The brief facts of the case are-

Toxic Epidermal Necrolysis ( TEN ) is a rare and deadly disease. It is an extoliative dermatological disorder of unknown cause. A patient with TEN loses epidermis in sheet-like fashion leaving extensive areas or denuded dermis that must be treated like a larze, superficial, partial-thickness burn wound. The incidence of TEN has been reported at 1 to 1.3 per million per year. The female-male ratio is 3:2. TEN accounts for nearly 1% of drug reactions that

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require hospitalization. TEN has a mortality rate of 25 to 70%. Smt. Anuradha Saha (in short Anuradha), aged about 36 years wife of Dr. Kunal Saha (complainant) became the unfortunate victim of TEN when she alongwith the complainant was in India for a holiday during April-May 1998. She and the complainant although of Indian original were settled in the United States of America. The complainant is a doctor by profession and was engaged in research on HIV / AIDS for the past fifteen years. Anuradha after acquiring her Graduation and Masters Degree was pursuing a Ph.D. programme in a university of U.S.A. She was a Child Psychologist by profession. Anuradha showed certain symptoms of rashes over her body and received treatment at the hands of Opposite Parties and some other doctors as outdoor patient uptil 10.05.1998 and she was admitted in Advanced Medicare and Research Institute Limited, Calcutta (for short, AMRI), on 11.05.1998, where she was treated by the above-named Opposite Parties and other doctors uptil 16.05.1998. As there was no improvement in her condition, she was shifted to Breach Candy Hospital, Mumbai, on 17.05.1998 by an air ambulance. She was treated in Breach Candy Hospital from 17.05.1998 evening till she breathed her last on 28.05.1998.

Our Complainant as husband of Anuradha felt that the doctors who treated Anuradha and the hospitals where she was treated were grossly negligent in her treatment and her death was occasioned due to gross negligence of the treating doctors and hospitals. Complainant, accordingly, got issued a legal notice to as many as 26 persons i.e. various doctors who treated Anuradha between end of April to the date of her death alleging negligence and deficiency in service on their part and claiming a total compensation exceeding Rs.55 crores from them. Complainant, thereafter filed the present complaint on 09.03.1999 before this Commission claiming a total compensation of Rs. Rs.77,07,45,000/- ( Seventy Seven Crores Seven Lakhs Fourty Five Thousand only). Later he also filed another complaint no. 179 of 2000 in this Commission against Breach Candy Hospital, its doctors and functionaries claiming a further compensation of Rs.25.30 crore (though the said complaint was later on withdrawn), thereby making claim of compensation exceeding Rs.102 crores, perhaps the highest ever claimed by any complainant for medical negligence before any consumer fora established under the provisions of Consumer Protection Act, 1986 ( in short, the Act). These are some of the facts which make the present case extra ordinary.

The present complaint was filed by the complainant against the above-named opposite parties, namely, Dr. Sukumar Mukherjee, Dr. B. Haldar (Baidyanath Halder), Advanced Medicare and Research Institute Limited ( in short the AMRI Hospital ) and Dr. Balram Prasad and Dr.Abani Roy Chowdhury (physician) and Dr. Kaushik Nandy (plastic surgeon), the Directors of the AMRI Hospital and others claiming a total compensation of Rs. Rs.77,07,45,000/- under different heads alleging various acts of commission and omission on the part of the doctors and hospital amounting to negligence and deficiency in service. Complainant through his brother- in-law Malay Kumar Ganguly also filed criminal complaint against some of the doctors and the hospital under section 304A IPC.

The complaint was resisted by the doctors and the hospital on a variety of grounds thereby denying any medical negligence or deficiency in service on their part. Parties led voluminous documentary and oral evidence and testimonies of some of the witness were even recorded

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through video conferencing through a Local Commissioner. After a protracted trial and hearing and on consideration of the evidence and material so produced on record and taking note of the legal position governing the question of medical negligence, this Commission ( by a three Member Bench presided over by the then President) dismissed the complaint by an order dated 01.06.2006 holding as under:

In the result, we reiterate that Doctors or Surgeons do not undertake that they will positively cure a patient. There may be occasions beyond the control of the medical practitioner to cure the patients. From the record, it would be difficult to arrive at the conclusion that the injection Depo-Medrol prescribed by Dr. Mukherjee was of such excessive dose that it would amount to deficiency in service by him which was his clinical assessment.

Thereafter, with regard to the alleged deficiency in the treatment given to Mrs. Anuradha by Opposite Party Doctors 2, 3, 5 and 6, there is no substance. The contention against the hospital that it was not having Burns-Ward, and therefore, the deceased suffered is also without substance. Hence, this complaint is dismissed. There shall be no order as to costs. Aggrieved by the dismissal of his complaint, the complainant filed Civil Appeal (No.1727 of 2007) in the Hon'ble Supreme Court. It would appear that even before the said appeal was filed before the Hon'ble Supreme Court, the Supreme Court was seized of the matter in Criminal Appeal Nos.1191-94 of 2005 filed by Malay Kumar Ganguly, the complainant in the criminal complaint, against the Orders passed by the Calcutta High Court. Since the Criminal Appeals and the Civil Appeal filed by the complainant in the present complaint raised the same questions of fact and law, the Hon'ble Supreme Court heard all the appeals together and decided the same by means of a detailed judgment dated 07.8.2009. By the said order, the Apex Court dismissed the Criminal Appeals filed by Shri Malay Kumar Ganguly but allowed the Civil Appeal No. 1727 of 2007 filed by the complainant and set aside the order dated 01.6.2006 passed by this Commission dismissing the complaint and remanded the matter to this Commission for the limited purpose of determining the adequate compensation, which the complainant is entitled to receive from the subsisting opposite parties by observing as under:

So far as the judgment of the Commission is concerned, it was clearly wrong in opining that there was no negligence on the part of the Hospital or the doctors. We, are, however, of the opinion, keeping in view the fact that Dr. Kaushik Nandy has done whatever was possible to be done and his line of treatment meets with the treatment protocol of one of the experts viz.. Prof. Jean Claude Roujeau although there may be otherwise difference of opinion, that he cannot be held to be guilty of negligence.

We remit the case back to the Commission only for the purpose of determination of the quantum of compensation. We, keeping in view the stand taken and conduct of AMRI and Dr. Mukherjee, direct that costs of Rs.5,00,000 and Rs.1,00,000 would be payable by AMRI and Dr. Mukherjee respectively.

We further direct that if any foreign experts are to be examined it shall be done only through video conferencing and at the cost of the respondents.

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Summary In view of the foregoing discussion, we conclude as under:

The facts of this case viz., residence of the complainant and Anuradha (deceased) in USA and they working for gain in that country; Anuradha having been a victim of a rare and deadly disease Toxic Epidermal Necrolysis (TEN) when she was in India during April-May 1998 and could not be cured of the said disease despite her treatment at two superspeciality medical centres of Kolkata and Mumbai and the huge claim of compensation exceeding Rs.77 crores made by the complainant for the medical negligence in the treatment of Anuradha makes the present case somewhat extraordinary.

The findings given and observations made by the Supreme Court in its judgment dated 07.08.2009 are absolutely binding on this Commission not only as ratio decidendi but also as obiter dicta also, the judgment having been rendered by the Supreme Court in appeal against the earlier order passed by a three Member Bench of this Commission and, therefore, no attempt can be allowed to read down / dilute the findings and observations made by the Supreme Court because the Supreme Court has remitted the complaint to this Commission only for the purpose of determination of the quantum of compensation after recording the finding of medical negligence against the opposite parties and others.

The task entrusted to the Commission may appear to be simple but the facts of the present case and the voluminous evidence led on behalf of the complainant has made it somewhat arduous. Still difficult was the task of apprortionment of the liability to pay the awarded amount by the different opposite parties and perhaps it was for this reason that the Supreme Court has remitted the matter to this Commission.

Multiplier method provided under the Motor Vehicles Act for calculating the compensation is the only proper and scientific method for determination of compensation even in the cases where death of the patient has been occasioned due to medical negligence / deficiency in service in the treatment of the patient, as there is no difference in legal theory between a patient dying through medical negligence and the victim dying in industrial or motor accident. The award of lumpsum compensation in cases of medical negligence has a great element of arbitrariness and subjectivity.

The foreign residence of the complainant or the patient and the income of the deceased patient in a foreign country are relevant factors but the compensation awarded by Indian Fora cannot be at par which are ordinarily granted by foreign courts in such cases. Socio economic conditions prevalent in this country and that of the opposite parties / defendants are relevant and must be taken into consideration so as to modulate the relief. A complainant cannot be allowed to get undue enrichment by making a fortune out of a misfortune. The theoretical opinion / assessment made by a Foreign Expert as to the future income of a person and situation prevalent in that country cannot form a sound basis for determination of future income of such person and the Commission has to work out the income of the deceased having regard to her last income and future prospects in terms of the criteria laid down by the Supreme Court. There exists no straight jacket formula for apportionment of the awarded compensation amongst various doctors and hospitals when there are so many actors who are responsible for negligence and the apportionment has to be made by evolving a criteria / formula which is just going by the nature and extent of medical negligence and deficiency in service established on

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the part of different doctors and hospitals. On a consideration of the entirety of the facts and circumstances, evidence and material brought on record, we hold that overall compensation on account of pecuniary and non pecuniary damages works out to Rs.1,72,87,500/- in the present case, out of which we must deduct 10% amount on account of the contributory negligence / interference of the complainant in the treatment of Anuradha. That will make the net payable amount of compensation to Rs.1,55,58,750/- (rounded of to Rs.1,55,60,000/-). From this amount, we must further deduct a sum of Rs.25,93,000/- which was payable by Dr. Abani Roy Chowdhury (deceased) or his Legal Representative as the complainant has forgone the claim against them. In view of the peculiar facts and circumstances of the case and as a special case, we have awarded a sum of Rs. 5,00,000/- as cost of litigation in the present proceedings. The above amount shall be paid by opposite parties no.1 to 4 to the complainant in the following manner:

Dr. Sukumar Mukherjee-opposite party no.1 shall pay a sum of Rs.40,40,000/- (Rupees Forty Lakh Forty Thousand only) i.e. [Rs.38,90,000/- towards compensation and Rs.1,50,000/- as cost of litigation].

i.

Dr. B. Haldar (Baidyanth Halder)-opposite party no.2 shall pay a sum of Rs.26,93,000/- (Rupees Twenty Six Lakh Ninety Three Thousand only) i.e. [Rs.25,93,000/- towards compensation and Rs.1,00,000/- as cost of litigation]

ii.

AMRI hospital-opposite party no.3 shall pay a sum of Rs.40,40,000/- (Rupees Forty Lakh Forty Thousand only ) i.e. [Rs.38,90,000/- towards compensation and Rs.1,50,000/- as cost of litigation.

iii.

(iv) Dr. Balram Prasad-opposite party no.4 shall pay a sum of Rs.26,93,000/- (Rupees Twenty Six Lakh Ninety Three Thousand only) i.e. [Rs.25,93,000/- towards compensation and Rs.1,00,000/- as cost of litigation] The opposite parties are directed to pay the aforesaid amounts to the complainant within a period of eight weeks from the date of this order, failing which the amount shall carry interest @ 12% p.a. w.e.f. the date of default."

The in the above-mentioned case the Hon'ble Supreme Court has held"Multiplier method provided under the Motor Vehicles Act for calculating the compensation is the only proper and scientific method for determination of compensation even in the cases where death of the patient has been occasioned due to medical negligence / deficiency in service in the treatment of the patient, as there is no difference in legal theory between a patient dying through medical negligence and the victim dying in industrial or motor accident. The award of lumpsum compensation in cases of medical negligence has a great element of arbitrariness and subjectivity". So it is also one of a further condition of the compensation in cases of medical negligence.

Now in the last we have to see that whether the room or ICU unit where the patient was kept or the room where Broncoscopy was done and other tests and examinations were done, was germfree, infection free or not. The opposite parties counsel did not say a single word about it. When the patient is admitted to hospital and as we know that patients of various diseases come to the hospital and they left the bacteria or virus or other pathogens behind them when they

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leave the hospital, therefore it is the prime duty of the hospital staff to make the atmosphere germ free. A patient who comes from outside into the hospital may become infectious by the germs or bacteria or virusus present in the hospital atmosphere. The guidelines have been made for the maintenance of the ICU etc.

Guidelines for prevention of hospital acquired infections

These guidelines, written for clinicians, contains evidence-based recommendations for the prevention of hospital acquired infections Hospital acquired infections are a major cause of mortality and morbidity and provide challenge to clinicians. Measures of infection control include identifying patients at risk of nosocomial infections, observing hand hygiene, following standard precautions to reduce transmission and strategies to reduce VAP, CR-BSI, CAUTI. Environmental factors and architectural lay out also need to be emphasized upon. Infection prevention in special subsets of patients - burns patients, include identifying sources of organism, identification of organisms, isolation if required, antibiotic prophylaxis to be used selectively, early removal of necrotic tissue, prevention of tetanus, early nutrition and surveillance. Immunodeficient and Transplant recipients are at a higher risk of opportunistic infections. The post tranplant timetable is divided into three time periods for determining risk of infections. Room ventilation, cleaning and decontamination, protective clothing with care regarding food requires special consideration. Monitoring and Surveillance are prioritized depending upon the needs. Designated infection control teams should supervise the process and help in collection and compilation of data. Antibiotic Stewardship Recommendations include constituting a team, close coordination between teams, audit, formulary restriction, de- escalation, optimizing dosing, active use of information technology among other measure. The recommendations in these guidelines are intended to support, and not replace, good clinical judgment. The recommendations are rated by a letter that indicates the strength of the recommendation and a Roman numeral that indicates the quality of evidence supporting the recommendation, so that readers can ascertain how best to apply the recommendations in their practice environments.

Introduction

Hospital acquired infections (HAIs) is a major safety concern for both health care providers and the patients. Considering morbidity, mortality, increased length of stay and the cost, efforts should be made to make the hospitals as safe as possible by preventing such infections.[1,2] These guidelines have been developed for health care personnel involved in patient care in wards and critical care areas and for persons responsible for surveillance and control of infections in hospital.

The principles of the grading of recommendations assessment, development and evaluation (GRADE) system is used to guide assessment of quality of evidence from high (A) to very low

(C) and to determine the strength of recommendations. Each recommendation is categorized on the basis of existing scientific data, theoretical rationale, applicability and economic impact. The GRADE system classifies recommendations as strong (grade 1) or weak (grade 2). The assignment of strong or weak is considered of greater clinical importance than a difference in letter level of quality of evidence.

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The system for categorizing recommendations in this guideline is as follows. Level of evidence

Evidence from at least one properly-designed randomized, controlled trial• Evidence from at least one well-designed clinical controlled analytic studies (preferably from more than one center), or from multiple time-series studies, or dramatic results from uncontrolled experiments

• Evidence from opinions of respected authorities based on the clinical experience, descriptive studies, or reports of expert committees.

• Strength of recommendation Strong (we recommend)• Weak (we suggest).• General Measures of Infection Control Isolation

Assess the need for isolation.[3] Screen all intensive care unit (ICU) patients for the following:

Neutropenia and immunological disorder•

Diarrhea•

Skin rashes•

Known communicable disease•

Known carriers of an epidemic strain of bacterium.•

1.

Identify the type of isolation needed.2. There are two types of isolation in the ICU:

Protective isolation for neutropenic or other immunocompromised patients to reduce the chances of acquiring opportunistic infections

• Source isolation of colonized or infected patients to minimize potential transmission to other patients or staff.

• Isolation rooms should have tight-fitting doors, glass partitions for observation and both negative-pressure (for source isolation) and positive-pressure (for protective isolation) ventilations.

Patient at risk of nosocomial infections

There are patient, therapy and environment related risk factors for the development of nosocomial infection.[3]

Age more than 70 years•

Shock•

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Major trauma• Acute renal failure• Coma•

Prior antibiotics• Mechanical ventilation• Drugs affecting the immune system (steroids, chemotherapy)• Indwelling catheters•

Prolonged ICU stay ( 3 days).•

Observe hand hygiene

Hands are the most common vehicle for transmission of organisms and "hand hygiene" is the single most effective means of preventing the horizontal transmission of infections among hospital patients and health care personnel.[4]

When and why - follow World Health Organizations (WHO′s) five moments for hand hygiene [Figure 1]

Figure 1

World Health Organization's five moments for hand hygiene

Before touching a patient (IB) - to protect the patient from harmful germs carried on your hands

• Before aseptic procedures (IB) - to protect the patient against harmful germs, including the patient's own germs

• After body fluid exposure/risk (IA) - to protect yourself and the health care environment from the harmful patient's germs

• After touching the patient (IB) - to protect yourself and the health care environment from the harmful patient's germs

• After touching the patient's surrounding (IB) - to protect yourself and the health care environment from the harmful patient's germs.

• (Remember there are two moments before and three moments after touching the patient). How

Wash hands with soap and water when they are soiled or visibly dirty with blood or other body fluids (IB). Wet your hands, apply soap and then scrub them vigorously for at least 15 s. Cover all surfaces of the hands and fingers, wash with water and then dry thoroughly using a disposable towel

• Use an alcohol-based hand rub (IA) e.g. 0.5% chlorhexidine with 70% w/v ethanol, if hands are not visibly dirty. A combination of chlorhexidine and alcohol is ideal as they cover Gram-positive and Gram-negative organisms, viruses, mycobacteria and fungi.

•

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Chlorhexidine also has residual activity. During surgical hand preparation, all hand jewelries (e.g. rings, watches and bracelets) must be removed (2A)

○

Finger nails should be trimmed to 0.5 cm (2A) with no nail polish or artificial nails

(2A)

○

Avoid wearing long sleeves, ties should be tucked in, house coats are discouraged and wearing scrubs is encouraged.

○

Follow standard precautions

Standard precautions include prudent preventive measures to be used at all times, regardless of a patient's infection status.[4]

Gloves

Sterile gloves should be worn after hand hygiene procedure while touching mucous membrane and non-intact skin and performing sterile procedures (2A) e.g. arterial, central line and Foley catheter insertion

Clean, non-sterile gloves are safe for touching blood, other body fluids, contaminated items and any other potentially infectious materials

• Change gloves between tasks and procedures in the same patient especially when moving from a contaminated body area to a clean body area (1A)

• Never wear the same pair of gloves for the care of more than one patient (1A)• Remove gloves after caring for a patient•

Practice hand hygiene whenever gloves are removed.•

Gown

Wear a gown to prevent soiling of clothing and skin during procedures that are likely to generate splashes of blood, body fluids, secretions or excretions (IB)

• The sterile gown is required only for aseptic procedures and for the rest, a clean, non- sterile gown is sufficient (2A)

• Remove the soiled gown as soon as possible, with care to avoid contamination.• Mask, eye protection/face shield

Wear a mask and adequate eye protection (eyeglasses are not enough), or a face shield to protect mucous membranes of the eyes, nose and mouth during procedures and patient care activities that are likely to generate splashes/sprays of blood and body fluids, etc.,

(2B)

• Patients, relatives and health care workers (HCWs) presenting with respiratory symptoms should also use masks (e.g. cough) (2A).

• Shoe and head coverings They are not required for routine care (2B).• Patient-care equipment

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Used patient-care equipment soiled with blood, body fluids, secretions, or excretions should be handled carefully to prevent skin and mucous membrane exposures, contamination of clothing and transfer of microorganisms to HCWs, other patients or the environment (1B)

• Ensure that reusable equipment is not used for the care of another patient until it has been cleaned and sterilized appropriately (2A)

• Ensure that single use items and sharps are discarded properly (1A).• Follow transmission-based precautions

In addition to standard precautions, the following should be observed in those patients known or suspected to have airborne, contact or droplet infections:[4]

Airborne precautions

Disease-causing microorganisms may be suspended in the air as small particles, aerosols, or dust and remain infective over time and distance, for example, Mycobacterium tuberculosis (pulmonary/laryngeal), varicella zoster virus (chickenpox), herpes zoster (shingles), rubella virus and measles

• Isolate with negative-pressure ventilation (2B)• Respiratory protection must be employed when entering the isolation room (1B)• Use the disposable N-95 respirator mask, which fits tightly around the nose and mouth to protect against both large and small droplets. This should be worn by all persons entering the room, including visitors (1B).

• Contact precautions Infections can be spread by usual direct or indirect contact with an infected person, the surfaces or patient care items in the room, for example, parainfluenza virus infection, respiratory syncytial virus infection, varicella (chickenpox), herpes zoster, hepatitis A and rotavirus infections.[4]

Isolation is required (1B)•

Non-critical patient-care equipment should preferably be of single use. If unavoidable, then clean and disinfect them adequately before using to another patient (2B)

• Limit transport of the patient (2B).• Droplet precautions

Microorganisms are also transmitted by droplets (large particles 5 μm in size) generated during coughing, sneezing and talking, or a short-distance travelling, for example, influenza virus, Bordetella pertussis, Hemophilus influenzae (meningitis, pneumonia), Neisseria meningitidis (meningitis, pneumonia and bacteremia), Mycoplasma pneumoniae, Severe acute respiratory syndrome-associated coronavirus, Group A Streptococcus, adenovirus and rhinovirus[4]

• Isolation is required (1A)• Respiratory protection must be employed when entering the isolation room or within 6-10 ft of the patient. Use the disposable N-95 respirator mask, which fits tightly around the

•

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nose and mouth to protect against both large and small droplets. This should be worn by all persons entering the room, including visitors (1B)

Limit transport of the patient (2B).•

Use specific strategies focused on prevention of specific nosocomial infections In addition to the standard and transmission-based precautions, there are several strategies focused on prevention of specific nosocomial infections in critically ill patients. Of these, ventilator-associated pneumonia (VAP), catheter-related bloodstream infection (CRBSI) and urinary tract infection (UTI) are the most important.

Strategies to reduce VAP

Avoid intubation whenever possible (2B)[5,6,7]•

Consider noninvasive ventilation whenever possible (2B)•

Prefer oral intubations to nasal unless contraindicated (2B)•

Keep head elevated at 30-45° in the semi-recumbent body position (IA)• Daily oral care with chlorhexidine solution of strength 0.12% (IA)• Daily sedation vacation if feasible and assessment of readiness to extubate (IA)• Avoid re intubation whenever possible (2B)•

Routine change of ventilator circuits is not required (2B)•

Monitor endotracheal tube cuff pressure (keep it 20 cm H2 O) to avoid air leaks around the cuff, which can allow entry of bacterial pathogens into the lower respiratory tract (2B)

• Prefer endotracheal tubes with a subglottic suction port to prevent pooling of secretions around the cuff leading to microaspiration (2A)

• The heat moisture exchanger may be better than the heated humidifier (2B)• Closed endotracheal suction systems may be better than the open suction (2B)• Periodically drain and discard any condensate that collects in the tubing of a mechanical ventilator (2B).

• Strategies to reduce CRBSI Prefer the upper extremity for catheter insertion. Avoid femoral route for central venous cannulation (CVC) (IA)[8]

• If the catheter is inserted in a lower extremity site, replace to an upper extremity site as soon as possible (2A)

• Use maximal sterile barrier precautions (cap, mask, sterile gown and sterile gloves) and a sterile full-body drape while inserting CVCs, peripherally inserted central catheters, or guidewire exchange (IA)

• Clean skin with more than 0.5% chlorhexidine preparation with alcohol (usually 2% chlorhexidine with 70% w/v ethanol) before CVC, arterial catheter insertion, etc., (IA)

• Use chlorhexidine/silver sulfadiazine or minocycline/rifampin-impregnated CVCs when the catheter is expected to remain in place for more than 5 days and only if the bloodstream infection rates are high in the unit despite successful implementation of measures to reduce CRBSI (2A)

• Use ultrasound-guided insertion if technology and expertise are available (IB)• Use either sterile gauze or sterile, transparent, semipermeable dressing to cover the catheter site (IA). Replace the catheter site dressing only when the dressing becomes

•

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damp, loosened, or visibly soiled Evaluate the catheter insertion site daily and check if a transparent dressing is present and palpate through the dressing for any tenderness (1B)

• Insertion date should be put on all vascular access devices (2B)• Use 2% chlorhexidine wash daily for skin cleansing to reduce CRBSI (2B)• Use needleless intravascular catheter access systems (2B) and avoid stopcocks. Closed catheter access systems should be preferred to open systems (2A)

• Clean injection ports with an appropriate antiseptic (chlorhexidine, povidone-iodine, an iodophor, or 70% alcohol), accessing the port only with sterile devices. Cap stopcocks when not in use (2A)

• Assess the need for the intravascular catheter daily and remove when not required (IA)• Peripheral lines should not be replaced more frequently than 72-96 h. Routine replacement of CVCs is not required (2A)

• Replace administration sets, including secondary sets and add-on devices, every day in patients receiving blood, blood products, or fat emulsions (2A)

• If other intravenous fluids are used, change no 96-h intervals and at least every 7 days

(IA)

• Needleless connectors should be changed frequently (every 72 h) (2A)• Replace disposable or reusable transducers at 96-h intervals (2A).• Strategies to reduce UTI

Insert catheters only for appropriate indications (2A)[9]• Follow aseptic insertion of the urinary catheter (IB)• Maintain a closed drainage system (IB)•

Maintain unobstructed urine flow. At all times the urinary catheter should be placed and taped above the thigh and the urinary bag should hang below the level of the bladder (2B)

• The urinary bag should never have floor contact (2B)• Changing indwelling catheters or drainage bags at fixed intervals is not recommended. Change only if there are clinical indications such as infection or obstruction, or when the closed system is compromised (2B)

• Remove the catheter when it is no longer needed (2A).• Consider environmental factors

Cleaning and disinfection

High-quality cleaning and disinfection of all patient-care areas is important, especially surfaces close to the patient (e.g. bedrails, bedside tables, doorknobs and equipment)[10]

• Some pathogens can survive for long periods in the environment, particularly methicillin- resistant Sataphylococcus aureus (MRSA), vancomycin-

resistant Enterococcus (VRE), Acinetobacter species, Clostridium difficile and norovirus

• EPA-registered disinfectants or detergents that best meet the overall needs of the ICU should be used for routine cleaning and disinfection

• Frequency of cleaning should be as follows: Surface cleaning (walls) twice weekly, floor cleaning 2-3 times/day and terminal cleaning (patient bed area) after discharge or death

(2B).

•

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Architecture and layout, especially while designing a new ICU The unit may be situated close to the operating theater and emergency department for easy accessibility, but should be away from the main ward areas (2B)[11]

• Central air-conditioning systems are designed in such a way that recirculated air must pass through appropriate filters (1B)[11]

• It is recommended that all air should be filtered to 99% efficiency down to 5 μm (1A)[11]• Suitable and safe air quality must be maintained at all times. Air movement should always be from clean to dirty areas (1A)[11]

• It is recommended to have a minimum of six total air changes per room per hour, with two air changes per hour composed of outside air (1B)[11]

• Isolation facility should be with both negative- and positive-pressure ventilations (2B)[11]• Clearly demarcated routes of traffic flow through the ICU are required (2B)[11]• Adequate space around beds is ideally 2.5-3 m (2B)•

Electricity, air, vacuum outlets/connections should not hamper access around the bed

(2B)[11]

• Adequate number of washbasins should be installed (2B)[11]• Alcohol gel dispensers are required at the ICU entry, exits, every bed space and every workstation (1B)[11]

• There should be separate medication preparation area (1B)[11]• There should be separate areas for clean storage and soiled and waste storage and disposal

(1B)[11]

• Adequate toilet facilities should be provided (1B)[11]• Organizational and administrative measures[4,11] Work with hospital administration for better patient to nurse ratio in the ICU (1B)[4,11]• Policies for controlling traffic flow to and from the unit to reduce sources of contamination from visitors, staff and equipment (1B)

• Waste and sharp disposal policy (1A)• Education and training for ICU staff about prevention of nosocomial infections (1A)• ICU protocols for prevention of nosocomial infections (1A)• Audit and surveillance of infections and infection control practices (IB)• Infection control team (multidisciplinary approach) (1B)•

Antibiotic stewardship (1B)•

Vaccination of health care personnel (1A).•

Guidelines for Infection Prevention in Burns Patients

Burn wounds can provide optimal conditions for colonization, infection and transmission of pathogens; infection acquired by burn patients is a frequent cause of morbidity and mortality. Epidemiology of infection

The development of infection depends on the presence of three conditions, a source of organisms; a mode of transmission; and the susceptibility of the patient. Source of organisms

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Sources of organisms are found in the patient's own endogenous (normal) flora, from exogenous sources in the environment and from health care personnel. Although burn wound surfaces are sterile immediately following thermal injury, these wounds eventually become colonized with microorganisms.[12] Gram-positive bacteria that survive the thermal insult, such as staphylococci located deep within sweat glands and hair follicles, heavily colonize the wound surface within the first 48 h unless topical antimicrobial agents are used.[13] Eventually (after an average of 5-7 days), these wounds are subsequently colonized with other microbes, including Gram-positive bacteria, Gram-negative bacteria and yeasts derived from the host's normal gastrointestinal and upper respiratory flora and/or from the hospital environment or that are transferred via a HCW hands.[12,14]

Mode of transmission

In burn patients, the primary mode is direct or indirect contact-either through the hands of the personnel caring for the patient or from contact with inappropriately decontaminated equipment.[15] Burn patients are unique in their susceptibility to colonization from organisms in the environment as well as in their propensity to disperse organisms into the surrounding environment. In general, the larger the burn injury, the greater the volume of organisms that will be dispersed into the environment from the patient.

Hydrotherapy equipment is an important environmental reservoir of Gram-negative organisms (2A).

• Patient susceptibility The patient has three principal defense against infection: Physical defenses, nonspecific immune responses and specific immune responses. Changes in these defenses determine the patient's susceptibility to infection. Invasive devices, such as endotracheal tubes, intravascular catheters and urinary catheters, bypass the body's normal defense mechanisms.[16,17] Culturing and surveillance

Burn wound flora and antibiotic susceptibility patterns change during the course of the patient's hospitalization so that the purposes of obtaining routine surveillance cultures are:

To provide early identification of organisms colonizing the wound•

To monitor the effectiveness of current wound treatment•

To guide perioperative or empiric antibiotic therapy•

To detect any cross-colonizations, which occur quickly so that further transmission can be prevented

• Routine surveillance wound cultures should be obtained when the patient is admitted and at least weekly until the wound is closed. Surveillance of infection has been shown to diminish the rate of nosocomial infection (2A).[18]

• Isolation guidelines Standard precautions should be followed when caring for all patients with burn injury. The effectiveness of simple protective barrier precautions reduces nosocomial colonization and infection (1A)[19]

•

100

It is recommended that patients with larger burn injuries be isolated in private rooms or other enclosed bed spaces to ensure physical separation from other patients on the unit. Such isolation has been associated with a decrease in cross transmission of organisms

(IB).[20,21]

• Patients with 30% TBSA burn injuries are more immunocompromised, due to the larger size of their injury. This, in combination with their loss of physical defenses and need for invasive devices, significantly increases their risk of infection. These patients also represent a significant risk for contamination of their surrounding environment with organisms, which may then be spread to other patients on the unit.

Environmental issues

Plants and flowers should not be allowed in units with burn patients because they harbor Gram-negative organisms, such as Pseudomonas species, other enteric Gram-negative organisms and fungi. Many of these organisms are intrinsically resistant to multiple antibiotics, which may serve as reservoirs to colonize the burn wound[22] (2A)

• Routine cleaning, disposal of waste and gathering of soiled linen is required to reduce the bioload of organisms, which are present and ensure that the unit is as clean as possible[22]

(2A)

• Routine environmental surveillance culturing is not generally recommended on units with burn patients[22] (2A).

• Antibiotic prophylaxis Several studies have demonstrated the role of topical antimicrobials in decreasing morbidity and mortality in patients with major burn injuries (partial-or full-thickness skin involvement), particularly before early excision[23] (1B)

• Topical antibiotic agents should first be applied directly to the patient's dressings before application to the burn wound to prevent contamination of the agent's container by burn wound flora

Studies of the clinical benefit of prophylactic courses of systemic antibiotics in burn patients in decreasing the occurrence of burn wound infections have not demonstrated improved outcome compared to the use of topical therapy along with surgical excision

• Systemic antibiotic administration in burn patients should therefore only be used selectively and for a short period of time. Due to the secondary bacteremia, burn wound manipulation and/or excision, prophylactic systemic antibiotic therapy may be given immediately before, during and for one or two doses after the procedure, particularly in burn patients with extensive injury (e.g. 40% TBSA) (2A).[24,25]

• Early burn wound excision now occurs within the first few days after burn injury and has resulted in improved survival. The primary aims of early excision are removal of the dead tissue that stimulates an overwhelming systemic inflammatory response syndrome and prevention of infection by temporary or permanent closure of the burn wound.[25] Furthermore, shortening the period of wound inflammation, which in turn reduces the development of hypertrophic scarring, may optimize the outcome in terms of function

101

and appearance.[25] This is achieved by early removal of necrotic tissue (e.g. eschar) and wound closure with autograft, allograft, or skin substitutes in selected patients. Early nutrition

Early enteral feeding diminished the incidence of wound colonization and infection by bowel flora and sepsis (IB).[26]

• Early enteral feeding is likely effective because it increases circulation to the bowel, thereby decreasing ischemia post-injury and the translocation of bowel flora. Prevention of tetanus

Burn centers routinely administer human tetanus immunoglobulin (250-500 IU) to provide immediate passive immunization regardless of the patient's active immunization status. Active immunization with tetanus toxoid is also given (0.5 ml intramuscularly) to burn patients who have not received a complete primary immunizing series or who have not received a tetanus toxoid booster within the past 10 years[27] (2A).

• Bloodstream and intravascular catheter infection Whenever possible, catheters should be placed through unburned skin, preferably at a sufficient distance from the wound to prevent contamination of the insertion site. This is not always feasible in patients with large burn injuries, requiring long-term vascular access[28] (2B). Pneumonia

Burn patients with severe inhalation injury requiring prolonged intubation are also at risk for developing VAP.

Prevention should also include vigorous chest physiotherapy, turning, coughing, deep breathing and suctioning[29] (2B).

•

UTI

Patients usually develop significant bacteriuria after 72 h of urinary catheter insertion, so these devices should be removed after the initial period of fluid resuscitation and output monitoring[15] (2B).

• Guidelines for Infection Control in the Special Subsets - Immunocompromised and Transplant Patients

Immunocompromised patients are those patients whose immune mechanisms are deficient because of immunologic disorders (e.g. human immunodeficiency virus (HIV) infection or congenital immune deficiency syndrome), chronic diseases (e.g. diabetes, cancer, emphysema, or cardiac failure), or immunosuppressive therapy (e.g. radiation, cytotoxic chemotherapy anti- rejection medication, or steroids). Immunocompromised patients who are identified as high-risk patients have the greatest risk of infection caused by airborne or waterborne microorganisms. Patients in this subset include persons who are severely neutropenic for prolonged periods of

102

time (i.e. an absolute neutrophil count (ANC) of 500 cells/mL), allogeneic HSCT patients and those who have received the most intensive chemotherapy (e.g. childhood acute myelogenous leukemia patients).[30]

In general, opportunistic infections result from at least 1 of 3 basic mechanisms: (1) Exogenous acquisition of a particularly virulent pathogen (e.g. meningococcal meningitis or pneumococcal pneumonia), (2) reactivation of an endogenous latent organism (e.g. herpes simplex virus, herpes zoster virus [HZV or shingles], or tuberculosis and (3) endogenous invasion of a normally commensal or saprophytic organism (e.g. bacteria, viruses, fungi, or protozoa/parasites).

The post-transplant timetable can be divided into three time periods:[31] During the 1^stmonth after transplantation: 95% of the infections are due to bacterial or candida infection of the surgical wound, vascular access, endotracheal tube, or drainage catheters. These infections are comparable to those observed in non-immunosuppressed patients undergoing similar surgery

• During the period 1-6 months after transplantation: Two classes of infection are observed:

Infections caused by immunomodulatory viruses and infections caused by opportunistic pathogens such as Pneumocystis carinii, Listeria monocytogenes and Aspergillus species

• In the late period: 6 months after transplantation, the patient population can be divided into three subgroups: more than two-thirds of transplant patients have had a good result from transplantation and are primarily at risk from community-acquired respiratory viruses. On an average 10-15% of transplant patients suffer from chronic viral infection, such as infection with hepatitis B or C virus, which progresses inexorably to end-stage organ dysfunction and/or cancer unless effective antiviral therapy can be administered. Finally, 5-10% are who have relatively poor allograft function and who have received excessive amounts of immunosuppression. These patients are the subgroup at greatest risk of opportunistic infection, particularly with such organisms as Cryptococcus neoformans, P. carinii and L. monocytogenes.

• Hand hygiene The most important intervention is hand hygiene. When hands are visibly dirty, contaminated with proteinaceous material, or visibly soiled with blood or body fluids, wash hands with either a non-antimicrobial soap and water or an antimicrobial soap and water[32] (IA)

• If hands are not visibly soiled, or after removing visible material with non-antimicrobial soap and water, the preferred method of hand decontamination is with an alcohol-based hand rub[32,33,34,35] (1B).

• Isolation Simple protective isolation offered no advantage over routine care for most immunocompromised patients (2B)

• Immunocompromised individuals should never be placed in the same room or adjacent to people with a known infection (1A)

• Isolation of potentially contagious patients within the ICU should be attempted if practical •

103

to reduce the chances of cross infection. Although isolation is recommended for control of airborne spread of pathogens, cross-colonization with organisms predominantly spread by contact (such as MRSA), infection may only be reduced by changing behavior of staff. In the absence of adequate isolation rooms, barrier precautions with gloves and gown combined with good hand hygiene is paramount[36] (1B).

Room ventilation

Patient should be placed in rooms with 12 air exchanges/h and point-of-use HEPA filters that are capable of removing particles 0.3 μm in diameter (2A)

• Inspection and preventive maintenance of duct and filter systems should occur on a routine, scheduled basis (2A)

• Patient room should have positive room air pressure when compared with any adjoining hallways, toilets and anterooms, if present (2A)

• The use of single rooms with HEPA filtration may reduce the risk of hospital-acquired infection by airborne fungi, in particular the Aspergillus genus. This is especially true where refurbishment, building or demolition are in progress in the hospital or nearby[37]

(IA).

• Cleaning Rooms should be cleaned 1 times/day with special attention to dust control (1A)• Exhaust vents, window sills and all horizontal surfaces should be cleaned with cloths and mop heads that have been premoistened with disinfectant (2B).

• Prohibit exposures of patients to such activities as vacuuming or other floor or carpet vacuuming that could cause aerosolization of fungal spores (e.g. Aspergillus species) (1B)

• Moisture problems (i.e. rainwater or plumbing leaks) should be promptly reported and repaired (1B)

• Organic materials that become moist must be dried or removed within 24-48 h to prevent fungal growth (1B).

• Medical devices and other equipment should be decontaminated according to existing guidance (2B). The role of cleaning and decontamination should not be underestimated. At times of local epidemics or outbreaks, the closure of part of or the whole unit should be considered to allow thorough cleaning. Hydrogen peroxide vapor decontamination has been shown to be superior to conventional cleaning but can only be used in enclosed rooms as it is toxic to humans. Interestingly, MRSA may not be completely cleared with a conventional solution containing 5-15% non-ionic surfactant and 5-15% cationic surfactant, diluted 1:500.[11]

• Guidelines exist for floor space in ICUs (ESICM and SCCM references). The transmission of micro-organisms will occur more readily in cramped conditions. There are recommendations for the number of isolation cubicles that should be available for patients with resistant organisms and for immunocompromised patients.[37,38]

Protective clothing

Protective clothing must, as a minimum, be used to prevent contact with bodily fluids or other sources of contamination and when in contact with broken skin or mucous

•

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membranes. Any protective clothing should be removed promptly when no longer required and disposed of as clinical waste[3,39] (1B). Food and drink

Hospital food is normally very safe. However, the immunocompromised patient is at increased risk of food-borne illness and the acquisition of harmful micro-organisms from some food and drink. Therefore immunocompromised individuals are advised to avoid certain high-risk foods, for example soft cheeses and foods made with raw egg, such as mayonnaise[3,39] (1B)

• All drinking water for immunocompromised patients (including bottled water) should be chemically sterilized or boiled (1B)

• Visitors who might have communicable infectious diseases (e.g. upper respiratory tract infections (URTIs), flu-like illnesses, recent exposure to communicable diseases, an active shingles rash whether covered or not, a VZV-like rash within 6 weeks of receiving a live- attenuated VZV vaccine, or a history of receiving an oral polio vaccine within the previous 3-6 weeks) should not be allowed to visit immunocompromised patients[40,41]

(1B)

• Vaccination in Immunocompromised patients should be done in accordance with the published guidelines.[42,43]

• Pharmacological prophylaxis against diseases in transplant patients may be done as per recommendations in the references mentioned.[40,43,44]

Monitoring of Infection Control

What should be monitored? Monitoring includes various aspects of infection control practices [Table 1]. Simultaneous monitoring of all the aspects might not be possible therefore prioritization must be done by the infection control team depending upon the need and situation. Monitoring of process compliance is most important to reduce incidence of HAI, preventing multidrug resistance to antimicrobials and protecting HCWs from getting infection. Methodology of monitoring should be adopted as per the institutional policy.[45,46,47] Environmental monitoring along with microbiological surveillance has been claimed to reduce infection rate. Adherence to hand hygiene is being considered as one of the most important preventive action.[47] Observed adherence to hand hygiene protocol ranges from 5% to 89% (38.7%) among the HCWs.

Table 1

Monitoring of Infection Control

Process related recommendations

Hand washing: This is the single most effective hygiene practice for minimizing health care associated infections. HCWs must wash their hands before and after every significant patient contact. Hand basins with hot and cold water supplies, non-touch taps with antisplash devices, supplies of liquid handwash (preferably in non-refillable disposable containers) and disposable paper towels or single-use, clean, cloth towels are

•

105

recommended to facilitate hand hygiene. CDC guidelines[48] and the WHO guidelines[4] recommend that HCWs wash their hands with soap and water when visibly soiled and exposure to potential spore-forming pathogens is strongly suspected or proven, including outbreaks of C. difficile (1B). Otherwise, hand rubbing with an alcohol based agent is recommended (1A) for all other opportunities as it is faster, more effective and better tolerated by the skin. Exposure of hands to body fluid in presence of intact skin deserves decontamination (recommendation level 1B) but it is particularly vital when skin is not intact or mucous membrane has been exposed (recommendation level 1A).[5] Compliance monitoring for hand hygiene among HCWs therefore had been given a higher recommendation level (1A).[4,48,49]

Recommendations for use of gloves:[50]

Sterile gloves - for procedures requiring a sterile field, involving normally sterile areas of the body

○

Non-sterile gloves - for procedures other than the above^○

General purpose utility gloves - for housekeeping and cleaning^○ Use of gloves had been advocated when it can be reasonably anticipated that contact of blood or other potentially infectious materials with, mucous membranes, or non- intact skin will occur (IC).[4]

○

• Recommendations for changing gloves:[50] After contact with each patient and when performing separate procedures on the same patient if cross-contamination is possible

○

as soon as gloves are damaged (torn or punctured);^○

After completion of any task not involving patients but requiring the use of gloves^○ Before answering telephones or recording patient notes^○

Remove gloves after caring for a patient. Do not wear the same pair of gloves for the care of more than one patient (IB).[4]

○

• Recommendations for eyewear or face-shields: During procedures where there is potential for splashing, splattering or spraying of blood or other body substances[50]

• Waste disposal and spillage: Disposal protocol should be followed differently for general waste (concern is not more than household waste), cytotoxic waste, pharmaceutical waste, chemical waste and radioactive waste. For blood spillage in ward or operation theater, cleaning should be done at the earliest with paper towels followed by water and detergents. Sodium hypochlorite is not necessary for such cleaning. Laboratory spillage should be absorbed on to paper towels and disposed of as clinical waste. The contaminated surfaces should be treated with 2.0-2.5% sodium hypochlorite, left for 1 h and cleaned again with paper towels that are disposed of as clinical waste. In suspected creutzfeldt-jackob disease spillage of brain tissue or spinal fluid is treated in the similar manner but the paper towels are incinerated.[50] It has been observed that HBV and HCV in dry blood remain infectious even when exposed to external environment for up to a week and 16 h respectively. Implications remain the same even if blood is invisible or not present in sufficient quantity.[51] Considering this glucometers should be cleaned and disinfected as per CDC recommendation after every use to avoid contamination[11,52]

•

6. Compliance monitoring of care bundles should be done in a very stringent manner. Non-compliance to a single measure should be interpreted as failure to comply with the whole bundle. Therefore, a higher target of 95% compliance had been advocated[47]

•

7. Training: Effectiveness of staff education on HAI prevention is controversial but as a •

106

part of comprehensive infection control program it's value had been appreciated.[53] Designated infection control personnel can help in imparting prescheduled training, maintaining record, monitoring the knowledge base and bed side application of the knowledge.[54] Ongoing staff education is also a regulatory need.[53] Education of HCW and periodic assessment of adherence to insertion and maintenance of intravascular catheters protocol had been given higher level of recommendation (Category IA).[55] New employee orientation to infection control program and making the employees responsible for infection prevention had been recommended by Joint Commission on Accreditation of Healthcare Organizations (JCAHOs)[53]

8. To prevent airborne transmission negative pressure single rooms (1/100 beds) with anterooms and fresh air at 100% (that is, no recirculating air) is recommended to achieve most effective dilution of airborne microorganisms[50]

•

9. Periodic safety and operational inspection should be done by engineering and building services department

•

10. Mortuary guidelines:[50] Body storage at an internal temperature of 4°C^○ Longer-term storage in a freezer maintained at −20°C^○ Mortuary must not be used except storage of bodies^○ All refrigerators/freezers should be monitored and fitted with alarms that operate 24 h a day

○

Mortuary design should minimize manual handling of bodies^○

Where autopsies are performed, dedicated room(s) should be used with negative air pressure ventilation.

○

• Who should monitor: Designated infection control nurses should supervise the process and help in collection and compilation of data. However, for case controlled study of an outbreak, the primary investigating team should include the hospital epidemiologist, the director of employee health, the infection-control team and microbiologist. External consultants might be necessary in some cases.[54]

How to monitor: Following methods had been advocated for monitoring HAI data.[56] Observations•

Interviews•

Surveys and inspections•

Quality assurance activities.•

Observation

Direct observation is the gold standard to monitor compliance with optimal hand hygiene practice. Monthly monitoring of hand hygiene product consumption (Soap, alcohol rub) had also been advocated as an indirect measure of hand hygiene but this needs further validation. Number of dispenser filled with alcohol rub and number of dispenser working when compared to total number of dispensers available are also simple monitoring parameters.[57] Predesigned format for survey, inspection and interview

Data collection and compliance monitoring are facilitated if a format is available for doing

107

so.[58] For full, partial and minimal compliance 85%, 76-84% and 75% respective scores had been suggested.[59]

Surveillance

Surveillance is defined as '′ongoing, systematic collection, analysis and interpretation of health data essential to the planning, implementation and evaluation of public health care practice. It is closely integrated with timely dissemination of these data to those who need to know.′'[58,60]

Periodicity of data collection

Frequency of data collection, analysis and generation of report for evaluation and taking corrective measures should also be predefined.[54] If data is being collected intermittently then, it should be done at least for four continuous weeks in each time period under study.[58] Authenticity of data remains a matter of concern therefore source of data should always be mentioned and its must be verified before relying on the same for decision making. Data can be presented as pooled mean, median and percentile manner. Team should further analyze and investigate extremely higher or lower rate or ratio ( 90^thpercentile, ≤10^thpercentile).[61] Automated monitoring

Automated monitoring helps in avoiding errors and variability related to manual collection of data. Hospitals with sophisticated information systems are in a position to streamline surveillance process through computer-based algorithms that identifies patients at highest risk of HAI.[54] Computerized surveillance helps in better implementation of preventive strategies, but lower infection rates had not been proven conclusively.[62,63] The use of sinks and hand rub dispensers had also been used for electronic monitoring of hand hygiene practice.[4,57] Endemic rate of infection

Surveillance of endemic infection is the focal point of infection control activity. It helps in generating a data base and identifying epidemic when incidence crosses the endemic threshold.[47] The first aim of surveillance is to determine endemic rate of infection.[54] The base line data of HAI helps in taking improvement initiatives. It has been claimed that infection rate can be reduced by 31-44% with the implementation of effective surveillance system.[18,64]

Outbreak investigation

Investigation for outbreak should be considered when monthly incidence of a particular type of infection is more than 95% of the confidence interval of same infection in the same month in the previous year.[54] Analysis of all isolates, patients' demographic data and exposure to potential risk factors (medication, procedure and contact) are necessary for such investigation. This should be followed by analysis of time interval between infection and exposure to potential risk factors. Based on the generated data, case controlled study is recommended according to age, gender and exposure to potential risk factors. This exercise helps in developing a hypothesis regarding source and transmission of infection. Temporary infection

108

control measures are implemented based on the hypothesis formed. Molecular typing is advocated if such facilities are available.[54]

Coding of clinical indicators, trend analysis and bench marking Use of ICD-10-AM codes for clinical indicators of infection control is desirable as it helps in data collating and benchmarking between health care institutions. However, all indicators do not have their ICD code.[58] Interhospital comparison of HAI demands standardization of definitions, data collection and analysis.[65] Therefore comparison of data might not be justified always due to differences in the infrastructure, quantitative and qualitative gap in human resource, compliance level, variation in the practices and case mix. Such exercise is further constrained because tools needed to compare infection rates for a given case mix is provided by very few systems.[65] Trend monitoring of unit's own data over a period of time therefore is more appropriate.[66]

Organism prevalence, sensitivity pattern and antimicrobial use

Tracking of organism prevalence, sensitivity pattern and antimicrobial use should be part of epidemiology program. Community acquired and HAI should be separated while analyzing the data.[54] Active and aggressive surveillance of all isolates and patients has been advocated on admission and weekly basis provided higher risk for carrying MRSA and VRE is anticipated. More frequent culture had been advised if 50% isolates are MRSA positive.[67] But this approach has been challenged.[68]

Recommendations for Antimicrobial Stewardship

Core members of a multidisciplinary antimicrobial stewardship program should include an infectious disease physician and a clinical pharmacist with infectious disease training

(1B)[69,70,71,72,73]

• Other members of the team may include clinical microbiologist, an information system specialist, an infection control professional and hospital epidemiologist (1C)

• In resource limited setting a physician (hospital based practitioner preferable) with interest in infectious disease should lead the program along with the hospital microbiologist (1C)

• Close collaboration between the antimicrobial stewardship team, microbiology lab, hospital pharmacy and infection control team should be maintained (1C)

• Involvement of the administration with their buy in to the program is essential for the success of any stewardship program (1C)

• It is desirable that antimicrobial stewardship programs function under the auspices of quality assurance and patient safety department (1C)

• Prospective audit of antimicrobial use with direct interaction and feedback to the prescriber by senior members of antimicrobial stewardship team can result in reduced inappropriate use of antibiotics (1A)

• This is the preferable mode of antimicrobial stewardship in an "open" prescription writing setting as prevalent in India (1C)

• Formulary restriction and preauthorization requirements can lead to significant reductions in antimicrobial use (1B)

• Formulary restriction may also help in decreasing nosocomial outbreak of resistant infection (2B)

•

109

Formulary restriction and preauthorization from a logistic point of view may not be universally applicable in an "open" prescription writing prevalent health care delivery system as is existing in India (1C)

• Continuing education of all the stakeholders should be done to provide a foundation of knowledge that will enhance and increase the acceptance of stewardship strategies (1C)

• Education alone without active intervention like audit and feedback do not have a sustained impact on prescribing behavior of physicians (2B)

• Guidelines and clinical pathways based on evidence and incorporating local microbiology and resistance pattern can improve antibiotic utilization (1A)

• Antimicrobial cycling to decrease antibiotic resistance has not been found to be useful and is logistically difficult in Indian setting (2B)

• Antimicrobial order form has been given a weak recommendation (2B) in IDSA guidelines of North America, but this may be a readily implementable, documentable and a useful tool for stewardship program in India (1C)

• There are insufficient data to recommend the routine use of combination therapy to prevent the emergence of resistance (2B)

• De-escalation of antibiotic once culture results are back is an essential ingredient of any stewardship program and should be practiced (1B)

• De-escalation is poorly practiced in India and an audit of de-escalation practices and education on its proper implementation should be an important ingredient of any antibiotic stewardship program in India (1C)

• Optimizing antibiotic dose taking into consideration pk/pd characteristic should be universally practiced (1B)

• As under dosing may be prevalent in resource limited setting a close vigilance on the appropriate dosing and a hospital information system and warning mechanism should be incorporated (1C)

• An early switch from parenteral to oral antibiotics is highly desirable specially in resource limited setting to decrease cost of therapy and should be actively implemented (1 C)

• Decreasing duration of antibiotic use as per clinical guideline to decrease the cost of therapy, antibiotic consumption and reduce side effects of drugs should be actively incorporated in the antibiotic stewardship program (1C)

• Active use of information technologies such as electronic medical record, hospital information system, computerized physician order entry and clinical decision support facilitates delivery of the stewardship program more effectively (1B)

• In resource limited setting an effort should be made customizing use of existing information technology and using indigenous innovation to utilize the existing resources to achieve similar objective (1C)

• Optimal use of microbiology lab is an essential ingredient of any stewardship program

(1C).

• The References

1. Plowman R, Graves N, Griffin M, Roberts JA, Swan AV, Cookson B, Taylor L. The socioeconomic burden of hospital acquired infection. London Public health laboratory service and the London school of hygiene and tropical Medicine. 1999 [Google Scholar]

2. Wenzel RP. The Lowbury Lecture. The economics of nosocomial infections. J Hosp Infect. 1995;31:79-87. [PubMed] [Google Scholar]

110

3. Guideline for isolation precautions: Preventing transmission of infectious agents in healthcare settings. 2014. Mar 10, Available

from: http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf . [PMC free article] [PubMed]

4. WHO guidelines on hand hygiene in health care: A summary. 2014. Mar 10, Available from: http://www.whqlibdoc.who.int/hq/2009/WHO_IER_PSP_2009.07_eng.pdf .

5. Maselli DJ, Restrepo MI. Strategies in the prevention of ventilator-associated pneumonia. Ther Adv Respir Dis. 2011;5:131-41. [PubMed] [Google Scholar]

6. Coffin SE, Klompas M, Classen D, Arias KM, Podgorny K, Anderson DJ, et al. Strategies to prevent ventilator-associated pneumonia in acute care hospitals. Infect Control Hosp Epidemiol. 2008;29(Suppl 1):S31-40. [PubMed] [Google Scholar]

7. Lorente L, Blot S, Rello J. Evidence on measures for the prevention of ventilator-associated pneumonia. Eur Respir J. 2007;30:1193-207. [PubMed] [Google Scholar]

8. Guidelines for the prevention of intravascular catheter-related infections. Available from http://www.cdc.gov/hicpac/pdf/guidelines/bsi-guidelines-2011.pdf .

9. Guidelines for prevention of catheter-associated urinary tract infections. Available from http://www.cdc.gov/hicpac/pdf/CAUTI/CAUTIguideline2009final.pdf .

10. Circulation for disinfection and sterilization in healthcare facilities. 2008. Available from: http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf .

11. Guidelines for environmental infection control in health care facilities. Available from: http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_HCF_03.pdf .

12. Wysocki AB. Evaluating and managing open skin wounds: Colonization versus infection. AACN Clin Issues. 2002;13:382-97. [PubMed] [Google Scholar]

13. Erol S, Altoparlak U, Akcay MN, Celebi F, Parlak M. Changes of microbial flora and wound colonization in burned patients. Burns. 2004;30:357-61. [PubMed] [Google Scholar]

14. LeVoyer T, Cioffi WG, Jr, Pratt L, Shippee R, McManus WF, Mason AD, Jr, et al. Alterations in intestinal permeability after thermal injury. Arch Surg. 1992;127:26-9. [PubMed] [Google Scholar]

15. Wurtz R, Karajovic M, Dacumos E, Jovanovic B, Hanumadass M. Nosocomial infections in a burn intensive care unit. Burns. 1995;21:181-4. [PubMed] [Google Scholar]

16. Goldmann DA, Pier GB. Pathogenesis of infections related to intravascular catheterization. Clin Microbiol Rev. 1993;6:176-92. [PMC free article] [PubMed] [Google Scholar]

17. Becker WK, Cioffi WG, Jr, McManus AT, Kim SH, McManus WF, Mason AD, et al. Fungal burn wound infection. A 10-year experience. Arch Surg. 1991;126:44-8. [PubMed] [Google Scholar]

111

18. Haley RW, Culver DH, White JW, Morgan WM, Emori TG, Munn VP, et al. The efficacy of infection surveillance and control programs in preventing nosocomial infections in US hospitals. Am J Epidemiol. 1985;121:182-205. [PubMed] [Google Scholar]

19. Klein BS, Perloff WH, Maki DG. Reduction of nosocomial infection during pediatric intensive care by protective isolation. N Engl J Med. 1989;320:1714-21. [PubMed] [Google Scholar]

20. Burke JF, Quinby WC, Bondoc CC, Sheehy EM, Moreno HC. The contribution of a bacterially isolated environment to the prevention of infection in seriously burned patients. Ann Surg. 1977;186:377-87. [PMC free article] [PubMed] [Google Scholar]

21. McManus AT, McManus WF, Mason AD, Jr, Aitcheson AR, Pruitt BA., Jr Microbial colonization in a new intensive care burn unit. A prospective cohort study. Arch Surg. 1985;120:217-23. [PubMed] [Google Scholar]

22. Kates SG, McGinley KJ, Larson EL, Leyden JJ. Indigenous multiresistant bacteria from flowers in hospital and nonhospital environments. Am J Infect Control. 1991;19:156-61. [PubMed] [Google Scholar]

23. Monafo WW, West MA. Current treatment recommendations for topical burn therapy. Drugs. 1990;40:364-73. [PubMed] [Google Scholar]

24. Mozingo DW, McManus AT, Kim SH, Pruitt BA., Jr Incidence of bacteremia after burn wound manipulation in the early postburn period. J

Trauma. 1997;42:1006-10. [PubMed] [Google Scholar]

25. Church D, Elsayed S, Reid O, Winston B, Lindsay R. Burn wound infections. Clin Microbiol Rev. 2006;19:403-34. [PMC free article] [PubMed] [Google Scholar]

26. Hart DW, Wolf SE, Chinkes DL, Beauford RB, Mlcak RP, Heggers JP, et al. Effects of early excision and aggressive enteral feeding on hypermetabolism, catabolism, and sepsis after severe burn. J Trauma. 2003;54:755-61. [PubMed] [Google Scholar]

27. Edlich RF, Hill LG, Mahler CA, Cox MJ, Becker DG, Horowitz JH, et al. Management and prevention of tetanus. J Long Term Eff Med Implants. 2003;13:139-54. [PubMed] [Google Scholar]

28. Lesseva M. Central venous catheter-related bacteraemia in burn patients. Scand J Infect Dis. 1998;30:585-9. [PubMed] [Google Scholar]

29. Sheridan RL, Kacmarek RM, McEttrick MM, Weber JM, Ryan CM, Doody DP, et al. Permissive hypercapnia as a ventilatory strategy in burned children: Effect on barotrauma, pneumonia, and mortality. J Trauma. 1995;39:854-9. [PubMed] [Google Scholar]

30. Linden PK. Approach to the immunocompromised host with infection in the intensive care unit. Infect Dis Clin North Am. 2009;23:535-56. [PubMed] [Google Scholar]

31. Fishman JA, Issa NC. Infection in organ transplantation: Risk factors and evolving patterns

112

of infection. Infect Dis Clin North Am. 2010;24:273-83. [PubMed] [Google Scholar]

32. Dykewicz DA, Jaffe H, Spira T, et al. Guidelines for preventing opportunistic infections among hematopoietic stem cell transplant recipients: recommendations of CDC, the Infectious Disease Society of America, and the American Society of Blood and Marrow Transplantation. [Last accessed date March 10, 2014];MMWR Morb Mortal Wkly Rep. 2000 49:1-128. [Google Scholar]

33. Boyce JM, Pittet D Healthcare Infection Control Practices Advisory Committee; HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Guideline for Hand Hygiene in Health-Care Settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Society for Healthcare Epidemiology of America/Association for Professionals in Infection Control/Infectious Diseases Society of America. [Last accessed date March 10, 2014]. Available at http://www.cdc.gov/mmwr/pdf/rr/rr5116.pdf . [PubMed]

34. Nishimura S, Kagehira M, Kono F, Nishimura M, Taenaka N. Handwashing before entering the intensive care unit: What we learned from continuous video-camera surveillance. [Last accessed date March 10, 2014];Am J Infect Control. 1999 27:367-9. [PubMed] [Google Scholar]

35. Pittet D. Hand hygiene: Improved standards and practice for hospital care. CurrOpin Infect Dis. 2003;16:327-35. [PubMed] [Google Scholar]

36. French GL, Otter JA, Shannon KP, Adams NM, Watling D, Parks MJ. Tackling contamination of the hospital environment by methicillin-resistant Staphylococcus aureus (MRSA): A comparison between conventional terminal cleaning and hydrogen peroxide vapour decontamination. J Hosp Infect. 2004;57:31-7. [PubMed] [Google Scholar]

37. Guidelines for intensive care unit design. Guidelines/Practice Parameters Committee of the American College of Critical Care Medicine, Society of Critical Care Medicine. Crit Care Med. 1995;23:582-8. [PubMed] [Google Scholar]

38. Ferdinande P. Recommendations on minimal requirements for Intensive Care Departments. Members of the Task Force of the European Society of Intensive Care Medicine. Intensive Care Med. 1997;23:226-32. [PubMed] [Google Scholar]

39. Centers for Disease Control and Prevention, Infectious Disease Society of America, American Society of Blood and Marrow Transplantation. Guidelines for preventing opportunistic infections among hematopoietic stem cell transplant recipients. MMWR Recomm Rep. 2000;49:1-125. CE1. [PubMed] [Google Scholar]

40. Green M, Avery R, Preiksaitis J. Guidelines for the prevention and management of infectious complications of solid organ transplantation. (57-109).Am J Transplant. 2004;4(Suppl 10):10-7. 160-3. [Google Scholar]

41. Recommendations for preventing transmission of infections among chronic hemodialysis patients. MMWR Recomm Rep. 2001;50:1-43. [PubMed] [Google Scholar]

113

42. Advisory Committee on Immunization Practices. Recommended adult immunization schedule: United States, 2010. Ann Intern Med. 2010;152:36-9. [PubMed] [Google Scholar]

43. Centers for Disease Control and Prevention. Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents: Recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. 2009 Apr 10; [PubMed] [Google Scholar]

44. Grabe M, Bishop MC, Bjerklund-Johansen TE, Botto H, Çek M, Lobel B, Naber KG, Palou J, Tenke P, Wagenlehner F, editors. Guidelines on urological infections. Arnhem, The Netherlands: European Association of Urology (EAU); 2009. Mar, UTIs in renal insufficiency, transplant recipients, diabetes mellitus and immunosuppression; pp. 52-63. Available at: http://www.guideline.gov/content.aspx?id=14806 . [Google Scholar]

45. Yokoe DS, Mermel LA, Deverick AJ, Kathleen AM, Burstin H, David CP, et al. Executive Summary: A Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals. Infection Control and Hospital

Epidemiology. 2008;29:S12-S21. [PubMed] [Google Scholar]

46. Starling B. Postnote July 2005 Number 247 Infection control in healthcare settings. [Last accessed date March 10, 2014]. Available

from: http://www.parliamentuk/parliamentary_offices/post/pubs2005.cfm .

47. Chastre J, Luyt CE. Ventilator-associated pneumonia. In: Mason RJ, Broaddus VC, Martin TR, et al., editors. Murray&Nadel's Textbook of Respiratory Medicine. 5th ed. chap 33. Philadelphia, PA: Elsevier Saunders; 2010. [Google Scholar]

48. Boyce JM, Pittet D. Guideline for Hand Hygiene in Health-Care Settings:

Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Morbid Mortal Wkly Rep. 2002;51:1-45. [PubMed] [Google Scholar]

49. Mody L, McNeil SA, Sun R, Bradley SE, Kauffman CA. Introduction of a waterless alcohol-based hand rub in a long-term-care facility. Infect Control Hosp Epidemiol. 2003;24:165-71. [PubMed] [Google Scholar]

50. Australian Government Department of Health and ageing; 2008. [Last accessed date March 10, 2014]. Infection control guidelines for the prevention of transmission of infectious diseases in the health care setting. Available from: http://www.health.gov.au/internet/main/./icg- guidelines-index.htm . [Google Scholar]

51. Perz JF, Thompson ND, Schaefer MK, Patel PR. US outbreak investigations highlight the need for safe injection practices and basic infection control. [Last accessed date March 10, 2014];Clin Liver Dis. 2010 14:137-51. [PubMed] [Google Scholar]

52. Centers for Disease Control and Prevention (CDC). Transmission of hepatitis B virus among persons undergoing blood glucose monitoring in long-term-care facilities - Mississippi, North Carolina, and Los Angeles County, California, 2003-2004. MMWR Morb Mortal Wkly Rep. 2005;54:220-3. [PubMed] [Google Scholar]

114

53. Mody L. Infection control issues in older adults. Clin Geriatr Med. 2007;23:499-514. vi. [PMC free article] [PubMed] [Google Scholar]

54. Edmond MB, Wenzel RP. Organization for infection control. In: Mandel GL, Bennet JE, Dolin R, editors. Principles and practice of infectious diseases. 5th ed. Philadelphia: Churchill Livingston; 2009. pp. 2988-2995. [Google Scholar]

55. Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, et al. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009;49:1-45. [PMC free article] [PubMed] [Google Scholar]

56. Review of outcomes data analysis HLTIN403B-Implement and monitor infection control policies and procedures. Available from: http://www.riskresponse.com. au/training/units-of- competency/hlt07-health/hltin403b-implement-and-monitor-infection-control-policies-and - procedures .

57. Hargreaves S. UK team adopts unique approach to hospital infection control. The Lancet. 2008;8(12):747. [Google Scholar]

58. Infection control program quality monitoring indicators. Vs 2. NSW Department of Health. 2005. Available at www.health.nsw.gov.au/pubs/2005/pdf/infection_ctrl_manual.pdf .

59. Department of Health U.K; 2005. ICNA Audit Tools for Monitoring ICNA Audit Tools for Monitoring Infection Control Guidelines within the Community Setting; pp. 1-48. Available at: http://www.ips.uk.net/icna/Admin/uploads/AuditTools2005.pdf . [Google Scholar]

60. Do AN, Ray BJ, Banerjee SN, Illian AF, Barnett BJ, Pham MH, et al. Bloodstream infection associated with needleless device use and the importance of infection-control practices in the home health care setting. J Infect Dis. 1999;179:442-8. [PubMed] [Google Scholar]

61. Edwards JR, Peterson KD, Mu Y, Banerjee S, Allen-Bridson K, Morrell G, et al. National Healthcare Safety Network (NHSN) report: Data summary for 2006 through 2008, issued December 2009. Am J Infect Control. 2009;37:783-805. [PubMed] [Google Scholar]

62. Boughton B. Computerized infection monitoring and rapid control measures benefit patients and hospitals. From Medscape Medical News. Available

from: http://www.medscape.com/viewarticle/725013 .

63. Pittet D, Allegranzi B, Sax H, Bertinato L, Concia E, Cookson B, et al. Considerations for a WHO European strategy on health-care-associated infection, surveillance, and control. Lancet Infect Dis. 2005;5:242-50. [PMC free article] [PubMed] [Google Scholar]

64. Centers for Disease Control and Prevention (CDC). Monitoring hospital-acquired infections to promote patient safety - United States, 1990-1999. MMWR Morb Mortal Wkly Rep. 2000;49:149-53. [PubMed] [Google Scholar]

65. Coffin SE, Zaoutis TE. Infection control, hospital epidemiology, and patient safety. Infect

115

Dis Clin North Am. 2005;19:647-65. [PubMed] [Google Scholar]

66. Ray B, Samaddar D.P, Todi S.K, Ramakrishnan N, George John, Suresh Ramasubban. Quality indicators for ICU: ISCCM guidelines for ICUs in India. Indian J Crit Care Med. 2009 Oct-Dec;13(4):173-206. [PMC free article] [PubMed] [Google Scholar]

67. Muto CA, Jernigan JA, Ostrowsky BE, Richet HM, Jarvis WR, Boyce JM, et al. SHEA guideline for preventing nosocomial transmission of multidrug-resistant strains of Staphylococcus aureus and Enterococcus. Infect Control Hosp Epidemiol. 2003;24:362-86. [PubMed] [Google Scholar]

68. Lautenbach E. Expanding the universe of methicillin-resistant staphylococcus aureus prevention. Ann Intern Med. 2008;148:474-6. [PubMed] [Google Scholar]

69. Fishman N. Antimicrobial stewardship. Am J Med. 2006;119(6 Suppl 1):S53-61. [PubMed] [Google Scholar]

70. Dellit TH, Owens RC, McGowan JE, Jr, Gerding DN, Weinstein RA, Burke JP, et al. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007;44:159-77. [PubMed] [Google Scholar]

71. Drew RH. Antimicrobial stewardship programs: How to start and steer a successful program. J Manag Care Pharm. 2009;15:S18-23. [PubMed] [Google Scholar]

72. Shah RC, Shah P. Antimicrobial stewardship in institutions and office practices. Indian J Pediatr. 2008;75:815-20. [PubMed] [Google Scholar]

73. Raghunath D. Emerging antibiotic resistance in bacteria with special reference to India. J Biosci. 2008;33:593-603. [PubMed] [Google Scholar]

We have seen that from the very beginning proper diagnosis and medicines were not up to the mark. There was no malaria and despite of it the specific drugs for Malaria were prescribed. There was no tuberculosis and despite of it drug for tuberculosis was prescribed. After admission to the hospital different kinds of infection may develop and for all the infection or side effects of the medicines, the patient cannot be blamed. What was the need of prolonged use of ventilator, has not been made clear. What was the need of Broncoscopy has also not made clear. When the opposite parties were unable to handle the situation of the patient, why did they not refer the patient to SGPGI in the beginning? The principle of res ipsa loquitur fully applies in this case because we have seen so many negligent act of the opposite party no 1 during total stay of the patient in the hospital. The opposite party in his written statement has stated that the hospital blamed for the sequelae of prolonged catheterisation and multiple fistulae in ano. They stated that the patient did not continue treatment for a long period as noted by the neuro physician regarding parkinsonism. How and under what circumstances the neuro physician came to conclusion that the patient did not take treatment for parkinsonism for a long time. The patient was a retired judge of State Judiciary and it cannot be taken as granted that he was so careless regarding his own ailments and diseases.

The opposite party put all the blame on the patient. If any medicine is given to a patient having

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no corresponding disease, it may cause side effects of the body and there are so many drug induced diseases noticed in various cases. A side effect can, theoretically, be positive. For example, laser treatment for cataracts sometimes improves a person's eyesight. An adverse effect, or adverse event, means an unwanted side effect. The treatment may be a medication, surgical procedure, or other kind of intervention, including complementary and alternative therapies.

Adverse effects can vary for each patient, depending on their general health, the state of their disease, age, weight, and gender. They can be mild, moderate, or severe. Some common examples mild adverse effects related to drugs include:

Constipation•

Skin rash or dermatitis•

Diarrhea•

Dizziness•

Drowsiness•

Dry mouth•

Headache•

Insomnia•

Nausea•

Examples of more serious effects include:

Suicidal thoughts•

Abnormal heart rhythms•

Internal bleeding•

Cancer•

Some effects are more likely than others. The PIL that comes with a drug or device will categorize effects according to their probability.

For example, research may have shown that a headache occurs in 1 in every 10 patients who use the drug according to the instructions. Heart palpitations may occur in 1 in every 100 patients.

It is important to check the PIL on getting new drugs, to find out what effects may occur and how likely these are. The PIL will also advise on whether an effect is classed as an emergency or not.

Drug-related problems are classified into seven categories, which are unnecessary drug therapy, needs additional drug, ineffective drug, dose too low, dose too high, adverse drug reaction, and noncompliance.

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Thus we have seen that there are so many drug induced problem in a patient if he has been given medicine unnecessarily or heavy dose has been given or wrong treatment has been given. In the present case as we have seen from the written statement of the opposite parties and also from the case history sheet of the patient that the opposite parties were negligent from the very beginning and they were not able to handle the problems of the patient and in spite of that they did not refer the patient to SGPGI in the beginning and when they failed to handle the various problems of the patient, they referred the patient to SGPGI but till then there remained no hope and the patient died before reaching SGPGI.

We would like to mention a case in which the Hon'ble NCDRC has held the Sahara Hospital guilty of medical negligence.

In the case of Gyan Mishra vs Sahara India Medical Institute ... Consumer Case no 998 OF 2015 Jt on 7 November, 2019 the Hon'ble NCDRC has held ,

"12. It was also submitted by the learned counsel for the opposite parties that no expert has been examined by the complainant to prove any negligence in the treatment of late Shri Gyan Mishra. In support of his contention, the learned counsel relied upon the decision of the Hon'ble Supreme Court dated 01.10.2018 in Civil Appeal No.3971 of 2011 Dr. S.K. Jhunjhunwala Vs. Mrs. Dhanwanti Kaur &Anr. Nowhere has the Hon'ble Supreme Court said in the above referred decision that even in a simple and uncomplicated case, based on admitted facts, the negligence in the treatment of a patient can be proved, without examining a medical expert. If the matter is simple and uncomplicated, the negligence can in an appropriate case, also be proved on the basis of the admitted facts and relevant medical literature written by medical experts. A reference in this regard can be made to the decision of the Hon'ble Supreme Court in V. Kishan Rao Vs. Nikhil Super Speciality Hospital &Anr. (2010) 5 SCC 513 decided on 08.3.2010, where the Hon'ble Supreme Court inter-alia held as under:

"18. In the opinion of this Court, before forming an opinion that expert evidence is necessary, the Fora under the Act must come to a conclusion that the case is complicated enough to require the opinion of an expert or that the facts of the case are such that it cannot be resolved by the members of the Fora without the assistance of expert opinion. This Court makes it clear that in these matters no mechanical approach can be followed by these Fora. Each case has to be judged on its own facts. If a decision is taken that in all cases medical negligence has to be proved on the basis of expert evidence, in that event the efficacy of remedy provided under this Act will beunnecessarily burdened and in many cases such remedy would be illusory.

34. Therefore, the general directions in para 106 in D'Souza quoted above are with great respect, inconsistent with the directions given in para 52 in Mathew which is a larger Bench decision.

38. A careful reading of the aforesaid principles laid down by this Court in Indian Medical Assn. makes the following position clear -

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(a) There may be simple cases of medical negligence where expert evidence is not required.

(b) Those cases should be decided by the Fora under the said Act on the basis of the procedure which has been prescribed under the said Act.

(c) In complicated cases where expert evidence is required the parties have a right to go to the civil court.

(d) That right of the parties to go to civil court is preserved under Section 3 of the Act.

45. It is clear from the statement of objects and reasons of the Act that it is to provide a forum for speedy and simple redressal of consumer disputes. Such avowed legislative purpose cannot be either defeated or diluted by superimposing a requirement of having expert evidence in all cases of medical negligence regardless of factual requirement of the case. If that is done the efficacy of remedy under the Act will be substantially curtained and in many cases the remedy will become illusory to the common man."

For the reasons stated hereinabove, I hold that the opposite party No.2 Dr. Sandeep Agarwal and opposite party No.3 Dr. Muffazal Ahmed were negligent in the treatment of the complainant, who died during pendency of this complaint. Since they were working with opposite party No.1, the said opposite party is also vicariously liable for the aforesaid negligent acts of opposite parties No. 2 and 3.

12.

14. The next question which comes up for consideration is with respect to the quantum of compensation. Though, the complainants have claimed compensation running into crores of rupees, the facts and circumstances of the case do not justify such a huge and fanciful compensation. The complainant was alive when this complaint was instituted and he died during pendency of this complaint. There is no evidence to prove that the complainant died on account of the deficiency attributed to the opposite parties in his treatment. His creatinine level was pretty high even at the time it was checked in Sahara Hospital on 24.12.2012, though he remained untreated for the kidney disease till the same was detected by opposite party No.3 Dr. Muffazal Ahmed. In December, 2013, it is not known how much more damage to his kidney occurred during the intervening period, though it can hardly be disputed that his kidneys must have suffered further damage on account of his creatinine level having not been managed for more than one year. This is also an admitted position that after his dialysis he was discharged on 19.12.2013. Though, Encicarb was advised to him without checking his ferritin level soon before the said injection was prescribed, there is no evidence to prove the actual ferritin level of the deceased at the time the said injection was advised to him. Though, the medicine Liofen which is contrary indicated in the case of a person suffering from kidney disease was also advised to him, it is not known what damage his system had suffered on account of the consumption of the said medicine by him.

15. Considering all the facts and circumstances of the case, opposite party No.2 Dr. Sandeep Agarwal is directed to pay a sum of Rs.20.00 lacs as compensation to the complainant, whereas opposite party No.3 Dr. Muffazal Ahmed is directed to pay a sum of Rs.10.00 lacs as compensation to him. Opposite party No.1 shall be vicariously liable to pay the aforesaid amounts to the complainant. In other words, the complainant shall be entitled to an aggregate

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sum of Rs.30.00 lacs as compensation, out of which Rs.20.00 lacs will be payable by opposite party No.2 Dr. Sandeep Agarwal and Rs.10.00 lacs will be payable by opposite party No.3 Dr. Muffazal Ahmed. The complainant shall be entitled to recover the whole of the said amount from opposite party No.1. The opposite parties shall also pay a sum of Rs.25,000/- as the cost of litigation to the complainants.

The compensation in terms of this order shall be paid within three months form today; failing which it shall carry interest @ 9% per annum with effect from three months form the date of this order, till the date of payment."

So it is clear that Sahara has been held negligent by Hon'ble NCDRC and Sahara Hospital has also been held negligent in a case decided by this State Consumer Commission. From all the facts and circumstances of the present case we are of the opinion that there is total lack of devotion of work and negligence has been shown at each level , which proves the deficiency of service on the part of the opposite party no 1. The principle of res ipsa loquitur fully applies in this case. We have perused the reliefs sought by the complainant and after all the evidences and medical records on file we came to the conclusion that the complainant is entitled for the following reliefs. All the doctors who treated the patient either belong to Sahara Hospital or called by Sahara Hospital and for their negligence and deficiency of service, Sahara Hospital is liable.

The complainant is entitled to get an amount of Rs.70 lakhs against the opposite parties for the mental, emotional, physical and financial loss suffered by her.

The complainant is also entitled to get Rs.50,000/- towards court of this case. The complainant has prayed for the grant of any relief in addition to the above and in this head we have discussed the condition of the patient at length and found that the patient was not a patient for the opposite parties but for them it was a live body for the experiment of various drugs. The patient was a judicial officer of the rank of District Judgebut he was treated mercilessly in the hospital ,the opposite party and the opposite party put him on ventilator and other unnecessary tests were performed for enhancing the bills of the patient. So we are of the opinion that for these shortcomings, negligence, wrong treatment of the patient, the complainant is entitled to get Rs.30 lakhs from the opposite parties. On all these amounts the complainant will be entitled to get an interest at a rate of 12% per annum from 27.04.2010 (date of admission in the Sahara Hospital) if paid within 60 days from the date of judgement of this complaint case otherwise the rate of interest shall be 15% per annum from 27.04.2010 till the date of actual payment. The complaint case is decided accordingly.

ORDER

1- The opposite party no.1 is directed to pay Rs.70 lakhs to the complainant with interest at a rate of 12% per annum from 27.04.2010 if paid within 60 days from the date of judgement of this complaint case otherwise the rate of interest shall be 15% per annum from 27.04.2010 till

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the date of actual payment for the mental, emotional, physical and financial loss suffered by her.

2- The opposite party no.1 is directed to pay Rs.50,000 to the complainant towards cost of the case with interest at a rate of 12% from 26.08.2015 (Date of filing of Complaint Case) if paid within 60 days from the date of judgement of this complaint case otherwise the rate of interest shall be 15% per annum from 27.04.2010 till the date of actual payment. 3- The opposite party no.1 is directed to pay Rs.30 lakhs to the complainant for those shortcomings, negligence, wrong treatment, trauma, depression of the patient and his family members during his treatment in the hospitalwith interest at a rate of 12% per annum from 27.04.2010 if paid within 60 days from the date of judgement of this complaint case otherwise the rate of interest shall be 15% per annum from 27.04.2010 till the date of actual payment. 4- The opposite party no.1 may be reimbursed from the opposite parties no.2 to 5 up to the extent of insured amount.

If the judgment is not complied with by the opposite party no.1 within 60 days from the date of judgment of this complaint case, the complainant shall be entitled to file execution case at the cost of the opposite party no.1.

The stenographer is requested to upload this order on the Website of this Commission today itself.

Certified copy of this judgment be provided to the parties as per rules.

(Vikas Saxena) (Rajendra Singh) Member Presiding Member

Judgment dated/typed signed by us and pronounced in the open court. Consign to the Record Room.

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[HON'BLE MR. Rajendra Singh]

PRESIDING MEMBER

[HON'BLE MR. Vikas Saxena]

JUDICIAL MEMBER

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