Medical device harms, hidden by regulator: policies akin to protection @USFDA


        

                   Modern medicine has been captivated by the  industry. In the name of people’s health, business and industry  receives a kind of  protection  by none other than regulator itself.  The report about USFDA,  hiding the adverse events or device failure and harm is just one example how  powerful  industry has become.  It is not always possible to identify  complications arising out of device failure and there can be possibility of  these  not  being reported. The numbers that are hidden may also represent a fraction of  actual number of harms related to device.  A sad truth of present era, where doctors are punished  and blamed for human errors or even  natural poor prognosis,  Medical industry remains not only  hidden behind the scenes, but  receives  policies akin to protection  by regulator.

USFDA ‘hid’ reports of medical device snags The US Food and Drug Administration (FDA), which claims to have stringent processes in place to ensure safety of medical devices, has been found to maintain a “hidden database” of reports of serious injuries and malfunction of devices. Since 2016, over a million incidents that were reported went to the hidden database rather than to the publicly available database of suspected device-associated deaths, serious injuries and malfunctions. This was revealed in an investigation carried out by Kaiser Health News, a US-based non-profit news service covering health news. The revelation has serious implications for India, which approves a lot of devices based on USFDA approval. KHN found that “about 100” devices including mechanical breathing machines and balloon pumps were granted “reporting exemptions” over the years. The investigation revealed that many doctors and engineers dedicated to improving device safety not only did not know the issues raised in these reports, they didn’t even know about the existence of the “hidden database” or the exemptions. While the agency hid such crucial information about device risks, lawsuits and FDA records show that patients have been injured, hundreds of times in some cases, noted KHN. According to KHN, FDA confirmed that the “registry exemption” was created without any public notice or regulations. “Any device manufacturer can request an exemption from its reporting requirements,” an FDA spokesperson told KHN. The USFDA’s public database that tracks medical device failures, Manufacturer and User Facility Device Experience (MAUDE), receives thousands of medical device reports that are used to detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. These reports are submitted by mandatory reporters — manufacturers, importers and device user facilities — and by voluntary reporters — healthcare professionals, patients and consumers. MAUDE is used by doctors to identify problems or to check the safety record of a particular device. But they could reach the wrong conclusion as they would be unaware of and have no access to the reports on the “registry exempted” products, pointed out a former FDA official to KHN. For instance, KHN found that in 2016, while reports of only 84 stapler injuries or malfunctions were submitted to the public database, nearly 10,000 malfunction reports were included in the hidden database. Medtronic, which owns Covidien, considered to be the market leader in surgical staplers, had used reporting exemption. Surgical staplers are used to cut and seal tissues or vessels quickly, especially during minimally invasive surgeries and if the device fails the patient could bleed to death unless the doctors moved quickly to resuscitate the patient and seal the tissue/vessel. After the KHN report was published, the FDA has written to doctors expressing concern about the safety of surgical staples and staplers. The agency said it has received reports of 366 deaths, over 9,000 serious injuries and over 32,000 malfunctions. The letter also acknowledged that the FDA was aware that “many more device malfunction reports during this time frame” were submitted as “summary reports”. The agency said it was analyzing the reports and that the results would be made public. According to the KHN report, the FDA has deemed manufacturers of over 5,600 types of devices including cardiac stents, leadless pacemakers and mechanical heart valves, eligible to file “voluntary malfunction summary reports”, one of the many exemption programmes. Ironically, in India, doctors and regulators have argued that FDA has the most stringent regulation for devices compared to regulators in Europe, Canada, Australia or Japan and have even sought to make it mandatory for devices to have USFDA approval to be eligible for government procurement tenders. This was especially evident during the efforts to cap the price of stents when top cardiologists argued for higher prices or even price cap exemption for USFDA-approved stents.

Black coat vs white coat. What if money part is taken out of medico legal cases?


What if  financial part  is taken out of medico-legal issues, like compensation and lawyers fee?  The cases will drop down drastically?  If money part is zero, only errors will be identified and punished. Few  will remain only for idea of revenge.  In an era where people cheat their brothers, sisters and spouses for money, it will be naïve to think that idea of money extracting from doctors does not exist.

Financial  zeroing  can be done  in larger public interest to  keep down the cost of medical expenses.  It is  because of career building of few professions, that medico-legal cases are being fueled. Medical errors and complications are integral part of the treatment . Even simplest of diseases carry some amount of risk.  These  will still remain, even if doctors are hanged to death. Natural complications, poor prognosis can be attributed to errors by clever lawyering and because of benefit derived by other professions.

     Many careers  are  shining in name of preventable deaths  and medical errors at the cost of medical profession.  The managers, right activists, media   and lawyers  have made their career and wealth out of it. Ask any doctor really, are these issues really preventable after a point.  The  line separating errors or natural complications is really blurred and arbitrary. People who work in life and death situation know it well that  even natural poor prognosis can be labelled and proved as error by retrospective analysis and wisdom of hindsight and more certainly with luxury of time at disposal for lawyers and courts.

     Lawyers  and courts  should also be given those fraction of moments to decide same as is available to doctors. Otherwise it becomes a unbalanced match specially when the amount of money which was paid to doctor to save a life was peanuts as compared to now being paid to punish him.

Real failures of Dr Hazida Bawa case: Five issues to ponder-why doctors suffer?


 The case of  Dr Hazida Bawa  is of importance worldwide in many ways, an opportunity  for learning some hard and truthful lessons, as it touched upon various crucial aspects involved in medical treatment, especially in difficult situations. Every one has sympathy for the deceased, but  to blame a human factor, doctors should not be presented as sacrificial lambs.

       The current verdict is nearer to reality and away from a feeling of revenge and harsher penalties. It  gives a hope  that now there will be  acknowledgement of the difficult circumstances and limitations of medical system in health care environment.  To make doctor scapegoat for the  system limitations, poor prognosis or severe disease may be satisfying for some but not sensible. In this case doctors lodged their protest, collected money for lawsuit and the decision was re-looked legally. But every  doctor may not be  lucky enough and may have to suffer  in silence.

 Real failure in this case will be ignoring the factors that actually cause huge suffering for doctors-

  1. Presumptive failure by retrospective analysis: Retrospective analysis of any treatment will always show few things at hindsight that could have been done and would have proved life saving.  One may presume that omission or commission  of certain actions during treatment would have saved the  life,   but one can’t be sure whether these additional presumed treatment would really have benefited the patient.  Therefore a  perception-reality gap is created and with  negative perception towards doctors, it is interpreted as a  failure of doctor merely on presumptive basis and hence declared as negligence.  The doctors who deal with life and death know that it is not correct interpretation, and no one can ever be sure of what the real outcome would be. They just do what they think will be most effective for the patient, and it may not eventually turn out to be the best ever.
  2. Variable interpretation: Same evidence, incidence and circumstances are interpreted and  judged differently by people and  even courts. Some will say it is negligence and other will say it is not. Some will bay for doctor’s blood and other will not. This variation in perception is not only in minds of lay men but also in the learned courts, who  decide  differently.  At the time of death of patient, a constant and  universal last link is only the doctor, that is visible. He is an unfortunate victim, a human factor   and blamed for  the harm done because of variable thought process.

 

  1. Medical knowledge vs wisdom: People who do not treat patients, may be very wise and may acquire medical knowledge by various sources. But medical wisdom comes  only after years of medical practice,  by observing varied situations and spectrum of diseases. An understanding of what can happen in given circumstances comes only by treating such   emergencies.         For non doctors, it is very difficult to  comprehend the medical complexities and real time scenarios. Even doctors, who do not treat regularly emergency patients, can attribute the harm as doctor’s  mistake.

 

  1. Feeling of revenge:  in case of an  adverse event, negative thoughts prevail all over. In present scenario with legal powers with the sufferer and common sentiments against doctors, it is easier to identify and blame some human factors.   Adverse outcome is frequently covered by media to create a sensation among masses.  Real circumstances can only be felt by doctors  but that remains unheard. Harm to patient, media cry and negative sentiments against the service providers creates a sense of revenge in mind of people.

 

  1. Doctor’s negligence vs system inadequacy; This visibility of doctor at the time of  declaration of death  or while treating the patient on his bedside, makes him vulnerable to all kinds of accusations. By application of an average wisdom, all deaths can be easily attributed or linked to fault of the doctor. Subtle presentations of severe disease, rapid deterioration, multi organ complexities, under staffing and sub optimal systems, inadequate equipment and  other innumerable shortcomings of the whole system may not be visible or not given consideration in the  haze, as compared to  publicity and attention  given to only doctor’s faults.

 

Society deserves the doctors, it chooses and nurtures. Musk-melon stem will not grow apples


Doctors are just as offshoots of a tree called as society. They essentially are the same as rest of the society.  It is a specialized branch of tree which helps other offshoots of tree to save others.  As  part of same tree, they resemble the parent society, of which they are part.  Society needs to choose and nurture a force of doctors carefully with an aim to combat for  safety of its own people.  

Since it is a difficult path  to be a good doctor, there has to be some reason why someone will  choose to be a doctor. The path will require sacrificing golden years of his life in studies  and  working hard for the benefit of others thereafter.

Our society fails to develops a robust system of choosing and  nurturing  good doctors and therefore  itself responsible for decline in standards of medical profession.

 

  1. Exorbitantly expensive medical education and lowered merit: aspiring doctors are now forced to pay exorbitant fee,  in millions. Many go under heavy debt to pay medical colleges fee. Children with lower ranks in merit pay millions and can  become doctors. The real problem here is that real deserving will be left out.

Medical students from the very onset are victim and witness to  these practices and   exploitation. They see their parents pay this unreasonable fee through their noses or take loans. Such blatant injustice  will have an everlasting effect on the young impressionable minds. Society gives them lessons of corruption and exploitation.

  1. Discouragement  of medical fraternity:  The adage “To err is human” probably does not apply to the doctors anymore. Hence they are harassed often for any adverse clinical outcome even though it may be because of poor prognosis of patient. They work under continuous fear and stress and are punished and assaulted for each small or big error. Society has failed to support them in their difficult times. Best and talented may try to shun away from the profession.  
  2. Industry earns, but blames doctor: Till now, doctor patient interaction was the central point of the health industry, a core around which medical industry revolved. But now   this interaction, treatment and  almost everything is controlled by industry. By provoking controversy about doctors for varied reasons, medical industry and law has positioned themselves between the doctor and  patient and  taken a center stage in health care. Every one associated with industry like medical education, pharmaceutical, suppliers, insurance, administrators, managers, equipment industry, insurance earn from the medical sector, but remain invisible. Blame for all the cost and sufferings is conveniently put on the doctor hence causing diminution  of respect. Loss of respect for the profession is a bad advertisement for good talent to the profession.
  3. Overzealous regulation of medical profession: because of falling standards, every one is feels a need for stricter punishing regulation of medical profession. Time and resources which should have been utilized for treatment of patients, has to be used for complex documentation, frivolous medical lawsuits and communication. It is not uncommon to use doctors as scapegoats to save the weak health system causing further oppression of medical profession.
  4. Exploitation by law industry: Even in few advanced countries, one can see instigating advertisement of lawyers on zero percent fee. While doctor may is paid miniscule amount of  money by patients, he will be sued for millions. And lawyers change in lakhs. Money earned by medical lawsuit is divided between client (so called patient) and lawyer.  Doctor will definitely divert their energies to save themselves from such practices rather than focusing on treatment of patient. In an era, where brothers and sisters fight for money, doctors are easiest target to extract money.
  5. Defining the patient as consumer has created fear in mind of doctors and deterioration of doctor patient relationship.
  6. Wrong projections by media: Painful retrospective analysis of work of doctor by media, courts and public continue. One stray incidence of even alleged or  perceived negligence is projected as generalization. Whole profession is painted in poor light. Whole community looses respect because of irresponsible behavior of some people in media to earn quick money and fame. Ultimately it will help everyone except doctor and patient and discourage the excellence in medical care.
  7. Doctor’s assault: the inability and lack of support of society to prevent assault against their savior will hit the enthusiasm of doctors towards patients. It will propagate children’s unwillingness to enter the profession amidst chaotic conditions.

       Apple tree will have apples and musk melons plant will  grow muskmelons only.  One should not expect apples to grow on muskmelon stem. If society has failed to demand for a good and robust system, failed to save them, it should not  rue scarcity of good doctors. Merit based cheap good medical education system is the need of the society. This is in interest of society to nurture good doctors for its own safety.

    Therefore the quality of doctors who survive and flourish in such system will be a natural consequence of  how society chooses and nurtures the best for themselves.

 

 

Dr Hazida Bawa-Garba case: sacrificial lambs “The doctors” and not health administrators? Dangerous precedence for doctors worldwide


Dr Hazida Bawa case is of importance worldwide in many ways, an (lost)opportunity  for learning some hard and truthful lessons, as it touched upon various crucial aspects involved in treatment, especially in difficult situations , for doctors.  At the time of death of patient, a constant and  universal last link is only the doctor, that is visible. This visibility of doctor at the time of  declaration of death  or while treating the patient on his bedside, makes him vulnerable to all kinds of accusations. By application of an average wisdom,  all deaths can be easily attributed or linked to fault of the doctor. Subtle presentations of severe disease, rapid deterioration, multi organ complexities, under staffing and sub optimal systems, equipment and  other innumerable shortcomings of the whole system may not be visible or not given consideration in the  haze, as compared to  publicity and attention  given to only doctor’s faults. This is specially so when the wisdom is applied retrospectively, with knowledge  of hindsight,  and by the people who have never treated emergencies or have never been in such difficult situations  themselves.

Analogy to  Dr Hazida Bawa case

        Imagine a situation where during a bad sea storm, large number of people are trapped and are in mortal danger. The coast guard on the duty tries his best in the emergency situation with his limited resources and saves a large number of people. There were only a few coast guards present, equipment were inadequate and sub optimal.  However the guards manage to salvage the situation by doing the best possible in the circumstances. There were instances, where they decide, act, communicate and document events simultaneously, in an instant.  Those who could not be saved were exposed to risk of death as resources allocated by authorities were limited.  The near and dear ones of those who died were unhappy and revengeful with the services. Inquiry is done to find out the cause of failure in preventing those deaths. Rather than appreciating the facts that greater proportion of victims were saved in those difficult circumstances, the guards are blamed for those who could not be saved. Guards who are already apologetic for not been able to save the few, are blamed for doing their duty shabbily after careful fault finding analysis of the event. The administrators  who are responsible for allocating the inadequate number of guards and equipment, who actually failed in their duty, also participate in pointing fingers at the guards.

  The saddest part was that courts also were  unwilling to apply wisdom to look beyond the guard faults and  reach beyond the fog in present hazy circumstances. Systems and administrative lapses and inadequacy of number of coast guards was not raised as a concern. The responsibility of the deaths is thus fixed on the persons who struggled to save the lives of many. Every one has great sympathies for the deceased, but there is another angle for doctors in such  difficult situations.

This is an analogy to Dr Hazida Bawa case, but similar unfortunate incidents are happening to medical professionals worldwide, more so in developing countries. The new regulated system of medicine has an aberrant evolution and   chooses to hang their own wounded soldier for not putting up the best fight, rather than accepting the limitations of medical science or errors in the supporting systems.  Was  she an easy scapegoat for some obviously non- admissible reasons prevalent?

Why is it always necessary to punish a doctor, and  conveniently overlook errors of the sub optimal  system in cases of unfavorable prognosis, especially in sick patients. Why a sub optimal system or unsafe working conditions  like  all other registrars were on leave simultaneously, or only one registrar in place of three and that too a trainee. There was no consultant or registrar covering her?   Why is a single doctor stuck in a difficult situation  not  treated as  just another human being in an emergency situation, especially in cases of very sick patients? Why administrators or managers are not punishable for putting doctor and patients at risk and unsafe condition ?

If a doctor is supposed to raise concern (may be at cost of his career), then what is the role of managers, management and administration?  Are they inefficient or incompetent  to anticipate the situation? A new doctor coming on duty can not anticipate the deficiency of system. He will not have time to assess the managerial deficiencies. Therefore raising a concern by doctor on duty is something, which is expected but at the same time not feasible always, in true sense.  This expectation to raise  a concern  may be  used to later implicate the doctor as to why he or she did not raise a concern.  At the same time it takes responsibility off, from the  administrators whose  duty was to raise concerns.

NHS is looked upon in the world as one of the better organized health care organization in terms of uniformity. If such an organization has to sacrifice its working hands in the form of scapegoats to prove its quality, deliberately overlooking its system errors, then it is a sad state for doctors all over the world. This would set a precedence for governments and health administrators, world over to be  fearless in  putting errors of sub optimal system under the carpet by punishing the doctors instead. Since there will always be a doctor in the end who will declare the death, is the last and common link in all deaths. Other circumstantial issues would be overlooked  because of sheer unwillingness to do so.

Irony of the situation is that generally people who have been invested with the power to decide on these issues of medical negligence  may  have  never faced  such situations themselves.  They may be the people in administrative positions who have never treated a single patient, leave aside emergencies.  They do not even  know, what it takes to deal with emergencies of life and death, that too multiple ones, with limited resources. The court takes years to decide on these issues discussed retrospectively with wisdom of hindsight, on issues which the doctor had to decide in a jiffy.  A person who perhaps can only imagine such a situation, or  never handle it himself, even in his wildest dreams is the one who decides what went wrong merely based on how the situation is placed and presented before him.

         If there is unsaid immunity to governments and administrators for providing a suboptimal systems, then the doctor should be the first person to get this immunity. But unfortunately nobody seems  to be willing to find out who is responsible for putting  the doctor  in such  a difficult situation, making everything error prone.

       If in such system a doctor is punished, then the administrator, manager or trust should be an automatic accomplice to the doctor’s punishment. Firstly   for providing an unsafe and  suboptimal system, and secondly for not raising a concern as management . Thirdly for putting it’s doctor in difficult circumstances. If it was an understaffed system, then disaster was bound to  happen sooner or later. This is a perfect example how management lapses contribute to death but doctors are the only ones who are entirely blamed and punished in isolation.

  Another sad part is the unwillingness of judiciary system to look at the larger picture and the fault in the system, which has led to mass demoralization of the doctors. The doctors are denied the true justice in many such cases.  They are being used as sacrificial lambs. Health administrators are obviously at an advantage enjoying the invisible immunity and perks, at the cost of medical professionals.  By crucification of the doctors, vengeance of the society is fulfilled and everyone feels  satisfied  with false sense of justice.  But does this give any advantage to the society? Definitely not. In fact  the society is thus raising a  demoralized force to be their care providers, who under duress, will definitely not perform to their very best.  If this is quality of justice for saviours, this demoralized force may also not be available in future.

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