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.

Health policies to cover mental illness: Insurance regulator IRDAI issued a circular directing insurers


Insurance regulator IRDAI on Thursday issued a circular directing insurers to cover mental illness, which has reached serious proportions in the country. The Mental Healthcare Act, 2017 — which came into force from May 29 — has made it mandatory to provide “for medical insurance for treatment of mental illness on the same basis as is available for treatment of physical illness”. But to date, none of India’s 33 insurers has introduced a product that covers ailments such as depression, schizophrenia, and bipolar disorder, even though such covers are commonplace in many countries. The IRDAI order says, “All insurance companies are hereby directed to comply with the…provisions of the Mental Healthcare Act, 2017 with immediate effect.”

“This will ensure a life of dignity to those who have mental health issues. We believe it will create awareness, acceptance, and inclusion of mental illness as any other physical ailment. It will ‘normalise’ diagnoses, by reducing associated myths and stigma. Today, no one can say we won’t cover cancer, tuberculosis or heart attack. So why do we have this block towards covering mental health issues? They are just as debilitating and corrosive to a person’s well-being as physical ailments.”

Mental health conditions have always been in the list of exclusions of health insurance policies. The only exceptions to this have been the coverage of development conditions such as autism and Down’s syndrome by the National Health Insurance Scheme, and a few private schemes like Star Health Insurance’s cover for autistic children. Companies wishing to include mental health coverage will have to file a fresh product with the IRDAI, or add this to an existing product and file again. “They have to revise the rates, look at the actuarial risk, increase premium if need be. So far, no insurance company has filed for such a change with the regulator,” said a government official .

“At the lower end you have anxiety and depression. At the upper end there’s obsessive compulsive disorder, bipolar, borderline narcissistic personality disorder. We should first cover the lower end. It does seem harsh to tell a person we can’t cover you, when they are already depressed,”

It is uncharted territory. There are two coverages needed: First, OPD cover for therapy, consultation and drugs. Second, hospitalisation or rehab, which would be long-term and expensive. In western countries, both are covered. But in India, it is untested ground.

Source. Times of India

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