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 US FDA 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 US FDA’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 exemptions’ programs. 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 US FDA 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 US FDA-approved stents. – TOI