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A new investigative report suggests that federal regulators have allowed medical device manufacturers to file reports involving serious and often life-threatening problems with defibrillators, surgical staplers and other devices in a database that was hidden away from the public.
According to a Kaiser Health News, the U.S. Food and Drug Administration (FDA) has allowed medical device manufacturers to file 1.1 million reports involving device malfunctions and patient injuries into an “alternative summary reporting” repository since 2016, instead of providing the information in the agency’s Manufacturer and User Facility Device Experience (MAUDE) database, which is publicly accessible.
This means that those device reports, which are required by law and often involve high-risk devices that could experience repeated reports of similar problems, were effectively hidden from public view, according to the report.
Surgical staplers were one of the devices where manufacturers were often granted those exemptions, according to the report. While surgeons nationwide had their own experiences with the staplers jamming or misfiring, causing surgical complications and patient injuries, when they went to search MAUDE to see if other doctors were having the same problems, the reports were not there.
The surgical stapler problems, which have existed for years, only came into sharp focus in March 2019, when the FDA announced it has received more than 9,000 reports of serious injuries, and 366 reports of deaths linked to the devices. This has resulted in newly proposed rules and guidance last month, and an Ethicon circular stapler recall last week.
The Kaiser Heath News report found that deaths must still be reported to MAUDE, regardless of exemptions. But malfunctions and serious injury reports were allowed to be squirrelled away from public view for about 100 medical devices.
The exemptions, and the alternative summary reporting list, predates 2016. In May 2008, CNN reports that Sprint Fidelis, an internal defibrillator implant by Medtronic was granted an exemption which allowed it to file reports on problems with the heart implant secretly because it agreed to initiate appropriate actions to resolve the problems and because the FDA deemed that further reports of harm would not provide the agency with any new data.
Two years later, a report published in the American Journal of Cardiology indicated that Medtronic Sprint Fidelis leads had a failure rate as high as 9.2%.
FDA officials acknowledged to the Kaiser Health News that the exemption process was put into place with no notice to the public and no official regulatory actions, indicating any medical device manufacturer could apply for such an exemption.
In 2017, alone, manufacturers used the list to hide more than 480,000 device-related injuries or malfunctions from public view, the report states.