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Millions of Reports Involving Medical Device Problems Released By FDA

Federal regulators have released millions of previously undisclosed adverse event reports, involving problems with medical devices, implants and surgical products that resulted in complications, as part of an effort that is designed to increase transparency.

The FDA issued a press statement on June 21, announcing the release of more than six million adverse event reports not previously seen by the public, which were part of a program known as the Alternative Summary Reporting (ASR) Program. Dr. Jeffrey Shuren, head of the agency’s Center for Devices and Radiological Health (CDRH) also announced the agency has formally ended the program.

The announcement came following an investigative report by Kaiser Health News in May 2019, which revealed that the ASR program had allowed medical device manufacturers to file reports of medical device malfunctions and patient injuries to the ASR for years, instead of providing the information to the agency’s Manufacturer and User Facility Device Experience (MAUDE) database, which is publicly accessible.

This means that those 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 Kaiser Health report.

That report only looked at 1.1 million such hidden adverse events dating back to 2016. According to Shuren’s statement, the ASR program ran for more than 20 years, resulting in millions of hidden reports.

The program granted exemptions to certain manufacturers for devices with well-known adverse events, allowing them to file those reports with the ASR on a quarterly basis. However, critics say that the program allowed many manufacturers to hide the scope of such problems by making it appear there were fewer incidents than there really were.

“Since the program’s inception in 1997, the FDA granted 108 such exemptions to individual manufacturers for certain well-known events associated with specific devices, which were often already described in the product labeling available to health care professionals and patients,” Shuren said in the statement. “The ASR Program allowed the FDA to more efficiently review reports of well-known, well-understood adverse events, so we could focus on identifying and taking action on new safety signals and less understood risks.”

However, he notes that in 2017, the FDA modified the program to require a companion medical device report so that MAUDE data included the total number of events reported every quarter, and that the FDA has been sunsetting the program since then. To end the program, the agency formally sent revocation letters to the last 13 remaining manufacturers with exemptions.

The last exemptions covered dental implants, implantable cardiac defibrillators, and pacemaker electrodes.

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