June 27, 2019

FDA shuts down its database that shielded adverse event reports from the public

Daily Briefing

    FDA on Friday said it has officially stopped using a database that had allowed medical device manufacturers to privately submit certain malfunction reports.

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    Background: Device manufacturers avoided publicly disclosing malfunctions by using FDA exemptions, KHN finds

    A Kaiser Health News investigation published earlier this year revealed that an internal database at FDA, known as the Alternative Summary Reporting (ASR) program, contained unpublicized adverse event reports for medical devices.

    The investigation focused on an FDA policy that allowed medical device manufacturers to privately submit certain malfunction reports as "summary reports." Those reports were disclosed to FDA, but they were not disclosed in the agency's public database called Manufacturer and User Facility Device Experience (MAUDE), according to KHN.

    An FDA official told KHN that the ASR program was exclusively intended for issues that were "well-known and well-documented with … FDA."

    But KHN's investigation showed that was not always the case. For example, KHN found that FDA's ASR database received about 10,000 surgical stapler malfunction reports in 2016—and doctors and researchers who rely on publicly available data to gauge medical device safety and risk were largely unaware those reports existed.

    FDA says it has stopped using the internal database, and has made all data public

    FDA on Friday announced that it has stopped using the ASR program, and that the agency has posted on its website all of the information that had been submitted to the database between 1999 and 2019.

    In an effort to make the data more accessible, FDA said it plans to update MAUDE and make the database more user friendly. FDA also said it plans to focus on modernizing surveillance systems to use real-world data to quickly identify and respond to device safety incidents. Jeff Shuren, director of FDA's Center for Devices and Radiological Health, said, "Modernized, active surveillance that utilizes real-world data is the future of medical device safety signal detection, and is a primary focus for the FDA" (Roza, Inside Health Policy, 6/21 [subscription required]; Garrity, Becker's Clinical Leadership & Infection Control, 6/24; Jewett, Kaiser Health News, 5/3; Paavola, Becker's Hospital Review, 5/6).

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