FDA exposes millions of medical device malfunctions kept secret from public

Brittany A. Roston - Jun 24, 2019, 6:47 pm CDT
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FDA exposes millions of medical device malfunctions kept secret from public

The FDA has formally ended its controversial Alternative Summary Reporting (ASR) program, which provided some manufacturers with exemptions related to reporting individual medical device reports. With that program now scrapped, the FDA has also posted ASR data that was submitted to the agency from 1999 through 2019, enabling the public to download all of that information via 20 individual zip files.

According to the FDA, formally ending the program involved revoking the remaining ASR exemptions that were available to 13 medical device manufacturers collectively behind pacemaker electrodes, implantable defibrillators, and dental implants. The ASR data dated from 1999 to 2019 can be manually downloaded as zip files located near the bottom of this page.

The ASR program was initiated in 1997, offering individual medical device report exemptions to 108 manufacturers. The exemptions allowed these companies to skip filing individual incident reports as long as the issue was ‘well-known and well-established’ as a risk for that particular device.

For example, if a medical device experienced an issue that was listed as a known risk in the product’s labeling, the company that made the product didn’t have to individually report that issue — as long as it had an exemption from the FDA, that is. In these cases, manufacturers were allowed to submit the issues in quarterly reports.

The program was controversial, but according to the FDA, ultimately intended for more efficiently reviewing incidents that were both well-known and well-understood in relation to things like pacemakers. The idea was that officials could spend more time focusing on lesser known and understood risks and identifying new safety concerns rather than spending time on known risks.

The public can find medical device reports in the FDA’s MAUDE database. In its statement today, the agency revealed plans to make this database more user-friendly within the next few years.


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