STAT+: Study reveals how often medical device makers report safety incidents late to FDA
In this edition of STAT's Health Tech newsletter: Medical device makers file safety incident reports late, and more.
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In a new study in the BMJ, researchers analyzed the Food and Drug Administration database where manufactures report adverse events and found that a huge number of reports come in late. Manufacturers are required to report issues within 30 days of finding out about them. Of 4.4 million manufacturer reports between 2019 and 2022, about 600,000, or nearly 14% came in late. Over 600,000 came in with missing or invalid dates. Notably, 1,004 deaths were reported late.
The authors tease out a number of interesting nuances to how reporting happens. For example, late reports were disproportionately released in batches by manufacturers, which the authors suggest “could stem from manufacturers knowingly withholding important safety information from the public.” The authors also concede it might just take time to verify reports. They also name the top 10 late reporters.
