FDA Misses Lessons of Device Recalls
6/24/2011 7:40:38 AM
A new report from the U.S. Government Accountability Office (GAO), the auditing arm of Congress, found that the Food and Drug Administration isn’t doing everything it can to learn from medical device recalls. That’s despite the fact that on average more than 700 medical devices are recalled each year. The report was requested by Sen. Chuck Grassley (R-Iowa), the chairman of the Finance Committee and Sen. Herb Kohl (D-Wisc.), the chairman of the Committee on Aging. The GAO investigators didn’t take issue with what the FDA does in initiating and classifying the mostly voluntary recalls of medical devices. Instead, they wrote that the agency took a haphazard approach to assessing the effectiveness of recalls and analyzing information after a recall. Those gaps represent a missed opportunity to learn went wrong and keep it from happening again, the GAO warned.