The Government Accountability Office released a bipartisan report detailing the shortcomings of the U.S. Food & Drug Administration’s system for reviewing and monitoring recalls, calling for more proactive oversight of recalls and enhanced review of trends.
Senators Chuck Grassley and Herb Kohl sponsored the report, which found that "gaps in the medical device recall process limited firms’ and FDA’s
abilities to ensure that the highest-risk recalls were implemented in an
effective and timely manner".
The FDA used recall data to monitor recalls and target firms for inspections but didn’t analyze the data for patterns that might indicate systemic problems.
The investigation concluded that the "FDA is missing an opportunity to use recall data to proactively identify and address the risks presented by unsafe devices," and the GAO recommended that the FDA routinely assess information on device recalls for patterns that might indicate recurring issues.
The GAO also pointed out that devices undergoing high-risk recall were sometimes hard to track down, and the FDA had no standard protocol for determining whether a company had done enough to correct a problem or remove enough faulty devices before terminating the recall.
“The FDA can’t tell if recalls of high-risk devices were carried out successfully because it lacks criteria for assessing device recalls and doesn’t routinely review recall data,” Grassley said. “Right now, it looks like the FDA is missing an opportunity to proactively identify and address risks presented by unsafe devices.”