FDA Misses Lessons of Device Recalls

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.

An open and charged AED. Image via Wikimedia Commons user Owain.davies.

Specifically, because of the FDA’s lack of analysis on medical device recalls, they couldn’t give definitive answers to questions from the GAO about the common causes of recalls, the trends in the number of recalls over time, the variation in recalls by risk level, the types of devices and medical specialties that account for the most recalls, and the length of time it takes for companies and the FDA to complete recall activities.

But the FDA told the GAO investigators that it does use recall information help target their inspections. And the GAO gave FDA a gold star from use of recall information to detect and address safety issues with automated external defibrillators. Late last year, the FDA held a conference on AEDs where in presented historical recall data to make the case for safety improvements in the device, the GAO wrote.

For its part, the FDA says it’s getting better. In statement in response to the GAO report, FDA officials said that last year launched the Recall Process Improvement Project, which is aimed at better educating the industry about the recall process. And about a year ago, the FDA began using recall data to aid in the review of devices. The agency has also developed initiatives that use recall data to help improve the safety of infusion pumps, external defibrillators, and radiation from medical procedures.

— Mary Ellen Schneider (on Twitter @MaryEllenNY)

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Filed under Cardiovascular Medicine, Drug And Device Safety, Emergency Medicine, Family Medicine, Health Policy, Hospital and Critical Care Medicine, IMNG, Internal Medicine, Nuclear Medicine, Practice Trends, Primary care, Radiology

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