The Food and Drug Administration's oversight of the medical-device recall process requires new procedures that measure and document how the agency handles the hundreds of recalls that occur annually, according to a Government Accountability Office report (PDF).
Device recall process needs new procedures, GAO says
After an 18-month performance audit, the GAO recommended the FDA develop a program to assess medical device recall information and then use the data to identify trends, including the number of recalls, the types of devices recalled and causes for the recalls.
“Several 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,” wrote the report's authors. “For many high-risk recalls, firms faced challenges, such as locating specific devices or device users, and thus could not correct or remove all devices.”
Other GAO recommendations include making medical device recall audit checks more consistent and creating criteria to access whether manufacturers have adequately conducted an “effective correction or removal action.”
The FDA agreed with the GAO's findings but also noted, “In recent years, the agency has experienced significant increases in the number of recalls of FDA-regulated products, some of which involve the largest and most complex recalls in FDA history,” in its response.
Manufacturers conducted 3,510 device recalls from 2005 to 2009.
The report found that despite having the data available, the FDA could not identify why 83% of recalls were class II, or recalls for devices with a moderate health risk; why class I recalls, which have the highest risks, more than doubled between 2008 and 2009; or why 86 recalls had been ongoing for five years.
“As currently structured, FDA's approach to oversight of medical device recalls is reactive—responding to individual recalls as they occur,” states the GAO. “Rather than pursuing a strictly case-by-case approach to overseeing recalls, FDA could take a more proactive approach to its oversight. The agency has a plethora of data available on thousands of recalls, but at present, is not effectively reviewing and analyzing these data in a systematic manner.”
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