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Capitol Health Call
August 10, 2011

Overseeing Device Recalls

JAMA. 2011;306(6):598. doi:10.1001/jama.2011.1122

Sen Chuck Grassley (R, Iowa) and Sen Herb Kohl (D, Wis), who have been critical of the Food and Drug Administration's oversight of medical devices, released a report June 21 and called on the agency to enhance its assessment of recalls of medical devices to better reduce the risk of serious health consequences from defective or unsafe devices.

The report, by the Government Accountability Office (GAO), said from 2005 through 2009, companies initiated 3510 medical device recalls, an average of about 700 per year (http://tinyurl.com/3vg2cxh). Although the FDA used recall data to monitor individual recalls and to target companies for inspections, it has not routinely analyzed such data to see whether there are systemic problems underlying trends in medical device recalls, the GAO said.

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