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Study: Recalled Devices Had Less Strict FDA Review

Researchers Say Many Recalled Medical Devices Were Approved in a Less Intensive Process
WebMD Health News
Reviewed by Laura J. Martin, MD

Feb. 14, 2011 -- More than three-quarters of medical devices involved in high-risk recalls in the last five years because they could cause serious harm or death to patients did not undergo FDA premarket approval, which requires clinical testing and inspections, a study shows.

Instead, these devices were cleared through an alternative FDA regulatory review, called a 510(k), which allows manufacturers to market devices as long as they can demonstrate that their products are similar enough to other products already on the market.

Some of the devices cleared this way that were later recalled as high risk include automated external defibrillators (AEDs), insulin pumps, intravenous infusion devices, and glucose meters.

Researchers point out that more than 20% of almost 1 million AEDs -- which are supposed to help resuscitate patients who are having life-threatening abnormal heart rhythms -- have been recalled and that some people may have died because of AED malfunctions.

“It was a surprise,” says study researcher Diana M. Zuckerman PhD, an epidemiologist at the National Research Center for Women and Families, a nonprofit think tank in Washington, D.C. “I knew, of course, that there would be some high-risk recalls of 510(k) devices, but I really didn’t expect that it would be the overwhelming majority.”

“Devices that are cleared through the 510(k) process are supposed to be moderate risk or low risk, with that definition that the FDA has. They shouldn’t be high risk when they’re recalled,” Zuckerman says.

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