EU and U.S. device recall rates equal

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Medical device recalls occur at comparable rates in Europe and the U.S., despite a typically lengthier review process in the U.S., according to a report released by the Advanced Medical Technology Association (AdvaMed).

The report found that the rate of severe recalls of medical devices in Europe was on par with equivalent class I device recalls in the U.S., with an average of 21 yearly recalls between 2005 and 2009 for each. Both the E.U. and the U.S. experienced dramatic increases in the number of severe recalls in 2009.
 
Cardiovascular devices had the highest recall rates, followed by general hospital recalls, orthopedics and anesthesiology. Manufacturing and design issues grossly outnumbered all other sources of class I recalls.

“It’s well-documented that it takes longer to bring medical technology to market in the U.S. than it does in Europe. Today’s report suggests that the delay denies patients access to the most up-to-date treatments and cures without a corresponding increase in safety,” argued Stephen J. Ubl, president and CEO of Washington, D.C.-based AdvaMed, which represents medical device manufacturers in advocating regulatory standards. The report was prepared for AdvaMed by the Boston Consulting Group.