Report Says U.S. and European Device Recalls About the Same Medical device recalls occur at compa

Report Says U.S. and European Device Recalls About the Same

Medical device recalls occur at comparable rates in Europe and the United States, despite a typically lengthier review process by the U.S. Food and Drug Administration (FDA), according to a report released by the Washington, D.C.-based 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 United States, with an average of 21 yearly recalls between 2005 and 2009 for each. Both the European Union and the United States 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, the report noted.

“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,” said Stephen J. Ubl, president and CEO of AdvaMed. The report was prepared for AdvaMed by the Boston Consulting Group.