02.04.11
A study recently was released that seems to indicate that despite more burdensome regulatory requirements and a lengthier review process in the United States, medical device recalls happen about the same in the European Union. This is significant evidence for those arguing against increased device review bureaucracy from the U.S. Food and Drug Administration (FDA). Many have argued that innovation in the United States will suffer as a result and Europe will become a first-stop proving ground for the latest and most, innovative medical technology.
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 released by the Washington, D.C.-based Advanced Medical Technology Association (AdvaMed), and prepared for AdvaMed by the Boston Consulting Group.
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.