Sunday, January 18, 2009

High risk medical devices escaped close review

Some medical devices for sensitive uses, from certain hip joints to a type of defibrillator, have won government approval without a close scientific review, congressional investigators said Thursday. Although Congress ordered the Food and Drug Administration years ago to resolve the issue, the agency approved 228 medical devices without a full scale review from 2003-2007, the Government Accountability Office said in a report.

Some devices approved under the less rigorous process have been recalled because of malfunctions and other problems, according to the consumer group Public Citizen. One device was an external defibrillator to assist heart attack victims.  "For years, Congress has required high-risk medical devices to undergo stringent premarket review, but GAO's findings show that is simply not happening in every case."