GAO says unsafe medical devices are still being soldby Martin Moylan, Minnesota Public Radio
St. Paul, Minn. — Government investigators told a U.S. Senate committee Wednesday that the Food and Drug Administration is not providing pre-market reviews that are thorough enough. The reviews are of medical devices such as hip joints and heart defibrillators.
Investigators from the Government Accountability Office said patients may be at risk. The GAO also found the FDA does not adequately monitor the performance of devices once they've been approved for market. Marcia Crosse is the GAO's director of health care.
"In our ongoing review of medical device recalls, we have identified gaps in FDA's processes that could allow unsafe or ineffective devices to continue to be used despite being recalled by the manufacturer," Crosse said.
But University of Minnesota law professor Ralph Hall said his study of the FDA's approval process found it be overwhelmingly reliable, providing the safety and effectiveness Congress has said it wants.
"The system is meeting the congressional mandate. Overall, it is performing very well. Greater than 99.5 percent of submissions do not result in a class 1 one recall," said Hall.
The GAO report came more than two years after the watchdog agency first cited problems with the FDA approval process for critical medical devices. Back then, the GAO faulted the FDA for not reclassifying more than 26 types of devices so they would receive more stringent reviews.