July 26, 2011
WASHINGTON, D.C. — DeAnn Friedholm, the director of Consumers Union’s health reform campaign, today made the following statement about the Institute of Medicine (IOM) report that found thousands of medical devices are allowed to go on the market without proper testing for safety. The report called on the Food and Drug Administration, which commissioned the report, to develop a new framework for ensuring the safety and effectiveness of these devices.
Friedholm said, “The IOM report makes it clear that the present system does not ensure the safety or effectiveness of many key medical devices. The report is a clear call for replacing the current system with one that does more to ensure safety and effectiveness, while encouraging innovations that promote the health of the individuals using devices.
“The report is a call for more science in the device-approval process. It is particularly strong in urging a comprehensive system of oversight that includes both a reliable pre-market review process and robust post-approval monitoring that quickly and effectively identifies problems with devices once they have entered the market. The report emphasizes the need for the FDA to have authority to use post-market tools that allow them more flexibility in limiting, recalling or banning devices that may put patients at risk of harm.
“As we enter the upcoming debate on reauthorization of MDUFA in 2012, our national system of oversight should ensure that the needs of patients and protection of their health is the primary focus.”