FDA calls on non-government experts to evaluate safety of heart devices
The U.S. FDA will look to non-government medical expert consultants to better determine the safety of heart devices such as pacemakers, defibrillators and other devices, according to a Reuters report.
The emphasis of the plan will be on devices that have already been granted certification by the FDA but have shown problems in actual application. Experts will be called in to assist in evaluating reports of problems with the medical devices and also to help determine if product recalls are appropriate, said Daniel Schultz, MD, director of the Center for Devices and Radiological Health, FDA, in comments relating to the plan.
"What we are going to try to do is engage some additional experts specifically in the field of electrophysiology, experts in pacemakers and ICDs," said Schultz.
One main FDA goal in using these experts is speed. The agency in the past has largely reviewed technologies before they hit the market, and is hampered by little time to review problems after the fact. The outside advisors will be able to provide evaluations of problems much more rapidly, Reuters reports.
Schultz indicated that the outside experts will be used sparingly on certain cases and will not be a part of the normal certification process used by the FDA.
The FDA has been under some heat following problems with a series of heart rhythm management devices made by Guidant Corp. The agency was roundly criticized for its failure to provide proper oversight regarding how Guidant reported problems to doctors and the public. Another worry for the agency is a pending report by a physician group that will suggest modifications as to the ways data regarding heart unit quality is gathered, Reuters reports.
The emphasis of the plan will be on devices that have already been granted certification by the FDA but have shown problems in actual application. Experts will be called in to assist in evaluating reports of problems with the medical devices and also to help determine if product recalls are appropriate, said Daniel Schultz, MD, director of the Center for Devices and Radiological Health, FDA, in comments relating to the plan.
"What we are going to try to do is engage some additional experts specifically in the field of electrophysiology, experts in pacemakers and ICDs," said Schultz.
One main FDA goal in using these experts is speed. The agency in the past has largely reviewed technologies before they hit the market, and is hampered by little time to review problems after the fact. The outside advisors will be able to provide evaluations of problems much more rapidly, Reuters reports.
Schultz indicated that the outside experts will be used sparingly on certain cases and will not be a part of the normal certification process used by the FDA.
The FDA has been under some heat following problems with a series of heart rhythm management devices made by Guidant Corp. The agency was roundly criticized for its failure to provide proper oversight regarding how Guidant reported problems to doctors and the public. Another worry for the agency is a pending report by a physician group that will suggest modifications as to the ways data regarding heart unit quality is gathered, Reuters reports.