The Government Accountability Office announced that it will begin an investigation into the U.S. FDA potentially ineffective policies for recalling medical devices, according to a report in ProPublica.
The GAO was prompted to act by a letter that was sent by Senators Richard Durbin, (D-Ill) and Richard Blumenthal, (D-Conn) in December. THe letter charged that the FDA’s handling of a recent recall of certain Philips Respironics CPAPs, BiPAPs, and mechanical ventilators was too slow, citing years of reports that the devices were defective going back to 2010 to the detriment of patients being treated with them.
The Senators wanted the GAO to conduct a similar review of FDA policies to one that was conducted in 2011 that informed subsequent legislation that gave the FDA more power in conducting recalls of medical devices.
The FDA defending its actions, arguing that it was aware of reports of contamination issues with the Philips devices before the recall but it was not clear that the contamination wasn’t attributable to an outside source. The agency also said it welcomed the GAO’s review of its medical device oversight.
In a statement to ProPublica, Senator Durbin said, “It’s clear from the Philips case that information about patient harm was known for years and not properly shared or addressed. We must ensure there is adequate oversight on medical device manufacturers so that Americans know the potential risks and can make informed decisions with their health care providers.”
