Senators urge GAO to review FDA oversight of recalls 

WASHINGTON – U.S. Senate Majority Whip Dick Durbin, D-Ill., and U.S. Sen. Richard Blumenthal, D-Conn., have sent a letter to the Government Accountability Office (GAO) calling on the agency to update its 2011 report entitled “Medical Devices: FDA Should Enhance Its Oversight of Recalls” in the wake of the Philips Respironics recall.   

The Senators sent the letter following the Pittsburgh Post-Gazette’s and ProPublica’s reporting on the recall of certain CPAP and other respiratory devices.  

“From contact lenses and catheters to prosthetics and pacemakers, medical devices improve and save lives,” the letter states. “Health care providers use them to diagnose and treat illnesses and injuries. Tens of millions of patients have implanted medical devices or use them in their homes to live healthier, more productive lives. But, there can be major risks. Due to unforeseen safety or manufacturing issues, medical devices can cause harm to patients, which can lead to a recall.” 

The letter goes on to note that in FY 2022, the FDA oversaw 898 medical device recalls, a 125% percent increase compared to FY 2012.  

The letter also follows Durbin’s introduction of the bicameral Medical Device Recall Improvement Act, a bill that would require the FDA to establish an electronic format for medical device recall notifications to streamline communication between medical device manufacturers, FDA, hospitals and health care professionals. It would also require manufacturers to include in recall notices information about how the recall could affect patients with medical devices and instruct hospitals and health care professionals to provide that information to patients.