This request comes in the wake of Philips’ recall of over 15 million respiratory devices that has been ongoing for two-and-a-half years. The GAO spokesperson mentioned that the office aims to start the investigation soon, but details about the timeline were not provided.
Senators Durbin and Blumenthal had expressed concerns about the FDA’s handling of medical device recalls, particularly citing missed opportunities in mitigating harm to patients affected by the Philips recall. The senators referred to a 2011 GAO report and posed 10 questions for the review, seeking insights into the FDA’s use of information to improve the recall process, its authority and actions for ensuring manufacturer-initiated recalls, factors contributing to the likelihood of recalls, and the potential impact of additional resources, funding, or legislative authorities on FDA oversight.
The GAO’s decision to investigate follows a series of high-profile device recalls and safety issues in recent years, including Philips’ ongoing recall of sleep apnea and ventilator machines. The FDA has faced criticism for its handling of safety concerns related to breast implant products, Bayer’s Essure birth control device, and Medtronic’s Heartware ventricular assist device. The Center for Devices and Radiological Health welcomes the review, though specific details about the scope and duration of the investigation remain unclear.