Majority Whip Dick Durbin (D-IL) and Sen. Richard Blumenthal (D-CT) sent the letter to the Government Accountability Office (GAO). The letter requests an update to a 2011 GAO report entitled “Medical Devices: FDA Should Enhance Its Oversight of Recalls.”
Durbin and Blumenthal’s scrutiny of FDA oversight comes in the wake of several developments in Philips’ respiratory device recall.
Since mid-2021, more than 5 million Philips Respironics devices have been recalled due to dangerous degradation of sound abatement foam. At least 385 deaths have been reported in connection with the foam-related recall.
While the company continues to work though its remediation process, more light has been shed on how the recall unfolded as it did. ProPublica and the Pittsburgh Post-Gazette first reported that Philips withheld its CPAP issues from the FDA for years. The reporting later revealed CEO Roy Jakobs’ knowledge of the ongoing issues and alleged approval of the sale of defective devices.
The senators say they sent their letter to the GAO following that reporting. In the letter, they wrote:
“From contact lenses and catheters to prosthetics and pacemakers, medical devices improve and save lives. 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.”
An FDA Center for Devices and Radiological Health (CDRH) spokesperson told MassDevice via email that “FDA welcomes GAO review of the agency’s oversight of medical device recalls.”
More in the letter around the FDA and Philips
The letter says the FDA oversaw 898 medical device recalls in 2022, representing a 125% increase compared to fiscal 2012. That also included 70 Class I (the most serious kind) recalls, a 15-year high. The agency received nearly 3 million adverse events reports in 2022, marking a 505% increase.
Durbin and Blumenthal highlight the “disastrous harm” caused by Philips’ failure to report defective devices. They say more than a decade passed, during which Philips knew of the issue, before the company initiated a recall.
“That is unacceptable,” the senators wrote.
They also say the FDA “missed several opportunities” to step in and mitigate the damage done in the recall. And, the agency did so knowing “Philips had a history of withholding adverse event reports from the agency.”
“FDA reportedly also received at least 30 adverse event reports related to degradation of the sound abatement foam significantly prior to the initiation of the recall,” they wrote. “FDA has stated that it ‘reviews all reports of adverse events associated with medical devices.’ However, it is not clear whether or not FDA took action to inform hospitals, health care providers, and patients about the potential risks.”
Senators urge the GAO
Durbin and Blumenthal end the letter by saying the GAO must update its report on medical device recalls. They want to ensure that the FDA “adequately fulfills its duty” to ensure that recalls take place in a timely manner.
Their letter followed Durbin’s introduction of legislation aiming to require the FDA to establish an electronic format for medical device recall notifications. The legislation seeks to streamline communication between medical device manufacturers, the FDA, hospital sand healthcare professionals.
They wrote:
“In 2011, GAO released a report about FDA’s oversight of medical device recalls that found FDA often failed to conduct recall-related inspections. It also found that FDA’s process to confirm the effectiveness of a recall was ‘ineffective,’ and that its process to terminate a recall increased ‘the risk that unsafe medical devices [could] continue to be used. Given recent reporting and the dramatic increase in recalls since then, it is clear that GAO and Congress must examine FDA’s oversight of medical device recalls once again.”
MassDevice reached out to the FDA for comment on this call to action — this story may be updated.