Congressional Watchdog to Launch Probe into FDA Medical Device Recall Oversight

One month after Senators Dick Durbin, D-Ill, and Richard Blumenthal, D-Conn, published an open letter to the Government Accountability Office (GAO) calling for a probe into how FDA tracks warnings about dangerous and recalled devices, the congressional watchdog is now launching an inquiry into the agency for the first time since 2011.

The request from the senators came after reports from ProPublica and the Pittsburgh Post-Gazette which detailed FDAs proposed mishandling of the years-long Philips Respironics recall, specifically calling back to how it appears the agency missed more than one opportunity to mitigate harm to patients using Philips recalled breathing machines.

“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,” the letter detailed. “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. Further, the Pittsburgh Post-Gazette and ProPublica’s reporting suggests that FDA knew Philips Respironics had a history of withholding adverse event reports from the agency, but still allowed it — and other medical device manufacturers — to submit late adverse event reports without appropriate enforcement for such violations.”

FDA has defended its handling of the recall, noting that while it received complaints about general contamination issues before the recall, the debris could have been caused by external sources unrelated to the degrading abatement foam and the reports did not indicate any patient harm.

The last time that GAO investigated FDA’s oversight of device recalls occurred in 2011 and found that the agency “often failed to conduct recall-related inspections and that its process to confirm the effectiveness of a recall was ineffective,” according to previous MD+DI reporting.

Additionally, it showed that the FDA’s process to terminate a recall increased “the risk that unsafe medical devices [could] continue to be used,” according to Durbin and Blumenthal.

The 2011 report was, at the time, then used to inform several congressional measures including the Food and Drug Administration Safety and Innovation Act, which reauthorized the FDA User Fee Amendments.

In the open letter, the senators asked for an update on the 2011 probe, listing 10 questions they urged GAO to consider, including the agencies authority and actions it has used to ensure manufacturers initiate recalls and whether additional resources, funding or legislative authorities would improve oversight.

While a GAO spokesperson has confirmed it is starting the FDA inquiry, information is not available detailing when it will begin or how long it will take.

A Center for Device and Radiological Health spokesperson told ProPublica that it welcomes the review but did not say what GAO will specifically look into.

“The FDA welcomes the opportunity for GAO review of the agency’s oversight of medical device recalls,” the agency said in a statement.