Devices

Update GAO Device Recall Oversight Report: Senators

David McFarland

— 2 min read
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Sens. Richard Durbin (D-IL) and Richard Blumenthal (D-CT) are asking the Government Accountability Office (GAO) to update its 2011 report recommending that FDA enhance its oversight of medical device recalls. The senators say an update is needed in light of the dramatic increase in overall device recalls, especially Class 1 recalls, and recent reporting involving the Philips Respironics recall of breathing machines.

In a 12/13 letter to GAO, the senators report that in Fiscal Year 2022, FDA oversaw 898 medical device recalls covering tens of millions of devices. They say that was a 125% increase over the 399 recalls in 2012. Also, they say, in FY 2022 there were 70 Class 1 recalls, a 15-year high. A similar increase was seen in medical device-related adverse event reports, from 486,986 in 2012 to 2,946,889 in FY 2022, a 505% increase.

After reviewing the ProPublica/Pittsburgh Post-Gazette reporting on issues involving the Philips Respironics recall for CPAPs, BiPAPs, and other breathing machines, the senators cite the GAO 2011 report that found FDA often failed to conduct recall-related inspections, the agency’s process to confirm recall effectiveness was inefficient, and the agency’s process to terminate a recall increased the risk that unsafe medical devices could continue to be used.

Congress used those findings as the basis for several measures included in the FDA Safety and Innovation Act that reauthorized user fees, they say. But, the senators write, “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.”

Durbin and Blumenthal urge GAO to conduct an updated review as soon as possible, considering these questions:

  • data on the number and characteristics of medical device recalls and the extent to which FDA uses that information to improve its oversight of recalls;
  • data on the authorities and actions FDA has used or taken to ensure that medical device manufacturers initiate recalls;
  • data on the authorities and actions FDA has used or taken when medical device manufacturers have not initiated timely recalls in compliance with federal regulations;
  • factors that could contribute to the likelihood of a medical device recall initiation;
  • additional resources, funding, or legislative authorities that would improve FDA’s oversight of medical device recalls;
  • data on the number and characteristics of adverse event reports submitted to FDA and the extent to which FDA uses this information to improve its oversight of medical device recalls;
  • data on the authorities and actions FDA has used or taken when manufacturers have not submitted timely adverse event reports in compliance with federal regulations;
  • data on factors that could contribute to the likelihood of an adverse event report submission; and
  • additional resources, funding, or authorities that would improve FDA’s oversight of adverse event reports.

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