Senators Richard Durbin, (D-Ill) and Richard Blumenthal, (D-Conn) requested that the Government Accountability Office (GAO) review what it saw were ineffective FDA policies surrounding recalls of medical devices.
In a letter to the GAO, Durbin and Blumenthal referenced Philips Respironics’ recall of its CPAPs, BiPAPs, and mechanical ventilators as an example of an ineffective recall strategy. The Senators said that media reports had determined that Philips knew about the problems with its devices as early as 2010 but didn’t report it to the FDA for a decade.
“Even when Philips Respironics conducted an internal health hazard evaluation, which confirmed that inhaling the chemicals from the sound abatement foam could cause “permanent impairment,” it did nothing, while patients suffered,” the letter states. “This is unacceptable.”
The letter also referenced a stark increase in medical device recalls in the past decade. According to the letter, the FDA oversaw 898 medical device recalls in 2022, a 125% increase compared to 2012, when there were 399 medical device recalls. The number includes 70 class I recalls, a 15-year high.
In 2011, the GAO released a report about FDA’s oversight of medical device recalls that found FDA often failed to conduct recall-related inspections. The report was used by Congress to pass legislation that improved the FDA’s ability to conduct recalls.
In light of recent failures and increases in medical device recalls, the Senators asked the GAO to conduct an updated review of the medical device recall policies so that Congress can use the information to guide legislation going forward. “Recalls must be conducted in an efficient manner in order to mitigate harm,” the letter states. “However, this does not happen all of the time.”
