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December 19, 2023
4 Min Read
Win McNamee / Getty Images News via Getty Images & Chip Somodevilla / Getty Images News via Getty Images
In 2022, nearly 900 medical devices were recalled by FDA, representing a 125% increase compared to 2012, which saw 399 recalls. That number included 70 Class I recalls — FDA’s highest and most serious classification — becoming a 15-year high. Medical device adverse event (AE) reports also increased by 505% from 2012 to 2022.
As an individual who remains glued to all medical device regulatory actions — especially pertaining to recalls — this number, while staggering, isn’t all that surprising. For the last two years, it seems I’m constantly reporting on another company in FDA’s cross hairs and I’d dare say this year’s recall and AE numbers will meet and maybe even surpass that of 2022.
But I’m not the only one taking notice of the hike.
Last week, two prominent United States senators published an open letter to the Government Accountability Office (GAO) — the investigative arm of Congress — calling for a probe into how FDA tracks warnings about dangerous and recalled devices as well as how it takes actions against companies that put its customers at risk.
Senators Dick Durbin, D-Ill, and Richard Blumenthal, D-Conn, were spurred to write the missive following Philips Respironics years-long recall of its CPAP and BiPAP machines. Specifically, the senators pointed to the revelatory article by the Pittsburgh Post-Gazette and ProPublica as a catalyst, which reported on how it appears Philips received AE reports about deteriorating abatement foam back in 2010. The company, however, didn’t inform FDA of any such documents and thousands of additional reports it received for more than 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 senators wrote. “That is unacceptable.”
FDA, according to the ProPublica and Post-Gazette report, also missed more than one opportunity to mitigate harm to patients using Philips recalled breathing machines.
“Additionally, it now appears that FDA missed several opportunities to mitigate the harm done to the millions of patients who have used these recalled medical devices,” according to the letter. “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. 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.
Now, the senators are urging GAO to look into how FDA ensures medical device companies initiate recalls in a timely manner, how the agency responds when manufacturers fail to comply, and what resources or legislation would be needed to improve its oversight.
The investigation would be conducted as an updated review of GAO’s 2011 report which examined FDA’s oversight of medical device recalls. The report found that FDA often failed to conduct recall-related inspections and that its process to confirm the effectiveness of a recall was ineffective. Additionally, it showed that FDA’s process to terminate a recall increased “the risk that unsafe medical devices [could] continue to be used, according to the two senators.
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.
Senators Durbin and Blumenthal said in their letter to GAO that due to the increase of recalls and explosive investigative reporting pertaining to potential mishandling, it was time to review the agency once again. “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,” they wrote. “We urge GAO to conduct an updated review as soon as possible.”
This is not Blumenthal’s first action in the aftermath of the ProPublica and Post-Gazette article. The senator, who sits on the Senate Judiciary Committee — which includes an investigations subcommittee that reviews violations of laws and regulations impacting national health and safety — with Durbin as Chair, asked the Justice Department in September to take immediate action against Philips considering the information gleaned from the piece. He later expanded this call for enforcement in a letter to FDA Commissioner Robert M. Califf and Attorney General Merrick Garland, in which we called the ProPublica and Post-Gazette findings “explosive”.
About the Author(s)
Managing Editor, MD+DI
Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].
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