Dive Brief:
- Two U.S. senators are asking the Government Accountability Office (GAO) and Congress to re-examine the Food and Drug Administration’s oversight of medical device recalls, citing a media investigation that concluded Philips Respironics and the agency knew about problems with the company’s respiratory machines for years before informing the public.
- Calling Philips’ handling of the device recall “unacceptable,” Sens. Richard Durbin, D-Ill., and Richard Blumenthal, D-Conn., said “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.”
- Adverse event reports to the FDA have climbed by more than 500% over the past decade, while medical device recalls have more than doubled, the senators said in a letter urging the GAO to conduct a review “as soon as possible.” A spokesperson from the FDA’s Center for Devices and Radiological Health said in an emailed statement that the “FDA welcomes GAO review of the agency’s oversight of medical device recalls.”
Dive Insight:
Philips Respironics recalled millions of sleep apnea machines and mechanical ventilators in 2021 after learning that the polyester-based polyurethane sound abatement foam in some of the devices could deteriorate and be inhaled. According to the FDA, the issue could cause headaches, vomiting, allergic reactions, asthma and “toxic or cancer-causing effects.”
In their letter to U.S. Comptroller General Gene Dodaro, Durbin and Blumenthal said recent reporting by the Pittsburgh Post-Gazette and ProPublica indicates both Philips Respironics and the FDA knew about the problem for several years before the recall was initiated.
The Post-Gazette and ProPublica investigation found that Philips Respironics received an adverse event report about the issue in 2010 and accumulated thousands of additional reports over more than a decade before informing the FDA or initiating a recall, the lawmakers said.
“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. That is unacceptable,” Durbin and Blumenthal wrote.
The 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 stated.
Philips said in an emailed statement it investigated and addressed complaints related to possible foam degradation on a case-by-case basis in the years before 2021, and acted to protect patient safety by initiating a recall of “significant scale” that year when it “became aware of the issue and its potential significance.”
“Although Philips and Philips Respironics only had a limited amount of information regarding the potential health risks, the recall decision was made in an abundance of caution, after careful consideration of a reasonable worst-case scenario, rather than deferring the recall decision to conduct more definitive testing,” a Philips spokesperson wrote in the email.
The company also said it continues to dedicate “all necessary resources” to ensure that impacted patients receive remediated devices.
“Philips and Philips Respironics share the same objective as the senators and FDA to ensure the highest standards of patient safety and quality in delivery of healthcare,” the spokesperson said. “We deeply apologize for this and continue to work hard to resolve this for our patients and customers.”
The Post-Gazette and ProPublica reports suggest the FDA knew Philips Respironics had a history of withholding adverse event reports but allowed the company and other medical device manufacturers to submit them late “without appropriate enforcement for such violations,” the senators said.
The GAO released a report in 2011 that found the FDA often failed to conduct recall-related inspections, its process to confirm the results of a recall was “ineffective,” and its process to terminate a recall increased the risk that unsafe medical devices could continue to be used, the senators wrote.
Congress used the report to inform several measures included in the Food and Drug Administration Safety and Innovation Act that reauthorized the FDA User Fee Amendments. “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,” the letter said.