FDA ‘remains unsatisfied’ with Philips’ handling of CPAP recall

We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” the FDA's device center director, Jeff Shuren, said in an update this week. (Photo by Sarah Silbiger/Getty Images)

Since Philips began its recall of millions of respiratory devices in June 2021, the FDA hasn’t been shy about criticizing how the company has handled the recall.

Certain Philips Respironics ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines

And over two years in, despite Philips’ efforts, the agency “remains unsatisfied with the status of this recall,” according to an update it released Thursday and attributed to Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

This time around, the FDA is taking issue with the independent testing Philips commissioned—on a post-recall request from the regulator—to assess the safety of the polyester-based polyurethane (PE-PUR) foam at the heart of the recall. The foam, which was added to many of Philips’ CPAP and BiPAP machines and ventilators to muffle sound and vibrations, was found to break down over time and possibly release debris and chemicals into a user’s airflow.

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Since the start of the recall, the FDA has warned that inhaling particles released by the disintegrating foam could potentially lead to internal and external irritation, headaches, asthma, nausea or “toxic or carcinogenic effects to organs, such as kidneys and liver.”

Meanwhile, though Philips initially issued similar warnings, it has since changed its tune, touting instead the results of the independent testing, which concluded that exposure to materials released by the foam “is unlikely to result in an appreciable harm to health in patients.”

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Those findings clash with the FDA’s tally of more than 105,000 medical device reports (MDRs) related to the recalled devices that it received between April 2021 and the end of March of this year, including 385 reports of death—though both the FDA and Philips have been quick to note that MDRs are unvetted submissions and therefore their contents may not be directly linked to Philips’ devices.

Additionally, some experts have singled out the genotoxicity findings in the Philips-commissioned testing: The foam repeatedly tested positive for genotoxicity, and though the device maker said the results still fell within acceptable safety standards, experts interviewed in a recent ProPublica report argued that genotoxicity in any capacity is cause for “alarm,” since it denotes an ability to damage the genetic information within a cell, potentially leading to cancer-causing mutations.

It should be noted that genotoxicity was found in in vitro animal testing, not in a human Clinical Trial.

The FDA recall shows the inconsistency of the FDA's methodology as it approved an mRNA COVID-19 vaccine without a full approval process, yet recalled a previously approved device

FDA ‘remains unsatisfied’ with Philips’ handling of CPAP recall