Still 'unsatisfied’ with Philips' handling of CPAP recall, FDA calls for additional safety testing

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.

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.

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.”

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 devicemaker 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.

Though it didn’t disclose which particular areas of the tests’ scope are at issue, the FDA expressed its own concern over Philips’ findings to date. In this week’s update, Shuren said the agency has called on Philips to perform more safety tests—a request to which the Dutch medtech giant has already agreed.

“The FDA has reviewed the available information and data provided to FDA by Philips. 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,” Shuren said, adding, “Based on the currently available information, the FDA maintains its recommendations regarding the potential health risks associated with the PE-PUR foam breakdown in these recalled devices.”

In a statement of its own, Philips said it’s still working with the FDA to hammer out the details on that additional testing.

“Philips’ first priority is the health and well-being of patients, both in terms of providing replacement devices and testing to seek more clarity on the safety of the sleep and respiratory care devices under the recall,” the statement continued. “Philips shares the same objective as the FDA and other regulators to ensure the highest standards of patient safety and quality in the delivery of healthcare. Philips remains committed to working closely with regulators across the world, as we continue to dedicate all necessary resources to ensure that patients receive remediated devices, and the test and research program is completed.”

In spite of Philips’ cooperation with the FDA’s requests throughout the recall period, however, this week’s rebuke appears to have spooked investors. Its stock price plunged nearly 10% overnight, from a closing price near $20 on Thursday afternoon to below $18 on Friday morning.

Additionally, analysts have suggested that the consent decree that’s long been hovering over Philips’ head could soon come crashing down on the company: “The additional testing requirement, continued dissatisfaction of Philips’ handling of the recall and the removal of the device from the shortage list, make a Respironics sales ban in the U.S. all the more likely,” a Bernstein analyst wrote this week.