Over two years into Philips’ ongoing recall of millions of respiratory devices, the FDA has expressed dissatisfaction with the progress of the recall efforts. The FDA’s concerns, articulated by Dr. Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health, pertain to the independent testing commissioned by Philips to assess the safety of the polyester-based polyurethane (PE-PUR) foam central to the recall.
This foam was incorporated into numerous Philips CPAP and BiPAP machines and ventilators to mitigate sound and vibrations but was found to degrade over time, potentially releasing debris and chemicals into users’ airflow. The FDA had previously warned that inhaling particles from the disintegrating foam could result in internal and external irritation, headaches, asthma, nausea, or even toxic and carcinogenic effects on organs like the kidneys and liver.
Despite initially echoing these warnings, Philips later shifted its stance, highlighting the outcomes of independent testing that indicated minimal harm to patients from exposure to foam-related materials. However, this perspective is in contrast to the FDA’s receipt of over 105,000 medical device reports (MDRs) linked to the recalled devices between April 2021 and March 2023, which included 385 reports of fatalities. Both the FDA and Philips have acknowledged that MDRs are unverified submissions and may not directly attribute their contents to Philips’ devices.
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Additionally, genotoxicity findings in Philips-commissioned testing have raised concerns. The foam repeatedly tested positive for genotoxicity, which experts argue is a cause for alarm since it signifies the potential to damage genetic information within cells, possibly leading to cancer-causing mutations. While Philips maintained that the results fell within acceptable safety standards, the FDA expressed its reservations about Philips’ findings.
“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. 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.”
– Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health
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Philips, in its response, emphasized its commitment to patient health and well-being, with a focus on providing replacement devices and conducting additional testing to clarify the safety of the affected sleep and respiratory care devices. The company remains dedicated to cooperating with regulators globally to ensure the highest standards of patient safety.
“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. 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.”
– Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health
Despite Philips’ ongoing cooperation with the FDA, the recent rebuke appears to have unsettled investors, leading to a nearly 10% decline in the company’s stock price overnight. Analysts have also suggested that a long-anticipated consent decree could potentially be imposed on Philips, including the possibility of a sales ban for Respironics devices in the US, due to the additional testing requirement, continued FDA dissatisfaction with the recall process, and the removal of the device from the shortage list.
