Philips CPAP Recall Notifications Have Been Inadequate, Failed To Warn About Sleep Apnea Foam Risks: FDA

The FDA criticized Philips CPAP recall notices after numerous consumer complaints indicating they had received few, if any, details about the risks associated with the machines.

The U.S. Food and Drug Administration (FDA) indicates that Philips CPAP recall notifications have failed to meet federal requirements, leaving too many consumers and medical equipment suppliers unaware of the health risks posed by toxic sound abatement foam used in millions of sleep apnea machines.

On March 10, the FDA sent a scathing letter (PDF) to Philips Respironics, notifying the company that recall notifications for DreamStation, CPAP, BiPAP and mechanical ventilators sold since 2019 have left many patients and medical equipment suppliers unaware of the recall and serious risk posed by using the breathing machines.

As a result of the inadequate Philips CPAP recall notice, the FDA indicates in a press release that it had to intervene “to eliminate the unreasonable risk of harm posed by the recalled products.”

More than 15 million Philips DreamStation, CPAP, BiPAP and mechanical ventilators were recalled in June 2021, after the manufacturer acknowledged that defective polyester-based polyurethane (PE-PUR) sound abatement foam inside the machines may degrade and breakdown, releasing toxic chemicals and debris directly into the machine air pathways as consumers use the breathing machines.

These problems have already been linked to reports of long-term side effects for Philips CPAP users, including respiratory injuries, lung damage and cancer, and thousands of former users are now pursuing lawsuits against the company.

The FDA notification order is an official acknowledgement that Philips Respironics has failed to adequately inform the public of the CPAP recall. The agency says the order was spurred by numerous complaints by patients and consumers who were unaware of the recall or lacked key details about what they should do because they never received an official recall notice; only hearing about the recall through other unofficial, and often incomplete, sources.

“The FDA has heard the frustration expressed by patients and durable medical equipment suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the press release. “Taking this action today enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by the foam used in the recalled products with patients and the public and to ensure that individuals who rely on these essential devices are receiving the important information they need from the company.”

The order requires Philips to notify all device users, retailers, distributors, health care providers and durable medical equipment suppliers about the recall and the health risks linked to the PE-PUR foam, and to give instructions on how device users can register their breathing assistance machines on its website. In addition, the order also requires Philips to explain to patients about the risks of using ozone cleaners like SoClean on the recalled Philips CPAP machines.

SoClean devices are intended to sterilize and deodorize CPAP breathing machines, which are used by individuals with sleep apnea. However, reports indicate that use of the machines may exacerbate or accelerate the rate at which the Philips CPAP foam breaks down and releases particles into the machine’s air pathways.

The FDA is also recommending Philips provide monthly updates to registered device users, informing them of the expected time they will receive a replacement and the current rate of replacement for recalled devices, as well as provide detailed information about the replacement process itself.

Philips has 45 days to respond to the notification order.

According to allegations raised in thousands of Philips CPAP recall lawsuits filed over the past year, the manufacturer knew or should have known about the problems with the sound abatement foam for years, yet continued to sell the breathing machines and withheld warnings, while it worked to develop a new version marketed as the DreamStation 2, which supposedly does not experience the same degradation.

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