FDA Tells Consumers How to Get Their Philips CPAP Replacement Prioritized

Amid continuing concerns about a lack of information and transparency following a massive sleep apnea machine recall issued last year, federal regulators have released updated guidelines for consumers describing how they can get their Philips CPAP replacement prioritized by the manufacturer.

The Philips Respironics recall was initially announced in June 2021, impacting an estimated 15 million DreamStation, CPAP, BiPAP and ventilator devices that were sold with a defective sound abatement foam, which has been found to deteriorate and release toxic particles directly into the machines’ air pathways.

Due to serious concerns about potential long-term side effects from breathing the CPAP foam, the FDA previously urged consumers to immediately stop using the machines for sleep apnea and other non-life sustaining treatments. However, replacement CPAP machines have been in short supply, and a Philips CPAP repair program is expected to take at least a year to complete.

Earlier this month, the FDA officials issued a scathing letter to the manufacturer, warning that the Philips CPAP recall notifications have been inadequate, leaving too many consumers and medical equipment manufacturers unaware of the health risks posed by continuing to use recalled sleep apnea machines with the toxic sound abatement foam.

This week, the agency updated the FDA’s Frequently Asked Questions page regarding the recall, adding new information about how consumers can be request a prioritized replacement of their Philips CPAP machine.

“If you want to be considered for prioritized replacement of your device, you may update your existing registration on the Philips Respironics’ online patient portal and provide additional information,” the FDA Philips Recall FAQ states. “You may visit the online patient portal and update your information even if you did not receive an email notification from Philips Respironics. If you do not provide the additional requested information, you will receive a replacement device based on when you registered.”

Questions About Safety of Repaired Philips CPAP Machines

Philips has indicated that it will attempt to repair recalled CPAP machines by removing the polyester-based polyurethane (PE-PUR) foam originally used, and replacing the sound abatement foam with a different material that it indicates is not prone to the same deterioration problems. However, the safety of these repaired Philips CPAP machines has not yet been independently certified, and the FDA has already expressed concerns about whether the replacement material may also release toxic chemicals and gasses.

Following an FDA inspection of the Philips manufacturing facility, the agency discovered that similar silicone foam used in a device marketed outside the U.S. failed a safety test for the release of “chemicals of concern”, which may also enter the machine’s air pathways, potentially causing similar health risks to the PE-PUR foam.

As a result, Philips has been required to retain an independent laboratory to perform additional testing to determine what safety risks the repaired CPAP machines with silicone foam may pose for consumers. However, the FDA is not yet recommending that patients who received a repaired device stop using their sleep apnea machine.

Philips CPAP Lawsuits

In the wake of the recall, tens of thousands of individuals nationwide are now pursuing a Philips CPAP lawsuit against the makers of the sleep apnea machines, already alleging that they developed various respiratory injuries and cancers that may have been caused by breathing the chemicals and gases released as the foam breaks down.

Given common questions of fact and law raised in product liability and class action lawsuits over recalled sleep apnea machines filed throughout the federal court system, the litigation has been centralized before Senior U.S. District Judge Joy Flowers Conti in the Western District of Pennsylvania for coordinated discovery and pretrial proceedings, as part of a multidistrict litigation (MDL).

There are also now a number of SoClean lawsuits being filed against the manufacturer of an ozone cleaning device commonly used to sanitize the Philips CPAP machines, alleging that the process accelerates the breakdown of the PE-PUR foam. However, SoClean maintains that ultimate responsibility for the CPAP recall rests with Philips, for selling a defectively designed machine and ignoring evidence that the foam was breaking down.