Philips Respironics issued a voluntary recall in 2021 due to issues with the sound abatement foam in their DreamStation and System One CPAPs and BiPAPs (1). The foam can potentially degrade and particles go into the airway of the user. Another issue is off-gassing of the foam, producing volatile organic compounds (VOC) gas, which is then inhaled by the user.
On December 21, 2022, a report was released regarding the continued testing of these CPAPs and the potentially harmful effects of these units on users if they continue using the CPAPs as-is (2). The FDA required additional testing after the initial recall was made.
The first-generation DreamStations have the polyester based polyurethane (PE-PUR) foam in the blower box around the blower to lessen the sound of the blower while the user sleeps. This is the foam that is recalled. In these recent tests, they used units that had varying degrees of foam degradation and exposed some units to high temperatures and humidity. They did not find any statistical difference between units with and without degradation as to how many particles were released from the units. They stated that all units were within the “ISO 18562-2 allowable limits for [particulate matter] emissions.”(2) Their conclusion regarding these findings is that the use of the first-generation DreamStations will not cause appreciable harm to the user. However, they did not disclose what appreciable harm is defined as. This statement still leaves open the possibility that some harm may come to the user, even if it is not life threatening.
The VOC emission testing of DreamStations was also discussed in the report (2). Again, they used units with varying degrees of foam degradation to determine the toxicological risk of inhaling the VOC gasses produced by the sound abatement foam. They again found no “appreciable harm” and concluded that it would not cause long-term health problems. But they did not discuss the short term health consequences of inhaling the VOC foam from the units.
Philips Respironics also tested the first-generation DreamStations with ozone cleaning. ResMed has reported previously that their testing of ozone cleaning on their devices degrades the acoustic foam in the Air10 line of CPAPs, and the use of cleaning will void the warranty of the blower (3). The Philips Respironics tests used units with varying ages of use. They tested units that were returned to them by the users who had reported the use of ozone cleaning (2). The results yielded a 14 times increased risk of the foam visibility disintegrating. However, they concluded again that particles breaking off from the foam is not likely to cause “appreciable harm” to the user. Testing on how ozone cleaning affects the release of VOC gasses is still underway.
We have found in our repairs of DreamStations that the foam gets sticky with the use of ozone cleaning and pieces of the foam would then break off into the blower motor and could be visible in the water chamber in the humidifier. If not trapped in the water in the humidifier, it could possibly go into the airway of the user.
Testing of Philips Respironics older model of CPAP and BiPAP, the SystemOne, and its portable model, the DreamStatio Go, is still ongoing (2). These devices use the same PePUR foam for sound abatement around the blower.
Philips Respironics suggests to physicians and first-generation DreamStation users discuss the risk versus benefits of continued use of the units (2). Patients can stop using the machine and use another unit not affected by the recall or alternative methods to treat their sleep apnea. If users are going to continue to use their devices as-is, they suggest that users not use ozone or UV light to clean their machines as they are not approved methods of CPAP and accessory cleaning. And as discussed above, ozone cleaning increases the likelihood of particulate matter release.
There is a remediation program in place to replace the PE-PUR foam with new blower boxes fitted with an FDA approved sound abatement foam. This new foam is silicone-based and is still undergoing additional testing for safety risks. This testing was mandated by the FDA in November 2021 after it had already approved the replacement foam. To get the blower box replaced in your first-generation DreamStation, you will need to register your device at http://www.philips.com/src-update (1). The replacement of the recalled part can only be done by the manufacturer, per FDA regulations.
- Philips Resironics. (2022). Voluntary Recall Information: Philips Respironics Sleep and Respiratory Care devices. http://www.philips.com/src-update
- Philips Respironics. (Dec 21, 2022). Philips provides update on completed set of test results for first-generation DreamStation sleep therapy devices. https://www.philips.com/a-w/about/news/archive/standard/news/press/2022/20221221-philips-provides-update-on-completed-set-of-test-results-for-first-generation-dreamstation-sleep-therapy-devices.html
- ResMed. (2022). Product Warranty Information. https://www.resmed.com/en-us/product-warranty-information/