More Concerning News for Users of Philips PAP Devices
People with obstructive sleep apnea (OSA) who use CPAP or bilevel PAP machines made by Philips have faced a Class I recall of their devices since June 2021.1
Many are still waiting for a replacement machine. Others have pursued a new “repair and replace” option offered in September. This offer replaces a problematic polyester-based polyurethane (PE-PUR) foam sound buffer with a safer option that does not deteriorate.2,3
Unfortunately, on November 12 the US Food and Drug Administration (FDA) issued a new statement identifying another potential safety risk. This link comes from the new foam option already being used as part of their “repair and replace” program.4
New Philips foam replacement safety questioned
Recently, the FDA received new information regarding the silicone-based foam product being used as a replacement for the PE-PUR foam buffer in Philips machines.
The new foam product failed a safety test in a similar device used outside the US.4
Philips had previously given the FDA testing results that showed this product to be acceptable and safe for use. However, the new foam releases volatile organic compounds (VOCs).4
VOCs are gas emissions that may have short- and long-term adverse health effects. According to Philips, these include irritation and inflammation to the eyes, nose, respiratory tract, and skin. Other side effects of VOC exposure include:5
- Toxic and carcinogenic effects
What does this mean for the 'repair and replace' program?
The FDA is now requesting that Philips run new safety tests in an independent lab.
Unfortunately, many people have already participated in the “repair and replace” option and are now using machines with the new foam product now under question for safety.
However, the FDA does not recommend participants in the “repair and replace” program stop using their machines, stating:
“At this time, the agency does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. … the agency has determined that discontinuing use of one of these devices may be more harmful to a patient’s health and quality of life.”4
Where can I get more information?
The FDA is prepared to communicate the results of these new safety tests as soon as they become available. In the meantime, they recommend anyone with concerns talk to their sleep doctor about using devices from the “repair and replace” program.
Meanwhile, Philips’ CEO Frans van Houten released a separate statement on November 14, saying:
“We will work closely with the FDA to clarify and follow up on the inspectional findings and its recent requests related to comprehensive testing...We remain fully committed to supporting the community of patients who rely on the affected devices, and the physicians and customers who are dedicated to meeting patient needs.”6
About the original recall
Problems with degrading foam in several of Philips’ PAP devices were linked last spring to both high heat and humidity environments and the unapproved use of ozone or other PAP cleaning devices.3
More than 2 million devices were recalled in June 2021. They include the following, made between 2009 and April 25, 2021:3
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- SystemOne (Q-Series)
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
By July 2021, the FDA had received about 1,200 complaints regarding the PE-PUR foam, with links to more than 100 injuries.6
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