Months after Philips began replacing potentially toxic polyester-based polyurethane (PER-PUR) foam in its recalled CPAP, BiPAP and ventilator machines, the FDA flagged another safety issue with the replacement foam.
In September 2021, Philips began replacing foam in about 15 million devices that it originally recalled in June 2021. The PE-PUR foam in recalled devices could degrade and emit toxic particles and gases called volatile organic compounds or VOCs. Ingested or inhaled particles or VOCs can cause CPAP side effects including: Breathing problems and irritation to the eyes, throat and nose.
They can also damage the nervous system and other organs. Some may even cause cancer.
Philips chose to replace the PE-PUR foam with a silicone-based foam, and the FDA originally approved the plan based on testing provided by Philips. But the FDA now says that information discovered during an inspection of Philips’ manufacturing facility revealed that the silicone foam used in a device marketed outside the U.S. failed a safety test for volatile organic compounds or VOCs.
“The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. 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 said in its recall update.
The agency ordered Philips to conduct independent testing on the silicone foam and will inform the public of the results when they are available. In the meantime, people who already received replacement devices from Philips shouldn’t stop using them because stopping treatment may be more harmful, the FDA said.