Philips posts FAQ on silicone foam
By HME News Staff
Updated 9:20 AM CST, Tue December 26, 2023
AMSTERDAM – Philips posted a new FAQ to its website on Dec. 22 that explains the use of silicone sound abatement foam in its DreamStation 2 and other sleep and respiratory devices that were remediated as part of its June 2021 recall. “We have received a number of questions about the silicone sound abatement foam used in repaired and new replacement devices, as well as widely in the industry,” the company states. “We believe it is important that patients, care providers and business customers have access to accurate information and, most importantly, that they know that the foam is safe.” In November 2021, the U.S. Food and Drug Administration asked Philips Respironics to further test the silicone foam for volatile organic compounds (VOCs). This testing was completed in accordance with the relevant industry standard and showed that any VOCs emitted by devices with silicone foam were significantly below the applicable toxicological thresholds. This included formaldehyde, which was also significantly below the applicable FDA and World Health Organization (WHO) thresholds. The final reports of that testing were submitted to FDA in August 2022, and Philips Respironics has received no comments on that testing from FDA to date. In the FAQ, Philips addressed questions like, “The silicone sound abatement foam used by Philips Respironics in the replacement devices has been shown in some tests to emit chemicals, including formaldehyde. Can you explain this?” and “Were any changes made to the silicone foam as a result of testing?”
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