Philips Respironics have received a number of questions about the silicone sound abatement foam used in the remediated sleep and respiratory care devices as part of the June 2021 Philips Respironics recall* and new DreamStation 1 devices sold into the market, as well as widely in the industry. Philips Respironics believes 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.
The repair and replacement program, which includes replacement of the PE-PUR sound abatement foam with silicone foam, is being implemented in consultation with the relevant competent authorities, including the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA). Philips Respironics devices with silicone sound abatement foam have been subject to extensive testing in accordance with the applicable regulatory standards, and Philips Respironics has not identified any safety issues.
In November 2021, FDA asked Philips Respironics to further test the silicone foam for volatile organic compounds (VOCs). Philips Respironics has completed testing in accordance with the relevant industry standard (ISO 18562-3; see below for more information). Philips Respironics has reported that any VOCs emitted by devices with silicone foam during this testing were significantly below the applicable toxicological thresholds. This included formaldehyde, which was also significantly below the applicable FDA and World Health Organization (WHO) thresholds. Philips Respironics submitted the final reports of that testing to FDA in August 2022.
Multiple independent, certified laboratories conducted the testing on behalf of Philips Respironics. Harmonization of toxicological thresholds is critical for interpretation across these laboratories. This is best practice and consistent with medical regulatory authorities’ practices. Philips Respironics proposed to the test laboratories to use the applicable WHO limit for formaldehyde. This limit is more conservative than the FDA limit: the FDA has recently released its own internationally harmonized formaldehyde limit that is more than two times higher than the WHO limit.
The purpose of a test according to ISO-18562-3 is to determine if a detected and quantified VOC is likely to be associated with a toxicological risk based upon exposure during use of the device. Importantly, there is a big difference between a hazard, which is something that – at certain levels – has the potential to cause harm, and a risk, which is the likelihood that a hazard will cause harm.
For example, formaldehyde, like many other compounds, is omnipresent in daily life. It is present in the human body, certain food (e.g., pears, cauliflower), cardboard, carpeting, etc. Formaldehyde can be a hazard, but it is only considered a risk when the exposure levels are above the applicable regulatory thresholds. Based on the extensive testing by multiple independent, certified laboratories, none of the VOCs, including formaldehyde, exceeded those thresholds.