AMSTERDAM (July 5, 2022)—A sampling of recalled CPAP devices showed significant foam degradation when ozone cleaning was used, said Philips Respironics in an update on its test and research program on polyester-based polyurethane (PE-PUR) sound abatement foam used in specific CPAP, BiPAP and mechanical ventilator devices. On June 14, 2021, Philips Respironics initiated a voluntary recall notification/field safety notice to address potential health risks related to the foam.
The most recent update included results from inspections of a sample of more than 60,000 returned first-generation DreamStation devices, which represent 68% of the recall. The sample included 36,341 devices for which the users reported no use of ozone cleaning, 11,309 devices for which the users reported use of ozone cleaning, and 13,197 devices for which it was reported unknown by the user whether ozone cleaning was used.
- 164 of 36,341 (0.5%) devices with self-reported no ozone use showed significant visible foam degradation.
- Devices with self-reported ozone use were 14x more likely to have significant visible foam degradation than those with self-reported no ozone use: 777 of 11,309 devices (7%) showed significant visible foam degradation.
- 422 devices of the inspected 60,847 returned/used devices are linked to a reported foam degradation complaint. However, only 18 out of these 422 devices (4%) actually showed visible foam degradation.
At the time the recall notification/field safety notice was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a worst-case scenario for the possible health risks out of an abundance of caution. Since then, together with five certified, independent testing laboratories in the US and Europe, as well as other qualified third-party experts, Philips Respironics has been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope the potential patient health risks related to possible emission of particulates from degraded foam and volatile organic compounds (VOCs).
The overall guidance for health care providers and patients in the recall notification/field safety notice remains unchanged at this time, the company said.
“I deeply regret the concern experienced by patients who rely on the affected Respironics sleep and respiratory devices for their health and quality of life and want to emphasize our commitment to providing them with a resolution as fast as possible,” said Frans van Houten, CEO of Royal Philips, Respironics’ parent company. “More than 1,000 of our colleagues are working extremely hard to achieve this. While certain prolonged tests across the affected product categories are still to be completed, the results to date for the first-generation DreamStation devices, which represent the majority of the registered affected devices, show a very low prevalence of visible foam degradation. In addition, the new and used first-generation DreamStation devices passed volatile organic compound and respirable particulate emission testing. This is very encouraging. Results to date also indicate that ozone cleaning significantly exacerbates foam degradation.”
Philips will continue to provide regular updates as new test results and assessments become available, as not all tests have been completed to date.
The complete update on the PE-PUR testing results and conclusions available to date can be found here.
