December 23, 2021
On June 14, 2021, Philips initiated a voluntary recall notification* for certain sleep and respiratory care products to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Since then, together with certified testing laboratories and 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 potential patient health risks related to possible emission of particulates from degraded foam and certain volatile organic compounds (VOCs). Philips Respironics is now providing an update on part of this test and research program. Specifically, this update covers the test results and assessment to date of the VOC emissions of the first-generation DreamStation devices. The first-generation DreamStation devices represent the majority of the registered affected devices. Additional testing is ongoing.**
Review of this assessment by an outside medical panel and Philips Respironics has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients.
The update on these findings is intended to inform healthcare providers of the most recent data, but the overall guidance for physicians and patients in the recall notification remains unchanged at this time.
At the time the recall notification was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment. Since then, using ISO 18562 guidance, VOC toxicological risk assessments were performed by certified testing laboratories and a qualified third-party expert based on the initial and new VOC testing performed to date. Philips Respironics has made this data available to the FDA and other competent authorities and is in the process of sharing this data with healthcare providers and patients.
It is important to note that the tested DreamStation devices were not exposed to ozone cleaning, in accordance with the instructions for use. Additionally, this new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices, and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. Further health risk assessments are ongoing.**
Comprehensive particulate testing and analyses are now expected to be completed in the second quarter of 2022, as testing protocols in compliance with the full extent of the relevant ISO standards for all affected product platforms require long lead times of multiple months. Philips Respironics will continue to provide updates on findings from these assessments.
For more information on the recall notification,* as well as instructions for customers, patients and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. The content of this press release is intended to inform healthcare providers of the most recent data, but the overall guidance for physicians and patients in the recall notification remains unchanged at this time.
* Voluntary recall notification in the U.S. / field safety notice outside the U.S.
** The ongoing test and the research program includes: Assessment of the health risks associated with VOC emission of the CPAP, BiPAP and Mechanical Ventilator devices affected by the recall notification; assessment of the health risks associated with possible degraded foam particulates for all affected devices; assessment of the health risks associated with exposure of the devices to repeated ozone cleaning.
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