Philips Respironics Update on Test Results for Apnea Devices

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Philips released today an update on the test and research program conducted by its subsidiary, Philips Respironics. This program evaluates potential health risks associated with the polyester-based polyurethane (PE-PUR) sound abatement foam in certain sleep therapy and ventilator devices. Associated researchers conclude that the health risks of the affected devices are low. In this post, we give the key findings of the update.

DreamStation recall

Philips’ voluntary recall notification of June 2021, addressed concerns related to the PE-PUR foam used in Philips sleep therapy devices. Particularly, in the DreamStation, System One, and DreamStation Go. These devices account for approximately 95% of registered apnea devices globally. The recall was initiated to assess potential health risks stemming from the foam’s degradation and the release of volatile organic compounds (VOCs) and particulate matter (PM) into the airway of patients using these devices.

Testing Process

To evaluate the potential risks, Philips Respironics collaborated with five independent, certified testing laboratories. Further, Philips enlisted the expertise of third-party qualified experts and an external medical panel. The testing followed internationally recognized industry standards, including ISO 18562 and ISO 10993.

Key Findings and Implications

What are the key findings and implications of the tests?

1. VOC Emissions. The test results indicate that exposure to VOC emissions from the PE-PUR foam in the first-generation DreamStation, System One, and DreamStation Go devices is unlikely to result in appreciable harm to patients’ health. Expanded testing and toxicological risk assessments concluded that VOC exposure in these devices is not expected to pose a significant risk.
2. PM Emissions. The assessments demonstrated that exposure to PM emissions from degraded foam in the affected sleep therapy devices is also unlikely to result in appreciable harm to patients’ health. The tests encompassed New, Used, and Lab-Aged devices, with compliance observed for PM emissions according to ISO 18562-2 limits. Even under very conservative assumptions, the risk assessment concluded that exposure to particulates from degraded foam is unlikely to result in significant harm to patients.
3. Ozone Cleaning Impact. The tests on first-generation DreamStation devices exposed to ozone cleaning revealed that while foam degradation was exacerbated, the resulting VOC emissions and PM emissions are still unlikely to cause appreciable harm to patients’ health. Researchers observed Diethylene glycol (DEG), detectable as a VOC, after 200 ozone cleaning cycles. However, the subsequent toxicological risk assessment did not suggest a significant risk to patients.

Ongoing Tests and Future Updates:

Philips Respironics conducts further tests and analyses to complete the risk assessments for System One and DreamStation Go devices treated with ozone cleaning. Additionally, testing and evaluation of Trilogy 100/200 and OmniLab Advanced Plus ventilator devices, which use a different type of PE-PUR foam, are underway. The company anticipates providing an update on these devices in the third quarter of 2023.

Guidance for Healthcare Providers and Patients

While awaiting the final conclusions from the FDA and other competent authorities, Philips Respironics advises healthcare providers, patients, and other stakeholders to refer to the complete May 16, 2023, update for informed decision-making. Philips urges patients, using affected, not yet remediated, sleep therapy devices, to register their products for remediation.

Philips Respironics also recommends that patients consult their healthcare providers to determine the most suitable treatment option for their condition. This may involve continuing the use of affected devices.