News and Updates > Update on completed set of test results for home sleep therapy devices
May 16, 2023
Patient safety is our top priority – and it is important that patients feel confident using the Philips Respironics devices. Since announcing the recall notification/field safety notice in June 2021, we have been conducting a comprehensive test and research program and have provided updates as the testing progressed in December 2021, June 2022 and December 2022. Building on past reports, the risk assessments have now been completed for the CPAP/BiPAP sleep therapy devices, including the first-generation DreamStation, System One and DreamStation GO devices. These devices represent approximately 95% of the registered devices globally. Additionally, tests and analyses have been completed for first-generation DreamStation devices that have been exposed to ozone cleaning.
The risk assessments have now been completed for the CPAP/BiPAP sleep therapy devices indicate that potential patient exposure to foam particulates and volatile organic compounds (VOCs) from the polyester-based polyurethane (PE-PUR) foam within the breathing gas pathway of these devices is unlikely to result in an appreciable harm to health in patients.*
The test and research program has been conducted together with five independent, certified testing laboratories, and the results have been reviewed and assessed by third-party qualified experts and Philips Respironics, as well as an external medical panel.
Philips Respironics is in the process of completing various remaining tests and analyses. The risk assessments for System One and DreamStation Go devices (that contain the same foam as the first-generation DreamStation devices) treated with ozone are being completed. For the Trilogy 100/200 and OmniLab Advanced Plus ventilator devices, VOC and PM testing continues, as well as chemical evaluation and toxicological risk assessment. These devices contain a different type of PE-PUR foam than the first-generation DreamStation devices.1 Philips Respironics expects to provide an update on this in Q3 2023.
Patients currently using an affected sleep therapy device that has not been remediated and not registered yet, are requested to register their devices to facilitate the remediation.
Philips Respironics continues to advise patients using affected sleep therapy devices that have not been remediated yet to contact their physician or care provider to decide on a suitable treatment for their condition, which may include stopping use of their device, continuing to use their affected device, using another similar device that is not part of the recall, or using alternative treatments for sleep apnea. Moreover, patients are advised to follow Philips Respironics’ instructions and recommended cleaning and replacement guidelines for their sleep therapy device and accessories. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep therapy devices or masks and should not be used.
Philips Respironics also continues to advise users of ventilator devices to contact their healthcare providers before making any changes to their therapy. Full test results are also available to clinicians.
* Philips Respironics has provided the completed set of test results and analyses for the CPAP/BiPAP therapy devices to the FDA and other competent authorities. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. 1. First-generation DreamStation, System One and DreamStation Go devices contain Type A PE-PUR foam, while Trilogy 100/200 devices contain Type B PE-PUR foam, and OmniLab Advanced Plus devices contain Type A and Type B PE-PUR foams. The known differences between the Type A and Type B foams are that Type B foam can be used with an acrylic pressure sensitive adhesive, has a lower density, has a different thickness, and also contains an additive to reduce potential flammability.
Healthcare providers, patients, and other stakeholders should use the complete update (including information on the limitations of the testing) for any informed decision making and should not solely rely on the overview from the press release.
Completion of the test and research program, as well as the remediation program remain Philips Respironics’ highest priorities. As described further below, Philips Respironics’ guidance for healthcare providers and patients using devices that have not been remediated yet, remains unchanged.
To date, a total of approximately 4.3 million devices have been remediated globally, of which approximately 2.3 million devices in the US. Patients with any remaining sleep therapy device currently in use that has not been remediated yet and not registered yet, are requested to register their product to facilitate the remediation of their devices.
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