News and Updates > Latest results and conclusions on the comprehensive test results for home sleep therapy devices
Latest results and conclusions on the comprehensive test results for home sleep therapy devices
August 7, 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 of specific sleep therapy and ventilator devices in June 2021, we have been conducting a comprehensive test and research program. We have provided updates as the testing progressed in December 2021, June 2022, December 2022 and May 2023 and now have additional results and conclusions including:
Test results and analyses for sleep therapy devices
Philips Respironics has completed testing and analyses on System One sleep therapy devices that have been exposed to ozone cleaning:
Exposure to VOC emissions from the assessed devices treated with ozone cleaning is unlikely to result in appreciable harm to health in patients.
Exposure to PM emissions from the assessed devices treated with ozone cleaning is unlikely to result in appreciable harm to health in patients.
Additional visual inspection of the foam in used first-generation DreamStation devices confirms the low prevalence of significant visual foam degradation/volume reduction
US and Canada:
An additional analysis using an algorithm to assess collected images of foam within a representative random sample of 100,000 used devices from the US and Canada (devices were selected to represent different manufacture dates) showed that 2,011 devices (~2%) were identified as having significant visual degradation/volume reduction.
A comparison of ozone use among these devices found that devices for which the user self-reported ozone use were approximately 17 times more likely to have significant visual foam degradation/volume reduction (1,368 out of 14,971 or 9.1%) than those where the user reported no ozone use (357 out of 68,702 or 0.5%).
Europe and Japan:
An additional analysis of images from a representative random sample of 152,000 devices from Europe and 241,000 devices from Japan were analyzed by an algorithm to identify significant visual degradation/volume reduction.
A subset of devices from Europe and Japan were identified by the algorithm as potentially having significant visual degradation/volume reduction, and this subset was manually inspected. It was observed that 17 devices of the 152,000 devices (~0.01 %) from Europe and 3 devices of the 241,000 devices (0.001%) from Japan had significant visual degradation/volume reduction.
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.
* 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.
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.
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.
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