Philips provides additional testing results on devices treated with ozone cleaning 

AMSTERDAM – Testing on the impact of ozone cleaning on the Philips System One and DreamStation Go sleep therapy devices shows volatile organic compounds and particulate matter emissions related to foam degradation are within the applicable safety limits and are unlikely to result in appreciable harm to health in patients, the company announced July 24. 

Additional visual assessments on used/returned first-generation DreamStation devices also confirmed the previously established low prevalence of significant visual foam degradation reduction/volume reduction in these devices, the company announced. 

More specifically, the testing found: 

• Exposure to VOC emissions from the assessed devices treated with ozone cleaning is unlikely to result in appreciable harm to health in patients. ISO 18562-3 VOC testing was conducted after up to 500 ozone cleaning cycles with each cycle simulating one night of use and then ozone cleaning. The VOC toxicological risk of this ozone-induced degradation determined that exposure to VOC emissions from the assessed System One devices exposed to ozone cleaning suggests no appreciable risk to health for patients. 

• Exposure to PM emissions from the assessed devices treated with ozone cleaning is unlikely to result in appreciable harm to health in patients. Regarding risks associated with respirable and non-respirable particulates, testing to date has been performed on devices with known ozone exposure. The third-party collective analysis concluded that exposure to particulate matter from ozone-induced degraded foam in System One devices is unlikely to result in appreciable harm to health in patients. 

The visual assessments found:  

• An additional analysis using an algorithm to assess collected images of foam within a representative random sample of 100,000 used devices from the U.S. 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%). 

Philips is in the process of completing various remaining tests and analyses. 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. It expects to provide an update on this in the third quarter of 2023.