Results for first-generation DreamStation devices not exposed to ozone cleaning:
- The new results indicate that exposure to particulate matter (PM) emissions from degraded foam in DreamStation devices, including potential respirable and non-respirable particulates, is unlikely to result in an appreciable harm to health in patients.
New, lab-aged and used devices were tested and all were compliant with ISO 18562-2  allowable limits for PM emissions. Testing was performed on devices with varying degrees of degradation (i.e., from no degradation to severe degradation), including 61 new devices, 96 used devices, and 24 devices with lab-aged foam that intentionally had been exposed to significantly elevated temperatures (≥80 oC) and humidity (≥75% RH) to accelerate degradation.
Further tested PM emissions of used devices with degradation were not statistically different than PM emissions of used devices without degradation, suggesting that degradation did not contribute to appreciable elevated levels of respirable particles in the devices tested.
Biocompatibility testing, including the chemical evaluation and toxicological risk assessment in accordance with ISO 10993 , is now complete for the foam in first-generation DreamStation devices. Even with the very conservative and theoretical assumption of exposure to all of the degraded PE-PUR foam within the device, the third-party risk assessment concluded that exposure to particulates from degraded foam in DreamStation devices, including potential respirable and non-respirable particulates, is unlikely to result in an appreciable harm to health in patients.
- The results further indicate that the exposure to volatile organic compound emissions (VOCs) is not anticipated to result in long-term health consequences for patients.
Expanded testing and toxicological risk assessments on multiple devices with new, used, and lab-aged foam have shown no appreciable harm to health for the VOCs detected. Therefore, exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not anticipated to result in long-term health consequences for patients based on ISO 18562-3  testing and evaluation of new, lab-aged and used devices. This is consistent with the results presented in December 2021. Similar to the PM testing described above, VOC testing was performed on new, lab-aged and used devices with varying degrees of degradation.
- Prevalence of visible foam degradation in inspected returned devices was found to be low.
Based on the visual inspection of the foam in returned first-generation DreamStation devices, the prevalence of visible foam degradation was found to be low. 164 out of 36,341 (0.5%) returned devices from the US and Canada were inspected and showed significant visible foam degradation. These devices were self-reported as not using ozone cleaning. Only 1 out of 2,469 (0.04%) inspected devices returned from multiple countries in Europe showed significant visible foam degradation. This included devices from the Netherlands, the UK, Italy, and Spain, ranged in age up to around 6 years. None of the 1,964 (0%) inspected returned devices from Japan showed significant visible degradation. This is consistent with the results presented in June 2022.
Visual inspection can only identify visible foam degradation and cannot measure volatile organic compounds generation or quantify particulate loss, therefore additional testing and analyses were performed as described above and in the complete update.