Test and research program
In December 2021, Philips provided an update on the VOC test results to-date for the first-generation DreamStation devices . The results indicate that the VOC concentrations are within safe exposure limits specified in the applicable safety standard (ISO 18562). Comprehensive particulate testing and analyses for the first-generation DreamStation devices are expected to be completed in the second quarter of 2022.
Initial testing results suggest that PE-PUR foam degradation in CPAP devices is accelerated by repeated exposure to ozone cleaning. The FDA and Philips have communicated and reiterated that ozone is not an approved cleaning agent. For example, as directed by FDA, Philips has prominently published information on the risk of using ozone cleaners on the landing page of the Philips Respironics field action website.
Philips is working cooperatively with the FDA and other competent authorities to update them on new test data as they become available. Philips is also working cooperatively with the FDA to develop a consolidated summary for healthcare providers on the available, finalized testing data, results, and conclusions, which will be updated as new test data becomes available.
Independent of Philips Respironics, in December 2021, an analysis was published in the American Journal of Respiratory and Critical Care Medicine  that did not find a higher risk of incident cancer among obstructive sleep apnea (OSA) patients who used a Philips Respironics PAP device as compared to OSA patients who used a PAP device from other manufacturers, or OSA patients without treatment. The analysis and conclusion were based on data from a large multicenter cohort study involving 6,900 OSA patients on PAP devices between 2012 and 2020, including 1,200 Philips Respironics PAP users. Philips Respironics was not involved in the study or the analysis.
 Philips Respironics’ monthly surveys indicate that nearly 80% (aggregate data) of responding Philips Respironics CPAP users in the US confirmed they were aware of the recall. Each study was conducted online on a national representative sample of 2,200 adults (and weighted based on age, gender, race, and education level). Results have a margin of error of +/- 2% at a 95% confidence level for the overall population.
 The vast majority of the registered affected devices in the US to date are in the first-generation DreamStation product family.
 An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. 1484–1488; Tetyana Kendzerska, Richard S. Leung, Mark I. Boulos, Daniel I. McIsaac, Brian J. Murray, Gregory L. Bryson, Robert Talarico, Atul Malhotra, Andrea S. Gershon, Constance Mackenzie, and Marcus Povitz. The analysis can be found here.