Sam Brusco, Associate Editor03.11.22
Philips Respironics yesterday released an update about the ongoing U.S. recall related to health risks from polyester-based polyurethane (PE-PUR) sound abatement foam in certain sleep and respiratory care products.
After two rounds of outreach the company reached the majority of the U.S. installed base to register about 2.6 million devices. To date, Philips Respironics has shipped over 650,000 replacement devices to U.S. customers and plans to complete the repair and replacement program in this year’s fourth quarter.
In December Philips released an update on VOC test results for first-gen DreamStation indicating VOC concentrations were with safe exposure limits specified in ISO 18562. Particulate testing and analyses for these devices are planned to be completed by the second quarter.
Initial results suggested PE-PUR foam degradation in CPAP devices is hastened by repeat exposure to ozone cleaning. FDA and Philips communicated and reiterated ozone is not an approved cleaning agent, and the information about risk of using ozone cleaners is available on Philips’ website.
Independent of Philips, the American Journal of Respiratory Care and Critical Care Medicine published an analysis that didn’t find higher risk of incident cancer in 6,900 obstructive sleep apnea (OSA) patients compared to OSA patients using a PAP device from other makers or those without treatment.
After two rounds of outreach the company reached the majority of the U.S. installed base to register about 2.6 million devices. To date, Philips Respironics has shipped over 650,000 replacement devices to U.S. customers and plans to complete the repair and replacement program in this year’s fourth quarter.
In December Philips released an update on VOC test results for first-gen DreamStation indicating VOC concentrations were with safe exposure limits specified in ISO 18562. Particulate testing and analyses for these devices are planned to be completed by the second quarter.
Initial results suggested PE-PUR foam degradation in CPAP devices is hastened by repeat exposure to ozone cleaning. FDA and Philips communicated and reiterated ozone is not an approved cleaning agent, and the information about risk of using ozone cleaners is available on Philips’ website.
Independent of Philips, the American Journal of Respiratory Care and Critical Care Medicine published an analysis that didn’t find higher risk of incident cancer in 6,900 obstructive sleep apnea (OSA) patients compared to OSA patients using a PAP device from other makers or those without treatment.