Philips Respironics provided an update on March 10, 2022, on the remediation status in the United States of the ongoing recall of certain sleep and respiratory care products in connection with identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. To date, the company has shipped a total of more than 650,000 replacement devices to customers in the United States and aims to complete the repair and replacement program in the fourth quarter of 2022.
Customer & Patient Outreach
Following two rounds of customer and patient outreach, about 2.6 million devices have been registered.
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. (Results have a margin of error of +/- 2% at a 95% confidence level for the overall population.)
Based on feedback from the FDA, Philips Respironics will be working with its durable medical equipment (DME) customers to allow the company to directly contact those patients and other end-users who may not yet have received notice of the recall.
In addition, Philips Respironics continues to utilize its current mobile application, DreamMapper, to send notifications to patients and consumers utilizing the application with information regarding the field action. The DreamMapper notification function is used to direct patients/consumers back to the field action website, which includes detailed information on the field action and the process for registering, and maintaining such registration, for a replacement device.
Test & 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.
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.