Philips Respironics provides an update for the United States on
March 10, 2022
Amsterdam, Netherlands – Royal Philips‘ (NYSE: PHG, AEX: PHIA), Philips Respironics, today provided an update on the status of the remediation in the United States of the ongoing recall of certain sleep and respiratory care products in connection with potential identified health risks associated with polyester-based technology. sound-absorbing polyurethane foam (PE-PUR) in these devices.
Client and Patient Education
After two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the United States, resulting in the registration of approximately 2.6 million devices in the country. Philips Respironics continues to monitor recall awareness for affected patients . Philips Respironics is working with the U.S. Food and Drug Administration (FDA) to increase awareness of the recall among patients, consumers and healthcare providers. Based on the FDA’s comments, Philips Respironics will work with its EMR customers to allow the company to directly contact patients and other end users who may not have yet received the recall notice.
Additionally, Philips Respironics continues to use its current mobile app, DreamMapper, to send notifications to patients and consumers using the app with information regarding the action in the field. The DreamMapper notification feature is used to redirect patients/consumers to the Field Action website, which includes detailed information about the Field Action and the process of registering and maintaining this record for a replacement device.
Repair and replacement program
To date, Philips Respironics has shipped a total of over 650,000 replacement devices to customers in the United States and aims to complete the repair and replacement program in Q4 2022.
Testing and research program
In December 2021, Philips provided an update on VOC test results to date for first generation DreamStation devices . The results indicate that the VOC concentrations are within the safe exposure limits specified in the applicable safety standard (ISO 18562). Full particle testing and analysis for first-generation DreamStation devices is expected to be completed in the second quarter of 2022.
Early test results suggest that the degradation of PE-PUR foam 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, in accordance with FDA guidelines, Philips has prominently posted information about the risk of using ozone cleaners on the Philips Respironics field action homepage. website.
Philips is working with the FDA and other relevant authorities to update them on new test data as it becomes available. Philips is also working with the FDA to develop a consolidated summary for healthcare providers of the available and finalized test data, results and conclusions, which will be updated as new data becomes available. test will be available.
Independently of Philips Respironics, in December 2021, an analysis was published in the American Journal of Respiratory and Critical Care Medicine  who did not find a higher risk of incident cancer in patients with obstructive sleep apnea (OSA) who used a Philips Respironics PAP device compared to OSA patients who used a PAP device from other manufacturers or patients OSA without treatment. The analysis and conclusion were based on data from a large, multicenter cohort study of 6,900 patients with OSA on PAP devices between 2012 and 2020, including 1,200 Philips Respironics PAP users. Philips Respironics was not involved in the study or analysis.
 Philips Respironics monthly surveys indicate that nearly 80% (aggregated data) of responding Philips Respironics CPAP users in the United States confirmed that they were aware of the recall. Each study was conducted online on a nationally representative sample of 2,200 adults (and weighted by age, gender, race, and education level). The results have a margin of error of +/- 2% at a 95% confidence level for the entire population.
 The vast majority of affected devices registered in the US to date belong to the first-generation DreamStation product family.
 An association between the manufacturer of positive pressure devices and incident cancer? An analysis of secondary data; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Number 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 is found here.
For more information, please contact:
Philips Global Press Office
Phone. : +31 6 10888824
Email: [email protected]
Philips Investor Relations
Phone. : +31 20 59 77055
Email: [email protected]
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving the health and well-being of people and driving better outcomes in the across the health continuum – from healthy living and prevention to diagnosis, treatment and home care. Philips relies on cutting-edge technology and in-depth clinical and consumer insights to deliver integrated solutions. Based in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as consumer health and care. residence. Philips generated sales of €17.2 billion in 2021 and employs approximately 78,000 employees with sales and service in over 100 countries. Information about Philips can be found at www.philips.com/newscenter.
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