Philips Respironics provides update for the US on ongoing CPAP, BiPAP and Mechanical Ventilator field action

Rhea-AI Summary

On March 10, 2022, Royal Philips' subsidiary, Philips Respironics, updated the status of the ongoing recall of certain sleep and respiratory care products due to health risks associated with PE-PUR foam. The company has registered approximately 2.6 million devices in the U.S. and shipped over 650,000 replacement units. Philips continues working closely with the FDA to enhance recall awareness and has emphasized the risks of using ozone cleaners. Initial tests indicated VOC concentrations are within safe limits, and a recent study found no significant cancer risk for OSA patients using Philips devices.

Positive

• Approximately 2.6 million devices registered in the U.S. as part of the recall.
• Over 650,000 replacement devices shipped to customers.
• Initial VOC test results indicate safe exposure levels for DreamStation devices.

Negative

• Potential health risk associated with PE-PUR foam in devices.
• Accelerated foam degradation linked to ozone cleaning, which is not approved by the FDA.

March 10, 2022

Amsterdam, the Netherlands – Royal Philips’ (NYSE: PHG, AEX: PHIA) subsidiary, Philips Respironics, today provided an update on the remediation status in the US 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.

Customer and patient outreach
Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. Philips Respironics continues to monitor recall awareness for affected patients [1]. Philips Respironics is working cooperatively with the US Food and Drug Administration (FDA) to further increase awareness for patients, consumers, and healthcare providers of the recall. Based on feedback from the FDA, Philips Respironics will be working with its DME customers to allow the company to directly contact those patients and other end-users that 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.

Repair and replacement program
To date, Philips Respironics has shipped a total of more than 650,000 replacement devices to customers in the US, and aims to complete the repair and replacement program in the fourth quarter of 2022.

Test and research program
In December 2021, Philips provided an update on the VOC test results to-date for the first-generation DreamStation devices [2]. 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 [2] 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.

[1] 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.

[2] The vast majority of the registered affected devices in the US to date are in the first-generation DreamStation product family.

[3] 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.

For further information, please contact:

Steve Klink
Philips Global Press Office
Tel.: +31 6 10888824
E-mail: steve.klink@philips.com

Derya Guzel
Philips Investor Relations
Tel.: +31 20 59 77055
E-mail: derya.guzel@philips.com

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2021 sales of EUR 17.2 billion and employs approximately 78,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

Forward-looking statements
This statement contains certain forward-looking statements with respect to the financial condition, results of operations and business of Philips and certain of the plans and objectives of Philips with respect to these items. Examples of forward-looking statements include statements made about the strategy, estimates of sales growth, future EBITA, future developments in Philips’ organic business and the completion of acquisitions and divestments. By their nature, these statements involve risk and uncertainty because they relate to future events and circumstances and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these statements.

FAQ

What is the latest update on the Philips Respironics recall?

Philips Respironics has registered approximately 2.6 million devices in the U.S. and shipped over 650,000 replacements as part of the ongoing recall.

How many replacement devices has Philips shipped?

Philips has shipped over 650,000 replacement devices to customers in the U.S. as part of the recall.

What risks are associated with the Philips Respironics devices?

There are potential health risks related to the polyester-based polyurethane (PE-PUR) foam used in certain sleep and respiratory care products.

What do initial tests indicate about VOC levels in Philips devices?

Initial VOC test results indicate that concentrations are within safe exposure limits specified in the applicable safety standards.

Is there any cancer risk associated with Philips PAP devices?

A recent study found no higher risk of incident cancer among OSA patients using Philips Respironics PAP devices compared to other brands or untreated patients.