CHEST CHEST News What You Need to Know About the Philips PAP Device Recall

What You Need to Know About the Philips PAP Device Recall

In June 2021, Philips Respironics issued a voluntary recall for some of their CPAP devices, BiPAP devices, and mechanical ventilators. CHEST continues to monitor the situation as it develops and is actively engaging with Philips and partner associations on behalf of you and your patients.

Available resources and guidance

Philips Statement on Recall and Replacement Program

Philips has released details on its process to replace the PE-PUR sound abatement foam in affected first-generation DreamStation devices, as well as to replace certain affected first-generation DreamStation CPAP devices in the US with DreamStation 2 CPAP devices.

Device Registration Process

Patients with affected devices should register their devices with Philips.

Philips Recall Notification

Access the latest information directly from Philips, including details on affected devices.

FDA Safety Communication

The US Food and Drug Administration has issued recommendations for patients, health care providers, and facilities.

AASM Resource Page

The American Academy of Sleep Medicine (AASM) offers guidance for clinicians, such as sample patient communications, clinical assessment tools, webinar recordings, and more.

Position Statement: Canadian Thoracic Society, Canadian Sleep Society, and Canadian Society of Respiratory Therapists

These societies have provided guidance to physicians and medical device distributors with regard to the recent recall notice.

Message from the CHEST President on Philips recall

Dear CHEST members,

In June, CHEST released information concerning the Philips Respironics voluntary recall for some of their CPAP devices, BiPAP devices, and mechanical ventilators. We continue to monitor the situation as it develops, but there has been minimal additional information to report.

As a reminder, Philips announced that there are possible health risks from exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. We have no information on the extent of the foam deterioration, nor do we know the likelihood of short-term or long-term harm. Philips hosts a Q&A on their website that acknowledges questions your patients likely have around the replacement of devices, but the path forward is not yet clear.

CHEST is working in conjunction with a number of partner associations on behalf of you and your patients. We issued a joint statement to the Centers for Medicare & Medicaid Services seeking support for the temporary suspension of the 90-day adherence rule, to allow patients to have existing equipment repaired or to receive new equipment from durable medical equipment (DME) suppliers. We also reached out to private payers. We are engaging with Philips to understand more about the data behind the voluntary recall. Read the full statement here:

CHEST Issues Joint Statement in Response to Philips Device Recall

At present, the risks and benefits of stopping CPAP are not fully understood. As clinicians, we must engage with our patients, carefully weigh their individual considerations, and make shared decisions with them. We invite you to watch the recorded webinar, Impact of the Philips PAP Recall on Patient Care and Sleep Center Operations, featuring experts from CHEST, the American Academy of Sleep Medicine, the American Academy of Neurology, the American Thoracic Society, the Canadian Sleep Society, and the Canadian Thoracic Society.

We, your CHEST leaders, are working hard to learn more about this situation, so we can provide guidance for our members. The moment we have new information, we will communicate it to you through this page, as well as our e-newsletters and on social media - primarily Twitter.

Please share this information with your colleagues and don’t hesitate to bring your questions and concerns to my attention.

Steven Q. Simpson, MD, FCCP
President, CHEST

Clinician infographic

CHEST has compiled information for clinicians on what approach to use for patients whose devices may be part of the Philips recall, emphasizing shared decision-making between patients and their health care providers.

Philips Recall of CPAPs, BiLevel PAPs, & Home Ventilators infographic
Philips recall infographic

For your patients

CHEST’s Sleep Medicine NetWork has created an easy reference sheet to help patients understand what steps to take, potential health risks, insurance information, and recommendations from Philips.