Resources on June 2021 recall
In June 2021, Philips announced a recall of certain CPAP, BiPAP, and mechanical ventilator devices due to potential health risks from the polyester-based polyurethane (PE-PUR) sound abatement foam used in affected devices. Since then, a number of resources have been released from Philips, the FDA, and other entities.
Philips PE-PUR Testing Results and Conclusions: Philips has released a report with updated information on testing results and third party confirmed conclusions to date on results and findings from testing PE-PUR foam used in recalled devices for volatile organic compounds, particulate matter, and other testing.
Information on Patient Prioritization: Philips has shared details on how the company is prioritizing remediation of those patients potentially at higher risk.
Clinical Bulletins: Access communications from Philips that update physicians on recent developments, as well as provide status updates on remediation efforts.
Understanding the Recall Process: A new webpage from Philips gives patients an overview of the recall process and enables them to check the status of their order.
FDA Safety Communication: The FDA has issued recommendations for patients, health care providers, and facilities.
Device Registration Process: Patients with affected devices should register their devices with Philips.
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.