Recently, Philips issued a recall notice for some of their Continuous Positive Airway Pressure, BiLevel Positive Airway Pressure devices, and Mechanical Ventilators due to potential health risks from the polyester-based polyurethane foam used in their devices. Specifically, the foam may degrade into particles that may be inhaled by the user. The potential risks of degraded foam exposure are listed on the manufacturer’s website.
In response to the recall, the ATS’s Sleep & Respiratory Neurobiology Assembly developed recommendations for sleep and critical care medicine professionals, which is available here.
Below, please find resources to help you navigate patient care and address inquiries. We will share updates here as further details become available.
Resources:
- Sleep and Respiratory Care Bulletin #6
- Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program
- Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam
- Philips provides update on the test and research program in connection with the CPAP, BiPAP and Mechanical Ventilator recall notification
- Philips Releases Clinical Support Information for DreamStation 2
- Supplemental Clinical Information for Physicians and Providers for Specific CPAP, Bi-Level PAP, and Mventilator Devices With the Use of Bacteria Filters
- View Philips FAQ.
- Watch a webinar with experts from the American Academy of Sleep Medicine (AASM), American Academy of Neurology, American College of Chest Physicians, Canadian Sleep Society, the ATS.View slides and a sample assessment here.
- AASM guidance
- Philips Guidance for Patients
- FDA Safety Communication
- Latest FDA Safety Communication
- Safety Alert from the Australian Department of Health
- Patient Message and Forms:
