On June 14, 2021, Philips initiated a voluntary recall notification in the U.S. (and an international field safety notice) for specific Philips Respironics models of continuous positive airway pressure (CPAP), bi-level positive airway pressure (BPAP), and mechanical ventilator devices, stating that the recall is to “ensure patient safety in consultation with regulatory agencies.” The recall is to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in certain devices. Philips reports that the foam-related complaint rate in 2020 was low (0.03%). However, Philips determined based on testing that there are possible risks to users related to the type of foam used in these devices. The risks include that the foam may degrade into particles, which may enter the device’s air pathway and be ingested or inhaled by the user. Potential risks include headache and respiratory problems. The foam also may off-gas certain chemicals which may be associated with headaches, irritation, hypersensitivity, nausea, vomiting, and possible toxic or carcinogenic effects. Philips indicates that this foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone. High heat and high humidity environments also may contribute to foam degradation. The majority of the affected devices are in the first-generation Dream Station product family. An expert panel from the AASM speculates that most serious potential effects related to foam are associated with repeated and prolonged use of affected devices.
We are using the following mitigation strategies to reduce the risk of using our Omni lab titration units: 1) Avoid the use of heated humidification 2) Maintain cooler temperatures in the bedroom environment. Additionally, we HAVE NEVER used ozone-based cleaning systems and carefully inspect the air path circuit before and after each use, looking for debris/foam particles as suggested by the FDA.
We are publishing this in the interest of transparency to inform you of this recall and the measures we are taking to reduce the potential risks noted above. To date, there are no reports of serious injury associated with the above recall. The alternative to proceeding with the recommended titration study is to attempt a trial of APAP (auto positive airway pressure therapy) at home. You would get the same machine that would be ordered following the overnight titration study but it WOULD NOT be programmed or customized to your specific needs.
If you elect to proceed with the in-lab polysomnogram with CPAP titration, we ask that you sign this statement (our staff can provide a PDF or you can sign at the time of our study) to acknowledge being informed of the recall, per the American Academy of Sleep Medicine’s guidelines. If you would like to proceed with APAP titration please let us know so we can order a device for you to use at home. If have additional questions please reach out to us through the patient portal or call to request an appointment with one of our sleep specialists.