Philips-Respironics, a medical device manufacturer for home ventilator and CPAP/BIPAP machines used to treat sleep apnea, recently announced a recall for many of their medical devices due to concerns that a sound reducing foam may degrade over time and enter into a patient's airway and lungs, posing severe medical risk.
Philips Respironics announced a voluntary recall notification (U.S. only) / field safety notice (International Markets) for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices: 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of ozone cleaners), and off-gassing may occur during initial operation and may possibly continue throughout the device’s useful life.
Advice for Patients and Customers
Philips advises patients and customers to take the following actions:
- For patients using affected BiLevel PAP and CPAP devices: Discontinue use of your device and work with your physician or durable medical equipment (DME) provider to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification.
- For patients using affected life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.
Patients, physicians and DME suppliers can call Philips at 877-907-7508 for additional support.
