Recommendations for Sleep and Critical Care Medicine Professionals Regarding Philips Recall Notice
Note: The information provided may be updated as further details become available.
Recently, Philips issued a recall notice for some of their positive airway pressure (PAP) devices 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.
According to the manufacturer, the degradation may be worsened by unapproved cleaning methods (e.g. ozone). The exact risks are unclear, but we hope that more information may be available in the near future.
Philips Respiratory Device Recall Notification
A variety of devices are involved in the recall; these include the first generation DreamStation devices though not the DreamStation 2 devices. Please refer to the complete list.
General Questions, Repair and Replacement
Philips is creating a registration process that will allow patients to look up their device serial number and begin a claim if the unit is affected.
Read the Philips press release for more information.
Patient Advice
For patients using life-sustaining mechanical ventilator devices, we would recommend that patients do not stop or alter prescribed therapy until after talking to your physician. Appropriate therapeutic decisions need to balance risks of continuing therapy versus temporarily discontinuing the device while awaiting a reasonable alternative.
For patients on Bi-level PAP and CPAP devices who have severe breathing difficulties, or were very sleepy during the daytime before treatment, have significant pulmonary, cardiovascular or neurologic comorbidity, or who work in safety-critical positions (e.g. professional drivers, pilots, heavy equipment operators), we would recommend that they not stop their prescribed therapy until first discussing with their physician. For other patients, Philips recommends the device should be discontinued and the physician/DME provider be contacted to determine the most appropriate option for continued treatment. If your physician determines that you should continue using this device, consider use of in-line bacterial filter. Consult your Instructions for Use for guidance on installation.
Recommendations from the Philips Website
Recommendations are based upon current information and may require further updates.
Patients, physicians and DME suppliers can call Philips at 877-907-7508 for additional support.
