The FDA has released an update regarding the recall of certain Philips Respironics ventilator devices and Positive Airway Pressure (PAP) devices. In November 2021, FDA posted an announcement related to a potential issue with the foam used for repair and replacement devices.
The FDA has requested that Philips Respironics retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. While this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. The FDA has reached this determination based on an overall benefit-risk assessment. At this time, the agency has determined that discontinuing use of one of these devices may be more harmful to a patient’s health and quality of life. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available
