On June 14, 2021, Philips Respironics, a major manufacturer of Positive Airway Pressure devices, better known as CPAP or BiPAP, announced a recall of 4 million of these devices. This announcement can be located (HERE).
The recall is due to the breakdown of the foam used to reduce sound and vibration that could break loose and travel through the air hose and covers 95 percent of the Philips devices issued since 2009. According to the Veterans Health Administration, 300,000 veterans have been issued a CPAP or similar device covered by this recall. The Food and Drug Administration (FDA) classified the recall of Phillips’ breathing devices and ventilators as Class 1, or the most serious type of recall, saying, “The use of these devices may cause serious injuries or death.” The FDA’s notice can be found (HERE).
According to communications obtained via MyHeatheVet from the VA Patient Safety Office, veterans who have been issued a Philips Respironics device by VA should register the device through the Philips Respironics patient online portal (HERE). Veterans can also call 877-907-7508 to complete the registration. Philips Respironics will then send a replacement device that could take several months. The company has identified the use of ozone or UV cleaning devices that may accelerate the breakdown of the foam and asks on its recall registration website if the user has been using either of these cleaning methods. This is to help the company prioritize the issuance or repair of recalled machines that have been exposed to ozone or UV.
Patients are advised to contact their sleep medicine professional to determine their best course of action during this recall, and reference “Sleep and Respiratory Care update- Clinical information for physicians” guidance from Phillips Respironics, available (HERE). Further, the VA Public Safety Office advises users who detect other problems with their device or experience new respiratory symptoms should contact their care team immediately. VA is working with the manufacturer on a solution and will provide additional information as it becomes available.