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PAP Recall Notice

To our Sound Sleep Health CPAP and BiPAP patients:

On June 14, 2021, Philips-Respironics issued a safety notification and recall notice for many of its PAP devices, including Dreamstation CPAP, BiPAP and ASV devices. You can read the notice at the following link.

Philips indicated that the recall pertains to sound isolation foam used in some of their devices. This foam has been found to degrade into fine particles in certain situations where the device was cleaned with an unapproved method, such as with an ozone based cleaning device. Although it is unlikely, Philips has expressed concern that the particles could be breathed in, causing irritation to the respiratory system. Philips also indicated that the foam particles could potentially be carcinogenic.

Philips-Respironics has advised patients to stop using their devices until further notice unless they are being used in a life-sustaining capacity.

SOUND SLEEP HEALTH’S POSITION: (THIS IS OUR OPINION ONLY AND MAY CHANGE AS THE SITUATION EVOLVES)

If you have a Philips device, what do you need to do?

Untreated sleep apnea can cause drowsiness and increased risk for cardiovascular problems such as heart rhythm disorders.

  • Every patient needs to individually weigh the risk of discontinuing CPAP temporarily versus continuing to use the device until the issue is resolved. Many patients have been using these devices for years already, so the added risk from using the devices for an additional short period of time is probably small.
  • If you have mild to moderate obstructive sleep apnea and don’t have daytime sleepiness when not using CPAP, consider discontinuing the use of your Philips device and checking their recall web page (see above) daily for updates. Philips has indicated that you will be able to register your device and get the appropriate replacement or retrofit.
  • If you have severe sleep apnea and/or if your apnea causes significant drowsiness if untreated, please contact Sound Sleep Health to schedule an appointment as soon as possible to go over treatment options with one of our providers.
  • Please discontinue use of any ozone based PAP cleaning equipment until further notice.
  • Please note that as of 2018, Sound Sleep Health no longer provides CPAP machines or supplies to patients. If you got your CPAP machine from us, we can assist you in transitioning to a medical equipment supplier for ongoing re-supply.