Philips PAP gadget recall: FAQs for sufferers

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On June 14, Philips issued a voluntary recall for particular Philips Respironics units. These embody CPAP and BPAP units to deal with obstructive sleep apnea. Listed here are solutions to some often requested questions concerning the recall.

The place can I discover details about the recall?

The recall notification is posted at philips.com/src-update. Additionally, the FDA has posted responses to a number of questions concerning the recall. Learn FAQs from the FDA.

How do I discover out if my PAP machine has been recalled?

You can begin by viewing an inventory of recalled units on the Philips web site. To verify that your gadget has been recalled, you want to go to the Philips registration web site to register your gadget. The web site offers you directions on how one can find the serial variety of your gadget. It additionally will information you thru the registration course of. You possibly can contact Philips at [email protected] or (877) 907-7508 for extra assist.

View a video on how one can register your gadget:

Will Philips substitute my PAP gadget?

Philips has acknowledged that it’ll restore or substitute recalled units. Philips is changing some units with new DreamStation 2 machines. These units have a unique, silicone-based foam that’s not included within the recall. Philips additionally plans to restore some recalled units by altering the froth. Philips acknowledged in September 2021 that the corporate intends to finish the restore and substitute applications inside roughly 12 months.

If my gadget has been recalled, ought to I cease utilizing it?

An FDA security communication advises you to speak to your well being care supplier to resolve on an acceptable therapy to your situation. Your medical supplier will help you establish when you ought to proceed or discontinue therapy. Your supplier might prescribe a brand new PAP gadget for you. Your supplier additionally might talk about different therapy choices with you.

Why have been the units recalled?

Philips signifies that there have been experiences of black particles being discovered within the tubing, masks, and across the connections to the gadget. These particles are from foam contained in the machine that’s used to maintain it quieter. The priority is that these particles could also be inhaled when the gadget is getting used. This might end in issues equivalent to complications, bronchial asthma, and nausea. Testing by Philips  additionally has discovered that there are VOCs (unstable natural compounds) which are being launched into the airflow from the CPAP gadget foam. These aren’t but recognized to have prompted medical points, however the FDA is anxious about what this will trigger sooner or later. Since this can be a new concern, Philips is accumulating information to higher perceive the potential threat of this foam.

The FDA notes that between 2014 and April 2021, Philips submitted 30 medical gadget experiences (eight from the U.S.) they recognized as associated to foam breakdown.  Previous to April 2021, the FDA didn’t obtain any medical gadget experiences of affected person harm or hurt associated to foam breakdown. Since April 2021, the FDA has obtained greater than 3,000 medical gadget experiences associated to foam breakdown.

What does this must do with ozone cleaners? How ought to I clear my PAP gadget?

Philips experiences that the froth used to maintain the units quieter breaks down faster when uncovered to excessive warmth, excessive humidity, and non-approved cleansing units that use ozone. The FDA recommends that you simply comply with the cleansing directions offered by the PAP producer. These instructions usually embody common cleansing of your masks, cushions, tubing and water chamber with cleaning soap and water. PAP producers additionally advocate altering your PAP filter regularly. An FDA security communication warned that it’s best to keep away from cleansing your PAP machine or equipment (equivalent to masks, tubing, headgear) with any gadget that makes use of ozone fuel or UV mild. In keeping with the FDA, it’s unknown if these cleaners are secure and efficient. See the FDA shopper replace for extra particulars. Moreover, Philips launched cleansing and inspection directions for present equipment.

Up to date Nov. 19, 2021

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