SAFETY NOTICE

Sleep apnea device manufacturer ResMed announced on November 21, 2023 that it was updating existing contraindications and warnings regarding its masks that contain magnetic harness clips.

In response to new information from the latest industry practices and global safety data, ResMed updates contraindications and warnings in its user guides to educate patients on the safe use of masks ResMed equipped with magnets.

These masks are used to deliver air to a patient from a continuous positive airway pressure machine, commonly called CPAP. Magnets are used in some ResMed masks to allow patients to easily attach and separate the headgear and rigid mask surround when putting on the mask. This can be particularly beneficial for disabled patients, especially those with dexterity or vision impairments.

The following ResMed masks contain magnets. If you do not use one of the masks identified below, this letter does not apply to you.

Refer to the official manufacturer’s letter for more information, available by clicking here.

Patients who have a contraindicated medical device or a medical device that may interfere with magnets or anyone in close physical contact with any of the affected products. Masks with magnetic components are contraindicated for patients when they, or anyone in close physical contact with the mask, have the following:

• Active medical implants that interact with magnets (e.g., pacemakers, implantable cardioverter defibrillators [ICDs], neurostimulators, cerebrospinal fluid [CSF] shunts, insulin pumps/infusions).
• Metallic implants/objects containing ferromagnetic material (e.g., aneurysm clamps/flow breakers, embolic coils, stents, valves, electrodes, implants intended to restore hearing or balance with implanted magnets, ocular implants , metal shards in the eye).

For people who are not affected by such devices, masks with magnets are safe and can continue to be used.

Médicus intends to provide, free of charge, a replacement solution in accordance with established standards to the persons concerned. (Limit one replacement per person.)

1. Check your eligibility
   1. The mask must be one of the targeted masks.
   2. The people must be covered by the recall (have a contraindication to the use of a mask with a magnet).
   3. Proof of your medical condition may be requested upon check-in.
2. Check the date of your purchase
   1. People who purchased a covered mask between January 1, 2020 and December 28, 2023 will be eligible for a free replacement solution (see covered masks).
3. Contact us to make an appointment with your respiratory therapist and proceed with the replacement
   1. By phone at 1-866-525-3757 Monday to Friday, 8:30 a.m. to 5 p.m.