Field Safety Notice: Resmed masks (with magnets)

In November 2023, Resmed published a field safety corrective action concerning their masks with magnets used to deliver air to patients from a positive air-pressure device.

Based on post-marketing surveillance data, Resmed has updated the contraindications and warnings for these masks with magnets. When these masks are used near certain implanted medical devices – such as pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, and insulin/infusion pumps – potential magnetic interference could cause a change in the function of these implanted devices. The issue also applies to metallic implants/objects containing ferromagnetic material, such as aneurysm clips/flow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, and metallic splinters in the eye.

As such, Resmed masks with magnets are to be kept at least 150 mm away from implants or medical devices that may be adversely affected by magnetic interference. This applies to patients and to anyone in close physical contact with a Resmed mask with magnets.

Which Resmed masks with magnets are affected?

Action to take

Resmed masks with magnets should not be used by patients with contraindications. Patients should contact their mask provider to replace their Resmed mask with magnets with an alternative mask without magnets as quickly as possible.

If an alternative mask is not available, patients should consult their physician for appropriate next steps regarding their therapy. During consultations with patients, physicians should:

• Determine whether the implant/medical device may be adversely affected by magnetic interference.
• Assess the impact of magnetic interference on the implant/medical device, and the risk of an incident occurring
• Assess the potential for magnetic interference when using a Resmed mask with magnets

Pending a replacement, patients should not suddenly stop using their mask without first discussing the matter with their physician. As a general rule, the risk of interference with a metallic device, whether implanted or not, can be avoided if the mask is kept more than 15 cm away from the device.