ResMed Masks with Magnets and Potential Magnetic Interference with Certain
Medical Devices

November 20, 2023

Products Affected:

All lots of ResMed masks with magnets: AirFit N10, AirFit N10 for Her, AirFit N20, AirFit N20 for Her,AirTouch N20, AirTouch N20 for Her, AirFit F20, AirFit F20 for Her, AirFit F20 NV, AirTouch F20, AirTouch, F20 for Her, AirFit F30, AirFit F30i.

 

Who does this apply to?

  • If you do not use a mask with magnets, the updated contraindications and warnings do not apply to you.
  • The updated contraindications for ResMed masks with magnets only apply if you, or anyone in close physical contact with you while using the mask (e.g., bed partner), has a certain implant or medical device that is identified below.
  • If you use a ResMed mask with magnets, you should also be aware of the updated warning noted below

General Product Description

The mask is a non-invasive interface, used for channeling airflow to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.

Magnets are used in some ResMed masks to facilitate a simple and easy way for patients to attach and detach the headgear to the mask frame when regularly fitting the mask for use. This can be notably beneficial to patients with disabilities, including those facing dexterity or vision impairment.

Updated Contraindications

Masks with magnetic components are contraindicated for use by patients where they, or

anyone in close physical contact while using the mask, have the following:

  • Active medical implants that interact with magnets (i.e., pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps)
  • Metallic implants/objects containing ferromagnetic material (i.e., aneurysm clips/flow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, metallic splinters in the eye)

Updated Warning:

Keep the mask magnets at a safe distance of at least 6 inches (150 mm) away from implants or medical devices that may be adversely affected by magnetic interference. This warning applies to you or anyone in close physical contact with your mask. The magnets are in the frame and lower headgear clips, with a magnetic field strength of up to 400mT. When worn, they connect to secure the mask but may inadvertently detach while asleep.

Implants/medical devices, including those listed within contraindications, may be adversely affected if they change function under external magnetic fields or contain ferromagnetic materials that attract/repel to magnetic fields (some metallic implants, e.g contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, and bone substitute devices). Consult your physician and manufacturer of your implant / other medical device for

information on the potential adverse effects of magnetic fields.

Note, not all models or variants of medical devices listed in the contraindications are affected by external magnetic fields. If you are not sure whether an implant or medical device falls under the contraindications, or you require additional information on the potential adverse effects of magnetic fields for your particular implant or medical device, please contact your physician/doctor. 

Does this apply to you?

If you are an InspiAIR patient and this notice/warning applies to you, please contact your local InspiAIR office using the form below. Your local InspiAIR will help answer any questions and have you fitted for a new mask without magnets.