Contraindicated patients using ResMed masks with magnets need to seek an alternative mask without magnets in a timely manner. Patients are instructed to contact their mask provider for alternative mask options. If an alternative mask is not available, they are instructed to consult with their physician/doctor on appropriate next steps regarding their therapy. Refer to the Physician Letter below for considerations on patient consultation relating to the risk of magnetic interference.

Yes. ResMed masks with magnets are safe when used in accordance with the updated instructions for use, including the contraindications and warnings.

ResMed masks with magnets continue to be available through authorized mask providers.

ResMed mask magnets have a strength typically between 250-300mT at the surface of the magnetic components. This is below the allowable safety limit guidelines of 400mT for general public use issued by the International Commission for Non-Ionizing Radiation Protection (ICNIRP). The magnetic strength dissipates with distance from the magnet and is less than 0.5mT at 2-inch (50mm) distance.

Source: The guidelines¹ for public exposure to static magnetic fields are established by the International Commission for Non-Ionizing Radiation Protection (ICNIRP) and are recognized by the World Health Organization (WHO).

The interaction of magnets with active implants varies, and not all active implants are affected by magnetic fields. Refer to the implant/medical device instructions for use, or contact the implant/medical device manufacturer, on safety information relating to exposure to static magnetic fields and the potential clinical effects.

 

Examples of interaction concern (non-exhaustive list):

• Some cerebrospinal fluid (CSF) shunts contain magnetically programmable valves that have the potential for inadvertent adjustment under the presence of external magnetic fields ²
• Cardiac implantable electronic devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators (ICD) commonly have sensors that, while exposed to external magnets, change the implant function (commonly referred to as ‘magnet mode’) ³

Under certain circumstances, there is the potential to lead to serious injury or death.

 

Some metallic implants/objects are made of ferromagnetic materials that are influenced (magnetically attracted/repelled) under magnetic fields and have the potential to change the position of the implant/object.

Non-ferromagnetic materials are widely used in implants today to enable magnetic resonance compatibility. However, some implants or older variants may contain ferromagnetic materials. For metallic implants, refer to the implant instructions for use or contact the implant manufacturer for safety information relating to exposure to static magnetic fields or MRI safety.

The effect of the magnets on metallic implants varies depending on the implant type and size, location of the implant, and proximity to the magnet.

Ferromagnetic refers to a material property that is influenced by magnetic fields (e.g., attracts/repels under magnetic fields). Materials that are ferromagnetic are generally made of iron, cobalt, nickel, or some alloys made of these elements.

Not all medical implants listed in the contraindications are made from ferromagnetic materials.

Masks with magnets can be used with implants designated MR-Safe since the implants have no scanning restrictions while exposed to the strong static magnetic fields generated during an MRI.

Implant types and models may have varying Magnetic Resonance (MR) environment safety classifications ⁴. For any other MR labeling (e.g., 'MR-Conditional'), refer to the implant instructions for use for safety information relating to exposure to static magnetic fields and the potential clinical effects.

Note, ResMed masks with magnets are not to be introduced to an MR environment.

 

Refer to the ResMed Mask Crosswalk in the Supporting Documents to identify alternative masks without magnets.

Actions to be taken by ResMed Mask Providers are outlined in the Field Safety Notice sent to all customers of ResMed that have purchased our masks with magnets.

1. Complete and return the acknowledgment form either online (where available) or at the end of the FSN.
2. For distributors and resellers, immediately provide a copy of this notice and the physician letter to prescribing physicians, and/or any other relevant healthcare professionals, notifying them of the updated labeling (contraindications and warning).
3. Immediately provide a copy of the patient letter to all patients currently using a ResMed mask with magnets, notifying them of the updated labeling (contraindications and warning). Note, patients are instructed in the patient letter to contact their mask provider for a replacement mask if they are now contraindicated.
4. Provide a replacement mask for contraindicated patients to an alternative mask without magnets in a timely manner. Where an alternative mask is not available, inform patients to consult with their physician.
5. Instruct patients to consult their physician and/or manufacturer of their implant / other medical device if they require additional information on the potential adverse effects of magnetic fields for their particular device (as described in warnings).