ResMed has issued an urgent field safety notice for its CPAP masks with magnets due to potential interference with some implants or certain medical devices.

The company says in the notice that it is updating the contraindications and warnings in its user guides to instruct patients on the safe use of masks with magnets “in response to new information from latest industry practices and global safety data.”

Magnets are used in some ResMed masks to provide 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. 

ResMed AirFit F30

The following ResMed masks contain magnets and are affected: 

  • Full face masks:
    • AirFit F20
    • AirFit F20 for Her 
    • AirTouch F20
    • AirTouch F20 for Her 
    • AirFit F30 
    • AirFit F30i 
  • Nasal masks:
    • AirFit N10
    • AirFit N10 for Her 
    • AirFit N20
    • AirFit N20 for Her 
    • AirTouch N20
    • AirTouch N20 for Her 
  • Non-vented mask:
    • AirFit F20 NV 

From 2014 to November 2023, ResMed has sold tens of millions of masks with magnets globally, according to the company’s safety notice. In this time, ResMed has submitted five reports of serious harm that were potentially related to magnetic interference with an implanted device (including implantable cardioverter defibrillators and cerebrospinal fluid shunts) to relevant regulatory authorities. No permanent injuries or deaths have been reported. 

What Has Changed? 

ResMed is updating the contraindications and warning relating to magnetic interference in its user guides for all masks with magnets. 

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 (ie, pacemakers, implantable cardioverter defibrillators, neurostimulators, cerebrospinal fluid shunts, and insulin/infusion pumps) 
  • Metallic implants/objects containing ferromagnetic material (ie, 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) 

In the updated warning, Resmed says users should keep the mask magnets at a safe distance of at least six inches away from implants or medical devices that may be adversely affected by magnetic interference. This warning applies to the user or anyone in close physical contact with the 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 and 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, eg, contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, and bone substitute devices). 

Users are advised to consult their physician and manufacturer of their implant or other medical device for information on the potential adverse effects of magnetic fields. 

Patient Safety Information 

ResMed’s masks with magnets are safe when used in accordance with the updated instructions for use including the contraindications and warnings, according to the company. 

When a magnet comes close to certain medical implants/devices (less than six inches) there is potential for magnetic interference to change the function of an implant/medical device and the position of implants made of ferromagnetic material. In rare circumstances, this can lead to serious injury or death. 

Contraindicated patients can avoid the potential harm from magnetic interference by using an alternative mask without magnets. All other patients using ResMed masks with magnets can continue to use the mask following the updated instructions for use. 

Contraindicated patients using a ResMed mask with magnets are advised to replace their mask containing magnets with an alternative mask without magnets in a timely manner. Users can contact their mask provider for alternative mask options. 

Those who have experience an adverse event related to the use of ResMed masks with magnets can contact ResMed or their mask provider. Alternatively, adverse events experienced with the use of this product may be reported to the US Food and Drug Administration’s MedWatch Adverse Event Reporting program.