ResMed masks with magnets - Product defect correction

The Therapeutic Goods Administration (TGA) advise that ResMed have updated the safety information and warnings for their masks that have magnets. 

If the magnets come too close to certain implanted devices, the implants may not work as they should. View the list of affected masks

What do prescribers/physicians need to do?

• Patients with affected masks will be contacted by their mask provider notifying them of updated labelling. 

• If an alternative mask is not available, the patient is being advised by their mask provider to contact their physician on appropriate next steps regarding their therapy. 

• Advise your patients on alternatives on a case-by-case basis.

• Discuss with your patient whether anyone in close physical contact while using the mask (e.g., bed partner) have implants or metallic medical devices. When close to the patient, others may also be at risk from the magnets.

View the patient letter

What are the risks?

The magnetic field may cause active implantable devices to malfunction or result in movement of other implantable devices which has the potential to lead to serious injury or death.

What is ResMed doing?
ResMed is revising their instructions (IFUs) to include additional contraindications and warnings against use with the wide range of medical devices.

Non-magnetic replacement masks will be made available.

Further information