Patient safety is ResMed's top priority, and we will always follow our guiding principles that prioritize patient needs and safety to ensure the best care is given to the millions of people we serve worldwide.
We understand how important the right mask is to ongoing therapy for people with sleep apnea, COPD, and other chronic diseases. Over the past year, we have been engaged in discussions with Health Regulators to ensure that we are up to date with the latest recommendations around the use of magnets when in close proximity to certain implants and medical devices.
To provide patients and healthcare professionals with updated guidance on the safe use of ResMed masks with magnets, we have updated the contraindications and warnings sections in our user guides. Our actions are in response to new information obtained through the latest regulatory recommendations, post-market surveillance, and industry practices related to the potential magnetic interference of our masks with magnets when in close proximity to certain implants or medical devices.
For more information, please refer to the FAQs below, and if you have questions about your specific situation, please consult your mask provider or physician/doctor.
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:
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.
Use the links below to find more information on each ResMed mask that features magnetic headgear clips. Product availability may differ in each country.
ResMed's masks with magnets are safe when used in accordance with the updated instructions for use, including the contraindications and warnings.
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. 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.
Replace your mask containing magnets with an alternative mask without magnets in a timely manner. Contact your mask provider for alternative mask options.
Note, ResMed is making our masks without magnets available to your mask provider for replacement purposes for contraindicated patients. If an alternative mask is not available, consult your physician/doctor for appropriate next steps regarding your therapy.
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 mask provider or physician/doctor.
Contraindications: conditions under which the mask is not to be used.
Warnings: identify a possible hazard and provide information on how to safely use the mask.