Updated Information on Masks with Magnets for Healthcare Professionals
Last updated: June 26, 2024
This information is for healthcare professionals only
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 apnoea, 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.
ResMed masks with magnets have magnetic clips to facilitate a simple and easy way for patients to attach and detach the headgear to the mask frame.
Labelling Updates
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. Only those that interact with magnets or contain ferromagnetic materials present the potential for magnetic interference.
FAQs for Healthcare Professionals
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.1
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 fields2
- 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 classifications4. For any other MR labelling (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.
FAQs for ResMed Mask Providers
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.
- Complete and return the acknowledgment form either online (where available) or at the end of the FSN.
- 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 labelling (contraindications and warning).
- Immediately provide a copy of the patient letter to all patients currently using a ResMed mask with magnets, notifying them of the updated labelling (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.
- 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.
- 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).
Contact us
If you have any questions or concerns or would like more information, contact your ResMed product representative.
If you do not have a ResMed product representative, please visit this page
Please refer to the user guides for relevant information related to any contraindications, warnings and precautions to be considered before and during use of the products.
*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.
References:
- ICNIRP Guidelines on Limits of Exposure to Static Magnetic Fields – published in: Health Physics 96(4):504-514; 2009 https://www.icnirp.org/cms/upload/publications/ICNIRPstatgdl.pdf
- https://www.fda.gov/medical-devices/cerebral-spinal-fluid-csf-shunt-systems/magnetic-field-interference-programmable-csf-shunts
- https://www.fda.gov/radiation-emitting-products/cell-phones/magnets-cell-phones-and-smart-watches-may-affect-pacemakers-and-other-implanted-medical-devices
- https://www.fda.gov/media/101221/download
Content last updated: 06/2024