ResMed Issues Urgent Field Safety Notice for Certain PAP Masks

By RTSleepWorld Staff

In an effort to furnish patients and healthcare professionals with the most current and comprehensive guidance concerning the secure utilization of ResMed masks equipped with magnets, ResMed has issued an Urgent Field Safety Notice and has revised the contraindications and warnings sections within its user guides. This initiative stems from their commitment to responsiveness and has been prompted by the acquisition of new information derived from the latest regulatory recommendations, post-market surveillance, and industry practices. This information specifically pertains to the potential magnetic interference that ResMed masks featuring magnets may pose when in close proximity to certain implants or medical devices.

Read the Urgent Field Safety Notice

In recent times, the use of masks with magnetic components has become increasingly popular. These masks, while innovative in design, come with specific guidelines to ensure the safety of individuals, especially those with medical implants. The updated contraindications and warnings are crucial for users to be aware of, as they pertain to potential interactions with active medical implants and the magnetic components of the mask.

Contraindications:

Masks featuring magnetic components are contraindicated for individuals with the following conditions:

1. Active Medical Implants that Interact with Magnets:
   • Pacemakers
   • Implantable Cardioverter Defibrillators (ICD)
   • Neurostimulators
   • Cerebrospinal Fluid (CSF) shunts
   • Insulin/Infusion pumps
2. Metallic Implants/Objects Containing Ferromagnetic Material:
   • 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:

For users of masks with magnetic components, it is imperative to adhere to the following 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.

Adverse Effects on Implants/Medical Devices:

It is crucial to understand that implants and medical devices, even those listed within contraindications, may be adversely affected if they:

• Change function under external magnetic fields
• Contain ferromagnetic materials that attract/repel to magnetic fields

Examples of such devices include contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, and bone substitute devices. Individuals are advised to consult both their physician and the manufacturer of their implant or other medical device for information on potential adverse effects related to magnetic fields.

Consultation and Clarification:

Notably, not all models or variants of medical devices listed in the contraindications are universally affected by external magnetic fields. Individuals who are uncertain about whether an implant or medical device falls under the contraindications or require additional information on potential adverse effects of magnetic fields for their particular implant or medical device are encouraged to contact their physician or doctor for clarification.

Visit ResMed’s special landing page, which contains additional mask information.