Field Safety Notice ResMed Masks with Magnets and Potential Magnetic Interference with Certain Medical Devices (ICN 2349)

Alert:

• The mask is a non-invasive interface, used for channelling airflow to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.
• Magnets are used in some ResMed masks to facilitate 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 is updating its existing contraindications and warnings to further inform patients and healthcare professionals on the safe use of ResMed masks with magnets. This is in response to new information obtained through post-market surveillance and industry practices related to possible magnetic interference when in close proximity to certain medical devices.
• In an update to the previously contraindicated metallic aneurysm haemostatic clips in the head and metallic splinters in one or both eyes following a penetrating eye injury, ResMed is further contraindicating the use of its masks with magnets for patients where they, or anyone in close physical contact while using the mask (for example, bed partner), have the following:
• Active medical implants that interact with magnets (pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps).
• 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).

Please note, not all models or manufactured 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.

Products Affected:

• There are 36 of these products available from NHS Supply Chain.
• 344 products were previously available from NHS Supply Chain as noted on the delisted tab in the attached product listing.
• Please note that some of these products are regional and not available to all customers.
• Please refer to the attached product listing and MPC (manufacturer’s product code) list for details of products affected by this Field Safety Notice.

Next Steps:

• The update to the warning includes the safe distance to the magnets has been increased from 2 inches (50 mm), and patients are now warned to keep the mask magnets at a safe distance of 6 inches (150 mm) away from implants or medical devices that may be adversely impacted by magnetic interference. This applies to patients, or anyone in close physical contact with the mask magnets.
• Refer to Appendix A – Labelling Updates, page 5 of the Field Safety Notice for complete contraindications and warnings.
• Please carefully read Appendix A for labelling updates, as it includes further examples of implants or medical devices that may be affected by magnetic interference.
• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Please also refer to the attached Physician Letter and Patient Letter provided by ResMed.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.