ResMed AirFit N10 Masks with Magnets User Manual

ResMed AirFit N10 Masks with Magnets

Specifications

• Product Name: ResMed Masks with Magnets
• Product Code: MWM-2023-FSN-01
• Date: 20 November 2023

Description
The ResMed Masks with Magnets are non-invasive interfaces 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. These masks feature magnets that facilitate easy attachment and detachment of the headgear to the mask frame, providing convenience for patients with disabilities or impairments.

Change Description
ResMed has updated the contraindications and warnings for their masks with magnets to provide patients and healthcare professionals with important safety information. This update is based on new information obtained through post- market surveillance and industry practices regarding potential magnetic interference when in close proximity to certain medical devices.

Update to Contraindications
In addition to the previously contraindicated metallic aneurysm hemostatic clips in the head and metallic splinters in one or both eyes following a penetrating eye injury, ResMed now further contraindicates the use of masks with magnets for patients who, or anyone in close physical contact with the patient, have the following:

• Medical devices that interact with magnets or contain ferromagnetic materials

Note that 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.

Update to Warnings
The safe distance from the magnets has been increased from 2 inches (50 mm) to 6 inches (150 mm). 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 warning applies to patients and anyone in close physical contact with the mask magnets.

Urgent Field Safety Notice

ResMed Masks with Magnets – Potential Magnetic Interference with Certain Medical Devices

PHYSICIAN LETTER
Reference: MWM-2023-FSN-01 Date: 20 November 2023\

Dear Physician/Doctor,
ResMed is providing you with important information regarding our masks with magnets, which may interact with some implants or certain medical devices. ResMed is updating the Contraindications and Warnings in our User Guides on the safe use of ResMed masks with magnets.

General Product Description
The mask is a non-invasive interface, used for channeling 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.

Description of Change
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.

Update to Contraindications

In an update to the previously contraindicated metallic aneurysm hemostatic 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 (e.g., bed partner), 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)

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.

Update to Warnings
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, for complete contraindications and warnings.

Patient Safety Information

• The masks are safe when used in accordance with the updated Instructions for Use, including the Contraindications and Warnings (refer to Appendix A).
• Under certain circumstances when a magnet is in close proximity to certain medical implants/devices, potential magnetic interference could affect the performance or implanted position of the medical implant/device which has the potential to lead to serious injury or death.
• From 2014 to November 2023, ResMed has sold tens of millions of masks with magnets globally. In this time, ResMed has submitted five (5) reports of serious harm (medical intervention/ hospitalisation) that were potentially related to magnetic interference with an implanted device (including ICD and CSF shunt implants) to relevant Regulatory Authorities. No permanent injuries or deaths have been reported.
• Contraindicated patients can avoid the potential of harm from magnetic interference by using alternative masks without magnets. All other patients using ResMed masks with magnets can continue to use the mask following the updated Instructions for Use.

Products Affected
ResMed’s masks with magnets are shown in Appendix B – ResMed Masks with Magnets. For ease of identification, the model of the mask and the magnetic clip positioning on the mask are highlighted in the images provided. This information is also provided to patients in the Patient Letter.
All other ResMed masks without magnets are not affected.

Actions by ResMed
ResMed is updating the Contraindications and Warning sections of the Instructions for Use (IFU) in the user guides of affected masks with magnets.
In addition, further information related to this notice will be made available at www.resmed.com/magnetupdate.
ResMed is making our masks without magnets available to your patient’s mask provider for replacement.

Information for Physicians
Newly contraindicated patients using ResMed masks with magnets need to seek an alternative mask without magnets in a timely manner. They are instructed to contact their mask provider for alternative mask options. If an alternative mask is not available, patients are instructed to consult with their physician on appropriate next steps regarding their therapy. The following considerations may be relevant in consultation with your patients:

• Identify if the implant/medical device can be adversely affected by magnetic interference. Some implants and medical devices are affected by magnetic fields as indicated in the updated Contraindication and Warning. This includes active medical implants that interact with magnets and metallic implants/objects containing ferromagnetic material.
• Consider the effect of magnetic interference to the implant/medical device and the potential for harm. Under the presence of magnetic fields, the effect and potential for harm varies across implants/medical devices and patient populations.
• Consider the potential for magnetic interference of the mask magnets to occur during use. Magnetic field exposure from the mask magnets (located in the frame and headgear clips) may occur during normal use, handling or inadvertently if clips detach during use. This applies to the patient and anyone in close physical contact while using the mask. As identified in the Warnings, users are warned to keep the magnets 6 inches (150mm) from implants or medical devices that may be adversely affected by magnetic interference.
• Consider whether newly contraindicated patients may continue therapy until an alternative mask is available. Some patients may not have an alternative mask readily available. On a case-by-case basis, you may want to discuss with the patient the benefits of continuing therapy against the risk of harm posed by magnetic interference. Ensure patients understand the continued need to switch to an alternative mask in a timely manner to minimise exposure to magnetic fields and the potential for adverse effects.
  Refer to the implant/medical device Instructions for Use (IFU), or contact the implant/medical device manufacturer, for safety information relating to exposure to static magnetic fields and the potential clinical effects.

Note, patients new to therapy are subject to the updated labelling. To ensure these patients are informed during their mask selection, it is important to identify if they have an
implant/medical device that may be adversely affected by magnetic interference and advise whether the use of masks with magnets is contraindicated. For those not contraindicated, the magnetic clips remain a beneficial feature for the regular fitting and use of masks.
Further information is also available at www.resmed.com/magnetupdate. Click on the Healthcare Professionals tab for relevant FAQs.

Reporting an Adverse Event

If your patient has experienced an adverse event related to the use of ResMed masks with magnets, please visit www.resmed.com/contact or contact the national Regulatory (competent) Authority.

Manufacturer
ResMed Pty Ltd
1 Elizabeth Macarthur Drive
Bella Vista 2153

Australia
We appreciate your support and consider this action necessary to ensure appropriate actions are taken for affected patients. Sincerely,

Dawn Y. Haake Chief Quality Officer

APPENDIX A – LABELLING UPDATES

Contraindication

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)

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.

APPENDIX B – RESMED MASKS WITH MAGNETS

Note,product availability may differ in each country.

Note, product availability may differ in each country.

References

• Updated Information on Masks with Magnets for Mask Users - CPAP - Magnet Guidelines

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