ResMed issues urgent field safety notice  

SAN DIEGO – ResMed issued an urgent field safety notice to patients on Nov. 20, detailing a potential issue with its masks with magnets interacting with some implants or medical devices. 

When a magnet comes close to certain medical implants/devices (less than 6 inches), the company says there is potential for magnetic interference to change: 

• the function of an implant/medical device 

• the position of implants made of ferromagnetic material 

In rare circumstances, ResMed says, this can lead to serious injury or death. 

As a result, the company has made the following updates to its contraindications and warnings: 

Contraindications 

Masks with magnets 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) 

Warnings 

• Keep the mask magnets at a safe distance of at least 6 inches away from implants or medical devices that may be adversely affected by magnetic interference. 

ResMed says the masks are safe when used in accordance with updated instructions, including the contraindications and warnings. 

Background 

From 2014 to November 2023, ResMed sold tens of millions of masks with magnets globally. In this time, the company has submitted five reports of serious harm (medical intervention /hospitalization) that were potentially related to magnetic interference with an implanted device (including implantable cardioverter defibrillators (ICD) and cerebrospinal fluid (CSF) shunts) to relevant regulatory authorities. No permanent injuries or deaths have been reported. 

Calls to action 

ResMed is instructing patients to: 

Replace affected masks 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. If an alternative mask is not available, consult your physician/doctor for appropriate next steps regarding your therapy. Dispose of the mask with magnets after you receive an alternative mask. 

The affected masks

• Full-face mask: AirFit F20, AirFit F20 for Her, AirTouch F20, AirTouch F20 for Her, AirFit F30, AirFit F30i 

• Nasal mask: AirFit N10, AirFit N10 for Her, AirFit N20, AirFit N20 for Her, AirTouch N20, AirTouch N20 for Her 

• Non-vented mask: AirFit F20 NV 

Go here to read the patient letter in full. 

Go here to read contraindications and warnings. 

• In 2022, a ResMed competitor, Philips Respironics, alerted patients that certain of its CPAP or Bi-level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects in the body.