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ResMed (NYSE:RMD) has issued an urgent safety notice for masks used with continuous positive airway pressure, or CPAP, machines over concerns that magnets contained in the masks may interfere with devices such as pacemakers, insulin pumps and metallic implants.
ResMed issued an urgent field safety notice earlier this week for several models of its AirFit masks, which use magnets to help users attach and detach headgear to the mask frame. It noted that the magnets are particularly helpful for those with dexterity or vision issues.
The medical device maker advised that mask magnets be kept at least six inches away from any medical devices or implants that may be negatively impacted by magnetic interference, adding that the magnets could detach during sleep. The company urged patients and caregivers to consult their physician or device manufacturer for information about how their device or implant could be impacted by the magnetic fields.
Implanted devices that may be impacted by the magnets include pacemakers, implantable cardioverter defibrillators, neurostimulators, cerebrospinal fluid shunts, insulin/infusion pumps, stents, aneurysm clips, and ocular implants.
ResMed added that the affected patients can substitute the masks for those without magnets.
The company said it has sold “tens of millions” of masks with magnets since 2014. As of November 2023, it has submitted to regulators five reports of harm that required hospitalization or medical intervention potentially related to magnetic interference. No deaths or permanent injuries have been reported, ResMed added.