ResMed is conducting a voluntary international discipline motion to replace its guides for all CPAP masks with magnets to tell customers about potential magnetic interference when magnets are close to sure implants and medical units within the physique.
This voluntary discipline correction doesn’t require a return of a masks with magnets until the affected person is contraindicated. All ResMed masks containing magnets are protected when utilized in accordance with the sector security discover and up to date directions to be used within the guides of affected masks.
A affected person is contraindicated the place they, or anybody in shut bodily contact whereas utilizing the masks, have the next:
- Energetic medical implants that work together with magnets (ie, pacemakers, implantable cardioverter defibrillators, neurostimulators, cerebrospinal fluid shunts, insulin/infusion pumps).
- Metallic implants/objects containing ferromagnetic materials (ie, aneurysm clips/movement disruption units, embolic coils, stents, valves, electrodes, implants to revive listening to or stability with implanted magnets, ocular implants, metallic splinters within the eye).
Sufferers utilizing the masks with magnets or anybody in shut bodily contact with masks magnets ought to preserve the magnets at a protected distance of six inches away from implants or medical units which may be adversely impacted by magnetic interference. Discuss with the ResMed magnet replace web site for extra details about the updates issued to contraindications and warning labels.
ResMed is notifying affected prospects and offering steerage for particular actions. ResMed has supplied a affected person letter to healthcare suppliers that features extra data concerning the contraindications and warnings for sufferers with the affected medical implants or units. Sufferers ought to seek the advice of their doctor and/or producer of their implant or different medical gadget in the event that they require extra data on the potential hostile results of magnetic fields for his or her gadget.
For sufferers the place they, or anybody in shut bodily contact, would not have a contraindicated gadget, no motion is required.
ResMed masks with magnets have been distributed nationwide and globally from 2014 to November 2023. ResMed has submitted 5 experiences of great hurt (medical intervention/hospitalization) that have been probably associated to magnetic interference of a masks with a magnet with an implanted gadget to related regulatory authorities. Up to now, no everlasting accidents or deaths have been reported.
The impacted Masks with Magnet product(s) may be recognized by the mannequin quantity: AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30, AirFit F30i on the cushion or body of the masks.
ResMed voluntarily up to date its contraindications and warning labels in response to new data obtained by means of post-market surveillance and trade practices. ResMed has notified the FDA and different international regulators the place required.
Customers with questions could contact ResMed at 1-800-424-0737, on-line at www.resmed.com/contact, or ResMed magnet replace web site for extra data. Adversarial occasions skilled with using this product could also be reported to the FDA’s MedWatch Adversarial Occasion Reporting program both on-line or by common mail or by fax. Name 1-800-332-1088 to request a type.