–No, this is a voluntary notification to inform users of specific sleep therapy masks containing such magnetic clips of the updated instructions and labeling. The already present warnings have been strengthened and contraindications have been added.

–Patients should only stop using the masks with magnets if the implanted metallic medical device/metallic object is contraindicated against the mask magnets. These patients should consult their physician immediately to determine if another mask can be used for their therapy.

–The masks with magnets may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

–Yes, these masks are safe and may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

–The magnetic headgear clips are used to attach the headgear straps to the masks, which is a method that is commonly used in the sleep therapy devices industry. Such magnetic clips are also used in the wearable electronics industry.

–Patients should only stop using the masks with magnets if the implanted metallic medical device/metallic object is contraindicated against the mask magnets. These patients should consult their physician immediately to determine if another mask can be used for their therapy.

–The field strength of the magnetic clips is less than 400 mT. The application of Life DME magnetic headgear clips and straps – according to the previous, as well as the current updated instructions and labeling – complies with the guidelines from the International Commission of Non-Ionizing Radiation Protection (ICNIRP), as well as the ISO  14117:2019-09 standard, for use of magnetic elements in the proximity of implanted medical devices.

–Yes, Life DME’s portfolio also includes sleep therapy masks that do not contain magnetic headgear clips.

–Yes, following the implementation of the updated instructions and labeling, we will continue to distribute masks with magnetic clips.

–This is a voluntary notification to users of specific CPAP or Bi-Level PAP therapy masks containing magnetic clips to inform them of the updated instructions and labeling, including the strengthened warning and added contraindication.

–All users should read and follow Life DME’s voluntarily updated warning and added contraindication described in the notification.

–This represents a new and industry-leading practice.

–Affected patients with questions may contact us on our customer service at 1-800-345-6443, (Monday – Friday; 8:30 AM ET to 8:00 PM ET) for more information about non-magnetic mask options.

–Patients may also contact their Durable Medical Equipment (DME) provider, which supplied the masks affected by this notice. We will work with DME providers and intends to provide a replacement mask without magnetic clips from within its mask portfolio for those patients who are currently affected by the added contraindication.

–Use of the mask is only contraindicated for patients and their household members, caregivers, and bed partners that may be in close vicinity to patients using the masks, that have implanted metallic medical devices/metallic objects that may be affected by magnets.

–More than 17 million masks containing magnetic clips have been distributed by Life DME to date.

–As of September 2022, Life DME has received 16 reports of patients suggesting that the mask magnets may have impacted their medical devices including pacemaker interference, pacemaker failure leading to a replacement, need of shunt adjustment, resetting of automatic implantable cardioverter defibrillator, seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats, and cognitive issues. Life DME has not received any reports of patient death in connection with this matter.