Customers Warned of Injury Risk Associated With Sleep Therapy Masks With Magnetic Clips
PITTSBURGH, Pa. — Consumers are being warned that the use of certain continuous or bi-level positive airway pressure — also known as CPAP and BiPap — therapy masks with magnetic headgear clips or straps should not be used by or near patients, household members, caregivers and bed partners who have metallic implanted devices or metallic objects in the body.
These masks 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.
Royal Philips, a subsidiary of Philips Respironics, issued the warning to alert consumers of updated instructions and labeling for the products.
“All users should read and follow Philips Respironics’ voluntarily updated warning and added contraindication described below,” the Food and Drug Administration said in an announcement, adding the warning, “represents a new and industry-leading practice.”
The magnetic headgear clips are used to attach the headgear straps to the mask, which is a method that is commonly used in the sleep therapy devices industry.
According to the announcement the use of the mask is not advised for patients and their household members, caregivers and bed partners that may be in their close vicinity that have implanted devices that may be affected by magnets.
These devices include, but are not limited to:
- Implantable cardioverter defibrillators.
- Magnetic metallic implants/electrodes/valves placed in upper limbs, torso or higher (i.e., neck and head).
- Cerebral spinal fluid shunts (e.g., ventriculoperitoneal shunt)
- Aneurysm clips.
- Embolic coils.
- Intracranial aneurysm intravascular flow disruption devices.
- Metallic cranial plates, screws, burr hole covers and bone substitute devices.
- Metallic splinters in the eye.
- Ocular implants (e.g., glaucoma implants, retinal implants).
- Certain contact lenses with metal.
- Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices and auditory brainstem implants).
- Magnetic denture attachments.
- Metallic gastrointestinal clips.
- Metallic stents (e.g., aneurysm, coronary, tracheobronchial and biliary).
- Implantable ports and pumps (e.g., insulin pumps).
- Hypoglossal nerve stimulators.
- Devices labeled as magnetic resonance unsafe.
- Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field.
Patients are further advised that they should consult their physician immediately to determine if another mask can be used for their therapy.
In the interim, the FDA advises that patients switch to a non-magnetic mask, if available, for continued therapy. Patients should properly dispose of the mask that has magnets after an alternative is obtained, it said.
According to the FDA, more than 17 million masks containing magnetic clips have been distributed by Philips Respironics to date.
As of Aug. 30, 2022, the company had received 14 reports of patients suggesting that the mask magnets may have impacted their medical devices including pacemaker interference, pacemaker failure leading to replacement, need of shunt adjustment, resetting of automatic implantable cardioverter defibrillators, seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats and cognitive issues.
Patients with questions may contact Philips Respironics’ customer service at 1-800-345-6443, Monday to Friday, 8:30 a.m. to 8:00 p.m. Eastern time, for more information about non-magnetic mask options.
Any adverse events experienced with the use of masks containing magnetic clips should be reported to the FDA’s MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fisher’s Lane, Rockville, MD 20852-9787, or on the web at www.fda.gov/medwatch.
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