(Washington) The FDA is advising the public that patients using ResMed’s CPAP Machine masks might pose a risk to others because of the magnets that the mask contains.
Those using the magnets should maintain a distance of at least 6 inches from others that have active medical implants that interact with magnets or metallic implants/objects containing ferromagnetic material.
ResMed has issued a field safety notice and an updated instructions for use found here.
Mask might interfere with:
- Active medical implants: pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps).
- Metalic/Ferromagnetic implants: 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.
