Veterans Administration email sent 09/26/22 RE: Phillips mask recall, FYI.

General Discussion on any topic relating to CPAP and/or Sleep Apnea.
User avatar
Chuck Connors
Posts: 255
Joined: Fri Apr 20, 2012 7:55 am

Veterans Administration email sent 09/26/22 RE: Phillips mask recall, FYI.

Post by Chuck Connors » Mon Sep 26, 2022 4:34 pm

Dear Veteran:

Your safety is our top priority. VA has learned of the recall on some Philips Respironics Masks with magnetic closures for use with Positive Airway Pressure devices (CPAP or Bilevel PAP). If you do not use a Philips Respironics mask with magnetic closures, it is not part of the recall, and you can ignore this email.

The magnetic closures for these masks can cause implanted medical devices to malfunction if they are within 6 inches of implanted metallic medical devices. These implanted medical devices can include pacemakers, implantable cardioverter defibrillators, neurostimulators, magnetic metallic implants/electrodes/valves (placed in upper limbs, torso, or higher), cerebral spinal fluid shunts (e.g., ventriculo peritoneal shunt), embolic coils, magnetic denture attachments, certain magnetic metallic implants and others. A list of devices that may be impacted is on the FDA website and is included below.

If you, household members, caregivers, or bed partners who may be in close vicinity to you, do not have implanted medical devices, or any of the other items listed below, then no action is needed and the mask is safe to use.

The masks included in the recall are Amara View Full Face Mask, DreamWisp Nasal Mask, DreamWear Full Face Mask, Wisp and Wisp Youth Nasal Mask, and the Therapy Mask 3100 NC/SP. VA has placed a hold on distributing these masks until updated warning labels are added or care providers confirm that the Veteran does not have one of the implanted devices noted in the recall.
If you have a mask with magnets and are concerned about interference with implanted devices, the magnets can be removed, and the Velcro strap will fit through the empty magnet space. You can contact your care provider to order plastic replacement clips or a different mask.

Implanted metallic medical devices of concern are:

• Pacemakers
• Implantable cardioverter defibrillators
• Metallic stents (such as aneurysm, coronary, tracheobronchial, and biliary)
• Neurostimulators (such as hypoglossal nerve stimulators)
• Magnetic metallic implants, electrodes, and valves placed in upper limbs, torso, neck, or head
• Cerebral spinal fluid shunts (such as ventriculoperitoneal shunt)
• Aneurysm clips
• Embolic coils
• Intracranial aneurysm intravascular flow disruption devices
• Metallic cranial plates, screws, burr hole covers, and bone substitute devices
• Ocular implants (such as glaucoma implants and retinal implants; intraocular lenses placed during cataract surgery are not impacted)
• 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
• Implantable ports and pumps (such as insulin pumps)
• Metallic gastrointestinal clips
• Certain metallic joint replacements
• Devices labeled as Magnetic Resonance (MR) Unsafe
• Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field
• Metallic splinters in the eye
• Metallic shrapnel in the body

If the magnets affect the functioning or induce movement of certain implanted metallic medical devices or metallic objects in the body, the potential risks may include:

• For cerebral spinal fluid and ventriculoperitoneal shunts: potential increased pressure on the eye or brain, which may be fatal.
• For aneurysm clips: disrupted suture lines or clip separation, which may be fatal.
• For pacemakers: heart block or irregular heartbeat, which may be fatal.
• For cardioverter defibrillators: may fail to shock, which may be fatal.
• For neurostimulators: compression of the brain, seizures, or lead migration, which may be fatal.

If you have an implant listed above and use a Philips Respironics mask with magnets:

• STOP using the affected mask if you have one of the implants/medical devices or retained metal listed above.
• Veterans who receive their care from VA should contact their VA Medical Center Sleep Clinic immediately to determine if another mask can be used for therapy. You can call your VA care team or send them a secure message through MyHealtheVet.
• In the interim, switch to a non-magnetic mask if available or remove the magnets and the Velcro strap will fit through the empty magnet space. You can also contact your care provider to order plastic replacement clips or a different mask.
• Ensure the recalled mask is kept at least 6 inches away from metallic medical implants, metallic objects in the body, and medical devices that can be impacted by the magnetic fields.
• Contact your health care provider immediately, if you experience any issues related to your medical device and report the issue through the FDA’s MedWatch Voluntary Reporting Form.
• Household members, caregivers, and bed partners with a medical implant/device must ensure the mask is kept at least 6 inches (approx. 15.24 cm) away from the medical implant(s)/device(s).

For more information on the recall, visit the Food and Drug Administration Safety Communication website or the VA Philips Respironics Recall site for frequently asked questions. A VA News article on the recall is available here. These sites will be updated as more information becomes available.

VA Sleep Medicine Team

User avatar
chunkyfrog
Posts: 34377
Joined: Mon Jul 12, 2010 5:10 pm
Location: Nebraska--I am sworn to keep the secret of this paradise.

Re: Veterans Administration email sent 09/26/22 RE: Phillips mask recall, FYI.

Post by chunkyfrog » Wed Sep 28, 2022 9:34 pm

Thank you for posting this reminder.
We need to be aware that rare earth magnets can be extremely strong,
compared to old style magnets--and far more dangerous if used carelessly.
The risks cannot be overstated.
Always be aware of what is used inside your body, and its magnetic properties.
I asked about my fusion hardware; and was assured that it is 100% MRI safe.

_________________
Mask: AirFit™ P10 For Her Nasal Pillow CPAP Mask with Headgear
Additional Comments: Airsense 10 Autoset for Her