Philips' face and nasal masks with magnetic clips

Philips Electronics Australia Ltd (Philips) is updating the safety information and warnings for their face and nasal masks that have magnetic clips.

If the magnets come too close to certain implanted devices, the implants don’t work as they should.

These masks are part of the kit used with Philips’s sleep apnoea machines.

Device description

The affected masks are:

• Amara View Minimal Contact Full-Face Mask
• DreamWear Full Face Mask
• DreamWisp Nasal Mask with Over the Nose Cushion
• Wisp Nasal Masks
• Wisp Youth Nasal Masks
• Therapy Mask 3100 NC/SP.

Images of the masks are shown below, with the magnetic components circled.

What do I need to do?

• Check if you use one of these masks.
• If you use one of these masks, review the list of devices below.
  • If you have any of the listed implantable medical devices, you should stop using your mask and speak to your doctor about using a different mask.
  • If you have one available, use a mask without magnetic clips.
  • Check if anyone in your household (including caregivers) have any of the implanted devices in the list. If they do, you must make sure the mask doesn’t come close to them (keep the mask at least 16cm away from their implant).

Magnets interfere with the following implantable devices

If you, your household members or caregivers have the following implanted medical devices, and you have a mask with magnets in the clips, you need to know there are associated health risks.

• Pacemakers
• Implantable cardioverter defibrillators (ICDs)
• Neurostimulators
• Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, neck or head
• Cerebral Spinal Fluid shunts eg. Ventriculo Peritoneal 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 eg. glaucoma and retinal implants
• Certain contact lenses with metal
• Implants to restore hearing or balance that have an implanted magnet eg. Cochlear implants, implanted bone conduction hearing devices and auditory brainstem implants
• Magnetic denture attachments
• Metallic gastrointestinal clips
• Metallic stents eg. aneurysm, coronary, tracheobronchial, biliary
• Implantable ports and pumps eg. insulin pumps
• Hypoglossal Nerve Stimulators
• Devices labelled as ‘magnetic resonance’ (MR) unsafe
• Magnetic metallic implants not labelled for MR or not evaluated for safety in a magnetic field.

What do prescribers need to do?

• Patients with affected masks will be contacted by Philips or their mask supplier. Advise your patients on alternatives so they do not use masks with magnets if they have an implant or metallic medical device listed above. This is due to the risk of the magnets in the mask affecting the function, or cause movement, of the implant or metallic device.
• Discuss with your patient whether any household members or caregivers have implants or metallic medical devices. When close to the patient, others may also be at risk from the magnets.
• Do not prescribe the affected masks to patients who have any of the devices listed above. Similarly, do not prescribe affected masks to patients with household members or caregivers who have any of the devices listed above.

What are the risks?

The risk is that the magnetic field may cause active implantable devices to malfunction or result in movement of other implantable devices. There have been reported cases of serious injury including:

• Pacemaker interference
• Pacemaker failure leading to replacement
• Need for shunt adjustment
• Need to reset automatic ICDs
• Seizures
• Periodic defibrillator shutdowns
• Arrhythmia
• Irregular blood pressure
• Change in heartbeats and cognitive issues.

What Philips is doing?

Philips is revising their instructions (IFUs) to include additional contraindications and warnings against use with the wide range of medical devices listed above.

Non-magnetic clips or replacement masks will be made available.

Further information

Contact the Philips Sleep & Respiratory Care support hotline on 1800 830 517 if you have one of these masks to organise a suitable replacement or if you require further information.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.