Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand) of Labeling Changes for Masks with Magnets

Following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, Philips Australia and New Zealand announced it is conducting an Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand for Amara View Minimal Contact Full-Face Mask, DreamWear Full Face Masks, DreamWisp Nasal Mask with Over the Nose Cushion, Wisp Nasal Masks and Wisp Youth Nasal Masks.

Philips Respironics (the manufacturer of the masks) at a global level has voluntarily updated the contraindication and warning labeling for masks with magnets. All individuals, who have, or are in close proximity to, a metallic implanted device, should read and follow Philips Respironics’ updated warning and added contraindications described below.

Philips has a range of mask options available, with and without magnets, designed to help support overall experience and comfort. However, if you, or someone you are in close proximity to, have an implanted metallic device, you should also talk to your clinician about what your mask options are.

What is Philips Respironics’ notification for masks with magnets?

This is a global voluntary notification to inform users of specific sleep therapy masks containing such magnetic components of the updated instructions and labeling. The already present warnings have been strengthened and contraindications have been added.

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.

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.

What is a Contraindication vs. a Warning?

A contraindication is a condition under which the device should not be used because the risk of use clearly outweighs any possible benefit. A warning alerts the patients about a situation which, if not avoided, could result in death or serious injury. Additionally, a warning may also describe potential serious adverse reactions and safety hazards. In short, a contraindication tells the user when a device should not be used, and a warning tells the user how to avoid sources of harm in the use of the device.

Contraindication

Use of the mask is 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 devices that may be affected by magnets, including but not limited to:

Pacemakers
Implantable cardioverter defibrillators (ICD)
Neurostimulators
Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e. neck and head)
CSF (cerebral spinal fluid) shunts (e.g., VP (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 (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, biliary)
Implantable ports and pumps (e.g., insulin pumps)
Hypoglossal Nerve Stimulators
Devices labeled as MR (magnetic resonance) unsafe
Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field

Warning

Magnets with a magnetic field strength of less than 400 mT are used in the mask. With the exception of the devices identified in the contraindication, ensure the mask is kept at least 6 inches (approx. 15.24 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This includes household members, caregivers, and bed partners that may be in close vicinity to patients that use the masks.

Masks with magnets include:

Amara View Full Face mask

DreamWisp Nasal Mask

DreamWear Full Face Mask

Wisp and Wisp Youth Nasal Mask

Therapy Mask 3100 NC/SP

This is a list of products affected globally. Note: Therapy Mask 3100 NC/SP is not registered and not for sale in Australia or New Zealand.

Questions and answers

Why is Philips Respironics issuing this notification?

Philips Respironics is issuing a global voluntary notification to users of certain patient masks for the application of sleep therapy, regarding how magnetic headgear clips in these units may interact with implanted metallic medical devices and/or metallic objects/debris in the body.
The notification is 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.
Philips following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, is conducting an Urgent Product Defect Correction in Australia and a Recall for Product Correction in New Zealand of Philips Amara View Minimal Contact Full-Face Mask, DreamWear Full Face Mask, DreamWisp Nasal Mask with Over the Nose Cushion, Wisp Nasal Masks, and Wisp Youth Nasal Masks (Note, this notification also applies to Therapy Mask 3100 which is not available in Australia and New Zealand).
Use of the mask is only contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity (6 inches approx. 15.24 cm) to patients using the masks, that have implanted metallic medical devices/metallic objects that may be affected by magnets.
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. Based on Philips Respironics’ analysis globally, this means that in most patient populations, approximately 95 percent of the patients should be able to continue using the mask as they have been.
In Australia, our goods and services come with guarantees that cannot be excluded under the Australian Consumer Law. Your rights under the Australian Consumer Law are in addition to any remedy the local Philips entity may provide you.
In New Zealand, for consumers under the Consumer Guarantees Act 1993 (NZ) (Act) who purchase the Goods for personal, domestic or household use: Our Goods come with guarantees that cannot be excluded under the Act.

Can I continue to use Philips Respironics’ masks?

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 (6 inches approx. 15.24 cm) 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.

Does Philips Respironics’ portfolio also include masks that do not contain magnetic components?

Yes, Philips Respironics’ portfolio also includes sleep therapy masks that do not contain magnets.

Will Philips Respironics continue to distribute masks with magnets?

Yes, following the implementation of the updated instructions and labeling, Philips Respironics will continue to distribute masks with magnets.

What will Philips Respironics do to support affected patients?

Affected patients with questions may contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 7255 2450 in New Zealand.
For the affected patient group, Philips will be remediating with clips to replace the magnets or a replacement mask.

Describe the actions that should be taken by DMEs, distributors, or prescribers of these masks in order to prevent risks for patients.

As a DME, distributor, or prescriber of these masks, you must take the following action:

Provide the Notice and copies of the included patient version of the Notice and FAQs document to all those who must be aware within your organization, and to any organizations where the affected devices have been transferred.
Provide the given copies of the included patient version of the Notice and FAQs document to all patients using the affected devices*.
*NOTE: Philips Respironics sells these products through DMEs/distributors and prescribers, and we may not have the contact information to reach all patients.
Fill out the Business Reply Form included with the letter and return it by email per the instructions in the form. This form serves as official acknowledgement that you have received this correction letter and completed the actions required for this medical device correction.
Patients should STOP using the affected mask if the implant/medical device is contraindicated against the mask magnets. Patients should consult their physician immediately to determine if another mask can be used for their therapy. In the interim, 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.
If patients, and household members, caregivers, and bed partners that may be in close vicinity to patients, do not have implanted medical devices, or metallic splinters in their eyes, then no action related to patients is needed.
Contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 7255 2450 in New Zealand to learn more about non-magnetic mask options.
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).