Vivisol

working together to improve lives by inspiring excellence in home healthcare

Dear Patient

Please be aware that Philips recently sent out a customer alert regarding several of their masks. We are writing to you to make you aware of the information contained in their letter and the instructions you should follow if you are impacted by this issue.

Philips have identified a very small issue impacting their masks that use magnets to keep them attached. Philips Respironics has distributed over 17 million masks containing magnetic clips. As of August 30, 2022, Philips Respironics has received 14 reports of patients suggesting that the mask magnets may have impacted their medical devices.

The issue relates to the following family of CPAP or Bi-Level PAP therapy masks with magnetic headgear clips:

The 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:

Pacemakers
Implantable cardioverter defibrillators (ICD)
Neurostimulators
Magnetic metallic implants/electrodes/ valves placed in upper limbs, torso, or higher (i.e. neck and head)
Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) 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 labelled as MR (Magnetic Resonance) unsafe
Magnetic metallic implants not labelled for MR or not evaluated for safety in a magnetic field

The mask is safe to carry on using. However, if you suspect you are in one of these groups:

You should stop using the affected mask if the implant/medical device is contraindicated against the mask magnets.

You should consult your physician or Dolby Vivisol on 0800 121 4012 immediately to determine if another mask can be used for their therapy. Dolby has a good supply of masks and you should swap out your mask to a non-magnetic mask in the event of you being in one of the impacted groups above to ensure your therapy can be continued.

Please dispose of the mask that has magnets after an alternative is obtained.

Types of Treatment

When diagnosing sleep apnoea, your doctor will consider the results of your sleep examination to determine the most appropriate treatment. The severity and frequency of the symptoms are important in determining the correct therapy. For example, if sleep apnoea occurs when you’re lying on your back then the doctor may prescribe a treatment to prevent you from rolling onto your back. The long term effects from untreated OSA can be severe, so it is important to use the treatment prescribed by your clinician. Vivisol can support you in this journey.

Lifestyle

You can also reduce your symptoms by making adjustments to your lifestyle.

Limit your alcohol consumption
Strive for a healthy weight
Stop smoking
Drink coffee, black tea and fizzy drinks in moderation and certainly not in the evening
Maintain fixed sleep times
Set up your bedroom for rest
Keep the bedroom, mattress and bedding free of dust to prevent allergic reactions

CPAP

An effective form of treatment for OSA is using CPAP – Continuous Positive Airway Pressure. This uses a machine to gently provide air into a mask, worn over your nose and mouth throughout the night while you sleep. The benefits are often felt very quickly, allowing your to return to a normal, or even improved quality of life.

BiPAP Therapy

A BiPAP (Bilevel Positive Airway Pressure), or Bilevel device, helps the transition from inhalation to exhalation by lowering pressure during exhalation to make it more comfortable for you.

APAP Therapy

Another form of PAP therapy is APAP (Automatic Positive Airway Pressure). Unlike CPAP, an APAP device varies the pressure depending on the constriction in the airways. An APAP device will automatically deliver pressure between a minimum and maximum setting. This means that the device changes the delivered pressure during sleep.

MAD

Mandibular Advancement Devices (MADs) open the airway by moving the lower jaw, or mandible, forward. This process holds the collapsible part of your airway open which prevents the narrowing or blocking of the airways.