Equipment & Device Issue Support

CPAP/NIV Masks with Magnetic Clips
CPAP Shortage

Safety notice for the use of CPAP/ NIV masks with magnetic clips: information for patients and their household members from the OSA Alliance

If you or a household member has a pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronisation therapy device (CRT) or metalwork in your upper body, you are advised not to use certain Philips masks with magnetic clips if at all possible, or at least keep them 15.2 cm (6 inches) away from the medical device/ implant. 

If this affects you, please contact your sleep and ventilation unit for advice. They will assess your risk, and if needed will provide you with an alternative mask as soon as one is available. If you are at risk of harm to your health or wellbeing without your CPAP/ NIV, you should keep using it in the normal way until the new mask is available. Not everyone is able to use ordinary clips, and your sleep unit will discuss the risks of using magnetic clips versus going without CPAP/ NIV with you.

Background
Many people have magnetic clips on their mask, because they are quick and easy to do up and release, particularly for those who have arthritis or reduced mobility or strength in their hands. However a strong magnet could temporarily interfere with certain medical devices if the magnet is held close to them, or it could cause metal work that is not securely anchored in place to move.

It is thought that the magnetic field around magnetic clips from other brands is not so strong, and therefore the same warning has not been put in place for all masks with magnetic clips. For example, ResMed advice their masks are not put within 5 cm (2 inches) of a pacemaker, ICD, CRT or metalwork.

Why are we issuing this warning?
Philips Respironics have advised their masks with magnetic clips are not used by people with these medical devices. See https://www.supplychain.nhs.uk/icn/field-safety-notice-philips-respironics-sleep-and-respiratory-care/. The strength of the magnetic field is around 400 mT. It is possible that this will be relevant to masks with magnetic clips from other manufacturers.

What is the risk?
It is very low, and is only a problem if the clips are held very close to the device/ implant. There have been only 14 reports of problems for people using magnetic clips in their masks out of 17 million masks issued. It is not known whether the faults were due to the magnetic clips or coincidence.

CPAP Shortage

CPAP shortages continue, with no indication of a return to normal before the end of the year.

We undertook two surveys in January and June, and the most recent results can be found in the abstract below. This abstract has been accepted by BTS and will be presented in November 2022.

OSA Alliance CPAP Supply BTS Abstract

There have been challenges to CPAP machine supply worldwide in 2022. These have included the withdrawal of Phillips machines following Field Safety Notice plus worldwide component shortage, pandemic-related freight and shipping issues.

Methods
To understand the issues around CPAP delivery, the OSA Alliance sent two email surveys to all UK Sleep Centres listed on the Sleep Apnoea Trust Association database in February and June 2022.

Results
Replies came from 22 (February) and 14 (June) UK centres, including all four nations.

91% (February) and 64% (June) of respondents confirmed ongoing CPAP machine supply shortages. In February, centres were receiving on average around 50% usual delivery versus 79% in June. In June centres described CPAP supply during the past 6 months as improved in 50%, worse in 43%, same in 7%.

In February, CPAP delays were described by centres supplied by Phillips or ResMed. In June, some sites had switched suppliers or were getting additional CPAP from other companies.  Humidifier shortage was also mentioned by some.

Patients on the waiting list for CPAP varied between UK centres from 0-400 (February) and 0-260 (June). All centres with CPAP shortages were using the prioritisation criteria set out by the BTS in both surveys.

In February, patients with the highest priority requiring urgent CPAP could start this quickly in all centres, but the average wait time to start routine CPAP was 13 weeks (range 2 to 40 weeks). In June the average wait for routine CPAP was 14.3 weeks (range 2-81weeks). In both surveys, the majority of centres said these delays were due to CPAP supply, not staff shortages.

Conclusions
CPAP supply issues have led to delays in treatment for patients with OSA in 2022. There is postcode variation in these delays. Sleep centres have sought alternative CPAP suppliers: this has been time-consuming, and teams are using less familiar CPAP models in their service, which are unlikely to have remote telemonitoring capacity. The shortage of humidifiers is another difficulty which could affect CPAP adherence. This CPAP supply issue is the latest challenge in a frequently under-resourced speciality.

ARTP Sleep Apnoea Consortium (SAC) Update

CPAP Testing Programme

• AT the ARTP SAC Meeting, it was unanimously agreed that ARTP SAC funds will be used to test new CPAP devices from the Far East that have been sold by UK suppliers to see if they achieve the ARTP SAC Testing Standards.
• Furthermore, the ARTP SAC unanimously agreed to the proposed testing standards for auto-titrating CPAP machines, so these will be used to test any submitted devices from manufacturers and if successful will appear on the ARTP SAC website as approved devices for UK departments.

Devices which have been tested and approved can be found here:

https://www.artp.org.uk/sleep-standards-of-care/cpap-device-certification

Privately Funded CPAP Machines

For those patients who have funded their CPAP machines privately, please click here to view a sample letter offering guidance.