Product Information
We have provided below the latest information on field notices and product recalls for healthcare professionals and your patients.
LATEST NEWS:
PHILIPS SAFETY NOTICE
(Silicone Sound Abatement Foam and Product Withdrawal)
Following the publication of articles in the Daily Mail week commencing 29/01/24 (see below), many sleep centres are experiencing high volumes of calls from concerned patients. We have produced a joint statement from the OSA Alliance and its member organisations (BSS, BTS, ARTP, AHS, SATA and the OSA Partnership Group) to clarify the position on the ongoing withdrawal of affected Philips’ devices which has been ongoing since 2021. The statement includes suggested advice to patients.
Joint Statement from OSA Alliance – Philips Respironics
(in association with BTS/BSS/ARTP/SATA/AHS/OSA Partnership Group)
This is a statement in response to the Daily Mail article from 1st February 2024 reporting on the problem with Philips Respironics CPAP Machines in the USA .
This is a problem which has been ongoing since 2021, leading to a recall and a halt in sales, in the USA only currently. While in the UK, there has been a replace and repair programme of Philips’ ventilators and CPAP machines.
Sleep and ventilation services have been working with Philips Respironics since 2021 to exchange devices and mitigate any risk. In rare cases there has been a problem with the noise-reducing foam in these machines that can degrade.
Other types of CPAP and newer Philips Respironics machines do not use this foam and there is no health concern regarding other types of machines.
ADVICE TO PATIENTS
- Continue using your machine.
- For further information please go to the Sleep Apnoea Trust website
- Philip’s Respironics CPAP devices have been recalled and sales halted in the USA, and a replace and repair programme of Philips Respironics ventilators and CPAP machines has been introduced in the UK as a precautionary measure whilst further scientific investigation is undertaken.
- Patients on CPAP can get cancer, as can the general population, but this does not mean the Philips Respironics CPAP devices which used the foam are the cause.
- The risk of not using your CPAP device, is, for most patients, higher than the risk of continuing to use the therapy.
- While we understand that people will have concerns, we ask that you don’t call your sleep centre but wait until your next scheduled appointment. If your concern is urgent, please email your sleep service wherever possible. However, there is no need to do anything urgent.
- This problem only affects Philips Respironics devices, other manufacturer’s CPAP devices, such as ResMed and Sefam, are not affected.
Please refer to the OSA Alliance website which includes statements from other manufacturers OSA Alliance Product Information
ADDITIONAL INFORMATION
We have also included links to information from Philips on this situation and clarification from other providers that their devices are not affected (again see below).
Recent Daily Mail coverage
https://www.dailymail.co.uk/health/article-13023713/Phillips-halt-sales-sleep-apnea-machines-cancer.html
https://www.dailymail.co.uk/health/article-13033859/recalled-Philips-CPAP-machines-600-deaths-cancers.html
https://www.dailymail.co.uk/wires/reuters/article-13029915/US-FDA-says-561-deaths-related-Philips-machines-2021.html
Philips
Progress Update January 24
https://www.philips.com/c-dam/
Recall explained:
https://www.philips.com/a-w/
Silicone Sound Abatement Foam
https://www.philips.com/a-w/
Medical Device Field Safety Notice (outside of the US)
https://www.philips.co.uk/
INFORMATION FROM OTHER PROVIDERS
ResMed
Information regarding Philips Recall (still current)
https://www.resmed.com/en-us/
Sefam information Philips Recall
Click here to view (PDF file)
The OSA Alliance is an umbrella organisation to facilitate collaboration between experts across UK patient and professional sleep organisations. Its remit focuses specifically on obstructive sleep apnoea, where a united approach can facilitate excellence in OSA-related care, education and resource. This website has been developed using the experience, expertise and views of the OSA Alliance. It is supported by funding from ResMed who have not been involved in any aspect of the site development.
Contact Us:
To find out more about the OSA Alliance,
please contact:
Gillian Gibbons
gillian@wychwoodcommunications.com
m: 07795 342804