Sleep Apnoea: Medical Equipment

Department of Health and Social Care written question – answered at on 9 February 2024.

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Photo of Fleur Anderson Fleur Anderson Shadow Minister (Northern Ireland)

To ask the Secretary of State for Health and Social Care, what assessment she has made of the safety of Philips CPAP machines in the NHS.

Photo of Andrew Stephenson Andrew Stephenson Assistant Whip, Minister of State (Department of Health and Social Care)

The Medicines and Heathcare products Regulatory Agency (MHRA) issued a National Patient Safety Alert to hospital trusts in response to two Field Safety Notices issued by Philips Respironics, regarding the risk of patient harm from Philips Continuous Positive Airway Pressure (CPAP) machines in June 2021.

This was due to degradation of the sound abatement foam in the CPAP Dreamstation devices. This led to a subsequent repair and replacement programme for all affected devices and their accessories. The progress of this programme is being monitored by the MHRA.

The MHRA conducted a risk benefit analysis to determine whether these CPAP devices should continue to be used while awaiting repair or replacement. The conclusion of this analysis was that, except for patients with specific risk factors, the known risks of the sudden discontinuation of treatment were higher than the potential risks posed by the degradation issue. The Patient Safety Alert advises that patients should continue using the affected machines unless advised otherwise by their patient care provider.

We would encourage patients to report any evidence of foam degradation, for example black marks or residue in their devices, directly via MHRA’s yellow card scheme.

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