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.

The most recent data available from Philips shows that as of 23 May 2022, 7% of the Philips continuous positive airway pressure (CPAP) machines for the home treatment of sleep apnoea registered as being in use by National Health Service patients have been replaced with new devices as part of the Philips ongoing remediation programme, with 93% of affected devices still in use. The Philips remediation programme aims to replace or repair all affected Philips CPAP machines affected by the field safety notice and registered as being in use within the next 12 months, with the proportions projected to be 50% replacement and 50% repair.

NHS England and NHS Improvement’s clinical respiratory networks will assist with the coordination of the repair and replace programme at regional level with Philips and local providers. The decision to apply filters is subject to clinical review with each patient. Data on the number of filters provided for use with affected Philips CPAP devices is not collected centrally. New Philips CPAP machines for the home treatment of sleep apnoea will be unavailable for purchase in the United Kingdom until Philips has completed the remediation programme. CPAP machines from alternative suppliers have been procured and are being supplied to NHS sleep services.

The most recent data available from Philips shows that as of 23 May 2022, 7% of the Philips continuous positive airway pressure (CPAP) machines for the home treatment of sleep apnoea registered as being in use by National Health Service patients have been replaced with new devices as part of the Philips ongoing remediation programme, with 93% of affected devices still in use. The Philips remediation programme aims to replace or repair all affected Philips CPAP machines affected by the field safety notice and registered as being in use within the next 12 months, with the proportions projected to be 50% replacement and 50% repair.

NHS England and NHS Improvement’s clinical respiratory networks will assist with the coordination of the repair and replace programme at regional level with Philips and local providers. The decision to apply filters is subject to clinical review with each patient. Data on the number of filters provided for use with affected Philips CPAP devices is not collected centrally. New Philips CPAP machines for the home treatment of sleep apnoea will be unavailable for purchase in the United Kingdom until Philips has completed the remediation programme. CPAP machines from alternative suppliers have been procured and are being supplied to NHS sleep services.

The most recent data available from Philips shows that as of 23 May 2022, 7% of the Philips continuous positive airway pressure (CPAP) machines for the home treatment of sleep apnoea registered as being in use by National Health Service patients have been replaced with new devices as part of the Philips ongoing remediation programme, with 93% of affected devices still in use. The Philips remediation programme aims to replace or repair all affected Philips CPAP machines affected by the field safety notice and registered as being in use within the next 12 months, with the proportions projected to be 50% replacement and 50% repair.

NHS England and NHS Improvement’s clinical respiratory networks will assist with the coordination of the repair and replace programme at regional level with Philips and local providers. The decision to apply filters is subject to clinical review with each patient. Data on the number of filters provided for use with affected Philips CPAP devices is not collected centrally. New Philips CPAP machines for the home treatment of sleep apnoea will be unavailable for purchase in the United Kingdom until Philips has completed the remediation programme. CPAP machines from alternative suppliers have been procured and are being supplied to NHS sleep services.

The most recent data available from Philips shows that as of 23 May 2022, 7% of the Philips continuous positive airway pressure (CPAP) machines for the home treatment of sleep apnoea registered as being in use by National Health Service patients have been replaced with new devices as part of the Philips ongoing remediation programme, with 93% of affected devices still in use. The Philips remediation programme aims to replace or repair all affected Philips CPAP machines affected by the field safety notice and registered as being in use within the next 12 months, with the proportions projected to be 50% replacement and 50% repair.

NHS England and NHS Improvement’s clinical respiratory networks will assist with the coordination of the repair and replace programme at regional level with Philips and local providers. The decision to apply filters is subject to clinical review with each patient. Data on the number of filters provided for use with affected Philips CPAP devices is not collected centrally. New Philips CPAP machines for the home treatment of sleep apnoea will be unavailable for purchase in the United Kingdom until Philips has completed the remediation programme. CPAP machines from alternative suppliers have been procured and are being supplied to NHS sleep services.