National Patient Safety Alert: Philips ventilator, CPAP and BiPAP devices

UPDATED with Risk Stratification Guidance 

Guidance on Clinical Risk Stratification is now available to support clinicians in their decision-making and when offering clinical advice to those patients who may be affected by this issue.

The guidance is available here.

Two Field Safety Notices were issued by Philips on 14 June 2021 about selected ventilator,  CPAP and BiPAP devices.  These devices are primarily used in patients with Obstructive Sleep Apnoea (OSA) and type 2 respiratory failure.

There is a risk of patient harm from degradation of the sound abatement foam found in these devices.  The foam is polyester-based polyurethane and on degradation can produce particles and volatile gas products which the user may inhale. This may result in potential health risks for the user. Reports of incidents related to this issue are rare, and no incidents of harm have been reported in the UK.

The MHRA has issued a National Patient Safety Alert.

Further information on the potential risks of degraded foam exposure are listed on the manufacturer’s website.

NHS England issued a letter to Trusts for cascade to Trust teams including a template letter for patients which can be found here.