In June 2021, Philips Respironics, released a field safety notice for sleep and respiratory care products due to potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in certain CPAP, BiPAP and mechanical ventilator devices.
See Philips link below.
Key points:
- Philips provide advice on the key methods used in the testing of their devices
- Prevalence of visible foam degradation (EU and JPN): None of the assessed devices from Europe or Japan showed significant visible degradation.
- Volatile Organic Compounds (VOCs): VOC emissions are below established limits based on ISO 18562-3
- New devices and used devices (including used devices with visible foam degradation) were tested and were all found to be compliant with ISO 18562-2 allowable limits for PM emissions.
- Philips have provided a list of devices already fully tested and those at various stages of testing which can be found via the link (web site)
- Philips are continuing with the device recall, repair and replacement program at this time.
Both the British Thoracic Society and the European Respiratory society provided guidance on the original FSN and have updated statements as more information has become available, see links.