On 22 June 2021, the medical device manufacturer Philips Respironics published a worldwide Field Safety Notice about CPAP (Continuous Positive Airway Pressure) and BiPAP (Biphasic Positive Airway Pressure) devices and mechanical ventilators. The affected devices may pose health risks due to quality problems with the sound abatement foam. The professional associations concerned have published their initial recommendations for healthcare professionals based on the information provided by the manufacturer to date, and in consultation with Swissmedic.
Update to Field Safety Notice from Philips Respironics regarding specific ventilators, sleep apnoea and respiratory care devices – recommendations from professional associations
Recommendations of the professional societies SGP and SSSSC published
16.07.2021
According to Philips, in some cases particles could become detached from the sound abatement foam and be inhaled by the user. In addition to this, the polyester-based polyurethane foam could release toxic chemicals that can the irritate the airways or cause headaches, dizziness or nausea, and may be carcinogenic in the long term. Swissmedic has previously received one notification of a patient with respiratory problems in Switzerland.
The devices are in use around the world, and Swissmedic is also working closely with partner authorities in other countries in the monitoring and implementation of the corrective measures to be carried out by the manufacturer. The manufacturer responsible for the field safety corrective actions has been asked to provide further toxicology tests on the risk potential as well as specific information on the repair and replacement programme, in addition to the information already available.
The manufacturer has published a list of the devices affected:
(www.philips.ch)
Including registration for repair and replacement programme, clinical information for doctors and suppliers, and questions and answers
Including registration for repair and replacement programme, clinical information for doctors and suppliers, and questions and answers
The Swiss Society of Pneumology (SGP), in collaboration with the Swiss Society for Sleep Research, Sleep Medicine and Chronobiology (SSSSC) and in agreement with Swissmedic, has published recommendations for medical professionals providing treatment:
SGP recommendations of 12 July 2021 on the FSCA from Philips Respironics
(www.pneumo.ch)
Recommendations of the Swiss Society of Pulmonology (SSP) dated 12 July 2021 on the field safety notification by Philips Respironics on CPAP/BiPAP devices and ventilators
Recommendations of the Swiss Society of Pulmonology (SSP) dated 12 July 2021 on the field safety notification by Philips Respironics on CPAP/BiPAP devices and ventilators
Users of the devices in question are recommended not to interrupt or modify the prescribed treatment themselves, and to discuss the next steps with their doctor.