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.
Latest information on the Field Safety Notice issued by Philips Respironics regarding specific ventilators, sleep apnoea and respiratory care devices
Information on the status of ongoing corrective actions
According to Philips, in some cases particles could become detached from the sound abatement foam and be inhaled by the user. Moreover, the polyester-based polyurethane foam could release toxic chemicals (known as VOCs – volatile organic compounds) that can then irritate the airways or cause headaches, dizziness or nausea, and may pose a cancer risk in the long term.
To investigate potentially toxic and carcinogenic effects, the manufacturer arranged for random samples from selected individual devices to be analysed. The independent assessment of the possible consequences of any inhaled chemicals by BfArM (Federal Institute for Drugs and Medical Devices in Germany) has also indicated that the health risk during long-term use is low. However, there is still a risk that patients may be exposed to particles and the substances contained in those particles.
Several million devices worldwide are affected. Supplying the necessary repair kits, whose conformity (safety and performance) has had to be confirmed by an inspection body, and the subsequent repair or replacement of the devices is currently being coordinated internationally in stages and will last at least until the end of the year. The manufacturer has published a list of the devices affected and further information:
Swissmedic is closely monitoring the implementation of corrective actions in Switzerland and keeping an eye on the latest measures and findings worldwide. The situation concerning the respiratory care devices and the corrective actions will be investigated in detail as part of an ongoing process. For example, Swissmedic has conducted an inspection of the manufacturer's Swiss branch.
As part of the corrective actions undertaken by Philips, patients have been informed about the next steps (e.g. replacement, repair) by the supplier of the respiratory care devices. Users of the devices in question are recommended not to interrupt or modify the prescribed treatment themselves, and to discuss the future course of action with their doctor.