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. Swissmedic is constantly reviewing the manufacturer's Field Safety Corrective Actions (FSCA) and is also in contact with partner authorities and medical professional associations. Affected users should not stop their treatment on their own initiative.
Philips Respironics: Worldwide safety notice for specific ventilators, sleep apnoea and respiratory care devices
Philips Respironics announces a repair and replacement programme for sound abatement foam components used in certain respiratory devices
28.06.2021
According to analyses undertaken by the manufacturer, particles can break away from the PE-PUR foam used for sound abatement in the affected devices. Apparently the foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone, and environmental conditions (high heat and humidity). These detached particles can cause acute irritation (skin, eyes, respiratory tract) and inflammatory or asthmatic reactions. Substances that are potentially harmful during long-term exposure can also be off-gassed, particularly during initial operation of the devices. Swissmedic has not received any incident reports from Switzerland to date. Further toxicology tests are being conducted by the manufacturer.
The affected respiratory devices are used very widely in Switzerland, including for sleep apnoea or by patients with impaired lung function. Swissmedic has asked Philips to submit the documentation required for the risk assessment, including toxicology reports and a detailed plan on the planned repair and replacement programme as well as any required immediate actions.
In Switzerland (as in the EU), medical devices are placed on the market without official authorisation. The manufacturers themselves bear overall responsibility for checking the conformity of their products. The authorities focus on market surveillance and the implementation of corrective actions for defective and/or non-conforming products.
Important information for users
You can find an overview of the affected devices and recommended actions on the website of the manufacturer Philips Respironics:
Philips Respironics Medical Device Field Safety Notice
(www.philips.ch)