Update on the safety notifications about CPAP, BiPAP and ventilator devices manufactured by Philips

date: 31/05/2022

Extensive analyses of Philips' CPAP, BiPAP and ventilator devices have not revealed toxicologically relevant levels of volatile organic compounds. Nevertheless, no risk can be excluded at this time: patients are advised to consult their physician about the further course of their treatment.

Following the news release of 20 July 2021, the FAMHP provides an update on two safety communications (NL/FR) about Philips' CPAP, BiPAP and ventilator devices. Several follow-up studies of volatile organic compounds (VOCs) and foam particles have been conducted on used Philips devices at the different stages of foam degradation and at different ages of the device. No toxicologically relevant levels of VOCs were detected during these studies. The risk for patients of being exposed to toxic levels of volatile organic compounds over an extended period of time is considered low and appears to be an issue only with individual devices. Nevertheless, given that certain analyzes (foam particles and toxic compounds) are still in progress, caution is still order and it is recommended to contact your treating physician to discuss the further course of your treatment. This is because the risk-benefit analysis is not only based on problems with the device but should also take into account the medical background of the individual patient. 

The FAMHP remains in contact with both the manufacturer and the other European competent authorities, the Belgian distributors and other stakeholders.

Philips has provided the physicians with additional clinical information (NL/FR) about potential toxicological risks. 

The FAMHP would like to emphasise the importance of registering the devices involved. All devices involved in these safety communications must be registered on the Philips website (NL/FR). The sooner they are registered, the sooner they will be included in Philips' schedule for replacement or repair.

The FAMHP asks all parties involved to continue and, where possible, intensify their efforts to support patients with device registration. Devices that are not registered will not be replaced or repaired.

Last updated on 31/05/2022