List of ventilator, CPAP, and BiPAP devices containing other types of foam material (not PE-PUR foam) in the breathing gas pathway

We are reviewing all ventilator, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) devices in the Australian Register of Therapeutic Goods (ARTG) to determine whether the devices incorporate harmful sound abatement foam. 

This action follows the identification of risks posed by a polyester-based polyurethane (PE-PUR) foam used as soundproofing material in devices supplied by Philips Electronics Australia Ltd.

During the review we have identified devices included in the ARTG that contain a different foam material (not PE-PUR foam) for sound abatement purpose in the breathing gas pathway. 

We have requested evidence regarding the long-term safety to ensure these devices are safe for use throughout their expected service life.

For sponsors who have not provided additional evidence to demonstrate the long-term safety of their devices for the intended service life of the devices, we have imposed conditions of inclusion (COI) on the ARTG entries to ensure the timely availability of this evidence to support their devices. 

The review of majority of devices has been completed.

Below is the list of devices that contain other foam material for sound abatement purposes. 

We will update the list with current status as the review progresses and is finalised. If hazards resulting in risks to health are identified for these devices, we will undertake appropriate product safety notification or recall action. 

Published: Information about Philips' recall action of correcting their affected devices.