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

The TGA is reviewing all ventilators, 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 polyester-based polyurethane (PE-PUR) foam used as soundproofing material in devices supplied by Philips Electronics Australia Ltd.

The TGA has 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. The TGA has requested evidence regarding the long-term safety to ensure these devices are safe for use throughout their expected service life; some of this information is still under review by the TGA.

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, the TGA has imposed conditions of inclusion (COI) on the ARTG entries to ensure the timely availability of this evidence to support their devices.

Below is the list of devices that contain other foam material for sound abatement purposes. The TGA will update the list with current status as the review progresses. If hazards resulting in risks to health are identified for these devices, the TGA will undertake appropriate product safety notification or recall action.

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