List of ventilators, CPAP, and BiPAP devices unaffected by foam material

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 clarify what devices incorporate sound abatement features. 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.

As we progress with the review, devices not affected by issues from any sound abatement foam will be listed in the table below. This includes devices that do not contain sound abatement foam material, or the location of the foam is separate from the breathing gas pathway and so may not present a risk to the user.

NOTE: The TGA will add devices to this list over the course of the post-market review, as the review of each device is completed. Please do not be alarmed or stop treatment if your device is not listed here to date. If new hazards resulting in risks to health are identified during our review, the TGA will undertake appropriate product safety notification or recall action.