Australian Agency Reviewing All Ventilators, CPAP and BiPAP Devices

Australia’s Therapeutic Goods Administration (TGA) announced that it is doing a postmarket review of all continuous and noncontinuous ventilators, acute care ventilators, ambulatory ventilators including continuous positive airway pressure (CPAP) devices, and bi-level positive airway pressure (BiPAP) devices that are listed in the Australian Register of Therapeutic Goods.

The agency is asking manufacturers to provide information on the type of soundproofing material they use and whether the devices pose an unnecessary risk to the health of the user during normal use.

The review was triggered by Philips’ international recall of its ventilators, CPAP and BiPAP devices due to risks posed by the polyester-based polyurethane foam used as soundproofing material.