TGA
The Therapeutic Goods Administration (TGA) has begun a post-market review of all devices in the Australian Register of Therapeutic Goods (ARTG) of the following kinds:
- continuous and non-continuous ventilators;
- acute care ventilators;
- ambulatory ventilators including continuous positive airway pressure (CPAP) devices; and
- bi-level positive airway pressure (BiPAP) devices.
This post-market review follows the identification of risks posed by a polyester-based polyurethane (PE-PUR) foam used as soundproofing material in ventilator, CPAP and BiPAP devices supplied by Philips Electronics Australia Ltd. The review has two purposes:
- to ensure devices included in the ARTG continue to meet the essential principles set out in the Therapeutic Goods (Medical Devices) Regulations 2002; and to confirm these devices remain safe for use, by checking if they are made using PE-PUR foam or any other potentially harmful soundproofing material.
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