Australia’s regulatory authority sues Philips over CPAP devices
By HME News Staff
Updated 10:11 AM CDT, Thu June 5, 2025
CANBERRA, Australia – The Therapeutic Goods Administration (TGA), Australia's regulatory authority for therapeutic goods, has commenced proceedings in the Federal Court of Australia against Philips Electronics Australia Limited (PEAL) for the alleged unlawful supply of medical devices that did not meet Australian safety and performance requirements. These included devices used by people at home who suffer from sleep apnea and devices used by patients who need help breathing. The devices, which were recalled in 2021, contained a polyester-based polyurethane (PE-PUR) foam used for noise suppression that had a real risk of degrading, allowing particulates to be inhaled or ingested by the patient, TGA says. Potential harm from short and intermediate exposure included skin, eye and respiratory tract irritation, inflammatory response, headache, asthma, effects on the user’s reproductive system and neoplasia, it says. Potential harm from long-term exposure included cytotoxic, genotoxic and carcinogenic effects, it says. TGA alleges that, due to the risk of the PE-PUR foam degrading, the devices supplied from June 2, 2019, to Oct. 13, 2022, were unsafe, did not perform as intended and were therefore unlawfully supplied. TGA alleges that there were more than 44,000 separate instances of unlawful supply of devices in that period.
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