Australian Regulators Sue Philips Over Illegal Medical Device Distribution

Australia's health regulatory authority, the Therapeutic Goods Administration (TGA), has initiated legal action against Philips in the Federal Court, accusing the company of illegally distributing medical devices that failed to comply with national safety standards. The case concerns devices used for sleep apnea management and respiratory support, which were recalled in 2021 due to safety concerns related to foam materials. Specifically, devices containing polyester-based polyurethane foam posed risks of degradation, leading to inhalation or ingestion of harmful particulates. Additionally, the Trilogy 100 devices were supplied with silicone foam as a substitute, which could detach and obstruct airflow, potentially causing ventilation failure and serious health complications such as hypoxia or asphyxia. The TGA claims that devices supplied between June 2019 and October 2022, numbering over 44,000 units, were unsafe, failed to meet performance criteria, and were unlawfully distributed.