The Therapeutic Goods Administration (TGA) 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 apnoea, and devices used by patients who need help breathing.
The devices contained a polyester-based polyurethane (PE-PUR) foam used for noise suppression. There was a real risk of the PE-PUR foam degrading and then particulates being inhaled or ingested by the patient. As a result, these devices were recalled in 2021 (see: TGA recall of Philips assisted breathing devices).
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. Potential harm from long term exposure included cytotoxic, genotoxic and carcinogenic effects.
In addition, for a particular model (Trilogy 100), PEAL supplied devices with a silicone foam as a replacement for devices containing the PE-PUR foam. There was a real risk of the silicone foam dislodging from its position and blocking the air pathway. This could stop the device from working, resulting in ventilation failure or underventilation. This could then result in hypoventilation, hypoxemia, hypercapnia and asphyxia.
The TGA alleges that, due to the risk of the PE-PUR foam degrading and silicone foam dislodging, the devices supplied from 2 June 2019 to 13 October 2022 (depending on the device) were unsafe, did not perform as intended, and were therefore unlawfully supplied.
The TGA alleges that there were over 44,000 separate instances of unlawful supply of devices in that period.
TGA takes action against breaches of Act
The regulatory scheme is critical to the health and safety of Australian consumers. The TGA investigates suspected unlawful activity in relation to therapeutic goods.
The TGA reminds sponsors that sanctions and penalties can apply if they unlawfully supply therapeutic goods. The range of compliance and enforcement tools include substantial fines and criminal or civil court action.
