Our medical devices regime is not fit for purpose

Our medical devices regime is not fit for purpose argues that Australia’s medical device oversight is failing in both transparency and data quality. The article notes that about 1.4 million medical devices are registered with the Therapeutic Goods Administration (TGA), while Australia’s health authorities report more than 150,000 incidents each year that require hospital treatment. It says the TGA will not disclose how many injury or death reports it receives annually, and investigators used digital tools to analyze more than 80,000 logs covering side effects, recalls, and hazard alerts. Since 2020, deaths involving devices total 679 and injuries 30,377, with the number rising. The investigation also claims the TGA database missed many deaths before October 2019 and that more than 55,000 devices were approved in the last decade versus 830 rejected, with about 85% relying on European certification that can be tied to for-profit notified bodies in Germany.