Our medical devices regime is not fit for purpose
Our medical devices regime is not fit for purpose
July 21, 2026 — 5:50pm
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About 1.4 million medical devices are registered with the Therapeutic Goods Administration. These devices are critical in maintaining a person’s health, and indeed can be instrumental in saving a life. At the same time, each year more than 150,000 incidents with devices require hospital treatment, according to the Australian Institute of Health and Welfare.
That offers only a partial insight into the scale of any issues, and getting a better picture is infuriatingly difficult. The TGA, which is the medical devices watchdog, will not say how many reports it receives of injuries or deaths linked to devices each year.
It took the Medical Malfunctions investigative series from this masthead and 60 Minutes to dig out data using digital scrapers and unearth more than 80,000 logs of medical device side effects, recalls and hazard alerts.
The series has also interviewed more than 70 patients, doctors, researchers, TGA staff and industry consultants, and has looked at court cases and coronial........
