Our medical devices regime is not fit for purpose

July 22, 2026 — 3:00am

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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, more than 150,000 incidents with devices require hospital treatment each year, 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, 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. What that showed is that the number of deaths, injuries and adverse-event reports is rising.........

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