July 21, 2026 – 7:50 p.m. Save You have reached your maximum number of saved items. Remove items from your saved list to add more. TOTOTO About 1.4 million medical devices are registered with the Therapeutic Goods Administration. These devices are critical to maintaining a person’s health and, in fact, can be instrumental in saving
About 1.4 million medical devices are registered with the Therapeutic Goods Administration. These devices are critical to maintaining a person’s health and, in fact, can be instrumental in saving a life. At the same time, more than 150,000 device incidents require hospital treatment each year, according to the Australian Institute of Health and Welfare.
That offers only a partial view of the magnitude of any problem, and getting a better picture is maddeningly difficult. The TGA, which is the medical devices watchdog, will not say how many reports it receives each year about device-related injuries or deaths.
Took the Medical Malfunction research series from this header and 60 minutes to extract data using digital scrapers and discover more than 80,000 records of medical device side effects, recalls and hazard alerts.
The series also interviewed more than 70 patients, doctors, researchers, TGA staff and industry consultants, and looked at court cases and coronial inquests.
What that showed is that the number of deaths, injuries and reports of adverse events is increasing. Since 2020, the number of deaths related to medical devices amounts to 679, while the injuries total 30,377.
The difficulty it took to discover which devices were involved in most of the incidents (information gleaned from an apparently public database) shows that the TGA’s diabolically designed website is completely unfit for purpose.
Not even the TGA has adequate control of its own data. The investigation found that many deaths before October 2019 were not recorded. After this newspaper questioned the TGA, it published warnings about a “technical problem” with the database.
The investigation has also revealed other systemic deficiencies. In the last decade, more than 55,000 devices have been approved for use in Australia and 830 have been rejected.
About 85 percent of those devices are approved through their European certification, some of which is granted by notified for-profit companies in Germany, which receive fees from the device manufacturers they certify.
This does not mean that certification is wrong, but reliance on such a limited and commercially motivated process casts doubt on the independence of the process.
As Associate Professor Marco Rizzi, an expert in therapeutic products at the University of Western Australia, says: “If you have the CE mark [European approval]gives you automatic entry without independent supervision.”
As TGA experts have told us, the flaws in the medical device approval and monitoring system plaguing this country are making the TGA’s stated aim of regulating therapeutic products in terms of “safety, efficacy, performance and quality to help protect and improve the health of Australians” meaningless.
Last November, during an online briefing for staff, TGA employees expressed doubts about the role and effectiveness of the regulator.
One of them said: “We are predisposed to serve the industry and not the general public, our most important actor.”
Another said: “Are we functioning as regulators or have we turned a blind eye to our responsibility in evaluating, evaluating and monitoring therapeutic products?”
The two observations go to the heart of what a regulatory regime should define. The only interested party whose life depends on the regimen is the patient.
The scope of device approvals by the TGA is such that it is impossible to carry out a true assessment and audit of each device; hence the dependence on European certification.
“There are too many devices to deal with,” said a former TGA medical device auditor. This, however, is a dangerous path, as another TGA member admitted: “It’s a race to the bottom. You can look for the one that helps you get ahead.”
It is also concerning that, as our reports have shown, a device manufacturer can claim that a device is “substantially equivalent” to others on the market and therefore deny having to undergo a clinical trial at all.
As our case studies have shown, the consequences of a defective medical device can dramatically change or threaten a person’s life. The TGA owes it to the public to provide freely accessible data so that informed decisions can be made within a trusted system. This is not the world we live in.
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