About 1.4 million medical devices are registered with the Medical Products Administration. These devices are important in maintaining a person’s health, and in fact can be important in saving lives. At the same time, each year more than 150,000 cases of equipment require hospital treatment, according to the Australian Institute of Health and Welfare.
That gives little insight into the extent of any issues, and getting a better picture is very difficult. The TGA, which is the medical devices agency, will not say how many reports it receives of device-related injuries or deaths each year.
It took Medical Problems series of observations from this title and 60 minutes data mining using digital logs and generating more than 80,000 medical device side effects records, reports and risk alerts.
The series has also interviewed more than 70 patients, doctors, researchers, TGA staff and industry consultants, and has looked at court cases and case studies.
What it has shown is that the number of deaths, injuries and adverse event reports is increasing. Since 2020, the number of deaths involving medical equipment has reached 679, with 30,377 injuries.
The difficulty it took to discover which devices were involved in the most incidents – information gathered from a seemingly public database – shows that the TGA’s diabolical website is completely unfit for purpose.
Even the TGA doesn’t have a good grip on its own data. The investigation found many deaths before October 2019 were not recorded. After this masthead questioned the TGA, it posted “technical issue” warnings in the database.
The investigation also revealed other systemic deficiencies. In the past decade, more than 55,000 devices have been approved for use in Australia and 830 have been rejected.
About 85 percent of the devices are certified through their European certification, some awarded by for-profit notified companies in Germany, which receive a fee from the manufacturers of the devices they certify.
This is not to say that accreditation is wrong, but relying on such a narrow and commercially motivated pipeline casts doubt on the independence of the process.
As Associate Professor Marco Rizzi, an expert in medical products at the University of Western Australia, says: “If you have a CE (European approval) mark, it gives you a direct entry without independent oversight.”
As TGA insiders have told us, flaws in the system for approving and tracking medical devices flooding the country undermine the TGA’s stated goal of regulating medical products for “safety, efficacy, performance and quality to help protect and improve the health of Australians”.
Last November, during an online staff meeting, TGA staff expressed doubts about the role and effectiveness of the regulator.
One said: “We have a preference for serving industry rather than the general public, our most important stakeholder.”
Another said: “Are we acting as regulators, or have we turned a blind eye to our responsibility in assessing, evaluating and monitoring medical products?”
These two statements go to the heart of what should define a regulatory regime. The only stakeholder whose life depends on the administration is the patient.
Such is the level of TGA approval of equipment that a true assessment and inspection of each equipment is impossible – thus dependent on European approval.
“There are too many devices to deal with,” said a former TGA medical device inspector. This, however, is a dangerous path, as another TGA insider admitted: “It’s a race to the bottom. You can shop around to get you through.”
It is also worrying that, as our reports have shown, a device manufacturer can claim a device is “substantially comparable” to others on the market and thus refuse to undergo clinical trials at all.
As our studies have shown, the results of a faulty medical device can significantly change or threaten a person’s life. The TGA owes it to the public to provide freely available data so that informed decisions can be made within a trusted framework. This is not the world we live in.
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