Australia's TGA slammed for device safety oversight

The FDA and EU officials aren't the only global regulators receiving criticism for oversight of medical devices. Australia's Therapeutic Goods Administration is being taken to task for its advice to doctors and patients on device safety. A group of articles in The Medical Journal of Australia assess the TGA's ability to regulate medical devices--and the authors don't give it an A.

As Annette Katelaris, the journal's editor, notes, the TGA has a limited role over device safety. It reviews a few products before they are released, but there is no formal monitoring after they go on the market. Instead, the medical community typically informs the regulatory body about possible harm drugs or devices can cause.

Recently, the TGA has sought to improve transparency and information provided about the safety of devices. But, as Dr. Richard McGee, a final year Ph.D. candidate at the University of Sydney school of public health, maintains, the regulator's website "is difficult to use, sometimes inconsistent and mostly uninforming." Any information about a device's safety profile is hard to obtain, thus possibly jeopardizing public health, he writes in an opinion piece in The Canberra Times.

Katelaris urges an update of the system, including adequate monitoring and harm prevention. "This process needs to be independent of industry, government and any one clinician," she concludes. "Timeliness, transparency and accessibility are also key requirements."

For its part, the TGA says it dedicated itself in December to "changing the way it communicates and engages with the community, and also to changing the framework for regulating medical devices," a spokeswoman told The Sydney Morning Herald. The agency is also planning to make its internal database on device accidents searchable by the public.

The articles come after the furor surrounding faulty breast implants made by the now-defunct French implant maker Poly Implant Prothese. European scientists are now pursuing an additional study focusing on the health and safety of patients who received those implants. Authors writing in the Australian journal also called upon the TGA to more effectively monitor women who receive breast implants. They maintain that the current system only has recorded a small number of implant recipients, The Australian reports.

Meanwhile, in the U.S., Robert Hauser of the Minneapolis Heart Institute Foundation questioned the efficacy of medical device postmarketing surveillance. He cited St. Jude Medical's ($STJ) Riata recall as an example of how the U.S. system isn't up to snuff. To remedy the situation, Hauser says the FDA must "mobilize available resources now to improve postmarketing surveillance for ... patients."

- check out Katelaris' piece
- read The Canberra Times article
- get more from the SMH
- see the story in The Australian

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