Australia's Version of FDA Lax on Medical Device Safety

Jane Akre
March 7, 2012

With the global news about the defective French breast implants called PIP filled with industrial silicone, the Canberra Times (here), published in the capital city of Australia, takes a look at how medical devices reach the market there.

Australia's version of the U.S. Food and Drug Administration (FDA) is called the Therapeutic Goods Administration (TGA) which oversees medical devices.

Just as in the U.S., medical devices receive far less scrutiny than prescription drugs. Just as in the U.S., drugs are tested for safety and efficacy in clinical trials, while medical devices can be approved and sold often without any clinical trials.

In the US, many devices are approved because of their similarity to devices already available on the market. This leads to a ''daisy chain'' effect where one device is approved based on a previous older device and so on, despite the fact that new devices may pose substantially greater risks to patients.

In the UK and Europe, medical devices resemble toasters in the way they make it to market. The reviewing agencies are funded by the device industry raising questions about conflict-of-interest. Once on the market, safety or lack of, may be determined by a loose system of adverse event reporting.

In Australia (AU), a medical device application is submitted so the device is on the register of therapeutic goods for use in that country with no further restrictions. The author, Richard McGee, found that there have been 300 unexplained deaths and 2,500 unexplained serious injuries linked to medical devices since 2000.

Just as in the U.S. there are gaps in the reporting of those adverse events or complications, compromising the data that is available. The TGA website is tough to maneuver and understand and even tougher to use.

McGee reports that this reporting system needs to change. First, he suggests a registration of medical devices used in Australia and when problems arise, doctors and patients need to be able to track the decision regulators are making about a problematic device.

"It is clear the potential for large-scale health gains, and unintended harms through device failure, are substantial," he writes.

"At a time when the device industry has seen large-scale device failures, it is troubling that our national regulator still lacks transparency. While reforms have been proposed, they may not yet go far enough. It is a matter of great public interest that the TGA rise to this challenge."

Dr Richard McGee is a final year PhD candidate at the Sydney School of Public Health, University of Sydney.#

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