Device sector faces scrutiny following international investigation

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Health minister Greg Hunt has asked the TGA for advice on whether additional measures are required to ensure the safety of medical devices in response to reports from the International Consortium of Investigative Journalists.

The consortium's latest investigation, 'The implant files', claims regulatory bodies around the world including the TGA have failed to ensure patient safety from "poorly tested implants".

The investigation across 36 countries, including Australia, has compiled an International Medical Devices Database.

According to the consortium, users can explore more than 70,000 product recalls, safety alerts and field safety notices undertaken in 11 countries.

The database includes over 3,500 product recalls undertaken in Australia since 2012.

The ABC, which is part of the investigation, has reported extensively on the issue in recent days highlighting some of the experiences of individual patients with implantable devices.

The investigation has accused device companies of actively opposing new safety regulations in some international jurisdictions. It has also accused regulators, including the TGA, of failing in their duty of care for patients.

The Medical Technology Association of Australia described the investigation and reporting as "inaccurate and sensationalist".

"We are disappointed at the irresponsible tone and the inaccuracies of the media coverage, which only serve to create unwarranted fear in the community and may cause Australians to avoid seeking treatment that would improve their quality of life," said CEO Ian Burgess.

"Australia has one of the most highly regulated and robust assessment systems in the world for medical technology. The Therapeutic Goods Administration is highly regarded globally for its commitment to safeguarding the Australian community. To suggest otherwise is unsubstantiated and ludicrous."

The investigation has criticised the 'conformity assessment' process used by the TGA under which it allows medical devices to be approved for use in Australia partly based on approval in jurisdictions like Europe.

TGA head John Skerritt told the ABC the process is not simply a rubber stamp for devices approved in Europe. 

"Australians can be proud of the professionalism of the regulator and the MedTech industry in appropriately managing risk while ensuring patients are able to access innovative and life changing medical technologies," said the MTAA's Burgess.

"It’s very disappointing to see Australian media outlets, such as the ABC, calling into question the integrity of the TGA, MedTech innovators and the dedicated Australians who work in the industry, by choosing to go down the path of sensationalism and biased reporting."

He continued, "Medical devices in Australia have helped millions of Australians live more productive and fulfilling lives. Of course, surgeries and medical treatment are always associated with a risk and the industry and regulators are always concerned when there has been an adverse outcome for a patient. But there are processes in place to monitor and track adverse events and take appropriate action.

"There therefore needs to be a measured consideration of the facts, which have, in this instance, been overlooked in the quest for sensationalism. Patients seeking treatment for debilitating conditions need to have the confidence in their medical professionals and the regulator to make informed decisions about their treatment.

"Advances in medical technology over the past 20 years have resulted in a 56% reduction in hospital stays, 25% decline in disability rates, 16% decline in annual mortality and increased life expectancy of approximately 3.2 years."