Regulation of medical devices

27 November 2018

Senator GRIFF (South Australia) (14:27): My question is to Senator Scullion, representing the Minister for Health. This week the ABC and Fairfax started issuing a series of reports called 'The Implant Files' as part of a collective effort by the International Consortium of Investigative Journalists. It uncovered concerning information about the lax domestic and international regulation of medical devices and the devastating impact of this on Australian patients. We've all learned that the US FDA has allowed 4,600 medical devices to be approved for export only. These are devices that it refuses to approve for use in Americans but that are exported for use in Australia and other countries without having any mandatory postmarket surveillance. Why does the TGA in Australia allow devices that the US FDA has not approved for its domestic use to be imported and implanted in Australian patients?

Senator SCULLION (Northern TerritoryMinister for Indigenous Affairs and Leader of The Nationals in the Senate) (14:28): I thank the senator for his question. Patient safety is the Australian government's highest priority. Before any medicines or medical devices can be supplied in Australia, irrespective of whether they've been certified or otherwise in other countries, they have to go through an extensive assessment and meet the highest levels of safety and quality. They're also monitored once they're on the market. The Therapeutic Goods Administration is regarded as one of the most thorough of all agencies around the world and has the highest standards of assessment for both medicines and medical devices. But there is always a level of risk associated with any medical procedure or device. Companies are required by law to report safety issues and adverse events to the TGA. The TGA will monitor ongoing safety and performance of devices that are on the market, and if issues arise the TGA will issue safety alerts, mandate changes to the product or recall the product from the market.

I acknowledge the recent media, and I have read much of it. The Minister for Health has tasked the head of the TGA, Professor John Skerritt, to review all of the claims made in the media regarding the regulation of medical devices and to provide advice to government on whether further safety measures are necessary.

As I indicated earlier in my answer, we have to go through an extensive assessment to ensure we're meeting the highest levels. We don't provide a rubber-stamp approval for any medical device for use in Australia just because it has been approved overseas. Part of your question was: 'It hasn't been approved in the United States, and it's now being used here.' I'll certainly check that, because I don't understand that to be the case. It's a question I asked earlier today.

Senator GRIFF (South Australia) (14:30): Minister, the TGA—and this would surprise a lot of people—only uses a paper based assessment for these devices and doesn't have an expert clinical committee to review the suitability of devices in Australian public hospitals. Can you provide, on notice, how many of these non-approved FDA export-only devices are currently in circulation in Australia and their average adverse event rate compared to the FDA fully approved devices?

Senator SCULLION (Northern TerritoryMinister for Indigenous Affairs and Leader of The Nationals in the Senate) (14:30): As I've indicated, I'll have to take that on notice, simply because I don't understand that to be the case. What I understand to be the case is that there is no device or medicine that is available in Australia that hasn't gone through the TGA approval process. You assert that that's not an approval process that you think is appropriate, so I'll be very sure to ensure that I provide an answer to your question on notice around the alleged paper process rather than an expert process. But I have been informed that there are a number of people, including Australia's Chief Medical Officer, who were involved in ensuring that the colleges of the practitioners are able to ensure that we're moving to mandatory reporting of any adverse effects. So we've talked, I suppose, in your questions and my answers, about approvals from the TGA, but that isn't in regard to a very important process about the actual practitioners responding— (Time expired)

Senator GRIFF (South Australia) (14:32): Minister, some of the devices in question that have been referred to in the articles relate to devices that the TGA approved, via paper, that were able to be used in public hospitals. Private hospitals go through a different process, by using the Prostheses List Advisory Committee, which is clinician based. Will the government consider referring all device approvals via the clinician based Prostheses List Advisory Committee?

Senator SCULLION (Northern TerritoryMinister for Indigenous Affairs and Leader of The Nationals in the Senate) (14:32): I will ask that question of the minister and I'll provide a prompt answer to that question, but I don't have that information to hand.

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