Poor regulation of medical devices is alarming

5 December 2018

Senator GRIFF (South Australia) (14:23): My question is to Minister Scullion, representing the Minister for Health. I have a follow-up to my question last week regarding the international investigation into medical devices and Australia being effectively a dumping ground for products not permitted for use in the US. One product, a shoulder implant named PyroTITAN, was approved by the Australian TGA in 2011 and classified as low risk. There were several early failures and, two years later, the device was suspended. However, patients were not notified by the implant sponsor or treating surgeons of any of the failures. By way of contrast, every registered vehicle owner with a faulty Takata airbag received a recall notification so they could mitigate the health risks of an exploding airbag. Why hasn't the government mandated that patients must be notified when an implanted medical device is found to be faulty?

Senator SCULLION (Northern TerritoryMinister for Indigenous Affairs and Leader of The Nationals in the Senate) (14:24): I thank the senator for the very important question. I understand that you and the office have had some discussions—I hope they were fruitful—with both representatives of Mr Hunt's office and the TGA. I understand there are a number of questions being considered and that we will be getting back to you on this matter.

Australia is not a dumping ground for therapeutic devices. That part of your question, I have to refute. I don't think that is the case, but I am more than happy to answer the other elements of your question. I think it is quite proper to point out the analogy of why is it that when my car looks like it might hurt me there is process under which there are mandatory legislative and regulatory requirements to ensure the owners of other cars are alerted? We do have a very important process under which the colleges of medical practice are informed about these matters, because it is actually their responsibility to ensure that doctors are required and mandated to report on a device or a failure of a device. The Chief Medical Officer has in fact written to that particular college, to the medical groups and to professional bodies to encourage them to consider the recommendations of the Senate inquiry into transvaginal mesh implants, which dealt with devices and the mandatory reporting more generally.

Senator GRIFF (South Australia) (14:26): For the colleges, as in the Orthopaedic Association, yes, there is a requirement for any surgeons to report issues, but that's not what I'm referring to. At this stage, when the TGA issues a hazard alert, they notify the device sponsor, the entity that brought it into the country, but there is no requirement for hospitals to tell clinicians or patients. Do you see this as a major failing?

Senator SCULLION (Northern TerritoryMinister for Indigenous Affairs and Leader of The Nationals in the Senate) (14:27): We're asking them to provide a recommendation on whether we regulate or legislate or leave it to them to mandate through the normal college process. We are expecting a response. We haven't got a response yet but, when we get that response, if that response is 'we think you should mandate in the way you're suggesting by either legislation or regulation' that might well be the case. But we're awaiting their response. I don't think it will be too far away. And I will ensure that, as soon as the government understands what the answer from the Chief Medical Officer is, we'll respond to your office in kind.

Senator GRIFF (South Australia) (14:27): Minister, you're referring to the colleges coming back and saying that should be the case. I assume that's what you're saying, which will definitely be the case. The issue may be with some of the device suppliers who, in the past, have always pushed back on contributing to some kind of register. But under the circumstances, will the government commit to a mandatory device register, at the very least for high-risk devices, going forward?

Senator SCULLION (Northern TerritoryMinister for Indigenous Affairs and Leader of The Nationals in the Senate) (14:28): Not being the minister, I can't give you a definitive answer on that. We have asked the colleges how they would wish us to respond. It is only my view—and I have listened carefully and read much of what you've put forward—that it's not a matter for the producers of the devices; it's their use in Australia that should be on a mandatory register, and any failings of that should be subject to mandatory reporting. We are waiting to hear back from industry, not from the device manufacturers or owners of those patents. I'm not the minister, so I can't guarantee how that will be, but we will take their recommendations seriously on whether to legislate or regulate, and we'll take that into consideration.

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