Senate Community Affairs Legislation Committee [Part 2], , 4:28:38 to 4:35:19
Officials discuss the implementation of mandatory reporting for medical device incidents and the staffing levels required for post-market surveillance.
Topics: Health, Public service staffing, Cost recovery
Speakers: Dr Marcelle Noja, Tracey Duffy, Speaker 29, Unknown Speaker
>> Thank you very much chair. My questions continue to be on medical device Thank you very much. So we established that um overseas warnings about device risks are passed on to users in Australia based on an um applicability test. Could you in the time available not in 10 minutes but are you able to succinctly define uh what is the in applicability test?
>> Uh thank you senator for the question. So there's no test per se that I can say it's you know a plus b plus c equals do a market action. What we do is we look at the nature of what the event may be. Sometimes they're small things where it's a software update and we work with the sponsor and actually often for these sorts of things the sponsors come to the TGA directly. We don't need to go to them. Other times there might be bigger signals and they might be things that aren't necessarily a particular thing that's occurred but we're seeing a bit of a pattern and overseas might be seeing a pattern and they're investigating it and so they might do a particular action. Other times we see patterns first we will investigate and we will undertake an action. So, it's it's a bit difficult to say here's a simple formula for it because it really is on a case-byase basis. That's on purpose because it is a riskbased framework. We fundamentally want the public to have access to devices. We want those to be safe and to perform as intended, but we also want to make sure that we intervene whenever something is a risk to the public.
So that's a big responsibility as opposed to simply just passing on the overseas warning.
>> That's right, Senator, because sometimes the overseas warnings aren't necessarily applicable. Like uh with the way we register products, there might be multiple products under an artg entry. And if we simply pass on a warning, that product may not be in the Australian public. And so you might inadvertently scare the public from accessing really important therapeutic goods because they see something that is not applicable to them. Um, as Miss Stuffy noted before, other times we pass on messages anyway. For example, we were concerned around the risk of some hyperbaric chambers and there was unfortunately a death overseas that occurred. We knew those products weren't being used in the same way in Australia. Nonetheless, we published information on our website just in case that there were members of the public that were accessing these products to make sure that there was appropriate safeguards and they had the information at hand.
>> I I understand. Thank you. Um I'm sorry to hear that the TGA has had um issues with staffing. So I understand that around half the staff it had around half the staff it needed to monitor adverse event alerts in 2024 and that was before there was mandatory reporting and mandatory reporting took effect in March this year and was expected to create a t-fold increase in reporting. So has there been an increase in reporting? Has it been tenfold? and I hope you can tell me that you now have the staff to attend to that increase.
>> Um so mandatory reporting that you referred to is mandatory reporting by healthcare facilities in Australia. So the 600 odd um hospitals that started reporting um certain certain um incidents to the TGA. um we we can say that over time the the number of staff in the medical devices um postmarket area has increased. In fact, we now have a surveillance branch um but that was in place in uh before the mandatory reporting started. Um in terms of the the mandatory reporting and the numbers that are coming in um Miss Nam Dr. know you might have those numbers in terms of the how many we've received um from hospitals since the the scheme started earlier this year.
>> Thanks Senator. We have had a large number of reports. On average we're having around 400 reports coming in a month uh through the mandatory reporting scheme. We have also had an increase in more general adverse event reports. What's really important about the increase in reports is the more reports we have, the more we are able to be really selective in the things that we investigate and the signals that we assess. So it lets us shift from having to really search for signals to letting the signals come out in their in their earnest. So whilst we have had a significant increase in reports, our investigations haven't had to increase substantially because what the increased reporting has shown us is that the the sponsors who are fundamentally responsible for undertaking investigations are doing so and we're able to be much more targeted in our
>> And so did you um get additional funding
additional funding in respect to the mandatory reporting scheme. It is in its early days, but we are looking at our systems more broadly to ensure that they remain fit for purpose.
>> Did you ask for more money and and weren't given it?
>> Um the funding that we receive in the TGA to do medical device activities is cost recovery funding. We either charge um we either have um fees for applicants or an annual charge for those um uh suppliers sponsors who have um products that they continue to supply in Australia. The the amount of funding that we allocate to our various activities is looked at on an annual basis and we determine on an annual basis how much funding we we divide between pre-market work and postmarket work noting what the volumes and the work that might be um expected to happen in the in the next year and then balance between the the two areas of work with the funding that's available. So over time, as I mentioned before, the funding allocated to postmarket and postmarket u monitoring has increased um and shifted the balance because that is where we've had to um focus our efforts over time because of that um analysis we do.