Unique Device Identification (UDI) information session for clinical quality registries

00:00 --> 00:20
HEWAGE, Nishie
Good afternoon and thank you for joining today's Unique Device Identification Information session for Clinical Quality Registries. I would like to begin this webinar with an acknowledgement of country. In the spirit of reconciliation, the Department of Health, Disability and Ageing acknowledges the traditional custodians of country

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HEWAGE, Nishie
throughout Australia and their connections to land, sea and community. We pay our respect to their elders past and present and extend our respects to all Aboriginal and Torres Strait Islander peoples today.

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HEWAGE, Nishie
Before we get started, I would like to give a brief introduction of our presenters today. Our first presenter will be Tracey Duffy, who is the First Assistant Secretary of the Medical Devices and Product Quality Division at the TGA. Our second speaker will be Gary Pascoe, who is the UDI Project Lead at the TGA.

00:53 --> 01:01
HEWAGE, Nishie
Now, without further ado, I would like to pass it on to our first speaker to get started with today's presentation. Over to you, Tracey.

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DUFFY, Tracey
Thank you, Nishie. Thanks everyone and welcome to our UDI presentation where we're particularly going to focus on Registries and this is the start of our journey into how we might look at working out our pathway forward.

01:21 --> 01:41
DUFFY, Tracey
to work collectively and collaboratively with Registries to support the implementation of UDI. So, this session today, in terms of the agenda, oh, the agenda just left. We're going to provide you a quick introduction about what UDI is for those who don't know.

01:41 --> 02:00
DUFFY, Tracey
Gary is going to then take us through what the requirements are for UDI in relation to the manufacturers who are required under law to provide the UDI when they're supplying products, medical devices in Australia. Gary is going to do a live demonstration, and our fingers are going to be crossed that live demonstration works well.

02:00 --> 02:18
DUFFY, Tracey
never know with live demonstrations. We're going to outline what the TGA support is and the team we have here. And then we've got some time set aside for questions and answers because there may be some questions that people might have as a result of the presentation and the demonstration that we provide.

02:18 --> 02:39 
DUFFY, Tracey
So next slide. Thank you. So, the UDI has been a flagship project that the TGA has been implementing for quite some time now. It was endorsed by the government, and it was a response in the government's response to recommendations to

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DUFFY, Tracey
the inquiry into transvaginal mesh. And that comes after a number of issues in relation to medical devices that the Australian public have, particularly women, for those first two elements that you can see on the screen, but also men for hip implants.

02:58 --> 03:21
DUFFY, Tracey
The government was really concerned about having a way to identify medical devices faster and more quickly, not only by the TGA, but within the healthcare system. It was taking too long to track and trace medical devices that have been implanted, and it was taking too long for a response to actually occur and information to go back

03:21 --> 03:40
DUFFY, Tracey
to those people who may have been implanted, particularly if they have a medical device that was of issue. So, the UDI is one of the key actions, along with others, as part of our ongoing monitoring and surveillance work that we do here at the TGA. But the UDI is one of the critical steps.

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DUFFY, Tracey
when it comes to improving patient safety and medical devices. And whilst the TGA remit is requiring legally the manufacturers introduce UDI, we are focused on encouraging and supporting healthcare adoption of the UDI into their systems and processes.

04:02 --> 04:22
DUFFY, Tracey
And Gary is going to provide some information and some suggested pathways forward that. And this is a global system. So, Australia is just one country who is introducing UDI. There are already some countries that have UDI and many more in the process of adopting.

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DUFFY, Tracey
So in terms of where it came from and who it's going to impact, this is a diagram of who we think the UDI will ultimately impact. Obviously the TGA, because TGA will review the UDI that is submitted to the TGA, but the TGA will also use that UDI not only for approval purposes,

4:43 --> 5:08
DUFFY, Tracey
but adverse events, recall management and market availability processes. So we'll include it right throughout our processes here at the TGA. As I said previously, manufacturers are legally, by our act and regulations, required to put information of the UDI onto their devices and in all packaging and submit that to the TGA database.

5:08 --> 5:29
DUFFY, Tracey
And they've got conformance and global compliance requirements on them as well as Australian requirements. Sponsors, the Australian supplier or importer will also play a role. And then we go on to the other collaborators. And these entities are outside the TGA regulatory remit

5:29 --> 5:48
DUFFY, Tracey
such as healthcare providers, individual healthcare records, payers or reimbursement organisations and clinical quality Registries, which is why we're here today. Each of these stakeholders play a critical role in the successful implementation and use of UDI in the Australian healthcare system going forward

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DUFFY, Tracey
to help device traceability, but also strengthen our data sharing and supporting better patient safety outcomes. So, with that, I'm going to hand over to Gary to go through in more detail what the UDI is and how it actually works. Thanks, Gary.

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PASCOE, Gary
Thank you, Tracey, and good afternoon, and thank you to everybody who's joining us today. As you can see from the diagram here, the picture, I'm Gary Pascoe. I've been leading the implementation of UDI here at the TGA for the last sort of five or so years, and working with me is a is a fantastic team of people who are sort of sitting

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PASCOE, Gary
in the background. So, while I'd like to take credit for a lot of the sort of quality work, there's an amazing team helping us do that. And some of those team are working in the background with us today as well. So, Carolyn Wilson, which I'll introduce you to later, is actually facilitating and coordinating a range of responses to questions. So, if you 

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PASCOE, Gary
do have questions because we, looking at the registrations today, we have a range of different stakeholders, different people with different levels of UDI expertise and understanding. So, we've focused this session on very much around the sort of UDI requirements and providing that high level summary of UDI and what that means for Registries.

7:03 --> 7:22
PASCOE, Gary
But fundamentally, we know some of you may also have very precise and specific questions. So, in addition to the question and answer session we have at the end of the webinar, feel free to put some questions into the Q&A as we're going, and then the team with Carolyn and others leading that will address those. If we don't get the chance to

7:22 --> 7:43
PASCOE, Gary
address them through the chat function, the Q&A function. We do have that time at the end to sort of address them and Carolyn will read them out. If unfortunately, we can't cover them in this webinar, we do ask that you, and it is something that is pressing, could you please send it to the UDI support team, which is at udi@health.gov.au and we'll look to sort of cover those questions.

7:43 --> 8:06
PASCOE, Gary
So as Tracey mentioned, very much focusing on this initial part of the session on the UDI requirements and provide some information in relation to the UDI requirements. So, I'll touch that at a high level and also looking at what that may mean for the Registries and the benefits. So fundamentally, we understand the Registries, and this is the start of the journey and through the conversations with Clinical Quality Registries.

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PASCOE, Gary
So we also, we accept that Registries are starting to understand how they use UDI, how they can get the information from the TGA or through the healthcare system. And we have some basic capabilities within the Australian UDI system at the moment to support that. But this is very much a sort of a

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PASCOE, Gary
I'd like to, if you can lead this webinar with an understanding that you can start to engage with the TGA, work with us around how we can start to work with you around evolving, using that information, how that information can then flow through and what we need to do in terms of the various stakeholders that Tracey mentioned to facilitate that process. So very interested in

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PASCOE, Gary
ongoing and further engagement with the Registries and I suspect hopefully this conversation will provide some background. So, the benefit from UDI for Registries very much really covers the breadth and the depth of the function of the Clinical Quality Registries. So, from our perspective and our ongoing engagement through healthcare and with Registries today,

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PASCOE, Gary
the UDI does allow more accurate device performance assessment information and certainly the ability to better identify devices to be able to connect those versions of the devices with sort of broader attributes and information about the devices. So, connecting product codes, catalogue numbers, reorder numbers,

9:28 --> 9:50
PASCOE, Gary
the Australian Registry of Therapeutic Goods Identifiers (ARTG IDs), and all of those attributes really are important. And being able to, UDI provides that ability to start to connect those things together. And certainly, as we know from a registry's point of view, the ability to connect information about the devices or data about the devices and then make more informed decisions is crucial. So

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PASCOE, Gary
we're definitely looking at that benefit, which in itself leads to more enhanced comparative study. So, the ability to study the UDI and the differences associated with our devices we know will be very beneficial. And as I'll touch on later, the fact that UDI is a globally consistent scheme allows you to identify that a

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PASCOE, Gary
particular device in Australia is exactly the same as that device or has the UDI for that will actually apply to the same device in other jurisdictions and other countries as well. So, getting that longitudinal analysis and actually being able to lift that up across different jurisdictions, we know that will be very beneficial for the Registries. As Tracey has mentioned, recall responses, the fact that we are looking for requirements for UDI to be on

10:33 --> 10:53
PASCOE, Gary
adverse event reports, device incident reports, the recall notices and various other post-market activities and information products will also allow not just the faster identification of the products by patients, but also the better identification by Registries and your work with all the different stakeholders that have actually

10:53 --> 11:11
PASCOE, Gary
will enable you to have better and more accurate information about particular devices. The fact that UDI will be on the device labels and products associated with the device will allow you to - and it'll come in two different forms, so both a machine readable and a human readable form -

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PASCOE, Gary
really the adoption of the barcoding and that's certainly one of the challenges we'll start to see with healthcare adoption and the ability to reduce errors through barcode, automated data capture will be wonderful.

11:24 --> 11:46
PASCOE, Gary
So essentially, we understand a lot of interest from Registries. We do see your ability to actually use the UDI to connect the various identifiers for devices or different codes used by different organisations and different stakeholders in the healthcare system to identify patterns, to identify, connect that around the particular products,

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PASCOE, Gary
any related products or variants also. So, we do see an enormous opportunity. And as I mentioned, this is very much that launch pad in to be able to work with the Registries to start thinking about how we can work with you to make this more valuable, but also then using that to help pull through and help us overcome some of the challenges we may have in between.

12:08 --> 12:29
PASCOE, Gary
So just quickly, why is UDI important? And I'll give a bit of an overview of the UDI, what that means, and how that will actually sort of be used. As I mentioned earlier, it is a part of a global system. The UDI system has been implemented in the United States by the US FDA since 2018. It was started in 2014.

12:29 --> 12:50

PASCOE, Gary
but they have been operational and running since that time. So, it's been running and been quite advantageous. And certainly, if you're looking for case studies or examples, some great examples in terms of the ability to identify products and manage recalls or look at sort of more extensive analytical capabilities from use of UDI

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PASCOE, Gary
then the United States of America is definitely that place. The European Union is undergoing the implementation of UDI and then other jurisdictions are working through that at the moment. So certainly, Australia is not the first, but essentially we are one of the earlier organisations, one of the earlier countries actually implementing UDI.

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PASCOE, Gary
And that's all been guided by an International Medical Devices Regulators Forum (IMDRF) guidance that had been developed that actually applies to all international medical device regulators that provides sort of the framework in terms of the UDI implementation. The other point that may be of interest to certainly Registry groups, the TGA is working with

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PASCOE, Gary
the Sparked programme at the Australian Digital Health Agency (ADHA) around how we can now start having medical devices included into the data interoperability framework. So as part of the Sparked FHIR program, and they are now looking at how they capture that information into their data sharing arrangements and that sort of standardisation around the sharing of medical device information and the use of UDI

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PASCOE, Gary
It's already captured into the international definition of HL7 FHIR, but it is certainly something you're now looking to implement in Australia and certainly we're seeing more and more momentum gaining in that regard. So certainly, those of you who are looking for those standards and the specifications for medical devices and the use of UDI, that's definitely coming.

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PASCOE, Gary
As I sort of mentioned earlier, I'll cover this again later on, the UDI does support the standardisation of data, device data, and can support the Registries in meeting your roles. We understand all of the challenges that you face. UDI can help in terms of proving accuracy of data, being able to enable the standardisation, facilitate the linkage of data across all those different

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PASCOE, Gary
device identifiers we've talked about. Ultimately, once it's worked its way through, and there's a lot of work needed to actually enable this to happen, to actually have it work through the healthcare system, but certainly enable real-time capture, enhance completeness, reduce your manual workload, and then strengthen traceability, which you all know then leads to those benefits that we talked about earlier.

14:59 --> 15:20
PASCOE, Gary
So let me just give you a bit of an introduction to what UDI is. I know some of you are quite well aware of it. Others are still trying to come up to speed with it. So, in Australia, the UDI system is effectively following that framework that was defined by the International Medical Device Regulators Forum. It really requires, or that standard has two aspects

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PASCOE, Gary
that really do require a medical device manufacturer to actually meet the sort of international obligations of the UDI system. The first one is the UDI needs to be, and the UDI is actually made-up of two parts, both a device Identifier and a production Identifier, and I'll talk about that in a moment, but that information is actually captured on the

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PASCOE, Gary
label of that individual device. So once the device is manufactured, the manufacturer is responsible for a labelling of the device, and on that label, has both the model Identifier as well as then the production information, so such as a batch number, a lot number, if the device is managed by serial number or particular expiry date, so it gives you that ability to

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PASCOE, Gary
to actually be more granular in relation to identifying when a specific device was manufactured, what lot it came from, or alternatively, being able to actually collect all the information about all the different batches and lots, depending on what you want to do. The UDI, both in the DI, the UDI Device Identifier (UDI-DI) and the UDI Production Identifier (UDI-PI),

16:20 --> 16:40
PASCOE, Gary
needs to be not just on the device itself, but all levels of packaging associated with the device. And the reason for that is to allow through the supply chain, the healthcare supply chain, as well as then within hospitals and certainly storage and inventory management in hospitals to identify not just the individual device, but to allow organisations to easily track and trace

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PASCOE, Gary
where in their stores and distribution centres, or even in terms of the use of the products where they sort of have been associated with a package of particular products rather than going down to individual device. So, it facilitates that faster identification, quicker recall, allow organisations not to go and unpack 

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PASCOE, Gary
products or boxes of packages of products and allows them to take those, find those boxes and then recall the actual box or take the full box off the shelf. In addition to the packaging and the labelling of the device, then we also, manufacturers and in Australia, the sponsor on their behalf,

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PASCOE, Gary
is required to submit data to a UDI, a centralised UDI database. And that's in Australia; we're calling that an Australian UDI database (AusUDID). And I'll give you a bit of an example of the live demonstration and touch on characteristics of that. But that database under the IMDRF sort of requirements is essentially to be free and available to anybody who's interested in looking at that data. So that's definitely easily

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PASCOE, Gary
able to be accessed by sponsors today. This third component, which is a bit unique to Australia, is essentially, we've also connected the UDI to the Australian Registry of Therapeutic Goods (ARTG) so that we know that the approval to supply the product, which is captured in the ARTG Identifier and the ARTG certificate and the approvals

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PASCOE, Gary
provided by the TGA to supply the device. And you can track that down then down to specific models of the device or specific instances. So, you're able to then look at a specific device in a healthcare setting or look at it in a clinical setting or in a registry setting and say, what is the actual ARTG that's associated with this device?

18:23 --> 18:43
PASCOE, Gary
By having that link to the ARTG, we're able to have that capability. And so, under the UDI requirements in the medical device regulations, the medical device sponsor has to, within 30 days of the product being supplied in Australia, ensure that the information about the device or the model of that device is in the ARTG. And I'll show some examples of that in a moment.

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PASCOE, Gary
The advantage of that is it actually allows you to start getting into variances and different characteristics because, those of you who dealt with ARTG, it talks about a kind of device concept and there may be a number of elements that sit under that device.

18:59 --> 19:22
PASCOE, Gary
We do have some questions from a number of you asking about what device classes, when they will come. So, I'll just quickly touch on those. So, we, in Australia, very much the focus, as Tracey mentioned, was really out of the sort of the Senate inquiry in terms of mesh and other sort of implantable products. So very much the focus is on those high risk products

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PASCOE, Gary
and the need to identify those products. So, the UDI requirements in Australia will apply to those high risk medical devices. So, in TGA device classification terms, that will be a class III, IIb, IIa and Is - so that's supplied sterile. So, if a device falls into those medical device categories, then it'll be mandatory for the

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PASCOE, Gary
sponsor to supply devices that are labelled with UDI as well as then supply the UDI data to the database. And similarly for in vitro diagnostic devices (IVDs), so class 4, 3, 2, and for class 1s is those products that have software based, so essentially software based IVDs, instrument analyser IVDs.

20:04 --> 20:23
PASCOE, Gary
So if they fall into any of those classifications, then UDI requirements will apply for them. What it won't apply to is those class I products, so either non-sterile, non-measuring devices or measuring devices, so class I or class m, or the remaining of the class 1 in vitro diagnostic devices. In addition, due to

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PASCOE, Gary
challenges with in-house IVDs or devices not on the ARTG, special access scheme or authorised prescriber devices, they are also exempt from being requiring a UDI on them. So essentially, devices will cover the bulk, and certainly those high risk devices and I know a lot of Registries are looking at

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PASCOE, Gary
Particularly those sort of high-risk devices, complex devices, and certainly these classifications will cover it.

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PASCOE, Gary
So the next question we're getting is when will it become mandatory? So it will be, it starts from the 1st of July of this year. So, we've actually had a period of time where we have allowed sponsors to comply with their and start to voluntarily submit data to the TGA. You may already see UDIs on devices coming through the healthcare system.

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PASCOE, Gary
or even in retail settings if they're the right classification. So those devices will have barcodes and other attributes. And then from the 1st of July, we have seen a lot of sponsors starting to go now in terms of providing the data to the TGA, so that's in our database. We currently have 41 odd thousand records in the database and we expect the number

21:32 --> 21:52 
PASCOE, Gary
to increase significantly in the next few weeks of leading up to the 1st of July. Now between the 1st of July and 2028, so we are getting questions, we have received some questions about implantable devices, so that period of time, due to some challenges in terms of the UDI implementation in other jurisdictions.

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PASCOE, Gary
While we actually require it for Class III and IIn devices from the 1st of July, there is a bit of a transition period for some of those products that are being reclassified or actually moving through the European recertification process. So, there is an extended period of time until about 2028 for those sort of device classes in terms of implantables and non-implantable products. So, there is

22:16 --> 22:37
PASCOE, Gary
more detail. and if you, I'll reference this through the whole webinar. If you do want the detail, then please go to the TGA UDI Hub and there's a range of information around that. Class IIa devices, so will start to become compliant from the 1st of July. Class I supplied sterile (class Is) from 2028 and then Class 3

22:37 --> 22:58 
PASCOE, Gary
for IVDs who will sort of follow on up to that. So, there is a bit more detail as I mentioned, so please visit the UDI website in relation to sort of finding out what specific devices fall into what categories during those transitions. The only other, a couple of key attributes I thought may be of interest to the Registries. So, the first one was...

22:58 --> 23:18 
PASCOE, Gary
UDI triggers. So as many of you know, the characteristics of the device may change over time and under the UDI scheme, and this is consistently with the International Medical Device Regulators Forum in terms of the rules that we define, we have attributes about a device, of the technical, clinical characteristics of the device.

23:18 --> 23:38
PASCOE, Gary
then to ensure that we're able to track back to the specific model if those characteristics change, then we have a different UDI for those products. So, if it's changing and you see on the in the screen there, the sort of trigger data elements, there may be some clinical characteristics that are changing, such as the label for single use, whether it's patched sterile.

23:38 --> 24:01
PASCOE, Gary
So if you're changing the sterility of the device, then the rules are essentially requiring medical device manufacturers to actually have a different UDI to provide that level of traceability back to the standards. Some other sort of characteristics that may not be less prevalent, but one of the key things with the UDI system was to allow the identification of the device through the brand name of the actual product. So

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PASCOE, Gary
in my simple and layman's parlance, that's essentially the name of the product that's on the box. And so essentially that requirement is a brand name. And so, the UDI provides that capability to put the brand name into the database. And so, for the manufacturers to add that information and then ultimately provide healthcare,

24:21 --> 24:40
PASCOE, Gary
Registries, consumers, patients, to be able to search on the name of the product they have in front of them. So, to ensure that we have accuracy and traceability, if the information about the brand is changing on the device and is changing the UDI database, that will also need to be a new device Identifier to be able to sort of track and trace that.

24:40 --> 25:00
PASCOE, Gary
There's a range of rules that are built into the database as well as the regulations to sort of stipulate and manage that. Similarly, as Tracey mentioned, UDI won't just be in the UDI database as part of the regulatory implementation. We are requiring it to be on patient implant cards (PICs), included on adverse event reports, device incident reports

25:00 --> 25:19
PASCOE, Gary
and market actions such as a recall or correction, and any market alerts that may sort of come up. So certainly we have there maybe questions or people asking questions around, will that also include on the stickers? So as the device comes through and some in a kit or in a loan kit or maybe small products. So,

25:19 --> 25:41
PASCOE, Gary
essentially, we're requiring the manufacturer to be able to have identifiers that relate to the device and if they're able to meet that through other means, but most of them actually are putting the UDI on the stickers. So, we expect to see that flowing through if you haven't seen that already. And that may either be an adjunct to some of the internal reference numbers they have, but also

25:41 --> 26:01
PASCOE, Gary
added to the sticker or replacing it. You'll start to see that shifting, and I imagine many of you have seen that already, but it is starting to work through. And similarly on information leaflets or any other leaflets, and some examples that we have in there in the instructions for use as well.

26:01 --> 26:21
PASCOE, Gary
So what's the aim and sort of as I mentioned, how does the UDI system work? And as sort of point out there, as Tracey mentioned, some of the remit of the TGA and then obviously then where our remit sort of ends and where we're looking to work with different stakeholders. So, I'll go through this very quickly. So, at the top left hand corner of the screen there,

26:21 --> 26:42
PASCOE, Gary
The UDI, so the manufacturer of the device needs to go to one of three approved organisations to issue the UDI, and that's to ensure that there is global uniqueness. So, as I mentioned earlier, so a device Identifier for a particular implantable in Australia will also be the device Identifier for that plan of implantable in other jurisdictions.

26:42 --> 27:04
PASCOE, Gary
And so that provides that level of traceability. So those organisations maintain that level of uniqueness. That goes on to the model of device. And then moving from the top to the bottom in that left-hand column, once that device is then manufactured and the specific batches and lots are run, the actual device Identifier and the production information, so

27:04 --> 27:25
PASCOE, Gary
as I mentioned earlier, the lot number or the batch number or expiry date, manufacturer date, depending on the product, needs to be encapsulated on the device label in both a human readable and a machine readable form. So, in the example there, if you can see it, it's a linear barcode which can be scannable either by healthcare or other stakeholders who actually may be working through it.

27:25 --> 27:45
PASCOE, Gary
That label will be on the device. It needs to be associated with the device. It also needs to be associated with all the levels of packaging. The sponsor will then supply that product. If I move through sort of the row of stakeholders at the bottom of that screen there, through the Australian sponsor, then into the hospital or healthcare organisations or other

27:45 --> 28:07
PASCOE, Gary
other purchases of those products. Once it's in the hospital system, then that Identifier, we're working with a number of different stakeholders to actually work with us in this regard, to actually start to scan, capture and flow that device identifiers through the hospital

28:07 --> 28:26 
PASCOE, Gary
clinical systems as well as inventory systems, patient administration systems. So ultimately for an implantable product, that device Identifier indicating the model of device and the production information about when it was produced to what lot number it was produced on would be associated with the patient and then ultimately then flows through to the Clinical Quality Registry

28:26 --> 28:45
PASCOE, Gary
that would actually support you. Now, obviously, another level of validation that you have is then once you get that information to reach back into the TGA to look at the Australian UDI database, which will have information about the device and provide that richer subset, richer set of data around the device, such as its clinical characteristics.

28:45 --> 28:58 
PASCOE, Gary
and other information linking back to the ARTG. And that, as I mentioned earlier, that database is available to patients, healthcare, any external stakeholder who is interested in receiving this information.

28:58 --> 29:20 
PASCOE, Gary
But we, as I paint that picture, it sounds all nice and perfect. There are some challenges and there are some things that we do see happening across the globe. And so, this is an area where we'd love to work more with Registries and other stakeholders to sort of work through this. So, it's not a perfect system yet, and particularly what's happening in terms of other sort of globally. So

29:20 --> 29:40 
PASCOE, Gary
we are working through this. So certainly, one of the things is we're seeing more and more challenges and certainly the global implementations. So inconsistent capture of data, device data, device usage and point of care. From a Registry's point of view, you're very interested in that. And so really the challenge is, as Tracey mentioned the remit of the TGA.

29:40 --> 29:59 
PASCOE, Gary
sort of ends at the regulation of the medical device sponsor and then having healthcare adopt it and ensure there's consistency is work that we're working with a number of other government stakeholders to actually implement that. And from a Registry's point of view, we would love your assistance in helping work through how we can make that and embed it through

29:59 --> 30:18 
PASCOE, Gary
your processes and systems. Ensuring the data is up to date and producing, improving data accuracy and completeness will be vital. Digital maturity, as many of you probably know, different hospitals, different organisations have different levels of maturity in terms of scanning, data sharing systems

30:18 --> 30:41 
PASCOE, Gary
and so we are very interested in working with, we'll create different circumstances and different solutions to help through that. And so, ensuring that we can support the different stakeholders at different levels of digital maturity will be important. So, the TGA is very interested in helping that. And obviously, the more, the less mature we are, the more sort of manual the process will be. So

30:41 --> 31:01
PASCOE, Gary
data sharing and governance would be very, very important, ensuring that we actually get consistency in the same interpretations of data and get the information exchange working. And as like I mentioned earlier, we are working with the digital health agency to actually ensure that UDI is now embedded into the interoperability 

31:01 --> 31:20 
PASCOE, Gary
standard for the HL7 FHIR and that's sort of starting to become well progressed. And then obviously moving away from manual submission methods, mailing in of sticker sheets, we know that's a sort of a classic problem that Registries are facing, getting the sort of time and the data and that sort of digital maturity curve.

31:20 --> 31:43 
PASCOE, Gary
And certainly something that we are looking to work with you and working, engaging a lot with healthcare. And I think when we talk about this, the TGA talks about this as the first wave is very much around the UDI use within health and the adoption by manufacturers and sponsors, ensuring the UDI is on the devices and it meets that requirement.

31:43 --> 31:51 
PASCOE, Gary
And now we're sort of reaching into that second wave to support the embedding of across that, across the healthcare sector, open up those benefits that we talked about.

31:51 --> 32:08
PASCOE, Gary
So hopefully this has been helpful. I'm going to actually do a bit of a demonstration. So, I've created some examples of, or I've got some examples of actual real live data. So, this is in front of you, you will see the

31:08 --> 32:30
PASCOE, Gary
access to the UDI database. So, if those of you who haven't seen it already, so this is the set of live data in the system. And so, as I mentioned earlier, this data is accessible to you, to Registries, other consumers to be able to read that. There's a range of different sort of rudimentary basic methods to be able to access that data now.

32:30 --> 32:52 
PASCOE, Gary
We would very strongly welcome engagement and sort of co-design work with Registries now to start talking about how you can electronically access this information, what other information, what would be the sort of reverse, any reverse processes that may be in place to actually help you do that. So, this is this is a AusUDID.tga.gov.au if you're looking for that link.

32:52 --> 33:14
PASCOE, Gary
I'll just go down and agree to the terms. In front of you is essentially a screen that the TGA is the sort of landing page for consumers and sort of non-authenticated non-sponsors within the database. So, as you can see here, the database actually provides a range of different functions and menus at the top. So, I'll just quickly move through those.

33:14 --> 33:37
PASCOE, Gary
The Devices tab provides you the ability, so this is all the information in the database that's currently there, so it's unfiltered. And when I scroll down here, you can see that there's 41,690 records. So, most of those, I think, is about, let's say, 90 plus, 95% of those devices are Class II products, because that's where the requirements are. But certainly there are

33:37 --> 33:57 
PASCOE, Gary
Class IIIs and other device types and classifications in there. The downloads feature may be of use and of interest to Registries. So, we have the ability for you to download the full database in a JSON format. So we are, we sort of kept this pretty simple at this stage to be able to allow the,

33:57 --> 34:17 
PASCOE, Gary
just to capture and understanding and start to familiarise yourself with the data. Ultimately, we would love to work with Registries as well as healthcare organisations to understand how we can electronically submit this through APIs or you can access it through APIs. So, there will be some work that we're looking to sort of embark on in coming

34:17 --> 34:37 
PASCOE, Gary
months around how we start to turn that into something that is real time accessible. So, but you can down, as you can see there, you can download the latest version of the database, so the full 41 odd thousand records, all different deltas associated with that. So, what I thought I might do is just also then sort of show some examples of some ability

34:37 --> 34:58
PASCOE, Gary
So what I will do is, because there's some examples, I'll find, you can search through this sort of keyword search to a range of different products. So, I'm going to pick a product from 3D Morphic, which is a spinal fusion cage. And as you can see here, there's different, there's two products in the database already. So that's

34:58 --> 35:18 
PASCOE, Gary
If those of you who are looking at the sort of spinal registry from the spinal registry, these products will then allow you to actually start to capture some information or find some information about that device. So, in the database, you can then, I've clicked into drilling into that information and what's in the database. So, this is sort of a highlighting

35:18 --> 35:38
PASCOE, Gary
headline information page using some of the characteristics that's in the database to either link it to say this is this is included on the ARTG, so it's been authorised for supply and based on its MRI safety characteristics, then we can we can present that information. So, information that may be in here, so

35:38 --> 35:49
PASCOE, Gary
which I'll just sort of work my way through the tabs on the right hand side. So how many devices, whether it's a unit of use, whether direct marking of the device is required. So, for those, the devices that are reusable and reprocessed, except for implantables, there is a requirement to have the UDI

35:39 --> 36:16
PASCOE, Gary
directly marked onto the device itself to ensure that it’ll continue to be accessible as it passes through the different reprocessing processes that you may go through the hospital. So, there's other information about the device, as I mentioned here, sort of

36:16 --> 36:36
PASCOE, Gary
brand name, model and version number, whether it includes software as a kit, who manufactured it, some information about the clinical characteristics of the device, so whether it's unsafe or MRI, whether it's conditionally unsafe. So, this is information that would typically come from the, that's now codified, that would typically come from the instructions for use

36:36 --> 36:57

PASCOE, Gary
or be on the label of the device itself. So, it allows you to start sort of capturing information, what different sterilisation methods have been defined by the manufacturer in terms of the product. Production information is, as we can see here, so the device is manufactured and they use batch number or lot or batch number to

36:57 --> 37:17
PASCOE, Gary
actually identify the particular production runs of the device. This page will provide a link back to the ARTG. So those of you who are familiar with the Australian Registered Therapeutic Goods provides that information associated with the ARTG. Any packaging or cataloguing information, so as you may have mentioned, may recall, I talked about

37:17 --> 37:37
PASCOE, Gary
There's this device itself, so this fusion cage, spinal fusion cage, is actually supplied in a box. It had, the three of them are supplied in a box with this number. And so, in this scenario, if the hospital only has the packaging Identifier, the Identifier of the actual that’s box sitting in their warehouse,

37:37 --> 37:56
PASCOE, Gary
they can use that to find the actual product as well. So, the database allows that sort of traceability up and down through the data to allow that to be able to be found easily. And here there will also be things like catalogue numbers or reorder numbers, depending on how that's defined in the hospital system or by the sponsor.

37:56 --> 38:18
PASCOE, Gary
And then you can use that to sort of search for the information as well. Any supporting documents. So, one of the things that the TGA has also then extended the UDI database to allow the capturing of patient information leaflets (PILs) or electronic instructions for use (eIFUs). So, to start opening up that opportunity for users of the product or users of the device to be able to start capture information and

38:18 --> 38:38
PASCOE, Gary
long term search on the product and then the history is really when the product, so we create the ability for versions to come through. So, I won't get too detailed into some of this, but I really encourage you to start looking at this product. There's probably a couple of other things I would like to cover. First of all is

38:38 --> 39:02

PASCOE, Gary
those of you who may be familiar, the database also uses a thing called the Global Medical Device Nomenclature (GMDN). So, we give you the ability to use the GMDN that's defined. So essentially, it's a nomenclature that's been associated with the device. If I click on this product and to go to the GMDN, so it gives you the ability to search for all devices that may fall into a certain

39:02 --> 39:23
PASCOE, Gary
category or definition advice. So, for example, if I sort of, if I go to this device and I'll sort of start to select anatomical specialty, it'll then allow me to drill down a navigation tree. So, I might use sort of dental devices, then it'll start to show which products actually fall into that and which, you know, be

39:23 --> 39:43
PASCOE, Gary
it's sort of independent of the manufacturer and how they define that. So, it'll provide all the devices are being characterised as a dental maxillofacial, maxillofacial devices. If you need to, you can start to sort of drill into more specific information. So, there might be dental prostheses.

39:43 --> 40:03
PASCOE, Gary
and associated devices. So, you can start to drill into that and then sort of into there. So, if you are looking for categories of devices and the ability to start to bring specific information about a device, then, or a grouping of devices, then this sort of capability may be of use to from a Registry point of view.

40:03 --> 40:23 
PASCOE, Gary
The other sort of final point I wanted to make was, the other thing is, those of you who may be familiar with the Australian Registry of Therapeutic Goods, one of the differences between the UDI and the ARTG is that we, an ARTG, an ARTG inclusion is for a kind of device. So, it essentially captures

40:23 --> 40:49 
PASCOE, Gary
If it's the same risk class, it's the same GMDN and code, manufacturer and sponsor, that may actually cover multiple variants of a particular device. So, the approval is provided to a kind of device and then that actually may have multiple variants of those devices. So, we're already starting to see with the introduction of UDI, we start to get more granularity in terms of the actual variants or other variations of those devices.

40:49 --> 41:12
PASCOE, Gary
So I've got one I've searched for earlier. So, if I use the ARTG inclusion 408217, which is essentially for this sort of implant solutions trading as Osteon Medical. As you can see here, I'll just expand the screen out a bit. As you can see here, this is now indicating under this one ARTG inclusion, there are

41:12 --> 41:29 
PASCOE, Gary
a significant number of products, I think there's 200 odd devices or individual models of device, and so that ranges from different types of screws, different types of, different variants of the screws, as well as then

41:29 --> 41:51 
PASCOE, Gary
Scroll down, there's I think, yeah, 255 records. So, we essentially be able to then allow you to identify different models or versions and actually start to drill into the actual model or variant of that device rather than sort of considering if you're being sort of constrained to that high level ARTG.

41:51 --> 42:11
PASCOE, Gary
And so through this information, as we can see, there's 255 variants associated with that, with that ARTG inclusion. We're seeing this opportunity for Registries and particularly to start to drill into the information about the sort of the individual products and start to dig in a bit more around, you know, what the product is,

42:11 --> 42:14
PASCOE, Gary
What other information does it maybe have on it?

42:14 --> 42:19
PASCOE, Gary
So I will just pause there and stop there.

42:19 --> 42:36
PASCOE, Gary
Close my screen and just going back to, so hopefully that's useful. As I mentioned, AusUDID.tga.gov.au is the URL. If you're interested in accessing that data, you will essentially have the ability to sort of access that immediately.

42:36 --> 42:57 
PASCOE, Gary
I do expect we are getting questions from, as pre-registration questions. You know, some of you were asking about when will I start to see the information for products. Some of it may be there. So, we have, I’ve mentioned 41,000 records in the database. We are anticipating we are getting a lot of organisations starting to look at their electronic

42:47 --> 43:17  
PASCOE, Gary
transmission of that data. So, I expect that to jump quite significantly in the coming weeks as more and more sponsors, particularly those that have different variants of a particular screw or rod or, you know, implantable products. So, it'll capture all those different permutations and combinations. So, we certainly encourage you if you do

43:17 --> 43:37 
PASCOE, Gary
want to use it to have a look at it. If there are any questions, please feel free to contact UDI@health.gov.au for any support if you do have any issues. So really just in summary, I'll just quickly say, as we mentioned earlier, I expect to see

43:37 --> 43:59
PASCOE, Gary
the UDI is helping you. We are seeing the UDI helping, you know, dealing with the challenges we know Registries are facing, you know, the quality of data, the inability to standardise, or the differences in terms of standardisation, the limited ability to link particular identifiers and devices, and then, you know, pull a holistic picture of those devices through things like

43:59 --> 44:19
PASCOE, Gary
the ARTG ID, the product codes, catalogue numbers, billing codes, and how that sort of works to actually give you the information you're looking for, and then all the challenges associated with that. So, UDI is early days, but essentially we do see that helping you improve your data accuracy.

44:19 --> 44:38
PASCOE, Gary
support the standardisation, both in terms of the identification of device, but also then longer term as part of that sort of standardisation through things like the HL7 FHIR Sparked program and ensuring that there's a standard language being used for those particular products.

44:38 --> 44:58
PASCOE, Gary
supporting that data linkage, data capture, and building out and really starting to bring some completeness to the information that you're sort of capturing. And then ultimately, it will lead to greater traceability, greater patient safety, which is really where we're, you know, the TGA has embarked on this journey to work through.

44:58 --> 45:01
PASCOE, Gary
So, I've rattled off a number of...

45:01 --> 45:21 
PASCOE, Gary
web addresses, e-mail addresses. So just to sort of recap on those, the team is very actively hopefully sort of responding to questions or hopefully getting questions. If you do want more information, please feel very free to go to the TGA UDI Hub. So, the QR code there will help you or

45:21 --> 45:42
PASCOE, Gary
Just Google TGA UDI hub and that will take you there. There is a dedicated support team in the background, so providing a whole range of support. Our focus is very much at the moment around ensuring manufacturers and sponsors are ready and actually getting them comfortable with what they need to do from their sort of regulatory obligations.

45:42 --> 46:02
PASCOE, Gary
However, we are getting a lot from healthcare and other downstream users and stakeholders in the data, of the data now. So, we are looking to get your thoughts and feedback and your assistance or requests from you to work out how we can support you. And then finally, as a demonstration, there was AusUDID.tga.gov.au.

46:02 --> 46:20
PASCOE, Gary
is the database. So, feel free to sort of access that. I am going to open the floor for questions. So, I might just hand to Carolyn and to have her read out any questions that may be there. Or if I answered everything, Carolyn, I remember thinking is beautiful and rosy.

46:20 --> 46:40 
WILSON, Carolyn
No, the questions are about to flood in. Just a reminder to people, if it's not there already, there will be a feedback link that will be in the chat. I really welcome anybody's views about what you found useful or what we could improve on next time. First question, Gary, is from Susannah Ahern. A compliment and a question. It's a great system.

46:40 --> 47:01
WILSON, Carolyn
How are you thinking that Clinical Quality Registries will be able to access the UDI data from surgeons and hospitals to add to their Clinical Quality Register (CQR) episode record? Susannah says, I think that surgeons entering the UDI manually is high risk for errors. Should the surgeon take and upload a photo to the CQR database?

47:01 --> 47:08
WILSON, Carolyn
or will the UDI barcode scanners be able to direct the scanned code directly to the Clinical Quality Registry?

47:08 --> 47:31
PASCOE, Gary
Yeah, thanks, Susannah that gets to the number of the probably the challenge that we have or the work we're doing and ultimately, and we talk about sort of perfect world and end state we're looking to go to, which is ultimately the plan is to have the UDI on the barcode on the device or associated with the device as it works through, because some of these products may be too small to actually have it on the device.

47:31 --> 47:52
PASCOE, Gary
have that scanned in the hospital, either the surgeon in a pre-operative process or perioperative or even possibly in some hospitals talking about post-operative, but that's essentially the point of data capture. Experience in certainly following the UK government and of the NHS and their implementation.

47:52 --> 48:11
PASCOE, Gary
In addition to dealing with the issues, like you talked about, I absolutely agree the risk of data entry issues is enormous in terms of manually capturing. And then, it is enormous, but the benefit that's come from being able to automate that at those processes at those times not just helps you in terms of the data flowing through,

48:11 --> 48:30 
PASCOE, Gary
but ultimately has saved time for the sort of clinical and nursing staff as well. So, there's a significant benefit, but ultimately that's where we're working with healthcare and other organisations to help sort of get ready and adopt that. We ultimately will then see that working with the stakeholders associated, have that flow through to you.

48:30 --> 48:51
PASCOE, Gary
through the sort of the processes that you may have, either electronically or other means to sort of get the data from the hospital and health care system. Now, I suspect there's many permutations and combinations of all of that and how the data flows. So happy to talk specifics. I think Tracey may have put a hand up as well. So, I sort of want to sort of cover that question as well.

48:51 --> 49:10
DUFFY, Tracey
Thanks, Gary. Thanks, Susannah, for that excellent question. I didn't expect anything less from you. Look, this is part of what we're trying to look at going forward is what are some use case examples to include in some documentation and some guidance information that will help people think about

49:10 --> 49:28 
DUFFY, Tracey
what could potentially be put in place at the point of care. And noting all the things that Gary mentioned, we're wanting to work closely with hospitals and with Registries to test out some of the information flows between

49:28 --> 49:42
DUFFY, Tracey
the various data sources, including the TGA database as well. So absolutely on the money. And if you're willing to help us do some of these test cases, we'd really appreciate it.

49:42 --> 49:53
WILSON, Carolyn
Excellent, thank you both. Next question, when will the rollout for orthopaedic prostheses begin and will the UDI be required to be on device stickers?

49:53 --> 50:15
PASCOE, Gary
So Carolyn, yeah, thank you for that. The orthopaedics has started. So essentially, well, it becomes mandatory, so we definitely have started. So, if you look at the database, there is orthopaedic products in the database already. So, some sponsors are already doing it. It becomes mandatory on the 1st of July 2026.

50:15 --> 50:37 
PASCOE, Gary
So in the coming months. We are seeing some challenges with sponsors sort of being ready and we have to give them a little time to actually ensure they're ready, particularly with data coming from Europe as well as while they’re working through that. The sponsor has the opportunity to sort of create, to apply for what's called a consent to supply (CtS) that gives them the ability to continue to supply the product

50:37 --> 50:55
PASCOE, Gary
as they get that data on, but certainly over the next 12 months, I would see, sorry, the next couple of months, I see quite a large volume of data sort of leading in, and then it will sort of depending as their readiness run for a number of months after that, but certainly it's starting. For non-

50:55 --> 51:09 
PASCOE, Gary
implantable products, there is a bit of a longer time because of some of the transition in Europe. But yeah, orthopaedics, I certainly see a lot of that coming very quickly if it's not there already.

51:09 --> 51:35
PASCOE, Gary
Sorry, stickers. So, the short answer is yes, we expect to see the UDI on stickers, depending on how the manufacturer and the sponsor label and identify the device. It is not mandatory because they may have other means of satisfying the UDI requirement, but we many most of the organisations we've spoken to expect them to see that on the stickers and so that would then

51:35 --> 51:41
PASCOE, Gary
help alleviate some of those sort of data scanning and capture issues that Susannah talked about as well.

51:41 --> 52:01
WILSON, Carolyn
Thank you, Gary. We've got about 7 minutes left. This is the last question that we've got at the moment. So, if anyone has any last minute questions, please feel free to put them in. This question, Gary, will the UDIs relevant to our data collection be available from the TGA for verification purposes?

51:01 --> 52:23
PASCOE, Gary
Yeah, look, that's a great question and we certainly would love to. So, picking up on Tracey's comment earlier, so if we would welcome the opportunity to work with Registries to do exactly that. So, we have created the database to be able to do that sort of backwards verification and confirm that the devices are there and also link it to ARTGs. So

52:23 --> 52:44
PASCOE, Gary
We, yes, it will be available and it will be possible. How you get that information, we we’re really very interested in working with you about, you know, whether an API is more suitable, what you'd like in that. Are there other methods that Registries would like to receive that data? So rather than going building that, those use cases that Tracey spoke about, we're very interested in.

52:44 --> 52:54
PASCOE, Gary
in talking to you. So please get in touch with us or we can follow up with you, but really welcome that opportunity, but it will be definitely available and it's at no cost and to you in terms of accessing.

52:54 --> 53:15
WILSON, Carolyn
Thank you. All right, last question from Manjaban. This is great, very helpful. If a device is initially export only, but later planned for ARTG inclusion, what is the TGA expectation on retrospective UDI compliance and AusUDID data submission?

53:15 --> 53:37
PASCOE, Gary
So if it's manufactured for export only, then it won't need a UDI because it's for export only in terms of that process. Once the device then, let's say, moved to supply into Australia and that's been approved, then the UDI data, so there's really the sort of three things will need to occur from

53:37 --> 54:00
PASCOE, Gary
the date that that approval is provided or the date that the product is then supplied into Australia as an approved product. You don't need to retrospectively go back and do that. There are some rules around existing devices, and it gets complex. But fundamentally, once the device has been approved and it's being supplied in Australia, that's the point that you then need to meet the UDI requirements.

54:00 --> 54:06
PASCOE, Gary
And so, it's the date of approval, or once it's moving into Australia.

54:06 --> 54:20 
WILSON, Carolyn
Excellent, thank you. We'll leave it at that for questions today. If you do have any questions that either weren't answered or any pop into your mind, feel free to e-mail us at udi@health.gov.au. Back to you, Gary, to wrap up.

54:20 --> 54:41
PASCOE, Gary
Yeah, thanks, Carolyn. And probably just wanted to thank everybody for taking the time and joining us. Really, it's fantastic and it's an exciting part for us now to sort of stage for us to sort of start having these discussions with Registries, work on those use cases, think about how we can support what you need to help perform your function and how that can sort of cover

54:41 --> 55:03
PASCOE, Gary
We don't have a link in here, so I'm sure we put it in the chat, but we would, as Carolyn mentioned, we would welcome any feedback on the session and the value of it, the merits of it. We definitely wanted to cover a lot. There's a lot to cover in a short period of time. So, if you are looking for more specific information, we're very happy to run sessions or sort of cover that. So please

55:03 --> 55:22
PASCOE, Gary
provide that feedback back as well so that we can kick along this sort of discussion and ongoing interactions with those people who are interested in using the UDI. But just wanted to sort of take the opportunity to thank you, thank everybody from the TGA team also to help us to get this point and respond to questions as they're coming. So

55:22 --> 55:29 
PASCOE, Gary
Really appreciate your time and happy to hand back to Nishie if there's anything else you'd like to cover.

55:29 --> 55:40 
HEWAGE, Nishie
Thank you, Gary. I think you've covered pretty much everything. Well, let's wrap it up here then. Have a great afternoon, everyone, and see you next time.

55:40 --> 55:42 
PASCOE, Gary
Thank you.