Considerations, challenges and implementation

Gary Pascoe

Dr Oliver Daly

Rachel Schulz

Rachel Schulz

So, good morning from, here, in Australia. Thank you and welcome to our first UDI (Unique Device Identification) webinar for 2023.

I would like to acknowledge the traditional owners and custodians of the land in which we meet today, and pay my respect for Elders, past, present, and emerging. I’d like to extend that acknowledgement and respect to any Aboriginal and Torres Strait Islander peoples here today.

I’d like to now pass over to today’s host Gary Pascoe, the UDI Product Manager, here, at TGA (Therapeutic Goods Administration).

Gary Pascoe

Thanks, Rachel, and good morning, good afternoon, good evening to all the viewers who are joining us. We have some great registrations and interest in today’s webinar, so, hopefully, everybody is able to join us that would like to.

So, as Rachel mentioned, this is the first UDI webinar for 2023, so I just wanted to wish everybody a Happy New Year and a Happy 2023, if we haven't spoken to you since the start of the new year.

As you can see from the slides in front of you, this is our 15th webinar for UDI. A large element of our focus to date has been predominantly around the provision of UDI data and the manufacturers’ and sponsors’ responsibility in providing data into the Australian UDI database.

We’ll continue to have those conversations as the UDI implementation progresses, and as we move closer and closer to the implementation of date. However, we’ll also start to be introducing some more flavours around the, obviously, the value of UDI within the healthcare system, and the implications and considerations for UDI within hospitals, healthcare providers, registries, other healthcare professionals.

So, a large emphasis of today is very much around bringing that to the floor and starting to bring that perspective into the conversation for UDI. So, I’d like to thank everybody for joining us, and for participating in that conversation. I’d particularly like to thank Dr Oliver Daly, who has joined us to be able to talk a bit about the UDI from the perspective of the healthcare system.

And then, you’ll see on the slide there, also, Jasmin Hyatt. So, while Jasmin doesn't have a speaking part today, a number of you will have been involved and engaged with Jasmin. She runs our UDI support team helpdesk, essentially, putting all the materials together. So, I’d just like to welcome both Oliver and Jasmin to the conversation and to the meeting.

So, today’s agenda is very much twofold. As I mentioned, we’ll start off with Oliver, who’s kindly agreed to presenting to us around the considerations and the benefits of UDI and healthcare. I’ll also then follow that up, give you all an update on the UDI project and where things are at from TGA’s perspective. The implementation of UDI.

Hopefully, answer some of the questions that a number of you have registered prior to the webinar, as part of that process. And then we’ll also set aside some time for questions and answers that you raise through the Slido app.

So, with no further ado, I just really wanted to introduce Dr Oliver Daly. Dr Daly is a practising urogynaecologist within the Western Health System, here, in Australia. Oliver has been an active member of the UDI community within the TGA, and as you see here, he’s been represented... The Co-Chair of the UDI Triggers Working Group that we ran in 2021.

Oliver, himself, has lived experience, in terms of the issues associated with recalling devices and, particularly, critical devices in medical crises, and issues and the challenges associated with doing that. So, he’s very much a supporter of the UDI and the implications of how that can support hospitals. He’s very interested in sharing his experiences around how that can support and assist both from a clinical and an operational perspective within the hospital system.

So, I just wanted to welcome Oliver, and thank you for your time, and hand over to you.

Dr Oliver Daly

Thank you very much, Gary, and thank you for everyone who’s attending. So, I’d particularly like to thank Tracey Duffy, and Gary, and then entire Australian, AusUDID (Australian Unique Device Identification Database) team. This is a really important initiative, and hopefully, I’ll be able to demonstrate why it is such a fundamental element of the entire system for monitoring clinical safety and performance.

I'm aware that there's a large range of stakeholders, you've got manufacturers, distributors, those who manage stock in hospitals, there's financial aspects. But I'm going to be focused predominantly on those clinical aspects of how do we make sure that devices are performing in the way that we expect.

So, we’ll just start with the problem that UDI really deals with. So, until this initiative, there's really been no single universal identifier that exists for devices implanted into patients. And this limits the capacity of the health information infrastructure, so the health system as a whole, and any systematic processes to record and document device information at the time of implantation in a patient.

And because we don’t have that source of information, it’s very difficult to identify, collate, analyse, and report devices that we used and what their performance is. This creates a problem for all users of the health system, so patients, clinicians, and health system regulators alike.

So, how do we know which patients have which device at a product level and a manufacturing level? How do we know if there's a batch issue, for example? How do we provide feedback to clinicians about patient outcomes to inform clinical practice? Devices change all the time, and clinicians are using different devices. How do they know that they're actually getting the results based on the available evidence?

And then, for groups like the TGA, how do we actually... If we don't know the denominators for which patients have which devices, how do you ascertain the incidence of adverse events and the effectiveness at a population level? And therefore, support those product safety and other evaluation processes to keep the Australian population safe.

So, I've got a few problematic device examples over the last 20 years or so. Some may know some of the lymphoma-associated issues with breast implants. These are rare outcomes, it’s only through the Breast Device Registry that they actually identified this, because it’s a rare outcome, you can't really identify it in randomised control trials.

And so, you really need large data and population-level data to identify that. But then, how do you... If you don't have the unique identifier that identifies that product, that breast implant, and the manufacturing details, how do you actually then do further investigation to further investigate that?

We’ve now got the metal-on-metal hip implants, and that there was a change in the design and composition of those devices that actually had significant safety and wellbeing impacts on patients and the performance of those implants. So, once again, how do you actually track that back to a particular device or the manufacturing information?

And then, most recently, the issues with transvaginal mesh, as the senate inquiry found, there was actually no way of knowing how many patients had had mesh. And because we didn't have those denominators, we actually didn't know... We couldn't really ascertain how big a problem those complications were.

And so, as we know, that has led to significant issues for women, and patients themselves. But also, clinical practice, in that there's... A lot of products are no longer available because of these safety concerns, even though they might have been effective, but that's as a consequence of the significant impact on women.

So, what does a UDI system enable? So, it enables this systematic prospective recording. And what I mean by prospective is when a surgeon is putting a device in, they can put the Unique Device Identifier into the medical record. That means you can record it at a patient level. That means you can ascertain the clinical denominators at all levels of the health system, potentially, to look at device usage, safety, and performance.

It also means that you can analyse those changes in device safety and performance over time. So, for example, the metal-on-metal hip implants. That, maybe, you could have picked that up earlier if there were issues.

You could link the device implantation details with other identifiers in the system. So, the procedure that's being done, diagnosis, and then following up from that, any complications that might be related.

So, in the case of transvaginal mesh, you might have found that if we were recording this prospectively, that you could have seen that there were a group of women who suddenly were on chronic pain medications after their surgery.

And so, really, it allows this analysis of outcomes, both, at the time of the implantation, if there's a complication intraoperatively or perioperatively, but also, longitudinally, over time.

And then we can, of course, ultimately, support the role of health authorities, such as the TGA when medical device safety issues are suspected, investigated, confirmed, and then it supports acting upon those. So, if you have this unique identifier, and the TGA sends out a product alert, they can look in their system and say, oh, this group of patients had these devices, and you can inform them, and then advise further action.

It may also be very useful for clinicians to know if there are certain devices not performing as expected. But also, sometimes manufacturers and distributors don’t know. So, it also enables us to provide that complete feedback loop. So, the UDI is critical to all of this.

How would it do this? Well, if we standardise... Now, I'm putting an acronym in, so the high-risk implantable device. So, all of these devices I've talked about are really these Class III devices, as per the classification. And so, you could, potentially, standardise... Or the UDID (Unique Device Identification Database) enables you to standardise the Product Information that is recorded by hospital staff.

It’s a single identifier that can be designed into hospital information systems and data collection processes. And that could be incorporated into other datasets, such as jurisdictional datasets, and other clinical recording processes, such as registries.

And then, you can also incorporate into data linkage and period reporting processes so that this may also support research activities. And down on the bottom-right, you can see an example of a label that could be put on these respective devices to make it very easy for staff to do this.

To provide a bit of background, the moment I knew that this was really important was... Some people may be aware of the Federal Court class action over the mesh devices, and we were mandated to an audit of those to identify patients who had received devices. And through doing that, I realised that nursing staff routinely collect this data. They put it on, whether it’s paper or electronically, in the different health information systems, they record this.

But the problem is that they're using a range of different identifiers to do that. So, the purpose is, really, that they... It’s very easy for the staff to know which identifier they should put into these systems to support these processes.

So, let’s look at some of the challenges. So, let’s look at hospital information systems incorporation. So, there are a number of ways that hospitals record data about implants.

There are operating theatre information systems. There are patient administration systems, sometimes they're used for that purpose too, and also, electronic medical records. And of course, some hospitals are still on paper. So, you do need a... This needs to be implemented in a way that irrespective of the way that implant data is collection, you can use the same UDID.

The really important thing is that you can support accurate routine and low-effort capture at the time of implantation. If you can do that, then it’s likely that you’ll get a higher ascertainment and a higher use of the UDID.

We need to look at how do we replace existing device identifiers. So, there's ARTG (Australian Register of Therapeutic Goods) codes, there's the Prosthesis List codes, which is used extensively in the private health system. And the National Products Catalogues, or stock control. So, we really need to look at how do we make sure that all of this is linked back, and, almost, aliased back to that single identifier.

And then, the other thing we need, too, is to make sure that hospitals are using the current UDID because this may change over time. So, aware that MBS has updates. The Prosthesis List has updates, how to actually dissimilate that to hospitals. And that could be either a manual upload or a machine-to-machine integration. We do need to make sure that hospital information systems are maintaining an up to date... Using the up-to-date version of the AusUDID.

Challenge two: so, where do we store, and how do we extract this and use it for all the purposes that I've talked about, and making sure that it does support these regulatory quality-improvement and research activities? Obviously, in a safe... Adhering to all of the privacy principles.

So, some of the considerations are should the UDID only be recorded in the patient record at a hospital level so that you only look for it when there is an issue identified. And obviously, retrospective analysis, that's going to support that process, but it wouldn't be prospected at a hospital, sorry, at a health system level.

Potentially, incorporate into My Health Record. So, we do give patients implant cards, but often they lose them, so maybe actually having a digital record of that would be a good option.

Is there a way that we have centralised storage in a specific register or dataset to support linkage activities? So, as a separate dataset to the existing ones. Or do we use one of the existing datasets, such as the Jurisdictional Administrative datasets?

So, in Victoria, we’ve got the Victorian Admitted Episode dataset. And that feeds into the National Hospital Morbidity database. And obviously, if you have diagnoses, procedures, and the implant, you've pretty much got a complete dataset.

The third challenge I’ll talk about is, really, reporting and data linkage. So, if we do want to support using this data for monitoring assessment and reporting this device performance, and patient outcomes, we really need to make sure we establish UDI as a minimum dataset for important adverse events, related to each of these high-risk implants or device types. Potentially, mapped to these diagnosis codes and the ACHI (Australian Classification of Health Interventions) codes, which is the standard way of recording procedure codes in the National Hospital Morbidity database.

How do we incorporate this into data linkage methodology and the periodic reports that may be at hospital or jurisdictional level? And how do we then incorporate analysis, further analysis, on this data, and make it available so that hospitals can use it, the regulators can use it, but also, clinical quality registries?

And just putting this into a bit of a flowchart of how such a system is really dependent on the AusUDID. So, if we have this unique... If we have the UDID, we’d really have to look at the different aspects of that, about how it’s used, and the various legislative and regulatory aspects of that, of making sure it’s used appropriately. And where that is stored.

We’d have to look at the different hospitals information systems and do a current state assessment of where is this data currently stored, through the different databases. As I've mentioned, there are a number of different databases that would use this identifier.

What are the requirements of hospitals to use this information? What changes would you have to make to these systems? Remember, we’d have to have a really good relationship with vendors because there's, obviously, a lot of development time and collaboration involved in making sure that the information systems actually can incorporate this data.

And how do you make sure there's compliance? So, how do you make sure that staff are actually using the correct identifier? And then, there is the use of this information by health system users, regulators, and stakeholders.

And then, the use of this data, as mentioned, we’d have to review the dataset options for where this information is stored. We’d have to look at these authorised users, who’s permitted to use this routinely, versus ad hoc requests.

How does this feed into the periodic data linkage reports, or perhaps, related to adverse events? So, if you've got an admission to hospital for a complication, how do we make sure that... How do we facilitate that being linked back to a certain device? So that's where the minimum datasets come in.

So, if I'm performing an operation for a complication, and it is related to a device, how do we incorporate that into the operation notes? So, then, that goes into these datasets so that we do have that complete feedback loop and can incorporate that into the data linkage.

And then, when we get into the analysis phase, how do we use that to identify the denominators and the specific rates, how does that feed into safety and quality assurance activities? And then also, feed into other sources of clinical outcomes and variables.

I've kept the presentation relatively short because I think it’s really important that people do have an opportunity to ask questions and further investigate, so that we can make sure that there are no other clinical aspects that haven’t been covered.

Gary Pascoe

Thank you, Dr Daly. So, really appreciate it. So, as mentioned, we would very much encourage questions. And I know there's a number coming through, and I think that the questions that have been asked really start to represent some of the things that are in consideration, that have been discussed here. So, we’ll set some time, as I mentioned, the questions and answers at the back end of this session. And so, we can address as many of those as we can.

Before we do that, I also wanted to provide an update on the UDI project, and where things are at. So, first of all, the UDI project is progressing well and progressing nicely. And essentially, there's a range of things that we’ve been doing around... Just continuing the work that we’re completing or wrapping up at the end of 2022. Predominantly around a number of core areas.

So, the first one is, obviously, those of you who have participated in the Sandpit database and the testing of our trial version of the Australian UDI Database, I’d like to thank everybody for that participation. That ran from 4th July through to 31st January. And I have a little bit of... So, a following slide to give a bit more of a breakdown of what came out of that. Essentially, that all closed on 31st January, and we certainly found that it was very successful.

As part of our next move within the technical aspects of the Australia UDI Database, we have moved the database and upgraded it to ensure that it is compliant within the Department of Health and Aged Care’s IT environment.

So that, essentially, has occurred, and is in the process of actually being tested and confirmed from a cybersecurity perspective. And essentially, just making sure all those components are in place and operating, with the intention of having what we’re calling a pre-production version of the database. Available for use by manufacturers, sponsors, healthcare providers, or anybody else who is interested in from March of this year.

So, as I mentioned, the next top point, we’re, essentially, aiming to have this release occurring in March of this year for testing by all the range of different providers that have access to the Sandpit version.

There are a number of questions you have asked around implications for the Australian UDI implementation and the changes, the recent changes, that have just been approved by the European Parliament around their dates for the implementation of the EUDAMED (European Databank on Medical Devices), and our MDR (Medical Device Regulation), and the implications of that for the rollout within Australia.

At this stage, and obviously, noting that this is subject to final approval from the government, and government direction, we’re still aiming for voluntary compliance release in May, end of April, or May, of this year. To be able to ensure that we can have a version of the database that reflects a production-like state that manufacturers, sponsors, in particular, can have some certainty around the data requirements, the rules, associated with the UDI database.

And then obviously, also then, for hospitals and other consumers, the users of the UDI data, to be able to start to get a feel for what that data would be and how they could use it within the systems, now, per the conversations that Dr Daly... And considerations that Dr Daly just put to us today.

The policy is still in development, and so, we have taken the feedback from the UDI Consultation Paper that was closed at the end of last year, October of last year. Used all that information to formulate policy, position, and advice to government. And that's, essentially, been worked through and approved by the government.

So, we’re working within the TGA to get to that point where we can provide some clarity and some certainty around the UDI database, and also, the UDI regulations. And I think there are a number of questions that have been asked, prior to this webinar, around particular dates, which we’ll come back and address. Unfortunately, certainty of those depends on final direction and confirmation by the Australian Government.

From the UDI project, we’ll recommence our technical working groups from 28th February. And with the predominance... The primary focus is, essentially, for us to be able to then focus on the provision and finalise some of the questions that we had, and work through with sponsors, in particular, around the submission of data into the UDI database.

So, as they're confident that as the devices then supplied in Australia, the UDI information is available for use within the healthcare setting that Dr Daly talked about.

And I also wanted to say our next webinar will actually be 28th March, so there's... We’ve just recently had a clash, so unfortunately, there's an incorrect date there, and we’ll change that before the slides go out. But our next webinar will be in March, the end of March, and essentially, looking at the focus on... Continue some of these conversations around how that impacts, or how UDI impacts healthcare settings, healthcare providers, hospitals, etc.

But also, then, looking to, at that stage, provide more clarity around what’s happening with the UDI database, the pre-production version of that database, and ensuring that we start to make more consumers of the UDI more aware of what’s happening from that perspective in implementation.

So, really, then, my final...  A little bit of a recap on the Sandpit. I know a number of you have participated and contributed to the Sandpit, and just, really, as I mentioned... It was open from 4th July. It ran for seven months. The original intention was to have Sandpit open for six months and, essentially, we extended that to the end of January.

We have... Actually, still operational, so from a technical perspective, if you have access to the Sandpit versions, it is still operational. However, with the pre-production version expected in the coming weeks, in the next month, that we won't be admitting new users into that Sandpit version. Because there are changes associated with access, and also, for manufacturers and sponsors to be able to use the system, there are some changes.

So, rather than confusing everybody, we have closed access to new users, but we certainly will be opening that up again with the pre-production version. We did have 422 users, which is... From original, when we started this process, we weren't sure how many we would get, and certainly, from our perspective, from the TGA’s point of view, we’ve had very active support, with 422 different users, representing 177 different organisations.

And as you can see in the slide, there, three-quarters of those were sponsors or manufacturers, with a number of other general-public users, who were interested in just understanding the UDI database.

Now, general-public users may have been just somebody who was a consumer or a patient, or alternatively, generally represented organisations. Such as other government agencies, healthcare providers, hospitals, and other third-parties interested in understanding the UDI data and getting a feel for what data is actually associated with the UDI record. And the information that could be used to support some of those clinical processes that Dr Daly talked about.

We had 50 comments. Essentially, we had a whole range of other comments that came outside of that feedback tool and came to the UDI support team. That, essentially, had a whole range of comments around usability improvements, updates, and issues associated with the rules and regulations that we had in place, that ran in parallel with our last Consultation Paper. That was useful, in terms of providing us some feedback around things like the data elements, the data dictionaries, and the validation rules that were being applied.

And so, all of those comments, effectively, we’ve been taking on board. Looked at by the TGA’s UDI team, with a large number of them in process of, or have been incorporated into the pre-production version of the next database. Alternatively, will be progressively implemented over the coming months before we finish our final rollout.

So, as I mentioned, just to recap. So, we’re looking to have a new version of the UDI database for testing and access, and that was what we would call the pre-production version because it will be very much moving down that production path.

It’ll be sitting with the Department of Health’s IT environment, so that will give us the ability to do things, such as validate ARTG entries with the UDI records. It gives us the ability to have users who have existing access through the TGA’s Business systems. You can use those logins and that access path to be able to access the TGA systems as part of that standard set of tools that you use today within the TGA’s environment.

There's a number of other improvements, such as the bulk uploads. So, we listened quite extensively to your feedback around bulk upload and have made a number of changes per our consultation before Christmas, as part of the technical working group. So, yes, look to see that in the coming weeks, as part of our releases through the pre-production version.

So, we have moved through these topics as a really... At a clip. And it’s a good pace, so what we would like to do is, then, just invite anybody who hasn't raised any questions, to put them into Slido. As you will see, a number of questions, actually, have been moving along.

We will just have a bit of a moment to give you a moment to, both, do that, in terms of put any further questions in. I did see that there was also the poll, thank you, in terms of the registration for the poll.

So, please, we would welcome your feedback, in terms of using the Slido poll to give us some feedback around how we went, whether there was some particular topics that you were interested in. We will use that to, both, shape, and form how we deliver these webinars, but also, then, make sure these future topics are covered.

Okay, so, thank you, Rachel. So, if everybody’s happy, I might just act as the Master of Ceremonies, and field the questions, and work through them as we... As we work through. And then, maybe, answer myself or hand them to Dr Daly, or others, as I see fit and relevant.

So, there's a number of questions, and I’ll start... There's a number of questions that were received in relation to the implementation of UDI within Australia, and dates and timeframes. And particularly, around the alignment with the European Medical Device Reforms and the In-Vitro Diagnostic Reforms, in terms of the regulations that they're looking at. And particularly, with the dates of the UDI implementation.

So, as I mentioned earlier, we are looking and still working through, subject to government approval, with the implementation of voluntary compliance for UDI, provision of data, and essentially, then, provision of devices with the UDI labelling on it, from 1st July... Sorry, from May, June this year. And essentially, be able to look... The manufacturers and sponsors can voluntarily submit that data to the Australia UDI Database, with the aim of having mandatory compliance for those high-risk devices.

So, as Dr Daly mentioned earlier, we have Class III and active implantable devices, we’re looking to have mandatory compliance of those, with effect, or taking effect, from 1st July 2024. So those dates are still our target.

The considerations in front of government are really the recent changes within the European timeframes and the dates that they're looking to roll out UDI within Europe. Ensuring one of the key requirements, or two of the key requirements for the Australia UDI implementation is ensuring that we’re aligned with the European and the US systems. Ensuring that we weren't introducing regulatory burden that was above and beyond where we could, in terms of the European implementation.

But also, the European dates ensure that we were consistent in and trying to create less impact as we could on the manufacturers and sponsors of those devices.

So, those sorts of factors, in terms of... I'm, unfortunately, unable to give you specifics, in terms of when those dates will be. It certainly is a consideration of government at the moment, around the implications of the recent changes that really came through last week, with the European Parliament, around changes to MDR dates and how that would then be rolled out as part of the Australia UDI implementation.

So, certainly, those dates are still working. Are really driving all the work that we’re doing, and, really, as part of that process, there's a question that has been asked around whether the... When the legislation or the draft regulations will be available.

And essentially, we’re still working to have those completed by... Certainly, within this half of the year, and then available to manufacturers and sponsors, and anybody else who is interested, to ensure that you understand what those implications are. And then, as part of that process, will be finalisation of those dates.

So, I will answer a number of other questions associated with some broad questions. So, first one is... Quite simply, we had a number of questions asking about can we get a copy of the recording and the webinar. So, there will be, definitely... That information will be made available to the participants of this webinar. But also, the TGA publishes that on its website once the webinar has been published and finalised. That will be in the incoming weeks once we’ve closed this out.

So, from a number of other questions we had before, the webinar around such things as what is the basic UDI-DI (Unique Device Identification Device Identifier) in the Australia database? One of the responses say this was found in one of the datasheets. This is referring... Basically, UDIDI is a concept that's being implemented in Europe, but won't be implemented within Australia.

And certainly, that's one of the areas that has... We’ve had extensive consultation with manufacturers, sponsors, and industry, over the last few years, around whether the basic UDIDI concept that the Europeans use will be introduced in Australia. That's certainly something we can confidently say isn't currently in our schedule for introduction.

Effectively, the Australian ARTG ID (Australian Register of Therapeutic Goods Identifier), and the entry within the Australian Registry of Therapeutic Goods provides that same sort of level of information that the basic UDIDI that the Europeans supply.

So, there was one question around... You mentioned the word universal when speaking of UDI. However, different countries may have different UDIs. Can you expand on how this will impact benefits?

So, probably one thing, the term. If we did use the term universal, certainly, that wasn't talking about the UDI. So, the U in UDI is Unique. And one of the key concepts of the identifier that's associated and attached with the device is that it is unique, and it is globally unique.

So, essentially, as part of the UDI process, Australia will be complying, looking to comply, with a similar process that other jurisdictions in Europe and the US use, around having an organisation, such as the Health Information Business Communications Council, or GS1 (Global Standards One), issue a unique identifier that will... And those organisations, as part of that requirement will be ensuring that that identifier is unique.

Definitely, as this question’s raised, there will be... There's a likelihood that those device identifiers, the UDIs, may vary from manufacturers in different locations. And definitely, it will be... It could be a situation arising, where the same device may have different device identifiers across each jurisdiction, across the globe.

However, within Australia, it doesn't really compromise or take away from the benefits of UDI. And as Dr Daly talked about, it still gives us that ability to uniquely identify the device through the Australian healthcare system, and realise the benefits around being able to quickly and easily, and unambiguously, identify the device and pull that device from within the healthcare system, where it’s been... So, hopefully, that answered the question.

I’ll move to the next question, which is the EU MDD (European Medical Device Directives) and EU MDR (European Medical Device Regulation) transition will apply UDI to imported medical devices prior to the TGA implementation? And really, I think this question has then said will manufacturer format be acceptable to this TGA reform?

And certainly, I'm thinking, I'm expecting, that that is talking about both the device identifier that's, maybe, used by the manufacturer, but also, the labelling that was put on the device.

Again, while this is subject to final confirmation from government, and is part of those considerations by government, the TGA consultation paper has certainly proposed, and that we released at the end of last year... And as proposing, we’ve had strong feedback in support of this, is to actually allow labelling and unique identifiers that are used in the US or the UN, UA... EU, sorry, to be used and accessible within Australia.

So, essentially, a device subject to the final regulations, looking to have a device that is manufactured in the US, or manufactured in the EU, and if it’s compliant with those EU MDR requirements, then we’re looking to be able to accept that within the Australia UDI... Australian system. And then, the UDI database.

Obviously, we would be requiring the manufacturer or sponsor to supply that data for the database, and there will be some Australian unique characteristics within that. Probably the best example will be the ARTGID. So, we are looking to be able to link individual models of the device that's a UDI reflect and indicate with the kind of device that... And the application and inclusion for the medical development within Australia.

So, there will be a linkage. We’re looking to be able to link the model of the device with the approval to supply the device. But essentially, that will be one of the unique elements within Australia. But effectively, looking to be able to make it as simple and low burden for manufacturers and sponsors to supply that data.

We have a number of questions on patient labels and PICs (Patient Implant Cards). And essentially, I might address a number of them together. So, we’ve got this one here, which is patient labels and patient implant cards of high-risk implantable devices already exist and are in use with identifiers and serial tracking. And essentially, how would UDI be of greater benefit?

So, effectively, UDI won't be replacing these. So, a UDI will be augmenting and adding to the patient implant cards and the labelling. So, we will... Essentially, the requirements will be for UDI this unique identifier, which includes both the model... The identifier with the model of the device, but also, some additional information.

And if the device has as serial number, it will be in that labelling to allow machine-readable or human-readable... Human reading of the label, to ensure that information then flows through the healthcare system.

And so, one of the requirements will be... And as part of the implementation of UDI and the regulations will then... Ensuring that the actual unique identifier is placed on the patient implant card, as part of that process.

So, as you have seen... Those who are familiar with patient implant cards, you will see, today, there is a provision, or there has been a provision for UDI on there. And what we’ll start to do once the UDI database and the UDI provision of data from sponsors becomes effective, that unique identifier will, actually, start to appear on the patient implant cards for activities and surgeries.

You've probably had enough of hearing from me, so I'm going to... There was one question for you, Dr Daly, which was... I'm happy to... If you're happy to take. So, Dr Daly, implantables, today, come with serial numbers, how would UDI change behaviour of a clinician to start tracking information that exists today?  

Dr Oliver Daly

I suspect you've just answered that question. But actually, the UDI will incorporate some of that serial number information. But I might have to throw to you, Gary, maybe, to expand on how that will be incorporated.

Gary Pascoe

Yes, thanks. Thank you. I think I may have. So, as part of this... Probably two things, the process that I've just talked about. So, I suspect some of these questions have indicated to me that we may need to provide, to some of the audience, around what is UDI and the broader context of UDI and what comes in the device identifier.

But essentially, at a high level, device labelling, once UDI regulations will take effect, will require two identifiers within the... On the label for the device. And that will, effectively, identify which one, which uniquely identifies the model of device. And then another part of that identifier will also then be information about the production of that device.

So, whether it’s a lot number, batch number, expiry date, or if the device is managed by serial number, the serial number of that particular, device, as well. And so, essentially, on the label... Or all levels of packaging associated with that label, will then have that identifier and that label, which can be machine- or human-readable.

To ensure that as the device moves its way through the healthcare system, from supply into Australia, into a procurement or inventory system, and then through elements of the clinical system. To ensure that information can either be entered by particular administrative staff, or ideally, be scanned electronically into the relevant systems that Dr Daly talked about.

You put your hand up, Dr Daly?

Dr Oliver Daly

I did, yes. Just further to that. And I think it was what impact does this have on clinicians. Well, as I previously mentioned, this is information that is already recorded by, often, nursing staff in theatres, so it goes on to the operation notes, that sort of thing.

So, instead of, say, the Prosthesis List number on there, the current... With the barcode, it’s currently on the boxes. It would be the UDID sticker that we showed that could, potentially, go into those notes.

So, it should... If this is actually being embedded into the health information systems, then it shouldn't actually require any change in behaviour from clinicians. And if we can sort out how this information is stored so that it can be extracted if a clinician wanted to do a bit of an audit on the products that they use, then that's going to benefit the clinicians, but without adding excessive or additional data collection burden on them.

Gary Pascoe

Thank you. Appreciate that. So, I might move to another question related to this theme around the impact on hospitals and facilities. There is one question that says how many hospitals and facilities have signed up to test the Sandpit?

I couldn't actually tell you specifically on the number, we have had some, but it is early days. The project, the UDI project, is conducting a number of early adopter trials and projects with some state-based healthcare systems. We are starting to talk to private healthcare providers, as well, to ensure that we understand the implications.

Because as Dr Daly mentioned, there are different states of maturity. There are different technologies and IT systems used within the hospital setting. And obviously, then, we’re looking to say how do you incorporate UDI within those and how does that change your work practices and what you do. And obviously, that is likely to be unique to each location, each facility, and particularly, may even be particular theatres or clinical practices within those facilities.

So, we are starting to work with, and looking to work with software providers for electronic medical records, patient administration, and procurement, particularly, around electronic health systems. And so, essentially, be able to ensure that those systems do incorporate the UDI as part of an identifier that flows through their particular technology.

So that is still early days. As part of that conversation, we’re working with a number of other organisations within the healthcare sector, and particularly, within government, such as the Australian Commission for Safety and Quality in Health Care. And other state-based healthcare providers, and other government sections within the Department of Health and Aged Care, to ensure that we can make this UDI implemented across the healthcare system as simply, and as quickly, and easily as possible.

The unfortunate thing is the TGA’s responsibility from a regulatory perspective is that we will regulate the supply of the device and ensuring that the device, when it’s supplied in Australia, will meet the UDI requirements, in terms of the labelling and the data provision. But there's, then, a whole range of other requirements within the hospital and healthcare system that steps outside of the TGA’s remit.

So, the TGA... And there was a couple of questions about how does the TGA mandate this to come forward. Essentially, this part of this process now to show the benefit, but TGA doesn’t step that far.

There was another question that came to mind, around... But I did see earlier... Around the protecting privacy and ensuring patient information wasn't shared. And off the top of my head, I think the question was, effectively, saying UDI is a global initiative, and if there is sharing UDI globally, then how do we protect patient information?

So, I just wanted to stress that the UDI itself is actually... The UDI database and the database that the TGA is developing does not contain any patient information. It’s, essentially, storing the attributes and the information about the device.

So, the unique identifier as the key, and then it’s the attributes about the device, and that is all. That information is then shared or being accessed by whoever’s interested in using that information. But the TGA is not collecting anything to do with patients’ medical records, or any clinical practices that, then, we feed back into the UDI database.

So, essentially, that identifier, the UDI key, is then shared and can be accessible by anybody in the healthcare system, or any hospital registry, healthcare professional within the healthcare system. But all of that association with patient records, in particular, is all still managed within the systems that sit within the hospital, within the registry, or within the personal record systems that we have.

So, there is none of that sharing, so there's no issues associated with patient information being shared through the UDI database. And that's not something that we cover.

Dr Daly, you had your hand up?

Dr Oliver Daly

Yes, I just want to clarify. Yes, so when we talk about centralised storage of patient information, for those who don't know, obviously, all of the statutory and mandatory datasets that hospitals have to provide, so the Admitted Episode databases... Datasets that also contribute to the National Hospital Morbidity Database.

So, there is, obviously, patient-level information in a lot of these, but there are very strict governance processes over how that is used. So, I guess one of the considerations I was putting forward is that given all those protections that exist with those datasets, one possibility is that you've had an extra data item, which is actually across one of the... The AusUDID, so that you can do that data linkage, particularly in the high-risk devices, where it is really important that we make sure that we identify any potential issues.

So, I think, particularly, there was a question that said centralised storage of patient information and UDI being international, it really comes back to your point that it’s the device identifier that is international. Or in this case, an Australian identifier, it’s not the patient information, if that makes sense.

So, Gary, there was one other question that I wanted to draw on, that’s been waiting, I think. Somebody asked how will hospitals be made to comply with minimum data collection requirements of the UDI? Are you happy if we answer that one?

Gary Pascoe

Absolutely.

Dr Oliver Daly

Great. There's quite a lot of interest in that question, understandably. But all the questions have been great, actually. My presentation was, really, presenting some of the key considerations, but they're, certainly, not all the considerations.

So, I guess the reason I told the anecdote about how... Device information is already recorded in the system, the problem is that a whole range of identifiers are used. So, it’s actually impossible for groups like the TGA to actually go back and identify if there's a problem device, to actually go back and do a retrospective look-back, it’s quite a lot of work to identify a specific device or batch number.

So that work is already done, so I actually don't think it’s, necessarily, that hospitals would be made to comply, as such, because they do this already. And this is where I draw on the fact that we want to make this as easy as possible to actually use this identifier in place of the existing ones that they use.

So, I think if we can... If you can meet those two criteria, make it easy, and incorporate into the existing data-collection processes, then they're the two biggest enablers of this being effective.

Gary Pascoe

Thank you. Yes, appreciate that, Dr Daly. It’s actually really important, in terms of understanding that, so thank you. I would like to, unfortunately, draw this to a close. We still have about thirty-odd questions I can see that still have to be responded to, so I’d just like to offer my apologies we’re not able to get to all your questions. Unfortunately, we’re about to hit time.

What we will be doing and what we will do is we’ll take all of these questions, collate them, and provide responses back to the group. We’ll actually include that as part of the wrap-up in the publishing of this webinar onto the TGA website once we finalise and wrap all that up.

So, we’ll make sure that we’ll address all of these questions. We may take a number of the questions that are common themes and address them collectively, but definitely looking to ensure that we have a written response to all of the questions you have asked.

If you may just flick back quickly, Rachel, or whoever is in control, to... Essentially, we also welcome your feedback or any other questions that you may be asking to our UDI support team. Jasmin is definitely willing and very interested in taking more questions. UDI@health.gov.au is the email address, so thank you very much for just that, Rachel.

And then, finally, then there's some other links in the pack on the next slide that will provide some additional information around what we’re doing, here, in Australia.

Those of you who aren't familiar with the UDI, I would recommend, probably, the first two. Go to the UDI Hub on the TGA website. As well as then, if you are a little more familiar with understanding what are some of the features and what we’re proposing for the Australian UDI system, I recommend you looking at the third UDI Consultation Paper, which is the second row on that website link.

So, again, I would just like to thank everybody for your questions, we really appreciate. And certainly, as Dr Daly’s mentioned, we’re looking at this to start to elicit further questions in understanding about UDI, and really wanted to thank you all for raising that.

And also, particularly, wanted to think Dr Daly for spending the time with us today, getting prepared, I know you have a very busy schedule, so taking this time out to prepare and get us going. So, I’d like to thank you very much for your time.

I wish you all a very happy rest of the day, or evening, depending on where you're coming from, and look forward to talking to you all again on 28th March. Thank you.