Accessing and using the Australian UDI database 'Sandpit'

Michelle Van Wijk

Thanks very much, Nishie. And welcome, everybody, to our tenth UDI webinar. And this morning, we’re going to be talking about accessing the UDI Sandpit and a little bit about the consultation as well. So, I’ll introduce you to the teams as I hand over to them to talk.

I’d also like, before we start, to acknowledge the traditional custodians of the land we’re meeting on today, which is the Ngunnawal people here in Canberra, and pay my respects to elders past and present. I would also like to extend that respect to Aboriginal and Torres Strait Islander peoples here today.

So, as I mentioned, today, we’ll talk about the consultation paper, the third consultation paper, the Sandpit, and then we’ll leave time at the end for questions and answers. As I’ve mentioned in previous webinars, we need to do further consultation on the regulatory feedback. So, we’ve done two consultations already. This will be our third consultation, really, to help inform the government decisions on the regulations themselves.

So, we plan to have this published in June or July, and it will be on our consultation hub, which will enable an online survey tool for feedback.

We’ll provide notification. So, we’ll let people know when we’ve published it and it’s up and running. We have a UDI mailing list, if you would like to be added to that, please let us know.

So, we’re looking at the moment of what the key areas of focus are going to be, and they’re likely to include the impacts of Australia potentially accepting both US FDA and EU-compliant labels, and what the data might mean. What the approach might be to transition for existing devices, but then also for device applications that the TGA receives through that transition period.

The provision of data and the data elements themselves. Which devices should be in scope, and which might be exempt from UDI requirements. Fees and charges. So, the fees and charges for UDI will be in place from July 2024. So, some feedback on those. Some information on adoption and use. So, where the regulatory framework might impact the use or the use of the UDIs in hospitals, for example, or clinical quality registries. And labelling. So, the regulations, and how they all need to work in Australia, around the labelling.

The plan is, at the moment, to have the consultation open for six weeks, and then there will be some time towards the end of the year for us to work through the regulatory processes to have them in place. And the plan is to have those in place by 1st January to support the voluntary compliance that we have in date and plan for 1st January as well.

I’ll now hand over to Gary Pascoe. So, Gary is our Australian UDI database Product Owner. He’s been a member of the team since November 2020, and he has responsibility for the development of the UDI database. Gary’s background is he’s a highly experienced product owner, and he has over 20 years in lead roles for the design and implementation of both business and IT services in government and in the private sector.

Gary is a strong advocate for close engagement and collaboration with all stakeholders and is very excited to have the Sandpit create these opportunities for UDI. So, without further ado, I will hand over to Gary.

Gary Pascoe

Thanks, Michelle, and thank you for the introduction but also the opportunity to talk today. So, hopefully, everybody can hear me okay and it’ll work through. So, as Michelle touched on, I’m here to talk to you about the Sandpit. Really, the things I wanted to cover, with time permitting, is obviously to talk a bit about the Sandpit, what it is, what our purpose is. It is very much an environment we’re looking to set up and get your feedback on. So, it isn’t something that we’re just releasing and things won’t change.

Between now and the Sandpit release and when we go live with voluntary compliance release in January 2023, we’re looking to get your feedback and, obviously, make adjustments and changes to the Sandpit version and what we developed.

So, I really wanted to talk through that, I’ll give you a bit of a demo as well. A demonstration of what we’ve developed to date, talk through some of the key concepts. Obviously, I won’t demonstrate all of it because that would take the fun out of you being able have the opportunity to use the Sandpit once we release it. And then also discuss a little bit around what we’re proposing to do in relation to the use of it, getting registrations, etc. We’ll also hear from Jasmin Hyatt, who is also part of the team, helping to provide support through Sandpit.

So, really, they’re the big things I wanted to cover, particularly around the objectives of Sandpit. And as I mentioned earlier, the Sandpit is very much an early release of the Australian UDI database. It’s very specifically being released. Certainly, it’s been built from the perspective that we establish a foundation set so that we can progress from there. It’s very particularly being released so that we provide an early opportunity for users, whether they are manufacturers, sponsors, other users of the UDI data, TGA staff even, to use it and provide their feedback, both in terms of the usability of the system we’re developing because one of the things we’re very guided by.

And it’s really important from the UDI development here, is to ensure that we are developing something that does make it easier or does support the roles of the manufacturer and sponsors, as well as other organisations like hospitals, registries, etc., to use the UDI data and make sure it’s actually built into their practices and processes. We’re also then looking to get your feedback on some of the features, things that may be missing, things you would like to tweak, as well as then support some of the consultation work.

We have embedded or built-in elements of the UDI rules that we’re considering and the data elements that are being considered as being socialised as part of the consultation paper that will come out. So, at the same time you’re reviewing the consultation paper, the database is there to bring it to life, to some extent, to be able to then say, how is this going to work? How does the database and the regulations all come together?

The database in itself is very much an early release. And so, a number of those rules that will either be, ultimately will land from a regulatory perspective once we go live with voluntary compliance, may not be there, or they’re there in a bit more of a light sense. We’ll look to evolve over the course of the months from July through to 2023 to be able to then just finalise those rules.

It’ll also be test data. So, we’ll be providing the opportunity for manufacturers, sponsors to submit their data within the database. So, that will give them the opportunity to test, and I’ll talk through some of those in a moment, about what those opportunities and avenues are.

Essentially, I really wanted to stress, though, that it will be test data. So, we want to make sure that whoever is using the database, has the opportunity to get the fullest extent of the features, noting that the data that may be in there, your manufacturers and sponsors that supplied this as a test bed and as something to help us support the process, that will be then cleaned out once we finish with the testing of the Sandpit version, and it will then become a bit more of an empty tool after we finished the testing.

The UDI Sandpit itself will actually endure past once we release the full version of the voluntary compliance solution, and it will become a production test bed or play environment for manufacturers, sponsors, anybody else who wants to familiarise themselves with the UDI solution, both in terms of data transmission, creating of data or use of it. So, before you actually make yourself available to the full production version of the database, it will continue. However, we will make sure it’s all cleaned out and ready in supporting that need.

I really just wanted to put those caveats, ensure that everyone is aware that there is some test data that’s going to be in there. As part of that process, and I’ll cover this a little bit more, we will be asking every user of the database to identify themselves, provide a logon, so that we can ensure that we cover that message so that everybody who’s using the database is aware that the data is test. That while it can be used, they should be taking that into consideration when they’ve started feeding that into any other information or systems they’re using.

The features are likely to change. So, like I mentioned, we are incorporating some primary version of the database now. So, it will look production like, but as we’re getting feedback through the Sandpit, we will be working through, taking feedback on usability, acceptable ways of presenting the information, what would make more sense from a sponsor, manufacturer, or a user of the UDI data, and refining those through the course of the months from July through to when we release the production version.

So, we do expect it to change, and we do expect it to continue to evolve and for you to see evolving versions of the Sandpit version over that time. Really I wanted to say, it is very much a production implementation however, so it’s not something you just throw away. And we have taken some of this work that we’ll be doing, and that’ll become the foundation as we’re moving forward.

A couple of things that we still are yet to do, and we wanted to touch on to ensure that everybody who is using the Sandpit version understood that there were aspects of it that haven’t been taken through to a final production state. So, we’ll be doing that work as we’re capturing the feedback from usability.

Things like support for multiple browsers. So, we actually have built it from a perspective of being able to allow online access through the standard and fairly contemporary set internet browsers that are being used today. And certainly, we’ve even tested on mobile devices, however, certain circumstances in the more aged browsers, there may be some issues associated with that.

While we would welcome your feedback in ensuring that we understand that we’ll be doing explicit testing for compatibility with those environments after the Sandpit is released.

So, just really wanted to ensure that if you are using an old browser, or you are using an older IT environment, please be aware of that as you’re using it. And if those things do come up, we would very much welcome your feedback and advice on ensuring that we know about those, as much as anything functional or improvements from a usability perspective.

The other thing I would like to say is because with the development of the Sandpit database, it is currently a standalone version of the UDI database. So, it does not integrate into aspects such as the Australian Register of Therapeutic Goods, or some of the other TGA processes and systems that some of you may be familiar with, such as TBS or eBS.

We’ll be looking to do that, and it is something that will be part of our roadmap and as part of our runway going forward through to the implementation from the voluntary compliance. However, because it is standalone at the moment, there are some things we’ve wrapped around it, such as the login and the user access services that we have, which some of you who are familiar as a sponsor, in particular, with the TGA business systems, it will be a slightly different experience in that.

So, it is something that we will be evolving and changing. And as part of our ongoing consultation from July through to December, we’ll be continuing to work through the various stakeholders to ensure that we provide that seamless interface. I just really wanted to highlight that there are some differences with that experience, and that is explicit and deliberate to ensure that we provide that independent experience, but we’ll look to integrate that going forward.

So, the other thing was we are really looking for a range of feedback. I’ll talk more about that in a moment. But we very much, and I think Michelle’s introduction, from my perspective, this is an opportunity for us to work closely with all the different stakeholders associated with the UDI and get your feedback on what works, what doesn’t work, what you would like to see different, even what you were thinking about in terms of future concepts that may come out of this, and future thinking around how can you use UDI and its integration with the way you do business.

We’re very eager to ensure that we get feedback from you, and we’ll talk a bit more about those channels and how we do that.

So, what is in the Sandpit? This slide here is just quickly talking about what we’ve done to develop the Sandpit version. Again, as I mentioned, we have deliberately picked these four groups of stakeholders in the first instance, and they will be continued to be grown out and evolved over the course of the Sandpit activity.

So, most of the engagement we’ve had, definitely around sponsors and manufacturers, we are also building it to support early adopters. So, one of the interesting things or one of the differences with the Australian UDI database, and those of you who have participated in the technical working groups or any of the prior consultations with the TGA in relation to UDI, you would know that we’re not just establishing a perspective on how we supply, or manufacturers and sponsors supply device information into the UDI database.

We’re also bringing that perspective into what the use of the UDI data, and how that would be supporting some of the downstream activities for hospitals, healthcare providers, registries, other interested parties in the healthcare system, and how UDI can support them.

We have a group of organisations, particularly within the healthcare system, that we have as early adopters of the UDI database and looking to use that for registries or healthcare. We’re building some capabilities to support their needs as well, to support that ongoing engagement from their perspective.

One of the critical components for UDI is to ensure that we can make device information available to the general public, and obviously, to ensure from that we keep coming back and looking at the primary goals to ensure that we can deliver safer devices and patient safety within Australia. Providing information to patients, providing information to the public on devices is a key part to that.

So, we have built some capabilities and I’ll talk through those in a moment, about what those capabilities are to support the general public looking at and viewing devices.

And then, the fourth user group is some work within the TGA staff to manage information about devices. We have, Jasmin and her team, some capabilities to manage access and reference data that we would look up, a list of values and other attributes associated with the UDI database, so we can provide the most seamless experience.

Those are the four major groups. Where we’re expecting to evolve is then introducing concepts. Certainly, the technical working group has been very strong in asking some of these questions, such as, what other user groups, such as agents, can we bring into the consideration?

So, they’re currently not in scope. Effectively, an agent we would treat as a sponsor and manufacturer, but once we move into that broader TGA business system environment, we’ll bring different capabilities in relation to agents, and their experience, and their particular needs.

So, really quickly, the Sandpit scope is very much covering those four groups. I’ll flip to the next slide because it covers specifically around this particular functionality. I’ll talk you through what has been developed, and what will likely to be developed in the coming weeks, and just see where we’re at.

So, these next few slides are actually talking a bit about those features that are on that group, on the slide supplied earlier so I won’t talk through all of this. Hopefully, it’s reasonably okay for you to read.

You see the features that will be available in the Sandpit. Essentially, the ability to create, read, update UDI data. A key component, obviously, is to be able to ensure that UDI records are entered into the database, and then that information is then available to whoever, whether that’s a sponsor, manufacturer, general public, etc.

We will be looking to do that and we will be supporting the provision of UDI data, both from an online perspective, so a user can log into the UDI portal and create individual records. Or alternatively, we will be bringing information in using the machine-to-machine capabilities that we have implemented, that will be mirroring US FDA’s GUDID standards or the structure that they’re using, which is using HL7 SPL format.

That, at the moment, is very much replicating what the US has done around the GUDID data input. And we’re also, in addition to that, adding some capability to bring data, those organisations, sponsors and manufacturers, who use the National Product Catalogue supplied by GS1. We have created the capability to input data into the UDI database using the National Product Catalogue as a data feed and been working with GS1 to ensure that that’s in place from day one for the Sandpit version.

Manufacturers and sponsors can create records as well as update the data that’s in those particular records, whether they’ve come in any of those methods, whether it’s online or through the machine-to-machine interfaces in the online system, as well as then sending updates as a machine-to-machine transaction or message that’s coming in.

We have implemented a number of the basic trigger rules. So, for those of you who have been participating in the triggers working group, we’ve actually implemented aspects of the trigger rules to ensure that when specific, key data associated with a UDI, such as key clinical information has changed, then we’ll be looking to trigger new UDI changes and new UDI updates associated with those characteristics and triggers.

At the moment, they reflect what has been issued in the TGA’s triggers paper, which we issued at the end of last year, and will be referenced and considered as part of the consultation paper that Michelle referred to earlier.

We have the capability for manufacturers and sponsors to manage their own UDI record. So, an individual record associated with a manufacturer, a record associated with a sponsor, we have controls in place to ensure that only the manufacturer and sponsor can update those records. Anybody else who isn’t a manufacturer or sponsor will have the ability to view and see that data, however they won’t be able to update. So, there’s a range of controls and considerations in there.

What’s likely to happen and come out once we’ve released Sandpit, and between July through to the implementation date for go-live and voluntary compliance, we are expecting such as changes to the data elements.

We’re already receiving feedback on these particular data elements from the community to say, these are the things to consider either putting in or taking out of the draft data set that we’ve already started to implement. And then we’re also getting feedback through the consultation paper as well, in relation to what those data elements may be.

At the moment, that’s likely to evolve. We’re still using the US GUDID, and the US data model, and the data attributes as being our guideline, and that’s through the consultation period, but also through engagements over the Sandpit, we’ll be working with all the stakeholders associated to ensure that we have that finalised, and then take that recommendation to government to ensure that then gets reflected in the UDI regulations.

There’s been some strong conversation, and we have not implemented it today, but there’s been strong conversation from the manufacturer and sponsor group, talking about record updates and corrections to UDI records.

At the moment, we have basic capabilities for doing that and don’t have the ability to introduce a grace period, but that is definitely one of the first aspects that we’re talking about. The concept of locking a UDI record and unlocking a record when there are maybe changes to UDI trigger fields and allowing a manufacturer and sponsor to create updates and corrections to records, is something that we’re looking to implement in the Sandpit version.

It hasn’t been done, and we will be working closely with manufacturers and sponsors over the coming months to finalise that, to ensure that we come up with a solution that’s best from that perspective.

The other key concept, and those of you who have been participating in the technical working group and have talked about some of the concepts that we’re looking to introduce. One of the Australian-unique circumstances is the situation where we have one manufacturer and multiple sponsors of the same device and ensuring that we have that ability for manufacturers and sponsors to ensure that they manage their data correctly, and ensure that nobody is inadvertently creating UDI records or changing UDI records as required.

The other key component we’ll be looking to implement is then the search and view of UDI data, and there’s a whole range of basic and early versions of searching information using keywords, using different attributes. One of the key feedbacks that we’ve had over both the UDI work, but also prior consultations within TGA, is for the ability to have a bit richer search capability. We have implemented aspects of that within the UDI database and also some aspects of that as part of the demonstration.

We also, as part of that searching capability, have introduced the ability to search and browse devices using the Global Medical Device Nomenclature. The terms and collective terms, to use the hierarchy within the collective terms that had been created by the GMDN agency to transverse, as well as then find different information about devices that may make it easier for users or manufacturers and sponsors to collect and collate information.

We also introduced some other capabilities, such as hover over text, so that from a usability and simple perspective, to be able to provide different explanations to highlight complex text. And for the layperson, in relation to medical devices, to be able to understand the actual description and definition of particular medical terms to try and bring some of those usability concepts in place. So, that’s really the core functions of what Sandpit will release.

From a receipt and use, and provision of the UDI data, as I mentioned earlier, we will have four methods for providing UDI data. It’s really then to cater for different types of manufacturers and sponsors, and different types of provisions. So, hopefully, we’re getting Sandpit users who look to cover all of those, and certainly to exercise and test all aspects.

We’ve had strong feedback and advice from manufacturers and sponsors that they were, from an international perspective, very interested in ensuring that there is a HL7 machine-to-machine data transfer, and we’ve implemented that using the US GUDID standards. We also have mentioned earlier the National Product Catalogue, as well as the ability to bulk upload data.

From a future perspective, we are likely to take refinements to those HL7 standards. We’ll look to finalise that from an Australian’s data feed specifically. We’ll be introducing some Australian-specific data elements, such as the ARTG identification number, so that we can ensure there’s linkage between ARTG and UDI as part of those data feeds, and that will be part of the evolution for the Sandpit version as we go forward.

As well as then capturing any feedback from the users, from the adoption of those machine-to-machine capabilities. And it’s certainly an area that we expect to see quite heavy usage in terms of the volumes that we’re expecting to receive from the Sandpit version.

Provision of UDI data at the moment is reasonably straightforward. We’re keeping the capability to download, mirroring what’s done with other regulators, to be able to download the whole UDI database using a range of different formats, whether that’s in Excel or other machine-based formats, such as JSON and XML. But allowing users to be able to download the whole database, and then upload that into whatever systems they have, or use an Excel spreadsheet to interpret and process that data.

At the moment, for the Sandpit version, when we go live, you’ll see the ability to bulk download all that information. We are looking then to take that and extend that to have more sophisticated capabilities after Sandpit go-live, and between then and the voluntary compliance based on feedback from our early adopter projects, ensuring that we can provide better machine-to-machine provision of the UDI data to be provided to whoever would like to consume that information.

So, those are the key features of what we’re looking to deliver. And it doesn’t sound like much, but there’s certainly a lot there. Other aspects, I want to touch on quickly, the ability to manage device life cycle. So, as part of the UDI record, we have some rich capability around being able to track history, understand all changes to a device, and for a user of the device or anybody who’s interested in the history of that device, to be able to track and see those changes over time.

The presentation of that at the moment is reasonably straightforward, and we’ll work with all the different groups to actually work out how we can better present that information, and the different aspects of versioning, and how different users would like to see device history and device life cycle change, and how that’s presented.

So, there’s some work we’ll be doing around that, we’ve built some very strong foundations in terms of being able to manage device life cycle, ranging from having draft versions, published versions of a device, and ensuring that we have capability for manufacturers and sponsors to publish versions for public consumption in advance or at a certain date. So, that’s a key component of what we will be delivering in the Sandpit.

We have the ability to link the UDI to the Australian Register of Therapeutic Goods, the ARTG. Very rudimentary at this stage, in terms of being able to provide the ARTG ID, and using that to connect with public summaries. We connected with the GMDN codes and ensuring that there’s a linkage there.

And as we move forward into the more integrated environment within health, we will then look for future considerations as part of the Sandpit, providing a richer set of integrations - ARTG, validation of ARTG, and then links to recalls, adverse events, protheses list, billing codes, etc.

So, at the moment, it has to cater for that. There’s a range of simple rules in place for managing the ARTG ID, and we’ll be looking to make that more advanced as we talk through manufacturers and sponsors and work out how that fits, and, obviously, then how that fits from a government perspective, in terms of implementation of UDI.

Some other basic capabilities. We can attach documents, and we’ve had good feedback and quite strong feedback in relation to be able to tag other information, documents such as patient information leaflets, other documents that may be related to the UDI. So, we’ve built the capability to be able to do that, you can upload a document, attach it to the UDI record or attach external links, that we then allow the user to click through, and also have a brief demonstration of that later.

The final concept that we’re looking into, we have implemented, and really is one of the things that we’re doing both in terms of establishing the UDI database to support the provision of information, to also then bring concepts to the table and to the different user groups about how they can use the UDI information to support their business process and actually take that forward.

So, we have the capability to scan barcodes, device labels, whether that’s a 1D or 2D data matrix barcode. We can scan a barcode, and then have it display different information, whatever is in the barcode. And if that particular device is in the UDI database, display that information.

And so that’s all in the Sandpit as it stands. And we welcome, and we intend to have some targeted consultation sessions with, particularly, early adopters, other organisations who may use this information, to say, how can we better represent that to support more extended capabilities?

Moving on from the features. I suspect all of you are then going, how do I get access to it? What do I do in terms of getting access to the Sandpit version? I just quickly wanted to just talk a bit about that from the process perspective, and how we go forward, and then work into a bit of a demonstration about what we’ve done and some of the key concepts.

So, as I mentioned before, we have the four major user groups. Manufacturers and sponsors, and I know we group them together. We will be having TGA staff, public, and then early adopters looking to use the database.

Because of our concern about the use of the UDI data, and because the regulatory environment isn’t in place yet, we want to ensure that every user of the database has an account, we know who they are. And for the Sandpit in particular, because it is test data, ensure that they’re aware and they commit to an undertaking that they will treat the test data with the right considerations as they’re using it.

And because of that, we’re creating a separate standalone user registration and account process, and it’s all based on a self-serve model. So, no real overhead and it’s consistent with what processes all of you may have used to date, in relation to creating an account and getting an account. Anybody who is looking to use the UDI Sandpit, whether it’s online or whether it’s through machine-to-machine access tokens, we’ll be asking you to create an account.

Before we create an account, we’d actually like you to register. And we’ll be opening up registrations, we’re looking to do that this week and get that information out, either through the TGA website, through the UDI hub, as well as direct information. So, we’re mailing that information out as soon as that becomes available, and I’ll walk a little bit through the registration process for you.

Essentially, why we’re doing that is so that we can ensure that we know what organisations, what individuals are looking to use the database. And from day one, once we go live, we’ll ensure that we can have a better understanding of how you are looking to use it, the types of information you’re looking to use, and we can more progressively and proactively manage the support that you need to have for the use of the database.

So, we may, depending on the number of organisations expressing an interest or the number of individuals expressing interest, we may have a progressive rollout. And in the first few weeks, we are likely to manage that so that we can have proper coverage of the different user groups and the different stakeholders, such as ensure we got proper coverage of manufacturers and sponsors, and we’re not all skewed to one particular type of manufacturer or sponsor. As well as then ensuring that we get coverage across the whole range of different users of the final UDI database.

So, we’ll be asking you to register interest. That information will go to our support and operations team, who will review that information to ensure that an individual’s email address and everything is okay. And we’ll then pass on an email to you to ensure that you have online access, to give you the ability to create your own account. That will all be, as I mentioned, self-served. So, once you’ve created your account, then you have the ability to use the online database.

And those of you who are familiar with the requirements for machine-to-machine credentials and access, then we’ll also give you the ability and provide the information to create your own access tokens, using a developer API gateway that we have established and put in place for this need.

So, again, it will be self-served. And through that process, will provide you with an access token, so that you can then attach that to your machine-to-machine transactions. And as that information flows into the Sandpit version of the database, we know who they are, and how we can better communicate where those messages are coming from.

So, as I mentioned, that registration process will open soon. We’re hoping to have that information out to you in the near future and ensure that we can get early access in. We’ve had a number of emails from people coming in already, saying, how do I get access, and how do I present the UDI information? So, we’re very keen to ensure that we can get that out early, and from early in July, we’re able to get you in and using immediately.

So, just very quickly. This is the version of the registration process, and this is what you will see when you get provided with a link to register. As you may see from here, and as Michelle talked a bit about the consultation hub using the consultation paper, we’re also using that. It’s a survey tool which we’re using to collect some information in relation to UDI database and your interest in it.

So, the registration process will present this information, and will provide a bit of background on what you can do and what you can’t do with the UDI database, and then ask you to click on a link to register.

I won’t go through the details of it. Essentially, we’re looking for some information around you, your organisation, the role that you’re looking to use the UDI database in. And we’ll essentially translate that into manufacturer, sponsors, and other users and TGA staff, and then use that information to help inform us around the different types of users that are looking to use the database.

We will also be surveying you and asking questions such as, would you like machine-to-machine access? So we can make sure that’s provisioned. As well as then a range of questions just to help us understand a bit about your interests and your organisation about readiness, for example, to say, what sort of scale of devices are you looking to put into the UDI database? And from a Sandpit perspective, are you expecting ten or less devices to be testing or above 100? So, we can use that information to better guide the process and ensure that we got the right levels of support in place for you.

Also, looking for timeframes to be able to get a feel for when you’d like to use it. We have had some contact already saying, we’d like to use it immediately, and others who say, I’ll need to have a couple of months before I can be ready. So, just to help us space out our time, ensure that we got the right levels of support in place, get some feedback in relation to how you want to use the UDI database in the Sandpit version.

There is the ability also for a person or individual to register other users. So, looking to capture if there is somebody from an organisation who wants to register different users from within their organisation.

Let’s say there’s two or three or five of you, then really this capability to provide you to register once, so that we can ensure that we can get the inputs and provide the data to you and the access to you in one go. So, it makes it easier from your perspective to have one person authorised to register. But if the organisation supports having multiple people, then we are very happy to do that.

I’m just going to quickly demonstrate and talk through some of the concepts. As you see here, I’m just signing on. So, once you’ve created an account, you’ll have this logon access process to be able to have access to the UDI Sandpit, and I wanted to talk through some of the key concepts that you will see in front of you.

So, we built a user interface based on fairly contemporary standards, which is feedback that’s come from through the Department of Health, and their design standards, as well as then feedback that’s come from the TGA, within the TGA, around how we should design and provide different user interfaces for manufacturers and sponsors.

I won’t talk through all the features, but a couple of key points I wanted to talk about. So, as you can see from here, the system is presenting a number of different options.

We have a menu bar at the top, which has home, other menu options moving to the right. That will stay fairly static and provides a range of features that every user will actually be able to have. And we’ll then tailor that interaction, depending on whether you’re a manufacturer, or a sponsor, general public, or TGA staff member. And we have a separate home page and a separate landing page for each organisation or each type of organisation.

I’ve logged in at the moment. This is in our test environment. I’ve been simulating myself as being a sponsor or manufacturer, and so, therefore, you’ll see a separate sponsor or manufacturer centre.

If you’re a consumer of the UDI data, such as maybe it’s a hospital or a general public person, then you’ll see a slightly different interface, and you’ll have different information presented as part of the options there. The reason for that is, obviously, different users will have different experiences and looking for different interactions, and so we’re tailoring it for that purpose.

What will be the same, however, is, you see, we will have a banner page, which we use to provide information out. And so that information is then updated and will be any information that we may want to broadcast to users of the Sandpit version, and we’re looking to do that fairly simplistically, and we have our support team, anything that we need to talk about in terms of issues or downtime, etc. So, that banner page will be updated and fairly dynamic as we’re going through.

Underneath that then will be a range of different services that, depending on what that user experiences, and in this case, sponsor or manufacturer, we provide a landing page that allows them to create a new record or continue working on a draft record.

For a manufacturer, sponsor, or any other organisation that may have multiple people that have been registered through the organisation, we also then just wanted to present who those users are so that you know who’s using the database on the Sandpit version from that perspective.

On that landing page will also be the support centre, contact details, and anything associated with how you get in touch with and how you provide feedback. We are looking for as much feedback as possible. I don’t know if I should make that statement, but all feedback is very welcome, and all comments will be very welcome, whether it’s good, bad, or indifferent. It is a process, and as I mentioned, for us to be an open and collaborative process to have you give your feedback on what’s working and what isn’t working.

So, as part of that process, what we would like to do, we’ve opened up a number of different methods to do that. We have a phone number, which will be set up. So, that number at the moment is not valid, but that number will be published once we have finalised the Sandpit version.

Many of you are probably familiar with the udi@health.gov.au email address, as well as then we’ve also created the ability to provide any feedback on any page. There’s a click on the feedback button on the bottom right-hand side here of your screen, to give any thoughts or suggestions on a particular page or anything you’re working through.

That information is then fed to our operations and support team to ensure that we can get that information and allow us to make decisions, and get your thoughts on things associated with changes or improvements.

I’m just really conscious of time, so I’m going to just work through at a high level. Sponsor or manufacturer, what you are going to see is the ability to have this landing page, to view UDI records that relate to your organisation. The ability to actually add new records, as you can see here. So, provide an online interface.

Also, the ability to manage any drafts. And as you can see, the number up here is the number of drafts. So, this is a test environment that we have created for testing of the database. So, we currently have 31 draft records recorded against that particular manufacturer and sponsor, that we have set up within the test environment. As well as then the ability to bulk upload record through an Excel file or an Excel spreadsheet, or bulk upload information associated with mapping ARTG IDs to the UDI records.

So, that information on that screen will change. In addition to the unique experience you will get from the home, we also have more generic capabilities, that will be available to all users to be able to search on a particular device. So, if I type in mesh, use different characteristics associated with keywords, then that will be provided and available to any user.

This is populated with information that’s come from the GUDID database, as well as information that has been supplied by our early adopter project. So, the data that’s in here is also test data.

In addition to that general search, we have the ability to search down by GMDN terms, as I touched on here. And essentially, I’m just going to scroll through and look at the different ways of actually searching through particular devices using the GMDN terminology.

For those users that are looking to use the database in concepts and bring the concepts in for providing UDI information and using it from either a general public user registry or a hospital, we have the ability, I won’t do it here, but to scan a barcode, whether it’s a 1D or 2D barcode, and have it supply the information. We can put that information into the database, into that screen, and then actually have it bring up particular information relating to that device, and it will translate the 2D or 1D barcode into the production identifier.

The other features. Downloading the database, as I mentioned earlier, as well as then a couple of concepts around recalling and providing adverse events.

And so at the moment, these are just test versions and concepts. So, this is the clickthrough ability once you have the UDI in place, we can then use that to link to an adverse event. And once we have the UDI information, bring up a form that will prepopulate the data associated with adverse events.

At the moment, because we’re not linked to adverse events within the health environment, that’s a demonstration or a dummy form. However, we’re looking to keep this information or these options here as a tool to help us talk through the different concepts and different way of going forward once we use the UDI database with early adopters.

So, I’m going to pause there. I’m going to finish there and come back to the slides and talk through key concepts. We’re very keen and very eager to ensure that people have access. I really just wanted to stress that all and any feedback is very welcome, and we’d love the opportunity to work with you. So, please feel free, once the registration and the process is open, to register your interest and also get in touch.

So, with no further ado, I might hand over to Jasmin, talking about all the feedback and all the questions. Jasmin will be responding to those. So, I’d just like to introduce Jasmin Hyatt. Jasmin has been with the TGA for about nine years, so for many years.

She’s actually had a number of customer-facing roles, and so the ideal person for taking this forward. She definitely has a passion for customer service, and she’ll be running our operations and engagement team, and I just really wanted to introduce you to Jasmin. So, over to you, Jasmin.

Jasmin Hyatt

Thanks so much, Gary. It’s a pleasure to be here this afternoon. And thanks, everyone, for joining us today. So, as Gary said, I’ve worked here for a number of years, and I am the manager for the engagement and operations team. So, basically, just wanted to introduce us and our function. We’re here to assist you guys to have an optimal UDI experience.

So, please reach out to us. I believe many of you have the email address, but it’s udi@health.gov.au. And as Gary said, we will be introducing a phone number shortly. But basically, reach out to us if you have any questions, and we’re here to help you, and we’re really happy to be a part of this. Thank you.

Michelle Van Wijk

Thanks so much, Jasmin and Gary. Hopefully that was useful information to everybody. We’ve got some questions online and a few minutes left. It’s great that we have a panel now, and I can provide the questions to the panel.

Is there a document with the data elements, including mandatory, optional, and edit rules? Also, what documents will be mandatory to upload? So, we will be doing some of that as part of the consultation work. But in the meantime, to align with the Sandpit, I’ll hand over to Gary to answer that.

Gary Pascoe

Thanks, Michelle. Short answer is, yes, there will be a document. So, we have a data dictionary, which we use and have shared with some of the technical working groups. It’s a good question actually, because we’ll use that and send that out to everybody to identify what those elements are, what’s mandatory, what’s not mandatory. Sorry, what was the other part of the question? What documents to upload and manage.

Michelle Van Wijk

Yes.

Gary Pascoe

At this stage, from a UDI database perspective, it’s not making the upload mandatory. It’s really just to give the manufacturers and sponsors who think it would be useful to attach that information that ability. So, it’s not mandatory at this stage. And obviously, part of the consultation paper and any other feedback received over the Sandpit period and then the consultation paper, we may adjust that. But at this stage of the Sandpit, nothing will be mandatory.

Michelle Van Wijk

Great. Okay, thank you. Next question also for you, Gary. Will the Sandpit support machine-to-machine for receiving UDI data? Or will it be user interface upload of HL7 SPL?

Gary Pascoe

Thanks, Michelle. Yes, it will receive machine-to-machine as an import. We’ll provide a definition of what that machine-to-machine interface will be. And as well as then, anybody who registers looking to use machine-to-machine access, we’ll provide this information to do that. But we are hoping and looking for as much machine-to-machine or transmission of data from manufacturer and sponsors, IT systems as possible, so we can exercise that. Absolutely, we’re doing that from day one with Sandpit.

Michelle Van Wijk

Great. Thank you. We probably have time for two more. Will we be able to provide the document attachment, so for example the patient information leaflets, via machine-to-machine, or will that only be possible via user interface upload?

Gary Pascoe

It’s a very good question. So, at the moment, for Sandpit, no, we don’t provide the attachment via machine-to-machine. It is something that we have been discussing and would love more feedback from manufacturers and sponsors of the value of that.

And obviously, then the issue we have, or one of the holdbacks that would then take us a little bit of a step away from what other jurisdictions are doing, and ensuring that we’re not creating unique circumstances, but we definitely feel there is a need. And so would welcome any feedback on manufacturers and sponsors or anybody to say that is something you’d like to have.

Michelle Van Wijk

Great. Thank you. And this might be the last one before we wrap up. We’ve got some other questions here that we’ll take on notice and provide answers for as well. So, the last one for this morning. Will third-party solution providers be able to get Sandpit credentials and technical specifications to establish a direct connection? And I assume that is for download of data, but feel free to answer for both, Gary.

Gary Pascoe

Yes. So, I’ll just say both, Michelle. For the provision of data, absolutely. And so that is available as well now. If you’re a third-party software provider and you’re willing to, when you register provide that information, and we’ll provide that definition. For the moment, for download of data and provision of UDI data to a third-party, we don’t have that ability, but it is something that we’re refining during the Sandpit.

And so, again, please register or provide your interest and let us know through the channels who you are and what you’d like to do to the UDI help email address, and we’ll look to work with you over those coming months to put that in place. So, certainly, we’re very conscious. And one of the things that’s coming to us as recurrent feedback over the recent working group sessions, is the ability to provide that data through a machine-to-machine interface. So, we’re very open to doing that and looking to have that happen in the coming months. So, love for people to work with and test on there.

Michelle Van Wijk

Right. And I might just sneak one more question in, because the answer, I think, is quite short. Will registrations be open throughout the duration of the Sandpit so that more users can gain access as needed, or does everyone need to register up front?

Gary Pascoe

For me, Michelle?

Michelle Van Wijk

Sorry. Yes, Gary, for you.

Gary Pascoe

That’s good. Yes, it will be. My apologies, I neglected to say that at the beginning. We will keep registrations open for the duration of Sandpit. And we also have the ability for, if you’re already registered, you can register other people on behalf of your organisation as well. So, that will be open the whole period of time. Obviously, as we get closer to a final production version, we may limit that, but it’s certainly very open, and we expect that to happen.

Michelle Van Wijk

Fantastic. All right, thank you so much to Gary and Jasmin for presenting this morning on the Sandpit. Hopefully, that was really useful in terms of initial data. If you’d like more at the next webinar, I know there are still questions coming through. If you’d like another discussion on the Sandpit at the next webinar in July, the third Tuesday in July, can you please let us know either through Slido or the poll, or to our UDI email address? And if we need to cover some more areas in a bit more detail, we can certainly do that at our next webinar.

But thank you. Please register. We’re very excited to be making the Sandpit available and to have six months to essentially work through, get the feedback, adjust it as we need to for usability, and really hear about how it might be used to help us refine it as we need before our proposed January voluntary compliance launch into production. So, thank you so much, everybody, for your time today, and look forward to seeing you in the Sandpit.