Unique Device Identification Webinar #12 - Q&A on the AusUDID Sandpit and update on UDI Consultation Paper 3
Presented by: Gary Pascoe, Therapeutic Goods Administration
Michelle Van Wijk, Therapeutic Goods Administration
Presented at: Online
Presentation date: Tuesday 16 August 2022
Presentation summary: Provide information to manufacturers, sponsors and users of the UDI data on how to access the AusUDID Sandpit.
Michelle Van Wijk
Good morning, everybody. I’d like to start by acknowledging the Ngunnawal people who are the traditional custodians of the land on which we gather today and pay my respects to the elders past and present. I extend that respect to Aboriginal and Torres Strait Islanders peoples here today. Welcome to our 12th webinar. We have someone in the team who’s off at the moment, so unfortunately Jasmin Hyatt can’t join us today, but Gary and I will cover the content that Jasmin was planning to.
If this is perhaps your first webinar, I’m Michelle Van Wijk. I am the lead for UDI implementation at the TGA and Gary Pascoe is our technical lead for the UDI database and other things. So we have had a number of questions over the last few webinars and in relation particularly to the Sandpit and the consultation. So really what we want to do today is provide answers to some of those questions that we’ve been asked but we haven’t been able to address in a webinar, for example, give some update on where the Sandpit is up to and the consultation paper. Then hopefully we’ll have some time at the end for more of those questions. We know there’s a lot of questions at the moment, so trying to really take some time today to focus on those.
So some of the questions we’ve got today, we’ve put answers here for anyone who can’t attend the webinar and just looks at the slide, but I’m going to talk them through. So one of the questions has been, if I can’t attend a live event due to the time differences… So we know Europe in particular is particularly difficult for some of the time zones. Will the webinar recording or slides be available after the event? So the answer is yes. They’re all available on the TGA UDI hub. So for every webinar, it will be the slide presentation, the recorded webinar, and a transcript if needed. So they’re available on the hub, so all of the past ones are there as well.
So while you might have registered, we might not have actually provided access just yet and we’re also managing the numbers. We’ve been really pleased with the interest and the number of registrations and we just want to make sure that all of our teams can manage that access appropriately so that we can manage the feedback as it comes in and manage the registrations. If for any reason you’ve registered and you think we might not have received it, please email us, email@example.com. If you haven’t registered, we’ll give you the link to register as well, we have a registration of interest there. So definitely looking for anyone who hasn’t registered and would like to get access, please register with us.
Another comment around the UDI hub perhaps not being quite up to date and, how could we share information? So the TGA is actually in the process of launching a new website and over August and September in particular there will be some work to bring the hub up to date in line with those website changes, but specifically in the meantime, if there’s something that’s not published or you can’t see that you’d like us to send to you directly, just send us an email and we will do that for you.
Some more questions and answers and a lot of these are related to the alignment of the Australian UDI to the EU, the IMDRF, and other countries. So the first one is, will the TGA UDI database be aligned with the EUDAMED database. There’s a little bit of difference between the EU database and the Australian situation in terms of the data we already collect. So EUDAMED is now being developed to support all of the EU medical device and in vitro diagnostic device regulations. It’s a very large, complex system.
We already have in Australia the Australian Register of Therapeutic Goods and that has got information on medical devices authorised for supply in Australia. That has been in place for many years. So what we’re doing in Australia is, we’re creating a second database. So our Australian UDI database will only contain the UDI data. It won’t contain all of the other device data. So there’ll be two sources of device data. We note that we’re still working through the data elements as part of the regulatory framework and the feedback on the database and its use and they may differ from EUDAMED. We know some of those are still emerging from an EU perspective as well.
So the next question is, can you provide more information on how Australia rules are different from the EU, USA, Canada, other countries? So really our plan is to align where feasible with the IMDRF forum guidance and application guide and the US and the EU. So we know in some cases that the requirements differ between those and the Australian government will be responsible for deciding the Australian UDI regulations. So that is the role of the government here. We don’t plan to publish anything that covers all of the similarities and differences across Australia and the other countries. That would be a really large piece of work.
So the next question is how closely will we be aligned with the IMDRF? So we’ve noted that we will be in principle aligned with the IMDRF, but we note there are some additional differences, for example, between the EU and the IMDRF requirements such as the requirement for a basic UDI, DI, and master UDI that are in EU that aren’t in the IMDRF guidance.
Next question is, when will we publish the Australian UDI data dictionary? So we plan to publish the draft data dictionary as part of our third consultation, which I’ll talk about a little bit later on this morning, and we’ll publish a version on the TGA UDI hub at that time. So the final data requirements will be part of the regulations and then we’ll publish a final version once the regulations are decided by government and we’ll put that information on our hub because that will form the basis of the data that needs to be provided to us.
Some more questions. Will plasma and blood products be included on the Australia UDID? So through the third consultation we’re seeking feedback as to the scope of the regulatory framework. What should be exempt from UDI requirements? So we’d really appreciate, when that’s published, any feedback around that.
Proposed timeline for the Australian UDI implementation. So our indicative timelines are voluntary compliance for high-risk devices from January 2023 and then, from July 2024, mandatory compliance for implantable devices. That covers allocation of UDIs, UDIs on labelling or the device itself, and provision of data to the regulator. We’re seeking feedback on those timeframes in more detail as part of the consultation paper as well.
The next question is, when can we expect the third consultation? I’ve mentioned it a lot, I know, in these other questions and we’re planning to release it in August. So we’ll notify all of our stakeholders that are on our UDI list or sponsors who are currently active using our systems to let you know it’s been published and we’ll put more information on the TGA website around that as well. So that is very close to being finalised and published.
I’m going to now hand over to Gary to answer some more of these Sandpit, more technical-specific questions. So over to you, Gary.
Thanks, Michelle. So good morning, good afternoon, good evening, everybody. As many of you know, I’m Gary Pascoe. I’m responsible for the development of the UDI database. By virtue of that, a number of the technical questions that people have asked, I’ll cover. I do note that a couple of these questions also may address some of the questions that have come through in Slido so please keep using Slido to raise these questions. I think we’ll have a reasonable amount of time today to cover the questions that have come up through Slido. So hopefully, if I don’t address anything specifically that you’re looking for, feel free to raise that in Slido and then we’ll come back to it at the end of the session.
So the first question is, is the data entered into the Sandpit only available to the data owner or can all users view it? So essentially the Sandpit version was being built on the principle of, all UDI data will be accessible and viewable for all users, whether you’re a manufacturer, a sponsor, or any other user wanting to view and just search for the UDI data. So all of that will be accessible once it’s been published.
So the database itself has a capability for a manufacturer or sponsor to add and update a UDI record, they can continue to draft that until they’re ready for it to be published and once they’ve published that record, they explicitly take that option. Then once that record has been published, then it’s viewable to any other user. The manufacturer and sponsor will have only the ability to create and amend records associated with their UDIs, but certainly anybody will be able to view it. So all records you’ll see in Sandpit to date have been created by manufacturers and sponsors and have been set as published by them as part of that validation process they’ve been working through.
The second question, is the Sandpit pre-populated with a database from an overseas database? At this stage, no. It is something we had considered when we opened the Sandpit. We started with Sandpit as a blank database and used that as an opportunity for manufacturers and sponsors to enter their data in so that they can test it and trial it from the perspective of having a blank database and starting from that perspective.
We are getting some users who are interested and saying, well, I’d like to have a select set of devices in the Sandpit and use that for viewing from a registry or from a hospital to healthcare provider perspective. So we are looking at the considerations with manufacturers and sponsors to add specific devices, but at this stage there hasn’t been any decision and we’re just using manufacturers and sponsors. We want to test the flow right from the manufacturers and sponsors through the various channels to get the data in the database rather than us artificially adding stuff in there.
The third question. So can more than two people have access and, if so, can this be done later? Absolutely. So there is no limit to the number of users who can access the Sandpit and we have a number of organisations who have registered up to ten people from their organisation. So we’re actively and openly encouraging as many as would like to be able to use Sandpit. The unfortunate thing is, the registration form does limit you to a number of users to two users per form. That was a bit of an issue with the form process that we have, but certainly if you do want to register more than two, we’d like you to register two on one form, go back and re-register, create a new form, and add multiple registrations to cover the number of people.
Certainly there’s no limits for the number of people you can register from your organisation and similarly we will continue to keep the registration process open for the entire Sandpit period. So running from now through to the December period, we’re looking for voluntary compliance to go live. We’ll be keeping that registration process open, so there will be no end date or no stoppage to that.
The fourth question. Will the production environment allow for multiple records per bulk upload spreadsheet? I see there was, just quickly, some questions around that similarly raised in the Slido questions that just came up. So it is an area that we’ve looked at. We’ve had extensive feedback and those of you who may not know, there is the ability to upload UDI records. However, at the moment it limits one file for one UDI record and we took that design decision from a perspective of making it simpler and easier and providing validations around the data that we uploaded.
There has been quite extensive feedback from a number of stakeholders saying, we’d like to have a look at this, and we’d like to see if we can get multiple records per Excel spreadsheet and have one spreadsheet cover multiple UDI records. We’ve captured that feedback. We’re actually looking at the design and the process for actually uploading at the moment and we’re taking your feedback and we’ll be coming back out to the various stakeholder groups and looking through what the options are in terms of uploading data differently through the bulk upload.
So I can’t talk specifically about whether it won’t be at the moment, but certainly it’s an area we’re looking for strong feedback and we’ll hopefully put some suggestions in in the next couple of weeks around options for how that can be improved and be seeking your feedback in relation to the merits or the pros and cons of each of those methods.
So moving on to the next slide, this is a question that was related to the bulk upload as well, which we thought was a very good one and one that we would like to take on board. Can the bulk upload template be provided online for allowing users to prepare ahead of time before they gain access to the Sandpit? So the first one is, thank you for that suggestion. It’s not something we had thought of, but we’re definitely looking at it as part of that bulk upload process. What’s the best method to provide that template so that you can actually pre-populate some of that information before you get access to Sandpit? Those who have access to Sandpit to date, there is the ability to download the template already and so you can use that template as then a guide for creating your UDI records, noting that it is something that is under review per my comments just before in the previous question.
Next question. Will the Australian basic UDI follow the same attribute requirements as the EU? It looks optional on the spreadsheet. Is this the plan for basic UDI? So as we publish the data dictionary and the bulk upload template to reflect a range of options that are being considered as part of the consultation paper, we’ve included the basic UDIDI and that has been included in the Sandpit as optional. So the bulk upload template caters for it. It is an optional requirement. However, noting that the requirements and the use of basic UDI and some of those other data elements will be covered as part of the consultation paper number three that Michelle has already mentioned and we’ll be looking for some feedback from stakeholders in terms of the merits from a basic UDIDI perspective. Once we have received that feedback that will feed into the decision by the Australian government to look at the final regulations and the final data elements.
Next question. Will the Sandpit data be scrubbed when the Aus UDID goes live? Yes. It will. The data in Sandpit is only being seen as test data and it will be something that is used for validation and assessment of the Sandpit. So we’re not seeing that as being data that would be supplied by manufacturers and sponsors from a final data set. So that will be required for voluntary compliance and the voluntary compliance once we go live will be a blank database and we’ll look for manufacturers and sponsors to populate that information right from day one. So we are looking for different devices and device information, but all of that will be cleaned out before we go live.
The final question on this page. Will the TGA be issuing guidance documents to help Sandpit users on testing protocols? We haven’t really prepared anything, but we are preparing some simple guidelines on organisations looking to use machine-to-machine in the national product catalogue for data exchange because there are some specific provisions or specific considerations we’d like to take into account for machine-to-machine and NPC data exchange and that’s largely around ensuring that we’re not overwhelmed with the numbers of records. If a sponsor or manufacturer chooses to send 10,000 records to us at once, it may be something that we’d like to manage and keep that done in a more progression and evolutionary manner.
So we haven’t really planned to issue anything around the use of the application itself or the online entry of records, but if people feel that is necessary and we’re taking the view that it is a reasonably intuitive and simple process, but if you do feel that’s necessary, please give us that feedback and we’ll look at publishing something. We have started sending out some information around the machine-to-machine and NPC data exchange.
Moving on to the next slide, we really just wanted to use this as a placeholder to just reiterate. We do have the Slido question and answers open, so please feel free to use that. If there is anything else that you’d like to ask, our engagement operations team can be contacted on firstname.lastname@example.org. The team is always looking forward to hearing from you in terms of feedback positive or negative or questions around how things are going. We’d also like to have any feedback from Sandpit or on the webinars.
I noticed some of you are already starting to use the feedback buttons that are in the Sandpit version, and we take that information and using that to start feeding into the refinements and evolutions that we have around the Sandpit versions but also then feeding into the design for the final development of the database. We’d like to reiterate, please feel free to send all feedback and thoughts and comments through to the database. I’d like to thank those of you who have done that to date. We’ve had some really good feedback and some great suggestions, so we’d love to see this keep coming. Thank you.
I’ll finish the questions and answers that came up in the last July webinar. I thought I may give you a quick update on the Sandpit as well. As of the 6th of August, it has moved on a little bit, we’ve had 250 registrations, which has been quite a mix of organisations and individuals. Most of those, about 70%, are from sponsor and manufacturer organisations although there is an increasing number of people who are interested in Sandpit either software providers who are acting on behalf of a sponsor or manufacturer or healthcare professionals are now starting to say, how can I use this UDI data and how could that then support some of the downstream processes from the healthcare?
So we continue getting interest in registrations and we have 141 registered users on the 6th of August. We now have about 167 of those accessing and that number, as I was saying this morning, is far greater than those who are still registered or waiting for access. So we are now closing out all of the final registrations. As Michelle talked about, we’re having a managed approach. Essentially we’re looking to close out all those registrations now in the coming week. We have a small number of UDI records created, so it represents, say, about 45 different sponsor manufacturer organisations. A little over half of those have actually created records within the database. So it’s a small number and we expect to see that number growing now that we’re starting to open up the machine-to-machine and the NPC data provision and essentially seeing greater numbers of records start to come.
It’s been great in terms of getting the feedback and seeing people using it. Feedback has ranged from thoughts around how we can change the look and feel, how we can actually better collate the information for particular devices or attributes of a device together so it better suits the business process for how manufacturers and sponsors work through to improvements with the bulk upload that I just talked about before. We’ve had 69 calls and 159 emails. So the team is working really well and we’re making an effort at this stage to respond quickly and in a timely manner to all the calls. So they’re enjoying the conversations and engagement with the various people who are calling and emailing.
We’ve actually released a couple of updates to the database and there’s another one which is imminent. So over the last six weeks, we’ve made two updates. We’re looking to roll those out every couple of weeks to make some fixes and changes to errors. We’ve simplified the login process and made it easier for those of you to put out your accounts, introduce a number of enhancements, as well as then starting to look at some other improvements to things like the bulk upload that we’ve talked about. So that will continue to happen and any major changes will be published and we’ll let everybody know, but there’s still an ongoing programme of work to just take your feedback and make refinements as we’re going.
And that’s me. So I might hand back over to you, Michelle. Again, I would just like to stress, we’ll have a little bit of time, so please feel free to raise any questions in Slido and we’ll look to get to those. I’ll hand back to you, Michelle.
Michelle Van Wijk
Thank you so much, Gary, and great to get that update on the Sandpit. So I’ll just move forward. So we’ve been working hard on consultation paper three and really the purpose of it is going to be to get detailed feedback to help provide information to government around what the regulations need to be to support the operational side of UDI. So we already made the act changes that we needed to or the government did and then we’ll move on to finalise the regulations.
So really the focus areas are likely to include; should Australia accept EU and US FDA-compliant labels and data? What might the implications of that be? The scope of devices on exemption… So what is in scope? Should, for example, class one be in scope or not? How do we align with the scope and exemptions across other countries? Phased implementation approach and I’ve seen there’s been some questions in Slido as well around the EUDAMED times but really what should that transition or that implementation look like in terms of risk classes? Who should provide and maintain the data so that a lot of the work around the Sandpit is helping to inform some of that but really seeking some information on the role that we have as a sponsor versus the manufacturer? What is going to minimise the regulatory burden there?
Labelling… So some feedback on labelling. From July 2024, UDI will need to be included in the TGA fees and charges. So we’re seeking some feedback around that. Then considerations for adoption and use… So a lot of our focus is on the provision of data, but we need to also seek feedback on the adoption and use of UDI in hospital systems in clinical quality registries, for example.
So we’ll give you a minute now. We’re up to questions and answers. I see things coming through in Slido, so we’ll just pause for a minute and ask you to do the live poll and then we’ll come back with questions in Slido. So we’ll have about half an hour for those. If you notice, Hannah in our team has been also adding things in that have been fed back to us in terms of questions, but we’ll go through and start to address those in a minute. Back to you, Nishi. Thank you.
Thank you, Michelle. So while you are providing your feedback and Michelle is going through the questions and Gary is, too, we will also send through some links to other social media pages and also to the UDI resource pages so you can set them up on your computers and use them to view later on.
Michelle Van Wijk
We’ll go through Slido now and we will start to address some of the questions. Some are a bit more technical. Some are around the timing. So what I will do is, I will read them out and either Gary or I will address those as we need to.
So I will start really at the top with, how will the TGA transition and implementation timelines be affected by the one-year delay of UDI EUDAMED, which is the database in Europe? It’s a really good question and we see that also in the US some of the timings around the transition are being delayed. So we’re seeking feedback on that in the consultation paper in terms of, what should our implementation timelines be and how might that be impacted with other countries and manufacturers also managing UDI across multiple countries? That is the plan there.
We have another question which we will definitely switch to because I know we’ve had a lot of questions around this. So, Gary, this one is going to be for you around the bulk upload. So the question is, the current bulk upload feature in the Sandpit requires one entry per file. Will the change in the final version of the UDI platform allow a true bulk upload? Based on the spreadsheets, I believe this question is relating to, rather than the machine-to-machine.
Yes. Thanks, Michelle. I read that note. I also see that this question has been asked and there has been 11 people who have also voted for it as well. So it’s again coming back to that point. It is something that we are looking at as part of the revisions to the bulk upload and we’ve had strong feedback to say similar comments. So I don't know what the final answer is, but we’ll be taking a couple of options and bringing it to our technical working group and others from a stakeholder perspective to be able to look at those options.
Interestingly enough, we’ve had some people say they like the single-file upload as well. So it is a bit of tension to ensure that we get it right, but it is something that we are definitely looking at. Whatever we do in terms of making the change, it will be done before we go live so that we ensure that we have something that everybody knows about, and we have settled around the reflections to what comes out of the regulations to make sure that’s right. Thanks, Michelle.
Michelle Van Wijk
Great. Thank you. Next question. Should we expect all medical devices, e.g. low-risk devices, will be covered as part of UDI? So it’s a really great question and one we will be seeking feedback on through the consultation paper because we know there are challenges around low-risk, high-volume devices like contact lenses. We know that there are some different regulations in the US around devices that are sold over the counter and may not be used in a hospital setting, for example, because they already have a universal product code to actually provide an identifier for those devices. So we would really appreciate everybody’s time to respond to us in the consultation paper to give us that information that will be considered as part of the regulations.
Similarly for the next question, is there an expected timeline for class one and two UDI? So that is the same. As part of the consultation paper we will be seeking feedback. So we have a proposed timeline in that consultation paper again to help focus the conversation and for that feedback. So it’s part of that process.
I’ll take the next one and actually I’ll take the next two, Gary, and then we’ll see from there. So how is the Sandpit different from the FDA GUDID and the EU EUDAMED? It’s a really good question. So the Sandpit is something that we have built specifically based on feedback from other country implementations and the idea of the Sandpit is that it will continue on in parallel with our UDI database. So it will be a permanent place that will have test data. It will allow training. It will allow connection of machine-to-machine and testing of those connections before a move into production. So we’ve got good feedback that having something like that that continues on will be useful. Next year we’ll have a live version and then we’ll have our Sandpit that will continue as well. So that’s different in terms of GUDID and EUDAMED. In terms of data published, most of the data from the final production Australian UDID will be published.
The next question is from somebody who has a question around which nomenclature is Australia using, GMDN or the European Medical Device Nomenclature? So the GMDN is our standard nomenclature across our regulatory framework, so not just for UDI. GMDN, Global Medical Device Nomenclature, will be mandatory for UDI. We’ve had feedback that collecting additional data if it’s not mandatory may place additional burden on manufacturers and sponsors. So unless we get feedback to the contrary, we’re not proposing to store EMDN for those devices as well.
Gary, this one I’m going to hand over to you. So when submitting feedback, can we use email instead of the feedback button? When using email, I can provide more detail with screenshots or file attachments.
Thanks, Michelle. So the short answer is, absolutely. We are happy either way. The concept behind the feedback button was really to be able to say, if somebody was in a particular screen and there was something top of mind or they felt at that time and expected to be fairly simple and straightforward and concise, use the feedback button. However, we really like the emails and being able to have a number of areas we’ve had feedback and screenshots and articulation of the issues that we’ve experienced or you have experienced have become really helpful through more of a bigger email. So absolutely, it doesn’t matter either way. If email suits you and that makes a lot more sense, then feel free to do that. The team gets to those pretty regularly, so we capture that and collate it all. So absolutely, not a problem.
Michelle Van Wijk
Great. I’ll have another one for you here as well. Will the TGA provide an API, an application programming interface, for the UDI database to access UDI data for reading?
No. At this stage for Sandpit we don’t have that on the radar. So we do have the ability to download data in a JSON format. So somebody can take it now and use it and upload it into systems. It is something that is on our roadmap to consider as part of the evolution of the new database and how it then progresses into the ability to use an API. We’ll be doing planning to do some work in understanding in terms of the attributes of the API, the frequency of data access, and real-time versus more batch processes. So there is some work we have to do, but certainly for Sandpit it’s not on our radar at this point in time.
Michelle Van Wijk
Thank you. Perhaps I’ll pass this one to you as well. Will UDI link to the ARTG and other lists such as the prosthesis list, recalls, or adverse events register?
Yes. So I’ll cover each of those separately. So when somebody, a manufacturer or a sponsor, creates a UDI record, we provide the provision to link and provide the ARTG ID for that particular device. By doing that, then the application will then provide a link through to the public summary from the ARTG for that particular device or for that ARTG entry that has been provided. So absolutely, it does do that. So the UDI Sandpit sits outside of the health environment and therefore doesn’t really have a lot of access to some of the health data around ARTG. We are looking to move that into and enrich that capability.
So essentially you’ll be able to link through and see the public summary at this stage and then we’ll continue to have that and look at how we can evolve that once we move into health. Prosthesis list, recalls, adverse events… It’s definitely something we’re looking at and how we can add that to the information within the UDI database. Obviously the challenge is, there may be multiple devices related to an ARTG entry. There may be multiple devices related to a recall or prosthesis list. So we’re working through those particular provisions at the moment, but certainly it’s something that we’ve been talking about and looking at how we can make that work, but ARTG is definitely on the plans and currently does that in Sandpit today.
Michelle Van Wijk
Great. Thank you. We’ve got a couple around the scope of devices and some of the data, so I’ll take a couple of those. Is it confirmed that only devices on the ARTG will need to be on the UDI database? For example, unapproved or special access scheme, for example… Will they be included? It’s a really good question and it’s one that is in the scope of the consultation paper. So to say exactly which devices, which risk class, which in vitro diagnostics, and for things like export only or special access scheme devices, will those be included? So I really appreciate feedback on those.
What is the intention of the optional basic UDIDI field? So I think we’ve covered that. So it was really to look at what might be useful, again subject to the final decisions of government around which data that we will keep.
Again, I think this question is along the same lines. Will TGA follow the master UDI concept for contact lenses that has been developed in EUDAMED? Will private label products require a UDIDI for the same device? So they’re things that we’re currently going to be consulting on.
Another question around the Sandpit, so a couple more for you, Gary. How can we communicate our observations from the Sandpit? We’ve noticed some oddities and bugs when using it, but overall it’s very good. So I think one of the benefits that we have is, this is a great period of six months to get feedback on what we’ve built. We really appreciate all the effort and time everyone is putting in. So, yes, there will be some oddities and bugs and things, but the idea is that we iron those out and work through those between now and early next year. But, Gary, I might pass that one over to you as well if you haven’t already covered it in discussing the difference between the feedback online and the email.
Yes. Thanks, Michelle. Just quickly, for certainly oddities and bugs, email is probably the best option. So the email address is email@example.com, and the team will take that and acknowledge and respond to it. So those sorts of things… We’d be happy to receive that via email. Of course, we’d also welcome any positive comments as well, so feel free to send those through. It’s always nice to see those as well. Certainly, as Michelle has already touched on, this is very much a pre-release, an early release of the database and designed to receive your feedback and thoughts and guidance. So please feel free to send anything, even if it’s something that just slightly doesn’t make sense to you, we would really appreciate hearing that via email.
Michelle Van Wijk
Great. Another question is, is it okay to enter made-up data in the Sandpit? Some of our data is fictional and was created to test different parameters. So I’ll pass that to you as well.
Yes, absolutely. From a Sandpit point of view, like I say, it’s testing, environment test data, and it won't be progressing through to production or environment. So please feel free to do that and whatever best suits for you to test the database would be welcome.
Michelle Van Wijk
Great. There’s a question on how long we’ll have for providing feedback to the consultation paper. So we will let you know when we publish that. It’s still something that’s being discussed as part of the approval process, as well.
Another question for you, Gary. When UDI database goes live, do we need to re-register or, as we already have Sandpit access, will it be automatic?
Yes. At this stage we may be looking at ways to do this, but essentially what we’ve done… Because Sandpit is independent of the final production environment, and we have created a registration online account creation process which is independent to the final implementation. Unfortunately, we will be asking you to re-register and we’ll run a process with you as we get closer to that production and go live.
Michelle Van Wijk
I’ll take a couple more. So there’s one question or a concern raised about using GMDN and it notes that the one in the current business system for product registration is rather outdated and, yes, we’re very much aware of that. We have made some improvements to that, but we haven’t finished that work yet. So we understand some GMDN terms may have been revised or obsoleted and they aren’t reflected in our current system. So the plan for UDI is that the way we manage the GMDN internally will be different and it will be up to date and kept in line with the GMDN agency code set, which we will download on a very regular basis.
The other point on the GMDN was a question around, GMDN is not free for all. So if you’re not aware, the agency, I think in 2019, no, perhaps more recently than that, has actually created a new level of membership which means that it’s free access. It’s a basic membership, so it doesn’t include some of the higher functions, but it means there is access to all of the codes as needed with no actual cost.
So another question around classes of device… So this one is around reusable surgical instruments. Again, that forms part of the scope that we will cover off as part of the consultation paper.
Another one that says, if we still haven’t received any response regarding access, should we follow up? How long should we wait? Please follow up. Send an email to firstname.lastname@example.org and the team will make sure that we did receive the original registration and that there’s not an issue in terms of not having received that and therefore not being on the list.
There’s one that I don't think we’ve covered. So I know we said we wouldn’t move the data across. Perhaps, Gary, you’ve already covered this, but I’ll just check. Since the UDI data in Sandpit will be erased when AusUDID goes live, does this mean we need to re-upload UDI data again after the system goes live?
Yes, Michelle. So the answer is yes. As I mentioned earlier, it’ll be test data or made-up data in the Sandpit environment. So we’ll obviously clean that out and ensure it’s clean and ready to go once UDI goes live. So the Sandpit itself will have a life after we have a production version of the database. So we will keep it available for people to test their different connections as well as then play and test it themselves, but it will be a separate, independent environment from the production version and we will be looking for manufacturers and sponsors to upload their UDI data from scratch once that happens.
Michelle Van Wijk
Great. A couple of other questions. So we have a question which is a really good one. What kind of support will we be providing? So will we be providing videos and screenshots and things to help everyone? Yes. We are planning to. So as part of the work we’re doing between now and January, we’re looking at not only what kind of documents like user guides we need to create but also how we can help everybody use the system easily and efficiently by creating other documents and webinars and recordings. So if you’ve got any specific ideas or feedback about something that would work well or something that perhaps wouldn’t work so well, we’d really appreciate you sharing that with us. Through our email is the best way, so email@example.com.
There’s some really good ideas coming through the questions. So there’s a question that says, will TGA provide a checklist of tasks that the industry can use as a guide to prepare ourselves before AusUDI goes live? That is a really good thought, so we’ll take that one on notice and we’ll have a look at what we can do in the timeframe and what format that might take.
If everyone thinks that’s really going to be helpful, then it’s something we can look to do and perhaps we can work with some of the manufacturers and organisations who have already had to implement UDI because they also supply to the US or the EU, for example, around if there’s anything that they found useful or not so useful. So I’m sure we can get some support on that one to provide that as well. We’re looking at, as part of our adoption work, something similar for hospitals and healthcare providers to actually help them prepare and understand what they need to do.
I’m just going through to see if there’s anything that perhaps we haven’t covered. So we’ve got a question about whether the classification in the indicative timeline covers both medical devices and in vitro diagnostics. It’s intended to, but if we need feedback to break those out, because I know the other countries have tended to break out the difference in timelines between medical devices and IVDs, and if no, when can we anticipate the requirements for IVDs? So the plan is that the requirements will all be done together. They won’t be separate between IVDs and the devices. So that will happen together. We might, based on feedback, choose to phase the implementation in the way the other countries already have by risk class and then by IVD or devices, but we really again appreciate your feedback on that as part of the consultation paper.
A question that I’m not sure we can answer, so I will maybe pass it to you, Gary, in the first instance and then we might have to take this one on notice. Can you discuss any alignment with the current commercial requirements regarding product data in GDSN? So actually I’ll take it, Gary. I’m not sure we can at the moment. We’re obviously working through the national product catalogue because that is the Australian component, but we certainly appreciate any input and we’ve had some discussions as part of a technical working group about whether we should open up the ability to provide data through the Global Data Synchronisation Network more broadly and we’re looking at what the demand for that might be and what the need might be.
In Australia some of the states and territories have mandated the use of the national product catalogue for supply and purchasing of devices. So that sits outside the TGA. They’re not decisions that we would make or be involved in. So I think hopefully I got the nuances of that question correct, but please let me know if I didn’t and we need to cover as well.
Can I add to that, too, Michelle? Just so that everybody knows, we are working with GS1 Australia obviously on what data does come across from the national product catalogue. So if that question is also covering ensuring what information flows from the NPCs into the UDI database, it’s certainly working closely with GS1 to make sure that covers and obviously what’s in our data dictionary or what would be our final published data elements will reflect or will ensure the NPC passes that information through. So if the angle on that question was a bit more technical, I’m happy to cover that as well.
Michelle Van Wijk
And I think we’ll do one last question and then we’ll wrap up. Obviously if there’s questions in between, we’ll address them at the next webinar as well and on our frequently asked questions on the website. So final question. What kind of communication protocol will be used to submit UDI data via machine-to-machine, AS2, AS4, or something different? So, Gary, I might pass that one over to you.
Yes. Thanks, Michelle. So we actually have two methods that we call effectively for electronic transfer of data over to the UDI database. So the first one, as I just talked about, was working with GS1 Australia, using the national product catalogue, to have the information out of the national product catalogue transferred or accessible into the UDI database if a sponsor or manufacturer chooses to use that as an option.
The other alternative is the machine-to-machine interface, which is using an API. It’s a RESTful API. We are actually using the HL7, so Health Level Seven, structured product language, so HL7 SPL, as the format. So we’re mirroring at the moment what the US FDA use for their data exchange and essentially taking that same process. So the format that we’re looking at matches the US FDA GUDID. Once we have the final take on the regulations and the data elements, we’ll ensure that that messaging format or messaging structure matches the data requirements that have been established as part of the regulatory requirements. That’s essentially the methods we’re using at the moment.
I’ll probably just take the chance to answer that, Michelle. We will be sending some more information out about that machine-to-machine interface and using an API gateway to be able to establish those connections to a range of people. So if you’re asking that question and you haven’t registered or you’d like to have machine-to-machine access, let us know through the email to the UDI helpdesk, so firstname.lastname@example.org. Thank you.
- Committee meetingsAdvisory Committee on Medical Devices (ACMD) meeting
- Committee meetingsAdvisory Committee on Medical Devices (ACMD) meeting
- Committee meetingsAdvisory Committee on Biologicals (ACB) meeting