Unique Device Identification Webinar #6 - 2021 Wrap-up and Q & A, 16 November 2021
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- Presented by: Michelle Van Wijk - Unique Device Identification Project Manager, TGA
- Presented at: Online webinar
- Presentation date: Tuesday 16 November 2021
- Presentation summary: A presentation on the current status of the work to establish the Australian UDI system, and questions and answers.
Recording of online webinar presentation
Michelle van Wijk
Good morning, everyone. Welcome to our sixth webinar for unique device identification in Australia. I'd like to begin by acknowledging the Ngunnawal people, the traditional custodians of the land on which we meet or virtually meet today, and pay my respects to elder's past and present. I extend that respect to any Aboriginal and Torres Strait Islander peoples attending today.
This is our last webinar for the year, and what we wanted to do was really provide an update of the year-end review, and then answer some of the questions that we've already received. And when we have time at the end, we'll take questions and answers at the end of the presentation as well.
As Rachel mentioned, the slides and the webinar recording will be available on the website as well, as are the previous five. So, if you wanted to go back through any of them, then you can do that there.
So, 2021. An interesting year, I think, by all accounts. What we have done this year is really start by having four streams of work around UDI, and we did this based on a lot of the learnings we've heard from our discussions with other regulators, but also other manufacturers and organisations from the US and the EU as part of their implementation. So, really, we are developing our regulatory framework. We are building our database and our technical solution.
We are working around accelerating adoption and enabling the adoption of the device identifiers in the broader healthcare ecosystem. So, hospitals, registries, inventory use, for example. And we're continuing our engagement, our collaboration, and I guess our co-design work around it.
So, you can see we've got quite a lot of things happening in parallel, and they each feed each other. So, when we're building our regulatory framework, that is input into our database and technical solution, and vice versa if there are considerations we need to make.
We also, later, ah earlier this year, talked about what our indicative timing might be. We've had a lot of questions around what the timing looks like. And we know from other implementations that it's quite a long process. That transition stage particularly.
So, we are building a sandpit. So, very important feedback we received was, make something available for general use and testing prior to production, and we're aiming to have that June next year. We want to have our regulations and guidance finished by mid-2023, and that will allow voluntary compliance at the end of 2023. And then our first mandatory compliance date in July 2024.
So, our feedback was, we need 12 months. Industry and others need 12 months to update their systems to cater for capturing the new data. And so, we've allowed that between when the regulations and guidance are finalised and when the first mandatory compliance date is.
In terms of the regulatory framework. We received approval for the TGA to invest money from its cash reserves to establish the Australia UDID. In February this year, we made amendments to the Therapeutic Goods Act to enable the establishment of the Australian UDI Database. We needed to do that as our very first step around our regulatory framework.
We undertook a second public consultation, primarily to focus on benefits and considerations around international alignment and for organisations that the TGA doesn't normally regulate as part of our regulatory framework. We are in the progress or in the process of comparing and identifying gaps across the International Medical Device Regulators Forum, the US, and the EU, from a regulatory framework perspective.
And we've attended and presented at various international meetings and workshops. And really, the benefit of that it's to communicate what we're doing around UDI, to get feedback, but also then to start with early adopters thinking about how they might incorporate UDI into their system.
So, for example, if there is a transformation project that's underway, or a new registry being started up, and it makes sense to try and include UDI right from the start of those, even though we know we're still on that journey to define our requirements and the data that will be collected by the TGA, and how that will look.
We've established our first working group. So, we established that late this year. We've had seven of our meetings to date, and we started very much around discovery discussions. So, what does that look like in terms of triggers? And sorry, I just noticed I haven't got triggers up there.
So, our first working group is really to look at under what circumstances should a UDI device identifier need to be changed. And then what is the impact of those changes through everybody that uses that data?
So, we started off with some discovery. What does it mean? What are the other regulators doing? How does that impact? What do we need to track over time? We gave some knowledge sharing. So, Australian participants who might not have had international exposure or experience with UDI, they started to learn more about what this means.
We've had a presentation which was a summary of our TGA considerations, but also the context around existing ARTG rule changes around device change requests and conformity assessments, for example. And we found, as part of those conversations, we had three emerging themes.
So, the clinical versus non-clinical changes. So, supply chain changes, for example, which might affect packaging or other aspects, but didn't impact the clinical use or the clinical device itself. What the challenges are particularly for manufacturers around devices sold in multiple markets. And the existing ARTG requirements and linkages.
So, in that group, there's about 28 participants across local global manufacturers, issuing agencies, healthcare organisation, and registries. So, that's been a really important piece of work we've been doing there. And that work will finish by the end of this year.
In terms of our database and technical solution. Those who have been with us for this whole journey will recognise the diagram on the left. And that really is around our principle about how we're going to deliver the database and technical solution.
And we looked at our risk versus time frame. So, higher risk means we start. We try some things. We might have some hypotheses. We progress. And then we stop and take stock. That's very difficult to say this morning. And then we work out what direction we take going forward. Compared to the more traditional approach, which is we gather all the requirements, and then we start to build.
And where we position UDI is really from a… We want to do some building, do some testing, and then stop and take stock, and then we're going to deliver it in different milestone increments. So, really, what might be a 90-day time period, what are we going to deliver? What is our outcomes we're aiming for in those 90 days? And you can see what's happened now is that that has become our roadmap.
So, it's not yet finalised in terms of endorsement, but it is our time frame that says, here's the business outcomes we're going to deliver as part of the UDI database and technical build. Here's what that looks like. And here's how we're going to prioritise how we build those things over time.
So, we're building some earlier and some later. Some, we'll need to do a lot of conceptual analysis work around to actually have something in place. Some will rely on working groups, like the triggers working group, for example, to provide input into what that solution might look like. And that will include, for example, what historical data we collect, how we connect that data over time. So that will come from the triggers working group initially.
So, that is on the right, our strategic roadmap that then aligns with what we're building over time, and how that functionality will be released.
We have a delivery technology partner, which is Modis Australia. And we've created an initial version of the Australian UDI Database. We had an early adopter version ready on the 1st October, but obviously that's a foundational version, and we'll continue to build on that over time, guided by the roadmap that I've just shared with you. We've taken a subset of the US UDI data and uploaded that from GUDID, the publicly available GUDID, into Australian UDI Database. We have about 14,000 device records in our sandpit at the moment.
We have the ability to search for devices and view or download results. You can access the data from a desktop, a phone, or a tablet. So, it's not dependent on the type of device you're using. You can scan a barcode. So, we've got the ability now to use the camera on your device to scan a barcode or a UDI label, and that brings up device information. And in fact, we've just added production information to that. So, we don't store it. But if you scan a device, for example, it will bring up an expiry date or a lot number, as part of that work.
And we've got a new portal in place, which means, as a sponsor, if you would like to enter a device, one device at a time, then you can actually go into the portal and start to enter that device in that manner. So, obviously, that will continue to evolve. But in terms of what we've achieved this year, we've got our foundation version there, and it's up and running.
We started a process to connect the GS1 National Product Catalogue, so for anyone overseas, that is the Global Data Synchronisation Network, to our sandpit Australian UDI Database to explore potential future use of the National Product Catalogue for provision of data. We know it's already used in other countries, for example, to provide data to the regulators there.
We have completed development and user acceptance testing for the daily addition of new Global Medical Device Nomenclature codes to the Australian Register of Therapeutic Goods. That will reduce the lag between the GMDN agency creating a new code and when it goes into our TGA systems.
So, we're anticipating that will be moved into production at the end of the month. And so, that means, from December forward, they should be much better aligned, and there should be a very small lag. We're planning to run those processes daily to update that. We know that's been a challenge for sponsors.
We're doing a lot of work around adoption. And so, what we've done to date is we've had discussions, and we've done some demonstrations with our sandpit database with registries and other health organisations. And we're finding that those demonstrations and the ability to have a tool that we can talk around really starts to help people get the vision in their head about what it might look like, what it might be, and how it might be used.
We've started to develop the point-of-care scenarios and use cases, again, to help with that enable the adoption process. So, organisations, healthcare organisations, for example, registries, can understand what the processes might need to look like going forward, and how the UDI will interact in those processes with the current system. So, for example, scanning a barcode at point of care and bringing up information about that particular device, that then might be implanted into a patient.
We've had discussions with Mercy Health in the USA, and Queensland Health, which is our first early adopter project, to leverage learning and share experience. So, Mercy Health has been very generous with their time in terms of talking through their experience, what worked well, what didn't, where some of the challenges were, so that we can learn from those and help understand what that journey is going to be for our first early adopter project with the Commission on Safety and Quality in Health Care, and Queensland Health.
We also did a presentation last week at the Australian Clinical Trials Association's Annual Science Meeting, Registries Special Interest Group Day. That's a very long title. Again, to start to share more broadly what we're doing, and to start to have organisations think about that adoption piece, and what that might look like, and start to plan for that. So, it's still early days, but there are good opportunities around, as I said, transformation, redeveloping systems, for example, new registries, as they come on board, to start to integrate UDI already.
So, as I mentioned, we have our first early adopter project with Queensland Health, and that's with the Australian Commission on Safety and Quality in Health Care, Queensland Health, and the TGA. And really, to look at how do we start to implement a UDI through a broader healthcare system? What needs to happen? What might that look like?
And there's lots of benefits to progressing that work early, in terms of capturing the device identifiers and making those links. But also, as you saw, those four streams of work we're doing in parallel, it gives us the ability to feed information from that process back into our development work as well. So, hopefully, we won't miss anything in that process. It helps inform it based on real-life use of the UDIs in the Australian healthcare system.
So, we have Ministerial and US FDA approval to use the US publicly available data from GUDID to support early adopter projects. So, there's a lot of device information that's already there.
As I said, we have our sandpit ready on 1st October to support that work. TGA and Queensland Health have both agreed to sponsor the work in collaboration with the Commission.
We are progressing the work, or Queensland Health is progressing work, to really look at what are the in-scope hospitals and devices. So, what hospitals will they be? How will those devices be used? Will we make sure we get enough numbers? So, a regional versus a metropolitan. More digitally mature. Perhaps, some less so. So, how do we get a range, a good range of devices and hospitals, to really start to test this in earnest?
We're also creating, as part of that process, a reusable framework called UDI for Hospitals, that will become a template that other hospitals and healthcare organisations can use as the basis then to help enable UDI adoption in those organisations.
We continue our engagements about lessons learned. So, really, that's one of our key principles in Australia. Because other organisations or other countries have gone ahead of us, we give that, we get that opportunity to really continue those discussions externally and learn. And so, we continue our regular discussions with other regulators.
We had our targeted meeting with Mercy Health and Queensland Health. That was incredibly informative. We have learnings from the US learning UDI community. So, all of their papers they produce are publicly available, and they've recently produced a recalls paper. We've also had someone from those groups, involved in those groups, involved in our triggers working groups, again, to provide information about some of the discussion and thought processes that from those early sessions to feed into our work.
We've had discussions with US surgeons and registry organisations. We've had presentations from issuing agencies that are the core… Theres three core issuing agencies used in a number of countries. So, two of those have presented. And we've also had learnings from our triggers working group session. So, they've been very valuable as well.
As you know, we've had webinars from June, and we started those with, really, a basic introduction to Australian UDI system, through to presentations by issuing agencies. Challenges and considerations on the journey was presented by Dennis Black from Becton, Dickinson. So, a global manufacturer's perspective, who's been on this UDI journey for a very long period of time, starting particularly with the US. And we also have talked a bit about what our considerations are from a TGA perspective.
So, this will be our wrap-up for the year. We won't be having one in December. And then we'll reconvene next year. So, really appreciate all of your feedback to date.
If you have feedback on what we need to present next year, please send that into our email@example.com, or you can type it into the chat there, at the polling, to help us make sure that we're targeting the right information in the right way for you going forward.
We've also created a UDI hub. So, we recognise that up-to-date information on where we are on the journey is going to be really important, and so we've established a UDI hub. And that gives you a place that you can go to look at our previous webinars, to look at progress to date, any communication activity, and there will be resources on there going forward. So, some of those links to external material that we think is very good from a contextual perspective as well.
And we're working on that frequently asked questions, pulling together all the questions we've had to date, and publishing it in a way that makes it easy to update, so you can see what's changed over time if you're looking at it regularly. But also, as we come to get to the point where we've answered some of those questions as we move forward, then we'll update that as well.
So, what I wanted to do now was really talk a bit about the questions and answers we've had to date, and then provide an opportunity at the end. So, we've received over 150 questions, which is really fantastic. There's a number of themes that we're seeing across those questions. And timing, and scope, and alignment to have been the top out of all of those we've received so far.
But really, we've had them around labelling, clinical use, collaboration and engagement, alignment with existing processes. So, as those questions come in, we align them. We see if we've answered them already. And then we provide answers to what we haven't covered.
So, as you saw from that first slide, I talked about the indicative timing. So, the transition period and the details of the compliance dates are still to be confirmed. But like the other countries, we plan to begin with the high-risk implantable devices first.
And we're continuing to explore the opportunity to accelerate our transition period, particularly for those devices which, in the main, might already be compliant with US or EU regulations.
And our considerations in forming these dates may include things like some feedback we've got to allow 12 months from the finalisation of the regulations to the first mandatory compliance date, to allow everybody time to update systems and prepare for the first compliance date.
We got consultation feedback that, perhaps, we could go a little faster in Australia, because UDI has been implemented in other countries, and perhaps we could consider voluntary submission of UDI ahead of mandatory compliance dates. And we also need to look at the Australian UDI Database and our linkages with the existing Australian Register of Therapeutic Goods, which will remain, and how that looks. So, we're working on all of those things, and we'll publish the definitive timelines when those are agreed.
So, this is, again, that slide I showed earlier, which has got our sandpit being available, indicative dates for regulations and guidelines, voluntary compliance, and then mandatory compliance. And that transition at the end is something we will need to provide further details on.
But if you've looked at the other country implementations, you'll see that, as a general rule, particularly for the US and the EU, there's two years between which class of devices and a breakdown between labelling, provision of data, and some of those various aspects. So, we're looking at all of that as part of our considerations.
In terms of international alignment. Our work will very much align with the IMDRF two papers, the guidance, and the application documents, both published on the IMDRF website. We are looking to initially align with the US FDA, where we need to, where there's any differences with IMDRF, but we also need to consider EU regulations. And so, for example, in our recent triggers working group, we looked at the triggers across all of those three.
We're also considering what additional or different data is collected by the EU, for example, as the European Medical Device Nomenclature. The EU has a basic UDI-DI, and a master UDI-DI. So, we're looking at those in terms of the additional information, what the benefits might be, but also around interoperability and harmonisation.
From a TGA perspective, we will have minimal additional requirements. We're working very hard to minimise those. But there will be some that are related to our regulatory framework and some of the differences in Australia. And so, for example, we have an ARTG-ID on our ARTG already. And so, we'll need to do things like link that to the UDI device identifier.
We have requirements around patient information leaflets and prosthesis billing codes in Australia. So, we're looking at those to see how they will benefit adoption, and what the benefits are, and we'll need to do some thinking there.
In terms of the scope of devices. So, we know that devices that are regulated by the TGA will be in scope, including software that's a medical device and regulated by the TGA. The UDI will be required for every model of device, and it will be different to the ARTG data, which contains information at the kind of device level.
There are lots of things we know we still need to explore. And so, one of those is, will non-ARTG-registered products be eligible to use a UDI? What will be in scope around Class 1 devices? What will be in scope for legacy devices, for kit systems, procedure packs, for patient-matched, custom-made devices? And also, things like, how do we use UDIs for spare parts that might be used in repairs? So, they're questions that have come through to us, and they're great, because they make sure that we're considering all we need to as part of this process.
We've had questions around the existing processes for inclusion on the Australian Register of Therapeutic Goods. And we know that each device record in the Australian UDI Database will include a list of relevant ARTG-IDs that relate to that model of device, and there may be one or many. And we know under current regulations, UDI is mandatory for the patient implant card if a device has an Australian UDI when we commence with our Australian UDI implementation.
So, we're still exploring some of the changes. So, for example, will a sponsor be required to submit a variation where a UDI is provided with updated labels? Will there be a review required as part of that, or an audit? How will that change? And linking of TGA data for UDI, including adverse events and recalls. There's been some questions also around quality management systems, and what might be the requirements in there for UDI.
So, we know the majority of the UDI data will be made publicly available, through a web interface, and through data downloads. So, automated downloads, for example. And we'll provide machine-to-machine capability for future data transmission, again, to do it in bulk and to reduce the regulatory burden. MRI compatibility is included in the IMDRF data set, and we're planning to capture it in the Australian UDI Database.
As I mentioned before, we're also providing a web interface to allow data entry for small numbers of devices at a time, to um in addition to what we're providing for provision of data in bulk.
So, some of the areas we're still exploring are, should the manufacturer be able to provide UDI data directly to the TGA? And that's based around our regulatory framework, where the sponsor is required to provide that data, where other countries, the manufacturer provides that data. The use of the National Product Catalogue or the Global Data Synchronisation Network for the provision of data.
We also, where there are practical elements of where a procedure pack or a system might be there with multiple devices in part of a pack. The final data set. So, we'll need to provide information around what that is. We're still working on that. And does it mean that the manufacturer will have to create a new UDI and packaging for each device that may have multiple sponsors in our Australian regulatory framework?
So, we also know that device information consists of data such as manufacturer, sponsor, whether the device is supplied sterile and so on, and it's generally static over time. The production information is a lot number, a batch number, manufacture date, expiry date, for example, and that changes every time the product is manufactured, and therefore is not stored in the regulator's database.
However, the production information will need to be stored in other systems, such as supply chain, hospital systems, patient electronic health records and registries, in order for the benefits of UDI to be realised. So, a sandpit version will be available for use in testing to start to test some of those connections between systems.
We're still looking at options for data exchange and interoperability, but we'll have a focus on contemporary best practice and alignment with industry standards. And the data elements, we'll also need to do further stakeholder consultation with, and we'll publish a data dictionary of the data elements. And one of the things that's been called out to us in the feedback is that different countries use the same term but have slightly different meanings. So, we'll take that into account as we go.
From a GMDN perspective, we know that it will be one of the data elements required to be provided with the device UDI data, but it won't replace… The UDI won't replace the GMDN. Each model of device will require a UDI and a GMDN code. We know that, currently, if there are no changes to the characteristics of a device, the GMDN is valid for the life of the device, even if the GMDN agency amends that code or makes it obsolete.
As part of the ARTG clean-up work we've been discussing around the GMDN, there is no plan to force sponsors to lodge change requests for their devices, and there's no plan to change the way the GMDN codes are implemented for Australian in vitro diagnostic devices.
So, we're still exploring whether there are benefits in potentially also collecting the European Medical Device Nomenclature. What processes might be in place for changing GMDN codes over time for devices? And the relationship between the ARTG and the UDI, because both of those data sets include GMDN, and we need to understand how they relate to each other.
In terms of generating UDIs and the work of the issuing agencies. So, we know issuing agencies are responsible for generating the UDIs, and that they are based on international standards. Australia is planning to accept UDIs created by the three core issuing agencies that are used in other countries, including GS1, Health Industry Business Communications Council, HIBCC, and the International Council for Commonality in Blood Banking Automation, so ICCBBA, including where those have already been applied to devices in the EU and the US.
So, we also know the manufacturer is responsible for obtaining UDIs from an issuing agency and allocating them to devices, and that is particularly relevant, given our regulatory role of our sponsors in Australia.
So, while we're considering our position on the issuing agency framework, we recognise that there are three issuing agencies. And we have also recently had a question about whether TGA will become an issuing agency, because that is something that's happened in another country as well.
In terms of labelling. So, as I've just mentioned, we plan to accept UDIs created by those three issuing agencies, and that UDI labelling won't be required for stock already supplied. So, if there is a device that's on a shelf in a hospital already, for example, that won't be required to be relabelled.
Some other things that we still need to explore is, will the implementation of UDI barcodes onto labels be considered a substantial change? And does that mean there's a requirement for a conformity assessment review?
What might those processes be? And what about the small products, where it would be difficult to put a UDI on the labelling, or in some cases on the device itself, if it needs to be direct marked? And we still need to consider what those requirements would be.
In terms of using clinical systems and patient records. So, we know that the UDI can potentially be captured or linked to a specific data in any system that explores the data, but it's outside the scope of the TGA UDI project. So, really, that comes back to those early adopter works to understand how it might look, and what those changes need to look like. And so, we're still continuing to explore the early adopter learnings.
In terms of collaboration and engagement. So, we started our first working group this year. We know we're expecting there to be more next year, to really focus on specific areas. And so, those are open to all. We welcome all participants. And each time we start them, we'll seek interest for each new working group.
If you'd like to register, please do it any time, and advise us if there's a particular topic you're most interested in, or if, generally, you'd like us to invite you to each of the working groups we establish. And you can do that via our UDI mailbox, firstname.lastname@example.org. As we've talked about, next year, we're going to seek further feedback on the operationalisation of the UDI twin form, our regulatory requirements, and our transition plan.
And our current thinking is that will be quarter one or quarter two next year. And it will include a lot of the work that we've already done to date, and the work of the triggers working group, for example. So, we really welcome and encourage any of that feedback you have, any questions, inviting us to speak in any forums you think might be appropriate for us as well. It's a really important part of what we're doing.
In terms of next steps. So, I talked about the regulatory consultation, quarter one, quarter two next year. So, we're in the process of preparing for that. And we'll continue with our co-design and collaboration probably in a more formal way from next year. I'm hoping we can do some travel, and therefore there will be some more face-to-face workshops, but we'll have to see how that plays out. Otherwise, we will do them virtually.
And additional early adopter projects. So, really looking for those opportunities to start to have organisations adopt and use UDI in systems.
Hi, everyone. I've got some really great questions. So, I'm happy to jump in while you're completing the poll and start with some of those. Please keep them coming. We've got six so far. So, I will take them from the top-down, and I'll answer the ones I can. But the ones we don't have answers to yet, I'm also going to read them out, because I think they're all really, really great questions, and they will form part of our considerations, and they will all go into our questions and answer list so that they are tracked over time.
So, the first question we have is, will UDI be required for medical devices supplied via the Special Access Scheme? So, for example, will orthopaedic implant parts imported via SAS for revision surgery require UDIs? Or will that be part of the full surgical implant kit, or the full group of devices there?
It's a really, really good question. It's one we're going to feed into our for-further-consideration, and we'll publish information about that as we go. And it will form part of the regulatory consultation early next year. So, really, really good question. Thank you so much for sharing that.
So, the next question we have is, will RFID be allowed for UDI in parallel to labelling with barcodes and reading requirements? And so, it'd be useful if the TGA can cover what our intents are around the RFID. So, also really, really good question, one we don't have an answer to right now. But again, it will inform our considerations, and that's something else that we'll see as part of that regulatory consultation next year. So, fantastic question.
Another one around, any update on the work we're doing around contact lenses? So, contact lenses falls into those devices which are high volume and low risk. And some of the challenges identified by the IMDRF and other countries is that it's an administrative overhead. It's a lot of data to collect in the database, but also it requires manufacturers or sponsors to provide that data as well. And so, one of the things we're watching closely is what the EU is doing around it, and then we will, as part of our framework, look at what we do for those devices.
So, it will be things like contact lenses, spectacle frames, and spectacle lenses, for example. There's a number of devices that fall into that category. So, really good question. Thank you. And as soon as there is an update, we will let you know. We don't have one right now.
Have a question on the National Product Catalogue, on whether our data will be provided to the TGA via the NPC, or we'll be providing data out via the NPC. And will sponsors need to keep both up to date? So, it's a really good question.
Part of the work that we're doing now in connecting our sandpit database to a non-production version of the NPC is start to explore that to understand how it's being used in other countries. Where the benefits will be. Were manufacturers already using it in providing data to us. What kind of formats that needs to look like. And what that interoperability looks like. So, what data comes in, and what goes back.
So, for example, something that might come back would be a message to say, we've successfully received your data. So, they're the sorts of things that we'll be looking at as part of that work we're doing with the National Product Catalogue now. So, more information will come up about that.
A question from, if you're part of a working group, do you need to keep registering for future groups? Good question. So, no, you don't need to keep registering. We have a master list of everybody that's provided their contact details for working groups, and we will track that. So, no, we would not like you to have to keep managing that and keep sending that to us. We will be doing that. So, very good question though. Thank you.
A question around kits, and whether that includes surgical loan kits. So, again, one of the challenges and complexities around international alignment is that different countries use different standards and terms in slightly different ways. Some of the feedback we've got, even from the UDI perspective.
So, when we put our proposed regulations and our consultations together, we'll be really clear what the definition is, and we obviously need to look at what our current definitions are, and make sure that that's taken into account as part of that process as well. So, thank you. And we know you know the kits is something we need to look at.
Had a question about whether we have any indication of other working groups in the new year, and what they might be. So, at this stage, we don't, but we'll start to look at that in the short term, because we know people are breaking for Christmas soon. Particularly, in Australia, where we have our long holidays and our school break in conjunction with Christmas, it can be quite a long break.
But we're really keen to start to do some of those focus areas like looking at our screen flow for entering a device UDI record, for example, how might that work. Have we got the order right? Are there things that we could do that would make it easier or faster? How might we use some of the data we already have in that process to prepopulate? Is that going to be possible?
So, really, we're going to start to look at some of the groups to give feedback. And it might be that we start to have more technical working groups, for example, that have a very deep focus in a particular area. So, we will provide information around that as soon as they become available. But there will definitely be more activity in that space next year. And as I said, hopefully, we'll be able to do some face-to-face workshops and discussions as well.
Another scope question around… And this has come up across other countries as well. Around what about devices that are used at home and are sold, perhaps, over the counter? We're seeing more and more through other retail outlets at the moment. And you know Blood pressure monitors is a key one of those, or thermometers. There are a number of those.
So, we're still looking at that in terms of the scope of device. But really, the expectation is that if it's a regulated device, it will need to have a UDI. But those specific scenarios, we do need to come back and cover off as part of our work, and they have come up in other countries as well.
And there's a question here that talks about some of the challenges of the matching the UDIs to products currently sold in retail. So, if you think about contact lenses and a whole range of those. So, the question is that, if we're looking at the master UDI that's being proposed by the EU, and some of those products are sold in retail, how is that going to work? And so, it's a really good question, and we know we need to look at all of those aspects when we do that.
I think the benefit of the working groups is that we're trying to really consider all the lenses. I was going to make a very, very bad joke. That was unintentional. But really look at all the different usage by healthcare providers, you know retail, hospitals, registries, sponsors, supply chain, inventory management.
So, when we're putting the working groups together, our goal is to get as many of these views as part of the early discussion as we can, so that we understand the impacts of particular regulatory approaches, or approaches that in our development of the database, that we need to take into account to help to minimise the regulatory burden for everybody that is using these and encourage the adoption and use. So, definitely, all of those lenses, we're aware that we need to take into account.
And so, the question that's a really good question. The next one is around, do we need to make sure that retail pharmacy, for example, are involved in those discussions? And yes, we do. So, when we put the working groups together, we need to… We go through, and we look at everyone who said they'll attend, and we look to see if there are any groups that are missing, and then we actively are looking for engagement from those groups as part of the process that we undertake.
So, very much we welcome everybody. We do try very hard to make sure that all of the groups are represented in those working groups. And we run them across Australia and overseas. Finding time frames that work for everybody is a huge challenge. And we know that EU, and some parts of the UK particularly, and the US are a bit difficult. But we do our best to find times that work for everybody as part of that process.
That's the end of the questions. So, I know some of those were, we need to take it into account we don't have answers yet. But really appreciate that you keep bringing those ones out, because that helps us to make sure that we are covering those lenses, that we perhaps might not have thought of, or scenarios that we need to take into account. So, questions are really important in helping us do that as part of this process.
So, I don't have any more questions. Thank you so much for everyone who's been through all of our six webinars this year. Really hope they've been useful. And really important mechanism for us to share the thinking and the understanding, and to bring everyone up to speed for a common understanding across UDI. We'll look forward very much to starting those again next year. But again, if you've got specific topics or recommendations for speakers, please send them through to us, and we'll look at all of those, as we put our plan together for next year.
- Committee meetingsAdvisory Committee on Medical Devices (ACMD) meeting
- Committee meetingsAdvisory Committee on Medical Devices (ACMD) meeting
- Committee meetingsAdvisory Committee on Biologicals (ACB) meeting