Australian UDI project update and discussing considerations and real-world benefits of adopting UDI in healthcare

20231121 - UDI Webinar 19 - Edited MP3 Audio

Speaker Key:

GP              Gary Pascoe

MS             Mike Schiller

JA               Jasmin Hyatt D23-4407456

00:00:09

GP              Good morning, good afternoon, good evening to all of you who are joining us. I'm really pleased to spend some time with our number 19 webinar for us here in Australia, for the Australian Unique Device Identification (UDI) implementation. Today, we’re really fortunate to have a guest speaker join us from the US Learning UDI Community (LUC), and the Association for Healthcare Resource and Materials Management (AHRMM), Mike Schiller. I’ll introduce Mike in a moment. 

                   Mike has offered to talk to us about the benefits of UDI and the considerations for UDI within the healthcare sector. Mike has an enormous amount of experience, and we really appreciate and thank Mike for his time. 

                   In addition to hearing from Mike, I know a number of you are interested in having an update on what we’re doing with the implementation of UDI here in Australia, so I’ll give you a little bit of an update as part of that process and talk through that.

00:01:02

                   And then we’ll have a break, and obviously, depending on where we land from the time perspective, get to as many questions as we can, and answer a number of the questions that you either have in relation to any material presented today, or alternatively, in relation to anything that may come up through the conversation. 

                   Thank you, again, and like I mentioned, our first speaker is Michael Schiller. Mike is a Senior Director of the Supply Chain for the American Hospital Association, and the Association of Health Care Resource and Materials Management in the United States, as well. 

                   Mike has 35 years of experience in the healthcare and supply chain, has an enormous and an immense understanding of both health care, supply chain, and also, then, how does all of that come together, in terms of the supply chain enabled point of care, and be able to deliver points of care. 

                   Mike has an enormous amount of experience in relation to UDI and is an active member of the AHRMM’s Learning UDI Community, as well. If you haven't seen the information or the content that's coming of the Learning UDI Community, I really strongly encourage you to have a look at that material. 

                   It brings a lot of great thought leadership, in relation to the implementation of UDI, but also, how does that work within the healthcare and the supply chain sector. The work that Mike and the team has done has been exceptional and really valuable to us, here, in Australia, in terms of the implementation of UDI, but also for what we do in Australia, but also just understanding what’s happening globally. 

00:02:39

                   Mike has kindly offered, he’ll probably regret putting his hand up, to me to do a presentation on what he’s seeing and what’s happening in the US around the implementation of UDI. 

                   For those of you who don’t know, the UDI within the US, is really ten years old this year, and recently just, I think, celebrated it’s tenth birthday. And really, in moving into the process of having the unique devices on the labels, on the devices, and looking at how it starts to work its way into the healthcare sector. The work that Mike and the AHRMM team is doing has really been helping to drive that, but also, there's a lot of really great insights, in terms of how that can benefit the healthcare sector. 

                   Mike is kindly giving us time, so with no further ado, I’d love to hand over to Mike and pass control to you, Mike. 

MS             Thank you, again, for that kind introduction, Gary, the pleasure’s all mine. I'm honoured to be asked to be a part of this presentation, and to share some of our learnings. You're right, we just celebrated the ten-year anniversary. September 24^th of this year was ten years that the UDI rule went live, here, in the US. I wish I can tell you that we’ve got everything solved and it’s all systems go, but something as complex as this and as complicated as the supply chain is, we’re still working through it. 

00:04:07

                   But to your point, the Learning UDI Community has been a real asset to all of the stakeholders here, in creating, number one, a community model. But more importantly, the opportunity to solve the challenges that come with a programme like the UDI, but solve those with a collective mindset, rather than organisations and stakeholder groups making up their own solutions. You end up having a very fractured environment. 

                   So, really pleased to be able to provide that resource. Gosh, we’ve been going at this, now, I want to say, six, seven years, with the LUC, so a lot of good resources out there. 

                   But let me jump into the presentation here, and what I want to start with is, actually, a slide from our group at the Food and Drug Administration (FDA), Indira Khanduri and her team. And what this really just highlights is, the number of countries that either have current UDI regulations in place, or the regulations are under development.

                   This is impressive when you look at the areas that are covered by either current or developing UDI programmes, and it really speaks to, I think, the need to harmonise a lot of the UDI. I think some of the challenges I’ll get into here, in just a moment or two, are going to be associated with this number of UDI programmes at a global level. 

                   You can see we’ve got US, European Union, Therapeutic Goods Administration (TGA), where you guys are at in the development and launch of your programme, South Korea, Turkey, Saudi Arabia. If you look at some of the major countries under development, India, Japan, again, Australia, Brazil, Singapore, Egypt. A lot of activity in the UDI space, which is, I think, at the end of the day, fabulous. I'm excited by this.

00:06:14

                   You think of COVID, here, in the US, we had the FDA began to release, what we call, the Emergency Use Authorisations, and that allowed non-FDA approved product into the US healthcare supply chain. 

                   Sure, it would have been great to have a global harmonised UDI database to begin to validate some of that product that was coming into the supply chain. Programmes like this really excite me, with the fact that we’ve got this many countries engaged in the development or live under the UDI programmes. But again, I think it does speak to the need of harmonising a lot of the requirements across these different UDI programmes. 

                   Let’s jump into some of the barriers for adoption, and I think one of the key barriers is lack of interoperability. When we begin to think of all the technical systems, the ERPs, here, Enterprise Resource Planning systems, our material management, or supply chain applications. When you think of electronic medical records, and again, just the number of electronic medical record applications, and the lack of a defined interface to share information. I know that Fast Healthcare Interoperability Resources (FHIR) is one of the standards that's coming out. 

                   But interoperability is definitely one of the technical barriers that we’re seeing across the field, and limiting just how rapidly we can share information across these different platforms. 

00:07:57

                   Along with those technical barriers are limited IT resources within the hospital setting. When we begin to think of a programme like the UDI, and we want to implement this programme, you're going to need to acquire your information technology professionals in the hospital setting. We need to look at that. 

                   Lack of integration, lost inventory, manual data entry, missed opportunities in decision-making, I think these are some of the barriers right now that we’re being faced with.

                   Multiple device identifiers (DIs). This was something that I had mentioned, again, when you've got all the countries that have either programmes in place or are beginning to develop their programmes, we’re going to see more Device Identifiers coming into the marketplace. 

                   To be perfectly honest, this is one of the struggles we had pre-UDI, where you had multiple catalogue numbers, you could have the same item in your Item Master, six times because you had a different catalogue number. Maybe you purchased it from a different distributor or supplier at one point in time. Or maybe the catalogue number changed. 

                   Again, from a tech standpoint, how do we manage those multiple Device Identifiers, when you begin to think that the UDI is at the packaging level? We need to have the fields to be able to track all of those multiple Device Identifiers. 

00:09:28

                   Here, in the US, we have what’s called the Global UDI Database. And one of our work groups, I'm trying to think which work group it was, the report that came out on a recommended practice is that the Device Identifiers, the multiple Device Identifiers appear in the Global UDI Database (GUDID), but with a bidirectional view, if you will.

                   If I go into our Global UDI Database and I select a Device Identifier, and there's a more recent Identifier, then I'm alerted to what the new Device Identifier was. Or if I happen to click into the new Device Identifier, to have that backwards compatibility or that backwards look to see what are the previous Device Identifiers. Again, just some of the technical challenges that we’re facing around multiple DIs. 

                   Again, a lot of our ERP systems... A lot of hospitals may have older versions of these ERP systems and don’t have the capabilities, and so, what we’re seeing is the management of multiple Device Identifiers being managed through a spreadsheet or some other mechanism that sits outside of the ERP. Again, not the ideal situation. But definitely, it’s a way to manage it, but it’s not the idea management, where we do need to see those extra fields. 

00:10:59

                   Provider recommendations. To minimise, again, UDI device triggers. What are the triggers that will cause the manufacturer to create a new Device Identifier for that product? A lot of these products look the same, but again, because of the differing requirements, manufacturers may have to create a new Device Identifier. 

                   One of our recommendations to governing bodies is can you take a look at what those triggers are again, can we harmonise what those triggers are, to avoid, or at least minimise the number of Device Identifiers that are coming into the marketplace. And then, having the required field in databases, as I just mentioned, where you can do a backwards look or a forward look to the Device Identifiers out there. 

                   When we begin to think of scanning in a clinical setting, one of the biggest points of frustration for the clinicians is to scan a product and not have that product information come up. 

                   That could very well be because we’ve got an item with one Device Identifier, but the Device Identifier that's in the operating room, or the operating arena, has a different Device Identifier. Maybe it’s trunk stock, or some product that a sales rep brought in. 

                   And so, again, some of these inconsistencies and these challenges with multiple Device Identifiers can really disrupt some of the scanning programs. And really, if you think about it, when you're in the operating room (OR) setting, there's a cadence, there's a rhythm that is taking place in that room, and you don't want to be throwing that off because now I can't scan and get that information into the Item Master. 

                   And the nurse, to be honest with you, isn't going to try two or three times. They’ll try once, maybe twice. How do we correct that? Again, through multiple Device Identifiers.

00:12:56

                   Some of the other challenges are scans. Some of the barcode labels, the UDI label, is incorrect, and it’s not scanning properly. One of the things that we’re doing here is, we have a programme, a number of hospitals are starting this, where they're beginning to track the scan performance of the UDI label. 

                   There's a number of reasons why a scan may not work. The barcode label could be damaged. You don't have the Device Identifier, again, in your Item Master. Or there's something wrong, there's a character that should not be in that UDI string, and that's not allowing the barcode to be properly read by your scanner software. 

                   Those are the barcode labels that we want to begin to identify, and then work with those suppliers, and say, hey, we’ve got a problem with this product, this barcode label. Again, it’s a very iterative process, but these are some of the challenges that we’re seeing on the provider side. 

                   Additionally, financial barriers. Margin pressures in hospitals, it’s significant. I don't know that it’s going to ease up any time soon. Financial barriers, capital budgets, the money allocated to these programmes may not be there, and it may not support the acquisition of scanning software. 

                   This is one of the things that we did within the Learning UDI Community, and we’ll get to that in just a minute, when we turn the conversation to the positive side of the equation on the number of success stories out there. 

00:14:31

                   This is why I put barriers to adoption first, I don't want to end with this. But we’ll talk about how we’re addressing this because of the realisation that resources are going to be scarce, whether it’s capital, whether it’s human resources, training, etc. Whatever those resources may be. 

                   Something that the FDA has just begun to do, now, is to monitor the data quality, and they are beginning to issue warning letters to companies that weren't in compliance with regulations. This is something now that we’re starting to see, where there's a little bit more focus being placed on the quality. Quality of the data and the Global UDI Database is really critically important. 

                   And so, where we have those inconsistencies or incorrect date, whether it’s the Global UDI Database, or just compliance with the regulation, again, the FDA is beginning to start to focus on that and has sent out letters to these manufactures. 

                   All right, let’s talk about the success stories and some of the benefits that we’re definitely seeing. Track-and-trace. This is a term, I know, that’s been very, very widely used, here, the US, coming out of COVID, track-and-trace, from Drug Supply Chain Security Act. Again, coming out of COVID, with the Emergency Use Authorisations, how can you track and trace the product, how can you ensure the integrity of the product that you're not allowing counterfeit product to come into your supply chain?

00:16:13     

                   Because the UDI can be tracked through the entire supply chain, it really does counter, or eliminate, reduce counterfeit products from coming into your supply chain. This, again, is something that’s incredibly important. We want to make sure that the products we’re using in the care of our patients are, in fact, the products that we should be using, and deliver the best outcomes that we intend them to produce. 

                   The FDA is also requesting that the UDI be used in recalls and in adverse event reporting. This is something that we’re seeing, now, more and more recalls are beginning to contain the UDI-DI, the Device Identifier, and the UDI-PI, the Production Identifier, information. 

                   That's critically important because as hospitals begin to consume this data, whether they’re consuming it on the supply chain side as their stocking product, or they're consuming the data and uploading it into the patient record during the course of a procedure, those two identifiers, Device Identifier, Production Identifier, are going to be critical in identifying patients who could be impacted by the recall. And more importantly, or equally importantly, where that product is, on-site we can pull it off of the shelves and not use it during the course of a case. 

                   Hospitals are using the UDI and identifying these recalled and expired products prior to use in the surgical setting, so they could be scanning the products and identifying that this product is either recalled, or the product has expired. 

00:17:57

                   The last thing you want to do is find out that you've used that, after the case has wrapped up, so a lot of scanning, a lot of focus on identifying these expired products, or even a short-expired product, do you want to use that in a case? A lot of this information on the frontend is going to be very, very important. And that's why we’re starting to see more hospitals begin to scan, at least, the implantables, what we call Class 3, the high-risk, the critical-implant items, they're beginning to scan these items.

                   Transparency. This is probably an overused word now, coming out of COVID. You hear about transparency all the time. You hear about visibility. But I'm going to tell you, it is so important to have these elements in your supply chain. So important to have them in the supply chain, the healthcare supply chain, not just the hospital, but across the entire healthcare field, so that we can understand what we have, where we have it. Those are so important. 

                   During COVID, the big terminology that was used was burn rate, what’s your burn rate, what’s your burn rate, and everybody had to report and understand what their burn rate is. Basically, the velocity how fast are these items moving through my hospital, how fast am I using these. 

                   Transparency and visibility are critical into understanding what I have, where I have it, will I run out of product. If there's a backorder situation, understanding what some of the potential other products are that I can use. Again, going back to track-and-trace, LOT, and serial number traceability. 

00:19:36

                   Utilisation and standardisation. This is an area where we’re really beginning to see a lot of traction around the UDI, when you begin to think of the real-time product tracking. Again, getting back to that velocity, how quickly products are moving through my health system, how quickly I'm using these on patients. 

                   And who is using what. If I've got five surgeons that all preform hip surgery, who is using what? If I can understand my utilisation, and then look at those opportunities to standardise because variation if the enemy of efficiency. If we can standardise, we can ensure that we’ve got similar outcomes across our patient population. Again, this an area where we’re really beginning to see a lot of uptake and a lot of traction, when it comes to UDI adoption. 

                   So, some of the success stories that we’re seeing, here. There's a hospital, and their Cath Lab, they're using, what we call, a PIM, a Product Item Master. A lot of third-party organisations will host these Product Item Masters, that have a lot of standardised and normalised data, and they’ll keep and track the UDI information in their Item Masters, as well. 

                   Hospitals will scan those, and they’ll capture the information, some will even go out to the GUDID and bring information in, but we’re seeing scanning in this hospital. St Luke’s is scanning products in their Cath Lab, and then uploading those products into their electronic medical record (EMR). As I mentioned earlier, part of that scan process is to identify short, dated, expired, or recalled product, prior to using it on the patient.

00:21:13

                   Another example is UT Southwestern is managing their crash carts, utilising the UDI. So, they’ll have packs, custom packs, these are packs, where you've got a number of different products that you’ll use, but instead of the individual products, they're all already custom packed. 

                   They will put the shortest expiration-dated product that's in that in pack, let's say there's 25 products in that pack, whichever product has the shortest expiration date, that will go on the outside of the pack. They can then scan that barcode, and understand which pack has that product in it. They can then take the pack, open it up... Or if the product is expired, they can take the pack, open it up, pull the expired product out, reuse the rest of the individual products, but more effectively managing their short expiration date, or expired products in their crash carts.

                   Just this process, alone, just crash carts in this hospital, resulted in an $8,000 reduction in expired products. Because if they could identify short-dated products, they could use those before they expired. 

                   More importantly, they experienced a $30,000 reduction in labour costs. They had multiple people going around and tracking these crash carts, and the expiration-dated products. They now have one person that does that. They've been able to reallocate these resources to other operations within the hospital. 

                   Another example, and this is something that I mentioned earlier, due to some of these financial pressures, we began, at the Learning UDI Community, to look at what is everybody doing. Everybody’s EDIing their products. Well, not everybody, but most every organisation is utilising electronic data exchange (EDI) to transmit their orders, to their distributors or to their suppliers. 

00:23:08     

                   Our thinking was, rather than looking at a net-new programme, where you’d have to go and get some scanners, you’d have to have IT resources to implement those scanners, you have to go through training with the clinicians, there's costs and resources there, let’s focus on something that everybody is doing. 

                   And so, what we’ve been promoting is, start with one supplier. Find that supplier that you do business with that is utilising the UDI in their programmes, and take those items in your Item Master, update them with that Device Identifier information from that manufacturer. And then, begin to EDI transact with that manufacturer. 

                   Start with one, work out the kinks, get those EDI transactions flowing, your 810s, your invoices, your 850s, your 855s, your 856. These are your purchase orders (PO), your PO acknowledgements, your shipping acknowledgments. Get all of this information electronically going back and forth between the organisations and eliminate a lot of the inefficiencies that you have, and errors, in these transmissions because you're utilising the UDI. 

                   A couple of great case examples, or success stories here. Cook, a medical manufacturer, here, in the US, found that when they transact a hospital that is using the UDI, their PO costs are $60. It’s $120 when they're transacting with a healthcare organisation that is not utilising the UDI. 

00:24:40

                   What Cook did was, they took a look at three years of contract savings, and they found that they were saving $1.2 million, in savings, by transacting with some of their hospitals, utilising the UDI. 

                   Froedtert is another hospital, up in the Wisconsin area, and they began to do this, they selected and partnered with Gore, cleaned their Item Master, and began to transact with Gore, the efficiencies, from an operation standpoint, were significant. They have since expanded that programme, now, and they're working with Cook, using the UDI in their transactions with Cook. 

                   Intermountain, a very large health system out in the mountain states, in the Western US, they're doing the same thing, and they're doing it with any and every supplier that is able to transact with the UDI. Again, a great way to really promote adoption of the UDI in a way that doesn't cost you anything other than just a little bit of resource time. And you're not doing the big bang clean my entire Item Master, you're doing just one supplier at a time. 

                   Another real-world example of the UDI is Kaiser. Kaiser uses the UDI in their case-build process. Basically, they're scanning the products that they're putting on their case carts, they're scanning products that are unused during the course of that surgical case, and they're putting those products back on their shelves. And with that information, they finetuning their preference lists, so that their preference lists are an accurate representation of what is used during the course of that procedure. 

00:26:23

                   There's a tremendous amount of efficiency on the workforce side because now I'm picking just the products that I need to pick. I'm not going back and forth for the products I don’t have, or putting products away that I'm not using, that I've already picked, and I really don't need to pick because I don't use those products. They're beginning to see a lot of operational efficiencies, there, within their procedural setting. 

                   A couple of examples of point-of-care, or point-of-use scanning. Again, Geisinger is doing this in their Cath Lab. I've mentioned St Luke’s, which is doing it in their Cath Lab. 

                   We had a small hospital up in New Hampshire, North Country Healthcare, that was populating their Item Master, the implants in their Item Master, with the UDI Device Identifier information, and scanning those implants into their electronic medical record. 

                   They were seeing efficiency there because they could capture utilisation, so they could begin to understand which implants are being used across a specific surgical procedure. More importantly, they're populating the patient record with that information, as opposed to manually entering the UDI device information into the patient record.

00:27:36

                   A lot of success stories, there. Let me go ahead, and let’s just jump in quickly, here, for the sake of time. We’re going to talk about the road ahead. What are some of the areas that we’ve got our sights set on, some of the benefits that we have yet to really begin to uncover. 

                   There's one very, very large system, here, in the US, that is beginning to look at demand forecasting, that's the holy grail, here, in the healthcare side. Retail’s been doing it for 40 years, so shh, don't tell us that, we think it’s pretty exciting that we’re coming you with demand forecasting. But it really optimises your replenishment practices, you're able to begin to share this information with your distributor, and you can imagine the upstream benefits. 

                   If we’re all capturing the data that we use, and sending that to our distributors, much like you see on the retail side, they can more effectively manage their supply chain, and upstream from them, the raw materials, and other manufacturers that they're getting supplies from. So, it has ramifications up and down the entire supply chain. 

                   Case studies. Some of the things we’re going to do, here, from the Learning UDI Community perspective is... Actually, our very first workgroup was around identifying case studies, who’s using the UDI, what are the benefits, what are the next steps. 

                   Well, the whole field has shifted. Podcasts are very, very popular, here, so we’re looking at identifying case studies with these success stories, and let’s just get a 12-minute podcast together. Let’s just begin to seed the field with ideas around how organisations are utilising the UDI. I gave you a smattering of examples, here, that show some of the breadth of these success stories, so let’s just get that out in a 12-minute podcast. So that's something that we’re looking at. 

00:29:27

                   2017, we had a very, very comprehensive workgroup that built the business case for the UDI. This was meant to show pre-UDI and post-UDI business workflows, and the efficiencies that UDI in those supply chain workflows and clinical workflows would bring about. 

                   We’re looking to expand on that, and come to you with the five-minute elevator speech, for supply chain professionals to go to their senior leaders and say here’s why we need to implement the UDI, here’s the bottom-line savings that we’re going to see right out of the gate. You need to lead with financial savings. And so, we want to create just that template that shows some of those benefits right of the gate. 

                   The development of a maturity model. This came, actually, out of conversation with Gary, and the idea of developing a maturity model. That can be outgrowth of our focus on the business case for the UDI. but really begin to show a roadmap on where you might be, as a healthcare organisation, and what steps you need to take to move to become fully adopted and utilising the UDI across or clinical and supply chain workflows. 

00:30:35

                   There's a large group, it’s called the Healthcare Transformation Group (HTG), which is made up of five healthcare systems, here, in the US. The health systems or Geisinger, Intermountain, Kaiser, Mercy, and the Mayo Clinic. The RMLUC worked very, very closely with HTG, and we do a lot of work sharing around UDI and UDI adoption. 

                   Some of the areas that we’re looking at are metrics, what metrics can we begin to put out there that people could begin to track their progress. At AHRMM, we have our KPI keys, which is a platform that has a number of different metrics, operational and aspirational. One of the areas is around resiliency and data standards, and so, we already have some metrics developed. 

                   With HTG, we want to work and define are these the right metrics, are there additional metrics that we should begin to track. This feeds into the maturity model, at the end of the day, so that you can track your progress. 

                   We want to develop a feedback loop to correct data in the GUDID. I started out our conversation with quality, and the focus on quality, and the information that's in the Global UDI Database, and it’s a continual cleanse. And so, we want to create some type of feedback loop between the hospitals, and the providers, and the suppliers in identifying where those data inconsistencies exist and how to clean those up. 

                   And then, to close out our conversation, here, really, it comes down as a call to action. The manufacturers have invested millions, in some cases, tens of millions of dollars in compliance with the UDI. Hospitals, it’s voluntary right now. 

00:32:23

                   The call to action, really, is to continue to just move towards full provider and full stakeholder engagement across that provider community. Because it’s voluntary, that's really the reason that LUC came about, was just to highlight these many examples, and come out with the recommended practices. Really, how do we continue to move the needle forward and provide our engagement. 

                   We’re looking at UDI in claims, that's an area that we were hopeful was going to pass, it didn't, and we’re going to continue our focus and our efforts on capturing the UDI in claims forms. More and more, I guess a simpler objective or call to action, really, is to begin to work with our GPOs and our suppliers, and really require all contracts and price files to contain the UDI information. 

                   We need to begin to put the UDI out there in all of these different segments that we work and operate within as supply chain professionals, so it’s easier to consume, it’s easier to bring into our Item Master. It’s easier to transact with. 

                   The tremendous efficiencies you saw, at one point, $2 million for Cook, that's some significant savings, there. If we can all operate within a collective supply chain much more efficiently and effectively, the savings, workforce, financial savings, is a benefit to all of us. 

                   With that, Gary, let me turn it over to you. I think I talked far longer than I was supposed to, so my apologies. 

00:33:57

GP              Thanks. Thank you, Mike. I just really wanted to say thank you for your insights. As you mentioned, and as we both mentioned, UDI is ten years old in the US. Certainly, the learnings that we have from the US FDA, but also, all the experiences and information you've supplied. We don't want to wait ten years to have this sort of same conversation, here, in Australia, so the TGA is very keen and really appreciative of the anecdotes, the stories, the case studies, and examples you supply. 

                   We’re very interested in having more of these sorts of conversations with the community within the healthcare sector to help understand that. As you touched on, the benefits can be quite large, they also can be quite diverse, and to work out how we go forward, is really our challenge. 

                   And certainly, the TGA, in conversations the UDI team has been having within the healthcare sector, is really about, a lot of people are starting to say, well, but this requires me to invest substantially in scanning, invest substantially in upgrading my IT systems. The impact on our point-of-care staff, etc. 

                   Obviously, there's a lot of concern, a lot of questions, as you touched on, with the barriers, but your advice around start small, start with something that allows us to just identify the benefit, and then grow up from that, it’s been fantastic. I think our opportunity to continue to with you and bring this to life, here, in Australia, will be fantastic, and I really appreciate your time and attention. 

00:35:29

                   For those who are attending and listening, I do encourage looking at the AHRMM, the Learning UDI Community, their website, there's some great and rich information there, and these little case studies may help resonate. 

                   If there's any specific questions you’d like to ask the TGA around the implementation or the benefits, and certainly, the work we’re doing with a number of hospital system... A small number of hospital systems, now, to bring this to life. We’re very happy and very eager to work with you because, certainly, we’re very eager to make this happen as soon as possible. Thank you again, Mike, and I really appreciate your time. 

                   Just a short moment, I will give you an update on the Australian UDI scenario, and where we’re at. This is a build on the information that we provided within the last webinar, and essentially, things are progressing really well, in relation to us finalising the key components for the Australian UDI implementation. 

                   Most of it’s working well. There have been a couple of challenges that we faced, but certainly, for those who are within the medical device sponsor or manufacturing field, we have opened up the Australian UDI Database. And using that to test and trial this provision of data and for the creation of the data for the first step in that chain that Mike talked about. Which is getting the data and labels, etc. and all the information into a UDI database, so it then can be used by hospitals, healthcare providers to do some of the intelligence and interrogation that Mike mentioned.

00:37:05

                   We currently have 1,338 records, and we have 81 sponsor organisations participating. And so, we have a range of different information, different device types, and that's going really well. 

                   I’d like to thank those sponsors who have been working with us, closely, in getting that together and putting that data in there. It’s great to see the cross-section and the types of devices that they are now starting to bring in. And really, thank you for your feedback. So that testing environment, also, then allows sponsors to give us some feedback, we can look at the real-life data and work out how we finetune that, to make sure that we ready to go when we need to. 

                   In addition to the standard UDI capabilities, thank you may recall that we have also added some additional capabilities into the Australian UDI Database (AusUDID), which is to allow the storage and the capture of patient information leaflets (PILs), either as a document, or as an electronic... Sorry, as an electronic link to a URL, to the manufacturers, or the sponsors website. 

                   The reason for that was, really, as part of that making it optional if an organisation sponsor wishes to link their patient information leaflets with the UDI, it will give almost a one-stop-shop, a single point, for sponsors, hospital, consumers, patients to start to come and have a look at. 

                   If I've got a device, I've got the information on the packaging around the device I have implanted, I can go to the Australia UDI Database and start to capture information or find out information about the product, itself, or its instructions for use. So that’s progressed really well. We’ve had some good testing and feedback from sponsors, and that’s the thing around it’s starting to bed down now. 

00:38:51

                   We’ve also introduced the machine-to-machine (M2M) method for those who are technically oriented. We now have a machine-to-machine data submission, using two methods. 

                   One, which is using GS1’s National Product Catalogue (NPC), so that's now able to send us data directly from the sponsors’ IT systems, into the TGA, as well as then, finalising another method using the HL7 SPL standards that's used within the US FDA. 

                   Really, the aim, there, is to make the path, the transition, for those organisations who are sending data to the US FDA, to make it as a simple step for them to be able to provide that information to Australia, as well. But really, then, the opportunity opens up for us to short circuit or shorten up some of that ten-year period that we were talking about before. 

                   We’re finalising capabilities around the corrections features, so allow sponsors to correct and maintain their data. We recognise that there are genuine mistakes that get made in the data. So, rather than forcing situations that create more and more of those Unique Device Identifiers, UDI-DIs, that Mike talked about, give the ability for sponsors to correct, or manufacturers to correct that data, to shorten up and reduce the proliferation of difficult identifiers, really, that’s starting to happen. 

00:40:10

                   The downstream effect is that means in our hospital, on a point-of-care, you’re getting a smaller number of identifiers for the same device, rather than leading to confusion about why are these things different, we started to simply that. 

                   And then, finally, really, our biggest hurdle at the moment is the finalising our implementation schedule, and that is in the process of actually working through and consulting with sponsors. 

                   A key factor in relation to finalising that timetable... Well, there are two key factors in finalising that timetable, which is showing you on the slide, here. The first factor is, in the bottom left-hand corner you see a little black dot, we’re, essentially, working with the regulatory drafter, here, in Australia, with the aim of having our UDI regulations take effect from the quarter two 2024. 

                   Those of you who participated in the last webinar, you’ll recognise that date, it’s the date we’re still working to. Our biggest challenge, or the biggest activity we need to finalise, in terms of firming up that date is being sure that we get into the regulatory drafting schedule, or the programme, that the Office of Parliamentary Council is working through, to ensure that they completed our regulations in the timeframe to get that. 

                   We’re working with them at the moment to finalise what those drafting instructions are and how they draft that material. But a key factor to that has been, also, then, our timetable.

00:41:37

                   Those of you who are in the medical device manufacturing, and have familiarity with what’s happening in Europe, it does have a big bearing on what we’re doing, here, in Australia, around our harmonisation with the European Medical Device Regulations and Reforms that they're doing, the MDR. 

                   One of the key considerations, it is something that we’re working through and consulting with sponsors at the moment, is the Europeans have recently moved the dates for when their European Database on Medical Devices (EUDAMED), which is, essentially, their European equivalent of the Australia UDI Database, have moved it out three years. They're now commencing quarter two 2027. In doing that, we’re now working with sponsors to understand their readiness and their ability to supply us with data and what that would mean for our timetable. 

                   Over the coming weeks, we will finalise that consultation, which will then allow us to communicate when the more definitive dates when we’re looking for regulations to take effect. But certainly, it’s an active process, and there's been ongoing engagement and consultation with sponsors around that date. 

                   So, working pretty hard to make sure that that information is finalised by the end of Christmas. By Christmas, sorry. And looking to have some certainty in the industry around their implementation, going forward. 

00:42:53

                   Again, just to wrap-up, I’d just like to say thank you to Mike. We will take a slight break now, just for a minute, just to regroup and allow you to do two things. One is to raise any questions or look at the questions that have been raised through Slido. If you see anything of interest, please, feel free to use the upvote, the thumbs-up for those questions. We will then come back and provide, in the next ten minutes, or so, with responses to those questions. 

JH              Okay, so we’ve got some questions that we had previously. In the essence of time, I think we’ve answered a few of these, Gary, already, but I’ll just go through, and you can let me know if you want to elaborate on anything. 

                   Can you show how real examples of when UDI has been used by the medical hospital institutions? This might actually be... I know Mike’s touched upon this quite a bit in his presentation today. 

GP              Yes, I agree, Jasmine. Feel free to raise more questions. Mike’s given us a good breadth of UDI benefits, from both within the inventory, warehouse management, management of the inventory within the hospitals, but also, some examples of point-of-care. 

                   If you do have any other questions or any specifics that you're looking for, for either, feel free to write to us at the UDI team. Or again, there is some really good information on the Learning UDI Community, which we will post as part of the information that we publish out for this webinar. If you're happy, we can move on to the next question. 

00:44:34

JA               Yes, absolutely. I think this one’s been touched upon, as well, Gary, but you might want to elaborate a little bit. What is being done to improve the traceability capability for hospitals, clinics, and GPs, so that the full benefits can be seen?

GP              Yes, that's a really good question. Again, we touched on it. There's a range of elements that need to be in place to give us that full traceability. And certainly, there's conversations that the TGA has been having with a number of state hospitals, some private hospitals, as well. 

                   This is early stages in their conversation around what they do to be able to capture the UDI information into their internal systems. But also, then, to ensure that it passes through, the UDI, all the various stages and points of interaction within the hospital, or eventually, to the patient record.      

                   We have mapped that out with some hospitals, we’re still working through that, and then in the process of actually working out what they need to do to be able to put in place some of those mechanisms. I’ll definitely be taking away from this conversation, Mike, to be able to say let’s just start simple. Only keep one or two items, and work through that, in terms of you can identify the benefit, you can really see a tangible benefit without major investment that may be seen to be required. 

                   We’ll also be taking that through to that conversation. There's still a bit of work that's yet to be done, and hospitals, in particular, need to factor that into their programmes of work. 

00:46:05

JH              Thanks, Gary. We’ve already touched upon this quite a bit, thanks to Mike, but we’ve got a question about the differences between what the US is doing and what is being done in other countries to enter and provide UDI data for medical devices. 

GP              Yes, I don't know if, Mike, there's anything specific you’d like to cover. I don't know, you were looking at... I can talk a little bit about other countries, and certainly, the provision of UDI data. 

                   And one of the things that we in Australia have done or are looking to finalise as part of our regulation, our policy direction, is ensure that we have a consistency of labelling. A US-compliant UDI label, or a European-compliant UDI label, as long as it meets the Australian labelling requirements that exist today, then we will accept those from the UDI perspective. 

                   There's two parts to that, which is, obviously, that will allow the introduction of products and devices that are already fit within the US or the European medical device regulatory framework to come in. And then, we’re working really closely with sponsors and the international manufacturers to ensure that the database supplier is as close to the European or the US dataset as possible. 

                   Now, there are some Australian-unique requirements, and some Australian-specific requirements, around how we regulate devices, and a really simple one is the inclusion of the Australian Register of Therapeutic Goods (ARTG) IDs, the ARTG Identifier, and we look to them to supply some additional information. We’re, certainly, working really closely to ensure that those devices can be brought into Australia easily, and then, how do we ensure that we have those technical methods to get the data into the Australian Database. I hope that answers the question. 

00:47:54

MS             Gary, if I could add, as we embark on identifying the suppliers that we’re bringing in and populating our Item Masters so that we can transact with those, part of our efforts with the American Health Technology Group (AHTG) is, really, to begin to develop a repository of those suppliers that are actively working in that UDI space, from a transactional efficiency standpoint. 

                   Happy to share that information with you and the rest of the TGA, to go ahead and use it. Because let's face it, we use a large subset of the same manufacturers and the same supplies. These are global manufacturers, so if we can identify some that, again, have robust capabilities, have already engaged with hospitals in the US on transactional data with the UDI, maybe that's a good place for you and your systems to start. 

GP              Yes, thanks, that's great, Mike. And just a bit of a corollary to that is we also are talking to some of the manufacturers of the electronic medical record systems, as well. Because they're doing that in the US, then what do they need to do, so things like Epic, Cerner, etc. so start bringing those things in, bring that into the mix, and make that take-up in the hospitals simpler, we hope. 

JH              Great. And the last question for this one, and I think we’ve already touched upon it. The vision of the government around next steps for implementation, regarding regulation of healthcare facilities and costs. 

00:49:28

GP              I’ll short answer that one, Jasmin. I actually couldn't talk on behalf of the government and what their vision is, in relation to that. The TGA’s responsibility, obviously, is the regulation of the supply of the device into Australia, so we make that as UDI will then make it mandatory for devices that fall into the UDI specifications. 

                   There's definitely work we’re talking to, there's a whole range of other stakeholders, then, around how we get that rolling through the various parts of the healthcare system. And certainly, at the moment, I couldn't talk around what the government’s vision on that, in relation to how they're making that happen. 

GP              First question today, this is, maybe, one for you, Mike. How do you US healthcare providers manage UDI-DI triggers? 

MS             Sure. There's a couple of different ways that they're managing it. A number of organisations are beginning to work with third-party companies. Again, they’ve got PIMs, Product Item Masters, it’s an extension of your Item Master, and the third-party company is responsible for keeping that up to date. They keep all of the information normalised, write the description, the UDI number. 

                   They’ll work with these third-party solutions companies around the management of that. Some will just create a spreadsheet and manage it outside of their ERPs. We’re seeing a lot of new investment in ERP systems, and a lot of conversions.

00:50:58

                   This is one of those areas, where it seems it’s very ten years, or so, you go put the RFP out for a new Enterprise Resource Planning system. We seem to be hitting that cycle, and it’s actually a very good time because the solutions out there now, the new versions, have those fields to capture multiple Device Identifiers at the product packaging level. 

                   For those hospitals that are converting the latest and greatest version, or a brand-new software solution, they’ll have those capabilities within their Enterprise Resource Planning system. But again, those who are operating on older versions that they do not have those fields, those are some of the other areas, again, that third party or just some external management of the multiple Device Identifiers.

JA               Great, wonderful. Thanks, Mike. Unfortunately, we’ve got to time, so, I don't know, Gary, if you just want to sneak in one last question very quickly?

GP              I might sneak in two, if that's all right, Jasmin. The first one is, there's a question about has there been a development of the devices of multiple sponsors? There has been, and as part of that consultation paper around the implementation dates, there's a proposed approach for that. You will see that paper in the coming weeks, around how the TGA is proposing to address that. 

                   There was one question about how to register for the AusUDID on the Australian UDI Database. On your screen, you’ll see that email address, udi@health.gov.au. Please, send an email to the team. That's Jasmin and her team, and they would gladly work with you to get access to the database. 

00:52:42

                   And then, one final one, if I may, Jasmin, will it be mandatory to upload electronic patient information leaflets to the UDI Database? No, it won't. As part of the requirement, it’ll be, essentially, the patient information management material, sorry, that the TGA is looking... The sponsors will need to maintain that, but it’ll be optional for you to supply, or sponsors to upload that information into the UDI Database. 

                   It’s another channel, or another means you may be able to use to have that accessible, so it won't be mandatory. Apologies for those questions that we haven't had a chance to answer, and like Jasmin mentioned, we’ll cover those as part of a response. 

                   In closing, I would just, again, like to thank you, all, for all your time, really appreciate the contribution and the questions that keep coming, helps us finetune our message. But certainly, the considerations now, as we’re getting closer and closer to this finalisation of UDI implementation, is adoption in health care. 

                   The stories and the case studies you've provided, Mike, really add a lot of colour and a lot of benefit to helping people understand what this means. I would, again, like to thank you for time, and really will continue to work with you as part of this process, so really appreciate it. Thank you, everybody, for your time today. 

00:54:04