Unique Device Identification Webinar #16 - The value of UDI for procurement and inventory management in hospitals

Rachel Schulz

Good morning, everyone. My name is Rachel from the TGA Learn area of the Therapeutic Goods Administration. Before we start, I’d like to acknowledge the traditional owners and custodians of the land in which we meet today, and pay my respect to Elders past, present and emerging. I’d like to extend that acknowledgement and respect to any Aboriginal and Torres Strait Islander peoples here with us today.

So, welcome to the UDI number 16 webinar. Now, without further ado, I will pass over the time to commence today’s webinar, Gary Pascoe, who is the UDI product manager. So, thank you, Gary. Over to you.

Gary Pascoe

Thanks, Rachel, and good morning or good evening to all of you who have joined us. So, thank you again for joining us, and as Rachel mentioned, this is UDI webinar number 16, so it’s been great in terms of the roles that we’ve been playing and talking through. And consistent with last webinar, the UDI work is progressing very nicely, and we would like to talk a little bit about that and give you all an update on how the UDI project’s progressing within the TGA towards the end of this session.

In the meantime, however, the UDI team is very keen, and certainly the TGA is very interested in ensuring that the UDI implementation, both within the regulatory environment, and the manufacturers and sponsors within Australia associated with supplying medical devices know what’s expected from them. But also, we all know that the implementation of successive UDI really comes from the implementation of the identifiers and its use across the healthcare system.

So, in keeping with a number of the other webinars that we’ve run recently, and certainly we’ve got one of the themes over the next coming weeks and months for the TGA, is ensuring that UDI is being implemented by the manufacturers and sponsors and to be able to help them understand the benefits and the implications of UDI across the healthcare system.

Those of you who attended last month’s webinar know that we had Dr Oliver Daley presenting about considerations for UDI within the clinical and hospital setting. And I’m really pleased to, this month, be able to introduce Michel and Joanna from Healthscope to be able to talk about UDI and the considerations for UDI within the supply chain within the hospital system, as well.

Michel and Joanna have been actively working with or have had a good relationship with the TGA in terms of considerations of UDI and are very passionate and interested in their understanding about UDI, and particularly how it can help introduce reforms or drive reforms within the supply chain and procurement sides within the hospital systems. So, Michel in particular is somebody who’s actively given feedback on the considerations for UDI and is very interested.

Michel and Joanna, I’ll allow you to introduce yourselves in terms of what your role is, but just a quick introduction. Michel is the Transformation Lead for Procurement and Supply Chain for Healthscope and is actually leading quite an interesting and exciting bit of work around the transformation of Healthscope’s initiatives and supply chain, and actually having perspective from a procurement through to clinical side of things being able to accurately and confidently identify devices and track them.

And then, Joanna who is playing a key role in making that work happen in terms of managing the change and understanding the implications of change across the various stakeholders associated with that. So, with no further ado, I’d really like to thank both Michel and Joanna for providing their time, and hand over to you, Michel, to give us your presentation.

Michel Hulzebos

Yes, thank you, Gary, and good morning, good evening to everyone. Thank you for joining today. My name is Michel Hulzebos and, as Gary was saying, I’m Transformation Lead for Procurement and Supply Chain at Healthscope at the moment.

So, what Jo and I want to cover today is some of the common issues that we have seen in healthcare, and certainly I’ve seen in healthcare, in Australia. Some of the common themes within healthcare in Australia in relation to how we manage data, how we manage supply chain overall, and where we see UDI playing a catalyst role in improving supply chain. But also, some of the roadblocks that we might see or that we have identified in that smooth implementation that we all would like.

So, just a quick introduction about myself. I’ve got 25 years’ experience in supply chain, different industries. I have a background in construction and mining and manufacturing. I worked in an international mail service, worked in pharmaceutical distribution in Sweden. I’ve got a background in IT, as well, with some years within ORACLE.

And over the last six to seven years, I’ve worked both in public and private health organisations here in Australia, and as I said, currently as a Transformation Lead for Procurement and Supply Chain at Healthscope. Besides that, I’m also a member of several groups and several groups outside of Healthscope, of TGA being one of those. Joanna?  

Joanna Giannone

Thank you, Michel, and hello to all. I am the Change Lead at Healthscope and, essentially, I have many years of experience in change management and associated project management. I actually started my career in the not-for-profit sector with a focus on seeking to change global famine issues. This piqued my interest in roles that were human-centred and supported improved employer experiences when implementing change.

So, essentially, what I started to do was capture as much of that experience as I could across many different industries from technology, also mining, financial, government and healthcare sectors. And started that process of learning how to implement change across various organisations, be it through process improvement, or potentially improving technology systems, upgrading the way in which people would access those technologies, new ways of working. And how to ensure that that implementation was successful so that people were upskilled in the appropriate methods of those new ways of working.

So, now, my role within Healthscope is to ensure that it does upgrade its technology, but also that it’s supported through the supply chain practices that are going to be necessary to ensure that there are better ways of working across the industry.

Michel Hulzebos

All right, so current state of healthcare. And I’ve addressed this in a previous seminar, one of the 16 that we have had before, where I went into some detail, but I just want to recap on that. This is not just for one organisation, this is overall what I have seen and what I’ve experienced in a number of organisations, both public and private. But we can state it fairly clearly that healthcare as an industry is lagging behind on other industries, and particularly how we are managing our supply chain and how we are managing our data.

So, generally, we can state that our data is managed poorly. I’ve seen several occasions of manual intervention of particular products and price data. We are also not a standards-driven industry. We don’t drive supply chain standards in our industry, and in some cases, we are not using the barcoding that is standard on the packaging. In certain cases, we even create our own barcodes, if we scan any barcodes at all.

We also don’t see supply chain as a key strategic area within our business, and that means that as an organisation, and I’m sure Jo will go through that, we are quite siloed between clinical teams, but also within the supply chain group in itself, between procurement and supply and logistics. So, we don’t see that as an overall end-to-end business process.

Since we are not managing our data properly, and since we are not managing our processes, we have a lack of metrics and analytics, so we can’t compare apples and apples, basically. And we have a low rate of digitalisation and technology implementation. Processes are not standardised, our data is not standardised, and therefore technology development is fairly basic. Which means as well that any change, particularly the change that we are trying to implement here with UDI, we have quite a hurdle around the technology and technology upgrade.

So, as a result of that, we are currently not able to track and trace products efficiently and safely in our supply chain, all the way from manufacture, all the way to the patient’s bedside. We do manage some of that, and we do manage that with varied success and quite manually, but not as a standardised, fully integrated, digitised process.

As a result of that, we also can’t track costs. If we can’t track our products through our supply chain, we can’t track our cost and benchmark, and build planning based on those data and make data-driven decisions. And through that, we have a very reactive supply chain. We are not managing our supply chain, we are not able to manage supply chain volatilities, as we have seen over the last few years in particular. So, the current side of supply chain. Over to you, Jo.

Joanna Giannone

Thank you, Michel. So, essentially, we know that we need to introduce change in healthcare. What we do know is that healthcare is very well versed at introducing change. In fact, they do it on a regular basis, especially when you start to consider all the compliance and regulatory requirements that they go through on a day-to-day basis and weekly basis.

So, in effect, they actually manage change constantly, and therefore, obviously to support it, they invest heavily in managing policy updates, process and procedural change communications, and the required skills training to obviously bring that change on board. However, when technology is introduced as part of the change, such as digitisation of a manual process, it’s not deemed as a compliance or regulatory requirement, but rather an enhancement or as an extension to the compliance activity.

As a result, it lacks the dedicated change management support to ensure that the technology changes are implemented in a balanced manner that’s going to be across the entire workflow process, from business support right through to clinical processes, essentially creating those silos. So, they’re not really managing it as they go through the process of what potentially is going to be a technology change.

So, when we look at the current state, as with most industries, healthcare is also experiencing challenges, which is evident across people, processes, technology and data. And in the current environment, hospital decisions are reactive, especially post-COVID impacts, globalisations of products, cost of living, and inflation pressure. They all have an impact to operations. And when you combine that with patient safety and cost being under greater scrutiny, the healthcare system is challenged to meet both.

We know that there are many reasons why, obviously, introducing change is going to be difficult. However, because they’re well practiced at introducing it, they’re also slow to introduce it, and it occurs especially across the technology, unless there’s a regulation to drive that requirement to occur in a way that’s faster.

So, reasons for this that we see could include risk aversion. We know that there’s a fear of doing certain things if it impacts patient care. There’s potentially lack of time and investment in uplifting capability, unless its compliance driven. There’s low-tech maturity among clinical frontline staff with little to no development focused on adopting technology changes. And continuous improvement lacks the investment required to become more proactive, further strengthening the reactive mode of today’s environment.

So, how can we help to implement change? We could potentially invest in continuous improvement and instil a culture where learning to change is a positive experience. We could look towards linking regulatory requirements to digital improvement whilst investing in skills uplift. And importantly, we can seek sponsorship across teams from clinical to business support teams, essentially creating that flow that needs to occur throughout the healthcare facility. Michel, I’ll throw over to you, and if you could help to explain how UDI can help to be that change force.

Michel Hulzebos

Sure. So, as Jo was saying, we all realise and we all know that even without the introduction of UDI and the conversations that we’ve had over the last few years around UDI, that change is required in healthcare in the way we are managing supply chain, the way we are procuring and supplying healthcare would need to change. So, we see UDI as being a catalyst in helping us driving that, and particularly from a data and from a technology perspective.

So, what UDI will help us do is to digitise and integrate supply chain processes across our hospital systems. So, all the way from when we receive physical goods all the way up to our clinical systems and building that clinical integrated supply chain that I keep talking about.

On the other side as well, the other side of the fence, when we are talking to any of our suppliers, we want to speak the same language. We want to standardise the language that we use with our suppliers, and suppliers with us. So, we receive all the data connected to these products in our supply chain and being able to easily and effectively absorb that and transport that through our technology.

And, as I mentioned, the current state of our supply chain doesn’t allow for that. The way we are managing data, the way our technology is developed doesn’t allow for that clinically integrated supply chain. That’s where we want to head to.

It will help us, as well, to drive proactive and strategic decision-making. If we can track products and if we understand exactly where products are being used, but also use the other data that we can gather in our clinical systems and in our supply chain systems, and we start linking those together, we can start making strategic decisions.

We can see which products have comparatively a better patient outcome. We can start comparing sites, hospitals, clinical processes, and help us to build that continuous improvement mindset that we so need in healthcare. We can drive these decisions by standardised data and improved data.

So, how do we get there? Well, technology is one part. We have technology that requires a lot of development, but it needs to develop with the same priority and focus as how we are driving change in our organisation when it comes down to compliance and regulatory changes, as Jo was explaining.

We also need to make sure, first of all, that we get an understanding of what supply chain is across all levels of the organisation and uplift the organisation. Make sure that we have an uplift in supply chain maturity in the organisation and integrate these processes across the business support functions and clinical functions.

And additionally, a directive would be good. So, if it’s a directive or a mandate around track and tracing of products. Now, if that isn’t possible, there is other ways and there’s other means of doing that, as well. We could compare and we could publish and show maturity levels between different organisations, of different organisations, how well are organisations managing their supply chain and measuring supply chain maturity of organisations, or the way they are managing their quality and data quality.

So, there’s a number of ways of doing that. We certainly see that UDI will help us drive that future state, and the future state is what we want to show on these next slides. There’s a lot of words we can say about it. It’s always easier to see exactly what it means. So, in one picture, connecting our hospital and our clinical systems to what we order from our manufacturers.

We tend to talk a lot, and particularly in this project as well around UDI, we tend to talk a lot about industry and logistics, and all the way up to the point where we physically receive the goods on the left side of this diagram. We tend to talk more about how we digitise the data between us and suppliers, and that’s exactly what we need to do. But there is the flip side, a back side of that. And it’s right on that point where we see some challenges, where we see some difficulties. Jo, maybe you want to go into that area.

Joanna Giannone

Sure. So, essentially, as Michel’s alluding to, once it hits the healthcare facility, that’s where people become involved. And tracking inventory to a designated location requires a reliable and seamless system that digitally tracks any manual handling of inventory across the facility, right to a patient’s bedside.

However, we know that there’s the challenge, and that challenge that many facilities face is that they have processes that differ across wards. They know that human error occurs, so it could be just as simple as being able to track a particular product all the way up to where it lands at the ward but being unable to track it thereafter.

Potentially what could be happening is, a product gets picked up, it’s replaced, it might be replaced in the wrong location, and we no longer have visibility of it. It might be place near a product that has similar packaging, and that could create issues. Or it could not be actually found. Under pressure, we know, people face, it may not actually be found quickly. And what results is more stock orders, so therefore we have overstock supply, and potentially even worse, stock that starts to become expired.

So, we know that there’s lots of challenges associated with that particular component of the healthcare facility, and that they’ll need to be upskilled in how to also be part of that integrated supply chain. Working in the healthcare facility is process driven and it’s highly reactive, we know that. So, supply needs to be effective with no room for error.

And the way in which we see that that’s essentially going to be possible is through digitisation. Because we know with digitisation, when you introduce it across the supply chain from the very beginning through to the healthcare facility, it creates greater accuracy. And that is critical when meeting quality requirements. So, it’s no longer just an enhancement, but becomes something that becomes part of the process of ensuring better quality care.

However, to do that, we know that clinical teams need help to adopt technology changes, such as the introduction of UDI. They need to see the link between patient care and effective supply chain practices with an alignment to quality assurance and compliance. That essentially becomes how we get to a point where we know that they are also understanding how it is that they are going to be able to be part of the supply chain when they understand that there is a link to patient care in what they do when it comes into the facility.

Digitising inventory management in healthcare facilities, when you talk across procurement, supply and clinical teams, will enable improved data that Michel talks about. It therefore leads to better planning and decision-making, accurate inventory traceability, which would be essential once it’s hit the actual healthcare facility. And we know that all of this is actually going to lead to improved employee experiences and ultimately better patient outcomes.

So, having an integration of all of the activities and functions that happen from the industry through to the logistics and the healthcare facilities, is actually a better outcome for the patients. Michel, did you want to add anything to that?

Michel Hulzebos

Yes, absolutely. And fantastic, great points, Jo. I think, in short, what we see here is, it’s not a problem around data. The data exists. The data standards exist, and they already exist in other industries, as well. They’re already utilised in other industries. And it is the uptake of those standards and changing those data standards in our industry that we need to do, but the data standards do not have to be reinvented.

The same is to say about the technology. The technology exists. There’s plenty of technologies around that support this. It is about linking the technologies, and it’s about building the supportive processes to help drive this. But I think, overall, we see part of this is how we interact internally within organisations, how we include clinicians, doctors, and other functions within this decision-making.

And I think I can’t express it better than this picture here. We’re all part of supply chain. Whether you’re a theatre nurse, a clinician, whether you’re a supply officer working in a pharmacy, we all make decisions that impact our supply chain, how we manage physical products from manufacturing all the way to the patient’s bedside, and how we manage the associated data that travels along with that. And that is where we need to get to. The issue is not data, it’s not technology. It is the people and the process that we need to develop.

Joanna Giannone

Yes, it’s that holistic approach that we really need to create within the healthcare facility itself, and we know that there is a current environment of silos. There is no supply chain methodology that exists, that says everyone is part of the supply chain. It essentially becomes something that a department looks after, and not necessarily where someone feels like they are in some way contributing to the supply chain and therefore the patient. That essentially covers the presentation that we wanted to give today.

Gary Pascoe

Thanks, Joanna. So, I might fill some of that pause, if you don’t mind. As I said before, thank you for your time. And it’s interesting, certainly for me, the concept of clinically integrated supply chains, was certainly one that’s really interesting from my perspective, and the role that UDI and certainly the TGA is very interested in.

So, here, you talk about the fact that the data is there. We’ve got this, it’s connecting the data, the systems, the process, and all those little islands, and the value of UDI being able to thread through and connect all those islands is certainly something that we see excitement in.

So, obviously that focus of UDI and the ability to record devices, ensure that we increase patients’ safety, is a critical factor. And in addition to that, the ability to connect all those islands and get that clinically integrated supply chain is something that we see as really exciting. And certainly, it’s helped me think about what we need to do from a UDI implementation perspective and who we need to engage.

I hope it’s answered some of those questions for some of our participants, and we’ll move to some of those questions and answers as part of our final wrap-up, as part of this webinar today. So, thank you very much.

Before I do that, I will actually just have a bit of a talk. I’m sure you’re interested in what’s happening with UDI project, so I’ll provide everybody with a really brief update for this month with where the UDI project is, particularly with the view to be able to then give you more information what’s coming, and our next webinar will then be predominantly focused on walking people through where UDI is at. So, we’ll lead the questions and answers after that.

So, for those of you who are interested, particularly from UDI project, again, this is very much the TGA is talking about it from the TGA’s remit. And obviously, the TGA’s responsibility is looking at ensuring that we have devices supplied into the Australian medical and healthcare system that match the UDI requirements.

And from the TGA’s perspective, this has very much been a focus of what we have been doing over the last years and months, and obviously then working through how that gets rolled through the supply chain and healthcare systems. So, I know there’s a lot of questions starting to come up around what we do within healthcare, and it’s something that we’ll be addressing, but generally that falls outside the remit of the Therapeutic Goods Administration.

But certainly, within our remit, the focus for us is very much around developing and making available what we’re calling the Australian UDI Database, the AusUDID pre-production environment. And that will be an environment, for those of you who are familiar with the sandpit that we released from July through to January of this year, which is a play environment that we made available to anybody who was interested to be able to provide feedback on both the rules and the look and feel of the database.

So, we had closed that environment at the end of January with the view of having a new version released within April. And we’re really progressing well, certainly from a technical point of view, progressing very well to have that ready for April release and April availability. We’ll be following the same concepts of what we did with the sandpit, which is making that environment progressively available to different stakeholder groups through April, May and June.

So, with very much the intention of still maintaining our trajectory and our target of having the UDI regulations or voluntary compliance for those manufacturers and sponsors who wish to use the UDI database and voluntary submit data and comply with the UDI regulations from 1st July of this year.

So, essentially, we’re still working through that. That environment is being readied. And we are starting to prepare the materials and talk to a number of early representatives from sponsors to be able to get their access and provide them access to give us feedback. And that will be a progressive implementation, so we won’t open the doors from day one. And we want to make sure that we have those who have participated in the sandpit, for example, having access and giving us feedback.

And then through the next coming months, we’ll start to open that up to other users, both within the manufacturer and sponsor community, but also others within healthcare. So, those within the hospital systems who are interested in understanding UDI, or the implications of UDI within environment, we’ll certainly be looking to open that up, as well. Our first priority will be ensuring we get the data into that environment, that matches the data supplied by the sponsor, and working through that.

So, that’s essentially the first couple of points there. Progressive release of pre-production through April. That version of the database will actually reflect the current data dictionary that has been shared with a number of stakeholders and technical working groups, and others within some of the forums that the TGA run, that will be looking to reflect that version of the data elements in the data dictionary that we have.

With the view, then, to finalising and progressing that over the coming months based on feedback, but also where we’re likely to land on the regulatory policy and the regulations for UDI. As it says on that third dot point, the UDI policy and regulations are still in development. The TGA has presented the concepts and proposed intention for a number of the UDI regulatory positions to a number of industry stakeholders over the last number of weeks.

Certainly, through the month of March, we’ve had some feedback from a number of peak bodies, as well as sponsors representing those as members of those peak bodies, as well as our technical working groups, providing feedback on the proposed position or the thinking around the proposed position. We’re in the process of just finalising all that, wrapping that up, and then submitting and providing that information to the Australian government to make their final approval around where that regulatory policy position has yet to be established.

It would be nice for everybody, I think, certainly from us and those who are listening here today, to be able to have some certainty around some of those areas, but it’s progressively becoming clearer and clearer. So, I wanted to thank all of you who have provided feedback, through whatever the channels are. Whether it’s through our sandpit and technical environments, our technical working groups, or recently through your consultations, or through the other consultation and feedback that we’ve sought out on the proposed regulatory position over the past weeks.

So, thank you, all. That’s all being put together and then finalised into a submission to the government, and we’re expecting that to occur soon. So, essentially, that’s what we’ll continue to work through, as we do know that time is of essence, and to ensure that we meet our goal of having a 1st July implementation of the voluntary compliance version database. All the material has to be brought together to make that happen. And then, in the process, starting to ensure that we’ve got guidance documentation to reflect that position, as well.

So, that’s all working a lot of activity. It’s also coming together into a really sharp point for the UDI project. In conjunction with that, we will continue to run our technical working groups. We’ve been mostly focused to date on the provision of data into the UDI database, so therefore considerations for sponsors in particular and medical devices manufacturers probably secondarily.

And the conversation to date has been very much around the submission of data into the UDI database, responsibilities of the sponsor, and particularly the unique scenario that we have within Australia about having a sponsor or multiple sponsors for the same device, and how that is managed and also then viewed within the healthcare system.

So, that’s continuing. We’ve had some very good and quite comprehensive feedback from a number of participants in our technical working group, and that group is available to anybody to join and participate, so it’s not a closed group. So, if you are interested in joining, there is a UDI mailbox which we’ll advertise at the end of the webinar to advertise what that group is.

So, if you aren’t participating and you’d like to participate, we’d be certainly very open for your participation. Our next meeting is on 4th April, and while that will continue to talk a bit about roles on sponsors and manufacturers, we will largely be walking the participants through where we’re at with the pre-production version, have a bit of an early look and feel as we’re about to release that through April.

We are in the process, I was hoping or aiming to have a confirmation today, but we’re not far off in terms of just publishing the responses to the questions that you asked at the last webinar towards the end of February. So, that will be published on the UDI Hub, and we’ll be emailing that out to all of those that participate here, as well as to the last webinar, to let you know what the responses are to those questions.

We did answer a number of them online at the time, and we’re definitely looking to provide written responses to a number of themes of those questions that were raised. So, due to the number of questions and the types of questions and the overlapping nature of questions, we have grouped a number of them together into themes. So, ideally, we’re looking to cover all of those in one particular response rather than having the same information repeated, and having you wade through all of that. So, that information will be available soon on the TGA website.

I also wanted to just let you know that the next webinar, so we have been planning to, or have been moving to less frequency. This is our number 17, so we’ve run 16 of those to date. And certainly, to ensure that we’re consistent with giving you information that’s useful, we are looking to have the next webinar on 16th May.

So, during April, our focus will be on the pre-production environment and ensuring that we have that ready and communicating what’s needed for the pre-production environment with a focus on sponsors and manufacturers. And so, we’re looking to then continue our webinar series from 16th May, which is a little over a month, or six weeks’ time.

So, we’ll certainly be looking to publish the agenda and putting out information about that in coming weeks, but just wanted to let you know that if there is something that you’re planning for April, that there won’t be a webinar for April, but certainly 16th May is our next date.

And finally, just to wrap up, again, I just wanted to say thank you to everybody who has been contributing to the discussion from the UDI development and the regulatory position in particular. There has been a lot of information and a lot of important time spent doing that, so we’d like to thank all of you for your contribution, for your input.

We are getting close, and we’re getting to the point where we can look to ensure that regulatory drafting and the regulatory position is well and truly established, and certainly is taking a lot of your feedback. As part of that confirmation of the regulatory position, we’ll be finalising and making sure all the responses to a number of these consultations are published and available on the TGA consultation hub, as well.

Okay, so finally, then, we do have a little bit of time, so 10 to 15 minutes to be able to just wrap up and answer any questions. I noticed just quickly while I was talking there were a number of questions that have popped up in the Slido questions, so I do invite you to continue to ask those questions.

What we will do now as a group is just look through those questions, look at how we respond. There are some for Michel and Joanna, as well, but we’ll be essentially looking to pull those questions together and provide a little bit of time this morning to be able to respond to those questions. And those that we don’t respond to, like I mentioned, we’ll be providing written response and publishing on the TGA website.

So, thank you for the number of questions. I’m not sure we’ll get through all of them today, but I will be looking to start from the top and maybe work our way through. So, if Michel and Joanna are happy for me to read the questions, and if there’s anything that’s related to your presentation, I’ll hand over to you, if that’s okay.

So, the first one I think is directed to me, hence has quite a bit of interest and upvoting. So, what’s the TGA’s position on the AusUDID guideline now that Europe has postponed EUDAMED? And essentially, will TGA postpone your timeline to wait until and EU Medical Device Regulations (MDR) and EUDAMED is fully in production.

And so, that’s certainly one of the considerations, so thank you, and I wouldn’t say fully in production. Considerations of the submission to the government and the considerations for the TGA in particular around the timing and implications of impact on sponsors and manufacturers for the go live of EUDAMED and also the European MDR, which has now been extended out.

We have had extensive conversation within the TGA, both from a UDI point of view as well as the MDR implementation, and what’s happening within device applications, reclassification areas, as well. At the moment, the TGA’s proposition is to continue to use 1st July 2024 as our proposed date for UDI to be mandatory compliant, or mandatory for the submission of devices for clasps through high-risk implantables and Class IIb devices.

So, we are continuing to work to that date. And certainly, looking from the perspective of then being able to provide the ability for those sponsors and manufacturers who submit devices within the US and are compliant with the US FDA rules, we are expecting a number of those to be available. And so, they can be submitted to the UDI database.

And then, certainly, conversations and analysis that we’ve done with the European-based manufacturers is they’ll be expecting them to have UDIs allocated and labels potentially allocated, but not having the data in the EUDAMED database. So, certainly, there’s potential for them to comply with the Australian UDI requirements. But also, for those who can’t, we’ll be offering a consent to supply process to have those ad hoc time-based exceptions that later continue to supply devices that may not be fully UDI compliant at that time.

The TGA is very particularly interested in ensuring that we bring on the benefits in some of the things that we talked about today in terms of UDI in the supply chain, UDI in the healthcare system as early as possible, and have that rolling through. And certainly, with the extensions in the EU MDR dates, so we could potentially push that out several years, and so we’re looking into how we can continue to find a balance between bringing in benefits of UDI in early, but also ensuring that we don’t create issues or burden from a regulatory and a manufacturer’s perspective.

So, we’re providing that consent to supply process, so that has definitely been a consideration as part of the final considerations by government in terms of those dates but note that we’re working for 1st July mandatory compliance from July 2024.

Next question which again had interest, so apologies to some of those jumping around. Retail and medical devices, orthotics, condoms, Band-Aids, etc. can be classed as I, II or III class devices. There are no significant retail consumer benefits from UDI implementation. And will the TGA adopt the EU approach to exclude all retail devices from UDI requirements rather than Class Is?

Certainly, the whole purpose of UDI is to ensure that from a patient’s safety, the ability to track and unambiguously identify devices in the healthcare system, whether they’re retail or whether they’re actually within hospital or other allied health systems. So, certainly, the TGA is very keen to ensure that, by definition, any devices that are classified as high risk, so from Class I sterile and above, so Class IIb, IIa, and Class III devices will continue.

There is a definite risk, and that’s by definition of the risk classification they’ll be given. Irrespective of how they’re used or sold, the TGA is looking to ensure that we can track and trace those devices through the healthcare system. And therefore, if the device requires inclusion on the ARTG, or the Australian Register of Therapeutic Goods, we’ll be seeking for UDI to be supplied, as well.

Now, again, I have to draw your attention to the consent to supply process. So, certainly, for those devices that are considered not be compliant with the essential principles, there is a process to allow sponsors to work through that.

Next question, how do we manage products where there are multiple sponsors? I probably can’t answer that question at the moment, because we are working through that. And as I mentioned, the technical working group is really looking at a number of considerations for how that works and looking at both the angles from the impact of manufacturers and sponsors, but also then the potential of trying to or looking to avoid confusion in the point of care within the healthcare system in terms of having multiple records that people have to work through.

So, unfortunately, I can’t answer that question at the moment, but it’s definitely something which is a hot topic that’s working through. Next question, how do you plan to deal with consumer healthcare products? Will EAN-13 be accepted as Automatic Information and Data Capture (AIDC) for items sold?

I’ll probably answer that first part of the question in terms of consumer health products as part of the retail conversation. For the EAN-13, for those of you who aren’t familiar, that is a standard that’s being applied for the barcoding and the carrier information that’s supplied on the label, that goes with the UDI. Australia will be consistent with the International Medical Device Regulators forum, as well as other regulators around the world, and not enforcing particular carrier requirements. We will be carrier agnostic. We’ll be Automatic Information and Data Capture (AIDC) agnostic.

And so, being in a position to what supports your supply chain, what supports your management of those devices through the supply and healthcare system, we’ll continue to support. And so, it’s not something that’s being mandated by the TGA, but obviously who you supply to and whose issue that’s identified may actually have some bearing on that.

Michel and Joanna, there is a question for you, if I may. How have you managed the internal engagement discussion around UDI? And I assume that’s within your organisations. Do you have any tips for other health providers who have not looked at the impact of UDI yet?

Joanna Giannone

I’ll start. Michel, feel free to add to it Essentially, for us, it’s all about early engagement. So, making sure that we can identify who are the various stakeholders across an organisation that need to be advised about what is coming. So, that way, we can make sure that they are involved as part of the conversation. So, how do we get ready, who do we need to involve, what exactly is it, what’s it going to mean?

Music to our ears when you say compliance, because that helps us to drive the message, right? So, it’s more about how we build the case for change that we can then communicate across Healthscope to make sure that people are aware that this is coming, and that there will be a process to introduce it.

And it may be in bite-sized appropriate ways to be able to introduce the process changes, but really, we want to be able to engage early. We want to be able to engage as many as possible. And being able to include clinical teams is fundamental to this, as well, because we know that that’s where potentially we will find out information that we don’t necessarily know. Michel, is there anything else?

Michel Hulzebos

Yes, so, the programme or projects that we are running at the moment is something that we’ve been working on and talking about over the last couple of years, and I’ve worked with Healthscope three years exactly this weekend. And we’ve been talking about this from day dot, and not just within procurement or not just within the supply teams, but across the board, also with clinical teams and the early engagement, as Joanna is talking about.

And it’s a very current and actual thing that we’re looking at now we come to the tail end. We’re really now coming to the point of implementation of technologies, of these new processes that we are developing, and seeking actively input from clinical teams to help us develop those future processes, help us develop the technology to support us, as well to build the understanding of what changes would need to be made at some point on the clinical side.

How are we going to integrate what we see in procurement systems? How are we going to integrate this down the track into the clinical systems? So, for us, it’s early engagement, and planting those seeds, and understanding what the benefits are from a clinical perspective once we are introducing UDI and this traceability and these efficient processes for supply chain, all across the supply chain, the clinically integrated supply chain.

So, it is early engagement, it is consistency in terminology. It’s speaking to all levels within the organisation. And I think that’s where both Joanna and I have seen some of the risks and issue that we have seen within Healthscope, but also see in other organisations, where organisations are quite siloed. And when you come from a procurement or a supply chain background, and you start talking to clinical leaders, the only way for them to see you is have the product there at the time that they need it.

That’s how they see supply chain. That’s the only engagement there. Whereas building that understanding and building that maturity level where they understand that the decisions that they make on a daily basis multiple times impacts how we are managing supply, how we are managing the information, when we need to order, and what data we need to provide them through the supply chain system.

So, early engagement. Standardisation of language, not just of data, but of language, as well. And in our case, we are also seeking support through the TGA by connecting and contacting the right people in our organisation on executive levels. I think that is proven to work, as well. Healthcare is still very much a top-down organisation, so that would help tremendously.

Gary Pascoe

Thanks, Michel. Thanks, Joanna. If I may, I’m going to hand another one back to you. This one may be a bit more precise. Has Healthscope tackled the ability to scan 2D barcodes, since many products have 2D barcodes on their UDI labels? This will be critical for you to capture the data you spoke about.

Michel Hulzebos

Yes, we’ve certainly identified the issue that we have with technology and technology hardware. So, we will tackle it, and it will be done in the timeline that we have set out. So, we’re changing our procurement and supply chain processes. We’re changing and improving how we are managing inventory. And through that, we will start to look at the technology and the hardware that we are using currently, both in inventory and in theatres.

And indeed, there is an issue with hardware only being able to scan linear barcodes at the moment. But besides scanning physical barcodes, there are some principles underneath that we need to try and solve first, so we proactively can start managing our inventory better. Scanning a barcode is only helpful when you’ve got the physical product, but you still need the underlying data connected to that product in your inventory and in your supply chain.

So, those are the first steps. What we are going to do within Healthscope is integrate directly into the National Product Catalogue (NPC). So, that helps us and drives data ownership back to sponsors and suppliers, and for suppliers and sponsors that are not on the NPC, we will also provide a method to digitally load this data into our technology using the same validation rules and validation methodology that Global Standards One (GS1) NPC is using.

So, that’s one step, is standardise that product data set and price information, as well, through the NPC. And the other part that we are looking at as part of this first stage is how we connect with suppliers. So, how we are actually purchasing, how we are actually sending purchase orders to suppliers. Today, it’s still done by email, or somebody picks up the phone and calls a supplier, and says, hey, we need a gadget, and a gadget arrives, and an invoice arrives, and we have no record of that in our system. And it’s not just in Healthscope where that happens, it happens everywhere.

So, we want to digitise that process. We want to be able to track and trace every purchase transaction in our technology, so we can track not only who we’re interacting with, what we are spending, but also receiving that particular product information. So, those product identifiers and the production identifiers which are part of the UDI process, your batch numbers, lot numbers, serial numbers and expiry date information, so we can manage our inventory actively.

So, those are the two key components, NPC integration and digital interaction with our suppliers through Electronic Data Interchange (EDI), mainly.

Joanna Giannone

And can I add to that, Michel?

Michel Hulzebos

Absolutely.

Joanna Giannone

I think what also Healthscope is doing is, by investing in a project that focuses on materials management, it starts to actually understand what exactly is going to be necessary from technology, from our processes, from our data, to make sure that it works. So, what we’re actually doing is implementing this via a pilot programme first, and that will uncover things that we will then learn from to understand what might be necessary next. Are there 2D barcode problems that we need to tackle when we do the next pilot? And so on, and so on.

So, I think that’s really important. It’s all about we know we’re not going to get everything right. We know that we’re going to find things across, there’s many different hospitals, many different ways of doing things, many different technologies that exist. So, we will be tackling it in a pilot programme, as well.

Gary Pascoe

Thank you. Thanks, Joanna. So, given the time, I might just squeeze one final question which I think is sitting at the top of the list. It’s currently outstanding with the most votes, so I’d like to cover that. Will Basic UDI-DI be used in the Australian UDI database?

The short answer is no. The Basic UDI-DI is a concept that is unique to Europe. It has certainly been set up by the European Union, European Commission for implementation of UDI in Europe, and particularly within the EUDAMED database. It is not a concept that will be implemented here in Australia.

And certainly, even our last consultation, the consultation prior to that, so 2020, we had strong feedback from within the healthcare sector and manufacturers and sponsors here in Australia in terms of the request to the TGA to not use that construct. So, certainly, it’s not something that will be used or implemented here in Australia. And we do have a number of questions around that, that people are asking, so I just want to use that final minute to just reassure everybody that won’t be happening here in Australia.

So, given that we’re at time, before I hand back to you, Rachel, I just wanted to say thank you again to Michel and Joanna. Your input and even just your responses to these questions have been outstanding, and I wanted to thank you for the time and the effort you’ve put together to be able to talk about this. And obviously, bringing my perspective UDI to light, but particularly your interest in the integrated supply chain, and bringing that and connecting with the clinical practices.

So, I really wish you all the best with this project. Thank you very much for your time. Thank you, everybody who’s joined us, and as I mentioned, the next UDI webinar will be on 16th May. In the interim, you’ll see in front of you on the screen there the udi@health.gov.au is our mailbox. So, if you have any questions or you have any requests or feedback, anybody who was interested in presenting as part of these webinar sessions, feel free to get in contact through this email address.

And so, just as a final wrap-up, thank you very much for your time. I wish you all the best with your days or evenings, depending on where you are from around the globe, and look forward to speaking you again in May. Thank you.