Webinar presentation: Unique Device Identification, 17 May 2022

Michelle Van Wijk

Welcome to our ninth webinar. We've very excited to have two very special invited guest speakers today to talk through some real-world experience in the use of UDIs, where it's been used particularly in the clinical and hospital settings. Before we begin I need to acknowledge that the Australian government is in caretaker mode, so we are about to have a federal election here next weekend, and in accordance with caretaker conventions I'll be limiting my statements today to factual issues and matters of administration.

This presentation is for information only and does not constitute legal or formal advice and should not be relied upon for any purpose other than learning. I'd like to also begin today by acknowledging the traditional custodians of the land we are meeting on, and in my case, here in Canberra, that's the Ngunnawal people. I wish to acknowledge and respect their continuing culture and the contribution they make to the life of this city and the region. I'd also like to acknowledge and welcome any other Aboriginal or Torres Strait islander people who might be attending today's event.

For today we have, as I mentioned, two very special invited guest speakers. We have Mr Mark Songhurst, from the Leeds Teaching Hospital Trust, and Kirk Kikirekov, from Prospitalia h-trak. If we have time, we'll have questions and answers at the end, but we can take those on notice if we don't quite get to them because we have those two very special presentations today.

So, I'd like to introduce Mark Songhurst. Mark has been working in the national hospital system for 23 years, for the last five years on the Scan4Safety team at Leeds Teaching Hospital NHS trust. He's now the programme lead driving further implementation and integration of GS1 standards into the organisation. Having worked for 13 years in internal audit, he has an in-depth understanding of the processes from across the hospital that go into delivering good patient care.

Mark is also a Future-Focused Finance ValueMaker and a School of Health and Care Radicals Change Agent. He has a real passion for working with people and understanding how people collaborate across the NHS to make changes that will have a lasting impact on the service we provide to our patients. Mark was awarded the Future-Focused Finance Award, they're all tongue-twisters today, by the HFMA in 2018 in recognition of his work locally, regionally, and nationally to improve NHS finance.

His infectious willingness to accept change, to walk alongside NHS staff of all levels, enabling them to engage with change and try something new, is helping drive the Scan for Safety project forward at Leeds. If the last two years in the healthcare industry have taught us anything, it is that we can no longer work alone. Therefore, Mark has been sharing his experience nationally and globally to ensure that the benefits that the GS1 standards and Scan for Safety bring can be shared.

So I'd like to hand over to Mark, with, also, a special note that he has had to attend this at a very difficult hour for him in the UK, so we really appreciate his commitment to sharing his knowledge and experience with us today. Over to you, Mark.

Mark Songhurst

Thank you, Michelle. So, good morning, good afternoon and good evening from Leeds in the UK. Hopefully today I'm going to take you on a bit of a journey of part of the work we are doing here at Leeds Teaching Hospitals, and how we are using unique device identification throughout our hospitals to improve patient care. As Michelle said, I am the programme lead for Scan4Safety at Leeds Teaching Hospitals, and our programme has been now in the organisation for six years. We are coming up to the sixth anniversary later this month.

Just so that I can set a bit of a picture for you, this is a slide used by my boss, and shows the complexity of the healthcare system in the UK alone. What we were actually looking at, for the small part that is the hospital, we are one of the purple boxes in the bottom right-hand corner. There is a whole range of the healthcare sector that goes on behind the scenes, but this is one tiny portion of it that is seen by our patients.

So, what were the national drivers for Scan4Safety? We started off in Europe in 2013 with a recall on breast implants after a company was using substandard products in manufacture. That at Leeds took us eight months of searching through paper records to be able to trace back to patients. That was seen as a shame. Luckily for the healthcare sector, of the 30,000 patients affected by this in the National Health Service we only had 465 cases reported where we'd used those products. But still we couldn't accurately and easily trace where those products had been.

At a similar time the food industry in the UK discovered that horse meat had been applied into various processed meat products, not labelled on the products, so people didn't know what they were eating. There was a very big recall done, and supermarkets removed those products from the shelves within half an hour. This was seen by the Department of Health, now the Department of Health and Social Care, as a real eye-opener that what we'd just been through on breast implants we couldn't replicate in a hospital.

And so that was brought into the National Health Service e-procurement strategy as to how we can use unique device identification and other standards to be able to recall products. There were some example sites picked, so we had examples of big hospital trusts like ourselves, and I'll come onto our organisation very shortly, all the way down to very small cottage hospitals, to see whether you could implement this at scale.

What we were trying to introduce was GS1 standards and the Pan-European Public Procurement Online standards. This became known as Scan4Safety, just to make it a lot easier for people to say than the Global Standards One, the Pan-European Public Procurement Online standards.

If I give you a welcome to Leeds, Leeds is in the north of England, and our trust looks after seven hospitals. They range from very small ambulatory hospitals at Seacroft, through to small cottage hospitals at Wharfedale, and then all the way up to our two main sites, St James' and Leeds General Infirmary, each of which have about 1,000 beds on them.

We are the largest provider of specialist adult and paediatric services in the UK, and we provide about 150 different specialist services in the organisation. We have a regional responsibility for 5.2 million people, and we do everything from heart valve replacement surgery, robotic surgery. We are a major trauma centre for the north of England, so we frequently end up with our patients being flown in by helicopter. We are a leading cancer centre, and we are the only UK hand transplant surgery setting.

The goals of our organisation are to be the best for patient safety, quality and experience, to be the best place to work, to offer a seamless and integrated care, and that's not just within our hospital. That's starting to look wider afield, so we're not just talking about one sector of our hospital to the next. We're talking with our community colleges, with our colleagues that are based in other hospitals across the region, and with social care settings, so that a patient sees care as one continuum, not as individual organisations all impacting.

We want to be the centre for research, innovation and education, as well as for the specialist services. And obviously, as with any organisation, we want to be financially sustainable, and we were one of the few trusts in the UK to be actually rated by the Care Quality Commission as outstanding for our use of resources.

What drives the work here at Leeds are the values that we have, and these were defined by the organisation. These have a real impact on what we can do and how we can work with people. So as a member of staff I am accountable to not only my managers, but to the patients whom we serve, and to other colleagues.

We work in a very collaborative manner, so just because I'm doing Scan4Safety and I sit within procurement, doesn't mean to say that I don't work alongside my clinical colleagues to deliver the best care possible and spend time with them in the healthcare settings, understanding how they work. We're empowered to make our own decisions, and with 18,000 members of staff here at Leeds, that's really important. I don't need permission all the time to do things. Actually, if it's in my role and my remit then that's how we make the changes happen.

We are fair in the way we work, and honest and transparent, and most importantly, we are patient-centred. So we are always looking for, where does the patient fit? And as we talk through unique device identification, then that is where actually keeping a focus on the patient is really important. When we undertook Scan4Safety, and started in our journey, one of the things that we did was we looked at a hospital that had already been doing this, and to Kirk's delight it will be that we actually followed Derby, who had already started well down the route of this using h-trak.

So, h-trak has been a part of the National Health Service and the journey of Scan4Safety. So, let's pick a product. We're going to pick this. It is a TAVI, a trans-aortic valve implantation. It could be known by its brand name, so we could pick that it's a Medtronic, just picking a brand name in general. It could be known as the manufacturer's part code, and that's quite often what our inventory teams talk about. Our data teams talk about it as an inventory management customer item number.

All of these cause confusion, because when you look at an electronic system, a manufacturer's product code could be the same for a variety of products. We did have, at one point, one manufacturer product code in our organisation that covered either a syringe, a blunt filter needle or a porcine heart valve. So if we'd have got the wrong company with the same manufacturer's product code we could have well and truly ended up with a shock if we'd have ordered a mass box of syringes but sent it to the heart valve company.

So what is needed is a unique way of identifying products. And in the UK we've mandated the use of GS1 standards within healthcare, and that allows us to use the GTIN as the mandated, globally-unique item, so that's the global trade item number. And that allows us to follow a product through at any point. So, when I'm talking about where does this fit in, how this works at Leeds at the moment is our clinical colleagues will identify that we need to use a specific product.

That could be because of the nature of the patient, so being the regional centre we could be the last option for surgery for a patient, so we may need a specific device for them. Once we've decided which product we need clinically then there is an approval from management, and there is a procurement process as to how we will get that item into the hospital.

At that point, once we've done all the procurement, we get the catalogue from the manufacturer, which contains the unique device identification details, so it starts to build that GTIN, so we know it is exactly the right product that goes through, and that assigns to our price list. We then enter that into the Trust catalogue, and you can see the one that we use at Leeds. There are alternatives out there, but our Trust catalogue holds all the data about that specific product.

We will then be able to use our inventory system to set the levels of that stock that we need. Is it a one-off item that will come in, be implanted, and possibly not used again? Is it an item that we need on the shelf continually, so our favoured items are all available there?

And as we bring that order in, we then get the next level of data about that product. So knowing exactly what it is in the unique device identification is really good, but at this point, when it hits the inventory system, we are starting to bring in the serial number, the batch number, the lot number, and the sterilisation expiry date, to be able to manage that product within the hospital, and we'll come onto how that fits later.

That same identification fits through the trust's financial enterprise resourcing platform, so it fits through all our orders. And where an item is on inventory we've agreed that stock level financially, so actually it's a smooth process in ordering. Our clinicians are not having to go out and order everything, and say, is this one we've want? If they've used it, the system tells us it's been used and will auto-replenish if we've set it to auto-replenish. We can actually automatically order things so that our clinicians just know that they need to go to the shelf and pick the next one up. There is never a worry that we will run out.

That data is then fed through the PEPPOL interchange. We send an order out. It goes out as clean data into the internet through the PEPPOL interchange and out to our distributor. That manufacturing distributor can then pick up their order, knowing exactly what we want. They can deliver the goods to the hospital. We are starting to work on getting advance shipping notices, so actually knowing exactly what is coming into the hospital, and then we will be able to receive the invoice from the supplier and actually pay that invoice within 30 days.

That's because with all of the data that flows through we can do a match on the product, on the quantity, and on the company very quickly, and that invoice can be paid through the system. So, unique device identification filtering in at all those levels in multiple forms is really important to the way in which we do business, but also let's look at how this affects our patients.

So if we look at a patient journey within the UK, our patients will quite often start their journey at their local doctor's surgery, especially for things that are going to be implanted. The other option, of course, is that they come in as a trauma patient through one of our ED, but we're just going to look at somebody that's needing surgery. We use the term elective in the UK, which means non-essential surgery or surgery that can planned as opposed to urgent care in the event of an accident.

Once you've seen your local doctor you will be referred to an outpatients' department where we will undertake some diagnostics. At this point, you will meet with some of our clinical teams, and our clinical teams will decide the best course of treatment with the patient. And at that point we can quite often say, this is the product we are going to use. What we're working on is actually taking that product at that point and starting to assign it to a patient.

A patient joins the waiting list. We schedule them for surgery. They will come in on the day of surgery and that product, then, is available for them. We take it off the shelf, we implant it into the patient in theatres and record its usage. And as part of that we're taking that into the medical record, so that we can recall at any point in a system that is appropriate for clinicians to understand. The patient will recover in hospital, they will discharge, and they will go back to their general practitioner, their local doctor.

So, how does that work in terms of that theatre piece? We have products on the shelf in two ways. We have our general stock and our consumables. These are items that are grabbed off the shelf. They are commonly known within the hospital as the plastic tat within procurement. So they are the small items, they are cannulas, they are syringes. These are not tracked by batch to a patient because we will use them very quickly, very frequently, and we don't use UDI for those products, other than in the ordering process.

The other form is full inventory, and that's the photograph on the bottom left-hand side. That's our interventional radiography labs at St James' Hospital. That storeroom will feed all of the products that we inventory manage, so those that we need UDI for. And the left-hand side of that storeroom, and part of the right-hand side, we know exactly which products are on the shelf using the UDI.

When we take that product we record it in the operating theatre against a certain number of other factors. We record it against the clinician who uses it. We record it against the place that that product has been used, and most importantly, we record it against the patient. We're also able to do the same for any blood that we use in that operation. So it's not just our products. It is also the blood, as well, that is used within the procedure.

At that point we have complete record of what happened in our operating theatre that we can access electronically. If you wanted to see it as a data systems flow, this is where that patient journey that I just described is seen in the blue boxes. And we pick up various items. We pick up on here the patient demographics from our patient administration system, so we're able to get an accurate record of which patients we've got.

We're currently working on integrating with our theatre management system so that we would be able to bring through what we know as the OPCS code, the Operating Procedure Clinical Standard code, and we're able to, then, bring that through into a record. And that all feeds into Omnicell. So we have our correct patient with the correct procedure, and we're able to pull a kitting list. And we're hoping in the next year to roll that kitting list out fully into our organisation.

In the background we're pulling all the product data and location data from the GS1 location management tool. From the product data we're pulling from the manufacturer through our systems, and that all links in together. Once we've got all that record in one place, we're feeding different systems out of it. So we're feeding our costing and patient-level costing teams data, that's the blue box. We're feeding PPM+, which is our in-house electronic health record, and we're starting that integration as we speak.

We know exactly where it's going to go. It's going to go automatically into the op note, so when a surgeon opens up their op note after a procedure they will know exactly which products we've used. And then we have further reporting that we need to do into the National Health Service digital team for registers on a national basis, this is products that we've used especially around implants. And we're working on automating that link as well.

This is a quote from a friend of mine who is a healthcare commentator in the UK, a former patients' advocate and former Chief Executive of hospital trusts, which says, “data is useless unless it's turned into information, and information is useless unless it's properly targeted.” And that's really important. The data is really good, but we have to target it. So we have to be able to assign meaning to it, whether that's the product and the patient assigned, the product and the location for recall. If we don't target that data properly then actually nobody uses it. So it's always worth bearing that in mind.

What are the benefits of the work we've done? We're able to control our stock far better, and part of our success in this is we've introduced inventory managers into our organisation, who manage stock on behalf of clinicians. On the left-hand side you'll see a picture of lots of items stacked up on a desk. This was £126,000-worth of stock. It went out of date in an RFID-controlled cabinet because nobody was looking at the data, nobody was looking at what was going to go out.

We knew all about the product, but nobody was looking at it. So as you start to implement this work on UDI, make sure you've got people looking at the data.

Does this work for recall? If you remember, at the start of my presentation I talked about it taking us eight months to sift through patient records on paper. With the product recall, this work had to be repeated in 2019, and these are the timings from that recall. So at 10:15 we received formal notification from our regulatory authority that a product no longer had a CE mark, so could not be used within the hospital.

Within 13 minutes we had confirmed that we did have some of those products in the organisation, and we'd also checked with the clinical areas that were using them that they weren't going to be used that day. By 11:42 on the same day we had removed those products from the shelves, they were in quarantine with our inventory managers and would not be used within surgery. Luckily we didn't need to do a recall of patients for this piece of work, so we were able to leave it at that.

If we'd have needed to recall patients, had they been using the Scan4Safety system, so time-wise if it was whilst we'd been using Scan4Safety in that area, we would have been able to recall those patients in that same time, and have a list given to a surgeon to revise the surgery and actually meet with the patients.

But there are financial benefits to being able to do this work. We've been able to reduce the amount of time that theatre staff are doing those product recalls because we know where to look for our products, exactly which shelf they should be on, and pull them back quickly.

We're able to reduce our inventory. Because we've got clean data going through, we know exactly how much of a product we are using and we are certain of that. So we're not placing a clinical member of staff under pressure of thinking, I've only got one of these on the shelf. If I drop it that's it, I've got to completely come out of the operation and start again. We're able to have the right amount on the shelves, but that is not to have excess stock.

So we started off looking at the TAVIs, the trans-aortic valve implantations. Those, in our Trust we were the largest centre in the UK for implanting those, but we had 16 weeks' worth of stock on the shelves. When we start looking at the data, we know we are not going to use 16 weeks' worth of stock before we can replenish it. We can replenish it within a week. So we're able to drop that down, and we know have 21 days' worth of stock available.

We're able to return stock into the healthcare system, and make sure that stock is used where it's needed. And if we've got a product that's going out of date, we're able to work with the manufacturer, because we know which product. We can take it off the shelf and send it to a hospital that can use it. Using this, it's also quicker and easier to recall those products or to manage them and get the information to the right place.

So we're building this into our new hospitals. The hospital that you see behind me will come online in 2026. It is a brand-new hospital in the city centre. Storage for product is a premium and there is a bonus for cutting down on the amount of storage space. So using systems like Omnicell, like h-trak, really do help in your inventory management. They decrease the amount of product you need on the shelf because you're able to manage your product in the correct way, so allowing our staff to live up to those Leeds way values, and to remain patient-centred in everything that we do with that product. Thank you very much.

Michelle Van Wijk

Thank you so much, Mark, really appreciate your presentation. We will move forward now. Just a reminder please that the questions are now open for Slido, so if you have any questions for Mark or for Kirk, please send them through Slido. Without further ado I'd like to reintroduce Kirk Kikirekov, who will be presenting from Prospitalia h-trak. And as you heard Mark talk through, he was also involved in some of the UK hospitals and some of that work.

Kirk's committed to achieving sustainable healthcare through digital technologies and has been dedicated to this cause for two decades. As the Managing Director of Prospitalia h-trak he specialises in innovative software solutions for the complex supply chains that exist for medical devices. This includes life-saving and life-enhancing technologies such as implantable prostheses and other medical devices.

His work has contributed to delivering innovative software for patient safety while also delivering cost savings and efficiency in the supply chain. He joined the h-trak business soon after the company's establishment in 2002, and has developed the capability of the business to where it is today with 25% of the Australian acute hospitals using the h-trak software and its internationalisation with growth in New Zealand, Germany, and the UK. I will hand over to you now, Kirk. Thank you.

Kirk Kikirekov

Thank you, Michelle, and thank you to all of your delegates online for joining this presentation. I'll talk a little bit first about our company, Prospitalia h-trak, where we've come from, the journey that we've been on to bring us to where we are today. And then my following slides will be more about the UDI, its role in all of this, and certainly Mark spoke very eloquently about the sorts of things that Leeds Hospital is doing with UDI technologies, but also some case studies or use cases for UDI in healthcare. It's more than just procurement, and Mark obviously alluded to that in terms of patient safety. But there are other use cases as well that need to be considered when creating or designing or implementing systems around the UDI.

A little bit about our company. This year marks actually 20 years since we established in Melbourne in 2002 in Australia. We were a start-up company back then. The vision of our company was always to develop our software as a service that would be cloud-based, that would have a component of that software on mobile technology, so that you can capture data at the patient bedside. That was the vision for the development of this company, or for the creation, establishment of the h-trak business, back in 2002.

And to this day we have lived up to that vision. The software has evolved. It's become more complicated and complex in the functionality that it delivers to the market through integrations with other systems within the ecosystem of hospitals. But that core principle of our company remains to this day. So by living up to that vision we're able to create a patient-centric system, designed for the unique challenges that exist in healthcare around medical devices.

So there's obviously the benefit of supply-chain and product replenishment, making sure that clinicians don't run out of products when they need them, that they are more efficient in the use of those products in terms of the inventory and how much inventory is held, and all of those sorts of supply-chain inventory-type benefits.

In Australia we have this unique consideration around prostheses billing, or billing for implantable devices. In most countries around the world the implantable devices are paid for through by the DRG for the entire episode of care. In Australia the prostheses for private patients, at least, not for public, are paid for by health insurance. So we have this unique consideration in Australia where we must capture all of the details that are required around the product, an implantable product, for private patients, that allow the billing process to occur seamlessly.

And without a system like the h-trak system, what we have out there is a lot of gaps in billing. It's as small as 20% but up to a 300% gap in billing. So in other words, savings that can be made by having an h-trak system are quite substantial in this area alone.

The third point there, product traceability to patient and documentation in the electronic medical record. Without a system like h-trak where you are capturing data at the point-of-care from information that's on the packaging of the product, usually barcode scanning, preferably barcode scanning, the documentation in the EMR usually occurs by somebody typing that information into the EMR. And the inherent problems with that, of errors or information not being clear, whereas when you're scanning a barcode you're getting the correct information all the time, and that information is being transferred to the electronic medical record.

And of course, patient safety, and I'll elaborate just a little bit on what Mark said. The product recall is fairly significant, as is expired stock. So when you scan a product for the barcode it has the expiry date on it, so particularly for those critical products like implants, the system is able to warn the user that there is an expired product there, as well as, of course, inventory, what expired product is in inventory.

So I mentioned the data capture at the bedside using mobile technology. In the early days it was PDA, it was some technology that's pretty much obsolete now. But these days we use android-based, essentially like mobile phone technology as scanners within these hospitals.

The other thing that we did from the outside was to develop a central product master database that will serve all of our customers. So we have an item master, if you like, a product master database of all the products that are consumed, purchased, used within these hospital settings, so that when you scan that barcode it's recognised, the product is recognised from that core database. And it contains core information in its product inscriptions, units of measure, rebate codes, in the Australian example, and so forth. So all the core information that's required for these certain transactions to occur.

And last point I'd like to make is that the UDI was a core design feature for our software from the outset. That is, 20 years ago we recognised that we had to have a UDI. It wasn't called UDI, of course, back then. It was referred to, in fact, as the universal product number, from America, and it was the recognition of two standards, in essence, at that time. The HIBCC and the GS1 standards.

And the FDA, of course, has issuing agencies, which I understand is a model that will be used in Australia, and the European Commission, of course, has issuing agencies, which will be HIBCC and GS1. And so that core principle has existed in our software from day one. And it's worked, and that's the main thing to recognise about that.

The other thing that our software does is we have a very detailed, because we were able to capture information at the bedside, we have very granular spend analytics at a procedure level, basically. And this enables our hospitals to be more efficient and design program to make savings, just to make improvements generally to the way they operate.

We integrate with all the core systems, the ecosystem, as it's called, within the hospital. So patient administration systems, electronic medical record, billing systems, ERP or Enterprise Resource Planning, and clinical costing systems. Our system in Australia is used by around 20% of the Australian acute hospitals, and that's growing at a rate of 30% per annum, year-on-year. And of the principal referral hospitals, so these are the big quaternary facilities that exist in Australia, around 50% of those principal referral hospitals in Australia are using the h-trak system.

We've expanded into New Zealand, and we have some good, solid customers there in Wellington and a few others that are coming onboard soon, in the UK and in Germany. Germany's growing at a rate of about 50% or 60% per annum right now, so there's big expansion of the h-trak system happening within that country.

And lastly, Mark did mention this but the h-trak system is used at Derby and Burton University Hospitals Foundation trust, and it was the first trust to be accredited under the Scan4Safety programme. I believe the accreditation happened in late 2017. But it was the first to be accredited under that Scan4Safety programme. It was one of the six demonstrator sites, Leeds and a number of others being the others.

Moving to my next slide, apologies for that. Okay, next slide. I've mentioned all of this, I'll just be very quick about it. But yes, the system is patient-centric model, data capture at the point-of-care, and if you can do that then you can have business processes that manage inventory well. You have reporting functionality at a very granular level. It facilitates the electronic transactions, e-purchasing, etc. It facilitates electronic billing, and of course, but not least, is patient safety because you are tracing product down to the lot, serial number, expiry date, to the patient.

So, why is the UDI important? A few points here. It provides certainty in the market. So for both suppliers and providers it provides a certainty about what investment to make for your systems, for the work that you do on cataloguing, and all of those sorts of things. So that is really important, to make sure you have take-up within, with suppliers and with providers. So I think the UDI is a very, very positive thing. It's certainly been very positive, with the FDA regulation around UDI there's been a very positive take-up of UDI technology.

It guarantees penetration. In other words, more providers, suppliers will take up that technology, which means that you get ubiquity across the market of these technologies. And I'll say technologies, UDI is one component of that. It's a facilitator that enables these systems to be built, basically.

Removes inconsistency, it reduces cost in duplication of effort and costly workarounds. It provides a consistent and reliable framework for software and systems developers. So for people like us who develop software, we need these sorts of things so that the software that you build doesn't have to have a whole bunch of workarounds and customisations, etc. So you're building upon a solid standards basis.

For Australia, by following the regulations that are already in place in the US through the FDA and the European Commission, we're a viable player. One of my next slides will talk about how much product is imported into Australia. We have to recognise that we don't do a lot of manufacturing in Australia, so we must follow what other jurisdictions have done in that space as well.

The TGA adopting the UDI is a logical extension of what is already happening globally. I've got a couple of example labels on the page here. You can see the first one is where the issuing agency is HIBCC, and they're using the HIBCC barcodes at the bottom there. Those barcodes contain the product identifier component, or data identifier, as it's called in the UDI language, as well as lot number, serial number, expiry date type information in that second barcode.

And the second one there, the issuing agency is GS1, and it's a similar thing. There's a barcode on that package. There's actually three on there but they're all the same thing, essentially the same thing. They're just stickers that are usually used when they take these stickers off and put them on patient record. That's the old way. And that still does happen a lot out in the marketplace.

Moving to my next slide, so what do we see in practice? From all the implementations that we've done, there's around 70 to 80 hospitals globally that use the h-trak system now. So what are we seeing in practice? More than 90% of the product usage data captured through h-trak is by scanning manufacturers' barcodes now. So that's actually quite a significant statistic. In the early days it was a lot less than that, so the global trend, and what the FDA has done, etc. has really contributed to a large extent to the automation, if you like, because scanning a barcode is an automated way of capturing this sort of data.

The other point is that more than 90% of medical devices by volume are imported into Australia, so there's not a lot of manufacturing that happens in Australia. The top 20 companies globally in Australia represent more than 70% of all medical devices sold into the Australian market. This is what we see consistently across all of our customers. And it's fair to say that that's also true in the other markets that we operate, so in the UK and Germany and New Zealand that is also the case.

So while there are a lot of companies, hundreds of medical devices companies in the world, it's the top 20 that do the most volume.

In Australia there are a few very large distributors, or largish distributors or importers that represent many manufacturers from overseas. So one example is LifeHealthcare, who are a distributor-importer of products from many places around the world, many manufacturers. These companies have very little control on what is included in the label. So they rely on standards being in place, the UDI standards.

There are equally, in Australia, a lot of small and medium enterprises that are importers of some very niche and highly specialised products. And these companies have even less influence on the manufacturing operations. So therefore, again, I stress that last point, it's logical for Australia to be in harmony with the FDA/EC on UDI.

Some of the challenges that we have seen. If doesn't happen very often, but when it does happen it is quite problematic, and that is the incorrect application of standards. So while a company in good faith has tried to use one of the standards in UDI, they sometimes don't apply it correctly, and that does result in some problems, because you have to disable, then, the barcode, so that it can't be scanned because it's incorrect.

That's something that the issuing agencies need to work with their supplier companies to make sure that they educate them properly on the application of the standards, as well.

The other challenge that still exists is with fragment sets. And by that we're talking about generally orthopaedics, but it does occur in other areas as well. Things like screws, plates, rods, etc. that are used in trauma or orthopaedics. These products are often supplied non-sterile. That means they arrive in the hospital, they go into caddies and things like that, and they have to go through a sterilisation process first. So they get put into these sterile trays, it goes through a sterilisation process.

And then when they reach the theatre, or the operating rooms, or the place where they do the surgery, there is no packaging so capturing the lot number or serial number for those products becomes almost impossible without some sort of workaround. So there are these challenges that still exist there. The other one is kits and bundled products. From a traceability standpoint, every product that you use on a patient needs to be captured for traceability. So the UDI, therefore, needs to be applied at the smallest unit, and that usually means the each, but that doesn't always happen because the supplier will consider the selling unit only.

So the labelling etc happens on the selling unit, that might have two, it might have five products in it, but that's not what gets implanted into the patient. So we have to be conscious of those sorts of use cases as well. The available real estate on product packages is also sometimes limiting as to what you can put on there. So there needs to be a clear definition of the use cases and the design of the systems to deal with all those unique use cases that exist in healthcare.

And finally, stakeholder engagement. So this is really critical. There needs to be a good education program around the UDI and the systems that are implemented, and how they are going to facilitate better processes. And that communication has to be at all levels, and there needs to be a really good, solid, change management program.

I'm conscious of time. I don't have a lot of time left, so I'll just very briefly talk about this slide. Typically, when we do rollouts, these are the sorts of systems that we find that we have to integrate into. So patient management, where we get demographic data coming into the h-trak system. Electronic medical record, where we write into the electronic medical record the consumption, the usage of products.

Operating room management systems, or theatre management systems, as they are commonly referred to, getting information on planned procedures and the documentation, actually, of the case back into h-trak, so that you've got granular data from which to analyse. Clinical costing, ERP and billing systems.

Just very briefly, implant registries. There are many implant registries, and these are mostly run by colleges, the College of Surgeons, for example. For example, the Australian Orthopaedic Association runs the National Joint Registry. These registries require not just the capture of products that are used, but there's certain clinical data as well that needs to be included on the record, that look at or over time, can analyse product efficacy. That's one of the core functions of some of these registries, so they can do their longitudinal studies, so that's also quite important.

Most of the time the capture of this data is by manual means, in other words these forms. There's an example form there that you see. It's a HIP form from the Australian Orthopaedics Association, the Joint Registry. These are filled in manually, generally, and so we want to make this electronic to make it more efficient, and also to avoid duplication of effort. I'll move on, I'm just conscious of time. We don't have much left.

So, example case studies. Customer A, B, C. Customer A, the prostheses in patient billing, because we were able to automate that process. There was a reduction in processing time of eight hours per day, resulting in a saving of $1.2 million, so it's massive operating efficiencies. Customer B, they went from $3.8 million billing to $5 million, a 30% improvement. Customer C, similar billing, went from $3 million to $9 million, a 300% improvement. And then they used the h-trak data to get savings from improved management of consumables and prosthetics, and they got $7 million per annum.

Just a few slides to show some business intelligence type dashboards. This is using our h-control product and you can see the sort of granular information you have on spend, down to procedure levels or specialty levels. And the next one along, we're looking at a total knee replacement, for example. Who are the surgeons, what did they spend, how long did they take, what was their average spend and who did they prefer to use? So this is the sort of information you can get to when you capture data at the bedside.

So that's my presentation, thank you.

Michelle Van Wijk

Thank you so much, Kirk and Mark, and I can see we're right on time now. We have a range of really, really good questions, so what we might do, to make sure that we cover them comprehensively, is we'll take them offline and we've got a recording of them, and we'll provide answers at the start of the next webinar. So we have probably about ten questions which are really, really good questions for Mark and for Kirk, so we'll do those, and Mark and Kirk, appreciate your input to those before our next webinar, if that's okay?

For anyone who can stay on, I'm just going to quickly go through one more slide before we finish up. We are going to talk in our June webinar on 21st June, about the Australian UDI Sandpit. So that is the ability now that we're planning to make available in July for users of the Australian UDI database to test and give us feedback on what we've built. To put data in, to take data out, to do searching, so all the functionality that's needed, to make sure we've built it in the right way.

So we've got some time between now and next year to get feedback, to have it used, and to get those things right. What we'll do in June is provide more information about the Sandpit, how you might use it, how to log on, what the processes are, specifically for the Sandpit. So again, apologies, we've run over, but I really want to thank Mark and Kirk for sharing their experience today. That was very helpful, and we have a really good range of questions, and we will take those and prepare those for the next webinar.

Thank you so much everybody. Have a lovely Tuesday and we'll see you back in June.