Unique Device Identification Webinar #14 - Guest speakers from Zebra Technologies will present on the UK Scan4Safety pilot
Presented by: Michelle van Wijk, Therapeutic Goods Administration
Brett Newstead (Zebra Technologies)
Presented at: Online
Presentation date: Tuesday 18 October 2022
Presentation summary: Guest speakers from Zebra Technologies will share observations and learnings from the UK Scan4Safety pilot. There will also be an update on the Australian UDI implementation.
Michelle van Wijk
Good morning, everybody. Welcome to our 14th Webinar for UDI. Before we start, I wish to acknowledge the traditional owners and custodians of the land on which we meet today, which is the Ngunnawal people, and pay respects to elders past, present and emerging, and I’d like to extend that acknowledgement and respect to any Aboriginal and Torres Strait Islander people here today.
Today, we have a full agenda. We have another invited guest presentation, which is Brett Newstead from Zebra Technologies, to give us a discussion about observations from Scan4Safety. And I’ll provide more information before we do the introductions. So we’re very appreciative of Zebra and Brett for making the time today. We’ll give you an update on the project, and we’ll have time for questions and answers. And we already have some pre-Webinar questions that we’ve put in Slido as well.
So from a Sandpit perspective, as you know, we opened that on 4 July to get feedback prior to our voluntary compliance day, just to make sure it’s usable, it’s fit for purpose, and to see if there’s anything we might need to adjust. So far, we have 364 registrations, with a really good mix across sponsors, manufacturers, some software providers, healthcare and TGA staff, including some regulatory organisations that provide data on behalf of sponsors and manufacturers.
So 362 users that have access to the Sandpit, and so far, 77 UDI records created using the portal and bulk upload. And hopefully, next time, at the next Webinar, that number will have gone up significantly, because the National Product Catalogue connection went live late last week and so there should be some of those records coming through, which is very exciting.
Our business support team has had 220 calls and 398 emails, and we’ve made some enhancements to the Sandpit to really reflect the feedback on usability, but also to fix some errors. We had some early ones, particularly around that log on and account process, so we’ve made changes to those. And we had lots of feedback on the bulk upload template, so we’ve made some changes to that as well.
In terms of progress towards the regulatory framework, we had a consultation that was opened on 31 August. And that closed last week, and we’re now in the process of reviewing those responses and the feedback. And that will all go to government for a decision on the regulatory framework, and then that will be implemented. So that work is in progress at the moment.
We continue our collaboration and engagement work. So the Sandpit does remain open and will stay open. We have these monthly Webinars. The Technical Working Group is now meeting regularly again. There was a short pause on that. And we continue to present, to engage and to work more broadly across our key stakeholders.
What I’d like to do now is give an introduction to Brett Newstead. So Zebra has very kindly agreed to speak today. And really, we see two reasons for how this presentation fits with the work around UDI. So firstly, you would remember, Mark Songhurst from Leeds National Health System Trust spoke to us about the clinical and the NHS experience around the Scan4Safety, which was the UK project.
And so we want to extend that now to talk a little bit more about some observations and some benefits from more of a technical perspective, but also from that particular project. And as Rachel said, we’ll share some of those links with you in the chat box because most of the documentation around Scan4Safety is publicly available. So if you haven’t had a chance to look at that, we’ll share those links.
I think the other key linkage between this presentation and the work we’ve been doing is that different organisations are at different stages of their digital journey. So some are still paper-based. Some are more mature. And so we really wanted to show some practical implementations around scanning.
Because that’s one of the key benefits of UDI, that ability to scan the barcode or the QR code and actually then have that data flow through automatically into systems, so reduce the need for that manual work. So we want to bring it to life through today’s presentation by Zebra Technologies.
So I just need to make a note there, that obviously the TGA is a government organisation, doesn’t recommend or endorse any particular provider or supplier. But we really think this is a very UDI-focused presentation that will be very, very helpful to everybody.
I’d like to now hand over to Brett Newstead. So Brett is one of the leads in Zebra Technologies in Australia, and he’ll do an introduction. We have some other speakers from Zebra Technologies. We’re very excited. We’re going to push our technology boundaries and hope the technology gods are smiling on us today. We’re going to try and do a couple of recorded interviews. So fingers crossed that that all goes to plan, but I’m sure it will go smoothly.
So thank you very much, Brett and the team, for making the time today to share your knowledge and expertise and talk to the group around Scan4Safety. So I’ll hand over to you, Brett. Thank you.
Thank you, Michelle. Thank you for the great introduction and thank you to you and your team for the great work you’re undertaking on the Unique Identification System as well.
And yes, let’s hope that the technology gods are smiling on us as we get through this, because we have done a couple of pre-recorded videos. We thought it would be a great opportunity for us to give some perspective from both the UK and from a regional perspective as well.
So healthcare is really important because I think it impacts everybody. It impacts either directly or through our families. And this is something that we feel really passionate about in terms of making sure that the healthcare experience is as safe as possible.
There’s definitely a link to the Webinar that was conducted, I think Webinar number nine, with Mark and Kirk, and I think they did some great presentations. And there were a couple of quotes that really resonated with us when we saw that, and hopefully we can elaborate on that and take that a little bit further.
So Mark, who is from Leeds Hospital, shared that data is useless unless it’s turned into information, and information is useless unless it’s properly targeted. So hopefully, we can give a little bit of a practical experience of where that can be addressed, and I guess it’s very much a starting point.
As Kirk shared, when scanning a barcode, you get the correct information every time. And that’s certainly something that has been fundamental to all of our solutions that we’ve been delivering. So today, I hope to provide some practical experiences on the benefits of UDI and scanning.
But first, I’m going to introduce Zebra Technologies. Zebra Technologies is an interesting company. And I’ll talk about our size and scope and how well people are aware of us, because we may well be the largest company you’ve never heard of. And I’ll explain that further.
We’ll talk a little bit about Unique Device Identification, talk around some key healthcare technologies involved in scanning in UDI. We’ll summarise the UK Scan4Safety programme, and I’ll actually interview our healthcare lead from the UK to talk a little bit about the UK programme.
We’ll also run some Australian case studies, including a video from Johnny Ong, who is our Asia-Pacific healthcare lead, and then summarise and end on a little bit about why UDI is important, a little bit of a conclusion. And we’re certainly available for any questions that you may have as well.
So I guess to introduce the speakers from our team, I’m a Director with Zebra Technologies. I’ve been within the industry that we work in, which is, I guess, primarily what we call data capture or enterprise mobility, for over 20 years, and I’ve been working across many vertical industries, from retail, transport, logistics, manufacturing and, of course, healthcare.
I am an engineer and I do have a bit of a technical slant to everything that I do, but I am also a Director of Sales. I was certainly involved in working with our team to make sure we deliver the best solutions for our customers.
Wayne Miller is our Healthcare Practice lead from Europe and has been working with many of our customers in that region for a long time. And Johnny Ong is our Healthcare Practice leader for our Asia-Pacific region as well and works very closely with our healthcare customers across the Asia-Pacific region.
So let’s turn to Zebra Technologies. So as I touched on, we may be the largest company that you’ve never heard of, but if you look closely, you’ll actually see our products in your everyday life. If you’re at your local supermarket, you look closely at what the staff are doing when they’re trying to keep the inventory on the shelves, you’ll actually see that they’re using our devices.
If you look at the way in which the PoS scanners are scanning items as you’re purchasing, and look closely again, you may see the Zebra logo. In some cases, it’s obscured, but you’ll see a lot of our products both in the front end and also on the floor in retail environments. If you’ve had parcels delivered to your doorstep, which I guess has certainly boomed through the recent events with COVID, and again, you look closely, you’ll see the Zebra logo on those devices that they’re using to make that delivery.
So we’ve been working in a lot of fundamental organisations for a long time. But because our devices are used from an operational perspective, our brand isn’t as broadly known as, I guess, a lot of other consumer brands out there.
So our business actually began more than 50 years ago, and that’s a long time for a technology company. And we started with very humble beginnings, where we developed the very first thermal printers, which was, I guess, the evolution of barcodes. In fact, the Zebra name actually came from the black and white stripes that you see on barcodes.
And it simply became that a lot of our customers, when we first started building those thermal barcode printers, referred to us as the Zebras because of the black and white stripes of the barcode. So our team decided to change the name, and hence we became Zebra Technologies from then on.
And our focus ever since those first thermal printers has been on developing purpose-built products and solutions for our customers. And what I mean by that is we do a lot of work to make sure that they work really effectively within the specific market or environment they work within. And some of the pictures at the bottom give you a little bit of a sense of what that means.
So for healthcare, we actually have created a variation of our products which is designed to withstand the harsh cleaning that may be required if the devices are used in a clinical sense and are exposed to patients who may have some sort of infection. And in those environments, the devices may need to be cleaned every hour. So we do a lot of work on purpose building the devices to be fit for that operation.
We also do some specialised RFID reading technology, wearable technology. We do a lot of work around making sure our devices are designed for voice and collaboration. And, of course, they’re tailored to the individual markets, whether it’s been delivering a parcel, rugged outdoor field users or inside a retail store, keeping inventory on the shelves. And, of course, in the hospital itself.
So we’ll talk a little bit about UDI. So the slide shows the UDI definition from the TGA webpage, and there’s a couple of weblinks here that you can access, one, I guess, back to the TGA webpage for the definition, and there’s also a reference to a video, which gives a really good understanding or briefing on UDI and scanning.
But in short, UDI is essentially a Unique Device Identifier. So it’s a number or alphanumeric characters that’s machine readable, but also printable, so that humans can read it as well, and it’s designed for really accurate capture of what that identifier is.
The UDI system is going to be hosted into a database, with links, which is going to allow people to access the data really quickly. And that can be incredibly important, especially if looking at a recall, where recalls really need to be addressed in minutes and hours rather than days or weeks. So having access to the accurate data and very quickly is really important.
But UDI systems have also been around for a long time, and we’ve tried to provide some context on some of the other industry verticals that are out there today. At a fundamental level, a unique identifier is labelled onto a product at manufacture. And that means that that product is now uniquely identified.
And by using global standards, it means it can be manufactured in one country, shipped to another, and still be a uniquely identifiable number to that specific product. And the key to that is that global standard to ensure that it flows all the way through.
And then one of the more common uses, and has been in place for decades, is actually being able to provide visibility of that item as it moves through supply chains. So it could be the movement of bulk or palletised or even individual items. There’s actually global standards for a bulk label.
So that could be a pallet full of individual items, where essentially, there’s a barcode that’s created and it represents all the items that are put into the pallet itself. And then that can be scanned. And at each point that it’s scanned, you’ve got full visibility that it’s in that pallet or container that’s being shifted.
Warehouse operations or distribution centres will commonly use the same unique identifiers to track the movement of each individual item so it doesn’t get lost. And in some cases, some of the more advanced distribution centres will even do things like track the serial numbers and also the expiry dates of the products as well. And a lot of that can be linked back to the global identifier.
And as I’d touched on earlier, where you’ll see our devices and where a lot of people are using the unique identifiers is in e-commerce, the parcels, so being able to trace that a parcel is being delivered to your doorstep.
But equally as important, a lot of people are demanding visibility of where their parcel is. When they order it online, they expect to know when it’s going to be delivered to them. So, often, you’ll see updates to show that the parcel has moved. You’ll see an update to see that it’s been delivered, say, to the local airport in Melbourne or Sydney.
And in that case, what’s happened is that somebody has scanned that unique identifier at that point, and then that information has gone up into the system so they can share that with you. But, of course, the inventory that keeps retail stores with stock on their shelves, and also accurately checking the stock that’s been sold when it’s been purchased as well.
So the key technologies in healthcare for scanning and UDI can be broken down, in our experience, into three main areas, the first being positive patient identification, second, clinical mobility, and the third is tracking and locationing.
So positive patient identification is really important in terms of patient safety, to make sure that the patient is being treated with the correct medicines, the people that are treating them have access to the correct medical records and information, and if specimens are taken, that we’re linking that specimen accurately back to that particular patient. And fundamentally, by using scanning technology, we’re able to link the two very, very accurately.
If we look at clinical mobility, this is about extending that positive patient identification to enable clinicians and healthcare workers to be able to do more at the bedside at the point that they’re going to be really effective. If they have to go back to their desk every time they want to check something or every time they need to write up data or information, they’re going to be spending most of their time commuting between the patient and their desk or trying to find somebody to collaborate with and back to their desk.
So this is all about empowering them to be able to do all of those actions when they’re actually out in the ward or if they’re with their colleagues, and be able to access all the information that they may need or to be able to print the labels which allow them to accurately identify specimens or other items.
And the third area, which is tracking and locationing, is an area that’s, I guess, evolving a little bit, has traditionally been barcodes, but we’re starting to see the emergence of RFID labels and RFID technology coming through, which provides a level of automation so that we can actually very quickly identify all the inventory in a particular item, for example, or we can actually identify where people are moving. So if there’s an infectious patient, we’ve got visibility of all the people that have come in contact with that particular patient.
So now I’ll move a little bit to the UK NHS Scan4Safety programme. So fundamentally, this is a programme which is set out to really investigate the benefit of point of care scanning, and understanding how that will improve the efficiency and the safety within the NHS.
The key area of focus was on scanning people, products, places and process to really understand the benefits of digitising the way in which healthcare workers operate and leveraging global unique identifiers in that process. It was spread across six UK National Health Service Trusts as demonstrator sites, and it was conducted over two years.
So the key areas that were explored was around efficiency, auditing and safety. So from a patient safety perspective, one of the big focus areas was on the speed and accurate recall process, because, unfortunately, there have been a number of patients that have suffered on recalls and still perhaps are suffering today, but also expanded out to reduction of drug errors and never events, which is all about improving the way in which patient safety and patient identification operates in hospitals.
It’s also about monitoring the effectiveness of equipment, which enables clinical workers to be able to access the right equipment much faster. They’re not rushing around, trying to find the equipment that they need. They’re able to identify where it is really quickly and accurately, and able to communicate amongst themselves to be able to track down that critical piece of equipment when they need to.
And, of course, managing medical supplies. And we’ll touch on, in the next slide, a little bit about the outcomes. But simply, the restocking process for supplies and medications certainly had a big impact through this programme, and some of the results were very, very impressive.
So this is straight out of the GS1 report on the UK NHS Scan4Safety. You can see the web link at the bottom of the slide as well. But in terms of the outcomes that came through, there were 140,000 clinical hours saved over the course of the programme. So what that means is that clinical workers were able to find more time to provide care to their patients.
From a financial perspective, they identified GBP £5 million in recurrent inventory savings and GBP £9 million in non-recurrent inventory savings, which is a huge amount of money to be able to free up and reinvest in other critical areas of the hospital.
And as Mark touched on in the previous Webinar, number nine, at Leeds, they were able to identify that they had the ability to reduce the amount of time to manage a recall from 8.3 days to 35 minutes. But that’s an incredible change just from simply implementing a system that gave them that traceability, and it’s really one of the core benefits of the UDI system.
But, of course, there are some further results. So the Royal Cornwall Hospital was able to share that they reduced preventable errors and they were able to eliminate all errors caused by wrong patient, wrong drug, wrong dose, wrong form. So that’s phenomenal, to be able to eliminate, through a two-year trial, all errors in that environment, and that ultimately drives greater patient safety.
So now, I’m going to hand over to a video from an interview between myself and Wayne Miller. Now, I’m just going to take control of the screen, so hopefully this works. So please bear with me. Hey. Good morning, Wayne Miller, from our UK team. Thank you for joining us today.
Thanks, Brett. Thanks for the invite. It’s a pleasure.
So we’re here for a quick interview to talk about Scan4Safety out of the UK. So I’ve got a couple of quick questions for you. So can you share with us your experience with Scan4Safety in the UK?
Certainly. If I may, let’s start with what Scan4Safety is. Scan4Safety is a programme by NHS England which sets out the use of standards. And it does what it says on the tin. It’s using scanning of patients, of locations, of drugs, devices, and brings that information together to improve safety.
But it doesn’t just improve safety. It also has the procurement process. So an international standard or a national standard, whichever you want to call Scan4Safety, just brings together unified ways of identifying things. So it’s unification of those identity standards.
So with the start of this a number of years back, it brought together what happens from the manufacturer, because the manufacturer is ultimately the organisation that puts the identity standard on a product or on a drug, and then follows those through the supply chain and allows procurement to procure the right kind of device or the right kind of thing, shall we say, because it creates an, again, unified standard.
They’re put into groups, so all drugs and all drugs of certain types go into groups. So if you want to buy paracetemol, you can look at all the providers of paracetemol, look for a like-for-like, look what they have in stock and what their cost is. But inside the hospital, it allows you to identify a patient, it allows you to identify a procedure, it allows you to identify the items that were used in that procedure, where it happened and when it happened, so it creates that unified reporting for an organisation such as the NHS to suck that information in and process.
Terrific. So what do you feel were the achieved outcomes of Scan4Safety based on the trials that were run in the UK?
So there are a few example sites. They’re what we call the demonstrator sites. There are six of these, and they’ve had different returns on these. And you can find these on the Scan4Safety website. And you look at places like Salisbury who had inventory issues, or not issues, but they reduced their inventory on hand.
And in 2017, they saved about £1 million worth because they understood what stock they had on hand, what the use-by date was on that stock, what the manufacturing date was on that stock, and it also allowed them to control the amount of stock they were purchasing. I believe they were overstocked, and it allowed them to reduce that stock burden, return that back into cash and ultimately invest that into patient care.
So Scan4Safety website were the best placed to look at those individual ROIs, but that’s ultimately what the NHS is looking for, is to reduce cost burden, improve services for the patient and return that free cash back into patient care.
And what does Scan4Safety mean to the hospitals themselves?
We all call the thing the same thing, as it were, to really simplify it. So an item has that identity on it that’s set at manufacturing. It has country of origin, it has who the manufacturer is, manufacturing date, use-by date, batch number, and in the description, access to a database tells you what it is.
So it allows a nurse to send a request for a specific item. So when they scan an item and use it on a patient, it triggers the whole supply chain to restock. It also allows people that aren’t medically trained to go and identify an item. You can send somebody off to go and search for an item that you need for patient care.
So it created unity in identification across healthcare, nursing teams that are vast in their age range, come from different backgrounds, call things by different names. Everyone refers to a mattress by a different name, maybe the manufacturer or what the mattress does. It creates unification on identity and saves money.
And how does Zebra support UDI implementations and UDI standards?
So the UDI standards set out the barcode and the type of information within that barcode. So then it allows hospitals to choose the right devices that support those standards. I’m sure we could all go online and pick out a scanner from the manufacturer, but does it comply to those UDI standards? So it allows hospitals to understand what they’re purchasing and does it fit their need.
Also, Zebra looks at devices that support use in the hands of the nurse. What does that mean? So if I’m scanning a device in a theatre, after that procedure, I need to sanitise all my devices. So we create a device that meets the UDI required standards and also allows you to clean that device in between patients. We call it rugged in not only software but also the device itself, so drop specs, a whole range of aspects that we have with the Zebra devices.
Terrific. Well, thank you very much, Wayne. I look forward to catching up soon, and thank you for joining this quick video.
Thanks very much.
So I’ll also run another quick video from Johnny Ong, who is going to run through a case study from a project that we did with the Royal Children’s Hospital here in Australia for tracking blood.
Hi, good morning, everyone. This is Johnny Ong. I’m the Healthcare Practice lead for Zebra Technologies. Today, I’m going to share everyone the Royal Children’s Hospital, which is a 250-patient tier hospital and also a major trauma centre which specialises in paediatrics in Victoria and a national centre for cardiac and liver transplantations.
The challenges which technicians face is that they are required to scan more than ten different types of barcodes from the blood bag. These barcodes serve different purposes and have different information, such as production date, the barcode, the blood group, and also contains other essential information such as DIN, which is known as the donor identification numbers. The barcodes have to be scanned in a particular sequence to ensure that that data is registered and captured correctly into the EMR.
The solutions that we put forward, firstly, is to understand the hospitals and the clinicians’ requirements on where do they want to implement, in which areas. We have identified that the solutions need to be implemented in high priority areas such as operating theatre, paediatric unit, the ICU and in the oncology because these are the areas that blood transfusions were likely to take place.
What we have done was that we have programmed custom-built sequencing software which is known as Zebra’s 123SCAN onto the scanners that instantly recognise all the barcodes on the blood bag using one click or two. It only scans the required barcodes which were automatically populated in the correct sequencing order with one pass, and it captures in the respective fields which are mapped up into the electronic health records.
The result was that these measures reduce the overall stress for the clinicians, and these also enable a much smoother workflow. And that leads to increased efficiency of the total scanning process, approximately more than 50%. And that leads to less waiting time for lifesaving blood transfusions. With that, this will have significantly increased staff satisfaction and increased patient satisfaction level.
So a quote that was from Adrian, who is the Chief Nursing Information Officer from Royal Children's Hospital, is that when it comes to blood transfusion, every minute, every second counts. Zebra’s solution has saved the clinicians precious time by significantly increasing the efficiency of the blood scanning processes and left clinicians with less stress, and they have more time to do what they can do the best, which is delivering outstanding care to the sick kids.
With this, I hope that this sharing session is beneficial, and hope to get more insight to everyone. Thank you so much.
So as we touched on, we thought we’d give you a little bit of flavour from, I guess, the UK and from across the region. And also, one of our great partners, h-trak, I believe presented in a previous Webinar, number nine. And they’ve been using a lot of our equipment for some of those installations.
h-trak has a software solution which is designed for tracking and identifying products in hospitals, but particularly in departments where surgical and interventional procedures are being performed. And this gives a few quotes from a couple of the hospitals that have deployed the system in terms of the outcomes that they’ve seen.
So St John of God, for example, have shared that they saw an eight-hour reduction in processing time of prostheses, which is a saving of $1.2 million per annum. And South Western Sydney Local Health District also shared that the revenue from prosthesis billing pre h-trak was at $3.8 million, but post h-trak increased by 30% to $5 million through the efficiency that they gained in the new system. And Western Sydney Local Health District had similar results, where they saw a $6 million per annum increase in prostheses billing as well.
So this comes back to the original quotes that I touched on from both Mark and Kirk, where, effectively, what they’re calling out is that the information has to be used to be useful. And these are good examples of where the information is being used, is really useful, and, of course, using scanning technologies means that the data is incredibly accurate.
So finally, UDI systems and systems which help to improve the efficiency in healthcare is more important than ever. Frontline nurses had a tough time through COVID, and they’re incredibly impacted and they’re right at the forefront of where a lot of these benefits come from.
So we’ve got various studies that show nurses, on average, create 27 workarounds per shift. They may spend 21 minutes per shift just trying to find equipment. 80% of physicians are at capacity or overextended. And for every hour clinicians spend with patients, they could be spending another two hours just documenting that. So there’s a lot of benefits that come through UDI and scanning systems in terms of the operational efficiency within healthcare.
But, of course, getting back to UDI, this is all about building digital health for Australia’s future. So UDI is based on global labelling standards. They’re both recognised and accredited product ID standards that are used right around the world and have been used in other vertical markets for a long time, always very effectively.
Positive digital identity is the foundation for patient safety, fewer workarounds, reducing frontline nursing fatigue, improved care and lower costs, freeing up more funding for other critical areas that can actually save more lives. And, of course, purpose-built healthcare-grade technologies provide the optimal method for capturing these benefits.
So thank you very much. That’s it from, I guess, our presentation, and we’re certainly open to any questions. I’m also joined by Johnny, who is also here to answer some of the questions as well, if you’ve got some.
Michelle van Wijk
Thank you so much, Brett, and appreciate the presentation but also the interviews, so all of the technology work. So thank you so much.
Yes, and you probably got to see how bad an interviewer I am, but we did our best.
Michelle van Wijk
No, thank you. We appreciate that input and that, in the UK, it’s not a very nice time to be up and being on a Webinar. So the recording was great. We will go through for some questions and answers. We’ll do our live poll, I think, and that’ll give us just a few minutes to look over some of the questions in there.
So I’ve noticed some of the questions are around the TGA and the Australian implementation. So if you have specific questions for Brett or the team, please put those in there as well. We’ve got them as a captive audience for the next 20 minutes, and so if you have questions, that would be great.
If there’s anything we can’t answer, then we will take that on notice and provide the answers, either on our website or at the next Webinar. And apologies, my system is doing some things in the background, and I suspect a software update. So if I have to turn off my video just to make that run smoothly, I might have to. So apologies in advance.
So I have a question for you, Brett, if that is okay. So the question is, is Scan4Safety a concept, and that the execution requires the implementation of an IT solution to actually perform the scanning and device recognition? So I’m happy to hand that one over to you if you’d like to respond to that one.
Yes, sure. So Scan4Safety is, I guess, a programme that was being implemented in the UK by the National Health Service, and yes, it does require an IT solution or software to be able to run the individual tests or the programmes that they were running.
h-trak, who was, I guess, a partner of ours and was also referenced through this was one of the software vendors involved in one of the trial concepts, and there are a number of others as well that went through that programme. And the software that was implemented was designed to test some of the key areas of focus for that Scan4Safety concept that was being tested.
Michelle van Wijk
Great. Thank you. And I think the other link there is that you need the standards as well as part of that process, so the definition of the standards then, and to allow the technology to do that scanning. We got another question too that we might have to take on notice. I’ll see, Brett, if you can answer this one.
But it was around, given that the Scan4Safety, the original trial, was a number of years ago now, where is that up to in the UK more broadly? So I haven’t got an update on that, but we could take that one on notice, unless, Brett, you have an update on it.
I can give some colour around it. So the Scan4Safety was run for two years and ended just before COVID. And during the COVID period, they essentially put it on hold. So the next phases of that is what the NHS is working through in terms of how they go from where they are today to the next phase. But it has largely just stalled because of COVID.
Michelle van Wijk
Great. Okay, thank you for that. Appreciate that. I’m just going through the questions again. I think the rest are related to the Australian implementation. So let me just see if there’s any others. They’re mostly around the Australian implementation. So I will take some of those, and then if there are others around Scan4Safety, then we’ll pass back to you, Brett.
So if I take them from some of the ones that are voted most popular, one is, will the Australian implementation dates shift if EUDAMED dates shift? It’s something that we’ve sought feedback on as part of the consultation process, because we know EUDAMED has been delayed, and what the impact might be of that.
I think the recent position in the EU is that they will implement all of EUDAMED together. There’s been a few changes on that. But we don’t yet have a position that says what that will do to our implementation dates, if those EUDAMED dates move out any further or change.
We have a really good one on GMDN. So how will we reconcile the use of the GMDN? Will we continue using the legacy ARTG assignments? It is a really, really good question. One of the challenges we have at the moment is some of the data in our legacy systems, including the ARTG systems, isn’t quite what it should be. Over time, some of that has not become as valid or as, high quality as it could be.
And so we’ve got a project that’s running under UDI to look at some of that data, because we recognise that that’s really important to the UDI work, and particularly where we’ve got some of the same data fields on the ARTG and in the UDI database.
So there’s some work that we’re doing around looking at that, looking at what that means in terms of validation, and then what that means for the ARTG data and assignments. So while we don’t have an answer on that, it is something we are looking at, at the moment. So that’s the GMDN one. We have Gary online, so if he’s available, we have another question on the bulk upload. So happy to hand that one over to Gary, if you can let me know if that’s possible.
It is possible, Michelle, so yes.
Michelle van Wijk
Fantastic. Thank you. We’ve had lots of questions on the bulk upload. And so we know it’s still being used and tested. And so we’ve got a question here that I thought would be good for everyone to hear the response to. So the question is that the new bulk upload template has a lot of fields that are mandatory and it’s quite different to the prior one. Is the expectation that all fields on this template will remain mandatory?
And so it’s just some of the timing around the consultation and the work that we’re doing on the Sandpit. So just an observation that we’ve made some of those things available in the Sandpit after the consultation has closed. So what might be, that the mechanism for providing feedback around some of those as well, I think, would be good to address, if you’re okay with that.
Yes, absolutely, Michelle, and thank you. It’s interesting that this question… So just prior to this Webinar, we had run our fortnightly Technical Working Group, which we discussed the bulk upload template in and the latest version of that.
So if you weren’t able to or whoever raised this question didn’t receive the invite to that technical working group and you’d like to continue to dialogue around bulk upload and other implementation considerations for some of the database, please send us an email at email@example.com to register your interest, and we’ll make sure that the invite goes out to you as part of the regular process which runs every fortnight.
So we had talked through, and this is the last workshop, is the bulk upload and the changes we’d make. And effectively, as Michelle just touched on, we had received a lot of feedback around the bulk upload template and the simplicity of it, or rather the complexity of it and how difficult it made it for manufacturers and the sponsors to load data into the database.
So based on that feedback, we had developed a prototype version, which is the new template that you would have seen and has just recently been sent out. And so the aim of that was to socialise that with all the various stakeholders who would be interested in uploading UDI data using that method, to get their feedback and thoughts.
So yes, it is quite different to the previous one, because essentially, the large areas of the feedback we received was, can you make it different to the previous one from the perspective of being able to simplify the process for manufacturers and sponsors to upload data?
Definitely, there is certainly ongoing conversation and discussion. So even though the consultation paper has closed, there’s definitely discussion around how that template would look and how that would implement. So we’re still very open, and the feedback around that bulk upload template is still very welcome. And certainly, through the technical working group or through the UDI helpdesk, please feel free to raise those comments and questions.
Coming back to addressing that comment about there being lots of fields that are mandatory, and we did talk a little bit about that earlier today, so we’re making that sort of distinction about what that template will reflect in the mandatory fields by analysing the consultation feedback, making a submission to government, and then the government providing their recommendations on what the regulatory position should be, and therefore, what data elements they’ll have to collect.
So that’s still an ongoing process, and we’ll use the consultation feedback to do that. The bulk template has a number of mandatory fields, and we’re looking at some of the feedback we received today, so we’ve called them mandatory, but effectively, they are mandatory because of some of the relationships with other fields.
And so really, feedback today was to say we need to make that distinction between what is actually a mandatory data element and then what may be required as part of the relationship between particular attributes of certain devices. So I suspect your question is really related to some of those areas, more around what would be required if a certain data element was there, such as the number of reprocessing uses or sterilisation indications, etc.
So we will continue to have that conversation. We’ll continue to socialise those comments as part of the bulk upload conversations with our Technical Working Groups, and it’s still a work in progress. So I just wanted to assure everybody that the consultation being closed hasn’t stopped the dialogue and the discussion around what the most useful method is for bulk upload.
So hopefully that answered your question. There’s a lot of information and so we’ve kept it open. But if you do have any further questions, feel free to either raise them here or send them to us through the helpdesk, the UDI mailbox, and we invite anybody and everybody to participate in the Technical Working Groups that run every fortnight. So the next one will be on 1 November. Thanks, Michelle.
Michelle van Wijk
Thank you so much for that, Gary. Brett, we have another question for you that’s come in. So a question on Scan4Safety and the other case study that we presented. Were they expected to meet any regulatory expectations?
So each project was certainly assessed against regulations and suitability. I’m not sure if the question is in relation to some sort of regulation around UDI. I guess that the UDI regulations are starting to filter through now. So they were compliant with what was available at the time. In the case of Scan4Safety, they decided to use, I think, GS1 as the basis for the barcode standard that they were using.
And of course, all of the equipment had to stand up to all the regulations for the NHS. Each software vendor also had to go through a selection process to validate their solution, and no doubt that also included things like security assessments and suitability within the system.
Michelle van Wijk
Brilliant. Thank you. Thank you so much. That was very helpful. We’ve got some questions around areas that we’ve consulted on in terms of the regulatory framework. So we won’t be able to answer those today, but I will just acknowledge what the questions were. So for product supplied as a kit, so for example, a rapid antigen test, is one UDI acceptable for the kit, or do all individual components need separate UDIs? So that is something that we’ll provide further advice on as the regulatory framework evolves.
And then a Class l question. So regarding using Master UDI-DI to group Class l devices to reduce the administrative burden, please provide clarification on how Australia plans to align with EU on this. So it was something that we consulted on in a paper, to really understand which devices should be in scope.
And we had some specific questions around Class l devices and whether those additional grouping mechanisms would be helpful or not. So they’re something that we will continue to look at and assess as we go through the feedback to that consultation paper.
As you would know, Class l devices, the low risk, high volume, particularly related to things like spectacle frames and lenses and contact lenses, continue to be a global UDI challenge, and UDI in EU is implementing that Master UDI-DI. And the US has recently put out some advice on over-the-counter products that are generally sold in chemists, for example, and not necessarily used in a clinical setting. So there’s still some work going on both of those.
So we might just squeeze in one more question before we finish. Actually, and I think this is probably another good one for you, Gary, if that is okay, and it’s what is the process for third-party submissions to create a solution provider account on behalf of their medical device customers? So if I’m one of those third-party providers or submitters of data, what is the process for me getting an account to log in, and how might that work? So I’m happy to hand that one over to you if you’d like to just provide a bit of an update on that. Thank you.
Yes, sure, Michelle. Thank you. So the current thinking and the current process is to leverage and use the existing TGA business systems, accounts and process that exists for those organisations who are engaging with the TGA as part of the online services that TGA offers.
So for third-party submitters, we’re looking through. And I’ve actually taken note, and we’ll work through that as part of our Technical Working Group coming through, and to show what that would look like. However, the going-in position, a position we are looking to put to the group is that the data submitters would effectively operate as an agent on behalf of the sponsor or manufacturer who they’re operating or submitting their data on behalf of.
So that would use the existing regime that’s in place, and then allow them to effectively act on behalf of their manufacturer and sponsor. And so if that was a submitter that did provide that service to a number of manufacturers and sponsors, we would actually work with them to be able to identify which those were and have them create separate relationships with those manufacturers and sponsors.
So I’d love some more feedback, and we may add that to one of the topics, for the Technical Working Group to actually walk through how that may float over the coming weeks.
Michelle van Wijk
Great. Thank you. And there’s one more quick one. We’ve got maybe half a second. Will the interfaces be different for data providers and data users? And the answer is yes, that the general interface and experience will be consistent, but some of the functions and how prominent they are and the flow around them will be different. So a data provider like a manufacturer or a sponsor will need to do different things to a data user, for example, and TGA staff will have a slightly different focus in what they can access, and how, as well.
So if you’ve looked at the Sandpit, there are specific pages relative into those organisations. If you want to see what others might see, perhaps if you’re a sponsor or you want to see what a user might see, you can certainly ask for an additional account with that focus so that you can actually see that side as well.
So we’re right on time now. I want to thank Brett and Johnny for joining us today and providing that information on Scan4Safety and some of the practicalities around how those things work in terms of the difference between the technology and the benefits. And thank you then to everybody for asking questions.
We’ll see you on the next Webinar, which will be the third Tuesday in November, 11:30am AEDT to 12:30pm AEDT. And any questions in the meantime, please don’t hesitate to reach out through our email or for information on the web. But also, as Gary said, if you’re not part of the Technical Working Group and would like to be, please also let us know. So thank you so much, everybody. Have a great rest of the Tuesday or start of the Tuesday, depending on where you’re dialling in from. All right. Thank you. Bye.
Thank you. Thank you. Bye-bye.
- Committee meetingsAdvisory Committee on Biologicals (ACB) meeting
- Committee meetingsAdvisory Committee on Medicines (ACM) meeting
- Committee meetingsAdvisory Committee on Medicines (ACM) meeting