Conversation: The UDI System and Global Regulatory Harmonization
February 10, 2021
The conversation below is a moderated discussion between Rich Kucera, CEO of Symmetric Health Solutions, and Terrie Reed, Director of Partner Relationships. It covers how problems in medical device identification gave rise to the UDI System in the US, what issues remained after its introduction, and why a global UDI system will be most effective if regulations are in harmony around the world.
Shivum: Terrie and Rich, thanks for joining me for this conversation about the UDI system and global regulatory harmonization in the healthcare supply chain. Terrie, I was wondering if you could kick this off by giving us a quick overview of the world before the introduction of the UDI system and why the decision was made at FDA to pursue its creation.
Terrie: The UDI System didn’t exist until it was put in a congressional law, Public Law 110 in 2007. And it was a little paragraph that said that the FDA was going to write a regulation that would allow for the adequate identification of the device through distribution. And so from that paragraph in 2007, FDA published around a 150 page regulation that was intended for manufacturers to set up the UDI system with FDA being the enforcer of that regulation.
That's the policy side of it. And the reason they put it into place was because, seems obvious now, but medications had NDC codes since 1972 and they were used to identify medications, but there was no such thing for medical devices. And it was really getting in the way of all the regulations FDA had, like adverse event reporting and recalls. When people reported adverse events or they tried to manage recalls, no one at FDA exactly knew what device they were talking about. UDI was meant to change all that.
Shivum: Got it, and so we had some examples of unique identifiers working with pharmaceutical products with the NDC. And then several reasons, public health and regulatory, to implement such a system for medical devices as well.
Rich, could you talk a little bit about some of the difficulties on the healthcare supply chain side Prior to the introduction of UDI?
Rich: Yeah. And some of them are obviously still here today as healthcare has moved into using a UDI. Similar issues existed, maybe not as pronounced as FDA, from a supply chain perspective. When I say supply chain, I mean procurement and inventory management. An issue for all parties in the supply chain has been the identification of an item, whether that's buying it, paying for it, keeping inventory stock levels really anything part of normal supply chain -- identifying an item, knowing actually what it is, knowing when you need to know about it to do the most basic activities has been difficult historically. Since that information was really generated by the manufacturers and not necessarily maintained anywhere, especially not with data standards. So you had issues.
Catalog numbers were historically and still are how things work. Those re identifiers are really just made up by the manufacturer for the items that they are selling. This resulted in duplication across different manufacturers and sometimes their own cataloguing systems. There isn’t any maintenance of this information in an accessible repository over time.
So UDI has really been helpful in terms of understanding what an item is at any point in time.
Shivum: Got it. And what did the UDI system change? Terrie, maybe if you want to start here and talk a little bit about the implementation process and what the current state is.
Terrie: At the FDA, the goal was for the UDI program to focus on the users of the UDI data. There were two requirements. One was that the manufacturer put the UDI on the label, and it had to be in human readable and machine readable format. Meaning it had to be scannable. And two, the manufacturers had to submit a set of data 16 required fields, but up to 62 other fields, and the repository would be managed by the National Library of Medicine. And the goal of the team was to make that database as accessible as possible to the people we knew were going to use it the most, which were hospitals and health care systems. The majority of us on the UDI team actually had backgrounds in hospitals and health systems. So we could envision how it could potentially be used in those IT systems. We didn't have supply chain experience! So a little bit of a gap. You can see some of those gaps today. But the intention was to move away from what FDA was traditionally doing, which was submission to FDA for regulatory compliance, to a repository that would be more accessible to the world. And so it was a mind game, as well as a technical solution. It was changing people's view of what that submitted data was going to be used for. And that, I think, was as much of a challenge in the layout and the enforcement, as was the technical side.
Shivum: Rich, do you want to add anything there?
Rich: Having a standard label and barcode format was new to the healthcare supply chain, having a repository of items and properties to identify them was brand new to the healthcare supply chain. There had been an attempt in the 90s at doing this within the industry. That didn't really take off. Some of the bigger manufacturers bought into it and started standardizing a bit, but nothing industry-wide, and not a repository where you could actually grab and use supply chain identifiers, barcodes, or standards. So really it’s been a big step for the industry in the right direction, to get better visibility and accuracy in the supply chain.
Shivum: So moving from a world where manufacturer name and catalog number were how items were identified to this unique system of identifying, where manufacturers have to submit standardized data on each item.
So with that solution in mind, what are some of the challenges that still exist, both in the US and abroad with respect to either the implementation of UDI, or the system as it stands?
Terrie: I mentioned that we didn't necessarily have all the supply chain experience that would have helped with this, although, in fairness, one of our leads, Jay Crowley, spent a couple of years trying to understand supply chain before we went out with the UDI system, and that was so that we wouldn't reinvent a wheel that already existed. That’s the reason why GS1 and HIBCC and ICCBA were selected as issuing agencies, because they were already in the marketplace. But that said, we did not make catalog number a required field in our database. And because we didn't make it a required field, very few manufacturers filled it in, because they were meeting regulatory requirements [without doing so]. Even though it was [an optional field] in the database, they didn't fill it in. That became a problem, because in the hospital systems we heard the difficulties they had in matching their existing catalog numbers and product numbers to these new things called device identifiers. And so it became a very manual process for hospitals.
And it was obvious that needed to be changed. But that goes back to what I said earlier -- it wasn't a technical problem so much as a regulatory and policy issue. It was very difficult to change something that was an optional field to a required field. And so that was a major issue that still lives with us today. It's easy to look back with 20/20 vision and see all the things that weren't exactly correct. For example, we hear today that sizes were not specified in AccessGUDID. But there were no standard sizes, so we started out with what we had at the time and standardized those. But because it's not an agile process to change that UDI database at FDA, it was difficult, even when we knew what to change, to actually make the changes.
Shivum: That was a very honest assessment of the pros and cons. Rich, could you react to that a little bit, particularly the catalog number piece?
Rich: Yeah. There were already issues with the catalog numbers. And I can see why people, even if it were required, had issues submitting. There's some nuances in the manufacturer cataloging number systems, where items aren't unique within a manufacturer. There are instances where companies catalog based off of the package, so a box is different than at the unit level, it's a different catalog number. So that wasn't necessarily even a [pre-existing] standard there to put in [as a GUDID required field]. No matter what it would have been difficult to line up. But something [for catalog numbers] being required would have definitely been helpful.
Another eye opening activity in lining up these data sets: From a hospital perspective, hospitals really knew these items more so in terms of how they're procured and not necessarily in terms of how they’re manufactured. And to explain that a little bit better. Oftentimes, you have the information [about an item] to buy it from somewhere, but you didn't know who was actually making it -- who was the company that was actually on the label. That's who is submitting data to GUDID and that label manufacturer information that is what's living in [the GUDID] database. That's not necessarily going to match up with what a hospital’s putting on a purchase order, even from a company name perspective. And not to add another layer here of catalog issues, but on top of that sometimes the catalog number when you go to order is in fact also different. So you have mappings in between where you're buying it, who that is versus the catalog number of who's making it. And you're trying to line up all of these data sets all to one standard. Bit of a nightmare.
Shivum: Got it. So if I'm understanding that correctly, there's a particular way the hospital understands an item with particular data fields, which is different than how the manufacturer views their own item with particular data fields. And then having those items distributed through third parties adds another layer to that data problem.
Terrie: Well that was something we also knew. That the system we were trying to standardize was coming out of a very complicated, chaotic space. And so we knew that we were going from chaos to standardization, and that it was going to take time. So there was that recognition. But you do make me feel better, Rich, that it wasn't a fatal flaw to make catalog number optional.
Rich: Would’ve been difficult no matter what.
Terrie: Thank you.
Shivum: Well, that's actually a perfect segue, Terrie, to think of this as a work in progress. Those are some of the challenges that our UDI system in the US is facing. Are other countries facing the same issues with identifying medical devices? And if so, are they looking at UDI systems as well?
So, it was not only Congress in 2007, but the International Medical Device Regulator Forum. That started about the same time [as GUDID]. 13 countries came together and agreed on the principles of what a global UDI System looks like. And I always thought that was such a fantastic idea -- to create a system and have agreed upon principles globally before you started implementing it, rather than after. This gave the system a chance to have some rules in place before countries started creating regulations and rolled them out. And they published the IMDRF guidance for a UDI system in September 2013, the same time as the [US] UDI Rule. And we did make sure as much as possible that we aligned with those rules. We do have a Congress and federal lawyers and regulators who made a few tweaks away from those principles. But generally, we stayed true to the IMDRF principles, and I believe the other countries are intending to do that as well.
Shivum: It's encouraging that there are rules informing UDI regulations. Has there been divergence and how other countries are going about creating their UDI system? And if so, what does that mean for the system?
Terrie: Short answer is, yes.
Yes, there is variability. And I can't explain why, honestly, except that different countries want their own sovereignty, as we all do, a little independence in how we roll things out. I’ve seen EUDAMED data elements. And there's an IMDRF document that compares the US to the European Union's data elements. And you can see some divergence. It all depends on how they roll it out in EUDAMED, like how they represent the data, where it starts to get confusing and burdensome for manufacturers.
Shivum: Got it. So it sounds like with the divergence of different UDI systems in different countries, it can be onerous on manufacturers and presumably has other data implications downstream. Rich, do you want to pick up that thread?
Rich: I’ll first say that I know for a fact that hospitals internationally have the same problems [as US hospitals] in terms of identifying items for procurement, inventory management, et cetra. In fact, some of those are even more pronounced from a global perspective. The world is becoming a lot smaller and the supply chains are becoming a lot smaller. And being able to speak the same language across countries is becoming critical. To compare product information across borders is something that's definitely needed in supply chain and is in fact being explored through many different avenues. UDI plays a critical role in that.
Some of the issues that started to happen when there are different standards across the country, in terms of how you refer to an item or categorize, means we're not really speaking the same language. And that makes all the benefits of a global UDI system start to crack in certain areas. And you have lots of Band-Aid approaches to fixing those problems. Really, at the end of the day, we do need global standards, even more so in the supply chain, so that we can properly procure and prepare and understand how to react to events like COVID. And as we see hurricanes and different natural disasters happen around the world. Everyone's in the same boat in terms of understanding what’s impacted, what they can do to mitigate the issues that they're going to face. We really all need to be speaking the same language.
Terrie: The IMDRF came into play again to help with speaking the same language back in 2018, five years after the first IMDRF guidance document was published. We the FDA presented to that group [of countries looking to implement a UDI System] all the lessons we learned we could possibly think of so that they could be incorporated into the other [developing] databases. And as we started sharing things that we have learned from US experience, there was a lot of head nodding [from other countries], to Rich's point. You know, that whole long list of challenges, like having multiple UDIs for what appears to be the same device, or, you know, the distributor and manufacturer not being the same. In this country we have a group called the Learning UDI Community [LUC], sponsored by the American Hospital Association. They've written a lot of white papers and identified a lot of challenges to UDI adoption. And I think, besides the data elements and the format of UDI, I think these other countries would be well served by learning from the US experience from the healthcare system point of view. And taking the best practices from AHRMM LUC and other early adopters. And I think a lot of [other countries] want to, you know, Australia, the European Union, very open to learning about how the UDI rolled out. Regulatory considerations may get in the way, but the regulators do want to know how we solved problems. I don't know from a supply chain perspective, Rich, how you experience that.
Rich: People are wanting to share [learnings]. Hospitals talking about their business processes, data standards, and even starting to partner on initiatives or things that are happening cross-border, trying to learn from one another. It's just not happening fast enough. And it requires more than just the hospitals working together. One thing about healthcare that I find fascinating is just how many different players there are, and the necessity for those different entities to really exist for healthcare to work. It's complex. And you need a lot of people at the table to really work out all of these different issues. You can't do it in a silo on your own.
Shivum: It's exciting to hear that there are so many opportunities for global collaboration when it comes to UDI. To wrap up here, if you had a wish list of changes to either the UDI system in the US or as we work toward global harmonization of UDI regulations, what would be your ideal changes?
Rich: I guess my first wish, something that could still happen. The US FDA did start UDI, are the farthest along, and have learned the most about it.
They have the opportunity to really push for this global dataset and standards. I haven't seen anything like that happening yet. But they have the best vantage point, knowledge and history to really drive a global standard forward. I think one of the biggest wishes I would have is to see that happen. For all these other countries as well as ourselves to benefit from global UDI dreams for the future.
Shivum: Perfect, Terrie?
Terrie: I agree. I agree with that. And I think we have some coordination and other federal agency opportunities. Because FDA’s role really is to regulate manufacturers. I mean, that's the mandate of FDA. But there are other federal agencies, for example, that regulate hospitals, like CMS. There are agencies that regulate electronic health records like ONC, there are agencies like the VA and DoD who have their own federal health systems. And I think better coordination and support and advocacy for all federal agencies to adopt a common national UDI system would help strengthen it here at home so that it could be disseminated more effectively globally. That kind of coordination has not happened. I know that the DoD and the VA are working toward UDI adoption. I'm not sure where they are with the process, but there's nothing publicly coordinated between FDA, VA, DoD to make that all happen. And I think that would really help.Shivum: More domestic collaboration makes sense, in addition to Rich's point about the FDA’s position for leading the global conversation on UDI. All right, well, thank you both for the time!