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U.S. Department of Health and Human Services

Medical Devices

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FDA Unique Device Identification Public Workshop: February 12, 2009 - Panel 1 Transcript

MR. JAY: Well, good morning, everyone. Thank you for coming. My name is Jay Crowley for those of you who don’t know me. I know many, many of you. And I’m very happy that you all could attend. We’ve been working on this project now for a long time. And I really do appreciate all the help that so many of you have given us over the years. and thank you again to all of you for everything. This is the UDI Public Workshop. So if you were looking for something else, you’re in the wrong place. This is it, guys. This is our opportunity.

If you have something to say about this, if you want us to know something, this is your opportunity. Take the gloves off. Let us hear it. A lot of people with a lot of strong ideas, strong opinions, about how this should work. And we want to hear it. And I think everyone here needs to hear it. We have folks representing the entire ... all stakeholders are here. And I think that’s great. And I really do appreciate everyone coming. And everyone needs to hear all of this. This is complicated. This is new. This is different. And we need to figure this out.

We all need to figure this out. Everyone has a roll. Everyone has a responsibility. So speak up, really. The workshops is designed to do this. We’ve set this up so that we’d have plenty of opportunity for interaction. We’re going to have four panels. I’m going to give a brief introduction. I hope ... did everyone get a handout? Did everyone get handouts? Does anyone need them? Terry, can you grab some extra handouts in case people didn’t get them? On the handout, you’ll see are the issues and then the questions that I hope that we spend some time going through I’m going to give a brief background introduction in a second.

But as you all know, I hope you all know, INFADA in September of ’07, FDA received this mandate. Go forth and bill to UDI system. And we are writing the proposed rules. This is how it works. And we need to get this right. We very much want to get this right. I think it’s very important that we get this right. So help us to get this right. This is what we’re doing. So four panels, four different topic areas. It was hard to break it up.

So don’t feel like if you have an issue that doesn’t fit neatly into one of the panels that you can’t bring it up, please feel free to. I just needed to divide up the day somehow. So this is how I divided it up. So I’m going to give a little introduction, put the questions out there. We’ll have four or five panelists who will give sort of their give of the world. We’re not trying to reach consensus here. This is just an opportunity to speak now or forever hold your peace. So our panelists will do their part.

We’ll open it up for questions and answers from the audience. There are microphones as you can see. This is being ... hence, all the cameras. You can see this is being webcast simultaneously and will be available later on. So when you do speak, please speak into the mike clearly, identify yourself, all that kind of good stuff. You know how it works. At the end of the day, when we get through these four panels, if we get through, and we’re still all in one piece, we have a couple of presenters that will say something at the end as well.

There will be a break between each of the panels. We’re going to try and go about an hour and fifteen minutes or so. Lunch is at noon hopefully if we get that far. There’s a bunch of places around here to eat. The hotel has also made an offer if you haven’t seen, I think you can for $12 buy a little ticket. I have no idea what they’re feeding you. But the hotel has provided something. So there’s a little room over there if you want to do that at the break or something, get yourself some lunch.

I also have other notes here. Put all your cell phones on vibrate, okay? So we don’t have any ringing phones. The presentations that you will see will be available on the web as soon as I can get them loaded. So don’t feel like you have to jot anything down. So all of that will be there. Any questions before we get going? Everyone got it? Come on in. Plenty of seats.

With that, I will go ahead. I apologize for those of you who have seen me speak before. I’m going to go through this very quickly. I know it’s old view for many of you. But this is our world view. This is what we’re trying to fix. From a medical device perspective, this is very simple visibility issue. We can’t ... we don’t know where medical devices are. We don’t all identify devices the same way. And therefore, we lose track. We lose visibility. And so, this is really ... this whole project is about identifying devices consistently and in a standard way. So that we can all talk about medical devices the same way.

That’s all we’re really trying to do here. At 50,000 feet, it’s very simple. If you get into the details, it’s very complicated. And that’s what we’re here today to do is to solve these details. So I think we all, I hope we’re all on the same page. I need help solving the details. How is this going to work for different device types, different domains, different environments? Help us figure out how this is going to work. So that we can come up with a regulation that’s doable, applicable and it’s going to work. Get us where we’re trying to go.

No big surprise here. Current device identification is a mess. Different manufacturers use different standards in different ways if they use anything at all. Distributors apply their own. Hospitals apply their own. Ad we just sort of cascade into this series of events which means that we can’t find devices. Erica always gets annoyed with me when I bring this up. But I do it only as a point of reference. For those of you know, FDA manages the national drug code, the NDC number, which identifies a specific pharmaceutical product at a specific level of packaging.

We’re not trying to recreate the NDC number here. So don’t think that that’s what we’re trying to do here. I don’t want to do that. But what’s interesting about the NDC number, which was developed in the late ‘60s and FDA took it over in the early ‘70s, was that though it was originally intended to facilitate reimbursement for pharmaceutical products, it has allowed a whole host of visibility and benefits for pharmaceutical products .

So, for example, when FDA came out with the bar code rule, put something into a linear bar code, you put the NDC number into the linear bar code. And that’s what we don’t have. That device rule does not have that NDC equivalent. And so to some extent, what we’re trying to do is come up with this NDC equivalent. We think we can do a better job. We think we can learn from some of the problems that NDC has run into over the years. But that’s what we’re trying to do. So we want to come up with a device identification system that’s consistent unambiguous, standardized as you can see her, and importantly harmonized internally.

So for those of you who don’t know, we’ve been working globally to come up with a unique identification system that is going to be ... that can be used, hopefully will be used, globally. So that that number, once applied to a product, can be used and distributed anywhere in the world. So keep that in mind as we work through this. If there are issues that you’re aware or things that we should take into consideration relative to global issues, please let us know.

And so, hopefully when we get done, this is where we’ll end up, with common understanding, common visibility, common definitions. We’ll all see the same. Even if we don’t have the product in hand, we’ll all be able to understand the product the same way, the device the same way. So this is our goal. Host of benefits. FDA’s very interested, of course, in the top two. And we’ll spend some time talking about recalls later on. But this is what we’re trying to ... these are the benefits that we’re trying to get to. There maybe others. But we definitely need everyone’s help in trying to get to this point.

As you know, FDA does quite a bit of post-market surveillance. It’s one of the cornerstones of what we do. And it’s often very difficult for us to do. Because we lack identification about specific devices and adverse event reports. What’s interesting, as you can see at the bottom under the face of things to come, is I found this in one of our adverse event reports. And for those of you that don’t know, it’s a unique device identifier, built according to a GS1 standard. Nobody at FDA knows what that means. And I bet most of you don’t know what it means either. It’s actually a J&J product I think. I don’t know if that’s good or not. But sorry, Tom.

But this is what we all need to be able to know. We need to be able to transact if you will on that number. And we all need to have visibility into what that means. So that provides not only the specific device that’s being reported on, but the lot and serial number. If you had your Batman decoder ring, you’d be able to know that.

One of our favorite topics, device recalls. There are a lot of them. And they happen. There’s no doubt. Things happen. We learn. We put devices on the market with limited knowledge, clinical trial knowledge. We learn about devices as they get used on different patient populations in different environments. All of this happens. And that’s okay. But then sometimes we learn and recalls happen. And so we just need to be able to do them better than we do now in an efficient and effective way that I think we’re not really able to do now.

So I’m not faulting anybody on recalls. We have a systems problem that we need to fix. We need visibility knowing where devices are. We need to find devices. So that we can remove them before they get used on patients. Or if they do, we can follow-up appropriately. And I mentioned, of course, Congress in their infinite wisdom decided that FDA needed a unique device identification system, sixty-five kind of simple words. But this is what we are trying to implement. These are the proposed rules that we are writing. And this is where we need your help.

So I’m just going to quickly go through this. And then we’re going to jump into the panel. The legislation says that the label of the device should have the UDI. Label is a defined term in our world. For those of you who don’t know, it’s that thing on the sterile package. The catheter inside is the thing on the box of gloves. It’s the thing on the infusion pump. And so in many cases, I think we can understand that label makes sense for many devices. But for many others, it doesn’t make sense. And we’ll get into that in panel two in particular.

And we can describe an alternative placement Congress said. So we need to think about what that means. Which devices require, for example, direct part marking if any. Where do you need the UDI on the device itself? Reusable surgical instruments, maybe some implants. I don’t know. That’s what we need to talk about. Or maybe it goes on higher levels of packaging for certain devices. This is what we need to try to understand.

We can exempt certain device. So, for those of you who don’t know, medical devices from an FDA perspective covers a very, very wide range of products. Lots of stuff that’s in retail, lots of stuff that gets used in the home. All sorts of IDD products. All sorts of dental products. Lots of things that maybe we don’t think of everyday as being products are. And what do we do about those? Do they need a UDI? Do they need some form of UDI? Again, this is where we need some help.

UDI must adequately identify the device and distribution use. This is really a panel four topic. What do we mean by this? How are we going to deal with UDI as it moves through the supply chain up into that point of patient use? How are we going to take advantage of this information? And UDI includes information on lot or serial number. And I think we’ll talk about that some more in panel one as well.

So this is what we’re going to do. We’re going to try to develop this UDI system. There’s four parts to it which very conveniently line up with our four panels. Isn’t that neat how that works? So we’re going to work through each one of these points one at a time. And on panel one, we’re going to talk about this UDI. What is it? How are we going to create it? All those wonderful issues. So just an example worth 1,000 words. And thank you to Tom from J&J for this example.

Just so that you understand what we’re talking about for those of you who have no idea what I’ve been saying. In the bottom left hand corner are two bar codes with some numbers underneath. And I think that this is a reasonable way to think about UDI. I can’t tell you that this is what it’s going to be. But I think this is a reasonable interpretation. So the top bar code, with a parenthetical 01 underneath is what we’re going to call a device identifier. And that tells us that it’s one of these things. And the bottom bar code with the parenthetical 17 and 10 are the lot and serial number.

So you have a human readable. You have a linear bar code. You have a device identifier. You have what we’re going to call a production identifier. That’s it. That’s UDI. It’s not very complicated on most devices. So that’s one way that it could be done. Here’s another example. UDI built according to HIPCA standard. Same idea. You can see the numbers. You can see the bar codes, device identifier, production identifier. The label of the device. So for those devices where there’s a label and UDI belongs on the label, this is what it could look like.

I think I’ve covered most of this. This is how we envision the UDI being built. Again, I’ve talked about a device identifier which tells us it’s one of these things. And then the production identifier is the lot or serial number and expiration date if the product carries one. So that’s our mental model right now of how we would develop the UDI. But we’ll get into some issues here.

Here’s our panel members. We’re going to go in this order I think. Isn’t that what we agreed, guys? And they’re going to give us their perspective on developing the UDI. And on your handout, and I also have here that we’ll get into a little bit later, there’s two pages of questions that I want you all to be thinking about as these folks are presenting. Because these are the questions I think we need to try to answer today. All right? I’m going to invite Bob Hankin up from HIVCC I hope. There it is. And ask him to present. Great. Bob.

MR. BOB HANKIN: Thank you, Jay. Good morning. It’s a pleasure to be here. I don’t know if I have the curse or the honor of being the first speaker of the day. I’m not sure exactly what that means. But if you’re the head of the train when there’s a crash, you’re the first to get demolished. So we’ll see how that goes. It’s a pleasure to be here. As you probably know, I’m the CEO of HIVCC. I’ve been there not since its founding, but close to it. HIVCC is twenty-five years old next month. And we have been around that long developing device IDs and product identification codes that are in wide use throughout the industry along with the GS1 codes.

Most of you are familiar with it. So I’m not going to spend too much time describing HIVCC’s background. But I do want to make one point though about HIVCC which I think is relevant. The HIVCC standard that we’re talking about today, which is part of the universal product number standard that we’re going to be emphasizing in my presentation, wasn’t the standard that was brought to the industry and recommended as a component of product ID. It was a standard that the industry developed before HIVCC existed.

It was originally developed by a taskforce of supply chain participants representing all the major players in the supply chain back in the early ‘80s. And once the standard was developed, it was developed because so many device manufacturers needed a standard to identify their products that would incorporate the product identifiers that they already were using and which were in widespread disbursement. These were alpha numeric codes. And there was difficulty in using the existing standards from the other sectors to apply them.

And so HIVCC standards were developed. And the taskforce that put them together then created HIVCC, the organization, which I’m a part of, to maintain the standard to get the accreditation that was necessary, et cetera, to become recognized by ANZIA and the like. And so a year after the standard was developed, HIVCC came into existence as an organization. A few years later, it became accredited by ANZI. A few years after that, our E-HIVCC organization was founded over in Europe. The same process occurred there where European accreditation occurred. And we’ve moved on from there.

And that’s our basic background. And so now we find ourselves a major player in the marketplace, particularly in devices. And there are literally millions of SKUs out there with HIVCC codes on them. And because HIVCC was developed within the health care sector so long ago, from the get go, from the very beginning, the standard included the specifications for serializing number, for including batch lot numbers, et cetera, expiration dates. Track and trace was part of the original thinking for the HIVCC code. Because the HIVCC code was being developed on behalf of the hospital folks who were concerned about the same things we’re talking about today, recalls and the like.

And so here we are today speaking to you at this FDA conference, really covering the same ground. Over the years, the technology has changed. We used to talk about bar codes. Then we talked about two-dimensional codes. Now we’re talking about RFID. So the carriers of the information have evolved and improved. The amount of information that can be carried on a package has now dramatically increased as you all know from your own experiences with chips and the like with your computers and your PCs. But the same subject is still the same subject, which is how do we identify devices?

Now, what we’ve chosen to do this morning is to focus directly on the questions that were posed to us by Jay and to provide our perspective on them. And over the course of the day, I’m sure we’ll have more discussions about this as we evolve and the session goes onto talk about specifics. I’m going to use my ten minutes though to try to emphasize the points I think need to be clarified today before FDA will have all the information it needs to move forward.

First and foremost, I think there’s a lot of confusion in the industry about what we mean by UDI. And there are many definitions. There’s a lot of confusion. People aren’t sure which direction to take with this. That concern isn’t necessarily focused on standards so much as it is on what we mean by UDI. The most extreme definition of UDI or the most complete definition if you want to look at it that way would be one in which every single item is identified uniquely. So the items that are identical would have separate serial numbers to represent those items.

Very elaborate and very necessary for some items, but certainly not for all. Less exacting definitions of UDI essentially fit the current definition in the standards which is to identify each type of item or each group of items and the manufacturer package level, et cetera. And so depending upon which definition of UDI you’re using, we’ve either already gotten there or we’re not there yet. And I think the key missing item over the years with respect to this subject has been the lack of a requirement that it exists. These standards are already out there.

The information that appears to be part of any of these definitions is already available and is embeddable using these standards on packaging. But there’s no requirement that they be there. And that I think is the problem that Jay was referring to. The most important thing that FDA can do for the industry is to require a UDI. Without inhibiting the use of the current standards that are already out there. Because they contain the information that’s going to be needed. The key to require everyone to actually use them.

And so that is the main point, if I could make any today, is that we need the requirement without creating a further impediment or increasing risks by limiting the requirements in such a way that existing product identifiers won’t be used. Because they’re already there and they work. That’s why HIVCC recommends that we focus on the universal product number, the UPN, which has been around for ten or fifteen years now, originally a DOD concept. And apply the UPN in developing the requirement for the UDI.

What is the UPN? Very simply, the UPN is a defined to include both the GS1 in the HIVCC standards which together are already probably present on 90 percent or more of the products and the devices that are out there. They’re just not being labeled in many cases. But they’re there. And so it stands to reason that FDA would leverage all that existing information and simply bless it as the UDI standard. I think the UPN is the proper and logical way to go to get this job done. It’s really that simple.

The issue isn’t the lack of information. It’s the lack of a requirement to use it. That would leverage a lot of existing information. It would minimize the cost of implementation. And it would also minimize the risk associated with forcing any labeler to either move from one standard to the other or to move to a completely different standard. That would lead to a lot of cross referencing. That would increase risk. And it would be counterproductive and completely unnecessary. So the FDA already has the advantage of the fact that this information is already out there. It’s just not being used.

With respect to serialization, which is the most extreme component of UDI, the one in which every single item, every pencil in a box of pencils would have its own serial number, that’s essential for products that have to be tracked and traced, for products that are, for example, implantable, invasive products, devices that carry some risk or need to be carefully monitored. It certainly isn’t necessary for consumables. There’s no point in serializing every bandage that’s out there, literally no point.

Now, there are some issues with respect to counterfeiting of such things, consumables and the like. But that’s really more of a problem for the manufacturers than it is for FDA. FDA’s focus is on reducing medical errors and patient safety and on track and trace. And so we recommend that serialization be limited to certain classes of devices where it’s necessary, but not placed upon consumables and other devices that really carry no particular risk. Or where the costs and the benefits simply don’t add up or match when you’re looking at the cost of serializing them.

One question that was put to us by FDA through Jay is the question of whether kits should have their own UDI, assembled kits of various items. And we believe, of course, they should have their own UDI because they are unique. And so even if a kit contains numerous items that have their own UDI, there has to be another UDI to represent their combination. Likewise, we don’t see a need for any exceptions when the definition of UDI is broad enough to encompass all of these various types of items. And thus, that’s our response to the question about exceptions. There are really no need for exceptions. It should be all encompassing.

Reused devices is another issue that’s complicated. We don’t have all the answers on that. We’re not going to recommend anything specific. Except that FDA needs to be very much involved in the issue of reused devices. We don’t believe that anything on a current package can be replaced if UDI is present in the format such as you saw in Jay’s examples. It simply isn’t defined for that purpose. It’s really there for electronic reading and not human reading. Even the human readable portion of a UDI is not human readable. Let’s face it. I don’t walk around with my phone number on my back. Because no one would know that’s my name. I prefer my name be there, spelled out correctly as it’s supposed to be spelled. And so I think that’s just common sense.

The question of if a device is altered whether it is required to have a new UDI, we believe it should. One of the benefits of using a UPN approach is that there’s literally an unlimited number of combinations of letters and numbers that will allow for the reassignment of UDIs in every instance. Practically, speaking, we wouldn’t run into limitations of that kind. And so, we don’t believe the UDI should ever be reused. And we don’t believe that there’s any need to reuse the UDI. Since they can simply be reassigned. And that will greatly benefit and avoid any possible errors for tracking and tracing.

The question of retail and health care settings was posed to us. That’s not really HIVCC’s area. Because HIVCC isn’t in retail labeling. HIVCC is involved in hospital supply chain and devices in particular. I’ll leave that question to my GS1 colleagues here on the panel. Suffice it to say based on our understanding, price check codes would not work for UDI. So there would have to be some revision of pharmaceutical packaging under the current UDI definition if these pharmaceuticals are used in both markets. As I said, I’ll leave that to my colleagues up here on the board.

More information about HIVCC. You know where to reach us I’m sure. I’ve got a few more minutes here. I want to make a few points if I could more informally. I’ve gotten to look at some of the presentations you’ll see over the course of the day. HIVCC’s approach to this day and to this panel is that we think this is a rather serious issue. We’re not making a sales or a marketing presentation here. I think over the course of the day, you’re going to hear a lot of marketing oriented presentations, a lot of sales pitches.

A lot of graphs, a lot of charts, a lot of benchmarks, a lot of goals, lots of best practices, lots of claims. What matters is what’s happening on the ground. And on the ground, nothing has changed now from twenty-five years ago except the technology which has made things better. There was a time when the issue of standards would have been a big deal with respect to UDI. There was a time when an organization that wanted to scan products encode products had to make a choice between these two standards that are up on the panel today.

Because the scanners were so crude and were so antiquated by today’s standards that they couldn’t’ read one standard if they were reading the other. There was a time when a scanner could only read numbers and could not read letters. There was a time when you had to have two scanners if you had both standards. Those days are long gone. The days of arguing about whether one standard is better than the other standard has long since passed. The technology’s taken care of that for us. It’s a no brainer at this point.

Which is why I think Jay in a comment to one of my staff a couple of weeks ago pointed out that he thought the standards issue wasn’t really the issue today. And so let’s do it in the morning and put it aside and move onto the more important things which is deployment. And I agree with that. It’s certainly true. There’s really no need to limit standards to either a numeric character set or an alpha numeric character set only. Because it’s no longer a problem.

And because of technology and because of the existence of these two standards and because they’re already there on so many devices, we really need to move past that discussion and that debate. No one benefits from it except perhaps the two standards groups themselves who are frankly nonprofits, but are trying to register as many users as they can and develop those fees.

But this audience has to look beyond that. And in particular, FDA has to look beyond that. Because there are more important things to do than worry about which group is going to wind up with the most labels. The private marketplace will take care of that. And companies that have alpha numeric codes are going to be oriented towards HIVCC. And companies that do not are going to be oriented towards GS1. And that’s fine. HIVCC has always been a supporter of these coexistence provisions that have been there for many years. And we’ve always focused more on the medical side, the health care side, of these issues rather than the marketing side.

And so I hope that you’ll all use that focus over the course of the day to critically analyze all the information you’re going to see, all the charts, all the graphs, all the claims. Because they’re largely irrelevant. What matters is what’s happening inside these warehouses. And the fact is if you go into any hospital anywhere in the world, you’re going to see both of these codes. They’re just there. They’re everywhere. They’re just not being required. And that’s where FDA can provide a very valuable service, not only the industry, but most important to the public which is their primary constituency. Thank you very much. And I look forward to speaking to you in the discussion.

MR. JAY: All right. Thank you, Bob. John, I think you’re up.

JOHN: Good morning, everyone. I want to thank the FDA for giving us this time to present to the UDI presentation. The first chart I have here is, as FDA has stated, that UDI can improve. Luckily for me, I got this from several of Jay’s presentations before I was able to coalesce it down. Basically, what the FDA is looking for from UDI is medical device recalls, systems and reduce medical errors and for the FDA to have a better handle on medical define the United States.

What we’ve tended to focus on in my presentations is to discuss the criteria for success for this. One is we think you should pick a global system. The FDA and the U.S. are no longer an island anymore. We’re all interrelated in one way or another, in a unique level at all levels of packaging, in the granularity of identification, consistent and standardized standards. And it has to be user driven and user supported. Very important.

I’m going to talk first about the global system. Why do you need global standards? The presentation of this picture here shows you. I know it’s kind of small. But there are five different bar codes on that package. Five bar codes and one data matrix. This is going on in Europe. They have to be scanned by different things. And it’s not only scanning. But they have to be pointing to different databases. So there’s no consistency there. If that nurse or doctor picks it up, which one do they scan?

And this is why we think when we’re talking about the GSQ global system, our system takes care of this. And if you look at one of the most widely used supply chain system in the world, we can make that statement. Over six billion transactions, six million scans a day. More than there are people on earth get scanned everyday by one of our bar codes.

Now, my colleague Erica is going to talk to this. Let me just say we’re in a 150 countries, thirty-five years of experience. Now, that’s the global system. I represent GS1 U.S. We’re the organization in the United States that implements the GS1 system in the United States. We’re in 23 industries, 200,000 members, 18,000 have registered as health care members. We have an entire division focused on health care, GS1 health care U.S. And importantly, which I’m going to bring up several times, is we’re a voluntary member driven standard. I’m going to emphasize that and you’re going to understand why.

So that’s the global system. You need a global system. The second is unique at all levels of packaging. This is the reason why we want uniqueness at each level of packaging. Now, this chart was borrowed from the Department of Defense. They did a study in their databases. As you can see, for this particular manufacturer’s numbers, 8630. As it goes through the supply chain, each hospital puts a different number on it.

So how do you determine what’s that product? You can’t. You can’t do recalls on it. You can’t do good identification on a product. Our system does not allow that. Each member that joins us gets a company prefix. They put that company prefix to create G10s, item identification. It uniquely identifies every product that they have, that they manufacture, they put in commercial service. In all 108 countries. All million members do this.

And I showed you a picture here of a G10 and a 128 symbol. So if you’re back looking at GS1 symbol, that’s what it looks like. It has the parentheses with the 01 in front. Now, one of the things here you really have to understand, G10 is the product identifier. But it’s part of a global system and it’s integrated. We have product identifiers, G10s. We have location identifiers. We have acid identifiers, logistics identifiers and service relations identifiers. These are put in carriers that are standardized globally by using an electronic communication standardized globally.

And they go into global databases, such as the global data synchronization network. And they really, this data, consistent data, really funds or really drives traceability for discovery in EPCIS. So we have to look at this as an integrated system. It’s not just the scanning of the products. It’s not just the marking on the product. It has to look at it with a gestalt for the entire global system.

I talked about GDSN. It’s the global database for G10s. It gives you data synchronization of the same data between customers and manufacturers and suppliers. And that is run or goes through twenty-six global certified data polls. Not twenty-six in the United States, twenty-six globally. Four here in the U.S., one in Germany, one in France, et cetera, et cetera. So this data is global.

So I talked about global, unique. Now let me talk about granularity of information or identification, pardon me. This is a little ladder of traceability that we’ve designed. I’ve talked about a G10. But I’m going to talk about this as part of a recall. A G10 as you know identifies a product that is a particular packaging level. So if the FDA hypothetically wants to recall all the sutures from a particular manufacturer and say withdraw all the G10s. So every suture made by a manufacturer could be recalled at one time. Kind of a shotgun approach. It’s been done in the past.

However, if they want more granularity, if they want to rifle that shot on it, they can ask for a G10 and lot number on the product. And recall just that lot number on that G10. If they want further granularity, you want a laser focus on particular items, they can demand G10 and serial number.

Now, our system allows for this today. It can be used today. We cannot tell the FDA what products or what categories they are. That’s for you folks to talk to my fine friend Jay here and advise him on what products should do this. We’re telling you our system does this today. And not only that, but these secondary items and identifications are what we call in our system application identifier. We have 150 other application identifiers.

So the system is expandable. If for some reason the FDA wants to know the weight of a particular product for some reason, we actually can bar code if you want to. So it’s expandable as it moves on. I wanted to give you an example of what this looks like. It’s G10, expiration date, lot and serial number. That’s what we see most commonly used in health care. It’s in a very expanded GS1 128 bar code symbol. That same data is in a symbol on the left, in the middle, which is a data matrix. And it’s also in the RFID tag, the EPC tag. The data is both forward and backwards compatible. Something you need to do as we move forward.

Right now, both of these are in our system today and in the global market system today. I talked global. I talked unique. I talked granularity. Now let’s talk consistent and standardized. Why is this important? This is a chart that I borrowed from premiere in their databases. By happenstance, four manufacturers happened to pick the same part number for the different products. This happens constantly all over the world, definitely in the United States.

So how do you source your products? How do you recall the sources? I want to recall Part #10313. Are you going to get the HF Scientifics? Or get Hanover? Or Electronics? What product are you going to get? As I explained before, the G10 doesn’t allow this. Each one of those manufacturers has a different company number, puts it together in a different G10. So that wouldn’t happen. In furtherance to this, we have very defined G10 allocation rules. These are global rules. What happens when these G10 change? What happens when a package changes?

Our rules are defined. I gave you one on there, 5.1.6. What happens when you move from one suture in a package to three in a package? It requires a new G10. Period. These rules are global. They’re well understood. They’re out there on our website. Take a look at them. They’re free. And it defines the conversation between manufacturers and suppliers.

But these are rules that go into the GMSP practice. We are a global standard. Erica’s going to talk to you about the number of countries we’re in and the health care products or associations that we’re working with. But we have a global standard. The standard does evolve. One thing you should come out of that is our standard has evolved and business needs has evolved also. And we have a process to change our standard, GSNP. This is something of a hallmark the FDA should look at. It’s an open and transparent process. You can look at it. It’s up there on our website. And this is constantly happening. We have a team of people looking at it across health and other industry verticals.

The last and not the least for sure is user driven and user supported. You want a standard that’s both user driven and user supported, very important. We are definitely user supported. In the United States alone, we have just one health care U.S. There are eighty-three companies, now eighty-five in the last week, that have signed up to help us develop guidelines for our standards within health care. We have guidelines everywhere else. How do we do this? How do we define this for the users?

The first product they came up with last year was the toolkit. How to define G10s for providers. The hospital is probably the least knowledgeable of our system. We have this out there on our table out there. We have copies of it. Take a copy home. Take it down from our website. Take a look at it. The supplier toolkits are out in March. These were designed by the groups. They put them all together. You saw the numbers of the folks that are there. It’s just a mix. It is a mix between manufacturers, IDNs, solution providers. So they all get together to help us design it to make it knowledgeable and acceptable for the folks that have to read it.

And I said this is user supported and user driven. Our users are driving us. They came up with this 2012 G10 sunrise date. We want G10s on our products by this date. And we’re starting to scramble. What does that mean? And we’ve come up with these from the workgroups. Used in business transactions, standard points of delivery, used in product recalls. This s what the group came up with. They came up with the sunrise date in 2012. And they came up with these different ideas of what explains what G10s mean.

We are supported. These are the healthcare stakeholders that have supported the use of GS1 standards, either by press announcements or changing the terms and conditions of the contracts like premiere Amerinet. And most recently SMI last week with their thirty-five IDNs put out a press release supporting the GS1 standards in these sunrise states. I think the GS1 system exceeds the EDI success criteria. We’re global, a global system, unique at all levels of packaging, granularity of identification, consistent and standardized, user driven, user supported. And we exceed it because it’s an integrated system. It’s not only that scanning of the ID at the product level. It goes in the databases. It has a set of rules that are global. A manufacturer can understand these rules and apply them not only here in the U.S., but everywhere else.

My final thought in nine minutes. When you do checkout or you go to the checkout lanes, could they have succeeded in different industries globally without their adoption of the GS1 standard? Not two standards because they want the one standard. The GS1 system would enable the success of UDI. The final thought is we think the GS1 system really is the right choice for UDI. Thank you. [applause]

MR. JAY: All right.

MS. ERICA: Good morning, ladies and gentlemen. My name is Erica. I am the Director of Health Care at Global Level at GS1. Jay, thank you very much for inviting me here for this very interesting and fascinating meeting. I would like to bring a little bit the global perspective to this U.S. meeting. As my colleague, John Roberts, already said, GS1 is a very global organization. And I think this map of the world shows this a little bit. We have 108 member organizations in the countries.

This can be very small organizations like in Kazastan with four to five people and can be very big organizations like here in the U.S. But we are on the ground. We are supporting really our users in the local language with a good understanding of the local situation. And we are a neutral platform bringing together really the stakeholders and developing standards in the supply chain. And we have a lot of experience with that in thirty years. It’s more than thirty years actually.

We have done this now in health care and created a few years ago the global health care user group. A group which kicked off with global manufacturers and was driven at the beginning by global manufacturers as well from the pharmaceutical as well from the medical device side. And I’m happy to have some of the founding members here today. In the meantime, this is really a global group which is really encompassing all kinds of stakeholders. From the manufacturers, as I said, pharmaceutical as well as medical devices, wholesalers, distributors, GPOs, hospitals, but also regulatory buddies and associations which is very important to get everybody to the table.

And the objective of the group is really to develop global standards to really improve patient safety. That’s the focus. We are sure while doing that, we will also enhance the supply chain efficiency in health care. And there is a lot of work to be done there. Already in 2006, this group has very clea4rly said and announced that they choose just one as the system of standards in health care. Why GS1? We are a truly global standard with really integrity of our system across the world with our unit numbering system which goes across borders.

With our really network of MOs, we are ensure that our standards are supported and adopted in every country. We are an open standard. Everybody can use our standards. And we ensure that our standards are interpretable. We have shown that our standards work. I think everybody, as John just said, is going shopping everyday and is using our standards and know it works. We would like to see the same happen in health care. The beep should be health care the same safe thing as in a supermarket.

And why also GS1, hospitals. And I have worked very long in a hospital. Hospitals don’t buy only medical devices. They buy all kinds of good. And they want to have one standard for that and not multiple ones. They buy drugs. They buy food. They buy office goods. All kinds of different purchasing is happening in a hospital. The global health care user group has really looked at the standards which we have in GS1 and has looked at how they can be applied in health care. We have three work streams which are active working today to develop global standards.

The first one is the AIDC application standard. That’s the group which is really looking at which data should be carried in which carrier on which package level for all health care products. And I must say a long work is kind of closing down and I hope in summer we will have a ratified standard for that. Traceability in health care is a very important issue. We are really working on developing standards, global standards, to ensure traceability from the point of manufacturing to the point of use, ensuring the safe and secure supply chain.

And the last one, global data synchronization and product classification. A group which is looking at health care, what is the need of health care, to leverage our existing network of data rules across the world and also developing a global classification. And we are very happy and proud that we have so many stakeholders involved in this work, including regulatory buddies. I know this is a U.S. meeting. But I wanted to bring to you a little bit what is happening around the world. And I’m excluding the U.S. here. Because I am sure that we will hear a lot of thoughts and things going on in the U.S.

But I wanted to point out that a lot is going on in the world. That’s the point where I must say a little bit disagree. I think the situation has changed. A lot is going on really. And I have often heard in the first year, so this is just the manufacturers are doing something. Hospitals are not active. I can tell you hospitals are active. and I would like to point out really a few to them. UNIHA is a group of French hospitals, 52 French hospitals, who got together, all the university hospitals included. They have decided they want to go standards. They want to use one standard. They request to use one standard.

We have really other hospital groups across the world. The Netherlands just recently, all the university hospitals in the Netherlands said we want to implement GS1 standards. We have Canada. Big TPOs met by Health Pro in Canada have publicly announced that they will work with GS1, that they will cooperate with GS1 and they will implement GS1 standards. Our next global conference in Vienna is hosted by a hospital group which is very much engaged with our work. And the meeting will take place in a hospital. The one at the end of the will take place in Hong Kong. And also there we will be hosted by the Hong Kong Hospital Authorities.

So I would really like to point out hospitals are very engaged. But we have also a lot of regulatory activities going on in the world and also here not talking about the FDA, but about other activities. Looking at the Shanghai FDA with whom we are working looking at what they want to do and rolling out their project for traceability really in whole China. Looking at the Japanese Ministry of Health which very recently has announced that they’re accommodating now GS1 global standards and guidelines and have changed the guidelines.

I think every global manufacturer here will know the name SS and the Spanish authorities have created a lot of attention around the world. But they are involved in our work teams. And they are committed to use global standards. And I think that’s really very important. Turkey. I think this is some topic which is discussed these days a lot in the manufacturers’ world at least. We are just again arranging a meeting with the Ministry of Health in our user community to discuss what is going on and what are the right steps to move ahead.

So really a lot is going on. Even if you look at the whole down under meter which is the E-Health Authority in Australia which is really working a lot in the field of medical catalogs and GS1 Australia which is hosting this medical catalogue for them. So I could continue this as you can see a lot. But just to give you a picture of a lot of things are going on in the world.

One which is very well known I think is the Department of Health in the U.K. which has already in 2007 published a guidance document very clearly recommending that the GS1 system should be rolled out in the U.K. Acknowledgement for the manufacturers who already do a lot in this direction and requesting from the hospitals to also get active. And a lot has happened in the last years in the U.K. And I think we will see very soon also the request of the purchasing agency in the U.K. asking for G10 if you want to participate in that ten year process.

We are very happy to work six years now close with Eucomed which is the European association of medical device manufacturers. And Eucomed has already in 2007 also issued a guidance document advising their members to look at the GS1 standards as the appropriate system. A lot is happening also in the countries really, where we get stakeholders, where we get authorities involved in so-called local health user groups and GS1 health care U.S. is probably one of the biggest ones. But there are a lot of others who are working very intensively. Just recently, we had a kick off in Japan with eighty participants. So a lot of activities in these groups by local stakeholders are coming together with local authorities. And this is very important for the work we are doing on a global level.

To finalize, I would really state that just one health care is really welcoming UDI and the benefit it will bring for patient safety. The condition with that is it should be really based on global standards. And we would really like to applaud the global harmonization taskforce. They’re a top working group and the FDA that they are really working on a global harmonized approach. And we are very grateful for that. Thank you, very much. [applause]

MR. JAY: Thank you, Erica. All right. Jean Sargent. There you are.

MS. JEAN SARGENT: Everyone knows who I am. Good morning, everyone. I’m Jean Sargent. I’m currently the Director of Supply Chain. And when I talk about U.K., it’s not United Kingdom health care. It is University of Kentucky health care. And we’re based in Lexington, Kentucky. Just want to get that clear. I’ll give you a little bit of background on U.K. You may think, well, we’re not a UCLA. We’re not a Mayo. We’re U.K. health care. But actually, we’re really moving up in the world of health care.

We’ve got two hospitals where we have the college of medicine, pharmacy, nursing, allied health and dental schools. And also physician practices. And we’re at over $100 million a year in purchases of medical supplies and pharmaceuticals. So we actually are pretty big out there. Support from the C suite. Back in ... when were you there, October? Back in October, we had the site visit from the FDA. Someone from GS1, Debbie Spring representing ARM and Dennis Black representing BD.

And what we did was we talked to different users within our hospital. We talked to clinical lab. We talked to my materials management staff. We talked to my materials management information system support people. We talked to pharmacy. Went into the OR, the cath lab, nursing units. Kind of did an all around look see at how do we do business? And I even learned things. Like clinical lab is looking at doing bed site scanning. Pharmacy is looking at doing bedside scanning. So I’m thinking, okay. What about supplies? Where does this fit in?

And so like I said, I learned that we’ve got lots of different things going on in our hospital. So not only do we have lots going on out and about, we have lots going on within the health care facility. So really looking at standards, it is needed not just outside, but within the health care facilities. At the end of the day, we had a meeting with our C suite. We got the CFO, the Chief Clinical Officer. And we actually got a few minutes with our CEO.

What I found interesting was what resonated with our CFO, he said that in his lifetime of being a CFO within health care that he’d had different boards of directors say to him why is it that health care doesn’t have the same type of standards as what you find out in retail? So he was really happy ... and this is kind of strange I thought ... but he was really happy to see that we’re actually moving in that direction. Our chief clinical officer which is our chief medical officer at a higher level, with him what resonated with was patient safety. And I actually got him to give me a quick little quote. He said by standardizing processes, nomenclature, products within health care, we reduce unnecessary variation. Thereby improving patient safety, efficiency and quality. So he’s definitely behind the standards and sees the importance of the standards.

We talk about having more than one system with all due respect to the different systems that are out there. And as we’ve begun our implementation, we see that having more than one system sustaining and maintaining one system, within our software is going to be difficult. So again, we’re adding inefficiency if we go in that direction. Right now, we’re working to integrate our systems. We are working with tissue tracking. And we’re working with the serial number tracking in our operating room, our cath lab, our interventional radiology.

So the staff actually scan the packages to add that serial number, lot information number, into our point of use system. But we’re not integrated to where that information flows freely over into our MMIS which is SAP and then onto the manufacturer. So what happens is when an order generate, it then takes a phone call. Our material staff has to cal purchasing to say here’s the serial number that goes with that. And then purchasing has to call the vendor that says here’s the serial number that goes with that order. So we’re not there. And again, it’s inefficiencies that we’re working to fix that inefficiency.

Being able to track and trace product from the manufacturer to the distributor, to the hospital, to the patient, into the medical record and on for payment is extremely important. And we need as we’re looking at implementing these standards, including the UDI. I think that we need to be very careful that we don’t overstep and we don’t make it complicated. We have to keep it simple.

As far as the bar codes, from my perspective whether it’s a 2D bar code or a linear bar code, I think that’s going to depend on going packaging. But what we need to do is we need to make sure that we educate, especially the providers, that they know what software and what hardware is going to be needed to have a successful implementation. So that they don’t buy something and have to buy something else later.

So again, there are several groups working towards standards and have been for many years. Chas has been around for a long time. ARM, back in 2006, the ARM board made a statement saying that we support standards. ARM is a division of the AHA, a membership division of the AHA for materials management with over 4,000 members. So again, there’s a lot of membership, a lot of buy power there.

SMI has thirty-two IDNs. Again, a lot of buy power within SMI are also manufacturers who participate. HSDSC. Again, I’ll talk a little bit more about them. But the GPOs, everybody is onboard. So we’re coming at this from a lot of different angles which is great. Because we need to come at this from a lot of different angles. The provider’s going to reach out to the manufacturers. But just the same, the manufacturers need to reach out to the providers.

So we need to come at this from a lot of different directions. So back in the fall in 2007 after this FDA ruling came out, a group of us got together and started talking about, okay. What can we do to drive adoption and implementation? That’s where the toolkits that John referred to came from. We decided that ... I said materials managers, supply chain executives. We don’t know this stuff. For the most part, we don’t know this stuff. As much work as had been done, we still didn’t know this.

So what we needed to do is hand a toolkit to the providers that said here is exactly how you would adopt and implement. Here’s what this means to you. Here’s how you sell it to your CEO or your C suite. Here’s what the return on investment is going to be. Because there is going to be funding that’s going to be necessary for this. And how do you adopt a sample project plan? So that that way, somebody can pick up this toolkit and take it and begin the process knowing that they’re going to need to call and talk to others for additional help. But at least, to give them the basic idea. So we were working at driving adoption, implementation and then obviously more education. Increased unity.

We have the ARM, HSCSC, CHAS and SMI working together. Some of the HOCSC. Our members included ten of the SMI members. So again, we’re overlapping here. We’ve got the GPOs. We have many of the larger manufacturers that are involved, Abbott, BD. So again, we’re looking at adoption from a lot of different angles and everybody thinking about standards from a lot of different angles all coming up at the same end point.

So last summer, Premiere came out with a letter in 2007 saying that they were supporting standards and they were going to drive standards adoption with their members. Amerinet has come out with the same type of letter. And other GPOs are working on their letters to come out shortly. There are also letters that came out from industry providers such as Mail Foundation, Sisters of Mercy, ROI, Ascension Health. And also as John stated earlier, SMI came out with a press release saying thirty-two industry provider members announced their support to work for the adoption of standards by the sunrise dates. Keeping in mind that those sunrise dates were adopted by the users, not by GS1.

I have a statement from Mayo. Unfortunately, Joe Dude who’s from Mayo who’s been a proponent was unable to be here. And so I said that on their behalf I would issue this statement for them. While we understand that governmental agencies are appropriately asking that the industry sort through specific implementation issues such as choosing a single standard, we ask that the FDA clarify UDI with the requirement that a single standard be utilized. The industry would benefit greatly with the adoption of a single standard. The best supply chains in the world function efficiently because of standards.

So the HSCSC solution was one voice for the mass communicating, educating, marketing, recruiting, all of the same type of information. And that what HSCSC did as an organization was they decided to merge in with the GS1. And that was a big decision made by a lot of people coming in again from a lot of different angles. That implementation took place last summer.

So as far as education, we have the toolkit development and distribution, the provider created and the provider is in the final stages to be issued out sometime in March. There are presentations from various industry leaders and various venues. I know that the GPOs are having meetings and are working with their membership. There are also manufacturers that have been asked to come to ARM regional meetings that say talk to us about the standards. I’ve been asked to go out and talk about the standards.

We’ve also got the work groups. And what’s interesting to me is that in the work groups, we had 166 members back in October of ‘07. We are now up to 344. So it’s obvious that we are gaining the momentum that is needed to implement these standards. Webinars attended by sellout audiences. Of course, mine are sellout. Maybe not some of the others. But, you know, we’re really getting the word out there. And it’s great to see the diversity in the attendees in those webinars, from software providers to health care providers, to manufacturers and even to payers are getting in on the webinars and wanting to know about this and understand it. So it’s great.

The other thing that I’ve suggested that I feel kind of strongly about is that we need to have information on the website that says here’s who’s participating. So, U.K. health care, we’re participating. We’re at the adoption stage. And here’s my contact information. BD is participating. And Dennis Black is the contact. And here’s his contact information. Because the manufacturer doesn’t want to try to have to figure out who in the health care provider they should contact. For the same thing we shouldn’t have to try to figure out within the manufacturer who do we contact to get started with this?

So again, the momentum, the 2010 and 2012 sunrise states, we know that we’re not going to have full adoption. But we’re looking more towards the 80/20 rule. And one of the reasons why those sunrise dates were established is because if we felt that if we don’t put a date out there, we will go on ad nauseum. And we’ll never get there. Of course, having an FDA or having a federal law indicating that we have to is going to drive that. But I think we need to be involved and work with the FDA, not have the FDA drive what it is that we do. And so thank you, Jay, for having this workshop.

So why GS1 run standards? The one system, the GLN, the G10 and the GDSM. It creates the traceability and supply chain. The recalls. As much as the FDA wants us to be able to do those recalls, I’m telling you, the health care providers want to be able to do those recalls. But we need to be able to do those in an efficient manner. Right now we’ve got an electronic version. But it doesn’t tell me specifically lot and serial number that I receive. By having this type of information flow, I know I can look at that list and say, oh. We did not get that serial number. So, no. We don’t have any of those. Or, yes, we did. Where are they? And go find them. So we need to create efficiencies.

Again, the system is used by one million companies worldwide. That says a lot. Other health care organizations across the globe use this standard. Again, we can’t have standards that maybe Japan says this is what I want on my device. But BD sells that same product or Bart or whomever it is sells that same product in the United States. So now we have to use whatever the UDI is that Japan has developed. Because the manufacturers can’t efficiently and effectively put on multiple bar codes or multiple identifiers on the private packaging.

Adoption is well underway. However, a well written regulation that the industry needs will ensure adoption and implementation. And what we all need to keep in mind is it’s patient safety is who’s at the end of this. Thank you. [applause]

MR. JAY: All right. Thank you, all. Thank you, panelists. Okay, guys. Here are our questions. In the interest of time, I’d like to open it up to the audience first. Anybody want to say anything?

MS. SUSAN ALTEF: Susan Altef, Food and Drug Administration, Office of (inaudible) Diagnostics. I heard the GS1 system being able to trace to the serial number. I don’t know if GS system has worked with the individual diagnostic industries to figure out if they are labeling a box of re-agents or a kit on the surface. Have they made a link between what’s in the boxes and what’s outside the box? Because in the industry, you have several re-agents that cross kits. And if one of those re-agents goes bad, the recall becomes complicated. So if GS1 is planning on doing something about being global and being able to label medical devices, in vitro diagnostics becomes important to make that link.
JAY: John.
JOHN: I believe the question is will GS1 work with diagnostic industry on kits basically. I did display that we do have a standard for kits and an explanation of it. I need to talk to you personally about does our standard address your needs. It might. I mean, we have our standard for kits and how to use our system in kits for a long time. It’s well-established. But let’s talk. I’m more than happy to talk to you about it and see if it fits your needs.
JAY: Anyone else? Yes.
MS: I’m (inaudible) from FDA. The impression I’m getting from all the presentations from GS1 related talks, give me the impression that you guys sort of work in progress.
MS: Is that a question or a statement?
MS: The question is is it a work in progress? We’ve had standards for some time. Our standards explain it. Now we’re giving guidelines on how to use the standards. I think that’s the difference. And whereas, before the manufacturers really used our standards. Now we’re getting down to the provider level. This is what you can expect to get. Is it a work in progress? It’s a global work in progress and it refines it. Because, as I told you, our standards do evolve. And the lady that came up, have we reached diagnostics? I don’t know. I need to talk to her about it. So our standard is constantly a work in progress.
FS: You are totally right it’s a work in progress. Because a lot of these standards in health care have never been defined to that level of detail like the lady just said from the diagnostic association. By the way, the European Diagnostic Association is involved, our work. So, yes. Some of the problems have never been defined in health care before.
MS: (inaudible) with Advantek. My question is really to the panelists as a group. One of the things that has not been mentioned is should anything else be included in the UDI? And I’m thinking particularly about the UNSPSC or the United Nations Standards Products and Services Code and how you would see linking that. Given the current economic situation, the need for a broader range of health care benefits across the country, how do you see linking the UNSPSC code into the proposed UDI?
MS: It seems I’m being asked to answer this question. My understanding of the UNSPSC code is that it’s a classification system. Is that correct?
MS: Well, that’s (inaudible) anybody up there. I apologize. Where the GS1 U.S. is a manager of it, it is a classification code for the manager. There are other classification codes out there. Sorry, I don’t want to put you on the spot.
MS: It is a classification code. And as such, it’s not terribly important that it be embedded with any UDI. UDIs are embedded under the classification. There have been several passes at classification codes over the years. And I would assume that somebody has to decide which group of devices belongs within a particular classification. And that classification will be ... there will be many such classifications. There have been attempts over the years to create them. They’re very controversial. Because device manufacturers don’t want to be lumped together with other device manufacturers. It tends to reduce their ability to differentiate.

However, I don’t think it’s directly germane to the question of what the product identifier is. FDA’s focus is not on classification so much as on track and trace and on unique identification of particular products. The classification systems are designed mostly to help buying groups which is a very valuable benefit. But I don’t think it really matters what that unique identifier is in order to satisfy the needs of any classification system.

FS: I would like to add that very clearly we should not put more information in the UDI than necessary. UDI is really a dump number which is then pointing to a database and a classification or nomenclature should be hold really in the database. If you’re looking at GDN. And that’s really where this information should be held.
MS: And again, Dick, for you, the UNSPSC, UN Special Products and Services Classification Code, is one of the complementary classification codes in global data synchronization network I work with. There are several in there. So if your product is in GDSN, then you get to pick the classification code. In the U.S., the hospitals and GPOs and manufacturers on spec very significantly. And we in the U.S. think it should be part of GDS. But that’s being discussed at a global level.
MS: Question? Yes, sir. Or a comment.
MS: A comment which may turn into a question. My name’s Harry Manilopolus. And there’s more to patient safety and ID than a lot number and serial number and recalling. There’s such as is it the right drug? Is it the right patient? Is it the right time? So a lot of bar code standards have involved focus on supply chain. And although we talk about patient safety, I’m hearing, well, it’s a dumb number. And you have to go look it up in the system. Those systems go down. So one of the important things is, yes, there are primary uses for UDI for identification.

But I believe the standards that are implemented should also be extensible to include other information useful to health care providers for patient safety. Otherwise, you get into the situation as John’s slide shows. Oh, we’ll have different bar codes for different things on the label. Things are getting smaller. We don’t have the space for multiple bar codes. The standard should be flexible. And I also believe versioning’s important to allow for changes as we learn more and evolve. Thanks.
MS: Before you run away, I’m sorry. Thank you for that. Any ideas on what kinds of information, additional information, might be included that would facilitate patient safety?
MS: Well, more from the medication than device side. You have different NDC numbers, for example, representing the same drug. And health care providers may sign a contract that says we’re buying from one company. So they’re getting one NDC number. But NDC has a problem with unit dose. It doesn’t mark products at the unit dose level. Unless the manufacturer ships it that way. And that’s an important consideration for UDI as well. When we’re talking about serialization, we are talking about marking the individual devices.

But what things are equivalent. I have brand X and brand Y. They’re very similar products. Their use is interchangeable. Should a UDI be extensible to allow marketing that equivalence number, for example. Another issue we run into is, again, what else would I need to know about the product that’s important for patient safety if I can’t go look up the number in a database? So it’s hard to think of exact examples with that where that would apply. Of course, medications has a lot of it.

One of the things that came up also was that we can talk about a manufacturer putting a device ID on let’s say a machine, a vital signs monitor, an infusion pump. Well, there are systems in place today that are deployed where not only do I have a manufacturer an model and serial number and other asset tracking, but the device says, hey. You can talk to me over a Bluetooth radio. And now you can electronically communicate with me. Here’s how.
FS: The GLN is the global location number. So the GLN would be like our account number. So as University of Kentucky, I will always be one two three. And you as Medred will always be three four five. So no matter who transacts with me or who transacts with you, you will always be known as that entity. So what it does is it gets rid of all of our account numbers that we have now. And it simplifies that process. The G10 is obviously similar to the UDI. And by transacting using that information.

So taking out what we have in our information systems now as providers is we have everybody has their own item master. So that item 1013, 3M 1050. It’s 3M 1050 drake. In my system, it’s item number 7467. But in the UCLA system, it’s item number one two three or whatever it is. So what we want to do is get away from using our own internal item masters and have the G10 number be the item. So that way what we have is we have our ... we have interfaces between our SAP system and our OR material system.

That information comes across with our SAP item master number. So when the staff goes to look for that information, they don’t know what our SAP number is. They’ve got the product in hand. Or they want to be able to search on it using G10. And so I think what it is it’s going to be something that we as material managers are going to have a hard time letting go of that item master and moving to the G10. But for the actual providers, the nursing, the staff at the bedside, they don’t care about that number. They want to see what that catalogue number or that G10 number is. So we’re looking at adoption by the end of 2012 of the G10. Does that answer?
MS: Thank you, Jean.
FS: I’m Karen Larson. And I work for a medical device industry that basically it’s a 4.5 millimeter long device. And the diameter’s as big as one of those periods on your slides. We don’t sell these individually. We sell them as a kit. And often, we bring in other products like sutures from other companies that we incorporate this in. Is it necessary to identify each one of those, each one of those 4.5 millimeters? And even though we’re bringing in sutures which are often packaged in more than one case and they come in cases of fifty. And they’re not labeled individually. But do we have to carry that information onto our product based on that label that they come with?
FS: It is a kit. But it includes ... it is a medical device. But we incorporate other products into this to make it work.
MS: Well, based on our discussions here today, that kit would have its own UDI. Now, the individual items that you’re acquiring would also have their own UDI if the FDA regulation requires it.
FS: But how does a biodegradable device have a UDI on it?
MS: Well, it’s on the packaging. It’s not ...
FS: It’s on the packaging. And we incorporate ... but we incorporate that biodegradable item into our product.
MS: You mean it disappears into your product?
FS: Not, it’s encased in our product. but once you put it in the body, it disappears.
MS: So what happens if there’s a recall on that biomedical and you have to open those kits and look at it? So the idea would be to have a UDI on it.
FS: On the kit ... on the label outside.
MS: But how do you know what’s in that kit? How do you know that biological wasn’t recalled? So it really ... again, according to ours, not knowing your particular product, but the way the kit rules are is that each product within it should have its own G10 or UDI as I said. Because if there’s a recall, they want to be able to open it and say, well, this is bad. Or this expired.
FS: I think what it is is that the kit ... each item would have its own identifier. So in your database, you would say kit number one two three incorporated these item. For recall purposes, the manufacturer would go to you and tell you these items were recalled. Then you would go to the providers that you took your number and gave to the providers and say this is under manufacturer recall.
FS: Thank you. That’s kind of what I was looking for. Because I didn’t know how to label some of that stuff. I appreciate it.
MS: With AIM USA. The question is ... and it was phoned in ... while these standards are unique within the health care industry, can you describe the interoperability for GS1 and HIVCC standards with ISO standards? Specifically ISO 15459 and 15434. That’s a high level question for you. Basically what we’re asking is since the Department of Defense is a long way along with their UID program and these two are going to come into interaction, we’re asking where do your standards fit with their standards?
MS: The DOD’s program which is part of the ISO device identifier initiative incorporates both HIVCC and GS1 standards. HIVCC has labels, identifiers or whatever they’re called, the letters LH and RH. Which is how HIVCC codes are identified within the UID system that you’re referring to, the ISO, MY codes. And so there’s not a contradiction between GS1 or HIVCC within the ISO approach. Both are embedded. Both of these standards are recognized by ISO in the same context.
MR. TOM STINGER: Tom Stinger from BJC. The one thing I wanted to say is that on the bar codes that we’re having, I’ve heard that these bar codes and the two standards are readable by multiple systems. And as far as I’m concerned personally, it really doesn’t matter whether it’s ... as long as it’s got the FDA required that manufacturers put this information on a package and that it’s readable by the systems that we use. And I really think that that ... I mean, I could see benefit one versus the other or having two. It doesn’t really matter.

It’s that you really can read this. And that everybody in the room does it. Because I think this is where ... if we’re just going to be, you know, I’m a member of the group to Jean is talking about and I agree. And I can read HIVCC. I can read GS1. I don’t care, Jean. You may. I mean, I care that the software we are going to buy can read both of them. And I’m right now at a challenge to find some software. We’re putting SIS in. And they’re telling me that they can’t read all the bar codes.

And I can’t tell you what the deal is. So really I think the FDA here really needs to push and say this is what is going to be required. And make the different players do it.
MS: You’re reflecting some of the points I tried to make earlier. And in this context, I wanted to also reflect on a point that was made in one of the other presentations. You know, this is a panel of three GS1 folks and HIVCC. But I’ve gotten used to that over the years. That goes with the territory. I kind of like that position for myself. But the point was made that there ought to be one standard. It was raised by someone here. I don’t recall who.

Well, let’s talk about that term standard. What FDA should be focusing on is one data standard. The information on every package should be exactly the same. GS1 codes and HIVCC codes contain exactly the same data. The difference between them is in the data carrier. And so this term standard is often misused or misrepresented. If FDA chooses to adopt UPN which is in fact a term, an umbrella term, representing the fact that both of these standards contain the same information, it will have in fact selected a single data standard.

The argument if you want to call it that or the debate or the competition, has more to do with which group gets to register the most companies. That should not be of concern to the FDA. The FDA should not care who’s going to wind up with more or less of these labels. The marketplace will work that out. The important thing is that we both adhere to the same data standard which we already do.

MS: I have to address that now, Bob. Well, one is we haven’t said anything about market share or signing up people. What we have brought up is that there is a movement within industry to select the GS1 standard within globally and U.S. Jean is not a GS1. Erica and I are paid by GS1. She’s a University of Kentucky materials manager. So let’s be real clear about it. Tom sits on one of our work groups. Tom stood up. And he has a different opinion. He’s allowed that opinion. But he’s in our work group, moving forward for our work in progress on how to embed these. That’s really the different. We have people on the ground that want our standards that are pushing for it. So as you said, the market will decide. And the market is deciding.
MS: Okay. That’s enough. That’s enough kids.
MS: We’re not going to argue this point. This is a political discussion that’s going on here.
MS: I’ve got enough information. That’s enough. That’s enough. Jim.
MR. JIM KELLER: Hi, I’m Jim Keller. And I’m with Eckery Institute. We used to be called ECRI Institute. We used to be called ECRI. I wanted to talk about adverse event surveillance. So we discussed the issue of identifying a recalled product. But I wanted to discuss figuring out whether or not a product needs to be recalled is a problem that’s been reported through an adverse event system. Specific to one model device or a class of devices. And I think, Jay, you might be a good person to start with that. So in other words, FDA doing an analysis to figure out whether or not a type of problem that’s been reported is specific to one vendor or a whole class of vendors. And how the standards that we’ve been discussing can be used for that kind of analysis.
MS: Well, that’s, I mean, very much why we’re involved in this is, as I showed before when we look at our adverse VIN reports, we can’t tell what device is being reported on. And we get ... and Jim knows this and others in the room, you know, when we get an adverse VIN report, often people, much like the Kleenex call one product by the same name, whether it’s actually made by that company or lot. And forget lot number or serial number, that’s just hopeless.

The reason that we’re in this game really is to see that UDI move all the way through to that point of patient use. And if there is a problem and somebody does submit an adverse VIN report, that’s what we get back. So we know specifically what device it is, who manufactured it and then hopefully the lot or serial number which lets us look and see whether it’s a lot problem or a broader problem. So it’s very, very important to us. And we’re working at FDA as well to accommodate UDI as it comes in on adverse net report. So very critical I think to what we’re doing.

MS: Could the GS1 and the HIVCC folks just talk about that as well? In terms of the identification of the classification of the device.
FS: I’ve been very clearly forever reporting, first you need to identify the item. I mean, before that it doesn’t make sense to report anything or do anything, any recall. And I think we will see different kind of importance in recalls and classification of products. But for that, of course, you have to have an identification on the system supporting that. Otherwise, you can’t do that. And it’s very important, I agree with you, for patient safety.
MS: This s just one step along the way in solving that dilemma. It’s a tool.
MS: I think your point, Jim, is the need for classification as well.
MS: Correct.
MS: And that’s something that I think we’ll get to, particularly when we get to panel three and we talk about data and databases. And Dick brought up earlier UNSPSC. And what the appropriate classification? And where does that belong? And can we then associate and our goal is to associate that particular device with a class of devices. So that as we do broader surveillance, we can see whether the problem is to a specific device manufacturer or a broader problem. So very much what we’re interested in doing. We have two more questions and then we’ll get ourselves a break. Yes, ma’am.
MS. JANICE HOGAN: My name is Janice Hogan. I’m with Hogan & Hartson. We’re a law firm. We represent hundreds of device companies. So one of the questions we’re being asked already is will the level of UDI that’s required by the same for everything form a tongue depressor to a proton beam therapy system? I’d like to hear the panel. And if you’d like to defer this to panel three, that’s fine too. But just talk about does the FDA contemplate a risk based approach to the level of UDI that’s required? Or is it really going to be one size fits all or at least common denominator?
MS: We’re hoping you can put a little tag on the tongue depressor. Is that going to be okay? This is a great question. IT’s a panel two issue. So I want to respect that question. And we will very much understand where does UDI go? How granular is it? And on what level of packaging and device? So it’s a great question. And we will get to it in panel two. I promise. Last question or comment.
MS: (inaudible) from Phillips Health Care in the Netherlands. I would like to go back to slide one. Because you stated for changes to a device. What is the exact definition of changes to a device?
MS: I’m hoping you’re going to tell me.
MS: Okay. Then I’ll try. Because we are selling systems that one certain model can have various configurations. In time, we even can extend that number of configurations with all kinds of accessories that in itself will probably be identified the UDI. Does it mean that everything in the main system also has to be renumbered with the new UDI? Because at that time, I think we are harming ourselves more than we have benefits from it.

So the second point is that you also have the opportunity to have upgrades to a system. So that we introduce functionalities. And that’s maybe a different question. So two questions. What about accessories to an existing system and upgrades to an existing system?

MS: Everyone got the question? So we’ve got the accessory issue and we’ve got the I guess it’s upgrades or changes. Well, we’ll call them upgrades to a device. Did you want to go first? Go ahead.
FS: We have discussed this kind of question very intensively in our global group. And John pointed already to the G10 allocation rules in which you can describe these kinds of scenarios and what the industry has agreed to as a standard, when to change and when not to change. It’s available publicly on the back side. And I’m happy to discuss this further with you.
MS: So rules that are described in the G10 rules are mandatory for this implementation?
FS: This is a globally voluntary standard which the industry has agreed to. And, of course, there were companies involved who had the same issues as you describe them. And they agree to something, what to do, when.
MS: Thank you
MS: All right. Well, we’re a couple of minutes behind schedule. But I’m sure that we’ll get caught up. I want to thank your Panel 1 members. Thank you. [applause] And I very much want to thank the audience. This is exactly how I want this to work. It took us a little while to get people to come up. But really come up, say your piece. Tell us what you think. Ask the questions. We’re going to take a fifteen minute break. I want to also recognize the exhibitors that are here, the solution providers. I appreciate them coming. Take a couple of minutes and introduce yourself to them. And I’ll see you back here in fifteen minutes. Thank you.

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