UNITED STATES OF AMERICA

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FOOD AND DRUG ADMINISTRATION

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

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PUBLIC MEETING ON UNIQUE DEVICE IDENTIFICATION

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WEDNESDAY,

OCTOBER 25, 2006

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The meeting came to order at 9:00

a.m. in Salon D of the Grand Ballroom of the

Gaithersburg Marriott, 9751 Washingtonian Blvd,

Gaithersburg, Maryland, DR. LARRY KESSLER,

Director of the Office of Science and Engineering

Laboratories, presiding.

I‑N‑D‑E‑X

AGENDA ITEM PAGE

Welcome 4

Dr. Janet Woodcock

Deputy Commissioner for Operations, FDA

Introduction and Format for the Meeting 11

Dr. Larry Kessler

Director, Office of Science and Engineering

Laboratories

Center or Devices and Radiological Health

Food and Drug Administration

The Benefits and Costs of a UDI System 16

Panel Discussion: 16

John Eyraud (Presenter), Eastern 16

Research Group

Jon White, M.D., AHRQ 31

Dr. Marcel Salive, CMS 34

Michelle Allender, Bon Secours Health 41

System

Joe Pleasant, Premier, Inc. 43

Paul Pandiscio, Johnson and Johnson 49

Audience discussion 66

Design and Implementation of a System of 99

UDI

Panel discussion: 99

Chuck Franz (Presenter), Cook Group, 99

Inc.

Michael Dempsey, Partners Health Care 110

Lu Figarella, HIBCC 114

Leighton Hansel, Abbott Laboratories 117

John Terwilliger, UCC 120

Audience discussion 143

I‑N‑D‑E‑X (Continued)

AGENDA ITEM (Continued) PAGE

The Development, Maintenance, and Use of a 178

Repository

Panel discussion: 178

Kathleen Garvin (Presenter), DOD 178

Steve Stemkowski, Premier, Inc. 195

Jonathan Sherman, DOD 201

Jon White, AHRQ 205

Dr. Randy Levin, FDA 210

Audience discussion 222

The Use of Automatic Identification 230

Technologies

Panel discussion: 230

Jim Keller (Presenter), ECRI 230

Dr. Julian Goldman, Partners 241

Health Care

Ilisa Bernstein, FDA 253

Ann Ferriter, FDA 258

John Terwilliger, UCC 259

Lu Figarella, HIBCC 264

Audience discussion 273

Other presentations from Public 276

Cathy Denning, Novation 276

Michael Dempsey, Partners Health Care 281

Richard Eaton, National Electrical 286

Manufacturers Association

Fred Freedman, Dental Trade Association 292

Dr. In Mun, Hospital Corporation of America 296

Mark Piper, DOD 304

Jeff Schaengold, Siemens 311

Elliot Sloane, Villanova School of Business 319

Brad Sokol, Fast Track Technologies 327

Jori Frahler, Medical Device Manufacturers 334

Association

Next steps, wrap up and housekeeping 340

Dr. Daniel Schultz

Director, Center for Devices and

Radiological Health, FDA

P‑R‑O‑C‑E‑E‑D‑I‑N‑G‑S

(9:04 a.m.)

MODERATOR KESSLER: Good morning. My name is Larry Kessler. I am from the
Food and Drug Administration. And I am pleased to present to you our
first presenter, Deputy Commissioner of the FDA, Dr. Janet Woodcock.

DR. WOODCOCK: Thank you, Larry.

WELCOME

DR. WOODCOCK: And good morning, everyone. I would like to thank you all
for coming to this important meeting. I think the topic that will be
discussed today has very important implications for public health.

The FDA and the Secretary of HHS, Secretary Levitt, really strongly
support the development of unique identifiers for medical products. For
the FDA, this has to do with the use and, of course, recalls, tracking,
identification of adverse events, and so forth. And for the Secretary, I
think for his larger vision of the electronic health record and the
information within that record pertaining to individual patients,
something that he is very committed to.

As you know, we started this effort with medical products in the drug
and biologics area. That has had an NDC code for a long time. That code
has a number of deficiencies in the modern world. And we have been going
through a long series of discussions about how that can be addressed.
And that will be addressed to some extent in a proposed rule that FDA
will be issuing on drug registration and listing.

However, a number of years ago, we also issued a rule on bar coding of
drugs and biologics that was able to use that NDC code to identify those
products in the hospitals and so forth with bar code readers.

And the rationale for this was more or less backed up by reports that
had been issued by the Institute of Medicine and others on medical
errors, particularly in hospitals, in dispensing and handling drugs and
giving the wrong drug to the wrong patient at the wrong time and so
forth. And it was felt that use of this bar code system combined with
the unique identifier, the NDC, could help stem the tide of medication
errors that are pretty well‑documented in the United States.

Now, we don\'t have the same kind of database on device errors, but that
does not mean we shouldn\'t be working on this issue. I think it\'s
extremely important.

Our ability at FDA to conduct effective post‑market surveillance is
hindered by the lack of specific device identification in many adverse
event reports.

For example, in one area of infusion pump MDRs, we found that half the
reports lacked specific identifying information that would be needed to
make trend analysis. And this, of course, is of great importance to each
manufacturer.

Now, we recognize, however, the complexity in the diversity of the
medical device industry and that one solution will really not fit the
entire industry. And that\'s why the center I think has convened this
workshop. They really need input. We need to understand the range of
issues that are faced in doing this and the range of potential solutions
and approaches to the problem.

We\'re also very sensitive at FDA and have been for a number of years to
the need to harmonize internationally. The device industry, like all the
other medical product industries, is a global industry. And we cannot
have simply U.S.‑centric approaches and solutions anymore. And we fully
recognize this.

We\'re early in the process here. We are really seeking input on what
the issues are approaching this and what potential solutions might be.
And we are very open I think to entertaining a range of approaches and
having a dialogue with all the stakeholders.

In addition to the adverse event reporting, we have to recognize that at
some point as the dream of electronic health records becomes a reality,
there will be an expectation that we will be able to record device
information within those electronic health records.

And, as I said, this is important to Secretary Levitt, but in his
January 2004 State of the Union address, President Bush highlighted the
importance of IT in health care. He said that computerizing health
records will allow us to avoid dangerous medical mistakes, reduce costs,
and improve care. And we will need to have computer‑readable
identification for medical products as part of the electronic health
record. There is simply no doubt about that.

We feel that unique device identifiers also can help in business areas
and inventory control and everything. We have talked to some of the
large health care organizations. This can improve delivery in the supply
chain efficiency. These are important issues for CMS as well as for the
VA and for the Department of Defense, who have made emergency
preparedness as well as battlefield readiness arguments for having
unique device identifiers so they know exactly what they have on hand
and they can verify their inventory and trace it down the supply chain.

So, most importantly, I think, we share the same customers. The industry
and FDA share a customer base, which is the health professionals; the
physicians; and nurses; the operating room technicians; and so forth;
and, most importantly, the patients.

And, as we look forward over the next ten years, as the electronic
health record and automation actually begin to take hold and improve the
health care system and be widely adopted, our customers will be
expecting that we have ready for that unique identifiers for medical
products that allow them to be part of the electronic health record and
the interchange of that information. I can tell you that is going to be
an absolute expectation of the customer base.

So, between us, we have to forge a solution that works for everyone so
that we are record for the next phase of health care, which I think will
do a tremendous amount to bring quality and uniformity and lower the
costs of care to the entire public of the United States.

So this is an important meeting because this is the beginning of a
journey to get those unique identifiers for the devices. And, as I said,
we\'re still working on the biologicals and the drugs to get that unique
identifier up to where it needs to be, but we hope by the time that
e‑health record is widely used, interchangeable, we, the industry and
the FDA, will have been prepared and medical products will be ready for
that future.

Thank you very much. And good luck today.

MODERATOR KESSLER: Thank you, Janet, appreciate it.

INTRODUCTION AND FORMAT FOR THE MEETING

MODERATOR KESSLER: So I am going to do the obligatory logistics stuff to
make sure that we all know how the meeting is going to run. And then
I\'ll make a few opening comments before we begin the first panel.

So simple logistics. Restrooms are down the hall. We have breakfast.
There\'s coffee out there, et cetera. If you did not register for the
meeting, if you just came in, we would appreciate at the first break
please make sure you sign in so we have an accurate record of who has
been here.

We are making a transcript of the presentations for the next couple of
days. So when you interact from the floor, we would like you to go to
the microphone. Please clearly identify yourself and speak into the
microphone so we can make an appropriate transcript.

Let\'s see. Cell phones off, please, or put them on vibrate or something
silent. The panel sessions. Our plan is to have four panel sessions
today. Each one roughly will go about an hour and 15 minutes. We\'re
going to have an opening presentation of roughly five minutes or so. And
then each of the panelists will interact. So that should be about 40
minutes, giving you and the audience around a half an hour to give us
some feedback.

And the purpose of the structure of this is to promote a real dialogue
here. I know it\'s a large room and sometimes you\'re uncomfortable
getting up, but we really hope that the people in the audience will ask
questions of the panelists and will interact with us as best as
possible.

The purpose of the meeting today is to have open dialogue about what we
feel is an important and very challenging set of issues that we face
trying to come to grips with whether or how to have unique device
identifiers on medical products.

So now a few opening comments from my perspective. As Dr. Woodcock said,
the reason we are here has to do with our customers, our stakeholders,
patients, and providers. And we had representatives certainly of the
providers here as well.

We are here primarily to promote and protect public health. That\'s what
we think our job is. I know most of my colleagues in the manufacturing
industry feel the same way.

We also are trying to work with our foreign regulatory partners in this.
We have a representative here from Health Canada, who I hope will get up
and say a few things because they have been struggling with some of the
same issues. And we are going to bring this issue up, as we have once
before. We\'ll bring it up again this year in the steering committee of
the global harmonization task force the end of November. So this is not
just a U.S. issue. We believe it\'s a worldwide issue.

That\'s why we\'re here in general. Why we\'re here specifically, as I
said, is to have open dialogue. We\'re here to listen. Those of us from
the FDA, in particular, are trying to figure out whether and how to
develop a regulatory strategy that makes sense to us, makes sense to the
industry, and ultimately is a positive benefit to patients and health
care providers. And that\'s what we aim for today. So the object today
is an open dialogue about those topics.

The first panel is going to concentrate on the essential questions of
the costs and benefits of such a system. At some level, if we pursue a
regulatory solution to this, we will be asked to make sure that the
benefits are commensurate with or outweigh the costs. And getting a
handle on both the benefit and the cost side has proven challenging for
us over the past year as we have worked with a number of our colleagues,
our contractors, with others of our partners in the federal system, and
in talking to industry. It\'s been very difficult to get an accurate
estimate of that. So that\'s going to be the first part of this.

After the first panel, we\'re going to assume in a sense that we\'re
going to move forward. And the remaining three panels will be about
different parts of how to implement such a system if we go forward. So
the first panel is really about the #whether#, the costs and the
benefits. And the second, third, and fourth panels are really about
mechanistic issues.

We\'re hoping to get out of here by 4:30 today. We may finish a little
earlier, depending on the debate. There\'s a lunch break scheduled. And,
Jay, can you tell me about the lunch break?

MR. CROWLEY: Lunch is on your own.

MODERATOR KESSLER: It\'s on your own.

MR. CROWLEY: There are plenty of restaurants around here.

MODERATOR KESSLER: You can eat in the hotel. And then you can walk down
toward the REO, anywhere. And then there are a dozen different
restaurants. You can ask recommendations if you\'d like.

Anything else logistically on this?

MR. CROWLEY: No.

MODERATOR KESSLER: Thank you.

It\'s my pleasure to introduce John Eyraud from ERG, Eastern Research
Group, to make the first presentation. John?

THE BENEFITS AND COSTS OF A UDI SYSTEM

PANEL DISCUSSION

MR. EYRAUD: Hello, everyone. I am John Eyraud with the Eastern Research
Group. We\'re an FDA contractor. And we have been doing some work for
the agency over the last couple of years in various pieces to look at
aspects of the UDI question on the health care sector.

A start on definitions. And one thing I would like to emphasize about
our report, we\'re providing some information here and even some very
preliminary cost numbers. The numbers are changing as we speak. And by
the time our report hits the Internet or it\'s released by the agency,
numbers will have changed, which is an aspect of our work. We are
providing some information here. And I hope you just understand the
context in which it is offered.

A start on a couple of definitions and our sense of what it is we should
be looking at. We\'re looking at a UDI as a serial number or another
kind of identifier on a medical device or simply a lot number when that
is sufficient, hopefully something electronically readable.

Our understanding is that it might not be necessary to serialize
everything as we look at this question. In general as I go forward, the
concepts that I am talking about represent our take on things and don\'t
represent an official FDA idea or perspective on things. And I\'ll
explain that further as we go.

We have tended to focus on the incremental costs in looking at the
medical device industry for the lowest level of existing labeling. We
haven\'t examined all of the supply chain implications and some of the
other kinds of labeling that might also be affected.

And in our conversations with industry thus far, there are some
consistency issues. And I think that we have not always held exactly the
same assumptions as industry in our discussions. And we are still trying
to work some of that out.

Again, we have tried to kind of anticipate if FDA were to make
guidelines or recommendations or regulations in this area, how they
might approach the topic. So we\'re not representing any official
policy.

But we have looked at ‑‑ let\'s see. Where am I here? We have looked at
a couple of things here. The goals for patient safety benefits, first of
all, three main areas: better identification of the devices implicated
in adverse events. This would be extremely valuable to the agency and
help the agency better sort out what some of the problems have been in
the field.

Also, an area would be more rapid and more accurate recalls, hospitals
would be able to identify, locate devices more quickly and remove them
from service as might be appropriate.

The last topic, enhanced capability for post‑market surveillance, this
would be an area of enormous benefit in research and in evaluation of
device operations. But it is hampered at present by so much difficulty
in identifying and comparing some of the models of medical devices that
are used.

Okay. Now, in order to achieve some of these benefits, the UDI would
have to be coupled with some changes and enhancements in information
technology in the hospital sector.

The UDI hopefully, though, would if medical devices were identified with
unique identifiers facilitate a lot of development of hospital IT
systems, facilitate hospital capture of the devices ID as they are
coming into the facility and any other locator systems they might
employ, facilitate ID of specific model information that might be useful
in the health care system and, again, comparisons of effectiveness of
medical devices.

Now, we took a really quick cut at recall savings that might be
applicable in the hospital. We have a few data points on this which we
have extrapolated somewhat aggressively and considered the possibility
that fully functioning UDI capability in the hospital might allow the
hospitals to save as much as half of the time that they spend executing
a recall when it occurs and made a number of other assumptions about the
share of recalls that hospitals have to react to and what have you.

And in looking at that, we generated an estimate of about \$35 million
in savings, again a very preliminary figure. And those assumptions going
into that are subject to change but, you know, kind of a nice number as
to what some of the possible enhancements and savings could be there. It
certainly is a difficult area for a lot of hospitals to execute the
recalls as efficiently as they would like.

Again, the hospital infrastructure development we\'re looking at the
need to capture the UDI in the incoming devices, ideally capture the
device information as the devices are used in patient care. Hopefully
this would feed into an electronic health record and would help
care‑givers know who was treated with which devices for those episodes
where there is some problem and need to go back and re‑evaluate some
aspects of the care.

Most aggressively, a UDI could even be used to facilitate the locator
systems in the hospitals and even for some devices possibly internal GPS
systems to locate devices, you know, as might be necessary or might be
helpful for various purposes. A lot of time is simply spent locating
devices to use on patients in the hospital.

Okay. Looking at in a basic sense some of the hospital costs to
implement some of the UDI requirements, we have made some preliminary
cuts at what this means in order to have the hospital get the data from
devices, get the UDI numbers into the electronic health records. And it
would take a fair amount of investment in scanning systems. Additional
wiring of the hospital to capture electronic information would probably
be incurred, substantial training for staff. Initial cut at some of
those costs comes to a first year investment cost of 1.4 billion.

Now, a lot of this is a complicated issue because we\'re looking at ‑‑
hospitals are making a lot of other investments, like bedside bar coding
of medications.

And in some ways, some of the UDI technologies could piggyback on those
technologies as they\'re used in the hospital. But UDI would require
certainly some additional investments in a lot of the same areas and
additional implementation of probably personal digital assistants and
scanners for doctors and medical staff.

Okay. We have pulled from the literature some of the other costs just
for some very crude comparison. Some of the costs have been estimated
for electronic health records.

Most of this information was derived from some work published by Renu
Kaushal and some other individuals. And the electronic health record
capital costs for a fairly advanced and a high‑level model system is
quite large. And UDI is a relatively small cut on that.

Turning to device manufacturing, some of the main cost components would
be the internal planning necessary to implement UDI, addition of online
bar code printing capabilities, the relabeling exercises that would be
required, and then IT integration and a variety of integration exercises
that would be part of that exercise for manufacturers.

A number of challenges would seem to be imposed there. A number of small
firms would need to add an online printing capability that they probably
don\'t have and often might not be really interested in adding.
Considerable IT system development might be needed for some firms to
track the additional information that they\'re now attaching to their
devices.

For some of the large firms we talked with, they estimate costs of
several million to add a UDI capability throughout their establishments.
We\'ve got widely varying costs I should emphasize. And the model for
applying these costs to the industries remains somewhat uncertain.

Another thing for the large manufacturer certainly is a need for some
fairly lengthy implementation period to get the systems in place and add
them into the complicated logistics of manufacturing.

Excluding for the time being the IT costs and, again, very preliminary
numbers here, with some basic sets of assumptions and cost estimates, we
generate a total estimate of a bit over \$400 million for the medical
device industry. I mean, the industry is huge with thousands of
establishments. So it doesn\'t take all that much pro forma costs to
generate fairly big total numbers there.

IT integration, we have sort of thrown the kitchen sink into this. And
based on the data we\'ve gotten from a number of manufacturers, again, I
would emphasize that in talking with the manufacturers, we have not
absolutely been able to make certain that all of our assumptions are
entirely coordinated, but we\'ve got a wide range of costs here. And if
we extrapolate out to all the large firms in the industry, in particular
where some of these terrific integration costs are, we get pretty big
numbers. So there are some challenges awaiting us.

External to the individual firms, there are, of course, costs implied in
sort of the standard‑setting exercise in order to develop consistency in
the UDI protocols in a product data utility that would allow people to
know and interpret the UDI numbers that they are seeing.

And there would also be a considerable training in communication for
users. As it is now, some people in hospitals complain about trying to
take information off some of the device packaging and being confused by
which numbers are applicable in which cases. So there is plenty of work
in standardization required.

We\'re still collecting information. So if you\'re out there and you\'re
interested in this area, we would love to hear from you. And we\'re
particularly interested in the sort of awkward and somewhat disruptive
elements of this in your manufacturing establishment or in the hospital.
And please give me a card or something. We would love to contact you if
you want to offer information.

Thanks very much.

(Applause.)

MODERATOR KESSLER: I like the part where John says if you\'re the
kitchen sink with the estimate and then the other part where he says,
\"Care to offer your estimate?\" So I think he\'s hoping that some of
you will sort of put some number in the hat. Maybe we should have a
little hat up here for John.

So a few logistics things I need to go over. Again, I would like to ask
those of you who did not register to please go out at the break and sign
in so we know who is here.

For those of you in the back, there are seats over here on the left. And
there are not very many. After they fill up, we will begin auctioning
them off and put into John\'s estimate.

Panel, there are a lot of mikes. The way we have done this, you have to
push to talk. So just remember that as well.

A few other things. At the end of the fourth panel, a number of people
have actually asked to make brief presentations. And we will give them
an opportunity. They will come up here. They will sit on the dias. They
will have their PowerPoint stuff loaded.

And if you wish to make a presentation and did not tell us ahead of
time, please tell either Jay Crowley back there, who is raising his hand
right now, or Dave Racene, who is hiding. Just tell them so we can get
this stuff loaded and be ready to do that at the end of the day.

There are some vendors here who have put their stuff in the hallway.
There are certain kinds of technologies that are relevant to device
identification. Please recognize, as you would imagine, these do not
represent FDA endorsements. We don\'t make any money from their vendors.
They are just there. So please go visit them as well.

Two other things I would like to mention. One, the issue of diversity,
we recognize at FDA ‑‑ and this is a very important point ‑‑ that the
scope and diversity of the medical device industry is enormous. We\'re
talking about products that are the size of a fingernail and the size of
an automobile.

So we really recognize that we are in an area where it is not clear that
one size fits all. And we are not here to try and shoehorn you or the
panels into a regulatory decision that is going to work well for
somebody and be absolutely untenable for others. So we\'re here to talk
about diversity and how we can use this as an exciting opportunity to
figure out how to use modern technology to enhance patient safety in
health care and not try to make a solution that will be inhibitive.

That is going to be a challenge because the technology of information
identification is also a moving target. So designing a regulatory
solution that is flexible over time is a challenge. So we really look
for your suggestions, not only to offer estimates of cost stuff but how
to do this. So that is going to be later.

And, finally, one of the slides that John put up I think was very
important. We need to figure out to what degree not only in the cost
side are we talking about costs but are there health care savings,
whether it\'s the manufacturers, providers, patients. And getting
savings estimates is just as important as part of weighing the checks
and balances here.

I am going to introduce the panel members now, give them a few minutes
to talk, and then open up the floor for discussion. So Jon White is from
the Agency for Healthcare Research and Quality. And he is part of their
section that does the health IT awards for all of AHRQ.

Next to him is Marcel Salive from the Center for Medicare and Medicaid
Services.

Michelle Allender is from Bon Secours Health. She\'s Director of
Clinical Resource Management.

Next to her is Joe Pleasant from Premier, Inc. Joe not only represents
Premier but also participates in the Global Standards 1 group, GS‑1, has
been working on this exact issue. And I hope he will provide that
perspective for us.

And, finally, on the right is Paul Pandiscio from Johnson and Johnson.

So this is our panel. And I will start on the right with Jon.

DR. WHITE: Good morning.

MODERATOR KESSLER: Good morning.

DR. WHITE: Thank you. It\'s always a challenge to follow the first
speaker. It\'s always a challenge to follow a good speaker. There\'s a
story about it.

A man dies in the great Johnstown flood, where the dam burst, and goes
to heaven and wakes up. God is standing before him. God says, \"Oh,
thank Myself that you\'re here. You know, we have been waiting for you.
We have got a panel discussion that we have got you on, a flood. So we
need you to come down the hall. We\'ve got you as the second
presenter.\"

And the man is going, \"Oh, thank you. Thank you, God. I\'m glad to be
on the panel. Who am I following?\"

And God says, \"Noah.\"

But, nonetheless, we\'ll try to carry on. I do not have quite as much
data for you, but if I don\'t have enough data, I can tell a story.

I do work at the Agency for Healthcare Research and Quality. I am a
family physician. But, interestingly, somehow I managed to wind up
managing the health IT portfolio at the agency.

So you can probably imagine that we place a premium on information and
data. And, actually, in my practice, we place a premium on that, too.
You know, occasionally I cut something or occasionally I inject
something, but, by and large, we manage information as providers. It\'s
what we do.

The story relating to what we\'re going to talk about today, as you can
imagine that the agency would think a lot about safety and quality of
care. About a year and a half ago, the director of our agency, Dr.
Carolyn Clancy, was approached by a group of orthopedic surgeons. He
said, \"Listen, we have this problem.\" And this is not to pick on hip
implants, but this is the story. \"We have this problem. We have had a
number of our operations fail recently. And we\'re kind of suspicious
that it\'s the actual device, the implant that\'s doing it. But we have
gone back through the records, we have no idea what we put in. So this
is what we think, but we can\'t figure it out one way or the other. Can
you help?\"

And we thought about that a lot. There\'s no way to either disprove that
and say, \"No, no. It\'s actually not the implant that\'s doing it but
some technique that you\'re using in the procedure\" or say, \"Well,
actually, it is the implant. You need to do something about it.\" So
it\'s the absence of data that keeps us from being able to provide
better care.

So I probably come down on the benefit side, as you can probably
imagine. There are certainly costs and issues associated with that. I
know very well because I spend a lot of my time thinking about
information systems and expensive information systems frequently. So
there is a trade‑off to be had, but I am looking forward to really
discussing that with you all today.

So thank you.

MODERATOR KESSLER: Thank you, Jon.

Marcel?

DR. SALIVE: I have a story about going third, but I won\'t tell it. I
know Dr. Clancy probably gets very nervous when the orthopedics come
forward.

Actually, I was at a meeting this week downtown. And I was with the
early adopters, the carotic stent and cardiac stent people, who were
meeting down in D.C. And every person whom ‑‑ I registered, I got my
name badge. It came with an RFID and a bar code ‑‑ not a bar code, an
electronic strip, magnetic strip. You can tell I know this stuff really
well.

As we were going in and out of the sessions, it was tracking where I was
at all times and keeping close tabs so I don\'t cheat on my CME
requirements, I think.

But I go into a panel discussion like this. And unlike our high tech
method here, they had digital dots printing out the names of each
person. And I noticed, though, when I was watching one of these panel
discussions that, despite all of this high tech, the wrong names were
under the wrong people.

(Laughter.)

DR. SALIVE: And so my good friend Dr. Mitch Krukov, not a good friend of
mine, but he\'s a panelist for you guys at FDA, was listed as some I
think Italian doctor.

DR. WHITE: This is what we call new and improved errors.

DR. SALIVE: Yes. So despite all of his RFID and his magnetic strip, I
think he sat at the wrong seat or something. And they had beaming in
video‑live cases from Italy and New York. You know, it was a very high
tech meeting, but that was what was going on.

I\'m from Medicare. I know everyone wants to know what Medicare is doing
on this. I think I want to focus, too, on the benefits, though. I think
to us, I would agree with the first speaker that the benefits deal with
to us the assurance of health benefits to the patient. And that\'s most
important to us.

I\'m in the coverage group for Medicare. We deal with the evidence for
coverage, for new technologies in particular, but we also are well‑aware
of all of the past technologies that are still in use and the ones that
have kind of fallen by the wayside.

I don\'t deal with the electronic health record, but that is also a big
initiative throughout Medicare and CMS. And also I think the value for
patient safety is prominent in this discussion.

I wanted to focus a little bit on the comparison of effectiveness
between devices. I think that is an important issue for Medicare in that
we want to see an increase in value for the health care dollars spent.

And I think if we don\'t really look at that ‑‑ and I know I have to not
disparage FDA too much, but when FDA approves something, some of the
devices are approved by a grand‑fathering process. And that process
doesn\'t always give us evidence of health benefits. It assumes that
evidence is in place.

Other devices are approved based on trials. Some of these trials don\'t
give us high quality evidence of benefit either, I would have to say.
There\'s the new non‑inferiority trial that I think is in vogue.

And, you know, at Medicare, it\'s very frustrating when something is
FDA‑approved on one of these pathways, saying it\'s equivalent or not
inferior or something else. And then people come to us and say, \"But
it\'s better. It\'s really better.\"

And we see the evidence. We know what is going on. And we want to see
better evidence that it is, in fact, better. And we want to encourage
that to be collected.

And I think it is fine how FDA does their business, but for us to pay,
we would like to see evidence of comparative effectiveness. And we have
payment incentives in place so you can be paid more, that the providers
can be paid more for something that is, in fact, a substantial clinical
improvement.

And so I think developing that evidence, this type of data can help us
develop that evidence. So our standard for approving something for
coverage is, is it reasonable and necessary for diagnosis and treatment
of illness? And that is, our standard is not the same standard used by
FDA for safety and effectiveness. So we have some differences there.

While we have held a very high standard for reasonable and necessary, we
are developing a process that\'s called coverage of evidence
development. And we used that a few times to cover promising
technologies with the caveat that data must be collected on the care
that\'s provided under this coverage with evidence development to ensure
that there are, in fact, health benefits being accrued by the patients.

So one example of this is the implantible defibrillators. And I think we
announced that coverage close to two years ago. And there were some
groups that were very well‑studied, and there was solid evidence of
benefit by the defibrillator implanted in those patients.

But there were other groups that the evidence was not so solid that we
thought was promising. And we said that we would expand coverage to
those groups with the contingency that the data be collected into a
patient registry. And that registry is now operational. It\'s been going
since the time of that decision.

I would say there are some data quality problems, particularly for the
device type and the device model, the brand. There are multiple
defibrillators on the market. There are, in fact, combination cardiac
resynchronization devices with defibrillators that are also doing the
same function as well as some other functions. So it\'s a complex area.
This would help us get that data and understand, I think, the
effectiveness and benefits the patients are getting.

So I think that is one incentive. The data quality handwritten by the
cathlab nurse, which I think is how this is most commonly done, has some
potential pitfalls that this might overcome.

So I think there are a lot of good incentives for this. I understand
some of the barriers to it. And I know that we have had a lot of
discussions in Medicare about what kind of payment incentives could we
provide. And those are still, I think, quite ongoing discussions.

Thanks.

MODERATOR KESSLER: Thanks, Marcel. And I want to thank him for in just a
few sentences and of his pippy observations speaking about the
limitations and problems that we have with the entire 510(k) system.

(Laughter.)

MODERATOR KESSLER: Those of you in the industry who are really fond of
510(k) maybe we\'ll have a separate meeting with Marcel and CMS later.

Michelle?

MS. ALLENDER: Good morning, everyone.

MODERATOR KESSLER: Good morning.

MS. ALLENDER: I actually am a registered nurse. I have a background in
administration managed care as well as surgical services and
perioperative services. So I hope to add to this discussion and any
questions that you may have the clinical perspective of how this system
may affect those clinicians working in the field.

I have worked probably about 20‑plus years in the field and then more
recently the past 4 years at the corporate office for Bon Secours Health
System. And, to say the least, it has been trying to track recalled
devices.

We are currently looking at a system to help us address the notification
of recalls but not necessarily the tracking of the recalls, which the
UDI system would add significant benefit to.

As my colleague said regarding cardiology items, the same thing is done
in the OR in terms of all of these manual logs of trying to track
devices and literally going through possibly hundreds of patients\'
records to find out and track down if something has been implanted or
used on a patient that has been possibly recalled. So I hope to add some
benefit to the discussion.

MODERATOR KESSLER: Thank you.

MR. PLEASANT: Good morning. In terms of recall improvement, unlike just
about every other product sold in the United States, medical devices
really can\'t be electronically tracked or inventoried. So finding those
recalled products is certainly unreliable.

As one of our hospital executives said, we receive several recall
notices per month which require a manual chart review, as Michelle said.
And every patient that might receive that is a period of time that we
don\'t know that we can track that back. Significant workload is
associated with that.

There is tremendous concern with care‑givers, et cetera. One large
health system was also recently adversely affected by three very public
class I recalls. And we have some documentation around what they went
through in terms of having to spend time trying to track those patients
down.

Another Premier Hospital executive said a significant risk to patient
care and safety is the possibility of implanting an outdated device or
using an outdated device because we cannot track outdated information
and bar code technology or lack of a UDI. It\'s not available from the
manufacturers.

Another area, a significant manual process that takes a lot of time for
hospital admissions as well as hospital folks, there\'s a significant
cost associated with having to do that.

Another one of our executives believes that UDI will improve their
ability to process recalls because currently they have risk management
safety and clinical engineering working together to establish manual
logs in the hospital so that they can actually extract that information
when a recall occurs.

So, again, I applaud John and them for beginning to attempt to identify
costs, but that\'s a significant cost and I am not sure we really have
been able to identify what we continue to work on.

In terms of adverse event reporting, accurate and reliable device
tracking would enable all of us in the supply chain in health care to be
able to better track potential device defects and be able to take a look
at those adverse effects on our patients.

Premier currently has a very large database. And we do this tracking and
try to look at adverse effects around drug information because we\'re
able to utilize an NDC. And I think in the medical device area we would
be able to do the same thing and be able to help identify those adverse
effects.

Reducing medical errors, being able to correctly identify devices,
tracking through health care system and inform proper practitioners
about potential dangers would reduce errors. According to a by the ERG,
UDI has the potential to facilitate education and device compatibility
problems. Implantible materials have actually turned out to be
incompatible with MRI devices resulting in injuries and deaths.

From the standpoint of the cost, as we have already heard, many
hospitals are in the process of implementing electronic health records
right now. And the fact that they are having to deal with the lack of a
standard not only in the medical device area, which they really haven\'t
gotten to, but they are having to deal with it in terms of clinical
processes, et cetera, and having a lot of work done in standards area
there, it\'s only a matter of time before medical devices need to be
able to pass, be passed electronically in electronic health records.

And shame on us that are involved in this if we don\'t deal with that
right now. Being able to pass that information from one hospital by way
of an electronic health record will have significant impact and benefits
to patients in terms of actually their electronic health record
identifying for them what they have had in other places.

And we have even heard personal health records, being able to have a
personal health record that shows clearly what kind of device or what
kind of work has been done for that particular patient is really
critical. So we need to get about establishing standards for medical
devices for that purpose.

In terms of the cost, we have talked a lot about this cost. And I know
that John\'s work is something that we can all kind of add to. I just
add that in terms of the work that we have been doing with CHES and the
work that the Department of Defense has been doing, there is a lot of
cost in terms of our hospitals particularly having to synchronize their
medical device databases with other supply chain partners.

There are many hospitals spending over \$100,000 just to synchronize
their master item files with others in the supply chain. And that\'s a
small part of it, but there\'s an awful lot of work that goes on in
terms of trying to get the supply chain efficient.

MODERATOR KESSLER: Before we turn it over to Paul, I just want to take
the Chair\'s prerogative for one second. Early in your discussion, Joe,
you mentioned that you actually have either data or documentation about
some of the hospitals who had to go through the recall process. So can
you provide that?

MR. PLEASANT: Yes.

MODERATOR KESSLER: Is that publicly available or is that proprietary?

MR. PLEASANT: Our plan would be to provide that in a response back to
you in terms of the upcoming response period.

MODERATOR KESSLER: And in terms of your last comment about the supply
chain efficiency and the costs that hospitals are currently bearing to
try and synchronize the systems, do you have some sense that we are
moving or need to move towards one uniform system so that after an
initial investment and training we have something that\'s working for
your hospital so they\'re not spending money every year trying to
resync?

MR. PLEASANT: Absolutely. Other industries have done that, as many of
you know. The grocery industries and others have a consistent weighing
of product data utility, where they all synchronize their files.

It allows them to do that in an efficient way versus every hospital
going out and trying to synchronize their them masters and their
descriptions with other partners that they have. And, quite frankly,
that gets out of date every month, for that matter, and new products are
introduced. And it may or may not get synchronized across the supply
chain.

Take significant dollars out of the system. Make it significantly more
efficient.

MODERATOR KESSLER: Thanks.

MR. PANDISCIO: Good morning. I would like to thank FDA for having me
here today. I do work for Johnson and Johnson. I am here in the capacity
of representing AdvaMed for the manufacturers\' association.

To the point of UDI directly to patient safety, we believe that
sufficient study and evidence doesn\'t exist to directly show the link
between UDI and direct patient safety benefits.

That does not mean that we don\'t see potential for value chain
efficiency benefits from better visibility into system‑wide inventories
and product movements.

Some keys here, though, to even potentially get at those efficiency or
we\'ll call them value chain or supply chain types of benefits are the
system would truly have to be system‑wide. And I think that\'s an
absolute must. What I mean by that is a system that is well‑adopted and
deployed, manufacturer all the way through provider to the point of use.

Further, I believe the standards that would drive the UDI system would
have to be global in nature. I know that theme has already come up once
or twice this morning. But I believe wholeheartedly in the convergence
of standards to drive global visibility and, in that, enabling the
structure to be in place.

And, finally, the point again to potentially get at the supply chain
efficiency benefits that are there, this whole system would have to be
very carefully and well‑constructed.

And what I mean by that, just a couple of points, is we really need to
design this for adoption. It\'s not really going to do us any good if
manufacturers are labeling product, are putting unique identifiers on
product, and the chain ends there or even ends at our distribution
point.

We really have to understand the inventories in the system, be it
regulatory incentives, cost reduction incentives, or other, or evidence
that maybe will exist in the future directly linking to patient safety
benefits.

Those incentives will need to be in place throughout the chain to drive
adoption. And I firmly believe that that really is the only way we are
going to see benefits here.

From a major cost standpoint, I think some of the reporting that has
been done from our perspective does a pretty fair job with identifying
the categories of cost, label changing, project management associated
throughout the chain, some capital costs, particularly if a
recommendation were made to utilize some form of auto identification, be
it bar code, RFID, et cetera.

And perhaps, as has been highlighted, the largest cost truly is a
systems integration cost. And, again, to the point of a well‑constructed
system it is going to be essential to derive this benefit, not only in
the U.S. but globally.

We\'re going to have to make this adoption systematic. This won\'t be
able to be in the vast majority of cases any type of a paper‑based
system. We talk about potentially uses in the EHR, development of
evidence‑based medicine.

And so the systemic adoption and building this into systems from an
integration standpoint is going to take time. And it\'s going to be
quite expensive.

It doesn\'t mean it can\'t be done. However, what I would ask people to
think about is from a standpoint of tying into major systems integration
and upgrade initiatives that are underway for similar or other purposes
as well may be the way to get this done. And, again, I think this is a
theme that we have heard a bit this morning.

For manufacturers, our ERP systems, our inventory control systems, are
on upgrade schedules, we do make continual investments in these systems.
And to marry enhancements like the potential of a UDI with the upgrade
cycles of these systems, which tend to be on something like a five to
seven‑year horizon, seems to potentially present an opportunity to
capture these new capabilities.

From the standpoint of auto identification, I do believe some form of
systemic auto‑ identification is necessary to drive this system as well
to count on removable labels or paper‑based pen and paper types of
systems to capture this system‑wide is probably not realistic and
certainly not realistic in my opinion globally.

And the final piece to add is just from a complexity standpoint. Well,
if we do these things right, the potential for efficiencies may exist.
We do have to keep in mind relative to the drug industry, medical
devices have an order of magnitude, at least one order of magnitude,
more products to be dealt with. And so appropriate timing and
consideration of that complexity must be taken.

Thank you.

MODERATOR KESSLER: Thank you, Paul.

So in a minute I am going to turn over the next half‑hour to you to make
comments. Please remember to come to the mike, identify yourself. Before
I do that, I want to make a couple of comments about just what we heard
from the panel and ask one question.

Speaking of Paul\'s most recent point about making the system‑wide
integration, I want him to be aware that we have spent a lot of time
working with our federal partners. And I have to give a lot of credit to
Michael Fitzmaurice specifically and the Agency for Health Care Research
and Quality, represented by John, who have been major players in helping
FDA move this forward. So it\'s really been terrific.

We have also had a lot of discussion and cooperation with the Center for
Medicare and Medicaid, with the Veterans Administration, with Department
of Defense. And I think it\'s important that if we move forward, that we
do it in a coordinated federal effort.

Having said that, it\'s very interesting we get phone calls occasionally
from parts of the government and they say, \"Oh, I\'m the UDI guy from
this part of the government,\" a week later we get a call from somebody
else in another city and they say, \"Oh, we\'re the UDI part for the
same part.\" So it gets confusing sometimes. The good news is there\'s
only one Center for Medical Devices as far as I can tell.

Let me ask one question of Marcel, if you don\'t mind. Can you speak ‑‑
and if it\'s not in your purview, you can say so ‑‑ for one or two
minutes ‑‑ and maybe John could add to this ‑‑ about the CMS and AHRQ
perspective on the electronic health record. Where are we today? Where
do you think we\'re going to be in three to five years?

As Paul mentioned, if we have a horizon that\'s about three to five,
maybe seven years, although I think seven may stretch the patience of
some of their colleagues, but if we had a three to five‑year horizon, do
we think we\'re going to be in a place where there is an electronic
health record that\'s collected through pre and post‑market surveillance
that is important for CMS that the supply chain can be moving along the
way? Where are we on that?

Marcel, your comments, please?

DR. SALIVE: Well, that\'s one of those questions where I like to answer
by saying that if I did know the answer to that, I would not be working
at CMS.

(Laughter.)

DR. SALIVE: You know, probably I would have a much better job.

DR. WHITE: What could be better than working for at CMS.

DR. SALIVE: I love my job, by the way.

(Laughter.)

DR. SALIVE: Actually, I was at a meeting a couple of years ago. I
thought a visionary person there made a good comment, which was that if
we do nothing, we will have the electronic health record everywhere by
2013. And so that is in your seven‑year horizon.

So I think we\'re not doing nothing. There\'s a lot going on. And so
there are incentives to be built into the system. We have provided some
small amounts of funding at this point I think to selected groups.

There\'s always a discussion at Medicare about new initiatives and how
do they tie into this piece. And so I think that\'s important to
recognize.

You know, we have had discussions with the Orthopods, actually, about
could we somehow facilitate device identifiers being placed on the
billing forms. And I think we said to them, \"The ball is in your court.
You need to push back.\" That\'s not a small task, actually, because
Medicare does not control the billing form.

There\'s now a national uniform billing committee, which deals with
that, but there are some modifications being made to that. And I agree
with the comments of kind of patience and synchronizing things and
getting them right the first time so that it can be successful.

So I do think we will be there, but, you know, the exact road we\'re
taking I\'m not that familiar with that one.

MODERATOR KESSLER: Jon?

DR. WHITE: Well, that\'s where I come in. First, there are a couple of
things I want to say. Mike Fitzmaurice has really been a leader for
this. I am kind of his proxy. So I am grateful for that acknowledgment.
Mike is a wonderful person to work with and has been around for a long
time.

Before I talk about the electronic health record, health IT stuff, just
after the discussion, I realized that it\'s kind of five on one. And
we\'ll talk Paul as one of them.

How many of you are from device manufacturers? Raise your hand and keep
them up.

(Whereupon, there was a show of hands.)

DR. WHITE: Okay. How many of you think that UDI is a bad idea? Keep your
hand up.

(Whereupon, there was a show of hands.)

DR. WHITE: Okay. All right. And so we can start from there. I didn\'t
think that was going to be the case, but I just wanted to ask. And that
helps me think about the discussion report.

Okay. Electronic health records and health IT generally speaking, there
has been a lot of activity in the federal space over the past two years.
It\'s kind of felt like being in a washing machine, frankly.

The Secretary has made it a very high priority. The President has made
it a priority. The Secretary has made it a priority. There are a number
of processes that are moving forward.

There is a federal advisory panel called the AHIC, American Health
Information Community. If you go to the HHS Web site and go to the front
page, go to the bottom right‑hand corner, there is a health information
technology that you can click on. And all the meetings are public. There
are workgroups. Those meetings are all public. You can watch it
streaming if you don\'t want to come to Washington to watch it. So a)
feel free to tune into that, b) There are other federal processes going
on. Two years ago, there was a national coordinator for health IT
appointed. There had been a number of contracts and activities going on
through their office that are doing things like harmonizing standards
relating to medical information, a lot of the things that I think you
referred to talk about medical processes and how do we start to
structure that data, as opposed to, you know, my bad doctor\'s
handwriting, which I have right here on the paper in front of me in a
chart.

Those processes are moving forward. I would be extraordinarily surprised
if we did nothing to have widespread adoption of electronic health
record by 2013. I think we will get there.

The numbers right now depend on the size of the medical group, actually.
For very small groups, it\'s in the single digits. For large medical
groups of 50‑plus, it\'s well over 50 percent. So there\'s varying
adoption, but it\'s out there and it\'s moving ahead. And there are some
processes trying to bring that together.

UDI can plug into that. Okay? There are numerous, you know, for my NIH
colleagues, receptor sites where that can happen. And we can talk about
what the best way to that is later on in the day. But there is a lot of
standardization effort that is moving forward. And we have been involved
in that to a degree. We can talk about that.

The other thing that I just want to really quickly mention is that ‑‑ so
that\'s health IT. There\'s also a quality measurement movement that\'s
been happening at the federal level as well, again, promoted by both the
President and the Secretary with some urgency.

And we\'re starting with things like do clinicians do the right things
for you as the patient and trying to measure that, but that is going to
expand. It will start small, but it will expand. And it will encompass
this field eventually.

Like it was said before, it will happen eventually. But I think there\'s
real opportunity for the folks in this room to be leaders and to
anticipate that and be ready and do some really good things ahead of
time.

MODERATOR KESSLER: Thank you, Jon.

So I would like to open the floor. For those of you who would like to
make comments, please feel free to come to the microphone.

I think we have been challenged in a way. Jon says five against one.
Paul I think challenged us to speak to the patient safety question. And
there has been a lot of talk about the cost issue and not as much about
patient safety. So if someone has comments about that?

MR. PANDISCIO: Could I just make a quick follow‑up comment before we ‑‑

MODERATOR KESSLER: You can. I see no one going up to the microphone. So
I\'m trying to figure out. Maybe I should offer incentives, like a free
510(k) or something, ‑‑

(Laughter.)

MODERATOR KESSLER: ‑‑ or, you know, waive a user fee or something or,
you know, give you a trip to Canada to visit Don Boyer in Ottawa in
January, something like that.

Paul?

MR. PANDISCIO: Thank you very much for the opportunity, just very
briefly and just to be clear ‑‑ and I hope the tone of my voice didn\'t
lead you to believe something that I didn\'t actually say because I
don\'t think that any of the manufactures think UDI essentially is a bad
idea.

I think the case that we\'re trying to put forward is if, in fact,
there\'s a patient safety benefit, let\'s get this right. Let\'s find
out where. Let\'s document it in peer review type of analyses, not do it
in a blanket type of way, and truly get to root cause to really derive a
benefit versus move too quickly in a non‑systemic way that potentially
could cause future work and in the end potentially delay the benefits in
total. So just to clarify that as well.

MODERATOR KESSLER: It\'s great to have industry be concerned that FDA
might move too quickly.

(Laughter.)

MODERATOR KESSLER: I have that on the record.

MR. PLEASANT: Larry, just a comment, just to follow up with what Paul
was saying. I agree with him. I think the industry as a whole has to
work together to make this right.

I don\'t think that we can look at one piece of the industry and say
that that group has to do it and we should put all the burden on them. I
think it needs to be a consolidated effort.

So I\'m not interested in picking on Paul or the manufacturers because I
think we have to work collaboratively to make that happen.

MODERATOR KESSLER: Thank you.

Sir?

AUDIENCE DISCUSSION

MR. SCHULMAN: Hello. My name is Seth Schulman. I work for Genzyme
Corporation.

I actually wanted to make a couple of over‑arching comments, which I
guess are ‑‑ I don\'t want to say that I\'m speaking on behalf of
Genzyme officially because, well, you might not like what I\'m saying,
but you might. But it actually ties in very nicely with the question
that you had posed, John, as to do we all think that UDIs are a good
thing or a bad thing.

I\'ll say that I do think that it is a very good thing. However, what I
do think is a bad thing is limiting the scope of it to devices. And I
say that, and that\'s why you might not like me because it\'s making it
a much more complicated process.

But I think we\'re looking at tracking devices, being able to have
granularities, where they\'re going, recall information, et cetera, et
cetera. There are a lot of similar programs going on with regards to
drugs and devices, such as the Pedigree Program, which is similar. It\'s
related. It\'s not identical. But I think there could be a lot of
overlap in that.

And I think we really need to look at that from a whole supply chain
perspective, a whole customer experience, that we\'re not setting up a
system in a regulatory framework that is going to have to change down
the road as we get more combination of drugs and devices or that we\'re
having hospital supply chains setting up two different systems, one to
accommodate all of the requirements for drugs and biologics and the
other one to accommodate all of the requirements for devices.

I am particularly interested in that because I actually work on a
product which is a device. However, one of the primary distribution
channels is pharmacies and specialty pharmacies.

We have gotten a lot of feedback from our customers in our supply chain
basically saying we want to comply with the Pedigree Program because our
systems are going to require it.

So if you don\'t, we\'re not going to be able to sell your product. So I
think we really need to consider that as distribution channels change
and develop over time that we\'re not putting it into a regulatory
framework that is going to end up being conflicting with the other
products.

MODERATOR KESSLER: Thank you.

Jon?

DR. WHITE: That is an excellent point.

Two thoughts. The first is with the support of CMS, we\'re conducting a
number of pilot studies under the Medicare Modernization Act to set
electronic prescribing standards. And in my spare time, I\'m the project
officer for those. And that is going to be coming out soon.

A number of those issues have raised their heads. We\'re looking at
RxNorm as an example and NDC codes and trying to think about where that
is and should go. And I think if Randy Levin is here, we\'ll probably
talk about that later this afternoon.

The other thing that I want to mention is that we also have a program
called CERTs, Centers for Excellence in Research and Therapeutics,
which, actually, in theory people think about as pharmaceuticals, but
actually extends to covered devices, too.

So at least we fully recognize and support that concept that there are a
lot of modalities. You know, if you talk about devices, you talk about
devices, but there are a lot of modalities that it extends to. So it\'s
a great comment.

MODERATOR KESSLER: Thanks.

Jim?

MR. KELLER: Good morning, everyone. My name is Jim Keller with ECRI. I
had a couple of questions for John, actually, related to the cost
information.

I\'m just curious about some examples related to assumptions that were
made on the two charts that you had in your presentation: the one on
estimated recall savings and then the potential hospital costs of UDI.

I just thought it would be interesting to hear some examples of what
helped you generate those charts. And I assume that there would be
published information at some point in time about that.

MR. EYRAUD: Right. The estimated recall savings, we had a number of
conversations with hospitals about their experiences there. And there\'s
also an estimate from John Hancock. I mean ‑‑ John Hancock ‑‑ Johns
Hopkins ‑‑

(Laughter.)

PARTICIPANT: Different American.

MR. EYRAUD: ‑‑ about their recall experiences, in which they quantified
the amount of time they spent basically trying to execute recalls. That
was probably the most well‑considered number we had.

Some of the other conversations I thought were a little casual. And we
didn\'t put all that complete faith in what some of the hospitals said
because we didn\'t really ask for a formal accounting of this.

We also had some input from ‑‑ well, I\'m not sure if I talked with you,
but I also talked with Dick Fiddleman from RASMAS. And I don\'t recall
if I had a specific data point that went into those specific
extrapolations, but he was sort of part of those discussions.

The other thing was about the hospital costs of UDI. We are mainly
looking at the costs of employing scanners sort of throughout the
hospital to capture the UDI information and put it into electronic
health records. To some extent, we also had some scanning systems
assumed for a purchasing or incoming material in the hospital. It\'s not
quite a comprehensive look at hospital costs, but those are the main
areas.

Does that address your question?

MR. KELLER: That\'s helpful.

MR. EYRAUD: Okay. We can maybe talk at other points.

MODERATOR KESSLER: On my right.

MR. MONROE: Hello. I am Napolean Monroe representing Henry Schein. We
are members of DTA, Dental Trade Alliances; and HIDA, Health Industry
Distributors Association.

Most of the work that has been done, and rightly so, is on the impact,
high‑risk devices, and hospital costs and benefits. We would encourage
looking at the effect on individual practices and on the distribution
network, distributors such as Henry Schein. I don\'t know if there has
been any study done already or if there is any contemplated or if there
are comments from the panel about any considerations that have been
given.

MODERATOR KESSLER: Thank you.

John, can you address that because I am not sure we have handled issues
of distributors.

MR. EYRAUD: We have not gotten far on the distribution chain, quite
frankly. I mean, it has been a lot of interest, but we haven\'t really
had enough information yet or had enough chance to compile information
about it.

MR. MONROE: We are deeply engaged in Pedigree. And, just as Mr.
Pandiscio says, whatever happens needs to be system‑wide because it will
affect down to the individual practitioner level.

The example given in the Federal Register was latex gloves. A medical
device, yes. We distribute a lot of them. And what consideration is
being given to the depth of applicability? Thank you.

MODERATOR KESSLER: So stay up there for just a second. I\'m hoping that
you and maybe the organization who represents distributors would be
willing to work with the FDA and with ERG to help us figure out what
kind of impact it would have and how the system could work to your
benefit.

MR. MONROE: Our interests are the same as yours.

MODERATOR KESSLER: And then back to the latex gloves issue, in terms of
depth of applicability, that\'s actually a technical issue that we are
going to handle sometime later today. So I hope we address that later.
Thank you.

MR. MELIA: I\'m Dick Melia. I\'m a member of the board of the
Hypertrophic Cardiomyopathy Association. And, Larry, you asked about
patient advocacy, your types of comments. I\'ll wear that hat for a
moment, although I worked with Larry before on the FDA.

Up to May, I was Director of Research Sciences for the National
Institute on Disability and Rehabilitation Research. So I guess I have a
little bit of a research orientation as well.

In the last week, I have had the opportunity to attend the third
international summit on hypertrophic cardiomyopathy that was just held
in Minneapolis. And I heard some very interesting reports from the 13
nations that were represented at that conference in relation to the use
of registries and registry information and observational study
information that relates to this heart condition of hypertrophic
cardiomyopathy, which is one of, as you may know, the leading conditions
that is treated by the use of ICDs.

I also have had the experience in the last week of reviewing some
projects at the Office of Science and Engineering Laboratories related
to cardiac resynchronization therapy and related ways of using
technology in relation to serious health conditions.

My point is that we are making great progress in the use of
observational methods and the use of registries to collect this
information. And I believe that the point was made about the diversity
and the many, many different types of devices, many, many different
types of challenges.

I believe there is a great opportunity for using our advances in the
areas of quasi‑experimental designs and observational studies to do
improved research that could bring together the types of quality work
that I have seen that AHRQ can do and that CMS can do.

I\'ve coordinated work with projects that with both of these agencies ‑‑
and I\'ve worked with the FDA in the past and now wearing a patient
advocacy hat, I\'m very optimistic that improved models of
quasi‑experimental and observational work can give us information that
we vitally need in this area.

Thank you.

MODERATOR KESSLER: Thank you.

Comment from the panel? Okay. Jon?

DR. WHITE: I\'m full of comments today. Cardiothoracic surgeons have an
excellent registry. I don\'t know how many of you know that, but they
for a number of years have been very carefully tracking outcomes,
procedures, a number of things. I\'ve come across this in the quality
measurement world.

There is great data available on registries. All data is not the same.
And the level of structuring that data is critical. There are great
opportunities, but I don\'t want to assign too much hope, you know, the
belief in new and shiny things that without some hard work, it will just
happen. It can happen, but it\'s going to require some serious
forethought.

MODERATOR KESSLER: Marcel?

DR. SALIVE: Yes. I think I would just link that comment to the earlier
comment from the gentleman from Genzyme and say that, you know, complex,
very sick patients have multiple co‑ morbid diseases and a lot of
different therapeutic strategies being applied to them.

I think when we\'re trying to conceptualize tracking all those
strategies, some are devices, some are maybe drugs and biologics. Others
may be even things like cardiac rehab, which doesn\'t have anything as
far as I know that the industry provides. Maybe it does these days.

So I think tracking all of that at the patient level is going to be very
important. And being able to link that and know because sometimes it\'s
a confounding factor, sometimes it maybe enhances the results of the
device. You know, we don\'t really know at this point. There are a lot
of hypotheses that we can look at in this if we get this data collected.
And, really, ultimately that is the issue, how do we get it aggregated
at some larger level so that it can be looked at this way.

I mean, I think the day‑to‑day patient management issues are very much
on the forefront of the developers of technology for EHR, but the next
step is this public health impact question.

MODERATOR KESSLER: I think one of the issues we face is while I think
the area you raised is very important, trying to estimate not only the
theoretical but the practical benefits we would see from that has been a
challenge.

Over here?

DR. SLOANE: Elliot Sloane, Professor of Information Systems at Villanova
University\'s School of Business. I\'m a voting member of the Health
Care Information Technology Standards Panel, which is on behalf of the
Secretary of Health and the President, working on moving the electronic
health record forward.

We had our first significant but not giant step forward by vote last
week. We put forward recommendations for the first part of the standards
for the first deliverables for prototype testing next year for an
electronic health record. That\'s a portion of the electronic health
record that we all envision.

We also by vote last Friday created a priority list to go to the
Secretary of Health and to Dr. Colander regarding the priorities for
next year\'s accomplishments and achievements. And in that, the
200‑member panel by consensus agreed to include medical devices as a
priority area for inclusion in the next generation; that is, next
year\'s definitions for the electronic health record.

And I would like to know from the panel, do you see that as a priority?
And if so, are you willing to encourage, I believe, those decisions for
setting next year\'s priorities will happen in the next month? Do you
see that as enough of a priority to voice those opinions to the
Secretary of Health so that the medical devices are on that list?

DR. WHITE: Is that going to be presented at next week\'s AHIC meeting to
the Secretary?

DR. SLOANE: That is correct.

DR. WHITE: Okay. All right. Is your expectation that if that is set as a
priority that there will be standards that can be harmonized or that the
group would potentially come back to the Secretary a year, year and a
half later and say, \"Standards do not exist. You need to have some
process for developing standards for it\"?

DR. SLOANE: That\'s correct. What should come from AHIC or AHIP, I
guess, is the next ‑‑

DR. WHITE: AHIP is America\'s Health Insurance Plans.

DR. SLOANE: I\'m so confused. Keep the acronyms straight. HCITSP is
supposed to receive a mission statement that tells us which standards to
work on for the end of September of 2007, to then be piloted and applied
in 2008.

DR. WHITE: I think it\'s a great lever to move forward this discussion
is my short answer. Of all the various contract activities that are
going on to the national coordinator\'s office, I have the greatest
faith in the HCITSP process. So I\'m really glad you\'re here, actually,
a number of excellent people working on it, great community to come
together and enter that.

The Secretary has placed priority on that. So as much as we say, you
know, #you really ought to do that,# your comment probably carries
equal, if not greater, weight, and the group\'s feedback to the
Secretary. And ultimately it goes to the Office of the National
Coordinator and Dr. Kolodner, as you mentioned, but I think it\'s a
great lever to move that forward.

MODERATOR KESSLER: Paul, did you want to comment?

MR. PANDISCIO: Yes. I would certainly support that. I think that\'s good
news. And I think we again in the medical device area have to get ahead
of that, rather than waiting until it\'s legislated and required and
people start doing their own standards. So let\'s get on with doing
standards now so that we\'ll be prepared when it\'s really time to put
it into the health record.

DR. HENSTEN: Thank you.

My name is Arne Hensten. I am from the University of Tromso in northern
Norway. My background is quality control of dental materials in the
Scandinavian countries, in IOM, Scandinavian dental materials.

And our experience is that when we\'re trying to identify what has gone
into patients. We meet a lot of problems. One is that dentists have
forgotten their material science they\'re working on: water, air, soil,
and fire, and maybe dental amalgam as the fifth element. And we\'re
trying to get into a better context.

Now, building, looking at the quality control of dental materials we
find that manufacturers are also in a situation where they say that
products may change but brand names are forever. Having it that way
makes it difficult to really go in and do any kind of sensible risk
analysis or whatever is put into a patient.

Building a new dental school with 100 chairs up there, I now have the
opportunity to implement a full quality control from the central
sterilizing unit to the materials used to the patient, and also all the
devices used to the context and for the medications.

The thing we find difficult in this situation is to write a good
specification for what kind of literature used for medical devices or
whichever one. And I would appreciate any kind of help in getting the
facts down on paper to how to really write the specification where you
put it in all of these quality aspects into the system that will benefit
the patient hopefully at the end.

Thank you.

MODERATOR KESSLER: Thank you.

MR. PANDISCIO: Excuse me. A quick comment to that. Just to reiterate,
you know, I think to help drive the efficient use of data, right, I had
mentioned earlier sort of a consolidation of global standards. And truly
getting it right is certainly a piece of the answer here.

Just a quick anecdote of my own on behalf of Johnson and Johnson, this
time for medical device products. We have many, many, as many of you
probably well know.

We currently bar code label with a bar code identifier, product
identifier, well over 90 percent of our products, all the way down to
unit of use, far over 90 percent.

The issue again back to the systemic uses, a fraction, I mean, a very
small fraction of that, is really read and inputted into a system and
integrated globally.

So, I mean, just another anecdote. I think manufacturers are willing to
do things to drive efficiency, to look for other benefits that may exist
that data supports. But I do think a consolidation of standards in
partnership with all of the different nodes of the supply chain is not
only unnecessary, but it\'s an absolute must ingredient to get this
right.

MR. LITTLEFIELD: Good morning, everybody. My name is Patrick
Littlefield. I am from WaveMark. We are a company that is currently in
market doing work with a process supply chain in EDI space.

What I would like to say is as an initial observation, the discussion
appears to be largely focused around the cost and appears to my
perspective to be light on benefits.

I would encourage both the FDA and the participants to continue to look
at the benefit side. Our work in the market suggests that the supply
chain is rich with opportunities for both participants. That is, the
providers and the device makers to benefit. And I firmly believe that
with proper kind of regulatory framework and guidance, market forces can
be harnessed, such that this is actually a win‑win and not simply a
subcost?

I want to recognize obviously investments will need to be made, but I
believe that systematically there are rich opportunities here for
everybody. Again, properly framed, the market can help get this job
done.

MODERATOR KESSLER: Thank you. I think we echo your sentiments in trying
to figure out how to get from here to there. So some day we would like
to be able to work with you on that.

Don?

MR. BOYER: Good morning. Larry mentioned that there was somebody here
from Health Canada. That is me. My name is Don Boyer. I am Manager of
the Licensing Services Division in the Bureau of Medical Devices.

The reason I am here, as most of you should know, Canada introduced a
new set of regulatory requirements in 1998. I worked on a working group
beginning in 1992 which put together 16 regulatory proposals for the new
regulatory framework in Canada. And in conversation with the FDA about a
month ago, I was happy to dust off one of our regulatory proposals dated
December 1995, which called for a bar code identifier in Canada.

That is why I am here. We are still very interested in this initiative.
Unfortunately, Canada being an importer nation, population about 30
million people, we import about 70 to 80 percent of our medical devices.
It\'s very difficult at that time to convince industry that they would
need to bar code every single one of their medical devices. So it did
not fly at that point in time.

However, you will notice in our medical devices regulations that each
medical device on its label must contain an identifier. We were able to
capture the word \"bar code\" in there. However, it says a unique or
combination of letters and numbers or a bar code identifier. So it is in
our regulations. It just is not used at this point in time. So we\'re
ready to go when you\'re ready to go.

I would agree with everything that I have read so far that has been
published by the FDA on this. Two things I wanted to mention from
Canada\'s perspective. Because we are an importer nation, one of the
major reasons we wanted this identifier was for import control. I
haven\'t seen that yet in anything published coming out of the FDA, but
being an importer nation is very important.

We don\'t have the resources at the border to be able to scan product
coming into the country to verify its regulatory compliance before it
enters the country.

The other initiative or the other thing that was mentioned in our
proposal of 1995, it would be a good way for users of medical devices to
verify the regulatory compliance before purchase through some type of
unique scanning system.

The last comment I want to make is I want to just echo Paul\'s comments
on the panel there. I believe it is extremely important that this
happens at an international level. However, sometimes things that occur
at the international level take a long time to get design developed and
implemented.

I do agree there are forms out there already, whether it\'s global
harmonization task force or ISO or some other mechanism. That\'s the
area which we should be starting at.

Message to the FDA: Please keep us involved in this process. We\'re very
interested. Thank you.

MODERATOR KESSLER: I want to thank Don for coming and acknowledging the
fact that we\'re about ten years behind the thinking of Health Canada.

(Laughter.)

MODERATOR KESSLER: And, as Joe was saying, we\'re probably a decade or
more behind the grocery industry. So it\'s easier for them to identify
that the 14‑ounce box of Corn Flakes is on sale this week and we can\'t
figure out what implantible cardio defibrillator went in someone last
week at a cost of \$26,000, so fascinating.

I think the last two comments, I will do Sandy first and then Bernie.
And then we\'ll take a break. So you guys are between us and a break.

MR. WEININGER: Thank you.

Sandy Weininger from the FDA. I just want to make a few brief comments
to tie this very strongly to safety.

We do an awful lot in the agency trying to figure out whether hazards
were appropriately mitigated and what the consequent risks are and what
the mitigations are acceptable.

And if you can\'t even figure out what the particular product
configuration is, it\'s really hard to do something about it. And so in
a number of databases that we have, we just can\'t figure out what is
the device consistently from product to product.

So from a safety perspective, I mean, I can\'t show you an article or
evidence that points that out, but I think an intellectual argument
could be made fairly easily.

Thank you.

MODERATOR KESSLER: Thank you.

Bernie, last comment.

MR. LIEBLER: Bernie Liebler from AdvaMed.

I want to make a comment on the framing of the question a bit because
earlier I forget who on the panel asked the device manufacturers \"Who
of you think this is a bad idea?\"

That\'s a little bit akin to the old joke about \"When did you stop
beating your wife?\" You know, the question might more appropriately
have been \"Have we made the safety case appropriately? Is it
compelling? And is it convincing?\"

Janet Woodcock said, \"We don\'t have the kind of data for device errors
that we have for drug errors, but we do have the solution.\" And I\'m
not sure that that\'s compelling either.

I\'m also going to tell one short story. I had an incident this summer
that I would have preferred not to. I was in a major health care
facility in northern Virginia. It\'s brand new. It\'s about a year and a
half old.

They did invest heavily in it. Each bed has its own PC installed for
entering data into the patient record. There are no charts. There also
are no bar codes.

When they came to administer drugs, they checked the patient number on
the wrist band. They asked you your name. They checked it against what
they had. They asked you your date of birth. And then they gave you the
medication.

They did not use bar codes. This facility is about a year and a half
old. So if bar codes are the panacea, why was it left out of that
design? I don\'t know, and I\'m not saying they\'re bad. I mean, my
point is we have to frame the issue. And are we getting to the right
place the right way?

Frankly, eventually yes, the answer is that we probably will be doing
everything electronically because that\'s the way we do it. But let\'s
do it right.

MODERATOR KESSLER: Jon and then Marcel?

DR. WHITE: I asked the question earlier. And I would probably make it
more akin to the question of when are we going to stop beating the
patient because the issue is that we don\'t have the data. That\'s
correct. And I don\'t want to make assumptions based on absent data.

But ultimately the reason I became a doctor and the reason that we all
do what we do is to provide health care. And ultimately that means to
patients. And I feel like it\'s my professional responsibility to them,
not just as a doctor but in representing the public interest as a member
of the federal government, to say we need to recognize that there is an
issue and we need to do something about it.

I would want to do it in a thoughtful way. Okay? I mean, that\'s not
about slap dash stuff. But I am about let\'s do something about it. So
agreed.

MODERATOR KESSLER: Okay.

DR. SALIVE: Can I?

MODERATOR KESSLER: Marcel?

DR. SALIVE: I wanted to just say I did start working back when at FDA in
vaccine safety and was part of the bar coding workgroup for that, which
I know has accomplished a great deal probably.

I think I will answer the AdvaMed comment with this. Okay? Look, you
don\'t want to be in the position of blocking this by saying there\'s no
data on patient safety. I know you didn\'t say that, but you want to be
proactive on patient safety because you don\'t want the Vioxx equivalent
in your industry, whatever that may be.

You want to prevent that. You want to be able to prevent it proactively
through all your systems. And this is just one of your systems to
prevent that. It\'s not a big one. There are many others that I know are
much more important. But you don\'t want this situation brought up by
the previous speaker by FDA. You want to know which patients have which
products.

So this is true. It was brought up at the very beginning that people are
not good at recording in the record what device they have implanted into
patients or justifying why they chose among some choices. And so you
have to be able to track this to know whether something is true, related
to the product, or not. And you need to be able to do that. It\'s vital
to your company\'s survival, frankly.

I think that\'s the business case. You don\'t necessarily need evidence
of prevention. I mean, I understand that you need a business case, that
it needs to be doable.

MODERATOR KESSLER: Thanks.

So a few little, tiny things. First, if you\'re sitting next to a chair
that\'s empty and you happen to have a coat or a briefcase there, there
are some people who don\'t have chairs.

So at the break, please pick up your coat ‑‑ if you want to hang it,
there are hangers on both corners ‑‑ so we can free up a couple of
seats.

Number two, we have lowered the temperature a little bit. We thought it
was quite warm. If it\'s either too cool or too hot, tell Dave in the
back, and we\'ll try and readjust. But it was getting a little warm. And
we figured with all these people, it would get warmer as the day went
on.

We\'re going to take a break for 15 minutes. You will hear us yell at
you in a few minutes.

And, finally, please let\'s thank the panel for their presentations.

(Applause.)

(Whereupon, the foregoing matter went off the record at 10:41 a.m. and
went back on the record at 10:58 a.m.)

MODERATOR KESSLER: We\'ve talked about cost. We\'ve talked about
benefits to some degree in I guess a limited way about you need device
identification issues.

Even though we are going to stray away from that to talk now in the next
panel about practical implementation, if you do have subsequent comments
about cost issues or benefit issues, please feel free to continue to
raise them during the day.

We\'re going to turn now to Chuck Franz, Vice President and CIO of the
Cook Group. Chuck?

DESIGN AND IMPLEMENTATION OF A SYSTEM OF UDI

PANEL DISCUSSION

MR. FRANZ: Good morning.

MODERATOR KESSLER: Good morning.

MR. FRANZ: Jay and David Racene asked me to speak today. I spoke with
them in March. What you will see here is Cook is a privately owned
company in Indiana.

And we faced this subject many years ago. And we made a changeover in
our system, much like my colleague from J&J commented on, about every
five to seven years you\'re looking at your supply chain. You\'re
looking internally and externally at the correct things to do. So what
this presentation will show you is some of what we went through and the
decisions that we had to make.

A personal story. Back in 1988, way back then, we had developed a bar
code system at Cook. And we\'re hearing from the marketplace in the
field that it had to be a certain style and it had to be implemented a
certain way.

I ventured out into many institutions. And what I found is the problem
that we still have today that has been talked about. And that is that
within the institution, one area said, \"Yeah, that would greatly
benefit me or us.\" Maybe that might be the surgical suite.

I went up to the critical care suite. They said, \"No. You don\'t need
to put that on there because we do our own.\" And, sure enough, they had
their own bar code printer. Every product that entered that suite, they
put their own bar code on it.

I don\'t know how far we have moved in the health care setting today,
but it\'s still the problem. The problem is having a global standard
that all of us as manufacturers, all of us as health care providers can
agree on, can support that ultimately is going to benefit the whole
health care supply chain and patients in the end.

This occurred about two to three years ago at Cook, but we boiled it
down to two different things. We used bar codes in the late \'90s and
early 2000 or RFID. There were several things that we kind of were
looking at. Do we change over? How do we change over? And what do we do?

We chose bar codes, to stay with them, for various reasons. But you can
kind of see our rationale down there on the RFID side. It\'s not always
compatible: potential interference, potential frequency interference.
And it\'s more costly than the bar code situation.

If you think of the global health care solution, we had better be
thinking about everywhere in the world. We had better be thinking about,
you know, Africa. We had better be thinking about Canada. We had better
be thinking about the U.S. We had better be thinking about Asia. And is
RFID, and the systems and the cost, available today everywhere in the
world? So, again, our decisions were taken about two to three years ago,
but those were the kinds of questions we asked ourselves.

Again, this is a Cook look at things. It\'s not an FDA look at things.
But this is what we looked at at Cook. And just to give you a little
idea of the changeover and the switchover and the scope of what we were
dealing with, in 2001, when we looked at this, we had 27,000 part
numbers. And we have reduced that to 17,000. So somewhere in between
there is the amount of products that we had to apply this code to and
change over within our own internal system.

EAN stands for European Article Number. Okay? So we got this out of
Europe in 2001. And there were requirements in Japan that this needed to
be on our product labels.

By April of 2002, we had converted over all of those 17 to 25 thousand
part numbers, let\'s say, and then launched it globally to our customers
in 2003. Okay? So, again, I\'ll go into a little bit more detail on the
amount of time that it takes and the troubles that we had.

But going back to the \'80s, again, do people use them today? From
industry\'s perspective, a very, very small amount use them. Internally
at Cook, this is all we use. This is the only thing we use.

And I\'ll show you all the things that an EAN code can give you
information on. And there\'s a standard that\'s set. But does the health
care industry use them? A very, very small percentage. And I\'ll give
you an example of that.

This is a breakdown of an EAN code. This is not everything. I think the
decision that has to be made globally again is what information needs to
be collected, what do we have to collect?

So far, again, in evaluating all the bar codes out there, the EAN codes
back in 2001, 2002, 2003 supplied far more information than the other
bar codes that were out there those days.

As you can see, it has an identifier on the front end. It labels every
manufacturer. The 00166 is actually a product number. And number 4 is a
check digit there on the very end. That\'s the basics: manufacturer,
part number.

That\'s just basic. If you get into now as you move on down through that
code, that\'s where you get into patient safety. We\'ve talked a lot
about the cost‑effectiveness and everything, but if you move into this
code and what it can do for you ‑‑ and when we looked at it, it didn\'t
matter which code it is. I\'m not up here saying everybody in the world
has got to go to EAN, but this is the kind of data. If you want to help
patients and you want to help the health care industry, we\'ve got to
get to the lot number level. We\'ve got to get to that unique
identifier. I\'m sure that any manufacturer in here is going to stand up
and say, \"We want to get there, too, because it helps us track our
product.\"

But, as you can see, you have an expiration date of that product. Each
one of those things in parentheses is what they call an application
indicator. Okay? So it tells what\'s coming next. You\'ve got a
packaging indicator. You actually have what we call a lot number or a
batch number down there at the bottom.

There\'s also an application indicator. And, again, our lot numbers
depending on the device, some of them are unique to a singular patient
and some of them are built in lots of 100. So this code supports both.
Okay?

You can actually get to application indicator 21. I\'m not going to get
into it but where it actually goes into a very specific unique
identifier. It\'s not on this sheet, but the EAN code is very, very
flexible and can support many, many different things, either down to a
patient or via lot number if it\'s a wire guide or a catheter.

Again, when you get to that lot number, that\'s where if ‑‑ just think
of a day. Unfortunately, every manufacturer has a recall of some sort,
labeling problem or something. Just think of a day where today currently
we as manufacturers supply to the FDA, to every regulatory agency,
\"Here are the lot numbers affected.\" It\'s then our responsibility to
notify the user base or the customers.

What a great thing it would be if you talk about patient safety if the
FDA or the Canadian government or the European government could work in
concert to get those devices back.

That\'s what a unique identifier system is. Right now it\'s
manufacturers trying to get them back. You know what? I don\'t think we
always get them all back. But if we\'re all in it for the patient, then
if we had this unique identifier system globally, then we all could work
together, regulators as well as industry.

Required materials. Just real basically, a cost of an EAN number is
dependent upon your sales. So it goes from \$750 to \$50,000. What I\'m
trying to show here is if somebody were to start this up, very basically
this is what it costs to set up one small, little bitty site.

So if you are a very small manufacturer, you would probably be on the
lower end of that scale, \$1,000 to get your EAN number, maybe \$5,000
for a printer and a scanner, set up 2 hours validation a week. I mean,
it\'s not that difficult.

Larger‑scaled manufacturers, ourselves included, that\'s going to cost a
little bit more. And so all the costs you heard earlier are very, very
valid. But when it comes down to helping that patient, let\'s say some
manufacturer somewhere in the world comes up with a great device. They
have one device, and they manufacture it. They could do this for this
amount of money in an IT implementation.

To go a little bit further into our implementation, again, back in 2001,
2002, and 2003, whenever we chose the market that we went into ‑‑ and,
again, they weren\'t all the same ‑‑ we would notify the market 3 months
in advance.

Some people have said to me or told me internally at the company,
\"Well, you can\'t change that because the customer won\'t like it.\"
And, again, that\'s where you find out the very small percentage of
people who are using the bar codes that you put on your product today
because I can probably count on two hands the amount of customers that
said, \"Help me with this transition.\"

But we basically notify the marketplace three months in advance, worked
with those individual customers that had the problem, then switched
over, helped them switch over their readers.

People think that you have to buy all sorts of new stuff. You don\'t.
The readers are there. The scanners are there most of the time. You have
to change what is being read within the hospital.

But, again, there is no unified standard in the United States as well as
many other markets in the world that we could standardize all those
things to. Okay? And, again, that comes down to what are the trackable
or traceable items that should be designed in a system?

The company switchover, I went through that a little bit earlier, but
that took ‑‑ at each location, we have eight ‑‑ about a month to turn
that over. And, as you saw earlier, globally that was 12 to 15 months to
implement what we call our unique identifier.

The customer switchover, I\'ve got question marks there because some
customers use it, but, again, it\'s a very, very small percentage. So I
think it\'s still ongoing from 2003.

Questions and panel discussion, but this is what it looks like on our
label. It\'s down there at the bottom. You can actually see the EAN
code. Again, whether these are read into a system, peeled off and placed
on a patient\'s chart or whatever, it\'s the key of identifying the
product, the batch number is where safety comes into play.

Thanks.

(Applause.)

MODERATOR KESSLER: Our panelists include Michael Dempsey from Partners
Health Care, Lu Figarella from HIBCC, Leighton Hansel from Abbott
Laboratories, and John Terwilliger from Global Standards One. And I\'ll
start with Michael.

MR. DEMPSEY: Hi. My name is Mike Dempsey. And in the interest of full
disclosure, I have to say that I founded a company five years ago called
Radiance that makes an active RFID system that\'s basically an indoor
GPS.

Although I sit in front of you today as a representative for Partners
Health Care and I\'m not an employee of Radiance anymore, I do have an
ongoing relationship with Radiance.

Radiance has deployed approximately 20 to 30 hospital‑wide
implementations of active RFID systems to track things. So we can talk
about that if you\'re interested, but that\'s not really what I\'m here
talking about here today. I\'m here representing Partners Health Care.

This summer I made a transition. And I\'m spending most of my time
working at Partners now. And Partners has something called a positive
identification standard. This was work that was started in 2004, so
originally started to positively identify patients and drugs to avoid
medication errors.

It turns out that the way it was designed was quite flexible, quite
XML‑like for the software people in the audience. And one of the things
that we wanted to do was not only identify the drug but be able to
identify dosages and some very specific information about the drug and
then use that information to automatically program infusion pumps. So
the implication of that is we needed to know what type of infusion pump
it was so you could program the infusion pump.

So we started with positively identifying patients and drugs and evolved
into identifying infusion pumps. And now the positive standard
identifies in patients, identifies patients, employees, drugs, both IV
drugs and non‑IV drugs, and devices. And, as it has turned out, that has
been a pretty powerful tool.

So now a clinician, for example, can walk up to a vital signs monitor.
And there\'s a 2D bar code on the front of the vital signs monitor. The
clinician shoots ‑‑ we\'re using the symbol MC50, which has a bar code
reader on it ‑‑ shoots that at the bar code on front, on the front of
the vital signs monitor. And it\'s essentially a speed dial.

So it says, \"All right. This is a CAS 740 monitor.\" It isn\'t normally
network connected. But the PDA can connect to it, capture the vital
signs, and push it into the electronic medical record.

If she scans, for example, a bag of IV medication in the 2D bar code on
the IV bag, there\'s the appropriate information about what was mixed
up, what the concentration is, what the dose rate is, and so on.

Then she can scan a smart infusion pump. And it says, \"I know this is
an Alaris pump or a Sigma pump\" or whatever. The PDA pushes that
information directly into the pump. And all the clinician needs to do is
just confirm that yes, this is for patient John Doe. This is insulin at
this rate.

Notice one of the subtleties in there. There\'s no ubiquitous network
connection that\'s required to make this happen. So we are in the
process of rolling this out. It\'s not ubiquitous yet by any means
within the Partners Health Care system, but there are some early very
positive outcomes of it. So if you want to talk more about it, grab me.

Thank you.

MODERATOR KESSLER: Thank you.

Lu?

MR. FIGARELLA: The accent you hear is the Spanish version of this also
available in SAP if you dial.

I am the co‑chair of the HIBCC Auto ID Committee. At this stage my wife
refers to it as my entrepreneurial stage. I come here not only as sort
of the Hair Club for Men, not only as somebody involved in it but also a
user.

I\'m a co‑founder of a surgical video microscope company. And so when
Larry mentions things like 510(k)\'s, I shiver, although I almost stood
when he made the offer, also a company that allows you to print your
tickets for events at home. And it kind of spread because my background
is really in auto ID.

And I was previously with RVSI ID matrixing vendors, so the data matrix.
I showed up there in time to work on this ECC‑200, which usually means
that you get to raise your hand for a couple of the positions.

Before that, I was with UPS. And, actually, when somebody mentioned
1988, you know, I was actually in a lot of places. Back when I started
with UPS, there were no bar codes on the packages. And so I look at all
of these things that we refer to as UDI system and data, et cetera.
We\'ll talk a little bit more about this in the afternoon and the
technicalities of it.

I look at it the same way that I did at UPS, which is a lot of the
stuff, you know, you would be amazed how much push you have in the
beginning from some of this stuff and once you make a nurse\'s job
easier, how quickly they become your new best friend if you did make
their job easier.

But when somebody looks at a design implementation of UDI, you know,
from a HIBCC perspective, I come to tell you that, as we mentioned back
in 2002, when the drug bar code was being discussed, that level of
uniqueness is really important. You know, you really have got to go all
the way this time if you\'re going to do it and really be able to
identify individual items because if you cannot separate one coffee cup
from the other coffee cup, you get some benefits, but you are putting
people through a lot of work. You might as well get all the benefits. So
a unique or a lot number is going to be a really important element of
what we\'re trying to do here.

Also, you know, we are an ANSI committee at HIBCC, the Auto ID
Committee. So, you know, they send you threatening letters if you don\'t
say good things about ANSI.

So at this stage, you know, you have to also ‑‑ when we sit here and
talk about global standards and all that, we have to take a moment to
look at what exists out there and what level of ISO standards are also
available that you can sort of piggyback on a number of these things.

You know, auto ID is a link to good data. And it has to be an important
part. You know, nobody fears that a UDI message gets garbled, but, as
one of the previous panelists mentioned, if you really think that
somebody is going to enter 15 numbers and not get it wrong, the dyslexic
engineer in the room has to tell you that it is just not going to
happen. People can\'t enter a Zip Code right. Forget 15 digits.

And, finally, you know, I would be remiss to say that, as we mentioned,
HIBCC is an option for thousands of labelers of devices. And, you know,
you sort of get a little bit of a price break on the numbers that you
saw there. Come see us, and we\'ll give you the details.

MODERATOR KESSLER: So before Leighton Hansel talks, Leighton has been
with Abbott for a few years but for a few centuries before that was at
the FDA. And we all worked for Leighton at one point or another. So I\'m
glad to introduce Leighton Hansel.

MR. HANSEL: Dr. Kessler, thank you for those kind words. You date me.

Even though I work for Abbott, I am here today representing AdvaMed. My
thunder was stolen by the last panel, Joe and Paul, the importance of
existing standards that are in place. The voluntary process can take
time, but it does eventually produce solutions that can endure over
time.

Having been involved in the standards process, I am convener of a study
group, Workgroup 3, which does symbology. And I never appreciated
symbology until I rented a car in Germany last year and the instructions
were in German. But, luckily, everything had a symbol on it which I
could figure out. So globalization is important, as was mentioned in the
last panel.

You know, Dr. Kessler\'s group is responsible for coordinating the
standards activities at CDRH, but I think that this effort is going to
involve nontraditional partners, supply chain, and people that maybe
normally aren\'t part of a regulatory authority\'s process to have this
work because I hear all of these separate groups talking about what
they\'re doing and I\'m sitting here wondering, are they talking, you
know, are they aware of what everyone else is doing because I think that
industry, I think the health care community, there has to be a known
strategy of where we are, where we\'re going so that people can start
planning.

I know that when DOD decided to require UPNs, that probably did a lot
for getting bar codes on expendable products. Now it\'s going to take
some incentive to have the bar coding utilized beyond the supply chain
at the hospital door.

And I think that the work that FDA has done with their two studies last
year in the work from ERG, I think they certainly have a good sense of
the challenges and the issues. But it\'s going to take everybody. It
just can\'t be the regulators, the device manufacturers. It\'s going to
take the health care community and other groups that provide support for
those groups for this to be successfully moved forward.

MODERATOR KESSLER: Thank you.

John?

MR. TERWILLIGER: It is a real pleasure to be here today. Before I start,
I\'ll probably just give you a little background. One point is I have
had the pleasure of being a medical device person in the standards world
in both manufacturing and distribution.

And another thing that is really exciting about today is since I have
been with GS‑1, almost ten years now, we have been talking about the
benefits of bar coding for patient safety.

And to actually have a discussion like this is almost like a culmination
of ten years of the work. So I really applaud everybody for this because
I assure you when we first used those phrases about ten years ago,
people used to look at me like, \"Are you out of your mind?\" I mean,
things have changed an awful lot. So I did really want to share that.

A little bit about I am here representing GS‑1. I am specifically from
GS‑1 U.S. here in the United States. I think it is important to
recognize that standards for UID per se for medical devices already
exist. And they are GS‑1 standards. They are broadly implemented.

We have here in the U.S. alone over 18,000 health care members spanning
both retail health care, also medical device, medical, surgical, and
pharmaceutical, which really is a broad breadth. And then around the
world, we have thousands more.

GS‑1 is a federation of over 100 member organizations around the world.
Each is focused on implementing the same standard. And also our global
organization perspective is we develop global standards. We do not
develop national standards.

And we have a number of health care groups populated by our members and
other users to really do that. So I want to get at that kind of global
element.

The other thing I also would like to note from that perspective that UID
standards already exist, since the 1970s pharmaceuticals have been
identified in the National Drug Code, as mentioned, and bar coded using
UPCs, Universal Product Code, which is actually a very simple way to
talk about a global trade item number, which has been mentioned in the
earlier presentation here.

G‑10s are a way to identify products. And G‑10s are the most implemented
product identification standard in the world, bar none. We estimate over
10 billion transactions are current each and every day around the globe
using these standards.

It has also been noted, I think, if you look across medical devices, a
great amount, maybe even most, are already identified, bar coding. As
Paul Pandiscio mentioned, they are at 90 percent. Other large
manufacturers are probably in that range. So much of the stuff is
already identified today with the UDI.

I think it\'s important to recognize what\'s really common out there is
the G‑10, which I mentioned before, the global trade item number, lot
numbers, and expiration dates. And then things can also be with serial
numbers as appropriate. Certain products would not require some number,
but we also have a way to do that, too.

I would like to mention one little thing, to make a distinction between
identifying items and identifying instances of items. When we start
talking about G‑10s and lot numbers or product identification, lot
expiration date, you\'re really talking about identifying the product,
not the instance of the product. I can\'t distinguish one glass or
another glass, one medical device from the same thing of another one.
That really requires some sort of serialization approach.

Those are two very different issues. So identifying products is actually
a very straightforward thing and very relatively inexpensive, as already
mentioned. When you move into serialization, the cost starts rising. I
actually will come back to that in just a second here.

I think it\'s also important to note, as mentioned, about some of the
benefits of pursuing UDI for the hospitals is really about supply chain
efficiency, in addition, of course, to patient safety.

GS‑1 standards really do cover all of those various things that
hospitals buy and other providers. Please remember that health care
providers buy a whole lot more than medical products, includes things
such as office products and housekeeping supplies and food service and
on and on and on.

And by embracing a broader standard including those, it drives the cost
down to implementation and really gives hospitals and other providers an
incentive to really capture everything. And that really should not be
lost here because the more you can use this investment to read bar
codes, et cetera, or RFID tags. It really makes it much cheaper and
really gives you kind of end‑to‑end solution for hospitals.

Also, as I mentioned, a little about RFID. We have a portion of GS‑1
called UPC Global focused at driving implementation of RFID tags for
identification, which has really changed significantly how products are
identified and really get at the serialization issue of identifying
every unique instance very simply because that\'s the very nature of
RFID. It also makes it much easier to collect up data.

One of the down sides of bar codes, of course, is they have to be
scanned on a time. RFID would allow us to basically capture this
information without really having to scan it per se but kind of run it
by the reader and it picks it all up, which can save considerable
amounts of effort. And it\'s really part of a progression of what\'s
occurring in the marketplace cross many products in many industries is
bar coding to RFID.

I really think that there is an opportunity for the FDA here to really
kind of embrace this concept of identification and really leave it up to
industry groups to work through this progression of as things migrate
from one data carrier to another bar code for this RFID. I know we\'re
going to talk more about that this afternoon. I think it\'s important to
recognize that.

I would also like to mention another thing. I think that there\'s a
wonderful opportunity here for the FDA considering rules here to really
drive the identification of all medical devices at all levels of
packaging.

Now, I would like to fully recognize something, that certainly there is
a wide diversity in medical devices in size and criticality, et cetera,
et cetera. And also certainly the cost and complexity of identifying
items is going to vary a lot, no ifs, ands, or buts about it.

But I think our objective should be to drive wherever possible, and I
think also we should recognize that some items, like an individual
cotton ball, probably don\'t justify a bar code. I mean, that would be
probably a little silly. We could do it, but I don\'t know if it gains
us an awful lot.

And I really would like to propose that the exception rule that that#s
underneath the current bar coding rule for drugs and biologics will be
put into place really to allow industry and/or through our health care
user groups to come back and propose this exception in certain areas.

I think we certainly are not going to identify today in one single pass
incentive, but I think as we work through industry, we really come forth
and really put those on the table.

One last thing. Concerning implementation, there has been a lot talked
about how hospitals and other health care providers really have not used
the bar code that manufacturers put out there. I would like to take a
little bit longer view on that.

And, really, by the FDA moving forward with this and ensuring the
ubiquity of marketing critical mass really resolves an issue for most
system of process. If you don\'t have everything kind of done one way,
it becomes very difficult and you are always working exceptions. So
moving forth removes that and will make it much easier to implement.

I think it is also important to recognize when the Universal Product
Code came out in the early 1970s, it took over 10 years for it to be
broadly adopted in the industry. Now, all of us in this room, for
instance, say, \"Well, it\'s always been there.\" Not really true. It
took about ten years to be really ubiquitous.

I will share with you, though, two things. One, Business Week issued an
article in the early \'80s that basically said the failure of the UPC.
On that one they ate their words. They were very wrong. It just takes a
while sometimes. So let\'s not forget that.

Thank you.

MODERATOR KESSLER: Thank you very much.

I am going to open up the mikes in just a second. I have a couple of
questions for the panel. You maybe might want to comment to each other.

Let me start with John at the end. One very technical question and then
a more general question. The technical one is, who and how is the G‑10
assigned? I\'m not sure everybody is familiar with it. I think it would
be useful.

And the second question is, you said you are the GS‑1 group has
established standards working with a wide spectrum of people in the
industry. So I want to get some sense of that, not just manufacturers.
You\'re talking about people all the way through the supply chain? Are
you also including the distributors? We had a comment before about the
distributors. And we haven\'t talked with them very much about the
impact on their process.

This panel is really about implementing. So talk to me a little bit
about it. Talk to me about who is involved and how do we make sure that
their processes are factored into the decision‑making that we\'re trying
to make from a regulatory and, as people talk about in the first panel,
a systems perspective. John?

MR. TERWILLIGER: Absolutely. The number one process for manufacturers
and others would be marking items, which includes, actually,
distributors will many times have their own private label goods or
others, would become a member of their local GS‑1 member organizations
for those companies based here in the United States to become a member
of GS‑1 U.S., if they\'re based on Canada GS‑1 Canada, if they\'re based
in the United Kingdom GS‑1 U.K. So to become a member, it would be
assigned a company prefix that was shown in Mr. Franz\'s slide that
basically identifies your company. Many manufacturers have one or more.
Many times they\'ve had more because they purchased other smaller
companies. They would then use those to identify their products. So that
they become a member.

Part of our processes, to include everybody, some users, would be we
have various user groups. We have specific ones at this point in time.
And they come and go as needed. We have the Healthcare User Group, the
HUG, which is a global group comprising a lot of leading manufacturers.
We have some people in the room here today.

It is also incorporating group purchasing organizations here in the
United States that participate. We have had health care providers
participating from around the globe. Our recent meeting in Paris we had
‑‑ there\'s a hospital group there from France who was joining in. So
they have been involved.

Our standards process is really trying to make sure and include all the
various participants in the supply chain or the entire process we\'re
after. If you don\'t get everybody, it really doesn\'t work by our
practice. We derive consensus‑based standards. And I think it has worked
out real well.

The other thing is GS‑1 if you ask any of the other member organizations
work with national groups to help implement standards. For instance, as
I mentioned, we have been a very active participant in the Coalition for
Health Care E‑Standards, CHES. We have actually worked with HIDA, as was
mentioned in the past, on their bar coding standards and others.

MODERATOR KESSLER: Thanks.

Let me ask Michael one question. You mentioned that in Partners, you
have gotten to the point where the information you collect is specific
to certain types of infusion pumps so that you can match the patient
with infusion rates and the drug and the pump.

Did that give you any ability ‑‑ and this is not meant to be critical,
please. There have been, unfortunately, a number of fairly high‑profile
infusion pump recalls. And this is not a comment about the industry. But
has your information allowed you to better identify the pumps and get
them off the market or off the floor, change them, update them? Has that
been helpful or has it been not part of your system?

MR. DEMPSEY: The primary driver for the positive patient ID standard has
not been to do any of what I guess I would call post‑market analysis.
It\'s more to prevent errors from happening in the first place.

So, for example, because the positive ID standard identifies patients,
employees, devices, and drugs, you can scan a Partners ID badge, scan a
patient ID badge at those places where it\'s implemented, scan a drug,
and scan the IV pump itself and through a local connection ensure that
the five rights are matched and, in fact, the pump is programmed
correctly.

So this was the evolution of the work from Dr. Nat Simms, who invented
the notion of smart pump libraries, keeping track of dose levels from
guard rails so if you\'ve got a smart pump that knows that it can\'t
give X amount of morphine, that\'s a great first step, but the logical
progression of that is then how do you get that information into the
pump without user error or minimizing the probability of user errors.

MODERATOR KESSLER: I guess I was asking if a company notified your
system \"There\'s a class I recall. So we want you to take some of those
pumps out of commission,\" can the scanning of that pump be programmed
in? So that when someone is about to use pump X ‑‑ I won\'t mention a
company ‑‑ the clinician knows that\'s not one that we really want to be
using today.

MR. DEMPSEY: Let me answer that two ways. If we had this system deployed
in a ubiquitous way, it could certainly potentially do that because the
PDAs that scan the pumps are enterprise class devices so you can push
new code down to the PDAs from a server. So you can certainly put that
in place.

Let me switch hats from Partners back to Radiance. Radiance makes this
active RFID system. And one of the primary purposes of the Radiance
system is to do just that. So you can push a button and say, \"Here are
all of the model XYZ devices and their location within the last ten
seconds.\"

MODERATOR KESSLER: Terrific. Thanks.

And finally, one last question. I think, Leighton, this might be for
you, but it could be for Chuck as well. My sense from hearing from Cook
earlier, from Johnson and Johnson, the vast, vast majority of the
products at some level are already uniquely identified. Sometimes it\'s
in a large package or a palette. Sometimes it\'s the individual product.

So I guess what I am asking is the following. It sounds like many of the
major manufacturers already have systems in place to do identification.
But the hospital is now facing multiple systems. They get one system
from Cook, 2D. J&J may be maybe single D. They want to employ the
Radiance RFID system. And that may work for certain devices, not others.

It sounds to me as if the industry has a wide variety of reasons to
identify their product. But at the moment, they and some of their
stakeholders, the hospital community aren\'t talking the same language.

Is that fair? I\'m not trying to be critical, trying to understand the
landscape. Leighton?

MR. HANSEL: Well, I think this goes back to my observation needed a
vision. If the health care users were aware of what standards were going
to be utilized and what the form of the bar code would be, then vendors
of bar code reading equipment would make them more adaptable.

I think, now that there is a likelihood that a hospital has a certain
application, they buy a reader that will work on that application, some
other kind of bar code comes in, of course, their equipment doesn\'t
work.

But I think where technology is going, having reading equipment that
could read a lot of different types of bar codes obviously is going to
be an advantage in the future.

MR. DEMPSEY: Can I make a comment on that?

MODERATOR KESSLER: Please.

MR. DEMPSEY: We have been putting forward this notion over the last
three or four years of something that we call context‑sensitive
medicine.

And the important take‑away there, as I think it was the first speaker
of the day mentioned, there isn\'t going to be one or I don\'t believe
there is going to be one solution that solves all the problems.

So in some instances, you are going to have 2D bar codes. Others you\'re
going to have data matrix. You\'ll have linear bar codes. You\'ll have
RFID. You\'ll have passive and active RFID. And, in fact, even if we put
forward standards where we say, \"If you have an active RFID, this is
the protocol that is going to follow,\" you still need to be thoughtful
on the back end the way these different bits of information get combined
at the application layer so, in fact, you can survive vendors going out
of business, new vendors coming in, changes in protocols, and, in fact,
have it integrated at your IT level, as opposed to the device level.

MR. FRANZ: It is exactly the problem I think that is out there and why
customers, you know, don\'t embrace all of these things because there
are so many different things coming at them. And I think globally what
we have to get to is what information, what are the pieces of
information that need to be collected. If that can be provided to us on
a global scale and on a U.S. scale, any manufacturer is going to conform
to that.

Any manufacturer if told will develop an RFID system, will develop a bar
code system, will develop whatever that will put things into the supply
chain in that manner. We in industry, we in manufacturing have that
capability and will conform to that.

So, again, then it makes it possible for the institution, wherever it
may be, to ‑‑ whether they want to use it or not, then they have a
fighting chance at tracking devices and tracking things through their
supply chain within their institution.

Again, the standard of what it is, what type of bar code it is, what
type of ‑‑ if it\'s RFID or whatever is not really the issue. It is what
information do we need to collect and what information do we want to
collect, and we\'ll supply it. And then various systems will be able to
read it.

MODERATOR KESSLER: Before John speaks, I want to encourage anybody in
the audience to get up at the mikes. After John makes a comment, we will
be turning the floor open to you all.

The questions I think have been raised I would love to hear from the
audience, what information do you think needs to be collected? What
would be of use? What are the high‑priority items? What level of
packaging should we be talking about in terms of whether it\'s bar
coding, RFID, or some identification?

And a key question for some of you, are there certain types of devices
that we\'re talking about that really fall outside this, that there is
no advantage? Is there something that we\'re missing here for which
there is not an advantage to be coding or is there some product that
ought to be done tomorrow because it is such high priority?

John?

MR. TERWILLIGER: Yes. Just to back up to talk about the bar coding
thing, I would like to definitely echo what Chuck said. It\'s really not
so much about the data carrier, whether it\'s a bar code or RFID, as it
is really about the data. That is the more important piece.

The other thing from a GS‑1 system perspective, we make sure and
incorporate the same data through all of the various data carriers,
which includes both linear bar codes, 2D, and RFID. So there really is a
progression here.

And the last little point is that most scanners today will scan almost
any of the bar codes. It\'s really kind of gotten to be a non‑issue.

MODERATOR KESSLER: So I want to make sure that is in the record. So your
sense so far today is that most scanners that are out there that are in
general use, as long as we program it correctly, the issue between 1D
and 2D bar codes and other bar coding systems is more or less going
away?

MR. TERWILLIGER: I have to be careful. You asked a little different
question.

Certainly for people who already have scanners and had them for some
time, they probably have a linear scanner. It\'s a laser scanner, which
will not do 2D.

However, if someone were to start today and would go out and buy
scanners, they will buy an optical scanner that will both do linear and
2D, basically the same price. Then it\'s really a non‑issue.

And, actually, even laser scanners will scan multiple types of bar code
symbols.

MODERATOR KESSLER: Thanks.

If you have been to the mike before, the transcript won\'t know it. So
please re‑identify yourself.

AUDIENCE DISCUSSION

MR. MONROE: I am Napolean Monroe representing Henry Schein.

A follow‑up on the previous question. There has been some mention of
which products should carry the bar code. I\'m not sure the panel can
answer. Perhaps if we could have FDA\'s thoughts or DOD\'s thoughts or
CMS on should each box of rubber gloves or each box of cotton balls
carry a bar code?

MODERATOR KESSLER: I\'ll take more questions from the panel. And then at
the end, I\'ll try and right before we break give you my guess as to
what we think we\'re thinking.

(Laughter.)

MODERATOR KESSLER: Boy, I can\'t wait to read that, my guess at what we
think we\'re thinking. Can you wind it back? Okay.

Wait. Jay is going to come up. Hang on. Yes?

MS. COOKE: Anne Cooke, Device and Diagnostics Letter. And pardon my
ignorance on this. This is fairly complicated. This is a technical
writing question that I have.

What I\'m looking at up there looks like a fairly coherent layout
graphically, how to present this information. And you mentioned that
hospitals were sort of given a variety of code styles maybe from
different companies.

And what I\'m wondering is, would it be a role for the regulatory bodies
to try to help implement at least a standard format for reading these
things, rather than having ‑‑ I know there\'s creativity involved in
being able to design your own way of doing things.

But, for instance, I have gone to my MSN home page before. And the tech
guys at MSN have decided to change up the format. So here I am used to
clicking over here, and suddenly all the information is over on the left
or whatever. It drives me insane.

I think there\'s a limit to the, shall we say, effectiveness of
creativity and of individualism. And I\'m just wondering what sort of is
being done to think about not just the data but how it is presented in a
way that would minimize misreading by sort of engendering an
organizational culture throughout the whole supply chain where everybody
is reading the same stuff at the same place in the same order, left,
right, et cetera.

Thanks.

MR. FRANZ: I think that is a very, very good point. Even on that label
up there, you can see we varied. The EAN code is at the bottom. We have
pulled out the very same code for a product code. But certainly a
standard that would say, \"We would like your RFID, your EAN code,\"
your whatever presented in a certain spot or a certain fashion would
only enhance patient care and readability anywhere.

And, again, industry would follow that. I mean, you tell us where to put
something from my perspective, you know, we\'re going to put it right
where you tell us.

But it is varied from all the different device manufacturers, you know,
into different markets. They\'re presented different ways. I wish I had
it up here, but I could give you a real good visual of what that looks
like. I brought it when I talked with David and Jay.

And it really needs to be looked at because if you saw this just board
of labels that we all provide in industry, they\'re all different.
They\'re all different. They\'re all different shapes, sizes, and so
certainly if there could be some standardization or format, that would
just add to patient care.

MODERATOR KESSLER: Lu?

MR. FIGARELLA: I think that the only word of caution, having hundreds of
thousands of SKUs, is that once again on the theme of English, it gets
to be like English. Those of us who learn it as a second language are
always taken aback by how many exceptions people have. You know?

(Laughter.)

MR. FIGARELLA: Why would I rule if you\'re going to have that many
exceptions? And that\'s really what happens. But at the same point, what
really I think ‑‑ I take the comment very seriously because one comment
made about people going out of business and probably being out there or
taken over by somebody else, what really matters is that your rules for
data have to be rules for data. As John said, you know, your rules for
data have to be rules.

What is in that message, the first end character, the second, whatever,
that has to be a rule. And then you have after that a bunch of
suggestions. And I think in many cases, part of the reason you have so
many things that are different is that we as standard setters worry very
much about the rules, but a lot of times we need more annexes on those
standards about suggestions to do this, do that because a lot of people
are new to their company, they get told, \"Make this label.\" And, you
know, if they have some suggestions of what they\'re supposed to be
doing, they probably would make them look a lot like the other ones. And
that would help the user.

That is really what happens here, that at the end of the day when you
implement a UDI, as I said before, you are going to have a lot of people
who never scan or anything, who for the first time get told, \"This is
part of your job. Enjoy.\"

MODERATOR KESSLER: I would like to acknowledge the very important
comment you made that we have begun to think about, ‑‑ and Jay Crowley,
whom I am working with, thinks about it quite a lot ‑‑ what are the
human factors issues here in designing such a system? And it does
provide an interesting challenge.

Over here?

MR. SOKOL: Yes. Hi. I\'m Brad Sokol, Fast Track Technologies.

Just as a general statement but some affirmation possibly, there are 11
different international nomenclatures that I have looked at for medical
devices specifically, not to mention all the private different types of
nomenclatures that have been mentioned.

Isn\'t it more important just to take a look at first how we look at the
data, the tag, and maybe have that tag to point to the database of
elements or events that you need so that you will be able to have this
universal device identifier? Does anybody have any comments on that?

MR. TERWILLIGER: Absolutely. I mean, I think you look at how the
standard for G‑10 works identifies the product and could point back to a
database for all the information about it. In the next session, I know
we are going to talk more about that.

And in our world, we would call it the global data synchronization
network of various data pools here in the United States. RS would be one
synch where that license plate of the G‑10 would really point back into
the database, would give all sorts of information with many, many
attributes and descriptions, et cetera, et cetera, et cetera. That
already exists.

MODERATOR KESSLER: And we\'re looking for very specific input about what
the database should look like. We\'re going to talk about it in a little
bit. What are the elements, et cetera?

Leighton has a comment. Do you want to hear from him first or do you
want to make another comment back and forth?

MR. SOKOL: Yes, if I may.

MODERATOR KESSLER: You may.

MR. SOKOL: Dr. Kessler, you basically said something about what should
be in this database/tag or labeler. I\'ve got a couple of suggestions
but nowhere near as in‑depth as this audience could possibly give you.
This is just one point of view.

Some of the things that really stand out that probably I would look at
in a database component query so the label would point to the database
would be software compliance.

You had mentioned before, you alluded to it with remote device
maintenance from what Mike Dempsey had brought up. The next thing would
be the last date of who it was used in that software compliance,
maintenance compliance, again, post‑approval.

And one of the things that is sticky for the medical device
manufacturing community right now is the possible liability from a
standpoint of safety alarms, a one or a two safety alarm. And if you
rate it that way and you go for a number two safety alarm, you\'re
locked. You\'re not as exposed from a liability standpoint.

However, the type of question that I believe you asked Mr. Dempsey was,
you know, can you give us this information because we would like it?
Well, I think from a manufacturer and a provider, health care provider
aspect, there\'s got to be a reciprocity in some type of limited
liability so that there could be free‑flowing communication.

Those are just some of the things that are a little different in the
database. I could go on on some things, but I just wanted to give you
some particulars that may not be necessarily looked at.

MODERATOR KESSLER: Thank you.

Leighton?

MR. HANSEL: I just wanted to say, you know, I think it will be important
to determine what data elements should be tied directly to the bar code
and what should go into the database in the way of attributes and so
forth.

I think the number of individual devices that are out there will make a
database a great challenge to establish and maintain current data with.

MODERATOR KESSLER: I\'m going to let you speak in just a second, but I
want to ask you about that. You said it will be a challenge. So is there
a reason it\'s harder for our industry to do it than the grocery
manufacturers?

I mean, they are just as cut‑throat as we are. What is their advantage
about the cereal?

MR. HANSEL: Well, here again, I would imagine if you don\'t keep it
current, then the grocery chains won\'t sell your product. But even the
IG report on drugs pointed out that one of the main private providers of
the information has to do a lot of work with the manufacturers to get
current data, keep it current, you know, essentially. It\'s just not
something that happens automatically. They indicate there was a fair
amount in need of interplay.

MODERATOR KESSLER: Fair.

MS. WORZALA: Good morning. Chantal Worzala from the American Hospital
Association. I just wanted to talk a little bit to the question of
implementation in hospitals and want to make it clear that hospitals are
really quite committed to adopting bar coding and other health IT
strategies as part of their commitment to improving patient safety. That
is really the goal.

And we did do a survey about a year ago on use of IT and found that
hospitals are starting to adopt bar coding technologies for many, many
purposes in labs, in their pharmacy supply chain, and the rest of their
supply chain, and also at the bedside for medication administration.

We do, however, have a significant problem when it comes to using bar
coding for medication administration in that many of the drugs that come
in are not bar coded at the unit of use. And so you\'re introducing
substantial costs and work in the hospital to take things packaged at a
larger level and repackage them and put the bar code on the drug. And
that\'s introducing both a cost and a potential place for human error to
come in when you\'re doing that on site repackaging and bar coding of
products.

So I think that does point to a lesson that could be learned here, which
is it\'s very important for the unique ID to be put on the unit of use.
And obviously there are things like cotton balls where it\'s not the
individual cotton ball.

But if you\'re talking about something that goes to a patient or touches
a patient or affects a patient, really, it does have to be at the unit
of use. Otherwise you\'re introducing more processes in the hospital and
potentially increased error.

MODERATOR KESSLER: That\'s a great comment. I think the FDA will take
that into serious consideration about unit of use. We know the
manufacturers, and we have had this discussion. And I hope that AHA will
come back to the table repeatedly because clearly if what you heard in
the first session, that this is going to have to be a system problem,
you are, if not the largest, one of the major stakeholders in the
process, in the system. And if it is not taken up by hospitals, it\'s
not going to be a useful system. So clearly we need your cooperation and
collaboration. So thanks for the comment.

Any response?

(No response.)

MODERATOR KESSLER: Okay. Jim?

MR. KELLER: Hello, everyone again. I\'m Jim Keller from ECRI. And I just
wanted to make a comment regarding nomenclature.

One key element that I haven\'t heard talked about much this morning,
and that\'s a standard medical device term. And so, as, Larry, you well
know, FDA puts out a lot of generic notices that may not be a specific
or model‑ specific recall, where a hospital would be required to scan
its inventory for just its pumps or its AEDs, as opposed to manual
defibrillators and so forth.

And so I just wanted to speak to the value of having a standard medical
device name as part of that identifier to assist in that process where,
like a generic safety report is out on a class of technologies. And
there are other elements that should go with it, too, but I think that
is one of the key points to consider.

MODERATOR KESSLER: Thank you.

DR. SLOANE: Professor Elliot Sloane again from Villanova University.

This Pepsi bottle, I buy these at Wal‑Mart for about a dime apiece. It
has a bar code, has a identifier, a unique identifier, 0339JE0923EX. And
I could read that with my hard contact lenses corrected to 20/15.

We have an elder population. We have home care. We have other points of
deployment. And to get Dr. Kessler off the hook and maybe off the hot
seat for a minute, maybe this panel could talk about where we should set
the lower threshold for unique identifiability for medical products.

And, as a context, an historian in the FDA was forced to recall
virtually all of the alcohol swabs from the market in some places, 100
percent of the single unit packaged alcohol swabs from the U.S. market.
People couldn\'t give themselves insulin shots. Physicians couldn\'t
give vaccines or inoculations. And people rediscovered cotton balls and
bottles of Ibuprofen.

I would just ask the panel to talk a little bit about what is a rational
bottom, where should the bar be? From a dollars and cents standpoint and
from a practical standpoint, what can or should be done?

MR. FIGARELLA: Let\'s start with one correction. That is not a unique
idea unless we define this because what you have is every other bottle
of Pepsi of that size having the same. And that\'s really one of the
first questions when we\'re talking here in the beginning. I think
somebody mentioned lot number or at least unique.

And what we really are saying when we talk about unique is to identify
that bottle of Pepsi versus every other bottle of Pepsi in this room.
And when you start doing that, as John did mention, you know, things
happen because you start to have your devices have to serialize, et
cetera, et cetera.

But at the same point you are correct. You really have to get down to
okay. Do I need to ‑‑ for example, somebody mentioned gloves. And you
cannot think, \"Well, they come in a box of 100 or 25. Let\'s track the
box, but let\'s not really go into each of the gloves.\" You know,
please, you know.

At the same point I think a lot of the value there is going to be, well,
how much is it if we did get to that point where the gloves are
important? Well, do we find every glove in the room and throw them away
and start from a new box that we know is good, those sort of things that
I think are going to drive that.

But I think it is really important at a basic thing to technically
understand that when you\'re talking about a lot batch number or you\'re
talking about a unique ID, we really are talking about identifying each
individual bottle of Pepsi in this room and being able to say, \"I have
the lot you want,\" almost like open it and see if you have the gift

MR. HINE: Good morning. I\'m Matthew Hine with the U.S. Department of
Commerce, International Trade Administration.

The last commenter was raising a good point about what happens with
products that are out there in the consumer world, knowing that there is
a lot of talk about doing a lot more remote telemedicine, remote
monitoring of patients and that kind of thing. How does the issue of
this unique device identifier take place with things that are outside of
the hospital environment?

Thank you.

MODERATOR KESSLER: One of the issues that we have been struggling with
at the FDA over the past couple of years actually has been a myriad of
issues related particularly to home care, which is one of the issues you
are raising.

We have noticed it\'s not a surprise to anyone that a lot of technology,
high technology, is moving from the bedside into the home environment.
The driver, of course, is cost.

Now, we are all left with the problem of how to deal with that because
you have, as was mentioned before, individuals, particularly as all of
us are an aging population with a lot of technology by the bedside. And
can we use these kinds of systems at the home care environment to
promote safety? And I think it\'s a number of questions we have been
asking.

I don\'t think we have easy solutions because we can think about a
hospital investing in scanners to make sure they\'re connecting the dots
in electronic health records. And I\'m not sure today that works in the
home care environment. Maybe it will.

Other comments?

MR. TERWILLIGER: Well, I guess I would beg to differ. I think, actually,
you know, that scanners have gotten so inexpensive there\'s no reason
everybody couldn\'t have them. Actually, a lot of products, cell phones,
will scan bar codes these days. That\'s become very, very common.

I think another analogy I would also throw out is that to talk about how
can it help telecare. Well, you know, I think it\'s really not a lot
different than self‑checkout at the registers and stores. And you
couldn\'t do that without a bar code. It would be impossible for people
to do self‑checkout.

And I think the opportunity for assistance to check, indeed, that the
patient scanned the right item, if they got a couple of them, they could
verify and a check could be put in place is very, very powerful. And
it\'s really part of all about patient safety.

MODERATOR KESSLER: Michael?

MR. DEMPSEY: Yes, one comment. You know, we seem to be making a
technological assumption that a unique ID is a bar code or an RFID. And
I appreciate that theoretically that is not correct.

So, for example, any medical device, whether it\'s in the home or in a
hospital, could have a unique ID. And that unique ID could be
communicated to other machines and not necessarily require anyone to
scan anything or do anything special.

So if grandma is at home with a home congestive heart failure system
that\'s measuring her weight every day, well, the unique ID of that
scale can be sent over the modem without her needing to do anything.

So, really, I think that the objective is to have a unique ID for
medical devices. And I think wherever there is a medical device, there
should be a unique ID.

MODERATOR KESSLER: Thanks.

We are getting close to lunch. So we will take the four questioners up
here. And then we\'ll do some lunch break.

MR. PERRIN: Dick Perrin from Advantech and from the Health Care Supply
Chain Standards Coalition.

Mike, I would ask the question. I noted recently that Radiance and
Partners, Brigham\'s and Women\'s Hospital, in fact, is expanding the
capability of that system for medical equipment tracking. And I would
ask whether that was done predominantly from the perspective of patient
safety or whether the drivers were for control of the assets and what
the other benefits are to drive that process going forward.

And then I would ask the other panelists to speak to the issues of
potential benefits beyond the issues of patient safety, as to how they
see that in their segments of industry as to benefitting their logistics
and supply chain management activities.

Thank you.

DR. WHITE: Sure. Partners Health Care is obviously an integrated
delivery network with a bunch of hospitals. Brigham and Women\'s is one
of those hospitals. They\'re deploying the Radiance system for logistics
and asset tracking, for finding the devices, for recalling the devices,
if necessary, having nurses be able to locate them more easily. A
secondary benefit is patient safety.

However, Mass. General has also deployed Radiance. And they are using it
more for patient safety.

MR. GOLDMAN: My name is Julian Goldman. I am an anesthesiologist and
member of Partners Health Care Biomedical Engineering.

I stood up here to make some comments that Mike ended up making or
alluding to, but I think there is a central theme here that we have to
remember, which is we\'re getting ahead of ourselves if we start to talk
about specific technology without thinking about use cases. And if we
start to think about use cases or clinical scenarios that exist today,
we also have to be careful because they are limited due to the absence
of technology.

So we have a chicken and egg problem here. We have to very carefully ask
the potential users of the systems what would they do differently and
what could they do differently if the technology existed.

So, for example, the ability to look at devices on a network and
identify them using a unique ID is something that would have pervasive
implications.

If you were to ask users today \"How are you using the system like
that?\" they would all give you a blank look and say, \"What do you
mean? We can\'t do that today.#

And so someone could come away from an answer like that and say, \"Well,
you see, it has no value.\" Well, in fact, that would be foolish. But
those are the things that happen routinely when questions are asked the
wrong way.

So a number of things that came up in this session could be distilled
down to asking in a different way what are the use cases and how would
you divide those between clinical benefits, either safety or health care
efficiency, what are the supply chain benefits in terms of economic
benefits, and what is the relationship between those two. And there are
substantial relationships between those two.

Thank you.

MR. SCHULMAN: Seth Schulman again.

I think my question, actually, is very similar to a lot of the comments
that have come up most recently for the panel. I was also particularly
interested in Dr. Kessler\'s response from the FDA perspective.

I realize it\'s very difficult to get into a great level of detail of
all the work that has happened up to this meeting from the FDA
perspective, CMS, all of the other partners who have been working on
this.

But I am interested to think of ‑‑ what I am hearing today is a lot of
the conceptual arguments and conclusions about what information would be
necessary, what the potential benefits from safety, efficiency, cost
reduction, et cetera, are.

And I guess my question is, has this really been looked at since it is
such a big program with many different implications and honestly many
different uses from supply chain benefits to recall benefits, et cetera?
Have all of these uses for the UDIs actually maybe even been
process‑mapped out?

And I think that from the device perspective of quality control, where
companies will set up manufacturing processes and say, \"Hey, you know,
this is great. It\'s really efficient,\" you come back and you look at
it. And it\'s a mean sigma of six sigma, et cetera. And you look through
a process map, and you realize you\'re touching the product 20 times
when you really could be doing it 10 times if you had looked at it
earlier and said what really is necessary.

So I know, again, I think I would restate that maybe we are putting the
cart before the horse a little bit in saying, \"Do we really understand
how the products and the information flows through each of these
systems, whether it\'s supply chain, necessary information for recall,
how it\'s touched,\" to really define what information is really
necessary to effectively perform all of those goals of this system and
to really maybe limit or really truly identify what the important
information needs to be included. Has that happened or is this the
beginning of that process?

MODERATOR KESSLER: This is the middle of that process, actually. I
wanted to answer simply just no and then let\'s go to lunch, but I
can\'t do that. I\'ll make a couple of comments to that.

If the panel wants to take any of that on before I make a comment, then
I will do my comment, and we\'ll go to lunch. John, you talked a lot.
We\'ll do Chuck.

MR. TERWILLIGER: Sure.

MR. FRANZ: I think that to answer that ‑‑ and it goes back to a question
that was asked earlier. And that is, what is the bare minimum?

And, again, it\'s been reiterated throughout the panel. And that is, you
have got to get to the batch number. You have got to get to the lot
number. You have got to get to the unique identifier.

And that is the lot number. It\'s not the UPC code that\'s on the bottle
of Pepsi. If we are to help, you know, the supply chain ‑‑ okay? ‑‑ or
if we are to help patient safety, we have got to start at a bare
minimum.

And I think Larry was saying no, we haven\'t started yet. There are
available systems out there, whether it be RFID, whether it be anything.
And we need to start someplace in gathering that information. Then the
benefits will expand.

But today we\'re confusing the marketplace. I mean, we as industry are
confusing the marketplace everywhere in the world. We\'re not adding
benefit. It\'s not used.

It can be. Certain systems are using it. But we\'re different than J&J,
different than Abbott, different than everyplace else. And we need this,
you know, if you look on a global basis. We just need it. As an
industry, we need it.

And so at the bare minimum, if you\'re going to get to that unique
identifier, it\'s going to be down to the batch level. And, again,
whether that is something that\'s implanted into a patient or whether
that is a box of gloves, that is the kind of information that we need to
be talking about in the very beginning.

MR. FRANZ: I think, by definition, a UID is going to be a small amount
of data. And it\'s really what you\'ve gotten is all of these sort of
attributes, other information, has to be stored in a database elsewhere.
There is just no way to carry that along effectively on the product. It
just doesn\'t work that way.

And I also share from kind of our experience over a 30‑year window the
type of data captured with 30 years ago, what that points to, the UPC,
is very different today. And it has gotten bigger and bigger and bigger.
So I think there is a natural progression there, and it cannot really be
encoded directly.

MODERATOR KESSLER: Leighton?

MR. HANSEL: I was just going to say that is one of the questions you
have out for public comment as to what the minimum data set should be.
And I think it\'s important for anyone who is planning on commenting to
address that and I think probably give them some reasons why each of
those elements are important.

MODERATOR KESSLER: Along those lines, one of the comments made by one of
the members here who came to a meeting recently of the FDA, which I
thought was outstanding, was not only do we have to think of the costs
and benefits of the entire system for unique device identification but
for each data element. It has its own costs and benefits. So that\'s
part of the things we\'re thinking about.

Let me try and address your question, are we at the beginning or the
end. We\'re in the middle of our deliberation. And I\'m hoping that this
meeting will bring us from the middle to the 90th percentile so that
over the next couple of months, not years, we can take this to the final
step and begin crafting the system that will make sense for all of us.

I need to comment about a couple of things. Although we started to think
about how the entire system would work, the Food and Drug Administration
we recognize is built on a series of laws which provides our regulatory
purview but also bounds it.

So one of the challenges we have will be to work with the hospital
industry because we do not regulate them. So even if tomorrow I tell
Chuck and Leighton, \"This is the system you will use\" and I am allowed
to do so and I put it in regulation and they\'ll do it, if the hospital
doesn\'t do it, I can\'t do much about that.

So this is really going to be a very important issue for us to think
through the entire system and work with our partners. It\'s one of the
reasons we have brought to the table not only ourselves but the VA, the
Veterans\' Administration; the big provider of health care, the
Department of Defense; Center for Medicare; Medicaid; and AHRQ. So it\'s
important for us to try and think through this system, but we\'re in the
middle, not at the end, of that process.

But the FDA, even if we make a decision, still has limitations on our
regulatory responsibilities in our purview. So that\'s just sort of a
fact of law. And I just want to make sure that is clear that we
recognize that.

I really want to make a very brief comment about what I think a couple
of people said, particularly Julian. We really should be thinking about
the system three and five and seven years down the road, not today.

What we can and can\'t do today is very different than what people put
in place five and ten years ago. And the systems are moving very fast.
So we really should think about the potential system and particularly
public health benefits that we could get from a system if we put it into
place with the right time frame.

We have talked to industry a lot. And one of the things they have told
us in cost is that the cost to industry, for example, will vary
dramatically by the amount of time we have to ramp up. The shorter the
ramp‑up, the more expensive. The longer the ramp‑up, the less expensive,
not free necessarily but much less expensive. You\'re talking about a
horizon of three to five years versus a horizon of one to two.

That\'s part of the thing that we have to decide here. If you heard from
Dr. Woodcock earlier that if in five years she is still sitting in the
chair as Deputy Commissioner of the FDA, maybe she will be Commissioner
of the FDA, and someone asks her, \"Gee, what can we read in medical
records for all medical products?\" The answer, \"Not much, won\'t go
very far.\"

So I think the agency is thinking our horizon is in three to five years
to have something significant done. But what is going to be done and the
possibilities and realizing the benefit of those possibilities is one of
the reasons we\'re having this debate.

I have some specific thoughts I\'ll mention later about where the FDA is
in its thinking. I\'ll reserve those after we go through one or both of
the next panels.

We are going to thank the panel in just a minute. We\'re going to have
lunch. It\'s now 10 after 12:00. I would like you to be back here
promptly at 1:30. And we will convene or the next panel. 1:15? How about
1:20? Give them five extra minutes. You\'ll need it.

(Laughter.)

MODERATOR KESSLER: 1:20. Thank the panel, please.

(Applause.)

(Whereupon, a luncheon recess was taken at 12:13 p.m.)

A‑F‑T‑E‑R‑N‑O‑O‑N S‑E‑S‑S‑I‑O‑N

(1:27 p.m.)

MODERATOR KESSLER: Hello. This is the third panel of the day. And as we
told you, we\'re trying where we can to possibly do some partnering; in
particular, with the Department of Defense.

We have had some outstanding collaboration with Kathleen Garvin. I\'m
pleased to introduce her, have her talk about the product data utility
information that they have been thinking about for the last few years.

Thanks, Kathleen.

(Applause.)

MS. GARVIN: Thanks, Dr. Kessler, for inviting me to speak and
participate on the panel. I\'m truly honored to be here to talk about
this very important topic.

THE DEVELOPMENT, MAINTENANCE, AND USE OF

A REPOSITORY

PANEL DISCUSSION

MS. GARVIN: I\'m here to represent the medical logistics community
within DOD and also our Veterans Administration partners. My cohort at
VA is here somewhere: Michelle. So we have been working jointly on this
data synchronization product data utility initiative.

And thirdly, I have been collaborating for the last few years very
closely with the Coalition for Health Care E‑Standards. And this is one
of their major initiatives: the implementation of a product data
utility.

Health care supply chain data is broken. And there are significant
impacts. A senior executive from a well‑known large manufacturer talked
to one of our working groups and said the problem is in the B with the
billions of dollars.

He said he can recognize from his place where he sits what the impacts
are. When he stratifies that across the industry and across all of
health care, it\'s incredibly significant. We have been working on
trying to resolve that issue.

So today I am going to talk a little bit about why DOD is involved. We
made a significant investment in dollars, both DOD and VA. And we\'re
not just talking the talk. We are walking the walk. We have built, and
we continue to refine a proof of principal pilot, product data utility,
for the health care industry.

I will talk a little bit about product data utility and how we think it
can be part of the solution for UDI and also the relationship of good
data to the patient safety issue.

Why do we get involved to begin with? Well, three years ago when we were
deployed to Iraq and a little bit before that Afghanistan, we had some
pretty big challenges.

The drug side of the house was okay. Everybody was using the NDC. Things
seemed to move pretty quickly. But in med surge, it was a little bit
harder.

So number one, my reason for getting involved was contingency and
wartime operations. That is DOD\'s number one mission: to support the
soldier in the field.

We recognize, however, that we can improve. The improvement in supply
chain efficiencies would filter down to our peacetime operations, which
are about 200 hospitals worldwide, and reduce the cost of health care
delivery in DOD.

Now, the arrow at the bottom was not part of our original mission, but
it\'s easy to see and recognize the relationship to this data to patient
safety, as I will talk about a little bit later.

So why do we have a problem with deployments? First of all, it\'s not
just readiness, go to war, Iraq, and Afghanistan. We also have to
respond to natural disasters, like Katrina and the tsunami. We work with
various organizations, very short notice, and expected very quick
deliveries.

When these things occur, we are inundated with requests. And the
requests have inconsistent, inaccurate, and duplicative data in product
numbers, in product names, product descriptions, and product packaging.
This slows us down more than we would like.

We do resource‑intensive cross‑referencing, banging databases together
here and there, to figure out what exactly is it that they want before
we can source it. We think that a PDU will increase our efficiency and
improve our response time.

And by the way, we\'re not the only ones who are getting inconsistent,
inaccurate, duplicative data. From working with industry, we see that
the problem is pervasive.

So how did we arrive at the solution of a product data utility? Leighton
Hansel earlier today from Abbott/AdvaMed talked about DOD and the UPN.
Yes, in the early \'90s, we attempted to establish a universal product
number for med surge items.

And although the assignment of numbers ranged anywhere from 60 to 90
percent, as Paul Pandiscio mentioned, J&J has 90 percent of its items
assigned to the unit of use, but that assignment, the unit of use, is
not standardized. And the UPNs aren\'t being used consistently
throughout the health care supply chain.

So just going after UPNs was not the solution. And we stepped back and
rethought and said there needs to be a systemic way of making sure that
these standards get released throughout the industry.

Well, the lesson learned from us was the grocery industry. The first
time they went out many, many years ago, they said, \"Well, we\'ll just
assign these numbers. Everybody will use them. And everything will be
fine.\" Wrong. They had to go back to the drawing board. And they had to
get together a product data utility‑like place where the data could be
centralized, synchronized.

So PDU is a system that interconnects all the trading partners. We\'re
talking about core data and standardizing on that core data, making sure
it\'s distributed throughout the entire supply chain.

I\'ve focused on the word \"utility,\" not repository. A utility
indicates an active process that needs to occur to ensure that
everyone\'s data is the same. A repository, which we already have
several of in our industry, is just databases where data sits.

So here is a, when I say \"notional,\" really notional, idea of a
product data utility, very simplistic. The important thing is
manufacturers on the left. Our model says manufacturers should be the
source of the data and the truth of the data. Other models in the
industry are different. They use algorithms to determine the truth,
whatever. We say manufacturers own the data, and it should come from
them.

The second premise is that the utility should be overseen by a supply
chain board of governors. And the utility, as I mentioned, is active. It
will actually take the data from the manufacturers and pull it in, make
sure it\'s complete, synchronize it, perform audits, validate it. And it
won\'t go out until it\'s certified, won\'t be distributed out to
everyone until it\'s certified according to the standards agreed to.

Now, I\'m not saying that the PDU is the answer for the FDA\'s UDI
program. However, there are many data elements, standard data elements,
that will be shared in UDI, as they are in many other programs. And I
see the health care data utility as one of the sources to feed the
FDA\'s UDI.

Following over towards the right, the data leaves the health care
product data utility to aggregators, exchanges, distributors, GPOs.
Ultimately it goes to the hospitals.

I would like you to take a look down at the bottom there. Why do we have
Wal‑Mart and retail down there? What do they have to do with anything?

Many of our manufacturers in health care are already sending data
through a very similar process on their consumer side to be able to sell
to Wal‑Mart and CVS, et cetera, et cetera, et cetera. So this is not
really a new thing for most manufacturers. They already use this
process.

Okay. We\'re looking at the principles of a product data utility. This
is not complete, but there were some bullets that I pulled from an
industry PDU feasibility study that was conducted in 2003.

It was a joint effort between CHES and HCEC. You can find it on either
Web site. But it wasn\'t just CHES and HCEC conducting it. There were
representatives from across the entire supply chain who participated.

One of the idea principles here is some of the things I mentioned
already. It should be open and neutral so that everyone can participate.
It should be a nonprofit headed by a governing body that will promote
industry standards with appropriate security and confidentiality, a
pricing model that will just cover costs, hence nonprofit. And it won\'t
process order transactions.

So what is the minimum data set? Talk about notional. This is just kind
of a made‑up. Whoever you ask, they say minimum data. It could be 50
fields, 30 fields, 10 fields, 100 fields.

I think we got up in our technical advisory group to hundreds of fields
when everybody in the supply chain gave their input. But there are
certain minimal key data that are shared by almost everyone. And some of
them are nomenclature, manufacturer, name, part number.

Universal product number I\'m using there. And I kind of made up myself
potentially an extension for serialization. I don\'t know how that would
happen, but I understand serialization is necessary in some of the
devices. So potentially there might be a way. It could be another bullet
or it could be part of that. So anyway, these are the things that we
think are probably minimum with lots more.

Another question that was raised in the package that I got for
discussion today was what other data would improve patient safety?
Certainly we have heard from the VA and others certain things that are
important to them to be included in our product data utility, like
whether or not it\'s sterile, whether it contains latex, is it reusable.

The medical safety data sheets issue we resolved by something we called
in our pilot med item link. And what we have done there is we have a URL
where if you\'re ordering an item from an ordering page, you have the
product up there. We have the URL there that connects directly to the
manufacturer\'s Web site for that product.

So you\'re looking. And you say, \"Gee, I need more information than
this database and our ordering system carry.\" Hit the URL, and you can
see everything the manufacturer has to say about that item from MSDS to
all the other technical information that they supply. So that\'s one way
we got around that issue. And a couple of others that I stole:
MRI‑incompatible and allergic reactions from David Racene\'s briefing.

So would the minimum data set differ for different service devices?
Well, I guess it would depend on what you call minimum. For example,
there are different categories. And I just threw three up there. Well,
you\'ve got implants. You\'ve got consumables. You\'ve got equipment.
And there are many, many other categories, as the FDA will determine.

You may say, \"Well, yes, we need different information here than there,
than there.\" However, I contend that across every one of those
categories, you\'re going to have some data that\'s going to be alike.
And that\'s the minimum data that could be shared in a PDU.

What does good data give you? These are taken from a working group
roundtable saying, \"What do you want out of this kind of thing?\" And
when you look at some of these things, many of them point to patient
safety.

I was reading an article in Health Care Purchasing News written by a
nurse, who said reducing costs in the supply chain to her automatically
applies to the patient because there is more money that can be devoted
to patient safety issues, a thought.

Reducing clinical frustration. Yes. Every time that nurse has to go and
track down an item, instead of taking care of her patient, that\'s a
patient safety issue.

Improving speed of delivery. Every time the right device or product is
not delivered and the doc is standing in the OR saying, \"Where is it?\"
that\'s a patient safety issue. Either you delay the surgery or you
substitute.

Analysis. Data. Well, data is it. Data is king these days. And hospitals
don\'t have enough of it to be able to do their jobs, like recalls. We
heard this morning many times about the manual efforts, going through
paper to try to pull out data for recalls. And hospitals would love to
get their arms around spend analysis to find the products that are most
efficacious to practice.

Some more information about the right data and how it benefits patient
safety, but before I get into that, this is one of my favorite quotes.
It\'s from the New York Times in June of 2000. The title of the article
was \"A Choice for the Heart.\"

\"Even as the use of expensive devices, like artificial knees and
defibrillators expands rapidly, patients and doctors get less
information about products that are implanted in their bodies than
consumers get on the safety and performance of their cars.\" It\'s quite
a statement.

So the right information. We\'re looking for products with best
outcomes, those that contribute to infections and adverse events, easier
recall, locating unsafe items, tracking devices in patients, tracking
critical equipment so you have better utilization and you don\'t have to
buy 10 of those, maybe you can get away with eight, and as we mentioned
earlier, sterile, non‑sterile, et cetera, et cetera.

Dr. Kessler mentioned earlier that there are other federal programs. And
DOD has its own unique identification program. It\'s not medical. It\'s
DOD‑wide. DOD also has their own RFID program that\'s not medical. It\'s
DOD‑wide. And each one of those is a separate and distinct program.

Homeland Security has just announced that they have a unique
identification program. I don\'t think any of the three have talked to
each other so far.

And then we have up and coming FDA UDI, again a separate and distinct
federal requirement to impose upon the manufacturers. And not lastly but
just most importantly, as we heard from our colleague from Villanova,
EHR is up and coming. And we\'re going to need a way to have in the
patient record exactly what was implanted in or used on a patient. And
it had better be accurate because so far the data doesn\'t prove to be
terribly accurate.

So we need consistent and accurate data to implement each of these.
Wouldn\'t it be a great idea if we could agree on the core data elements
across DOD, FDA, Homeland Security, et cetera, et cetera, et cetera? We
think there would be much greater efficiencies across the supply chain.

So yes, it\'s all about collaboration, leveraging existing knowledge and
expertise in the industry, partnering where it makes the most sense,
both across the supply chain and in the federal government and supply
chain/federal government, along with the standards organizations. We
think the medical product data utility is the vehicle to get there.

So what is next? Fix the broken data. It will facilitate patient safety.
We need to gain commitment and consensus from the supply chain and
government organizations and execute an industry PDU.

It should be industry‑funded and sponsored. The government can\'t do it
alone. And we think that this would be a solution that would meet the
needs of all health care participants. Mandatory FDA UDI initiative can
help drive this.

Thank you for your attention.

(Applause.)

MODERATOR KESSLER: Thanks, Kathleen.

So the focus if you haven\'t figured it out of this session is
development, maintenance, and use of maybe utility, not repository, for
UDI or unique device identification. So we\'re going to try and ask the
questions about what are those data elements?

Kathleen, I don\'t know if you mentioned it, but at one point, your
group had thought about how many elements belong in this utility, in
this arena. And I think you had gotten up to 120 or a couple hundred. So
not many of us think of it as a minimum data set, but I think we would
talk about some of that in the next few minutes.

So I am going to introduce the panel: Steve Stemkowski from Premier. To
his right is Jonathan Sherman, also the Department of Defense; Jon White
again, I think still wearing the Jon White hat this time, still; and
then Randy Levin from the FDA. So Steven?

MR. STEMKOWSKI: Hi. I hope everybody had a good lunch. They never got to
us at our table. So we\'re still waiting for the cake outside.

I am with Premier. And I work in the health care informatics group
within Premier. So I come at this issue a little bit differently from
the supply chain management issues that UDI raises.

The health care informatics group at Premier does a couple of things.
They work predominantly with our hospitals in the alliance to facilitate
their comparative analysis by using a large data repository of hospital
billing and administrative and other types of data and associated
consulting services.

And the second part of what informatics is up to is where I come in. And
that is in our pharmaceutical research services group. This group
conducts surveillance and outcome studies predominantly with the
pharmaceutical companies and to some extent the medical device industry
as well.

And in the course of the last several weeks, I had been asked to look
into some of the medical devices themselves. The patient safety issue is
where I think most of this comes down.

And that is the question we were asked at this point was, can you
identify a device that was administered to a patient using your data set
in a retrospective manner?

So several weeks ago, we began exploring that opportunity and looked at
several products. We looked at cardiac rhythm management devices. We
looked at stents. We looked at some surgical adhesion gels and so forth.
And one of the products we ended up with, and this is probably the
biggest example of why a minimum data set is so important, is a certain
surgical mesh product that was the subject of a Class I recall.

You saw that diagram from Kathleen\'s PowerPoint that showed the
disconnect between hospitals and the data aggregators and the suppliers.

It became readily apparent as we began looking at all of this data that
hospitals may receive bar coded product, but none of it or very little
of it ever makes its way into the hospitals\' internal data systems.

And so when we looked at this particular surgical mesh product, we had
to go not to our standard definitions for these things, which would have
been nice and more reliable, but we had to go actually to the hospital
charge masters themselves.

And I was looking at data for over 400 hospitals and ultimately ended up
with about 40 or so hospitals that actually had enough information in
their charge description master to tell me that that was the product
that was recalled. And from that, we had an estimated 50 or so
discharges that we believe were administered the product after the date
of recall.

So I think the reason that this happened is because of that disconnect
between the hospitals and the other end of the supply chain and even the
middle parts when it comes to distributors because these hospitals set
up a charge master to facilitate their billing and charging to insurers
and to patients. It doesn\'t always reflect exactly what was in there.

And so you know, there may have been more patients that receive these
products. I don\'t know. But without a minimum data set, I can\'t make
any further assessment than that.

I think there is enough indication in the work that we have done, and
this is preliminary so far. We haven\'t made any attempt yet to look at
whether these patients had any more adverse outcomes than other patients
like them, but without this standardization in hospital data, in
particular, or in the device data that is used, we can\'t make those
assessments.

And so the points earlier today were we need to do these studies. And
absolutely we do. I think there is enough indication that would warrant
moving further down the path to make those studies possible.

So that\'s how I come at this. I think there is a considerable patient
safety issue that we can do a better job of surveillance on products
that are already on the marketplace, we can help hospitals determine
what sort of effectiveness various products have. And I think that the
minimum data set is essential to that function.

One of the questions we were asked to address was, what does this
minimum data set look like? Kathleen gave a pretty good answer to that
question. There were a few items that I would have suggested. One would
be adding the serial number for products that are serialed, expiration
dates, lot numbers. And I think it\'s important when we look at this to
have some standard way of classifying the devices.

I think we talked about this earlier this morning, but I would like to
reiterate that point, understanding how a particular device fits into
the scheme of patient care and what other devices that are similar in
approach I think is essential to making some of these comparisons.

As for where this information is obtained, I think we all agree. I think
the manufacturers would agree. It seems from what I have heard today
that there is every interest in the part of the device manufacturers to
supply information about their product to some level of standard.

I think that that is where it needs to start. The key is to how that
transfers down the rest of the supply chain and ultimately makes it to
the hospital, which is going to be where it is critical.

MODERATOR KESSLER: Thanks.

MR. SHERMAN: Hi. My name is Jonathan Sherman. I work for the Defense
Medical Logistics Standard Support Program Office. We have developed and
fielded an automated information system that is used at, it\'s an
automated logistics system that\'s used at 168 Department of Defense
sites.

We have been managing equipment for property and maintenance purposes by
assigning a unique item identification to every item that comes into the
hospital. And this is done automatically by the automated system, which
we call DMLSS, Defense Medical Logistics Standard Support system.

And this number is unique, though, only to that facility. When an item
is transferred between facilities and is picked up at the other
hospital, the DMLSS system gives it a new number.

We are also right now in the middle of implementing the DOD unique
identification program, which will provide a unique identification for
that piece of equipment across the entire enterprise and throughout its
life cycle. There are a couple of gentlemen here from the UID program
office. They may speak at the microphone. I\'m not sure.

And as I said, we are at 168 sites around the world. As we are
implementing the DOD‑unique item identification program, we are making
some modifications to our existing system.

We are upgrading our bar code scanners to read the two‑dimensional data
matrix bar code, which is the DOD‑required bar code for that program.
And the requirement is to have the manufacturers of those equipment
items eventually create the unique item identifier. And when/if the item
is sold to the Department of Defense, the information on the unique item
identifier along with a number of data attributes, some required, some
not, which would constitute a minimum data set for the Department of
Defense, will be registered by the manufacturer into the DOD item unique
identification registry.

Addressing the issue of minimum data set, repositories, registries,
those types of things, one of the things that we are looking for in the
Department of Defense in the military health system is the ability to
automatically populate our catalogue records, our property records, and
our maintenance records with accurate, clean, and current data. And the
only way that this can happen is through an industry product data
utility that is maintained by the manufacturer with the most current
data possible. And that in terms of supply chain management is something
that the Department of Defense military health system really would like
to see happen.

I don\'t need to address minimum data set. It\'s already been
articulated. But I also participate in a bar code workgroup within the
military health system that has been looking at point of delivery of
medicine within the hospital using a bar code system.

And just to give you some idea, we have been working on that for over a
year now, trying to determine how best to do this and implement it.
Recently it has been expanded to look at use of bar code and other
automated information technology across the entire hospital, you know,
where should bar codes be used besides delivery of medicine at the
bedside. So the military health system is continuing to pursue that as
well. This information, of course, is vital to that.

Another interesting point is that the DOD military health system has a
single organization that receives and consolidates recall notices for
the Department of Defense and sends those out through various electronic
means to all of our medical facilities. And of course, once we receive
them, again, it becomes a manually intensive search for those items and
to ensure that we\'re actually looking at the correct item. And of
course, what we\'re talking about working on here today would
significantly speed up that process.

Thank you.

MODERATOR KESSLER: Thank you.

Jon?

DR. WHITE: Good afternoon. Good afternoon.

MODERATOR KESSLER: Good afternoon.

DR. WHITE: Thank you. Postprandial stupor sets in.

I am back and have been listening to the presentations with great
interest. And I have been thinking about the scope of what we have been
asked to talk about as a panel. And I know that the good Dr. Levin, next
to me, is going to talk about drugs.

So I want to talk to you about something that perhaps hasn\'t been
touched on but was a very important and exciting part of my medical
training: federal process. That\'s a joke. Okay. All right. Live crowd.

And here is why I bring up the subject of federal process. I think what
I am hearing from the group today is there is some commitment to a
collaborative process. Do you think that is accurate, a collaborative
process between to move forward with making this work for everybody and
work for all the various different stakeholders? And when you talk about
health care, it\'s a really big group of stakeholders with very diverse
needs.

I am going to reflect back to you some processes in which I have been
involved federally that have been collaborative and have been meant to
be collaborative from the get‑go for my colleagues at FDA and for you
all as industry to consider for ways that you might go forward with
doing this.

I mentioned the e‑prescribing standards projects earlier today. The
Medicare Modernization Act in 2003 said that there have got to be
prescribing standards to make a long story short.

The way that moved forward was NCBHS, National Committee for Bio and
Health Statistics, held hearings for a period of time, I think it was a
year and a half or two years, something like that, about the status of
electronic prescribing and standards that existed out there and did a
very thorough job of collecting that information and made
recommendations to the Secretary about initial standards and standards
that ought to be tested in keeping with the Medicare Modernization Act.

CMS proposed a regulation. It was adopted for initial standards. We at
AHRQ were given the opportunity to work with CMS to start a number of
projects, which were grants, which had been industry and academics and
health care providers working together to take a look at these standards
and to feed back some reasonable data, not just about what works and
what doesn\'t, but what\'s the impact of adopting these things. And that
information is going to be coming out in the near future. And there will
be another round of proposed rulemaking.

Another process I have been involved in was alluded to earlier today. It
was the AHIC, which is the American Health Information Community. And
this is moving forward standardization of health IT and electronic
health records.

Basically, the Secretary created a FACA committee, the American Health
Information Community, which goes out, solicits use cases, and then has
workers that work through the use cases and come back and make
recommendations to the Secretary. Okay? That\'s a different way to do
it.

Another process that I am involved with is the ACQA, or Ambulatory Care
Quality Alliance. This is, if you can imagine this, America\'s Health
Insurance Plans, the American College of Physicians, the American
Academy of Family Physicians, and AHRQ, so the government, doctors, and
payers convening this. It\'s quite a crowd. And the meetings are very
exciting. That is somewhat outside of the federal process but has
federal involvement. Okay?

The topic of the talk that we\'re talking about today is \"Development,
Maintenance, and Use.\" Okay? We\'ve talked about uses, talked about
some specific products that exist. We\'ve talked about maintenance. But
the development, and not just the technical development but the process
development, is going to be key. And as you move forward with this and
we move forward with it, it\'s something that you want to consider
carefully.

So thanks.

MODERATOR KESSLER: Randy?

DR. LEVIN: I\'m the token drug person from the FDA. As I\'ve been
listening to the discussion, a lot of the topics and the issues are very
similar to what we have been hearing and that drug issues or drug
listing process, very much the same. And with discussion inside the FDA
between devices and drugs, we\'re seeing that there\'s a lot of
collaboration that we can do just within FDA with our standards and with
our processes so that we can collaborate and reduce our resources and
improve our efficiency.

The drug activity has been also part of a larger collaboration between a
lot of the government partners. We have developed a federal medication
terminology standard that takes into account drug models from three
different agencies: from RxNorm, from National Library of Medicine, the
National Drug File; reference terminology from the VA; and the structure
product labeling and drug listing from the FDA.

And we have been working with the National Cancer Institute; Enterprise
Vocabulary Services; and of course, AHRQ in this activity to get this
moving. And AHRQ has been providing tremendous support for us to help
put this forward.

We have also been working with standards development organizations,
Health Level 7, and the National Council for Prescription Drug Products
in this activity. We have just recently joined the ISO Technical
Committee on Health Informatics, TC‑215, and working on their Working
Group 6 on pharmaceutical and medicines. There is also a working group
in that technical committee for device nomenclature and activity there.

Also, there is International Regulators Association for Devices of the
Global Harmonization Task Force, but for drug groups, there is the
International Conference on Harmonization for Human Pharmaceuticals. And
there is one for veterinary medicine as well. And we have been working
in those areas on harmonizing for our drug listing activities.

We have been working on drug listing since the \'60s. So we have a long
history of this. It doesn\'t start with, Medicare started this activity
for Medicare reimbursement. That was the purpose for the National Drug
Code.

Over the years, the requirements have grown. And the use of the National
Drug Code has grown as well. Recently, just recently, we published a
proposed regulation to change our drug listing regulation to bring the
National Drug Code up into be a more robust identifier.

I think that some people have talked about how there are problems with
the National Drug Code. And we have just proposed regulation changes to
change that.

A lot of the requirements for the National Drug Code is the same thing
that has been talked about here, you know, what data do you collect,
what is a drug, what is a device, that type of question. The use cases
for the National Drug Code and other identifiers has grown to include
identification at the proprietary level, so the brand name at the
non‑proprietary level, at the generic level, as well as even at the part
level or the ingredient level.

So there are a lot of increased requirements in use cases as well as the
serialization of drugs and the pedigree. I think someone had mentioned
that earlier as well.

So those are all looking at expanding and we\'re looking at, one, our
proposed regulation to address many of those issues as well as other
regulations, other activities to address these different requirements.

One of the issues that we found out; that is, that we need to have very
well‑defined rules to establish to work on these requirements, and we
need to define what is a product. And that\'s a lot of the activity that
you\'re talking about here.

And what level do you assign the code? I think someone brought up
earlier about that unit of use to assign a code, a product identifier at
that level. We have addressed that in our proposed rule as well.

Also, once you define the rules, you need to have a central authority
that will help people follow the rules. We did have rules in our past
regulations, but the manufacturers were generating the codes. And some
were following the rules or have interpreted the rules in various ways.
So there are a lot of inconsistencies on how people were defining what
the drug product was.

So in our proposed rule, we\'re proposing that the FDA be a central
authority for assigning the National Drug Code so that we can follow
those rules and enforce those rules.

In our international discussions with our other regulations, they\'re
looking at the other regulators doing something similar, where each
region would assign a code to their products. And then using a way that
we could identify where each code comes from, what region, we can have
an international code.

We have been working on standards for exchanging this information. A
standard that we have developed in Health Level 7 is called the
structured product labeling. This is a standard that includes both the
content of the labeling information as well as this drug listing
information. And we\'re looking at this standard to be used for other
products that the FDA regulates.

And we have also been developing terminology standards, as I mentioned
earlier, federal medication terminology standards. One standard that was
developed is a unique ingredient identifier that, again, goes across all
FDA‑regulated products that provide identifiers for products, whether it
be human drug, animal drug, or food, dietary supplement, et cetera.

After looking at the rules and developing the standards, we worked on
systems so that we can automate this process and that we move from our
paper‑based process to an electronic process and then work on a way to
distribute the information, in which we have partnered with the National
Library of Medicine to distribute the structured product labeling with
all the drug listing information through a site called the DailyMed,
where we would provide up‑to‑date information about the products. As
they change, you update the structured product labeling with the listing
information and put it onto the site.

Then it is a standardized format. This is an XML machine‑readable
format. And the health information suppliers can take that information,
download it, and then use it in their systems to bring it forward to the
health care community.

MODERATOR KESSLER: Thank you.

I\'m going to ask you all a question in a second. I\'m going to ask
Randy a question now and let you think about it for a minute while I\'m
asking them something. We think of you as much more than a token from
the drugs folks. Really, Randy, you need to know that.

Really, we actually think of you as a potential important partner in
this, a critical partner, especially because we just I think have begun
to see the revolution of drug‑device combinations. And I think all the
more reason that we should be thinking together about this system.

I\'m going to ask you if you could name a couple of lessons that you
have learned, been through the wars that you have been with the drug
system, that we can make sure that we\'re taking on board as we think
for the future.

So why don\'t you think about it for a minute? And then I\'m going to
ask you all if you can contribute to addressing a couple of the
questions that these folks have begun to talk about and want to extend
it. Should a code if it exists be human‑readable or is that not
necessarily an important feature of what we\'re thinking about? That\'s
been something we have been debating.

We have also been asking whether any unique identifier should have
intelligence, meaning it should have information in those digits that
can be utilized by the practitioner directly. That\'s not necessarily
part of some of these codes, but it\'s something we have been thinking
through.

And then we want to ask a little bit about what are those minimum data
items? I think Kathleen has already suggested some. Is there something
we\'re missing? Is there something pivotal that you think is really
important? Is it very important for a certain type of device and not
others? That would be fine to mention as well.

So now I\'m going to give you a few seconds to think. Randy, a couple of
lessons learned?

DR. LEVIN: Well, I tried to go over some things that we felt were real
important. And I think a lot of that is what you are addressing here, is
that you need to define what\'s the purpose of what you\'re trying to
accomplish and that we develop the use cases and then the data elements
based on that.

So when we went and talked to the different groups, they were talking
about using for electronic prescribing all sorts of different
activities. And some were prescribing at the proprietary level. Some
were at the generic level. And they want the ingredient level, too.

So gathering those kinds of requirements and then the other what we have
learned over the years with the drug listing is that it needs to be done
centrally.

There needs to be a central authority for this because as it\'s sort of
a voluntary, not voluntary. People have to list for the drug products,
but people forget to list, they are late on listing. And no one in the
United States today has a comprehensive list of these national drug
codes as a result. So that\'s a major problem. The identifier was not
robust because of this lack of a central authority who could reinforce
all the rules that you define.

When a product changes, if you change an ingredient, you\'re going to
change your product at your code. And if some companies interpreted it
differently, that means you couldn\'t determine what your identifier
really stood for. So we figured you need rules and you need this to
enforce those rules and then the standards. You need a standard way to
exchange the information.

MODERATOR KESSLER: It is interesting you raise that. And I invite you
all to get up to the mikes while I\'m commenting back with Randy. I
think those are great lessons.

One of the struggles we have in medical devices has to do with a topic
like software. So medical device software takes a lot of different
types. Some software is an independent device, but much software
actually is embedded in the device.

So the device looks and acts like a pacemaker can. The software in it
runs it. A company will change the software. They haven\'t changed the
device, but the software version has changed. That\'s critical
information. These are problems that you haven\'t had to face in drugs
but things that we have to figure out how to solve.

DR. LEVIN: Yes. Clearly, the activity in drugs is much simpler than the
challenge you have in devices, but the issues are very similar.

Another issue that we had is that we didn\'t figure that when we provide
this information on the product, we\'re not the experts to know the best
ways, all the ways that it can be used, and that the different, we want
to partner with the health information suppliers, make the information
available, no cost, in a standardized format so anyone could then take
that information, put it into their systems, provide the value added,
and address the customers\' needs, which, you know, the FDA wouldn\'t
have to address all of those needs.

MODERATOR KESSLER: Comments from the floor?

AUDIENCE DISCUSSION

MS. BERMAN: I want to ask you a question.

MODERATOR KESSLER: First identify yourself, please.

MS. BERMAN: Hi. I\'m Sandy Berman. I work with the FDA. And I\'m on the
Home Health Care Committee.

When Dr. Kessler asked about should it be human‑readable, my question
is, is this going to be a universal code or symbols because I know when
we look at health literacy and how many different types of instructions
we need on labels, it\'s very difficult.

And I know just in Montgomery County, there are over 364 languages
spoken here. So it\'s going to be very interesting to see how you\'re
going to do this if you\'re going to do this on a global nature.

And one other thing I want to mention since I am on the Home Health Care
Committee, we\'re looking at medical devices that have migrated from the
hospital or clinical setting into the home environment.

And a lot of times when these devices go into the home, they really
weren\'t studied. I guess there was a lot of clinical data in the home
environment. A lot of it is in the hospital type of setting.

So it\'s really difficult for us to capture that type of information
about what is going on in the home. And some thoughts were to maybe have
this user identification code or nomenclature on the device.

And that way a patient could either call in if there was an unusual
incident or reported for an MDR reporting, medical device reporting. And
that way our committee or even the agency can get information or
feedback on what exactly is going on into the home.

So if you would like to make any comments on that?

DR. LEVIN: At least from the drug perspective, again, in our proposed
regulations, we are proposing that the National Drug Code be on every
label so that people could use that information to have access to
additional information that the original national drug code was actually
three different codes. One was a labeler who was labeling the product.
One is for the product. And one is for the packaging.

But these codes themselves really didn\'t have any meaning within
themselves. So you would have to go and access information elsewhere to
find out what the codes stood for.

MR. SHERMAN: And that goes along with what Dr. Kessler mentioned
earlier, whether this is going to be a smart number that can convey some
information about the piece of equipment or whether it would be a dumb
number, which then would lead you to have to access the database of
attributes in order to determine what that item actually is, who
manufactured it, et cetera.

MODERATOR KESSLER: I think the home health care issue is really very
challenging for us. I didn\'t realize 364 languages were spoken. You
said in Montgomery County?

MS. BERMAN: Yes.

MODERATOR KESSLER: Three hundred sixty‑four? Are you including FDA
languages in that?

(Laughter.)

MODERATOR KESSLER: FDA‑speak?

MS. BERMAN: Montgomery County is a very diverse county. And I think it
is because we have a lot of military people stationed here and a lot of
people from the embassies here.

MODERATOR KESSLER: I\'ll repeat what she said. She is just saying that
Montgomery County is a very diverse community, principally because of
some of the transient nature of the military around here, so 364
languages.

I don\'t think we have thought all the way through that, but we
recognize it as an important challenge. Thanks, Sandy.

DR. HENSTEN: Thank you.

Arne Hensten from Norway again. There are two issues that I think I
would like to see considered here in the minimum data sets because the
regulatory requirements are different in the various countries.

The European Medical Devices Directive has safety issues, both for the
patient, also for the users, which would be a different regulation here,
I guess. And also what we are seeing now very heavily promoted in Europe
is in the kind of environmental issue that could be part of the product
when it\'s destroyed or when you\'re using it.

So when we talk about minimum data sets, I think the number is going to
grow indefinitely, but I would like to see if you do have some kind of
plan or a system if you would like to include also the international
perspective for the occupational problems and for the environmental
part.

MODERATOR KESSLER: So let me ask you a question about that. In terms of
environmental problems, I think, actually, we have a requirement in the
FDA if we are going to promulgate a regulation, we actually have a
little section where we have to think through environmental
consequences.

So you\'re suggesting that somewhere in the data system, I\'m not sure
it would be in the number, you would be able to access whether disposal
of that kind of equipment or device would have environmental impact.

Is that what you\'re asking?

DR. HENSTEN: Yes.

MODERATOR KESSLER: Okay. And then explain more about the occupational
risk issue. What are you expecting or hoping to see in the data set?

DR. HENSTEN: Well, after working for 30 years with the various reactions
to dental materials, what we have to see in the first place to see the
reactions is in the occupational people, in occupation with allergies or
that kind of reaction.

So you need to be able to have identification of the product for that
reason also because otherwise you have got 250 implant manufacturers or
250 amalgam manufacturers. If you do have a better system of identifying
the various products, you could minimize the number somewhat.

But we do see the occupational problems as a very important issue. And
for the European Medical Devices Directive, that is written into the
directive very clearly, the risk‑benefit also for the user.

MODERATOR KESSLER: Thanks.

Okay. It looks like we\'re having a slow moment. That\'s fine. Is break
ready? Okay. So we\'re going to take a brief break. It\'s about 2:15.
Break until 2:30.

Just so you know, we\'re going to come back, do the last panel. Then
people who have asked to make presentations will be given a brief period
of time with their presentations. And we\'ll do a wrap‑up. So 15
minutes, please.

Thank you.

(Whereupon, the foregoing matter went off the record at 2:20 p.m. and
went back on the record at 2:40 p.m.)

MODERATOR KESSLER: Home stretch. We\'re going to talk now with the last
panel about the use of automatic identification technologies. And we\'re
starting to address, again, some more technical issues.

I am pleased to present one of my good friends and colleagues: Jim
Keller from ECRI. He will begin with the first presentation. And we\'ll
go on from there.

Thank you.

THE USE OF AUTOMATIC IDENTIFICATION TECHNOLOGIES

PANEL DISCUSSION

MR. KELLER: Good afternoon, everyone. Thanks, Dr. Kessler. It\'s really
nice to be here today. And I think this is an important topic that we
all are learning a lot from today from the different comments from the
folks today.

I was asked to do a couple of things to start off this panel. I\'m going
to provide just a little bit of background, some ECRI perspectives on
the topic, and then also to briefly review the ECRI white paper, the
white paper that ECRI produced for FDA. And I will provide you a link to
that. And then we can go into the panel discussion.

Just real quickly, ECRI is an organization that has been around for a
long time. And some of the things that we have done that are relevant to
today\'s discussion have to do with the problem reporting system for
medical devices that we have been running for about 35 years. We have
been for about the same amount of time running a program to disseminate
hazard and recall information related to medical devices.

And then we also have developed and maintained a universal medical
device nomenclature system that is a naming convention for all types of
medical devices, from reagents to Band‑Aids to a picture archiving and
communications system.

Some of the slides that I have will have been touched on today. I was
thinking as we got to the end of the day, some of the subject matter has
been covered a couple of different times. But from ECRI\'s point of
view, there\'s clearly potential value, significant potential value, in
using a unique identifier for medical devices and in the patient safety
realm, obviously assisting with recalls, tracking medical devices,
incidents, helping to identify incompatible or counterfeit devices ‑‑ we
heard a little bit about the counterfeit devices earlier today, I think
‑‑ and then in the inventory management area.

I was reminded of one of my DOD colleagues, who told me a number of
years ago when they were looking at inventories across the Department of
Defense during the Y2K days, when they were trying to determine whether
or not there were any Y2K incompatibility problems with the medical
devices in their inventories, one of the folks that I have worked with
said, \"I didn\'t know that there were so many different ways to name a
defibrillator.\" And I think just within one database within an
institution, there were multiple names for a defibrillator.

And also getting to some of the values of having unique identifier: cost
containment. And clearly you can help improve the supply chain. You can
ideally improve on costs.

Some of the challenges we have heard about, the diversity among
different types of devices to be identified. And even within a device
category, that\'s a challenge. So using a defibrillator as an example,
is the device a manual defibrillator or an automated defibrillator? With
a pulse oximeter, is it a standard pulse oximeter or is it a pulse
oximeter with motion artifact rejection?

And then another question is, is this thing a device, a drug‑eluting
stent? How are you going to handle that? And then diversity among the
different types of identification technologies, we have been hearing a
lot about bar code and RFID. And I\'ll touch on some of the other things
that are out there that are intended to do some of the same things that
the RFID technology will do.

Nonstandard approach to device identification and inventory management
across institutions. And I remember back in the Y2K days when ECRI was
helping hospitals to review inventories, I couldn\'t believe how many
different terms were used for different devices within those
inventories. And then you have to think about the fact that hospitals
have multiple inventories within their own institution.

So a computerized maintenance management system is an application
that\'s used in the clinical engineering department that has much of the
capital equipment inventory but not necessarily all of the inventory.
And then you have the materials management database. And then you have a
separate database that might be used in a purchasing area or a database
in the radiology department and so forth. So there is a lot of
complexity. And all of this ties into high potential costs for
implementation of the system.

Quickly, to review the white paper that was produced by ECRI for FDA.
First off, the most important piece of information is the third bullet.
And that\'s the link to that document. And that is on the FDA Web site.

The white paper was commissioned by FDA for ECRI to provide an extensive
overview on automatic identification of medical devices. We did an
extensive review of the available literature and provided an overview of
the different types of identification technologies that could be
considered for this application and then provided some commentary from
ECRI.

The white paper is organized with a technology overview. So we covered
an overview of bar code identification systems and then described the
RFID systems. There was detailed discussion of automatic identification
technologies for medical devices.

So we surveyed who is using the technology, how it is being used,
potential benefits for the different types of technologies. You will
find information in the document on stakeholders\' position statements
that do exist related to this topic, relevant standards, existing
classifications for unique identifiers, discussion about nomenclature,
and what type of elements are built into nomenclature, et cetera.

And so some of the content, as I said before, described the bar code
identification technologies and pointed to the fact that these are
valuable but have some limitations in that they\'re a line of sight
reader with a limited range so someone has to walk around the hospital
with a hand‑held reader to get the information that you need.

Clearly they are widely adopted and are the first choice in terms of
reading a unique identification number on a product. And they\'re
relatively expensive.

Regarding radiofrequency identification, ECRI is in the middle of doing
a comparative study of some of the technologies in this class. And one
of the first things that we realized as we were naming what we were
going to write about in the publication data research is going to be in
is it\'s not just RFID. We\'re doing a review of asset‑tracking systems
for medical devices. And as we started to do some of the research and
evaluation work, we realized that there were multiple different methods
for doing the same kind of thing.

So there\'s RFID. There are wi‑fi systems. There are ultra‑wide band
systems. There are systems out there that use IR in combination with
RFID. And then there is an ultrasound‑based system. So there\'s a
variety of technologies that are in this classification.

With the RFID‑type technology, it\'s a new and emerging technology that
can be used over a wide range within the health care facility, but the
cost for the tags and the readers and the associated software can be
relatively high, especially compared to the bar coding systems.

Some of the perspectives from ECRI regarding the topic of unique
identification have to do with the varying sizes of medical devices and
the different types that are out there, sterilization and disinfection,
issues of reusable medical devices, and should you be labeling the
packaging or the device itself. If you\'re labeling the packaging and
you\'re talking about a reusable medical device, then that is gone.

I\'ve done many medical device accident investigations over the years
since I have been working at ECRI. And one of the most common problems
that we run into is when you go in and do an investigation in the
hospital to find out what happened, frequently the packaging for the
device is gone. And that is, the identifying information for that device
is gone.

There is a growing number of devices with built‑in software and
interconnections. Dr. Kessler referred to that. And from one day to the
next, computer‑based medical devices is not going to be the same thing.

A medical device manufacturer may push out a patch to correct a bug or
they may push out a patch to correct a security issue. And then a
patient monitor, for example, may be completely different from one day
to another because it\'s a modular‑based device. And it may have pulse
oximetry in it as an adjunct piece of monitoring and then may have
entitled CO2 added to it. So these devices will be changing over time.

Some of the things we need to think about in terms of applying a unique
identifier ‑‑ and we heard about this earlier ‑‑ is whether or not to
apply human‑readable versus a machine‑readable identifier.

And then I touched on the fact that there is rapid evolution of the
reader technologies. And you\'re not going to be able to establish one
reader technology and have that stick for a number of years going
forward.

So additional perspectives. Automatic identification of medical devices
has tremendous potential. The diversity on a variety of levels is going
to make universal implementation of this very difficult and costly. And
one of the things that might be considered is to address high‑value
technologies first. And what I mean by high‑value technologies is things
that have the most patient safety implications, for example.

So infusion pumps are an example technology that might be looked at
first from a unique identifier and how a classification or a requirement
from FDA to touch on infusion pumps and maybe implantible devices,
things where there is high risk, where the patient may die if the device
fails and then see how that works and then evolve it to be more
widespread.

So some of the facts that the rapid evolution of the identification
technologies is going to limit your ability to standardize on one method
may allow us to address a small number of devices first for unique
identification, get it right on a small number of devices, and then
expand it beyond the rest of the system or to the rest of the different
technology devices.

So, with that, I\'m going to pass it on to Dr. Kessler and the rest of
the panel and for discussion. Thank you very much.

MODERATOR KESSLER: Thank you, Jim.

(Applause.)

MODERATOR KESSLER: I\'m going to ask Julian Goldman of Partners to speak
first. I\'m just going to stand up. And we\'ll try to keep them to 20‑30
minutes.

DR. GOLDMAN: This was a last‑minute suggestion so that, instead of just
reading a page of notes, I would project it. I don\'t have any slides,
just a quick set of notes. There we go, almost like magic or like
interoperability.

Well, my name is Julian Goldman. I\'m an anesthesiologist at Mass.
General Hospital. I am a physician adviser to Partners Health Care
Biomedical Engineering.

I have been also directing a program on medical device interoperability
for the last few years. And that program has been coordinated with many
of the folks in the audience as a part of the broad collaboration.

That is moving all over. Sorry. We have been working on a program. I\'m
going to try to fix that so no one gets too dizzy. Is that okay?

We have been working on a program on the operating room of the future
that opened in the Summer of 2002, which has given us an opportunity to
try many innovative technologies in a clinical environment.

The OR of the future is sort of like a living laboratory for technology.
We don\'t do experimental surgery, but we do have a chance to use many
devices, such as rolling out an indoor positioning system using active
RFID, innovative RF‑based cabinets for storing devices, and many things
like that.

I just organized my thoughts here in this document. And so I would like
to share it with you. The first thing I would like to point out is to
share the mission for Partners Health Care Biomedical Engineering,
which, to paraphrase, is that no patient shall be harmed by any medical
device.

And so we have to keep remembering that our business here really is to
take care of patients. It may be to improve the quality of the delivery
of health care. It may be to reduce adverse events. It may be all the
different things that we know that we can do, but we certainly want to
keep remembering that that is the purpose. It\'s to prevent that,
prevent harm, and to help heal disease.

So what is the goal of this work in unique medical device ID? From our
perspective, this is one piece of the puzzle. You have to take a systems
view. And this provides a capability to support other solutions in the
health care systems base.

Which devices should it apply to? I don\'t know the answer but probably
all devices above a certain threshold, certain threshold for risk, for
cost, for size. And that will be figured out. The military I think has
done that with a \$5,000 price tag or something like that. So that will
get sorted out but probably for most devices.

But don\'t forget that we\'re not only talking about the hospital. As it
was mentioned in previous conversations or presentations today entering
Q&A, there is a dramatic movement of caring for patients in the home
environment.

And when we see the kinds of activities that are coming together, such
as the Continual Health Alliance, which was formed in June of this year,
now has, I believe, 50 or so companies that are members of continuum,
pushing for a logo compliance of interoperability, there is a need to
inventory devices in the patient\'s home.

And a use case was mentioned earlier by someone who had a comment that
there are hundreds of languages and how will we deal with that. I don\'t
know the answer to that, but I want to point that out as the kind of
question that needs to be captured as a use case.

The use case is an example of a patient at home who speaks another
language who may have to read a devices ID and then report that. Is that
a valid case? I don\'t know. If it\'s just a number, does it make it
easier to do that? I\'m not sure. Is the solution to take a photograph
and to e‑mail it? I don\'t know.

But I think that most of the time, as technology moves forward, it will
be reading the information automatically over the network. We won\'t be
asking people to report back a 30‑digit string in a language that we
don\'t understand or over a poor connection.

Do we need this process? Do we need FDA leadership? Well, can we just do
this on our own? Well, we are doing it on our own. We\'re doing it on
our own in our hospital. People are doing it on their own hospital.

We buy devices. We apply new numbers and new stickers. We bind the
things together in our homegrown database. And it\'s terribly
inefficient, and it\'s a good source for errors. And it prevents the
collection of data at a national level for national investigations and
for pursuing potential device problems nationally.

So sure, we can do it ourselves. And we can keep doing it poorly. It\'s
as if we didn\'t have Social Security numbers or passport numbers.

We also have the potential problem of having the same serial number from
two different manufacturers. And then we have to sort out the
difference. So for all the reasons that anyone who knows anything about
databases knows, yes, we can do it, but it\'s a bad idea.

Now, how many devices are we talking about? Well, I don\'t know the
universe of medical devices, but I can provide some numbers for you. Let
me scroll down to bring that up higher on the page. There\'s a reason
that people use PowerPoint, instead of Word.

The Partners Health Service Health Care manages 33,918 devices as of
September of 2005. Those are the numbers of medical devices we actively
track. It does not include implants and things like that. It\'s things
that biomedical engineering tracks in our database.

Last week we had a scientific exhibit at the American Society of
Anesthesiologists\' annual meeting. As part of that exhibit, which was a
collaboration of a number of interested parties helping to move medical
device interoperability forward, Kaiser Permanente presented data for
the first time in a public forum. And they disclosed that they managed
300,000 medical devices. Again, this is just management from a
biomedical engineering perspective.

Let\'s talk about the benefits and applications of this type of
technology or this type of infrastructure. Well, unique medical device
ID is a key element of a larger infrastructure. And many applications
will be part of a framework that require UID functionality to be
effective.

We have been using indoor positioning system technology to track
patients, to track things, to look at associations between things. And
Mike Dempsey talked about that this morning. Well, naturally it\'s
pretty difficult to use that if you can\'t identify the things initially
and bind them together in the database.

We need to be able to support preventive maintenance and servicing of
devices. It is tremendously difficult to find devices and then be sure
that they have been upgraded and one is compliant for JCAHO purposes.

Now, one of the key messages I would like to leave you with is the need
for this work to be driven by requirements. And a good requirement was
the example from earlier today. And we have been working on obtaining
clinical requirements over the last two years from clinical groups and
from clinical engineers in various national forums.

I took a look in our database to try to pull out some of the clinical
requirements that I thought fit with the discussion today. And here are
eight of them. And they\'re not all unique. Some of them apply to the
discussions that we have had.

Number one is the need for device IDs to support network medical device
systems that are to support safe networking of medical devices to
accomplish new tasks; for example, for safe medication administration or
to verify that an IV pump that is being used as part of that system
actually is a device that can support that use because, for example,
some infusion devices aren\'t accurate and within certain infusion
ranges.

And those things are known ahead of time. And one can prevent potential
errors or adverse events just by making sure that the wrong device
isn\'t selected for an application.

Number two, to verify device patches and upgrades are performed
correctly, this is a major challenge for us now in the hospital.

Number three, closed loop control. Closed loop control using
physiological data, closed loop control, for example, to improve the
safety of PCA opioid administration, you know, push the button, get the
pain shot on the hospital ward.

That system is a system fraught with problems. And patients are being
injured. That was a focus at a Anesthesia Patient Safety Foundation
meeting a week ago. And to do that well, we have to network devices
together. And then we have to know the capabilities of those devices, if
they can support the algorithms that will be used clinically.

Number four, we all have discussed that there is a need for
comprehensive population of the electronic medical record. And the need
for that is to support many activities, including, of course, CQI.

Automated inventory for system readiness. It would be very helpful if
one could look at a hospital inventory, rapidly take a snapshot,
identify the devices that are in use. And then if Hurricane Katrina is
bearing down on that hospital, we know which devices have to be set up
elsewhere to support that patient population; again, very difficult to
do today but quite possible if we can interrogate over the network, ID
the devices, and know what is being used, identify devices that are
being used in the wrong environment, integrate IPS, indoor positioning
systems ‑‑ I mentioned that before ‑‑ and also to find urgently needed
devices. Believe it or not, this is a big problem.

You need a pacemaker quickly somewhere in the hospital. You need to be
able to find it. One way to do that is by having unique IDs on the
devices and tying that in with another system. Again, that\'s a system
problem. It\'s a system solution. This is an element of the system.

In terms of specific technologies, I don\'t have specific
recommendations except to say we have tried a bunch of them: active and
passive RFID and various solutions. And that is not for us to think
about today.

In conclusion, ‑‑

(Laughter.)

DR. GOLDMAN: ‑‑ the demand for interoperability to improve patient
safety and health care efficiency can benefit greatly from unique
medical device IDs. I think it\'s time for us to act. And, like Legos,
it\'s a matter of producing the building blocks and then letting other
people build the solutions. And we have to look forward. We have to be
innovative. And, frankly, I think that the FDA can provide significant
leadership in this area, Larry.

Thank you very much.

(Applause.)

MODERATOR KESSLER: Thank you.

The rest of the panel includes Ilisa Bernstein from the Office of Policy
at FDA; Ann Ferriter from the Office of Device Evaluation at FDA; and,
again, two familiar faces: John Terwilliger and Lu Figarella.

Ilisa?

MS. BERNSTEIN: Thank you. Hi. Thank you for inviting me here today.

I know Randy on the last panel said that he was a token drug person. He
was actually the token drug guy. I\'m the token drug girl here. So my
experience in this area is with drugs. And I\'ll tell you a little bit
about it.

I\'m sorry. Unfortunately, I was unable to attend the earlier part of
this meeting. And I don\'t want to repeat anything. So the two areas in
the drug side of FDA that were using these technologies is for the bar
code rule and for electronic pedigree or for pedigrees for creating a
chain of custody for a drug or a document or a chain of custody
document.

So for the bar code rule ‑‑ did you cover that already? No? Well, I\'ll
just briefly give a brief overview. What the bar code rule does is it
went into effect in 2004. And, as of April of 2006, all drugs that are
used, prescription drugs that are used in hospitals and OTC drugs that
are used in hospitals pursuant to an order or a prescription, have to
have a bar code.

In the rule, we required, at a minimum, a linear bar code. At the time
when we were doing the proposed rule and the final rule, the only
information that we had when we did the economic analysis, the
cost‑benefit came out in favor of a linear bar code at the time.

We had said in the proposed rule that at some point once the bar code
rule is in effect, we\'re going to look at other automatic
identification technologies and look at their use as well. And right now
it may be a little too early to evaluate that now that that April 2006
went into place, but we\'ll probably start thinking about this very
shortly.

In the area for pedigree, I know this is mostly a device crowd. So, just
in summary, there is a pedigree requirement for prescription drugs that
for certain wholesale distributions of prescription drugs, not all
wholesalers have to pass a pedigree. And I won\'t go into the whole
thing. That would be a whole other two hours here. But for certain
wholesale distributions, a pedigree has to be passed. The regulations
and the law do not specify whether it\'s a paper pedigree or an
electronic pedigree.

In 2004, FDA put together a big counterfeit drug task force to look at
the issue of counterfeit drugs in the drug supply chain and to identify
vulnerabilities in the drug supply chain and try and identify ways that
we can minimize those vulnerabilities to create a safe and secure supply
chain.

One of the key elements of that initiative was it was calling for a
widespread use of an electronic pedigree for all transactions involving
drugs from the time it leaves a manufacturer all the way until it gets
to a pharmacy. We have no requirements here, but this is what we called
for as our action plan for the drug supply community to put this in
place.

And so we put out a report. And we have said this many times in several
reports ‑‑ it\'s all on FDA\'s Web page at www.fda.gov/counterfeit ‑‑
that in order to get to an e‑pedigree, the most promising technology is
RFID. But that\'s not the only way to get there.

So we have said that other technologies, auto‑identification
technologies, could be useful. But we are putting a lot of effort in
trying to move the pharmaceutical community and manufacturers,
wholesalers, and pharmacies to use RFID. But the ultimate goal here is
an e‑pedigree. So that you have a document that shows who has had that
drug and in the supply chain as it moved.

And so just an update on where that is in the drug side, there is a
great deal of effort by UPC Global within the UPC global community to
create standards from an electronic pedigree for track and trace, for
use of RFID on drugs, prescription drugs.

There are a number of pharmaceutical companies who already have put some
tags, RFID tags, on individual units. And the key here is mass
serialization so that each individual product would have its own unique
number, just like you\'re talking about here.

And there is still talk about doing standards. As many of you know,
we\'re not there yet, but this is the ultimate goal. And there is a lot
of effort moving in that direction to get there.

We at FDA are very hopeful that if we all work together to get there,
that this would be useful and extremely beneficial to secure our drug
supply chain.

So I\'ll stop there.

MR. FERRITER: Hello. I am Anne Ferriter. And I work in the Center for
Devices. So this is our device meeting to talk about unique device
identifiers, but there are device identifiers already in use in the
market.

There are bar codes and RFID on many things. Bar codes are present on
almost all medical device labeling and packaging. It\'s also used on
patient identification bracelets.

RFID devices have been cleared through the 510(k) process. There are two
patient identification devices: implantible VeriChip and the adhesive
Surge chip. RFID is also integrated into medical devices, like wireless
monitors, for device identification.

So the technology is being used, not in a standard way, but it\'s out
there. RFID is also used on health care‑related items that aren\'t
considered medical devices. There\'s been some work on blood bag
tagging, for example, with RFID to limit the number of incorrect
transfusions.

Through our 513(g) process, we have decided that that is not a medical
device. And neither is a device inventory cabinet. But CDRH is looking
at these uses of RFID and keeping an eye on how they are being used in
the hospitals.

We realize that one solution isn\'t going to fit all devices. It\'s
unlikely that FDA is going to ask resorbable suture manufacturers to put
an RFID chip on a resorbable suture, but something like an MRI machine,
it wouldn\'t make sense to have the RFID on the packaging or any unique
identifier.

Even given that we\'re going to have to go a lot of different directions
on medical device labeling, we do want to be compatible with both the
Center for Drugs, with DOD, and with EPC standards. So we are talking to
all of these people to learn what is going on.

MODERATOR KESSLER: Thanks.

MR. TERWILLIGER: I\'m back. A little bit about automatic identification
technologies. I want to back up on one point, and that is, why do we do
it? And this is something I think most people maybe haven\'t thought
through.

The reason we do automatic identification technologies, whether or not
it\'s bar coding or RFID, is about accurate data capture. That\'s why we
do this. It\'s not about pretty art work.

Also, another way I like to think about it is if you think any process
includes the phrases, \"Write it down, and someone is going to keypunch
it in,\" what it really, really says is, I\'m going to scribble it so no
one can read it, and I\'m going to keypunch it in wrong again, again,
and again.

So if we think we\'re going to get to correct data in electronic health
records that involve anything about people typing data in, we\'re
sorely, sorely mistaken. And that\'s really what automatic
identification technology is about. And I think, particularly for
products used for patient care, it\'s really about capturing them
automatically. And I think we should be very focused on that.

Also, there\'s been a lot of discussion here about I know marking
things. I know a couple of providers or end‑users talk about we mark
them ourselves. How sad. I don\'t know how else to phrase that because
the manufacturer is the absolute cheapest place to put on automatic
identification technology. Anyplace else in the supply chain is very
expensive. It\'s just orders of magnitude more. So I think that\'s one
we should all keep in mind.

Another thing I would like to share with you, I am unaware of any
broadly implemented AIT application that uses lots of data. So,
actually, we are the data carries all sorts of stuff or even smart
numbers, shall we say, again, broadly implemented.

Most all of them, even that I\'m aware of, use more of a kind of a
license plate approach, where it\'s kind of an identifier pointing back
to data. It is very difficult and expensive to carry lots of data in an
AIT approach. It\'s just not done that way.

And, like I said, I am absolutely unaware of any broadly implemented
system that works like that. So I would like to share that, which really
comes down to this idea of smart numbers. Smart numbers ultimately fail,
ultimately, ultimately fail. And I wouldn\'t use the word \"dumb\"
numbers. Unintelligent. They\'re really license plates back to the real
data.

And I think nothing we have mentioned earlier ‑‑ the data points back to
changes over time. I think, as the community becomes more sophisticated,
things get added on. And things that used to be important will drop off.
So I think that\'s important. And if you\'re bar coding all of that, it
will always never be right.

I think another thing I would like to point out, the creativity in
automatic identification technology is not an objective here. I really
would like to put this forth. Mass adoption implementation, that\'s the
objective. Unfortunately, the world is littered with AIT technologies.
Our providers have great fun doing it, but they aren\'t broadly
implemented. It\'s not what we\'re after here. So I\'ll throw that out.

And then probably the last little thing, I really would like to
encourage the FDA to promote the adoption of existing standards ‑‑ you
made mention of a few of them ‑‑ which really runs kind of our product
identification lot numbers, expiration dates, and serial numbers, and
let the community work through the various standards processes to adopt
new automatic identification technologies as they evolve because there
is no way that the rule will ever keep up with what is going on in the
industry. And I think that the industry is in a good position to really
better reflect over a longer time frame what is the best approach to
collect data.

And, last but not least, our health care user group, the HUG, as I
mentioned earlier, has been very focused on many of these issues. And we
actually have a road map for actually working through these. So many of
the things that you talked about, like what data should be bar coded and
actually some of the automatic identification technologies, we are
really kind of reevaluating to make sure we haven\'t missed anything. So
much of that is actually going on today.

Thank you.

MODERATOR KESSLER: Thanks.

Lu?

MR. FIGARELLA: Last time they told me to project. So hopefully you can
hear me.

I think the points are well‑made. You hear sort of a theme of \"Well, we
tried this system\" or \"that system.\" When you look at the use of auto
ID technology, I think you have to ‑‑ and it was said before. I\'ll
reiterate it. You have to separate the data from the data carrier. I
think the data carrier is all of the things that we talked about here,
whether it\'s RFID or 1D bar code or 2D bar code.

You know, for a while, one of my previous jobs, they had a joke about
the color of blue, which was every two months, it seemed a new
two‑dimensional bar code was invented, you know, because it was better
than the other one.

And the answer is that always continues to happen. You want the
standards that exist, you know, all the work that we have done with ISO
and other places, not just here but in Europe and other places. You
really want those standards to tell you how to carry the ‑‑ not
necessarily to have smart numbers but to have a good rationale for how
you came up to what your unique identification is, rather than just, you
know, from 1,000 to 2,000, you got those. Those things are I think
well‑understood, well‑done.

Somebody mentioned in a previous presentation the whole UID effort at
the DOD, where they clipped it off at \$5,000. But they\'ve done a
tremendous service for all of us because part of what the DOD did is
essentially say, \"Okay. These are the issuing agencies for this UIDs.\"

And GS‑1 is one of them. HIBCC is another. Dun and Bradstreet is
another. These are people who have a data identifier that essentially
allows you to use.

As mentioned by somebody before, it\'s a triad. Think of it as 1D bar
code, 2D bar codes, or RFID as those three legs of the stool. And you
decide which one you\'re going to use for a particular application.

That\'s really my message to the FDA. I think that we have to look at
solutions that allow, if possible, not necessarily give a manufacturer
20 choices but really give somebody a choice of ‑‑ in this particular
application, maybe it\'s a class 3 device, implantible, et cetera. We
will mandate an RFID or not, but these other applications are less
important.

Perhaps what you end up doing is you end up saying, \"Well, you could do
it this way or this way. This is the data we\'re going to require you to
have so that we can find it, whatever we decide to look for it, but
these are the choices of manufacturer.\" Again, you know, somebody who
makes products.

You really hate to have anybody tell you this is the only way you\'re
going to do it because instantly whoever is that solution, the price
just added a zero. It\'s amazing how it happens overnight.

The data size is important ‑‑ we talked about it before ‑‑ because,
again, you\'re not going to get ‑‑ it used to be called label inflation.
I need another byte for something else. And before you know it, you\'re
wrapping the bar code around the package. And you still can\'t read it.

So those are the things for us. Again, keep on thinking of the data and
the data carriers, two different entities. And really think about what
you want to mandate for data you have to generate and then see if that
maps to the data carriers.

It may be yes, for example, when you use a HBIC number that you have a
primary and a secondary and two bar codes, which isn\'t a problem if you
have an MRI machine, but if you have something that is very small,
contact lenses or any other device like that, what you really may want
to end up doing is mandating, well, we\'ll either have less data or you
really will have to go to this to the bar code or this RFID. And,
really, you know, this is your poison, but we want the data tracked.

We thank you.

MODERATOR KESSLER: Thanks, Lu.

I am going to turn the mics open in just a second. It\'s a very
important comment. That you make that the data system and the carrier,
the number are separate issues and that we don\'t have to confuse them
is something that I think we have learned along the process.

And I really appreciate John\'s offer from GS‑1 of the road map. I would
love a road map. And if it gets me somewhere, it will even be better.

Where does the road map get us, John?

MR. TERWILLIGER: The road map I am talking about is our user group as
they attack some problems around standards and implementation of the
GS‑1 system. There are a number of steps involved we actually have
posted on the Web site. Is it gs1.org/hug? Yes, www.gs1.org/hug.

MODERATOR KESSLER: Does that include the processes that we have been
talking about today; for example, implementation at the hospital level,
implementation at the health professional level.

I have the wonderful man who has come all the way from Norway to build a
dental system around this. So is that going to help him as well? Does
the road map get to Norway?

MR. TERWILLIGER: Oh, absolutely. Well, it\'s global. It\'s global. I
think the thing is we\'re still working more at kind of these
fundamental data levels of making sure that we have things properly
identified and properly bar coded or automatic identification analogies
so you can see global, too, and really get in and set the stage for some
of the things you have just asked about.

MODERATOR KESSLER: Mics are open if you have a question or a comment to
make to the panel.

I\'m going to ask Ilisa something about counterfeiting, leave it open
for you. Then the next plane is we have a series of presenters who are
going to come up, do very brief presentations. They have asked for a few
minutes on the floor to make some comment about what we have done today.

And then we have a treat at the end of the day of a few minutes and
closing comments from Dr. Daniel Schultz, who has come here. He\'s the
Director of the Center for Device and Radiological Health. He has some
of his own thoughts about this as well. So you may want to wait for
that. For those of you who don\'t have airplanes, it would be worth a
few minutes of waiting.

Ilisa, I want to ask you about counterfeiting because I know you have
been enmeshed in this with the drugs world because you are the drugs gal
here. To what degree has this been a problem? Is it an emerging problem?
I think we started to see it in devices, and we just hadn\'t seen it
before.

And is there some consideration about how that might affect what you are
doing in terms of the device world because I think sadly it\'s a very
current problem for us?

MS. BERNSTEIN: Yes. Counterfeiting. I mean, I guess I always qualify
this when I say, well, talking about all these initiatives to secure the
drug chain from counterfeiting, our drug supply is among the safest in
the world, but counterfeiting is a huge problem globally. We have seen
it in the United States. We have seen it in our own drug supply. And
even one case is too many. So the efforts are worth what we are doing.

What we are doing on the drug side, I guess what you are asking is, can
it be used for the devices as well? It could. I know that within the
community that\'s looking at the standards, they\'re setting up a device
working group to look at some things as well.

Right now I would say that most of our efforts, though, are on the drug
side. And because that is where a lot of ‑‑ at least for the pedigree,
there is a prescription Drug Marketing Act, which is under the Food,
Drug, and Cosmetic Act, which governs prescription drugs and pedigrees
there. So that\'s where a lot of our efforts are focused right now.

MODERATOR KESSLER: Thank you.

Brad?

AUDIENCE DISCUSSION

MR. SOKOL: I\'m Brad Sokol from Fast Track Technologies.

A case could be made for medical device pedigree. I just wanted to point
a couple of areas out in where we could as an industry point to those
like the pharma did, the pharma industry did.

Number one, the medical device record, under the Federal Food and Drug
and Cosmetic Act, any use error states that, frankly, one should report
that use error. Now, it\'s not enforced, although it could be. So
that\'s number one.

Number two, when you\'re looking at 21 CFR 820.7(g), which is the
installation and qualification of successful process verification for
devices, ‑‑ and this means equipment and maintenance calibration ‑‑ this
is another area that states that there should be a pedigree, could be
interpreted as a pedigree exists for medical devices.

And, finally, there is a movement going on right now for
hospital‑associated infections, where states are requiring the reporting
of these infections and how those infections came about.

In fact, there are 27 factors, which I will not go into at this point.
One of those happens to be instrumentation and devices. So those are the
three areas where pedigree if we wanted to make a case and interpret the
existing regulations on the books, that\'s one way we can interpret the
medical device pedigree.

MODERATOR KESSLER: Comments? Ann?

MR. FERRITER: Yes. I would like to comment on the NDR reporting. I think
that\'s a great use for unique device identifiers. What unique device
identifiers could also give us would be the number of devices that are
out there. If we get 100 NDRs, we don\'t know at this point whether
that\'s for 100 devices that were implanted or several thousand. So it
is a very interesting use.

Thanks.

MODERATOR KESSLER: Other comments from the floor?

(No response.)

MODERATOR KESSLER: I want to thank the device panel.

(Applause.)

MODERATOR KESSLER: I\'m going to ask the following people to come up one
at a time, a very brief presentation. And then we\'ll begin doing
wrap‑up. And the mics will be open for some comments at the end of this.

So Cathy Denning from Novation, please. And then in order just get
ready: Michael Dempsey, Richard Eaton, Fred Freedman, Dr. In Mun, Mark
Piper, Jeff Schaengold, Elliot Sloane, and Brad Sokol. Cathy?

One more thing to the presenters. I\'m going to sit down. When I stand
up, five minutes are over. And I\'ll just sort of quietly slide this
way.

MS. DENNING: I use my watch. I was a trainer.

MODERATOR KESSLER: Good.

OTHER PRESENTATIONS FROM PUBLIC

MS. DENNING: Good afternoon, everybody. I am Cathy Denning, and I work
for a company that\'s called Novation. We are the supply company. We do
contracting for about 2,500 member hospitals for VHA and UHC.

In addition to that, this is what we represent from a statistical
perspective. VHA has over 2,400 members. UHC has 200 members and
represents a large percentage of the university health systems
throughout the country.

In addition to those two, we also have a sibling company called HPPI,
which stands for Healthcare Purchasing Partners International. And now
we also are part of a company that is called Novation U.K. We are the
contracting side of the U.K. as well for the device perspective, not for
the pharmacy side.

Nationally Novation purchases are \$29.7 billion through these different
entities. It represents 26 percent of community hospitals, 70 percent of
academic medical centers, 26 percent of the staff beds, 30 percent of
admissions, and 29 percent of the total surgeries in the country today.

We would like to advocate from a public health and safety benefit
perspective for unique device identification. We believe that it would
positively impact patient safety and quality in addition to the health
care supply chain efficiencies that I will go into in a little bit. And
I will stay within my five minutes.

From a medical accuracy perspective, it\'s interesting that the last
comments around counterfeit products and drugs were mentioned. In one of
our VHA facilities, we had patients and implanted 30 of them, to be
exact, with counterfeit mesh.

I would like to think that if we had a way of uniquely identifying
products as they enter that hospital, we would know whether or those
products potentially were counterfeit.

And I do realize how wily some people can be when they want to be
dishonest, but just last week I think we also heard about the blood
glucose monitoring strips that are also counterfeit.

From a product substitution perspective, when we have large recalls and
backorders, when we have disasters across the country, certainly from a
product substitution perspective, being able to identify when a product
is both functionally and actually equivalent to another product would
certainly provide for the easy movement of one product from here to here
and, consequently, not interrupt the care of that particular patient.

Product shortages are an ongoing issue again. It goes all the way back
to raw materials. But I do believe that from the standpoint of being
able to look and to aggregate the different products again from a safety
standpoint as well as supply chain efficiency, that would bring some
benefit as well.

Recalls and product withdrawals. Of course, as you can see from the
previous slide, we have a lot of hospitals who have to manage large
numbers of both device as well as drug recalls on a daily basis.

I think there was an article last week that was published that said that
hospitals have had to manage over 600 drug recalls on average, which
would mean that that is more than one a day across the country.

From a supply chain efficiency perspective, unique device identification
would enable inventory management, item master management, recall
management, charge master management, and electronic medical record,
being able to track and trend which device made it into which patient,
how much it cost. Whether you\'re paying for a product that went into
that patient or got charted on somebody else is certainly something that
I would think that all payers, including CMS, would be interested in.

From a charge master and recall management standpoint at the end of the
day, it also is about bringing efficiencies and being able to track and
trend.

Inventory management. You know, right now there are disparate systems.
And I have heard a lot today about why hospitals don\'t adopt those
coding systems that are out there. We right now are gathering
information. We have a survey that is in process. And we will provide
those statistics and data to the FDA.

What we have preliminarily looked at is that and what our members have
told us is that at the end of the day they have disparate coding systems
that come into them. And they have to figure out some way of making
sense of that.

When they get it, they then have to turn around and code it so that
it\'s recognized across their system. So we would like to have a call,
really, for a mandatory system that is consistent where the nomenclature
is recognized globally.

In order for us to really be able to make this work, we believe that
that is what we have to do, is come together from a collaborative
perspective and really advocate on behalf at the end of the day on the
patient.

(Applause.)

MODERATOR KESSLER: Thank you.

Michael? Michael Dempsey again from Partners Health Care.

MR. DEMPSEY: Hello again. I prepared this presentation, really, for a
different context, but after sitting here for the day and listening to
all of the expertise in the audience, I am quite humbled by the amount
of thought that is going into this. So I am going to change it up a
little bit.

What I would like to do is just share with you a vision, maybe something
to get people excited by. Partners Health Care has our own version of a
unique ID. As I mentioned on the panel discussion, we ended up here. We
ended up with this originally starting with patients and then moving on
to medication safety. It\'s not deployed ubiquitously, but it does exist
in some of the practices.

So you can imagine that once we collectively decide what the unique ID
is for medical devices, that in a couple of years, we might be in the
same spot that Partners is today, some limited deployment but something
that works.

And now is where it gets interesting. We deployed it, started talking to
clinicians, and clinicians came up with amazing and fun and exciting and
very invigorating ways to use it. And I\'m going to share with you one
of those.

So that is nearly impossible to see, but down at the bottom there in
that white box is the unique ID. It\'s self‑identifying. That happens to
identify a drug, and it identifies the dosage and so on. And it\'s all
encoded in that 2D bar code.

So these are some of the records that are included in there. And you can
see it\'s quite complex, has versioning numbers, has care area
information. Different drugs are used differently in different care
areas, bolus rates, and so on. I can share with you the details of this.
If you\'re interested, contact me. This really isn\'t important.

But here is the unexpected benefit. We realize that this unique ID could
become a speed dial. So, in fact, it was in one of the outpatient
clinics with a medical assistant. So this is a paraprofessional,
typically has gone through 16 weeks of training, not a rocket scientist.
And they came up with this notion of capturing vital signs and putting
it into the electronic health record using the speed dial.

So, effectively, what you see there is the vital signs monitor. It\'s a
CASS 740 vital signs monitor that has no network connectivity, never
has, and probably never will. It\'s inexpensive. It\'s typically found
in a doctor\'s office.

On the front of it is literally taped that 2D bar code that says, \"This
is a CASS 740,\" its model number, and its revision number. And you
communicate to it with whatever, infrared, Bluetooth, however you
communicate with it.

So then the clinician uses her PDA, which has a bar code scanner; scans
that 2D bar code. And the PDA says, \"Oh, I know this is a vital signs
monitor. So I\'m expecting to capture vital signs. And I know how to
communicate with it.\" So it sucks the vital signs out of the PDA and
pushes it up over the wireless network into the longitudinal medical
record.

Now, what are the benefits of this? One and most significantly is it\'s
work flow‑sensitive. So if you scan a vital signs monitor, it does
something different, the PDA does something different, than if you scan
a smart IV pump. Right?

The smart IV pump scan tells the PDA that you\'re dealing with drugs.
There must be a drug someplace. And, in fact, since we have this notion
of unit‑specific identifiers, you can have a smart IV pump in an
oncology unit perform differently than the identical smart IV Pump
that\'s in the pediatric unit or in the OR because they have different
care practices.

All of this is enabled by the unique ID. The important point of this is
that the unique ID has all of the advantages that we have been talking
about that are obvious. But I believe that once we as a group of caring
medical professionals implement it, our clinical teams will figure out a
lot more applications of it in ways that we haven\'t contemplated today
that will make it very powerful and important.

Thank you.

(Applause.)

MODERATOR KESSLER: Thanks a lot, Michael.

Richard Eaton from the National Electrical Manufacturers Association.

MR. EATON: Good afternoon. Are we holding up? I\'m from the National
Electrical Manufacturers Association, NEMA, in Rosslyn, Virginia. I want
to tell you a little bit about NEMA, also share some views with you that
we have on UDI, talk about some problems and issues that we see with the
potential system, suggest some next steps, and some essential
requirements.

What is NEMA? NEMA is the primary standards development organization for
medical imaging and therapy systems equipment. Our Diagnostic Imaging
and Therapy System Division members manufacture over 90 percent of the
market for all these big ticket capital equipment items: X‑ray, includes
mammography; CT; radiation therapy, which includes linear accelerators;
magnetic resonance devices; nuclear medicine imaging, which includes
PET; diagnostic ultrasound devices; and medical imaging informatics
devices, or PAX.

NEMA generally supports a UDI system, which is practical,
cost‑effective, and improves patient safety. The link with patient
safety is absolutely essential.

We are ready to work with FDA and all key stakeholders to achieve this
goal. And we believe all key stakeholders must become involved in this
process to ensure success. Everybody who is going to touch this system
needs to be involved in it or, else, it will not work.

Let\'s talk about some problems. The first and most important problem
is, what are we trying to fix? What problems are we trying to solve? We
can\'t develop a fix if there needs to be a fix unless we define the
problem first.

Now, on capital equipment, we already have identifiers. Many of our
members already have bar codes on their devices. Some of our capital
equipment is already marked with serial numbers. And this is used to
track products for recalls and adverse events. And the tracking of these
begins in manufacturing through installation.

The RAD Health Act requires identifiers on X‑ray components. Our concern
is that a new UDI system would conflict with the existing requirements
that our X‑ray equipment manufacturers already have to adhere to.

I want to emphasize that the same regulations if a UDI regulation is
passed have to apply to both users and manufacturers.

Other issues of importance, who is going to train the users to utilize
this system in the hospitals, doctors\' office, or wherever they are
installed? We need to know what the cost impact of increases in user and
manufacturer infrastructure. And there will be infrastructure changes in
the manufacturers to develop these codes, to revise them, maintain them.
We need to be aware of electronic medical records and privacy issues.

I don\'t have the answers about the identification technologies, but, as
you have heard today, there are many different identification
technologies that could be employed. Which are the right ones?

And, as already alluded to, the software revisions, how do we
accommodate this on our devices, which are constantly receiving software
revisions?

Now, what essential requirements would we want in a UDI system? The most
important one is that it must and must enhance patient safety. That is
the primary reason for being for a UDI system. It may have a lot of
other benefits that we have already heard about, but patient safety is
primary.

We\'re also very much believing that we have to have harmonization with
the systems and regulations around the world. Global harmonization is
our absolute goal. We need one worldwide system. You have heard today
there are a lot of systems that are already out there. We don\'t want a
proliferation of systems. We want to move toward one system.

We also need to have the identifier provide only essential information,
which is related to patient safety. Again, the needs of FDA
manufacturers and users need to be satisfied and should, as I said
before, require compliance from both manufacturers and users.

A UDI system also has to be flexible. It has to adapt to changes in
technology. And our goal there is to achieve a least burdensome system,
which does not impose onerous, regulatory, or financial burdens.

Next steps. I believe we should form an interdisciplinary task force
representing users, industry and FDA. We can develop potential
approaches, identify the process and the next steps through the task
force and Federal Register. And I understand FDA will be publishing a
summary of this meeting.

In conclusion, we support a practical, cost‑effective UDI system which
enhances patient safety. But, again, problem definition is essential
before we embark on this.

Phase‑in process of five years is what we are recommending. We must
resolve critical details and issues, proposing grandfathering existing
devices.

And last, but certainly not least, we need a mechanism to evaluate the
system as we develop it, involving all key stakeholders, and revise the
system if needed. We should link this UDI system to performance goals
and safety‑related goals, like recalls and adverse event reporting. In
other words, how is the system working? And we need a system which will
be able to do that.

Thank you.

MODERATOR KESSLER: Thank you.

(Applause.)

MODERATOR KESSLER: Fred Freedman from the Dental Trade Association.

A couple of comments while Fred is coming up here that Richard made.
We\'re very cognizant of the issues, some of the issues, he has raised,
some very challenging ones, specifically things like software versions
and how to keep that fresh and into a data system that is accurate. That
is a very challenging problem.

The other problem he also mentioned is legacy equipment because there
are many, many thousands of items on the floors of hospitals today or in
patients. And the question is, how do we handle that? That is a
challenging issue for us.

DR. FREEDMAN: Thank you, Dr. Kessler.

I just want to start off be saying thank you for providing this forum
today for all of us. I found this very useful. We have been represented
by a few people here from the dental trade. And we\'re grateful to have
the opportunity to speak. We have heard a lot of common sense spoken in
the room today. And we hope to contribute as we go forward.

The Dental Trade Alliance, an association comprised of 220 members,
represents manufacturers, distributors, and laboratories providing
medical devices to the dental industry, including many of the largest
and smaller manufacturers.

Since unification of the highly respected Dental Manufacturers of
America and American Dental Trade Associations, DTA members have been
involved in all aspects of dental, including manufacturing,
distribution, export, import, and international commerce. The public\'s
overall oral health and patient safety are priorities for all DTA member
companies.

DTA applauds FDA for promoting public health care and encouraging full
disclosure of medical devices. Because dental‑type medical devices offer
little risk to the public, the dental trade agrees new regulations for
identification of medical devices should be instituted in a way that is
very practical, flexible, and not burdensome to small companies. The DTA
position refers to these following points.

DTA does not believe UDIs will prove particularly practical for dental
offices and their patients.

Time is a factor in implementing UDI requirements. DTA believes a
five‑year period is the minimum time required for manufacturers to
implement new regulations. Five years provides flexibility without undue
hardships for the industry.

Neither the use nor the format of unique device identifiers should be
mandatory except where their absence would result in a major health care
risk.

UDIs should be based on existing standards which are well integrated
into the marketplace and meet basic requirements.

UDI will add cost and may be onerous for small manufacturers,
distributors, and users. A general information campaign is required,
particularly geared towards the general public.

Elements should be limited to manufacturer\'s number, product number,
lot number, and expiration dates when necessary.

UDIs should be only required on the sales packaging unit except for
large equipment.

Government efforts to require UDIs should include Centers for Medicare
and Medicaid Services, Department of Defense, and others.

Any development of a UDI requirement should be closely aligned with
international global harmonization.

DTA strongly urges consideration of these important criteria when
implementing new procedures for identification of medical devices. Thank
you.

(Applause.)

MODERATOR KESSLER: Dr. Mun from HCA, Hospital Corporation of America.
Great.

DR. MUN: Good afternoon. I would like to share some of the work we have
done with medical device marking using RFID and bar code. We start
basically when the IOM report came out in 1999. There was a very fine
line at the report saying that bar code is a very important factor to
reduce medical errors.

So if you look at bar code in health care, I guess bar code was invented
much, much earlier than 1983, but year 2005, which was last year, there
is only about 9.4 percent of hospitals using bar code for medication
delivery.

And so in terms of identification technology, obviously bar code was
earlier one. It\'s easy to use. And it\'s quite well‑known technology.

So in HCA, we actually implemented a bar code point of care system. The
steps we have taken, we started February 2000 as one of the major
patient safety initiatives. And then at that time, our expectation was
that we would implement the system throughout our facilities by the year
2010. And that was because the cost we were aware of was \$400,000 to
\$1 million per facility. However, after we installed, we realized it
wasn\'t as bad as it appeared. And so we have accelerated
implementation.

So by 2005, we actually have implemented throughout our system. We
actually delivered 115 million transactions. So even though the GS
gentleman says that we are clueless, we have slightly a little bit of
idea about what ID is.

Lessons we learned from BTOC is that it definitely does reduce the
errors and it helps to make complete documentations. And there\'s
definitely improved patient safety.

However, bar code does have certain problems. One is everybody must be
engaged. And our nurses are much smarter than we are. They know how to
get around occasionally.

And so at the same time we have looked at RFID. And RFID, we decided to
look at asset management. The reason is that I work for a for‑profit
hospital. So we have to get numbers met at the end of the day.

And so we are looking where we could use RFID. And we found the RFID for
the device management actually would work out very nicely because we
realized that there was data before us saying that mobile equipment
utilization is 45 percent. Hospital loses quite a bit of money once in a
while. And at the end of the year, we have a problem with inventory
management. And, of course, there are always complaints when there are
infection rates that we are not doing very well.

And so steps we\'re taking, we started looking at the year 2000. And we
have looked at the bar code, passive RFID, active RFID. And then about
2003, we decided we will go with active RFID, for two reasons:
reliability and automation. That is, passive RFID, we found out it will
not work when we really need it. And active RFID, we know when it works.
So that was one of the major criteria.

And then we selected vendors out of nine vendors we have investigated
about a year or two. The criteria was the battery life because we wanted
to last much longer than a few months, then size of tag because we
wanted to be able to track as many equipment as possible. And we also
want to know what resolution we can find the equipment.

And so we implemented a pilot system in 2005. And this is a
configuration. We are using basically 433 megahertz tag, and we are
tracking currently 2,500 items in a hospital.

These items we tagged, almost everything, anything which can move. We
don\'t do it based on price. MRI is very expensive, \$2.5 million. We
don\'t tag. It doesn\'t move hopefully.

(Laughter.)

DR. MUN: However, the thermometers, which are maybe 50 bucks, we do tag
because that\'s something the nurses need.

And we have found out some interesting things right after we installed.
About 30 percent of infusion pumps simply don\'t move, despite the fact
that nurses insists we must buy pumps every time. So we have some idea.
Now we can go back and talk with nurses, why they don\'t need any more.

And this is data from one of the institutions where they have done the
work a little bit earlier than us. They were basically able to
demonstrate a cost saving of \$1.5 million. This excludes cost avoidance
or such savings.

The current status is that we have done all of these things, and there
are a few hiccups, as you may expect. We found out that some of our
nurses are much smarter than we are.

And then we have interfaced the biomedical service database. So now we
know exactly when the device is serviced and when it should be serviced.

We are also getting some interesting information. For instance, as I
mentioned, some of the items simply don\'t move. And they say they
don\'t have it. So we know we need to manage these things better.

And also we found out some interesting relationships among items, like
rental equipment and discharge. We rent equipment when patient comes in,
but we don\'t know when to stop that rental because when discharge, we
don\'t tell the guy, \"We no longer need it.\" So we see huge savings at
that side.

And also because we have seen a lot of work flows we can improve using
this technology, we are looking at the surgical chart tracking in OR,
improvements in ER as well as ICU. And also we will be able to give
information on physicians\' PDA where the patient is so when he rounds,
he doesn\'t have to waste his time going in the wrong place.

And what we have learned is that equipment or any technology you put in,
it\'s just a cost. You have to sweat it out. You have to work at it. You
have to make sure that your workload is matching with what you do. And
if it doesn\'t, then we have to change it and make sure everybody works
at it.

The lessons we have learned is that RFID medical device, asset
management using active RFID is cost‑effective. However, there are a few
other issues which we have identified.

One of the worst problems is, what do you do with the database? This is
one entry in the database. It\'s the same equipment. This equipment is
known as a patient lift. But nurses call it agile lift. And common name
used by industry is lift/patient. So if you search this database, as
previous speakers talked about, it\'s a mess.

So we decided, why can\'t you use 2D bar code? So the reason is that
it\'s cheap, at least compared to RFID. And there are less physics
problems. And we can address item level very easily. And also it
provides lots and lots of data.

Now, some people say we don\'t want to give data to the end users. Come
on. We are the guy who has to manage patients. If you don\'t have any
data, how do we manage them? We must have data. So please don\'t insist
not giving us data. Please give us data.

So, for instance, we can put a 2D bar code, human‑readable information.
Current tag can be put into 2D bar code and put right next to it. And I
believe this helps considerably in managing.

And I don\'t know about DOD, but for our hospital, some of the guys who
are looking for equipment, they are the lowest‑paid people in the
hospital. They really don\'t know one from the other. And it\'s vital
for us to provide additional information to these people.

What we would like from FDA and everybody else from here is that we
would like to have a cost‑effective unifying standard which will cover
staff budgets, patient restraint, IV medication, non‑IVs, medical
devices, and blood products if it is possible. It may not be possible.
So this is just my shopping list, shall we say.

And so we are looking at a couple of other different documents to figure
out what to do. And we are extremely interested in what Partners is
doing. And hopefully we will be able to work with them.

Thank you very much.

(Applause.)

MODERATOR KESSLER: Mark Piper is next from DOD. And those of you who
will be watching the FDA Web site will see that Dr. Mun will become a
visiting member of FDA soon, nothing to do with the fact that he has got
all the right answers for me.

(Laughter.)

MR. PIPER: Hi. I am Mark Piper. I am with the Department of Defense
Unique Identification Program Office. And I am here specifically to talk
with you about item unique identification.

I actually work for Keane Systems. We are one of the management
consulting companies to the DOD with regards to unique identification.

Just to give you a little bit of background about the DOD\'s item‑unique
identification program, it is approximately five years old. It was
launched in 2002 formally with policy guidance that came out then. And
if you take a look at some of the business drivers that we found, such
as better value for the dollar spent, full accountability, and asset
management, adverse event tracking, personnel safety, they are similar
to the business drivers that we have all heard here today with regards
to health care.

And certainly the Department of Defense item‑unique identification
program includes health care system, health care items, health care
devices, as well as other types of Department of Defense systems.

One of the things that we looked at was we focused on the data and the
processes that are involved. Basically we looked at item‑unique
identification as the information key. It consists of the enterprise
identifier lot, batch, or part number, as required, and also a serial
number.

And within that, we chose a two‑dimensional data matrix as the data
carrier, adhering to international standards with regards to syntax and
semantics.

What we allowed for was the manufacturer actually gets to select the
methodologies for serialization. We use the enterprise identifier in
their serial number or the enterprise identifier part number, serial
number, and the equivalent with regards to GAIA, GRAI, and for
serialized items, VIN number, and ESN.

We looked at processes from the perspective of we will have both
operational and business processes regarding manufacturing, repair, the
actual business of receiving, paying for material, and then
accountability for that material and where it is located within an
operation.

Today the item‑unique identification program has over 700,000 items
entered into the item‑unique identification registry. Somebody asked me
earlier from one of the device manufacturers, \"Mark, are you going to
get up and say, \'Been there, done that\'\"? Yes, we have been there and
done that.

And we very much want to thank the help and participation that we have
gotten from the FDA and the support that we have gotten from people like
Dr. Larry Kessler as well as Mr. David Racene and also from the Defense
Logistics Medical Supply Center with Kathy Garvin as well as the support
that we have gotten from the Defense Medical Logistics Standard Support
Service with Jon Sherman because we have been able to integrate the
requirements for medical items, medical devices within all of DOD. I\'ll
say items that are purchased or procured and all items that we have to
manage.

Something that is interesting is 65 percent of the items that have been
registered are registered by small commercial operations. To us a small
operation is somebody who is \$250,000 in revenue. And certainly we have
other suppliers within our supply chain that go up to \$30,000 billion
as far as corporations go.

We have done some cost analysis. And whenever you work in a repetitive
manufacturing environment, the cost of marking an item can drop to as
low as 20 cents. And if you begin to look at non‑repetitive
manufacturing, it could be as much as 10 to 20 dollars per item.

The UID program, item‑unique identification program, was built on
certain foundations. And we looked at this is a program that has to be
commercially robust in that our suppliers, whether or not they\'re in
other areas as far as systems or within the medical and health care
industry, go through mergers and acquisitions. And our item‑unique
identification program has to be able to perform and identify items with
regards to both commercial mergers and acquisitions as well as
divestitures of operations.

We have a global supply chain. And, as you know, many of you currently
participate in that global supply chain. We have to look at an item
through its complete life cycle management from the manufacturer to the
supplier, through the health care provider, down to the patient. And you
can translate that in other defense systems to manufacturer, supplier,
distributor, and soldier.

Many types of devices have to be identified within the Department of
Defense program. And we have to be able to operate and interact with
many different types of systems, both from our own internal operations
as well as commercial systems throughout our supplier community.

What we looked at additionally were how do we distinguish and enable
identification, description of the item, and location. And we made a
distinction between identifying an item versus describing it.

For example, I can give you the vehicle identification number for my
car. And then if you took a look at it, you would say, \"Okay. It\'s a
silver Ford Taurus.\" But there\'s a distinction between identifying it
and describing it. And then you can say, \"Okay. It\'s registered in the
State of Virginia.\"

Global unique identification has to fulfill each one of these
requirements within the Department of Defense. And these are \"or\" type
statements. If the item is serial‑managed within the Department of
Defense, then it has to have an item‑unique identifier. If it\'s part of
our controlled inventory, it has to have an item‑unique identifier or if
it\'s a safety or mission‑essential‑type item, it has to have an
item‑unique identifier or if it\'s greater than \$5,000 in value. So I
could actually have an item that costs 50 cents. And if it\'s safety and
mission‑essential, it has to be uniquely identified.

So that\'s the conclusion of my presentation. I wanted to thank
everybody very much for allowing us this opportunity to discuss things.

MODERATOR KESSLER: Thanks.

(Applause.)

MODERATOR KESSLER: Jeff Schaengold from Siemens and then Elliot Sloane
and Brad Sokol. Jeff? And I promise you we will be out around 4:30.

MR. SCHAENGOLD: Good afternoon, everyone. Actually, that was me before
the meeting today. Siemens is a leading device manufacturer, also a
leading symbology manufacturer. And we\'re very much committed to mass
serialization.

We look at the UDI program as really mass serialization, not as much as
a technology. And when we look at mass serialization, we look at it
globally. And when you really look at a global effect, there is a
manufacturer out there of ink jet cartridges that basically applies a
unique serial number on every ink cartridge they produce and they
distribute. And they track every one of them.

And the real question that comes to our mind is if they can produce
hundreds of millions of these cartridges and track every one of them
using 2D bar code, why can\'t we do it with medical devices?

The other element that we have to look at is that we have 420 million
passengers who fly in the U.S. every year. And it\'s growing by six,
seven percent a year. That ticket number is a unique identifier. We can
track passengers through a unique identifier, but, for some reason, we
can\'t track medical devices.

We have 13 billion parts a year that we mark in the automotive industry.
We do it with bar code. We do it with RFID. We do it with data matrix on
metal, 13 billion parts. We somehow seem to manage that, but we can\'t
seem to manage it in a medical environment.

So what we would like to do is we would like to offer the premise that
creating and maintaining a UDI architecture is really all about mass
serialization. It\'s about designing the identifier first and then
utilizing prevailing technologies in direct part marking, instead of
reinventing.

Now, what will happen is that once you create that foundation, that
infrastructure, that cornerstone, pure economics and the ingenuity of
man will basically drive everybody around that architecture.

So what we are looking at is we are saying that the DOD, for instance,
has a UID program that\'s excellent. We see the AIAG has a program for
medical devices. GS‑1 and EPC Global has one. From our perspective,
it\'s like, for Pete sakes, choose one.

When you look at it, the basic architectures are relatively the same.
There are slight nuances. And we can go into some of the particulars,
where we say in many respects, you have to pay a little bit more with
GS‑1 and EPC Global, you have to pay a little bit less with DOD, but the
reality is pick and go with it.

Now, what we suggest is that we respectfully would recommend to the
medical device supply chain community that you pick a structure. And the
second step is you create an adjudication body.

In other words, we have heard it all here today. We have to define what
is a medical device and which is a medical device. We have to define
what we are going to use as a serial number, where we\'re going to put
the digit here and a digit there.

Decide. Get a group together. Get a body that\'s basically going to be
our court system. And get everybody to come in and make their case.
Decide on the case. And continue to move forward.

It isn\'t really about the technology. The technology is only a method.
It\'s only a means to this. The reality is anybody who wants to can
contact me, and I\'ll send it to them. But when you look on this, we do
a matrix. 2D works well here, and RFID works well here, and Locator
works here. But at the end of the day, it\'s about direct part marking.

Assign the bloody serial number to it. And the rest of the world will
figure out a way to utilize that serial number in one way or another. We
will collaborate. We will be interoperable. We will do all that stuff or
we can spend the next 15 years trying to figure out how to build a
superhighway, an intelligent highway, when all we want is a bicycle.

The reality here is that 2D bar code is an excellent low‑cost way of
serializing everything from latex to metals to aluminum to jet parts to
CAT scans, et cetera. And, by the way, we make every one of those.

We can even track something that is so small that it is barely visible
to the eye. And we can read millions of these in a matter of about two
and a half seconds. So we can read these in batch because we use optical
technology. As you have seen out in the floor today, we can laser mark.
We can read these laser marks. And it\'s not expensive.

So what happens here is that UDI just basically needs to have an
architecture. Everybody just basically say, \"Let\'s go with the
architecture\" and move forward.

So what happens here is that from a Siemens perspective, you\'re looking
at a company that not only is one of the world\'s largest medical
devices manufacturers, but we\'re so committed to mass serialization
that also we have been 17 years in RFID. We do RFID tag medical devices
today.

We sold over 300,000 readers around the world over the last dozen or so
years. We bought RBSI, which you heard earlier today from Lu, which is
one of the innovators in 2D bar codes. And we own that now.

We are the most pronounced DPM competency center. That\'s direct part
marking. And we do serialization of optical verification.

Now, this is kind of my presentation. I have about 45 seconds, I
believe. But the reality is I also kept thinking during the conference
some of the things that analogous to what we are talking about.

Easy pass toll systems, 20 billion transactions a year. Is that really
that much different than medical devices? Twenty billion transactions.
It seems to be working pretty well. And, by the way, if you pass through
a toll booth and it doesn\'t read your RFID, they take an image of your
license plate. And they send you a letter. We can do the same thing in
the hospital and in the medical device world.

The thing from Siemens\' perspective is I can tell you it\'s kind of
selfish. I do not want to be the chairman of the board of Sony having to
answer to the board about why my market cap went down 14 percent because
my batteries blow up laptops and I can\'t decide which battery is
blowing up which laptop.

If I do a really good job of serializing my product, the product I
produce, a catastrophic event will have a less financially detrimental
impact to my market cap. So I have a vested interest in making sure that
I keep promoting serialization of the product that I sell. And
throughout my supply chain, the more focused I am where my product is,
the more focused I am on being able to adjust to a recall.

And the last thing I want to say is look at the linear bar code. Forget
the bar code itself. It\'s really the UPC, the Universal Product Code.
Thirty years ago the first one was at Wrigley\'s on a Wrigley\'s chewing
gum in March.

It took 10 years before anybody realized that you really need to use it
100 percent because I don\'t know about you guys, but I used to stand in
line in the mid 1980s at Home Depot for 20 minutes while they said,
\"Plumbing, plumbing, price check\" because it didn\'t have a UPC code.
And then we became universal. And today everything has a UPC code.

So we are suggesting very strongly from Siemens pick and choose an
architecture and just move on with it and just go with it and don\'t
worry about inventing new things. Everything has been invented.

Thank you.

(Applause.)

MODERATOR KESSLER: Elliot Sloane from Villanova.

DR. SLOANE: Thank you. It is a pleasure to be here.

I will weave a number of my Villanova topics into this, the e‑commerce,
the telecommunications, the database, the e‑health, and a whole bunch of
other things.

And while I am simply a professor, I am not just a professor. I have a
little bit of another background. I was Vice President, CIO, and COO of
VCRI for 15 years: from 1975 to 1990. I was responsible for building, my
team was responsible for building, the recall system, the health
advisory alerts, the UMDNS system.

I had the pleasure of working with John Vilforth, Jim Benson, Walt
Gonducker addressing these things quite a while ago. And we are
hopefully more than halfway along this discussion. Hopefully we are
getting to the end of this discussion.

The next ten years of my life I worked at MedEx. I spent ten years
trying to stay out of the FDA\'s radar screen. MedEx was a medical
device manufacturer.

At its peak, we owned 500,000 pieces of medical equipment, which we
rented to hospitals throughout the United States. We owned nearly
100,000 infusion pumps, 25,000 ventilators. We managed all of that with
a bar code system with our own unique device identification system. And
if I have anything to claim about my ten years at MedEx, it\'s that we
were never sued for injuring or killing a patient.

We did get a chance to work with the FDA at the end of that period for
working with Phil Phorpolo and the other Dr. Kessler in terms of medical
device safety, maintenance, and the like. And today I teach in Villanova
and work in the areas of health care information systems and related
topics.

Reality check number one, medical devices really do kill people. I
investigated my first medical device death in the late \'70s and almost
every year since then have been involved in medical device death
investigations, including, unfortunately, some involving MedEx devices
in the early \'90s.

It turned out it wasn\'t MedEx devices, actually. It was an accessory, a
\$500 accessory, part of a manufacturer\'s device in the bed next to
where the MedEx equipment was. I got to meet some very nice folks from
the FDA with shiny badges that weekend.

Reality check number two, nearly 30 percent of all health care is
occurring outside of hospital walls already. That number is actually
ancient. It\'s too low. That\'s just the home care piece. It doesn\'t
count physician offices. It doesn\'t count all of the other allied
health and the self‑health that is going on.

Durable medical device firms, of course, I was part of that at MedEx.
MedEx is now part of Hillrom. Other big organizations like Modern
Medical, big organizations like UHS, there are hundreds of thousands, if
not millions, of medical devices on rent in hospitals day in, day out.

To give you a sense of that, with MedEx\'s inventory seven years ago
now, we had on any given day 60 to 100 thousand pieces of life support
equipment in hospitals, home health care, and other settings. That was
day in/day out 365 days a year.

So there\'s a lot of change happening pushing this even further. And if
you don\'t believe that, I went shopping. I just wanted to see what was
happening out in the world. And I thought I would just check out the
market.

I went to my favorite shopping emporium online, Amazon. In Amazon ‑‑ you
can\'t read this ‑‑ in addition to AEDs up here of various brands,
glucometers of all sorts, it gets rather interesting when you get down
to devices like pulse oximeters of different sorts, a tens units. And,
in fact, down here is even a diathermy ultrasound treatment device.
There\'s a number of physiologic monitoring. These are non‑evasive blood
pressure monitoring technologies, almost every brand and manufacturer.

And, by the way, the prices on these range from about 100 to 200
dollars, on up. It doesn\'t stop there. Full‑out medical monitoring
systems, \$1,300, goes down into a CPAP, continuous positive airway
pressure, devices ‑‑ I\'m the only guy in the business school that
understands what all this stuff is ‑‑ and moving into pulse oximeters of
various sorts and even a 12‑channel ECG monitor and recorder that\'s
available from Bertech price is about \$3,200.

So I\'m a pragmatic person. I go right to where the things are happening
on the World Wide Web to see what\'s happening.

Accessories of all sorts. One minute. Accessories of all sorts out there
as well. Ponder medical device recalls. How are all these recalls,
maintenance support things being done for all of those devices out in
the non‑hospital settings? If we don\'t have a unique device identifier,
we won\'t be able to get to them and support them.

Reality check three, a third of every health care dollar is wasted, not
my numbers. Those are the government\'s numbers or at least the
Institute of Medicine and National Academy of Engineering. So process
improvement is a big, big plus.

RFID, as only one part of RF proliferation, every medical device for a
few dollars has the ability to be tracked, to communicate. And they\'re
putting batteries and wireless in our pockets. Why aren\'t they putting
it in medical devices? Well, in fact, they are. Most next generation
devices will all feed to a telecommunications network. And they all use
IEEE standards of various sorts. The devil is in the details.

Reality check number four, this I talked about. I won\'t go into it now.
The electronic health record is unfolding. We need it. It is in order to
implement the electronic health record with medical devices, every
device, just like our cell phones, has to have a unique identification.
In order to keep track of each device, there has to be a unique code to
allow that data to transfer reliably and accurately into an electronic
health record, a telemedicine system, and the like.

Quick lessons here. Manual data entry is not going to work. It has to be
readable. There has to be a human‑readable form for everything. And it
can\'t just be manual data entry. Two percent is the best you can get
for manual data entry. You heard about the millions of transactions that
go into just individual organizations, work at two percent. That error
rate is far too high. You have to have each piece of medical device.

I put on the bottom, \"Check digits.\" \"Check digits\" means you can\'t
make a mistake when you enter something. My checkbook, my account has a
check digit on it. One of those numbers make sure if I get the digits
wrong, it will not enter the data.

So one of the mistakes we made in creating UMDNS is we didn\'t create a
check digit. It\'s cheap. It\'s easy. NIST right down the road can give
us algorithms for that.

Lay persons\' English description because people have to be able to say
what it is, not a multi‑polysyllabic sentence or phrase.

Wireless technology I already talked about. In addition to UDI, each
device has to be assigned a clear permanent electronic product
classification. We need to know what it is. Dr. Mun made that point.
We\'ll leave it at that.

And each of these ‑‑ redundant.

If you need to find me, Google me. I\'m out there. And thank you for the
opportunity to present.

(Applause.)

MODERATOR KESSLER: The last of our presentations is Brad Sokol. Then
we\'ll let the mikes open for a couple of minutes if there are any other
comments that we have not yet heard today. Then we\'ll do a closing.

MR. SOKOL: Thank you, Dr. Kessler, Jay, Dave. Thank you very much.

Just to tell you a little bit about what I am going to talk about today
is just I\'m going to catapult you into the future about two years and
talk a little bit about patient safety and infection and how does that
relate to the UID.

After doing studies for the last three years, I would be happy to talk
with anyone after about these numbers. Thirteen thousand to 26,000
mortalities a year are directly or indirectly attributed to medical
device procedures, processes, infections, saving approximately \$3.1
billion a year.

We need to develop a comprehensive interoperable health care model to
include medical non‑electrical instruments and supplies. These numbers
were verified by two epidemiologists out of UIC.

The factors to consider for a system we\'ll talk about next; the
drivers; the impact of the UDI; and then, finally, the concluding
comments.

The ability to incorporate the UDI system into an interoperable health
care model. When we talk about the interoperability, we\'re talking
about that now with the patient record.

We need to address the patient record. We need to address the medical
devices. It all needs to operate together. It\'s fine for electronic
medical devices under IEEE 1073.3, but we don\'t have anything for
instrumentation or supplies.

There are some very unique life cycle events experienced by a medical
device that may not be experienced by other devices or other methods in
medical industry. One is the reprocessing of medical devices and
associated regulations.

Recently the FDC passed something called 502.u, which happens to be the
labeling of a reprocessed device. Well, there is a little bit of a
problem there. You have to keep the manufacturer\'s name on it. And now
you have to have the reprocessor\'s name on it in one of three
scenarios. I won\'t get into it that much.

Distributor relabeling. Rentals, loaners, sterilization cycles,
maintenance cycles. I mentioned earlier medical device reports and
history reports.

Adverse event reporting. We haven\'t talked about that today yet. And
it\'s really something that\'s quite important. And, finally, state
reporting.

One of the things that I think we all really need in this industry if
you\'re looking at both the patient side and the medical manufacturers\'
side is you need a de‑referenced database environment where all queries
have confidentiality, integrity, authentication, and anonymity because
we fear as the medical device manufacturers the liabilities. On the
other side, though, the patients fear that their privacy is going to be
interrupted. So anonymity is very important in a de‑referenced database
environment; in other words, a hidden database environment.

Patient privacy. I just talked about that. Focus on infection control.
And this is very important. Design a model to increase our abilities to
better detect the chain of transmission of infections by integrating the
UDI procedure and patient record. Currently there is nothing to
integrate the procedure and the patient record.

Finally, I\'ve got to tell you as an independent researcher and a
consultant but mostly, half the time, an independent researcher, I\'ve
been blessed with being able to talk with a lot of people around the
world. And for the last eight months, I\'ve tried to see if there was a
way to get these different nomenclatures together and people together. I
am here to report that, unfortunately, I was unsuccessful.

So getting past the vested economic and political bias of the current
players, be it medical devices, be it patients, be it the nomenclature
societies, is absolutely important to look at that side. All I can say
is that it\'s a very difficult problem we face here. I won\'t say that
much more on it.

Device maintenance. We just talked about that. We need to look at the
proper chain of transmission. We talked a little bit about theft and
counterfeiting.

We need to enable a process to track reprocessing, recalls, rentals,
loaning of medical devices, and reducing the counterfeit of instruments.
There are ways to do that. I happen to know there are several esteemed
colleagues that I have been working side by side with but not with
exactly, sharing information from an intellectual point of view, that
these things are possible.

Increased supply chain acid visibility, you heard that probably from
hearing Joe. Matching patient record to diagnostics, to device to
patient, scheduled procedure, and infection cause, very important.

Again, I keep coming back to infection. Reducing the stay of
hospital‑associated infections and length of stay, reducing mortalities,
and ensuring sterilization, ensuring sterilization, the process and the
work flow, through proper device usage on the correct patient.

Finally, the issue. Lack of informatic tools. We have all agreed on that
today. I put to you that the solution is actually to look at something
called the seven device L\'s, that I call them: last manufacturer, very
simple; last maintenance; last sterilization; last location; last user;
last procedure; and last patient, just seven things, but there are a lot
of things that go into those seven things.

That will inevitably help prevent 13,000 to 26,000 mortalities a year
and save us \$5 billion a year. As I mentioned before, the next issue,
11 nomenclatures, I suggest a universal translator. If you remember Star
Trek, that\'s what I suggest.

Finally, the confidentiality. Let me just go to the conclusion here. The
failure to incorporate comparative relationships with a medical device,
nomenclature, error reporting, patient record, and procedure will yield
in an unstable interoperability health care model.

If we wait until infection control yields an immediate ROI or until we
reach a global political compromise, it may be too late. All I can say
to you, let\'s not wait for catastrophic disease outbreak to implement
UDI, which inevitably can reduce those mortalities.

Thank you.

(Applause.)

MODERATOR KESSLER: With all those L\'s, how appropriate for Brad to be
our last speaker.

Is there anybody else who would like to make a brief comment before Dan
and I close? Don\'t forget to identify yourself.

MS. FRAHLER: Good afternoon. My name is Jori Frahler. And on behalf of
the innovative and entrepreneurial companies that the Medical Device
Manufacturers Association represents, I would like to thank FDA for
convening this meeting to discuss this issue of unique device
identification systems for medical devices.

MDMA has met with FDA and other stakeholders to begin discussions about
this issue. However, we believe there are many unanswered questions that
need to be addressed before moving forward with any UDI initiative.

While MDMA supports the universal device identification system, we
strongly believe that it should be a voluntary process. Much has been
made of the potential health and safety benefits of UDI, comparing it to
the mandatory drug bar coding system.

However, this analogy does not hold up when looked at closely. Unlike
pharmaceuticals, there are very few, if any, compatibility issues that
exist between two devices that would impact safety or efficacy.
Therefore, the policy justifications that exist in the pharmaceutical
industry for a universal bar code system do not exist for medical
devices.

If, however, FDA can provide data that suggests compatibility issues for
particular devices, mandatory UDIs for those devices may be warranted.

In closing, MDMA does look forward to continuing this dialogue with FDA
and other stakeholders to answer the many questions that remain about a
universal UDI system. And we would like the FDA to form a UDI task force
with efforts of everyone in this room. With a UDI task force, I am
confident we can develop a globally harmonized, yet voluntary UDI system
that will benefit all stakeholders.

Thank you.

MODERATOR KESSLER: Thanks.

Any other comments? You will get your chance. First of all, if you
don\'t mind, I would like to thank all of the presenters, both the
people we had on the panel and the people who just did the last
presentation. So let\'s give them just a very brief round of applause.

(Applause.)

MODERATOR KESSLER: All the presentations you saw today will be soon on
our Web site. That\'s first.

Second of all, allow me to thank the people who helped me organize this:
Jay Crowley, who is standing up in the back; and Dave Racene. And we had
some help from Ann Marie Williams putting this together. I want to thank
all of them for the hard work they did to put together this meeting.

So you\'re probably wondering a little bit our process and what we are
thinking. So I am going to give you a little bit of that process and a
couple of thoughts and let Dr. Schultz close in terms of the global
thoughts where the Center for Devices is going.

First of all, as most of you know, there is a deadline coming up
November 9th for comments about what we are talking about. We urge you
to get in your comments to us as soon as you can so we can think about
them.

If you get a comment in a day later, it\'s not like we won\'t look at
it, but we would really appreciate giving it to us because Jay, David,
and I will have to make a presentation, not only to Dan, but, as you
heard from Dr. Woodcock, this is of interest not only at the agency
level but at the department level. So any decisions we take forward
we\'re going to have to vet at the very highest levels of the
department.

And you saw the broad interest from our partners from Medicare and
Medicaid, from AHRQ, from DOD, the VA. And we\'re going to have to work
with them very closely. So if we take any solution forward, it\'s in
collaboration with them, not something that\'s separate. So it\'s very
important to us to do that.

And we have to take this forward. So the sooner you get comments to us,
the better, the more we can handle them in our decision‑making process.

A couple of things we are thinking about. Clearly we understand the
diversity of the medical device industry. We\'re aware that it is made
up of many, many companies, from very small companies, very large
companies that make a very diverse range of products. So thinking
through the solution has been a challenge. We mentioned things like
software versions, legacy products, et cetera; so a lot of issues that
we have to handle.

Clearly we are going to tie this to issues of safety and performance.
Those are the issues that we are concerned with. And I promise you that
we are going to keep those in mind very closely. We\'re not going to try
and create a solution that doesn\'t fit the problems that we\'re facing.
It is very important to us.

And, finally, I would like to say one of the things that we are trying
to do is challenge ourselves to think about the system for the future.
If we are going to be moving in this direction, solving today\'s problem
is only part of the issue. We have to think through where is the puck
going to be in five years, not where is it today. And that is a
challenge for all of us in health care for us in a regulatory
environment.

So I appreciate your time and your attention and will turn it over to
have some closing remarks made by Dr. Schultz. Dan?

(Applause.)

DR. SCHULTZ: Thank you, Larry.

NEXT STEPS, WRAP UP AND HOUSEKEEPING

DR. SCHULTZ: For sure I am not going to take my five minutes. I promise
you that. One thing I\'m pretty good at is looking at faces and sort of
gauging where people are. And as far as I can tell, it\'s time to move
from bar codes to barstools. So we\'ll be out of here very, very
shortly.

I do want to say thank you and thank you to particularly Larry, who has
been waging this war for a long time, Jay, David, everybody who put this
meeting together, all the speakers.

And I want to say something to all of you because we hear over and over
and over again that there needs to be collaboration. Well, there\'s only
one way you can get collaboration. And that\'s to have people actually
show up.

So, for me, looking at this audience and seeing the diversity and the
number of groups and the number of individuals who are represented, the
first step in getting collaboration has been achieved by getting this
group together and discussing this issue and putting things on the
table.

Clearly we have got a ways to go. I understand that there are complex
issues that we need to deal with. But getting everybody together is
clearly the first step.

Larry said that I was going to discuss for a minute how this fits in
with our overall center priorities. And clearly our priority in the past
year and in the coming year has been trying to \"connect the dots\" in
all parts of our post‑market surveillance program.

We look at unique identifiers as a keystone to that effort. So very
clearly we see this as a major, major, major important initiative in
terms of being able to provide for the safety of medical devices. And,
therefore, it\'s something that we are going to pursue vigorously, both
now and in the future.

We want to be able to do this collaboratively. And, as I said, you know,
I think that the first step in that process has been achieved, but we
want you to continue to participate because there are other ways to do
this. But I think that the way that we would prefer to do this is to get
the input from all of our stakeholders and try to do something that wins
for all of us.

And I also want to, finally, thank our government partners. And there
are a number of them whom we have worked very closely with. And, again,
we want to continue to work with them and with our partners around the
world because I heard frequently people talked about the idea of doing
this not just in the U.S. but on a global scale. And we certainly agree
with that. That is something that we will be shooting for as well.

So, again, thank you very much. Thanks to Larry. Thanks to Jay. Thanks
to David. And thank you. Have a safe trip home. And we will be talking
to you. Bye.

(Applause.)

(Whereupon, the foregoing matter was concluded at 4:32 p.m.)