WORKSHOP ON MEDICAL DEVICE INTEROPERABILITY:...

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Free State Reporting, Inc. 1378 Cape Saint Claire Road

Annapolis, MD 21409

WORKSHOP ON MEDICAL DEVICE INTEROPERABILITY:

ACHIEVING SAFETY AND EFFECTIVENESS

+ + +

CO-SPONSORED BY FDA/CDRH, CONTINUA HEALTH ALLIANCE, AND CIMIT

+ + +

January 27, 2010

9:00 a.m.

FDA White Oak Campus 10903 New Hampshire Avenue Silver Spring, MD 20993

WORKSHOP ORGANIZING COMMITTEE:

FDA: JOHN F. MURRAY, JR. FDA/CDRH Office of Compliance SANDY WEININGER, Ph.D. FDA/CDRH/OSEL/DESE CIMIT/MEDICAL DEVICE INTEROPERABILITY PROGRAM: JULIAN M. GOLDMAN, M.D. Director, Medical Device Interoperability Program, CIMIT Medical Director, Partners HealthCare Biomedical Engineering SUSAN WHITEHEAD Medical Device Interoperability Program, CIMIT CONTINUA HEALTH ALLIANCE: MICHAEL ROBKIN Anakena Solutions SCOTT THIEL, M.B.A., M.T.(ASCP), R.A.C. Roche Diagnostics Corp.

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PRESENTERS: TRACY RAUSCH TIM GEE BRAD THOMPSON JULIAN GOLDMAN, M.D. JOHN F. MURRAY, JR. TERRIE REED

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INDEX PAGE

SESSIONS REPORT BACK High Acuity Regulated Manufacturers - 481 Care Providers/Hospitals - Tracy Rausch 485 Q&A 489 Infrastructure - Tim Gee 499 Q&A 505 Low Acuity Regulated Manufacturers - Brad Thompson 516 Q&A 523 Research/Policy - Julian Goldman, M.D. 526 FDA REPORT BACK Prototype Submission, Risk Model, Work on Use Cases, and Formation of Working Groups - John F. Murray, Jr. 537 Q&A: WHEN IS MY SMARTPHONE A MEDICAL DEVICE? - John F. Murray, Jr. and Brad Thompson 553 PRESENTATION UDI - Terrie Reed 578 Q&A 584 CLOSING 592

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M E E T I N G

(9:00 a.m.)

DR. WEININGER: Good morning. Can you hear

me?

UNIDENTIFIED SPEAKER: Yes, very nice.

DR. WEININGER: I'd like to back started

today. I have a special announcements to keep us all

close logistical. If you brought a USB stick up here

to deliver your presentation and you don't seem to

have it in your pocket, it's probably sitting up here

still, so come and get it.

UNIDENTIFIED SPEAKER: Can you just throw

it?

DR. WEININGER: What's that?

UNIDENTIFIED SPEAKER: Can you just throw

it?

DR. WEININGER: Do you want all five of

them?

(Laughter.)

UNIDENTIFIED SPEAKER: Yes.

DR. SAMARAS: How many gigabytes are they?

Or are they megabytes?

DR. WEININGER: No, idea. This one has a

phone number on it, so that must belong to someone.

All right. If you're taxiing, carpooling,

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whatever, there's a sign-up sheet out front on the

registration desk. So that's a self-serve, help-

yourself thing. And I would advise you to call the

taxis at least a half-hour before you need them. So

we need to wrap up here by about 11:30 because it

turns out there's another meeting coming right in.

And our group picture will be at 11:45,

down in the atrium again, just like last night. So

Flue (ph.) is going to stand up on a ladder and get a

different kind of picture today, and everybody please

show up. Again, please clean up so that our AB staff

doesn't have to do it. As it turns out, they did it

and not the house cleaning staff.

And you can see our agenda is up front. So

we're going to start with some of the session report

backs and work through. And again, I appreciate

everybody staying conscious and tuned in and focused

because we're trying to deliver the best content we

can, and so some of the elegance of workshop flow

sometimes falls by the wayside.

So without further ado, I'm going introduce

Julian, who's going to tell you what we're going to

do, even though he doesn't know that.

DR. SAMARAS: Make something up, Julian.

DR. GOLDMAN: Thank you, Sandy. Good

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morning, everyone. For those of you who have

survived and are still here, that's impressive.

Everybody's looking a little tired today. I heard a

lot of good things about people wanting to review,

study, disseminate, and share the presentations, the

content, and I think there's been an underground

effort already for people to try to gather some of

the content and the slides and scrape them off this

computer and start to share them.

So I think that that's going to happen. So

for you all who presented and posted -- you know, you

have your slides. Of course, they're all published.

You should be aware that they probably will travel

quite bit. Now, it was our intent to request from

all presenters that they submit to us their final

presentations in case there were any changes along

the way from their prior, their early submissions

last week.

But I think what's actually happened is

those final presentations are on the computer,

they're all here, and so kind of all being gathered.

I suspect that what happens if we find we're missing

any, we'll probably contact the presenter and ask for

that to be sent to us. Also, it's our expectation

that, according to Glen, all of these -- all the

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content that's been streamed on the web is actually

stored and will be available for viewing later. So

the URL for that site where the content is located

will be added to the website that you used to, you

know, get information about this workshop, and it has

all the other documents posted. So as soon as I have

that, I'll post it to the web, and everyone else will

have that, and you'll be able to watch this. If you

have insomnia, you know, it'll be handy or whatever.

So Sandy covered the logistics. I don't

have any other logistics. I think now we're going to

the session report backs, and the session chairs will

come up and report session -- the first session,

Session 1, yesterday will report, and I think after

each session we'll ensure that other participants in

that session will add any content, you know, if

anything was missed by the session chair. And then

after that we'll move on to the -- I'm not sure if

we're going to do the FDA report back or to the

second session at that point. Mike Robkin typed this

up and --

MR. ROBKIN: We'll do all four sessions.

We'll do the four breakout groups.

DR. GOLDMAN: There are two sessions.

We'll probably do the second session later.

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MR. ROBKIN: I would suggest doing the

breakout groups together, Session 1 and 2, by

breakout group. That's what I would suggest.

DR. GOLDMAN: Well, let's start with

Session 1 while --

MARK: So I have the manufacturers' high

acuity space. And we have about six pages of

breakout notes that will show up eventually on the

website as well. I didn't try to -- it's all fine

print and not organized. But for the first session,

we basically did a brainstorming on the topics that

people wanted to talk about, plus the questions that

were asked.

And in doing that we came up with three

themes, the first one of which is there remains a

need for some sort of independent verification,

validation, certification, pick your poison, path for

interoperability going to the EHR. Now, that was

transferred off to another group in the second

session, so hopefully they did something with that.

I don't know. I haven't have seen that report yet.

Perhaps the biggest and loudest concern

that came out within seconds of starting was the

concern over the uncertain regulatory pathway and

then classification as it relates interoperable

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systems. What happens if somebody plugs in something

at a higher classification? Is that something that

means you're invalid? What's the regulatory pathway

through the FDA? I know we're going to hear a little

more about that from John later. And I think it was

pretty much universal that everyone felt that was the

most significant issue.

In talking, then, also at the point-of-care

area, there was fairly reasonable concurrence that

the technology needed to support that is incompletely

described today. There are lots of standards, lots

of pieces of the pie, but it's not a whole pie yet.

And so there remains work to do in that

space to fulfill the vision that Dr. Goldman spoke of

before, of being able to do closed loop control

interoperably or even just the safety interlocks.

Not all of the pieces are there to do that. And so

that remains significant work left to be done on the

technology side. Undoubtedly solvable, but it will

be hard. It's not an easy job.

Moving on to to the second session, where

we then tried to tackle those high-level problems, a

lot of discussion about we need to move away from the

full systems validation approach. And if you

remember the slide the first day, the big globe with

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all the actions, the permutations, the number of

possible permutations is just too large, both for the

FDA to review permutation by permutation and for the

manufacturers to submit that way. So some other

means has to be developed because that means just

can't be done.

There was also a fair amount of discussion

about the possibility of producing a collaborative

pre-IDE or pilot 510(k) for a plug-and-play

interoperable system to give both the manufacturers

and ODE some experience with what are the questions

that need to be addressed, how do we go about

demonstrating what needs to be demonstrated, so

nobody quite knows what that is yet.

We further then talked about how that, if

we chose as a model for that an ICE-like system, and

then we discussed two different possible scenarios,

both of which Dr. Goldman put on the table earlier in

the week, the ventilator/X-ray synchronization or the

PCA lockout from respiratory distress scenario. Both

of those give you the possibility of multi-vendors

for the medical devices to be as a monitor for the

actuator. You could conceivably even have more than

one vendor for the network controller and then the

actual application doing the work, and that would be

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a good model for teasing out the regulatory issues.

There were some presumptions in that, that the filing

was done by a device company, somebody who's

registered, somebody that exists, that the actual

configuration of the equipment would be something

that the responsible organization, the hospital or

the user of the equipment, could plug and play.

We're designing for multi-interoperable

devices, hopefully open, and would rely on that

network controller layer to do the adaptation between

the protocols; in effect, what Dave Arney showed.

And his work could in fact be a prototype for some of

the hardware of that because it does some of those

things. It actually exists.

We also spent some time talking about

possible longer-term opportunities in the regulatory

space. If we actually figured out how to do this in

a way that ODE found acceptable, then perhaps this

group could create a 510(k) that becomes publicly

available without redactions so everybody can see how

to do it. Furthermore, if we could get those safety

issues incorporated in the standards, then you'd be

able to use an abbreviated 510(k) process for the

clearance of those network attributes. Going one

step beyond that creatively would be to submit that

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via the de novo process and actually invent a

classification for such a network, where the special

control would be those standards if they, in fact,

addressed all the issues. And then you have a clear

regulatory pathway to success. And that was the work

of that group.

Any questions? Yes. For those who were

there, what else did we talk about that wasn't

summarized at high level there? All of those

individual things that were typed, that file will be

part of the record. And you all saw that because we

were beaming it in real time.

DR. SAMARAS: I have a question, but I'd

rather keep it until the very end after we're done.

MARK: That works. Who's next?

MS. RAUSCH: We kept this as part of the

health provider group, so it'll probably be a very

different conversation here, a very different

conversation than -- group. Actually, you know, we

started with a lot concerns. So one of the first

thing that came out was a conversation about the

glucometer measuring and controlling the infusion

pump, and basically there was a lot of conversation

about the communication around it. There wasn't a

lot of communication conversation that they thought

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about the safety, rather. The actual control part of

it was more interesting to someone than the

communication part of it, and I thought that kind of

set the tone for the rest of the -- you know, the

rest of the group meeting.

The other one was they started talking

about, you know, we had an example of vital signs

measurement at home, and it was a great idea. They

jump, they move forward. It notifies the patient

when it failed to send, but it didn't notify the

nurse who was actually monitoring the system that

they weren't getting data, and that's something that

I think that comes back to what we talked about

yesterday, of the variation between who the consumer

of the data is and what the vendor's intended use

was.

And the fact is that if you have a home

system, you know, how is the person who's looking at

the data -- I don't think that part of it's actually

been a conversation of how do you know when you're

not getting the data? You know, I think that goes

back to the question of what don't you know and who

assumes the risk if the data hasn't been transmitted,

if a nurse is supposed to be monitoring that patient

on a regular basis and they suddenly don't get the

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data. And that was actually a very -- we had a good

chunk of our conversation about that.

The next part that was a really big part

was medical device management. Basically, part of it

was, when software upgrades occur within the system,

connectivity is lost a lot of times with the current

interconnected systems, and not all the devices

behaved the same due to software and upgrades today

break today's interconnectivity.

And the other part of the conversation is

the software that we have today in devices is still

managed like the hardware of the original -- you

know, before there was a connectivity. And so

software upgrades right now have to occur one device

at a time, and this poses to be a huge burden on

medical systems, and to continue to have to do that

with more and more connectivity and more and more

software upgrades is just a burden on the healthcare

system. So this was a concern when we started having

connectivity.

Another conversation we had was systematic

failures, not only catastrophic failures, but how is

all of this impacted if the hospital's infrastructure

goes down? How can you continue to provide care and

what are the risks? And there were several examples

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of things that occurred when the hospital

infrastructure went down and the functionality was

actually lost and was still to be able to provide

care.

We had a conversation about some wireless

security and how a lot of medical devices don't meet

the security requirements for their hospital's

infrastructure.

And the last conversation -- let's see if I

can put this tactfully. But there's a lot of

concerns related around the implementation of

technology by individuals who are not experienced in

the clinical environment.

So the fact is that you have to understand

what your workflow and your processes are to have

someone come in and implement and design a technology

system into that environment. And one of the major

concerns is, if we have more and more of this, you

know, where is the experienced and skilled staff that

can actually come in and implement this right the

first time?

And then we talked about several scenarios,

but I think the biggest part of the scenarios that we

discussed wasn't actual clinical situations but what

could go wrong in a clinical situation, and in

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addition of missed use cases to the clinical,

whatever use case we choose to use is extremely

important in this environment. So whether it's, you

know, a catastrophic system failure -- I mean, I'm

not going to go through them all because we had a

pretty substantial list of misuses, and we'll post

that at the system. So is there anybody else in the

group -- did I miss something?

DR. SAMARAS: That was very tactful.

DR. GOLDMAN: Any questions?

MS. RAUSCH: It wasn't that tactful in the

meeting.

DR. GOLDMAN: Tracy, take questions as

well.

MS. RAUSCH: Yeah, does anybody have

questions? Comments?

UNIDENTIFIED SPEAKER: I'd like to

understand more of what you mean by the issue of what

you tried to express tactfully. I've done system

integration stuff --

MS. RAUSCH: Right.

UNIDENTIFIED SPEAKER: -- and I know what

it's like to have clueless people involved, and there

are like a hundred different ways that can show up.

What's your practical concern?

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MS. RAUSCH: The practical concern is that

if you don't have someone who understands the culture

and the way care is provided -- and I think the best

example is if someone walks in and says, Well, this

is how it needs to be done now, and you don't

understand the clinical culture and the clinical

process. And although it may not be the best

process, you have to let the experts actually decide

if that process needs to change. You can't tell them

how to do it.

UNIDENTIFIED SPEAKER: So from other

industries, the solution to that is to have the

people who do the work involved in the process.

MS. RAUSCH: Absolutely.

UNIDENTIFIED SPEAKER: And make that

mandatory.

MS. RAUSCH: Yeah.

UNIDENTIFIED SPEAKER: That means that

every installation of the same system in different

environments is going to be slightly --

DR. WEININGER: Use the microphone,

microphone.

UNIDENTIFIED SPEAKER: You know, if you

have customized solutions for each environment, then

that system that is interoperable is not going to be

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able to be supported, you know, in a much more

universal fashion.

MS. RAUSCH: We weren't talking about a

customized solution in each environment.

UNIDENTIFIED SPEAKER: But if the end user

is configuring the system, right, and a third party

is supporting it, then -- and the third party is

supporting several systems across different

enterprises, then these support issues are going to

be different in a way that, you know, would create

issues. So there has to be a more standardized way

of implementing this, rather than in -- way.

MS. RAUSCH: I agree, but I think what

we're getting is the end user involved from day one

is the most important thing of this is what we're

trying to say.

DR. BLOCK: Frank Block from VCU. You said

the devices were upgraded one device at a time. For

20 years that has not been true. Multi-parameter

patient monitors have been upgraded over the network

just like IT pushes out new software to PCs.

MS. RAUSCH: I think that's an exception to

the case. Infusion pumps are usually upgraded one

unit at a time. Most lower acuity vital signs

monitors are the same way. It's a single -- it's a

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per device upgrade.

DR. BLOCK: And I just wanted to speak to

your point about the nurse doesn't know and they

don't get the data in. I don't really see how that

could possibly be a problem. That's like your

burglar alarm company. If your unit doesn't call in

once a day, they know there's a problem, and they'll

start calling you. If the nurse knows the data is

supposed to be coming in for Ms. Jones, obviously the

nurse knows whether the data is or isn't coming in

for Ms. Jones.

MS. RAUSCH: Right. And the input that we

got was basically that it causes a lot of anxiety

towards the clinical staff, of not knowing what to

expect. That's what's coming across.

UNIDENTIFIED SPEAKER: I agree with your

statement about the culture, and I think that design

controls and proper design can handle some of that.

MS. RAUSCH: Right.

UNIDENTIFIED SPEAKER: But I do think one

aspect of this, which we actually did touch upon in

the research and policy group, was the fact that it

is more than just parochial intervention or control

associated with a local device.

MS. RAUSCH: Right.

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UNIDENTIFIED SPEAKER: It involves and

really will involve more of the EMR aspects of

things, scheduling, et cetera. So as an example,

radiologic order entry associated with feedback to

the X-ray. This type of information -- and there are

numerous scenarios. We focused on a couple scenarios

that are potentially popular at the moment. There

are many, many, many scenarios. We're not going to

enumerate them all.

The point, though, is that in addressing

this problem of interoperability, really what we're

talking about is bringing in more of the information

that is typically available in EMR. So the interop

is going to involve much more than just one device or

one specific control or a communication device. It

would involve essentially the system.

And so part of the system specification,

the analysis associated with system specification, is

going really to involve the EMR. And I believe that

you will find, over time, that this is going to

become a necessity.

MS. RAUSCH: I don't disagree with that at

all.

UNIDENTIFIED SPEAKER: I have two comments.

One is that it's an article of faith in human factors

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engineering that all the stakeholders need to be

involved.

MR. ROBKIN: We can't hear you.

UNIDENTIFIED SPEAKER: It's an article of

faith in human factors engineering that all the

stakeholders need to be involved. Otherwise you get

a suboptimal engineering solution. So that's from

the technical side. From a regulatory side, though,

if all of a sudden you have the user customizing the

system, at what point does the user become a

manufacturer?

MR. ROBKIN: I can address this. So

speaking as a participant, first I wanted to add to

Dr. Block's point. If the nurses who were doing

remote monitoring are used to a device that had an

intended use with a fully reliable set of

infrastructure, it probably knows when a

communication is down and has some sort of alarm or

some sort of notification. And so the nurse is used

to workflow where, when the communication is gone,

they find out about accurately.

If we go to a remote monitoring

infrastructure, let's say an unreliable

infrastructure which is fine and has a lot of value,

the manufacturer of a device probably understands

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perfectly that the infrastructure is going to go

down. But the nurse, who got the device from their

administration and the administration got it from

purchasing, purchasing got it from -- you know, the

device, in fact, is different workflow, may not be

communicated to the nurse and that's where the

problem comes up, that they're expecting a workflow

that accurately tells them when the communication

link is down and now it's been replaced with one

where they're supposed to go and figure that out or

look for missing data.

That's the sort of interoperability issue I

touched on with my -- which is this is a workflow

interoperability issue, and when the technology

changes, then they should be taken into account.

Back to George's comments and some of your

comments, the kind of things we talked about is when

medical devices become interoperable, they have more

of an IT component and what our concern was, that the

clinical engineers, who have clinical engineering,

may not have the IT background to support

interoperability of some of these functions.

And on the other side, if the medical

device is supported by hospital IT personnel, because

they're now PC-driven IT devices, they don't have the

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clinical engineering skills necessary to support them

as medical devices. And everybody probably does not

have the systems integration and systems engineering

and root cause analysis skills that comes from being

a systems integrator anywhere in the hospital.

DR. SAMARAS: But what about the issue of

customizing making you a manufacturer? Because it

ain't what you bought from the original --

DR. WEININGER: Use the mike.

DR. SAMARAS: -- from the OEM.

MR. ROBKIN: I'll repeat. So I think your

question is, when they're integrating interoperable

devices, they are essentially becoming manufacturers

of new medical devices. This goes back to a previous

presentation from yesterday. It's a very good

question. When they configure an EHR, are they

making a new medical device? When they write their

own interfaces between regulated medical devices, are

they becoming a medical device manufacturer? And I

have to say that's a really a good question.

DR. SAMARAS: Without a really good answer

on it.

MS. RAUSCH: Yeah, exactly.

UNIDENTIFIED SPEAKER: Perhaps there is a

model that does exist, though. There are many

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models, but perhaps there are models that we can

apply. There are enough clinical guidelines and

protocols and standards of practice that are

published in our news as part of that -- space

practice in all units. For many, many different

practices in medicine, there are hundreds and

thousands of guidelines better and they're routinely

modified --

MS. RAUSCH: Right.

UNIDENTIFIED SPEAKER: -- based upon best

practices. And they're routinely modified by local

clinical staff and then accepted through a jury

process, essentially, within the environment, within

the enterprise. There is a possibility that this

model could be -- let there be light.

(Laughter.)

UNIDENTIFIED SPEAKER: Apparently there's

gremlins.

UNIDENTIFIED SPEAKER: It's over here. He

was just leaning up against --

(Laughter.)

UNIDENTIFIED SPEAKER: The point very, very

quickly is that clinical guidelines are part of

evidence-based practice. Protocols are part of

evidence-based practice. They are used, they're

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applied, they are used for treatment diagnosis, but

yet they are also -- they can also be modified.

Perhaps there's a model that's similar to that.

MS. RAUSCH: I actually think that's a

great idea, you know, that there's going to have to

be some controls put on how the processes are

modified and what occurs. I think the concerns that

came out of this group were more, you know, to Mike's

point of, internal to this, you also have the problem

of, you know, the IT department doesn't understand

the clinical process, a lot of clinical engineering

departments don't understand the IT process, and it's

a collision of two very different worlds and very

different cultures on how this works out. And I

think a lot of the times the device manufacturers

put --

UNIDENTIFIED SPEAKER: So, then, maybe

there's another recommendation that should come out,

which should be in terms of future education.

MS. RAUSCH: Yes.

UNIDENTIFIED SPEAKER: Future education

requirements.

MS. RAUSCH: Yeah. And I think that's one

thing that we haven't talked about in this meeting is

what is the education requirements for these new

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systems that are put in place that are very much a

hybrid between the two worlds? Anybody else?

(Applause.)

MR. GEE: Okay, this is the infrastructure

breakout session, and we had a lot of discussion

around the different layers that arise between the

individual medical devices, the overall system, how

it's applied in the hospital, the infrastructure that

it runs on that's run by the hospital. We spent a

lot of time talking about that.

That revolved or evolved into a discussion

about all the ambiguity around dividing

responsibilities and who's responsible for what,

running through the whole sort of design

implementation and management process. One of the

key issues that we discussed was this, you know, we

need to recognize that there is a system integrator

role that has evolved.

And right now the system integrator role is

typically assumed by one of the medical device

manufacturer systems, or maybe it's a medical device

data system manufacturer who assumes that role, but

it's not one that's officially acknowledged, and we

sort of treat it like it was an old-school medical

device manufacturer that's just making a standalone

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box. And so I think that the group expressed a

desire to have some guidance from the FDA and get a

description of a optimal regulatory framework for

that kind of thing.

From a conclusion standpoint, we felt that

it was clear that responsibility extends beyond the

regulated manufacturer and, in particular, extends to

the provider who's using the system and maintaining

it. And we also talked about the knowledge gaps that

you mentioned, Tracy.

There's regulatory manufacturers --

regulated manufacturers, the medical device guys, who

have knowledge gaps on interoperability, what it

means to design and sell and support a medical device

that's really an information appliance on a network.

There are infrastructure manufacturers that don't

really understand the healthcare environment, and

there's providers who don't really understand

interoperability, you know, as it affects them.

And Tracy, we were just talking about the

whole IT departments not understanding the clinical

piece and the biomeds not understanding the IT piece.

And this might be a good opportunity to extend the

IEC 80001 group and sort of add to the scope of that

over time to be able to create a framework that

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extends beyond just risk management to other policies

and procedures for managing those systems.

And then there was a lot of discussion

about profiles. It would be great if we could

develop some defined profiles around both the

requirements or design inputs side as well as on the

actual product side, as far as infrastructure and you

know, interfaces and standards and things like that.

There was a clear consensus in our group that we'd

like a process for systems that does not include

clearance and approvals. And while --

(Laughter.)

MR. GEE: Yeah, that's not particularly

realistic. It would be nice to get some guidance on

where we should draw the line between doing a letter

to file and at what time do we really need to do a

new submission.

And I think that in the discussion there

were a number of examples that could easily be done

as letters to file, and you know, just because you've

changed the model of the router that you're

supporting doesn't mean that you have to do a new

510(k) submission. But some clarity on that would be

helpful. And it was also suggested to use the 513(g)

process to drive some responses on this and other

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topics.

Some of the solution ideas we came up with

was, in fact, developing industry profiles to reduce

variables among medical device manufacturers that

agree that this -- for these kinds of

interoperability things, this is how we're going to

do it. And that, then, would be communicated to both

infrastructure manufacturers, among medical device

manufacturers, and also to provider organizations.

And there's, I'm sure, an opportunity to do

the same thing from a infrastructure manufacturer

perspective as well as the customers get together and

say, you know, we've got all of this variability.

This is how we as a provider industry would like to

see the manufacturers provide these kind of solutions

to us. As I mentioned earlier, indirectly, some FDA

guidance on the system integrator role and how that

fits into the regulatory framework would be most

helpful.

There was a lot of discussion, too, on the

need for test and certification, that having the

standards is great, but just conforming to a standard

doesn't necessarily guarantee interoperability. So

there needs to be a framework for providing that and

not just sort of an informal kind of test and

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certification but a test and certification that's

going to really meet the requirements, the regulatory

requirements for the kind of products we're talking

about.

And then it was suggested that the FDA

adopt a CE Mark kind of regulatory framework and that

that, in addition to providing greater harmonization

globally, would maybe provide a better structure for

dealing with systems of systems and systems

integrators and things like.

And there was also a question about the use

of the combination product framework and how we might

be able to leverage that with these type of products

and then use that to come up with some approaches and

communicate the best approaches and the processes.

When we were talking about test and

certification, the issue of some kind of a consortium

as a framework for everybody working together came

up, and you know, something like that would

facilitate trusted relationships among the

participants.

We decided that it would be a good idea to

query the IHE and Continua both to see if they had an

interest in stepping up to support the, I think,

unique requirements for what we're doing as opposed

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to what those two organizations are presently doing.

And the potential also to create some kind of acute

care-focused alliance similar to what Continua is

doing in the ambulatory space.

There was also a lot of discussion around

engaging NIST and how we might be able to better take

advantage of their expertise in the kinds of things

that they can offer because they have a lot of

potential for helping us from an interoperability

standpoint, and again, being able to drive a

recognition from a regulatory perspective as well as

for everybody else to sort of acknowledge and deal

with this directly, the role of the systems

integrator and exactly what that means.

There was another interesting idea about

creating an actual interoperable or interoperability

gateway. This would be a product designed to cover

specific use cases, hopefully a relatively broad set

of use cases. It would be almost like an open source

kind of project that could be implemented by a

variety of people, but it would all be the same

product. And that could then be used as a cross-

vendor interoperability platform, keep the

interoperability layer sort of small so that there's

plenty of room for individual vendors to offer their

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own unique value propositions and then use that to

leverage NIST from a use case and test fixture and

test and certification perspective. And it was also

suggested that there may be a way to leverage the

National Health Information Network efforts.

And I was at the last connect -- MEHIN

(ph.) connect meeting in Portland, Oregon a few weeks

ago, and there is an awareness of medical device

integration among the MEHIN and the connect community

as well as the guys that are in the government

running the program. It's not obviously an immediate

item on their roadmap, but -- and I hope that we can

make progress between now and when they get around to

it that we don't need them, but if we don't, then we

may be able to leverage them in three or four years.

And that's it. Yes?

DR. SAMARAS: I was going to wait until the

end to ask this question, but I find myself foaming

at the mouth, so --

DR. WEININGER: Please speak up.

DR. SAMARAS: Yes, in my thinking, if you

collapse the regulatory and the technical, the

engineering issues, onto a single continuum, you'd

get at one extreme, based on the medical device

definition which says an accessory is -- to a medical

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device is a medical device at that highest

classification. All of a sudden every single

connection from front to back becomes a medical

device and creates a regulatory headache that is

going to give migraines to everybody. Now, certainly

at that end of the spectrum we could have tacit

approval by the FDA or formal approval by the FDA to

ignore infrastructure, what we call infrastructure

issues.

But the first time that we get a

catastrophe, the public pressure to overturn that and

therefore the ability of the FDA to continue to do

that tacitly or formally is going to be difficult to

deal with.

At the other end of that spectrum -- and I

think there's lots of places in between. But at the

other end, the McDonald's network interface appliance

that he showed yesterday on the screen, if we could

divide that box so that one side of that box is a

Class III regulated medical device and the other side

of that box is a non-regulated IT device, then all of

a sudden, yes, you can obtain physiological data and

such from existing regulated medical devices.

And on the back end, which is unregulated,

it would be no different than the doctor or the nurse

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carrying around a piece of paper, which is a practice

of medicine, and the practice of medicine doctrine

excludes the FDA from regulating that.

So I see two extremes, and I'm just

wondering what you're thinking was where it makes

sense to fall anywhere inside that continuum.

MR. GEE: Well, that's not an issue that we

addressed directly in our group, but if you look at

-- it did come up indirectly because there were some

people from Boston Scientific in our group talking

about, you know, their implantable is a Class III

device, and as they sort of go out from that to some

kind of gateway device that goes on to the internet

to an application on the server, all of those

products are a Class III device.

And I think back to some of my experience

developing patient monitoring systems and the patient

monitor is a Class II device, the central station's a

Class II device, the server that we developed and was

the HL7 gateway wasn't a Class II device, it wasn't a

regulated device, but we made it. It was an

accessory to our product. So it seems like there is

some inconsistent --

DR. SAMARAS: Well, that's that tacit

approval I was talking about.

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MR. GEE: -- application. Right. So if

there was some way, some process, and maybe it's the

de novo process or something, where we could make it

a more formal and more clearly delineated kind of

distinction, that would be good. Because I don't

think it's fair to the folks like Boston Scientific

to have that kind of burden, nor is it particularly

advantageous for the market, I think, from an

innovation and a capability standpoint, if you can't

take advantage of basic technologies that are being

used commonly in other medical devices.

DR. SAMARAS: Well, it gives practitioners

more flexibility if you don't go that direction.

MR. GEE: You're correct, but practitioners

would have more flexibility if they didn't -- if

everything wasn't burdened with that Class III

designation. Any other questions or comments? Yes?

UNIDENTIFIED SPEAKER: You can you comment

on your -- or expand on the comment of using

combination products as a framework? What aspects of

that were you referring to?

MR. GEE: Well, right now the FDA has

special guidance and regulatory frameworks for

different kinds of combination products, and it's

usually things like a drug-eluting stent, you know, a

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medical device that has a pharmacological component.

But there's also some mention of combination devices

that are IT medical devices, and it would be nice to

see that framework be more developed and more clearly

defined so that we could help handle -- manage these

interoperable situations better.

UNIDENTIFIED SPEAKER: Given Tracy's

comments about the bridge between IT knowledge of

clinical and clinical knowledge of IT, and given how

much we've talked about systems integrators being

such an important role and a difficult-to-fill role,

was there any discussion about perhaps a

certification program versus some integrators?

MR. GEE: I don't recall any discussion

about that. It's a great idea. We did talk about

certification of solutions and that certification

would be -- and I think it is more probably better to

target it towards the actual implementations of

products that are in use, as opposed to certification

of a company delivering a service.

UNIDENTIFIED SPEAKER: Or perhaps it's

both. But --

MR. GEE: Yeah.

UNIDENTIFIED SPEAKER: -- I certainly trust

my -- I go and select my general contractor for a

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house, and there's a whole less risk in a house.

MR. GEE: Right. Yes, that makes sense.

UNIDENTIFIED SPEAKER: And that's regulated

by the county. You know, you can't get the building

permit without X.

MR. GEE: I know my county would love to be

able to get into that business and maybe assess some

property taxes to hospitals to pay for that.

(Laughter.)

MR. GEE: Yes, Dick.

MR. MOBERG: Tim, I like the idea of a

gateway, and I just question the open source versus

defining the interfaces, in terms of the approach to

this.

MR. GEE: Yes. And the details of how that

would be framed so that you could get the kind of

outcome you're looking for, it doesn't have to be

open source. Where do you draw the line, though, if

it does need to be defined? And if it's a black box

that has defined APIs and you know, maybe you have

multiple vendors who create their black boxes with

the same APIs, what's in between the APIs can be

their stuff and no one knows what it is.

UNIDENTIFIED SPEAKER: Hi, Tim. I just

wanted to remind you that one of the things we did

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discuss was not necessarily certification of system

integrators, but if there was going to be a

regulatory framework or guidance, that essentially it

be process oriented. So the idea was --

MR. GEE: Yes.

UNIDENTIFIED SPEAKER: -- that system

integrators would be responsible and that they would

come under some sort of an authority or some sort of

guidance. And perhaps the FDA, rather than

submitting that integration, that composite system,

as a device under their current 510(k) framework,

what you do is basically you go back and plot in a

actual fact to make sure that they could -- that they

actually followed the process.

And the other thing that I wanted to point

out was John Zaleski was talking about essentially

the clinical practice, and I think that's another

point that we discussed, and I wanted to stress is

that when you build these composite devices, mostly I

don't see us really developing a lot of -- what I'd

like to see is the profiling effort driven by

essentially the clinical need and the clinical

practice.

So although I wouldn't want to prevent

doctors and hospitals from assembling as they see

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fit, I think we'd be -- I would not like to see that

as the -- as a common model. So I think having

profiles with very specific integrations that are

driven by clinical practice is the way to go.

MR. GEE: Yeah, just to expand on that, we

did have a lot of discussion about requirements

gathering and making sure that the right requirements

were gathered before the product was either

configured or designed.

DR. SAMARAS: Similar to what the folks

presented from MGH yesterday, when I worked at the

University of Maryland Medical School, I integrated

systems. This was 30 years ago, basically. I built

them or hooked up to different bits and pieces, and I

did that under the authority of one or more

physicians. That was the legal authority that I had

to do that.

Even though I was a PE, that made no

difference. The only thing that gave me the

authority to put those together so they could be used

on patients was this practice of medicine doctrine

and the fact that the physicians are authorizing me

to do so.

What causes me some concern, while I

support the idea of certifying folks that are, you

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know, clinical engineers with IT training and back

and forth, is that regardless of how you build these

systems, the folks that are using them are going to

find a need and an opportunity to modify them, and

they are just like we've talked about with the work-

arounds with nurses, how brilliantly they do that.

And at some point we're going to need to know when is

it a practice of medicine and when is it a

manufactured device and regulated by the federal

government.

MR. GEE: That's an excellent point. I

think hospitals are looking at developing the

policies and procedures to blend the IT and biomed

functions to deal with systems like this, and their

hospitals need to include some kind of governance

through their physicians, whether it's the chief

medical officer or the chief of staff or somebody, to

provide that physician oversight so they have that in

place. Sandy?

DR. WEININGER: So I'll add to the mix or

the confusion. The distinction between configuring a

system, and in this case we're considering a system

of multiple vendors, and actually programming. So in

a configuration, you're usually selecting from

pre-described lists of things, and the assumption is

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that someone in the background has checked out the

interdependencies, whereas in programming, you know,

with Excel you can go off -- you can build anything

you want and all kinds of new interdependencies might

show up. And so if you're a physician practicing

medicine, does that mean that the physician is then

responsible for all those interactions which they

likely have no clue about, particularly the IT

infrastructure things, which they have no idea what's

happening in the back end?

MR. GEE: And I think doing things,

modifying devices under the guidance of a physician

is a great strategy for an academic medical center

but maybe not for a community hospital. Yes?

DR. BLOCK: Yeah, Frank Block from VCU.

Thirty years ago -- I mentioned this the other day --

Duke was building its own medical monitors for use in

its own operating room, and we were told at that time

that since we were not marketing them or selling

them, we were not subject to any FDA regulations

whatsoever. I'd like to ask the FDA people, is that

still true today? If I build my own box in my

hospital and I don't market it and I don't sell it,

am I subject to the FDA rules or not?

DR. WEININGER: You're cruel, very cruel.

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MR. GEE: Did the FDA tell you that, or did

someone else tell you that at the time?

MR. MURRAY: That's my first question. Who

told you that?

(Laughter.)

MR. MURRAY: And do you have it in writing?

(Laughter.)

MR. MURRAY: A lot of these questions that

Mr. Gee is getting now actually belong to Bradley and

I, and we hope to cover those in our session at

10:30, so you can kind of get off his back a little

bit.

(Laughter.)

MR. GEE: Yeah.

UNIDENTIFIED SPEAKER: Okay. So the point

that I just wanted to make, I think, we were talking

a little bit about the difference between

configuration versus programming, and I think that

line has been getting ever more blurred most recently

with a lot of the systems that are out there.

I mean, you know, a configuration is never

-- these days, is not as simple as just, you know,

using drop-downs. You can really, you know,

configure the system to the point that it has its own

logic, its own workflow engine and whatnot in there.

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So making that distinction, programming versus

configuring, is a not a clear line by any means, and

the systems are so configurable that you can't make

that distinction, I don't think.

MR. GEE: That's especially true, I think,

with rules engines and decision support engines.

DR. SLOANE: Elliot Sloane at Drexel

University. I just want to put out, there's a fairly

large body of regulatory organizations, who we're not

including in this discussion, that come under the

HIPAA and HITECH and emerging certification area.

Those rules may be out next week. And we really have

to look at the big picture because the enterprise and

the physician is going to have meet all of those

master's wishes and that includes privacy,

encryption, security, data sharing.

And so to add to our shoulders, our

collective shoulders, is that I think we need a

bigger community to have this discussion. So if we

have it one time, we'll just back five years from now

discovering a frontier we forgot and we never saw.

MR. GEE: I've been given the hook. So

goodbye, and whoever's next, come on up.

(Applause.)

MR. THOMPSON: All right. There were

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actually two of us facilitating, Jeff Secunda and I.

So I don't know if you want to get by a mike so you

can correct me if I -- when I screw up.

One of the issues, I suppose, is accurately

defining what this group was all about. We were

called the low acuity group. I think really what we

were focused on was home health remote monitoring and

mobile health. Those were most of the examples that

we talked about.

And what I did is, we took a fair amount of

notes, and last night, when it was late, I tried to

organize them and group them around regulatory themes

so that the comments would relate to some particular

part of the regulation. I thought that might help.

I hope I didn't take too many liberties, but the

folks in the group can tell me if I did.

I'm hearing a common theme in a lot of

these reports, that the scope of FDA regulation is

one of the issues that interests people the most.

What is a regulated article and what is not? That

was certainly, I would say, just about the number one

issue that we discussed as we went around the table.

It's what people commented on.

And, for example, in this particular area,

we've got the use of the cell phone, and there are a

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lot of different ways that a cell phone might be used

in this situation. I'm not going to go through all

of them. I've listed just a few of them here. We

talked about a home hub as well, and we talked about

off-the-shelf software and how it might be used. I'm

going to defer that discussion really because that's

what John is going to cover in about a half hour.

He's going to help people, sort of, by tackling some

of these specific use cases and talk about what's a

regulated article and what is not a regulated

article. So that's one, I think, really tangible

benefit from this conference is we're going to get

some real-time guidance on it. But that was the

number one issue we discussed.

The second issue is, once you get past that

question of whether something's a medical device or

not, if it is a device, the second question is, how

is it regulated? What level is it regulated? What

classification do you place it in? And we approached

this a couple of different ways.

One was the issue that was just raised a

few moments ago, which is, if you've got a whole

bunch of devices that may be Class I and you throw a

Class III in there, does it raise everything up? All

right, that's a conundrum that we face in this group,

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and it's something that we could use some guidance

on. In addition to that, you have -- basically, when

you take one of these devices that should be very low

risk and you look at the risk/benefit analysis of

using that device, it really ought to be in a very

low risk classification. It ought to be in Class I

because the uses to which it's employed are simply

unlikely to cause significant health hazard. So that

was another issue, is whether these things are

properly classified in the first place.

All right. So we get past that and we get

to the general topic of intended use, and this is an

area that we spent a fair amount of time talking

about. It just seems like there's a lot of things

that people want to do in this space that could

potentially impact the intended use and therefore

impact how it's regulated by FDA.

One issue that kept coming up, as I said,

you know, we like to be able to put devices out there

with what would amount to tool claim. And a tool

claim, for those of you not familiar with that term,

is you say that a scalpel cuts, you talk about the

function of it rather than specifically the clinical

utility of how you use the scalpel. Well, the same

in electronics. All of this IT stuff, we could say

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what it does in a literal sense but not specifically

talk about its clinical utility and let that evolve.

People want to know, is that okay, is that an

appropriate model for how to approach this?

In addition, the second issue is a lot of

people want to get a general connectivity claim

without having to specify to what particular cell

phone, or whatever, might connect. And that raises

challenges currently at FDA because it's very hard to

get an open-ended claim like that through the Agency.

The other issue that came up, again under

this theme of intended use, is when you start package

devices together or start to label them for use

together, how that affects the intended use. Does it

make a system out of it always, or is there a way to

give some latitude to folks to co-package things

without necessarily changing the intended use of it?

Another thing we talked about is evidence.

All right. So you've figured out that you do have a

medical device, you've figured out what class it's

in, and you need to get FDA clearance for it. What

is the evidence required in order to secure that

clearance? How do you show substantial equivalence,

if you're in the 510(k) realm, with one of these, for

example, open-ended claims? It's very difficult

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currently to figure out exactly what evidence will

accomplish that.

A lot of folks wanted to talk about

standards and certification standards and

certifications to how the device can interconnect

without going beyond that, specifically making a

system claim and then having to prove that

connectivity.

And then there were people who wanted to

simple explore a whole new paradigm for how you would

look at these systems and how you would regulate

these systems, and they wanted to stratify it using

the medical device model, stratify it based on risk

and treat appropriately those that have very little

intrinsic risk associated with them. So that was

another theme under this general rubric of evidence.

A number of folks wanted simple clarity

about FDA's expectations on specific features and

performance associated with devices. So they wanted

to know, will latency be a problem? Will FDA object

if a 510(k) comes to them and there's some

significant latency associated with the products that

are part of the system? They wanted to learn about

what is expected in the way of design features, and

are there going to be limits on an appropriate

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population for these things? Is FDA going to say

that you need to be able to screen or somehow qualify

the people who could use these articles? How do you

deal in a 510(k) submission with an open source

platform? What kind of evidence and what kind of

references do you need?

Usability issues and protection against

interference from other software. We talked about,

you know, an Apple iPhone is in some ways a very

uncontrolled environment. Lots of things get added

to it. How do you cope with that from a regulatory

standpoint?

We didn't discuss these issues in great

detail. We simply noted that Scott did a nice job of

summarizing these issues in his presentation

yesterday, so we discussed them briefly but not in

any real detail. We agreed that they were issues.

We reserved a little bit of time at the

end, after talking about those substantive issues, to

talk about what happens after today, what happens

after this meeting, and from a process standpoint,

how can we keep this stuff moving forward? And we

concluded that really the next step is to take some

of those issues that we just discussed, and maybe

others, and figure out which are the most important

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and therefore which the industry needs to focus on.

But we also talked on a more practical level of how.

Who is going to do this? And the nice thing about

this low acuity space is that the Continua

organization was very focused on it, and Chuck, who

was in our meeting, volunteered that the Continua

organization would serve as a forum for continuing

the discussion of these issues.

We talked about mechanically how best to do

it, whether we can come up with specific case studies

that we can present to FDA to get concrete reaction

from. We talked about drafting our own proposed

guidance documents that would then share with FDA.

We didn't really arrive at consensus on that.

We talked about the comparative utility of

it. If you go with a single case study, then you get

a single answer. If you go with a guidance, then you

get something that's broader and focused but maybe

harder to deal with. So there's pros and cons to

each one of those, and I think that's still an open

question for the group. Jeff, what have I left out?

MR. SECUNDA: Nothing.

MR. THOMPSON: Questions? Comments?

Concerns?

UNIDENTIFIED SPEAKER: Yeah, I would like

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to ask a question about the home care devices. Right

now we are piloting one of the gadgets we market to

reduce readmission of surgical patients. So from our

point of view, I think at least data acquisition,

front end, of that device, whatever it may be, I

think it needs to be regulated or controlled because,

for instance, if the temperature measurement is wrong

by five degrees, it'll be a disaster. Or a scale

which does not produce reproducible results would be

also a problem. So I think those devices need to be

controlled because otherwise, I mean, we would not be

able to deliver proper care.

And, you know, for instance, you know, to

save, let's say, healthcare money if we can discharge

patients, let's say, half a day early, there would be

huge savings, at least from the hospital's point of

view. So from our point of view, I think, certainly

communication issues and the connector issues and all

of that, that's a difficult issue. That's more of a

stand aside. But I think at least data acquisition,

front end, someone needs to regulate that because

otherwise consistent care will be very difficult to

deliver.

MR. THOMPSON: Well, that's actually a good

topic for John to address when we have -- John to

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address when we have our --

(Laughter.)

MR. THOMPSON: -- Q and A session in about

30 minutes.

UNIDENTIFIED SPEAKER: One other aspect of

this, potentially, is that there is an overlap

between home health and lifestyle as well, and

lifestyle use potentially is nonmedical but not

noninterventional. So where's the fuzzy line between

those two?

MR. THOMPSON: And I skipped over that, or

I went too fast in the slide I had on what is a

regulated device. I talked about medical versus

consumer indication, and when is a wellness claim

just health and fitness versus when is it specific

enough to become a "medical claim" and therefore

trigger regulation? We're going hear all the answers

to that --

(Laughter.)

MR. THOMPSON: -- in about 30 minutes.

UNIDENTIFIED SPEAKER: You know, I might

add also that there might be a further fuzzy line

with discharge devices. So for that very purpose,

there's a much more intimate connection between the

hospital and the patient, for their benefit and the

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patient's benefit, as opposed to a long-term home

healthcare situation that might include a third-

party, not a hospital-based, operation.

MR. THOMPSON: Other questions or concerns?

If not, thank you.

(Applause.)

DR. GOLDMAN: All right, any questions? So

I'm going to go through a few slides of what we

discussed in our breakout session on research related

-- research and process. There are more details, of

course, than I'm presenting, and there's a pretty

comprehensive document of minutes or notes that

John Zaleski took and this is based upon that.

One of the things we discussed was patient

data association, and of course the importance of

this was discussed on day one. And we discussed the

notion that interoperability, access to devices and

the data, could support greater contextual awareness,

which would support better association of data to

devices and patients to the data and to the devices.

We also discussed, as had been presented

previously, the notion that probabilistic association

was important and useful. Doug Rosendale presented

that on the first day. And we discussed that with

more comprehensive data and with knowledge of the

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devices in the environment, it would facilitate

probabilistic association and therefore address one

of the great challenges that we have today, which of

course is typically exacerbated with wireless systems

and there isn't a cable that one can trace to the

device, although we did have a healthy discussion

about that point.

We also discussed that data logging could

help with post hoc data analysis for research. You

know, comprehensive databases can do the things that

we can't do today, in terms of monitoring of patient

populations and supporting research and the notion

that this would be -- it really should become a

central part of how NIH research is performed, for

example. And of course it would facilitate, or it

could, adverse event reporting and analysis and near

misses, hopefully more so than adverse events.

We discussed for some time the notion that

one should look at both the benefits and the risks of

tighter integration and data availability, and the

notion that integrated systems created by medical

device interoperability will have benefits and risks.

The tight coupling that had been discussed or

presented through some Q and A the other day -- I

think Frank Block insinuated some of that discussion

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-- is truly a potential issue and we have to consider

that. But, you know, one of the challenges that we

have is how do we develop and identify metrics of

safety and outcome? We don't know yet, and if we

wait for typical types of studies, you know,

randomized control studies, they're probably not the

right thing to do to assess capabilities and

infrastructure.

So we talked about differentiating the

benefit of a platform and improving capabilities

versus the benefit of each app for the platform. If

you think of the iPhone, a bad app doesn't mean they

have a bad platform. Similarly, if you have a bad

platform that doesn't support good apps, you're stuck

as well.

So the notion of separating the

capabilities and functionality from the clinical

applications that are delivered was something that we

discussed. We don't have an answer for that, but we

think it's an important question.

New problems can be created, that's kind of

understood, and how one looks at this and studies

these things, in terms of how one approaches it

statistically, was discussed because it was kind of

agreed that, generally speaking, the methods that we

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use are -- the expertise available in the community

is not up to the task from a statistical perspective.

Maureen presented us with an interesting

concept graph meticulously crafted during the session

on the back of a sheet of paper. It's redrawn here

with extreme -- with similar attention to detail. So

you have two vertical bars. The one on the left says

this is the incidence of problems. This is what we

know about in the current state, whatever these

adverse events and near misses might be. If you look

at the bar on the right, well, it's shorter, so

therefore things are better. And that's true; things

are better.

But buried in that data is the red bar,

which says, well, there are new events that are

occurring, and we have to somehow tease out these new

events or increasing frequency of some older events

versus a total reduction that we're seeing. And so

this is another, you know, interesting notion and a

good question for somebody to consider.

The unique device identifier, the UDI,

which is being promulgated by the FDA -- Terrie is

somewhere in here, and she'll present more about that

a little bit later. She's coming in later and will

present that to the group. But we did discuss that

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there may be a role of the UDI in identifying devices

on the networks, identifying devices in a system, and

the possibility that, linked with the concept of UDI,

it would be providing more complete failure modes

that would be suitable for adverse event reporting.

And hopefully we can do a better job of automating

that and collecting data in the environment in

general because we know that collecting accurate and

complete enriched contextual data is really one of

the great challenges today.

So it's very difficult to assess a problem

when it happens. It may not be a medical device

problem. It could be a training problem. It could

be a use problem and so forth. Whatever it is

typically we just don't know what happened.

We talked about the apps. We didn't use

that word, but I guess that's the word to use now, is

the apps. So the key benefit of interoperability and

system integration is the implementation of these

clinical applications. It's not the only benefit,

but it's one of the major benefits, is that there

will be a means to deliver the smarter and better

ways of doing things.

So, therefore, we need tools to build and

deliver these clinical applications, and we've seen

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that these things are starting to emerge, but they're

all different today, and so there will have to be

some consistency and quality around that.

We talked about the need for real-time

decision support tools and a platform to deliver

these. Perhaps the tools could, at one point, be

platform agnostic and be transferred easily between

platforms if they're standardized.

And we briefly touched on the notion that

there could be interaction between applications,

typically not applications that are passively reading

and presenting data but those that are performing

some type of action, perhaps adjusting a medication

or titrating something, or presenting conflicting

information. One algorithm that says increase your

insulin and another says decrease your insulin, or

one that says increase your insulin and the other

that says, you know, decrease your glucose intake.

So we had to think about the fact that we don't have

conflicting recommendations.

There were questions brought up about the

network itself, network performance and reliability;

how should that be addressed? That was just

presented. I won't spend more time on that. But the

role of computing was brought in and the notion of

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what algorithms need to be in the patient

environment, wherever that might be, and which

algorithms can be hosted more remotely, and that

would then depend upon the reliability of the system

and the acuity of the application.

Does a network sort of have to be able to

hide some gray medical, like gray or medical device

and some networks not? This was already touched on

as well. And also the notion that one of the real

benefits is in encapsulating stuff, you know, in

between standardized interfaces to insulate what's

going on inside from what's outside.

Then, you know, the notion of, you know --

so of course that would then -- the performance of

whatever's inside would have to be addressed, but it

would be addressed separately, hopefully from -- so

as to simplify the system and its use, and then

discuss the role of SOA, but not in great depth.

So then, moving on to our afternoon -- to

our next session, or not -- I think it's here. I

couldn't even spell my own name correctly. Okay.

There we go. So first we did some brainstorming with

a blank slate. That wasn't intentional.

(Laughter.)

DR. GOLDMAN: Then we talked about some

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specific use cases. One of them was a hypoglycemia

alarm. And the idea here is, you know, we wanted to

introduce specific devices and control the notion of

what was going on. So there's a patient in a

hospital, in this case, with a continuous glucometer,

either invasive or noninvasive glucometer, and the

interoperability piece would be that there could be

different continuous noninvasive and invasive

glucometers. They are appearing on the market.

Those would connect to some type of

interface, a gateway, and then, as you can see, it

goes over the network somewhere off the screen

because we don't know where it goes, and then it

comes back and then it ends up in the EMR. And the

EMR collects the data, and then the EMR sends the

data or uses an application which connects to it

somehow also off the screen, intentionally, and

there's a dotted line here because it's in a

different city or a different country or a different

planet. We don't know. It's the cloud.

So the application brought this

hypoglycemia alarm, and then the information goes

from the app over, again, the network, which we don't

know exactly where it goes, and ends up at the

central station and provides the clinical alarm. And

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we also talked about the notion that there might be a

wireless or SMS over it as well. So that's one of

the use cases we discussed, and we thought that it

brought in some specific notions of the fact that it

is a clinical alarm that's important, that's being

displayed on equipment that is currently used for

just that purpose, but the application is being

posted not locally, and so how does one deal with

that? Is that relevant or not? So that was one use

case, high-level use case.

And then two more that are somewhat

similar, and these are in a high acuity patient

environment. This one is closed loop fluid

resuscitation and the other is closed loop blood

pressure control. So the idea here is that there's a

-- there are devices connected to the patient.

There's an intravenous infusion pump which can

deliver boluses of intravenous fluid.

This is a device that has been under

development for a resuscitation of injured soldiers

and transports that deliver fluid boluses to maintain

or achieve and maintain a certain blood pressure.

And the blood pressure is measured actually

invasively, but it could be -- it may be both.

Details aren't really important. So you have some

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monitors and devices, and they're connected through

some type of integration hub. I just wrote down

network integration here. There is continuous data

logging, as I discussed before, and we thought that

was -- that's important for many reasons when looking

at a system like this because these things will fail,

especially when they're in helicopters and so forth.

And then there's a clinical information

system interface to pull patient data or to transmit

a reduced dataset or a lower bandwidth dataset. And

then there's the applications that run this. And

these are all assumed to be not on a cloud. You can

see they're all located around the patient.

And so the idea that long distance network

failures would be relevant was kind of eliminated

from this scenario intentionally. So one of them was

the fluid resuscitation, and the other was lowering

blood pressure with a sodium nitroprusside infusion,

which actually was developed decades ago. It goes to

the control of infusion. But we wanted to bring that

back, knowing that had been actually an FDA-cleared

device a few decades ago, bring that back but kind of

in a modern notion with a different architecture and

with interoperable components.

The closed loop control, the notion of

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closed loop control being distributed with one device

that provides the medication and another device which

measures blood pressure and having that integrated is

also supported within the IEC physiologic closed loop

control standard, the notion of distributed control

in IEC 60601-1-10. So those are the two.

And then just to conclude, these two high

acuity scenarios map very well onto the ICE

functional architecture that's in ASDMF-2761, where,

in the previous example, you know, what we're calling

the app and an app platform is what's called in the

standard the ICE supervisor, and then the network

integration that occurs with these plugged-in devices

are called in the standard the network controller.

The data logger is the data logger. And what we call

the use case, a clinical information system

interface, is called in the standard the external

interface.

And then it's shown in this case that these

devices are interoperable, are compatible in that

way, and the way that's depicted in the diagram in

the standards is that they have a nice compatible

interface. It doesn't specify how. It's just the

notion that these are interoperable. So those are

the cases we came up with to convey certain specific

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notions.

And anyone else who was in the group,

please, this is a good time to tell me what I missed,

what I didn't present or correct anything. All

right. Are there any questions from others who

weren't with us? All right, thank you.

(Applause.)

DR. GOLDMAN: Here's Johnny.

(Laughter.)

DR. SAMARAS: You planned that.

DR. GOLDMAN: I was waiting for that.

Thank you.

MR. MURRAY: I have a thousand different

thoughts in my head, so I really feel disadvantaged

to get up here and speak. You know, after about a

week of thinking about this, I'd better to actually

talk about it. But I do have some notes. They keep

changing as I hear more information.

The first thing is the disclaimer like

Scott had. I'm only up here to tell you what my

opinion is, and the way the FDA works, unless you get

it in writing, it's not a formalized opinion. So

that's a very important concept. What I say here is

what synthesize and what I'm thinking about right

now. There are a lot of people from the FDA here.

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Someone from standards, Carol Herman, Director of

Standards. We have people from compliance, ODE. The

two primary ODE people who would be very helpful in

this couldn't make it this week. One person had to

go to Ohio, her father's very ill, and the other

gentleman, Tony Watson, went off -- he went off to

Japan for an assignment. I think we're going to get

a lot more help from ODE when they come back to help

with his problem.

I think we have a great problem here. I

think there's a lot of great people here. It was

very interesting to hear everybody's opinion. It's

great to be in the presence of a hundred or so people

that actually know what the heck is going on and

really care about their business, and it's very, very

important to clarify this.

But I have to tell you, you're exactly in

my sweet spot. I get phone calls about this every

day of my life and e-mails about this every day of my

life, and I try as hard as I can try to move this

problem forward, but only as one crumb at a time.

And it's hard to build a pyramid when you're moving

things one crumb at a time.

So I'm going to put a name to this effort.

I'm going to focus on making this a quantum leap. In

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other words, we can't go and change the Food and Drug

Law. Well, we could, but that would be a pretty high

effort. We can't really go and change 30 years worth

of medical device practice. That would be very hard

to do. But what we can do is focus on the tools that

are available to us and how we can utilize those

tools to focus on tomorrow rather than being linked

to the past in the substantial equivalence business.

I'm really a huge fan of this de novo

process. I know Tony Watson's been involved in this.

In other words, if we figure out a way to set

ourselves in a new path that will, number one, meet

the FDA requirements and meet the -- and number two,

meet the clinical requirement and the industry

requirement. That's the chance, the opportunity that

we actually have here. And this is a great

opportunity because we have so many people that know

so much stuff to work on it.

The way it currently works is the

individual companies walk through the door, they get

their 510(k) service, their PMA service, their BIEE

(ph.). And what is that old saying? It doesn't

amount to a molehill, all these little crumbs. We

need to get all of these people together and kind of

make that work forward. And Brad and I are going to

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talk about some misnomers related to regulatory

theory. Every meeting I go to I hear people very

confused about this, and I can completely understand

why. If you don't live and breath this every day

like I do, you can quickly get confused by the

different paths they go along. So I think someone

needs to be in charge here.

(Laughter.)

MR. MURRAY: Someone needs to stand up and

say, I want to be in charge here.

DR. GOLDMAN: I agree, someone should do

that.

DR. SAMARAS: Aren't you already standing?

(Laughter.)

MR. MURRAY: It's not going to be someone

from the FDA. We've gone this far. You know, I'm

now convinced this is a huge problem. When you first

started talking to me, I was like, I couldn't

understand what you were saying. Now I understand.

I've heard all these examples, all of this kind of

stuff, and now I get it. I don't always got it from

the compliance point of view, but I never got it from

the whole clinical, how this all fits together. So

we need to have a structure. And we need everybody

in this room to say, I'm either in or I'm out. You

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may not be a leader but you're going to be a

contributor. I think at least everybody in this room

is one giant working group of some kind. I don't

know what to call it. And of course these are just

my ideas. I'm not giving you commands. I have no

authority. I have no legal authority. I don't have

$30 billion. That was a joke. No one's laughing.

(Laughter.)

MR. MURRAY: There was a slide that

Dr. Shuren had. It had four elements, use cases,

engineering, risk, and management and control of

this, right? I'm going to put a fifth category in,

which is this whole regulatory process. And I'm

going to volunteer Brad and myself to kind of lead

that group, to try to get that group organized and

take volunteers, anybody who's a regulatory theory

specialist, or whatever, that wants to be involved in

that.

Of course, this is going to be a big e-mail

process. It's not going to be much doing face-to-

face. But somebody else needs to take charge of

these other groups and kind of fill out the

engineering solution and do the risk management, do

the use case and put it all together. I think this

report, when it gets put together -- I guess Glen and

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you guys are going to do this -- will be a phenomenal

resource to get us started.

So I think we need to get organized and

we're going to need a plan, how we put all of this

together and say we need to make this not so big that

we can't do it, but it has to be big enough to get

something done. I think we're at the right place and

the right time. There's a lot of things that have

happened in the last year.

Just last week, Dr. Shuren got up and

talked about the strategic plan. He talked about

TPLC, total product lifecycle control. That's one of

the issues on his radar, his agenda. Donna-Bea is a

big fan of this, of course. She's the Director of

ODE. She enabled this workshop to happen. I sent

her a thank you note after coming here the other day

and she sent back, you got to come over and see me

after the workshop and tell me what's going on, tell

me what you want to do. So I think we can get her

engaged.

But we can't go to ODE and we can't go to

Donna-Bea with theories. We need to bring solid

information, kind of worked-out problems with worked-

out solutions. And we don't want to go to ODE with

problems we don't have proposed answers for. And you

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have to think like the regulator thinks. In other

words, a lot of people seem to think that FDA just

annoys people because it's fun.

(Laughter.)

MR. MURRAY: That's not true. You know, we

all have -- there's a central problem here. How do

you deliver good patient care or the public health?

Everybody who looks at this problem has a different

set of needs. The lawyers have a different set of

needs, the regulators, the physicians, the standards

folks. We have to figure out how do we keep the

wheel in balance, right? If one part of that

customer set gets out of whack -- and that's kind of

where we are now.

So I'm encouraging us to get this

organized, put it together and really work towards

moving to our own separate place, a quantum leap, so

to speak, where we get really our own classification,

we build an architecture, we start adding pieces to

this, and we kind of separate ourselves from being

attached to the substantial equivalence of all the

other devices.

Of course, a lot of the devices, like

infusion pumps and things, will still remain

classified devices under their own category. But we

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want to try to draw that separation line between that

and this in a regulated way because in reality the

majority of stuff that's up here obviously needs a

definition of a device.

Which brings me to my next point, which is

that I heard a lot of discussion about, well, the FDA

is not doing this and the FDA is not doing that.

Just because the FDA is not doing something does not

mean the FDA has decided that that's the policy that

is today or will be in the future. What it simply

means is that we haven't got around to it basing it

on a resource problem, a risk analysis problem, a

political problem, a legal problem.

Because we have a long chain of command, a

lot of things have to get lined up for us to take

some kind of action. We can have a genius idea in

compliance and we finally get the director of

compliance to agree, then we got to get the center

director to agree, and then we've got to go to the

chief counsel's office and, oh, by the way, then

someone says, well, is this going to go to the Office

of Management and Budget? Or is it going to go -- I

heard a comment one day like, well, who's going to

tell the President? I volunteered to tell the

President, but they just ignored me.

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(Laughter.)

MR. MURRAY: Probably a good choice on

their part.

(Laughter.)

MR. MURRAY: So being proactive in a huge

group like this is very good because typically an

individual company comes in there and makes their

case and then they go away. And there's no built-up

corporate knowledge there. There's no layer. And

then someone else comes to a different branch or a

different division at ODE, and they make their case

and then that corporate knowledge gets lost. So if

we can put together the corporate knowledge within

this group and build a case in a team way, I think we

can make that leap.

It's going to require a lot of companies

out there to change the way they think about this

problem and change the way they interact with other

companies. I'm not sure a lot of companies are going

to be willing to do that. Some will, some won't.

But I think that if we form a team -- and the other

key thing is all of this needs to be out in the open.

We want to share all of this information with all the

people. We want them to understand where we're going

and why we're going there in an open fashion so they

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can say, okay, I agree with that, or, okay, I don't.

Someone mentioned we've left somebody out. We want

everybody to be aware. So if we leave somebody out,

they get a chance to get in right up front. So I

think communication is a huge issue, and I think we

need to say everybody's an equal here.

Now, what I'm going to commit to here and

the only thing I can do, I long ago stopped being a

scientist or an engineering expert. I did come here

once. In fact, how did I get in the device business?

I was working for the Department of the Navy. We

were working on this big, huge ship, and I was

integrating the software for aviation systems and the

missile systems and airplanes and things like that,

and we had a couple interoperability problems. We

wanted to make sure that when we were launching

Harrier jump jets, that we didn't shoot the gun and

blow up the jet before it got off the deck.

(Laughter.)

MR. MURRAY: That's a big interoperability

problem.

(Laughter.)

DR. SAMARAS: That's why they're supposed

to jump.

MR. MURRAY: Jump faster. They had to jump

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faster. One of the very first assignments I had, I

just got a job there and they said what do you want

John to do this week? And they said review these

drawings from the shipyard. And they come in here.

Review these drawings. I'm like what do you me to

review them for? And they gave me the ship spec, and

it was like eight feet long, and I've got to start

reviewing these drawings. So I come to the

conclusion by noon that the ship is the wrong length.

(Laughter.)

MR. MURRAY: And I'm like, this cannot be.

It's off by 18 inches. This is a 900-foot ship, and

it's off by 18 inches. So I go and get some of the

other guys and we looked through this thing, and we

looked at this for three days before we could tell

the boss. You can't tell your boss the ship is the

wrong length.

(Laughter.)

MR. MURRAY: So we finally concluded that

the ship was the wrong length. Ingalls had made the

ship -- Ingalls Shipbuilding in Mississippi had made

the ship 18 inches too long as composed in the ship

spec. So we had to research it and figure this whole

thing out, and we found out that the problem was that

on the original ship, the form of the flight deck

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flat and on the new class ships, they were rounded

off and they specified a radius of 18 inches, or a

diameter of 18 inches, and the shipbuilder made it

into a radius of 18 inches, which made the ship the

wrong size.

I mean, this is a small error. So we're

like, okay, we got to get them to change these

drawings, and we're thinking -- we estimated the

total cost of this would be $50,000. That seems

pretty reasonable in DoD terms. So it went to the

shipyard and it came back, and they said it'll be

$500,000. We're like why is that? Because you got

to remember that when you change the size of the

ship, you change the rims or the frame base to hold

the ship up. Every light on the flight deck is

attached to a light fixture that's shock-hardened,

and every drawing all the way up and down had to be

changed. $500,000.

Anyway, I'm working on this OSG project,

and one day they're having this problem. The ship

had six high-tech operating rooms. They're like six

shock trauma units. The ship sits off the beach, and

they fly injured marines back from the beach, and

they take on the ship and they treat them, a critical

care, a shock trauma kind of thing. And they said,

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well, we have a problem with some medical devices.

I'm like what are you talking about? So they had all

of these medical devices from commercial vendors

trying to put on this Navy ship that didn't meet Navy

specs, and they said we need somebody to work on this

problem. So I volunteered to -- you know, I figured

that would be like a spare job.

I started working on devices and ended up

meeting a lot of device manufacturers. I met some

folks from the FDA, and they said we have a software

problem. This is back in like 1991, right after

Therac-25, and that's how I got on to my journey here

of interoperability.

So I think it's a great project, and I

think we should try to make this a quantum leap

thing. I think it requires a lot of team effort. I

have like 40 pages of notes here, and I can't put

that all together in one presentation. But unless

you have any questions about the project itself --

and I want to know who's in charge, you know what I

mean?

DR. GOLDMAN: My wife.

(Laughter.)

MR. MURRAY: That's the rest of your life.

DR. GOLDMAN: Yeah.

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MR. MURRAY: I'm talking about this

project.

UNIDENTIFIED SPEAKER: The same thing.

DR. GOLDMAN: Keep on plugging away.

MR. MURRAY: So I think that someone -- I

think the steering committee -- and I'll volunteer

somebody to go off and write some kind of report and

set some kind of plan and action and get this moving

forward. And if Sandy and I will go talk to Donna-

Bea and a lot of other folks, it'd be a good thing.

So we're going to shift --

DR. SAMARAS: John, I heard something, that

Amy might be willing to help with this report-

generating stuff.

MR. MURRAY: What kind of report?

DR. SAMARAS: For this workshop. Are you

talking to me or you talking to Jill?

MR. MURRAY: You're saying that Jill, from

Amy, is volunteering to write the report?

DR. SAMARAS: No, no, no, I didn't say

that.

(Laughter.)

UNIDENTIFIED SPEAKER: I think it's

something that could be floored.

MR. MURRAY: Get a hold of her. Well,

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there was no Amy person in the back. There she is.

DR. GOLDMAN: So, John, the steering

committee will continue, you know, to do the

post-workshop stuff just as the pre-workshop stuff.

MR. MURRAY: Okay.

DR. GOLDMAN: So that's the commitment that

was made.

MR. MURRAY: Yes, ma'am.

UNIDENTIFIED SPEAKER: John, do you know

what the turnaround is currently on a standard de

novo process?

MR. MURRAY: I do not know that

information. But I do think that going through this

the first time will be the most difficult. But once

you establish a method and a mechanism, that's the

whole thing, is to work with ODE and set up some kind

of mechanism to make this work on a regular basis.

That would be my goal.

But we can talk about more about the de

novo process and the regulatory process later. I'm

supposed to be focusing this section on what I

thought about this workshop, how interesting I think

it is, how challenging it is, and how I think we

should actually do it. But I can only contribute

what I know best, which is what -- I invented a new

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term, software compliance science. And I'm the only

on in the field, so I'm the expert.

(Laughter.)

UNIDENTIFIED SPEAKER: I just wanted to

suggest that we're all focused on safety, but one of

my concerns is we continue with the adage of the

least burdensome approach. Let's find the best

approach that's the "most efficient." And my focus

is entirely in the medical arena and totally on

patient safety and treating patients, and I just want

to make sure that in the process of moving forward,

we don't create more bureaucracy; we actually solve

the problem effectively.

MR. MURRAY: Well, I think that when we

make a regulatory approach plan and go to ODE, then

we have to evaluate the feedback we get and decide

whether we want to continue that way because we may

decide that it's better the old way. You never

really know what's going to happen when you try to

make these kind of things happen. But I think if you

honestly explore the questions up front and you come

up with kind of valid answers, I think you'll have

much more success than going there with open-ended

questions or regulatory -- I think that's the general

policy. Yes, George.

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DR. SAMARAS: I just wanted to follow on

with John's point about focusing on safety and

pointing out that there is an opportunity cost to not

going down this path. So that if in fact

interoperable systems make patient care safer, or we

expect that they will, and we don't -- and we botch

it or we don't do it correctly, then there's an

opportunity cost associated with that.

MR. MURRAY: Are you ready to do our

little --

DR. GOLDMAN: Is Terrie here? Let me just

check and see if Terrie -- is Terrie here? Terrie,

are you here?

(Pause.)

MR. MURRAY: I just want to start with the

number one concept in medical device regulation,

which is the entire center -- the entire device

regulation begins with a concept that is based on the

intended use. Nowhere in that intended use statement

does it either exempt or include any type of

technology. It's applicable to any type of

technology.

So the first question that the FDA always

asks is what is the intended use of your product? We

want to focus on that clinical application of that

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product. Brad gave one example about a laser or a

cutting device. What are you cutting with it? And

that's very, very important from their perspective.

So when people call me, they always start

out by giving me this huge technical description of

their product. As a first step, that's not relevant

to the question about whether it's a device or not.

So the step in the process is making a determination

of whether your product is a device or not. And then

we can move down the scale to decide what components

are in your system and how that system will be

classified. And once we determine how it will be

classified, we can decide how it should be regulated.

So let's provide a couple different

examples here and talk about what parts of a system

are devices and what part of a system are components.

I'll start with a recent -- there was a 510(k) that

included an iPhone -- I think it was an iPhone -- and

the intended use of this product was the remote

viewing of -- I don't know if it was fetal images or

Doppler sound on the product. So let's talk about

whether or not that makes the iPhone a medical

device. I'll ask Brad that question.

MR. THOMPSON: I thought this was your

show.

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MR. MURRAY: I don't want you to sit there

and shake your head off.

MR. THOMPSON: I wholeheartedly agree that

the approach and vision under the law is to look at

the intended use, and that's why, when you guys start

preparing the next steps and you do these case

studies or whatever acronym we came up with or name

for these -- I don't want to say fictitious because I

got corrected on that. But when we come up with

these issues to bring to the FDA, the tendency, I

think, among the group is to get very specific on

various technologies and alternative technologies and

so forth, and really that stuff doesn't drive it. It

is the intended use. So that's where we're going to

have to be careful and figure out exactly how we want

to position this.

But on the specific question that John

asked about the iPhone, I think, John, you would also

agree that it depends not only what the statements

are but who's making the statements. So let's say

you have two different parties. You have the folks

who are making the phone, then you have the folks who

are making the application that's used on the phone.

The people who are making the application

that's used on the phone might make medical claims

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that it is to be used to visual fetal images.

They've made their application a medical device.

That software is a medical device. If the phone is

simply bought off the shelf and there's no medical

claims at all about the phone, then the maker of the

phone does not have an obligation to comply with the

FDA requirements. They're selling a consumer device

that consumers buy. The application maker has the

responsibilities. But those responsibilities include

making sure that the application will work on the

phone.

So it becomes the burden of the software

developer to look not only at their software but the

system in which their software will be placed, to

make sure that those two things can function together

in the expected environment in which they'll be

operated. Would you agree with that, John?

MR. MURRAY: Yeah. The law always goes

back the claimer, the person who makes the claim, and

this person made a claim that they had a system.

They could display remotely the fetal images. So

that system, including the software and all the

components that they selected to use in that system,

become their responsibility under the quality of the

system. Under the law, in this particular case --

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this is a tricky point. Under the law, because it's

a component a device, the iPhone in that instance is

a medical device, but it doesn't make the

manufacturer of the iPhone a medical device

manufacturer. It simply makes it -- it puts it under

the regulatory authority of the FDA.

Now, I always told a story about jelly

beans. I don't even want to know what your system's

made of. I can assume it's made of jelly beans. And

then one day I'm reading an article, and this guy's

telling a story about popsicle sticks, and I said I

got to talk to this guy. And this is the guy. So

when he teaches his law school class, he talks about

how popsicle sticks can actually become medical

devices. And I talk about how jelly beans can become

devices.

This little theory or this little legal

thing does not only apply to software; it applies to

every other thing in the universe, too. If I make a

battery, I'm Eveready or Rayovac and I make a

battery, it's just a commercial battery and I say we

can use it on commercial products, it's not a device.

But certain people like to make batteries and claim

they can be used in hearing aids, they can be used

in, I guess, infusion pumps and all kinds of other

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devices, which makes them an accessory to that kind

of product. So this all comes down to what you claim

and what you write.

I mean, let's take a company like Dell.

Dell, to the best of my knowledge today, is not a

medical device manufacturer because they haven't made

any claims about the use of their products with any

specific intended use. They simply sell a

commercial, general-use information technology

product into the workspace. But yet a lot of people

use their product as components of their medical

device systems. That does not make Dell responsible

in any way to meet the Food, Drug and Cosmetic Act,

but it does make the claimer responsible for that.

So there was a picture, I think, that

showed all these different components, and if the

picture was up there you'd kind of start going --

MR. THOMPSON: Is that what you're thinking

of?

MR. MURRAY: Yeah, that's a pretty good

one. So what we have on the left, we have -- these

are all classified devices.

MR. THOMPSON: Those are all sensors of

various sorts.

MR. MURRAY: Right. And then we have a

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Bluetooth, right? So the cell phone tower -- is that

what that is?

MR. THOMPSON: Yeah.

MR. MURRAY: Verizon's not a medical device

manufacturer. The world wide web and the internet's

generally not a medical device manufacturer, unless

of course you sell a specific VPN or some other kind

of product like that for a specific remote display of

medical devices or medical imaging.

Now, one of the problems that we've had and

one of the issues we've had in the past is when

people make these claims, these products tend to

become known as accessories to existing classified

devices. And that becomes problematic for the

manufacturer because if you have an accessory to a

Class III device, it has to come in as a Class III

device.

It also becomes problematic for the Agency

because they get a lot of submissions that really

need a lesser submission, they need a lesser

oversight. So that's one of the problems we can

hopefully solve with this new structure we're trying

to put together.

MR. THOMPSON: John, can I pose to you a

couple of specific questions in this context that

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people have asked me? I'd like to get your thought

on it.

MR. MURRAY: Go ahead.

MR. THOMPSON: They're interested in

exactly where the line is, and they're thinking about

the cell phone manufacturer, and I'll give you two

different intended uses. One, the cell phone

manufacturer makes no adjustment to its features or

anything else about the phone, but they realize, they

read in the literature, they hear in the marketplace

that their phone is being used to connect to some of

these sensors.

So some marketing guy at the cell phone

company gets a great idea. Hey, let's say, and by

the way, if you buy our cell phone, you can connect

to these wonderful sensors and that makes it really

handy and useful to use. No changes to the cell

phone. It's the same cell phone that everybody else

in America buys from them, but this marketing guy has

said -- has noticed that it's being used in this way

and just encourages that use. Has he made it into a

medical device?

MR. MURRAY: Well, in my opinion, I'm not

going to focus on the changes to the cell phone, I'm

going to focus on what the guy -- what they now

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claim. And if I was to see this claim, what I would

argue or recommend or suggest to my management -- and

this goes into the system and gets reviewed by a

bunch of other folks and the end result is the input.

But I would argue that if you make a claim that

you've added some software to your cell phone that

would allow it to attach to a medical device for

viewing of the parameters of that device, then that's

a device because it now has the same intended use as

the local display that was on that device. So it's

the making of that claim that I would argue is

significant.

Of course, that doesn't necessarily mean

that immediately the FDA is going to make a decision

to actively regulate those products because in fact

the FDA -- there's a lot of what I refer to -- as

outliers. Outlanders maybe is better. They're not

liars, they're layers. They actually make devices.

They don't know that they make devices or they do

know that they make devices, but they can't even

spell FDA. And they're out there doing their

business all the time, but yet the FDA doesn't have

an active program to address that issue. And I think

that's a matter of risk management and a time

resource problem.

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But I will tell you that when your product,

which is an outlier, becomes problematic to public

health, you will see some action on the part of the

FDA. And you don't really see that, you know, across

the board in public health life, but if you're that

individual company and you create a public health

problem or create a risk in an clinical environment,

that's how you can raise the action. So there's

actually two ways to get the FDA's attention. One is

to make an application a 510(k), a PMA, an IEE, and

the other one is to cause a public health problem and

you get our attention.

MR. THOMPSON: There are two gentlemen over

here, I think, who want to add something.

DR. SAMARAS: I'm surprised, counselor,

that you did not accuse him of being nonresponsive to

the specific question you asked. He did not say

anything, John, about changing any software. It's

the same. All that got done was some marketeer got

the bright idea to say, hey, you can use this with a

medical device. Not providing the software, not

being responsible for installing the app. I'm going

to nail you to the wall here; that's what I'm trying

to do.

MR. MURRAY: My interpretation of the law

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is that if you have any type of marketing or written

literature, even on the internet or in a magazine or

a spoken word at a conference, that basically

identified your product with the intended use on a

clinical application, then you will probably have

crossed the line into medical device land.

DR. SAMARAS: That salesman made it a

medical device regardless of whether there was any

software or hardware changes?

MR. MURRAY: That will be correct. Now, I

will point out that we handle each one of these cases

on a case-by-case basis. So what I think about this

and what my director thinks about this may be two

different things, but I have a pretty high percentage

rate.

UNIDENTIFIED SPEAKER: It seems to me that

it's tied very closely to a written intended use. If

I'm a physician and I have a resident who is looking

at a patient and sees bed sores, he takes a photo on

a phone, sends it to me on my phone, I look at it and

I write a course of antibiotic, a script for an

antibiotic on the basis of that, it's practice of

medicine.

But if what you're claiming is that your

transmitting images over the internet for the purpose

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of diagnosis and treatment, what I've just done is I

diagnosed and I've written a script to treat a

patient on the basis of something I've seen. So it

seems to me it's the written intended use.

MR. THOMPSON: Can I tackle that one? It

is not the written intended use. It's whose

intention we're focused on. It's the seller of the

device that we care about, not the user of the

device. Off-label use is perfectly legal. Anybody

can use an FDA-regulated article within the practice

of medicine, and so long as some lawyer doesn't sue

them over it for malpractice, they can use it to

their heart's content.

The issue is how the seller, the

manufacturer and seller of a product promotes the

use. And in that vein, it has nothing to do with

what's written versus oral. It can be shown simply

through your actions that you intend for the article.

You only go to medical meetings and so forth to

promote it, instead of going to consumer meetings and

so forth. So it's the full range of actions that

show what the intended use is. But it's the

manufacturer that counts, not the user.

MR. COOPER: And I think that's a good

point. And you know, playing off that note, not --

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well, I guess to be specific. So with the iPhone,

for example, it was promoted at Macworld, which is an

Apple conference, to use, you know, this Airstrip-

type software, which is medical software which has an

intended use. But you know, Steve Jobs was up there

on stage promoting it. So is the iPhone a medical

device because they said that? I mean, to my

knowledge, it's not right now, but what I'm hearing

is it is.

MR. THOMPSON: John, I'm going to let you

take that one.

(Laughter.)

MR. MURRAY: What was the term you use,

attorney-client privilege?

(Laughter.)

MR. MURRAY: I would just say at this

moment that there are many things discussed on an

everyday basis within the FDA that are under a future

decision-making process, and some take a long time

for that decision to occur and some don't.

DR. SAMARAS: It's called taking the Fifth.

MR. MURRAY: Some never get a decision.

That's all I have to say about that.

(Laughter.)

DR. SAMARAS: That's what I thought.

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MR. THOMPSON: And Todd, I didn't mean to

get you off your -- you've got another question? But

we can go back to this, too.

MR. COOPER: I can step back and continue.

I can ask this --

MR. MURRAY: I just wanted to add one other

thing. A user can use a device in any way he or she

chooses. But that user can become a device

manufacturer if they start writing about it and

selling it to other people. In other words, an

individual practitioner or a user can take that

device and do whatever they want with it. That's

fine.

We also tell people -- and this is really

hard for me to say out loud, but it's true. A user

can modify a device in any way they choose to meet

their own need and that makes manufacturers want to

have a stroke. But that's the way of the law. The

FDA laws don't prohibit somebody from changing

things.

An example. I get phone calls all the

time. People have medical imaging systems and they

go to their vendor and they want to get another disk

drive and the vendor wants to charge them $6,000.

And they say, I can get the same thing from Dell for

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$500. And the manufacturer says, no, you can't get

the same thing. But the user says, I only have $500.

I'm going that way. So they then change that disk

drive with a product that hasn't been validated by

the manufacturer. And then the next question is --

this is going to back to you, Brad. What's the legal

liability here? Who owns that problem? And I don't

think that's actually been decided in a court of law.

MR. THOMPSON: I'm not sure it's been

definitively decided, but I know that lawyers have

strong views on it, that those who basically use the

product contrary to the labeled instructions for use

take it upon themselves if they cause problems by

departing from the manufacturer's use.

DR. WEININGER: I want to read an online

question to you. So here's an online question. It

says, I think there's a huge difference between a

clinician making a claim about intended use and the

manufacturer making that claim.

MR. MURRAY: Well, there's some confusion

in that question because I think you want to say the

maker of the product making that claim, right? When

you use the word manufacturer, I immediately assume

you're talking about medical device manufacturer.

Anyone can make a claim about a product and make it a

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device, but the second part of that has to be

introduced into interstate commerce, right?

MR. THOMPSON: Actually, the interstate

commerce element was effectively removed by a

presumption that all devices are in interstate

commerce. So that issue no longer is an obstacle.

MR. MURRAY: I guess, when he's talking

about the user, he's talking about an individual

person using it in a certain way.

MR. THOMPSON: Yeah, the FDA has spoken or

addressed this in other settings outside of connected

health, where products get used or changed by a user

and then resold, and the key really is -- there's a

very practical key, and that is that the Agency

permits that in some cases where that user is him or

herself regulated. So doctors and pharmacists and

others who operate under a licensing scheme have

certain latitude that the FDA allows them because

they're under a different regulatory scheme, but only

to a point.

And the classic example is pharmacy

compounding, where pharmacists were getting a little

overzealous and in effect turning into manufacturers

and making their own products. And FDA said, well,

we don't care that you're a licensed pharmacist. You

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look more like a manufacturer because you're doing it

on a large scale, you're doing it in advance of the

patient need, simply to have on hand, you're doing

all the things that normally are associated with

manufacturing. So in that instance, they said, look,

you are a manufacturer even though the shingle on the

wall says pharmacy.

MR. MURRAY: Yeah. I tried to point out

before that there's a continuum question to go on

here. The first one is the legal definition of

device. Then there's other questions that come along

like, well, what's the risk to public health? What

kind of actions are you taking? I mean, there's a

lot of other details that get filled in to help the

FDA decide how they're going to actively regulate

that product.

There's a lot of products on the market

that meet the definition of a device that the FDA

doesn't actively regulate, and they haven't made a

formal decision to put that in writing. And one of

my favorite ones is like when somebody said, well, is

an ambulance a medical device? And you can say that

legally meets the definition of device, but we're not

going to be pulling vehicles into White Oak here and

checking under the hood and seeing if they're

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substantially equivalent to some Mack truck or

something.

MR. THOMPSON: That's exactly right. In

some cases FDA has actually gone and classified and

either exempted formally or come up with an approach,

but a lot of it unfortunately is uncodified. It's

just, I'm afraid, law or handed down within the

Agency.

UNIDENTIFIED SPEAKER: Precedent.

MR. THOMPSON: Precedent. Thank you.

MR. MURRAY: I discovered in the 513(g)

process, which is a process we can regulate or the

FDA and ask questions about the classification or the

device status of your product, and we had gone

through and written a couple of these letters to

people and said, well, your products are a device,

but currently we haven't established a policy on

this. So in the meantime we suggest that you

register a list, follow the party system, but you

don't need to make a submission until we call for

one.

So we sent out a bunch of these letters,

and then one day I got a phone call from a company,

and they said, well, we tried to register our list,

but they won't let us because we don't have a pro

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code. And this is the only company out of all the

companies who got this letter -- these one people

tried to do the right thing and they couldn't

register a list. So I said, well, why can't we get

them a pro code? And the answer that came back was,

well, we can't get them a pro code, that we're

exercising and enforcing discretion, unless you make

a formal decision that we're exercising and enforcing

discretion and give them a pro code. So there's a

lot of issues related to this. There's no simple

answer that exists for all of these kind of things.

MR. THOMPSON: Maybe to take on a specific

area, I'm trying to think of a good wellness example

where we can draw or see the fine line between

regulated and not regulated as well. And, you know,

there are a lot of exercise equipment that might be

out there and the exercise equipment, whether it's

the actual bicycle or treadmill or a sensor,

whatever, might be for general physical conditioning

of the kind that an athlete or anybody else who wants

to be in good shape might use. So it's limited to

that.

You might have some of those same articles

where the claims go a step further and say this is

really good for cardiac rehab patients. Just, again,

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maybe it's the treadmill, maybe it has a couple extra

doodads that allow for better monitoring of the heart

rate or something on it, but it's fundamentally still

a treadmill. Where's the line in those sorts of

cases between a regulated article and a non-regulated

article?

MR. MURRAY: I'm just the software guy. So

what I do in a case like that is we have these

meetings and we get together with actual

practitioners that work at the FDA, medical doctors,

and we ask them that question about what their

opinion would be about is that a clinical

application, public health application, and things

like that. So they give us feedback on that.

MR. THOMPSON: Because there are similar

lines that need to be drawn between, for example,

those of us who just need to lose a few pounds and

where obesity is actually a medical condition. So a

claim that relates to obesity could in some cases

amount to a medical claim. Is that your

understanding?

MR. MURRAY: Well, my advice there -- I'm

not a doctor but I play one at the FDA -- would be if

you call over to ODE and find out what branch would

cover such a product and talk to the branch chief

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about that because that branch chief has been looking

at 510(k)'s in that area for a long time, and he or

she will immediately be able to say, I've never seen

one those, or I've seen a hundred of those. And once

they say, I've seen 12 of those, you'll know your

answer. That would be your definitive answer. If

they say, well, I've never seen one, then you can

have a conversation about that.

But between what becomes like the novice

like myself, like that's really part of a treatment

diagnosis or cure of disease. That would be just my

opinion. But there's a whole clinical aspect of that

that we cover. My personal opinion and my personal

recommendation would be that exercise equipment,

unless it has some specific thing that's going to

make your left ventricle stronger, would probably be

in a generic category. It would not be a medical

device. But that's just my opinion.

DR. GOLDMAN: John, can you guys wrap up in

about five minutes?

MR. THOMPSON: Okay, any time.

MR. MURRAY: Whenever they cut me off, I'll

be done.

DR. WEININGER: They're not really pulse

oximeters because they're not medical devices.

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MR. MURRAY: Microphone, please.

DR. WEININGER: There are what are called

health fitness devices. I think that's what we call

them. And they used to be called pulse oximeters.

So if you go climb a mountain and you want to know

whether you need to take supplemental oxygen, you're

not using a medical device per se.

You know, if you're flying in your airplane

at 10,000 feet and the oxygen's really thin and you

want to see if you're desaturating, you're not using

a pulse oximeter. Technically, you're using some

other gadget which tells you the same information.

DR. SAMARAS: Well, my understanding is

that Nonin, who makes medical pulse oximeters, also

makes a pulse oximeter, a little clip-on-the-finger

cheapie deal that is not regulated as a medical

device. And that is one example of that line that

you were trying draw.

MR. MURRAY: Well, there's a difference

between the term it's not a regulated as a device or

it's not actively regulated as a device. A lot of

these questions have never actually been addressed

because people have chosen not to address them.

MR. THOMPSON: And, frankly, some of those

articles are medical devices and they're Class I

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exempt from nearly every requirement. So

functionally, you don't have to worry about FDA

because it's exempt from pretty much everything. But

if it ever hurt somebody, it would be considered an

adulterated medical device, and the recall

authorities and so forth that FDA has would come into

play. But the fact of the matter is there's a lot of

this low-grade stuff that is right there in the

classification regulations, but it's exempt. So

manufacturers don't --

DR. SAMARAS: Yeah, but pulse oxes are

Class II.

DR. WEININGER: Microphone.

MR. THOMPSON: I agree with that.

UNIDENTIFIED SPEAKER: I can actually

address that. I know about that product. Nonin has

two models. Internally they're identical. They're

labeled differently, different instructions for use

and different intended use. One's a medical device,

one is not, and they've got the letter from the FDA

saying that the one that's not is not.

MR. MURRAY: There was just a guidance

document published about amplified sound devices,

which was very illuminating. It took a lot of things

that people used to be considering that could be

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classified as hearing aids, and it just simply set

those aside. And that's the kind of activity that

would be required to set these kind of things aside.

But the real truth is that there is not enough

resources on the planet. The Food and Drug Law is so

broad, it could be applied in everything, and I think

that's by design.

So by design, the FDA has the authority,

when necessary, to address public health issues

related to devices, related to drugs, related to

biologics, related to vet medicine, related to foods.

And we are only, in my opinion, kind of operating in

one small sector of a thin diagram, so to speak.

UNIDENTIFIED SPEAKER: So if we stay in

this first model -- come back to the first model for

a moment -- about the iPhone. The picture's not up

there, but back to the iPhone. So I have an

application that I've -- a clinician and I put

together a service that I believe can be properly

delivered on the iPhone, and I'm willing to accept

that it's a medical device.

What are the expectations at the FDA for me

to assure that I'm manufacturing, supporting it in

control? I can't control the iPhone's push from

Apple with updates to their firmware, and I can't

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control the user's updates of music and other apps.

What boundaries would you expect? Would I have to

lock out any other applications on that iPhone? What

would you expect in this emerging consumer hybrid

area?

MR. MURRAY: The X-ray patients on that

have those orders in your risk analysis. And if you

take a look at the off-the-shelf software guidance

document, I actually think that document's pretty

well applicable to off-the-shelf hardware too. So

the question in my mind from our viewpoint would be,

well, what's the worse thing that can happen here?

Let's take an example. Let's take a laser

or a surgery device which is running on Windows and

think about how you would like to be getting laser

eye surgery when the blue screen of death occurred.

That would be problematic. So you're going to be

needing some way to address that risk. So you need

to look at the risk related to using this iPhone and

demonstrate that you've addressed those risks

appropriately.

There could be some cases, as talked about

in the off-the-shelf software guidance, where it may

not be applicable for you to use that technology or

choose that as a component. But for the most part, a

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lot of these are lower risk or moderate risk kind of

products that don't have huge issues.

DR. GOLDMAN: Okay, I think that's a wrap.

(Applause.)

DR. GOLDMAN: Sandy is going to introduce

Terrie, and Terrie's going to speak.

DR. WEININGER: Well, as best I can.

Terrie's going to come up. Terrie Reed is going to

talk about UDI and its implications and where it

stands. And if I could tell you what Terrie's

position was today, I actually would, but she's

changing and acquiring new responsibilities. So I'm

going to let her introduce herself and give you two

or three words about herself.

MS. REED: Well, that's because my job

keeps changing, literally, and I'm just being

flexible. So that's the way we work at FDA. But

what I am going towards, my focus, my vision for my

job and my boss' vision is to take this UDI work.

I've also worked -- and I'll talk a little bit, if I

have enough time, on some control terminology. I

worked with Sandy, actually, on it.

And so there are a lot of standards. HL7 I

work with. But it's about -- it's not about

standards associated with a medical device or is it a

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medical device or not. It's about how's the data get

into FDA and how do we use it and how we do tell

manufacturers to submit date electronically? So it's

a little bit of a different spin, but it all

intersects in all of this world.

I have this slide to remind me. As the UDI

project goes along, it is very complicated, and I

start to get headaches by the end of the day, you

know, what is this all about? What are we doing?

And this is a quote from someone who was writing in a

journal about hospital information, and they say, in

attempting to arrive at the truth, I've applied every

-- information.

But in scarcely an instance have I been

able to obtain hospital records fit for any purpose

of comparison. If they could be obtained, they would

show how money was being spent, what amount of -- was

really being done, and the improved statistics would

tell us more of the relative value of particular

operations and modes of treatment and the truth

ascertained would improve the treatment and

management of the sick. So if you can guess who said

this -- whoops. Notes on hospitals, 1859. That's

only 151 years ago, but hopefully we'll get UDI out

before that.

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So I'm going to give you an update on UDI

very quickly. I'll talk about the authority, where

we have the authority to establish the project,

establishment of UDI, database issues, implementation

issues, and like I said, if we have time, we'll do

the event problem. I assume someone's going to tell

me if I run out of time.

If you haven't seen it, this is in the FDA

Amendments Act of 2007. I've highlighted in blue

specifically where it says that the UDI system

requiring the labeling of a device to have a unique

identifier and that identifier shall adequately

identify the device through distribution and use. So

that was in 2007.

And the healthcare reform bill that we're

all aware of has a section that specifically says

electronic exchange and use in certified electronic

health records of a unique device identifier for each

covered device. And that refers back to that FDAA

Act. And it also says that we will issue a proposed

regulation to implement that six months after the

date of the enactment of the healthcare reform bill.

So when someone asks, are we working on a

proposed reg? yes, we are. We've read, you know,

that this could happen and we meet weekly, biweekly,

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e-mails back and forth. So as you know, it's a very

complicated area, lots of issues, and defining how to

sign that UDI is very complicated. So all of you

know this. You know, there's no one standard way to

identify a device. The only thing that you may not

know, because you're not -- I assume a lot of you

aren't in the supply chain -- is that there are so

many different numbers. It's not that we don't have

one standard number, there's just a ton of numbers

for a particular device. I have a table on one

presentation where there's like 32 numbers that could

identify one particular catheter by one particular

manufacturer. So we are trying to get that and

simplify that down to just one.

So the goal of our project is to develop a

whole system, a device identification system that's

unambiguous and standardized, unique at all levels of

packaging. A very important point is that it's

harmonized internationally. If you're familiar with

the National Drug Code, that is a national standard

and this project has always been focused globally.

We have a globally unique ID because we are a global

world, right? And we are to facilitate that storage,

exchange and integration of data.

So we have four steps. It sounds very

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simple. We're going to develop the standard system

to sign that unique ID, place the UDI in a human-

readable or auto-ID on a device, create and maintain

a UDI database, which at this point we're thinking is

going to be external to FDA but managed by FDA, and

global, like I said. And that database will contain

that number, that UDI number, but also associated

attributes. And those attributes are being developed

right now, meeting this afternoon and tomorrow, and

they're being coordinated by working with HL7, if

you're aware of the SPL message, you know, working

with Global Harmonization Task Force. They have a

draft work group, so we're trying.

And now I said 11073, to be aware of that

and how does that relate. So it's good that I went

to the HL7 meeting last week to learn more about

that. So the more dialogue we have, the more I find

other connections.

And then promoting adoption. And I put

this slide in, and don't hold me to the exact data

elements because I put a draft example up there very

large because we are doing all of this collaboration

and coordination with the standards groups. But I

wanted to show you that, you know, this is a

dexterous, finger-mounted locking forceps. So that's

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the label we're talking about, and the bar code on

there is the UDI that we're talking about. And the

illustration on this is that we see the connection

between having that information on that label and

having it in discreet fields that can then be

submitted to this UDI database. So things like is it

controlled by expiration date, you know, who's the

labeler, brand name, those are kinds of attributes,

although, like I said, those aren't the final

attributes.

These are the GHTF draft attributes, and I

believe I put the website. You can do a search on

Google and get hyphen GHTFUDI, and you'll get the

draft document that lists these attributes. So these

are the ones that GHTF are putting forward. They're

requesting comments by March 15th, I think. So you

can take a look at those. Here are some other ones.

Yes, I put it at the bottom of it because it's very

long. So see that GHTF draft discussion paper.

So once all of this is done, the database

is developed, but the reg is done and the

manufacturers know what to submit, then we see the

unique device identifier as a foundational element,

we hope, and we see that it will provide the

foundation for more efficient device recalls, improve

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post-market surveillance, better adverse event

reporting, and all of these things. But only if you

get it captured, stored, integrated and exchanged by

all stakeholders. So that's our biggest issue.

So adoption and implementation, you know,

hospital uptake and use of this, and we're hoping, by

being in the healthcare reform bill or by integrating

it with reimbursement with CMS or in some other way,

that this will allow UDI to be in the electronic

medical records. And we recognize, by these material

management systems, we want to integrate the UDI with

adverse event reporting.

Like I said, you know, we'll explore a

relationship with that UDI code device. So I've had

some discussions with people around that, the 11073.

And you know, making that UDID, the unique device

identifier database, useful and able to be submitted

and also downloaded from. So that is the UDI.

(Applause.)

DR. GOLDMAN: Questions for Terrie? Talk

to the microphone, please.

MR. RAJAGOPALAN: Can you hear me? I work

for PriceWaterhouseCoopers. I have just two

questions for you. One is about if UDI is going to

mandated for as a critical element in the electronic

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health record program, has there been any solution

thought of in terms of devices where you actually

don't have a place to put the UDI marking?

MS. REED: On the label.

MR. RAJAGOPALAN: Yeah. And secondly, the

clarification is extremely important, that a UDI

doesn't substitute a product label. These are two

different things. The actual product label is more

critical, right?

MS. REED: Right.

MR. RAJAGOPALAN: So any solution in terms

of for those devices, you really don't have a place

to put the UDI mark.

MS. REED: There will be provisions in the

reg for exceptions or, you know, a claim for

exception or direct part marking, but I had

discussions about all of those things.

MR. RAJAGOPALAN: And the follow-on

question is, is it expected that the UDI mark has to

be there for the life of a device?

MS. REED: I can't answer that right now.

MR. RAJAGOPALAN: Okay, thank you.

MS. REED: Sorry.

UNIDENTIFIED SPEAKER: I visited the

workshop last year on UDI that was held, and there

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seemed to be a focus on devices other than electronic

medical devices, and it was more examples that you

provided here. And specifically, on the software

version of an electronic medical device, which is

important, I think, for some safety and quality, is

there any work on that or suggestions?

MS. REED: Actually some of the things that

we're doing to try and work through these issues is

-- and I didn't mention, but we're having pilots and

discussions with manufacturers. One of the

discussions, we're arranging a phone call -- I don't

think the date and time has been set up -- on

software. So if you're interested in that and you

want to be on that call, let me know. I have cards.

I brought my cards.

UNIDENTIFIED SPEAKER: I have a question.

The DoD has done some of the supply chain work and

they support multiple protocols, the way I

understand. What FDA decides, is that going to be

compatible or is there are going to be any way to

translate back and forth?

MS. REED: Are you saying about HVICC and

GS1? Is that the point you're referring to?

UNIDENTIFIED SPEAKER: Yeah, DoD also

supports other headers as well, the way I understand,

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some financial information. But there are like

definitely more than two types of numbers they

support. So I'm just curious whether --

MS. REED: We are not going to identify a

single UDI type code.

UNIDENTIFIED SPEAKER: I see. Thank you.

DR. BLOCK: Frank Block from VCU. I have

what I think is an ignorant question, but I keep

getting conflicting information. Is the intent of

the UDI to label a type of device, or is it really

intended to serve as a serial number for each

individual device of that type? And some people have

suggested that yes, that means a box of band-aids,

every band-aid would have to have its own distinct

number.

MS. REED: That gets into -- we are having

these discussions with manufacturers -- levels of

packaging, and you know, where -- through

distribution and use was in the act and we're trying

to define what that means in terms of, no, it won't

be the individual band-aid, but it'll be the box.

You know, where is that label on the device?

UNIDENTIFIED SPEAKER: I wanted to ask you

if you have any thought of the ID going to be purely

electronic, so it can be, let's say, the content that

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was on that sheet, instead of the labeling or on the

label and also on that sheet, which might facilitate,

actually, some of the tracking.

DR. GOLDMAN: Go you mean network readable?

UNIDENTIFIED SPEAKER: It can be many

different things.

MS. REED: It's on the physical label, but

like I said, there can be exceptions and --

UNIDENTIFIED SPEAKER: Okay. And then, is

there something like this for pharma?

MS. REED: The National Drug Code?

UNIDENTIFIED SPEAKER: Yes.

MS. REED: Yeah, that's been established

since 1972.

UNIDENTIFIED SPEAKER: The UDI sounds very

similar in a lot of ways to what's done in cellular

telephony, where each handset has what's called an

IMEI. And I can't remember the terminology there,

but it's a unique identifier for every single cell

phone. Actually, there's a database. You can find

out who that IMEI belongs to. And through the

provider, you could actually find out what phone

number is associated to that device.

Beyond that, that provides you a nice way

to start leveraging functionality into that remote

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device. And a cell phone is a very inexpensive

product nowadays. It's a $10 bill of materials for

the manufacturer, a very inexpensive phone. So it's

not out of the class of what we're considering here

in terms of -- especially in home care medical

devices.

But once you have that network

connectivity, like Dr. Goldman was just asking about,

you could actually query the device, or what is this

device? When was the last time it was maintained?

How are the batteries? What's the expected expiry

date of this device? You can find out a lot of other

things once you have that connectivity and that

unique identifier.

So this is a neat effort. It's been done

in its own way in the cellular telephony industry.

And certainly the IEEE has something that's called

the organizational unique identifier for every

device, and that's a huge set of bits that only a

certain subset of them are specified by the IEEE so

that it can say it's a free scale semiconductor part

or it's somebody else's, Broadcom, something like

that.

And beyond that, the manufacturer has

flexibility in deciding what the remainder of those

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bits will say. Will it say it's the device model, a

specific, you know, class of device? It could be a

bunch of different things that are carried in there.

So there are some efforts that have been done before

in this space, that are very successful and that

could serve as at least a guide or a model for your

efforts. I mean, I think this is an exciting effort.

MS. REED: I'd like to --

UNIDENTIFIED SPEAKER: I just wanted to

point out that we've talked about intended use, and

going back to Terrie's slide and what Congress has

intended, this is to cover all medical devices and

the specific applications within electronic devices.

Network-compatible electronic devices is really a

narrow subset. So I think it's admirable, but we

have to remember there's a huge world out there.

And the only other point I wanted to make

is, in all of the discussions I've heard either from

FDA or from GHTF, the information in the database is

static. It's not dynamic. So that creates a huge

problem with software revision. It's one thing to

have UDI on a software package as it's sold. It's

another thing to keep track of the revisions, and

that's a huge problem, and personally I don't think

it's part of what UDI is capable of tracking.

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MS. REED: But we are going to have the

phone call.

DR. GOLDMAN: I'm going to take the

prerogative for asking the last question. We're just

a few minutes behind, but I want to ask it for

myself, and I want to see what everyone else thinks.

I'm getting the sense that network readability, and

therefore usability of the UDI as part of the network

system, an interoperable system, is not clearly on

the roadmap. I assumed it would be there from day

one. It was in the public comments early on, but I

may be mistaken. So could you clarify that?

MS. REED: Well, it's there, it's there,

but the focus really has been on the supply chain in

that area and --

DR. GOLDMAN: All right. So at this

point --

MS. REED: But we are here.

DR. GOLDMAN: Yeah, right. That's good.

And you're here. So I wonder, if you'd like to take

back not just my opinion, but is there anyone else

here that thinks that it might be important for UDI

or something similar to be network readable? With a

show of hands. So I think there are two or three

people who didn't raise their hands. So maybe we can

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carry that message back --

MS. REED: Sure.

DR. GOLDMAN: -- from this workshop.

MS. REED: Right.

DR. GOLDMAN: Right. So thank you very

much, Terrie.

MS. REED: Okay.

(Applause.)

DR. GOLDMAN: All right, I think it's time

to call up the steering committee and see if they can

steer their way up here. I don't know where, but

somewhere up here. All right. So, right, a couple

-- several different things.

There isn't much time for chatting, but I

think it was important. We've all discussed our

plans to have the steering committee come up here.

We were supposed to be handed a bushel of tomatoes,

and fortunately they forgot to do that. Well, maybe

it had to do with the clean-up issue.

And I wanted to state what we expect our

follow-up plans to be. There's an expectation that

we will receive the development of a report of this

workshop, and so that is an expected planned outcome,

the report. There will be a call for volunteers, for

participants to continue this work. So we expect it

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to be and continue to be an open process and

inclusive, and for those who have the time and energy

to make commitments to do various things, we'll be

asking for that. Please extend invitations to those

who weren't able to attend the workshop. The door is

open for them as well. In order for this to be

successful, it will take the community to get the job

done.

Part of the responsibility and plan for the

steering committee is to develop a plan going forward

and then to share that plan and then to modify that

plan based upon input from a broader community. But

we will take a first stab at the plan, including, as

was discussed in some depth, the notion of a

prototype submission to a regulatory pathway of one

or more devices or systems yet to be determined. But

we are depending upon regulatory expertise, other

expertise, and of course upon the FDA's good graces

to help guide us through that and navigate those

waters.

The presentations, as I mentioned earlier,

just to repeat, the video, the presentation we

believe will be -- continue to be hosted on our

website probably for a year, at least, and we'll post

the URL for that on the same website. Just go to

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mdpnp.org and you'll see the FDA workshop link and

all the information is there. We'll upload more

documents as they become available.

And then, while I have the mike, I'll just

say thank you to everyone who's been here. We're not

about to finish yet, but I'll just say thank you.

They did a lot of hard work, the steering committee.

We got to know each other all too well over too many

hours and too many months. We've actually been

working on this for quite a long time, and it took

quite a bit of commitment to work through the

surprises along the way.

And I want to extend a thank you to the FDA

for hosting the workshop and for providing the

resources and the commitment to get this done. You

know, just having the workshop, as we know, is a very

strong expression of support by the FDA to leverage

interoperability to improve the public health, to

improve patient safety. And that really has to

remain our focus all along the path; otherwise, we'll

get lost on some technology issue or some other

issue, when it really has to be about patient safety

and public health. I also want to thank Glen and

other, you know, unsung heroes back here.

(Applause.)

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DR. GOLDMAN: And again, while I have the

mike, there are two USB sticks that are still here

that belong to -- well, I don't know who. Another

reminder to please clean up after yourselves when you

leave here in about another five minutes, and then

we're going to go downstairs for a group photo. And

that's all I have to say about that. So let me hand

over the mike.

MR. MERKLE: Yeah, I -- for also the last

word. I would like to thank everybody, everyone for

the active and engaged participation. I speak on

behalf of Continua, and I can say Continua is really

being a proud sponsor of that event, and I'm glad

that they made the commitment to also help to follow

up on the issues that we uncovered.

And again, thank you for the organizing

committee, steering committee, for everyone who

remained. Many thanks also go out to the three

ladies on the registration. Don't forget, they made

it possible to get food, get transportation -- so

thank you very much, and it was a long endeavor, and

safe travels.

(Applause.)

DR. GOLDMAN: Well, now that I took your

seat, Horst, I'm going to give you mine.

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MR. MERKLE: That's good.

DR. GOLDMAN: Are there any other comments

that anyone else wants to make? Oh, that's right.

Thank you, Sue. Sue Whitehead has reminded there are

people out there in video land, web land, and thank

you for staying with us, if there is anyone left. Is

there anyone left? Oh, they're still online. They

probably forgot to hang up.

(Laughter.)

DR. GOLDMAN: Are there any more people?

UNIDENTIFIED SPEAKER: There, they just

hung up. They're hanging up now.

DR. SAMARAS: There are a lot people

sleeping out there.

DR. GOLDMAN: Thirty-three people. I'll

try not to insult anyone else. We'll keep it at 33.

Yeah. So there really have been quite a few people

staying online through the web links, and I'm really

impressed at the sophistication now of the

capabilities.

So also I'll say thank you to CIMIT and the

MDPnP program. We're really also quite delighted to

have the opportunity to sponsor what we could. And

thank Continua for funding -- sponsoring the dinner.

That worked out quite well, I think, all in all. So

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the next stop is downstairs, right?

UNIDENTIFIED SPEAKER: Downstairs.

DR. GOLDMAN: Have a safe trip downstairs.

See you there.

(Whereupon, at 11:45 a.m., the meeting was

concluded.)

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C E R T I F I C A T E

This is to certify that the attached proceedings

in the matter of:

WORKSHOP ON MEDICAL DEVICE INTEROPERABILITY: ACHIEVING SAFETY AND EFFECTIVENESS

January 27, 2010

Silver Spring, Maryland

were held as herein appears, and that this is the

original transcription thereof for the files of the

Food and Drug Administration, Center for Devices and

Radiological Health, Medical Devices Advisory

Committee.

____________________________

RONALDO OTERO,

Official Reporter

(410) 974-0947

WORKSHOP ON MEDICAL DEVICE INTEROPERABILITY:...

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