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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
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