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Medical Devices

Medical Device Use in the Home Environment Workshop: Implications for the Safe and Effective Use of Medical Device Technology Migrating Into the Home, May 24, 2010 (Breakout Sessions)


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               GUIDANCE WORKSHOP:

                  INTO THE HOME

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              MONDAY, MAY 24, 2010

      The session came to order at 1:00 p.m.
in room Chesapeake I of the Hilton Washington
DC/Silver Spring, 8727 Colesville Road, Silver
Spring, Maryland. Suzanne Gardner, Ph.D.,

              P R O C E E D I N G S
                                       1:02 p.m.
            DR. GARDNER:  Okay.  So, everybody
put away your BlackBerrys or whatever else
you're doing.  
            And this is the session that we
want to discuss again what's called post 
market, which is really about the devices that
are on the market and how do we as an FDA, and
certainly that means having everybody get
better information about the hazards that are
out there?  And, you know, along with that, we
can have some discussion about how we can
think about minimizing some of those hazards. 
            Right before lunch I talked to
Lisa and one of the things I recommended to
her, if you're not very familiar with our
guidance world    well, let me just ask, how
many of you are sticking around for the
infusion pump work shop?  
            That's great.  That's great. 
Because if you are and you're familiar with
what FDA is doing with infusion pump right
now, you will see the guidance document that
we've put out.  And in that document are
really    what we do is outline our
expectations for industries and for users. 
            So, as we develop this guidance
document that we're here to talk about today,
that's one of the things that we want your
help with in thinking about what we can do for
the guidance document and understanding that
that has a fairly big impact on how folks do
            We have Jeanette back there who's
taking notes, and we're going to take some of
our major points and we'll get to talk about
them when we go back into the big session.
            So, let me also get a sense, how
many are manufacturing folks here?
            Okay.  And what else do we have? 
Marsha, we heard from you, so I don't know how
you'd characterize what you represent.
            MS. NUSGART:  Representing the
manufacturing folks and providers.
            DR. GARDNER:  Okay.
            MR. BECK:  We're a distributor in
home health care and service customers'
            DR. GARDNER:  Okay.
            MS. NUSGART:  What might be
interesting is knowing the different devices
that are represented here in the room.  You
know, that might play a part.
            DR. GARDNER:  Well, let's take a
quick go around.  Why don't you give us your
name and tell us just    you know, we can
spend a few minutes doing that, because I only
have a sense of what our environment is here
and who's represented.  So, let's start here.
            MR. BECK:  Well, my name is Jim
Beck and on behalf of this row here, we're
with Medical Specialties out of Stoughton,
Massachusetts.  We're a national distributor
for home health care focused in on primarily
the infusion market.  But we have how many
different devices?
            MR. MILOSTAN:  We have over 30,000
devices that we currently own and we're
tracking over 100,000 right down to the
patient level, our customers.
            MR. BECK:  So, 130,000 devices
that we track with our fixed asset systems.
            MR. WARD:  We track every event
from how often they get washed to when they
break to what parts we put into them when they
            DR. GARDNER:  First of all, can
everybody hear?  
            If I had designed this session, I
would have us in a circle and not sitting the
way you are all right now.  But please be
aware that you have colleagues here that can't
hear you in the background, because this is
important information.  And maybe we'll get
back to that, but go ahead and tell them what
you just said.
            MR. WARD:  Yes, so we have a
software system that is designed to take a
pump from when it's born in a manufacturing
facility to when it goes to a health care
provider, all the way out to the patient, back
in for service.  So, we track every
preventative maintenance activity, every part
that's being put into it, every type of
breakdown a pump might experience.  And we do
that for over 100,000 devices in the industry. 
It's all real time and it's across the whole
country.  And we track for all the largest
infusion companies like Walgreen's.  We track
every single device they have.
            DR. GARDNER:  Okay.  Thank you. 
What about, Marsha, your row?
            MS. NUSGART:  Marsha Nusgart,
executive director for a number of different
coalitions representing wound care,
respiratory care, enteral nutrition and also
the Alliance of Wound Care Stakeholders.
            MR. VIERLING:  I'm Philip Vierling
of Kalypto Medical, manufacturer of negative
pressure wound therapy.
            MR. KHOROWSHASHI:  Hamid
Khorowshashi with Prospera Negative Pressure
Wound Therapy.
            DR. GARDNER:  Okay.
            MS. McDONALD:  Michele McDonald
with Abbott Nutrition, oral pumps and
nutrition products.
            MR. BURKHOLDER:  I'm Jay
Burkholder.  I'm with DEKA R&D.  We do
engineering, research and development.
            DR. GARDNER:  Okay.  And way over
here?  Really, you're going to stay over
there?  You need to be plugged in.
            MS. ST. ONGE:  Karen St. Onge with
NxStage Medical, hemodialysis.
            DR. GARDNER:  Okay.  Go back and
forth this way.
            MS. RODRIGUEZ:  Dana Rodriguez
with Newport Medical Instruments, ventilators.
            MS. TODD:  I'm Joan Todd, nurse
consultant.  I'm review adverse events with
physical devices.
            MR. SAMEC:  Robert Samec,
CareFusion, home care ventilation.
            MR. POSEY:  Ernest Posey with the
Posey Company.  We make rehab products.
            DR. GARDNER:  I'm sorry.  You make
            MR. POSEY:  Rehab products.
            DR. GARDNER:  Oh, okay.  Good.
            MS. THOMAS:  I'm Debbie Thomas,
West Pharmaceutical Services, primary and
secondary components, medical devices, 
manufacture safety system, reconstitution
systems, mostly class II devices like bio 
adapters and things like that.
            DR. PURPURA:  Joe Purpura, medical
director of medical device safety, Baxter
Healthcare.  I'm also an assistant professor
at Northwestern University Med School and I
teach the patient safety curriculum.
            MS. SKEENS:  Lisa Skeens of Baxter
Healthcare specifically focused on renal
dialysis, both peritoneal dialysis in the
home, as well as hemodialysis.
            MR. MOSKOWITZ:  Aaron Moskowitz
with the Biomedical Research and Education
Foundation.  We're a nonprofit involved with 
patient safety.
            DR. GARDNER:  Okay.  It's your
            MS. NAPOLOTINO:  Jenny Napolotino
for the FDA.  I'm with the CDRH.
            COURT REPORTER:  I'm sorry, I
can't hear.
            MS. LYNDEN GREEN:  I'm Maureen
Lynden Green.  I'm with Fresenius Medical
Care, home dialysis as well, both peritoneal
dialysis as well as the home hemodialysis.
            MS. BIERMAN:  Beth Bierman.  I'm
with Morgan Lewis.  We represent manufacturers
of medical devices.
            DR. GARDNER:  I'm sorry.
            MS. BIERMAN:  We represent
manufacturers of medical devices.
            DR. GARDNER:  Okay.
            MR. YOUNG:  Brian Young, KCI,
manufacturer of negative pressure wound
therapy devices.
            MR. PAPADOPOULOS:  Daniel
            MS. HOFFMAN:  My name's Laurie
            DR. GARDNER:  Okay.  So, I guess
one opening question would be, and we also
when we first started this conversation    let
me just ask those of you that are responsible
for the manufacture and then subsequent
oversight of your devices; and you know the
large percent of it's going into the home, how
do you monitor the safety of these devices as
they move out of the home into the
manufacturing community, or into the home use
            I guess you could tell your story
            MR. WARD:  Oh, sure.  We monitor
the devices because we are connected to
everyone of our customers and they use our
system because it helps them.  Their primary
incentive is that they don't lose devices as
often.  But their secondary benefit is that
they get much more efficient use out of the
devices.  So, they might be able to get 80
percent utilization if they use our system. 
            What we get is the ability to give
them early warning.  There was a device that
needed a software grade immediately this year,
actually last year.  We were able to identify
all of the devices for our customers in a
matter of three hours to the patient level and
mark them for software upgrade.  And they were
able to turn that around in, you know, about
a tenth of the time it would have taken them
if they didn't have our system.
            MS. TODD:  Question.  Is this all
dependent on your consumers registering with
you once they buy your product, or how do you
get that list to have that contact?
            MR. WARD:  You know, it's kind of
taken a life of its own.  We supply a service
that is used quite frequently and we have a
lot of market share, but we added the software
system that we believe is exactly what we're
all talking about.  And so, if they sign up
with us, they get the software system and then
we track their pumps on everything from when
there's a defect in a product, when a
manufacturer makes a change on a certain
capacitor.  We can tell which serial numbers
in the field require the upgrade all the way
to the patient level.
            MS. McDONALD:  Do you then
communicate to the manufacturer if there's any
complaints or adverse events?  Or how does
            MR. WARD:  We do communicate
frequently with the manufacturers and we are
being brought in more and more to do a lot of
the repairs.  But with adverse events, we
right now are leaving that up to the health
care providers to communicate that.
            MS. McDONALD:  To the
            MR. WARD:  Yes.
            MS. McDONALD:  Okay. 
            MS. TODD:  So, you don't feel an
obligation that you should report adverse
events back to the manufacturer that you're
aware of that information and are contracting
with you?
            MR. WARD:  An obligation?  No, I
think we don't even know of all of the adverse
events.  We know when there's a default with
the product or when it breaks and what's wrong
with it, but by the time we get it in our
hands, we're repairing it.
            MS. McDONALD:  Are you 1345 
            MR. WARD:  Yes.
            MS. NUSGART:  Sue, I was going to
say also that that's difficult, depending on
what you're talking about.  All the different
durable medical equipment, prosthetics,
product supplies, the whole DME, you know,
range of things, depending upon what the
actual distribution chain is, and that's what
so different because all of these different
devices have different methods of
distribution.  In some instances you have the
manufacturer that also serves as the supplier
and will ship it, you know, to the patient's
home.  But dependent again whether it's
durable medical equipment, whether it's a
supply, it may go from the manufacturer to a
distributor, primary distributor, secondary
distributor, then perhaps a durable medical
equipment supplier and then to the patient, or
any variation of this.  So, that's what's
always been very difficult to figure out. 
            From the manufacturer's point of
view, you know, there may be two or three
different types of distribution networks
before it actually gets, you know, to the
patient, the caregiver and then you kind of
lose track of those types of things.  That's
where, you know, the UDI is probably going to
very, you know, important down the road.
            DR. GARDNER:  Yes, actually it
will.  Yes?
            MR. SAMEC:  I can touch on our
experience with our CareFusion home care
ventilation.  We have an install base
worldwide of probably 50,000 devices. 
Essentially, in the U.S. the home care use of
ventilation, it's a tracked device, so we do
have very good records of the location at
least to the home care dealer, which would be
the primary distributor.  And the dealer then
obviously maintains its own records of
actually where the device is located at any
given time.
            We track all the maintenance, all
the requests for service, anything that fits
into the complaint reporting system.  And
essentially with that data obviously our first
priority is to take care of the initial
concern or issue, but then all that data is
trended monthly.  We basically have upper and
lower control limits that we look at for
different issues.  Certain things that are
particular just, if you will, known things
that would flag for a safety issue and provide
investigation.  And obviously then follow
through with that is the medical device
reporting or any of the European or Canadian
or Japanese reporting requirements.  So, we
have a comprehensive system to basically enter
the data, track the data, manipulate the data
and try to look for any type of trend
regardless if it's user error or product
            DR. GARDNER:  Yes?
            MS. SKEENS:  One issue we're
having    I think we have a similar     But
one of the things we're struggling, if it's
not just getting all of the initial data, but
meaningful data, and not that you can actually
do a proper investigation and have, you know,
assignment of cause to one particular device. 
And if there's a system of devices, our recent
interaction with OSB has indicated if you
don't have enough information, you really need
to go ahead and report that against all the
devices that 
            DR. GARDNER:  Yes, you do.
            MS. SKEENS:     potentially
implicated.  But then it goes to a lot of
information, but not really meaningful
information.  So, it's not just getting, you
know, enough reports, but they have to have
enough data in them that they actually are
meaningful and can help you understand   
            DR. GARDNER:  Right.  That's
obvious.  I mean, if you're not getting it,
we're not getting it.
            DR. PURPURA:  I want to ask you a
question.  You made a comment that your
feedback from home users produced poor quality
data.  Is that because you don't have
denominator data, or why is that 
            DR. GARDNER:  Well, I mean, it's
not necessarily worse than our other problems. 
Well, it's a little worse, but not necessarily
            First of all, as manufacturers;
and I would like to talk about this more, I'm
assuming that in spite of your systems that
you struggle to get information to you.  And
you struggle.  I know you struggle even in
hospitals, because I know how many of you have
come back and said to us I can't get the
hospital to give me the device, therefore I
can't evaluate it.  Or we get back to you and
you say I can't get back to the user, no one
will talk to me, or they've thrown way the
whatever, and so whatever.  
            So, you take those everyday
problems and then you magnify them, right,
because with home care you've now stepped out
of an environment that has a risk manager, may
have processes and procedures or whatever that
will help get you some of that information. 
            So, to my way of thinking, you
take the normal problems that we or you have
in getting the information that we want and
then you move it to an environment that is
infinitely more difficult to have the
information flow up.  That's my assumption of
how it works.  
            And as I said, we have in HomeNet,
where we have 26 organizations that came in
enthusiastically and had been on the phone
with us and had Webinars and whatever, they're
not reporting to us.  
            DR. PURPURA:  Do you see that the
manufacturers are    when you do get the
reports from home users that they do put in
the reports that you've also received from
manufacturers?  And then the follow up
question is, is the quality the same in terms
of the richness of the data that you're
            DR. GARDNER:  I don't know that I
can tell you that we've done a study, that I
can give you a systematic answer; and maybe
Joan can fill in on this.  I would say we see
great variability.  And sometimes
manufacturers are bad reporters.  Sometimes
they can't get the information and sometimes,
you know, the people reporting to them aren't
very good.  So, we see all that across our
reports.  Joan?
            DR. PURPURA:  I can see
manufacturers making home users better
reporters through efforts that we could
            DR. GARDNER:  Well, that I'd love
to hear.
            DR. PURPURA:  Yes, it just popped
into my head right now, so give me a month and
I'll send you an email.  But I think that's
something that would be useful.  We can teach
them that, you know, we're all in this
together and here are some of the things that
we need to help improve products.
            MS. McDONALD:  Well, and two
things and then I want to follow up on that,
because I agree.  If you know your home user,
they're captive.  I mean, you're more likely
to be able to get to first hand information,
retain the product or the disposable, which a
lot of times is the tricky piece to get.  That
is part of the system evaluation that is
elusive.  But I think what I would wonder is
if FDA has data that suggests that there's a
different experience in the home user than
there is in the institutional user that's
driving, you know, this initiative other than
just the pure migration of the devices.
            DR. GARDNER:  Right.  Right.  And
I think again, and Joan's one of our analysts,
so she can weigh in; this is fine.  Most of my
information comes from MedSun in terms of the
comparison.  And that is where we have been
able to get into the hospitals and we have
been able to get much improved information
that comes from the hospitals and some of our
other sort of networks.  And let me take an
example.  The laboratories, prior to MedSun,
laboratories didn't report to us.  They had no
idea they were supposed to report as a matter
of fact.  So, with MedSun came LabNet and we
got    we actually have quite a few
laboratories into the program and they're
actually reporting adverse events.
            So, we have some successes for a
non reporting group and in HomeNet we have not
yet been able to do that.  So, that's kind of
my information.
            MS. SKEENS:  And it might be
interesting if this    especially for some of
these diseases that have a lot of co 
morbidities and are maybe serious life 
threatening illnesses to have people
understand what is an adverse event related to
a medical device versus what is related to an
underlying disease or what may be perceived to
be, you know, just therapy related.
            DR. GARDNER:  Yes.
            MS. SKEENS:  And I think that's
something where reporters, whether it's
patients or healthcare providers, really may
need additional guidance in trying to
differentiate that.  And I saw that on one of
the slides, but I do think that is interesting
if we could, you know, help people kind of
make that differentiation and know maybe when
to report.
            DR. GARDNER:  Yes.  I mean, and we
tend to, when asked that question, talk in
very regulatory language.  And I think we need
to move out of that and talk about sort of
more concrete things that, you know, is
related to whatever.
            MS. TODD:  We do get volunteer
reports, the consumers, the non mandatory
reports that come into us.  And it's sort of
a different variety, but they tend to report
   one is they sometimes don't know how to
report or the words are just out there enough
to say we want your reports, you know, as a
            But also, when they tend to
report, it's just that a lot of times they put
in missing data or they won't have    they get
the brand name wrong or they'll mis assign the
product to the wrong manufacturer.  And so
it's hard for us sometimes to match up the
report to the manufacturer report when they
submit that in.  But we find the voluntary
report is very rich in the event description
of what happened.  Sometimes not, but more
times it is.  And a lot of times when the
manufacturer does find what matches up,
they'll just send that along, you know, too,
with it.
            And then the other thing was that
a lot of times the consumer doesn't want to
have their identity known to the manufacturer,
and that's sort of what we    our effort.  I
think what we tend to do is try to make that
aware.  Say, you know, go ahead and send it
into the manufacturer because that way they
can do adequate follow up, because there's a
lot of education out there to users to say
report and then, you know, let your identity
be known.
            MS. McDONALD:  What's the basis of
the identity concern?  I guess I would be
curious, so we could learn to give them
whatever    if it's a privacy issue or
something.  But, I mean, in the end they're
missing out on getting either compensation or
at least giving us information that could help
improve the product.
            MS. TODD:  Well, I think on our
part we've always protected the identity of
the individual unless they want to be known. 
Some people feel they may be retaliated upon,
or maybe, you know, they feel like if they've
gotten a product from a manufacturer that
they've used and they have to go back to them,
especially smaller towns, they feel like, oh,
that they upset them or they're not going to
be able to get the thing   
            PARTICIPANT:  The distributor
might be his brother in law.
            MS. TODD:  But there's an whole
list of those of those which   
            DR. PURPURA:  There's an analogy
to that on the pharmaco vigilance side where
providers are very hesitant to report adverse
events because they know they'll get a
blizzard of faxes and, you know, sort of this
never ending   
            MS. McDONALD:  For the
investigation team you mean, the manufacturer? 
Yes, I think that's the problem, I think,
again trying to balance.  You're trying to say
what prevents us?  It's sort of a double edged
sword, you know, and that's one of the things
we used to feel like we were having to pit
ourselves against our customers and threaten
to get stuff saying, well, the FDA    you
know, there's this regulation, you know, and
figure out the best model.  But from the home
user, I think if there's a privacy issue of a
disease state or something, we can work with
that.  We're not subject to comply with HIPAA,
I don't believe, the manufacturers.
            DR. PURPURA:  Yes, if you have 
the information.
            MS. McDONALD:  We are?  Okay. 
Wasn't sure, because I brought this up before
            DR. PURPURA:  Well, we do and we
believe we are, but I guess I'm   
            MS. McDONALD:  You know, it's
funny, I don't disagree with it, but I think
the point is because we've submitted things to
the FDA with details, and then I've raised
that and I've been told that we don't fall
under the scope as a manufacturer of who's
supposed to comply with HIPAA.  And, you know,
if you look at tick and tie, it's like, duh,
you're right.  But in the end, it's kind of
like well the purpose is to protect people's
privacy.  So, it's kind of like, you know   
I mean, we can get picky, too.  
            But the point is, so I was just
curious.  And really if there's something that
you know for certain that we could better
understand, get in the head of the customer,
because, you know, it's frustrating for us,
too, to not understand that they've got an
            MS. TODD:  You know, I think it's
good customer service is that we want to hear
from you.
            MS. McDONALD:  Yes.
            MS. TODD:  We want to, you know,
share what your problems are with the product,
we want to make you happy.  But I think a lot
of times people just are hesitant, as you were
saying, to feel like they're going to be
identified, feeling something may come back to
them that they   
            MS. McDONALD:  Or the hassles
            DR. PURPURA:  Right.  And a lot of
times they don't understand that we are HIPAA 
compliant.  I mean, I've even seen that from
the risk managers at hospital levels.  They
just don't understand, you know the    they
don't understand the purpose of HIPAA. 
            MS. McDONALD:  Yes.
            DR. PURPURA:  Right.  I think that
sometimes people don't understand that, you
know, everyone has to be compliant.  
            MS. McDONALD:  Yes, I guess I get
that actually    I think sometimes people
don't understand that, because I used the
example what if it were, you know, you were
the one sending in the information?  How would
you like to be handled?  But what I think
about the hassle piece, as I've heard, and I'm
one of these people who tries to get more
information and improve the product, but a lot
of times we point back to the FDA.  This is
what we have to do and that just kind of
instigates this, what a hassle.  And people
avoid.  So, I think we got to figure out the
middle ground and, you know, capturing the
information that's so less regulatory, but
more customer service.
            DR. GARDNER:  So, I want to
continue this.  Again, I want to go back to
our MedSun experience because we had the same
push back, you know?  How come you don't
report it to us?  Well, because all our
reports go into a black box and I've got a
billion people to report to, and so I can't
bother reporting to the FDA.  What good is it
for me to do that?  And I'm really worried
about confidentiality because no one really
understands it.  So, then it's much easier not
to do it than to sort of get our way through
            So, we did a pilot to sort to see
whether we could get more reports by
addressing some of these barriers.  And so,
I'm just sharing this little bit of wisdom. 
And I think this is a real challenge for us in
dealing with home care.  How do you get to the
people that you need to hear from and tell
them and let them know that, yes, it is a
regulatory thing, but it's important for
patient safety to have this information.  I
care a whole lot about what happens to you and
what happens to your family and I need to know
this so that we can make a better product. 
Or, you know, bring it down to a level that
people everyday can feel is not regulatory,
but actually, you know, a concern about them. 
And it's hard probably from your level, but
then there's something I'm imaging that you
need to push down into your staff.
            MR. PAPADOPOULOS:  Are you working
at all with any of the home health agencies
that are out there?  Are they part of the home
health agencies?  Are they part of home
reporting or something?
            DR. GARDNER:  Yes.  Yes.  Yes.  
            MR. PAPADOPOULOS:  So, you are
working with them?
            DR. GARDNER:  We are, yes.  And
they don't get the information, so they can't
give it to us, so   
            MR. PAPADOPOULOS:  They're not
getting it from the patient, you're saying?
            DR. GARDNER:  Right.  Right.
            MR. PAPADOPOULOS:  I think that's
our duty.  I think that should be the first
thing that a patient sees when they open a box
of whatever, that here's our mission and this
is our duty and here's how you can help us.
            MS. McDONALD:  Is that labeling
though?  Yes, you know what I'm saying?
            MR. PAPADOPOULOS:  Yes.
            MS. McDONALD:  I mean, this is
where again    I mean, I think we all   
            DR. PURPURA:  Yes, I know.
            MS. McDONALD:  Yes.
            DR. PURPURA:  And it's sort of
regulatory, can get    I don't want to say
common sense, but, you know, it can interfere. 
            MR. YOUNG:  But I just wanted to
say that from our perspective as a
manufacturer, it's kind of like putting
together the pieces of a puzzle.  The data
streams come from a number of sources.  I just
jotted down a few while we were sitting here. 
And I would think it's rare that we get the
whole story from just one source of
information.  So, for us, we have the home
health organization, we have the prescribing
clinician, we have the patient or patient's
relative providing care.  We have our   
            COURT REPORTER:  I'm having
trouble hearing him.
            MR. YOUNG:     organization.
            DR. GARDNER:  Can you speak up for
            MR. YOUNG:  We have our 24/7 call
center, a global clinical account manager, and
we have a medical safety department that also
takes information.  So, we could have up to 10
data streams for one event.  And that's really
not until you put all those together that you
have a complete picture.  And there can be
occasions where just talking to the patient
does not in any sense give a clear people of
what happened.  Sometimes patients are
motivated by financial interests.  Maybe
there's a concern there of payment.  You don't
get to the bottom of that talking to just one
person.  You have to speak with many people to
get the complete picture.
            DR. GARDNER:  Over here?
            MS. RODRIGUEZ:  Yes, I was just
going to say I think one of the things that 
            DR. GARDNER:  Speak up a little.
            MS. RODRIGUEZ:  We deal, like you
were saying, with many different avenues of
getting information, because you've got the
actual patient user information, but they're
frequently with a home care agency.  There's
also usually a service entity that's involved. 
            And the one thing that I've
learned in trying to deal with the complaints
is, you know, you guys are saying help the
patients or help them to tell us to make the
product better.  Quite frankly, I don't think
they really care about making the product
better.  What they want is they want their
problem to go away.  It's like the lady said
this morning, these people are tired, they're
hassled, they've got a bajillion things on
their plate, and the last thing they really
care about is answering our hundred questions
and making our product better.  They actually
assume our products should be good when they
get it and it should have worked the way it
should have.  And they're really quite
frustrated that it didn't meet their needs and
they just want that frustration to go away.
            So, one of the things that we have
sort of learned over the last couple of years
is to utilize those multiple streams of
information to train our people, our clinical
people that are taking that first call at
midnight or 2:00 in the morning and solving
the problem.  We're trying to train those
people to say, okay, look, be aware.  Listen
for the keys and the clues that tell you this
might have been an malfunction, this might
have been a user error.  Try to get as much
information as you can as unobtrusively as you
can while you're solving the problem so that
we can get as many pieces of information so we
can put it together.  And then we work with
our tech support that then had to help the
home care agency to fix the problem.  We try
to put all the pieces together to make it as
seamless for our customers as we can, because
quite frankly, they're irritated that they
have the problem to begin with.  They really
don't want the hundred questions.  
            So, if we can try to gather it
without creating more of a hassle for them,
that makes their life a heck of lot better. 
And it is a real challenge and it takes
training a lot of people in our organization. 
We can't rely just on my two complaint
handlers to do it, because quite frankly, if
my complaint handlers call a customer, they've
got their checklist.  They're going to go down
their hundred questions.  They're going to say
was it this, was it this or this?  And they're
going to end up irritating the person.  
            But if I give it to my clinical
specialist who's a nurse, she's much more
empathetic, she takes time, she's concerned
about how the patient was, a much softer
touch.   And yet, if she's well trained and
knows what to go after, then afterwards I can
interface with her and I can get a lot more
information.  So, it's training a lot of
people internally to help me gather all those
pieces so my guys can put the puzzle together
on the back end.  It's a lot of effort, but
that's the way I think works actually better.
            MS. RODRIGUEZ:  But that's a lot
of effort, like you said, you said puzzle. 
You said a lot of things that are, you know,
defining our environment.  What you just said,
I mean, I totally appreciate.  The customer
wants us to make their problem go away, yet
we're burdening them with our problem of I got
to have all these questions asked.  And I
think this is what the balance has to be and
maybe this is where in looking at FDA guidance
is how do we minimize the intrusion and get
that narrative that is more the stream that's
going to tell you the story and then we figure
it out and not have to worry about you have to
say the magic words so then I can code it
            MS. McDONALD:  Right.  Because
they're not going to say the magic words a lot
of times.
            MS. RODRIGUEZ:  Yes, and that's
the struggle I have in trying to develop
better systems myself.  And especially if
you're in a larger organization, you know,
you've got a script and you're looking for
            MS. McDONALD:  And checklists.
            MS. RODRIGUEZ:  Yes.  But the
narrative is the piece that a lot of people
are not able to manage.  And then when we go
to manage the narrative, we end up like, you
know, losing the data stream that I think
we're all trying to get.
            MS. McDONALD:  Yes.
            DR. GARDNER:  Other comments,
            I'm curious about whether any of
you use Internet types of    for, I don't
know, training, tracking, whatever, but also
if you have thoughts    I mean, it's early
yet, but patient health records are sort of
here and coming big time, and electronic
health records.  And I'm wondering if you have
any thoughts about communicating with your
customers that way or sending information to
them that way, or whatever?
            MS. SKEENS:  Yes, well, we're
already doing that.  In fact, we're doing it
some for adverse events where we're giving the
option being able to fill out the information
electronically through the Web site as opposed
to, you know, spending a lot of time on the
phone.  They can follow up electronically at
their convenience, again in the hopes of
getting more meaningful data, you know, giving
them those options to report online or even
to, you know, do follow up information online
in addition to other things, information
through the Web and Web based training and
things like that.
            MS. RODRIGUEZ:  We have the same
thing.  We have a portal on our Web site that
they can go to and they can enter either
product suggestions for improvement, which
sometimes is linked to, gee, I had this
problem and I wish it would have done this,
and that gives us another trail to go follow. 
So, they can either put product suggestions or
they can put complaints in.  And then we can
screen those to see if they are actual device
            MR. BECK:  Susan?
            DR. GARDNER:  Yes?
            MR. BECK:  We do online customer
input satisfaction servicing, et cetera.  We
also do training vignettes.  So, there's a
secure log on.  Some of our customers have the
ability for a new device launch, as an
example.  We might even have a vignette that
helps the manufacturer put that device out
there for certain customers in a manner that
educates how do to use it.  It sort of
capitalizes and stands upon that the customer
capability to outreach to a number of
different users.
            DR. GARDNER:  Very interesting.
            MS. MILOSTAN:  And I can tell you
that in using our systems we also still have,
because we've been doing this for 25 years,
where the customers will call in and state
that they've had a problem with a device that
they're renting, that they're owning that
we're going to service.  And when they called
in that information, we've gotten a certain
bit of specificity, but people have actually
engaged and use our system that have that same
access, but they're allowed to do it on the
Internet at their off hours, at their break
time or maybe at home.  We're getting much
more detailed information.  So, when those
devices arrive back in my door, I know a lot
more about what happened to that device and
what I'm going to be seeing then when it gets
there, rather than somebody calling me and
saying the pump is broken.
            MR. WARD:  The other thing about
that is it's a permanent note on that device
down to the serial number level and it's
attached to the repair ticket.  So, you'll see
what the true outcome was from what either a
patient complaint or the health care
provider's complaint was, and it never goes
away.  And then all of the parts and the true
outcome is attached to the original complaint
that was given by the patient or health care
            DR. GARDNER:  Very interesting.
            MR. YOUNG:  Yes, you raised a good
point with respect to new products, the 
requirements, at least in Europe for post 
market surveillance.  When we launch something
new, we're very proactive about collecting
data from use of the product.  And so, in the
first six months we might be reaching out to
all the customers that got that product.  We
collect a lot of information and that's very
useful to establish an early baseline in terms
of issues that are occurring.  Then we make
corrections of course and at some stage in the
life cycle of the product, it turns into more
of a monitoring event that we're trying to
discuss in that way.
            DR. GARDNER:  That's really
interesting.  You took the idea of doing the
training and the everything that you could get
back to each time.  You don't have to keep   
where's that piece of paper that I had, you
know, these instructions in French on
whatever, right?  I can just get on    it's
like going to YouTube, right?  And here's the
instructions again.
            MR. WARD:  One of the big things
we're doing now as well is we're starting to
look at the data logs that come in from the
devices, you know, so much great information. 
That's why was thinking about your situation.
            MS. SKEENS:  Yes, we do that too
actually, is to look at data logs and analyze
those for trending and complaints.
            MR. WARD:  Since we do patient
level tracking, the data log is associated by
date to every patient.  So, when you go back,
you can get a great retrospective look at the
conversation you had and the interview you had
and then apply by day the real story once you
get the device back.
            MS. SKEENS:  Right.  Right. 
            MS. McDONALD:  And that
compensates for where you have little or no
information?  It's a broken type of thing and
then you can sort of reconstruct possibly what
the malfunction was and   
            MR. WARD:  Exactly.
            MS. McDONALD:  Okay.
            MR. WARD:  And the other thing is
it helps you learn how to ask better questions
over time.
            DR. GARDNER:  Good point. 
Anything else?
            MR. SAMEC:  I'd just add on that
we've had data logs for about the last eight
to ten years and they can be tremendously
valuable as a piece of information.  You'd
never want to use it independently, but it can
trigger questions and essentially get the
person who's reporting the event to get more
involved because we can, you know, politely
and professionally challenge what the report
is by saying, you know, review of the data log
indicates this is what may have occurred and
that may trigger another thought to say, well,
you know, you're right, on second thought. 
And we'll have the ability to reevaluate the
event again.
            DR. GARDNER:  Any other examples
or comments?  
            We're moving toward new
availability of information.  Someone
mentioned UDI and I will tell you UDI is
coming; not fast enough for us, but we are
working on it.  It's extremely complicated, as
you might imagine, but it's a key component I
think for all of us of really how we
understand what's going on with the products
once they're out of your manufacturing plant
and sort of how we recognize them and how
people track and keep information on them.  
            Electronic health records and
patient health records again is going to be
sort of another new world, I think, in our
ability to understand and keep track of
            Phil, you were telling me an
interesting story before we started, and do
you mind sharing that, because it's sort of   
            MR. VIERLING:  I actually
introduced myself as a medical device
manufacturer.  As a consumer I also have 
experienced the complexity of this issue
having a 23 week old premature grandson born
who came home to live with us with all the
equipment; the ventilator, the oxygen, the
respirator, the GI tube.  We had two
incidences where he coded in the house.  
            And looking at it as a device
manufacturer, the equipment performed to
specification.  The DME company had a
respiratory therapist who trained us.  Should
we have a power failure, here's how to use the
Ambu Bag to resuscitate your child.  But it
wasn't power failure in the middle of winter
in Minnesota.  It was a nursing error.  And we
were able to resuscitate him.
            But as I thought about this from
us that sell equipment now to a DME company,
I thought the FDA's asking the right question
this morning of saying there are
specifications that we need to be building our
device to make it    use the KISS principle or
sixth grade/eight grade, all those types of
standards for safety.  They acknowledge the
complexity between we sell it to the device or
the DME company, they're training the
consumer, they're also training the home
health agency on the use of the device.  
            And the question that I'm still
wrestling with is how do we try to, since it's
a class II device and we're the manufacturer,
ensure competency and compliance down that
distribution channel once we sell the device? 
And I'm all for the UDI labels, but you know,
we lose that tracking unless we ask our
distribution channels now to make sure that
they're follow up systems are as robust as
yours, that they're able to track everything
back to us.
            And I don't have an answer to the
gentleman in the middle of the table; give me
a month to think about it and maybe I'll come
back, but I don't know if that's more
different types of training manuals.  I don't
know if we try to tie our distribution into
ensuring that our DME channels have to be some
sort of    you know, follow the Medicare
certification, that they need to be Medicare 
certified, knowing that that's a little
different than the home health agencies who
may be under a different certification, but
how do we    also you could have competing
regulatory bodies here.  And we're ultimately
responsible to the FDA trying to ensure that
and say I don't know how you're going to get
that complexity.  But as a grandfather, I get
it.  You see a blue child and you say, okay,
I get it.  
            DR. GARDNER:  The baby's fine, by
the way.
            MR. VIERLING:  Yes, the baby's
            DR. GARDNER:  He has pictures.
            DR. PURPURA:  Must have had a good
CPR.  But to go back to the root issue there,
I mean, the nurse error, I suppose it was a
use error of some type and maybe that's, you
know, our duty is to go    and I know that
this isn't the human factors breakout, but you
know, why did that happen?  Why was the safe
thing not the simplest thing for that nurse to
            MR. VIERLING:  Well, it's even
more frustrating.  This example, it was a
training night.  The nurse who was training
the trainer and the trainer froze.  It was a
19 year old daughter that came in and saw it
and says I'm taking over, and was told by a
doctor that you do have the right to make that
medical call, right?  So, I don't think you'll
ever be able to regulate user error.  You
know, that's the problem we have to realize
with the device.
            DR. PURPURA:  Is the agency going
to go to use error as opposed to user error in
accord with some of the other standards?
            DR. GARDNER:  Yes, I think
            DR. BRADY:  I think that's the
plan, yes.  And I know that's global
harmonization as well.
            DR. GARDNER:  So, any more
comments about this problem?  I mean, you make
your product, you may do a lot of human factor
testing, you may do a lot of everything you're
supposed to do, but then it's this
distribution chain.  And how do you get that
information, that oversight, that tracking,
whatever, down to the place where you want it
to be?  Or is that the key question?
            MR. VIERLING:  It's a good
dialogue.  I would say the one side of this
says what we should do as industry is have a
different type of IFU, whether it's for the
patient, whether it's for the clinician, if we
know there's going to be a clinician, and
whether it's going to be our durable medical
or our distribution channel.  One side says
that would be helpful.  You know, it's the
right thing to do.  
            The fear that brings it up is how
would the agency then come back and say,
Philip, how are you going to ensure compliance
on all three of those entities?  Because just
listening to these people, you have 130,000
devices from how many different endpoints that
go into that and it's exponentially a real
tough matrix.  And that's where I don't have
an answer for you.  One part would be easy to
do, might be the right thing, but the
enforcement of it, I'm not sure yet.
            DR. GARDNER:  Other thoughts? 
Some heads nodding.
            MS. SKEENS:  I do think there's a
parallels with risk management on the drug
side and just really again making sure that
manufacturers have done everything they can in
providing, you know, not just something that,
you know, one training manual, etcetera, but
really doing everything they can to, one,
having an intuitive design as risk management,
but then through our materials and even our
training materials that we provide the
trainer, just making it as easy as possible
and as clear as possible so that there's less
risk involved.  It's all about risk
minimization and really trying to reduce that
as much as possible.
            MS. McDONALD:  Is there any
assumption here that some devices can't go
into the home care environment?  I mean, this
is where the assumption here is everything is
migrating to home care, but maybe the data, if
we get enough of it, would say clearly    and
whether it's FDA and the manufacturer, but at
some point maybe some tough decisions are
going to have to be made that these types of
devices just absolutely can't go into home
care and you have to label them for those
restrictions.  Because right now it seems like
   so, but that's why I think we need that
feedback also in the guidance that something
that might be a trigger, whether, you know,
from a risk management perspective or even up
front that just says there's got to be some
sort of limit to protect both the home user
and the manufacturer from an assumption that
everything is capable of going in the home for
home care use.
            DR. GARDNER:  Right.  Mary, do you
want to comment on that as our home care
expert, because this is the question about   
a good question, I mean, should everything go
into the home?  And, I mean, FDA's answer to
that would be no, by the way.  Everything
shouldn't go into the home unless it's
indicated and there's proper labeling and
proper indications.  But do you have anything
else you want to say?
            DR. BRADY:  No, I do believe that
everything eventually will end up in the home
in some way or another, if not temporarily,
then I believe permanently.  If you're looking
at X rays, things in the home, you're going to
be looking at CAT scans and MRIs probably very
soon, little affordable machines going into
home.  Who would have thought that a
hyperbaric chamber would go into the home? 
So, I think we have to operate under the
assumption that everything will find a way
into the home.  If it's even approved or
cleared for home use, that it could migrate
into the home and we need to be aggressive in
that.  And not probably in the guidance, but
that would be in the regulatory guidance and
we could provide some possible limitations
saying, we know that this poses a danger here
and we are now going to tell you that you
either have to label this for home use and go
through the guidance process, or specifically
state that this is not for home use.
            MS. McDONALD:  So, really if a
manufacturer wants to    if there's a
foreseeable risk that they know will be in the
home care and they want to make it clear it's
up to them, it's incumbent on them to put that
in their labeling?
            DR. BRADY:  Yes.
            MS. McDONALD:  And that way then,
it's really if you're going to make any change
right now and you know your devices aren't
suitable for home, you should at least make
that labeling change, given like what you're
saying, the migration is just    it's
inevitable is what you're saying.
            DR. BRADY:  It is, yes.
            DR. GARDNER:  Okay.  So, let me
get back to    I mean, our overall question
was how can we get better information, and
we've sort of explored that through a number
of different channels.  But before I    are
there any other thoughts about that?  I mean,
you all have given us some of the ideas that
you have, but I don't want to    this is sort
of the core post market question.  Do you have
any other ideas, other suggestions?  How can
we help you get better information would be
really good.  
            MR. WARD:  I mean, in the future
we foresee talking to the data logs of all
these pieces of equipment and then putting an
exception report together that would analyze
which patients are compliant, which ones need
help, which ones are not educated and hitting
the wrong buttons, and having that in real
time.  And that's really where we're going
anyway with it.  And it's totally connecting
the data log and understanding what the
prescription is.
            DR. GARDNER:  And again, sort of
another challenge that    yes, this device can
go in the home.  It's labeled to go into the
homes, whatever.  There are certain homes
probably that never should have whatever
they're unfortunately going to equipped with
because, you know, that's just sort of the
sorry state of whatever that situation is.
            MS. SKEENS:  But it's interesting
who makes that risk/benefit decision around
having access to care.  I mean, for someone to
deny access to care at home, especially if
they don't have funding to have it in the
hospital, I mean, it's just a very interesting
question around who makes that decision around
denying access to care versus   
            MR. WARD:  You know, we could be
more objective if you do it like Jim is
saying; that is, having for the more critical
pieces of equipment that are a little more
difficult or complex, having a training
program that does give you a score, that does
show competency, instead of just a sheet of
paper that has good instruction on it.  But
you actually are to a degree certifying people
in the home to use the equipment.  Then you're
covering yourself and you're doing the right
thing and you're forcing people to take the
time to be able to score out on a competency.
            MS. McDONALD:  Well, you should be
able to just take a score already with the
clinical user, the highly trained person to
see how well they're doing to determine what's
your coefficient for likelihood of success in
the home market.  I mean, you know, this is
one other thing.  That's what I'm saying.  Is
there maybe already data that suggests certain
either environments or devices aren't suitable
for home use.  And I think we ought to, you
know, almost segregate those and then focus on
those that are more likely to, you know, have
success.  Because then from there we'd glean
probably a good set of principles that seem to
make these devices more useable and then apply
it to those other high risks.  It seems like
we're kind of    we're all in right now.
            MR. WARD:  Well, what if someone
scores out well on a competency and you're
saying it's not a device that should be used,
but yet obviously there's people in that home
that can use that device well?
            MS. McDONALD:  Well, I'm just
saying in general for devices versus the
devices that are    because it is.  We get
very discreet down the line.  The distributor
might be a great distributor and training
people, but then again it's always at that   
you know, it's almost like you want to create
an FMEA for the home use and get to that score
of likelihood of no adverse    or, you know,
of hazards.
            MR. MOSKOWITZ:  What if the FDA
found devices that cause problems at home at
a higher rate and made registration required? 
And it's still good for the home, but the user
is in contact with the manufacturer or the
            DR. GARDNER:  So, you're saying
before a product moves into the home, they
would have to have some    
            MR. MOSKOWITZ:  Maybe not all of
it, but   
            DR. GARDNER:  I mean, it would end
up actually being a registry that we control?
            PARTICIPANT:  What does that get
            DR. GARDNER:  I mean, that's all
right.  That's a suggestion.
            MR. MOSKOWITZ:  Well, or the
manufacturer.  I mean, they do    we have
requirements for other devices the
manufacturer has to keep track of, so maybe
some just need greater oversight.  I'm not
            DR. GARDNER:  Okay.  Anything
            DR. PURPURA:  Do you segregate
data.  When you're trending stuff, do you
segregate home use, clinical use?  And how
transparent is that and how can people get it?
            MS. TODD:  Yes, we certainly look
at those factors when we look at them, because
we'll do an aggregate across all device types
and then we'll look and say is this happening
in the home, is this happening in a user
facility, hospital, or, you know, which
particular one?  
            DR. PURPURA:  Yes.
            MS. TODD:  So, that certainly is a
factor, yes.
            DR. GARDNER:  I mean, and
typically when we're doing these things, I
mean, most of you know this, we get back to
you, to the manufacturer.  You guys know this
better than we do.  Hopefully you have better
information somewhere than we do.  Sometimes
you can't have them, but, you know, we do.
            DR. PURPURA:  But in terms of
looking at the overall migration into the
home, you know, just looking at general trends
that might be useful in terms of the design
devices down the road.
            DR. GARDNER:  I don't think    I
mean, our information is not necessarily
better than   
            MS. TODD:  It's limited whatever's
been checked, like they check the box that it
was home use or the manufacturer tells us
that, you know, it was used at home, because
we're just depending on what you tell us
because we're, you know, not actively going
after each of the event reporters.
            DR. GARDNER:  And there's a class
of products here that we tend to    we, FDA,
now thanks to the vendor/home use umbrella
that I think people classically don't.  And
that happens to be for example with implants. 
That was part of what Don Witters was trying
to point out.  And even our center director,
we have this conversation as well, you know, 
really talking about, you know, hips or
cardiac, you know, pacers or whatever.  Well,
at some point you do have to talk about those
things because the home environment is the
different environment and you still have to
worry about the electronic magnetic
interference and, you know, the dog eating,
whatever else is going to happen.  So, the
home use question is much broader I think than
we tend think of the home care nurse coming in
and setting up the infusion pump.
            Anything else?
            (No audible response.)
            DR. GARDNER:  So, this is good,
because we're at 2:00 and there's about 15
minutes until we start again.  I need to put
my head together with my scribe and give a
brief report out, which I will do.  And then
hopefully if you guys think I miss something
big, you'll raise your hand and participate. 
Thanks very much.
            (Whereupon, the above entitled
matter went off the record at 1:55 p.m.)

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