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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 (Transcript Part 2)

            MS. GARVIN:  Okay.  Next on our
agenda will be the public comment section and
we're going to be using a lighting system here
that you see at the end of the table.  And
please keep your comments as succinct as
possible and related to the topic as possible. 
I'm going to start off by calling up the first
name, and forgive me if I mispronounce your
names.  The first person is Mr. Prabku
            MR. AMBATIPUDI:  I wasn't on the
            MS. GARVIN:  Okay.  How about
Bernie Barbour?  
            (No audible response.)
            No?  Christopher Blagg?
            (No audible response.)
            MS. GARVIN:  Dennis Cook?
            (No audible response.)
            MS. GARVIN:  This will go quickly. 
Okay.  Another name I'm going to mispronounce,
Parakash Deedwania?
            (No audible response.)
            MS. GARVIN:  Robert DiTullio.
            MR. DiTULLIO:  That's me.
            MS. GARVIN:  Okay, step right up.
            MR. DiTULLIO:  So, that means I
have plenty of time, is that correct?
            MS. GARVIN:  We're going to cut
you a little break then.
            MR. DiTULLIO:  So, good morning. 
My name is Robert DiTullio and I'm with
Inverness Medical Innovations.  We're a major
global developer, manufacturer and marketer of
advanced rapid professional point of care and
consumer diagnostic products.  And such near 
patient testing has immense untapped utility
in the home and increasing the availability of
safe and effective diagnostic products into
the home will enable through greater
participation of the individual and, under
medical supervision, better medical outcomes
than are available today.
            We believe that in order to truly
address the vitally important issue of
continually rising health care costs, FDA must
allow greater accessibility of home health
care devices.  Doing so will lead to a
reduction in the number of unnecessary
hospital admissions.  With the advance of
device connectivity via internet enabled
diagnostics, such a reduction could easily be
obtained without sacrificing safety and
effectiveness of patient diagnostic testing. 
All of these possibilities will represent the
most definitive step in the direction of
reducing the cost of health care.  
            Inverness Medical Innovations
lauds the agency for holding this workshop and
hopes that it begins to hasten the
availability and utilization of safe and
effective diagnostics into the patient's home
and challenges FDA to consider novel and
resourceful means of achieving this goal. 
Thank you.
            MS. GARVIN:  Thank you.  Okay. 
Next, Ms. Loretta Dorn?
            (No audible response.)
            MS. GARVIN:  Michael Eckstein?
            (No audible response.)
            MS. GARVIN:  Brenda Edin?
            (No audible response.)
            MS. GARVIN:  Michael Flessner?
            (No audible response.)
            MS. GARVIN:  Okay.  Mr. Konstantin
            (No audible response.)
            MS. GARVIN:  Mike Griffiths?
            (No audible response.)
            MS. GARVIN:  Rod Kinley?
            (No audible response.)
            MS. GARVIN:  Hey, you guys are
just making me pronounce these names for fun.
            Okay.  Hamid Khosrowshashi?
            (No audible response.)
            MS. GARVIN:  Okay.  Nancy Kramer?
            MS. KRAMER:  Hi, I'm Nancy Kramer. 
I'm with the National Home Infusion
Association and we're a trade association that
represents providers of infusion therapy,
primarily licensed retail pharmacies as well
as manufacturers who make the equipment that
our nurses and pharmacists use in the home.  
            As we were listening this morning
to the incredibly well informed presentations;
and thank you so much for pulling all of this
together and giving us this opportunity to
address this very critical issue, one of the
challenges that we have in the home infusion
setting, particularly around infusion pumps
and devices, is not only the longevity of the
devices in the marketplace, that many of them
have been in use for 20 years or more, great
reliable devices, but opportunities always
arise for improvement.  We've had historically
a great relationship from an industry
perspective between manufacturers and users
and a lot of the issues that come up are
resolved fairly quickly and collaboratively. 
And we want to make sure that as the
improvement process goes forward, that ability
to communicate provider to manufacturer and to
facilitate improvement continues and that we
have a really open process for that type of
            But in addition, from a patient
perspective, from an education perspective,
much of what we do is very customized and very
tailored from a patient specific perspective. 
So, one given infusion pump or infusion device
may have a set of instructions that work for
a patient, but another patient may not be
given quite the same level of training or
understanding because their use of the device
may be different from the therapy that's being
administered.  So, asking the manufacturer to
come up with the specific instructions that
meet every patient's needs will be a challenge
and has been a challenge.   So, we really need
to have partnership there with the industry,
the clinicians that use the device and train
the device and the manufacturers that come up
with the technology.
            So, that's my thoughts.
            MS. GARVIN:  Thank you.
            Michele McDonald?
            (No audible response.)
            MS. GARVIN:  Aaron Moskowitz?
            MR. MOSKOWITZ:  I am Aaron
Moskowitz of the Biomedical Research and
Education Foundation.  Thank you for putting
this on.  
            I wanted to emphasize that, really
it was in the last presentation, the use of
post market analysis and reports that come
into MAUDE and MedSun, and really the value to
patients when they're able to hear about other
user experience with their device.  And
hopefully those experiences and reports could
be incorporated into future consumer education
beyond just labeling on how to use it
correctly.  Because troubleshooting and things
to look out are really valuable.  Thanks.
            MS. GARVIN:  Thank you.
            Joseph Murnane?
            MR. MURNANE:  How do you do?  My
name is Joe Murnane.  I work for Underwriters
Laboratories.  I guess most of you associate
that with testing, certification, product
            I was one of the members of Joint
Working Group 6 that helped develop the  1 11
standard that Dave has talked about quite a
bit, and I do think it is a very valuable
            By the way, this is essentially a
firm.  One of the lesser known aspects of UL
is that they operate various councils.  The
one that has a remarkable overlap with the
work at hand today is the Consumer Advisory
Council.  I'll read you a brief synopsis of
what that does.
            "This council, which was
established in 1967, is composed of
representatives of academia, insurance,
government agencies, along with home
economists, public safety officials, retailers
and individuals associated with consumer 
oriented media.  The group advises on
establishing levels of safety for consumer
products, user experiences, product failures
and educating the general public on the
limitations and safe uses of specific consumer
            Certainly, the medical equipment
for home use is a definable specific user
product.  By utilizing or cooperating with
this consumer council, you can really extend
the reach of the aims that FDA is trying to
put forth today.  I think there is every
indication that this is the future.  This is
the way things are trending.  
            We've mentioned the Baby Boomers,
we've mentioned a lot of things.  This council
in '67    at that point in time; frighteningly
enough, I still worked for UL at that time;
don't do the math, I would have said for
medical equipment that's ridiculous.  Even 10
years ago I might have said, no, this is
absurd.  But today, definitely.  These are now
consumer products.  Thank you.
            MS. GARVIN:  Thank you.
            Okay.  Ms. Anna Nowobilski 
            MS. NOWOBILSKI VASILIOS:  Close. 
I'll give you credit for that.
            MS. GARVIN:  Okay.  Thank you.
            MS. NOWOBILSKI VASILIOS:  Hello,
my name is Anna Nowobilski Vasilios, and I'm
an independent health care consultant.  I'm
also a member of the American Society of
Health System Pharmacists, the National Home
Infusion Association, the American Society
Parenteral and Enteral Nutrition, and also a
surveyor for ACHC.
            I really want to commend you for
putting this initiative together.  Not only
will it address the issues of migrating the
technology from the inpatient to the
outpatient setting, but as was briefly
mentioned earlier; and I do want to underline
it, there is a grave problem within the
inpatient setting of this technology migrating
back from the home environment back into the
hospital environment.  And specifically, your
initiative to create a Web enabled resource
for the labeling of these products will not
only help the home environment, but also help
significantly the inpatient environment.  So,
thank you so much.
            MS. GARVER:  Thank you.
            Marcia Nusgart?
            MS. NUSGART:  Good morning.  My
name's Marcia Nusgart and while I'm a
pharmacist by education, I now serve as the
executive director for three distinct medical
device coalitions that represent products for
use in the home; enteral nutrition,
respiratory care and wound care, as well as
the Alliance of Wound Care Stakeholders, which
is a multidisciplinary clinical organization. 
            It's a pleasure to be here today. 
I've been involved in FDA conferences on human
factors and home care devices.  That's where
Suzanne and I met in the late 1990s, I
believe, when I served as vice president for
Home Care for the Health Industry
Manufacturers Association, which is now
            Over the past decade I've had the
pleasure to serve on the FDA Home Care
Committee chaired by Mary Brady and
participate in the 2007 FDA Home Care Meeting
in Houston, and most recently the National
Research Council's Role of Human Factors in
Home Care.  We've really had the pleasure of
working with Mary over the past few years and
I have to say that she's come to our meetings,
we've given her feedback on that definition of
home care, and we wanted to talk about some of
those issues today.
            Since so may of the devices are
being brought from the acute care area to the
home, which is why we're really here today, we
believe that this is a very important and
timely issue and compliment the FDA for
launching the Medical Device Home Use
Initiative and bringing it to the forefront. 
And we also appreciate Mary Brady's dedication
and really transparency, because she has
reached out, she's been at MedTrade, she's
been at wound care meetings and she has
reached out to physicians, clinicians and
other folks, as well as though here today to
be able to get this done.
            We will be submitting written
comments, but I just wanted to mention two
items which really did peak our members'
            One was one that Dave had
mentioned already, which was the topic of
unique risks in the home care environment that
needed to be factored into device design.  And
electrical risks really do need to be
emphasized, especially for those respiratory
patients that many of the devices that need to
be used have to be on their own electrical
            Also the unique characteristics
then users in the home environment need to be
factored into device design was also an area
of interest to my members.  They don't believe
enough information was contained currently
that addressed the type of testing that needs
to be put into the new product testing, want
to see further information contained in that. 
            And also the issue of usability
testing in particular.  Who can they use like
the companies for usability testing?  While
labs do usability tests in product design to
factor in the characteristics for the device
to qualify for use in the particular
environment, are there other entities that can
be utilized?  And this could be certainly a
topic for further discussion.
            We appreciate the fact of what the
FDA is doing in putting this information
really in a guidance document, then and a
regulation.  I think that everybody in this
room really agrees with that.  And we look
forward to working with you both as a resource
today; there's a number of our members in the
audience today, and also in the future.  
            Thank you so much.  This is a very
important conference.
            MS. GARVIN:  Thank you.  Is Mary
Rodgers here?
            (No audible response.)
            MS. GARVIN:  Okay.  Susan Rolih?
            (No audible response.)
            MS. GARVIN:  Beth Rossheim?
            (No audible response.)
            MS. GARVIN:  Ms. Aguta Smieja.
            MS. SMIEJA:  Great job on the
name, but I don't have any comments.
            MS. GARVIN:  Okay.  Molly Story?
            MS. STORY:  I'm Mary Follett
Story.  I work at the National Research
Council, which is part of the National
Academies, and there I am a study director of
the study of the role of human factors in home
health care.  
            I also have done a lot of
consulting to the medical device industry and
I've tested hundreds of people on dozens of
products, everything from light switches and
fire extinguishers to blood glucose monitors,
PT/INR devices and radiology equipment.
            I've also worked primarily with
people with disabilities, so I want to
underscore the importance of user testing
really and often.  I want to make the point
since there are some many manufacturers here
today that the earlier in the process you do
it, the fewer people you need to uncover some
really big problems.  It's diminishing
returns.  The better your device, the more
polished it is.  The more people it takes, but
the fewer problems you find.  I just think
it's incredibly important.  No matter how much
I think I know about a device, when I go and
test it with real people, they tell me things
I could never imagine.  So, I just wanted to
underscore that.  Thank you.
            MS. GARVIN:  Thank you.
            Lawrence Wasserman?
            (No audible response.)
            MS. GARVIN:  And finally, Stephen
            (No audible response.)
            MS. GARVIN:  Okay.  Mary has an
email comment she's going to read.
            DR. BRADY:  I'm just going to read
portions of this, but this lady asked if we
could do it because she couldn't be here
            "Because I am the primary
caregiver for my aged, ill and disabled
husband for over 13 years and I'm in charge of
all his medications and devices, I will be
unable to take part on the workshop.  
            Had I been able to speak, I would
have outlined to you the three areas in which
I continually take a responsibility not far
different from his primary care physician.  Of
course I make decisions on my own after
consultation with his own doctors, but time is
always a problem and often I need to make
decisions immediately without a consultant.  
            These include:  (1) Monitoring,
irrigating and changing a suprapubic urinary
catheter at all times of the day and night in
circumstances of clogging or infection; (2)
informing technologists who are performing
imaging studies as to whether his implanted
intrathecal pain pump will interfere with the
study or damage the pump or him; and (3)
observe his vital signs, daily general health,
noting if there is increased weakness,
fatigue, inability to regulate his body
temperature, dehydration, adequate food
intake, bowel regularity, mental status,
sufficient sleep, depression and anxiety and

reporting these to the primary care doctor if
something seems amiss to me.  This method has
saved his life on several occasions.  These
are tasks I perform 24 hours a day.  
            I have tried to convey to you that
caregiving is not only the ability to
manipulate and manage medical devices, but the
need to create a safe and creative environment
where life can continue in a quasi stable
atmosphere.  It takes patience, love and
loyalty, intelligence, assertiveness and
unspeakable energy.  Help is needed.  It is
            Thank you for your opportunity to
record my experiences.  I hope my comments
will inform your workshop."
            This is signed by Beth Ann
Rossheim, Ph.D., M.E.D. from Williamsburg,
            MS. GARVIN:  Actually, since we
have additional time, we're going to open up
the session for any comments or questions that
you might have about post market surveillance,
since we skipped that initially.
            Okay.  Go to the microphone.
            MS. McDONALD:  Susan, you had
mentioned that there is no home use box to
check on the current 3500(a) forms and with
the new infusion pump guidance there's a post 
market discussion.  Do you anticipate that
there will be any changes specific to home use
tracking for the medical device?
            DR. GARDNER:  Actually, there is a
box that indicates that it was used in the
home.  It's just that when we see that and we
look at the reports, we often find that we
don't get the information that we need.  And
so, if I were to tell you, you know, we have
X, I think, Mary, what is 19,000 or something
reports with those boxes checked, I will also
tell you that from that information we have
learned just very little about what the real
needs are and what the real problems are.
            But let me just expand.  I mean,
one of the things that we could do in the
guidance, for example, is to give better
definitions about what to report.  I mean, I
think you'd see this in the infusion pump
guidance.  I mean, when you are reporting
something about an infusion pump, you should
include whatever information.  So, that is
something that we could talk about in terms of
the guidance document.
            DR. ZIONE ALALE:  Good morning. 
My name is Dr. Rhoda Zione Alale.  I'm a Ph.D.
nurse and I'm a health physicist.
            My concern is what manufacturers
are doing about monitoring the non ionizing
radiation in your sleep apnea monitors and
your CPAP machines and your oxygen machines,
because anything that gives off or that uses
electricity, can also converge when you have
these devices within 12 inches of each other. 
            Just one case I want to bring to
the table.  I became a nurse health physicist
after I bought a home and found out it was
built on nuclear waste that was not that far
from a radio station antenna.  I had a son
born with left brain encephalopathy who was
able to overcome a number of things, went on
to become a world class athlete and was on a
29 nation tour.  When he came home to this
house, within three weeks he lost 60 percent
of his brain theta wave and ended up in the
hospital for a year.  
            I also at the same time had a baby
that had Sturge's lethal dwarfism who was in
the hospital every five days and we couldn't
figure out why he was so unstable at home. 
When we went to look at his home situation, he
had a oxygen intake, he had his sleep apnea
machine, he had his tube feeding machine, all
of them were within a foot of each other.  He
was in a steel baby crib that was within 10
inches or so of wall.  And when we measured
the radiation convergence of that; your body
is not supposed to be exposed to more than 50
hertz, this little baby that was 19 months was
being exposed to over 4,000 hertz of radiation
that was causing a massive radiation assault.
            And so, as I've gone on to study
other equipment like the TENS units.  Whenever
you use a TENS unit within two feet of a wall
and you have a patient within two feet of
wall, that TENS unit, instead of working
therapeutically for the patient, works
adversely and can actually dehydrate the
intercellular fluid.  
            So, there has to be    in the home
with all this wireless and everything's
electronic in bedrooms, it has made home care
for nurses overwhelming.  The little home care
safety eval that we do now is not adequate
because we must begin to look at patients with
all this electronic stuff in their bedroom,
because it can contribute to stroke, heart
attack, fibromyalgia.  It can contribute to
autism, etcetera.  Thank you.
            MR. GARVIN:  Are there any
additional questions or comments?
            (No audible response.)
            MS. GARVIN:  Okay.  
            DR. BRADY:  Sandy Berman will let
you know where your breakout sessions are for
the afternoon.  So, when you come back from
lunch, please go straight to your breakout
sessions.  If you haven't signed up for one
yet, please do so and remember to fill out
your questionnaires.  There is a box out
            MS. BERMAN:  The human factors
will be meeting in the Maryland Room, which is
the room you're in now.  Wireless discussion
will be in Chesapeake Room 2, and that's down
the corridor there to my left.  Post market
breakout, Chesapeake Room 1.  Potomac Room is
with patient labeling.  All of those are on
this floor.  The discussion on the environment
is in the Assembly Room, and that's
downstairs.  So, you can either take the steps
down, or you can take the elevator to M.  And
then you take a left out of the elevator and
you're going to see the Assembly Room written
there right above the door.  And we will be
starting on time at 1:00.  Thank you.
            (Whereupon, the hearing was
recessed at 11:52 a.m. to reconvene at 2:33
p.m. this same day.)
        A F T E R N O O N  S E S S I O N
                                       2:33 p.m.
            DR. GARDNER:  Okay.  So, over the
last hour and 15 minutes or so everyone broke
out into particular work groups.  Some of the
areas of focus were looking at human factors
in the user.  We've had one group look at the
environment of use.  Patient labeling.  Also
we've looked at wireless and also looking at
post market concerns.
            So, what we're going to do is one
person from each one of these breakout
sessions is going to come.  They were all
doing their notes electronically, so we're
going to share that with the entire group. 
We're going to rotate every 15 minutes or so,
based on how much information.  If they're
getting closed to being finished, we'll let
them run just a little bit over.  
            And then afterwards we will
actually have question and answer, because you
might hear something from the labeling section
and you were in the wireless group and you
might need confirmation or you might need to
add a little bit where you wouldn't have had
the opportunity because you were in the
wireless group or the human factors.  So,
we're still going to be taking your
information from your questions in the
question and answer session as well.
            So, we're going to start with
environmental.  Step on up.
            MR. OSBORN:  While Sandy's
bringing that up, the highest level conclusion
that the group came to was that the home
health care standard from IEC addressed the
environmental issues quite fully and quite
well.  Clearly that standard is focused on
electrical equipment and systems, but in fact
other than the electrical parts the standard
is a whole risk management standard.  It
addresses all of the related hazards and is
completely applicable to all medical devices
insofar as they're covered.  
            So, for things like cleaning and
disinfection and temperature and pressure and
humidity and all those sorts of things,
completely relevant and certainly the
usability section is completely relevant to
anything that has a human interface.
            How you doing, Sandy?
            MR. WEININGER:  Well, it's   
            MS. BROOKS:  He's having a human
factors issue here.
            MR. WEININGER:  It's slower than I
            MR. OSBORN:  Ooh.  And for Mary,
of course, we would hope that the future
guidance document will be structured along the
lines of 1 11 and reflect its content.
            MR. WEININGER:  All right.  Can
everybody hear me?
            AUDIENCE MEMBER:  Can you see it
            MR. WEININGER:  No, I got bifocals
on.  I can't see a thing.
            MR. OSBORN:  I resemble that
            MR. WEININGER:  So, our group was
about the physical hazards associated with the
home use environment.  And I'm going to run
through these in no particular order.  We
really didn't have time to digest and analyze
them.  So, it can stimulate some further
conversation about them.
            So, we started really with the
60601 1 11 standard as an all hazard standard. 
It took several years with a lot of effort
going into trying to understand what the whole
use environment is.  It's not just an
electrical hazard standard.  It's a whole
hazard standard.  
            And so, whereas it was built as a
601 family standard, which means it's designed
for electro medical devices, it's principles
are applicable for all the devices that would
go into home use.  So, things like dropping
and shock and vibration and labeling, those
are principles which are applicable to all
medical devices.  And so, an awful lot can be
gained by understanding the essence of 601 1 
            So, there was some discussion
about whether it covers integration with cell
phones and what is a particular medical
device?  And what are the hazards introduced,
for example, with cell phones with
electromagnetic interference.  And again,
those issues were addressed.  
            I'm trying to be too specific
            There was some discussion about
generation of patient IDs and names and how
you link them up to your device, and some of
those things kind of got off topic as from a
physical environment perspective, but are
certainly important about how you go about
making that association.
            There was discussion about
electrical supply mains, what happens when the
voltage dips or sags or gets noisy in either
blackouts or brownouts or extended periods of
time.  We had some discussions about which
standards addressed them.  And those of you
familiar with the IEC standards, there are
significant numbers of standards which try to
address those types of hazards.
            We talked about whether the
medical device industry can interact more with
the building infrastructure industry to try to
perhaps prevent or present a safer
environment.  And of course, we always talk
about the FDA and what the FDA can do and who
the FDA actually regulates, which is on the
medical device manufacturer and not any
infrastructure type folks.
            We talked about 60601 1 2, which
is the electromagnetic compatibility standard. 
And while it doesn't currently adequately
address home care, there's a new work item for
   I guess it's actually underway within the
next few years to try to incorporate the
appropriate requirements for electromagnetic
compatibility.  And I'll tell you that it's
quite the struggle, because the more rigorous
your requirements are, the more expensive it
is to build the particular product.  And of
course fewer people want you to have those, or
fewer manufacturers want you to have those
types of restrictions, because it just gets
very expensive and time consuming to produce
your devices.  And in the case of some
devices, they might not work anymore just
because you've hardened them so much.  Like
pulse oximeters which require a very sensitive
front end will not work if you shield them too
            All right.  We talked about some
power consumption issues.  For example, is
there a requirement that a certain amount of
time for battery backup should be    there
should be a requirement for that.  601 1 11

has a disclosure requirement, but no
particular times.  The discussion was that
it's, if you will, use dependent, so you can't
have a horizontal requirement that covers all
            We talked about the use of compact
florescent lights and how those are adding
electromagnetic noise to the environment if
they're not used properly.  Some of them have
filters; some don't.  We talked about the
coming wave of LEDs which will replace the
compact florescent lights.  
            We talked about the potential for
device injury due to emissions from medical
devices and particularly if you have large
groupings of medical devices, the possibility
for injury rises.
            We talked a little bit about the
process of the development of the guidance
document and whether the guidance document can
leverage 60601 1 and 601 1 11 and its
collaterals.  It would seem logical that those
proceed as siblings as opposed to individual
devices.  And we in the FDA, we have some
guidance documents which heavily leverage
recognized standards and it's actually much
easier to maintain that way because the
standards group is already maintaining it and
FDA can come along periodically and say, well,
here's the extra things which we want to add
onto that.
            There was some discussion, as I
said before, about FDA's oversight of home
health care agencies.  It would be nice if
home health care agencies had recommended
practices, and they may; I'm just not aware of
them, so I don't want to say bad things about
that.  But the issue is that it's an
environment that all the different
stakeholders should know what all the other
stakeholders are doing and you shouldn't sub 
optimize.  And one group can go off and do
great and wonderful things, but it might turn
out that in the long run that's hurting the
whole group.  So, knowledge of the regulatory
environment and the safety environment is
            Let's see.  So, we talked about
different characteristics of the physical
environment, which is the name of our
committee, so we talked about temperature and
pressure.  And clearly if you use your
ventilator in Denver, well, then that
barometric pressure is going to be quite a bit
different than at sea level.  And actually had
some devices that they didn't bother to do
that in the early days.  And 601 does a pretty
job of addressing those types of broad
horizontal basic safety aspects.  Again, more
reason why it can act as a foundation for any
guidance documents we go off and build.
            We talked about some of the
deficiencies of 601 1 11, which are the EMC
immunity levels and how those are currently
being worked on.  And one of the issues that
came up, as I mentioned before, was the
convergence of multiple devices and either
from a physical hazards/electromagnetic energy
perspective, or even from an information
perspective.  How you get devices to play well
together needs to be addressed.  Particularly
in the home I could imagine if you have
multiple devices that are calling for the
attention of the caregiver, that can lead to
its own human factors issues and I presume
those will be handled in the Human Factors
            Dave, you have any comments that I
left out?
            MR. OSBORN:  There was one
specific question that I had addressed in my
presentation, which was here the environmental
limits for pressure or altitude, and in fact
they're there.  There are 700 to 1060
hectopascals, the same numbers that had been
in the second edition of 601.  Otherwise, I
think you did a great job.
            MR. WEININGER:  Thank you. 
Questions?  Comments?  Help to make this
better?  You're welcome.  
            MS. BROOKS:  Great.  Thank you. 
Thanks, Sandy.  Appreciate it and appreciate
the breakout session looking at the
environment of use of medical devices.
            We're next going to move to human
            MS. WINSTEL:  Okay.  I would like
to thank everybody who was in this session
with me.  It was fascinating working from the
caregiver side to hear the multiple
            We were talking about when the
user is other than the    well, I should say
patient.  And I turned some questions to the
group and then we did a breakout into four
different breakout groups.  We wanted to talk
about the industry's need to identify the
appropriate patient population and whether or
not the device needed to be disability 
friendly as well as caregiver friendly.  
            And we had four different breakout
groups.  One that was tasked to list the
barriers that face family caregivers as they
are becoming familiar with a device.  What are
the appropriate sources of training, whether
that's going to be manufacturer, a train the 
trainer model in a health care setting, or
whether it's going to be a train the trainer
model of one family member to another family
member to the school nurse to the home health
aid and so.  What does the training need to
look like given some of the barriers that face
the family caregivers?  And we did some work
on the identity of the user groups as they
move forward in the guidance document, talking
about who are the family caregivers, who are
going to be these user groups other than
health care professionals and home health for
these devices?
            There are 17 slides for Mary to
take away and work with, and we're going to
try and go through some of this feedback very
            But some of the barriers that we
really wanted to bring to your attention was
   what we tasked here is that the mental
strength, because as the caregiver is suddenly
given this device, where are they in their
life?  What are they able to absorb about the
disease state, about their change in life and
so on?  And you can look through this as we go
through.  And we also talked a lot about some
of the financial and insurance burdens that
the caregivers are facing.  Where is there
going to be reimbursement?  Where is there
not, especially around training time from the
medical institutions?  Are the caregivers
overwhelmed by technology?  This is a serious
concern.  In some of the research done at
National Family Caregivers, we have learned
that many family caregivers are not using a
computer, are not on the Internet.  This is a
significant concern as manufacturers are
putting user manuals online.  We also talked
about delivery model coordination so we could
have some cohesive delivery.
            Another group was talking about
the sources of training.  We're talking about
training material that's coming from the
manufacturer, but then where does it go?  It
can go to the sales force where we have the
health care professional being trained by the
sales force.  We have a nurse.  In an ideal
situation, a nurse then would train a family
caregiver or another health care professional. 
Then one family member training another. 
Sometimes there's a sales force to the
patient, and sometimes that caregiver is
picking up the equipment on eBay with no
training.  The materials can come over the
customer service line.  There can be online
chat or video/audio over the Internet.  That
gives us some nice interactive models, but it
doesn't address the situations of the family
caregivers who do not have computers.
            We talked a little bit about how
the industry sometimes might feel a little
stymied by the fact that they cannot determine
the exact specific who is receiving and using
the device.  There might need to be a feedback
loop on that.  And how should and can the non 
medical professional labeling be developed? 
So, there are lots of FDA guidelines that are
not user friendly to the non medical
professional.  So, how can we segregate that
noise from the stressed caregiver and what
they need to learn?  
            Okay.  What does the training look
like?  This was fascinating.  I wish I had
spent more time listening in on this group. 
They talked about four different vectors that
they were exploring and a four dimensional
cube model.  Sounds great.  They were talking
about the nature of the device.  Some devices
are cognitively complex; some manually
complex.  There's the cube of the delivery of
care.  We are of course focusing on that which
is home, although a lot of the in transit of
course is what we're talking about here.  The
nature of the user.  And then the training
itself, and that can either be self directed
or facilitated.  And both of those can either
be static or interactive.  Ideally, of course
you would have a multiple training session
with lots of follow ups.  But then again that
would be the ideal.
            Then we talked a lot about who is
the user?  What's the actual division between
the patient and the caregiver?  We have to
note that the caregiver is not a single person
necessarily.  That person can be in flux.  One
of the examples given is a child with Type I
diabetes.  At the home the caregiver is
probably mom and then they go to school and
it's the school nurse.  And then the go the
after school setting and the camp setting. 
Lots of different caregivers happening.  It
can change from one family member to the
other.  In an ideal situation there will be a
family member getting respite help from a home
health agency.  So, lots of different people
can be interacting with this device.
            There's a range of ages,
education, nationalities, languages, technical
literacy, language literacy, numeric literacy,
all sorts of factors affecting any one given
caregiver's understanding and adaptation of
this device.  
            Please remember, as Suzanne
mentioned earlier, and I think everybody in
our session embraced and understood, the
caregivers are stressed.  So, this is not a
situation where you can pull somebody in off
the street and say let's test and see if you
understand these directions.  You really have
to do it with somebody who is walking in those
shoes at the moment.
            The other thing that the group
brought out, which I thought was a lovely
point, is to remind us all that the direct
emotional relationship that exists between a
caregiver and their patient is very different
than that between the medical professional and
the patient.  And also that caregivers are not
trained as problem solvers.  They never took
differential diagnosis.  They can't solve the
problems in the same way.
            We then separated out some general
comments.  One is that we needed to say that
certain devices need to be active in order to
determine if the patient can really use the
device and that this might affect some
validation studies.  So, the device actually
has to be on and working in order for us to
determine if a validation study can happen. 
That might be a challenge.
            We were taking consideration of
who the user    you want to use the user
groups earlier in the design phase and
consistently in the design phase.  So, it
becomes a very iterative process.  Bring the
caregivers in very early in the design phase
as you're going through it, see how it's
going, bring them in again, bring them in
again, bring them in again.  Solve the
problems before they happen.
            We talked about segmenting
devices.  Not everything's the same.  The
difference between an infusion pump and a
breast pump.  Okay?  It's not going to
necessarily require the same type of training. 
Should they indeed be treated in the same type
of way in the guidance?  Is there any way to
separate things out and have different
classes?  The question that we came up with
was, you know, when does an iPhone become a
medical device?  And they told us there is an
app right now that will walk you through
compression only CPR and at the end of the app
they're working it out so that the app will
dial 911.  Well, at what point is that a
medical device?
            When we start to think about there
being multiple classes or degrees of home
medical devices, we also have to consider that
there would be a different level of training
that should be required for different types of
devices.  And, not just a different level of
training, but different methods of training. 
Now, also when we're talking about different
methods of training, there are so many
different paths for the device to get into the
user's hands.  The labeling can be missing. 
Well, that's one scenario.  The labeling can
also be the wrong labeling.  Maybe it's the
labeling that was intended for that nurse who
was going to be trained by the distributor's
sales rep.  And then that winds up being the
labeling in the hands of the family caregiver
and it's a vocabulary they can't understand.
So, we talked about several different issues
of the path of the device actually getting
into the hands of the family caregiver and
making sure that the right labeling and
training is getting to the right person, and
that those need to be perhaps at different
            We did have some discussion; no
offense intended, that we did not have
necessarily all the right partners in the room
for this discussion.  We wanted to have this
conversation with home care agencies, home
medical equipment organizations.  We wanted to
have pharmacies here, some clinical
pharmacologists, hospice agencies, the
insurance companies and CMS.  We talked quite
a bit about reimbursement.  For example, I
opened with the simple fact and the wonderful
brochure that's in your packet that says if
you've got home health equipment, one of the
things you should do is talk to your doctor
and ask your doctor the following the
questions.  Well, if you're on Medicare or
Medicaid, and with most private insurance,
you're doctor will not be reimbursed to have
that conversation.  So, that would be a
serious issue.
            Another comment on labeling from
the manufacturing side, they would like some
FDA guidance on specificity and the industry
is willing to help with developing some
classifications and degrees of those home use
devices.  I think that would be a consistent
theme throughout.  Of course, we did know that
we need to be mindful of the cost, but
sometimes there need to be a few extra steps
to make sure we're saving a few extra lives.
            We also need a direct line to
realize that sometimes the device is going to
go directly from the manufacturer to me, the
neophyte.  I know nothing.  Nobody will be
stepping in in between.  It will go right from
manufacturer to caregiver and what can be in
the place in the middle to help me?  
            We did, as I said, talk about
reimbursement and training.  We have to assume
that no one is going to retain more than half
of what they're taught, and it is important
that the materials that go home are both
useful and something the user can refer to. 
And that's where we were getting into
separating out some of the regulatory language
from the user guides.  
            There we go.  It's right there. 
Separated out.  Device classification again. 
Sometimes the manufacturers are saying that
they need to use words that are good for the
user, but they're required to use language
that is designed for the physician, and where
and how can they use both?  There are some
questions around social media.  How can we
leverage the user base of collective
experience?  How can a manufacturer use and
interact with that information?  Not in a
marketing sense, but in reaching out to that
home user through social media, through forums
and so on.
            We did look a little bit at what
do we do with those older devices that are out
there in the field, the ones that are not
meant to be used in the home?  But we all go,
yes, they're out there.  They're being used. 
They don't have the right label on them. 
Who's responsible for that?  Who can step up
to protect the patient in that case?  And
again, differentiating between devices.
            And that's what we came up with.
            MS. BROOKS:  Thank you, Lisa. 
Appreciate it.  A lot of good information came
from the working group.
            Okay.  Next we're going to   
let's see, is our wireless group available to
            MR. WITTERS:  Good afternoon
again.  I'd like to thank all the folks that
were in our session.  There was a really good
discussion, I think.  And thank Terri for
taking some copious notes.  We have several
points, but obviously we weren't alone in
getting a lot of feedback.
            Our group had about 20
participants in it, including myself and
Terri.  About 13 of these were related to
medical device manufacturers directly.  Some
were wireless industry or wireless vendors. 
Some were other organizations, another
government person, and some were in the sort
of academic and entrepreneurial type of
organizations loosely associated with medical
device work.
            There was quite a bit of
discussion about the wireless guidance that I
mentioned this morning, which is available and
being finalized now, and how that applies and
how this may differ in the guidance for the
home care devices.  And we were trying to talk
about that a little bit more focused on home
care and what might be in the home care
guidance as opposed to something that's more
general on specifically the wireless medical
device systems.  And of course, there was a
lot of commonality.  
            Should we define the term "medical
device" in particular for the home care,
because in wireless technology, as the last
speaker talked about, what about these new
platforms, these new smartphones, this new
mobile health drive?  Where does that enter
into the picture and how much of that?  We
spent awhile figuring out how much of that
might be actually in such a guidance,
particularly since is there a distinction
between the medical device and pieces that are
simply transmitting some information, or
somehow transmitting patient information? 
Where do they fit in? 
            If there's a cutoff, would it be
particularly with the part that has a very
specific or well defined medical device type
of function, an algorithm or center that's
actually on the patient as opposed to
something that's somewhere in between sending
the data.  One of the examples that we were
talking about was the cellular network and how
that fits into it, which is carrying
information, but how much of that may or may
not fit into it?  
            Talking about, well, burden of
proof.  I'm not sure we were trying to get at
that particular one, but where these aspects
come in, who's responsible for what portion of
this?  Is it the medical device manufacturer
that has developed this that connects to say
the Internet wirelessly?  Is it the Internet
provider?  Is it a global network?  How much
of that?  
            One point that was made by one of
the audience was about validating or verifying
the communication, something that was related
to this Part 11 about electronic signatures. 
I wasn't quite clear how much of that might
apply here, but the idea is making sure that
the system works properly, that it gets the
signals that need to get across in the timely
fashion they need to get across in.
            I mentioned about cognitive
technology just to sort of lob a few things at
the audience and the cognitive radio is a
newer technology that's coming out now.  It's
still in the relatively formative stages, but
it will dramatically change wireless
technology.  It will have the capability of
basically thinking for itself, determining
where the frequencies that it can use in the
spectrum that it's designed to be used in,
where there are free places for perhaps only
a millisecond or so, and sneak some signals in
there and in other places, and how that might
affect these systems.  
            Is there a possibility of
establishing a test environment for home care
and how might that be different from other
devices?  We spoke about that because there
are some standards for electromagnetic
compatibility that are being developed right
now that increase some of the immunity
testing; that is, the immunity of the device
to outside signals.  And some of those higher
levels of immunity are much more difficult and
much more expensive to perform testing to and
much more rigorous to do that to.  And how
would this set in if we have an environment in
the home that's particular?  Getting a handle
on that is going to be difficult.
            Should we define some of these in
terms of the wireless, what should they be? 
Should this information be in a separate
guidance, particularly for particular devices? 
Say for example, more direct specific things
on the wireless that may be for particular
kind of devices, say for monitors or
ventilator equipment, or something like that,
or dialysis.
            Should we define what should be in
the guidance by the level of risk?  We spoke
about that.  I spoke a little bit about that
this morning.  It's not an entirely linear 
type of approach necessarily, but maybe
there's a whole group of home care devices
that have low risk that don't need quite as
much testing as rigor in their approach to
            We also spoke about the devices
and the alerts or alarms that are in there. 
Should they be built in so they monitor the
wireless working in transmitting data?  Your
cell phones are polling constantly, depending
on the technology.  It's once every second,
once every sub second, perhaps every couple of
seconds or more.  Should medical devices
particularly in the home have that capability? 
Again, getting back to risk, maybe that needs
to be looked at in terms of particular kinds
of devices.
            We talked about the cellular
systems.  There was a lot of talk about
cellular as sort of a backbone that devices in
the home could be built to connect to and the
Internet.  And we spoke about other wireless
            A lot about distinctions between
monitoring and using the device, simply
checking to see that the device is actually
working and then perhaps creating a
methodology or a process by which some central
unit some distance away can have control over
that and perhaps troubleshoot it wirelessly or
in parts of it wirelessly.
            We spoke about some of the
mandatory standards, regulations, requirements
that FCC, Federal Communication Commission
had, because this falls under their authority,
the air waves and how that's protected.  And
if the device causes interference of products,
that should be in the labeling of course. 
Wasn't clear about what we need to do about
that one, because FCC does have a requirement
about that interference, but there may be
situations where that could be exacerbated
perhaps in the home environment.
            Future possibilities.  I threw out
a couple of questions just off the top of my
head to these people in the audience because
many of them there were manufacturers.  And
this is more on the technical side, if you
were given by the FCC a portion of the
spectrum, which right now would be billions of
dollars worth, what would you do with it? 
Would you create these systems on your own? 
And we had some discussion about that.  It
takes a long time to create these systems and
create the process and the technology, and
it's not cheap.  One comment was you could do
something and create a thermometer that now is
way too expensive to market because it has all
these capabilities, but it's just too costly
to make and make a profit on.  There are those
aspects of course.
            One of the things that we talked
about, and I think I wanted to wind up with
this one, should we revisit some guidance or
any of these guidances in a set period of time
because this technology, the wireless
technology is changing so rapidly, so
dramatically?  Perhaps in two years this may
be totally out of date.  It may not be. 
Portions of it may be, but it needs to be
perhaps re looked at on a regular basis, sort
of like the way the standards are supposed to
be, but many cases don't quite get there. 
That's a real issue that needs to be
addressed.  Is it worthwhile putting up some
kind of standard time frame in this guidance,
something that puts a handle on re looking at
it and updating it, especially with the
wireless technology where it does change so
            Is there another process?  Are
there other groups that this could be worked
in?  And there was quite a bit of discussion
about a few groups that do have interest in
the wireless technology that go beyond home
care.  And there was some discussion about
whether or not the home care is a subset of
that and necessarily should be focused on
that, or whether another entire document that
aims at some of these particular lines of
communication should be developed, and who
might do that.
            One last question.  There was some
question about whether wireless technology in
and of itself in a system would necessarily
ever have a component that would require
clinical testing.  And there was a bit of
discussion, and at least from my perspective,
I could see possibilities in that realm
depending on how far one goes into the
technology.  Body area networks are being
developed now.  Some of them may be implants
or partially worn.  That may require, just
because of what it is and how it works, some
sort of clinical aspect or clinical trial.
            Another issue was security.  We
touched on that quite a bit about the security
of the wireless signals themselves and how
could that be done.  
            We also touched upon lost power. 
If you lose power in these systems, because
here we just had a little bit of snow a few
months ago and that kind of damaged our power
and it took awhile for some of us to get back. 
And some people in other parts of the country
were not quite attuned to that particular
aspect, but they saw the real concerns about
losing power in these systems.  Because if
you're depending on a cell system for part of
the system and the cell power goes down for
whatever reason, or parts of that system, say
a hurricane or something, then that is a real
issue that needs to be dealt with.
            Testing and other things, and of
course this thing about the mobile apps,
mobile applications on such platforms as
smartphones and how do deal with those.  
            This is a very quick summary of
the questions and discussions which I thought
was very rich, very good, very interactive. 
And of course, we could have spent a lot more
time to do that, but I think we got some
really good ideas for things in this area.
            MS. BROOKS:  Thank you, Skip.  
            Okay.  So moving right along,
we're going to look at patient labeling
breakout session and Pat's going to speak for
            We're just going to try to
increase the font size a little bit.  We love
the technology, but I know people in the back
might have a little bit of trouble seeing
that.  Is that a little bit better?  Yes? 
            Okay.  Thank you, Pat.
            MS. PATTERSON:  I'd like to thank
the Potomac Group who participated in the
labeling and the training.  I thought it was
a really interesting discussion.  And it's
also one of the things that I think is so
worthwhile about this kind of workshop, and I
thank for the opportunity to be here, is to
really hear from different points of view,
people who are doing different things and see
the world from different vantage points.  I
think it's really been an enriching experience
for me, so thank you for allowing me to
            We talked obviously about the
labeling and the training.  There were a
couple of major themes that seemed to be
consistently expressed throughout the session. 
The beginning one was one size doesn't fit all
model.  This notion that labeling has to
address different devices, some relatively
easy, some relatively complex, various users,
some professional, some novice, some who are,
you know, computer savvy, some people who, you
know, don't know anything about technology,
and that the labeling needs to address the
users and we just can't assume that one size

is going to do it for everyone.
            The fact that the less complex
devices are lumped with the more complex
devices, the same regs might not be
applicable.  That was expressed not only in
the context of the infusion pump guidance, but
also in terms of sort of a cautionary word
with any labeling and training kinds of
guidance documents is just recognizing that
you don't need to build an elephant all the
time if an ant will do, and that we just need
to be aware of that.
            The suggestion that we would like
guidance to be less prescriptive, more user 
friendly regulations to make it easier for the
industry to comply.  I think this was
addressing a couple of different things.  One
is sometimes the regulations or the guidance
documents do make us feel like we have to put
stuff in there that users don't need, users
don't want.  At the same time, manufacturers
feel concerned that they need to have
information in there to protect themselves. 
You know, when that was being expressed, just
in my head I was recalling the McDonald's and
the hot coffee.  You know, do we need a 50 
page manual about how to extract hot coffee
from the little drive through window.  And we
had some discussion about that.
            Labeling that was described as
pedantic, it should be practical but it should
describe the performance characteristics
needed.  Again, this whole issue of how do we
make the labeling appropriate for the user and
how they are going to interact with the
            Again, some conflict with what
some of the guidance documents say and what we
think the labeling needs to say.  In some
cases the guidance documents themselves are
pretty hard to understand, so how are we going
to apply them?  So, we would like to have
labeling documents that speak English, that
speak to us as you're asking us to speak to
others.  There was a little bit of discussion
about grade reading level.  And being the
curmudgeon that I am, and one guidance
document that did talk about grade reading
level, I did a grade reading analysis on it
and it wasn't even close to sixth or eighth
grade.  But I'm a curmudgeon like that.  That
CDRH needs to have more guidance on the
labeling and the safety standards.  
            We talked a little bit about too
much focus relying on clinicians to train on
the device.  And I'm not sure if this is where
we did it or the person who said this, but it
was raised a couple of times, and it was the
manufacturers will do the best they can,
including validating testing their labeling. 
And then that labeling gets handed off to a
clinician of some sort, and then the clinician
will modify it, customize it.  And then you
have absolutely no idea what it was that the
end user actually got trained on.  And what
the end user got trained on may work, may not
work.  It may have been validated.  It
probably wasn't validated.  So, there seems to
be more than a few gaps along the process.
            Customers want simple labeling
materials versus the manufacturers feeling the
need to perhaps include more information
because of this liability.  And where you can
get so much in that domain, so much of the
liability, you know, warning, warning,
warning, caution, caution language, that
they're just not going to use it.  They're
just going to say, hey, I'm not even going to
be bothered with this.  It's too intimidating. 
It's too scary.  
            We talked a little bit about the
contradiction.  Since everyone likes the
simplified version for the patient, but the
manufacturers, again wanting to protect
themselves for the liability, so there seem to
be these kind of two ends fighting each other. 
Maybe was there a possibility where we could
include the labeling for the actual user and
then include all the other stuff for everybody
else someplace else.  There was some
discussion about that.
            Again, too many warnings.  It
won't protect the patient because they're not
using it, which I think I see a lot of that.
            The multifaceted approach was
needed.  Different training instructions again
for the patients, clinicians, train the 
trainer for the nurses, and going beyond the
user guide.  I think a lot of that was boiling
down to if you've got different users who are
interacting with the device differently, it
kind of stands to reason you're going to have
to have instructions and labeling that will
reflect that.  The complication of labeling in
institutional versus home care settings may
require a multifaceted training approach. 
Again, I think if we're looking at different
users, different environments, different
contexts, the training and the labeling needs
to address what the users are actually going
to be.  Again, those outcomes of value, how
they're going to be interacting with the
            A lot of discussion about what we
wanted to see in labeling guidance and what we
didn't.  The FDA can't be too prescriptive. 
General guidelines with generally accepted
methodologies.  Again, I guess this gets back
to a little bit one size fits all.  It's this
balance of being not too prescriptive, but yet
giving enough information so that people can
understand what it is the FDA is looking for,
what it is that the FDA wants to see.
            The infusion pump information,
that was discussed again as sort of an
example.  Needing to define perhaps different
components for each of the particular
therapies.  One person talked about that in a
clinical environment, hospitals for example
like to see    using the example of an
infusion pump, they like to see one pump that
does 1,000 different things so that 1,000
different users can interact with it.  Where
when you migrate that to the home environment,
you know, Mrs. Smith might only want it to do
one or two things and, you know, Mr. Peters
only wants it to do two or three things, and
if we have to keep including all of these
different things, we are making the devices
very, very complex for people.  And we talked
about segmentation, and I believe that same
term was used in your session as well, and I
think that's a really important one.
            Labeling probably including who to
call when the device doesn't work.  And then
Mary Brooks talked about having lock out
modes.  Access codes should be readily
available.  Again, the topic here was you
really got a lot of conversation.  You're
going to have an interesting next two days,
Mary.  That'll teach you.
            Again, this notion of wanting the
pump to be easy to use, reliable, durable,
being important issues.  And that the FDA; and
we're very happy about that, the agency
listening to all viewpoints was great.  I
think everybody appreciated that you have had
this meeting here.  It's been fabulous.
            Again, the dilemma for the
industry.  Simple instructions at a sixth 
grade level versus product liability.  That
came up repeatedly over and over and over
again, is how do we balance that?  And I think
if we can have some further discussion on
that, and there can be at least some
discussion of that in a guidance document, I
think a lot of people would be very happy with
            This was an interesting
discussion.  We started talking about users in
terms of age.  There is no simple device even
   I didn't say that this time, so don't blame
me for that one    even for single use
devices, especially for pediatric age
population.  Does the FDA have product
labeling standards for pediatric populations
since peds actually may need to know how to
use the device and have to understand the
instructions?  I think that's really becoming
an interesting topic of discussion as not only
are more devices migrating into the home
environment, but the users are now becoming
that much more complex and that much more
diverse.  And instructions for kids, wouldn't
that be interesting what that would look like? 
I'm guessing that the adults would probably
prefer them, too, but that's just me.
            Difficulty in writing a label for

a particular group involved in care versus a
label for the actual patient.  Again, I think
we're talking about similar to what your group
found.  You've just got so many different
users and how do we address the needs of those
various users? 
            A discussion came up with
combination products.  Clinicians need to
decide who is appropriate.  This I thought was
a really important point and a really useful
point, that maybe part of this home use
labeling/training, one of the early on
decisions that needs to be made is is this
person appropriate for this device?  Maybe
they're not appropriate for the device, either
because they have a very complex health care
state like perhaps Alzheimer's or whatever the
thing is.  And I think the group in your said
   it was interesting, a lot of the same
things came up.  Clearly, we're just the two
smartest groups in the room.  I mean, wow,
            Guidance was requested from the
FDA on font size.  I actually think that
guidance does exist, but it's usually never
employed.  It's always, you know, how small
can we make this user guide in 27 languages.
            Talked a little bit about older
users.  We talked about the younger users. 
Talked about the older users and their needs
and that the older users tend not to play and
tinker with a complicated device.  They don't. 
Younger people will tend to.  Older people, if
they're finding the instructions difficult to
understand, they're likely to just put them
down and then abandon the device and then
nobody wins.  The manufacturers don't win and
they don't get the benefit of the therapy.
            We talked about audio instructions
within the device itself, the talking meter
that I think Molly Story may have mentioned to
us earlier.  The notion of imbedding the
instructions audibly so that someone can turn
on and actually get audibly walked through. 
First do this, then do this, then do that. 
There was some discussion that, you know, gee,
that sounds like it would be expensive.  Gee,
that sounds like it might be complicated. 
Some companies are doing it.  Some companies
are thinking about doing it.   
            In the same vein we talked about
imbedding the instructions onboard in the
display, something referred to as electronic
performance support systems.  It's a
methodology that's quite prominent in most
other industries, but for some reason not in
our industry.  Where you have essentially the
quick start guide on the device itself could
be useful.
            I asked the question what would
like the FDA not to pursue?  You know, stay
away from this.  Don't give us any
instructions on this.  And it was basically
give us the minimum requirements.  Give us the
objective, but don't be prescriptive.  
            Again, something else that came up
that I thought was interesting because I'd
never heard it before, again the benefit of
being part of this workshop, how to update
older product instructions that are not very
clear.  Can the FDA tell us how to do that
without requiring us to resubmit a 510(k),
which would be great, wouldn't it?  Some
instructions are just really, you know,
wretched, and you know who you are.  And you'd
like the opportunity to improve them, but
you're concerned about having to possibly
resubmit a new 510(k), because the first
question, as some pointed out, one of the
existing guidance documents is have you
changed the labeling?  You know, there you go.
            We talked about software and the
version of the software.  There was some
discussion about wouldn't it be great if we
use electronic instructions instead of having
all this paper stuff, have it available
online.  There was some discussion about, you
know, not everybody has access to it.  Maybe
there's away around that.  Maybe again going
back to one size doesn't fit all.  Then part
of the discussion was the version of the
software that would be needed and how to
update it.  And then the usability of the Web
site itself, because then how do you download
the correct instructions for your particular
            And I guess I already mentioned
that one.  I just thought that was so
interesting.  How to update the labeling
without having to resubmit a 510(k).  I think
if there was some guidance about that in the
guidance document, you would make a lot of
people happy.
            And, let me see.  We had a lot of
really good discussion.  Qualification of
users needed for the devices.  Again, that
notion of not everybody should be    just
simply say if you're a home person, you know,
here, granny, you know, take the device home
and go have it, that there should be some
criteria for selecting.  
            New 510(k)s shouldn't have to be
needed again for the new labeling.
            And then I asked the question if I
had said anything in my presentation that
either didn't make sense or that they didn't
agree with.  And they were too chicken to
admit, because nobody said anything, and I
don't believe that.  
            And I think that was it.  Thank
            MS. BROOKS:  All right.  Thank
you, Pat.
            And lastly, we're going to have
Dr. Susan Gardner come and speak with us about
the post market breakout session.
            DR. GARDNER:  Well, for some
reason we didn't get the message about our
electronic presentation here.  I'm not sure
why, but Jeannette took notes for me and I'm
going to tell you what we were doing, and
we'll be able to do that later.  That also will
save us five minutes of changing computers and
setting it up and all of that stuff which, you
know, again towards the end of the day.
            In going over the notes and sort
of thinking about what the discussion was,
there were a couple key things.  One is we
would agree, there were some key people that
were missing that we would have liked to had
at the table.  I would liked to hear much more
from the people that really are on the
caregiving end of the situation.
            The second thing is, the group
actually was in violent agreement that we have
a really hard problem to solve here.  And then
reflecting on this, it reflects the problem
that we as FDA have in general about what is
virtually a passive surveillance system, which
means that we rely on the people outside of us
getting the information and giving it back to
us.  And as we turn more towards looking to
become a more surveillance system, I think
this will also be something that impacts the
home health care industry.  Again, all the
problems that we have normally getting device
information just get magnified by home care
because you're one step further into that sort
of passive surveillance system.
            So, we talked about, you know,
some of the problems.  I mean, why is it so
difficult?  And I think there's no big a ha
moments here.  Again, sort of a lot of
agreement.  People aren't very good reporters
and frankly the FDA form is not a very user 
friendly form, even if we should get that far
to do it.  We all know there's lots of missing
data and it's hard to get really good
explanation and it's hard to get back to the
reporter to find out what really went on.  
            But we talked more about also the
reluctance on the part of the patient perhaps
or the caregiver to give that information
because they may worry or tied into real
privacy issues, which I think people will
become increasingly concerned about.  And
perhaps if you're sick, you worry about that
might impact somehow your insurance and they
worry somehow that might impact their ability
to get reimbursed for, you know, their disease
and for the equipment that they have.  And so
once again, what are sort of the usual
problems we have in getting information get
magnified in the home care setting.
            There was a request, and we get
these requests often, and it certainly will be
part of the guidance document, to make it as
clear as we can about what really is
reportable to the FDA.  
            So, the other thing that was
talked about is the fact that there's multiple
data streams for folks that are in the
business of manufacturing home care products. 
And I believe someone named 11 different data
streams of places where information could come
and how do you cover that and how do you get
people to give you the right information or
the best information, given the multitude of
folks out there that are interacting between
perhaps the manufacturer and getting right
down into the patient level?
            And I think that although we
didn't say this, certainly looking over the
notes; and I hope the folks would agree, that,
you know, if we're going to think that we're
going to rely on the patient and we're going
to rely on the home caregiver to give us
really good information about adverse events
and what's going on, we probably are not going
to move a whole lot further than we are now,
with the exception of the fact that we started
to talk about, you know, this electronic age,
and there's sort of two pieces about this. 
And I would certainly agree that not everybody
in the world has the Internet or uses it. 
Nonetheless, we have a very low bar right now,
so, you know, if we can start using more
electronic age to step it up, I think we're
still ahead of the game.  
            But one has to do with folks whose
business it is actually to track devices.  And
I believe they said that originally this was
set up because no wanted to lose them, which
was sort of a, you know, what happened to that
device?  Now I can't account for it.  But in
doing that, they actually acquire a fair
amount of information and that information
becomes a good source of looking across the
data, looking at trends, using data logs to
get information.  So, you're relying against
the individual adverse event.  You're actually
relying on what I refer to as no longer a
passive system, but a more active data source
to get that.
            Also, those kind of systems, it
was pointed out, gives you permanent
information.  You have the record available. 
You can look back in time and can establish an
early baseline for what you may see in the
future.  So again, those type of systems have
some hope for getting better information.
            During this discussion we also
briefly    I think I mentioned, because I may
know more about this right now, because
sitting in my office is unique device
identifiers.  And if you are in the business
of trying to track medical equipment or get
information about medical equipment or
whatever, you know we are badly hampered by
the fact that we don't have a unique device
identifier.  Yes, we have bar codes and yes
that can be used, but bar codes are
meaningless to anybody except perhaps the
person that invented the bar code.  So, I will
assure you that that's very high on our list
and we're working hard on what's really a very
difficult problem, but one that we absolutely
understand that we have to solve to make this
better for everybody.
            And let me back up, because I
forgot to say something that was really
important that someone talked about.  Although
acknowledging the difficulty of getting to the
caretaker and the patient, someone gave some
very good discussion points about things that
the manufacturer can and has considered in
this case about collecting information about
problems.  And that is, that the patient
really could care less about the fact that you
have to report to FDA.  They've got a problem. 
They need to have that problem fixed.  So,
being sensitive to that and training the
person who is on the phone taking this call is
really important.  And if you do this really
well, you may be able to both meet your
customer needs and get the information that
you need to really understand what's going on. 
But in doing that, it means that you have to
be sensitive and thoughtful ahead of time
about the person.  They're not just picking up
the phone and sort of blindly recording little
check boxes.  You really need to spend some
time talking to this customer/complaint person
to get good information.
            So, then we talked briefly about
more sort of moving into the electronic age. 
And again, I was talking to you about sort of
existing data sources and data logs that you
may not have thought could be valuable in
giving you the information, but also thinking
about what's coming very quickly, which you
all know about or is here in a lot of cases,
is electronic health records and the patient
health record.  So, we will be seeing a day
and age where    again, it's already happened
in lots of places, but increasingly where the
patient has access to their own health care
record and they're communicating very directly
with their physician or physician's assistant. 
And so, as that happens we need to be attuned
to the fact of what are the opportunities
here?  As the Internet gives us opportunities
to do training videos opposed to just having
the little paper and audible languages, the
electronic patient health records may give us
opportunities to get feedback from the patient
and the caregiver, again get better
information about what's happening.
            One of the ways that electronic
health records are used for the drug people,
or they're looking into, is to have cues in
the electronic health records.  So, when a
physician discontinues a drug, something pops
up quickly and says did you do this, because
there's an adverse event?  That's nice, really
good information for drugs.  Really much more
difficult, but not impossible for the device
industry.  Because we have some many products,
you know, it's hard to get one solution that
fits all.  But again, as we go down this path
we can think about how we can use these
records and how we might be able to build in
algorithms or cues that might give us
information, or at least let us know that
there has been a problem and maybe we can go
back and try to figure out what that is.
            And then the other discussion was
maybe there are devices that just shouldn't go
into the home.  And while we certainly
acknowledge that that seems to be the
direction that everything is going, it is
certainly up to us, and I think in doing our
guidance document, that we need to talk about
some of those parameters and what they might
            Okay.  If anyone in the group has
more to add, please raise your hand and jump

in.  Thanks.
            MS. BROOKS:  Thank you, Dr.
Gardner.  Appreciate it.
            We've received a tremendous amount
of feedback from the breakout sessions.  And
right now we're going to open it up for
question and answers.  So, if you've heard
something in one of the breakout sessions and
you would like to respond to that particular
group, or you have a question, please feel
free.  Remember this is interactive and we
want everyone to participate.
            Okay.  We also have a mic in the
middle of the room and we'll be passing one
around.  So, you can ask directly to the panel
members up here and you can also ask directly
back to the breakout session group.
            MR. WELSH:  Actually, I think it's
probably directed at you, and it has to do
with the labeling repository and    
            MS. BROOKS:  Speak directly into
the mic.
            MR. WELSH:     whether or not any
thought has been given to how it would address
single use devices where generally the
labeling is there with the device.  Is it
really within the intent to gather information
on all home use devices, or only those devices
that are durable?  You know, how far down is
that going?
            DR. BRADY:  I think I can answer
that.  We're still in the process of
developing this labeling repository and trying
to figure out what it is we need and don't
need.  That's why we're doing the pilot, to
see what kind of information comes in and what
really is necessary.  What do people want to
see when they're trying to find labeling on
the Web.  Is it really a disposable device, or
is it something that they want to have
information on their legacy device, or
something that's new that the manufacturer no
longer has on their Web site?  We're trying to
gather this, and that's what we'll do during
that pilot period.
            In addition to that though, to
answer your question, I think we will probably
end up going in a direction of there will
probably be some devices that will be excepted
from having their labeling up on the Web site. 
We haven't gone that far to address that yet
and we will more than likely have a public
workshop on that one as well, because we want
to get your feedback on what we think is
essential.  But it will be information.  It
will be instructions for use.  It will be
graphics.  What it will not be, it will not be
the technical manual, it will not be the big
user manual and it will not have the lock out
mechanisms on there.  That's the plan right
now, because we believe that that's something
that goes between the health care professional
and the manufacturer unless we hear something
different from the public.  But that should be
something that stays separate at this point.
            Does that answer your question?
            MR. WELSH:  Yes.  
            MR. DiTULLIO:  So, this is
directed to Susan on the post market group. 
So, your comments about, I guess it's FDA's
displeasure on the MDR or the reporting system
in terms of it not being active, in terms of
it being passive and not really fulfilling
what it was intended to do, your not the first
person I've heard from the FDA publicly talk
about this.  I know the FDA is displeased
about it.  And so, in terms of how the
partnership between the agency and the
manufacturers and the people who train the
users, in terms of that whole partnership, how
could that be, because I actually see that
being a key point in whether you believe that
we could further move into the home in a safe
manner knowing that there might be
underreporting or what have you, right?
            DR. GARDNER:  Well, I don't 
            MR. DiTULLIO:  That's not on. 
Before you answer, let me say this:  Being in
manufacturing now for 36 years, I believe
manufacturers do a good job of reporting.  And
there's a quality system mechanism that
actually leads you to reporting starting with
the knowledge of the customer complaint and
how you handle that customer complaint and
then going through the checklist of exactly
how you evaluate it from a safety point of
view and so on.  And that leads to a decision
and the decision is auditable.  So people find
the information, they evaluate the information
and report the information or they don't and
they document it otherwise.  So, it must be
that the user facilities are the ones that are
underreporting in your mind, or are you
disagreeing with the premise that I was
            DR. GARDNER:  You know, in some
respect you don't know what you don't know. 
But, first of all, let me sort of re 
characterize the MDR system.  It is    say for
the best, it is primarily a passive reporting
system.  In the world of surveillance, that is
not where you would like to be.  And anybody
that's doing any kind of surveillance would
want to move from a passive system where
people just are sending in things sort of
because they have recognized it to a more
active surveillance system where you actually
either encourage or directly get information,
or have it in registries or clinical trials,
or whatever.
            So, I think we realize the
limitations of the system.  At the moment
though it is also the key way that we get
information.  And despite its shortcomings,
every single day we see signals that we act
on.  So, it's key and yet we know it could be
so much better than that.
            I would love to say that I think
all manufacturers are good reporters; they
aren't, but I'm not condemning the industry as
a whole.  Please, don't take it as that.  But
I can also tell you from experience, you know,
there are folks that could do better.  But I
think my overall opinion is that industry is
concerned about their customers and their
patients, and they're trying very hard to do
a good job.
            Is your information limited by
user facilities and users?  Absolutely it is. 
And I think there's a whole bunch of reasons
why that is true also.  Some of the fears that
I talked about, the liability fears, you know,
are pervasive in many different aspects.  I
know in MedSun, a lot of the hospitals, we
always encourage them to give the device back
to the manufacturer.  And we say, look, they
know the device better than we do.  If you
want to understand what happened, you have to
give it back to the manufacturer.  And they
often say, well, our risk manager, our lawyer;
you know, you know this story, won't let us do
it because there's liability concerns.  
            Again, there continues to be lack
of recognition that an incident is related to
the device.  And, you know, all those things
are just one more reason why sort of the
current state of affairs with this passive
system doesn't give any of us the information
that we would really like to have to look at
these products.
            We do see the coming of UDI.  We
see the coming of electronic health records. 
We see the increased interest in registries as
being a boon to all of us that are concerned
about patient safety, because I think we will
get better information.  I'm sure we'll get
better information.  And, you know, I don't
think that means that MDR then becomes
unimportant.  I think it actually will stay
important, but I think it will move from being
the biggest thing we have right now to one way
of looking at getting signals.  And that will
be then merged in or looked at with other
available information.  
            And that's really similar to the
way we use MedSun right now.  We get 90
percent of our reports in MDR from the
manufacturing community, but we have this core
of hospitals that are giving us really good
information, too.  So, we get to look at those
systems together.  Again, as we start
developing registries, we'll have the other
information to put in.  And so, we're not sort
of worried about whether we're really seeing
something or not.  
            Does that answer your question?
            DR. BRADY:  Susan, I'd like to add
onto that.  I thought that was a very good
response.  I also wanted to add, one of the
things that we're trying to do with the Home
Use Initiative is to really reach out to the
health care professional in the home and the
caregivers and care recipients.  And as I
said, one of the earlier things that we were
doing was educational outreach.  And we want
them to know what a medical device is, number
one, and number two, your reporting
responsibilities.  Not obligations
necessarily, but responsibilities.  That you
need to take charge of your medical device and
how you're interacting with it.  And if there
are problems, you need to let the manufacturer
know so that they can remedy it, because it's
unfair to the manufacturer as well. 
            And secondly, I'd like to say too,
I think manufacturers can help us out and
probably in their decision making tree is this
reportable or not?  Can I develop a couple of
extra questions in my decision making tree? 
When I find out where that event occurred,
what are some of those other things that I
need to be looking for that we talked about
today?  How were you interacting with that
device?  Who was interacting with that device? 
What was going on in the environment around
you?  I'm not telling you to get a whole tome
on it, but maybe ask a few more probing
questions on that.
            The section where we ask for the
location of the 3500(a), on the reporting
form, is not a mandatory thing.  So if you
don't fill that out, we don't send it back to
you and dun you for it.  So, we end up with a
lot of blank pages or we end up with something
that's a little bit obscure, because we see
the word "home" or "school" or "hospital," but
we don't know anything more than that.  We
don't even know where in the hospital
            So, having the manufacturer maybe
probe a little bit more when you're getting a
complaint and then we will work on the side
with the users to educate them on what a
device is and what they need to do to report
problems.  Maybe we can do a little bit better
            MR. DiTULLIO:  Susan, you
addressed it very well, very articulately.  I
was bringing it up in the context of, well,
you're here for this meeting, so clearly post 
market is very important in the home use
environment, probably way more so than it is
in the professional environment because we're
maybe even more concerned about being further
away from a professional or a manufacturer who
would facilitate a report.  Okay?  So, knowing
that there's this issue in the better world,
in the professional world, we clearly not only
need to resolve that by understanding it and
fixing it, but we actually have to increase
the veracity of it because going into the home
is going to be yet a more stringent
environment, a more difficult environment for
the enforcement.  If it's passive now, it will
become even more passive.  Although, if my
mother were at home using a medical device by
herself, she'd be the first to complain, I'll
tell you that.  That's the reason I brought
that up.
            DR. GARDNER:  Okay.  Yes.  Well, I
mean, by agreeing with you, and all of you,
about the challenges of getting good
information from home care, that certainly
doesn't mean that    and I don't think anyone
has done this, it is still the manufacturer's
job to do the best that you can and think as
cleverly as you can to get the information. 
I mean, you have to monitor your products and
know what's safe out there.  But, we do agree
that you face formidable challenges.  As Mary
said, we will do the best we can on our part
to inform the user that this is an important
piece of information.  
            Again, that's an important piece
of our MedSun Program, to continually remind
users who have said to us, well, I don't want
to tell the manufacturer.  And our response
is, well, you have to tell the manufacturer
because that's the only way we can get this
            Part of the home use group, and
again part of MedSun is we've developed
materials, we have posters to put in the
hospitals, we have things that we send around,
and we have brochures, again to try to do
outreach to encourage reporting.  So, the
acknowledgment mostly is this is a
particularly difficult place to do it, but we
all need to try and get there.  And I do think
that the future offers more hope through
electronics and whatever.  
            MR. WILCOX:  I just have a
technical question.  I'm sure that various
people in the room as they go home will have
some brilliant idea about what needs to go
into this guidance.  What's going to be the
most efficient way to send you additional
            DR. BRADY:  Where you registered
online for the meeting there's also a section
now open for electronic comments, and we'll
have that open for another month.  So, please
feel free to use that and we will take those
and they will be part of this whole
transcription process.
            DR. ZIONE ALALE:  I'd like to
address my question to the gentleman that had
the wireless group.  And my concern as a
registered nurse and a professor of nursing is
that is the FDA prepared to provide guidance
in how strong the wireless frequency can be? 
            This is my concern.  Our
communities, especially in our urban
communities, are increasing in radioactive
frequencies by the rate of 100,000 percent per
year.  Some of our North American cities have
enormous, with cell phone towers, radiation. 
And CDC has reported that we've moved in
autism from one child in 10,000 20 years ago
to one child in 150 two years ago.  And now
the latest report is that in some communities
like Arkansas one child in 60 is autistic.
            And the scientists have documented
that this non ionizing radiation that's coming
from electronics and wireless is contributing
to the loss of a vital function of immunity
called apoptosis.  In other words, when your
body makes an abnormal cell, you have a built
in mechanism to destroy that cell.  The
radiation arrests that in the body because the
magnetic polarity of wireless and of radiation
electronics causes cells to spin backwards. 
There is limits that have been established by
National Institute of Health and they're
telling us that anything above a half a
milligauss of radiation can become highly
assaulted through DNA and stop apoptosis.  
            My concern as a nurse with
wireless telemedicine is that when you send a
digital pulse to the patient's house to zap
them, if they've got wireless from their
computer in the home, if they've got a digital
TV or a plasma flat screen, and they've got
their cell phone charger and lamps and stereos
at the head of the bed, and then if they're in
a Zone 1 that the EPA has defined a
radioactive environment    like Ohio, we're 80
percent Zone 1, meaning that we are post World
War II with a lot of radioactive ground.  And
you send a digital pulse there, you could
actually hyper stimulate them and throw them
in a heart attack.  
            And so, there has to be some kind
of way of regulating this.  This is not just
a figment of my imagination.  This is
happening in Chicago right now, because Con
Edison has digitalized the electronic meters. 
And a company flew me to Chicago and we went
to a mansion.  People's hair was walking
around in the air from the convergence.  The
mother couldn't kiss her children anymore
because they were shocking each other.  And we
had to put mitigations in that home to lower
it.  And this is a real concern.  
            I am one of thousands of women in
American with radiation dermatitis to my
breasts.  I fight breast cancer every day.  My
breasts got fired, charred with radiation and
turned black.  And I got passionate about this
because I had to go to Frankfurt, Germany to
meet doctors and to learn how to restore when
the doctors gave up on my breast tissue after
eight months of suffering.
            MS. BROOKS:  Okay.  So, the
question that you're asking the FDA then,
because we're way behind schedule here   
            DR. ZIONE ALALE:  Okay.
            MS. BROOKS:     is you're asking
the FDA are we going to put limits on
            DR. ZIONE ALALE:  Yes.
            MS. BROOKS:  Skip, do you feel
comfortable speaking to that?
            MR. WITTERS:  I am not a human
exposure expert, so no.
            MS. BROOKS:  Okay.
            DR. ZIONE ALALE:  Okay.  Thank
            MS. BROOKS:  But we will take your
comments.  We're taking everyone's comments.
            And we got time for one more quick
little one.  We see a couple people here
who've been holding on for awhile.
            AUDIENCE MEMBER:  Hi, I had a
quick question regarding a shift towards
telemedicine.  Clearly, there's going to be
cases where the caregiver would want total
access to all the information that would be
provided by a device.  But I was also
wondering if there would be some guidance
provided for cases where due to liability
reasons possibly the patient would not be
allowed to have full access to the information
to prevent say self diagnosis or something
along those lines, where the data would be
delivered directly to a physician.  So, I'm
thinking primarily telemedicine on this one. 
Is that something that could be addressed in
the guidance?
            MR. WITTERS:  Yes.  I think we
spoke about the remote readout and monitoring
of patients.  And I think I mentioned about
the remote capabilities that might be planned
for actually remotely turning on various
functions of medical devices over some piece
that may have wireless technology to it. 
            Telemedicine is a big issue,
particularly in rural and areas that are
outside of the urban and suburban.  Several
countries have a big portion of that.  The
U.S. has a large effort in the Indian Health
Organization, for example.  Canadian
government has a large effort in that area as
well that has a lot of lessons that we are
hoping we've heard some of and we'll learn
more about.  So, yes, that's a big issue.  I
think a lot of it will be hopefully learned
and used in this document that we're trying to
            MR. DESAI:  In the guidance
document, the 6061 1 11 one, is that a primary
document that is going to be mentioned for
environmental factors for non electrical
systems?  Thank you.
            DR. BRADY:  You mean   
            MR. DESAI:  For non electrical.
            DR. BRADY:  For non electrical. 
There are    oh, I should probably let Dave
answer that.
            MR. OSBORN:  As to what the FDA
does, we'll find out over time and perhaps we
can have some influence to that.  It is
certainly true that 1 11 has in it many
requirements that are equally applicable to
non electrical medical devices as medical
devices.  As I was listening to several of the
issues that have been raised in the area of
labeling, I didn't speak to the labeling
section because they asked me to speak to the
environmental section, but I lost count, but
well over a dozen of the issues that were
raised are explicitly covered in the labeling
            I see some shaking heads from the
other experts who were involved.  So, Brody or
Joe, did you keep count as to how many were
            (No audible response.)
            MS. BROOKS:  So, we are doing the
wrap up session right now.  And I just had one
comment back from all the great comments from
the breakout session.  It seems like there's
a lot of concern about updating your labeling
and whether or not it requires a new 510(k). 
How many people, a show of hands, are going to
be here tomorrow and Wednesday for the
infusion pump?
            Okay.  Great.  I'm pretty sure I
know the answer, but I don't have enough
stripes on my shoulders yet or on my sleeves
to answer that, so I'll get that answer
tonight and update the group tomorrow, because
I will be speaking a couple times tomorrow
morning.  And we'll make sure that we also can
post that information hopefully on the Web
            DR. BRADY:  I just have one favor
to ask manufacturers.  Has anybody ever used
the self checkout at Giant or another grocery
store?  They're probably the most evil
invention I've ever seen.  I tried to use one
yesterday and I always try to fool that thing. 
I think this time I'm going to get through
without somebody having to come and help me. 
And yesterday I bought a card and it was it
the first I buzzed through.  And I put it on
the rolling thing and it went down to the
bottom, but it didn't make it quite to the
bottom.  So, the lady stopped me, the little
voice, and she says move your card to the
bottom.  And I didn't want to move it to the
bottom.  I just wanted to get everything else
down there, too.  She would not let me do
anything else.  
            So, when you're designing your
devices, please, in the future, keep these in
consideration.  Please do not use a self 
checkout thing as an idea how you want to do
this, because they're evil.
            I don't know how that went through
my mind.  I think when I was sitting up here
it was like, oh, gosh, what is not user 
friendly that people thing is great?  
            I want to spend just a few minutes
going through some take home notes that I
have.  I feel we got just a wealth of
information today.  I thought this was a
really good group of people who really
initiated a lot of discussion, a lot of
questions.  Areas where we thought we were
going in the right direction like with the
labeling definition and the home medical
device labeling definition may be not so good. 
And that's why you ask other people, because
you know you get involved in things and you're
thinking I'm heading in the right direction. 
And then somebody tells you, no, you're not. 
And then multiply that times ten or fifteen,
no, you're not.  
            So, this has been just tremendous
for us and we are going to take what you've
said to heart.  And the things that we can't
agree with, we will tell you when we can't
agree with them and the other things we will
try to incorporate.  I personally really
appreciate this.  This is going to be a very
difficult guidance document to write, or I
thought it was, but with a lot of the help of
you, I think it's going to be a lot better.
            We had a lot of really good take 
home notes from the breakout sessions, but
what I do hear is that we need to seriously
consider the existing standards for devices
and adopt them where we can.  All of the
international standards, ignore that place. 
We're not there today.  
            And use the existing guidances
that FDA already has in place for other pieces
like the patient labeling and our human
factors, or update those as necessary to be
incorporated into the home use labeling
            In the area of the caregiver and
care recipient, we need to look at the
barriers that they face, which we pretty much
confirmed in the breakout session that there
are a lot of barriers, and I think we got a
really good list today during the breakout
            There are a lot of sources of
training and we need to look at the type and
the source of training.
            Training needs to be geared toward
the end user, whether it's self directed or
facilitated, but it needs to be geared toward
the end user.  I think that confirmed some of
our thinking as well. 
            Know the user.  It can be multiple
people interacting with a device, especially
when people are out in an ambulatory mode or
children are going to school.  A lot of people
are interacting with that device and we need
to keep that in mind.
            Keep the user involved throughout
the design process.  
            Separate the types of training
depending on the complexity of the device. 
And I think I heard that numerous times.
            There are different paths that
devices get into homes and we need to take
that into consideration and be appreciative of
that when the manufacturer's designing
something, because they don't know every
direction it's going to go.  But there are
many different ways that devices do get into
            With manufacturing labeling, I
heard we need a classification or degrees of
home use devices possibly by risk.  That's the
first I've heard of that.  So that was a very
interesting point.
            We need to address the legacy
devices that are out there and we need to work
with reimbursement.  As much as I don't like
that word, we do need to work with that.
            In the area of wireless, there is
a difference between medical devices and ones
that just transmit data.  And we're going to
need to be pretty clear on that, if not in
this guidance, in a  subsequent guidance or
ones that we revise with the wireless.
            We need to validate the
communication, both the outgoing communication
and the feedback.  And we need to find out
what's the best way to get validation for
            We need to address interference,
and we kind of knew that one as well.  That
validated something we were thinking.  
            And we need to look about the
emerging technologies and the existing ones
and how quickly they're changing, and do we
want to incorporate potential obsolescence
into our guidance document?  Or what do we do
with that information knowing that in two
years    which it usually takes us three years
to write a guidance, right?  Do we really want
to have something like that in there?  So, I
thought that was a very important point.
            Also, the different areas of
security and power and dedicated bandwidth or
spectrums need to be addressed, and that will
be addressed.
            In the area of patient labeling,
labeling cannot be standardized.  It has to be
kind of general.  It cannot be prescriptive. 
We can't be too prescriptive for the
manufacturers so that all of sudden it just
becomes such a horrible burden to even try to
follow this guidance, but the guidance needs
to be general enough so that it will cover a
bunch of different users in a bunch of
different environments.  But it also needs to
make sure that it's not too general, yet not
too prescriptive.  So, we have a little bit of
an area to work with in there, but we need to
balance that.
            We need to balance the level of
simplicity and the level of training that
people get to.  We had a lot of discussion
about the eighth grade level of education and
sixth grade and Alzheimer's and people with
other cognitive problems.  So, that is
something we need to really try to work on and
probably try to figure out a way to help the
manufacturers get some good user testing
            In the area of post market, the
privacy issues, insurance issues,
reimbursement issues, all lead to no
reporting, so how do we get around that?
            We need to make the reporting
requirements very clear in the guidance
document.  And we have to make sure it's
getting to all the people who    I don't know
what I wrote there.
            So, let's see.  The methods to
track the devices must be used whether it's
UDI or bar codes.  I know radio frequency is
another popular way, but there are ways to
track devices and we need to address that some
way, probably in a more general sense.  If you
are tracking your device, how are you tracking
your device versus being prescriptive and
saying this is how you must track your device.
            Customer service came up over and
over again.  Customer service has to be good. 
I would even submit it has to be excellent. 
That is the contact that you have with that
patient or caregiver and that is the contact
that caregiver or patient has with you.  You
want that to be the best it possibly can be
and it will eliminate a lot more problems in
the future, I believe.
            And that there are opportunities
in the electronic health records area and we
should be looking at ways to build in
algorithms to help with that problem.
            Two things I didn't hear from the
breakout sessions, but I did hear earlier
today, is that we need to think about, and
maybe not in this guidance, but somewhere
along the line, the devices that are going
from home to hospital and how that needs to be
addressed.  I don't know that that is an FDA
issue, but it is something we need to at least
talk and either rule out or decide that we're
going to do something about it.  
            The other big area is the
purchasing of prescription devices on the
Internet.  Huge problem.  That really is a
worse problem for the manufacturers than it is
for us, because you are losing out on some
good customers.  So, that's a compliance
issue.  We weren't addressing compliance
today, but it is something we need to really
be thinking about in this area of home use.
            And if there aren't any other
questions, I really, really thank you for
coming today.  This has been so beneficial. 
And we will try to get back to you as soon as
possible.  We're going to get the slides up
hopefully on our Web site by the end of the
week, if not sooner.  I'm going to trust Ian
to work with our Web people.
            And the transcription services
takes about two weeks, but everybody will get
a copy.  That will go up on our Web site as
well.  If you gave us your email, we will
inform you by email that that information is
up, so you don't have to be looking for it all
the time.  Okay?
            Thank you very much.
            (Whereupon, the meeting was
adjourned at 4:12 p.m.)

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