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Medical Devices

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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 1)

  U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

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          FOOD AND DRUG ADMINISTRATION

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   MEDICAL DEVICE USE IN THE HOME ENVIRONMENT
               GUIDANCE WORKSHOP:

   IMPLICATIONS FOR THE SAFE AND EFFECTIVE USE
     OF MEDICAL DEVICE TECHNOLOGY MIGRATING
                  INTO THE HOME

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              MONDAY, MAY 24, 2010

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            The meeting came to order at 8:00
a.m. in the Maryland Room of the Hilton
Washington DC/Silver Spring, 8727 Colesville
Road, Silver Spring, Maryland, Mary Brady
presiding.

PRESENT:
MARY BRADY, RN, MSN, OSB/CDRH/FDA
MARY BROOKS, BSN, MS, OSB/CDRH/FDA
SONNA PATEL, PhD, OSB/CDRH/FDA
JANETTE COLLINS MITCHELL, MS, RN, OC/CDRH/FDA
SUZANNE MINTZ, President and CEO, National 
      Family Caregivers Association 
DAVE OSBORN, Standards Coordinator, Philips 
      Healthcare
PAT PATTERSON, CPT, Human Factors Expert, 
      Agilis Consulting
DON WITTERS, OSEL/CDRH/FDA
SUSAN GARDNER,PhD, OSB/CDRH/FDA
TERRI GARVIN, ESQ., OCER/CDRH/FDA
LISA WINSTEL, NFCA
SANDY BERMAN

                 C O N T E N T S

Our Charge, Mary Brady. . . . . . . . . . . . .4

General Overview of Pre Market and Post 
Market, Mary Brooks . . . . . . . . . . . . . 22

Discussion of the HHC Definition and Feedback,
Sonna Patel . . . . . . . . . . . . . . . . . 37

PRE MARKET
Unique Characteristics of the Environment
Dave Osborn . . . . . . . . . . . . . . . . . 59

Human Factors and the Unique Characteristics
of the User, Susan Mintz. . . . . . . . . . . 74

Caregiver and Patient Labeling
Pat Patterson . . . . . . . . . . . . . . . . 94

Wireless Issues in the Home, Don Witters. . .110

Questions and Answers . . . . . . . . . . . .126

POST MARKET 
Post Market Issues
Susan Gardner . . . . . . . . . . . . . . . .145

Public Comment
Robert DiTullio . . . . . . . . . . . . . . .159
Nancy Kramer. . . . . . . . . . . . . . . . .163
Aaron Moskowitz . . . . . . . . . . . . . . .165
Joseph Murnane. . . . . . . . . . . . . . . .166
Anna Nowobilski Vasilios. . . . . . . . . . .168
Marcia Nusgart. . . . . . . . . . . . . . . .169
Molly Story . . . . . . . . . . . . . . . . .173

Questions and Answers . . . . . . . . . . . .177







                 C O N T E N T S

Reconvene with Reports by Breakout Groups
Environment of Use, Sandy Weininger . . . . .186

Human Factors, Lisa Winstel . . . . . . . . .195

Wireless, Don Witters . . . . . . . . . . . .208

Patient Labeling, Pat Patterson . . . . . . .220

Post Market, Susan Gardner. . . . . . . . . .235

Additional Questions and Comments . . . . . .245

FDA Summary, Action Items, Future Work. . . .266

Adjourn
 
              P R O C E E D I N G S
                                       8:13 a.m.
            DR. BRADY:  Good morning.  I'm
going to get started.  I apologize for the
delay.  Apparently there are a lot of traffic
issues around here, and there are a lot of
parking issues that we weren't aware of.  So 
this is the first time we've really used this
building for a public workshop, so we're kind
of learning the ropes.
            Anyway, I wanted to welcome you
today and thank you for spending your time and
money to come to this FDA workshop.  It's our
first public workshop we've had on the Home
Use Initiative.  
            I'm going to make sure everybody
can hear me.  You're all good?  Okay.
            I see some familiar faces, and I
see some new faces out there, and I know that
we're all here for one purpose and that's to
assure that medical device use is safe in the
home environment.  Today is jam packed.  I
have allotted a little bit of extra time at
the end of the day so in case we're running
behind,  like we are already, and we'll just
keep plugging along, and hopefully we can get
things done.
            I am Mary Brady.  I've chaired the
Home Health Care Committee at CDRH, at the
Center for Devices and Radiological Health,
since 2001.  I've been with FDA for over 20
years.  I bring a nursing background with a
lot of clinical in the hospital, long term
care, public health, the Peace Corps, and FDA. 
I also have done home care.  I have a master's
in nursing and a post    it's an early
doctorate in international nursing.  
            I started FDA reviewing adverse
event reports, and I looked at infusion pumps. 
That was my job for almost two years, just
looking at infusion pumps.  Then I moved to
supervising the nurses who were reviewing the
adverse event reports, eventually going to
interpreting the regulation for adverse event
reporting to industry and to user facilities. 
And now I'm working in a global atmosphere for
global harmonization, international standards,
and also with the Home Use Initiative.
            I'm going to give you    actually
I'm going to ask you to please look through
your folders briefly.  When you look on the
right side, you're going to have the agenda,
you're going to have logistics for today, and
you'll have the white paper on the right side. 
The white paper is what was released to the
press on April 20th of this year.  When you
have some time, just take a look through it. 
And that's all of the initiatives that we're
going to be doing with home use and medical
devices.
            I'm going to go through the agenda
in just a couple of minutes.  The left side
has information just for you.  There's a
couple of different sheets of web sites. 
They're different sheets, so don't throw one
away thinking we have duplicated it.  They're
very informative and quite handy to have
because navigating an FDA web site can be
difficult at times.  
            There are some brochures in there
that the Home Health Committee has done, and
you will also find some MedSun information.
There's also a questionnaire in the back.  So
if you can take five or six minutes sometime
today and fill that out.  We're going to have
a box in the back where you registered and got
your badges, and if you could just throw that
in there.  We don't need your name.  We just
need some information, if you could do that
for us, please.
            So now I'm going to go on.  I'm
going to give you a brief history of the
committee.  Back in 2001, our then center
director Dr. David Fiegal asked us were we
looking at everything that we needed to be
looking at?  If we weren't looking at
everything, what were we missing?  And at that
point I wrote a paper and I said we need to be
looking at the safe migration of medical
devices going into the home environment.  This
is a burgeoning industry, and we need to take
a look more closely at that, given that most
of our devices are cleared or approved for use
in a clinical environment by clinical people. 
            So, at that point, Dr. Fiegal
said, please, go ahead and let's start looking
at that.  We formed a committee, and we spent
a year looking at what FDA had been doing on
the inside, what the outside, the public was
doing, and what were the gaps in between.  
            In September of 2002, we held a
public meeting where we asked people, we said
this is where we're thinking that we should be
going.  Do you have any suggestions?  And that
was a very helpful meeting because at that
time we were then able to identify what we
felt were the seven different stakeholders
that are necessary for safe medical device use
in the home.  And we were also able to start
gearing where we wanted to start focusing our
work.
            The seven stakeholders that we
believe are important for home use are
manufacturers, distributors, human factors
experts, professional organizations, health
care professionals, other government agencies,
and, of course, the main person, the
caregivers and the care recipients.  
            One thing that everybody asked us
to do was they said, please, you're the
government.  Please don't write new
regulations for this.  Can you look and see
what you already have existing in your
regulations and help us that way?  So we spent
the next few years focusing on what we had in
our regulations and what we didn't.  What we
had in guidances and what we didn't.  What
standards had and what they didn't have.  And
we started to really narrow down where we
wanted to go.  
            We spent time at this point doing
a lot of educational outreach, trying to teach
people what a medical device was.  We ended up
having exhibits down at Medtrade, we went to
different conferences that pertained to home
care and spoke at those.  We wrote many
different articles, and we also put together
some brochures that you have to educate people
about medical devices and their safety.  All
of these activities then led to the Home Use
Initiative that came out last month in April. 
All of those different focus activities led us
to those five areas.
            So these are the five areas for
the Home Use Initiative which you'll see in
your white paper.  The highlighted one is the
one we're working on today, and that is
guidance for pre and post market design,
testing, and monitoring.  
            Mary Brooks is going to explain to
you what guidance is, but basically pre market
is geared towards manufacturers.  I just want
you to know there's people other than
manufacturers here, so, and we need to explain
that.  Pre market is geared toward
manufacturers.  And post market surveillance
is geared towards manufacturers, home care
agencies, and other user facilities, and also
the health care professionals and the lay
users of these devices.  
            We're also going to be working
with accrediting bodies.  There are three main
accrediting bodies for home health care
agencies.  We're going to be working with
them, developing agreements to find out where
we can put medical devices into their
standards.
            We're going to enhance
surveillance.  And it's not one that we're
focusing in depth on today, however, Susan
Gardner will be presenting what we looked at
for enhanced surveillance activities because
surveillance will be in our guidance document
for the post market area.  
            We're looking at developing a
labeling repository.  And what I mean by this
is it's something very similar to what    if
you've only been on DailyMed, you can see you
can pull out any medication that you want and
get all of the information that you want on
that medication.  So what we're trying to do
here is eventually get all medical device
labeling out there for both old and new
devices.  This is a very, very long term
project.  We are starting with home use
labeled devices.  Okay?  And we're going to
ask manufacturers to voluntarily submit their
labeling, and we're going to work with those
manufacturers to get it submitted to us
electronically.  
            We had the 60 day notice went out
last Tuesday.  Some of you might be aware of
that, and that's the notice saying that we are
going to be asking for this, and we'll be
getting comments back.  We'll respond to those
comments, and then we will go ahead with a
final 30 day notice.  Okay?  And then whoever
volunteers, and we do have one so far, we will
work with them closely to pass the information
on electronically into FDA's site.
            Finally, there's outreach to the
public.  And here we are, we're going to be
developing videos.  And the first ones that we
develop are going to be educational videos for
lay care people and for health care
professionals.  A lot of people tend to think
of medical devices as being lifts and scooters
and wheelchairs, which of course they are, but
there's many other things out there, and we
want people to be aware of what it is that FDA
does regulate.
            We're going to be increasing our
presence at the different conferences and
exhibits and working with manufacturers who
want to become compliant with the law, or if
they are already compliant with the law, that
we can work with them to talk about the home
use guidance area.  And we're also going to be
working with the Healthy Homes Initiative at
the Centers for Disease Control.
            Today's assignment, okay, help us
make a good guidance document.  The first
thing is please listen to the speakers.  We
are going to have four pre market areas. 
Before that, though, we will have    Mary
Brooks; like I said, will explain what
guidance is and give you an example so you
have an idea.  
            Sonna Patel is going to spend some
time on our definition, and we're going to ask
for a little bit of feedback during that time. 
As you know, in the federal government,
definitions are very important.  We put our
definition together based on feedback from the
stakeholders and now we're looking at you to
say are we going in the right direction?  We
have received some feedback from some groups,
but we're asking all of you today to just take
a look and see if you understand what we're
trying to tell you what a home medical device
is.
            Then we will cover our current
thinking based on all of this feedback over
the years.  Our current thinking is from the
information from the stakeholders, and we are
going to share with you what we want to be
writing in a guidance for pre and post market. 
In the pre market area, if Suzanne Mintz
comes, we're still looking for her, she will
tell you about the unique characteristics of
the user in the home.  Okay?  
            Dave Osborn will be telling you
about the physical environment and how it is
unique to the home versus the hospital
environment.  He's going to use the newly 
developed International Standard for Home
Medical Equipment as his foundation for his
talk.
            Pat Patterson will tell you about
the importance of labeling and training for
the caregiver, the care recipient, and for the
health care professional who is going to be
doing the training in the home.  Don Witters
is going to tell you about the issues
surrounding wireless technology and devices in
the home.  I'm not forgetting Susan.  Susan 
Gardner, as I said before, will tell you about
the many ways that we can enhance surveillance
of devices that are used in the home.  
            After the pre market session,
there will be a question and answer period. 
It's going to be for about 20 minutes.  Please
ask questions during that time that are
pertinent to the talks of the people who have
just given them.  If you don't get a chance
during that session, please attend the
breakout session for that particular area and
ask your question then.  We're asking for a
lot of feedback today.  Susan will also have
a question and answer session after the post 
market area, so just keep that in mind.  
            There's also a session for public
comments.  We had asked people ahead of time
if they had a public comment to make.  We have
approximately 30 people who have asked to make
a public comment.  We're going to ask you to
keep your comments short.  We have the list,
and we will call your name.  When you hear
your name, please feel free to come up and
make your public comment.  As I said, I built
in some time this afternoon, so if we end up
having more people who would like to make a
public comment, please let me know at lunch
time, and I'll see if we can accommodate you
this afternoon.  
            During the breakout sessions this
afternoon; and you're going to choose from one
of the five different areas from the
presenters, please participate.  Please.  This
is your time to tell the federal government
what we are missing, what is good, what is
bad, at that point.  Please participate.  And
I ask you, if you haven't signed up, sign up
before lunch.  We need to have a breakout of
the number of people going into each room
because each room is a different size.  So
when you come back from lunch, I want you to
just take a look, and then we'll tell you
where to go.  But you'll meet in here first.
            I just want to warn you that lunch
is very short.  It's 50 minutes.  There are
places across the street.  There are places
downstairs where you can eat.  If you need to
bring your food back with you, please bring
your food back in with you to the breakout
session.  We're fine with that.  And I
apologize, we are unable to provide you with
food.  
            And you should have all of your
badges.  And then finally, if you forget what
session you are attending, there's a little
line on your badge, and you can write it in
there and then put it back in there.  Some
people tend to forget where they wanted to go. 
            And I see Suzanne has come.
            What we will do after the breakout
session then is we will ask for salient points
to be brought back to the main group.  Each of
the facilitators of these breakout sessions
will bring back those salient points and share
with everybody else so that everybody knows
where everybody else is coming from during
that point.  And then we'll have time to
discuss those this afternoon.  So that's the
plan for the afternoon.
            If you end up thinking of
something after today is over, we do have a
place for electronic comments on the docket,
and that will be open through the end of June.
            What we should not focus on today. 
Other portions of the white paper.  Even
though they are very interesting, we don't
have time to look at the other portions of the
white paper today, so I ask that you continue
to focus just on the pre and post market
guidance portion of the white paper.  
            As for marketing any product
today, during the question and answer session
or public comment section, I ask that you not
try to market your product.  If you want to
market your product, please talk to us
separately.  If you're having issues with
marketing your product, please talk to us
separately.  This is an FDA meeting on
developing a guidance document.
            It is not about reimbursement. 
And surprisingly, some people who are just not
real familiar with the government tend to
think of FDA as also a reimbursement place. 
We are a device approver, clearance and
surveillance and compliance regulatory agency. 
Our sister agency, CMS, Center for Medicare,
is the one who does the reimbursement.  So if
you could keep your questions away from
reimbursement, we wouldn't be able to answer
them anyway.
            If you have problems with FDA and
you're unhappy with the way we do different
things, please take us aside separately and
talk to us about that, or we can set up a
separate meeting.  The question and answer
session and the public comment session should
be geared towards the guidance today and not
towards any problems you might be having with
FDA.
            So what we will do is we're going
to take your comments into consideration and
we're going to provide feedback on our
thinking.  We'll provide some of that today,
this afternoon after we hear all of the
salient points.  We're going to provide the
transcript on our web site.  We have a
transcription person here today; he's going to
be helping us with this, and we should have
that up within a couple of weeks.
            We're going to try to issue a
draft of the guidance for public comment in 10
to 12 months.  That is the plan right now.  We
have a lot of things already in place thanks
to a lot of feedback over the years, so we're
hoping that today will confirm what we've been
thinking and add probably a couple other
things that we hadn't been thinking about.  
            So with that, I'm going to
introduce Mary Brooks, and I'm going to say a
little something about Mary here.  Mary has
been with FDA for five years.  She has a BSN,
and she also has a master's in science quality
systems management.  She has clinical
experience in the Army, at Walter Reed and in
home health.  She also has had 30 years of
caregiver experience, having cared for a
family member with a chronic illness.  
            I also have cared for a member
with a chronic illness for eight years, so
this is near and dear to our hearts.
            So with that, I'm going to give
you to Mary.
            (Applause.)
            MS. BROOKS:  Thank you, Mary.  I
really appreciate the nice introduction and I
apologize for being late.  I was probably on
the toll road with Susan.
            MS. MINTZ:  I have no excuse.  I
live 10 minutes away.
            MS. BROOKS:  Oh, okay.  Well, I'm
down in Loudoun County, Virginia, so that's a
trek for me on a rainy Monday morning.  Even
leaving early and preparing can be a challenge
at best.
            Okay.  Good morning.  Again, my
name is Mary Brooks.  I'm in the Office of
Surveillance and Biometrics with Susan
Gardner.  And just like Mary Brady, at the
current I am reviewing adverse event reports
for the agency.  I've been part of the Home
Care Committee when I was in the pre market
ODE part of the FDA.  
            Today I'm going to speak just
briefly, very, very briefly.  Just like a
lottery ticket, we're going to scratch the
surface of a few offices here in CDRH and
hopefully at the end of the day we'll be all
big winners because we're going to develop a
guidance document.  And as Mary said, guidance
documents are very time consuming, so we
really do appreciate your input and it's very
valuable today.
            Under HHS we have several offices
and FDA is one of the offices under HHS. 
Within FDA, we have several centers.  The
center that is going to be developing the
guidance document for you today is for the
Center for Devices and Radiological Health. 
Within CDRH we have several more offices, and
that is Office of Device Evaluation and Office
of Surveillance, Office of Compliance, Office
of Engineering and Laboratories, and OCER.
            So, an overview of device
regulation, again this is the 10,000 foot
level.  CDRH is responsible for regulating
firms which manufacture, repackage, relabel
and import medical devices sold in the United
States.  CDRH regulates radiation emitting
medical and non medical electronic products
such as lasers, X ray systems, ultrasound
equipment, microwave ovens and color
televisions.  
            Medical devices are classified in
three categories.  We put them in Class I,
Class II and Class III.  FDA regulatory
control increases as we move up the classes. 
So, Class I devices are mostly exempt from the
pre market review process which is known as
the 510(k).  Most of the Class II devices do
require pre market 510(k) clearance.  And most
Class III devices require pre market approval
where they have to prove safety and
effectiveness.
            Under the device classification,
in order to get the various classes, there's
lots of things that are taken into
consideration.  Those considerations depend on
the intended use of the device, the
indications for use of the device, the risk to
the patient and also the risk to the user.
            Class I devices generally include
devices at the lowest risk.  And as you move
up the classifications, the risk becomes
higher.  We know as of today roughly 74
percent of all Class I devices are exempt from
the pre market notification.  
            Under the Office of Device
Evaluation, responsibility for the evaluation
of the pre market submissions from the medical
device industry, ODE plans, coordinates and
renders agency decisions regarding marketing
medical devices in the United States.  
            Under the Office of Device
Evaluation, again there are four types of pre 
market submissions.  The pre market
notification submissions is 510(k)s, pre 
market approvals; more or less known as PMAs,
product development protocols, and those are
your IDEs and your pre IDEs, and your
humanitarian device exemption applications,
those are HDEs, and those are devices that are
for a very, very small group of the
population.
            Again, there is the Office of
Surveillance and Biometrics.  And big picture
is the responsibility for the overall
evaluation of post market device safety and
effectiveness once the device is on the
market.  And again, Susan Gardner will be
talking more about OSB this morning.
            Again, OSB receives and evaluates
adverse event reports.  These reports come
from manufacturers under the 3500(a) and also
from the user facilities and the hospitals
under the 3500(a).  And we also receive
voluntary reports under the MedWatch voluntary
document.
            All of these adverse event reports
are put into a system called MAUDE.  We love
her dearly.  And the MAUDE database is a
searchable database.  It's also available on
the FDA's website for the public, along with
MedSun reports.  
            OSB also has post market safety
communications responsibilities.  Some of
these responsibilities include working with
the MedSun newspapers to MedSun hospitals
providing newspapers, newsletters to the
country.  And also, the FDA provides patient
safety news broadcasts.  And again, all of
this is available on the Internet.  
            OSB also works with pre market and
the post approval studies, making sure the
post approval studies are completed.  And OSB
also has a 522 post market surveillance
studies.  So if a device is acting or having
unknown adverse events post clearance, OSB has
the authority to ask for a 522 study to try to
answer some of the concerns that they're
seeing post market.  
            OSB also works with OCER, Office
of Communications, and we help support them in
communications to health care professionals.
            So, today we're here to get your
input on developing a guidance document.  So,
what is a guidance document?  A guidance
document represents the FDA's current thinking
on a topic.  It does not create or confer with
any rights for or on any person, it doesn't
not operate to bind the FDA or the public, and
we do allow alternative approaches.
            Guidance documents in general. 
There's two categories.  We have general
control.  These are non binding
recommendations to manufacturers.  And special
control guidance documents are a little more
prescriptive.
            This is a guidance document that I
have worked on pretty intensely for the last
two years.  It just came out for public
comment, and tomorrow and Wednesday we're
actually going to have a workshop on this
guidance document.  So, now I'm just going to
very quickly go to the guidance document and
we're just going to flip through it so that
you have an idea as to what a guidance
document is itself.
            So, this is the total product life
cycle for infusion pumps.  And within this
document, as you can see, and this will be the
same for the guidance document that we develop
today, there is going to be an opportunity for
public comment, and it will be available on
the Internet.  We will take the public
comments and incorporate it back into the
guidance document.  
            There's an introduction period in
the guidance document itself, so we're
actually introducing what products that we
want to cover.  So, our charge is looking at
the homecare environment.  So, that would be
our introduction and our scope.  As you can
tell, they're very lengthy and long and we do
cover lots of different aspects.
            We talk about risk to the health
of the patients that are using them, and also
to the operators.  
            In this particular guidance
document for infusion pumps we're asking for
assurance case studies.
            Alarms are concerning for us in
this particular guidance document, so we've
asked manufacturers to consider alarms.  So,
as you go through the day, think about what
you have concerns of for a device that's in
the home environment, because you get to help
make up all of the various elements.  These
elements that are in this particular guidance
document are from the pre  and post market,
and also the post market adverse event reports
we've been able to incorporate back into the
pre market guidance.  And that whole process
is called TPLC, which is the total product
life cycle.  
            You know, people wonder what comes
first, the chicken or the egg.  Well, when it
comes with device, we know that it's in the
lab with device design.  So, we want to make
sure that once that device has been cleared,
or if it's a Class I and it just needs
registration and listing, that the
manufacturer looks at how that device operates
once it's in the home environment.  And
whatever happens to that device, whether it's
an adverse event or a component failure, they
take that information and they put it right
back into device design to create the next
generation or an improved model.  
            So, in the guidance document here,
we've asked them to look at various components
that have been part of the post market device
failures, putting it back into the pre market
design.  
            So, we've asked them to look at
alarms and also for warnings, we've asked them
to look at other safety mechanisms and also
reliability.  We also asked them to look at
operational hazards.  And for infusion pumps,
we know some of the operational hazards are
air in line, occlusion, free flow, reverse
flow, are just a few, in addition to leakage
and also flow rate accuracy.  And there's the
flow rate accuracy.
            We also asked them to look at
environmental hazards.  And having been on the
Home Health Committee with Mary and working on
the guidance document, I was able to make sure
that some of the components for home health
was also brought into the infusion pumps,
because we know that infusion pumps are widely
used in the home setting.  So, we've asked
them to look at for the environment hazards to
look at electricity, to look at cleaning, to
look at labeling.  
            Again, we've asked them to look at
electrical hazards.  Hardware hazards,
software hazards.  So, if you know that this
medical device that you're concerned with
that's going to be in the home environment and
it has software, that we might want to think
about putting some sort of warning in there
for software.  
            We've asked them to look at
mechanical hazards, biological and chemical
hazards.  We've asked them to look at reuse. 
How do you clean your device if you know that
it's going from one patient to another
patient.  So, if it's not a single use device,
if it's a reuse device, we've asked them to
consider cleaning.  And when you have a
medical device in the home, does the home
environment have the proper cleaning solutions
available?  Can they use something from the
local grocery store to clean the device, or
does it have to be a medical grade cleaner
that you would receive from the hospital or
the DME company?  
            We also asked them to look at the
shelf life.  How long is your device intended
to be used in the home environment, for
example, for homecare devices?  We also asked
manufacturers to look at use hazards in
relationship to the infusion pumps.
            And a big component is human
factors.  How does the device operate?  We've
asked that manufacturers actually test the
device in the environment in which it's
intended to be used by the people who is
intended to use them.  So, if you're marketing
a medical device that's going to be used in
the home environment for patients and
caregivers, like an insulin pump, then it
needs to be tested with those same people, so
lay people in the home environment.  
            And for infusion pumps we actually
ask for clinical evaluation.  And risk
management.  
            So, these are just a few, a few,
quite a few.  It's an infusion pump.  And
these are critical care devices and Class II
devices.  
            And this is a component.  We did
ask them to look at home use labeling, making
sure that the pump is labeled specifically for
the environment in which the pump is intended
to be used.  
            And also, with the TPLC process,
looking at the total product life cycle.  We
actually asked manufacturers to consider how
the device operates once it's been cleared. 
In this particular device classification,
we're actually asking for inspections prior to
the 510(k) approval and also to be looking at
their reportability protocols.  
            So again, this is a guidance
document.  As you can see, this particular one
is 34 pages long.  It's as long as it needs to
be.  So, it can be five pages; it can be 100
pages.  This is a guidance that we    our
current FDA thinking.  We're going to take
your input today, put it into the guidance
document and it will be as long as it needs to
be to get the point across to manufacturers
and to the public on how we get safe devices
in the home.  
            So, as you go through your day,
like, Mary Brady had just said earlier, make
sure that you keep in mind what our purpose is
today.  We are going to be developing a
guidance document.  And I know this was a
little much for early morning; we probably
still need some more caffeine, but this is
what our charge is today.  We're developing a
document so that it incorporates home use
environment.  Thank you.
            (Applause.)
            DR. BRADY:  Thank you, Mary.
            I want to introduce Sonna Patel. 
She is in our Office of Device Evaluation. 
Sonna has been with FDA for four years.  She
is a biomedical engineer and she joined the
Home Health Care Committee almost as soon as
she got to FDA.  She has a vested interest in
this as well, and we're very grateful to have
somebody in our pre market area working with
us on the Home Health Initiative.  
            And Sonna is going to go through
the home use definition with you.  So this is
a chance for you to provide some input during
this time, and there's a microphone in the
middle.  I'll let Sonna take it from here
though.
            DR. PATEL:  Thank you, Mary.  So,
good morning.  As Mary mentioned, I'm on the
pre market side, so I do a lot of the
evaluations in the division of cardiovascular
devices.  If you have any beef with us on the
pre market side, please save it for later.
            So, as Mary stated, the purpose of
this session is to discuss the home health
care definition and get your comments and
opinions on what you think it means to you and
how it can be improved.  
            I would like to point out that we
do have a transcriptionist who's here today,
so I was planning on taking some notes by hand
for everyone to see, but since we'll have such
an accurate account of your comments, I'll
probably refrain from doing that and I think
just sort of to facilitate the discussion
moving forward.
            So, if you look at your white
paper that was in your folder on page 3, it's
the second paragraph, this definition is what
FDA has come up with so far to define a home
health care device.  A home use medical device
is a device intended for users in a non 
clinical or transitory environment which is
managed partly or wholly by the user, requires
adequate labeling for the user, and may
require training for the user by a licensed
health care professional in order to be used
safely and effectively.
            So, this is what FDA has come up
with feedback internally and some feedback
externally; although, Mary, I think you can
confirm, this is the first time we've really
asked for the public's comment.  So we would
appreciate anyone who has something to say
about it, to come up to the microphone and
introduce yourself and let us know what you
think.  
            DR. BRADY:  Or I can pass this to
you as well.
            DR. PATEL:  If there are no
comments, we're happy to go with this
definition.
            MS. MINTZ:  I think it's important
to mention that it is managed partly or wholly
by the user, but also by a family member, or
friend, or somebody who is not part of the
professional environment who is working with
that person.  Those aren't the exact words
obviously, but the intent.
            DR. PATEL:  So, would it be
helpful to include the definition of "the
user?"
            MS. MINTZ:  Yes, you could do it
that way.
            DR. PATEL:  I think this
definition and then somehow incorporate a user
definition.
            MS. MINTZ:  Perfect.
            MR. OSBORN:  In fact, I would
think that it needs to be the lay user.  The
critical issue here from a use viewpoint is
who's using it and the differences between the
lay user and the trained health care
professional.  Notwithstanding that, when we
look at the environment, who's using it is not
the critical factor for home health care. 
It's where it's being used, because there are
many physical attributes that are independent
of who is using it.  So, I would strongly
recommend that you look at the definition in
the Home Health Care Standard where we had
people for six years working on this, and I
believe it covers exactly what you want.  And
Mary certainly has a copy.  I will be showing
that in my talk.
            DR. PATEL:  So, Dave, you're
saying "non clinical" or "transitory" is not
sufficient for the environment?
            MR. OSBORN:  Absolutely not.  If a
visiting nurse brings a piece of equipment
into the home to use, and for instance it has
a three wire plug, and it's a home that was
built before the late '60s, there's going to
be no safe place to plug it in.  
            DR. PATEL:  Any other comments?
            AUDIENCE MEMBER:  I suggest you'll
probably also need a definition for
"labeling."
            MS. JOHANNSON:  I see that you
focus on the words "recover" and
"rehabilitate," but there are certainly
devices that we have that are for life long
monitoring such as with ICDs.
            AUDIENCE MEMBER:  I just want to
add my name to Suzanne's comments redefining
or defining the definition of "user" to
include a family member or caregiver, because
I think in some instances it may be someone
other than the person directly in need of the
device and might need assistance and help.  
            DR. PATEL:  So, I would like to
emphasize that we certainly were intending
"the user" to indicate a patient or someone
who is receiving the device in addition to the
individual who would be administering care and
may be using the device who was also not the
patient.  But I do understand the point about
defining specifically who the user is.
            AUDIENCE MEMBER:  I would suggest
that we need to clarify "licensed" and
potentially look at "qualified" or "other
measures" to define "licensed."
            DR. PATEL:  Okay.  
            MS. MINTZ:  And this is about
devices that are going into a home to be used
by everyday people.  And I think your language
needs to reflect that, because it sets a tone
for everything that you're doing.  So,
somebody had mentioned about the terminology
here about "non clinical" or "transitory
environment."  For the user, it's where they
live, whether it's transitory or not, so we
have to think about in those terms.
            DR. PATEL:  That's a good point.
            MR. OSBORN:  We need to remember
that patients sometimes are in their
automobile or on the bus.
            DR. PATEL:  Yes.
            MR. OSBORN:  They might be at
work.  So really, from an environment
viewpoint we're talking about any environment
that's not a professional health care facility
or emergency medical service.  Emergency
medical service is an interesting bridge,
because that equipment can be anywhere for a
very temporary period.  Remember, in the U.S.
we have a scoop and go philosophy.  So, that
will be in the home on occasion, but that
stuff tends to be battery powered and even if
it were say to interfere with your TV for the
five minutes they were there, you really
wouldn't care.  
            So, in the development of the Home
Health Care Standard, we realized by the time
we got done there are really three
environments of use.  There's the professional
health care facility, there's the home health
care environment and emergency medical
services.  And the home health care
environment includes transportation, work
places, the home, going on a walk.  We have a
lot of people on ventilators who take their
wheelchairs or scooters outdoors.  These are
all home health care environments.  And I'll
be talking about that in more detail.
            AUDIENCE MEMBER:  I apologize.  I
arrived late, so I missed the discussion on
the scope.  But in terms of the definition for
"medical device," it seems to me you're
talking a lot about equipment, primarily
electrical type things rather than simple
medical devices.  So, I just wanted to get
some clarification on that in that definition
such as an injector, auto injector, something
on that lines.
            DR. PATEL:  So, our interpretation
of the language "medical device" is as it's
written in the CFR.  And so, unfortunately I
don't know it off the top of my head, but I
think the injectors, anything that's
considered a medical device would fall into
this category.  Just the medical device
definition, obviously not the home part.
            MS. HOSTE:  I was just wondering
if the emphasis might be more on safety and
efficacy rather than on labeling and training. 
So, the goal is that they're safe and
efficacious and ideally that would be because
they're intuitive to use.  So, it could be the
usability and then it may be enhanced with
labeling or enhanced with further required
training.  I'm not sure if it's something to
think about.
            DR. PATEL:  Can you clarify what
you mean?  So, we have "safely and
effectively" as the last part.  Are you saying
that in order to emphasize safety and
effective use, to make it earlier in the
definition?
            MS. HOSTE:  Well, what I think is
"it's managed partially or wholly by the user
in a safe and efficacious manner.  In order to
ensure that, it could be intuitive design or
labeling or training, or all of them."
            AUDIENCE MEMBER:  I'd like to
mention too as a home care nurse for 15 years,
we had a lot of patients that were on
electronic pumps, home care pumps, but they'd
go to the hospital.  They'd leave the home
care pump in place, and actually they would
continue to care for the pump just because it
was such a specialized therapy that was 24/7. 
So, and the hospitals a lot times didn't have
the types of pump that were needed for the
small dosages.  So, I'm not sure where that
would fit, having that transition from home to
hospital, hospital to home, keeping the same
pump with the layperson continuing to care for
it.  
            DR. PATEL:  So, you're asking
about where device that's used or transferred
from the hospital to the home, if that would
fall into this type of definition?
            AUDIENCE MEMBER:  Or what would be
   you know, I guess where the definition
would be when you are making that transition
back and forth and they're using a home care
device in the hospital environment and how
that training goes.
            MR. OSBORN:  There's sort of two
issues there as I see it.  One is that many
hospitals don't allow the home care devices
back into the institution primarily for
liability reasons.  If we look at the physical
requirements, typically the home use devices
have a more severe set of requirements than
the hospital use devices so that in terms of
the environment of use a home use device will
work just fine in a hospital because it's a
less severe environment.  But that doesn't
necessarily mean that the institution will
permit it.
            DR. PATEL:  So, just from my
personal experience on the pre market side, my
expertise is in ventricular assist devices;
and some of you in the audience may work with
them or are familiar with them, and these are
devices that are essentially implantable
hearts.  And we have started to ask for
extensive testing for these devices to be used
in the home because they are implanted in the
hospital.  The patients are in the hospital
for several days with the devices and the
devices are intended to go home with the
patient.  They're permanent implantables, and
there's also an external component, which is
the controller.  So, we tend to ask for the
more extreme testing knowing that the devices
will be going in transition from home to
hospital and often back.  I don't know if that
answers your question.
            AUDIENCE MEMBER:  The definition
include device managed partially and wholly by
the user, however, there is some devices not
managed by the user, as monitors, for example,
but used in user environment.  So, do you want
to include that in the definition, or would
you like to exclude those devices?
            DR. PATEL:  So devices that are
not  
            AUDIENCE MEMBER:  Devices managed
fully by the physician, like a monitor set up
on the patient but used in the user
environment.
            DR. PATEL:  So, my understanding
is because those devices are still used in the
home, that we'd still want to include them. 
And the user in that case would then be the
doctor, but there would still need to be
environmental considerations, for example, if
not necessarily the medical aspect of it.
            MR. OSBORN:  We'll spend some more
time on this topic when I get up, because I
think that there's an entirely different
approach we can take to this definition that
will work a lot better.
            MR. WELSH:  The language appears
to be geared toward prescription devices, and
I would ask that if this is intended to not
overlap the existing guidance on devices that
are cleared for OTC use that that somehow be
established in the guidance.  I'm not sure if
that's the intent, but   
            DR. PATEL:  Okay.  Thank you.
            DR. BRADY:  It is prescription in
OTC, but we'll take that into consideration. 
Thank you.
            AUDIENCE MEMBER:  Your definition
says "licensed" in your PowerPoint, but on the
guidance it doesn't say "licensed health care
professional," and there are a lot of training
that's done by non licensed people who are
dispensing a device.  Would you clarify why
you went to "licensed" in your   
            DR. PATEL:  That may have been a
typo.  I'm sorry, are you talking about the
white paper?
            AUDIENCE MEMBER:  Yes, the white
paper doesn't say "licensed," and here you say
"licensed health care professional."
            DR. PATEL:  I'm sorry, that was a
typo.
            AUDIENCE MEMBER:  Which way is the
typo?
            DR. BRADY:  We were considering
"licensed health care professional," and we
would like your feedback on that if you
believe "licensed" should be removed.  It was
removed in the white paper.  I believe that
was a typographical error.  It should be
"licensed" as what we're showing up here.  But
we need your feedback if you feel that that is
something that needs to be addressed here.
            AUDIENCE MEMBER:  I think there's
a lot of devices that are dispensed and
trained by non licensed personnel that are
still going to the home.  If you're trying to
restrict it to only licensed devices, that's
fine, but I think you would want to broaden it
by removing that restriction to cover more
devices that are going into the home.
            DR. BRADY:  Just a comment on
that, too.  It was something that we did
discuss and so we did change it to "may
require training for the user by a licensed
health care professional."  So, we did qualify
that.  However, if that's still confusing,
then we will need to address that more.
            AUDIENCE MEMBER:  I would just say
"may require training in order go into the
home," so that it says someone has to train. 
So, my wife has a glucose meter.  She got
trained on it.  I don't know if that person
was a licensed health care professional or
just a representative of the industry that
trained her on it.  So, if you want to broaden
it, take away "licensed" to say it's only a
professionals.
            AUDIENCE MEMBER:  On that same
line, instead of saying "licensed," maybe "a
qualified health care professional," because
I am a respiratory therapist and there are
some states that do not require licensure at
this time.  But we would hope that they would
be qualified, whoever that health care
professional is.
            MR. OSBORN:  We handled that one
in the standard by saying "trained health care
personnel."  And again, this is an
international standard, so our concept of both
prescription and licensing doesn't translate
well to all countries.  But I agree with the
comment from the floor that need to very
careful with licensure.  It varies by states,
sometimes even less than a state.  And really,
the issue is the level of training on the
specific kind of device.  So, a surgeon might
be a trained or licensed health care provider,
but has no idea how to run a ventilator.
            AUDIENCE MEMBER:  I just wanted to
add my voice to the comment that was made by
this woman right here in the black, which I
very much appreciated.  In terms of a
definition, it seems to me that we should
truncate it, "partly or wholly by the user
safely and effectively," eliminating
everything else that comes afterwards.  All of
that it seems to me is not part of a
definition of a home care device.  It is a
part of what would be in the guidance and it
just further narrows and makes it confusing I
think to understand what devices you're
talking about.  You've got "may" in there. 
That "may" should not be part of a definition. 
So, all of that stuff I think should be
removed.
            MS. JOHANNSON:  It would be
helpful to understand what you mean by
"permanent implants" and if that excludes any
type of permanent implants, or if you're
intending to mean all permanent implants that
go into any patient.
            DR. PATEL:  Go ahead, Mary.
            DR. BRADY:  Oh, I was going to say
the intent was also with permanent implants.
            DR. PATEL:  And the reason for
that I think is because there are
environmental considerations.
            MS. JOHANNSON:  I was just
wondering if there are boundaries or
limitations with that.  I mean, you have knee
implants, you have stents, you have, you know,
spinal implants.  Are you meaning everything
that goes home into the body of a patient, or
are you meaning, you know, a subset of that?
            DR. PATEL:  Well, I think a good
point was raised, and two people have echoed
this, about the safety and the effectiveness
of the device.  And I think what we're going
to take back and consider certainly is the
fact that if the device can be used safely and
effectively and doesn't require labeling, like
a knee implant or a spinal implant, for
example, then although it still may be
considered a home use device, it may not
require the additional training or labeling
that we're talking about in this definition.
            Mary, is that appropriate?
            DR. BRADY:  Yes.
            AUDIENCE MEMBER:  With the
definition that you just used about an
implantable device such as the spinal devices
or knees, etcetera, I don't understand why
that would be a home use medical device.  It's
permanently in your body.  There's nothing you
have to do with it.  It either works or it
doesn't work.  And if it doesn't work, you're
going to see a qualified physician.  So, I see
home use device as something where the user
has to interact with the equipment.
            DR. BRADY:  What we also have to
take into consideration is how the environment
might act/react with that implant.  You think
of aneurysm clips and some other of the
devices that could be affected by
electromagnetic interference.  So, we were
taking all of these into account, however, we
will take your comment into account as well.
            MR. OSBORN:  Yes, to follow up on
that, I think there are two issues that you
need to be focused on.  One, whether or not
there is a human interface to the device.  If
there's no human interface, then a whole raft
of the issues in home health care go away,
like an orthopedic implant.
            If, on the other hand, it's an
active implantable where the environment is
likely to have a potential impact on it; for
instance, EMC, then there are very significant
concerns.  But there are devices that have no
human interface and have no real interaction
with the outside; a typical orthopedic
implant, and I wouldn't think you would be
caring about those in this particular guidance
document.
            AUDIENCE MEMBER:  With the
electrical equipment, I understand there will
be EMC to consider, but that should be part of
the approval or clearance process, which is
really part of design controls.  And so hence,
I don't that is really part of this definition
of home use devices.
            DR. PATEL:  Were there any other
comments?
            (No audible response.)
            DR. PATEL:  If there are no other
comments, I'll turn it over to Mary to
introduce the next speaker.  Thank you,
everyone.
            Oh, Suzanne?
            MS. MINTZ:  Since we are on this
topic, maybe it would be good for him to
present next instead of me.
            MS. COLLINS MITCHELL:  Good
morning.  I would like to introduce Dave
Osborn from Phillips Healthcare.  Dave is the
manager of international standards for
Phillips Healthcare in Andover, Massachusetts. 
He represents Phillips at standard
organizations on matters affecting medical
device industry.  He serves as secretary to
the International Standard Organization, the
ISO.  He's the secretary of several joint
working groups such as the Usability, Home
Care and Respiratory Gas Monitoring Groups. 
He particularly is active in the development;
he was active, that is, in the development of
the third edition of the IEC 6601 1 and now
with the amendment A1.  Please join me in
welcoming Dave Osborn.
            (Applause.)
            MR. OSBORN:  So, I should start
some disclosures.  Not only do I manage
Phillips Healthcare Standards Program, I'm the
chair of the AME Standards Strategy Committee
and I'm on the AME board of directors.  
            Would like to point out to
everyone that the June 2010 Horizons will be
a special issue devoted to home health care.
            And I was the secretary to the
joint working group that produced the
Collateral Standard to 601 for Home Health
Care.  So, we're proud to announce that just
last month the Collateral Standard to 601 for
Home Health Care was published.  The FDA was
significantly involved.  Now, this standard is
only for equipment, things with electricity. 
But nonetheless, many of the concepts in it
are directly applicable to all medical
devices.
            So, what is the home health care
environment?  We struggled for many meetings
over several years to try to figure that out,
because it's very complicated.  And where we
ended up is here, and there are a couple of
very important things to understand.  I'm
going to start from the bottom and work up.
            Regardless of whether the
equipment is operated by a lay operator    and
throughout this standard we have an adjective
"lay" meaning someone who's not skilled in the
art.  And we didn't say "licensed" on purpose,
because that doesn't work everywhere.  But
equipment, whether it's used by the lay
operator or a trained health care
professional, if it's in the patient's home,
it's home health care equipment.  And we'll go
over some of the reasons why here in a couple
of minutes.  
            So, what is the home health care
environment?  Well, it's not a professional
health care facility, because in a
professional health care facility you have
trained operators available when patients are
available.  That's a key distinction.  
            And then there's this emergency
medical services, which we're treating today
in the world of 601 as part of the
professional health care environment. 
However, I can tell you that a proposed new
work item hit my in tray in the last month or
two and there's a request from Northern Europe
and also from the United States to begin work
on a collateral standard for emergency medical
services as an environment, to bring all of
those requirements into one place.  So, just
a never ending battle.
            So, what's different about this
environment?  The electrical supply is
different.  You don't have a hospital bio med,
you don't have backup generators, you don't
have the kind of control that you have in a
professional health care facility.  And what
does that mean?  Well, believe it or not, we
believe, or actually the power company is
allowed to go minus 10 percent.  The wiring of
the building is allowed to absorb four
percent.  So, in the home you could go minus
14 percent.  We therefore set the requirement
at minus 15 percent, and that's more severe
than in the hospital.  
            And if it was a life supporting
device, we tacked on a little bit more,
because here in the Northeast and certainly in
California in the summer time, we get things
called brownouts.  And if you're on the
ventilator or dialysis or anything else, you
really don't want the equipment to stop
working while you're being treated.  
            No protective earth.  Older homes
in the United States do not have three wire
plugs.  Or if they do, that third pin isn't
connected to anything, as I found out when I
moved into my house.  And my youngest child
was born with respiratory problems and needed
a nebulizer and we brought it home and there
was no place to plug it in safely.  And, yes,
you can go down to the hardware store and get
one of those nice little cheaters, but you've
just lost half of your electrical safety
protection when you do that.  And now a single
electrical failure will electrocute you.  Not
a good solution.
            In many countries; Japan, Denmark,
Norway, there is no earth ground.  Norway's a
big hunk of granite.  You can't get it. 
Doesn't exist.  So, if you're a worldwide
manufacturer, you put a three pin plug on your
device, there are a whole raft of places it
can't be used safely.  And even in a country
like Germany, where all outlets are three wire
outlets, the people who do home care work
there will tell you it's a lot more than 10
percent of those outlets that actually aren't
connected.  Three pin plugs are dangerous in
the home unless it's a brand new home.
            Temperature and humidity.  We know
about professional health care facilities here
in the United States.  They're like 100
percent air conditioned.  Well, that's not
true in the home health care environment.  As
Pat will tell you, it's already hit triple
digits in Arizona this year.  The dark days
have begun.  If it's the winter in New England
or Minnesota, it gets really cold and you kind
of expect the equipment to work as you carry
it from the car in.  
            And in fact, the standard has a
thermal transition or thermal shock test for
things that are transit operable.  What is
transit operable?  It's a new term that we
invented in the standard for devices that are
intended to work while moving.  A lot of the
home health care devices are transit operable. 
You wear them on your belt or they're bolted
to the wheelchair or the scooter.  They're not
just a patient in a bed like they are in the
ICU.  This stuff moves around, and that has an
impact both in the temperature and humidity,
and also in the shock and vibration.
            Patients are going to put some of
this equipment in the car.  And if they're not
in it 24/7, it might actually stay in the
trunk for a few hours and get to the outside
temperature, which in Tucson in the summer is
really hot and; I see Brody out there, in
Minneapolis, Minnesota is really cold.  And if
the device isn't going to work after that,
it's not going to be very useful in the home
health care environment.
            We also have a term called "body 
worn," because in addition to transit 
operable, there's a body worn category which
has yet some different characteristics.  
            Now, for those of you who are
familiar with electrical equipment, we do an
accessibility test in 601.  We have this
articulated finger that you poke around the
holes and openings to look for leakage
current, and it's an adult finger.  Well, an
adult finger is not the only finger that may
be around the equipment in the home.  So, for
home health care, we've added in the child
finger, which is also available in the IEC
test suite.  So, home health care equipment
also has to be examined with a child's finger
for accessibility for things like shock
hazards and leakage current.
            We also require that all applied
parts be floating applied parts.  Remember,
you can't rely on the basic safety of a
protective earth connection that isn't there. 
So, you need the higher dielectric capability
of a floating applied part to keep from
electrocuting someone.  
            Usability.  Pat's going to talk
about that, that we have an international
standard for usability, IEC 62366.  And the
home health care standard has as whole list of
attributes that need to be evaluated to that
usability standard.  And you got to remember
that the operator isn't a well educated health
care professional.  The standard requires that
your operator profile includes something with
only an eighth grade education.  Some would
argue that's too high and it ought to be a
sixth grade education. It's got to be easy. 
You can't have a huge long complicated
instruction book and be successful and safe in
the home health care environment.
            So, here are some of the
attributes written into 601 1 11 for the home
environment, things that you have to
specifically look at and do usability analysis
on.  Give you a chance to look at that list.
            And when you get to a specific
device, you can expect that the specific or
particular standard for that device is going
to add to this list.  These are just sort of
the general ones that most devices have.  And
this one here on the bottom is rather
important.  And if you've got little parts,
you're going to have a problem, because little
kids are going to try to eat them.
            Some equipment can become
contaminated in use.  And it can, you've got
to be able to clean, disinfect and/or
sterilize as is appropriate in the home.  So,
that means you need to have validated
processes for that and those processes have to
be capable of being performed in the home.  No
ethylene dioxide, please.  Or, you're going to
have to label the equipment for professional
reprocessing between uses or between patients,
as might be applicable.  
            You think for instance of a home
care ventilator.  It might make a fair amount
of sense to professionally reprocess it
between patients.  Nonetheless, there are
cleaning and disinfections required while in
use because it's going to be used for a long
period of time.  And nosocomial infections are
a problem in home ventilation just like they
are in critical care ventilation.
            Dust and water protection.  Even
inside the house, this is not a super 
controlled environment.  And so, the minimum
requirement that the committee felt was
appropriate for home health care is IP21, and
that of equivalent to a light rain.  And
that's for things that are reasonable
stationary and not moved around.  If on the
other hand, it's transit operable or body worn
or hand held, it's going to see more than
light rain.  People go for walks, and as it
did this morning, it started raining rather
hard while you were outdoors.  And if you're
on a ventilator, you really don't want it to
stop working when that happens, or an infusion
pump on your belt.  And there are a lot of
people walking around every day with devices
and going to work and riding on the bus, and
such.  So, we consider these enclosure
protection levels normal condition for those
of you who know about 601.  What you're going
to see in normal use in the home health care
environment.
            Mechanical strength.  Home
operators are not as gentle as the folks in
the hospital who get a bad review if they
break things.  So, there are shock and
vibration requirements for all devices.  And
these are survivability tests, so they're much
more severe than you expect to see in use, but
it's very hard to test equipment effectively
on the shock and vibration table.  A drop test
only lasts for a few milliseconds.  And it's
extremely difficult to evaluate that the
device is working while you do that, so we up
the levels and look at these as survivability
tests.  
            Again, for things that are
transit operable, things that are intended to
work in everyday movement, the levels are
higher.  And for portable equipment or things
on wheels; again, go back to that ventilator
that's bolted to the wheelchair or bolted to
the scooter, you have a drop test as well. 
And of course, little hand held things drop
all the time.  And for those are familiar with
601, there's an additional test in 601 for
hand held things onto a wooden floor at one
meter.  Right, Brody?  So, these are in
addition to that.
            The electromagnetic environment. 
This is a class B emissions environment.  Home
health care equipment is intended for domestic
establishments.  That means you have to have
very small emissions so that you don't mess up
radio and TV signals.  If you're in an
apartment building, your next door neighbor is
not going to be real happy with you if they
can't use their radio or use their television. 
            Immunity.  At the moment we've
defaulted to the levels that are in 6601 1 2. 
However, that committee is hard at work on a
new addition that will very clearly have more
severe limits in it than the limits that are
currently in that standard.  And there's a
good reason for that.  
            Think of a typical GSM cell phone. 
That's a two watt transmitter.  So, if you're
half a meter away from it and do the
calculations that are in 601 1 2, that says
you need a 20 volt per meter immunity level. 
Now, how many people in this room really think
that patients are going to keep their cell
phone 18 inches away from their medical
device?  I certainly don't.  So, higher levels
are going to be necessary or you're going to
have problems and your patients are going to
have problems, and somebody from compliance is
going to come visit you.
            Lastly, the joint working group
considered issues 1, 2, 3 and 5 from the call
to this workshop and the development of 6601 
1 11.  And I believe that the standard very
effectively controls the risks associated with
those issues.  So, I certainly challenge the
FDA to write that standard into the guidance
document as a suggestion, as an adequate
special control for home health care devices
for the issues covered.  
            Now, if you have a particular
device, there's going to be some other issues
as well, but I think an overwhelming majority
of the horizontal issues have been very well
addressed by this standard.  
            Thank you and are there any
questions?
            (Applause.)
            DR. BRADY:  We'll go and hold the
questions until after everybody in the pre 
market area speaks, so in the interest of time
we'll just keep moving on.
            MS. COLLINS MITCHELL:  Allow me to
introduce Susan Mintz.  Susan is a social
entrepreneur who took the personal experience
of her husband's diagnosis of MS and built a
national organization for the benefit of
family and caregivers, and that organization
is the National Family Caregivers Association. 
            Ms. Mintz is recognized as a
forward thinking leader on family caregivers
and related policy issues.  She has provided
testimony to Congress, written extensively and
is often quoted by popular press.  She's the
author of several books including, "A Family
Caregiver Speaks Up: It Doesn't Have to be
This Hard."  This was published in 2007. 
            Please welcome Susan Mintz.
            (Applause.)
            MS. MINTZ:  Good morning.  I have
to tell you all the things Dave said scared
the hell out of me.  I don't want to have to
worry about any of that.  I just want things
to work easily, and easily is a word that you
really need to keep in mind during all of
this.
            How many people here are from out
of town?
            (No audible response.)
            MS. MINTZ:  Okay.  Well, on behalf
of Washington, I will apologize for the
weather.  It's supposed to rain in April and
we're supposed to have glorious Mays, but it's
been very screwed up this year.  But people
will say that about everything in Washington,
so maybe it is appropriate.
            I'd like to get a sense of who is
here.  I don't work in your world, so who here
is an equipment manufacturer?
            Who's with FDA or other government
agencies?
            Okay.  Minor.  DME providers?
            Okay.  Clinicians?
            Did I leave anybody out?
            Okay.  So, mainly manufacturers. 
Great.
            Let me just give you a bit of
background about NFCA.  It is an organization
for family caregivers.  We define family
caregivers as a person who is providing care
for a family member or friend who has a
chronic illness or disability.  This can
happen of course anyplace across the life span
and the specific disease is irrelevant, as is
the actual relationship, because there are
common issues that all family caregivers
share, and that is what we focus on as we
provide them with education, community and
advocacy.
            So, you've been looking at this
for too long.  Let's move forth.
            I hope everybody can see this
cartoon.  I love it.  It says, "You can get
dressed now.  The doctor saw you when you
weren't looking."  And it really does speak to
so much of what is going on in health care
today, because everybody's asked to do things
so quickly.  But not everybody of course can
do things all that quickly.  People with
chronic illnesses and disabilities and just
the frailties of old age dance to a different
tune, and you need to think about that in
terms of the equipment you design for use by
them and us.
            Equipment makes our lives possible
in this day and age.  You know, years ago
people just died when they had some sort of a
problem.  That's not the case at the moment,
and I think a great example of course is Chris
Reeve who never would have survived for eight
years without the ventilator that helped him
until he was eventually actually able to get
off of it.  
            And I tell people that I drive a
Mercedes Dodge.  There is the cost of the
minivan and then there's the cost of the
conversion.  So, by the time you put the two
together, you've bought yourself a small
Mercedes.  Doesn't look like it, doesn't drive
like it, doesn't have the resale value.
Nevertheless, it is a Mercedes Dodge.  And you
may not think of that as a piece of equipment,
but it enables our life to have life, and so
we definitely do.
            And so, actually on behalf of all
of us who need the equipment that you create,
I just want to say thank you for doing what
you do, because you make our lives possible.
            So, let me tell you what
characterizes equipment and medical devices
for me.  It can be as simple as a transfer
belt, because for me, equipment replaces body
parts that no longer function as they should,
or it augments abilities that have declined. 
And so, as you know, it comes in all shapes
and sizes and some of it's real simple, and
some of it is extraordinarily complex.  And I
think that's more and more the case with all
the things that happen in the home.  And I
think, you know, a lot of those particular
issues were really just addressed, whether
it's something that needs a lot of maintenance
or, you know, it's maintenance free, whether
it's got lots of little parts or it's just,
you know, one thing.  
            And so, what you really need to be
thinking about is that you need to develop a
mind set that helps you understand to the
extent possible how we use the products that
you create and under what conditions.  And
ultimately it's all about communications.  You
need to know your audience, your target
market.  And I'm a great fan of the TV series
"Criminal Minds".  Does anybody else watch
that?
            I've become addicted to this show. 
And what it's about is a special FBI unit
whose members are all profilers.  They study
human behavior so that they can come up with
a description that will help them and local
law enforcement find the people who have
created this most horrendous, horrendous,
horrendous acts.  And so, they develop a
profile of these people they call "unsubs,"
which stands for unknown suspects.
            And so, what I'm saying is that
you need to become profilers.  You need to
understand the nature of the patients and
family caregivers who are going to use your
product.  And the term "patients" of course is
a health care term.  To us, the people who
need your equipment aren't patients.  They're
parents, they're spouses, they're kids,
they're friends.  And it's not really just
semantics.  It's a different approach to who
the people are.
            And so, again some of these things
were touched on.  What kind of training are we
going to need?  Most often people get very
little training.  It certainly isn't repeated. 
It's hard for you to know whether we're
actually using it correctly.  And so,
everything needs to not only come with
instructions that are easy to understand   
and I firmly believe that means pictures as
well as words that the two together are that
much more powerful.  And you have to
understand that doing business to business
transactions are extraordinarily different
from transactions with consumers.  And
although you as the manufacturer may not be
selling directly to us, you are still
responsible for that product.  So, think BP. 
A place none of us really want to be.
            So, who needs equipment and
medical devices?  I think it's just good to
get some sense of the demographics.  There are
between 40 to 50 million people in this
country with a disability.  And people on
Medicare, not all of them are over 65.  Seven
million of them are younger than that and
they're there because they have disabilities
and need products and services.  And then of
course, there's a whole bunch who are 85 and
over.  And people over 85 are the faster
growing cohort in this country.  With a
marketing hat on, I would say to you there
definitely is money in them there hills
because of the population.  
            Boomer.  First Boomer turns 65
next year, and I must admit I am one of them,
barely.  I was born on the sixth day of the
second month of the first year of the Boom, so
I kind of like that because, you know, there
will still be a lot of things around before
the peak hits unless we really change the way
we're doing things.  But, I do think that
Boomers as consumers are going to be very
different than our parents.  You know, I grew
up in the '60s and we were all thought of as
change agents, people who weren't going to put
up with the status quo.  We were spoiled
brats.  We wanted things to be our way.  Well,
I'm not sure that we should expect anything
different going forward, especially when we
see what our parents and grandparents have had
to go through.  
            We really are living in a time
that didn't exist before.  People never did
live this long before.  We didn't save premie
kids, babies the way we do now and the fact
that we can do that has created so many more
children in this country with disabilities and
developmental delays.  So, the wonders of
medical science are indeed wonderful, but they
also create situations that then need
addressing.
            And so, who cares for people with
disabilities, with chronic conditions?  Most
of the care in this country is done by people
like me, not professionals, not in medical
settings.  And so, more and more things are
going to be coming home, not because the
system wants to save money only, but because
that's where people really want to be.  It is
actually the law of the land and there is an
additional $50 million in the president's
budget for home and community based services. 
It really is where the action is.
            So, let me tell you a little bit
about family caregivers.  We're a mess.  We're
overworked and we're exhausted.  We're working
women.  A typical family caregiver still has
at least one kid at home and all of this takes
a toll on family caregivers.  The extreme
stress levels of family caregivers are so high
that it causes us to have conditions and
illnesses at much higher rates than the rest
of the population.  Depression is extremely
high in the caregiving community, twice as
high for children of aging parents, four times
as high for spouses.  I've been there four
times.  And so, sometimes you have to wonder
who's needing the care and who's giving it.
            So, another thing I think that's
important to recognize is that family
caregivers tend not to ask for help.  I'm an
anomaly; I always ask for help and I never
turn it down.  But because most people are
going to keep trying and trying to do
something by themselves, you need to take that
into account when you are creating equipment. 
And you've got to remember above all else that
we didn't go to medical school, we didn't go
to nursing school, we're not PTs.  And even
those people who are in the medical
profession, when they're dealing with their
only family member, everything they've ever
learned goes out the window.  There is a
reason that surgeons do not operate on their
own family members.  
            So, I want to read some things to
you to give you a real life understanding of
what actually happens with equipment.
            My husband says I make things
complicated because I'm always doing things
twice, like not bringing it over with me
initially.
            So, I want to read you something
actually from my book.  My friend Eve, who was
a highly resourceful caregiver for her husband
before he passed away, says she reached her
frustration limit when equipment broke or
didn't function the way it was supposed to. 
She tells the story of the company sales rep
who told her over the phone that the lifts his
company manufactured to help transfer a non 
mobile person from bed to wheelchair never
break.  Well, she stood there in her bedroom
with a broken bolt in her hand and the lift in
pieces on the floor.  "My first reaction was
to scream at the guy," she said, "but then I
realized I'd get more help if I didn't rant
and rave, but rather told him in no uncertain
terms how I needed him to fix my problem." 
Not everybody would have been like Eve.  They
would have ranted and raved, and you need to
deal with that as well, but customer service
is critical.  That's pretty laughable.
            And then I want to read you
something else.  This is from an amazing book
called "Rough Crossings: Family Caregivers'
Odyssey Through the Health Care System."  It
was put out by the United Hospital Fund of New
York.  I'm not sure if it's still available. 
            But, a woman whose husband
returned from the hospital after a stroke had
difficulty monitoring a feeding tube which had
confusing computer settings.  She'd seen it in
the hospital, but received little training on
how to use it at home.  "I was terrified of
it," she said.  "It's broken twice.  When we
left the hospital, they showed me one, two,
three and that's it.  They said, 'Don't worry. 
You'll learn it.'"  Enough said.
            And so, my advice to you is to
design with a KISS.  I'm sure everybody's
familiar with the statement keep it simple,
stupid, and this indeed is critical.  
            I went into an Apple store
yesterday actually to look at the iPad because
it struck me, it might be the perfect thing
for my 93 year old mom who is not online yet. 
And it really is so intuitive and, you know,
you just move your finger over the whole
thing.  It struck me this might be the way
that she could get on email and converse with
her grandkids and her great grandkids and see
pictures of them.  
            And so, you need to think that way
to make it as easy as possible.  Most of the
people who are going to use this are in their
mid 40s or above; at least from the caregiver
perspective, so no small print, please.  
            And to me, one of the most
critical things is what I'm calling a feedback
loop.  If you're going to somebody's house for
the first time and they give you directions
and, you know, you're driving along and you
think you should have gotten somewhere already
and you're a little nervous, but then you see,
you know, the gas station on the right that
she mentioned and you know you're going in the
right direction.  Well, I would say that
patients and family caregivers need sign posts
along the way as well.  They need to know that
they're doing it right as they progress in the
steps to get something working.
            And so, these are my overall
recommendations for the agency and for the
industry.  In the patient safety movement and
in the disability movement there's an
expression: Nothing about me without me. 
Don't design in a vacuum.  Bring us in.  Have
panels of family caregivers and patients to be
with you during the design process, to test
things out.  What makes sense to you may make
absolutely no sense to us.  And quite frankly,
if you haven't walked in our shoes, if you
haven't had a chronic illness and disability,
if you haven't been a family caregiver, there
are things that you just can't understand. 
And so, I would advise you definitely to do
that.  You need to know us.  That's really
what it comes down to.
            And, you know, pictures speak
louder than words and together they're that
much more powerful.  So, I do think
instructions need to be graphic.  Even
something like the transfer belt, which is
something that Steven and I use all the time
because he's in a chair.  Well, I bought it
from a professionals catalog; it didn't come
with any instructions.  And Steven's PT showed
me how to use it, but everybody has a PT.  And
so, even something as simple as this belt
should come with instructions.  
            And, you know, as I mentioned
before, the whole concept of customer service
is absolutely critical.  There is an
apocryphal story about Nordstrom's, the
retailer who is just known for their service,
and it's a story that a man came into a store
with a tire and he brought it over to a
salesperson and wanted to return it.  And she
said, oh, yes, sir, absolutely.  And guy gave
her the tire and he walked away.  But
Nordstrom's doesn't sell tires.  So, that is
the ultimate in customer service.
            I want to leave you with one final
thought which I think will give you a sense of
the emotion that is involved in this for all
of us.  
            And of course the piece of paper I
had in that one little part is no longer
there, so bear with me.  
            Well, as I'm looking for the poem,
let me give you the background of it.  I went
to the beach one weekend by myself for a
respite.  And Steven had recently gotten his
first wheelchair, because the scooter he had
been using was no longer adequate.  And so, it
was a pretty sad time for us.  And so, you
know, a lot of emotions I had to deal with and
he did as well.  
            And so, while at the beach sitting
on the sand and soaking up the warm rays of
the sun alone with my thoughts and feelings,
I wrote a poem that was inspired by of all
things a beach chair.  The poem erupted out of
my brain in only a few minutes and poured onto
the writing pad that was propped up against my
thighs.  It was a very dark poem reflecting
all the painful emotions the purchase of the
wheelchair engendered.  I expressed my fears
and my anger.  It was the visible
representation of the pain that I held inside. 
It was a poem written by a woman who
definitely saw her glass has half empty.  
            But the sun was shining.  I was
enjoying a respite and I decided to think
about Steven's need for the wheelchair in a
different way.  I ripped up the first poem and
began again.  The poem that came from my inner
core the second time around was more upbeat. 
It looked at the doors that the wheelchair
opened for Steven and me, not the ones that
had been closed.  This is the poem that I
called, "The Chair," but wonder now if I
should rename it, "Life Depends on Your Point
of View."
            "It sits there at the crest of the
hill on the rise just before the sand dips
towards the water's edge, a lone beach chair,
seemingly abandoned.  It's a jaunty chair with
it's yellow striped canvas seat and sailboats
floating on its blue and yellow back support. 
It lists just a bit to the left, almost
rakishly as it nestles in the sand surveying
the sea.  It's a chair made just for sitting,
and sitting on the sand at that.  It has no
legs to get in the way of stretching out,
relaxing and letting the sun seep into your
bones and warm your soul.  
            It's so unlike another chair I
know, a black chair with wheels, a chair that
does not survey the vastness of the ocean with
a jaunty air, but rather a chair that defines
a narrower kingdom.  And yet, I think this
other chair is a happier chair than the one
that sits and stares out to sea, for it is a
chair with wheels that take the place of legs
no longer able to propel their owner forth.
            The other chair is not made for
sitting and looking at the world.  It's a
chair built for exploring, for meeting life
face to face and tasting of its spirit. 
Perhaps this chair should have a seat of
yellow and white stripes and a back support
adorned with sailboats, a far better statement
of its adventurous and joyous possibilities."
            Thank you.
            (Applause.)
            MS. COLLINS MITCHELL:  Thank you,
Susan.  
            Our next speaker is Pat Patterson. 
Pat is a certified performance technologist
and president of Agilis Consulting Group. 
She's a contributor to the documentation
chapter of the recently published standard
HE75, the human factors design for medical
devices.  And this is by the Association for
the Advancement of Medical Instrumentation,
the AAMI.  And she's a member of AAMI's
Medical Device and Systems in the Home Care
Application Committee.
            Join me in welcoming Pat
Patterson.
            (Applause.)
            MS. PATTERSON:  Good morning and
thank you for being here.  Susan, please don't
apologize for the weather.  When you live
where it's terminally sunny, I actually enjoy
seeing clouds, but some people think I'm
weird, and they're right.
            (Whereupon, a video was played.)
            MS. PATTERSON:  For the next few
minutes I'm going to talk to you about
labeling and training.  Before I do though,
I'd like to set it in the context.  Labeling
and training is actually part of a much larger
field called human factors.  And as some of
you know, human factors deals with the
interaction between the user and the device. 
And we look at the user, we look at what's
their abilities, what are their limitations,
what mental model do they bring to you with
your device, what does it remind them of?  And
then we look at the device to see how does it
support user performance; the alarms, the
displays, the controls and the labeling and
the training, because that's part of how the
user interacts with your device.  So, while
we're talking about a very small portion of
human factors, it is part of a much larger
field.
            Because this is the initiative
workshop kick off, so to speak, I thought it
might be useful to have some assumptions.  You
might agree with them, you might not agree
with them.  Perhaps we can talk about them
this afternoon or even after this workshop is
over.  But these are some assumptions that I
thought would be worth noting.
            The first assumption is that
labeling and training can never substitute for
a well designed device.  I can see Darrell's
head.  Yes, Darrell.  I've been learned well,
Darrell.  It can't.  It can sometimes help and
it can oftentimes actually make it worse.  Can
never substitute for.  
            We want to maximize the
effectiveness of our labeling and training,
but we want to minimize the cost.  We don't
want to spend $100 when $10 would suffice. 
Most of us have budget limited resources.
            If we can describe the
performance, the user performance in
sufficient detail, we can teach it to other
people.  
            And then finally, the overall
purpose of labeling and training is to support
safe and accurate user performance to produce
outcomes of value.  Outcomes of value.  What
do I mean by that?  
            Take a look at these three
statements and tell me which is the most
valuable to you?  I understand aerodynamics. 
I can do these tasks.  I can perform a
preflight check.  I can land a plane in bad
weather.  Passengers arrive safely at
destination.  Now as a frequent flyer, I can
tell you which statement I think is more
valuable.  
            Let's take a look at a medical
example.  I understand the importance of
administering the right dose of medication. 
I can do these tasks.  I can set up the pump. 
I can set the correct dose at the correct
flow.  Mrs. Jones is medicated per doctor's
orders with no adverse events.  
            Last one.  I know how to adjust
the respiration settings.  I can do these
tasks.  I can set respiratory rate, set tidal
volume, adjust flow rate.  Following a low
pressure alarm, baby Chris is receiving oxygen
at the correct flow rate and at the correct
pressure.
            When we talk about labeling and
training, we're usually talking about them in
the context of user performance.  It's one of
those words we kick around a lot.  What do we
mean by performance?  Performance is actually
a summary term and a part of that incremental
summary term has to do with the knowledge.  I
understand, I know.  But it goes beyond that
to incorporate the skills, the tasks that the
user needs to perform.  I can set, I can
adjust.  
            But even that's not enough. 
Working a medical device correctly and safely
is more than just button pushing.  It's about
producing those outcomes of value.  What is it
that the user wants to achieve that matters to
them?  The medicated patient.  The following
the alarm.  Receiving the correct oxygen.  And
at some level we can step back even farther
and say for what purpose?  What are we trying
to accomplish?  Safe and accurate use,
improved health and lower costs.  What's
important to recognize is that performance
unfolds in this direction.  I think something,
I can do something, I get the results I want,
and there's some greater good.  
            But we analyze performance in the
opposite direction.  We begin looking what are
we trying to accomplish?  Now, given our
users, what are the outcomes of value that
they need to produce with this device?  Then
we step back and say, okay, now what are the
tasks that they're going to have to perform in
order to produce those outcomes of value?  And
we do what's called a task analysis.  We get
way more detail than that is.  And then we
back up again and we say, okay, now what are
the knowledge increments that they will need
to know in order to intelligently perform
those tasks?  
            One of the things that has a huge,
huge, huge influence on performance is memory. 
There's long term memory, short term memory,
working memory.  Some people define long term
memory as anything longer than 18 seconds and
my time is already up.  Does anybody remember
in the second outcomes of value example what
the second statement was?
            It's okay.  You didn't hurt my
feelings, because I'm not training; I'm
talking.  There's a difference.
            When we look at the different ways
to achieve performance, and again that
performance being safe and accurate user
performance, we talk about training.  We talk
about training.  And do we ever ask what is
the definition of training?  These are not
approved definitions; these are our
definitions, but I think it's a place to
start.  Wouldn't it be wonderful if at some
point we shared the same nomenclature?  
            Training is a planned experience
when there is a lack of skills and knowledge
that enables the user again to produce those
outcomes of value; it's more than button
pushing, that is often associated with long 
term memory.  I often hear people complain, I
don't know why they screwed up.  I don't know
why they made the mistake.  We trained them. 
As though that somehow is descriptive of
actually what went on.  We have this
assumption that because they were in training,
that somehow they're supposed to remember
stuff.  Eighteen seconds ain't a long time,
guys.  
            The other way we can achieve
performance is the ubiquitous user guides,
quick start guides, those sorts of things.  I
like to call those performance aids, because
in reality that is exactly what they're
supposed to do.  They are supposed to be
aiding the performance of the user.
            Here's another definition; again,
not an official definition, but one that we
found particular useful.  A storage place for
information other than long term memory. 
Because it's so complex and the consequences
of error are so severe, we don't want you to
try to memorize it.  We want you to use an aid
of some sort.  It gives direction on when and
how to perform the task and it is written so
that it is accessible while the person is
doing the task.  
            Accessible real time.  What does
that mean?  It means that they're able to use
that performance aid while they're actually
doing the task.  That means two things:  (1)
is we eliminate the problem of the 18 second
long term memory; but (2), it also means that
it suggests how we have to actually produce
the instructions and format the instructions
so they are useable.  
            We also want it to be written at a
level of detail to minimize trial and error. 
Trial and error might be just plain
frustrating when you're learning how to use
your new smartphone, or in my case, my new
computer.  It can be downright dangerous when
we're talking about a medical device.  
            The third way to achieve
performance, training plus the user guides, in
which case now we have a partial.  We want
some information in long term memory and we
want some to be accessible outside of the
brain power.  What's important to note here is
that the decisions of what we're using should
be overt decisions.  There are algorithms that
will enable you to make a decision that says
is this a user guide only?  Is this a training
only?  Is this a both?  And if it's a both,
how do they fit together?  I've seen
situations where you have one team do the user
guide, another time do the training, and they
don't even look like they belong to the same
device.  So, it can happen, but it needs to
happen as a coherent whole.  
            (Whereupon, a video was played.)
            MS. PATTERSON:  So, this gentleman
is saying the user guide didn't take the user
by the hand enough.  How do we know?  
            These are three excerpts I pulled
off the Internet.  I can't even tell you what
the devices were; I don't remember, but I can
tell you that they were all from user guides
that were intended to be used by laypeople in
a home environment.  
            First one.  Prior to each use
inspect product for damage.  Do not use if any
damage is found.  Thank you.  Does that sound
like it's supposed to be minimizing trial and
error?  Yes, I don't think so.  
            Parents should carefully inspect
electrodes, lead wires, power cords and plugs. 
Work for you?  No.  Open to interpretation. 
Open to accessibility.  You know, that
instruction is clearly not intended to be used
as they're actually doing the instruction.
            The third one.  A simple five step
setup process; and that's how the user guide
described it, simple, is followed by one
warning and four notes including this one:  A
mask should not be used in the pulse dose
delivery mode as it might not fit to the face
well enough to allow the conserving device to
sense inhalation efforts.  Also, the
therapeutic effect of the oxygen conserving
device would not be realized as the dose of
oxygen would be diluted in the mask prior to
inhalation.  Does it work for you?  
            One of the benefits of having good
definitions is that you don't even have to
have a clue what this device is and you don't
have to really be an expert in the device. 
The definition of accessible real time is, the
persons performing the task minimize trial and
error.  We know it doesn't work.  
            The only way you can really know
for sure; and even then it's still open to,
you know, what happens after it gets in the
hands of real users, but the only way you have
a snail's bit of hope if your training and
labeling truly is effective is doing something
called human factors testing.  The excerpts,
the video excerpts that you have been seeing
are actually excerpts taken from a human
factors study that we did a couple of weeks
ago, clearly on a user guide.  
            What makes human factors testing
different is that it is a very systematic
process of observing and recording members of
the target audience.  These are not the
product development team people.  These are
not your relatives.  These are people who
actually have whatever the condition is that
this device is intended to serve performing
real tasks with either a real or simulated
device.  You don't want to wait two weeks
before your FDA submission to do this.  You
can do this with prototypes.  In fact, you
should be doing it with prototypes.  But what
you're doing is you're setting as real world
condition and giving the user whatever it is
that they would be expected to have in real
world, and just let it happen, and videotape
it.  
            One of the things that I think
makes human factors medical devices so
different than the human factors for that
smartphone and for your new computer is
something called use error.  Use error can be
defined as an act or an omission of an act
that something bad happens when that user's
interacting with the device.  The manufacturer
did not intend it and the user did not expect
it.  It's one of those, oh, my gosh, who could
have thunk?  
            I have seen user guides go through
literally nine review steps, nine people
reviewing it, redlining the dickens out of it. 
Not one reviewer has the device in their hand. 
They're reading the instructions as though
they're reading the front page of the New York
Times, and they're all quibbling about is this
word the right word?  I think the comma should
belong there.  Then you put in the hands of an
actual real user and it blows up and no one
can figure out why.  Because only the user can
identify these things.  If you want to shorten
your process for getting labeling and training
out there, knock down the reviews and increase
the number of users.  I would hire Susan in a
heartbeat, by the way.
            MS. MINTZ:  I do consulting.
            MS. PATTERSON:  So, that's what
we're looking for.  We're looking for those
opportunities that can either cause harm to
the patient, to the user, sometimes to the
device, or that cause the person not to get
the therapy that your device is intended to
provide.  You guys work hard on these things,
I know, so we want this to happen.  
            If you're interested, I would
invite you to take a look at AAMI's newest
human factors standard, HE75, Human Factors
Design for Medical Devices.  There are people
in this room who spent years of labor and love
producing that document.  It is beautiful.  It
is a rich resource.  There is a chapter in
there on documentation.  Some of this stuff is
covered in there.  But if you don't have it,
get it.
            Well, I've been talking about
users kind of assuming maybe lay users; and
caregivers certainly can be lay, as Susan told
us.  If this Home Health Care Initiative and
the system is going to work, we have to begin
to bring in the caregivers in a really formal
and a really systematic way.  These are the
folks who have to meet the challenge, whether
they be lay caregivers or professional.  
            We don't have time to go into it
right now, but I would invite you to look at 
this performance model in terms of how do we
develop caregivers?  What is an outcome or
outcomes of value that a caregiver provides? 
It's more than knowing how to put somebody in
and out of a wheelchair.  It's much more than
that.  It's important.  What we do in this
room is important.
            (Whereupon, a video was played.)
            MS. PATTERSON:  Thank you.
            MS. COLLINS MITCHELL:  Thank you,
Pat.  
            Our next speaker is Don Witters. 
Don is a biomedical engineer with the Office
of Science of Engineer Laboratories.  He leads
CDRH/FDA Electromagnetic Compatibility and
Wireless Work Group that develops information
recommendation guidances and coordinates the
EMC and wireless standard efforts.  He has
worked at CDRH and its predecessor the Bureau
for Radiological Health for over 30 years.  He
is the primary author of the draft wireless
medical device guidance.
            Please help me in welcoming Don
Witters.
            (Applause.)
            MR. WITTERS:  Thank you.  Good
morning.  It's getting a little late in the
morning.  I know we're a little bit behind
schedule, but if you bear with me for a few
minutes.
            How many of you actually    I bet
you all have cell phones, right?  Some of you
probably have some really smart phones and
things like that.  How many of you actually
have passwords on your cell phones?  A few. 
Now, that's great.  Security is an issue with
wireless.  Since these signals are going out
into the ether basically, anybody can pick
them up.  In fact, you can buy little products
that you can sniff them out very easily. 
They're $20 or so.  And with those kinds of
products, you can find out who has wireless
and perhaps how you can get into it.
            I just wanted to show you very
quickly an example of electromagnetic
interference.  These right here are coming
from this BlackBerry in this person's pocket. 
So, there are issues with electromagnetic
compatibility and interference that we need to
be well aware of.  We've all heard of in the
last few years things about cell phones and
pacemakers and other sorts of issues with
electromagnetic compatibility.
            I'm going to speak mostly about
the wireless issues.  That's the technology,
how it's used, what it's used for.  In home
health care, this can be safe, effective and
secure, but it requires designing it properly,
it requires testing, deploying and really
managing that for the wireless risks and
hazards associated with that.
            So, my purpose very quickly this
morning is to go over what some of these
wireless technologies are, how they can be
used, how they are being used, what sort of
things are the risks involved with this and
how you can address that, and give you an idea
about some of the challenges and opportunities
that are in this area right now.  And wireless
is increasing not only in our hands in every
day life, but it's going more and more into
the home use environment.  Go over the
technology very quickly, some of the issues in
home here, addressing these issues and the
challenges.  
            Well, wireless is everywhere. 
Everything under the sun uses wireless. 
Wireless goes back about 120 years or plus in
terms of that technology, but only in the past
few years have we really started to grasp it
again.  All of these different kinds of
technologies are available right now and many
more.  We have products such as monitoring
systems used in the home that are wirelessly
sending signals perhaps through a cellular
network or other ware.  We have implanted
devices that both use wireless to connect to
the outside, but also from the outside locally
to something perhaps distant.  We have glucose
meters and devices that can attach or work
directly with cell phones.  You have
smartphones that now can display various types
of physiological signals.  Here's one that I
like to point out.  This is actually an RFID,
radio frequency identification chip that can
be implanted.  And now they're much smaller
than this.  We actually reviewed this and it
went through five or six years ago.
            So, what are some of the issues in
the home environment?  It's uncontrolled, as
Dave mentioned.  Very uncontrolled.  You have
many wireless emitters both in and out of the
home.  In fact, if you were to go home and you
had some kind of wireless computer system in
your home, you could probably pick up several,
perhaps your neighbors' and you might find
that those aren't even protected.  There have
been people who have exploited that in
nefarious ways, but just know that there are
many sources both in and out of the home. 
Your wiring is a source of electromagnetic
energy.  Your motors.  Perhaps you have a
microwave oven.  Perhaps you have an induction
range.  Perhaps you have many different things
in your house that are using electric energy
and these create electric and magnetic fields
that can potentially interact with some of
these.
            You have things outside of the
home that you can't control.  You may be
living near a broadcast or TV station.  You
may be living near an airport that has radars. 
You may be in the vicinity of a cellular
tower.  All of these create energy levels that
fall off with distance of course, but they're
still there.  They're everywhere.  And in
fact, if you didn't have them, your cell phone
wouldn't work.  You probably wouldn't be
carrying it.
            There's little oversight, in some
cases no oversight.  As we've just seen in
several demonstrations of technical knowledge,
you can probably expect that to be pretty
close to zero generally.
            Rapid changing technology.  How
many have had cell phones you've changed in
the last year?  In the last two years?  Right. 
This changes very rapidly and it's changing as
we speak.  And the wireless technology we're
using now today in two years will be
completely different.  
            It's both a source.  It actually
emits energy.  That's it's sending a signal
back to the cell site or wherever.  It's going
between your printer or your company say.  It
also is a victim for electromagnetic.  That
signal can be disrupted.  It can be interfered
with.  
            These are some of the hazardous
situations that lead to the risks that are
specific to wireless, although they do have
applications in networks and other areas, but
these are things that we look at for wireless.
            Quality of service.  QOS, quality
of service.  When you think about that,
perhaps on your cell phone you might think
about that related to but not entirely
encompassed by the number of bars that you
have.  If you're in an urban or suburban area,
this is generally not a problem.  But when you
get out of those areas; or if you see the
commercials one vendor versus another, we have
more coverage, we don't, how do you protect
against that or how do you make sure that in
the environment that you want to use these
devices, or anywhere in between, it's going to
work.  
            Data integrity means just that,
the data is going to be correct, it's going to
be timely.  
            Coexistence is another issue. 
There are so many of these systems wirelessly
now, millions, hundreds of millions.  How do
they all coexist, because most of them are
operating on a handful of frequencies. 
There's only one protected frequency for
medical systems in the U.S., and really I'm
not sure if that's applicable worldwide.  
            Security.  Security is an issue. 
Starts with simple things like passwords, but
it goes well beyond that.  Most of your
computer systems that you have at home
probably don't have any security and you've
never enabled it.  It doesn't come enabled. 
Unless you do it yourself, it won't be there. 
Things like Bluetooth do have some security,
but Bluetooth has a nice little function
called Discovery.  If you're walking down a
hall and you discover something, you might
want to see what it is.  Well, what if you're
walking down the hall of a hospital or in a
home and you discovered now a dialysis
machine?  Oh, that's interesting.  Maybe I'd
like to change that.  Most of them that we
look at, obviously we ask that question, how
are you making sure that that security is
enabled and adequate for the use of that
device?
            Risk.  Obviously it goes up as it
gets closer to critical life functions.  High 
priority alarms.  If you want somebody to
react immediately and that system doesn't go
through your wireless system or the various
parts of the system that it's connected to,
that could be a problem.  If it's delivering
therapy, a drug or something like that, there
are things that we even want to go to remote
control.  And that's now more and more
advancing on actual use situations.  This is
a shared risk environment.  Everybody has to
share in this.  If you don't into it looking
as a shared risk environment and only
protecting or dealing with one part of that
risk, you may be overlooking other places.
            It's related to the system. 
What's an intended use?  What's the
technology?  Some are much more adapted to
certain things than others.  And the data
that's transmitted.  It's not just a matter of
data.  It's a matter of the system, looking at
the entire system as our last speaker talked
about.  
            Low priority.  Well, what happens
if it doesn't get there five minutes from now,
ten minutes from now, two hours from now,
today?  Maybe it's not that important.  It'll
get there eventually or you'll make some sort
of follow up to get it to you.  Those are
lower priorities.  The consequences of not
getting that data across that link correctly,
timely and securely, these are the issues that
really need to be looked at.
            When we look at wireless
technology in submissions, I'll go through
just a few of the questions that we're
typically asking about this.  
            A good description.  That is, what
is the actual wireless technology?  People say
Wi Fi.  That's not all that well defined. 
What exactly is the technology?
            The quality of service needed. 
So, you understand how these can go across the
ether, what the parameters that you need to
have for that to happen correctly, timely and
securely within the system that you have. 
            Coexistence.  Unfortunately
there's not a good test for this, and I'll
explain in a couple of minutes why.
            Data integrity, data security and
electromagnetic compatibility.  These are all
aspects of questions that we have.  These are
all out of the draft wireless guidance that
you can get it.  It's been up since 2007. 
We're finalizing it now.  Took into account
many different comments and many different
experiences that we've had.  We think this is
an excellent document.
            Let me speak just a minute for
coexistence.  This is what we're talking
about.  Here is your device, whatever it
happens to be; not going to look like this in
most cases, and here's the link that you're
trying to make sure is the secured link, the
one that your system needs to operate.  And
then you introduce all of these other emitters
that are working, some of them on the same
frequency, some of them nearby frequencies,
some of them different frequencies.  You also
have another one of your devices.  How close
can they get?  As we heard about the cell
phone on top of a device, you would expect
that two devices will possibly be on top of
each other literally.  Maybe they were
intended that way; maybe they weren't.  You
may have some reason that these have to be
separated by certain distances, or these kinds
of things. 
            Microwave ovens.  Most of the
popular wireless technology; in fact, the
biggest group uses the same frequency
microwave ovens use.  Microwave ovens are well
known, have been documented to cause problems
with these if the oven is leaking badly.  If
it's even in the next room, it could go right
through the wall if it's leaking badly.  Most
ovens don't.  That's another area that we
actually deal with.  We do oversee microwave
ovens.  And by and large they don't leak very
much, but people do things to the oven like
taking off the doors or taking the glass out
of the door.  Unfortunately that's happened.
            Challenges and opportunity.  More
home care, more functions, less on sight
management.  Perhaps less management at all. 
Maybe it's a phone call.  Maybe it's a call
center.  Maybe it's a Web site.  Who knows? 
You have the situation of the bolt breaking. 
What happens when you get very complex systems
that are supposedly simple and something
doesn't go right?  I know I've had to call up
the call center just to get my Internet
working properly.
            Changing wireless technology. 
Wider integration, more use of wireless
resources.  It's a much wider use of wireless
technology.  Everybody wants to go wireless. 
They want to get rid of the wires.  Well, we
know how that worked with Toyota.  Toyota
isn't wireless, but it went from a wired,
basically a hard wire system, a mechanical
system, to something that was electronic
through a computer.  And there were issues
potentially about electromagnetic
compatibility with that.  These are potential
issues that need to be dealt with.
            Greater needed for shared risk. 
Everybody shares in this.  The broadcasters
with television may share in this.  Ten years
ago or so we found that there were telemetry
systems in hospitals, not in the home of
course, that were taken off the air by a new
television technology, digital TV, which we've
all switched over to, because the old system
allowed hospitals and everybody else to use
vacant TV channels.  And guess what, there
weren't any more.  
            Need for information and
standards.  Definitely.  And safe, secure and
reliable medical systems are really dependent
on some of these.  
            This leads us to the opportunity. 
We can create it, like we're here today to
create a document that really does try to
start to answer some of these questions, pose
some more questions and develop a framework by
which this kind of technology can be used
wider, safely and securely.
            I'll just summarize real quickly. 
The home environment presents challenges and
opportunities.  It's rapidly increasing and it
continues to change and evolve.  It's risk
management that has to be dealt with; that's
what we're really talking about, in a shared 
risk environment.  
            There's a lack of adequate tools
and clear pathways for this.  We need to have
more engagement by all the parties, and this
is a wonderful opportunity for that.
            Addressing wireless should include
these kinds of issues which are in our
guidance:  A good description of the
characteristics, a good quality of service,
data integrity, coexistence and the rest of
these, and labeling of course.  But we've all
heard about how much labeling needs to be
addressed in most of these kinds of systems.
            I'll leave you with this thought
basically:  Making this work requires a lot of
research, a lot of risk awareness and
management overall by all parties involved in
this.  Everybody has a piece.  Stakeholder
engagement, like these meetings, but more so,
intense to develop the real tools and a
proactive approach to safe, secure, reliable
deployment.
            I'll leave you with this one   
this is my information    with this one
thought.
            (Whereupon, a graphic was shown.)
            Now, you think this is funny. 
These are the kind of things that can happen. 
This is why wireless and wireless issues are
important as we go forward.  There have in
fact been things that aren't too far from
this, but you hope that things like the
clapper aren't involved in them, but you can
never tell.  Thank you very much.
            (Applause.)
            MS. COLLINS MITCHELL:  Thank you,
Don.
            For almost two hours you have
heard some very thought provoking information
related to unique characteristics of the
environment, caregivers and patient labeling,
and wireless issues in the home.  We're going
to open the panel for some questions and
answers for about 15 minutes.
            DR. PURPURA:  Hi.  I represent
industry, but as a former health care provider
I know one thing that I would never ever want
to do is ask a patient to get rid of a beloved
pet.  And I was wondering if, I guess, today
if I would pose the question if you considered
that as part of the environment, because I
know of situations where pets do interact with
medical devices?
            MR. OSBORN:  There's no question
that that can be part of the environment,
particularly for things that need cleaning and
disinfection.  The equipment standard didn't
explicitly mention that much other than I
think there's one bullet point and a note that
says you need to consider that.  
            DR. BRADY:  I think we called it
the pets, pests and vermin or children   
            MR. OSBORN:  Yes.  In fact, it's
not just pets.  It's cockroaches and other
things.
            MS. McDONALD:  I had a question
about the pre market.  During one of the
discussions the infusion pump guidance was
brought up.  The definition for that regulated
device specifies it's a device used in the
health care facility, yet the home care
labeling and definition is going to possibly
change that.  The question I have is, is the
regulation going to change for each home care
device to include if the device is going to be
used in health care facilities and in home
use, or are there going to be separate new
regulations for those devices?
            MS. BROOKS:  I can speak to that. 
We are going to change the regulation to
better define the environment of use for
infusion pumps, so I can make comments to that
for the infusion pump guidance.  We're in the
works.  Takes time.
            DR. BRADY:  Any other questions?
            AUDIENCE MEMBER:  I had a question
for Don on the definition of the shared risk
environment.  Typically we would be doing risk
assessment with regards to a particular
device.  When you say shared risk environment,
where are the boundaries, because environments
can be very different as far as different
people having different types of interfering
sources?  Where do we draw those lines to do
a shared risked environment assessment?
            MR. WITTERS:  Well, that's an
excellent question.  I don't know at this
point.  It really depends on the device and
the device system.  For example, we've had
devices relatively recently that depend on a
cellular network for communication.  In this
particular case, we asked questions about how
are you going to make sure that this patient
is going to have the quality of service they
need?  They in fact reached out to the vendor
and the wireless carrier and were able to come
to some arrangement about what sort of service
they needed, where it was and the vendor of
the wireless would be the one would help
determine that this particular product would
be needed in order to make that cellular
connection in this particular location.
            It's not well defined at this
point, but there are many parties that can
play in this.  It depends on how wide the
system is and what's involved in it.
            AUDIENCE MEMBER:  Excuse me, I
have a question on electromagnetic
compatibility.  I have an antique diathermy
machine that I just acquired on eBay.  I'm
just playing with it.  And it wipes out my
cell phone, computer; it even triggers my
paper shredder, and it probably takes out a
two or three block radius in my neighborhood. 
And I'm wondering what about devices that are
designed to produce lots of RF energy,
electrosurgical generators, diathermy
machines, things of that nature?  Is it
acceptable to just say that you can't use
certain devices with this device?
            MR. OSBORN:  The home environment
is a class B environment.  That kind of
equipment is industrial equipment and it's not
permitted by law in many jurisdictions, and
certainly in the United States for use.  The
FCC can come knocking on your door using that
in a home environment because it's against the
law.
            AUDIENCE MEMBER:  Well, this new
technology that produces RF energy, there's
lots of stuff in the home that's designed to
produce RF energy.  This was a medical device
from the 1940s, but I'm sure you can still get
devices like this in the home today.  This is
not an industrial device at all.  
            MR. WITTERS:  Yes, unfortunately
that's true.  You can get practically anything
on eBay.  Intercontinental ballistic missile,
I'd guess you could probably get, too. 
Medical devices unfortunately are readily
available.  Explants like pacemakers have been
on there.  Those are definitely prescription
devices.  
            The electromagnetic compatibility
is only as good as what that device may have
met at some point, and even after that is not
so clear.  I don't know how one would go about
a priori understanding that or even finding a
solution for what you're talking about, but it
sounds like you've got one that definitely
wouldn't meet class B.  And it would be a
perfectly legitimate device.  For example,
diathermy devices don't have to meet any of
this.  They in fact were intended to radiate
energy to do something, heat muscle, heat
tissue, et cetera.  They're well known
radiators.  
            Unfortunately we've had adverse
events, some of them very serious that were
related to things like that.  Electrosurgical
units, well known problematic for almost any
other device because they do generate such a
large amount of energy.  But there is a
standard specifically for that in each
standard iteration; the newest one was last
year or two, I think, improves on that and
offers more information.  Unfortunately your
example is all too common, that these kinds of
things can happen and they do happen.  Just
points out how uncontrolled these environments
tend to be.
            MR. DESAI:  Hi, I represent the
industry.  Every talk here I'm listening is
all related to electromechanical systems, IEC
6061.  How are you thinking about simpler
products which do not use electromechanical
components associated with?  Thank you.
            MR. WITTERS:  As far as the human
interface goes, the Usability Standard 62366
is for all medical devices, as is HE75.  So,
the usability aspects are covered there, and
I think covered quite well.  
            When you start looking at other
devices, if they don't have a human interface
and they don't use electricity, the number of
issues begin to go down a great deal.  But
most devices, unless they're implants, have a
human interface.
            MS. PATTERSON:  Can I add
something to that?  I always get a little bit
nervous when someone uses the word simple in
the context of a medical device.  We've worked
with devices that don't have so much as a
battery in them, different kinds of EpiPen
kinds of drug delivery devices, and bad things
can happen.  They're can be things like people
accidently stick themselves in really, really
bad places and they weren't expecting to get
the drug.  We've worked with lancing devices
that are used in conjunction with a blood
glucose meter and I've seem people rocket the
lansing device across a room by accident.  
            So, I think that even though those
devices would certainly be considered simpler
than the electromechanical kinds of things
that you're talking about; and I would invite
Susan to add to this, devices that don't have
so much as a battery can cause some real
difficulties for users.
            DR. BRADY:  I would like to add to
that as well.  We did talk a little bit;
Suzanne in her talk, about a few things that
seem to very simple devices.  They help lift
somebody up that no longer can lift themselves
up.  If there are no instructions for use or
the instructions for use are so complicated
that that person can't use that, it doesn't
matter how simple that device appears.  It is
complex to that ultimate user.  
            The example of the Hoyer lift I
thought was incredible.  Somebody who thinks
this is just going to function on a regular
basis every day, it breaks.  What do they do? 
They call the company.  The company says,
well, our devices don't break.  Well, there
she stands.  Now she is in an emergency
situation.  What is she supposed to do?  
            So, I feel that devices, whether
they appear to be complex or simple, I put
them all in the same category at this point,
depending on the user and the environment.
            MS. MINTZ:  And I think, you know,
in a home environment until somebody gets so
completely comfortable with something, there
is an emotional impact, a stress level.  So
they're not necessarily thinking as clearly as
they might.  You know, if somebody needs help
doing it, then you get the interaction between
the ultimate user and the family caregiver,
whoever is helping them and that, you know,
gets in the way as well.  
            So, I know Pat doesn't like the
word simple, but take it in the context of
make it easy.  Don't add to the stress, I
think is the way to say it.  And I really do
believe that you can't do it alone.  It
doesn't make any sense. 
            I remember my dad had had a stroke
and so there was like an apartment set up in
the hospital to help him learn some navigation
and how to get in and out of bed.  It's
totally irrelevant, because it's not like your
own home.  And I think that's really critical.
            MS. JOHANNSON:  I have a question
for you regarding the guidance document.  Has
there been or will there be global
collaboration to allow for one design that
works globally, particularly for traveling
patients?
            MR. OSBORN:  Well, certainly for
equipment IEC 6601 1 11 had that in mind.  And
we looked at worldwide issues, but there are
many devices that don't involve electricity
that aren't covered.  And the usability issues
I think are very, very significant.  If the
device has a user interface, if it's for home
health care, it needs usability work full
stop.
            AUDIENCE MEMBER:  A couple
questions for Dave.  Right that the FDA put
out a couple many years ago said sixth grade
education, yet you said eighth grade education
in your standard.  And do you expect us to
find eighth grade educated people to test the
IFUs with?  And has our education level
decreased so much that you're moving from
sixth to eighth grade for what we're looking
for in the country?  And do we take it from a
demographic across the country, or eighth
grade in a specific area, because I think
eighth grade may change as we move across the
country and the world?
            MR. OSBORN:  Certainly as one
moves around the world that's an issue.  There
was a fair amount of debate over whether we
should even mention a level of education.  And
at one point it was sixth grade and at one
point it was eighth grade.  It ended up eighth
grade at the end.  
            Usability studies need to be
performed with operators that meet all of our
operator profiles.  I'll let Pat speak to
that.  She's much more the expert.  And
there's a German expert who kept talking about
the eighth grade ADD boy which barely is sixth
grade, and this was a German speaking, it's a
relevant issue in terms of that.  There are
many tools that you can use in terms of
looking for instance at instructions for use
to determine, if you will, the English level
of writing, and there are similar tools in
other languages.  But you need to do usability
studies with the intended operator or they're
not valid.  
            MS. PATTERSON:  Right.  I would
add to that, when I started out in the medical
field transferring from Fortune 500 stuff, it
was very typical that the labeling was
subjected to nothing more than comprehension
tests and they stuck to that sixth grader,
they depended upon that sixth grade.  And they
would run them through computerized programs
to see if it was at a sixth grade reading
level, and they would artificially pick a
paragraph that didn't have words in it like
hypoglycemic, because obviously that ain't no
sixth grade reading level.  
            And I think one of the things that
his changing, and again I think one of the
benefits of HE75 is the recognition that the
labeling and instructional material needs to
be hands tested.  It needs to be can they read
it, can they understand it, but more
importantly can they do it, can they follow
those instructions?  It matters not to me. 
And I saw this once where someone was testing
the labeling by having matching columns.  Can
you match the word to the right definition? 
I almost fell off of my chair.  It needs to be
tested in that way.  
            So, while I think it's
appropriate, okay to have some kind of grade
level reading, I would be cautious about
thinking that that's the one criterion that
you really need to strike for.  It was a shot
in the dark; I think it's where we were 30
years ago, but I think that we've gotten
beyond that today.
            DR. BRADY:  Okay.  We're going to
take one more question here.  And I would say
we're running out of time, so we want to stay
on track.  But during the breakout sessions
this afternoon, make sure that you ask these
questions that you're holding right now. 
Write them down so you don't forget, because
we really want to know what your thoughts are. 
So, just hold them right now.  And we have one
more question.  
            MS. YOUNG:  I just wanted to make
a couple quick comments.  One is that
certainly I would agree with Pat that don't
rely on that grade level, because I could
write you sixth grade instructions that still
would be completely and totally
incomprehensible and not able for people to
follow.  
            But I wanted to make another
comment about the idea of simple devices and
where issues are.  I'm involved with Western
Michigan University and we ran a tele health
study recently where people were asked to take
their blood pressure.  And these were older
folks, between 60 and 90 actually.  And we
found that a third of them either could not
use the traditional blood pressure cuff to
take their pressure or they could not
interpret it.  And so, if you think there are
not problems with simpler devices, simpler
devices are not simple and blood pressure is
a tough concept for somebody who's oxygen
deprived, who doesn't know anything about
blood pressure, etcetera.  And I think you
have to consider those things.
            Finally, I would make a plug for
better and diverse training materials from
manufacturers, and I would make that plug on
behalf of the nurses who are often the folks
who have to do the training, and we do not
give them very good tools to use with
patients.
            MS. COLLINS MITCHELL:  Thank you
so much.  We have heard the comments and we'll
take these comments back as we prepare these
guidances.  We'll have a 10 minute break and
then we'll return to this room.  Thank you so
much.
            MS. MINTZ:  I just wanted to say
I'm not going to be here for the breakout
sessions but Lisa Winstel; if you would stand,
from NMCA will be.  
            (Whereupon, the above entitled
matter went off the record at 10:57 a.m. and
resumed at 11:14 a.m.)
            MS. COLLINS MITCHELL:  Okay. 
There has been a slight change in our agenda. 
After the next speaker we're not going to have
the question and answer period.  We're going
to allow you to ask those questions in the
breakout session.  
            But today, it's my honor to
introduce Dr. Susan Gardner and I hope that
everyone is enjoying and finding the
conference informative and enjoyable.
            The next speaker is Dr. Gardner. 
Dr. Gardner joined the FDA in 1995 as the
deputy director of the Office of Surveillance
and Biometrics in the Center for Devices and
Radiological Health.  In 2002, Dr. Gardner
became the director of the Office of
Surveillance and Biometrics.  
            The responsibilities of the Office
of Surveillance and Biometrics include the
monitoring and review of post market studies,
post market signal detection through the
monitoring of adverse event databases and
other data resources.  
            Prior to joining the FDA, Dr.
Gardner was the associate director of health
studies at Westat, a social science research
firm.  
            Dr. Gardner received her nursing
degree from the Johns Hopkins School of
Nursing, a bachelor's or arts in sociology
from Boston University and a doctorate in
medical sociology from Catholic University.
            Please join me in welcoming Dr.
Susan Gardner.
            (Applause.)
            DR. GARDNER:  All right.  It's
almost no longer morning.  I'm going to give
you a crash course in post market
surveillance.  And for those of you who are
not students of the regulatory system, post 
market actually means the products are on the
market, not post market.  So, go figure how
the terminology got where it is, but that's
what we intend to call it.
            And unlike the speakers ahead of
me, I probably am not going to bring you to
tears or make you laugh through this talk.  We
really had some wonderful talks, but
regulatory stuff tends to be a little drier
than that.
            All right.  The objectives of our
surveillance program of course are to first of
all ensure some reasonable safety and
effectiveness of the medical devices which we
regulate and we want to be able to identify
and if possible prevent the occurrence of
adverse events related to the products.  When
harm does occur, we want to figure out the
cause of those problems and we want to capture
that information and use that information to
better inform decision makers.  And you can
think of decision makers in the broadest
terms.  It's both the day to day work that FDA
does, it's those of you working in the homes
taking care of your loved ones, it's people in
the hospitals, all the way up our Congress.
            We have a number of information
sources, and I will give you the punch line
right now.  In spite of this, we do not have
very good information of the problems going on
in the home.  We have our Medical Device
Reporting Program, we have our MedSun Program,
we have epi research, post market studies and
our important collaborations with our
partners.  And I'm going to briefly talk about
each of these.
            Medical device reporting. 
Manufacturers are required to report device 
related deaths, serious injuries and certain
malfunctions to the FDA within 30 days, and
the regulation says of becoming aware of those
events.  We receive over 200,000 individual
reports a year of adverse events.  That number
continued to increase since the mid '90s.  We
also receive about 200,000, and sometimes
more, reports that are in a summary format. 
These reports come from devices that are well
known and the adverse events are well known. 
So, instead of filling out an entire
individual report, they come in summary format
which allows us to trend them.
            Over 90 percent of the reports we
have under MDR are from the manufacturers.  We
have a small number of reports from the
clinical community; which I'm going to tell
you about, and we also have voluntary reports.
            MDR reports are reviewed by a
group of staff that are primarily nurses, but
we also have biomedical engineers, and we have
some people with other specialized backgrounds
such as radiation physiology.  We look for
unexpected events, something that we hadn't
anticipated, and either we're seeing that as
something new or we're seeing it at an
increased risk level.  
            I will tell you that we do not
have denominators in most cases without a lot
of extra work, and because we have a lot of
underreporting, we know we don't have good
numerators.  So, when I'm talking to you about
increased risk level, I will tell you that
that is a very, very difficult thing to find.
On the other hand, there are some adverse
events that should never occur; in that case,
it makes it easy.
            We also look for user error. 
We've already talked this morning about human
factors issues.  That's extremely important. 
We do think it's the responsibility of the
manufacturer to address human factors and user
errors when we see them.  
            We're able to look at problems
that are happening across device types, such
as the infusion pumps that Mary Brooks talked
about earlier this morning, and we look for
problems that are not corrected by the
manufacturer.
            Under the law, the Safe Medical
Device Act, user facilities are also required
to report deaths related to medical devices to
FDA and deaths and serious injuries to the
manufacturer.  However, we have only
traditionally received a very small number of
reports from user facilities.  By user
facilities, we include hospitals and nursing
homes, home health care agencies, dialysis
units and the like.  And I'm going to tell you
about the MedSun Program and what we found out
about user facility reporting.
            When I got to FDA in the mid 1990s
and into the 2000s, I was actually surprised
that we had such few reports from the clinical
users.  These are the people that are on the
ground using the devices and why weren't they
talking to us and telling us what was going
on?  So, we created the Medical Device
Surveillance Network.  This is a program that
started with 25 hospitals that has grown to a
network of 350 user facilities now.  This
gives us real time reporting from the clinical
users.  And in fact, some days it's very real 
time.  We really have formed a partnership
with these hospitals who feel free to pick up
the phone and call us and not wait whatever
period of time it takes us to get the report.
We go to these sites and they're specifically
trained to report medical device adverse
events to us and to recognize medical device
adverse events.  
            The core of the program is really
a robust and ongoing sharing of patient safety
information to these facilities so they
realize that reporting to us has a benefit and
giving as much information as we can to
improve safety in their hospitals.  They
emphasis is on prevention, and we also have a
lot of focus on human factors.  Once again,
these people are the direct line to us from
the user community.
            In addition to giving us reports,
the MedSun people give us some real time
information that's valuable for our decision
making.  We are able to go to them if we see
an event and ask them if this is happening in
their hospitals.  Because of our Paperwork
Reduction and OMB rules, we usually can only
ask that question to nine facilities, but you
can get a very quick read of whether we're
seeing something very unusual or whether
they're also having that problem.  
            We also are able to go to them and
ask them about information that we're putting
out in communications that we're putting out,
whether it makes sense to them, whether it's
something that's going to be applicable to
their facility.
            We do get reports of near misses
and close calls.  And in fact, the bulk of the
reports are near misses and close calls.  And
we have been able to take a lot of regulatory
actions on that information, again receiving
it before somebody is actually hurt.
            What we've done in the last couple
of years is tried to go deeper into the
reporting community.  We really want to hear,
really want to hear from the users.  So, we
have put together what we call sub networks. 
We have one called KidNet that operates in the
PICUs and the ICUs.  LabNet operates in the
laboratory environment.  HeartNet in cardiac
cath and we also have HomeNet, which I'll tell
you more about in just a minute.  
            Right now we're piloting yet
another program which is our Regional Rep
Program.  We actually have people on the
ground in the field who are going into the
hospitals and helping the MedSun hospitals
with their reporting and other activities
related to the program.  
            For HomeNet we have 26 sites
enrolled.  The very sad news is that from
September 2008 to essentially today, we've
only received 14 reports from seven different
sites.  They're probably the usual culprits
you might expect; infusion pumps, pulse
oximeters, beds, syringe pumps.  In fact,
we've talked about more things here than we
actually have reports on that we know are
problems.  We do have ongoing efforts to
increase the reporting on HomeNet and we're
also considering other strategies for getting
additional post market information.
            We know and have recognized some
of the barriers to this kind of reporting,
because we've actually gone out and talked to
people about it.  If you are at all familiar
with the reporting form we use, the 3500(a),
you know that it is not a particularly user 
friendly form.  And in fact, the form was
designed for drugs and biologics and devices. 
And that's handy, so the user doesn't have a
lot of forms to go through.  But if you were
going to design a form that really got the
information that we needed for things like
home care, that probably wouldn't be what you
would use.  
            So, in our MDR database, although
we have a fair number of reports, it's very
difficult to tell if it really is a home use
issue.  There is a box that you check.  As I
mentioned before, we have a lot of
underreporting and we're very well aware of
that.  And frankly, the reports are not very
complete.  People are not inherently good
reporters and they're looking at the problem
from their perspective, and that often doesn't
include the information that we need to make
a good assessment.
            It's sometimes a challenge to go
back to the reporter, and again that is
particularly true in the home care
environment.  A lot of people don't have the
knowledge, the skills, the ability to really
recognize that an incident might be device 
related, and we run into this all the time. 
For example, years ago we had a catheter that
was coated with a particular chemical and
people were having allergic reactions.  But if
you have a very sick person who's going bad,
it takes a lot of skill to think about the
fact that it might be this catheter that's
contributing to that.
            Other barriers include a knowledge
gap between recognizing the device related
event and then taking action to report. 
Again, particularly in the home care
situation, you're several steps removed from
the hospital environment, so you have to see
the event, recognize that it's happened, get
the information to the right person to be able
to report it and get back to you.
            There's a fair amount of home care
and nursing assistant turnover, so training
may happen for some group and then most of
those people turnover and they aren't
available when something else happens.
            And again, the benefits of
reporting are not always apparent.  If we get
the report and if we take action, it may be
something that actually the person giving the
report knows nothing about.  And as I say, we
realized when we set up the MedSun Program
that the core and the key to the program is to
make the reporter realize their reports are
not going into a black hole and that we are
taking action and improving the safety.  And
home health care agencies all have different
policies and procedures, so again it's hard to
get a coordinated effort from that.
            Other sources of information, yes
we do have post approval studies.  Those are
condition of approval studies, so if a high 
risk device, which we call our PMA device, is
approved and we know it's to go into the home
care environment and is labeled, and that's
one of the indications, we may get
information.  We may order a post approval
study as part of the condition of approval
study and get information from that.  
            We also have the ability to order
post market studies in something that we call
our 522 Program.  So, if we see problems and
we need additional information, we can order
the company to do a study for us.  There are
some limitations to that particular ability,
because these studies are limited to three
years.  And obviously, if it's something that
we need to take regulatory action, we don't
bother doing the study.  But if we really see
something where we need to gather more
information, we do have the ability to order
that study.
            We do have a robust Epidemiology
Program in the Office of Surveillance and
Biometrics who do studies in real world
situations.  We're becoming more adept at
using registries, observational database and
other surveillance systems.  It is not so
often however that these are available to the
home care type of population and the home care
devices that we are concerned about.  Again,
getting the information flow from the home
back up to where we need it or into these
databases or studies is really quite
challenging.
            Finally, I think of utmost
importance and I think the place that we need
to go and really look closely is our
partnerships and collaborations with academic
partners, certainly professional organizations
or other government agencies such as the VA,
for example, or DoD, and these active targeted
consumer groups such as Suzanne is heading up
now.  People who have headed up or have formed
their own groups and their own consumer group
because they have a child or somebody in their
family that they're really interested in
helping really can be important sources of
information.  So, we're looking closely at how
we can connect better to those organizations
also.
            Okay.  That's it.