RFID - Medical Device Use in the Home Environment Workshop Part1

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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 ColesvilleRoad, 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 ConsultingDON 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


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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 . . . . . . . . . . . . . . .159Nancy 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


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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 everybodycan 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 theCenter 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 tointerpreting 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 youhave 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


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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 thatfor 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 mostof 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 wefelt 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 usto 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


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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 usto 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 towardmanufacturers. 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'refocusing 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 devicelabeling 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


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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 careprofessionals. 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 beworking 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 aregoing 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


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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 surveillanceof 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 youwhere 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


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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 knowswhere 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 continueto 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 tothink 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 answersession 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


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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 tointroduce 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 giveyou 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, myname 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 aguidance 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


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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 colortelevisions.

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 evaluationof 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 arefor 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


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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 safetycommunications 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 hasthe 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 andwe'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.


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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 reportswe'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'san 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 atoperational 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,


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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 thinkabout 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 thelocal 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'sintended 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 IIdevices.

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


14/57

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 manufacturersand 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 themiddle. 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


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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 canconfirm, 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 whollyby 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 hadpeople 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


16/57

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 toadd 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 aboutdefining 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 theylive, 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


17/57

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 onthe 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'sconsidered 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 whatyou 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 onelectronic 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.


18/57

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 twoissues 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 mypersonal 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 themore 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

notAUDIENCE 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


19/57

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, butDR. 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 thewhite 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 diddiscuss 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


20/57

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 forthat 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


21/57

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 environmentmight 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 anactive 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 isreally 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


22/57

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, theISO. 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 Committeeand 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 medicaldevices.

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


23/57

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 ofthose 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 minus14 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'tconnected 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 abig 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


24/57

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 athermal 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 ofthis 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 arefamiliar 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


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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 theattributes 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 itbetween 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 reasonablestationary 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


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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, butit'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 tothe 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 isnot 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 saysyou 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


27/57

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 welladdressed 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 offamily 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 scaredthe 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 peoplewill 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.


28/57

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 weprovide 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 justthe 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 aMercedes 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 whatyou 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


29/57

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. Andultimately 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 aprofile 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 thingswere 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. Andalthough 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


30/57

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, soI 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 hadto 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 peoplelike 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 hasat 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


31/57

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 medicalprofession, 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 somethingactually 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 rantand 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 husbandreturned 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,


32/57

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 care

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RFID - Medical Device Use in the Home Environment Workshop Part1

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