FDA WEBINAR

MARCH 25, 2008


JOY KNISKERN: ... Center and your moderator for

today's Webinar on the applicability of the Food, Drug &

Cosmetic Act to the reuse of AT devices.

This is the first in a policy series presented by

the Pass It On Center, a series of Webinars targeted to

help all of our reuse program staff structure, really

operate reuse activities. And what we're really focused on

is doing this so that our reuse activities are done in a

way that is safe and appropriate for your customers.

For this entire policy series we've extended

invitations to state AT programs, all of the AT reuse model

demonstration grantees, and the National Task Force on AT

Reuse. And for those of you who don't know, that's our

Pass It On Center's advisory group.

And because of you, a national audience of AT

reutilizers, you've demonstrated really an abiding interest

in strengthening all of your AT reuse activities. And

we've heard from many of you about how important it is for

us to work on some of the policies and operational

guidelines and things like that. So that's what it's all

about.

Carolyn Phillips earlier this week -- who is the

director of our Pass It On Center -- and she's here with us

today. Hello, Carolyn -- forwarded to you two handouts we

are going to be using for today's Webinar. One is entitled

"Guidance for Assistive Technology Reuse Programs on the

Applicability of the Food, Drug & Cosmetic Act to

Reutilization of AT." And then there's another handout

that's a table on safe practices and guidelines for AT

Reutilization Activities. And those handouts were really

background information for you.

Our presenter today, our guest speaker, is Jessica

Brodey, whom I'll introduce in a moment. And she has

actually put together a PowerPoint to walk you through what

is in those other source documents.

Many of you -- and if you haven't received that,

then please let us know, and we will e-mail that to you

after the Webinar today.

Many of you, as I mentioned, have spoken to the

need for us to really take a closer look at how the Food,

Drug & Cosmetic Act relates to the use of -- reuse of AT,

and so that's our topic today.

But before we begin, we found that it really helps,

when we get a large group together, to kind of go through

some brief instructions on how to use the Webinar

conference room and some of the features.

And so joining us today, I'd like to introduce Tom

Patterson, who's the program coordinator of the Pass It On

Center. And he's developed some handout information that

he's going to put up on the screen in just a minute, and

he's going to walk you through those instructions.

Tom? Okay. Tom, for some reason or other, we're

not hearing -- I can see that you are speaking on your

microphone, and if you could check that. Otherwise, I'll

go through the handout.

TOM PATTERSON: Thank you, Joy, for pointing that

out. I was doing that as an example of what not to do.

When you want to speak, you can press the "Control"

key, and that will turn your microphone on. Or down at the

bottom -- the right-hand bottom, there's a "Microphone"

button that you can press.

Also, if you have a microphone, you can -- the

first thing is to check and make sure that your computer

is -- your sound on your computer is enabled. That's a

basic. And then there's instructions here for going

through and checking your microphone. And that's under

"Files" and "Microphone Settings." And you can check that.

Also, a microphone isn't totally necessary to

participate in the Webinar. There is a text-chat area in

the middle -- well, over on the right side of your screen,

and you can enter the text in that middle section, and when

you press "Enter," it will show up on the screen. And

that's another alternative way of communicating.

When you want to speak, when you have a question,

you can press the "Control" key or click on the

"Microphone" button, and that will put you in the queue.

And when the person who is currently speaking is done, the

first person in the queue will automatically be able to

begin speaking. Their microphone will be opened.

And if you are uncertain as to whether you're being

heard, or if you're having difficulty hearing someone, you

can contact me directly -- Tom Patterson -- by clicking on

my name, and that will -- right clicking on my name, and

that will bring you to an option where you can send a

private message.

So click on my right -- my name using the right

button, and you can send me a private message saying that

you're having difficulty. That will hopefully limit some

of the "I can't hear you. Can you hear me?" discussion

that can interfere with the general presentation.

So when -- if we put a Web address in the web-chat

area, it is clickable, and you can click on that and go to

that Web site.

Let's see. There are several accessibility

features in using this program. For microphone settings,

blind users or those with low vision can access a slider by

using the Alt-M key combination. And colors for the

text-chat area can also be changed so they can be more

"readibly" read.

If you go to the "Options" menu at the top, there's

a whole list of accessibility features such as green focus,

speech options. You can have the text read to you.

Those are just some of the features that will

hopefully help make this go smoothly for you and so that

you can concentrate on the content and not the process of

the Webinar.

If you are having difficulty, you can send me a

private message, or you can call (404) 345-5682, and I will

attempt to assist you. Thank you.

JOY KNISKERN: Thank you, Tom. I really appreciate

your instruction and giving us those tips.

And so I'd like to introduce our guest speaker

today, Jessica Brodey, who's an attorney and public policy

consultant, whose practice focuses on developing and

implementing policies to improve access to persons with

disabilities in education, work, community, and daily

living.

She serves as the director of advocacy and

governmental relations for the Assistive Technology

Industry Association that we refer to as ATIA. She's also

involved in many, many national initiatives that concern

improving accessibility, access to and acquisition of

assistive technology.

She serves on the Pass It On Center's national task

force, which I referred to earlier. And through her work

with us, Jessica has worked closely to analyze the FDA act

and its applicability to AT reuse activities over the past

year.

Jessica, I'd like to welcome you. We're very

honored and pleased that you're joining us today and

appreciate all of the work that you've done to date. And

we will have time for questions and answers during this

Webinar.

Jessica?

JESSICA BRODEY: Thank you for that kind

introduction, Joy.

I just wanted to thank everybody for coming today

and wanted to let you know a little bit about how this

system works.

As many of you can see, in the public-chat area

there's an opportunity if you want to type in some

questions and hit "Return" and post them for everyone to

see. Along the way, we'll be putting up slides, and I'll

be talking about the Food and Drug Administration today and

how that may or may not apply to assistive technology

reutilization.

And if you have questions that crop up along the

way and want an opportunity to ask something fast, please

feel free to post your question in the public-chat area,

and I will do my best to address that along the way.

Tom, can you move to the first slide? I don't see

anything posted yet.

I'm going to just go ahead. And if you don't see

any of the slides yet, please feel free to post something

up there.

The agenda for today -- we've already done the

introduction. I'm going to talk to you about a new policy

series that we're going to be unveiling today that will be

taking place over the next several months.

I'm then going to get into the discussion of the

food administration regulations and how those regulations

impact reutilization activities. We have made specific

guidelines and recommendations for how to best handle for

reassignment, refurbishment, and recycling programs. We

have a separate but similar set of guidelines for exchange

programs and may be involved in remanufacturing.

Can we move on to the next slide, please.

So first off, the policy series. All Webinars that

we're discussing will take place from 2:00 to 3:30 p.m.

eastern standard time.

There have been so many questions about policies

and procedures. We keep discussing them on our end, and

many of you keep asking what they are, how do we go about

writing policies and procedures.

In response to those requests, we are going to

conduct a series of Webinars to address your questions. We

like to think of these Webinars as coaching sessions.

There will be an opportunity to discuss structures for good

policies and procedures.

We're hoping to provide step-by-step information

and guidance on how you would go about writing policies and

procedures and what you need to do that. You'll have some

opportunities to share and discuss existing policies and

procedures that your reutilization programs may have.

Next slide, please.

And here are the three upcoming Webinars that we

have set. The first one is on April 22nd. We're going to

be focusing on organizational structure, governance, and

insurance. And within this we are going to be discussing

status, acting models, board of directors, advisory

committees, management activities. And we'll be talking

about the range of different types of insurance policies

you may want to consider for your organization.

On May 13th we'll be discussing user services.

We'll look at client intake, equipment matching, training

and technical assistance, delivery, follow-up, and Web site

operation.

Then on June 17th we'll move on to program

operations. The topics here will include your facilities,

acquisition and donations, inventory management,

evaluation, repairing and refurbishing, sanitization,

storage, distribution, transportation of equipment,

disposal and recycling, and Web site operations.

It is really important to note that the point of

this is to sort of look at what you as an organization can

do in each of these areas to try and mitigate liability for

other problems that may arise.

And I know that so many of you are eager to get

into the nitty-gritty, day-to-day user services and program

operations. But we are starting with your organizational

structure because we truly believe that having a sound

organizational structure, governance, and your insurance

coverages really helps mitigate any liability that may crop

up as you're engaging in your direct services.

Next slide, please.

So FDA, the Food and Drug Administration. Many of

you [audio went down] [are aware that the FDA] has

jurisdiction over the manufacture and distribution of

medical devices as defined in the Food, Drug & Cosmetic

Act. Some AT devices may fall within the definition of a

medical device.

Next slide.

I have here the definition of what is a medical

device, and it is, according to the law, "an instrument,

apparatus, implement, machine, contrivance, implant,

in vitro reagent, or other similar-related article which is

recognized in the national formulary, intended for use in

the diagnosis of disease or other conditions or in the

cure, mitigation, treatment, or prevention of disease and

intended to affect the structure or any function of the

body of man or other animals."

So when you look at this definition, it's fairly

broad. And everyone thinks, "I still am not a hundred

percent sure what a medical device is. What's that mean?"

And I'm here to tell you that the definition of a

medical device is very broad. And many of the things that

we deal with in our reutilization programs could, in fact,

constitute medical devices. And that is why ... [audio

went down] ... to you about the FDA and what something

being classified as a medical device might mean to your

program.

Next slide, please.

When a medical device is regulated, there's a whole

host of things that the FDA may require that you do.

Medical device -- dealing in medical devices -- and again,

this is usually commercial distribution of medical devices,

so many of you are not impacted by that.

So a commercial distribution of medical devices

requires registration. There's often a requirement of

device listing. Certain types of devices need to have

premarket notification or approval. You have to sometimes

engage in studies for -- clinical studies to make sure that

those devices are safe. There's quality system regulation.

There's labeling requirements. And there's

medical-device-reporting requirements.

And I know that all of us sitting here looking at

this see this entire list, and we start to panic about how

all these things are going to affect our programs.

One of the things that is important to note is that

the guidelines that we are presenting here today is to

really help you avoid those activities that are going to

trigger a situation in which you might be then subject to

all of these complex FDA regulations.

Next slide, please.

So as we keep saying, the FDA regulations are

relevant to any entity using a medical device in a

commercial activity. This may include -- when we talk

about activities, using a medical device, we mean

manufacturing, remanufacturing, distributing,

redistributing, packaging, repackaging, labeling

relabeling.

Most activities of AT reutilization [inaudible].

Somebody from DC -- Paul Holland from DC Shares just asked,

"What is the definition of 'commercial' for this purpose?"

I do not have a direct definition of "commercial"

that came out of the regulations, unfortunately. I think

it is safe to say that "commercial" generally means

distributed in commerce. And it usually indicates for a

fee.

It is possible, however, that not-for-profit

distribution could trigger the FDA regulations. In most

cases, commercial is associated with a fee. Some of your

organizations, however, do take voluntary contributions or

do charge certain fees.

So in thinking about your organizations and how the

FDA regulations play in, you do want to think about your

own structure and if you are setting up your money systems

in such a way that makes it appear that your organization

is engaged in commercial distribution of a medical device.

Next slide, please.

Another thing that's important to note, the FDA

also has some regulations about devices. It classifies

them as either for prescription use or for over-the-counter

use.

If a device is treated, when it's approved by the

Food and Drug Administration, as for prescription purposes

only, it is approved only for dispensing under the

supervision of a licensed practitioner. That ... [audio

went down] ... occasion follows the device. It is

irrelevant to what kind of an activity or program you run.

So if a particular wheelchair is classified as a

prescription wheelchair, if your device -- if your program

in any way touches that device, that device is only

supposed to be distributed in any manner or utilized in any

manner under the supervision of a licensed practitioner.

So it is important to think about those devices

that are in your program and if any of those devices might

trigger prescription usage.

Next slide.

So we've created a set of basic guidelines to help

your programs that are involved in reutilization activities

navigate the pitfalls. We've kind of created three

categories.

We lumped device reassignment, refurbishment, and

recycling activities into one category because there are

very few differences in the action these programs should

take to sort of steer clear of the FDA requirements.

Device exchange, however, is a little bit different

because of the way devices pass through the program. So we

put that in its own category. And again, with device

remanufacturing, we have dealt with that separately as

well.

We hope that our recommendations will aid you guys

in understanding the steps you should take to avoid

liability and possibly falling under FDA regulations.

Next slide.

So the first recommendation we have that applied to

that first category is to inform consumers. We encourage

you to warn your buyers about the risks of acquiring

reutilized devices; clarify what warranties, if any, are

offered with the devices; create and post a list of best

practices for consumers who are acquiring reutilized

devices to educate the consumers and to protect

reutilization programs.

This is really critical because informed consumers

understand what they're doing. It makes it more difficult

for them to later come back and say, "We didn't know about

this."

So we really encourage you to do your best to let

programs know what you're doing, what the purposes are, and

what pitfalls they may encounter along the way.

Next slide, please.

Again, we also encourage you to know your

inventory, to be aware of all of the different types and

brands of products available through your program.

This is critical because, if you are distributing

prescription devices, you need to know that so that those

devices are [inaudible] appropriate.

If you have only wheelchairs or only bedpans or a

mix of things coming in, it is really critical that you

just know what things are coming through. There's a whole

host of areas where that becomes relevant. And your

ability to understand what is passed through your program

and what you have in stock will affect your ability to

appropriately respond and address ... [audio went down].

We encourage you to address sanitization

guidelines. We will be posting some guidelines and

products ... [audio went down] should be sanitized

according to the manufacturer's specifications. We

strongly encourage you to stay on top of this because one

of the things that can really trigger ... [audio went

down] ...

Next slide, please.

Now, this is where knowing your inventory really

comes in as well. We encourage you to track Class 1

FDA-issued warnings, bans, or recalls. So you need to

[audio skipped] [know if] the devices in your inventory are

subject to warnings, bans, or recalls.

One way you could do that is to subscribe to the

FDA alerts of medical device recalls or FDA e-mail

notifications. And we have a link for you. So those of

you who are interested, you can click on the link from the

screen, and it will take you off these slides and to that

Web site.

If you have any recalled or banned medical devices,

we strongly encourage you to immediately remove them from

your inventory. One of the things, if you have those

devices in your possession, recalls generally just ask you

to send it back, and sometimes you get a new device, or it

can be repaired.

If a device is banned, you should not be

distributing it at all. And often there's some either

compensation or some other corrective action that is taken

so that you can turn that device back in and not have it as

a loss to your program.

But if you distribute those materials and later

somebody is injured because that device has reached the

hands of somebody and caused injury, that is potentially a

liability pitfall. So we encourage you to really look out

for and try to identify the warnings, bans, and recalls.

For those who refurbish, remanufacture, and

recycle, you may be able to fix the problem identified in

the recall to the manufacturer's specifications. You can

simply recycle the parts not affected by the recall. You

can utilize those links that are provided through the FDA

to get the product fixed or replaced and then use that new

product in your program.

Next slide, please.

This is another critical point. We are encouraging

you to maintain business records of your inventory and your

customers. AT reutilization programs should keep ordinary

business records of inventory and customers. A flexible

database with search capacity will allow the program staff

to locate medical devices that have been recalled that you

suspect may be in your inventory.

Search capacity will enable a designated staff or

volunteer to search for medical devices that appear on the

FDA medical device recall alerts; notify customers who may

have received these devices about the FDA alert; advise

customers about appropriate steps they can take to stop

using the device, to dispose of them, or to have them

replaced.

I see a question posted on the right regarding

sanitizing: "Is it in the better interest to post and

clearly state to the consumer that the item has been

refurbished and sanitized or best to leave it as a silent

acknowledgment?"

I think that it's always better to let people know

what you are and aren't doing. If it's a device that all

you are doing is merely sanitizing and send it, then that's

an important thing to note and to inform consumers of.

If you are refurbishing it, you can let consumers

know that this is, number one, not a new device; number

two, that it has been restored to manufacturer's

[inaudible], and that it has been sanitized.

So communicating what you have and have not done is

critical. Do understand that, at any point where you do

more than just sanitize something and send it out, such as

refurbish, you are accepting an additional level of

responsibility for the work that you are doing.

Most of you know that you are not guaranteeing that

your work is going to last and the products won't break in

the future. But one thing that you do, to some extent,

guarantee is that you haven't caused harm to the product

through your repairs and that the repairs you have done are

to the manufacturer's specifications and standards, that

they have been done sufficiently and adequately.

But again, it's important to notify consumers what

it is that they're getting and what they're not getting.

If you're making assertions about what you've done, it's

also important to know what warranties you are or are not

providing.

You may say, "It's given as is. We have done our

best to restore these to manufacturer's specifications. We

cannot guarantee how long these will continue to work,"

et cetera.

DC Shares is letting everyone know that they

include a written disclaimer that equipment is in as-is

condition. And again, that is a great, great point to do,

that it is done as-is.

It is still important to let people know what steps

you have taken and what you haven't. Have they been

inspected in some way or have they not been? If you are

just merely ... [audio skips] ... You can say, "These

devices have not been inspected. They are being offered as

is. We have sanitized them, but we have not done any tests

to ensure that the -- how well they are functioning."

That's an important disclosure to make because

consumers then need to assess that and understand what

promises you are making along with that delivery.

Next slide, please.

Earlier I had mentioned that some devices may be

prescription, and it's important to know your inventory so

that you can identify what devices are prescription, what

devices may be regulated, what devices might be subject to

recalls.

When you're doing all of this, part of this is also

making sure that you are complying with prescription-use

practices. If you are utilizing prescription medical

devices in your program, you should ensure that you are

only dispensing those devices under the supervision of a

licensed practitioner.

Now, please note that this language -- "supervision

of a licensed practitioner" -- is a little vague. It

doesn't say it must be a medical doctor. It doesn't say

who specifically is a licensed practitioner. But -- and it

may be enough to just have the recommendation or a referral

from an appropriate specialist.

But you need to make sure that you are taking steps

that are consistent with what your program practices are to

do -- to only distribute those prescription medical devices

under the supervision of a licensed practitioner.

You need to determine what products you feel are

appropriate and what level of supervision is also

appropriate to your program. What that does is it allows

you to say, "Yes, we were under the supervision of a

licensed practitioner."

It may be sufficient that you have a note from a

doctor, a conversation, or something that lets you know

what particular type of device [audio skipped]. If you

have evaluations that have been done or "we have an

evaluation," that may be sufficient for your program.

It's what your program, in consulting with others

in your field, determines is appropriate and normal in your

area. However, those other devices are distributed the

first time around, you should be engaging in similar

practices to make sure that you are not giving out those

devices in a manner that so far departs from the normal

standard of care that it subjects you to liability.

Next slide, please.

This is really an important, important point for

those engaging in refurbishment. All repairs or

adjustments made to devices should be conducted by a

qualified technician unless the manufacturer specifies

[audio skipped] someone with experience refurbishing that

type of device with proper skills and training to

understand the manufacturer's specifications and conduct

the repairs as specified.

So it's not just necessarily the, you know, kid who

volunteers every once in a while who walks into the shop

and who's never looked at the specifications before. It

needs to be someone who has been trained in some manner,

who knows how to look at these specifications, who can

understand when it says a particular type of a bolt, if

they found the correct bolt to place on that wheelchair or

that device.

So again, a qualified person -- a qualified

technician is a person you can trust to safely service or

repair the device.

So someone asked me, "Wheelchairs, AAC devices --"

this was from Cathy Prevrotski -- and I apologize if I've

mispronounced your name "-- wheelchairs, AAC devices,

standers, et cetera, all require a written scrip from a

physician to approve the purchase of the devices."

Wanted to know if I'm saying that they are all

regarded as a medical device unless require approval the

second time around by an SLP or physician.

Here's an important distinction to make. Some

things require a prescription so that your insurance will

pay for it. The device itself was not necessarily set up

for a prescription use.

If a device merely needed a prescription the first

time around so that insurance would pay for it, that's not

what we're talking about. That's [audio went down] ...

What we're looking for is when the FDA approves a

particular medical device -- and it can be a wheelchair.

In most cases it's not an AAC device, but it could be.

Same with the stander -- it will say sort of at the bottom

of the approval application "for prescription use only" or

"over-the-counter use." If it's over-the-counter use, you

do not need to have any kind of a licensed supervisor, an

SLP or a physician, any way at all, to oversee or supervise

that distribution.

How ... [audio down] ... FDA form it specifically

says that this particular device is for prescription use

only. That is when you need to have -- it doesn't

necessarily have to be a new SLP or physician evaluation.

It means that you need to have this distributed in that

manner.

So if this person -- if you want to take an old

recommendation that had been written up by an SLP or a

physician that it said that they need this particular type

of device, that may be sufficient for you.

If you have somebody in-house, if you have some

other person doing evaluations for seating and positioning

who is appropriately licensed, only those devices that are

specifically specified as prescription use are the ones

that you have to be concerned about.

Many wheelchairs are not for prescription use. I

think pretty much all AAC devices are not marked as for

prescription use. It is not every device that's a medical

device. It is only those devices that are not marked as

[audio failed] only.

Chris Brand has written that all DME mobility

devices are allowed to be purchased by a private party in

Georgia. I can only say that there are absolutely mobility

devices that are marked by the FDA as for prescription use

only.

It is not the majority of them, but there are some,

particularly the ones that are electric and motorized, not

all of them, but again a significant percentage of them.

Most of the nonmotorized wheelchairs are not for

prescription use. However, some of them with highly

specialized seating may be. What is critical is that -- it

is that you do check these devices. You cannot assume,

just because it's a wheelchair or just because it's a

scooter or just because it's this or just because it's

that, that it is never for prescription. You should check

that.

Again, Chris is saying that electric wheelchairs

can be bought without a prescription. That is true for

some of them. There are absolutely some wheelchairs listed

on the FDA Web site that are for prescription use only.

And if you are found to be distributing those particular

devices without the supervision of a licensed practitioner,

it is a violation of federal law.

And that is a very important point to note. And so

everyone should be checking this and be on top of that.

Next slide, please.

Report adverse events. The FDA does not require

that reutilizers report incidents of serious injury or

death involving a device to the FDA or to the device

manufacturer. However, reutilization programs should keep

records of any complaints or reports of such incidents.

We also encourage you to do more than just simply

keep these reports. While there is no duty for you to turn

around and report this either to the FDA or to the

manufacturer, if you are receiving a report that something

negative has happened, we strongly encourage you to, number

one, report that to the manufacturer because the

manufacturer, once notified, has an obligation to report

that adverse event up to the FDA. And if adverse events

aren't appropriately collected and reported, someone could

be injured as a result of that.

If a faulty device design causes a serious injury

or death, it is important that the manufacturer becomes

aware of the danger. And we encourage you to participate

in that duty.

Next slide.

Understand and apply state statutes and

regulations. Some states have chosen to regulate the

reutilization of medical devices. Now, this is an

additional layer on top of what the FDA is doing. You

should consult your applicable state statutes and

regulations to be sure that they are in compliance with --

to be sure that you are in compliance with your state and

local law.

There's two comments. First by Chris. He's

writing that he thinks that liability relates to the

person's prescription issuing or matching incorrectly.

And if you are the person handing out the

wheelchair -- and I have spoken to people from the FDA

about this.

If you are the organization that is distributing

the wheelchair, and it is -- you are doing it, and it is a

prescription device, and there is no supervision of any

kind -- and that doesn't necessarily mean somebody standing

over watching you do it. The supervision could be that

you've taken a written prescription from the person or you

have a reference by a doctor. That may be sufficient that

those two things have matched up, but that you have to in

some way have integrated the process of supervision for the

distribution of that.

Paul Holland was asking about the FDA certification

on the wheelchairs. There is a Web site that we have in

the memo we are distributing that [audio skipped] many of

the devices and the initial applications listed.

All devices are -- once they're approved are

published in the federal register, and that is not an easy

way to have to search through the federal register finding

the devices.

There is a Web site that is -- that contains most

devices in it but not every single device, unfortunately.

We are trying to see if there's a better database out there

somewhere that we can refer you to. But right now there's

a link that is in the memo that we will be distributing and

posting on the Pass It On Center Web site, and you can

click on that and search for a particular device.

At the bottom of the application page, there's a

box that says "over-the-counter" or "prescription use," and

it's checked. And depending on which one is checked

depends on how you have to treat that device.

In most cases, most of your basic wheelchairs are

over-the-counter devices. There are just certain

circumstances where they are not. And you may want to

check your inventory for those devices that you most

commonly have passed through. And if you have something

different or out of the ordinary, you might also want to

check on that as well.

Next slide, please.

We also encourage you to consider partners. If you

work closely with local vendors, those vendors could be a

great asset in helping you identify what devices might be

prescription medical devices. They can help you if you're

seeking supervision from licensed practitioners, if you're

trying to track FDA recalls and report medical device

incidents.

Next slide.

End-of-life recycling is often a part of the

recycling and reutilization process. If you are

refurbishing, many times you will break down old devices,

you'll use some parts that are still good in refurbishing

other units. And what's left over you'll want to dispose

of.

If a program is recycling parts in order to use

them to refurbish or remanufacture devices, you should be

aware and comply with the state's solid waste and e-waste

laws and regulations when disposing of the parts that

cannot be reutilized.

What's important here is that there are so many

states that are engaging in these electronic-waste laws and

in just a lot of these types of waste in general, some of

them with mechanical parts.

There are a lot of standards about where you can

dispose of them, how they must be disposed of, and whether

or not you have to pay charges. Look into those and make

sure that you comply.

Next slide.

So again, we separated out the guidelines for

exchange programs. We felt that there were slight

differences for exchange programs because they are not

directly distributing to consumers. The focus is on

educating consumers of the risks.

The devices made available for exchange continue to

be subject to any warnings, bans, or recalls issued by the

FDA. Therefore, a program that facilitates the exchange of

a device subject to a warning, ban, or recall, might be

subject to liability.

What we encourage you to do is to turn that

obligation or that risk on to your consumers by educating

them.

Next slide, please.

As you can see, many of these are the same. We

encourage you to inform your consumers, warn them about the

risks of acquiring devices, clarify what warranties are

being offered, a list of best practices, buyer beware,

guidelines for consumers.

For example, you can encourage them to get the

serial numbers off the products and then check those with

the manufacturers to find out the last state that they were

aware that that device was in. You can -- and whether

those devices can still have batteries replaced, for

example.

You can request that sellers clarify what

warranties, if any, are offered with the device. And you

should also encourage the consumers to ask about the

warranties and for copies of user guides.

Ken Reid had asked if I can give an example of a

wheelchair that can only be sold by a prescription only.

Today I do not have the name of one. I can go and look

some up and try to send that out to you later. I know that

I did several searches, and I was able to find easily three

or four of them that were for prescription only.

And again, none of those brands stuck [audio went

down] ... and I was just doing a sample to find out if

there was a way that we could easily determine that it was

impossible to find any wheelchairs that required

prescription use only. And, in fact, there are several

wheelchairs that do require prescription use only.

Paul asked if this was about seating and

positioning. No. There were -- a couple of these were

sort of the motorized wheelchairs. Several of these were

not your basic wheelchair. They were a little bit more

complex and had special seating and everything involved in

them. So they were sort of a higher-level,

higher-functioning wheelchair that then triggered the

responsibility.

Anything that the FDA decides that use without

supervision could cause harm or injury is when they might

classify something as for prescription. So your basic

device is probably not going to be deemed as causing any

kind of harm or injury if it's being used by the average

person without supervision.

But certain motorized wheelchairs might. Certain

special seats, because they can cause harm, also might. So

those were the devices that were more likely to have a

prescription tag put on there. And again, this is not the

majority of wheelchairs. There is a smaller number of

them. But there are some.

So if you are one of those programs -- [audio

skipped] in the entire gamut of wheelchairs, at some point

it would not surprise me if one of those prescription

devices passed through your program.

Next slide, please.

Once again, we encourage you to know your

inventory. This time it's a little bit different. We're

not encouraging you to know your inventory so that you can

track every little thing that's happening.

But if there are some obvious -- if there's a very

large ban or if there's a big recall that's happened and

you have a lot of those devices going through the program,

you may want to flag your system in some way to let people

know that they should not be distributing things on your

Web site, that they should be subjecting them to the

recalls and to inform your consumers about particular

devices that maybe are often being passed through your Web

sites, that these are subject to recall and to be careful

about certain model numbers or model years.

If you are aware that a banned device is available

for exchange or something that has been recalled because it

was dangerous, that device should be removed if you can

identify where that is on your site or it is brought to

your attention.

Next device -- next slide, please.

Joy wrote something about seller agreements might

be good. And I think what she is trying to get at is that,

for many of these things on your Web site, we do encourage

you to -- for the sellers that are posting devices, we

encourage you to post sort of a seller agreement; that they

state that this is not a prescription device; that they

state that they own the device; that they do not believe

it's subject to any bans or recalls.

You can give them a series of questions that they

have to check off and assert before they are allowed to

post that device to your site.

Again, addressing sanitization guidelines. Because

none of the exchange programs actually put their hands on

these products, it is not that we are encouraging you to

sanitize the products yourself. What we are suggesting is

that you inform both buyers and sellers about appropriate

steps that they should take to sanitize devices.

You can encourage your sellers to sanitize. Maybe

you can encourage them to have a little box checked about

whether or not the device has been sanitized prior to

distribution.

Once these devices are received, the sanitization

guidelines are something that can help buyers know what

they should do with their devices before utilizing them.

We do think that it's a good idea that you

encourage your sellers to sanitize all devices that they

exchange and that you post sanitization guidelines as a

notice to both the sellers and the buyers.

Next slide, please.

Once again, we encourage you to keep an eye on and

track Class 1 FDA-issued warnings, bans, or recalls. For

this particular effort, this is really not so that you're

going to be following and pulling every little thing that

might be posted.

But this is something that you may want to turn

around and post on your Web site, have sort of a hot-button

area, the latest recalls that you think might be relevant

to the exchange Web site and to post them there.

You should have a mechanism for removing medical

devices from your listing if you're notified that the

listed product is recalled or banned. So again, some way

that, if you know that something is a problem, if a

consumer calls and tells you this, if you find out that one

person is repeatedly doing this over and over again, that

you have a way of pulling that down and readdressing that

concern.

Next slide, please.

Again, we encourage you to maintain business

records of inventory and customers. Exchange programs

should know whether or not a particular type of device

passed through the program, which consumer possesses the

device, and how to contact that consumer to inform him or

her of the recall or warning.

Again, this is not always something that is

feasible or possible. And we do encourage, however, that

you do this to whatever extent it is possible. If there's

a way for you to track it, if this information is being

passed through your program, then we encourage you to

maintain that as a normal business record.

If any of that information is strictly individual

to individual, whatever information you can capture about

who the seller was and what the device was, this may be

relevant to then pass along because perhaps the seller can

reach out and contact people.

So Joy was just letting people know that, in

signing up on the FDA alert, she has even received some of

the Class 2 alerts even though the FDA says that they only

issue Class 1 alerts -- notices about Class 1 alerts.

Beth Mineo has asked about sample or recommended

language for things like seller agreements or best-practice

documents would be helpful.

Agreed. We are working on some of that kind of

language, Beth, that we can have distributed and posted.

Some of the things that we're getting together or at

least -- at the very least, things that we believe should

be included in some kind of a best-practices or

seller-agreement document. So those will be -- we will be

unveiling those over the next coming months.

Next slide, please.

Once again, comply with prescription-use practices.

This is not something that is incumbent upon the exchange

program because they are not the ones doing the

distribution. But you should be informing consumers that

prescription medical devices should only be dispensed under

the supervision of a licensed practitioner.

If you can ask those listing products for sale to

verify that the device being listed is not a prescription

device, that is one way to sort of cover your own tracks

because they're making those assertions.

We're not suggesting that you double-check all of

these assertions, but it puts your ability to sort of

protect yourself at ease. You can say, "We asked. They

said it was not prescription. That's what we understood it

to be. And that's how -- you know, we only allow things

that are not for prescription to be listed."

And if someone checks "yes" it's for prescription,

you may want to have some kind of a flag that disables that

from listing in your system.

Next slide, please.

Report adverse events. Again, this is not a

situation in which the programs who are engaged in exchange

activities should be doing all the reporting or worried

about all of these things that are happening.

However, if you get any complaints or reports of

incidents, we encourage you to keep records of those. And

if a faulty device design causes a serious injury or death

or really anything that you think is relevant or important,

we do encourage you to reach out to the manufacturer and

pass on that complaint so that they are aware of that

danger.

Once things are reported to the manufacturer, they

are then obligated to turn around and report that up to the

FDA. So we just want our programs who are involved in

reutilization to really understand their place in the chain

and that the information that they receive may not get

where it needs to go if there is not an active role taken

by the programs in ensuring that that happens.

So it's sort of a good-citizen approach. We

encourage all of our reutilization programs to act as good

citizens. And when those complaints come to you, keep

track of them and report them up in the best way that you

can.

We don't think that you should seek them out or ask

for people to submit things. But inevitably those kinds of

complaints are likely to cross the threshold of your

programs.

Next slide, please.

Again, understand and apply state statutes and

regulations. There may be no applicable FDA regulations or

statutes governing reutilization activities. But some

states have chosen to regulate the reutilization of medical

devices.

State statutes and regulations may also govern

contract relationships and warranty promises for the

exchanges that happen through your program. Exchange

programs should understand how these laws may impact

exchanges and inform consumers of these laws.

So if you're in a state that's always buyer beware,

you may want to put a warning up there for your consumers

that says, "When you buy this device, understand that no

warranties are being given, that, you know, you're buying

this as is."

Reutilization programs should also consult the

applicable state statutes and regulations to be sure that

they are in compliance with state or local law. So again,

are you properly licensed to conduct your activities over

the web? Just your basic legal check that every program

should be doing.

Next slide, please.

Guidelines for device remanufacturing. We went

ahead and broke this out as a separate category because

basically what we have to say is that, if you are engaged

in remanufacturing, that means taking a device and building

it to a new specification that's different from the

original manufacturer's specification, this is absolutely

[inaudible] activity. It becomes a new device.

Because of the complexities involved in

remanufacturing, we encourage AT reutilization programs to

avoid remanufacturing. If you choose to remanufacture, it

will be critical to identify and comply with the FDA

regulations for remanufacturers, including registration,

device listing, premarket notification or approval as

appropriate, labeling guidelines, quality system

regulations, and reporting.

Next slide, please.

This is the announcement of the next Webinar.

Before we get to this, I'm going to open up the mike to

questions. So if people have questions one at a time, we

can go ahead and ask them, and I'm happy to respond to

anything. Let me release the mike.

The first question that was posted was from Joanne

Willis, Touch the Future ReBoot. She put, "Does adding a

switch to a radio, is this remanufacturing?"

No, it is not. There is a definition of

remanufacturing out there. Again, things that are

considered accessories to the original device that are --

that aid in the operation of the device -- so mounting

things, switches, et cetera -- that would not be considered

remanufacturing if the original underlying device is built

to the original manufacturer specifications.

So again, you're looking at the underlying device,

not accessory add-ons that are in addition to, to help with

the operation of the device.

Swapping out wheels could be considered

remanufacturing. And again, using completely different

size wheels and different screws to attach those wheels,

that would be perhaps an example of remanufacturing.

Anyone at all? Questions?

JOY KNISKERN: Jessica, there is a question from

ReBoot that clarifies their original question and then a

comment from Romeao [phonetic].

JESSICA BRODEY: Thank you. I had missed the

second question from ReBoot.

... interfaces through the battery compartment.

I'm not sure if -- if it's a switch that is for -- again,

it's an accessory so that you are making it accessible for

somebody to utilize something to -- maybe to turn it on or

off, that is considered an accessory. It is not changing

the base device.

Now, you might have to ... [audio went down] ... to

tap into it, and I think there's a question about whether

it's ... [audio went down] ... as in a battery interrupter.

I'll have to pull the exact language. But

basically, if things are seen as an accessory, as a means

to access or to accessorize the base devise, that is not

remanufacturing.

It is when you take a basic component, like the

seat, and you decide to swap out a thicker seat or a

thinner seat or a different material or use new screws or

make the legs a little bit longer or the back of the chair

a little bit higher, those are examples of remanufacturing

because you are changing the original manufacturing

specifications for the basic device.

Then -- so Paul Holland's point is well noted.

Most standard wheelchairs are specified to receive

different wheels. And again, that is still in compliance

with manufacturer's specifications. If there are a wide

range of wheels that are acceptable, that's still to

manufacturer's specifications.

Rick Geringer had asked, "Does the [inaudible] or

just prescription equipment?"

Again, all equipment ... [audio went down] ...

taking something, and you are restoring it to the

manufacturer's specifications. That's refurbishing. If

you are ... [audio went down] ... something different, if

you are putting the seat from one wheelchair that is

completely different and attaching the legs to a different

brand wheelchair and mixing and matching all of these

different things together, what you've essentially done is

manufactured a new device that doesn't comply with any

existing standards.

You've created your own set of standards and your

own device. And that is creating a new medical device, and

that raises the question of how that impacts both commerce

and the FDA. And you are then treading into a very gray

area that varies [inaudible] FDA regulations for creating a

new device.

Romeao [phonetic] had asked if we could send out

the forms that we had mentioned in the beginning.

All of the forms will be going out and will be

available on the Web site, so I believe that that's going

to happen.

Another example -- so Joanne Willis had asked about

taking the mouse and re-adapting it so there is a switch

port.

Again, those kinds of things are considered

accessories and sort of changing to make an accommodation.

It is not considered as remanufacturing. So you are safe

in all of those kinds of categories where you are adding

on. And even if it involves altering something small to

accommodate the add-on, you are not changing the basic

construction or build of it. You are swapping out -- you

are adding on and attaching in.

So what about utilizing a device without all the

components; a tub bench designed to have a back, but you

don't install it, even though some come this way?

If this particular device is approved as having the

back and it is only supposed to be distributed with the

back, then it is important that you restore it in that way.

If, however, it's a bench, and the back, let's say,

is an optional feature of the tub -- so, for example, my

grandmother had one, and you could have handles put on in

one place or another. They were movable. You could choose

to have the seat put on in a certain way, or you could

choose to turn it the other way.

If you do it in any of the configurations that are

authorized, that is fine. If you leave off parts that are

optional or are considered extra, that's okay. What you

have to do is comply with the minimum specifications for

how things must be assembled together.

If something is designed to have a back and you are

distributing it without a back, it could be that the FDA

has determined that device is only safe for distributing

with a back on.

So Rick Geringer has asked, "For clarification, do

these regulations apply to just equipment that is sold or

to equipment that is loaned out by nonprofit independent

living centers, for example?"

I think that that's a really good question. The

FDA, in general, looks at medical devices as items of

commerce, things that are always sold.

However, as I noted earlier, anything that the FDA

regulates looks at the -- it attaches to the device. So

whatever activity that device is engaged in, the FDA

regulations relate to that device.

So that device is approved for certain uses as it

is appropriately manufactured. If what you're doing

changes the structure of the device, then you are no longer

using an approved medical device, and what you have created

and are in some way distributing is different from what

would have been FDA approved.

And it's one of those very fine lines that you have

to walk if you are then exceeding the goodwill of what the

FDA allows by changing the makeup of the device and

utilizing it, even if it's just for loan.

As Joy said, this is about safe and appropriate

usage. Devices are approved by the FDA, and they are

approved to be configured in a certain way and to certain

specifications.

If you as an organization are taking it upon

yourselves to change that configuration, you have, in

essence, created a new device, and that device is not FDA

approved. So if you are then disseminating that in some

way, you are taking an action that may exceed the

authorization of what the FDA has allowed for different

devices, and there could be consequences to that.

No, if you are adding Velcro to help hold the item

or polymers, et cetera, like that, no, I would not say that

that is any kind of remanufacturing. That again, is seen

as an accessory. It is something that is superficial.

It's sort of like painting something blue. It does not

relate to the underlying specifications.

Now, if you are removing certain -- if the device

requires that certain nonslip surfaces be put beneath it

and you remove those to substitute out something else, that

could be an issue. But simply adding a gripping device or

a little bit of traction or something that is beneficial in

that respect should not in any way undermine the original

specifications.

JOY KNISKERN: I just wanted to make one comment

related to that last question, too, is, I know, from work

that we had done many years ago when we initially started

our assistive technology program and our lending libraries,

we did a lot of work, just as you had said, Jessica, in

looking at state regulations and statutes.

But in this case, we didn't have any of those

things in those days that related to AT reuse, but we did

contact the Occupational Therapy Association and began to

look at some of the state statutes regarding, you know,

where professionals should be involved.

And I know that at that time, there were issues

that came up when it has to do with anything, you know,

matching assistive technology appropriately, gripping,

holding, anything where you might be reusing -- doing

repetitive actions of any kind.

And so I think, with some of these things, you just

really have to use your judgment and be sure that you do

look at your state statutes and work on your collaborative

relationship so that you've got -- and I know that many of

you are doing this where you've got people who work with

you in answering some of the questions that come up

regarding these kinds of issues.

JESSICA BRODEY: And again, while we are taking the

stance that, if it is remanufacturing, we think that it

opens a big can of worms, and to that extent we are

encouraging programs to avoid remanufacturing.

As a program, you may decide that you are willing

to open that can of worms and that you feel that you are

safe taking those actions in remanufacturing.

We're not telling you that you can't do that or

that there will be -- you know, that you're not allowed to

make that determination. ... [audio went down] ...

something we want programs to be conscious of, that, as the

Pass It On Center, we think that ... [audio went down] ...

it is just safer and easier to avoid liability on a whole

host of different levels if those engaged in reutilization

can avoid remanufacturing.

It may be that your program feels that it cannot

avoid remanufacturing, and it is willing to take those

risks. That is a fair decision to make. But just

understand that those are the choices that your program is

making.

JOY KNISKERN: And I see a comment from ReBoot.

And so, Jessica, I don't know if you had a chance to spot

that. And then I've got a couple of questions after that.

JESSICA BRODEY: I was just reading the ReBoot

comment.

Joanne Willis wrote, "I can think of an example

whether a holder might be used for a device such as an AAC

device. This falls and injures or damages device. I would

see this as a risk."

It is a liability risk, in general. It is not,

under the umbrella of the FDA, an issue in terms of, does

that make you subject to remanufacturing. So that is a

distinction that I would like to make.

We will be talking along the way about programs,

activities, and whether -- I think that that's the -- I

want to say that's the June Webinar. But we will be

talking about how specific actions that you take on,

activities that you perform that could have ramifications

and result in injury.

That's a different set of liability concerns than

this FDA issue. But you're right. Putting something -- a

holder on and attaching a holder, this could fall and

injure or damage that device, or it could injure and damage

a person, and does that put you at risk? And we will

discuss those risks and ways that you can try to mitigate

those possible risks.

There's a second question here from Rick Geringer,

and he says, "In follow-up to my previous question, if

besides remanufacturing issues, if the other regulations

like sanitization, prescription devices distributed under

supervision of licensed practitioners, et cetera, also

applies to nonprofit independent living centers loan

closets."

And the answer is that certainly, with respect to

sanitization and prescription devices, those things we do

believe are good practices for everyone.

The requirement with respect to prescription

devices attaches to the device. It is irrelevant who has

that device or what path it goes on. If a device is ever

labeled through the FDA [audio went down] [as a

prescription device], it is always a prescription device.

It cannot be passed from person to person or organization

to person without the supervision of a licensed

individual -- a licensed practitioner.

So again, that key is whether or not the device is

prescription. If you are dealing in over-the-counter

devices, that supervision issue becomes completely

irrelevant.

And the degree of supervision with respect to

prescription devices is a much lower level than the degree

of supervision and authorization that is required for

prescription medicines, over-the-counter prescription

pills.

The differences are that you -- for prescription

pills always must have a written prescription. Always,

without a doubt, it has to always be by a medical doctor.

There are certain tracking guidelines and requirements that

are prescription.

The only requirement is that they be distributed

under the supervision of a licensed practitioner. The FDA

does not specify which licensed practitioners. It doesn't

specify to what extent that supervision has to be done. So

those are the distinctions.

... [audio went down] ... to the device. So if a

device is subject to those requirements, then the device is

always subject to those requirements.

Sanitization, however, is not an FDA requirement.

That is really what we would say is a good practice. And a

good practice, this is something that we think you should

do. Because if you don't sanitize devices and you're

handing them out and a disease is passed or someone becomes

sick, that risks exposing you to liability.

And it also risks complaints eventually getting

passed up to the FDA and the FDA saying, "Whoa, all of

these programs are engaging in these activities, and

they're not engaging in the same standards that we hold our

original manufacturers to. We're going to start imposing a

whole lot more obligations and restrictions on them."

So we think, by professionalizing our activities

and by taking steps to sanitize and do the right things and

to treat these devices much in the same way they would be

treated by others who are directly under the FDA's

[inaudible] approach and a good business practice.

So to that extent, I do think that these

recommendations apply to nonprofit independent living

centers and loan closets.

Chris Brand had asked whether I'm saying that a

prescription item is very different from an item that may

be prescribed for someone and regulations are very

different as well.

That's exactly correct. That is exactly correct,

Chris. There is a distinction between something that may

be prescribed. So, for example, in most cases, because

individuals are seeking insurance, the medical doctors or

the licensed practitioners will prescribe a particular

wheelchair, a particular brand, some seating requirements,

et cetera. And that prescription is written because you

want insurance coverage for the device.

So insurance isn't going to cover it unless your

doctor says it's medically necessary, and the prescription

proves that point -- that it's medically necessary.

That doesn't mean the device must only be

administered under the supervision of a licensed

practitioner. That is a distinction.

But a prescription device, however, is something

that is deemed by the FDA, upon their approval of the

device, for use and distribution in the United States.

They say "over-the-counter"; they say "prescription." And

they stamp it one of those two categories.

And that determination is made by the FDA based on

how dangerous they think that device is. So it's kind of

like when you go to the hospital, and you might get

prescribed Tylenol by your doctor for your pain. That's an

over-the-counter medicine, but it's being prescribed by the

doctor. And in that case, insurance covers it.

And it's just a unique situation that comes up with

medical devices, that you can have something that is

prescribed by a doctor, but it may not necessarily be a

prescription device. We don't want to confuse those.

I also think Jeremy's point is well taken. There

is no definitive listing that we can find right now that

specifies every single thing out there which is

prescription and that which is not. So we have a link to a

good database that has a lot of the content in it.

Each of these devices, when they are approved, are

listed in the federal register. It is very difficult to

search through the entire federal register page by page and

try to find all of these devices all of the time.

There is a database that is a good database. And

we are working to see if there is a better way to help you

always identify what is a prescription and what is not. It

is not an easy process.

And I think that Chris's point is well taken, that

most of the time, most of the devices that many of you will

be dealing with will not be prescription devices. So it

should be easier to identify groups of those that are and

be careful with those devices.

And I think, in the event that you are unsure, it's

always good to err on the side of caution: ask for a

prescription; ask for some kind of oversight; find your own

SLP or other AT specialist to make that recommendation.

And then you have a record that this device is appropriate.

Again, that's certainly a cost involved, but I

think we're really only looking at it for those highly

specialized-type devices that are likely to cause injury if

being misused.

And I'm going to turn this back to Joy now for her

questions.

JOY KNISKERN: I don't know if Linda Morgan was

attempting to talk a moment ago, and I will ask my

questions after we let her -- see if she can talk.

I'm not sure, Linda, if it would work for you to

type in your question. I did not hear you talking. And so

I will go ahead and pose my question to Jessica. And if,

Linda, yours comes in, then we'll switch to you first.

And one of the questions that's come up in the past

has been what about -- what should reuse programs do in

terms of labeling the items that they're reutilizing? And

hope that you could address that, Jessica.

JESSICA BRODEY: Sure. I'd be happy to.

First, I think it's key, when we're talking about

labeling, to understand that medical devices have very

strict labeling requirements. So you want to be very

careful not to relabel, not to rebrand or put your own name

or change the existing labels that come with whatever

devices they are. You want to leave as much as possible

the original labels on.

Now, sometimes devices will come through, and they

are missing the original labels, and there's nothing that

you can do about that.

But with respect to labeling that exists, we

strongly encourage you not to strip those labels off and

remove them or cover them up with your own labels. If you

want to put your own label on so that people can contact

you, find a different spot from the other manufacturer

label. So that's one thing that I think is important.

Again, it's also about what you should be telling

people. You want to make clear, in your communications and

in the information that you distribute, that the devices

that you are giving out are not new, that you have not

manufactured them in the first instance.

If you've repaired them in some way, you should

inform people that these devices may or may not have been

damaged in some way or broken, that they have been

refurbished and that they have been adjusted in some way or

that you have fixed them. And you can put out there that

you used appropriate technicians.

It's also good to communicate that you perhaps are

presenting them as is, that you have done your best to

restore them to original manufacturer's specifications, but

you cannot guarantee how long that will hold, et cetera.

So I think that that answers Joy's question, if I

understood it correctly. But it's important that you are

honest and upfront with the activities that you are doing.

And at the same time, it's important that you do not try to

take too much claim or ownership over devices for branding

and labeling because, in doing that, you might put yourself

into a position where you ... [audio went down] ... more

than you mean to.

And I saw that Linda typed, and I'm glad that this

discussion has been very helpful. If you have any

questions, Linda, please feel free to type them here.

It seems we have to have a cataloging system in

place for sanitizing in order to support our statements in

the event that there was a claim made. You can make

statements to folks, but without a consistent process

supporting it, it would just be your word to theirs.

That's a very good point. I think that, if there's

some way to sort of mark in your system, you know, items

that are received, checking off that the items have, in

fact, been sanitized.

And this gets back to our discussion that will come

later about written policies and procedures. You want to

be able to say that things have been sanitized in

accordance with your set standards that you have created

for your organizations and that all of these things have

been done.

And the more businesslike and routine these

procedures are, that things always go through these

processes, that backs you up.

Because business practices, even if you can't prove

the absolute truth, yes or no, of a particular device, if

you can prove that these business practices exist, if you

can prove that it is common to always use your specific

business practices, that is something that can back up your

word because it would be unusual to deviate from existing

business practices in a particular organization.

JOY KNISKERN: I think that one of the comments I

wanted to make, Jessica, was that I know that -- and this

goes back to the labeling, and it also addresses what you

just said.

I think that there are a number of programs that do

have their own program label, like Friends of Disabled

Adults and Children and so on, that do put their label on,

don't cover up what the manufacturer's label was, so that,

if they do have a problem with the device, they're more

likely to call the reutilizer first as opposed to the

manufacturer or vendor. And I know that's been an issue

that some of the vendors and manufacturers have mentioned

about AT reuse programs.

The second thought about sort of a stamp of

approval where you put your program name, I don't know if

this would work to answer Tiffany's question, but perhaps

if you had policies and standards in place whereby you've

done your sanitization and you've got written-in policy

that no stamp of -- your program stamp is not put on it

until these things are done.

I don't know if that would be something that would

be a response to a couple of the questions there.

JESSICA BRODEY: Joy, I think that that's actually

great. That's exactly what I was saying with the policies

and procedures. If you enter it into your system or if you

only put -- it only goes to the stamping station after it's

been through these six steps and it's been checked in and

out and then moved there.

So there is a written procedure that says that the

existence of this label indicates that it was sanitized,

and nothing goes out the door without a label on it. So if

it's in your hands, and it came from our program, it means

that at one point [inaudible] have a label on it, and it

was sanitized, that there is no way it would have gotten

through without that process.

Paul Holland from DC Shares wrote, "Our retail

vendors request that their label be removed."

That's very interesting, and we have heard that

before. You are not the first person to raise that issue.

Some of that is because they don't really want

complaints if there are further problems, so they ask that

you remove their labels. And it's a touchy situation for

addressing them.

And again, I understand the retail vendors'

concerns. You know, you heard before [inaudible] Industry

Association. It's a very big concern of vendors because

they don't want this label necessarily out there for a

product that might no longer really be up to par and then

get all the complaints about it.

By the same token, removing a lot of these labels

can sort of conflict with what the FDA wants you to do. So

there is this tension between honoring the requests of the

vendors and really trying to avoid accepting liability in

some way that you don't want to.

And one of the activities that the FDA looks to is,

do you label and package a particular device. And by

stripping labels and putting your own on it, to some extent

you are taking on that onus.

And so it puts a gray area in there. You know,

thinking that you're a not-for-profit, making -- you know,

that that will always make you safe is not necessarily

true. ... [audio went down] ... by which the FDA

protections are being removed by the labels being present.

That puts you in the middle of commerce and having an

impact on commerce, and it does raise a concern.

Ken Reid wrote, "Does anyone have a fee schedule

that we can possibly see to use as a reference as to what

they charge for power wheelchairs, manuals, and scooters?"

I think that goes out to the pubic if somebody

wants to share that. That is not something that I have.

And again, be very careful for how you might charge

fees. If you are a program that does charge fees directly

for the things that you distribute, please understand that

you are absolutely then in a situation where you are

engaging in commercial distribution of a device.

If you're charging fees for your services and the

time that you spend in matching or offering or bringing

people into your program, that is different than charging

fees for a particular device. And you do want to make sure

that you don't cross that line because of what that might

subject you to.

I think that -- Joy just wrote, "We could possibly

come up with a canned statement that programs could use to

share with vendors regarding the FDA."

Heather Young has asked whether it's possible for

the Pass It On Center to provide a list of retail prices of

devices we can check our fee schedules against?

And I'll defer to Joy on that one.

JOY KNISKERN: We have actually -- we talked even a

year ago -- not quite a year ago with our national task

force about some of the ideas about coming up with some

kind of a blue book listing of all kinds of devices.

And we felt that that just was -- far exceeded the

capability of our center to be able to do that. And I know

that you can -- oh, you're talking in terms of your fee

schedules, the services.

You're talking about fee schedules for your

services or fee schedules for -- or, you know, like the

manufacturer retail listing of the devices?

Again, I go back to what we talked about earlier,

and that is that what we would recommend is that you not

charge for those devices but you really look at the

specific reutilization services that you're providing,

everything from accepting donations -- I've heard of some

programs where they request a donation of a fee when

somebody even gives a donation; they're not asking for a

piece of equipment -- and, you know, the sanitization you

do; the repairs; the refurbishing; the extra supplies you

might have to buy. Those are things that I think you

could -- many programs do charge for.

And there's a lot of conversation going here. So

Jessica has indicated that there's a national listing for

Medicare devices and that it -- Medicaid, of course, as we

know, varies from state-reimbursement practices.

Tiffany has asked whether or not there is any

advisement on how we can distinguish this with a consumer.

And, Jessica, I'm going to turn it over to you so

that we can make this more of a live conversation.

JESSICA BRODEY: I was just addressing the question

about a fee schedule for particular devices.

And Medicare does have sort of a national listing

of what they will allow to be paid for each -- for each

different device that is on the Medicare schedule. Those

are not very generous allowances, but it may give you

something to start off ... [audio went down] ... looking to

charge.

From Tiffany about how we can distinguish this with

the consumer. I think you're talking about the distinction

between charging for the device versus charging for the

services. And I think you could charge a [membership fee]

... [audio went down] ... or you could charge a cleaning

fee or you charge a matching fee or an evaluation fee. I

think you have to name it something that makes it clear

that it is separate from the device. And I would not have

that fee vary from device to device because then it looks

like you're charging for the device.

And let's see. We have "Medicare fee prices are

typically overpriced."

That depends on if you're talking to the

manufacturer or the individual. Manufacturers usually say

that the Medicare listed price is about less than half of

what they really would charge otherwise. So they think

that the Medicare rates are pretty low.

So then Tiffany was talking about the fee being

different based on the item which [inaudible] fee for the

item.

Again, you can have -- a wheelchair could have more

steps that you have to charge for versus -- you know, it

could be sanitization. You could have different sizes of

the devices. And you could have classes of size and that,

if it falls into one of -- you know, the Class 1, Class 2,

Class 3, that's your cleaning fee varies based on that.

Ken is saying, "Say we have a power wheelchair and

suggested retail is $21,000 for a chair. Want to sell the

chair for $7,000. Are we in a situation that might be

questioned under the FDA?"

I would say yes. I think that the minute you are

selling a medical device that is for a fee and it is

absolutely for a commercial -- you know, it is part of a

commercial distribution, you then have to go through the

same processes of any other commercial distributor for

those devices.

And you are welcome to do that, but if you are

selling devices in some manner, and you are not registered

in accordance with the FDA, it takes one unhappy person to

report you.

And again, the likely people to report you may very

well be the manufacturers because they don't want to see

you selling their devices without complying with all the

other standards.

JOY KNISKERN: I think that we have had some

wonderful discussion here today. And I'm noticing sadly

that it's almost 3:30. And I think we probably have time

for one or two more questions, and then we'll close out our

day.

Would anybody have any other questions they'd like

to offer to Jessica?

Okay. I would like to thank you very much,

Jessica, for sharing this very important information. I

think it's been -- based on the discussion and the

commentary, that there's a lot of interest in this topic.

There are a lot of questions about what we're doing with AT

reuse and the FDA applicability.

And we do hope you, on behalf of the Pass It On

Center, as Jessica has said, join us for our next Webinar

on April 22nd at 2:00 p.m. eastern standard time.

Also, we'd like to remind you that Tom Patterson

will be sending out today's program evaluation via

SurveyMonkey. And we certainly welcome your ideas, your

comments, any suggestions. If there are ideas for future

topics related to this one that we've discussed today, we

certainly would like to hear from you about that as well.

And as Jessica mentioned and we've mentioned, we

will be posting all of the information, the handouts that

were circulated as background information for this Webinar,

as well as Jessica's PowerPoint information.

So thanks so much, and y'all have a great day.