UNITED STATES ACCESS BOARD

WASHINGTON, DC

Wednesday, March 14, 2012

US ACCESS BOARD CONFERENCE ROOM

1331 F STREET, NW, SUITE 800

WASHINGTON, DC 20004-1111

PUBLIC HEARING:

Notice of Proposed Rulemaking 

on Medical Diagnostic Equipment Standards

Members Present:

Regina Blye

Karen Braitmayer

John Box

Christopher Hart

Phillip Jenkins

Mat McCollough

Neil Melick

Howard Rosenblum

Deborah Ryan

Nancy Starnes

Gary Talbot

Hans Van Winkle

David Murphy, DOD

Angela Scott, HHS

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NOTE: This text is being provided in a rough draft format. 

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is provided in order to facilitate communication 

accessibility and may not be a totally verbatim record 

of the proceedings. 
Wednesday, March 14, 2012

9:00 AM

US Access Board Public Hearing

Medical Diagnostic, Equipment Standards NPRM

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WITNESSES:

1. Lindsay Morris, Senior Director, Government Relations, Medical Imaging &

Technology Alliance (MITA) 

2. Jon Wells, Director of Marketing, Medical Products and Services

3. Carol Bradley, J.D., Disability Access Officer, Sutter Health, Office of the 

General Counsel

4. Rosemary Ciotti, RN, MSN< CRNP, Accessible Living, Inc., Arlington, VA

5. June Kailes, MSW, Associate Director and Adjunct Associate Professor, 

Western University of Health Sciences

6. Margaret Stineman, M.D., Professor of Physical Medicine and Rehabilitation, 

University of Pennsylvania 

7. David Hausmann, CEO, Hausmann Industries

8. Joe Isaacs, Vice President for Public Policy, United Spinal Association 

9. Kat Taylor, Disability Program Manager, The Equal Rights Center

10. Barbara l. Kornblau, JD, OTR, Coalition for Disability Health Equity, 

American Public Health Association 

11. Kelly Buckland, Executive Director, National Council on Independent Living 

12. Linda Manning, consumer, New York City, NY

13. Jeff Baker, Medical Technology, Inc., Salt Lake City, UT

>>Gary Talbot: Good morning, everybody. We'll give you a 5-minute 

warning. We plan to start in about five minutes, please. 

>> I have a blank screen. But I don't think it's going to bring up anything 

previously. You want to try again? Okay. Now, it's coming up. 

>>Gary Talbot: Okay. Welcome, everybody. Welcome to the Access 

Board's public hearing on medical diagnostic equipment standards. I'm the chair of 
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the committee, and my name is Gary Talbot. Before we begin, I'll pass it to our board 

chair, with some nice background music to begin. 

>> NANCY STARNES: Thank you. Nancy Starnes, public member and to 

my right is... 

>> John Box, public member. 

>> Karen Braitmayer, public member. 

>> Good morning. My name is Mathew McCollough. 

>> Phil Jenkins, public member. 

>> Good morning. Regina Blye, public member. 

>> Chris Hart, public member. 

>> David Murphy, federal liaison, DoD. 

>>Gary Talbot: Well, thank you, everybody, and again, welcome to the 

Access Board. Just a couple of things before we call the first witness, we're going to 

try and keep everybody to five minutes. We have got 10 people on the sign-up list. 

We also have another list in the back while folks have signed up while they're here 

and what we usually do is try to keep strict to the five minutes so I'll give you a 1-

minute warning and if we have time left over at the end and you would like to come 

back up and say something, you certainly can do that but we want to make sure we 

get everybody through that does sign up and has something to say. So with that, we'll 

go ahead and get started and our first witness is Lindsey Morris. 

>>Earlene Sesker: Excuse me. Before we start, let me just go over briefly a 

few procedures if that's okay -- general procedures that we would like -- okay. I'm 

sorry. My name is Earlene Sesker, and I'm the lead staff on the rulemaking for the 
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medical diagnostics equipment. And so we know that's why we're here today. and we 

wanted to let you know that for anyone that feels that you have more to say that you 

don't have that opportunity today, or based on something that you hear today that you 

would like to say something, we are having a second hearing on May 8th, in Atlanta, 

at the Atlanta Hilton, and remember that the comment period does end June 8th. As 

Gary has already mentioned, we'd like to hold it to 5-7 minutes; and we will have 

open mic at the end. We also ask that if you - to please turn off all of your cell 

phones and anything like that before we get started. Your transcripts and information 

will be held and will be part of the docket. If you had any written comments or 

PowerPoint, please give them to the staff at the registration desk. 

Please refrain from reacting in public to anything that our witnesses may say

or anything that you may hear from the board and with that, now, as Gary said, we are 

ready to start. 

Lindsay Morris, Senior Director, Government Relations, Medical Imaging & 

Technology Alliance (MITA)

>>Lindsay Morris: Thank you. Great. Well, thank you so much for allowing 

me to testify. And speak to you today. I'm with the medical imaging and technology

alliance where we are a medical imaging manufacturers and I just want to start by 

saying we know and our companies know that without accessible medical equipment 

individuals with disabilities may not have equal access to quality medical care and 

that's something that we're certainly acutely aware of. 
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I also wanted to thank the Access Board for their willingness to be open and 

listen to our concerns and input and feedback and being very open just in this process 

generally. We very much appreciate it and hope that we can be a good resource to 

share some of our technical expertise with regards to the equipment. 

As you may know, the issue of accessibility has long been a concern for 

medic companies. Our companies represent a range of modalities. It really ranges 

from MR and CT, which are being big machines to smaller more portable devices like 

ultrasound, even some in x-ray equipment as well. 

As you can imagine, though, representing this broad range of modalities does 

mean that we need to really look in-depth at each modality and what the standards 

may mean for each of those. That's something that we're working very intently with 

all of our member companies and we intend to come back at your May hearing and 

have a focus on each of those modalities so that we really can give a deep dive on that 

and make sure that you have all of that information and hopefully also prior to your 

June cut-off date for the formal comments and we will be submitting formal 

comments as well. Second, as the Access Board has pointed out as you do not have 

enforceability of standards but we do take them very seriously. We know that you are 

working very closely with DOJ and FDA we appreciate that and we hope that that 

continues and we certainly want to be a part of that process as well because we know 

that this will certainly impact folks for time to come, so we certainly appreciate the 

work that you have done and hope that it will continue. Third, our manufacturers 

have long sought to ensure that equipment is accessible and safe for the full range of 

patients and this also really include the people who -- the technologists, the people 
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who run the equipment itself in order to avoid workplace injury for example so all of 

these features are things that we have taken into account or that our companies have 

taken into account in designing the equipment. And further, it should be also pointed 

out that this is equipment that a trained technologist is always there to help the 

patient, regardless of their issue of -- any issues of mobility, so it really is important 

to note that no matter what the patient, this is complex machinery for the most part 

particularly when you think of CT and MR, so we want to make sure that the patient 

is, both for their safety and for the safety of the equipment, that they are able to have

that help in accessing the equipment. 

Fourth, it's also important to note that all diagnostic equipment that our 

member companies manufacturers have gone through rigorous FDA approval process 

and offer a lot of accessibility features and as I sort of mentioned before, for instance, 

mammography and x-ray and ultra-sound equipment tend to be smaller, more 

adjustable equipment, often times more portable and can come to a patient's bedside 

in many instances. On the other hand, the bigger MR and CT equipment, they're 

much larger, fixed pieces around which rooms are even designed specifically for 

them. 

They require a greater shielding against exposure to radiation and magnetic 

forces. MR machines themselves are very powerful magnets because they can 

interfere with magnetic force field in the room, metal and electronic objects are not 

allowed in the exam room at all and this includes wheelchairs because they really are 

a danger to the patients, the technologists and the equipment itself. As you may have 

seen in previous testimony that was given on behalf of MITA, I think a picture was 
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shown where it shows a wheelchair actually being sucked into an MRI machine so it's 

a very real danger for those metal pieces to be in the room, so that's something that 

we're, you know, certainly acutely aware of as we're assessing the draft standards that 

are out. Lastly we just want to point out in NPRM there was a note that there may 

some economic benefit to manufacturers and finalization of these standards. We just 

really wanted to point out that we're very sensitive to the fact that we want to make 

sure the customers who have purchased the equipment are able to really be able to use 

the full useful life of the equipment. In a lot of cases like I said with MR and CT 

equipment, they have built whole rooms around this and it can be a sizable capital 

investment for them. So we just wanted to address that, make sure you understood 

where we're coming from. We want to make sure that the equipment is able to use 

for its useful life. 

And with that, again, I just wanted to remind you again, we are working on 

this. We will -- we want to get you the information on each individual modality and 

we'll be working on that over the course of the next couple of months and look 

forward to the May hearing as well. Thank you. 

>> Gary Talbot: Great. Thank you very much. Thank you for your 

testimony. 

>> Lindsay Morris: Thank you. 

>> Gary Talbot: And if any member has any questions, just holler out, just 

say something and I'll make sure I stop, okay? Our next witness is Jon Wells. 
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Jon Wells, Director of Marketing, MidMark Medical Products and Services

>> Jon Wells: Good morning. First I would like to thank the board for the 

opportunity to speak at this hearing. Midmark has a long history in the medical 

equipment marketplace and has been designing and manufacturing accessible 

equipment even before the discussion of establishing these standards began. In our 

vision statement from our CEO, Dr. Anne Klamar, we state Midmark is passionate by

making a difference in every life we touch in supporting this effort and this is what 

we do. In regard to the standards I do applaud the effort of the Access Board as a 

development of standards is sorely needed. We as a manufacturer and our customers 

are ready for the next steps as we need to know what constitutes an accessible piece 

of equipment today, we are dealing with these issues today. I'm proud to say based 

on our long experience in the field that this is doable. We can achieve a much more 

accessible health care environment, not only for patients in wheelchairs but for a 

much broader group. 

Moving in this direction also has a potential to save cost by improving work 

flow in an exam room space in and around the patient. In addition other benefits will 

result from these standards such as reducing never events such as patient falls, 

reducing staff back injuries and improving caregiver access to the patient resulting in 

safer and more efficient work spaces. In regard to the proposed standards what I 

would like to do is bring forward a few themes to the Board's attention. Keep in mind 

detail comments will be submitted June 8th so much more detail will come. But the 
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first theme is in regard to universal design. We feel we need to develop health care 

spaces that are accessible to all. Think about work flow. Think about experience and 

receiving and giving care. 

These are not isolated pieces of equipment but parts of a whole. This is not 

binary, whether it's accessible or not. There are various degrees of patient disability

in the need for wheelchairs and scooters, the need for different types of access for 

these types of patients such as patients who are pregnant, bariatric, elderly, someone 

who has a recent foot surgery even struggles to get around so when we think about 

the accessibility of these spaces, there's many, many degrees of this that we need to 

take into consideration. With that, let's consider the patient-caregiver interaction. 

The caregiver requires access to the patient. Access to enable the acquisition of vital 

signs first, access to engage in a meaningful rapport and of course access for the 

physical evaluation and perhaps some diagnostic testing. One example that's 

mentioned in the standard as support services do get larger we have to consider the 

physician now as has to bend and reach during standard examinations in minor 

procedures. Using this example we would need to be aware of others around this 

practice and around these work flows and how they interact and we certainly don't 

want to improve patient access to a piece of equipment but inadvertently limit access 

by the caregiver lessening the effectiveness of the overall encounter -- that 

patient/physician interaction -is key and we can't limit that in any way so we feel 

there will be some trade-offs as we go through these standards and how we can make 

it both accessible as well as accessible for the caregiver to the patient. 
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In regard to width in the patient, side rails can be too far apart. The industry 

does struggle with this even today. This restricts the ability to use both arms or side 

rails simultaneously. A patient with limited trunk strength needs both rails to support 

themselves with confidence, especially on the table being raised in order to be 

examined properly. 

Keep in mind as well there are new elements in the exam space such as access 

to and delivery of digital data, electronic medical records and such. How can we 

improve this interaction to all, all the while providing needed access to the equipment 

for patients with disabilities? 

In summary we believe we need to move towards a solution of universal 

design that all rooms can be more accessible and more useable for all patients. There 

will be some trade-offs in regards to the existing proposed standards but this is 

doable. We're actually very close today. I appreciate the opportunity to spend a few 

minutes with you and we look forward to submitting comments to the June 8th 

submittal. 

>>Gary Talbot: Thank you very much. Do the board members have any 

questions? Thank you, Jon. And next up is Carol Bradley. I apologize, I skipped out 

of order, and so I apologize, Carol. 

Carol J. Bradley, J.D., Disability Access Officer, Sutter Health, Office of the General 

Counsel 
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>>Carol Bradley: No problem. Good morning. I'm Carol Bradley, I'm the 

Sutter Health's disability access officer. Sutter Health serves patients and their 

families in more than 100 Northern California cities and towns. Sutter health's 

doctors, not for profit hospitals, outpatient clinics, regional home health and 

occupational programs and other health care service providers share resources and 

expertise to advance health care quality and access. We're quite a diverse company. 

We have relationships with nearly 3500 physicians and our Sutter medical 

network includes many of California's top-performing, highest-quality physician 

organizations as measured annually by the integrated health care association. 

Sutter Health implemented a disability access program to expand our expertise 

on accessibility and to make significant improvements to our facilities, processes and 

tools to help ensure all patients have equal access to quality health care services. 

One key component of our program is a focus on the equipment accessibility. 

Our system surveyed seven types of medical and diagnostic equipment for 

accessibility including beds, exam tables, procedure chairs, weight scales and 

imaging and Mammography equipment along with lifts and transfer apparatuses. 

Based on our data we collected, we are creating internal equipment standards 

to designate the equipment that meets the accessibility criteria. For gaps in available 

equipment, our system is developing policy solutions that support accessible services. 
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As we walk through this comprehensive process in the absence of standards, 

we found our services -- ourselves adopting an approach that focused on the 

positioning of patients. 

This is the underlying approach for our policy for medical imaging, 

therapeutic and diagnostic procedures. We are pleased that the board's recommended 

standards have adopted a similar approach. Drawing on the best research and 

recommendations provided during the board's regulatory process. 

Thank you for the opportunity to respectfully highlight one gap we see in the 

proposed standard as well as a need we see, which is currently under addressed by the 

equipment marketplace. 

We note that the minimum weight capacity for the equipment remains a 

visible gap in the proposed standards. 

Health care providers each day face the need for equipment to hold adequate 

weight capacity to accommodate a wide range of patient populations when equipment 

is not able to physically accommodate the weight capacity of all patients it can expose 

both patients and providers to unsafe practices or substandard care. Our system 

expert serving patients with disabilities recommend the need for adequate weight 

capacity. Our recommendation for the weight capacity for the transfer surface is to 

accommodate a weight of no less than 400 pounds. 

The weight minimum would allow for us and the use of the equipment with a 

broad range of patients. High weight capacity is also critical for scales that 

accommodate wheelchairs or other wheeled mobility devices. 
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We recommend a weight capacity of no less than 800 pounds to accommodate 

the many heavy wheeled mobility devices. 

This standard would help providers capture accurate patient weights to 

support safe medication delivery, monitor health indicators linked to weight, and to 

meet the standard of care for all patients. 

Additionally we continue to see gaps in the availability of proper accessible 

equipment from vendors. A few key gaps include a lack of specialty tables used for 

medical imaging, diagnostic and therapeutic procedures as well as infusion chairs and 

gurneys. Currently many of these equipment types do not meet the specified height 

criteria. We hope to see the standards increase equipment options available to serve 

all patients. 

Especially important to ensure the time line for health systems to comply with 

standards once adopted, that must be considered carefully. For those who have 

purchased equipment designated for accessibility which does not meet these proposed 

standards, allowing the use of recent purchases for the full life of the equipment is 

critical. In other words, where our system has very carefully investigated the most 

accessible exam tables and purchased those, we hope that our system would be able 

to use those during the entire life of that particular equipment. And once 

repurchasing would meet the new proposed standards, so in terms of scoping we hope 

the board considers that. 
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We also would recommend that for big-ticket equipment, the board and the 

Department of Justice will set the scoping standards to consider allowing replacement 

of equipment as the trigger for purchase. 

Allowing compliance with the new standards over a period of time will assure 

the most cost-effective approach and this is an issue critical for all concerned about 

rising health care costs. 

We also note that in many cases the vendors and equipment marketplace will 

need some time to catch up. 

We respectfully ask you to consider our perspective and look forward to the 

final adoption of the standards. 

We believe these standards will improve the provision of health care for all 

patients. Thank you. 

>>Gary Talbot: Thank you very much. Are there any questions? 

>>Phillip Jenkins: Hi, Carol. This is Phil Jenkins, public member. Thank 

you for your testimony. I was wondering if you might give us some further 

information about the broadening of the -- who we could serve by using the 400 

pounds for the transfer equipment and 800 pounds for the scales. Do you have any 

data you can share with us? 

>>Carol Bradley: Well, we don't have data, but what we find is that when the 

accessible table serves a broad range of folks, that's going to mean that you don't have 

to have a lot of extra specialty equipment. And so we sort of looked at what's on the 
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market. And in our experience, the best options do allow for 400 pounds. And so 

that was the basis for our recommendation. 

We do also note that certainly as folks get, you know, our society gets larger, 

that it's important to accommodate a weight capacity. We did note that there are 

tables out there that do serve that weight capacity. 

>>Phillip Jenkins: Thank you. 

>>Mathew McCollough: Good morning. My name is Mat. You mentioned 

that we need to give the medical industry a time to catch up in terms of the 

equipment. What's the life span of the equipment, are we talking about 20 years, 40 

years? 

Like in my mind in terms of with people with disabilities need this lift day-today, so we have to wait for the industry to take up what the needs of people with 

disabilities and we're placed at such a disadvantage until they catch up. So could you 

give us like a proper time frame? What would you propose in terms of trying to be 

enforceable? 

>>Carol Bradley: Well, it would be hard for me to try to come up with a 

specific time line. I guess I would say in my comments I distinguished sort of two 

approaches. One is recognizing that for those systems that have been proactive and 

have gone ahead and purchased what is the best in the market to meet accessibility

while the standards -- you know, before the standard were promulgated, that there 

should be a recognition that -- for example, there's no table as I understand it out there 

currently that meets the transfer surface dimensions that are specified in the standards 
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and, you know, the problem with that is so we're purchasing new tables that are going 

to have a life -- and to be honest, I'm not an equipment person, so I'm not sure the life. 

But they're more expensive than probably we would have been purchasing in other 

settings and we're making sure that we're purchasing those. In a situation where 

you've been proactive, we hope that the scoping standards will allow for that. Now, I 

don't have a specific recommendation and so where we have been proactive I hope 

that the life of the equipment would be considered. 

And I guess my second point was that for big-ticket items, some of the bigger 

more expensive equipment that I think at this point -- and -- our system has certainly 

developed policy solutions to make sure we're addressing all gaps because obviously

it's very important that people with disabilities get health care. And as a person with 

a disability myself, I'm well aware of that. But I think that, you know, we do have to 

consider the life of the equipment and what it will take. And I guess in our system we 

tend to distinguish -- I mean, where our position is you have to have a method for 

serving patients, so hopefully that's helpful. Thank you. 

>>Mathew McCollough: Thank you. 

>>Gary Talbot: Thank you very much. Our next witness is Rosemary Ciotti. 

Thank you. Welcome. 

Rosemary Ciotti, RN, MSN, CRNP, Accessible Living, Inc. 
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>> Rosemary Ciotti: Hi. Good morning to everybody. It's great to be here. I 

was here in 2010 and certainly you all have done a tremendous amount of work and 

should be very proud. 

In section 510 of the rehab act recommendations are complete and it is my

belief that it will be a significant step forward for ensuring that people with 

disabilities can access medical care. Should these recommendations be adopted by

the appropriate regulatory bodies as mandatory requirements, it is my belief that the 

guarantee of accessible diagnostic studies and treatments will be life saving for 

persons with disabilities. 

I'm an advanced practice nurse, nurse practitioner who works with people 

with disabilities primarily spinal cord injuries in the community. My goal is to 

maximize their wellness, keep them independent, keep them at home. 

When it is necessary for them to be hospitalized, I work as a member of the 

team at the hospital since no two people with a disability have the same needs and 

those needs need to be met exactly for them to come through the hospital experience 

no worse for the wear and to be transitioned back into their home as quickly as 

possible and to prevent any bypassing into any institutional care, so that is the goal of 

accessible living incorporated. 

One of the things that I would like to make a point of at the beginning is as 

you look at this and the universal design, you will be doing more than what may be 

apparent as your mission goal. Hospitals and the medical system are made for ablebodied people. There are many people with disabilities who are trained health care 
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professionals who are not able to work at their profession because hospitals are not 

universally designed, the equipment is not universally designed. And so once you 

become disabled doesn't matter if you're a nurse practitioner, a physician, you are no 

longer able to be employed in a hospital setting. It's not because you can't do the 

work. It's because the built environment is not accommodating and the equipment is 

not accommodating. It has nothing to do with the person's skills. So not only will 

you be providing life-saving care by making universal design the norm for people, 

you will now be also able to allow people to stay employed because this equipment 

will be universally designed and you will remove one of the biggest barriers to 

professionals being able to remain in the hospital setting after they have become 

disabled and non-ambulatory is usually the biggest barrier because now the tables are 

too high, the equipment is too high, the counters are too high. But as we move into 

universal design, you will be doing much more than what may have been apparent 

when you started this process. So for that, and many other people, professionals with 

disabilities will be forever thankful. 

I took it as questions when I went through what I felt that I could be additive 

to today and I was going to start with question 11, are there types of diagnostic 

equipment that cannot conform to certain technical criteria for access? 

And one such imaging machine that was called out was the Dexa scanner. 

People with disabilities, people who are wheelchair users almost always will have 

bone loss and will need this scanner and the way it's engineered now, it is not 

accessible for independent transfer. 
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I do not believe that we need to accept this as a standard. If we can have 

computers that can go into our pockets now, I think they can do better with the 

scanner. 

I think that with medical engineering tasked to do this, either the surface that 

you lie on can either come out and lower for somebody to independently transfer and 

then rise up and go back over the scanner or the scanner can be made much more 

compact. 

The way it's designed now, you can't even get a Hoyer lift under it, so it 

makes even a Hoyer lift transfer dangerous and I just think the whole machine needs 

to be reengineered and a scanner is something that is very essential to be watching 

bone mass for people with disabilities. So I would hope that you would seriously

look at that. 

If in the meantime they say they can't do that, my suggestion would be a ramp 

on wheels that people can enter and exit that can be rolled next to the scanner so that 

people can independently transfer on, but the common wisdom is this is what it is and 

it can't be moved and you can't independently transfer and there are a lot of people 

who have been injured by people trying to lift them on to -- drag them on top of these 

scanners. So this is a really important thing I hope that we can make some headway

with. 

I support the -- under M301.2.1 and 302.2.1, I also support the Access Board's 

recommendation that the adjustable height surface have a minimum of 17 inches and 

a maximum of 25 inches for patient transfer since there has become such a wide 
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variability with some of the mid-range scooter, wheelchairs and the scooters that 

seem to be much higher than they were a number of years ago when these standards 

were first set. 

In answer to question 13, should the technical criteria specify that the height 

of the transfer surface from the floor be measured to the top of the upholstery under 

static conditions without compression that would me my preference-- if it's decided to 

go with some amount of deflection being permitted, I hope that that amount of 

deflection permitted is very narrow. When it comes to the surfaces as in dentist 

chairs and in some GYN chairs that have come on line, the upholstery has become 

more of a sense of style than with large contours around the end that has nothing to 

do with positioning. It's simply a style, sort of like a car seat that some more 

luxurious car seats will have more padding makes transferring very difficult because 

then you can have as much as a 2.5 inch incline to where the actual seat is. 

Oh, I thought I had five minutes. Okay. If I only have one more minute left 

then I want to spend it on mammography machines. The current state of 

mammography machines is untenable and when I was doing this, working on this, it 

was also during national breast cancer month in October and it was at the same time 

that the FDA has just approved a brand-new mammography machine that has been 

completely redesigned and been in Europe for a couple of years and is now FDA 

approved. I hope one can look at this. It's made by Giato that as perhaps being the 

standard that we use going forward. It is designed much more like a dentist x-ray

machine where the pole is off to the side and that the important x-ray parts come to 

the patient. 
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The person can be seated comfortably in a wheelchair. There are no bars to 

grab where now a woman has to lean forward, either be tethered if they don't have 

hand control. Try to grasp the concept is that you sit in the chair, it comes to you. 

There is no grabbing. They have realized the science with this is that without 

grabbing you can examine two centimeters more of breast tissue. They don't want the 

pectoral muscle of the chest to be tightened. The main thing is you have wide 

expanse to get under this machine. It comes to the person. They don't have to have

upper body support in order to have this. It also has the ability to know when the 

compression of the breast platform is sufficient without it just being done by a 

technician. 

So I hope that people can look at this and realize that we don't have to worry

about the depth and the toe clearance and the knee clearance as we do with all the 

traditional mammography machines. 

This will go a long way to providing life-saving screening for women with 

disabilities. And I think my time is up. 

Thank you so much and I will submit the rest of my comments. 

>>Gary Talbot: Thank you. Go ahead, Regina. 

>>Regina Blye: Regina Blye, public member. You have a unique perspective 

because you're also a person with a disability and professional. You gave examples 

of the equipment that would be needed for someone needing the service, but can you 

give an example of barriers that you might have faced because you said you were 
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looking for universal design. But can you give me some examples of what could be 

fixed or better? 

>>Rosemary Ciotti: All the exam tables, once the standards come online and 

they have it --

>>Regina Blye: I mean as far as you navigating. 

>>Rosemary Ciotti: Right. I can't navigate because the tables are too high. 

They don't come down far enough. I'm very capable of doing a complete physical 

exam, but when they don't lower far enough, it's the height that I can't do a complete 

exam. 

So as all these tables have to come down lower, it will permit clinicians in 

wheelchairs to be able to function fully and competently. 

>>Gary Talbot: Go ahead, Nancy. 

>> NANCY STARNES: Nancy Starnes, public member. Do you have any 

experience with the necessity of padding though, like a quad pad or something for 

people who have to remain on a surface for an extended period and maybe have a lot 

of bony prominences? 

>>Rosemary Ciotti: I think this is important and I didn't know if this was the 

appropriate forum. We have a lot of preventable, serious wounds that happen 

particularly in the cardiac lab where somebody may have to be on their back for a 

good long time for a cardiac Cath and maybe stents and this is where if somebody is 

to that point that they have has cardiac insufficiencies, they may have hypertension 
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and diabetes and we get a lot of problems with serious skin breakdowns and there is a 

padding that is made that I would like to see be standard on these and it is right across 

the hip and would allow protection during these extended periods and it's there. It 

needs to be used and it would save enormous health care dollars and saves lives 

because at that point when you have a stage 3 or 4 wound breakdown from somebody

after a cardiac Cath, that can certainly be the cause of death and the chances of them 

surviving that and the surgeries and the drain on the body to have a stage 3 or 4 that 

came as a result of a diagnostic study is something that is in our power to prevent. 

If I could just say one more thing...the Hoyer lifts, if you can, the big problem 

we have with Hoyer lifts is that people don't know how to use them. Training is not 

mandatory and they're never there when you need them. I hope when you come up 

with these regulations that there will be some standards of how many there have to 

be, one per department, something. And if you can make the joint accreditation for 

hospitals, have this as a mandatory requirement as part of their accreditation of 

hospitals I think this would go a long way to helping people with disabilities who 

need Hoyer lift transfer, to be able to have them and have them safely. But right now 

there's no mandatory training. We ask, please. But the joint accreditation for 

hospitals mandates other training and I really believe this is life and safety. 

>>Gary Talbot: Thank you very much. 

>>Rosemary Ciotti: Thank you for indulging me and sorry for going over. 
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June Kailes, MSW, Associate Director and Adjunct Associate Professor Western 

University of Health Sciences

>>Gary Talbot: Our next witness is by conference -- by phone, June Kailes. 

>>Rose Marie Bunales Operator, locate June Kailes and unmute when ready. 

>>June Kailes: Thank you. Gary, can you hear me? 

>>Gary Talbot: Yes, we can. 

>>June Kailes: Great. And thanks to the board for the remote access and I'm 

just grateful that at this hour in the morning there's no camera. Although rest assured 

I am dressed appropriately. 

>> Gary Talbot: You bet. 

>>June Kailes: My comments are based on a research conducted in 2009 

related to mammography and the name of the project was mammography, addressing 

equipment design which I will submit. 

The project was supported by the Nancy R. Gillman Foundation and in 

addition to my comments this research also addressed the foot and knee clearance of 

the mammography machine, positioning ability and hand holds and the depth of the 

outer edge of the breast plate to the poles and these are related to the traditional 

machines. Not the new one that Rosemary mentioned. 
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The practical was done cooperatively with Flora Toveg who was at the time 

was breast health access for women with disabilities in Berkeley, California. The 

focus group's interviews were conducted at Alta Bates medical center in Oakland, 

California during February of '09. 

These participants were presented seven mammography technologists from 

two breast health screening sites and they had an average of 15 years of experience 

each working with women with disabilities. So my first recommendation is to the 

board, is that as part of your process, that the board invest time to interview at length 

some of the real experts, those in practice and in the case of mammography, it's the 

experience of the seasoned technologist who work with large groups of people with 

disabilities. And these are technologists that unless you really seek them out, they 

will not be responding to this NPRM. 

So regarding mammography equipment, I'll focus my -- on these two 

questions. Question 36, is the proposed height range for the breast platform 30 inches 

high minimum and 40 inches high maximum above the floor sufficient to 

accommodate patients seated in a wheelchair? 

The answer is no, it is not sufficient. We recommend a 24 to 26-inch 

minimum to accommodate some wheelchair users and other short individuals. 

Current digital machines already achieve this such as the Hologic Selenia 

imaging plate from the floor to top of the plate I believe is 26 inches. 

Question -- same question, part B...are there other features of the breast 

platform that the technical criteria should address to ensure accessibility? And, yes. 
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One of the issues that the technologists have mentioned as well as women 

who experience mammography will comment on is the thickness and size of the plate 

and the receptor are features that can interfere with the wheelchair user as they have 

to be rotated. The technologists in the study commented that when they do, they call 

it a medial lateral oblique view, the MLO, that patients in wheelchairs, when receptor 

is turned over, you are really hitting their stomach more than when you have a smaller 

receptor so that it interferes with positioning and also can cause some pain so again 

the thickness of the receptor is an issue. In terms of question 37B, can a floating 

removable seat be required on other types of diagnostic equipment used by patients in 

a standing position? 

The answer is yes but be careful. Be cautious. There's no one chair that 

works for all diagnostic equipment. 

We found that in terms of the chair, the key issues reported by the 

technologists was that there isn't a good model on the market that meets their needs so 

they don't really use them. The technologists reported using their mammography

chairs less than 10% of the time because of poor design. Technologists prefer they

have the wheelchair users remain in their wheelchairs because these chairs offered 

less stability and support. Wheelchair users with non-detachable arms on their chairs 

were transferred by two technologists into a standard fixed chair with no armrest. 

They said if we had an auxiliary chair with the features we wanted, we would 

use it not only for women in wheelchairs but also with unsteady or elderly ladies, 

quote, unquote. So the detailed features they wanted to see in an auxiliary chair for 
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mammography included a chair with adjustable height, removable foot rest or those 

that flipped totally out of the way, removable and adjustable armrests, a shorter seat 

length that is an adjustable seat length hip to knees and they said quote, unquote, the 

seat to be shorter for a patient in a wheelchair. If the seat is too long, it makes it too 

hard to get in. If it was shorter, a patient could also maneuver their legs or we could 

assist with the maneuvering and positioning and we could get people as close as they

need to be. We are also putting pillows behind women to push them forward. 

They recommended some kind of position strap or seat belts for trunk 

supports and which are critical to stability, especially for elder patients and other 

patients who may be weak. For example, from chemo and other kinds of balance 

issues. They wanted a reclining seat back in case of an emergency the patient needs 

to be in a supine, on their back position. 

And they said the ideal chair would have a circular seat with wheels and locks 

and motorized seat height adjustor was preferred over the foot pedal pump and this is 

especially true with more obese patients. Since the ideal chair is not available, they

report adopting their technique as best they can to ensure the best image they can, but 

admitted that that's not always adequate. 

So thank you for allowing me to dig deeper in these two areas and I'll submit 

the study as well as many, many, many more comments. Thank you. 

>>Gary Talbot: Thank you very much, June. Does the board have any 

questions? Thank you very much, June. 

>>June Kailes: Okay. Thank you. 
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Margaret Steinman, M.D., Professor of Physical Medicine and Rehabilitation, 

University of Pennsylvania

>>Gary Talbot: Next witness is Margaret Stineman. 

>>Rose Marie Bunales: Operator, locate Margaret Stineman and unmute 

when ready. 

>>OPERATOR: Margaret Stineman, your line is open. 

>>Margaret Stineman: Great. Can everybody hear me? 

>>Gary Talbot: Yes, we can. Good morning. 

>>Margaret Stineman: Good morning, everybody. This is really an amazing, 

exciting experience to hear everybody's comments so far. About me, I'm a physician. 

I have taken care of people with severe disabilities for two decades and also a person 

with disabilities myself and I went through some of your questions as well as sort of 

the basic structure of your report which I found to be very exciting and really an 

incredible testimony that our society is now realizing the importance of accessibility

and diagnostic equipment. 

I'll start first with the basic assumption that all people will be able to enter 

independently into a diagnostic device and this touches on an issue that was already

raised and that is that we actually can't necessarily expect that all people with 
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disabilities will have the capacity to enter independently so that the universal design 

really needs to facilitate assistance of a helper and in terms of the dynamics, lifting 

and so forth, that that helper is going to need to be able to accomplish in trying to 

helping the patient transfer. 

So secondly, I wanted to also talk about your concept of using anatomic 

landmarks for directing the -- I'm sorry, I wanted to talk about the possibility of 

actually extending these standards to include equipment that is used in treatment and 

there is one example that I think is very critical and that is the fact that when people 

get radiation for various types of cancer you need to use, landmarks to direct the 

position of the radiation equipment very accurately so when you have people with 

disabilities often times the deformities that occurred in their bodies would make these 

landmarks invalid. 

But moving from that issue I'm also going to talk about the organizing criteria, 

the technical criteria that you're using, which I found is actually quite excellent. You 

were talking mostly about positions that patients need to be placed in functionally. 

But in addition to talking about the positions of placing the patient, I would consider 

adding additional dimensions such as verbal communication, hearing, seeing, 

understanding, and also education in that people who have not had advanced 

education in terms of understanding how to use this diagnostic equipment from the 

standpoint of the patient we need to consider ways of communicating with them so 

that it becomes clear what is required and sometimes in certain procedures if the 

patient doesn't understand what is going to happen because of a hearing problem or 

communication problem, the patient could be placed at risk if they can't do what is 
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expected, so I also went through some of your questions and I'll talk about some of 

them. 

First is question number 23, which relates to the use of stirrups in various 

procedure chairs. And the example that was given, your dynamic study is actually a 

very important example and in my opinion it would be very, very important to have 

stirrups in support of patient's legs that are going to have that procedure because a 

large proportion of people that need your dynamic analyses are paralyzed, are going 

to need to have that type of support in order to have the test. 

The next question that I looked at, I'm going to talk about is question 30. And 

that relates to edge protection in equipment where there's going to be a raised 

platform for the person using a wheelchair. I think that that is very, very critical in 

terms of safety. They have basically the edge protection and I wasn't quite sure about 

the exception that followed in that it talked about the need to enter and exit if there's a 

ramp and I felt that if the platform is raised above the floor, unless the ramp is 

actually in a position where the person were to move or overshoot the platform, there 

should also be a protection that could be placed on the exit area while the procedure is 

occurring that can be then removed for another patient to exit. 

So the next question that I looked at and wanted to talk about was question 32 

and it relates to scooter use that I believe also that June talked about and many people 

but not all who use scooters can transfer independently and sometimes the scooters 

are rather large and so that if the space cannot legitimately accommodate the scooter, 
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I think there needs to be a folding chair, a seat that could be provided with all of the 

concerns that June raised I certainly agree with. 

And that positioning seat, for example, if there is a folding seat, I felt that you 

need to consider having a seat belt on that seat as well as something that would allow 

to help with side stability if the individual has sitting issues in terms of being able to 

maintain the seated position. 

The next question will I talk about is 41 and I felt this was a really critical 

question that related to diagnostic equipment where communication instructions are 

required and the question was should you provide audible, visible and tactile 

communication? 

And I think that is critical -- did somebody want to say something? 

>>Regina Blye: No. 

>>Margaret Stineman: Okay. I think that providing that kind of 

communication is critical. I've had many patients, for example, who have hearing 

impairments who have been utterly completely terrorized by MRI machines where 

they could feel the vibrations. They can't communicate with the operator, so that I

felt that things like having braille on call bells and written materials -- so for example 

in the ideal world, I would love to see inside an MRI machine some type of a video 

device that could have typed communication with the operator as well as sound 

activated as well as some type of a braille plate that could be placed somewhere in the 

machine that the person's hand could actually be resting on should they have vision 

problems that would basically communicate with them. 
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The final thing that I will say that I felt was really important and this is not 

addressed in the technical standards and that is standards that would help with people 

that have intellectual disability and I'm not quite sure how that would work, but it is 

something to think about and a lot of the people that I've spoken with who are 

patients who have disabilities really emphasize the importance of not just the built 

equipment, but the equipment-human interaction and I like the idea of ensuring that 

there are certain standards for particular types of equipment in hospitals as well as 

training to use it with regard to people with different types of disabilities. So that as 

you develop your standards for the physical qualities of the equipment, please think 

about the human factors as well that would go along with the instructions and training 

programs. Thank you. 

>>Gary Talbot: Thank you very much, Margaret. Does the board have any 

questions? Well, thank you, again, for your testimony. 

>>Margaret Stineman: Thank you for having me. 

David Hausmann, CEO, Hausmann Industries

>>Gary Talbot: Next up is David Hausmann. 

>>David Hausmann: Good morning. Thank you for allowing me to present 

today to the committee. I'm David Hausmann, CEO of Hausmann Industries, Inc. 

We are a 55 year old plus US based manufacturer of medical and physical therapy 
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equipment and we're a pioneer and innovator of wheelchair accessible products. This 

is demonstrated by our association with the late Dr. Sandra Wellner who was 

disabled and one of the key advocates of wheelchair accessibility in the exam room. 

We have sold over 6500 wheelchair accessible tables and mat platforms from 2000 to 

present. In 1993 we made a prototype power wheelchair accessible examination table 

for Dr. Wellner's use. She applied for a US patent for this table and Hausmann 

Industries became the exclusive manufacturer. For your reference, the CME Review 

article published in 1999, practical considerations and performance of physical 

examination of women with disabilities authored by Drs. Wellner, Foley, Nossick,

and Holmes ---quote a significant barrier for women with limited mobility is the 

height and width of the examination table, an accessible hi-low height 19 to 20 inches 

off the ground is one solution. 

As a matter of background Hausmann Industries supplied wheelchair 

accessible examination tables to the New York state accessible table project as part of 

the New York State initiative in 2002 and 2003 to increase access to cancer screening 

for women with disabilities. The tables were placed in clinics and physicians' offices 

that participate in the state's healthy women partnership program. More than 60,000 

women received breast and cervical screening annually through this program. 

As an innovator of wheelchair accessible products we have several concerns 

about the direction we see the guidelines moving towards. While we support overall 

objective we are concerned about overly rigid specifications that, we feel are 

unnecessary and pose an unfair hardship on us and potentially other manufacturers. 

Let me address in general terms some of the relevant details in chapter M3, technical 
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criteria - the transfer surface height. We have concerns about the proposed low 

height requirement of 17 to 19 inches for exam tables. Our barrier free examination 

table has a low height of 20 inches and has worked well and has been entirely

satisfactory in our installed base for approximately 1,000 units. As a respected 

market innovator we have not encountered a need for lower height. We feel that our 

design has many advantages over the competition as this table has a linear actuator 

that delivers superior performance and product life. We offer a 3-year warranty of 

one of the longest in the marketplace and have a true 400 pound dynamic weight 

capacity which has been tested to a 1600 pound static load. 

The design limitation -- the design has a limitation that attaining a lower 

height is difficult. Hence, we suggest the transfer surface height range be 17 to 20 

inches. This will allow our installed base to meet the proposed new regulations and 

customers to decide which product is best suited to their needs. 

On page 54, transfer site obstructions, armrest, foot rest, side rails and 

stirrups, we developed the design of vertically sliding locking safety rails that slide up 

to lock. These safety rails prevent the patient from rolling off the table and can be 

used as a grab bar to assist the patient in the transfer process. Our safety rails are 18 

inches wide and 10 inches above the work surface when elevated and locked in 

position. We suggest that safety rails, these safety rails armrest, grab bars should be 

optional equipment and in any event, if required, be a minimum of 18 inches wide 

instead of 20 inches to allow existing products to be compliant and avoid 

unnecessary retooling. 
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Page 54, stirrups. All examination tables are supplied with retractable 

adjustable stirrups at the foot end of the table-- these general purpose stirrups work 

well for most patients under most circumstances. Padded surgical boot stirrups such 

as Alan medical systems’ yellow fin stirrups are proprietary and very specialized. 

These stirrups may be required for a limited number of disabled patients. They are 

generally sold directly by the manufacturer to the facility. Hence, this is best treated 

as an optional item rather than as a required feature that will eliminate many 

manufacturers to not have access to these. Additionally the manufacturer suggested 

retail price can exceed 3500 per stirrup set and this will add considerably to the cost 

of each table. The surgical boot stirrups can be readily field installed should facilities 

need them. In concluding I strongly urge you consider these modest suggestions to 

broaden the proposed guidelines and ensure the free market can continue to operate to 

best supply the needs of the disabled patients. We feel some of the guidelines may 

unfairly favor Midmark the dominate exam table manufacturer. We wish to preserve 

a fair and even playing field so that no qualified manufacturer large or small is 

excluded because a manufacturer to slightly different specifications that are equally 

safe and effective. As a leading manufacturer of power mat platforms and treatment 

tables using the rehabilitation environment that also serves the disabled population, 

we will be even further negatively impacted by the proposed 19 inch low height 

requirement when these regulations extend into this area. Therefore expanding the 

proposed minimum height range of 20 inches is monumentally significant. 

I want to thank the committee for your consideration of our comments here 

today and all the fine work you have been doing. Thank you. 
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>>Gary Talbot: Thank you very much. Does anybody have any questions? 

Thank you for your testimony. Next witness is Linda Manning. 

>>Rose Marie Bunales: Operator, do you have Linda Napolitano Manning on 

the line? If so, unmute when ready. 

>>OPERATOR: I don't show a Linda online. 

Joe Isaacs, Vice President for Public Policy, United Spinal Association 

>>Gary Talbot: We'll go to the next witness. Joe Isaacs? 

>>Joe Isaacs: Good morning, everyone. 

>>Gary Talbot: Good morning. 

>>Joe Isaacs: I should say at the outset a disclaimer that I'm not a medical 

equipment expert, but I play one occasionally on television. 

>>On behalf of Americans with spinal cord injuries and disorders nationwide, 

the United Spinal Association wishes to thank the U.S. Access Board for this 

opportunity to comment publicly on the proposed accessibility standards for 

diagnostic medical equipment. Since 1946 the United Spinal Association has 

advocated on behalf of the interest of those living with spinal cord injuries and 

disorders such as post-polio syndrome, multiple sclerosis, amyotropic lateral sclerosis 

and spina bifida. We have more than 37,000 members and 62 chapters and support 
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groups nationwide. I mention this because my brief remarks today will focus on 

issues raised routinely by our members about their challenges in addressing medical 

equipment addressed by the proposed accessibility standards. 

Accessibility to hospitals, doctor's offices, clinics and other health care 

providers is essential in providing medical care to people with disabilities due to 

physical barriers, individuals with disabilities are not as likely as those with 

disabilities to receive routine examinations, diagnostic testing and preventive medical 

care. 

United Spinal Association has asked its members and others with disabilities 

about the barriers they encounter when seeking medical care equipment. The most 

frequent responses involved access to examination tables, dentist chairs, scales, and 

mammography and colonoscopy equipment. Tables and chairs are not adjustable for 

easy transfer. Create a huge barrier to individuals using wheelchairs or those of short 

stature. If they were not informed in advance to bring someone with them to help 

them transfer onto the furniture equipment, these patients were often told at their 

appointment that they could not be treated at that particular facility. Perhaps lacking 

lifting equipment, having too few staff available and trained to move the patient 

safely or fear of liability, medical and support staff at these facilities would not 

provide assistance to these patients to take advantage of a basic and more 

sophisticated diagnostic equipment such as magnetic resonance imaging. 

Another barrier is weight scales. As most patients are required to stand and be 

weighed as part of routine medical examination and key to diagnostic analysis, an 
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important factor of the impact of obesity on a wide range of diseases and disorders 

and especially when active exercise can often be generally restricted due to paralysis 

and other physical limitations. Even if a scale is accessible and is large enough to 

weigh a person still sitting in his or her wheelchair, the accuracy of the result should 

not depend on the patient's knowledge of the wheelchair's exact weight in order to do 

the math. Not having the weight of a patient or an inaccurate weight could seriously

undermine the effectiveness of any medication where dosage depends on the patient's 

weight and related absorption rate. United Spinal Association would like to see 

adjustable examination tables, accessible scales, Hoyer lifts and other adaptive 

medical equipment be readily available at all clinical settings to serve people with 

disabilities. We believe the proposed accessibility standards will provide the needed 

technical criteria to ensure access to diagnostic medical equipment when serving 

those with disabilities. 

It must be re-emphasized as well that the space within which such equipment 

is situated must be sufficient to accommodate the capacity to reach the equipment by 

those requiring wheelchairs, powered mobility devices and other assistive 

technologies. Now I made my disclaimer early on but United Spinal accessibility

services program provides consultations to builders and contractors that build clinical 

facilities and serve wheelchair users including those with canes and walkers and 

scooters. Our certified specialists, plan examiners, attorneys, architects and code 

enforcement officials maintain the highest accessibility standards under the ADA as 

key consultants on projects big and small including arenas such as Yankee stadium, 

other sports venues like the new Nets arena, museums. We're located in New York. 
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You'll notice the New York orientation, residential projects, medical facilities and 

concert halls. Recognizing our limited time here, this team of professionals will take 

the feedback that has been provided by our members and apply its own knowledge 

and practical experience to respond further to the 46 specific questions raised in the 

proposed accessibility standards. They wanted to have me convey to you that they

stand ready and welcome the opportunity to assist the Access Board in any way it 

can. Thank you for this opportunity. 

>>Gary Talbot: Thank you very much, Joe. Does anybody have any

questions? 

>>Christopher Hart: Joe, hi. Chris Hart, public member. Do you have any

data that would speak to supporting the 17 height of requirement for transfer height? 

Because as you know it's a pretty ubiquitous height that we have used for years in all 

manner of rulemaking. 

>>Joe Isaacs: Well, I would agree with you and the statement I made about 

stature was critical and infused into this testimony. By those individuals, I was 

describing that our experts. I don't know the answer about the data but I will certainly

come back to the Access Board with the information. Thanks for asking, Chris. 

>>Gary Talbot: Thank you very much. We appreciate it. We're going to take 

a short break. We're going to leave the phone line open and we'll take just a 10-

minute break. So it's what, 10:45, so it's take a 10-minute break and be back. Thank 

you. 

(Break) 
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>>Gary Talbot: Okay, if I could ask everybody to take their seats and for the 

board members to have their seats back up here. Thank you. 

Kat Taylor, Disability Rights Program Manager, The Equal Rights Center

>>Gary Talbot: Okay. We'll reconvene. Next up for the next witness is Kat 

Taylor. 

>>Kat Taylor: Good morning. I'm Kat Taylor, the disabilities rights program 

manager at the Equal Rights Center. For nearly 30 years the Equal Rights Center has 

been fighting discriminations faced by people with disabilities. With more than 4,000 

members in every state and the District of Columbia we have increasingly engaged in 

efforts which are forward looking and seek to proactively promote equal participation 

of people with disabilities in all aspects of life. We have been working to eliminate 

barriers and health care access for several years, specifically with Washington 

Hospital Center, Howard University Hospital and eye care centers of America. Most 

recently we conducted an extensive national research regarding the dearth of 

accessible healthcare service and we released a report, Ill-prepared: health care's 

barriers for people with disabilities. 

We continue to receive complaints from individuals with disabilities who are 

denied health care because they cannot access their doctor's office or once in an office 
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cannot utilize equipment, or lastly are denied reasonable accommodation. These 

barriers are not only unacceptable but entirely preventable. 

The ERC would first like to compliment the access board on the work that has 

been completed on the draft standard. Although current standards for accessible 

design include limited guidance, the standards for medical diagnostic equipment, 

supply medical service providers and advocates like myself with essential information 

to ensure the accessibility of health care services. We would like to provide 

comments on how the standards can be revised to improve their clarity and encourage 

even greater accessibility. In response to question 3 regarding the organization of 

technical criteria for medical diagnostic equipment, the standards are generally clear, 

but explanations could be added to provide further clarification. First, it would be 

very beneficial to provide a list of equipment that falls within each category. 

This would not have to be an exhaustive list, but a comprehensive list would 

improve readers' understanding of the standards and hold healthcare providers 

accountable to ensure the equipment listed is indeed accessible. For example, 

diagnostic equipment used by patients in a prone or side-lying position should include 

examples such as equipment used for MRI, DEXA scans, PET scans, examination 

tables and CT scans. Slight revisions at the beginning of each section to provide a list 

of examples will clarify for medical providers which equipment is covered by the 

standards. A list of equipment to add to each section is provided in our amended 

standards for your review. We also believe the medical community could assist in 

expanding upon the list. 
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Second, guidance should be provided on the need for varying position options 

for medical equipment. It is not acceptable for any specific type of diagnostic 

equipment to only be available to those who can stand or those that can independently 

transfer from their wheelchairs. Provision should be added within the standards to 

clarify this need for medical providers. Adding provisions at the beginning of M302 

and M304 explaining the diagnostic equipment must be provided in such a way to 

accommodate those who cannot stand or cannot independently transfer is crucial. 

In response to question 6 whether other terms in the proposed standard should 

be defined...the definition of medical diagnostic equipment should be amended to 

promote the greatest accessibility possible. We think the current definition should be 

amended to state: all equipment used in or in conjunction with medical settings by 

health care providers for diagnostic purposes. This definition is intended to be 

inclusive of all medical equipment in which any part of equipment is used for 

diagnostic purposes for any amount of time. Such an inclusive definition would 

ensure that general medical equipment such as tables and scales are covered by the 

standards. 

Second, providing definitions for lift and base would improve readers' 

understanding of the lift requirements. Again, we have suggested definitions in our 

written comments. 

In response to questions 4 and 7, regarding whether the language and figures 

can be improved to provide more clarity and help readers better understand how the 

technical criteria apply to diagnostic equipment. 
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Clarification regarding the lifts would be extremely helpful. First I want to 

reiterate Rosemary's comment, the standard regarding how many lifts are required in 

a facility would be very beneficial. While we understand that the Access Board is not 

the governing authority of scoping requirements, clear language which states a lift 

must be available that each piece of diagnostic equipment is necessary for proper 

application of the standards. In addition, the space requirements regarding the lift and 

base are unclear. In addition to providing definitions stated previously, improving 

figure M-3 would be beneficial for readers. For example, the last drawing should be 

modified by removing the people, and labeling the base, clearance and base, and 

clearance around base, to improve understanding. 

Again, the ERC wants to applaud and thank the Access Board for all the work 

that's been completed thus far on the standards and I'm happy to answer any questions 

at this time. 

>>Gary Talbot: Thank you very much. Does anybody have any questions? 

Well, thank you for your testimony. 

>>Kat Taylor: Thank you. 

Barbara L. Kornblau, JD, OTR, Coalition for Disability Health Equity, American 

Public Health Association

>>Gary Talbot: The next witness is Barbara Kornblau. 
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>>Barbara Kornblau: Good morning and thank you very much for the 

opportunity to speak before you today. I'm representing three groups, the Coalition 

For Disability Health Equity, which is a working group of disability advocates, 

disability researchers, disability public health providers and disability service 

providers who advocate for health equity for members of the cross-disability

community. 

The second group is Access Living, nationally recognized leading force in 

disability, the disability advocacy community that challenges stereotypes, protect 

civil rights and champion social reform. 

And the third group and I want to clarify, it's the disability section of the 

American Public Health Association. I don't represent the entire American Public 

Health Association. And the disability section is concerned with people with 

disabilities having access to prevention and primary care. 

We are all concerned, three groups, about health disparities faced by people 

with disabilities. We realize that your task is to develop specific standards for 

accessible medical equipment and we agree that this is the first step needed to 

decrease disability health disparities and to assure that people with disabilities have 

access to care and we certainly appreciate all of the work that you have done so far. 

Our concern is that as you develop these standards, that you consider the --

our overall policy concern that training people in the best practices of using the 

equipment is essential. 
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I confess that I still need to find a teenager when I want to program my VCR, 

but I guess that's old fashion now. They're called DVRs now. 

And as an occupational therapist working in the clinics I remember working in 

a place where they had this beautiful big piece of metal equipment. I didn't know 

what it was, but it was used to dry hot pad covers and I asked someone what is that 

and they told me 2000 something equipment. Why doesn't anyone use it? They said 

the person who knew how to use it left. So we don't want to see accessible equipment 

relegated to a storage room because no one knows how to use it or find it. We have 

had people say that they're in a clinic, in a hospital and there's no Hoyer lift. Nobody

knows where it is to transfer them. So in question 2, the board asks what are the 

barriers are there that affect accessibility and usability of medical diagnostic 

equipment, what should we address in the future and updates to the standard? 

Well, a major barrier that affects accessibility and usability of medical 

diagnostic equipment is the lack of knowledge and attitude of the providers and the 

care of their staff. Wheelchair users have been turned away from colonoscopy exams 

because the health care provider didn't know how to position them as patients. 

Something that accessible equipment wouldn't fix without training. 

Special Olympics, healthy athletes programs data tells us that people with 

intellectual disabilities must see 50 providers before they find one trained to treat 

them and studies show that people with mental health disabilities die 25 years earlier 

from preventable, treatable conditions like diabetes compared to people without 

disabilities. People with Autism may not get their blood pressure taken because they
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do not like to be touched and an accessible blood pressure cuff may not override the 

inability of the provider to use it with autistic individuals. 

Health care providers, and this is a really big problem, often tell wheelchair 

users to bring someone with them to help transfer them from their wheelchairs or, in 

the case of a friend of mine, I went with her to help hold her legs up so she could 

have a pelvic exam and ended up having stage 3 cervical cancer and died a month 

later at age 31 because it took us three months to find someone after her urine which 

was catheterizing herself had occult blood so we just couldn't find someone who was 

willing so finally I said I'll hold her legs up. I'll transfer her. All you have to do is 

put the speculum in and do your job. That shouldn't happen. That's still a training 

issue. It can be accessible but where are you going to position the person's legs if 

they can't do it themselves. Well, adjustable equipment is critically important, so we 

are going to give you more comments but we want to address this particular issue 

about having someone come with you to help with care or do transfers. 

Well, adjustable equipment is critically important to assure quality health care 

for people with disabilities, the mere acquisition of such equipment, while necessary, 

is not sufficient. People who use wheelchairs and other mobility devices can only

benefit from medical equipment if they can transfer from their wheelchairs to the 

equipment. We can't ignore the necessity of the appropriate transfer of people with 

mobility devices if the board expects people to actually use the equipment. 

We urge the board to address this subject in order to make its equipment 

standards fully effective. We recommend that the board consider the best practice 
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principles set forth in an amendment to the Illinois Hospital Licensing Act that 

accesses -- that Access Living in Chicago played a key role in advocating for. There 

are two factors of critical importance in the standards. Individual preference of 

manual or mechanical lifting should be honored in order to promote choice, 

autonomy and dignity in the transfer/lift process. Individuals with disabilities should 

be given the opportunity to choose among a range of transfer options since they know 

the transfer and lift assistance that will work best for them. Some will not require any 

mechanical or manual lifting but a simple minimal assist/transfer and even those are 

often, you know, turned away from medical practices. 

All staff should be trained in the proper use of lifting equipment, including its 

location and condition. A critical component that must be included is at least annual 

lifting and transferring competency training in both mechanical and manual 

techniques, including ergonomic principles and where there is a no-lift policy, where 

are those lifting devices? Where are the lift assists? Maybe, you know, they could be 

put on the back of your name badge with "RACE" (for the fires) ... "where is the lift"? 

In conclusion, in addition to technical standards for accessible medical 

equipment, the overriding policy needs to include provisions for training providers 

and their staff and best practice of how to use the equipment and how to properly lift 

and/or transfer people so that they can use the equipment and the equipment is 

properly used, not relegated to a closet. 

Thank you very much for the opportunity to speak today and we will be 

submitting more detailed comments before the deadline. Thank you. 
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>>Gary Talbot: Thank you very much. Does any member have a question? 

Thank you very much. 

Kelly Buckland, Executive Director, National Council on Independent Living

>>Gary Talbot: Next witness is Kelly Buckland. Take your time. 

>>Kelly Buckland: Thank you and good morning. My name is Kelly 

Buckland. I'm the executive director of the National Council on Independent Living. 

We are the longest and oldest cross-disability national organization representing 

people with disabilities, centers for independent living, which are nonprofit, 

nonresidential advocacy organizations for people with disabilities and statewide 

independent living councils and we're honored to be here today to testify on this. 

Although 22 years after the passage of the Americans with Disabilities Act, you 

would think that this would have already occurred. People have been going too long 

without accessible medical equipment and diagnostics and have died earlier than they

should have just because of the lack of accessibility. 

So with the development of new medical devices and new computer 

applications and a plethora of new preventative tests, it's critical that these 

technologies be designed and used in a way that increases the inclusion, 

independence and empowerment of Americans with disabilities as well as American 

seniors. In settlement agreements with certain providers, the Department of Justice 
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has in the past made an attempt to address access to some exam, imaging and 

treatment equipment. But more must be done to establish guidelines and then 

enforceable standards so that all equipment is accessible, across the spectrum of 

health care facilities and providers in America. 

NCIL board member, Mark Derry, has been an accessibility consultant 

providing advice to hospitals, imaging centers, surgical centers and rural health care 

clinics for 15 years. When trying to provide good accessibility advice, he could 

always point to the ADA accessibility guidelines for the built environment but could 

only apply what he knew, made up good accessibility to other features like imaging 

and diagnostic equipment for lack of specific guidelines for that technology. His 

experience with decision makers and equipment, people at the facilities, is that if you 

provide them with guidance, they will follow it. This rulemaking is exactly what the 

medical community and people with disabilities need. 

We have seen how quickly manufacturers adapt equipment and develop new 

features that are brought about by better accessibility guidelines but actually are more 

usable by everybody and benefit many. The manufacturers need the guidance and 

input to provide those products that will be more usable by people with disabilities 

and thereby increase the services provided and newer equipment procured. The same 

features that make the equipment more usable benefit the growing number of older 

Americans with disabilities to ensure that quality health care is available to everyone. 

We at NCIL have heard loud and clear from our membership that access to 

diagnostic imaging and treatment equipment is a huge barrier, especially in rural 
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settings. Many NCIL members with disabilities have personal stories including me, 

all right, of being denied effective medical care just based on the barriers to using 

existing equipment or because the only way to gain access is by being lifted by 

untrained or careless staff. 

NCIL would be promoting the submission of comments by its membership as 

well as coordinating a group of interested individuals from existing NCIL committees 

such as the NCIL health care subcommittee and the ADA/civil rights committee to 

provide comments on behalf of NCIL before the deadline for submission in June. 

NCIL would appreciate the opportunity to provide additional participation on 

the advisory committee as the rulemaking process proceeds. And again, I thank you 

for the opportunity to provide testimony and would stand open for any questions. 

>>Gary Talbot: Thank you very much, Kelly. Does any member have a 

question? Mathew. 

>>Mathew McCollough: It's more of a comment. I greatly appreciate Kelly 

Buckland being here and I really appreciate the fact that you emphasize that the 

manufacturers have to be more inclusive of folks with disabilities in terms of their 

equipment and my comment is that I truly believe that the standards would address 

the fact that if folks -- if more folks with disabilities have access to the medical 

equipment, that means greater position in the long term which would lower the costs 

of health care costs over time. And I think that's the message that NCIL and other 

national disability organizations could quite possibly communicate to the 

manufacturers saying if you get diagnosed early, you will drive down the cost of 
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health care over time because if folks with disabilities have a bad experience using 

the equipment, that means that they won't go back to the doctors, which would over 

time increase the cost of health care simply because they're not taking care of 

business. 

So I think that message that NCIL and other national disability organizations 

could really change the mindset that with the manufacturers, that really are worried 

about the bottom line of costs and equipment and having their doctors and their 

systems buy the equipment saying that if you have more accessible equipment, you'll 

see a greater clientele over time, so I just wanted to say that openly. 

>>Kelly Buckland: Thank you, Mat. I completely agree and I think Ms. 

Kornblau's testimony pointed that some really good examples of exactly how that 

could work. 

>>Nancy Starnes: Nancy Starnes, public member. I just wanted to ask, if you 

would hazard a guess, how many of your members live in rural areas? Because you 

did bring up the issue that there may be additional disparate impact on people who 

live where you don't have these -- people who may be more informed or may be able 

to tap into the needs of folks with disabilities more readily. 

>>Kelly Buckland: I wouldn't -- Nancy, I wouldn't hazard a guess on exactly

how many. But centers are in 700 different locations across the United States and 

they're in -- they are located in a lot of rural areas like -- I mean, the one that comes to 

mind for me always when you talk about rural stuff is Alaska. Alaska has a 

population of about 100 million -- or I mean a million. Sorry. A million people. 
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About half of them live in Anchorage and Alaska is the biggest state in the 

union. So there's 500,000 people spread across the rest of the state. So there's places 

that people with disabilities live at that you can't get to without getting on an airplane. 

And that's just one example. There is a lot of rural areas. I mean, even in 

states like New York, there's rural areas served by centers. So -- but that might be a 

better question to ask APRIL, which is the association program rural independent 

living. But NCIL also -- I mean, NCIL does have a lot of rural members also and 

shares a lot of members with APRIL but it is a problem in rural areas but also urban 

areas as well. 

>>Phillip Jenkins: I have a question. Phil Jenkins, public member. You 

mentioned the word more access to more people, those kinds of things. When you 

submit written comments, if you could tie those statements also to some of these

actual technical standards. We heard testimony today about 17 inches, 19 inches, 20 

inches, if you could give us any input on how many more would be accommodated or 

any issues you have seen when we get down to trying to decide between some of 

these real technical specifications. If you could do that, that would really help us. 

>>Kelly Buckland: We will be happy to do that and as I concluded in my

testimony, we'd like to be a part of that process as it moves forward. Mr. Derry who 

is the chair of the ADA civil rights committee of NCIL is a real expert in exactly

those kinds of standards and can provide - and he wanted to be here today to actually 

testify instead of me and he would have probably been much better at it, but he wasn't 

able to be here because of his work. He's actually working on a place, helping them 
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improve their access right now so he couldn't leave, but he can provide a lot of that 

exact kind of input that you're looking for. 

>>Phillip Jenkins: Thank you. 

>>Gary Talbot: Thank you very much. Anybody else? Want to thank you 

very much for your testimony. 

>>Kelly Buckland: Thank you. 

>>Gary Talbot: Rose? Are we gonna ... ? 

>>Rose Marie Bunales: Sure - Operator, one last call for Linda Napolitano 

Manning? Do you have her on the line? 

Linda Napolitano Manning, consumer, New York City, NY

>>OPERATOR: Yes, her line is now open. 

>>Rose Marie Bunales: Okay. Great. Thank you. 

>>Gary Talbot: Hi, Linda. Are you there? 

>>Linda Manning: I'm here. 

>>Gary Talbot: Go ahead. 
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>>Linda Manning: Okay. Hi. My name is Linda Napolitano Manning. I'm 

from Long Island, New York; I'm a disabled woman, I use a wheelchair and I'm 

unable to transfer myself onto examination tables. First of all I want to thank you all 

for addressing this very, very important issue. It's been a problem that I've been 

concerned about and complaining about for many years. I've written to health 

departments, I've written to politicians, I've spoken to so many different medical staff 

and nobody's -- I don't know, they just don't seem to really understand how important 

this is. 

They don't understand the accessibility. You know, when I go into any kind 

of doctors office and the medical staff will say to me, do you need help? And I say, 

yes, I need help in transferring. And they say no problem, we can help you. But 

they're saying we can help you means we can hold on to you while you stand up and 

get on to the table. And of course I'm not able to stand at all. 

What I just wanted to talk about, you know, briefly -- I'm talking from, you 

know, from a personal point of view...I wanted to speak about the examination tables, 

especially at gynecologist offices. I try to have an annual exam every year -- you 

know, every year, and for many years I was very fortunate in that I had family

members who were able to come with me and able to lift me. 

But, of course, things have changed. People have gotten older. People have 

back problems. People are not able to lift me any longer. So I do need a lift. 
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I was not going to the gynecologist for a few years because I had no way of 

being examined. So I thought, well, maybe if I go to a hospital, I went to a local 

hospital hoping that they would be able to help me. I was wrong. 

They said that there was no way that anybody could lift me. They wouldn't 

take the responsibility, and so I said, well, do you have a Hoyer lift? 

No, we don't have a Hoyer lift and I was surprised. I said I can't believe that a 

hospital doesn't have a Hoyer lift. And they said well, even if we did have a Hoyer 

lift, we don't have the kind of exam tables that work well with Hoyer lifts. So I had to 

come home and I wasn't able to be examined. 

You know, I find that -- well, not only me, but all the other disabled people 

that I know say they're going through the same thing wherever they go, whatever 

doctor they go to, they can't get on the examination tables. They can't take important 

medical tests, you know, such as MRIs and CAT scans and sonograms. So, yeah, we 

are neglecting our health. 

I did find one doctor at one time who said that he would be able to lift me and 

put me on the table and he did, but he did not know how to do it properly and he did 

hurt me. 

So this is what I wanted to talk about mainly from a personal point of view. 

I'm so glad that this important issue is being addressed because I've been feeling very

frustrated. I just didn't know what to do, who to talk to anymore and I'm so glad that 

you're finally addressing this. Thank you. 
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>>Gary Talbot: Thank you very much, Linda. Is there any comments from 

the board? Thank you very much for your comments? 

>>Linda Manning: Thank you. 

>>Gary Talbot: And with that, we'll go ahead and open it up to -- I think 

that's it, Rose, all of the people that signed up? Okay. We can go ahead and open it 

up to open mic if there's somebody that would like to come up and testify or if 

someone testified earlier and needed to take a little bit more time, you're free to do 

that. Seeing no takers...yes, sir? 

Jeff Baker, Medical Technology, Inc. 

>>Jeff Baker: My name is Jeff Baker. I'm with a manufacturing firm called 

Medical Technology, Incorporated in Salt Lake City, Utah, and first of all I didn't 

come with any prepared comments, but wanted to just mostly listen to what was 

going on. And I do applaud your willingness to look at all avenues, all perspectives 

in this decision making process. 

And I would just ask you to consider a couple of things in your rulemaking 

and that would be regarding the 17 to 19-inch requirement that you're 

considering...you can get a certain types of medical tables or chairs so low that they 

become nonfunctional once they get to a raised position and I draw your attention to 

say ENT chairs. ENT chairs are primarily used in the upright position. They raise 

the patient up while they're sitting up, do examinations, but there are some balance 
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procedures and so forth where they need to lay the patient down. So as they lay the 

patient down, they lay the back backwards and that's either done manually or by a 

power that the leg rest also comes up and the foot rest flattens out and the foot rest is 

an important component in the ENT chair because patients don't like to sit for long 

extended times with their feet dangling. 

And so as the back of that leg rest comes up, the lower you get a chair to the 

floor, the shorter the leg rest becomes and then that forces the patient's calf and feet 

and so forth to extend on to the hardened foot rest that is normally meant to support 

their feet with shoes on, that sort of thing. So you get a chair that ends up being 

absolutely -- maybe too short. 

Or even a medium sized patient let alone a tall person that could be disabled. 

The other area I would like to address would be the area of podiatry chairs. 

Podiatry chairs typically are 3-power chairs/3-function chairs. They have a power up, 

power back and a power seat tilt. And they typically have an extendable foot rest to 

accommodate patients of various heights and so the access that is -- you're proposing 

the standard of accessing it from two places, that is from the long side and the short 

side, at least the short side access if it were to be that low would be a problem 

because they're going to be trying to shimmy up -- scoot themselves up on a seat that 

typically has a little bit of contour to it so that -- and that contour is put into the seat 

for patient comfort because they're sitting there and sometimes for long periods of 

times, so you put a -- as manufacturers, we put a little bit of tilt or cant to the seat or 

actually to the foot rest where it joins the seat. 
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I don't know if I'm being descriptive enough there or not, but basically you 

have the seat portion and then the foot rest portion and that foot rest portion is the 

area that usually extends, so that would present a problem for a disabled person to go 

up that 6 or 7-degree angle that is put into that sort of thing and it would also present 

a problem in the sense that the seat and leg rest combination is a fair -- it's a fair 

distance, even when it's all the way collapsed. It would be a ways to get to the arms 

for that person to help get themselves on the seat. 

And so those are just a couple of things that I would recommend that you 

consider in the type of equipment in getting that minimum dimension too low that 

would actually hinder the functionality of the chair or table to the patient and 

certainly to the operator. 

One more comment about a 17-inch height...there are some -- I'm not sure 

what you call them, but there are some limitations in how low you can get something 

and then how high you can get something, and still remain in the size envelope that 

would accommodate the lifts that you're speaking of also accommodate the physician 

or the nurse assistant in getting around the back of a table, so in getting so low, you 

may end up making it so that the practitioner has a difficult time getting the chair high 

enough or the table high enough to be able to functionally perform their examinations 

and over time it may lead to injuries to the medical staff. That's all I had. 

>>Gary Talbot: Thank you. 

>>Phillip Jenkins: I have a question. Phil Jenkins here. Thank you, Mr. 

Baker, right? Are there any of these chairs, you talked about ENT and the podiatry
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chairs, are there manufacturers - and you're one of them - do they ever allow them to 

detach the foot rests and remove them or --

>>Jeff Baker: No, they do not. They actually - promote the foot rest to fold 

up so that they can be accessed from the front of the chair. 

>>Phillip Jenkins: But not at that low height? 

>>Jeff Baker: But as you get the distance between the -- under the knee and 

the bottom of your foot closer, you can see that when the patient goes back and again 

that's only in a limited number of procedures. For instance, they have a balance 

procedure that they need a patient flat so they can drop the headrest rapidly. 

So typically the ENT examinations are -- and treatments are not done in the 

supine position. And so that doesn't enter into the situation. But when they do go 

back and they are at an angle that's all the way back, a tall person, if they are trying to 

keep their feet on this metal foot section, their knees are pointed way up in the air and 

depending on how tall they are, I mean, their knees -- their thighs could perhaps be at 

20 to 30-degree angle off of the seat. 

>>Gary Talbot: If I could ask a follow-up question. Gary Talbot, Public 

Member. Don't most of these have a vertical adjust where you can adjust that up 

vertically once they get on? 

>>Jeff Baker: Oh, yes, ENT chairs -- now, I'm speaking of the fixed distance 

between the seat and the foot rest. 

>>Gary Talbot: Sure. Sure. 
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>>Jeff Baker: So as the back lays down and the leg rest comes up and the 

foot rest flattens out, if that patient wants to keep their feet on that metal plate that 

they are -- that they were resting on originally, that causes their knees to rise so that --

I guess I -- in a written comment, we'll do a better job of showing what I'm talking 

about, but that's essentially -- yes. You can independently raise a patient up and 

down currently about 18 inches, so if I was a very tall doctor for instance and the 

entry height was cleared down at 17 inches, which may include in fact the nonexpanded -- or the expanded condition of the upholstery, that means that the substrate 

that I'm sitting on is even lower than that and perhaps if it's 2 inches of foam, maybe 

that's 15 inches, and so to get it up to say 40 inches, which might be the -- well, 

probably wouldn't be 40 inches. Probably 36 inches for me but some of the tallest 

doctors, you would have a very long excursion and currently there isn't any way of 

getting that much excursion out of a base like that within the confines of the size that 

a base has to be to be able to effect movement of the doctor or the nurse around the 

patient from the side and from the rear and also -- I lost my train of thought there, but 

--

>>Gary Talbot: It would be helpful if you provide that in your written 

comments. 

>>Jeff Baker: And, yes, we'll follow that up with some drawings, but I just 

would suggest that the board would consider those kinds of things that could be 

adversely affected on the patient's point of view and also the provider's point of view. 
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>>Gary Talbot: Great. Thank you very much. Anybody else? Thank you. 

Sure, come on up. 

Rosemary Ciotti, RN, MSN, CRNP, Accessible Living, Inc., Arlington, VA

>>Rosemary Ciotti: Hi. Just a couple of other things that I think are 

important. One is the visual field study apparatus that people -- that ophthalmologists 

and optometrists use. The current configuration is that you look into a scope and 

given something with a button on top when you see -- that you have to press -- if you 

see different things in your field of vision and then they get to evaluate the grid to see 

what you missed and what you didn't. But as you can tell the design of this is not an 

appropriate design for anybody who has any impairment of fine motor skills and so I 

would like to have people look at this and to at least consider the soft buttons that you 

often see that can be used by anybody, that can be activated either by a knuckle or 

anything -- now, if somebody has no use at all of their hands, I don't know if it can be 

adopted as a sip and puff, but this is something that is very important so that 

everybody can have field of vision exams but the current status eliminates a great 

many people from being able to be evaluated. 

The other thing that I would like to ask that you look at is on question 43, it 

talks about the unobstructed reach or side reach of 48 inches maximum high. And I 

would really like to see more evaluation of this because my patients, anybody with a 

high level of injury, neurologic degenerative disorders, muscular dystrophy, those 

kinds of thing, that's not a realistic reach range so I was hoping to bring it to your 
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attention that maybe you can take another look at that reach range and maybe there 

could be some further discussions about that. Thanks. 

>>Gary Talbot: Thank you very much. Any questions from the board? 

>>Phillip Jenkins: Yes, Rosemary - this is Phil Jenkins. You were talking 

about the button and other types of soft buttons, large buttons, perhaps even -- is there 

any insight you can give us on different solutions you may have seen? 

>>Rosemary Ciotti: Well, I think that if you can have -- there is a catalog of 

buttons for adaptive equipment, and that have very, very low pressure needed to 

activate them and they can also be plugged in like a USB port so that they can be 

brought to the patient wherever -- if they have very minimum ability to move, but 

they have a little bit, which take only the most minimal amount of -- at response to 

activate these buttons, so there is an entire catalog of buttons for adaptive equipment 

that I think is what we should be looking at. 

>>Phillip Jenkins: Would you expect the patient to bring that? 

>>Rosemary Ciotti: No. No. I think that -- I think it should be universal 

design. 

>>Phillip Jenkins: So like to plug in one of these --

>>Rosemary Ciotti: Right. I think it's something everybody could use instead 

of the hand held with the button. I don't see why one of these soft buttons can't be 

used by the masses. And so it's just one for everybody. And I would think that that 
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would get probably 99.9% of the population. These buttons have been so 

sophisticated. 

>>Gary Talbot: Thank you very much. Well, with that, I don't think -- oops. 

>>Rose Marie Bunales: Should I have the operator poll the listeners? 

>>Gary Talbot: Yeah, see if there's any -- yeah, go ahead, please. 

>>Rose Marie Bunales: Operator, would you poll the listeners to see if 

anybody is willing to testify. 

>>OPERATOR: If you would like to testify, please press star 1 on your 

touchtone phone. 

>>Rose Marie Bunales: Queue and unmute whenever you're ready. 

>>OPERATOR: At this time, no one has pressed star 1. 

>>Rose Marie Bunales: Okay. Thank you. 

>>Gary Talbot: Well, thank you again to everyone. We really appreciate 

your time. And before you leave, I'm going to ask Earlene to just talk about the 

advisory committee notice for a moment. 

>>Earlene Sesker: Okay. Again, thanks, everyone, for being here today and 

testifying. Just wanted to remind everyone that yesterday we did publish the advisory

committee notice, so we will be forming the advisory committee. We're accepting 

applications as we speak. So if any of you are interested and I know a few of you did 
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mention that you're open to continuing to help us, feel free to now put in your 

applications because we are starting to form that advisory committee. Thank you. 

>>Gary Talbot: Thank you again and thank you, board. 

>>Rose Marie Bunales: Operator, the public hearing is concluded. Please 

disconnect all lines. Thank you for your assistance. 

>>OPERATOR: Thank you for participating in today's conference. Please 

disconnect your lines at this time. 

END Public Hearing