**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 Bl ye Karen Braitmay er John Box Christopher Hart Phillip Jenkins Mat McCollough Neil Melick Howard Rosenblum Deborah R yan Nancy Starnes Gary Talbot Hans Van Winkle David Murph y, DOD Angela Scott, HHS
**CART PROVIDER:** Metro Reporters, Inc. 703.968.9796 **NOTE:** This text is being provided in a rough draft format. Communication Access Realtime Translation (CART) 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 CART Services Provided by : Metro Reporters

**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 Ph ys ical Medicine and Rehabilitation, University

of Pennsylvania 7. David Hausmann, CEO, Hausmann Industries 8. Joe I saacs, 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 Bucklan d, 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, every body . We'll give y ou a 5
- minute warning. We plan to st art in about five minutes, please.
>> I have a blank screen. But I don't think it's going to bring up an ything previously . You want to try again? Okay . Now, it's coming up.
>> Gary Talbot: Okay . Welcome, every body . Welcome to the Access Board's public hearing on medical diagnostic equipment standards. I'm the chair ofUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 3 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 y ou. Nancy Starnes, public member and to my right is...
>> John Box, public member.
>> Karen Braitmay er, public member.
>> Good morning. M y name is Mathew McCollough.
>> Phil Jenkins, public member.
>> Good morning. Regina Bl ye, public member.
>> Chri s Hart, public member.
>> David Murph y, federal liaison, DoD.
>> Gary Talbot: Well, thank you, every body , 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 every

body 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 t ime left over at the end and you would like to come back up and say

something, you certainl y can do that but we want to make sure we get every body through that does sign up and has something to say . So with that, we'll go ahead and get started and our fir st witness is L indsey Morris.
>> Earlene Sesker: Excuse me. Before we start, let me just go over briefl y 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 theUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 4 medical diagnostics equipment. And so we know that's wh y we're here today. and we wanted to let y ou know that for an yone that feels that you have more to say that y ou don't have that opportunity today , or based on something that y ou hear today that y ou 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 alread y m entioned, 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 an ything like that before we get started. Your transcripts and information will be held and will be part of the docket. If you had an y written comments or PowerPoint , please give them to the staff at the registration des k. Please refrain from reacting in public to an ything that our witnesses may say
or an ything that y ou may hear from the board and with that, now, as Gary said, we are read y to start.
Lindsay Morris, Senior Director , Government Relations, Medical Imag ing & Technology

Alliance (MITA)

>> Lindsay

Morris: Thank y ou. Great. Well, thank y ou so much for allowing me to testify . And speak to y ou 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 acutel y aware of.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 5 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 generall y. We very

much appreciate it and hope that we can be a good reso urce to share some of our technical expertise with regards to the equipment. As y ou 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 y ou 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 reall y can give a deep dive on that and make sure that you have all of that information and hopefull y 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 y ou do not have
e nforceability

of standards but we do take them very seriousl y. 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 th is will certainly

impact folks for time to come, so we certainl y 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 patient s and this also really include the people who
-- the technologists, the peopleUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 6 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 alway s there to help the patient, regardless of their issue of
-- an y issues of mobility , so it really is important t o note that no matter what the patient, this is complex machinery for the most part particularl y when you think of CT and MR, so we want to make sure that the patient is, both for their safet y and for the safet y 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 m entioned before, for instance, mammograph y 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 inter fere 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 reall y are a danger to the patients, the technologists and the equipment itself. As you may have
se en in previous testimony that was given on behalf of MITA, I think a picture wasUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 7 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 , y ou know, certainly acutel y aware of as we're assessing the draft standards that are out. Lastl y 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 reall y 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 reall y be able to use the full useful life of the equipment. In a lot of cases like Isaid with MR and CT equi pment, 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 y ou 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 y ou.

>> Gary Talbot: Great. Thank you very much. Thank y ou for y our testimony
.
>> Lindsay

Morris: Thank y ou.

>> 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.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 8 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 Midmar k 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 an d our customers are read y 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 achiev e 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 b y improving work flow in an exam room space in and around the patient. In a ddition 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 pro posed 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 theUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 9 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 d isability in the need for wheelchairs and scooters, the need for different t ypes of access for these ty pes of patients such as patients who are pregnant, bariatric, elderly , someone who has a recent foot surgery eve n struggles to get around so when we think about the accessibility

of these spaces, there's man y, 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 phy sical evaluation and perhaps some diagnostic testing. One example that's mentioned in the standard as support ser vices do get larger we have to consider the phy sician now as has to bend and reach during standard examinations in minor procedures. Using this example w e would need to be aware of others aro und this practice and around these work flow s and how they inter act 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/phy sician 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.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 10 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 supp ort themselves with confidence, especiall y on the table being raised in order to be examined properl y. 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. Ho w 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 actuall y 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 an y questions? Thank y ou, Jon. And next up is Carol Bradley . I apologize, I skipped out of order, and so I apologize, Carol.

Carol J. Bradley , J.D., D isability Access Officer, Sutter Health, Office of the General CounselUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 11 >> 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 quali ty and access. We're quite a diverse company
. We have relationships with nearl y 3500 ph ys icians and our Sutter medical network includes man y of California's top
- performing, highest
- qualit y 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 sy stem survey ed seven ty pes of medical and diagnostic equipment for accessibility

including beds, exam tables, procedure chairs, weight scales and ima ging 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 sy stem is developing policy solutions that support accessible services.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 12 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, therapeut ic 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 y ou for the opportunity to resp ectfully

highlight one gap we see in the proposed standard as well as a need we see, which is currentl y 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 phy sicall y accommodate the weight capacity of all patients it can expose bo th patients and providers to unsafe practices or substandard care. Our s ys tem 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.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 13 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 specialt y tables used for medical imaging, diagnostic and therapeutic procedures as well as infusion chairs and gurney s. Currentl y man y of these equipment t ypes do not meet the specified height criteria. We hope to see the standards increase equipment options available to serve all patients. Especiall y important to ensure the time line for health sy stems to comply with standards once adopted, that must be considered carefull y. 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 s ys tem has very carefully investigated the most accessible exam tables and purchased those, we hope that our s ys tem 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.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 14 We also would recommend that for big
- ticket equipment, the board and the Department of Justice wil l 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 co ncerned 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 respectfull y 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 yo u 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 an y 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 theUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 15 mark et. 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, y ou know, our societ y 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 capacit y.

>> Phillip Jenkins: Thank y ou.

>> Mathew McCollough: Good morning. M y name is Mat. You mentioned that we need to give the medical industry a time to catch up in term s of the equipment. What's the life span of the equipment, are we talking about 20 y ears, 40 ye ars? Like in my

mind in terms of with people with disabilities need this lift day
- to day , so we have to wait for the industry to take up what the needs of pe ople with disabilities and we're placed at such a disadvantage until they catch up. So could y ou 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 c ome up with a specific time line. I guess Iwould say in my comments Idistinguished sort of two approaches. One is recognizing that for those s ys tems that have been proactive and have gone ahead and purchased what is the best in the market to meet acces sibility while the standards
-- yo u 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 currentl y that meets the transfer surface dimensions that are specified in the standardsUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 16 and, y ou 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 probabl y we would have been pur chasing in other settings and we're making sure that we're purchasing those. In a situation where yo u' 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 proacti ve Ihope that the life of the equipment would be considered. And I guess m y second point was that for big
- ticket items, some of the bigger more expensive equipment that Ithink at this point
-- and
-- our sy stem has certainl y 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

my self, I'm well aware of that. But I think that, y ou know, we do have to consider the life of the equipment and what it will take. And I guess in our sy stem we tend to distinguish
-- I mean, where our position is y ou have to have a method for serving patients, so hopefully that's helpful. Thank y ou.

>> Mathew McCollough: Thank y ou.

>> Gary T albot: Thank you very

much. Our next witness is Rosemary Ciotti. Thank y ou. Welcome.

Rosemary

Ciotti, RN, MSN, CRNP, Accessible Living, Inc.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 17 >> Rosemary

Ciotti: Hi. Good morning to everybody . It's great to be here. I was here in 2010 and certainly y ou 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 wi ll 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 d iagnostic 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 . M y 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 th em 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 by passing 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 yo u look at this and the universal design, y ou will be doing more than what may be apparent as your mission goal. Hospitals and the medical system are made for able
bodied people. Ther e are many people with disabilities who are trained health careUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 18 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 y ou become disabled doesn't m atter if you're a nurse practitioner, a ph ys ician, 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 ha s nothing to do with the person's skills. So not only will yo u be providing life
- saving care b y making universal design the norm for people, yo u will now be also able to allow people to stay employ ed 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 usuall y 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 t ook it as questions when Iwent through what I felt that Icould be additive to today and I was going to start with question 11, are there t ypes of diagnostic equipment that cannot conform to certain technical criteria for access? And one such imaging m achine 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.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 19 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 yo u 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, y ou can't even get a Hoy er lift under it, so it makes even a Ho ye r 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 Iwould hope that y ou would seriously look at that. If in the meantime they

say they can't do that, m y 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 independentl y transfer on, but the common wisdom is this is what it is and it can't b e moved and yo u 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
s canners. 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 wideUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 20 variability

with some of the mid
- range scooter, wheelchairs and the scooters that seem to be much higher than they were a number of y ears 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, Ihope that that amount of deflection perm itted 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 st yl e 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 y ou 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 onl y have one more minute left then Iwant to spend it on mammography machines. The current state of mammograph y m achines 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 y ears 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.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 21 The person can be seated comfortabl y 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 yo u 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 bod y 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 Ihope that people can look at this and realize that we don't have to wo rry 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 Ithink my time is up. Thank y ou so much and I will submit the rest of my comments.

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

>> Regina Bl ye: Regina Blye, public member. You have a unique perspective because you're also a person with a disability and professional. You gave example s of the equipment that would be needed for someone needing the service, but can you give an example of barriers that y ou might have faced because you said y ou wereUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 22 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 Bl ye: I mean as far as you navigating.

>> Rosemary

Ciotti: Right. Ican't navigate because the tables are too high. They don't come down far enough. I'm very capable of doing a complete phy sical 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 an y experience with the necessity of padding though, like a quad pad or something for people who have to remain on a sur face for an extended period and may be have a lot of bony prominences?

>> Rosemary

Ciotti: Ithink this is important and I didn't know if this was the appropriate forum. We have a lot of preventable, serious wounds that happen particularl y in the cardia c lab where somebod y m ay have to be on their back for a good long time for a cardiac Cath and may be stents and this is where if somebody is to that point that they

have has cardiac insufficiencies, they may have hy pertensionUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 23 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 y ou have a stage 3 or 4 wound breakdown from somebody after a cardiac Cath, th at can certainl y 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 Hoy er lifts, if y ou can, the big problem we have with Hoy er lifts is that people don't know how to use them. Training is not mandatory

and they 're never there when you need them. Ihope when y ou come up with these regulations that there will be some standards of how man y 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 Ithink this would go a long way to helping people with disabilities who need Ho ye r lift transfer, to be able to have them and have them safel y. But right now there's no mandatory

training. We ask, please. But the joint accreditation for hospitals mandates oth er training and I really believe this is life and safet y.

>> Gary Talbot: Thank you very

much.

>> Rosemary

Ciotti: Thank y ou for indulging me and sorry for going over.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 24 June Kailes, MSW, Associate Director and Adjunct Associate Professor Western Un iversity

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 y ou hear me?

>> Gary Talbot: Y es, 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 mammograph y and the name of the project was mammograph y, 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 mammograph y 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.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 25 The practical was done cooperativel y 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 y ears 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 y ou reall y 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, i s 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 alread y 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, y es.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 26 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 latera l oblique view, the MLO, that patients in wheelchairs, when receptor is turned over, you are really hitting their stomach more than when y ou 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 t ypes of diagnostic equipment used by patients in a standing position? The answer is y es 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 b y the technologists was that there isn't a good model on the market that meets their needs so they don't reall y 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 b y 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 elderl y l adies, quote, unquote. So the detailed features they wanted to see in an auxiliary chair forUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 27 mammograph y included a chair with adjus table height, removable foot rest or those that flipped totally

out of the way , removable and adjustable armrests, a shorte r seat length that is an adjustable seat length hip to knee s 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 the ir 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 sup ports 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 especiall y true with more obese patients. Since the id eal 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 alway s adequate. So thank y ou for allowing me to dig deeper in these two areas and I'll submit the study as well as many , many , man y more comments. Thank you.

>> Gary Talbot: Thank you very

much, June. Does the board have an y questions? Thank y ou very much, June.

>> June Kailes: Okay . Thank y ou.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 28 Margaret Steinman , M.D., Professor of Phy sical Medicine and Rehabilitation, University

of Pennsylvania

>> Gary Talbot: Next witness is Margaret Stineman.

>> Rose Marie Bunales: Operator, locate Margaret Stineman and unmute when read y.

>> OPERATOR: Margaret Stineman, y our line is op en.

>> Margaret Stineman: Great. Can every body hear me?

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

>> Margaret Stineman: Good morning, every body . This is really

an amazing, exciting experience to hear every body 's comments so far. About me, I'm a phy sician. I have taken care of people with severe disabilities for two decades and also a person with disabilities my self and Iwent through some of y our 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 societ y 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 independentl y into a diagnostic device and this touches on an issue that was already raised and that is that we actuall y can't necessarily expect that all people withUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 29 disabilities will have the capacity to enter independently

so that the universal design reall y needs to facilitate assistance of a he lper and in terms of the dy namics, 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 y our concept of using anatomic landmarks for directin g the
-- I'm sorry , I wanted to talk about the possibility of actuall y extending these standards to include equipment that is used in treatment and there is one example that Ithink is very critical and that is the fact that when people get radiation for v arious types of cancer yo u need to use, landmarks to direct the position of the radiation equipment very accurately

so when y ou 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 ter

ms 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 isUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 30 expected, so I also went through some of your questions and I'll talk about some of them. First is question numbe r 23, which relates to the use of stirrups in various procedure chairs. And the example that was given, y our d yn amic 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 leg s that are going to have that procedure because a large proportion of people that need your d yn amic anal ys es are paral yz ed, are going to need to have that t ype of support in order to have the test. The next question that Ilooked at, I'm going to talk a bout 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 safet y. They

have basicall y 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 actuall y in a position where the person were to move o r 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 q uestion 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,US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 31 I think there needs to be a folding chair, a seat that could be provided with all of the concerns that June raised Icertainly 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 ab le to maintain the seated position. The next question will Italk about is 41 and I felt this was a reall y critical question that related to diagnostic equipment where communication instructions are required and the question was should y ou provide audib le, visible and tactile communication? And I think that is critical
-- did somebody want to say

something?

>> Regina Bl ye: No.

>> Margaret Stineman: Okay . I think that providing that kind of communication is critical. I've had man y patients, for example, who have hearing impairments who have been utterl y completel y 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 mat erials
-- so for example in the ideal world, I would love to see inside an MRImachine some t ype of a video device that could have t yped communication with the operator as well as sound activated as well as some ty pe 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.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 32 The final thing that I will say that I felt was reall y 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 d isabilities 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 ty pes of equipment in hospitals as well as training to use it w ith regard to people with different ty pes of disabilities. So that as yo u develop y our standards for the phy sical qualities of the equipment, please think about the human factors as well that would go along with the instructions and training programs. Th ank you.

>> Gary Talbot: Thank you very

much, Margaret. Does the board have an y 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 ye ar old plus US based manufacturer of medical and phy sical therap yUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 33 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 protot ype 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 y our reference, the CME Review article published in 1999, practical considerations and performance of phy sical examination of women with disabilities a uthored 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
a ccessible 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 ph ys icians' off ices that participate in the state's health y women partnership program. More than 60,000 women receive d breast and cervical screening annually through this program. As an innovator of wheelchair accessible products we have several concerns about the dir ection we see the guidelines moving towards. While we support overall objective we are concerned about overl y rigid specifications that, we feel are unnecessary

and pose an unfair hardship on us and potentially other manufacturers. Let me address in gene ral terms some of the relevant details in chapter M3, technicalUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 34 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 man y advantages over the co mpetition as this table has a linear actuator that delivers superior performance and product life. We offer a 3
- ye ar 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 regulatio ns 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 safet y rails that slide up to lock. These safet y 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 safet y rails are 18 inches wide and 10 inches above the work surface when elevated and locked in position. We su ggest that safet y rails, these safet y 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.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 35 P age 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 medi cal s ys tems ’ yellow fin stirrups are proprietary and very specialized. These stirrups may

be required for a limited number of disabled patients. They are generall y sold directly b y the manufacturer to the facility . Hence, this is best treated as an opti onal 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 considerabl y to the cost of each table. The surgical boot stirrups can be readily field installed should facilities need them. In concluding I strongl y urge you consider these modest suggestions to broaden the proposed guidelines and ensure the free market can continue to operate to best suppl y the needs of the disabled patients. We feel some of the guidelines may unfairl y 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 slightl y 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 negativel y impacted b y 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 y ou have been doing. Thank y ou.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 36 >> Gary Talbot: Thank you very

much. Does an ybody have an y questions? Thank y ou for y our testimony . Next witness is Linda Manning.

>> Rose Marie Bunales: Operator, do y ou have Linda Napolitano Manning on the line? I f so, unmute when read y.

>> OPERATOR: I don't show a L inda online.

Joe I saacs, Vice President for Public Policy , United Spinal Association

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

>> Joe I saacs: Good morning, every one.

>> Gary Talbot: Good morning.

>> Joe I saacs: I should say at the outset a disclaimer that I'm not a medical equipment expert, but Iplay one occasionally

on television.

>> On behalf of Americans with spinal cord injuries and disorders nationwide, the United Spinal Associ ation 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 sy ndrome, multiple sclerosis, amy otropic lateral sclerosis and spina bifida. We have more than 3 7,000 members and 62 chapters and supportUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 37 groups nationwide. I mention this because my brief remarks today

will focus on issues raised routinel y b y our members about their challenges in addressing medical equipment addressed b y 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 phy sical barriers, individuals with disabilities are not as likely as those with d isabilities 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 equipme nt. The most fr equent response s involved access to examination tables, dentist chairs, scales, and mammograph y and colonoscopy equipment. Tables and chairs are not adjustable for
eas y transfer. Create a huge barrier to individuals using wheelchairs or those of short st ature. If they

were not informed in advance to bring someone with them to help them transfer onto the furniture equipment, these patients we re often told at their appointment that they

could not be treated at that particular facility . Perhaps lacking lif ting equipment, having too few staff available and trained to move the patient safel y 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 dia gnostic 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 analy sis, anUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 38 important factor of the impact of ob esit y on a wide range of diseases and disorders and especially

when active exercise can often be generall y restricted due to paral ys is and other ph ys ical 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 an y 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, Hoy er 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
- e mphasized as well that the space within which such equipment is situated must be sufficient to accommodate the capacit y to reach the equipment by those requiring wheelchairs, powered mobility devices and other assistive technologies. Now I made my disclai mer earl y 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, attorney s, 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.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 39 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 b y our members and appl y 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 y ou that they stand read y and welcome the opportunity to assist the Access Board in an y way it can. Thank you for this opportunity
.
>> Gary Talbot: Thank you very

much, Joe. Does any

body have any questions?

>> Christopher Hart: Joe, hi. Chris Hart, public member. Do you have any data that would speak to supportin g the 17 height of requirement for transfer height? Because as y ou know it's a prett y ubiquitous height that we have used for years in all manner of rulemaking.

>> Joe Is aacs : Well, Iwould 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. Idon't know the answer about the data but I will certainly come back to the Acc ess 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 yo u. (Break)US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 40 >> Gary Talbot: Okay , if Icould ask every body to take their seats and for the board members to have their seats back up here. Thank y ou.

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 E qual Rights Center. For nearl y 30 years the Equal Rights Center has been fighting discriminations faced b y people with disabilities. With more than 4,000 members in every

state and the District of Columbia we have increasingly engaged in efforts which ar e 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 ye ars, specificall y with Washington Hospital Center, Ho ward University Hospital and ey e care centers of America. Most recentl y we conducted an extensive national research regarding the dearth of accessible healthcare service and we released a report, I ll
- prepared: health care's barriers for people with disabil ities. 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 officeUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 41 cannot utilize equipment , or lastly are denied reasonable accommodation. These barriers are not onl y 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 my self 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 h old 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, e xamination 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.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 42 Second, guidance should be provided on the need for varying position options for medical equipment. It is not acceptable for any specific ty

pe of diagnostic equipment to only

be available to those who can stand or those that can independentl y 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 independentl y transfer is crucial. In response to question 6 whether other terms in the proposed standard shou ld 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 b y h ealth 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 gener al 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 appl y to diagnostic equipment.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 43 Clarification regarding the lifts would be extremely helpful. First I want to reiterate Rosemary 's comment, the standard regarding how man y lifts are required in a facilit y would be very beneficial. While we understand that the Access Board is not the governing authorit y 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 defi nitions 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 happ y to answer an y questions at this time.

>> Gary Talbot: Thank you very

much. Does an ybody have an y questions? Well, thank y ou for your testimony
.
>> Kat Taylor: Thank y ou.

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

>> Gary Talbot: The next witness is Barbara Kornblau
.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 44 >> Barbara Kornblau: Good mor ning and thank you very

much for the opportunity

to speak before y ou 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 provi ders and disability service providers who advocate for health equit y for members of the cross
- disability community
. The second group is Access L iving , nationall y recognized leading force in disability , the disability

advocacy

community

that challenges s tereot ypes, 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 Am erican Public Health Association . And the dis ability 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 st andards 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 don e so far. Our concern is that as yo u develop these standards, that y ou consider the
-- our overall policy

concern that training people in the best practices of using the equipment is essential.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 45 I confess that I still need to find a teenager when I want to program m y VC R, but Iguess that's old fashion now. They 're called DVRs now
. And as an occupational therapist working in the clinics Iremember 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 tol d me 2000 something equipment. Why doesn't an yone 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 Hoy er 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 sh ould 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 use rs 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 Oly

mpics, 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 y ears earlier from preventable, treatable conditions like diabetes compared to p eople without disabilities. People with Autism may not get their blood pressure taken because theyUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 46 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 y our 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 som eone come with you to help with care or do transfers. Well, adjustable equipment is critically important to assure qualit y 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 full y effective. We recommend that the board consider the best practiceUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 47 principles set forth in an amendment to the Illinois Hospi tal L icensing Act that
accesses -- that Access Li ving in Chicago play ed 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 promo te choice, autonomy and dignit y 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 wi ll not require an y mechanical or manual lifting but a simple minimal assist/transfer and even those are often, y ou know, turned away from medical practices. All staff should be trained in the proper use of lifting equipment, including its location and c ondition. 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 devi ces? Where are the lift assists? May be, 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 properl y used, not relegated to a closet. Thank y ou very

much for the opportunity to speak today

and we will be submitting more detailed comments before the deadline. Thank you.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 48 >> Gary Talbot: Thank you very

much. Does an y member have a question? Thank y ou very

much.

Kelly B uckland, Executive Director, National Council on Independent Living

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

>> Kell y Buckland: Thank y ou and good morning. M y name is Kelly Buckland. I'm the executive director of the National Council on In dependent L iving
. 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 disabilit ies and statewide independent living councils and we're honored to be here today to testify on this. Although 22 ye ars after the passage of the Americans with Disabilities Act, y ou would think that this would have alread y 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 prev entative 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 JusticeUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 49 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 o f 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 g ood accessibility advice, he could alway s point to the ADA accessibility guidelines for the built environment but could only appl y what he knew, made up good accessibility to other features like imaging and diagnostic equipment for lack of specific guideli nes for that technology. His experience with decision makers and equipment, people at the facilities, is that if y ou 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 every body and benefit man y. The manufacturers need the guidance and input to prov ide those products that will be more usable by people with disabilities and thereb y 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 disab ilities to ensure that qualit y health care is available to every one. We at NCIL have heard loud and clear from our membership that access to diagnostic imaging and treatment equipment is a huge barrier, especiall y in ruralUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 50 settings. Man y NC IL members w ith 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 onl y wa y 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 beha lf 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 testimo ny

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. Igreatl y appreciate Kelly Buckland being here and I reall y appreciate th e fact that y ou emphasize that the manufacturers have to be more inclusive of folks with disabilities in terms of their equipment and my

comment is that Itrul y believe that the standards would address the fact that if folks
-- if more folks with disabilit ies 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 earl y, you will drive down the cost ofUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 51 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 Ithink that message that NCIL and other national disability organizations could reall y change the mindset that w ith the manufacturers, that really are worried about the bottom line of costs and equipment and having their doctors and their sy stems buy

the equipment saying that if y ou have more accessible equipment, y ou'll see a greater clientele over time, so I just wanted to say that openly
.
>> Kell y Buckland: Thank y ou, Mat. I completely agree and I think Ms. Kornblau's testimony

pointed that some reall y good examples of exactly how that could work.

>>Nancy Starnes: Nancy

Starnes, public member. Ijust want ed to ask, if y ou would hazard a guess, how many of y our members live in rural areas? Because y ou did bring up the issue that there may be a dditional 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 readil y.

>> Kell y Buckland: I wouldn't
-- Nancy , Iwouldn'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 alway s when y ou talk about rural stuff is Alaska. Alaska has a population of about 100 million
-- or Imean a million. Sorry . A million people.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 52 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 y ou 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 Y o rk, there's rural areas served b y 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: Ihave a question. Phil Jenkins, public member. You mentio ned the word more access to more people, those kinds of things. When y ou submit written comments, if y ou could tie those statements also to some of the se actual technical standards. We heard testimony today about 17 inches, 19 inches, 20 inches, if you c ould give us any input on how many

more would be accommodated or any issues y ou have seen when we get down to trying to decide between some of these real technical specifications. If you could do that, that would reall y help us.

>> Kell y Buckland : We w ill 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 provi de
- and he wanted to be here today to actuall y testify instead of me and he would have probabl y been much better at it, but he wasn't able to be here because of his work. He's actuall y working on a place, helping themUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 53 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 y ou.

>> Gary Talbot: Thank you very

much. An ybod y else? Want to thank you very much for y our testimony
.
>> Kell y Buckland: T hank y ou.

>> Gary Talbot: Rose? Are we gonna ... ?

>> Rose Marie Bunales: Sure
- Operator, one last call for Linda Napolitano Manning? Do y ou 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, L inda. Are you there?

>> Linda Manning: I'm here.

>> Gary Talbot: Go ahead.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 54 >> Linda Manning: Okay . Hi. My name is L inda Napolitano Manning. I'm from L ong Island, New York; I'm a disabled woman, Iuse a wheelchair and I'm unable to transfer m ys elf onto examination tables. First of all I want to thank y ou all for addressing this very , very important issue. It's been a problem that I've been concerned about and complaining about for many y ears. 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 k

now, they just don't seem to reall y understand how important this is. They

don't understand the accessibility . You know, when I go into an y kind of doctors office and the medical staff will say to me, do y ou need help? And I say , ye s, I need help in transferring. And they say no problem, we can help y ou. But they 're saying we can help y ou means we can hold on to y ou while you stand up and get on to the table. And of course I'm not able to stand at all. What Ijust wanted to talk about, y ou know, briefly
-- I'm talking from, you know, from a personal point of view...I wanted to speak about the examination tables, especiall y at gynecologist offices. I try to have an annual exam every ye ar -- you know, every

y ear, and for many

y ears 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 an y longer. So I do need a lift.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 55 I was n ot going to the gynecologist for a few ye ars because I had no way of being examined. So Ithought, well, may be if I go to a hospital, Iwent to a local hospital hoping that they

would be able to help me. Iwas wrong. They said that there was no way th at an ybod y could lift me. They wouldn't take the responsibility , and so Isaid, well, do y ou have a Ho ye r lift? No, we don't have a Ho yer lift and I was surprised. I said I can't believe that a hospital doesn't have a Hoy er lift. And they said well, even if we did have a Ho yer lift, we don't have the kind of exam tables that work well with Hoy er lifts. So Ihad 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 Iknow s ay

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, y ou know, such as MRI s and CAT scans and sonograms. So, y eah, we are neglecting our h ealth. 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 properl y and he did hurt me. So this is what Iwanted to talk about mainly from a personal point o f 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 any more and I'm so glad that yo u' re finall y addressing this. Thank y ou.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 56 >> Gary Talbot: Thank yo u very

much, Linda. Is there an y comments from the board? Thank y ou very much for y our comments?

>> Linda Manning: Thank y ou.

>> 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 testifie d earlier and needed to take a little bit more time, y ou'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 , Incorporate d in Salt Lake City , Utah , and first of all I didn't come with an y prepared comments, but wanted to just mostly listen to what was going on. And I do applaud y our 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 y ou'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 Idraw y our attention to say ENT chairs. ENT chairs are primaril y used in the upright position. They raise the patient up while they 're sitting up, do examinations, but there are some balanceUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 57 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 th e 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 ca lf 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
-- may

be too short. Or even a medium sized patient let alon e a tall person that could be disabled. The other area I would like to address would be the area of podiatry chairs. Podiatry chairs ty picall y are 3
- power chairs / 3
- function chairs. They have a power up, power back and a power seat tilt. And they t ypi cally 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 we re 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 ty picall y has a little bit of contour to it so that
-- and that contour is put into the seat for patient comfort because they're sitt ing there and sometimes for long periods of times, so y ou put a -- as manufacturers, we put a little bit of tilt or cant to the seat or actuall y to the foot rest where it joins the seat.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 58 I don't know if I'm being descriptive enough there or not, but bas ically y ou 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 way s 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 t ype of equipment in getting that minimum dimension too low that would actuall y hinder the functionality of the chair or table to the patient and certainl y to the operator. One more comment about a 17
- inch height...there are some
-- I'm not sure what y ou call them, but there are some limitations in how low y ou can get something and then how high you can get something , and still remain in the size envelope that would accommod ate the lifts that you're speaking of a lso accommodate the phy sician or the nurse assistant in getting around the back of a table, so in getting so low , y ou 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: Ihave a question. Phil Jenkins here. Thank y ou, Mr. Baker, right? Are there any of these chairs, y ou talked about ENT and the podiatryUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 59 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

actuall y - 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 yo u get the distance between the
-- under the knee and the bottom of y our foot closer, y ou can see that when the patient goes back and again that's onl y 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 rapid ly
. So ty picall y 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 verticall y once they

get on?

>> Jeff Baker: Oh, y es, ENT chairs
-- now, I'm speaking of the fixed distance between the seat and th e foot rest.

>> Gary Talbot: Sure. Sure.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 60 >> Jeff Baker: So as the back lay s 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 origin all y, 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
-- ye s. 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 non
expanded
-- 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, may be 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. Probabl y 36 inches for me but some of the tallest doctors, y ou would have a very long excursion and currentl y there isn't an y wa y 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 a lso
-- I lost m y train of thought there, but

--
>> Gary

Talbot: It would be helpful if y ou provide that in y our written comments.

>> Jeff Baker: And, y es, 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 adversel y affected on the patient's point of view and also the provider's point of view.US Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 61 >> Gary Talbot: Great. Thank you very much. Any

body else? Thank you. Sure, come on up.

Rosemary

Ciotti, RN, MSN, CRNP, Ac cessible 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 y ou see -- that y ou have to press
-- if you see different things in y our field of vision and then they get to evaluate the grid to see what y ou missed and what y ou didn't. But as y ou can tell the design of this is not an appropriate design for anybod y who has an y 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 an ybod y, that can be activated either by a knuckle or any thing
-- 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 every body 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 reall y like to see more evaluation of this because m y patients, an yb ody with a high level of injury , neurologic degenerative disorders, muscular dy strophy, those kinds of thing, that's not a realistic reach range so I was hoping to bring it to y ourUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 62 attention that may

be 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. An y questions from the board?

>> Phillip Jenkins: Yes, Rosemary
- this is Phil Jenkins. Y ou were talking about the button and other ty pes of soft buttons, large buttons, perhaps even
-- is there any insight y ou can give us on different solutions y ou may have seen?

>> Rosemary

Ciotti: Well, Ithink that if you can have
-- there is a catalo g 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 onl y the most minimal amount of
-- at response to activate these buttons, so there is an entire catalog of buttons for adaptive equipment that Ithink is what we should be looking at.

>> Phillip Jenkins: Would y ou 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. Ithink it's something every body could use instead of the hand held with the button. Idon'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 thatUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 63 would get probabl y 99.9% of the population. These buttons have been so sophisticated.

>> Gary Talbot: Thank you very

much. Well, with that, Idon't think
-- oops.

>> Rose Marie Bunales: Should Ihave the operator poll the listeners?

>> Gary Talbot: Yeah, see if there's any
-- ye ah, go ahead, please.

>> Rose Marie Bunales: Operator , would y ou poll the listeners to see if any body 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 y ou'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 every one. We reall y appreciate yo ur 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, every one, for being here today and testifying. Just wanted to remind every one 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 didUS Access Board Public Hearing March 14, 2012

Medical Diagnostic Equipment Standards NPRM Unofficial Transcripts Washington, DC Page 64 mention that you're open to continuing to help us, feel free to now put in yo ur applications because we are starting to form that advisory c ommittee. Thank y ou.

>> Gary Talbot: Thank you again and thank you, board.

>> Rose Marie Bunales: Operator, the public hearing is concluded. Please disconnect all lines. Thank y ou for y our assistance.

>> OPERATOR: Thank y ou for participating in today 's conference. Please disconnect your lines at this time.

END Public Hearing