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Medical Diagnostic Equipment NPRM May 8, 2012

Atlanta, GA Page 1 of 88

US Access Board Public Hearing

Tuesday, May 8, 2012

9:00 a.m. – 12:30 p.m.

Atlanta Hilton Hotel Ballroom

255 Courtland Street, NE

Atlanta, GA

Notice of Proposed Rulemaking on

Medical Diagnostic Equipment

Access Board Members Present:

Karen Braitmayer, Access Board Chair

Regina Blye

John G. Box

Edward Gee

Christopher Hart

Phillip Jenkins

Mat McCollough

Neil Melick

Howard Rosenblum

Deborah Ryan

Nancy Starnes

Gary L. Talbot, Medical Diagnostic 

Equipment Ad Hoc Committee Chair

Hans Van Winkle

Witnesses:

1. Joseph Drago, Vice President, Scale-Tronix Inc.

2. Pamela Dorwarth, Former Access Board member

3. Liz Persaud, Training and Outreach Coordinator, Tools for Life

4. Elisabeth George, Vice President Global Government Affairs, Regulations & 

Standards, Philips Healthcare; Medical Imaging and Technology Alliance 

(MITA); Chairperson, Technical and Regulatory Committee

5. John LaViola, Vice President-Engineering, Hologic, Inc.

6. Glenn Nygard, Director Engineering R&D, Skeletal Health Division, Hologic, 

Inc.

7. Ed Toerek, Director, Quality and Regulatory, CT/NM Imaging Systems, 

Philips Healthcare

8. John Jaeckle, Chief Regulatory Affairs Strategist, GE Healthcare
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9. Milind Dhamankar, M.D., Sr. Director, Product Marketing, Siemens Medical 

Solutions USA Inc.

10. Tony Roder, Regulatory Affairs Strategy Director, GE Healthcare

11. Shelly Simmons, Chair, Statewide Independent Living Council of Georgia

12. Carolyn Phillips, Director of the Georgia Assistive Technology Act Program, 

Tools for Life

13. Margo Waters, Independent Living Coordinator, disABILITY LINK

14. John Wells, Director of Marketing, Medical Products and Services, Midmark 

Corporation

>> KAREN BRAITMAYER: Now I'm pleased to turn the meeting over 

to my fellow board member, Gary Talbot. He has chaired the medical diagnostic 

equipment ad hoc committee since its inception two years ago and will be 

chairing today's hearing. 

>> GARY TALBOT: Thank you, madam chair. My name is Gary

Talbot, public member. Welcome to everyone. Thank you for coming today. 

This is the second of our public hearings on accessibility standards for medical 

diagnostic equipment. The first hearing was held on March 14th of this year, in 

Washington DC. We received a variety of comments. Before we get started with 

our hearing today, I'll ask all the other Board members present to introduce 

themselves, and starting with you, Regina, please. 

>> REGINA BLYE: Good morning. Regina, Blye, public member from 

Austin, Texas. 
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>> CHRISTOPHER HART: Good morning. Chris Hart, public member 

from Boston Massachusetts. 

>> JOHN BOX: John Box, public member from southern California. 

>> HOWARD ROSENBLUM: Good morning. My name is Howard 

Rosenblum from Silver Spring, Maryland. 

>> NEIL MELICK: I'm Neil Melick public member, West Palm Beach, 

Florida. 

>> GARY TALBOT: Gary Talbot, public member, currently 

Wilmington, Delaware. 

>> KAREN BRAITMAYER: Good Morning, I'm Karen Braitmayer, 

public member from Seattle, Washington. 

>> PHILLIP JENKINS: Hi there, this is Phil Jenkins, also a member of 

the Board that represents the public. That's what the term public member means 

for any of you that are new. We're appointed to represent you on this Board. 

There are other members of the board who represent agencies in the federal 

government, but most of us that are public members, are representing the public 
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on this board. And I'm from Austin, Texas as well. 

>> DEBORAH RYAN: Good Morning, Debra Ryan, public member 

from Boston. 

>> MATHEW MCCOLLOUGH: Good Morning, my name is Matt 

McCollough from Washington, DC. 

>> HANS VAN WINKLE: I'm Hans Van Winkle, public member from 

New Jersey. 

>> NANCY STARNES: Good Morning, Nancy Starnes, public member, 

Virginia. 

>> EDWARD GEE: Ed Gee, public member, Atlanta. 

>> GARY TALBOT: Well thank you to everybody. I'm going to turn it 

over now to Rex Pace from our Access Board staff. He'll briefly go over the 

hearing procedures for today and thank you again to everyone for coming. Rex. 

>> REX PACE: Okay. If we could turn on the PowerPoints. The 

PowerPoints will be shown on my screen to my right. If you're interested in 
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seeing any presentations today, bear that in mind. And again, this is the public 

hearing on the notice of proposed rulemaking to establish standards for accessible 

medical diagnostic equipment. And just to note the comment period closes on 

June 8th this year. Okay, here we go. If can you skip on to the third slide. Okay. 

So let's go to the hearing procedures. Registered speakers may speak for five 

minutes. I will give you a four minute warning. So you'll know -- where you are 

in the time. After all of registered speakers have presented, there will be an open 

mic session for others to testify. Please notify staff at the registration desk if you 

want to testify and have not preregistered. Also, please turn off or silence your 

cell phones. Next slide, please. And a transcript will be kept and entered into the 

docket as was for the first hearing we'll be doing one for this one too. Written 

remarks or PowerPoint shows should be given to the staff at the registration desk. 

And please refrain from reacting publicly to witness presentation or Board 

member comments or member statements. With that, I will turn it back over to 

Board member Mr. Talbot, and we'll proceed with the witnesses. 

>> GARY TALBOT: Thank you, Rex. Our first witness is Joseph Drago. 

>> JOSEPH DRAGO: Good morning. 

>> GARY TALBOT: Good Morning and if you could introduce yourself, 

please. 
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>> JOSEPH DRAGO: Sure. Good morning. I'm Joe Drago, I'm vice 

president with Scale-Tronix, and Scale-Tronix has been in business for 38 years. 

We're a digital electronic scale manufacturer, we're privately held with offices in 

New York City. And manufacturing still in the good old USA in Carol Stream, 

Illinois. The VA tells us that two out of every three digital electronic scales in 

acute care hospitals are manufactured by Scale-Tronix. We've been the leading 

manufacturer of digital electronic scales for quite some time. We've gone through 

several generations of our products. And we maintain a niche in medical 

weighing for acute care hospitals. Approximately five to eight years ago, we 

were involved with a number of consulting groups that were hired by major 

hospital firms primarily in California to adhere to ADA standards. And there 

were groups of scale manufacturers and other equipment manufacturers that were 

brought in, in order to standardize to best meet the needs of patients with special 

needs and also compliance with the ADA program. Consistently, when ScaleTronix has been in this kind of competitive situation, hospital systems have 

standardized on our products. I say products in the plural, not just the single --

not just the single item to do everything when it comes to assisting those people. 

We welcome the opportunity to comment today. We have applied for a position 

to be on the committee that serves later in the fall and we're awaiting notification 

to see if we've been accepted. We feel that the need exists for the right scale 

standards, and we want to make a further contribution to it. Everybody wants one 
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scale to do everything. They want one scale to do stretcher patients; they want 

one scale to weigh a thousand-pound patient. They want one scale to serve 

bariatric wheelchairs that are completely deep. They want one scale to do a spinal 

cord injury patient that might come into the facility. As a scale manufacturer, we 

could basically build anything, however, there are some limitations that your 

hospital members face on a day-to-day basis, and it's in this regard that I'll make 

some comments on the drawing that was submitted as far as the scale standards 

are concerned. That drawing, the first comment I'll make is that the 

recommendation was for 2-inch lip on ramps, and going up to the scale platform. 

To begin with, if you have a low profile platform to begin with, and your standard 

is going to be 2-inches or less on the profile itself, you're literally adding a patient 

safety concern by having a 2-inch lip on that ramp itself. Your diagram shows a 

patient walking up on to that platform. And from a patient safety standpoint, the 

2-inch lip would add to rather to than assist those types of patients. In a 

wheelchair setting, if a patient is up on to that platform, then when they go to exit 

that platform, they only have 2-inch profile in order to get down to floor level. If 

you add a 2-inch lip and somebody goes up onto that ramp, now you've got 4 

inches and you're increasing the possibility of tipping. So we politely suggest that 

a 2-inch lip should not be on there to begin with. As far as standards are 

concerned, rather than having one standard that does everything, perhaps there 

should be a stand-on scale standard, and perhaps there should be a wheelchairscale standard, and the next comment that I have is platform size. In the drawing, 
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we show a huge platform and we only show one access ramp. The reason why

that they have, I'm assuming one platform is once a wheelchair gets up there, they

need a radius to turn in order to get off that platform. We suggest two platforms, 

therefore limiting the size. Lastly, and there are several others, the suggestion for 

two handrails on the platform is well-founded, however, again from a patient 

safety standpoint, we suggest that if you had wheelchair standards and that patient 

needed the assistance of two handrails to walk up a long ramp, perhaps they

should be weighed instead of on a stand-on version of the scale, perhaps they

should sit in a four legged chair or to be in a wheelchair. So briefly, I know I 

have limited time, looking at the standards that have been put forward, there are --

there is no scale manufacturer that manufactures a piece of equipment that is so 

large it presents problems from the standpoint of transportation and equipment 

design. There is existing technology, flush mounted floor scales being one and a 

number of other products that are in our catalog. I speak of this generically, it's 

not only Scale-Tronics that would offer these products, but they're available. 

Thank you so much. 

>> GARY TALBOT: Thank you very much, Mr. Drago. Thank you for 

your comments. Our next witness is Patricia P -- I'm sorry. Pam Dorwarth, 

former Access Board member. And then Patricia will be next. 

>> PAMELA DORWATH: Thank you so much for the captioning. As a 
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former Board member, I'm so excited to see everybody. I can't contain myself. 

My comments are I'm an ADA liaison, have been for 19 years in the state of 

Florida. Besides other positions in Florida for people with disabilities and of 

course my past membership on the Board. I'm just going to make a few 

comments. The gentlemen that was just here has hit it on the nail. People with 

disabilities have different strengths, have different abilities, no matter -- you can't 

have a category or a dimension for just one person that has -- is in a wheelchair 

versus a walker, rollator like myself, which converts to a wheelchair. The 

complaint of people with disabilities hearing impaired, the blind, the deaf is again, 

the same thing, you can't have one scale. Everything judged on or say minimum, 

because guaranteed everybody is going to do just that minimum, and you have no 

longer met the needs of people with disabilities. And a couple of examples would 

be since my move after 28 years in Sarasota to the pan handle, they too don't even 

know what the Access Board is or Florida Access Board, which is devastating to 

the people. I live in a complex with 60 other people that have physical 

disabilities, including seven are deaf, and two that are blind. None of their needs 

are met, period. Because they're not even aware that they're required by law to 

make things accessible or even just a bit accessible for those people. We need to 

get the dimensions or your criteria, your stipulations more accommodating or 

adjustable so it can meet all those different -- I don't have the upper body strength

in this rollator chair than I did in my regular wheelchair. I'm starting to lose my

vision. So you can't judge a disability with limitations either, because every
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person's disability has different parameters. And I that was going to tell you, but I

left my notes with my son. Some personal examples of stories that happened. 

Again, like the gentleman said before, you go to move up to something and it 

turns out to be 4 inches versus 2-inches versus what it's really supposed to be, and 

you can't make it and nobody is there to help you. Don't ever assume that there's 

somebody there to help you. Because they are not. And you end up on the floor 

or else hurt more, whether it's a mammogram or whatever the testing happens to 

be. We need to have a different way of making your standards so that it has better 

realm of reach to meet greater quantity of people with different disabilities rather 

than a stipulation of a particular standard, because we're not meeting but a 

fraction of what we need to do. Like I said, I left my notes, but I'm so excited to 

see everybody. And I'm very grateful for the comments that the people are 

making. Because I will be inclusive in my reports back to the people that I report 

to as an ADA liaison. Because they come to me with their people with 

disabilities, all different disabilities, and say, why are they doing this to me? Are 

they so prejudice they don't care? That's not the case. And we're trying to get rid 

of that and make the whole country and everything else more accessible for 

everybody. Thank you and it's so great to see you all. Thank you. 

>> GARY TALBOT: Thank you so much, Pamela. Anybody have 

questions for Pam? Any board members? 
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>> PHILLIP JENKINS: I do, Gary, thank you. Phil Jenkins. Hi, Pam. I 

have a question regarding the various needs. As you know, on the Board we are 

tasked to find these different standards. 

>> PAMELA DORWATH: Exactly. 

>> PHILLIP JENKINS: If we take the example of the scale, and I'll 

probably have the same question for Mr. Drago. Should we have three standards 

for three different scales? Should we have four? Should we have five? 

>> PAMELA DORWARTH: I think you need to have a range, also with 

that range, have whatever the limitations happens to be for that particular 

disability. It can't be so definitive. It can't be so just saying like we say

minimum; I guarantee the manufacturers are going to have that minimum. But 

that doesn't meet the needs of all the different -- you need to have a range or an 

adjustable change. 

>> PHILLIP JENKINS: We appreciate your input on what those ranges 

should be, and -- 

>> PAMELA DORWARTH: Yeah. I also put in for the advisory board 

so that -- because I'm out there and I have the disabilities. I'm hearing impaired 
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and epilepsy. Please don't do any flashing for people that are hearing impaired, 

because you'll give me seizure. Thank you very much. All those different things 

that I have personally experienced or brought to me by other people with 

disabilities to add to the input. So I appreciate the question. Yes. 

>> GARY TALBOT: Thank you very much, Pam. And our next witness 

is Patricia Puckett and next on deck is Liz Persaud. Thank you, Rex. Patricia 

Puckett? 

>> REGINA BLYE: She's here. She's coming around the corner. She's 

here. 

>> GARY TALBOT: Good. 

>> PATRICIA PUCKETT: Thank you very much. Actually, my board 

chair, Simmons is going to provide the testimony for today, but she hasn't arrived 

yet, and so if we could bump us to later, will that work? 

>> GARY TALBOT: Yeah. That's fine. Thank you very much. Next up 

is Ms. Liz Persaud. 

>> GARY TALBOT: While we're getting set up, the next person will be 
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Elizabeth George. 

>> LIZ PERSAUD: Good morning. I'm Liz Persaud. I'm with the 

Georgia Institute of Technology Tools for Life Program, which is the Assistive 

Technology Act Program of Georgia. It's an honor to be here before you today to 

give testimony in regards to my personal experience when it comes to overcoming

barriers to medical equipment. Just to give a brief background on my medical 

diagnosis, at the age of nine months I was diagnosed with a form of muscular 

dystrophy, called spinal musculature atrophy type II. SMA type two is a 

progressive neuromuscular, neurodegenerative disease, that’s a mouthful. It 

manifests in two specific ways for me. When I was born, I had a curvature of my

spine, which I had a spinal fusion to correct that when I was nine years old. It 

does progress in long-term progressive muscle weakness. Every day the ways it 

affects me is through muscle and joint pain, muscle fatigue, and I'm also 

physically dependent on others for assistance with transferring, bathing, dressing, 

eating and transportation. As somebody with a disability, I'm no stranger to the 

medical community. And over the years of visiting doctors, offices and going 

through the emergency room and having numerous medical procedures done, I've 

realized there are two main barriers I encounter frequently, those are accessibility

and attitudinal. So up here on the slide, I have two photos that briefly describe 

some of the accessibility barriers I encounter. On the top left-hand side is a 

picture of me checking in at my doctor's office. In the photo, most of you can see 
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that the counter to check in actually comes up to pretty much my chin, my nose 

level. Which makes it nearly impossible or impossible for me to sign in, to 

exchange insurance cards, ID, and to interact with the medical staff. The good 

thing, the flip side of that is that when I check out of the office, they have a lower 

counter, which kind of makes me giggle a little, because I think, why isn't that a 

standard that all the counters, no matter where you are accessing in the doctor's 

office, you can just access in different various levels. The next thing I encounter 

just as I'm going through my appointment for the day is the scale to get weighed. 

I can't tell you the last time that I actually got weighed at a doctor's appointment. 

I guess I'm on any given day whatever I feel like weighing is what I tell them 

when they asked me how much do I weigh. The next thing is the exam room 

table. That's something that it's been years and years since I was a little girl that 

I've been on an exam room table. The next photo underneath the photo that I just 

described is a picture of the exam room table and my doctor's office. It's a small 

table, like most other exam room tables, but it's cramped in the corner. As you 

can see on the right-hand side, there's the edge of the counter that has all the 

medical supplies, and there's no room for me to maneuver. Basic procedures, like 

getting a mammogram or getting an x-ray, or a gynecological exam, all of those 

are nearly impossible, extremely uncomfortable, very painful. Most of my exams 

are actually done in my wheelchair, which I feel safer that way, but at the same 

time, I feel like that isn't something that should be done. Am I actually getting the 

same treatment as other patients without disabilities? Up here I have a photo of 
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my wheelchair without me in it. There's a white sheet that's actually made out of 

a thicker material that's spread across the seat of my wheelchair along the back of 

my wheelchair. And that's a transfer sheet that my mom actually made for me 

many years ago. It's something that I use when I transfer in and out of the 

wheelchair, when I'm going to the doctor's appointments that a lift isn't available 

and that's something that I have to use. Luckily I'm prepared in advance to have 

that available. So the other thing I wanted to address quickly is the attitudinal 

barriers I encounter. We know in the disability community that attitudes are the 

real disability. I truly don't think about my disability until I encounter somewhere 

that I cannot access or until someone focuses on my weaknesses or the things that 

I can't do. When I'm at the doctor's office, I just want equal treatment. I don't 

want that unbelievable focus on my life expectancy, how much longer do I have 

left to live. Oftentimes I'm even denied tests in a very casual manner, "Oh we 

can't transfer you to this table. Well, you're young, you're okay, so you'll be okay, 

we'll take care of that 20 or 30 years down the road when we need to." A few 

recommendations I have for you all that I think are extremely important. As I

mentioned earlier, just having all the counters, check-in, check-out counters, they

should be crenellated - alternating heights to accommodate wheelchair and 

various other needs. More space in the exam room. It gets cramped when you 

have a power wheelchair, your attendant, the doctor, nurse, exam table, chairs and 

all the other equipment that needs to be in there. And accessible exam tables and 

diagnostic machines are prevalent. What would it like if I or other women that 
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are in wheelchairs got mammograms but they were laying down and more 

comfortable? Is that a possibility, I don't know, but maybe it's something worth 

looking into. And then definitely, disability awareness training just to freshen up 

on the interaction and getting those basics down. One thing that I've had 

conversations with folks about, which I would suggest is maybe something to 

look into in the future, is accessible workout equipment. Because we're all about, 

in our society, about preventing measures to even be at the doctor in the first 

place, and taking medication. So, what would it look like if workout equipment 

was accessible, so people who utilize wheelchairs and or other various mobility

devices could access it, be comfortable and be in the gym working alongside other 

folks without disabilities, something to think about. I appreciate your time and 

thank you for listening. 

>> GARY TALBOT: Thank you very much, Liz. That was really good. 

I think there's many of us that really appreciate what you said, and concur. Any 

questions? Regina? 

>> REGINA BLYE: Hi, Regina Blye, public member. You mentioned 

the medical tables, could you give me an idea of what would work for you as far 

as height, width, I know everyone's disability is different, but this would kind of 

give us an idea of what would accommodate you. 
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>> LIZ PERSAUD: Exactly. The nature of my disability now is I do not 

transfer without a Hoyer lift or some type of transfer lift. Oftentimes, when I'm 

getting out of my wheelchair on the bed, even when I travel to hotels, I have to 

make sure that there is clearance underneath the bed so that the legs of the lift can 

go underneath. The same thing would have to happen for an exam table or some

surface I'm transferring onto is that I'm able to suspend over the platform and to 

easily roll that lift to that surface. 

>> REGINA BLYE: Thank you. 

>> GARY TALBOT: Any other questions from the Board members? 

Boy, Liz, thank you very much, we appreciate it. Thank You. 

>> LIZ PERSAUD: Thank you. Thank you for the time. 

>> GARY TALBOT: Elizabeth George. And then next on deck, I'm 

sorry, is John Laviola. John, you're next. [Laughter]. 

>> ELISABETH GEORGE: He knows. Good morning. Vice Chair 

Braitmayer, Access Board, and everyone here today. My name is Elizabeth 

George, it's E-L-I-S-A-B-E-T-H and the last name is George, G-E-O-R-G-E. I'm 

the Vice President of Global Government Affairs, Regulations, and Standards for 
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Phillips, based in Massachusetts. Would like to thank you for your invitation 

today to present on behalf of medical imaging device manufacturers which are 

represented by Medical Imaging and Technology Alliance, MITA. It is an honor 

to be here to speak on this important issue on ensuring appropriate access to 

medical diagnostic equipment for persons with disabilities. MITA knows that 

without accessible medical equipment, individuals with disabilities may not have 

equal access to quality medical care. I have bio-electrical engineering bachelor's 

of science, and engineering management masters in science, I've worked in the 

medical device arena for more than 30 years and in medical devices regulations 

for more than 20 years. First, we want to point out the issue of accessibility, both 

for patients and operators of the equipment has long been and continues to be a 

primary concern of the companies that MITA represents. We appreciate the work 

that the Access Board has done and shortly you'll hear from some of my 

colleagues on a more in-depth technical analysis of the impact of the proposed 

standards on various medical imaging modalities, including x-ray imaging, 

computed tomography, diagnostic ultrasound, nuclear medicine imaging, and 

magnetic resonance, which are primarily used for diagnostic purposes; which are 

primarily used in the screening for common diseases, which relies on early 

detection to ensure the most beneficial outcomes. I would like to share a personal 

standpoint. Having been a primary care provider for a number of years for my

mother after she had a stroke that left her paralyzed, I personally helped her 

access an MR scanner when she required an MRI exam. With my support, as 
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well as the clinician's guidance, we ensured that she was placed properly on the 

table to ensure the shortest possible exam time with the most effective image 

quality results. It is important to realize that the role of that physician and the 

technologists play is quite important in positioning. Hospitals are under legal 

constraints with respect to radiological equipment and are extensively involved in 

internally training their employees as well. Second, while the Access Board has 

pointed out that it does not have enforceability authority for the proposed 

standards, MITA members take them very seriously. Further, we are aware that 

the Department of Justice is closely monitoring the development of these 

proposed standards and is poised to move forward as an enforcement mechanism 

using their authority under the Americans with Disabilities Act. We respectfully

request that coordination on all levels with all stakeholders manufacturers --

excuse me -- users, patient advocates, the FDA and hospital administrators needs 

to occur to ensure access to imaging equipment for all users. Third, it is 

important to note that all the diagnostic imaging equipment that our member 

companies manufacture are subject to the U.S. Federal Code of Regulations. 

These devices are developed, manufactured and distributed subject to quality 

systems requirements. These requirements define the requirements for design, 

verification, validation. It is important to know that for each of these new 

designs, we must submit a 510K clearance to market these devices, the process 

requires us to assess whether these requirements are safe and effective for these 

changes. The imaging equipment offer many features to ensure accessibility for 
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patients. We are required to utilize recognized standards, including the 

ANSI/AAMI Human Factors Engineering Standard, as well as International 

Medical Device Risk Management Standard. Our manufacturers have sought to 

improve the picture clarity, application, dose management and overall 

supplication to support human factors of these life saving devices while at the 

same time, ensuring that the equipment is accessible for the full range of patients 

in need of this equipment. Likewise, they've also made great strides in ensuring 

that the equipment accommodates the needs of the healthcare workers who 

position the patients and guide testing so as to reduce their risk in workplace 

injury. As previously stated, my colleagues will discuss current accessibility

features of the screening and diagnostic services, as well as potential opportunity

for modifications. I would like to share a quick example. For example, if we had 

to modify the height of a table for an MRI machine, the things we need to take 

into consideration include the impact to installation, technical feasibility, physical 

ability to enter and move through the opening in the device, the image quality and 

overall reliability and safety of the device. When we do these design changes, it 

is required that we develop a design history file and make this assessment for its 

safety and efficacy of the device and ensure it has not changed. Things we take 

into consideration include customer input, new regulations and standards, cost 

reduction efforts, as well as potentially new applications. Lastly, in the Access 

Board notice of proposed rulemaking, you note that there are maybe an economic 

benefit to some manufacturers in the finalization of these standards. As stated at 
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the outset, we want to emphasize that our goal has been and continues to be to 

ensure access to screening and diagnostic equipment for all patients. 

Concurrently, our member companies want to ensure that those customers who 

purchase their products are ensured the ability to continue to use their equipment 

for its full useful life due to the extensive capital investment. We would like to 

thank you for this time and consideration and look forward to working with you 

going forward. We're now going to transition into the modality specific 

presentations, with a very brief overview of our ultrasound devices, these devices 

are completely portable and not patient operated. Therefore, this is a device that 

already enables unrestricted access and enables access per the proposed 

rulemaking. A variety of tables that could be utilized with the equipment are 

stand alone and not a part of the ultrasound equipment. Now we would be 

moving on to the mammography devices. 

>> GARY TALBOT: Thank you very much, Elisabeth. Thank you for 

your comments. Questions from the Board members? One down there on the 

right. Please go ahead. 

>> NANCY STARNES: Nancy Starnes, public member. I know you say

that you get input from people who are going to be using -- people with 

disabilities who may be using these devices. How formal is that process? Is it 

only provide input sporadically when you consider a new design, or is this an on-
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going input source for you? 

>> ELISABETH GEORGE: There are multiple aspects of this per our 

quality system regulations that the FDA has imposed on us. As part of a new 

design process we actually actively go out and seek communication with the -- all 

of the stakeholders, so users, the patient population, we collect those inputs as part 

of our design process. We also get on-going continued input throughout the 

process from patients, from clinicians on the quality, on its ease of use, et cetera. 

Those are all design inputs into our product so we're doing continual design 

improvements on our devices. 

>> NANCY STARNES: Thank you very much. 

>> GARY TALBOT: Thank you, Nancy. Any other questions from the 

Board? 

>> PHILLIP JENKINS: Hi. Phil Jenkins, one other question. Elisabeth, 

thanks for your comments. You mentioned a number of different US Federal 

Codes and Regulations, the 510K process, we would appreciate in your input if 

you'd give us the list of those things that you need to adhere to and specifically if 

there's any perceived conflicts between the proposed regs and some of the safety 

regs or help us understand where you see the difficulty in meeting both. 
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>> ELISABETH GEORGE: Certainly we'll make sure to include that in 

the inputs. 

>> GARY TALBOT: Thank you. 

>> GARY TALBOT: John Laviola please, and next up is Glenn Nygard. 

>> JOHN LAVIOLA: I'm John Laviola, I'm here with the MITA group, 

but I'm Vice President of Engineering for Hologic, Inc. We're a company 

dedicated to women's health. I'm here to speak about the mammography segment. 

I want to start by saying that we are certainly committed to provide accessibility

for all patients undergoing a mammogram. I speak for Hologic directly, but I

know, amongst our peers, we're very passionate about women's health and 

particularly mammography. That's something that has a lot of visibility in our 

day-to-day lives, thankfully over the last 20 years there's a lot of awareness, and 

certainly something that we live as associates of Hologic and I know my peers 

feel the same from their competitive businesses. We do have regulatory

requirements that we just spoke about that appropriately assess human factors and 

accessibility, but, to date there are no comprehensive accessibility standards 

unfortunately for our products. Accordingly, MITA is eager and honestly I think 

very excited to engage in collaborating with the Access Board and establish 
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appropriate accessibility standards. This slide I put a couple examples of current 

designs from major manufacturers. You can note -- I'm not sure if I can reach 

with my laser pointer, or if it works. But you can note along the C-arm we'll talk 

about standing supports, and knee and toe clearance, et cetera. I wanted to point 

out there are some handles for immobilizing and positioning the patient along the 

C arm. The C arm is what we call the structure that travels between the x-ray

source and the detector, as you can see in the picture. And also note there's a 

vertical adjustment of that C arm to accommodate various patients, whether 

they're standing or seated. And to Liz's point, there actually, I didn’t have it in my

notes here, but there actually is what we call a decubitus table, a table provided 

for mammography so women can lie down. There's an opening, too, that wraps 

around the detector so a woman could potentially be in a position where they're 

not prone or supine, but laying down, decubitus, to use the medical term. There is 

no compromise to image quality and no compromise to care. Specific questions 

were asked in the proposed requirements. And the rest of my slides really address 

some key areas, we couldn't address them all. But areas that we're most 

concerned about or we think there needs to be some clarification, or where there 

are some ambiguities, are the breast platform definition, the knee and toe 

clearance, and the standing supports. The breast platform requirements in 

particular, there's a specific question about the minimum height of the platform. 

The clause in the proposed standard suggests that 30-inch minimum. In our 

experience, this is not typical in the Hologic products or our competitors' 
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products; we typically provide a minimum height as low as 25 inches. This is 

based on customer feedback to provide a lower C arm to get more flexible 

accessibility. This is a good example I believe of how MITA and representative 

companies can engage the Access Board and help you craft meaningful 

accessibility requirements. Knee and toe clearance, in clause M303.2.4 -- that 

makes some assumptions that we also need to review. They talk about an 

absolute 25-inch specification for platform depth and with clearance to the floor. 

They don't necessarily anticipate typically good design of gantries and other 

system dependencies, such as how much breast platform depth and knee clearance 

you get at various heights of the breast platform. One example is that clearance 

that goes straight to the floor. This particular system would not be compliant, 

because of this small lip that you can see. It can be provided. That lip is 

important for the structural stability of the device, for seismic structural strength 

and also for -- to make it safe when installing. These are rather heavy devices, 

before they're bolted to the floor, they have to be positioned, and without that lip, 

there could be some danger of it tipping. So again, I think we can work with the 

Access Board to help clarify these sorts of requirements and make sure that we 

can come up with a standard that works. Another area is the standing support. 

Standing support features clause, in M305.3.2. derive the standing support 

features from architectural guidance for accessible bathing fixtures. Now, the 

supports identified on the mammography system were never intended for 

someone to lift themselves up for positioning. They really were intended to 
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immobilize the patient, position the patient's arm, keep their arms out of the x-ray

field while they're imaging the breast. And you can see in this example here there 

also is in that standard are some recommendations about the height. You can see 

that the standing support needs to be positioned relative to the breast height and 

the gripping surface so the arm can be appropriately supported and be held out of 

the way. Moving quickly, because I'm running out of time. Another area I think 

we can help in collaborate and developing more meaningful standards, we talked 

in all the pictures, you saw a woman getting a mammogram in this top down 

orientation only. Part of standard screening mammography is also do a rotated 

view. You can see that in a rotated view in a wheelchair, this can become even 

more difficult. That's not to say that in some wheelchairs provide clear access to 

believe able to do this, but there are some that have particular structures in place 

that would make this difficult. We can help out in establishing this as well. 

Again, we want to collaborate on particularly on diagnostic views and 

interventional view, and all the potential modalities our devices are used for. 

There was a specific question about design cycles, and design cycles typically for 

this type of equipment; capital equipment would be multi-year programs. So if 

changes were to be implemented [inaudible], it would typically be a multi-year 

type effort in light of Liz's earlier comments about what it takes to get something 

through the FDA. So. Moving forward. We certainly want to engage the Access 

Board. We think this is very meaningful work, and we think we can provide a lot 

of input and technical information to support your work. And, I just want to let 
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you know we did early homework on this. I recently attended an international 

Committee on Mammography Safety and Performance, MT31, and handed out a 

spreadsheet of all your clauses so we can collect data from Siemens and Hologic, 

and from all the representatives that were there, GE and others, to get information 

so we could provide it to the Board so you can get an idea of what all the 

worldwide manufacturers have in terms of geometry complications and such. 

Sorry if I spoke too quickly. 

>> GARY TALBOT: Alright, thank you very much, John. If I could ask 

a quick question. Just so I understand, and I think the plate you were talking 

about, on the one picture where you were talking about the toe clearance, and you 

needed the piece on the front of the device to come out like it did for seismic, was 

the point that because the plate comes out far enough you really don't need the toe 

clearance? Is that what you are that saying? 

>> JOHN LAVIOLA: Well, this might be our interpretation of the 

standard, was that you needed to have clearance under the breast platform straight 

to the floor and there could be nothing in its way. And that small plate lip, which 

doesn't appear to, at least in this picture, doesn't appear to create a restriction, 

wouldn't, in our interpretation of the clause, violate that. Is that right? 

>> GARY TALBOT: Okay, thank you. I appreciate it. 
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>> JOHN LAVIOLA: It's a small part. 

>> GARY TALBOT: Thank you. Any other questions from the board 

members? Matt. 

>> MATHEW MCCOLLOUGH: Mat McCollough, public member. Sir, 

I'm from DC and DC has the highest mortality rate among women with breast 

cancer. My concern from the disability community is for women that have severe 

neuromuscular type of disabilities. The types of photos that you've shown were 

people that were able to sit up straight, stabilized and so forth. But for folks that 

have severe neuromuscular disabilities, will not getting diagnosed in that case. So 

my question is, are there technologies that could have gone beyond the typical 

stationary breast machine system that wouldn't require a woman or a gentleman, 

that will have to really be still, and be in such a position that would require an 

accurate reading per se? 

>> JOHN LAVIOLA: Let me make sure I understand. I want to make 

sure I understand your assumption. You can be seated, or as I was saying earlier, 

laying down. You’re concerned about motion? About a person in motion?

>> MATHEW MCCOLLOUGH: Yeah. Well, let's take people with 
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disabilities, let's talk about senior citizens that their bodies break down and so 

they may not have total control or over their body function per se. In that case, 

my concern is still the same tendency of senior citizens of getting proper 

diagnostic readings per se. And so until the actual technology ... has the 

technology caught up where it could possibly include people with neuromuscular 

disabilities that can't control shaking, per se during the process? 

>> JOHN LAVIOLA: I understand. Mammography probably has 

unfortunately possibly, I will apologize to all women, because of the 

immobilization of the breast, probably is least likely to have some of the issues 

you're talking about, because the breast is immobilized. I mean, any motion, 

potentially is going to cause motion artifact. You don't want tissue to be moving; 

we're essentially taking a photograph. If anybody has had that experience with a 

camera with fast motion. So, things that we do do, I don't necessarily design 

around the table here, but things we do do, is try to shorten exposure times to an 

absolute minimum so that we can accommodate subtle motion without 

compromising image quality. I know this is difficult with some of the other 

modalities, but this is something, again my point earlier, is it would be good for us 

to collaborate on understanding how we might be able to solve some of these 

challenges. 

>> MATHEW MCCOLLOUGH: Thank you. 
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>> GARY TALBOT: Thank you. Any other questions from the Board? 

Thank you very much, John, we appreciate it. 

>> JOHN LAVIOLA: Thank you. 

>> GARY TALBOT: Next is Glenn Nygard. And next up after Glenn is 

John Jaeckle. 

>> GLENN NYGARD: Hello, my name is Glenn N-Y-G-A-R-D. I work 

for Hologic Corporation in Massachusetts. And, the systems I'm here to talk 

about, the technology is called DEXA, but something we all are familiar with, it's 

bone mineral density scanning for osteoporosis assessment. These scanners are 

very important for treating a devastating disease, and is particularly bad for 

people who cannot perform a weight bearing exercise. The reason for DEXA, it's 

a simple abbreviation - and I'll explain it why it's in this use, universal. It is dual 

energy x-ray absorbtiometry. And it was previously abbreviated DEXA; the 

modern is just DXA. But, that is a bone mineral density scanning technology

using dual energy x-ray. The most important thing is here representing DXA as 

being part of MITA is very important to us. We would like to best understand 

these rules as they're being developed and to provide our input but also to hear 

and better understand the needs of all patients for access to this essential 
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equipment. The area we're most focused is on the diagnostic quality and safety. 

But beyond that, having a safe, dignified exam is important to us across the board. 

So while I represent the DXA industry, I work for one of the major companies, 

Hologic, the other companies have the same motivations, good intention. There 

are other applications; I'll leave that for the readers of the slide. I think we're 

really here to talk about osteoporosis assessment as the main function of this 

equipment. This is an interesting picture that shows a couple of things that are 

important. These are two competitive systems: the one on the left, I believe, has a 

28 table height; the one on the right has a 25-inch table height. If you look at the 

system on the left, you can see there's a very large mass beneath the patient. That 

is a motion control system. It's a very large x-ray system. The x-ray also has 

moving filtration elements as well as beam forming. All that rides on a carriage 

which fits below a structure, which holds a pad on which the patient sits during 

the exam. That same type of equipment can be seen in the system on the right, 

but you can't see through it because of its closed design. The other feature of the 

equipment that's kind of standard is called the C arm. You can see the C that's 

over the patient. That arm can be moved with a motion control system down to 

the end of the table to facilitate the patient getting on to or off of the table. The 

other take-away from this is that the tables have to be one piece and have to be 

radio transparent. They have to pass x-rays in a uniform way, because these 

systems, they don't know if we're looking a bone or an artifact at the table. The 

most important function they do is quantify bone mineral density. But, our 
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inability to break the table, or to section it in some way that would allow parts of 

it to - I'll make things up - tip down or become a lift, that's a big challenge for 

something that has to be one piece and pass x-rays in such a way that they all get 

to the patient. Continuing on, the patient height of 25 inches or more may require 

transfer assistance. I mentioned the C arm can move. There is also in the third 

bullet, a floor arm scan which can be done for patient whose cannot get on to the 

table. There's a picture of that scan here. I can say that what will work is 

probably a scan that is used much less frequently than hip and spine scans for this 

diagnosis. The other thing that's important is these exams have to be performed 

on a regular basis. There are treatments for this disease, and all the treatments 

come with complications, so there are a set of guidelines, give too much, not give 

enough, but monitor. Typically you're monitored once a year to see if your 

treatment profile is working or not harming you, more importantly. The question 

was asked, what other barriers may exist to this equipment, and I think as had 

been mentioned previously, room planning is very important. If in order to 

reduce the apparent table height for the user, we would like to perhaps have a 

ramp, if room ramps were standardized; it would be a lot easier for patients to get 

on to and off the equipment if the equipment is older, and not being redesigned 

for incremental improvement. So some features now comply. The proposed table 

height requirement is a challenge for us. I'm going to hone in on that, because I 

showed the picture of it that makes it clear there's a lot of technological 

equipment below the table with the Legacy System and the system level design is 
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required to start with a smaller x-ray source, a smaller motion control system, 

smaller frame. In addition, the present time, these systems, the majority of them 

do not have lifts to lift the patient; they're a fixed height with steel pedestals. In 

order to get down low enough to accommodate 17 inches and then to get back up 

would require a sizable elevator system. The costs would be several thousand 

dollars, and the motors alone, just the material for motors to elevate. But I bring 

that up, not to try to mitigate our concern. We're greatly concerned about this. 

We would like to provide access to all patients. And I thank you all very much 

for allowing me to speak here. If there are any questions, I'll be happy to answer 

them. 

>> GARY TALBOT: Thank you, Glenn, thank you very much. Are there 

any questions from the Board? Chris? 

>> CHRISTOPHER HART: Yeah. Chris Hart, public member. You 

mentioned the padding along the actual platform a while ago. When we were in 

Dallas, one of the issues that we heard or saw was the padding compresses to a 

degree that it may get more difficult to transfer off of the platform once you've 

had your scan. Is that something that you see as a problem? 

>> GLENN NYGARD: Yes. I think that the padding is a challenge. In 

many examinations, they'll put a sterile drape on top of the padding - you're right. 
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But the nature of the type of plastic that we use, which is designed not to allow 

biological ingress and be easily cleaned, it can tend on stick to your skin. But that 

is an issue, and I think the selection of those materials, and perhaps either 

recommendation or standard to say use a sterile drape to ease friction on the skin 

for sliding on and off is a very valid concern and concern for industry, as well. 

>> GARY TALBOT: Thanks, Chris, Hans. 

>> HANS VAN WINKLE: Mr. Nygard, I thank you for your comments. 

I was interested in your comment about the interaction of the room dimensions or 

the equipment dimensions. Do we really -- Gary, I don't think we've spent a lot of 

time on that, but clearly, there is an interaction between the two. And we'd be 

interested to learn more from you and any data you have where either equipment 

can be made more accessible by having certain dimensions in the room. Or, it 

may well be that we could ... and we're certainly concerned about the cost of this 

equipment. Because the more expensive it is, the less likely this equipment will 

be available to patients. So any data that you have that tell us that, we're not 

authorized to discuss room dimension, I don't think, Gary, but certainly if there 

are some data that would allow us to make better use of the equipment, that would 

be very useful. 

>> GLENN NYGARD: I'll provide some data on at least what we're 
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aware of in terms of room planning problems. Can't say what an ideal room is; 

it's not my area of expertise, but yes, I'll provide data. 

>> GARY TALBOT: Thank you. I think it's Nancy down there. 

>> NANCY STARNES: It is. I'm down here. Nancy Starnes, public 

member. In looking at your images, it's hard to tell if there's any padding on those 

tables. And certainly when you're working with people with certain types of 

disabilities, the bony prominences tend to within, I've been told in less than 10 

minutes, you're going to begin to get a stage one decubitus ulcer or skin break 

down from that. Has there been any consideration to what sort of padding needs 

to be on the equipment? 

>> GLENN NYGARD: I'm not familiar with the history of the padding. 

What we typically use, we have standards for how stiff it is, obviously, how 

radio-transparent it is, that is, it will not affect the image quality. Today the 

padding on systems that I've been on is comfortable, but I wouldn't say it's overly

thick, around three quarters of an inch thick. Whenever we make a change or 

look at change material, outside the area of strength or whether it works with the 

x-ray system, because it's a human interface, it's very important to us, something 

we look at closely. I just don't have experience with the selection process it's 

gone through in the last several reiterations. I will be mindful of it for our next 
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iteration. 

>> NANCY STARNES: I appreciate that. Thank you. 

>> GLENN NYGARD: Thank you. 

>> GARY TALBOT: Any other questions? Chris? 

>> CHRISTOPHER HART: I wanted to go back to your concern about 

the elevator height adjustability. Correct me if I'm wrong, but for the 19th or 20th 

century, when you wanted to change elevation on a bed, you cranked it. And then 

somewhere in the 80s, we started to see electrical motors. So I'm trying to 

understand your cost implication of several thousand dollars to do that. Is that 

something that you can back up and submit to the Board so that we understand 

why that would be such a big cost factor? 

>> GLENN NYGARD: Certainly. Yes, I can provide data to the Board. 

We do use elevators on some of our more expensive systems that require elevated 

motion for rotation of the C arm. I'll provide data. 

>> GARY TALBOT: Regina? 
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>> REGINA BLYE: I'm fine. Thank you. 

>> MATHEW MCCOLLOUGH: I'm trying to understand why the table 

itself can't be adjusted. So what exactly is underneath the person that's -- is there 

technology underneath that person? And is that technology on are you saying that 

technology is so huge that it can't be placed anywhere else within the room? If 

that's the case, if the technology is so large, I'm trying to understand why 

standards haven't been developed to try and make it smaller, because there's like 

standards dealing with computers, laptop computers. We have small sets there in 

relation to the computer, it seems like we've been able to bring it down to a much 

manageable size in terms of having people with disabilities use the type of 

technology. I'm just wondering in terms of the medical industry, it seems like the 

medical industry is not picking up what the modern times concerns, the size of 

different technologies. Does that make sense at all? 

>> GARY TALBOT: Well, I think one question I had for Glenn is I just 

wanted to ask on the equipment that is underneath the bed, you have one at 28 

inches, one at 25 inches, there's a difference between those two. Has your 

organization, has MITA or someone in the organization looked at what it would 

cost to lower that? To be able to lower it so you'd make those changes to the 

motor heights or how they're located and those kinds of things? And I think to 

Matt's point, is there any opportunity to move something that maybe is that one 
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piece that just can't be made smaller so you can get that table height down some. 

>> GLENN NYGARD: I'll try to address both. I think they're both good 

questions. With regard to the technology that's underneath patient, the biggest 

single piece is the x-ray subsystem. So our x-ray subsystem weighs around 250 

pounds and that includes high voltage transformer, x-ray shielding, the x-ray tube 

itself, rectification circuitry and the controller that runs all of that. The system 

happens to be pulsed. And that's how we accomplish the dual energy of DXA. 

That system, today, can be redesigned, it's a multi-year effort, but there are certain 

fundamental dimensions that can be cannot be made smaller like laptops. 

Unfortunately the x-ray tube wants to get bigger and not smaller because of the 

need to address bariatric patients. The x-ray shielding cannot be much smaller 

because of the standards imposed. You have a certain size x-ray tube and certain 

size and weight of x-ray shielding. The other challenge and the challenge we're 

up for improving is the high voltage that's required for x-ray. Our high voltage 

pulse is 140,000 volts. In addition to making sure the x-ray comes out the right 

place, the correct amount of x-ray comes out and radiation does not come out in 

the wrong place, we also have to be concerned about cooling the high voltage 

system and insulating it so it doesn't arc and damage the equipment or otherwise 

cause harm. With regard to our ability to improve it, yes, we can. We have 

looked at competitive devices; we do that as a matter of course. And I don't have 

a design to express here, but prior to coming before the Board, I did look around 
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at our equipment very closely using a yardstick and tape measure, and I don't 

think that we can easily get down to 17. Doesn't mean we can't, by changing the 

x-ray source and some of the other things down there. But I can say that there 

does appear to be an opportunity to come down, I'll say several inches. 

>> GARY TALBOT: Great - boy, that's awesome. Thank you, Glenn. 

Thank you very much for your comments. We really appreciate it. Thank you. 

>> GLENN NYGARD: Thank you. Next up is John Jaeckle. And then 

Ed Toerek will be next. 

>> ED TOEREK: Yeah. We're going to combine our presentation ... 

>> GARY TALBOT: Oh, great! 

>> ED TOEREK: ... because it's CT and molecular energy, and a lot of 

the medical imaging devices now, the PET and -- other [inaudible] mag devices 

come with the CT, we thought it was a natural one, so we thought we'd combine 

because of the similarities. 

>> REX PACE: You'll still be speaking sequentially though? 
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>> JOHN JAECKLE: Well, I think we were going to talk back and forth 

if that's okay. 

>> GARY TALBOT: Yeah. That's great. It will work. 

>> JOHN JAECKLE: All right. If anybody wants to see a plastic model 

of the CT system, 

>> GARY TALBOT: You can pass this around to everybody. 

>> REX PACE: I will tell you when you hit the five minute mark. 

>> JOHN JAECKLE: It's one continuous kind of piece, because it all 

flows together. The only reason -- my name is John Jaeckle. I work for GE 

Health Care. I'm the Chair of the MITA CT group. And the co-chair of the 

MITA MI-Dose Reduction Task Force. I want to highlight I'm the Chair of the 

ICMP30 group. We had heard John previously on mammo; he's on part of the 

mammo team. The IEC sets the international safety and performance standards 

for medical electrical equipment. I think that's a good opportunity to broaden 

some of these requirements. So they don't just apply to the U.S. and hence, some 

of us, with these broader capabilities have been nominated to the oversight board 

afterwards; and we very much look forward to doing that. And that may be also 
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where some of these conflicting requirements may come in. I've been very

impressed with the comments here today, and the interactivity, so I hope our 

presentation can address some of the questions that have been asked and also 

provide some more thought provoking introductions. Ed and I are going to share 

this presentation, kinda go back and forth. We don't know which one the straight 

man is or not, but we'll figure out as we go. 

>> GARY TALBOT: Thank you. 

>> ED TOEREK: Good Morning. My name is Ed Toerek. Due to the 

uncommon spelling, I was asked to spell it. It's E-D-U-A-R-D T-O-E-R-E-K. 

>> JOHN JAECKLE: For the record, mine is John J-A-E-C-K-L-E. 

>> ED TOEREK: I'm a Director of Quality and Regulatory at Phillips 

healthcare have worked there for 26 years; I have a bachelors of electrical 

engineering degree and experience in MR, nuclear medicine, and CT. I'm also the 

Vice Chair of the MITA CT Group. I'd like to thank the Access Board for the 

opportunity to present on this very important topic this morning. As Elisabeth 

stated earlier, in her opening remarks, one goal of manufacturers has long been 

and continues to be to ensure access to diagnostic equipment for all patients, it 

must be noted that these are prescription-only devices and the clinical objective of 
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a study is to acquire diagnostic data for all patients for the area of interests that are 

within the capabilities of the equipment. CT is used predominantly to generate 

3D anatomical images. CT systems use an x-ray tube which rotates around the 

patient collecting data from different angles, which are then combined to create 

cross-sectional images. In nuclear medicine, an ionizing agent is administered to 

the patient rather than being delivered from an external source, such as in the CT 

systems. Nuclear medicine includes spect and PET scanners. In this case, PET 

scanners are not for your household companions, Fido or Mr. Whiskers; rather it 

stands for positron emission tomography. PET is one of the most frequently used 

molecular imaging procedures. Molecular imaging is a type of medical imaging 

that provides detailed pictures of what is happening inside the body at the 

molecular and cellular level. 

>> COURT REPORTER: Can you slow down a little? 

>> ED TOEREK: Yes. Molecular imaging allows physicians to see how 

the body is functioning and to measure its chemical and biological processes. 

Most nuclear medicine cameras are combined with a CT scanner which is referred 

to as multi-modality or hybrid scanners, because these hybrid systems are so 

common we are combining the CT and nuclear medicine presentations this 

morning. Here are some images of a CT system. The -- that includes a -- you 

can't see: I apologize for that. Includes the gantry - big piece of the equipment is 
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called the gantry, and the patient table is in front of the gantry and has the ability

to adjust vertically for patient loading considerations and translates the patient 

into the board of the gantry for imaging. The x-ray tube rotates inside the gantry

and emits x-rays through the little window that you can see inside the central 

board of that gantry. Here are images of a couple of PETCT scanners, different 

configurations; the image on the top has a separate gantry for the CT scanner and 

another one for the PET scanner. The patient is in front of the table and imaged 

through both of those gantries. The second image is a -- has one that combines 

the nuclear detectors and x-ray system in one larger gantry. It's a deeper, larger 

piece of equipment. The patient goes through both of those technologies. 

>> JOHN JAEKLE: Yeah; if I can just add some things. On the lower 

picture here, because the tube on top, you can see that the PET and the CT 

acquisitions are back to back, so they're farther apart. So that table on the bottom 

has to have two positions. A CT position and a PET position. You see there's an 

additional pedestal underneath which adds height. You have to translate the table 

in farther for the PET. So are some of the considerations that might be unique 

when you have a combined system versus the model I sent with the single system 

where that table could be lowered to the floor. 

>> ED TOEREK: Thanks. This is an image of a general nuclear 

medicine gamma camera which also can be configured as a spec CT system by
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adding an x-ray tube and a flat panel detector to the gantry, which is shown at the 

top, the gantry is the x-ray tube. Note all of these systems are stationary systems, 

which are fixed to the floor. These general nuclear medicine gamma cameras can 

accommodate multiple patient positioning options, including seated in a chair, 

wheelchair, standing or lying on a gurney or hospital bed directly. CT scanners 

are excellent in providing structural, anatomic, and pathological information and 

are used frequently in emergency room evaluations. CT can be viewed in two 

dimensional and three dimensional modes. The images shown here include a 

planar view of the cerebral brain vasculature, 3D images of the heart and coronary

vessels, and planar cross-sectional views of the chest. Images here demonstrate a 

CTA run off scan; the first image demonstrates a patient with most of the skeletal 

anatomy removed to better demonstrate the chest, abdomen and lower extremity

vasculature. The middle and third images show the abdomen and a view of the 

femoral arteries surrounding vasculature, and includes the skeletal and anatomic 

structures. High quality diagnostic images are the ultimate goal of the system. 

This is what these systems have to provide in order for the physicians to make 

their final diagnosis. These systems are for prescription-use only; are not 

independently used by patients. A technologist is always present for the study 

who discusses the examination with the patient, assesses the ability of the patient 

to complete the study, assists in placement and positioning of the patient on the 

table, and patient preparation for oral and IV injections of contrast material. 

These systems are designed for virtually all situations, including critical care, 
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limited mobility, trauma, emergency room cases, unconscious and serious ill 

patients, so we do have to be able to accommodate all types of patient 

populations. Some of the common technical criteria for most of these devices is 

M301, which is for supine, prone, and side laying positions, this includes, CT, 

MR, PET, SPECT, PET CT, SPECT CT, and PET MR scanners. Additional 

criteria, M302, 303, and 304, apply to general nuclear medicine where the patient 

can also be positioned in the seated wheelchair and standing positions. There are 

no patient operable parts in these systems, so criteria 307 does not apply in this 

case. Some common or typical features of the current design include a long 

couch or patient table for the patient to lie down on during the scan. The table can 

be raised and lowered to facilitate patient transfer. Patient transfer from a gurney

to a table is very common in a hospital and ER setting. There are a wide variety

of patient positioning pads and straps to ensure proper patient positioning and 

patient comfort. This also goes partially to address the concern that Mr. 

McCollough raised where a patient may not be able to remain still during the 

extent of the exam. So the position pads and straps are there to help stabilize the 

patient during the exam. Patient lift compatibility does exist with a number of 

system configurations; however, there are a wide variety of different types of 

patient lifts and different systems as well. Not all of them are fully compatible. 

There are special considerations for MR due to the magnetic fields and you'll hear 

about that in an upcoming presentation. 
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>> JOHN JAECKLE: Again, on the transfer surface side, I mentioned a 

bit of the considerations on the PET. A lot of the same considerations we've 

heard on DXA apply to the CT table. Underneath that table, there are motorized 

functions in there to raise and lower the table -- -there's also -- that move the 

cradle in. That has to be very precise; the federal requirement is within 1 

millimeter. Most manufacturers make that accurate to within a quarter of a 

millimeter. It's a very precision device to move in. You need to know exactly

where you are on the body that you're imaging. One of the considerations, and 

this is where the international standards piece comes in, if there are supports on 

the device, so if there's a requirement for 250-pound handle, the international 

standards will apply at either four times or up to a 12 times safety factor on top of 

that, depending on if it's under fatigue loading or the type of material used. So if 

you specify a 250-pound handle, manufacturers design and test it to at least a 

thousand pounds, if not 2,000 pounds. So that's something to also consider. On 

top of that, which means you've got to find something big and structural to put 

that on. Those types of changes may impact clinical utility or impact the broader 

access. There's a lot of weighing going on here. In the end, we need to still 

deliver those high quality, very detailed diagnostic images, because you're not 

getting one of these scans unless there's something pretty serious, and the 

physicians need that. We wouldn't want to necessarily give access and then get a 

bad exam. That doesn't work out. Here of common illustrations of what can be 

done - I know it's not a CT table, but some of our tables, depending on types, we 
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have different models. Some go down to 17 inches. Some don't yet. There is 

access on most of our tables for a Hoyer lift to come in from the foot end of the 

table on the model coming in. Definitely, again, this is where we want to work 

with the stakeholders on room design, there's a lot of stuff you can do on the room 

layouts. All of our equipment that we're talking about here today, there will be 

considerations for MR, but the MI and CT would accommodate a ceiling lift as 

part of the room layout. Here is a patient doing a transfer on a transfer board; this 

would be a patient from an ER or hospital room setting. Again back to facility --

setting requirements. These are large capital equipment planned in advance. 

Manufacturers go in and work with the site on the room layouts. Everyone is a 

custom design so there's opportunity there. Some of these sites are more than 400 

square foot. You have to put lead shielding around them. Currently, we work 

with the facility so if they want to have requirements for the ADA, those can be 

considered. We think one area where there's a chance for good collaborations is 

that manufacturers in their setting guides can put in "here is an alternative room 

layout for better access." And that would help the planners. We talked about 

existing clearances. This slide shows that there's an envelope around that CT 

system – the dotted line that goes around it. That is governed now here by two 

things. One is the National Electric Code, and the other is OSHA. We're working 

on the equipment. So the National Electric Code requires fire egress and the 

OSHA requires service clearances for working on live energized parts. Also you 

see here the way this room is laid out there's a large door to come in, and 
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accommodates in this case a person on a stretcher. So on these types of systems, 

we're talking about larger spaces that can easily be put into accommodate more 

issues. We do have communications, our systems have intercoms, and breathing 

lights, and the window to see it. Here is an example of the breathing lights that 

tell the patient how to breathe. You can do a demonstration mode on this to prep 

them ahead of time - that's right on the gantry. Training is provided by the 

manufacturers. Also part of being a radiological technician does include proper 

training on transferring. Hospitals should have that. Again, the larger solution 

here, it's important that the hospital staffs have enough trained people and 

equipment ready to help or to have facilities such as if you can't get a table lower, 

raise the floor by a couple inches and have a ramp up to that. There's more than 

one of these approaches for the equipment. So it might be easier to put a two by

four width on the floor than try to get a whole new piece of high tech equipment. 

Other standards, we can submit these that we have to apply - we can give you the 

whole list of that. transition time. Again, we go through a rigorous quality 

system management, and typically multi-year projects to get stuff in. We think 

that the two methods is very supportable. New requirements do go into fuller

production; we've talked about that we do get user inputs as a formal process. I

mentioned that we would like to see -- we would be happy to work with, I think 

there's good opportunity here to have these enhanced planning guides to facilitate 

the access, because that's the end goal here. We're eager to participate in the 

future endeavors and the oversight board. Of course as technology continues to 
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advance, we take into consideration a lot of manufacturers have gone to like the 

bariatric tables, we heard there was user need for that, so we've designed tables. 

But there's tradeoffs when we went to the heavier design table. Obviously, we're 

committed to providing safe and effective equipment and we look forward to 

future collaboration. I think there's a lot of things we can work on together. And, 

again what we heard before, there might not be any one size fits all solution here. 

So I think it's important to have a technical knowledge of each of the different 

modalities and what can be done and what you can do in maybe a short-term goal, 

intermediate term goal and longer term goal. Thank you. 

>> GARY TALBOT: Thank you very much, we really appreciate it. Any 

questions from the Board members? 

>> MATHEW MCCOLLOUGH: So, I've never had a CT scan before, but 

how -- so long does the patient have to be in the machine. 

>> ED TOEREK: Okay. CT scans itself are very quick. It's one of the 

fastest one. 

>> JOHN JAECKLE: The actual x-ray is on for probably less than 10 

seconds. But there is prep time. So the technologist would bring the patient into 

the room, get them onto the table, and then get them positioned on the table. 
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Once you're on the table, you don't want to move. So again you're taking a 

picture. That's why there's breathing lights. Because you have to lots of times 

hold your breath, you don't want the respiratory motion. Some scans require an 

injection of IV contrast. So you might be on the table a bit longer for that. 

Because that has to be timed with the start of the scan to hit the phase right. But 

the actual time the x-ray is on is probably like 10 seconds. A ballpark figure of a 

turnaround time from the time you get in the room and leave are probably 15 

minutes. Nuclear scans are longer because there, you're injected with a radio 

isotope so you want to minimize how much radiation a person's getting. You 

have a very low count rate. Those exams can take half an hour because you have 

to accumulate the counts over time. But in those exams, the techs will typically

be in there. My wife has gone through a series of these from breast cancer. The 

techs come in and say, how are you doing and whatnot. It's different for the 

molecular imaging part versus the CT part. 

>> MATHEW MCCOLLOUGH: I'm going to back to DC. DC also has a 

huge deaf population as well. Howard Rosenblum and I come from DC. In terms 

of the deaf community, in terms of the equipment, there needs to be real 

communication between the technicians and once you're in this machine, it's hard

to communicate clearly. And so and Howard may want to step in as well. One of 

the standards in terms of making sure that the proper communication occurs with 

the person who is deaf. So. 
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>> JOHN JAECKLE: Yeah. Very good. The communication piece, CT 

is relatively quiet compared to MR. If needed the technologist can go into the 

room and do a CT scan. That happens frequently with pediatric patients because 

they feel more comfortable. So the technologist can be there. You saw we have 

the breathing lights that can be demonstrated ahead of time. "Here is where you 

hold your breath, you watch this count down." That's the main thing you need to 

do for communications. There's also intercom systems between the two, those are 

in multi lingual, if you have a canned -- 

>> MATHEW MCCOLLOUGH: One more -- one more point with the 

intercom. It wouldn't necessarily work with a deaf person. 

>> JOHN JAECKLE: No. For people with hearing impairments, we 

would rely on the breathing lights and again back to the facility thing, does the 

facility need to provide somebody who can do sign language or something with a 

hearing impaired person to give them the instructions or develop a series of 

readable cards. 

>> GARY TALBOT: Howard? 

>> HOWARD ROSENBLUM: Is it on? I think it's on. 
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>> GARY TALBOT: Yeah. It's on. 

>> HOWARD ROSENBLUM: Hi, Howard Rosenblum, public member. 

I want to follow up with that last question if I could. If the instructions, let's say

for the breathing part or the information that needs on to be shared with the 

patient, I mean, for even with a hearing loss, are they provided with a head set? 

What is shared? Other instructions other than the breathing part, how are the 

instructions given to the patient? 

>> ED TOEREK: From the equipment perspective, there isn't any 

additional information that's provided from the equipment itself, other than the 

visual cues from the breathing lights and x-ray on indicators. Those other types 

of instructions would have to come from the technician in the room that's 

administering the scan, is what the patient needs to do and when they need to do 

it. 

>> GARY TALBOT: I guess if I could follow up with Howard's question 

for a second. Do we provide the audio PA piece because you're providing more 

information that just kind of enhances and makes the patient feel more 

comfortable or is it critical information? I guess what I'm struggling with, if the 

light is enough, why isn't the light enough for everyone? If you're also providing 
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audio, what we're concerned about is there a way that you can do that visually? 

Could you have something with text? 

>> JOHN JAECKLE: Yeah. I -- we'll do it. Part of the audio is that the 

technician typically wouldn't be in the room because of the x-ray exposure to the 

technician, but they can hear if the patient wants to say something. So it's a two 

way communication. So that's the other aspect of having it. Not necessarily

giving them information. That information would be given to them ahead of time 

while they're being prepped and "you're about to have the scan," "you're going to 

see this breathing light" and whatnot. With the breathing light also comes a 

prerecorded multi-lingual message; doesn't address the deaf folks, just to have a 

broader sense of coverage. I think to answer your question, the intercom isn't also 

important for the technician who might not be in the room to hear if the patient 

has a problem: "I'm feeling claustrophobic," or "I'm feeling sick," or "something 

is wrong". 

>> GARY TALBOT: How would the deaf patient be able to signal the 

attendant, the technician that they're having an issue? How would that be done? 

Is there a button they could push or something like that? 

>> ED TOEREK: for the CT scan, not a separate button. But the -- it's an 

open mic, and we also have the window between the scan room and the 
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technician, there's a visual contact as well. So they'll see if the patient is in 

distress or if they hear any sounds coming from there. To comment on the 

breathing light versus the voice commands, those are redundant. The commands 

coming from the system tell the patient to hold their breath just like the breathing 

lights do. It's both visual and audible. 

>> JOHN JAECKLE: But MR has like squeeze balls that could be 

incorporated onto a CT system. 

>> ED TOEREK: As long as it's not in the field of -- 

>> JOHN JAECKLE: Right. You have to make sure it's not in the field 

of x-ray view. 

>> GARY TALBOT: Okay. Thank you. Any other questions from the 

board? Howard? 

>> HOWARD ROSENBLUM: One last thing. Why couldn't we put 

some kind of -- something to -- a button for an emergency distress signal so -- if a 

person can't verbalize their distress? 

>> JOHN JAECKLE: We agree, we could have the squeeze ball in the 
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person's hand, a button, like MR does. 

>> GARY TALBOT: Because that wouldn't impact the equipment. You 

could do that separately. 

>> JOHN JAECKLE: It could be a separate -- a separate circuit, right. 

Yes. 

>> GARY TALBOT: That's a great idea. Thank you very much. I'm 

sorry. At the end, Regina? 

>> REGINA BLYE: Regina Blye public comment. Just wanted to 

expand on that. If you are going to do some sort of alert system, make sure you 

consider hand dexterity, some people aren't able to do the squeeze. You 

mentioned squeeze, take that into consideration. 

>> JOHN JAECKLE: Again, I think that's why it's important to work 

with all the stakeholders here to figure out what is a good solution or alternative 

solutions for those. Thank you.

>> GARY TALBOT: Great. Thank you very much. Okay. Next up is 

Milind. Thank you, Milind. I appreciate your helping me. And then next up after 
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Milind is Tony Roder. 

>> MILIND DHAMANKAR: So good morning everybody. My name is 

Milind DHAMANKAR. M-I-L-I-N-D D-H-A-M-A-N-K-A-R and I appreciate 

this opportunity to present in front of the board. I am a physician on the other 

side of providing health care, now working with the medical device company. I'm 

an MR expert for more than 20 years, being in R and D, and now am heading in 

the Sieman's health care as Senior Director for Product Marketing. John and Ed 

gave you a very good overview of what these modalities are, particularly in 

context of the CT scan and PET scanners. Most of it does apply to MR as well, in 

terms of that it is a fixed equipment, it is a prescription-only imaging modality, 

and is very complicated as well. What this slide gives, or shows, is what does an 

MR exam do? I'm going to use the five minutes to give you an overview of the 

differences between these modalities, because MR is a little special. I always feel 

that way. But the importance is what is in that technology, what makes it 

different and challenging when we consider all these aspects of safety as well as 

efficacy for the equipment. So MR is all about imaging the hydrogen protons in 

the body and it's the water molecule. For that, what you require is a strong 

magnet and radio frequency waves. With that, you get a very good multi-angled 

image, which gives you very good resolution in terms of seeing what's wrong into 

the body, as shown over here. And you can see these white spots, which are very

different into the organ, and you can identify the pathology. It also gives 
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challenges in its installation. You need a very dedicated MR room, which is 

known as a radio frequency cabin to isolate the noise which is coming in between 

other frequencies within the magnet. Because that contributes the quality of the 

image, and that is critical. But what is also important is the ferrous material 

within the magnet room and this is what differentiates this modality, but very

critical when it comes to what is the facility doing for the system and how it is 

planned. So what you can see here is common objects, which are with the patient, 

like the oxygen cylinder or the IV pull. If they are ferrous, are going to be 

dangerous items for the patient and the technologist as well. And it is very

important that one is aware and the site is being trained to take all these 

nonferrous material into consideration. Ed and John covered that, but I will again 

highlight that in respect to MR in particular. We have the ability to image 

patients in the supine, prone, and the decubitus position; the image over here 

shows a person in the decubitus position with the quad laid down. This is a very

important thing that you could have patients- even pediatric patients - in any

position, and yet can get images very well. What you see here is a 3D image, 

which is also giving curved multi-planar reconstructions, giving the ability to scan 

patients with very difficult anatomies as well. MRI is designed effectively with 

image patients, all ages and sizes. The patient, table weight, the bore size plays a 

very important role to give access to different kinds of patients. MR conditional -

and that's where this modality has, that everything within the magnet room needs 

to be MR conditional because of the presence of this large magnet. However, we 
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have detachable tables which could go out of the magnet room; the patient is 

prepared outside the magnet room and can then have a more compatible 

wheelchairs where they then could be positioned into it. So detachable tables help 

in MR to prepare the patient outside this magnet room as well. When it comes to 

other things like positioning cushions, having different coils, ability to position 

the patient and prepare the patient outside, particularly for breast imaging, we 

know that a woman has to be in the prone position, they can prepare the woman 

outside the MR room and wheel back with the [inaudible]-table as well. Table 

tops, transfer tables, Ed and John showed those same similar transfer supports 

could be used. Only thing, they need to be nonmagnetic, "MR conditional." You 

have large coils, which are fitting into all sizes, will give the ability to scan the 

patient and get diagnostic image quality. I know the discussion on patient 

communication, MR has a challenge here, and with your proposed requirement on 

306.1, because of the gradient noise, because there is gradient noise while the MR 

exam is on, it is important to identify how we are communicating. And I think 

this is a very good input, which all venders do take seriously. We have at least 

two types of communications, and because it's a low-radiation kind of modality, 

the presence of somebody within the magnet - a relative or help, to give tactile 

communications, particularly for children who don't require sedation, but could 

have their parents in, is a very important aspect of tactile communication possible 

on MR as well. Again, I think I really thank this opportunity to present within my 

time limits; I tried to differentiate what MR could bring on and what are the 
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differences for MR, and we look forward to see how we could accommodate 

those recommendations. Thank you. 

>> GARY TALBOT: Thank you very much, any questions from the 

Board? Thank you very much. We appreciate your testimony. Thank you. Next 

up is Tony Roder. And then after Tony, is Shelly Simmons. 

>> TONY RODER: Good morning everyone. Thank you for the 

opportunity to present today in front of the Access Board and the other presenters 

as well as the audience. My name is Tony R-O-D-E-R I'm a Regulatory Affairs 

Director for GE Health Care, also the Vice Chair of the MITA X-Ray Section and 

Chair of the CT Group, and Co-Seer of the European Trade Association. I have a 

background in engineering, nuclear power, regulatory affairs and all kinds of 

things. So although I'm here to talk specifically about the modalities of 

interventional x-ray and general x-ray, they share a lot of the same general 

considerations you've heard from other modalities that have already presented. 

And part of these manufacturers, we are committed to enabling patient access. 

We need to generate these images and we need to figure out a way to generate the 

images. It's a very complex set of requirements that are put into the design and 

use of this equipment that have to, in the end, result in a diagnostic image that 

facilitates care. Ultimate goal. You've heard that many times today, but that's the 

ultimate goal. And there are some specific considerations for the facilities. These 
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are big capital pieces of equipment in most cases, that require some significant 

investment and that goes along with acquisition and use. And really we see the 

future of finding effective solutions as being in stakeholder collaboration. 

Because each group brings a different piece of knowledge to the table, we're able 

to facilitate the best solutions. I'd really like to talk a little about some specifics 

with the interventional and general x-rays. So interventional equipment, this is 

used in a surgical type setting, we're talking about procedures that involve stent 

placement, we're talking about orthopedic surgeries, we're talking about that type 

of procedure. In reality, these patients are sedated always. There is no access on 

and off the table in the room. It's always going to be under sedation. So from an 

interventional x-ray perspective, that's the type of use case we're dealing with. 

And there are different types: fixed and mobile. The fixed type will be in a 

surgical setting by itself bolted to the floor. The mobile units could be brought 

into a surgery suite when needed and taken back out. But still, the procedures are 

done in that type of setting. X-ray equipment in general, again, fixed or mobile, 

this is the type of equipment, two dimensional images could be either real time or 

static, and there's been some major advances in this type of equipment over the 

last several years with regards to detector technologies that could be either 

tethered or wireless. So inside the room, if you can get to the room, you can get 

the tube and the detector in a place, in almost any position to image. And those 

images, I think there was a concern I heard earlier that is that the same care? Am 

I getting the same quality care by imaging not on the table or not in this position 
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or standing against a wall as I am in a chair? And in these cases, yes, that is the 

same standard of care for this type of detector technology I'm talking about here. 

So there's a lot of access that's enabled by that time of system today. This page 

really just shows some of the other types of material and equipment that 

manufacturers and facilities can use, depending on the clinical situation. It 

depends, is it appropriate for that specific situation, that specific device? You see 

examples here, wheelchair ramps, wireless non-tethered detectors like I just talked 

about, and patient positioning aids or additional comfort type of devices when it 

requires longer term positioning for the image. I just wanted to give a quick 

example of a technical limitation for some of this equipment. So what you see 

pictured here, difficult to see here. You're not going to be able to see my laser. 

On the right is a fluoroscopic system, generates real time images. Again, used 

sometimes for more slight interventional type procedures, not as complex perhaps 

as some of the interventional equipment I talked about. But that table underneath 

there, you see two different configurations, one on the right and one on the left. 

The one on the right has an overhead x-ray tube, and on the left has an underneath 

x-ray tube, so two different types. The primary thing I want to point out here, 

just as discussed with the DXA system, the physical constraints of the tube, we 

can't shrink it quite like we can with computers, but there may be opportunities, 

but it's completely dependent on the specific system, what the goals of that system

are and the technical limitations around the design, but there are definite 

constraints that need to be rationalized when you're doing these designs. So just 
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in closing, I want to again thank the group for letting us present today. We are 

committed to enabling patient access. That's the number one goal. We commend 

what is happening and we want to be a part of it. We bring a unique perspective 

and although there's been a lot of potential solutions discussed today, I think 

there's -- to identify the real steps in going forward, we want to be at the table 

with the advisory committee and help try to look at what we can do from potential 

site planning. Adapting proposed requirements, if there are limitations that 

prevent us from doing certain things, we can be there to help walk you through 

those. And then we also, as discussed in many of the presentations, understand 

the timing it takes for this development and what even might be possible from that 

perspective. And lastly, again, we just want to reemphasize, we see the future in 

this as getting all the stakeholders together, patient advocates, user groups, the 

people that push the buttons, turn the knobs, the people that read the images, and 

hospital administers that have to understand constraints, get the equipment in, 

service it, make sure it's available for the patients, regulators like the FDA, I think 

are a prime example of a stakeholder and manufacturers. So, thank you again for 

your time. If there's any questions. For either myself or any of my colleagues 

that you've thought of. Thank you for your time. 

>> GARY TALBOT: Thank you, Tony, thank you very much. Board 

members, any questions? 
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>> PHILLIP JENKINS: This is Phil Jenkins, hi, Tony. Question: You 

talked about the various stakeholders, the techs, the admin, has there ever been a 

place with all those folks have come together before to discuss other types of 

issues, safety, access or anything else? 

>> TONY RODER: Yes, definitely a good example, and this is 

something that I'm sure many of you have heard of the medical radiation 

concerns, FDA, stakeholder groups like ASRT, AAPM, ACR, MITA, and that's a 

prime example of one where manufacturers have said, "let's talk, let's get together, 

let's find solutions to the overall problem." Not any one group may own all the 

keys. It's going to take a collaborative effort, it's going to take a lot of different 

folks. That's one example. We could obviously provide some details on how 

maybe that was accomplished. And obviously I think we have -- yeah. An 

example would be we hold a stakeholders meeting every year at RS&A. That's 

one of the specifics of how we accomplish it. We do -- get all the folks in a room 

at one time and we talk about what are the current challenges, what do we need to 

work on for the next year. Let's set priorities because we can't tackle the whole 

thing at once. That's part of other thing I think we have to acknowledge is that 

each of these pieces takes time, so let's identify where the priorities lie. Let's do 

those actions and move forward. That's an example. I think in our written 

comments, we'd be able to provide more details on those types of things. 
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>> GARY TALBOT: That would be great. Thank you. Hans. 

>> HANS VAN WINKLE: Mr. Roder, thank you. In listening to your 

testimony and others, it's apparent that one of the issues is that because of the 

complexity and the physical constraints of the equipment, that causes problems 

for people with disabilities who don't always conform to what seem to be sort of 

standards. It would seem to me that the more mobile and the more flexible 

equipment can be that it would be easier to work the problem the other way 

around, to conform to patient limitations, those with disabilities. We've heard a 

little bit of testimony about the possibilities of technology. I guess there are some 

physical constraints we're all used to, the devices now that we can do 

technologically, miniaturization ... Sorry. I didn't mean to steal your --

[laughter]. I gave it back. I want everyone to witness that. But I guess there are 

some things that cannot be done. The size of cath node tubes and things of that 

nature. Do you think there are going to be technological breakthroughs in any

particular areas that will help us solve this dilemma, or are we stuck with what we 

have? We've seen the equipment here. And again, it seems to be pretty fixed, 

pretty large, pretty inflexible. Do you think there's some technology that might 

help us solve this dilemma? 

>> TONY RODER: I mean, we look at the technology and obviously, 

you know, people are always working on what's the next piece of technology. 
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Each of these types of devices has its own unique characteristics that it is 

specifically designed to try to help solve the clinical problem. A clinical need 

arises and we need to image this, or we need to have this fidelity of image or this 

quality, or we need to have this mobility right with it. Can all the pieces of 

equipment meet the same amount of flexibility? Probably not, from what you've 

seen. So certain pieces of equipment have an inherent ability to be more flexible. 

Does that mean in the future they wouldn't be able to? I don't know if I can -- I 

can't answer that question today. I don't have the crystal ball I can look at to find 

out where we might be going specifically. But they have their own niche. Sorry 

if that doesn't answer -- 

>> HANS VAN WIINKLE: No, I understood. As we develop standards, 

it would be go good to sort of know if we're sort of stuck with these physical 

dimensions, physical problems and have to design around that vice, we can expect

technological solutions. Where we could really -- that would allow us to go to 

more performance types of specifications; it's the debate we've been having in the 

Board, what extent do we specify? 2.53-inches versus can we set a performance 

standard for this. I'm trying to get a sense from you. 

>> TONY RODER: Yes. Some of the specifics, for example, like 

MRCT, there's geometric requirements right there, and limitations that we 

currently can't go beyond in some cases. You talked about trying to increase bore 
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sizes and do this type of thing. Some of those it just takes iterative changes over 

time in order to be able to accomplish that and still maintain that ultimate goal, 

which is that diagnostic image. That evolves over time. 

>> SPEAKER: If I could add, as an example. On a CT -- 

>> GARY TALBOT: You'd need to use the mic, please. 

>> HANS VAN WINKLE: Kind of a group session here, Gary. 

>> GARY TALBOT: That's fine. 

>> JOHN JAECKLE: I just want to give you an example of that, for like 

CT systems, as the technology progresses, what's happening in CT is you want the 

tube to go around faster to get you better images, or that the bore size increases to 

accommodate larger patients. But it's very critical that that gantry is perfectly

stable. Because we talked about quarter millimeter precision. That needs to be 

securely anchored to the floor, same with the table. That's where you bump up 

into some -- on some of these pieces, it's very difficult to move. Or, like an MR 

magnet - that magnet's got to be super cooled and not easily moved. Tony gave 

good examples in the x-ray field where you can take the detector out and move it. 

So I think again, it's back to modality specific, what advances are able to be made. 
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>> HANS VAN WINKLE: So in the case of something that has to be 

super stabilized, we have to figure out ways to get the patient to conform to those 

requirements, whereas in other areas, we can get the equipment to conform with 

the patient's requirements. 

>> JOHN JAECKLE: I think there's a lot of room you need made into 

facility layouts to help. Either with overhead lifts, or raising the floors, or other 

layout issues to do it on these equipments that really need to be bolted to the floor, 

or have auxiliary equipments to make sure they're performing correctly. 

>> HANS VAN WINKLE: Gary, I think that's an area that we need to 

examine, we focused on the equipment itself, but it's clear in a couple of 

comments that the room dimensions and those dimensions play a critical role 

here. I don't know how we deal with that, because we have specific authorization, 

maybe sort of advisory or we give a recommendation that these aspects be 

considered in future studies, we're on some pretty tight timelines here, I don't 

think we can incorporate it now. 

>> SPEAKER: From manufacturers, that's why we think we could be 

more than happy to accommodate working with you guys to say what are the right 

considerations for the layout. If you take the equipment, manufacturer shall 
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provide alternate room layouts for their equipment that would incorporate XY and 

Z considerations to the site, then the sites, that would give them a lot of help in 

site planning and to build those out. 

>> GARY TALBOT: Nancy? 

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

Could you gentlemen remind me about the life span of some of this equipment? 

Obviously, as we develop standards, there's going to be a phase-in period. 

Nobody is going to be throwing out equipment they've already purchased. 

>> TONY RODER: The life span is, again, going to be pretty variable by

the type of device, but a lot of this equipment, the big capital could be decades. 

There's x-ray systems that have been operating for 50 years. That's atypical. But 

I would say on the order of five to 10 years, it's a typical type of life span for a lot 

of these devices, and John, anybody else have specific -- 

>> JOHN JAECKLE: ... And the example, like in the CTs or the MRs, 

the latest technology are put into premium flagship, new products that a lot of 

academic institutions or very cutting edge people will adapt to first, the more 

expensive. And then we have different tiers of products, like a performance and a 

value segment. Once the academic institution may use the latest equipment for a 
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number of years, they want the next latest and greatest thing, because they want to 

publish on and do research. So that equipment is resold down to the next tier of 

hospital, and it flows down to community hospitals and whatnot like that. So that 

is kind of the life span of equipment. So they do last quite a long time. 

>> TONY RODER: But again, pretty variable too by the type of device. 

And really the designs are put together for these devices not to be short-term. 

They're big capital pieces of equipment. So serviceable and continued use. 

>> GARY TALBOT: Thank you very much, you guys. Thank you. Next 

up is Shelly Simmons. And then after Shelly is Carolyn Philips. 

>> SHELLY SIMMONS: Good morning. Thank you so much for this 

opportunity to speak with you today. My name is Shelly Simmons, S-H-E-L-L-Y 

S-I-M-M-O-N-S, and I chair the Statewide Independent Living Council of 

Georgia. With the development of new medical devices and new preventive tests, 

it is critical these technologies be designed and used in a way that increases the 

inclusion, empowerment, and independence of Americans with disabilities as well 

as our seniors. The Department of Justice, through settlement agreements has 

made attempts to address access to some exam, imaging, and treatment 

equipment, but more needs to be done. Must be done to establish guidelines and 

enforceable standards so that all equipment is accessible across the spectrum of 
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health care facilities and providers in the U.S. I can tell you personally of the 

challenges I face whenever I seek medical attention. Trying to avoid the 

frustration of not having the accessible equipment or trained staff to adequately

assist me is more than a notion. I always inform nurses, health care facilities, and 

schedulers that I am a patient that requires maximum assistance. I even go into 

detail of the needs I have for each visit. But for the lack of not knowing how to 

assist, not caring to assist, or not being able to accommodate a person with a 

disability is a huge barrier. I have shown up to appointments with no patient lift 

and a staff that is untrained to help transfer. I've even been dropped doing an 

actual transfer. Mammogram appointments go well beyond scheduled times, 

because of the difficulty of getting my chair in the right position, but out of the 

way of the imaging machine. The tedious search for a dental office with rooms 

large enough to accommodate a wheelchair, and access to the x-ray area. Because 

of these barriers, my health care is delayed and at times denied. But my story is 

not uncommon. I'm always hearing of similar stories from colleagues and other 

persons from the disabled community, especially from those in rural areas. I

honestly believe manufacturers need the guidance and input in order to provide 

products and equipment that are more usable by people with disabilities, thereby 

increasing the services provided and new equipment obtained. The same features 

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

persons with disabilities. To ensure that quality health care is available to 

everyone, I sincerely hope and strongly suggest the recommendations of the U.S. 
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Access Board are considered and implemented. I thank you so much for your 

undivided attention. Are there any questions for me? 

>> GARY TALBOT: Thank you. Any questions from the board? 

Regina? 

>> REGINA BLYE: Not so much a question, but a comment. I just want 

to say I appreciate Shelly. We've met before. I don't know if you remember me. 

>> SHELLY SIMMONS: Yes, I do. 

>> REGINA BLYE: Consumer input or individual input on the behalf of 

centers for independent living, stated wide independent living councils, ADAPT

and other organizations, because that gives us a perspective of what people with 

disabilities need. So thank you. 

>> GARY TALBOT: Thank you very much. We appreciate it. Next is 

Carolyn Philips, and next up after Carolyn is Margo Waters. 

>> CAROLYN PHILIPS: Hi. Hello everybody. I'm really glad y'all are 

doing this in Atlanta. I welcome you, hope you've had a good stay so far. I am 

Carolyn Philips, the Director of Tools For Life, which is the state Assistive 
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Technology Act. We're very active in a lot of areas, as you know, those of you 

familiar with the AT Act, including health care, helping people access and 

understand what's going on when it comes to getting the appointments they need, 

navigating the system, we've worked with doctors, hospitals, and patients with 

disabilities. But, I want to share with you two stories, personal perspectives on 

this. One, my mother has Huntington’s disease, I'm not sure how many of you are 

familiar with Huntington's, but it's a neurodegenerative disease process, I have 56 

cousins in Georgia. Well, there's over 400 folks with Huntington's in Georgia, but 

there's 56 cousins of mine that I could name, that all have this disability where it's 

affecting their ability to move. My mom has had all those tests we were talking 

about, and it's been difficult. We've yet to have really good results from an MRI

or a PET or a CAT scan, what have you, because of her movement and because of 

her lack of following directions, her noncompliance, if you will. They tell her to 

breathe or not breathe and she's like, “I can't control that.” We have to figure 

some of those things out. I'm very encouraged about the advances that have been 

made. It sounds great, but I would like to see us have it where we won't have to 

worry about breathing, that we don't have to worry about instructions, and that 

people can get the results. It's a complicated situation in that MRIs, PET scans, 

all of those things would greatly benefit the Huntington’s disease community and 

other affected communities, because that's the only way you know how the 

disease is progressing. The flip-side is that a lot of these folks can't get the results

that they need. So, the second part, is that I also have dyslexia, a learning 
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disability. I'm one of 15 percent of the folks in the U.S. that have these wonderful 

things. Dyslexia, dysgraphia, dyscalculia, auditory processing, I have all those 

'DYS's and navigating the system can be complicated. I once again have showed 

up for all the tests we were talking about earlier and I'm always doing the wrong 

thing. I can't find any information as to what I'm supposed to be doing. People 

hand me a piece of paper and are like, "here -- follow these instructions", and I'll 

say can you read it to me? And they'll say "oh, can you get somebody else to read 

it to you?" Sure. It would be good to have a point where we have standards that 

are public that you can go, here - this is how you prepare for this test, here is what 

the results are from this test. Here is how to read this, how to interpret it, and 

what these tests actually mean. I've worked with so many folks within the 

learning disability community that, they get this information, hey, you need to 

have this test and they don't really understand why they're doing that. And so it's 

also a pride thing where people don't want to ask. They'd rather call me or talk to 

my partner who is a nurse, who is actually a nurse to the learning disability 

community when it comes to all of this, to help figure these things out. So, I 

encourage you as we're looking at this very hopeful, these hopeful advancements. 

I've been a long supporter of the Access Board and the great work you're doing. 

Please keep in mind we need to think from start to finish. It's not just about 

making a piece of technology accessible. It's about everybody understanding 

from the moment you find out you have to have that test, to the moment you get 

that diagnosis, or you get the results. The whole process is understandable to 
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everyone and accessible to everyone. The other thing is I once showed up for a 

test and they said you're noncompliant because I prepared for the wrong test. And 

so I thought I was going to have an MRI, I actually prepared for some kind of 

colostomy thing. Who knew, right? They're like: "you're noncompliant," and I'm 

like: "You're actually noncompliant! You're the one who should have told me 

what I should have been doing instead of pointing me to a random website." So I 

once again appreciate your time and I appreciate what you're doing. I think your 

work is incredibly valuable, and I appreciate you all being a strong voice, along 

with ADAPT, and NICKL, and the AT Act folks, that are out there alongside. So 

thank you.

>> GARY TALBOT: Thank you very much. Any questions from the 

Board? Thank you very much. We appreciate it. 

>> GARY TALBOT: Next is Margo Waters and after Margo is Janet 

Barlow. 

>> MARGO WATERS: Good morning. My name is M-A-R-G-O 

Waters and I am here representing several people, quite a few people from our 

disability community. I am an Independent Living Coordinator at Disability Link 

and so some of the concerns have already been mentioned. Ms. Simmons did an 

excellent overview of the challenges that folks with disabilities often encounter. I 
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also brought some other issues and concerns from others that Shelly didn't cover. 

Some of the things were like having accessible entrances to a lot of facilities 

where folks who are visually impaired who can't often navigate their way, where 

they were requesting that braille be a part of the signage, large print, like for 

elevator access and the registration form. They mentioned that for the visually

impaired that was a challenge there, maybe large print and braille. And at the 

dentist's offices, that there's not often folks -- some people in our community who 

can't transfer out of their wheelchairs, the dental equipment is not accessible for 

them to receive treatment. And it was mentioned about the examination rooms, a 

little bit small when us with wheelchairs are often in the rooms, there's not enough 

room in there to navigate even possibly even if we have to transfer alone, and that 

was another concern. For me, I have a concern about oftentimes when I go to the 

doctor, the equipment that is used to weigh us not being accessible to properly get 

weighed. I often, for several months have sought out to get weighed, and they

want to know how much your wheelchair weighs. And I guess they were going to 

figure that out manually about giving me an idea of what I possibly weigh, when 

sometimes that's really important to me as I battle with my diagnosis of MS, 

trying to keep my weight down so that I can be able to still get around. So 

improvements in that area. Even though so far there has been some advancements 

and I have had some visits with diagnostic -- going to have a diagnostic test that 

went very well, and I usually -- I have saw this kind of improvement in some of 

the newer facilities, like the breast cancer centers and things like that. And I've 
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had a bone density test that the table where I had to transfer was perfect. It fit just 

right, it was easy and accessible. So the improvements that are being made and 

those that will come would be a great tribute to us in the disability community. 

So thank you for your time. 

>> GARY TALBOT: Thank you very much. Any questions from Board 

members? Thank you very much. We appreciate it.

>> GARY TALBOT: Next up is John Wells. And after John, we'll ask 

Drago to come back up for just a few minutes. I know a couple folks had a 

question and I was remiss in not offering them the opportunity originally. Thank 

you, John. 

>> JOHN WELLS: Thank you. Good morning. My name is John Wells, 

I'm with Midmark Corporation; we're a manufacturer of exam tables. At the 

meeting in Washington in March, I explained Midmark is committed to universal 

design to minimize the need for separate, dedicated rooms for people with 

disabilities. We support designs and encourage flexible spaces that improve the 

lives of patient, staff and health care providers. We think a lot about patient and 

caregiver interactions, the caregiver requires access to the patient to perform 

physical exams, tests and procedures. If the tables are too wide, the care giver has 

to bend and reach in ways that lessen the effectiveness of the encounter. We also 
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think about tradeoffs. For example, when you increased width of the tables, to 

accommodate bariatric patients, average size or smaller stature patients will not be 

able to use both side rails simultaneously. We'll be showing this graphically in 

our June 8 submittals, and we'll just have to be careful to keep in mind that 

changes we make to medical equipment that are more accessible for one patient 

could also make it less accessible for another. With that, we do feel there are 

solutions available. Since the last meeting we have done further thinking about 

the proposed standard. We thought we'd share a few with the Board. Tradeoffs

are the recurring theme. At Midmark we find today, healthcare providers are 

planning for approximately a 10 by 10 foot room - 10 feet by 10 feet in size. In 

urban areas like New York City, that room size is often smaller - 8 by 10, or even 

8 by 8. When establishing the requirements for medical diagnostic equipment, we 

encourage the board to consider the standard equipment needs to be included in 

health care providers examination room and ensure the size requirements of the 

exam tables and chairs fit within the rooms of those size to support clinical work 

flows, while allowing adequate clearance around to facilitate the patient and 

provider mobility. There are solutions around that, even in smaller size rooms 

that we feel are applicable. We'll show those in our June 8 submittals as well. 

We encourage the Board to take into account that as exam sizes tables do get 

larger, the risk of the equipment tipping does increase. To prevent this dangerous 

tipping, the base of the tables and chairs increase in size; that's not just the 

regulatory standards and those types of things that come into play. However, 
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increasing the size of the patient takes up more space in the room as well. And 

limits the area under the table needed to aid in transfers. In regard to redesign to 

accommodate lifts, in a typical facility, a hallway can encompass three to 20 

rooms - it could be like an exam or treatment area pod. Each one of these rooms 

will include an exam table, at a cost of approximately $2,000 and upwards. 

Considering a table lift would be in the range of $2,000 as well. We would ask 

the Board to consider a redesign of a lift standard with a larger access point 

providing access for the patient versus the facility, reinvesting in each table to fit 

an existing lift standard. It seems as though we're change the tables to fit a lift. I

think there are options in regards to changing minor modifications to a lift that 

could have a lot of tables that are even accessible today, that would apply to lift 

standards in the future. We've asked to consider that. Lastly, as stated 

previously, we continue to support the Board's proposal to provide that a

minimum height a table or chair must adjust should be in the proposed range of 

17 to 19-inches, measured to the top with uncompressed foam. One thing I do 

want to add in regard to a lot of the scale discussions, we did -- Midmark released 

a product the scale was built inside of the table. So when the patient is transferred 

to the table, there's not need to be that extra step in that process, so there are 

solutions out there that could alleviate some of these steps and some pieces that 

may be more elegant and actually very simple for everyone. That also takes steps 

out of the work flow, it also takes steps out of process for the caregivers and staff, 

and we all win in those types of scenarios. With that, I appreciate the opportunity
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to spend a few minutes with you today. And we at Midmark look forward to 

providing further detail in our June 8 submittal. Thank you. 

>> GARY TALBOT: Thank you very much. We appreciate it. Any

questions? Regina? 

>> REGINA BLYE: Not so much a question, but a consideration. I know 

earlier you stated widening the board for bariatric patients, but as fellow board 

member Hans stated earlier, we have a common theme. You have the size of the 

equipment versus the size of the examining room, but one thing to consider, I use 

a wheelchair, and the width of the board is not very wide. So when I go to 

transfer, it makes it difficult because there's not much space for me to be able to 

put my hand and rotate. So the extra space is also needed and not so much just 

for bariatric, but also for transfer purposes. And so I know that also does take in 

consideration with the space in the room, but just don't limit it to bariatric 

concerns, there are also people who have spinal cord injuries or limited movement 

that could use that extra space for sliding over. 

>> JOHN WELLS: Thank you. And I will comment that some of the old 

exam tables were rather narrow. Today's standard is 28 inches. And the proposed 

standard is 30. And on bariatric tables, that can weigh up to 850 pounds, that's 

32. We found that 28 is very acceptable even for side and rotation and access. I'd 
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be curious on the Board's recommendations outside of what was previously an 

exam table from 20 years ago versus what's actually in the market today. 30 

inches is a very wide table in those spaces. And we would ask some 

consideration on that. 

>> GARY TALBOT: Hans. 

>> HANS VAN WINKLE: Mr. Wells, thank you. As an engineer, I'm 

always looking for elegant solutions, I really liked your thought. Thinking about 

this a little bit, I've always assumed a table is a table and we've been concerned 

with simple dimensions on that. Do you see other areas for elegant solutions with 

a table becomes an intelligent table and allows us to do multi functionality. 

>> JOHN WELLS: Absolutely. There's a lot of transition with electronic 

medical records, so the PCs in the space are much more accessible than they ever 

were. And that is completely changing the workflows, so there's a lot of options, 

where using that device, that PC in the space could manage a lot of things, 

equipment in the space, the tables, functions of the table, scale, take that data to 

push it through so the staff doesn't have to retype and all those things. We're just 

scratching the surface. The PC entering the exam room is something that's just 

revolutionary. It's been outside of room for so long and it's about time. We're 

going to see a lot of progress of technology in this space. 
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>> GARY TALBOT: Thank you. Phil? 

>> PHILLIP JENKINS: I think the exact same question. Adding the 

scale to the exam table, is there anything else besides the personal computer being 

added to the room? Any other combinations of new technology being put 

together? 

>> JOHN WELLS: Well, if you look at like vital signs acquisition, a lot 

of spaces, like a scale, historically in a physician's office a scale is in a hallway, 

and it's not only is it HIPAA and having your scale being seen by everyone, it's 

very awkward and in the northern states, when it's winter, you're putting all your 

bags down, your coats down and all those types of things. You think about that 

type of work flow. But there's also pods and triage areas where you have the vital 

signs being taken, blood pressure, height, weight, pulse, all those types of things, 

we feel those are going to condense around the exam room space so the patient 

only has to be transferred once, they come into the space, they come into the 

clinic, they go right to the exam table, they can get the weight, they can do the 

vitals and do all the types of testing before the patient is seen by the caregiver, as 

soon as they're done, they can checkout in that space, we think that's going to be a 

very simplistic approach to considering what we have today to what the future is 

going to be in the physician office. 
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>> PHILLIP JENKINS: Thanks. 

>> GARY TALBOT: Thank you very much. Any other questions? 

Well, thank you. We appreciate it. If we could ask Mr. Joe Drago to come back 

up, please. I think Phil you had questions? Thank you for sticking around for us, 

Mr. Drago. 

>> PHILLIP JENKINS: Hi Mr. Drago, Phil Jenkins, public member; you 

were talking earlier about the different requirements for scales, that there wasn't 

one size fits all type scale. I think we started the discussion in the room. Maybe 

we can continue that. Should we -- we love your input on should we have three 

types of scale requirements? Four? Five? We'd like your input how do we -- 

>> JOSEPH DRAGO: Looking at the basic drawing that you came up 

with, to separate out a stand-on patient from a wheelchair patient, I think goes a 

lot toward solving one of the problems, because there's not only Scale-Tronix, but 

a wide range of scale manufacturers that make perfectly adequate digital 

electronic stand-on scales, and if you're look for standards that go into a hospital, 

many of your hospitals have gotten portable stand-on scales that have handrails on 

there, they're easy to access, they have high weighing capacities. If your 

standards are also going to apply to doctor's offices, now you have a problem. 
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Because many of your doctor's offices, the scales that are in there should be 

candidates for the Smithsonian. They're your old fashioned, balance beam scales, 

they are tiny platforms. The profile of those tiny platforms are 4 inches. There's 

no handrails. So if you want to start and say, wait minute, I need a stand on scale 

standard, there's innumerable scale manufacturers that could provide that in 

existing technology. What do you need to do? You have to maybe have a 

standard to say that stand-on scales must weigh a patient above 600 pounds. 

Why? That knocks out all the antiquated pieces of equipment that cause patients 

with special needs, problems. Anything above five or 600 pounds that comes 

with a handrail is a solution to that stand-on scale process. Moving on. If there 

were wheelchair scales, standards for those, those wheelchair patients or patients 

with special needs if they can't be wheeled on, possibly they could sit. Now it's a 

duality. And in your diagram, you're showing a single ramp. Well, single ramps, 

by design, require larger platforms. We at Scale-Tronix have a dual ramp. It's a 

folding ramp that folds into a platform. When the ramps are open, you can pull a 

patient up on to the platform and continue across that platform so that the wheels 

of a wheelchair don't have to reverse in order to clear the platform itself. So now 

what are we talking about? We're talking about scales that have two problems 

here. Across your seat. 

>> DAVID CAPOZZI: Have you to use the microphone. 
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>> JOSEPH DRAGO: Now have you scales that have challenges for 

bariatric patients that have a large capacity that goes across the seat, but also you 

have spinal cord injury patients where that dimension is not problematic. The 

back wheel to front wheel is problematic. So in a design standpoint, there are in 

today's technology portable scales that have dual ramps that have smaller 

platforms that have solved many of the concerns that you folks are looking at. 

Lastly, from a technology standpoint, there are fold down scales, it's called 

stowaway technology, so that when the scale is not in use, it's less than 4 inches 

off the wall. When the platform comes down, now there are small beveled edges 

that are less than an inch across that give easy access for a wheelchair patient to 

those platforms. Overall solution when it comes to wheelchairs, if you want to 

project out to a year, 2020, any new construction or renovation in any kind of 

medical facility, you might want to think about flush mounted floor scales. That 

does away with any kind of profile. So if you're a wheelchair patient and you 

come into that medical facility, there's no bounce whatsoever. So whether you're 

a private practice or whether you're a major medical facility, that scale literally is 

built into the floor. Well, to move it from point A to point B, is that a big deal? 

No. If you do renovation, you just fill in the hole, a new rough in frame goes to a 

new location, and you're back in business. Okay? Two standards, I guess. 

Separate out. Don't have your patients that really need the stability to stand on a 

scale. Walk up any type of ramp. That's a safety issue. Have them be on a stand 

on scale or weigh them in a wheelchair or on a chair. 
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Atlanta, GA Page 85 of 88

>> PHILLIP JENKINS: Follow-up question. We heard earlier about 

putting the scale in the exam table. I don't think we would want everyone to 

transfer to an exam table to get weighed. Would that be a third option, if we had 

an exam table, a stand-up and a wheelchair?

>> JOSEPH DRAGO: Again, I mentioned earlier that Scale-Tronix has 

been at this for 38 years, and we make high capacity 880 to 1,000-pound scales.

And the accuracy is 100 grams. Over the 38 years that the company has been in 

business, with all due respect to all these manufacturers, many companies that 

wanted to add bells and whistles to their products. They might make an excellent 

acute care bed. They might make an excellent exam table or whatever piece of 

equipment; however, when it comes to the technology to put an accurate scale 

into another piece of equipment, is it possible? Yes, it is. Unfortunately, they're 

not scale manufacturers. So do you want to transfer into something that's not 

going to achieve your purpose? I can't answer that right now. I know that 

hospitals across the country that in their ICUs, they went from old fashioned sling 

type scales that were -- and by the way, Scale-Tronix was the 38 years ago, 

Carolyn Lepler had the idea that there had to be a better way to weigh a patient in 

a bedridden situation, and that design of a sling scale was hers. She's still the 

owner of the company today, and the point here is that we've gone through a wide 

range of things. Your Hill-Rom and Stryker and your major people put scales in 
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Medical Diagnostic Equipment NPRM May 8, 2012

Atlanta, GA Page 86 of 88

their beds years ago and the trend is getting away from it, because they have 

problems with accuracy, not that the -- so there's other challenges to say, oh gee, I 

can simply add a -- an accurate scale to a particular piece of equipment. In 

theory, it's a good idea. In practicality, I'm not sure it does the purpose. 

>> GARY TALBOT: If I could ask one follow-up. Have you guys ever 

done a mat, just a flat mat that sits on the floor? I've seen those at our vet's offices 

office for our dogs. I don't know the accuracy, whether or not it's as accurate as it 

would need to be. 

>> JOSEPH DRAGO: Again, maybe for veterinary purposes, it might 

make sense, but the technology to do patient weighing, it just isn't there. We've 

looked at a whole wide range of things. The in-floor scale concept. If you 

legislate to say after a particular date, any new construction or renovation, you've 

solved the problems that have been created by the -- by someone trying to give a 

product for everything. Thank you so much. 

>> GARY TALBOT: Thank you very much. We appreciate it. And I 

think that's -- I think that's it. Right? Yeah. We have just a couple minutes left. 

If somebody else wants to say something, we'll have open mic for a couple of 

minutes. 
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Medical Diagnostic Equipment NPRM May 8, 2012

Atlanta, GA Page 87 of 88

>> PAMELA DORWARTH: Thank you. It's Pam Dorwarth again. I just 

wanted to reaffirm because a lot of the speakers you've had up there. I've done 

the CT scans, the MRIs, I've done the -- I'm the diversity disability as you know.

And again, I come to the same point. We're trying to change -- we're making 

standards for the machines itself to change their purpose and their functionality

being correct versus trying to change how we get accessibility from the different 

diversified -- do you understand what I'm trying to say? We're looking at it from 

a backwards way is what I'm saying. We need to be changing how we can get 

people with different disabilities to the equipment, not change the equipment and

its functionality. I would have hated to have all the different testing and stuff that 

I had to do for my cancers, strokes, and the epilepsy, change those tables and 

everything, so they cannot properly function and give me the right treatment, or 

accurately. The same with the scales, when I went to rehab, they had -- the guy 

just rolled me on the wheelchair right there. Why change all those standards to 

one that can't fit all? Because that takes away the functionality. We need to 

change how we get the different diversity of disabilities. The other thing, and I

don't know how to do anything about this. But in rural areas, small towns, 

doctor's offices, hospitals, testing diagnostic centers, they feel they can't afford to 

have equipment that's ADA compliant, because their coverage through Medicaid 

or whatever, lack of insurance, doesn't allow them to have the right equipment. 

So they turn people away with disabilities. This happens every single day. And I 

know we can't do anything about that. But they make their apologies and tell 
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Medical Diagnostic Equipment NPRM May 8, 2012

Atlanta, GA Page 88 of 88

them they're compassionate. They'll suggest to the patient that they find 

somebody that has the proper equipment that takes their Medicaid or whatever 

their lack of insurance is. And they don't even help you. They'll tell you, go find 

somebody because it's not available here. I don't know what we can do to change 

about that, other than educating, but their excuse is, if they didn't have to meet 

certain standards, then they probably could afford that equipment. So that was --

that was something I -- just to make you aware of. There's nothing you can 

change, but something when you're thinking about making standards. 

>> GARY TALBOT: Thank you very much, Pam. Well, thank you very

much. We've reached 12 noon, and we'll close the hearing now, but thank you to 

everyone for your testimony, for coming and spending the morning with us, we 

really appreciate it. Thanks to the Board members as well. Thank you very 

much. 

[End of meeting.]