US Access Board Public Hearing: Unofficial Transcripts

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 Braitmay er, Access Board Chair Regina Bl ye John G. Box Edward Gee Christopher Hart Phillip Jenkins Mat McCollough Neil Melick Howard Rosenblum Deborah R yan 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 L ife 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 L aViola , Vice President
- Engineering, Hologic, I nc. 6. Glenn Ny gard , Director Engineering R&D, Skeletal Health Division , Hologic, In c. 7. Ed Toerek , Director, Quality and Regulatory , CT/NM Imaging S ys tems, Philips Healthcare 8. John Jaeckle , Chief Regulatory Affairs Strategist, GE HealthcareUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **2** of **88** 9. Milind D hamankar , 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. Caroly

n Phillips , Director of the Georgia Assistive Technology Act Program, Tools for L ife 13. Margo Waters , Independent L iving 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 y ears ago and will be chairing today 's hearing.

>> GARY TALBOT : Thank y ou, madam chair. My name is Gary Talbot, public member. Welcome to every one. Thank y ou 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 ye ar, in Washington DC. We received a variet y of comments. Before we get started with our hearing today , I 'll ask all the other B oard members present to introduce themselves, and starting with y ou, Regina, please.

>> REGINA BLYE: Good morning. Regina, Bl ye, public member from Austin, Texas.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **3** of **88** >> CHRI STOPHER HART: Good morning. Chris Hart, public member from Boston Massachusetts. >> JOHN BOX: John Box, public member from southern California.

>> HOWARD ROSEN BLUM: Good morning. My name is Howard Rosenblum from Silver Spring, Mary land. >> NEIL MELICK: I'm Neil Melick public member, West Palm Beach, Florida.
>> GARY TALBOT: Gary Talbot, public member, currentl y Wilmington, Delaware.

>> KAREN BRAITMA YER: Good Morning, I'm Karen Braitmay er, public member from Seattle, Washington.
>> PHILLIP JENKINS: Hi there, this is Phil Jenkins, also a member of the B oard that represents the public. That's what the term public member means for an y of you that are new. We're appointed to represent y ou on this B oard. 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 publicUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **4** of **88** 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 y ou to every body . I'm going to turn it over now to Rex Pace from our Access Board staff. He'll briefl y go over the hearing procedures for today and thank you again to every one for coming. Rex. >> REX PACE: Okay . If we could turn on the PowerPoints. The PowerPoints will be shown on my screen to m y right. If you're interested inUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **5** of **88** seeing an y presentat ions 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. Iwill give y ou a four minute warning. So y ou'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 y ou want to testify

and have not preregistered. Also, please turn off or silence y our 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 publicl y to w itness presentation or B oard member comments or member statements. With that, Iwill turn it back over to B oard member Mr. Talbot, and we'll proceed with the witnesses. >> GARY TALBOT: Thank y ou, Rex. Our first witness is Joseph Drago.

>> JOSEPH D RAGO: Good morning.

>> GARY TALBOT: Goo d Morning and if you could introduce yourself, please.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **6** of **88** >> 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 y ears. We're a digital electronic scale manufacturer, we're privatel y held with offices in New York Cit y. 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 hospital s 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. Appr oximately five to eight ye ars ago, we were involved with a number of consulting groups that were hired b y major hospital firms primarily

in California to adhere to ADA standards. And there were groups of scale manufacturers and other equipment manufacture rs 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 Scale
Tronix has been in this kind of competitive situation, hospital sy stems have standard ized on our products. Isay products in the plural, not just the single
-- not just the single item to do every thing 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. Every body wants oneUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **7** of **88** scale to do every

thing. Th ey

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 th e facility . As a scale manufacturer, we could basicall y build an ything, 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 go ing up to the scale platform. To begin with, if y ou have a low profile platform to begin with, and y our standard is going to be 2
- inches or less on the profile itself, y ou' re literall y adding a patient safet y concern b y 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 ty pes 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 yo u add a 2
- i nch lip and somebody goes up onto that ramp, now you've got 4 inches and you're increasing the possibility of tipping. So we politel y suggest that a 2
- inch lip should not be on there to begin with. As far as standards are concerned, rather than hav ing one standard that does every thing, perhaps there should be a stand
- on scale standard, and perhaps there should be a wheelchair
scale standard, and the next comment that Ihave is platform size. In the drawing,US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **8** of **88** we show a huge platform and we onl y 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 seve ral others, the suggestion for two handrails on the platform is well
- founded, however, again from a patient safet y standpoint, we suggest that if you had wheelchair standards and that patient needed the assistance of two handrails to walk up a long ramp, p erhaps 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 briefl y, 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 oth er products that are in our catalog. I speak of this genericall y, it's not only Scale
- Tronics that would offer these products, but they 're available. Thank y ou so much.

>> GARY TAL BOT: Thank y ou very much, Mr. Drago. Thank you for yo ur comments. Our next witness is Patricia P
-- I'm sorr y. Pam Dorwarth, former Access Board member. And then Patricia will be next.
>> PAMELA DORWATH: Thank you so much for the captioning. As aUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **9** of **88** former B oard member, I'm so excited to see everybody . I can't contain my self. My comments are I'm an ADA liaison, have been for 19 y ears in the state of Florida. Besides other positions in Florida for people with disabilities and of
course m y past membership on the Board. I'm just going to make a few comments. The gentl emen 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 my self, 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. Every thing judged on or say

minimum, because guaranteed everybod y is going t o do just that minimum, and you have no longer met the needs of people with disabilities. And a couple of examples would be since m y 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 phy sical 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 yo ur criteria, your stipulations more accommodating or adjustable so it can meet all those different
-- I don't have the upper bod y s trength in this rollator chair than I did in m y regular wheelchair. I'm starting to lose my vision. So you can't judge a disability with limitations either, because everyUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **10** of **88** person's disability

has different parameters. And I that was going to tell yo u, but I lef t my notes with m y son. Some personal examples of stories that happened. Again, like the gentleman said before, yo u 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 yo u can't make it and nobody is there to help y ou. Don't ever assume that there's somebody

there to help you. Because they are not. And y ou 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 yo ur 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. L ike I sai d, I left my notes, but I'm so excited to see every body . 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 the ir people with disabilities, all different disabilities, and say , wh y are they doing this to me? Are they so prejudice they

don't care? That's not the case. And we're try ing to get rid of that and make the whole country and every

thing else more accessib le for every body . Thank y ou and it's so great to see you all. Thank you. >> GARY TALBOT: Thank y ou so much, Pamela. Any body have questions for Pam? Any

board members?US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **11** of **88** >> 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 questi on for Mr. Drago. Should we have three standards for three different scales? Should we have four? Should we have five?

>> PAMELA DORWARTH: Ithink y ou need to have a range, also with that range, have whatever the limitations happens to be for that par ticular disability . It can't be so definitive. It can't be so just say ing 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 adjustabl e 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 impairedUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **12** of **88** and ep ileps y. Please don't do an y flashing for people that are hearing impaired, because you'll give me seizure. Thank y ou very much. All those different things that Ihave personall y experienced or brought to me by other people with disabilities to add to th e input. So Iappreciate the question. Yes. >> GARY TALBOT: Thank y ou very much, Pam. And our next witness is Patricia Puckett and next on deck is L iz Persaud. Thank y ou, Rex. Patricia Puckett? >> REGINA BLYE: She's here. She's coming around the corner. She's here.
>> GARY TALBOT: Good.

>> PATRI CI A PUCKETT: Thank y ou very much. Actually , m y board chair , Simmons is going to provide the testimony for today , but she hasn't arrived ye t, and so if we could bump us to later, will that work ? >> GARY TALBOT: Yeah. That's fine. Thank y ou very much. Next up is Ms. L iz Persaud. >> GARY TALBOT: While we're getting set up, the next person will beUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **13** of **88** Elizabeth George. >> LIZ PERSAUD: Good morning. I'm Liz Persaud. I'm with the Georg ia 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 testimon y in regards to my personal experience when it comes to overcoming barriers to medical equipment. Just to give a brief background on m y medical diagnosis, at the age of nine months Iwas diagnosed with a form of muscular dy strophy , called spinal mu sculature atroph y t ype II. SMA type two is a progressive neuromuscular, neurodegenerative disease, that’s a mouthful. It manifests in two specific way s 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 musc le weakness. Every day the way s it affects me is through muscle and joint pain, muscle fatigue, and I'm also phy sicall y 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 ye ars 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 accessibil ity 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 y ou can seeUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **14** of **88** that the counter to check in actually comes up to pretty

much m y 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, wh y isn't that a standard that all the counters, no matter where you are accessing in the doctor's office, you can just access i n different various levels. The next thing Iencounter 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 actuall y got weighed at a doctor's appointment. I guess I'm on an y 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 ye ars and y ears since I was a little girl that I've been on an exam room table. The next phot o underneath the photo that Ijust 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 nearl y impossible, extremely uncomfortable, very painful. Most of my

exams are actuall y done in m y wheelchair, which I feel safer that way , but at the same time, Ifeel 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 ofUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **15** of **88** my wheelchair without me in it. There's a white sheet that's actuall y 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 m y mom actually made for me many y ears 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 Iencounter somewhere that Icannot access or un til 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 den ied 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 y ears 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 cramp ed when y ou have a power wheelchair, y our 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 thatUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **16** of **88** are in wheelchairs got mammograms but they were laying down and more comfortable? I s that a possibility , I don't know, but may be it's something worth looking into. And then definitely , disability awareness training just to freshen up on the interaction an d getting those basics down. One thing that I've had conversations with folks about, which I would suggest is may be 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 gy m working alongside other folks without disabilities, something to think about. Iappreciate y our time and thank y ou for listening. >> GARY TALBOT: Thank y ou very much, Liz. That was really good. I think there's man y of us that reall y appreciate what you said, and concur. Any questions? Regina? >> REGINA BLYE: Hi, Regina Bl ye, 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 every one's disability is different, but this would kind of give us an idea of what would accommodate you.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **17** of **88** >> LIZ PERSAUD: Exactly . The nature of my disability now is I do not transfer without a Ho yer lift or some ty pe of transfer lift. Oftentime s, when I'm getting out of m y 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 s ome 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 y ou. >> GARY TALBOT: Any other questions from the B oard members? Bo y, Liz, thank you very much, we app reciate it. Thank You.

>> LIZ PERSAUD: Thank y ou. Thank y ou for the time. >> GARY TALBOT: Elizabeth George. And then ne xt on deck, I'm sorry , is John Laviola. John, y ou're next. [ Laughter ]. >> ELISABETH GEORGE: He knows. Good morning. Vi ce C hair Braitmay er, Access Board , and every one here today . M y 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 forUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **18** of **88** Phillips, based in Massachusetts. Would like to thank y ou for y our invitation today to present on behalf of medical imaging device manufacturers which are represented b y Medical Imaging and Technology Alliance , MITA. Itis an honor to be here to speak on this important issue on ensuring appropriate access to medical diagnostic equipment for persons with disabilities. MI TA knows that without accessible medical equipment, individuals with disabilities may not have equal access to qualit y medical care. I have bio
- electric al 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 ye ars. First, we want to point out the issue of accessi bility , 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 shortl y you'll hear from some of m y colleagues on a more in
- depth technical anal ys is of the impact of the proposed standards on various medical imaging modalities, including x
- ray imaging, computed tomograph y, diagnostic ultrasound, nuclear medicine imaging, and magnetic resonance, which are primaril y us ed for diagnostic purposes ; which are primarily used in the screening for common diseases, which relies on earl y detection to ensure the most beneficial outcomes. I would like to share a personal standpoint. Having been a primary care provider for a numb er of y ears for my mother after she had a stroke that left her paral yz ed, Ipersonall y helped her access an MR scanner when she required an MRI exam. With my support, asUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **19** of **88** well as the clinician's guidance, we ensured that she was placed properl y on the tabl e to ensure the shortest possible exam time with the most effective image quality results. It is important to realize that the role of that phy sician 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 employ ees as well. Second, while the Access Board has pointed out that it does not have enforceability authority for the proposed standards , MI TA members take the m very seriously . Further, we are aware that the D epartment of J ustice is closely monitoring the development of these proposed standards and is poised to move forward as an enforcement mechanism using their authorit y under the Americans with Disabilities A ct. 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 i s 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 sy stems requirements. T hese 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 man y features to ensure accessibility forUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **20** of **88** patients. We are required to utilize recognized standards, including the ANSI/AAMI Human Factors Engineering Standard , as well as Internati onal 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. L ikewise, 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 a s 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 exampl e. For example, i f 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 , phy sical ability to enter and move through the opening in the device, th e 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 safet y and efficacy of the device and ensure it has not changed. Thin gs we take into consideration include customer input, new regulations and standards, cost reduction efforts, as well as potentially new applications. L astl y, in the Access Board notice of proposed rulemaking , you note that there are maybe an economic bene fit to some manufacturers in the finalization of these standards. As stated atUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **21** of **88** 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. Concurrentl y, our member c ompanies 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 y ou for this time an d consideration and look forward to working with y ou 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 alread y 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 mammograph y devices. >> GARY TALBOT: Thank y ou very much, Elisabeth. Thank y ou for yo ur comments. Questions from the B oard members? One down there on the right. Please go ahead.
>> NANCY STARNES: Nancy Starnes, public member . I know you say that y ou 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 y ou consider a new design, or is this an on
-US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **22** of **88** goin g input source for yo u? >> ELISABETH GEORGE: There are multiple aspects of this per our quality s ys tem regulations that the FDA has imposed on us. As part of a new design process we actually activel y go out and seek communication with the
-- all of th e 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 a ll design inputs into our product so we're doing continual design improvements on our devices. >> NANCY STARNES: Thank y ou very much. >> GARY TALBOT: Thank y ou, 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 F ederal C odes and R egulations, the 510K process, we would appreciate in y our input if yo u' d give us the list of those th ings that you need to adhere to and specifically if there's an y perceived conflicts between the proposed regs and some of the safet y regs or help us understand where you see the difficulty in meeting both.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **23** of **88** >> ELISABETH GEORGE: Certainly we'll make sure to include that in the inputs. >> GARY TALBOT: Thank y ou.
>> GARY TALBOT: John L aviola please, and next up is Glenn Ny gard.
>> JOHN LAVIOLA: I'm John L aviola, I'm here with the MI TA group, but I'm Vice Preside nt of Engineering for Hologic, Inc . We're a compan y dedicated to women's health. I'm here to speak about the mammograph y s egment. I want to start b y sa yi ng that we are certainl y committed to provide accessibility for all patients undergoing a mammogram. I speak for Hologic directly , bu t I know, amongst our peers, we're very passionate about women's health and particularl y mammography. That's something that has a lot of visibility in our day
- to - day

lives, thankfully

over the last 20 y ears there's a lot of awareness, and certainl y someth ing that we live as associates of Hologic and I know m y 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 unfortunatel y for our products. Accordingl y, MITA is eager and honestl y I think very excited to engage in collaborating with the Access Board and establishUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **24** of **88** 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 wa nted 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 y ou 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 L iz's point, there actuall y, I didn’t have it in my notes here, but there actually is what we call a decubitus table, a table provided for mammog raph y 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 lay ing down, decubitus, to use the medical term. There is no compromise to image qua lity and no compromise to care. Specific questions were asked in the proposed requirements. And the rest of m y 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 so me 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 p latform. 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'US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **25** of **88** products; we t ypicall y 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 Ibelieve 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 necessaril y anticipate typically good design of gantries and other sy stem dependencies, such as how much breast platform depth and knee clearance yo u get at various heights of the breast platform. One example is that clearance that goes straight to the floor. This particular s ys tem would not be compliant, because of this small lip that y ou 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 bol ted to the floor, they have to be positioned, and without that lip, there could be some danger of it tipping. So again, Ithink 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 supp ort. Standing support features clause, in M305.3.2. d erive the standing support features from architectural guidance for accessible bathing fixtures. Now, the supports identified on the mammograph y s ys tem we re never intended for someone to lift themselves up for positioning. They reall y were intended toUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **26** of **88** 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 o f 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 . P art of standard screening mammograph y 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 ther e are some that have particular structures in place that would make this difficult. We can help out in establishing this as well. Again, w e want to collaborate on particularl y on diagnostic views and interventional view, and all the potential modalities our devices are used for. There was a specific question about design cy cles, and design cy cles t ypically for this ty pe of equipment; capital equipment would be multi
- ye ar programs. So if changes were to be implemented [inaudible], it would ty picall y be a multi
- year ty pe 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 y our work. And, I just want to letUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **27** of **88** yo u know we did earl y homework on this. I recently attended an inte rnational Committee on Mammography Safet y 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 y ou 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. I f I could ask a quick question. Just so Iunderstand, and I think the plate y ou were talking about, on the one picture where you wer e talking about the toe clearance, and y ou 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 reall y don't need the toe clearance? I s that what you are that saying ? >> JOHN LAVIOLA: Well, this might be our interpretation of the standard, was that y ou 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 y ou. I appreciate it.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **28** of **88** >> JOHN LAVIOLA: It's a small part.

>> GARY TALBOT: Thank y ou. An y other questions from the board members? Matt. >> MATHEW MCCOLLOUGH: Mat McCollough, public member. Sir, I'm from DC and DC has the highest mortalit y rate among women with breast cancer. M y concern from the disability community

is for women that have severe neuromuscular t ype of disabilities. The ty pes 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 diagn os ed in that case . So my question is, are there technologies that could have gone bey ond the t ypical stationary breast machine sy stem that wouldn't require a woman or a gentleman, that will have to reall y be still, and be in such a position that would req uire an accurate reading per se?
>> JOHN LAVIOLA: Let me make sure I understand. Iwant 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 withUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **29** of **88** 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 read ings 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 probabl y has unfortunatel y possibly, I will apologize to all women, because of the immobilization of the breast, probabl y is least likely to have some of the issues yo u' 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 any body has had that experience with a camera with fast motion. So, things that we do do, Idon'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 ear lier, 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.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **30** of **88** >> GARY TALBOT: Thank y ou. Any other questions from the Board? Thank y ou very

much, John, we appreciate it. >> JOHN LAVIOLA: Thank y ou. >> GARY TALBOT: Next is Glenn Ny gard. 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 sy stems I'm here to talk about, the technology

is called DEXA , but something we all are familiar with, it's bone mineral densit y scanning for osteoporosis assessment. These scanners are very important for treating a devastating disease, and is particularl y 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 D EXA; 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 a s 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 essentialUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **31** of **88** equipment. The area we're most focused is on the diagnostic qualit y and safety. But bey ond that, having a saf e, dignified exam is important to us across the board. So while Irepresent the DXA industry , Iwork 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 reall y 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 sy stems: the on e on the left, I believe, has a 28 table height; the one on the right has a 25
- inch table height. If y ou look at the sy stem on the left, you can see there's a very large mass beneath the patient. That is a motion control sy stem. It' s a very large x
- ray sy stem. 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 ty

pe of equipment can be seen in the sy stem on the right, but y ou 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 sy stem down t o 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
- ray s in a uniform way , because these sy stems, 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, ourUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **32** of **88** inability to break the table, or to section it in some way that would allow parts of it to
- I'll make th ings up
- tip down or become a lift, that's a big challenge for something that has to be one piece and pass x
- ray s 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 m entioned 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 frequentl y 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 y ou're monitored once a y ear to see if y our treatment profile is working or not harming you, more importantly. The question was asked, what other barriers may exist to this equipment, an d Ithink as had been mentioned previously , room planning is very important. I f 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 pic ture of it that makes it clear there's a lot of technological equipment below the table with the Legacy Sy stem and the sy stem level design isUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **33** of **88** required to start with a smaller x
- ray source, a smaller motion control sy stem, smaller frame. In addition, the p resent time, these sy stems, the majorit y of them do not have lifts to lift the patient; they're a fixed height with ste e l pedestals. In order to get down low enough to accommodate 17 inches and then to get back up would require a sizable elevator s ys tem. 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 greatl y concerned about this. We would like to provide access to all patients. And Ithank y ou all very much for allowing me to speak here. If there are an y questions, I'll be happ y to answer them. >> GARY TALBOT: Thank y ou, Glenn, thank you very much. Are there any questions from the B oard? Chris?

>> CHRI STOPHER 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 pl atform once you've had y our scan. Is that something that y ou 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.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **34** of **88** But the nature of the t ype of plastic that we use, which is designed not to allow biological ingress and be easily cleaned, it can tend on stick to y our 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. Ny gard, I thank you for y our comments. I was interested in y our 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 clearl y, there is an interaction between the two. And we'd be interested to lear

n more from y ou and any data yo u 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 certainl y concerned about the cost of this equipment. Because the more expen sive it is, the less likely this equipment will be available to patients. So any data that y ou have that tell us that, we're not authorized to discuss room dimension, Idon't think, Gary , but certainl y if there are some data that would allow us to make be tter use of the equipment, that would be very useful. >> GLENN NYGARD: I'll provide some data on at least what we'reUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **35** of **88** aware of in terms of room planning problems. Can't say what an ideal room is ; it's not my

area of expertise, but y es, I'll provide data. >> GARY TALBOT: Thank y ou. 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 an y padding on those tables. And certainly

when y ou're working with people with certain ty pes of disabilities, the bony

prominences tend to within, I've been told in less than 10 minutes, y ou're going to begin to get a stage one decubitus ulcer or skin b reak down from that. Has there been an y 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 ty

pically use, we have standards for how stiff it is, obviously , h ow radio
- transparent it is, that is, it will not affect the image quality . Today the padding on s ys tems that I've been on is comfortable, but Iwouldn't say it's overly thick, around three quarters of an inch thick. Whenever we make a change or look at c hange material, outside the area of strength or whether it works with the
x - ray s ys tem, because it's a human interface, it's very important to us, something we look at closel y. I just don't have experience with the selection process it's gone through in the last several reiterations. Iwill be mindful of it for our nextUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **36** of **88** iteration.

>> NANCY STARNES: Iappreciate that. Thank y ou. >> GLENN NYGARD: Thank y ou. >> GARY TALBOT: Any other questions? Chris?

>> CHRI STOPHER HART: Iwanted to go back to y our concern about the elevator height adjustability . Correct me if I'm wrong, but for the 19th or 20th century , when y ou wanted to change elevation on a bed, y ou cranked it. And then somewhere in the 80s, we started to see electrical motors. So I'm tr yi ng to understand your cost implication of several thousand dollars to do that. I s 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 sy stems that require elevated motion for rotation of the C arm. I'll provide data. >> GARY TALBOT: Regina?US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **37** of **88** >> REGINA BLYE: I'm fine. Thank you.
>> MATHEW MCCOL LOUGH: I'm try ing 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 p laced any where else within the room? If that's the case, if the technology is so large, I'm trying to understand wh y 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 ty pe of technology . I'm just wondering in terms of the medical industry , it see ms 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, Ithink 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 MI TA 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 Ithink to Matt's point, is there an y opportunity to move someth ing that may be is that oneUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **38** of **88** 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

subsy stem. So our x
- ray subsy stem 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 s ys tem happens to be pulsed. And that's how we accomplish the dual energy of DXA. That sy stem, today , can be redesigned, it's a multi
- ye ar effort, but there are certain fundamental dimensions that can be cannot be made smaller like laptops. Unfortunatel y 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

shieldin g. 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 sy stem and insulating it so it doesn't arc and damage the equipment or otherwise cause harm. With regard to our ability to improve it, y es, 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 aroundUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **39** of **88** 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: G reat - boy , that's awesome. Thank y ou, Glenn. Thank y ou very

much for y our comments. We really appreciate it. Thank y ou. >> GLENN NYGARD: Thank y ou. 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?US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **40** of **88** >> JOHN JAECKL E: Well, Ithink we were going to talk back and forth if that's okay
. >> GARY TALBOT: Yeah. That's great. It will work.

>> JOHN JAECKL E: All right. If an ybod y wants to see a plastic model of the CT sy stem, >> GARY TALBOT: You can pass this around to every body
. >> REX PACE: I will tell y ou when you hit the five minute mark.

>> JOHN JAECKL E: It's one continuous kind of piece, because it all flows together. The onl y reason -- my name is John Jaeckle. I work for GE Health C are. I'm the Chair of the MITA CT group. And the co
- chair of the MI TA MI
- Dose Reduction Task Force . I w ant 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. Ithink that's a good opportunit y to broaden some of these requirements. So the y 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 alsoUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **41** of **88** where some of these conflicting requirements may come in. I've been very impressed with the comments here today , and the interactivit y, so I hope our presentation can address some of the questions that have been asked and also provide some more thought pr ovoking 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 y ou. >> ED TOEREK: Good Morning. M y name is E d 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 JAECKL E: 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 M ITA 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 no ted that these are prescription
- onl y devices and the clinical objective ofUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **42** of **88** 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 sy stems use an x - ray tube which r otates around the patient collecting data from different angles, which are then c ombined 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 i n the CT sy stems. 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 tomograph y. PET is one of the most frequently used molecul ar imaging procedures . Molecular imaging is a t ype of medical imaging that provides detailed pictures of what is happening inside the bod y at the molecular and cellular level.
>> COURT REPORTER: Can y ou slow down a little?
>> ED TOEREK: Yes. Mole cular imaging allows phy sicians 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 hy brid scanners, because these hy brid s ys tems are so common we are combining the CT and nuclear medicine presentations this morning. Here are some images of a CT s ys tem. The
-- that includes a
-- you can't see: I apologize for that . Includes the gantry - big piece of the equipment isUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **43** of **88** 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
- ray s through the little window that y ou can see inside the central board of th at 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 s ys tem in one larger gantry . It's a deepe r, larger piece of equipment. The patient goes through both of those technologies.

>> JOHN JAEKL E: Yeah; if I can just add some things. On the lower picture here, because the tube on top, y ou can see that the PET and the CT acquisitions are back to b ack, 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 Isent with the single sy stem 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 s ys tem byUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **44** of **88** 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 sy stems are stationary s ystems, which are fixed to the floo r. These general nuclear medicine gamma cameras can accommodate multiple patient positioning options, including seated in a chair, wheelchair, standing or ly ingon a gurney or hospital bed directl y. CT scanners are excellent in providing structural, anat omic, 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 extremi ty 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 qualit y diagnostic images are the ultimate goal of the s ys tem. This is what these sy stems have to provide in order for the ph ys icians to make their final diagnosis. These s ys tems are for prescription
- use only ; are not independentl y used b y 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 s ys tems are designed for virtuall y a ll situations, including critical care,US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **45** of **88** limited mobility , trauma, emergency room cases, unconscious and serious ill patients, so we do have to be able to accommodate all ty pes of patient populations. Some of the common technical criteria for most of these devices is M301, which is for supine, prone, and side lay ing 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 pos itioned in the seated wheelchair and standing positions. There are no patient operable parts in these sy stems, so criteria 307 does not appl y in this case. Some common or ty pical features of the current design include a long couch or patient table for th e 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 partiall y 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 ar e there to help stabilize the patient during the exam. Patient lift compatibility does exist with a number of sy stem configurations; however, there are a wide variet y of different t ypes of patient lifts and different sy stems 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.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **46** of **88** >> JOHN JAECKL E: Again, on the transfer surface side, I mentioned a bit of the considerations on the PET. A l ot of the same considerations we've heard on DXA appl y 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 requi rement 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 th is is where the international standards piece comes in , i f 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, dep ending on if it's under fatigue loading or the ty pe of material used. So if yo u 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 y ou' ve got to find something big and structural to put that on. Those ty

pes 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 phy sicians 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 t ypes, weUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **47** of **88** have different models. Some go down to 17 inches. Some don't y et. There is access on most of our tables for a Ho ye r lift to come in from the f oot 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 lay outs. All of our equipment that we're talking about here today , there wil l be considerations for MR, but the MIand CT would accommodate a ceiling lift as part of the room lay out. 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
-- sett ing requirements. These are large capital equipment planned in advance. Manufacturers go in and work with the site on the room lay outs. Every one is a custom design so there's opportunity there. Some of the se 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 lay out 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 sy stem

– the dotted line that goes around it
. That is governed now here b y 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 y ou see here the way

this room is laid out there's a large door to come in, andUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **48** of **88** accommodates in this case a person on a stretcher. So on these ty pes o f sy stems, we're talking about larger spaces that can easily be put into accommodate more issues. We do have communications, our sy stems 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 read y to help or to have facilities such as if y ou can't get a table lower, raise the floor b y a couple in ches 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 th at we have to apply
- we can give y ou the whole list of that. transition time. Again, we go through a rigorous qualit y sy stem management, and ty picall y multi
- ye ar projects to get stuff in. We think that the two methods is very supportable. New requirem ents do go into full er 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 opportunit y 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 toUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **49** of **88** advance, we take into consideration a lot of manufacturers have gone to like the bar iatric 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 collaborati on. 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 Ithink it's important to have a technical knowledge of each of the different modalities and what can be done and what y ou can do in may be a short
- term goal, intermediate term goal and longer term goal. Thank y ou. >> GARY TALBOT: Thank y ou very much, we reall y appreciate it. An y questions from the B oard 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 JAECKL E: The actual x
- ray is on for probably

less than 10 seconds. But there is prep time. So the technologist would bring the pat ient into the room, get them onto the table, and then get them positioned on the table.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **50** of **88** Once you're on the table, you don't want to move. So again you're taking a picture. That's wh y ther e's breathing lights. Because y ou have to lots of times hold y our breath, you don't want the respiratory motion. Some scans require an injection of IV contrast. So y ou might be on the table a bit longer for that. Because that has to be timed with the s tart 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 y ou get in the room and leave are probabl y 15 minutes. Nuclear scans are longer because there, yo u' re injected with a radio isotope so y ou 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 y ou have to accumulate the counts over time. But in those exams, the techs wil l ty pically be in there. M y 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 ba ck to DC. DC also has a huge deaf population as well. Howard Rosenblum and Icome 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 clearl y . 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.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **51** of **88** >> JOHN JAECKL E: Yeah. Very good. The communication piece , C T is relatively

quiet compared to MR. I f needed the technologist can go into the room and do a CT scan. That happens frequentl y 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 y ou hold y our breath, you watch this count down." That's the main thing you need to do for communications. There's also intercom s ys tems between the two, those are in multi lingual, if y ou ha ve a canned
--
>> MATHEW MCCOLLOUGH: One more
-- one more point with the intercom. It wouldn't necessaril y work with a deaf person.

>> JOHN JAECKL E: No. For people with hearing impairments, we would rel y 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: I s it on? Ithink it's on.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **52** of **88** >> 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, Imean, 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 an y 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 ty pes of instructions would have to come from the techn ician 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 m ore 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, wh y isn't the light enough for everyone? I f you're also providingUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **53** of **88** audio, what we're concerned about is there a way that y ou can do that visually ? Could y ou have something with text?

>> JOHN JAECKL E: Yeah. I
-- we'll do it. Part of the audio is that the technician t ypicall y 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 tim e while they 're being prepped and "y ou're about to have the scan," "y ou'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 sen se 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".

>> G ARY 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 theUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **54** of **88** 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 breath ing light versus the voice commands, those are redundant. The commands coming from the sy stem tell the patient to hold their breath just like the breathing lights do. It' s both visual and audible.

>> JOHN JAECKL E: But MR has like squeeze ball s that c ould be incorporated onto a CT sy stem. >> ED TOEREK: As long as it's not in the field of
--
>> JOHN JAECKL E: Right. You have to make sure it's not in the field of x
- ray view. >> GARY TALBOT: Okay . Thank y ou. An y other questions from the boar d? 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 JAECKL E: We agree , we could have the squeeze ball in theUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **55** of **88** person's hand, a button, like MR does. >> GARY TALBOT: Because that wouldn't impact the equipment. You could do that separatel y.
>> JOHN JAECKL E: 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 Bl ye public comment. Just wanted to expand on that. I f you are going to do some sort of alert s ys tem, make sure y ou consider hand dexterity , some people aren't able to do the squeeze. You mentioned squeeze, take that into consideration.

>> JOHN JAECKL E: Again, I think that's wh y it's important to work with all the stakeholders here to figure out what is a good solution or alternative solutions for those. Thank y ou.
>> GARY TALBOT: Great. Thank you very much. Okay . Next up is Milind. Thank y ou, Milind. Iappreciate y our helping me. And then next up afterUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **56** of **88** Milind is Tony

Roder. >> MILIND DHAMANKAR: So good morning every body . M y name is Milind DHA MANKAR. 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 phy sician on the other side of providing health care, now working with the medical device company. I'm an MR expert for more than 20 y ears, 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, particularl y i n context of the CT scan and PET scanners . M ost of it does a pply 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. Ialway s 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 safet y as well a s efficacy for the equipment. So MR is all about imaging the hy drogen protons in the body and it's the water molecule. For that, what y ou require is a strong magnet and radio frequency waves. With that, y ou get a very good multi
- angled image, which give s y ou 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 y ou can identify the pathology . It also givesUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **57** of **88** challenges in its installation. Y ou 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 imp ortant 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 facilit y doing for the s ys tem and how it is planned. So what you can see here is common objects, which are with the patient, like the ox ygen c yl inder 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 nonfe rrous material into consideration. Ed and John covered that, but I will again highlight that in respect to MR in particular. We have the abilit y 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 y ou could have patients
- even pediatric patients
- in any position, and y et can get images very well. What y ou see here is a 3D image, which is also giving curved multi
- plan ar reconstructions, giving the ability to scan patients with very

difficult anatomies as well. MRI is designed effectivel y with image patients , all ages and sizes. The patient, table weight , the bore size play s a very important role to give access to dif ferent kinds of patients. MR conditional
- and that's where this modality has, that every

thing within the magnet room needs to be MR conditional because of the presence of this large magnet. However, weUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **58** of **88** have detachable tables which could go out of the ma gnet 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. Onl y 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 qualit y. I know the discussion on patient communication, MR has a challenge here, and with y our proposed requirement on 306.1, because of the gradient noise, becaus e 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 ty pes of communications, and because it's a low
- radi ation 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 communicat ion possible on MR as well. Again, I think Ireall y thank this opportunity to present within my time limits ; I tried to differentiate what MR could bring on and what are theUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **59** of **88** differences for MR, and we look forward to see how we could accommodate those rec ommendations. Thank y ou. >> GARY TALBOT: Thank y ou very much, any questions from the Board? Thank y ou very

much. We appreciate y our testimony . Thank you. Next up is Tony

Roder. And then after Tony , is Shelly Simmons.
>> TONY RODER: Good morni ng every one. Thank y ou 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
- R ay 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 specificall y 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 alread y presented. And part of these manufacturers, we are committed to enabling patient access. We need to generate these im ages 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. TheseUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **60** of **88** are big capital pieces of equipment in most cases , that require some significant investment and that goes along with acquis ition 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 reall y like to talk a little about some specifics with the interventional and general x
- ray s. So interventional equipment, this is used in a surgical t ype setting, we're talking about procedures that involve stent placement, we're talking about orthopedic surgeries, we're t alking about that ty pe of procedure. In realit y, these patients are sedated alway s. There is no access on and off the table in the room. It' s alway s going to be under sedation. So from an interventional x
- ray

perspective, that's the t ype of use case we 're dealing with. And there are different types: fixed and mobile. The fixed ty pe will be in a surgical setting b y itself bolted to the floor. The mobile units could be brought into a surgery

suite when needed and taken back out. But still , the proced ures are done in that ty

pe of setting. X
- ray

equipment in general, again, fixed or mobile, this is the ty

pe of equipment, two dimensional images could be either real time or static, and there's been some major advances in this ty pe of equipment over the l ast several ye ars 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 an y 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 b y imaging not on the table or not in this positionUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **61** of **88** or standing against a wall as I am in a chair? And in these cases, ye s, that is the same standard of care for this ty pe of detector technology I 'm talking about here. So there's a lot of access that's enabled b y that time of s ys tem today . This page reall y 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 ty pe 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 y ou see pictured here, difficult to see here. You're not going to be able to see m y laser. On the right is a fluoroscopic sy stem, generates real time images. Again, used sometimes for more slight interventional ty pe 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 ty

pes. The primary

thing I want to point out here , just as discussed with the DXA s ys tem, the ph ys ical constraints of the tube, we can't shrink it quite like we can with computers, but there may be opportunities, but it's completel y dependent on the specific s ys tem, what the goals of that sy stem 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 justUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **62** of **88** in closing, I want to again thank the group for letting us present today . We are committed to e nabling 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 rea l 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 y ou through those. And then we also, as discussed in man y 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 reemphas ize, 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 th e 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 y ou again for yo ur time. If there's any

questions. For either m yself or an y of m y c olleagues that y ou've thought of. Thank y ou for y our time. >> GARY TALBOT: Thank y ou, Tony , thank you very much. Board members, an y questions?US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **63** of **88** >> PHILLIP JENKINS: This is Phil Jenkins, hi, Tony . Question: You talked about the various stakehold ers, the techs, the admin, has there ever been a place with all those folks have come together before to discuss other t ypes of issues, safet y, access or anything else? >> TONY RODER: Yes, definitely a good example, and this is something that I'm sure many of yo u have heard of the medical radiation concerns, FDA, stakeholder groups like ASRT, AAPM, ACR, MI TA, 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 key s. 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 may be that was accomplished. And obviously Ithink we hav e -- ye ah. An example would be we hold a stakeholders meeting every y ear 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 y ear. L et'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. Ithink in our written comments, we'd be able to provide more details on those ty pes of things.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **64** of **88** >> GARY TALBOT: That would be great. Thank y ou. Hans.
>> HANS VAN WINKLE: Mr. Roder, thank y ou. In listening to y our testimony and others, it's apparent that one of the issues is that because of the complexity

and the phy sical constraints of the equipment, that causes problems for people with disabilities who don't alway s 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 phy sical constraints we're all used to, the devices now that we can do technologicall y, miniaturization ... Sorry . I didn't mean to steal y our -- [laughter]. I gave it back. I want every one 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 y ou think there's some technology that might help us solve this dilemma?

>> TONY RODER: I mean, we look at the technology and obviousl y, yo u know, people are alway s working on what's the next piece of technology
.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **65** of **88** Each of these ty

pes of devices has its own unique characteristics that it is specificall y designed to try to help solve the clinical pr oblem. 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? Idon't know if I can
-- I can't answer that question today . I don't have the cry stal ball I can look at to find out where we might be going specificall y. 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 phy sical dimensions, phy sical problems and have to design around that vice, we can expect technological solutions. Where we could reall y -- that would allow us to go to more performance t ypes 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 try ing to get a sense from y ou.

>> TONY RODER: Yes. Some of the specifics, for example, like MRCT, there's geometric requirements right there, and limitations that we currentl y can't go beyond in some cases. You talked about trying to increase boreUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **66** of **88** sizes and do this ty

pe 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 JAECKL E : I just want to give y ou an example of that, for like CT sy stems, as the technology progresses, wh at's happening in CT is y ou 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 millimete r precision. That needs to be securel y anchored to the floor, same with the table. That's where y ou 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 mo ved. Ton y gave good examples in the x
- ray field where y ou can take the detector out and move it. So Ithink again, it's back to modality specific, what advances are able to be made.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **67** of **88** >> HANS VAN WINKLE: So in the case of something that has to be super stabilized, we have to figure out way s 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 JAECKL E : I think there's a lot of room y ou need made into facility lay outs to help. Either with overhead lifts, or raising the floors, or other lay out 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, bec ause we have specific authorization, may be sort of advisory

or we give a recommendation that these aspects be considered in future studies, we're on some prett y t ight timelines here, I don't think we can incorporate it now.
>> SPEAKER: From manufacture rs, that's wh y we think we could be more than happ y to accommodate working with you gu ys to say what are the right considerations for the layout. I f you take the equipment, manufacturer shallUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **68** of **88** provide alternate room layouts for their equipment that would i ncorporate 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 y ou, Nancy Starnes, public member. Could y ou gentlemen remind me about the life span of some of this equipment? Obviously , as we develop standards, there's going to be a phas e - 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 ty pe of device, but a lot of this equipment, the big capital could be decades. There's x
- ray

s ys tems that have been operating for 50 y ears. That's aty pical. But I would say

on the order of five to 10 y ears, it's a ty pical ty pe of life span for a lot of these devices, and John, any body else have specific
--

>> JOHN JAECKL E : ... A nd 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 aUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **69** of **88** number of ye ars, 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 th at is kind of the life span of equipment. So they do last quite a long time. >> TONY RODER: But again, prett y variable too by the t ype of device. An d reall y 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 y ou very much, you gu ys . Thank you. Next up is Shelly

Simmons. And then after Shell y is Caroly n Philips. >> SHELLY SIMMONS: Good morning. Thank you so much for this opportunity

to speak with y ou today . M y name is Shelly Simmons, S
- H
- E
- L
- L
- Y S
- I
- M
- M
- O
- N
- S , and I chair the Statewide Independent L iving 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 D epartment of J ustice, through settlement agreements has made attempts to address access to some exam, imaging, and treatment equipment , b ut more needs to be done. Must be done to establish guidelines and enforceable standards so that all equipment is accessible across the spectrum ofUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **70** of **88** health care facilities and providers in the U.S. I can tell y ou personall y of the challenges I face whenever I seek medical attention . Try ing to avoid the frustration of not having the accessible equipment or trained staff to adequately assist me is more than a notion. Ialway s 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 bey ond scheduled times, because of the difficulty

of getting m y chair in the right position, but out of the way of the i maging 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, m y health care is delay ed and at times denied. But m y story is not uncommon. I'm alway s 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 b y people with disabilities, thereb y 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 qualit y health care is av ailable to every one, I sincerel y hope and strongl y suggest the recommendations of the U.S.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **71** of **88** Access Board are considered and implemented. I thank y ou so much for your undivided attention. Are there an y questions for me ? >> GARY TALBOT: Thank y ou. Any questions from the board? Regina? >> REGINA BLYE: Not so much a question, but a comment. I just want to say Iappreciate Shell y. 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 y ou.
>> GARY TALBOT: Thank y ou very much. We appreciate it. Next is Caroly n Philips, and next up after Caroly n is Margo Waters. >> CAROLYN PHILIPS: Hi. Hello every body . I'm reall y glad y'all are doing this in Atlanta. I welcome you, hope you've had a good stay so far. I am Caroly n Philips, the Director of Tools For L ife , which is the state AssistiveUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **72** of **88** Technology

Act . We're very

active in a lot of areas, as y ou know, those of y ou familiar with the AT Act , including health care, helping people access and understand what's g oing on when it comes to getting the appointments they need, navigating the s ys tem, we've worked with doctors, hospitals, and patients with disabilities. But, Iwant to share with y ou two stories, personal perspectives on this. One, my

mother has Hunting ton’s disease, I'm not sure how many of y ou 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, becaus e of her movement and because of her lack of following directions, her noncompliance, if y ou 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 Iwould 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 MRI s , PET scans, all of those things would greatl y benefit the Huntington’s disease community and other affected communities, because that's the only way y ou 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 dy slexia, a learningUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **73** of **88** disability . I'm one of 15 pe rcent of the folks in the U.S. that have these wonderful things. Dy slexia, dy sgraphia , dy scalculia , auditory processing, I have all those 'D Y S' s and navigating the sy stem can be complicated. Ionce again have showed up for all the tests we were talking about earlier and I'm alway s doing the wrong thing. I can't find an y information as to what I'm supposed to be doing. People hand me a piece of pa

per and are like, "here
-- follow these instructions", and I'll say can y ou read it to me? And they 'll say "oh, can y ou get somebod y 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 y ou 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 , y ou 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 actuall y 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 y ou'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 every body understanding from the moment y ou find out y ou have to have that test, to the moment y ou ge t that diagnosis, or you get the results. The whole process is understandable toUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **74** of **88** every one and accessible to every one. The other thing is I once showed up for a test and they

said y ou're noncompliant because I prepared for the wrong test. And so Ithough t I was going to have an MRI, I actuall y prepared for some kind of colostomy

thing. Who knew, right? They 're like: "y ou're noncompliant," and I'm like: "You're actuall y 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 yo ur time and I appreciate what y ou're doing. I think y our work is incredibl y valuable, and I appreciate you all being a strong voice, along with ADAPT, and NICKL , and the AT Act fo lks, that are out there alongside. So thank y ou. >> GARY TALBOT: Thank y ou very much. Any

questions from the Board? Thank y ou very

much. We appreciate it. >> GARY TALBOT: Next is Margo W aters and after Margo is Janet Barlow
.
>> MARGO WATERS: Good morning. M y 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 L ink and so some of the concerns have alread y been mentioned. Ms . Simmons di d an excellent over

view of the challenges that folks with disabilities often encounter. IUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **75** of **88** 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 , m ay be 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 re ceive 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 conce rn. 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 y our wheelchair weighs. And I guess they were going to figure that out manuall y 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, try ing to keep m y 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'veUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **76** of **88** had a bone density

test that the table where I had to transfer was perfect. It fit just right, it was eas y 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 y ou for your time. >> GARY TALBOT: Thank y ou very much. An y 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 offerin g them the opportunity originall y. Thank yo u, John. >> JOHN WELLS: Thank y ou. 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 comm itted 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 a nd
caregiver interactions, the care giver requires access to the patient to perform phy sical 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 alsoUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **77** of **88** think about tradeoffs . For example, when y ou 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 b y 10 foot room
- 1 0 feet b y 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 an d 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 size s tables do get larger, the ris k 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 ty

pes of things that come into play . However,US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **78** of **88** 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 ty pical facilit y, a hallway

can encompass three to 20
rooms - it could be like an exam or tr eatment 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 modif ications to a lift that could have a lot of tables that are even accessible today , that would appl y to lift standards in the future. We've asked to consider that. Lastly, as stated previously , we continue to support the B oard'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 s cale 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 actuall y very simple for every one. 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 ty pes of scenarios. With that, Iappreciate the opportunityUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **79** of **88** to spend a few minut es with y ou today . And we at Midmark look forward to providing further detail in our June 8 submittal. Thank y ou. >> GARY TALBOT: Thank y ou very much. We appreciate it. Any questions? Regina? >> REGINA BLYE: Not so much a question, but a cons ideration. Iknow 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 bariatr ic, but also for transfer purposes. And so Iknow 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 e xtra space for sliding over. >> JOHN WELLS: Thank y ou. 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'dUS Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **80** of **88** be curious on the Board's recommendations outside of what was previousl y an exam table from 20 y ears 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 y ou. As an engineer, I'm alway s looking for elegant solutions, Ireall y liked y our 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 y ou 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 ret ype 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 i t' s about time. We're going to see a lot of progress of technology in this space.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **81** of **88** >> GARY TALBOT: Thank y ou. Phil?
>> PHILLIP JENKINS: I thi nk the exact same question. Adding the scale to the exam table, is there an ything else besides the personal computer being added to the room? Any

other combinations of new technology being put together? >> JOHN WELLS: Well, if y ou look at like vital signs acquisition, a lot of spaces, like a scale, historically in a ph ys ician's office a scale is in a hallway , and it's not onl y is it HI PAA and having y our scale being seen by every one, it's very awkward and in the northern states, when it's winter, y ou 're putting all your bags down, your coats down and all those types of things. You think about that ty pe of work flow. But there's also pods and triage areas where y ou have the vital signs being taken, blood pressure, height, weight, pulse, all those ty p es 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 vita ls and do all the ty

pes 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 t o be in the ph ys ician office.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **82** of **88** >> PHILLIP JENKINS: Thanks. >> GARY TALBOT: Thank y ou very much. Any

other questions? Well, thank y ou. 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 ty

pe scale. I think we started the discussion in the room. May be we can continue that. Should we
-- we love y our input on should we have three ty pes of scale requirements? Four? Five? We'd like y our 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 onl y Scale
- Tronix, but a wide range of scale manufacturers that make perfectl y adequate digital electronic stand
- on scales, and if y ou're look for standards that go into a hospital, many of yo ur hospitals have gotten portable stand
- on scales that have handrails on there, they 're easy

to access, they

have high weighing capacities. If y our standards are also going to apply to doctor's offices, now y ou have a problem.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **83** of **88** Because man y 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 y ou want to start and say , wait minute, Ineed a stand on scale standard, there's innumerable scale manufacturers that could provide that in existing technology . What do y ou need to do? Yo u have to may be 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. Any thing 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 y our diagram, y ou' 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 th e 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.

>> DAV ID CAPOZZI: Have you to use the microphone.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **84** of **88** >> JOSEPH DRAGO: Now have you scales that have challenges for bariatric patients that have a large capacit y that goes across the seat, but also y ou 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 so lved many of the concerns that y ou folks are looking at. Lastl y, 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 come s down, now there are small beveled edges that are less than an inch across that give eas y 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 an y kind of medical facility , y ou 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 y ou' 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, y ou just fill in the hole, a new rough i n frame goes to a new location, and you're back in business. Okay ? Two standards, I guess. Separate out. Don't have y our patients that reall y need the stability to stand on a scale. Walk up an y t ype of ramp. That's a safet y i ssue. Have them be on a stand on scale or weigh them in a wheelchair or on a chair.US Access Board Public Hearing: Unofficial Transcripts

Medical Diagnostic Equipment NPRM May 8, 2012 **Atlanta, GA** Page **85** of **88** >> PHILLIP JENKINS: Follow
- up question. We heard earlier about putting the scale in the exam table. Idon't think we would want every one 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 ye ars, and we make high capacity 880 to 1,000
- pound scales. And the accuracy

is 100 grams. Over the 38 years that the compan y has been in business, with all due respect to all these manufacturers, man y 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 y ou want to transfer into som ething that's not going to achieve your purpose? Ican't answer that right now. I know that hospitals across the country that in their ICUs, they

went from old fashioned sling ty pe scales that were
-- and by the way , Scale
- Tronix was the 38 y ears ago, Caroly n 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 compan y today, and the point here is that we've gone through a wide range of things. Your Hill
- Rom and Stry ker and your major people put scales inUS Access Board Public Hearing: Unofficial Transcripts

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 practicalit y, I'm not sure it does the purpose.
>> GARY TALBOT: If I could ask one follow
- up. Have y ou guy s 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, may be 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 y ou legislate to say

after a particular date, any new construction or renovation, y ou' ve solved the problems that have been created b y the
-- by someone trying to give a product for every

thing. Thank y ou so much. >> GARY TALBOT: Thank y ou 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 somebod y else wants to say so mething, we'll have open mic for a couple of minutes.US Access Board Public Hearing: Unofficial Transcripts

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 div ersity disability as y ou 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 try ing to change how we get accessibility fr om the different diversified
-- do y ou understand what I'm try ing to say ? We're looking at it from a backwards way

is what I'm say ing. 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 m y cancers, strokes, and the epilepsy, change those tables and every thing, so they cannot properl y function and give me the right treatment, or
accuratel y. The same with the scales, when I went to rehab, they had
-- the gu y 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 th e 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 co mpliant, 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 an ything about that. But they make their apologies and tellUS Access Board Public Hearing: Unofficial Transcripts

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 y ou. They 'll t ell y ou, 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 probabl y could afford that equipment. So that was -- that was something I
-- just to make y ou aware of. There's nothing y ou can change, but something when y ou're thinking about making standards. >> GARY TALBOT: Thank y ou very much , Pam . Well, thank you very much. We've reached 12 noon, and we'll close the hearing now, but thank you to every one for your testimony , for coming and spending the morning with us, we reall y appreciate it. Thanks to the Board members as well. Thank you very much. [End of meeting.]