1

M I N OR I T Y RE PORT O N T RAN S F ER S URF AC E H E I GH T RE CO M M EN DA T I ON S O F T H E U .S. ACC E S S BOARD A D V I S OR Y CO M M I TT EE **RE :**  **N P**  **R**

**M :**  **M 301.2.1**  **AN D**  **M302.2.1 H**  **E I**  **G H**  **T** I
. In tr oduc t i on T h i s M i n o r i ty R epo r

t h a s b een de v e l oped by th e f o l l o w i ng med i c a l d i a gnos t i c i m a g i ng equ i p ment i ndu s try me m

be r s of the A dv i so ry C o mmitt ee t o th e U .S. A cce s s B oa r d , i n c l u d i n g : G E H ea lth c a re , Phi l i ps H e a l th c a re , Si e me n s Hea l th c a r e , and H o l o g ic , Inc. T he pur pose of th i s M i n o r it

y R epo rt i s t o ma ke a f

o r mal r e co mmenda ti o n f

o r a mi n i m

u m tr an s f er su r f a c e l ow h e i ght of 1 9 i n ches f

o r d i a gnos t i c i ma g i ng m ed i cal equ i p men t
. II
. R eco mm enda ti o n s of D i a gnos t i c I ma g i ng Equi p ment M a nu f a c tur e r s on T r an s f

e r Sur f a ce Low H e i ght T he a f o r e m ent i oned med i c al d i a gnos t i c i ma g i ng equ i p ment manu f a c tur e r s sup p o r

t a 19 i n c h m

i n i m u m tr a n s f er s u r f ace l ow h e i ght f

or the f o l l o wi ng r eas o ns: 1. A s tan d

ard s ho u ld s e t a m i n i m um tr an s f er su r f ace low he i

g h t req u i r e m e n t w h i ch is re a sona b l e and ac h i e v ab l e g i ven the t e chn i c al a nd en g i n e e r i ng re sou r c e co n s tr

a i n t s u pon the equ i

p m ent m anu f a c t u re r . D i a gnos t i c i ma g i ng equ i p m ent i s c o m p r i s e d o f b o th the i ma g e de t ec t o r s / s c ann e r , s uch as an x -r ay s c an n e r , o r nu c l e ar med i c i n e ca m e r a s , o r i ma g i ng equ i p ment us i ng a b o r e , s uch a s C T , P E T and MR I , as w e l l a s th e t ab l e s u ppo rt i ng the p ati e n t
. I

t sh o u l d be r e co gn i z ed th at the t ab l e, w h i ch suppo rt s the pat i e nt w ho i s unde r g o i ng th e d i a gnos t i c i m a g i ng p r ocedur e, i s a n i n t e gr al p a rt of th at equ i p men t , and i t s p r e c i se a l i gn ment w ith t he i ma g i ng s c an n e r

/ bo r e i t s e l f i s e s s e n t i a l t o ach i e v i ng d i a gnos t i c qu a l i t y i ma g e s . I t i s i m po rt a nt t o r e co gn i z e , g i v en the i nt e gr at ed n a tu r e of th e t ab l e t o th e s y s t em and i t s i ma g i ng pe r f o rmance, th at a c h an g e of e v en a f ew i n ch e s i n m

i n i m u m tr an s f er su r f a c e l ow he i ght con s ti tut es a s i gn i fi c ant en g i ne e ri ng c h an g e t o the d e v i ce. Any su c h c han g e m ust en s ur e the r e a

r e no adv e r se e f

f e c t s t o i ma g e qua l ity , s y s t em pe r f o r man c e, and p a t i e nt s a f

e ty . C o m

p l e t e s c ann e r r e - t e st i ng and re - ce rt i f

i c at i o n und e r our f

o rmal F D A qua l i ty s y s t em and de s i gn co n tr o l s a r e needed t o v e r if

y o v e r a l l s ys t em pe rf

o r ma nce and s a f

e ty . Mo r e o v e r , th e m ost s i gn i f i c ant o f th e s e de s i gn chan g es can r e s ul t i n c a s c ad i ng a lt e r a t i ons t o the s c an n e r , p o t e nt i a l l y l e a d i ng t o un a cc e p t a b l e he at i ng i n the c a s e of MR, i m pac t s on i ma g e s i gna l / qu a l i ty , and c h an g es i n do s e l e v e l s t o e n su r e th e s a me, e ff

e c t i v e , h i gh qu a l it

y i ma g e s and i nc r ea s ed e x a mi nat i on t i me s , th at i s, a dd i t i on a l w o rk f l ow s t e p s . I

t shou l d be n o t e d th at f

u tu r e de si gn p ro

j e c t s a r e i n th e work s m any y ear s b ef o r e th e y beco me c o mme r c i a ll y a v a i l ab l e. 2. There w a s no c o m

pe l l i ng e vi de n ce p r es en t ed o f s i gn i f i cant a cc e

ss i m pro v ement f

o r di ag no s ti c i m ag i ng de v i c es a t 17 i nc he s th a t w o u l

d w ar rant the a d

di t i on a l e ff o r t s, t i m i ng and r eso u r c e

s .2

D uri ng the m ee t i n g s of the A dv i so ry C o mmitt ee, th e r e w as no co m pe l li ng e v i de nc e p r e s e nt ed i n su p po r t o f a mi n i m

um tr an s f er l ow h e i ght of 17 i nch e s as th e new s t a n da r d f o r a cc e s s . T h e o ri g i n a l N o t i c e of P r op o s e d R u l e m a ki ng ( N P RM ) p r o p os a l w as f or a m i n i m u m he i ght i n th e r an g e of 1 7 t o 19 i nch e s. This w o u l d ha v e a l l o w ed a t a b l e th at l o w e r s t o a 19 i n ch mi n i m u m he i ght t o meet th e s t an d a r d. T h e r e d i d not app e ar t o be su f fi c i e nt , s o l i d e v i de n ce p r e s e n t e d th at 19 i n c hes m

i n i m um he i ght w as not ade q

uat e , a n d th at 17 i n c hes w a s n e ce s s i t at ed t o p r o v i de acc e s s . I t sho u l d a l so b e r e co gn i z ed, th at d u e t o the p r ec i s i on w o rk w h i ch i s r equ i r ed i n th e de si gn of d i a gno s t i c i ma g i ng equ i p men t , and the n ec es s ity of co m p li a n ce wi th r e g

u l at o ry r equ ir e m en t s , w i th e a ch i n c h of d e c r ease i n m i n i m um he i ght f

r om 19 i nc h e s , the t i me and co s t s w h i ch a r e r equ i r ed f

or e qu i p ment r e - de si gn g o up exp o nent i a ll y . H o w e v e r , the C o mm

itt ee d i d a gr ee th at a

n ad d i t i on a l r equ i r e m en t , that of ad j u s t ab i l ity up t o 25 i nch e s , w as c r i t i c a l t o e n su r e ac c e s s , g i v en the v a r i e ty of mob il i ty de v i ce s ea t i ng h e i gh t s. We be l i e v e the ad d i t i on o f the ad j u s t ab i l ity r e q

u i r e m ent d e l i v e r s by f

a r a l a r g er i n c r e as e i n a cc e ss than h a v i ng a si n g l e mi n i m um he i ght of 17 i nch e s. A s a s t and a r d , w e be l i e v e th e i nc r ea s ed acc e ss g oal i s w e l l met by h a v i ng a 19 i nch mi n i m um h e i ght and tr an s f

e r h e i ght a d

j u s t ab i l ity . H a v i ng an add i t i o n al ex t e n s i on t o the N PRM t o r equ i r e a f i xed m i n i m u m of 17 i n ches wo u l d p r o v i de o n l y a m a r g i nal i nc r ea s e i n th e pop ul ati o n s e rv ed ( s ee I t em 3 be l ow f

o r f ur ther d e t a i l s )

. 3. W h il e i t is i de a l f

or t ra n s f er su r f ac e s t o be a t th e s a m e he i

g h t as th e s e a t h e i

g h t s o f m ob i l i t y dev i ces, th e re is e v i d

ence that no n - l ev e l i nde

p ende n t t ran s f e r s are a l s o f ea s i b l e. T he o r i g i nal N o t i ce o f P r o p os e d R u l e m a ki ng ( N P RM) Pr e a m b l e e x p l a i ns the mo ti v a ti on f

or a mi n i m u m tr an sf e r h e i ght of 17 i n c hes w ith the f o ll o w i n g :

“ T ran s f er su r f ac e s th at a re ad

j u s t a b l e t o the s a m e h e i

gh t s a s the s eat h e i

g h t s of m ob i l i t

y de v i c es r e du c e th e e

ff o rt n eed e d to tra n s

f e r s i nce pa t i e n t

s d o n ot ha v e t o l i

f t th e i r bo d

y w e i ght t o m a ke up the d i f f e r en c e b e tw een the tw o su r

f ac e s, i n one d

i rec t io n or the o t

he r .” 1 T he N P R M th en g oes on t o d i s c uss w h ee l ch a i r s e a t h e i gh t s, wi th the 5 th pe r ce nt i l e l o w e s t s e at he i ght b e i ng 17.3 i nch e s, ac co r d i ng t o the ID eA s tudy 2

. Wh i l e i t i s i de a l f

or tr an s f er su r f ac e s t o be a

t the s a me he i ght a s th e s e at h e i gh t s o f mob ility de v i ces, th e r e i s e v i d ence t hat i nde p end e nt tr a

ns f e r s a r e a l so f

ea s i b l e w i th a s e at h e i ght d i s c r e p ancy of up t o tw o i n ches. A s i s d i s c u s s e d i n S e c t i on 3.3.1 of the f u l l C o mmitt ee r ep o rt , the Co m m itt e e co n s i d ered t

he f i nd i n g s fr om the U n i v e r s ity of P i t t s b ur gh H uman En g i nee r i ng R e s e a r ch L a bo r a t o r i es ( H E RL) s tu dy that l oo ked a t tr a ns f e r s , and how d i f

f e r e n t c ond i ti o n s a ff

e ct the a b i l i t i es o f w he e l ed m ob i l ity de v i c e s (WMD) us e r s t o tr a n s f e r f r om the i r WM D t o an o th e r sur f ac e 3

. O ne o f th e g oa l s o f th e s tudy w as t o “d e t e rm i ne ac c ep t ab l e r an g es f

o r n o n - l e v el tr a n s f e r s ( e. g . v e rt i c a l h e i ght d i f f e r enc e s ) ”. A po r

t i on of th e s tudy ’ s r e s u l t s a r e s h o w n i n T ab l e 1

1 N otice o f P r op o se d R u l em a k i n g ( N PRM). Pre a m b l e , p age 1 8. 2 ID e A C e n ter St ud y a t t h e U n i ve r s ity o f B uff al o , N e w Yor k : Th e Wh ee l e d Mo b ility A n t h r op o me try P r o je c t, Fi n a l R e p ort, p age 49, Fi g u re 3
- 5, r efe r e n ce t o “ All D e v ice T yp e s * ”
. 3 “ T h e I m p act o f T ra n s f e r S e t u p o n th e P e r f or m a n ce o f Indep e nd e n t T ra n s f e r s : Fin a l R e p o rt ” ; H u m an E n gine e ri n g R e s e arch L a b orat o ri es , V A Pit t s bu rgh H e al th care S y s t em , U n i ve r s ity o f P it t s bu rg h
.3

be l o w . I t sho u l d be no t ed t

hat the a dd i t i on of a 3

- i nch g ap next t o th e tr a n s f e r s u r f ace ( pe rm i t t ed by the Co m

m itt e e ’ s r eco mmenda ti on) may i m pact the pe r c ent a g es shown h e r e , b ut i n f o rma ti on w as not p r e s e nt ed th a

t d ir ec tl y co rr e l at ed s t ep he i gh t , g ap, and ab i l i ty t o tr a n s f e r . Furth er i n f o rma ti on w o u l d b e n e e d ed t o q ua nt i f y th i s d i r e c tl y . **T able**  **1. A p**  **o r**  **t i**  **on o**  **f t**  **he resu**  **l t**  **s p**  **re s**  **en t**  **ed i**  **n t**  **he HER** **L s**  **t u**  **d y**  **t o**  **d e**  **t e**  **r m**  **i ne**  **a ccep**  **t able**  **ranges f**  **or n**  **on -**  **l ev**  **e l**  **t ran**  **s f** 

**ers. St**  **e p**  **H e**  **i ght**  ( N o obs tr u c t i ons or ga

ps b e tw een th e tran s

f er su r f ace a nd W

M D i n t e n t i o n a l l

y i n tro d uced) **P e**  **rce n**  **t age**  **o f**  **I n**  **d i**  **v i**  **d u**  **a l**  **s A**  **ble T**  **o**

**C o**  **m pl**  **e t**  **e T h**  **e T**  **ran s**  **f**

**er** 0” 96% 1” 94% 2” 86%
T h e se fi n d i n g s s u gg e s t that tho s e i n d i v i du a l s w ith s e a t he i gh t s ≥ 18 i n c hes h i gh sh o u l d be ab l e t o i nde p ende n

t l y tr a n s f e r t o a n a d j u s t ab l e -he i ght tr a n s f

er sur f ace w i th a 1 9

- i nch mi n i m u m he i gh t , s i n c e th e s t ep i n h e i ght wi l l a l w a y s be no mo r e than o n e i n c h. For th e s ma l l p o pu l a t i on of i nd i v i d u a l s w i th a s e a

t h e i ght b e tw een 1 7 .3 (5 th pe r ce n t il e ) a n d 18 i nc h e s , the m ax i m u m s t ep he i ght wi l l be tw o i n ches. B a s ed on th i s s tudy , o n l y a bout 1 4 % o f the i nd i v i d

u a l s i n th i s a l r e a dy v e ry s ma l l pop u l ati o n may need f ur t h e r a s s i s t a

nce i n tr an s f

e rri n g . I n so m e i ns t an c e s , tr a n s f

e r o r pos i ti o n i ng supp o r

t s m ay e v en be ab l e t o p r o v i de th i s a s s i s t anc e , thu s m a i n t a i n i n g i ndepen d ence of tr a n s f e r . T h i s s tudy sh o w ed th a t a d d i ng a gr ab b ar f

or p at i e n t su p po r t h e l p e d s o me whee l ch a i r us e r s t o t r an s f e r at a h e i ght at w h i ch they cou l d not tr a ns f e r p r e v i ou s l y . O ne of the Co mmitt ee ’ s c o nce rn s r e g a r d i ng th i s p a rt i c u l ar s tudy w as th a

t the s tu d y sub j e c t s d i d not n e ce s s a ri l y r e f

l e c t th e g ene r al p opu l at i on o f p e r so n s who use W M D
. O f t he p eo p l e s tud i ed, 88 w e r e m en and 24 w e r e w o men. A la r g e num ber of sub j ec t s i n th e s tudy w e r e v e t e r a n s who pa rt i c i p at ed i n o r g an i z ed s p o rt s -r e l a t e d e v en t s . T he s tu dy d i d f i nd, thou gh, th at the sub

j ec t s’ da i l y ac ti v i ty l e v e l s a

pa r t f r om the ti me of those sp o rt s e v en t s d i d n o t d i f f er fr om adu l t W M D us e r s who l i v e i n the co mm un ity . W e do a c k

no w l ed g e the c onc e rn a

bout th e pop ul a t i on s tu d i ed and un d e r s t and th at the fi ndi n g s a nd p e r c ent a g es abo v e ma y not p r o v i de s tri c t g u i d ance o n how ma n y peop l e w i l l be a

b l e t o tr ans f

er g i v en a n o n - l e v el tr an s f e r s i t u a t i on. H o w e v e r , w e be l i e v e th at th e i n s i gh t s f

r om th i s st

udy a r e v e ry i m

po rt ant t o t ake i n t o c o n s i de r at i on w h en s e t ti ng a mi n i m u m l ow he i ght f

or tra ns f e r s u r f ac e s, s i nce t

h e r e a r e i n f a ct many i nd i v i du a l s w ho w i l l be ab l e t o i nd e pend e nt l y tr a n s f er wi th a 1 or 2

- i nch s t e p h e i gh t
. Wh i l e s e t ti ng th e mi n i m u m l ow he i gh t , w e a l s o b e li e v e i t i s i m po rt a nt t o sp e c i fi c a l l y con si d e r the i n d i v i dua l s w ho w il l be i m pac t ed by th i s l ow h e i ght r equ i r e m en t
. M a ny of the w hee l c ha i r s w it h l ow s eat h e i gh t s ( e s p ec i a l l y i n the 1 7
- 18 i nch r an g e) a r e m anual w h e e l c h a i r s. M any manual w hee l c ha i r us e r s may use mo r e upp e r body s tr en gth i n mo v i n g a r ound f or da y - t o - d a y ac ti v i t i e s th an p o w er w he e l c h a i r and s c oo t er u s e r s do, and s o a non - l e v el tr an s f e r may not be as d i f

f i cu l t f or tho s e i nd i v i d

u a l s. 4. D i agno s t i c i m agi ng de v i c e s r e q u i re a tr

a i n ed t ech n i c i a n pr es ent t o a i d a l l pa t i e n t s i n a c cess i ng the tab l e i n th e p r o

per i m a g i ng p o s i t i on.4

D i a gnos t i c i ma g i ng de v i ces ope r a t e w ith a h i gh l e v el o f p r e c i s i o n. I t i s i m po rt ant t o r eco gn i z e th at p r o per pat i e n

t p o s i ti o n i ng on the t ab l e f o r d i a gnos t i c i ma g i ng de v i ces, wh e th e r th ey a r e x r a y , nuc l ear med i c i n e , P E T or MRI de v i ces, i s e s s e nt i al t o a c h i e v i ng d i a gnos t i c qu a l i ty i ma g e s . In o r der t o a ch i e v e d i a gno s t i c qu a l ity i ma g e s , tr a i ned t e chno l o g i s t s a r e r e qu i r ed t o pos i ti o n a l l pa t i e nt s p r op e rl y , r e g a r d l es s of the p a t i e nt ’ s ab i l ity or d i s ab i l i ty t o a c ce s s th e equi p men t
. I I I
. Propo s ed a l t e r

n a t i v e m echan i s m s t o e n

han c e p at i ent a c cess t o d i a gnos t i c i ma g i ng equ i p ment G i v en the c on s tr a i nt s on t a b l e r ed e s i gn due t o d i a gno s ti c nee d s , a n d ph y s i c al a nd en g i nee r i ng li m

it at i ons of many of the wi d e v a r i e ty of i ma g i ng t ab l e s, th e r e w i l l b e many t y pes of i ma g i ng t ab l es th at wi l l not be ab l e t o a ch i e v e e v en a 19 i n ch mi n i m u m i f the t abl e i t s e l f m

ust b e m od if

i ed. F o r e xa m

p l e, i n a C T/P E T s y s t e m , the p ati e nt supp o rt sur f ace i s l o c at ed on t op o f a tr an s p o r t e r , w h i ch adds t o the h e i ght o f t he tr a n sp o r t sur f a c e. D X A bone den s i t o me try sy st e m s ar e curr e ntl y at a f i x e d he i ght o f 2 5
- 28 i nc h es b e cause th e i ma g i ng ha r dw a r e i s l oc at ed ben e a th the p at i e nt and th e p r ec i se pos i ti o n of the pat i e nt s up p o rt su r f a c e r e l ati v e t o the x

-r ay equ i p ment i s c r i t i cal t o the c l i n i c al e f fi c acy o f th e de v i c e . I

n the ca s e of D X A s y s t e m s, i t may be m ost e f

f e c ti v e to sp e c i f

y a s p e c i fi c r an g e o f f

i xed h e i gh t s th at t

he t ab l e co u l d be at t o f

ac i l i t at e i nde p ende nt tr a

ns f e r , s i m il a r t o the f i xed h e i ght s t a n da

r ds f o r e v e ry day it e m s li ke b ench e s, b ath i ng fi x tur e s , a nd r ec r e ati o n al s t

r uc t ur e s. For a l l o th e r s y s t e m s, t he C o mm itt ee w as t o l d t

hat i t n e eded t o co n s i d er o n l y mod ifi c at i ons t o the t ab l es the m s el v e s . T o the i ma g i ng i ndus try th i s s e e m s t o b e a r ath e r a r b i tr a ry con s t

r a i n t , and one th at i s n o t r e f l e c ti v e o f th e s y s t em na t

ur e o f d i a gnos t i c i ma g i ng s y s t e m s, the i r i n s t a l l at i o n s, nor an a c t u a l r equ ir e m ent i n the l aw. We b e l i e v e th at s y s t em acces s i b i l i ty con f i g ur at i ons d i s cu s s e d i n S e c ti on 7 of th e C o mm itt ee ’ s R epo r

t , i .e., a nc il l a ry equ i p ment that i s not at t a c hed d i r e c tl y t o the t a b l e , but r a

th e r that i s p a r

t of t he r oom la y ou t , w il l need t o p l ay an e s s e nti al r o l e i n enab li ng mo r e i m a g i ng equ i p ment t o meet th e s co p e of the p r o pos e d new s t and a

r ds. These a l t er

na t i v e m eans c an t a ke m a n y f o r m s , and th e i r sp e c i f

i c de si gns wo u l d n e ed t o be w o rked out wi t

h a pp r o p r i at e s t a keho l d e r s t o max i m i z e s a f e ty , pa t i e nt h a

nd l i n g , a n d of c o ur s e , a c ce s s. I m p l e m en t a ti o n of th e se a l t e rn ati v e s , and o th e r s, wil l a ll ow many mo r e pa t i e nt s w i th d i s ab i l i t i e s t o ac c e s s the e qu i p men t , and c an be i m p l e m en t ed f

ar mo r e qu i c k l y and c o s t e ff e c t i v e l y than the s i gn i f

i c a nt ti me and c o s t s w h i ch w o u l d be r equ i r ed f or equ i p ment r e - de si gn. M any a s pe c t s o f the s y s t em acces s i b i l ity con f i g ur a t i on conc e pt w o ul d a l s o be ab l e t o be ap p l i ed t o s y s t e m s a l r e a dy i n us e , t he r eby i n c r e a s i ng th e i r acc e s s i b i l i ty . T he ad d ed be n e f

i t s of i m p l e m en t a t i on of th e s e a l t e rnat i v e m eans a r e the s i gn i f i c a nt s a v i n g s i n he a lth c a

r e co s t s , t i me li e r i m

p l e m en t at i on and b r oa d er s y s t em co v e r a g e w h i ch w o u l d b e r ea l i z ed due t o a v o i d ance of co s t l y , equ i p ment re - de si gn co s t s. S i nce our m u tu a l g oal i s t o en h ance and i m p r ove ac c e s s of p a t i e nt s t o med i cal d i a gnos t i c equ i p m en t , w e ur g e th e Acc e ss B o a r d t o g i v e s e r i ous con s i d er a t i on t o th e s e a l t e rnat i v e means whi c h wi l l enab l e u s t o qu i c kl y acco mmoda t e m any mo r e pa t i e nt s w ith d i s a b i l i t i e s .5

C onc l u s i on A s d i a gno s ti c i ma g i ng equ i p ment manu f ac tu r e r s, we ar e co mm

itt ed t o a ch i e v i ng acce s s of a l l p a t i ent s t o d i a gnos t i c i ma g i ng equ i p m en t
. We s t a n d r e ady t o w o r k w ith a l l s t a keho l d e r s t o a cco m p li sh th i s g oa l

. I f y ou ha v e any que st i ons, or n e ed f u r ther i n f o rma ti o n, p l e a se do not he s i t a t e t o c o n t a c t us. We w o u l d be p l e a s e d t o f

ur th e r d i s c u s s th e s e i s s u es wi t h y ou. Sin c e r e l y , J o hn J a ec kl e E l i s ab e th G e o r g e H ans B e i n ke M i ch e ll e Lu s tr i no

G E H ea l thc a

r e Phi l i ps H e a l th c a r e Si e mens H e a lth car e H o l o g ic , I nc.