**Hologic, Inc.** 36 Apple Ridge Road, Danbury, CT 06810 USA Main: +1.203.207.4500 Fax: +1.203.207.4596 

### MINORITY REPORT: CONSIDERA TIONS	FOR	THE	APPLICA TION	OF ACCESSIBILITY	ST

ANDARDS	T O PR ONE	BREAST	BIOPSY TA BLES John	LaViola, G VP,	Women’s	Health	Group,	Product	Development,	Hologic,	Inc. Michelle	Lustrino,	Mechanical	Engineer, Product	Development, Hologic,	Inc. Prone	breast	biopsy	tables	were	considered	by	the	“Imaging	Equipment	with	Transfer Surfaces”	sub

- committee	and	are	described	in	Section	4.3.2	of	th e	full	committee	report.		A s discussed	in	the	report,	prone	breast	biopsy	tables	are one	of	several	equivalent	clinical options used	for	specialized	interventional	breast	biopsy	procedures. Minimally,	they require	local	anesthetics , and	at	times	require	some level	of	patient	sedati on. Section	4.3.3 of	the	full	committee	report state s, “T he	Committee	viewed	imaging	systems	used	for interventions	and	biopsies	in	patients	who	are	typically	sedated	as	outside	the	scope	of	the accessibility	standards.” Although, in	many	cases prone	bio psy	procedures	require	only local	anesthetics, prone	breast	biopsy	tables should	be exempt from	the	related	transfer height and	lift	compatibility requirements	under	consideration	by	the	committee’s standards	and	rules	determination	processes .	Therefore, H ologic	is	submitting	this	report to support	this	exemption	by describing	the	relevant	clinical	use	cases	and	the	practical application	of	the committee’s consideration	of alternative lift	compatibility	requirements. The	process	of	detecting	breast	cancer begins	with	regular	mammography	screening
exams. If	an	area	of	concern	has	been	detected,	then	the	patient	may	be	asked	to	have	more images	of	their	breast	taken	in	what	is	considered	a	diagnostic	mammogram.		It	is	only after	these	images	are	taken	and a	r egion	of	interest (e.g., calcifications	or suspicious architectural	distortion) has	been	detected	that	a	patient	will	be	required	to	go	for	a minimally	invasive	image

- guided breast	biopsy procedure. A	breast	biopsy	is a minimally invasive surgical	procedu re	used	to	sample	tissue	from a	region	of	interest,	and	is	the	last of	multiple	steps	required	to	diagnose	breast	cancer.		While	it	is	an	important	step	in	the diagnosis,	it	is	the	screening	mammogram	that	is	used	to determine suspicious regions	of interes t and	begin clinical	work

- up	of	these	regions .		It	is	critical	that	women	have independent	access	to	screening	mammography	equipment	and	that	they	can	be	examined with	as	much	ease	as	possible,	as	independent	access	will	impact	their	likelihood	to	get the i r	regular	mammograms.		However, breast	biopsy	procedures are	prescribed	in response	to	a	specific clinical concern with	multiple	health care and	accessibility considerations jointly	evaluated	by	the	patient	and	the	care	provider .	Accordingly, independent patient access ibility to	breast	biopsy	procedures is	not the overriding clinical concern	and	would not likely	interfere	with the patient’ s access	to	health	care

. Breast	biopsies may	be performed with	the	patient	in a prone ,	seated, or	decubitus position

. A dedicated prone	breast	biopsy	table is	used	only	for	biopsy	procedures	in	the prone	position.	Equivalent	care	can	be	provided	with	biopsy accessories	attached	to upright	mammography	equipment with	patients	in seated or	decubitus position s. I t	should**Hologic, Inc.** 36 Apple Ridge Road, Danbury, CT 06810 USA Main: +1.203.207.4500 Fax: +1.203.207.4596 www.hologic.com

be	n oted	that	for	lesions	that	can	be	readily	localized	with	ultrasound	imaging,	supine breast	biopsies	are typically	performed. Additionally,	some	clinical	situations	may	indicate an	open	surgical	biopsy	with	the	patient	under	general	anesthesia.

It	is	critical	that	there be a	method	by	which	all	patients	can	safely	access medical diagnostic	equipment

. During	a	prone	biopsy	procedure	(Figure	1),	the	patient	lies	in	the prone	position	on	a	cushioned	table,	with	her	breast	positioned	beneath	the	patient support	surface	while	the	physician	works	underneath	the	table,	out	of	sight	of	the	patient. This	configuration	increases	patient	comfort and thereby	is	an	advantage	for	the	use of prone	biopsy	tables

.

**Figure 1**  **. Example prone breast biopsy table. The patient is lying in the prone position on a cushioned table, with her breast**  **positioned beneath the patient support surface while the physician works underneath the table.**
Because	the	procedure	takes	place	underneath	the	patient	support surface,	provisions	are needed	under	the	table	for	imaging	and	biopsy	equipment	and	for	a	drive	mechanism	to move	the	table	to	a	height	that	allows	comfortable	physician	access,	while	also	maintaining access	to	the	patient	from	the	front	and	back	of	the	m achine.		As	a	result	of	these	technical and	clinical	use constraints,	the	minimum	possible	table	height	in	the	table	shown	i n	Figure 1	is	37	inches.		With	the table surface	at	these	heights, all	patients	are	assisted	in	getting onto	the	table	either	with	a step	stool	or	with	a	supplemental	patient	transfer	device	(e.g. , a stretcher).		While	future	redesign	may	be	able	to	decrease	this	height	by	a	few	inches,	it would	be	cost	prohibitive	(and	technically	infeasible	through	practical	means)	to	redesign the	system	to	achieve	any	of	the	transfer	heights	described	by	Section	M301	(even	with the accessibility	configurations discussed	in	Section	7	of	the	full	Committee	report ). This,	however,	does	not	mean	that	the	prone	biopsy	table	is in accessible	to	patients	in wheelchairs.		While	they	may	not	be	able	to	independently	transfer	onto	the	breast	biopsy**Hologic, Inc.** 36 Apple Ridge Road, Danbury, CT 06810 USA Main: +1.203.207.4500 Fax: +1.203.207.4596 www.hologic.com

table,	they	can	still	access	the	table	through	transfer	via	an	accessible stretcher (or	other supplemental	transfer	device).		In	this	case, the	patient can independently	transfer	onto	the stretcher,	the stretcher will	be	raised	to	the	height	of	the	biopsy	table,	and	the	patient	will transfer	laterally	onto	the	prone	biopsy	table.		While	this	process	will	likely	require	the assistance	of	a	tech nologist,	the	patient	will	be	supported	throughout	the	entire	lateral transfer,	unlike	when	they	are	transferring	from	their	wheelchair	to	the stretcher,	thus minimizing	the	safety	concerns	for	the	technologist	and	the	patient.		The	technologist	can utiliz e	slip/slide	sheets,	boards,	or	other	aids,	to	assist	with	lateral	transfers i

. Furthermore,	if	there	are	no	obstructions	to	the	transfer	surface,	the	top	of	the stretcher and	the	top	of	the	biopsy	table	can	act	as	one	continuous	surface	on	which	the	pati ent positioning	takes	place ,	giving	the	patient	ample	space	to	use	to	turn	over	into	the	prone position .		Once	the	patient	is	safely	in	position,	the stretcher can	be	moved	out	of	the	way. Hologic	understands	the	tremendous	benefits	of	independent	transfe rs,	but	due	to	the nature	of	this	particular	procedure,	transfer	via	an	accessible	supplemental	patient	transfer device	appropriately	manages	patient	accessibility	and	use	risks,	and	provides	enhanced patient	comfort	during	the	procedure.
Th e	above	transfer	procedure is	an	example	of	how	using	a	supplemental	patient	transfer device	provides	a	valuable	method	of	assisted	transfer	as	an	alternative	to	the	use	of portable	or	overhead	lifts. In	the	case	of	prone	biopsy, this	method is	a safe , effective ,	and efficient	way to	transfer	and	position	the	patient.		In	cases	such	as	these,	where	a	stretcher

assisted transfer	is	used	for	its	positioning and	safety benefits,	provisions	for	portable	and overhead	lifts are not	required. If a	patient	requires	a	lift	to transfer	out	of her wheelchair, she can	use	one	for	the	initial transfer	to	the	stretcher.		In	these	cases	especially,	it	will	be important	that	the	patient	has	ample	space	to	move	into	the	prone	position ,	which	wil l	be made possible by the	stretcher

- based transfer method. Seated	position	breast	biopsies	with	an	upright	device	provide	the	same	efficacy	and
a ccuracy	as	prone	biopsies ii, and	therefore a re	equally	effective	in	diagnostic	work

- up	of the	patient

. If	there	are	concerns	of	patient	vasovagal	re sponse	with	the	seated	breast biopsy,	they	can	likely	be	mitigated	by	decubitus	positioning	of	the	patient. Since	the se procedures take	place	using	a	screening	mammography	system,	all	patients	will	be	able	to achieve	independent	access	to	an	upright	biops y	and	thus	patients	who	are	unable	to access	a	prone	biopsy	table,	even	with	the	help	of	a	supplemental	patient	transfer	device, can	still	have	a	breast	biopsy.		However,	it	would	be	detrimental	to	the	patients	and	to	the healthcare	system	to	rule	prone	bi opsy	systems	inaccessible	due	to	the	technical constraints	that	minimize	the	ability	for	purely	independent	transfer.
All	breast biopsy	case s should be evaluated for	their individual clinical	and	accessibility needs .		When	a	breast	biopsy	is	prescribed, the	physician	must	work	with	the	patient	to ensure	that	the	right	biopsy	procedure	is	chosen	for	them,	taking	into	account	any	benefits or	risks of	that	particular	procedure .		In	order	to	maximize	patient	care,	it	is	important	that**Hologic, Inc.** 36 Apple Ridge Road, Danbury, CT 06810 USA Main: +1.203.207.4500 Fax: +1.203.207.4596 www.hologic.com

the	prone	biopsy table is	included	as an accessible	option	by	this	standards

- setting	process , provided	that	there	is	a	plan	in	place	to	safely	complete	the	assisted	transfers	at	any	site where	this	technology	is	used. Hologic	is	fully	committed	to	ensuring	that	our	products	are accessible	to	all	patients	and we	appreciate	the	opportunity	to	work	with	the	Access	Board	during	this	process.		If	you have	any	questions	or	need	further	information	regarding	the	information	presented	here, please	do	not	hesitate	to	let	us	know.

i U.S. Department of Justice, Disability Rights Section. U.S. Department of Health and Human Services, Office for Civil Rights. “Americans with Disabilities Act: Access To Medical Care For Individuals With Mobility Disabilities.” Part 4: Accessible Medical Equipment. 15

- 16.

ii Wunderbaldinger P, Wolf, G, Turetschek K, Helbich TH. “Comparison of Sitting Versus Prone Position for Stereotactic Large

- Core Breast Biopsy in Surg ically Proven Lesions.” American Journal of Roentgenology. 2002. 178:5, 1221

- 1225.