,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #ajjhh  ,,9 ,,! ,,h\se ,,(         
,,repres5tatives  ,augu/ #ac1 #bjbf,mrs4
 ,f\%ee introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to direct !       
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 to conduct a /udy to assess !   
pot5tial = exp&+ ! safe & effective use 
( reprocess$ s+le-use devices1 & = o!r  
purposes4  #a4 ,reprocess+ ( s+le-use   
devices  7a7  ,/udy  ,! ,secret>y (     
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs 79 ?is    
section ref]r$ to z ! ,secret>y71 %all  
conduct a /udy to assess ! pot5tial =   
exp&+ ! safe & effective use (          
reprocess$ s+le-use devices4  7b7       
,prim>y crit]ia ,9 conduct+ ! /udy "u   
subsection 7a71 ! ,secret>y %all ensure 
t pati5t safety & infection prev5tion   
are ! prim>y crit]ia us$ 9 exam9+ !     
pot5tial = reprocess+ s+le-use devices1 
) /ratification by risk category &      

cl9ical use4  7c7 ,focus on ?ird-,p>ty  
reprocessors ,9 conduct+ ! /udy "u      
subsection 7a71 ! ,secret>y %all        
evaluate opportunities =1 & b>ri]s to1 !
 exp&$ use ( qualifi$ ?ird-p>ty         
reprocessors4  7d7 ,cont5ts ,9 conduct+ 
! /udy "u subsection 7a71 ! ,secret>y   
%all exam9e1 at a m9imum-- 7#a7 exi/+   
pa?ways ( ! ,food & ,drug ,adm9i/ration 
= ! reprocess+ ( s+le-use devices1      
includ+ in/ances 9 :i* curr5t rules are 
suffici5t & in/ances 9 :i* b>ri]s exi/2 
7#b7 ! role ( ?ird-p>ty reprocessors (  
s+le-use devices v]sus 9-h\se hospital  
reprocess+2  7#c7 ! op]ational          
feasibility ( reprocess+ s+le-use       
devices1 includ+ /]ile process+         
capacity1 /aff+1 equipm5t1 *a9 ( cu/ody1
 track+1 & quality assurance2  7#d7 !   
f9ancial & environm5tal return (        
reprocess+ s+le-use devices1 tak+ into  
consid]ation wa/e r$uction1 co/ sav+s1 &
 any add$ labor1 capital1 or compliance 
burd52 &  7#e7 issues relat$ to         
liability & acc\ntability if a          

reprocess$ s+le-use device fails or     
contributes to pati5t h>m4  7e7         
,consid]ations ,9 conduct+ ! /udy "u    
subsection 7a71 ! ,secret>y %all        
consid]1 ) respect to ! reprocess+ (    
s+le-use devices-- 7#a7 cl9ical outcomes
 & device p]=mance2  7#b7 validat$      
reprocess+-cycle limits2  7#c7          
collection & transportation logi/ics2   
7#d7 ! p]c5tage ( collect$ devices t c  
be reprocess$2  7#e7 contractual or     
te*nical b>ri]s2 &  7#f7 full lifecycle 
f9ancial & environm5tal impact4  7f7    
,consultation ,9 conduct+ ! /udy "u     
subsection 7a71 ! ,secret>y %all seek   
input f--  7#a7 non-,f$]al entities1    
includ+ hospitals1 supply *a9 lead]s1   
infection prev5tion organizations1 /]ile
 process+ organizations1 cl9icians1 &   
appropriate indu/ry repres5tatives2 &   
7#b7 ,f$]al entities1 includ+ ! ,food & 
,drug ,adm9i/ration1 ! ,c5t]s = ,disease
 ,control & ,prev5tion1 & ! ,c5t]s =    
,m$ic>e  ,m$icaid ,s]vices4  7g7        
,def9itions ,9 ?is section1 ! t]ms      

device1 reprocess$1 & s+le-use device h 
! mean+s giv5 su* t]ms 9 section #bja ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cba74  7h7 ,report to   
,congress ,n lat] ?an #a ye> aft] ! date
 ( enactm5t ( ?is ,act1 ! ,secret>y %all
 transmit to ,congress a report on !    
results ( ! /udy1 includ+--  7#a7 a li/+
 ( s+le-use devices t ! ,secret>y       
det]m9es h ! pot5tial = reprocess+1     
includ+ an id5tification (-- 7,a7       
devices curr5tly legally m>ket$ =       
reprocess+2  7,b7 devices = :i*         
reprocess+ is support$ by suffici5t     
evid5ce2 &  7,c7 devices = :i*          
reprocess+ requires fur!r rese>*2 &     
7#b7 recomm5dations = programs &        
activities to provide = su* reprocess+1 
includ+ ! use (-- 7,a7 qualifi$         
?ird-p>ty reprocessors2  7,b7           
appropriate clean+ & /]ilization        
te*nology2  7,c7 quality assurance &    
track+ sy/ems2 &  7,d7 infection        
prev5tion controls4