MedicalT echnology andt heH ealth CareS ystem A Studoyf thDei ffusoifo n Equipment-Embodied Technology A Reportb yt he CommittoeneT echnologayn dH ealtCahre AssembolfyE ngineering NationRaels earcCho uncil and InstitoufMt eed icine NATIONAL ACADEMY OF SCIENCES WashingtOn, D.C. 1979 Medical Technology and the Health Care System: A Study of the Diffusion of Equipment-Embodied Technology http://www.nap.edu/catalog.php?record_id=18439 NOTIC:E The porjectt hat tihse s ubjecto ft hisr eportw as approvbeyd t heGo verninBqo arodf t heN ationReasle archC ouncil, whosmee mbersa red rawnf romt heC ouncilso ft heN ationAacla demy ofS cienc,e tsheN ationAacla demyo fE nqineienrq, antdh eI nsti­ tuteo fM ediicn.e Theme mbers oft hec ommitteer esponisblef or ther eportw erec hsoenf ort hiers pceialco pmetensc aned withr e­ qardf ora ppropriateb alnace. Thisr eporth asb eenr eviewbeyd a qrouopt hetrh ant hea uthors accorditnoqp roceduraepsp rovbeyd a ReportRe view Committeceo n­ sisitnqo fm emberso ft heN ationAacald emoy fS cinece,s theN a­ tionaAlc ademyo fE nqieneri,n aqnd tIhnets ituteo fMe dicin.e Thisr epo rt reprseentwso rkun derC otnracNtS FC -31b0e tweetnh e NationAacla edmyo fS cienceansd theN ationSacil enceF oundati.o n Library ofC onrqessCa tlaoqC ardNumbe r 79-81480 InteartinonaSlt andaBorodk Number 0-309-02865-5 Avaaibell from: Officeof Pulbicatnis,o NationalA cademoyf Sciecnes 2101Co nstiuttoinA venu,e N.W., Washinq,t Do.n.C 20418 Printeidn t heU ntiedS tateosf Am erica Copyright © National Academy of Sciences. All rights reserved. Medical Technology and the Health Care System: A Study of the Diffusion of Equipment-Embodied Technology http://www.nap.edu/catalog.php?record_id=18439 COMMITTEEO N TECHNOLOYG AND HEALTHC ARE CHARLES A. SANDERS (Chariman), Generla Dirceto,r Massachuestts Generla Hopsital MORRIS F.C OLLE,N Dirceto,r MedicaMle thodRses earc,h thPee r­ manenteMe dical Group AMITAIE TZINOI, ProfessoofrS ociogly,o ColumbiaU niversiyt,a nd Direocrt, Cetnerf orP olicyRe search CHARLES D. FLAGLE, Professoro fH ealht SevriceAsdm initsrati,o n Scholo oHfy gienaned PubliHce alt,h theJ ohnHso piknsU ni­ veristy GE RALD A.GO RDON , Direocrt, Centefro rA ppiledS oicalS cienc,e BotsonU niversity ANTHONY A.RO MEO , AssoicateP rofessoofrE coniomc,s theU nievrsiy t ofC onncetciut HENNINGE .V ONG IERKE, Direocrt, Biodynacmsia ndB ioncisD iviison, AerospacMee dcialRe searcLhab orato,r WyrightP-atteornsA ir ForcBea se WILLIAM s. YAMAMOTO , Professora ndC hairman, Departmenotf C lniical Engienreing, GeorgWea shingtUoninve ristyM edicla Center MICHAEL ZUBKOF,F Profesosra ndC hairman, Departmento fC ommunity Mediicne, DartmoutMehd ical School JUDITH L.W AGNER, StduyD irector JANEK INSMAN, Conslutant MADALYN POLLITT DIANE WEAVER iii Copyright © National Academy of Sciences. All rights reserved. Medical Technology and the Health Care System: A Study of the Diffusion of Equipment-Embodied Technology http://www.nap.edu/catalog.php?record_id=18439 PREFACE Thisr eporte xamniest hepo liyc anrdes earcihs uses baisct ot he relationshbiepwt eenn ewm edicatle cholnoyg andt he effiicency ande fefcitvenesosf t he healh tcares yst.e mTheN ationRae­l serachC oucni'lsC ommitteeo nT echnloogy andH ealh tCar,e org­a niezdj onitlyi n1 97b6y theA ssemblyo fE ngineerainndtg h e Instuitteo fM ediicn,e hasa ssesstehdep rocesbsy w hicht ech­ noloyg fidnsi tsw ayi not theh eatlh care tseyms,i denitfyinga nd analiynzgs uccsesesan d iflaruesi nt hep rcoesso ft echonlogcial chan.g eIdeally, themo re effectei avnde fifcinett echonlogies shoulbde intorduceqdui ckly:o therss houldn ot. The ciotmmtee hasa ttemptetdo d etemrinet he extentto w hich thseei dearle ­ sutlsa cutalyl doo ccura nd, whent heyd on',t whyn ot. Ino ur revieowf t hee videnbceea rinong itshq uestoin,w eh avei denitfeid areawsh eremo re reserachi sn eeedd. SCOPEA ND LIMITATIONS The committeel imiteidt si nquriyt oa ne xaminatioonf " equipemnt­ embodeidt ehcnolo,g"yw hichi st hee quipment,p rocedsu,rs eervcie,s ors ystmse thatd epenpdr imarliyu ponc apitaelq uiepnmt. Fetal monitorinegq uiepnmt, coornayr caer units,f iber-potice nodsocpic procuerdse,a ndm edicailnf ormatiosny tsemsd,i verstheo ugthh ey are, allf allw ihtint hes tduy'sp urveiw. Thes tudye xcldued otheri mportantt echonlogiciannlo vaitonsi n heha clatres,u cha s newt hreapeiuctd rugosr n ew sguircaplr ocuerdse forw hich par­ ticuleaqru ipmewnats n otr euqierd. Asa fisrta pporximatioonf t he issuest o baed drsesde,t he committeei denitfieda serieosf q uesiton:s v Copyright © National Academy of Sciences. All rights reserved. Medical Technology and the Health Care System: A Study of the Diffusion of Equipment-Embodied Technology http://www.nap.edu/catalog.php?record_id=18439 vi What isk nownab outt her elatinoshpi ofe quipment-embodied • technolotogh ye lathc arec ostasn ds oicalb enfeits?A ret here cateogrieosf sutcechh nloogyt hata rew ortthh eirc osta nd othertsh ata ren ot? What facotrsd eterminteh ew ayd eciisonsa rema de about the • acecptancoef n ewe quipmeenmbto-diedt echnoloigyn toh elathc aer? Aret here patriculacart eogreiso ft echnolotghya ta rel ikelyt o bea doptetdo or apidlayn du ncriticya olrlt oos lowly?T ow hat extentd o currnetp ublicpo liciecso tnrbiutet o suchp rolbems? How iisnf ormaitonab outt hee ffecteinvsesa nde ffiicencyo f • newt ehcnolyo gdevleopeadn du sed? At whats tagien t hep rcoess oft echnicaclh angies i nformationg enreated?To whate xtent doest hed evleopmenta ndd issmienatioonf i nformatiaobonu tme d­ icalt echnologyn eedt ob e improved? Fromt heo utsett hec ommittedee icdedn ott or eveiwt hes tatoef thea rti nd evleoipng patriculakrin dso fme dicalt ecnhologyn or didi ta ttemptt oi denitfys ingificanto pportuintiefso rR &Do f newt echlnooyg--althougthh ec ommitteies qu itec erta�sn ucha studcyo ulbde u sefutlo t hosef ederaagle nicest hata rer espon­ siblef or supoprtingR &Da ctitviie.s Thec ommittedei dn ota n­a lyzet hes ubstnatianlumb er ofi ssuesa ssocitaedw ithb imeodical resaerhc policy, sucha st her elatiev meritso ft argedt veersus untargeteidn evstgiationosro f larggrena tso vers mall gratns, thec onitnuiy t orfe serachf udnin,g thep eerr evieowf r eserach prpoosal,s andt he orgainztaionasltr ucturoer p roecssmo st con­ ducivet o innovaitonsi nm edicatle chnoogly.T hesew erer uled outf ort wor easo:n sThei sseus dh ajustb eenc onisdreed btyh e Presiednt'sB iomedicalRe searchP aenl, and tthieem availablef or thes tudy moedfi catlec hnloogyd idn ota llowf ore xpnadintgh e scopeo ft hec ommittee'sw or.k Thec ommitteiem psoeds everala didtionallim itatiounposn it­ selfi nr ecognitoifot nh ec onstraionftt sim e andt hea besnceo f objectiev stduieso nc etraint opics.T hu,s itd idn otd eliberate the technicailss ues aisastoecdw iht deevloipng equipmte-nmbeodied technloog,y inclduingt hen eedfo rt rainetdec hincamla npoweorr f or R&Ds etitngsi nw hich thec ollaboratioofnme dicine ande ngineer­ ingc anb emo st prodtuciev.*I td idn ote xaminfeu llyt hei nful­ ence tohfe b iomedicaell etcroincsa nde quipmenti ndusiterso nt he procesosf t echincalc hnagei nh elathc aren�o rd idi te vaulate thee xtentto w hich thei ndustrdye teirnmest hed ierctionosf *Onec ommittemeemb er,W ililam Yamamoto , hast akene xceptiotno the limitesdc opeo ft hes tudiyn t hisc onnecitona sw ella ss ome oft hei mplciatioonfst he conclsuionsa ndr ecommendtaion.s His dissentivnige wa ppaersa sA ppnedixA . Copyright © National Academy of Sciences. All rights reserved. Medical Technology and the Health Care System: A Study of the Diffusion of Equipment-Embodied Technology http://www.nap.edu/catalog.php?record_id=18439 vii deevlpoment and distbruitioonf nemwe dicalt echnoloyg ors ipmly respondst o thdee mandsa nd neeodfst heh ealth cares ytsem, mainlyb ecuaser eliabled ataab outt hea ctviitieosf e quipment makersa rev itruallyun attainlabe. Indee,d thec ommitteea ssumed ini tsd eliberatiotnhsa tn ewm edicalt echlnoogyr eslutsl argely from tdheeman d exrpessedi nt he" marke,t"w hic,h int hec aseo f theh ealht cares yst,e mmeanpsh yiscian,s hospitsal,o thre proivd­ ers, and tphubel i.c Conseqtuley,n thec ommitteea ssessedt he nature tohfema rkets ingalsi ns omed epthan d nott hee xtentto whicthhe bimoedicaleq uipmeinntd ustmaryy bea powe rfulf orce inc reatinga marketf ori tsp rodusc.t Fianlyl,t hes tuddyi dn otd ealw iht thei suseso fe thicaaln d soicalc hoicensow made possibleb y the availabiiltyo fm edical equipmetnotp rolongl ief ort hef innaciaclo stosf s ucht echnlo­ ogyo ne ither thei ndiivduapla tienatn dt hei mmediatfea imlyo r the rest soocfi ety. Medicalt echlnooyg rasiesman y fundmeantal questionsabo ut previoluysun contorlleda spectosf life. Itpo s­ sesessan implicti powert or edsitriubtew ealthi nt hes oicetya nd to confebre nfeitsupo n some tohfe mo st underpriilveegd. Ietn ­ dowsh elathp ractitiownietrhsn ewpo werso verl ief andd eat.h It cretaes newj obsan d dipslcaeso ldj obs. While tchoemm itteree cgo­ nizetsh ed iffeernitali mpactso ft echonlogiccahla ngoen soicety that mediicnen owpo ssess,e ssuche thicaaln ds oicalq uestoins haven otb eena drdessedi nt hes tudy.Th e committ'eesma in focus hasb eeno nt hec ostasn de ffecteinvseso ft hep rcoesso ft echno­ logiccahla ng,e noto nt hee quitoyf itcso nesquecnes. METHODOLOGY The committee, conisstnigo fs peciailstsi ne ngienrein,g meidcnie, economcis, soicolgoy, andh ealthc area dminisattiron, met four timest o deliberatteh ei ssue,s reaccho nlcuisons, andd evleop a seto fr ecommendatifoonrpos l icya ndr esaercht hatb earo nm edi­ calt ecnholoyg. Ina dditino,t hec ommitteer eviweeda serieosf studpya perst hati tc ommissione.d Fouro ft hep aperwse rec ase stduieso fp atricurl eaquimepnt-embodied technloog.y Theo ther papersi nlcudeda na nalsyiso fp roperrtiyg htspo licierse ltaed to the introdtuiocno fn ewme dicatle chlnoogy, ane xaminationo f thei mpacto fs tatea ndl ocarle gultaionosn me dicalte chnloog,y anda n assessmento ft hee conoimcc osto fe quimepnt-emboditeedc h­ nology. Whileth e cmmiossionepda presp rovided oofin tes p rin­ cipal srocueso fi nformatio,n thec ommittedei dn ota lways accpet ora grewei th theirf indingasn dc onclsuinos. Some of thpea pres arei nlcudedh ere( pApenidxesB -G)s ot hatr eaders mayh avea ccess to thesoeth erwisunep ublishedd ocumnets. Copyright © National Academy of Sciences. All rights reserved. Medical Technology and the Health Care System: A Study of the Diffusion of Equipment-Embodied Technology http://www.nap.edu/catalog.php?record_id=18439 viii Thec ommitteeh elda no penm eetingt oc olletchte v iweso fc on­ cernedc itizeonnst hec ritcialp rolbemso ft echnloogiccahla nge int heh ealht cares ysetm. Thep ublic'svi wesw eret hes ubject ofa ntoherd eilbreaitve meetinbgy t hec ommittee. ORGANIZATIOONF TH E REPORT Thisr eprotc ontaiannsi ntordutcionan d summary, fours ubseuqent chapetr,s anda ppendsix.e Chpater2 reveiwsw hati sk nownab out thee conomci costosf t hev ariousp esto yfm edicatlec hnloogy. Chpater3 analzyes thea dpotioann du seo fn ewt ehcnolyo gint he healht cares ytsem, identifyings pecfiicf atcosr thatma y tendt o eihteri nhibito re ncouratgheep roecs.s Chpater4 exploretsh e poliyc otpiontso d ealw iht thper olbems int hea dopitona ndu se ofme dicailn novaitons.C hpater5 disucssetsh ec ritailcq uestino ofh owe vaulaitve inofrmatioins g enerataenddd isseminatetdh rough­ outt hep roecsso ft echonlogiccahlan gean d howt hatp rcoessc an bei mproved. There aree ighta ppnedixetso t he rretpo. AppenidxA is the disesntign opniiono fc ommittemee mberW illiam s. Yamamoto. Ap­ penidxesB througGh a res ixc ommissionepdap erst oa ssistth ec om­ mitteei ni tsa naliysso ft hep ertineinstus es andt op rovidcea se studieso fp aritculatre cnholgoie.s AppnedixH isa lisitngo f indivaidlusw hoa tetndetdh eo penm eetinogn t hep rocesosf t ech­ nologiccahla nge. ANOTHERW ORD Whent hiss tudyw as undertake,n thec ommitteec hairman wasJ ordan J.B aurch, ProfessoofrE nigneeirnga ndB uisnessA dminitsratni o atD artmouthC ollege.D r.B arcuha nda ntohero riginmeamble r, KareDna viso ft heB rookingsI nstuittio,n letf thec ommitteea fewmo nthsa ftearwrdw hen etyhw erea ppointetdop ositoinsi n Presdietn Carte'rsA dmniitsratoin. Threeo thre membersl etf the committeea fetrp atriicpatingi ni tsi nitidaelil berationTsh.e y areE dwarBdur ge,r ClinicaAlss itsantP rofessoart G eortgoewnU ni­ veristy MedicaCle ntre;A laiGn. E nthov,e nthMaer rinesr. Eccles ProfessoofrP ublicand PriavteM anagemeanttS tanfordU nivesrit;y andW alteAr. Rosenbliht,P roovsto ft heM assachuesttsI nstuitte of Thencology. Thec ommitteei sg ratfeult ot hseep epolef or thieri nciisve ideaisn t hee arlmyo nths tohifs s tudy. Copyright © National Academy of Sciences. All rights reserved. Medical Technology and the Health Care System: A Study of the Diffusion of Equipment-Embodied Technology http://www.nap.edu/catalog.php?record_id=18439 CONTENTS 1 INTROCDTIUON AND SUMMARY 1 The Proecsso fT echnicaClh ang,e 3 Summaryo fF indinsg nadR ecommendatio,n 1s1 2 ECONOIMCC OSTS 14 ConcepotfsE conmoicC ost,s 14 The DierctC ostosf Eq uipmnet-Embodied Technoloyg,1 5 The Impacto fM edicaTelc hnlooyg onT oatlH ealht CareC ost,s 17 TheS ociaBle nfeitasn dC ostso fN ewM edical Tehcnoloyg, 19 The DistirbutioonfC ostansd Benfeitosf N ew Equipment-Embo diedT echonlogy, 20 Conlcuison,s 21 3 PROBLEMS INAD OPTINO AND USE 23 Theroieso fH opsitaBle hvaio,r 24 � EmpiriaclEv idencoen t heD iffuison of Equimepnt-EmbodieTde cnhoolgy, 27 xTheI mpacto ft he Healht CareF innacnigS ytsem ont heA dotpino andU seo fEq uipment­ Embod iedT echnoolgy, 33 The Impact ofD efenisveM edicineo nAd optino and Useo fN ewT echnloogy, 39 TheI mpcato fO rgainzatni oofH ealthCa re Sevriceso nA dpotino andU se, 39 �Concluison,s 44 ix Copyright © National Academy of Sciences. All rights reserved. Medical Technology and the Health Care System: A Study of the Diffusion of Equipment-Embodied Technology http://www.nap.edu/catalog.php?record_id=18439 4 ALTERNATIVE APPRTOO ATCEHCEHSN OLOGY MANAGEMENT 46 IF unidngo fD evleopmentaElf fort,s 47 · DirecRteg ulatni oofI ntordcutiono fN ew Equiepnm-tEmbodiedT echnlooyg,4 8 .1D irecRteg ulaitono ft heA dotpiona ndU seo f Equimepnt-EmbodiedT echnology, 52 tP aymenPtol iceis, 56 Healh tManpowPeroi lcie,s 62 Informtaino DissemiinoantS traegtise,6 3 A Cavaeto nt heE xpansiono fRe gulatoyr Program,s 64 '\S ummary, 6 7 5 THEEV ALUATION OQFU IPEMENT-EMBOD IED TECHNOLOGY 68 What ShoulPdot entiUasle rosf E quipment-Embodied TehcnologyKn ow AboutT ecnhoolgy,? 68 � To What ExtenAtr eE xsitingP rocdeurse for Genreatinagn dU singI nfomratino on Equiepnmt-EmbodieTde cnholoyg Inadequat,e ?75 PropsoedS olutiotnost heP rbole,m 79 GLOSSARY 85 REFERENCES 87 APPENIDXES A AD ISSNETINGO PININO Willima s. Yamamoto 99 B A CASES TUDOYF MAMM OGRAPHY MorrisF .C ollen 101 C ACA SE STUDOYF MULTIHAPSICHE ALTH TESTIGN Morris F.C ollen 124 D GASTRIFCRE EZIGN--A STUDYO FD IFFUISON OF A MEDICAL INNOVIAOTN Harvevy. Finbeegr 173 X Copyright © National Academy of Sciences. All rights reserved.