Equipment-related incidents in the operating room: an analysis of occurrence, underlying causes and consequences for the clinical process

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1 1 Univrsity of Twnt, School of Managmnt and Govrnanc, Dpartmnt of Halth Tchnology and Srvics Rsarch, Enschd, Th Nthrlands 2 Isala Klinikn, Hospital, Opration Rooms Dpartmnt, Zwoll, Th Nthrlands 3 Mdisch Spctrum Twnt, Dpartmnt of Mdical Physics, Hospital, Enschd, Th Nthrlands Corrspondnc to Dr W H van Hartn, Univrsity of Twnt, Dpartmnt of Halth Tchnology and Srvics Rsarch, PO Box 217, 7500 AE Enschd, Th Nthrlands; w.h.vanhartn@utwnt.nl Accptd 4 March 2010 QHC Onlin First, publishd on 16 Jun 2010 as /qshc Quality improvmnt rport Equipmnt-rlatd incidnts in th oprating room: an analysis of occurrnc, undrlying causs and consquncs for th clinical procss I Wubbn, 1 J G van Mann, 1 B J van dn Akkr, 2 S R Vaartjs, 3 W H van Hartn 1 ABSTRACT Background Equipmnt-rlatd incidnts in th oprating room (OR) can affct quality of car. In this study, th authors dtrmind th occurrnc and ffcts on th car procss in a larg taching hospital. Mthods During a 4-wk priod, OR nurss rportd quipmnt-rlatd incidnts during surgry procdurs in both locations of th hospital. Th incidnts wr rportd using a sparat form for ach incidnt. A structurd analysis (PRISMA) was usd to analys incidnts that rsultd in srious dlays (>15 min). Rsults Forms wr rturnd for 911 out of 1580 surgris (57.7%). In total, 148 incidnts wr rgistrd, rlating to a total of 29 h and 45 min of xtra work. In addition, 12 h and 9 min of oprational dlay was rgistrd. Most incidnts involvd instrumnts (46%) or mdical dvics (28%). 68% occurrd during surgry and 32% during th prparation phas. No dirct physical harm was rportd, although indirct harm, lik longr anasthsia, did occur and can b dfind as an advrs vnt. 10% of th incidnts ld to a dlay of ovr 15 min. For ths incidnts, managmnt dcisions (g, invntory capacity, planning procdur) was th most ncountrd root caus. Only six out of th 148 incidnts found corrspondd with th blamfr rporting databas. Conclusions Equipmnt-rlatd incidnts occurrd frquntly in th involvd hospital sits (up to 15.9%) and rsultd in som xtra work and additional minuts of dlay pr vnt. Managmnt dcisions hav considrabl influnc on th occurrnc of quipmntrlatd incidnts. Thr was srious undr-rporting of incidnts. Litratur suggsts that advrs vnts in hospitals occur at unaccptably high rats 15 and that a considrabl prcntag ar prvntabl. 236 Th xact numbr of (nar) incidnts in hospitals is unknown, as good incidnt-rporting systms ar lacking or ar usd inconsistntly. 7 With rspct to incidnts in th oprating room (OR), Coopr concluds in two studis that 14% of incidnts during anasthsia procdurs ar th rsult of ovrt quipmnt failur. 89 In addition, quipmnt dsign was indictabl in many catgoris of human rror, as wr inadquat xprinc and insufficint familiarity with quipmnt. 8 This distinction in rror causation can b rlatd to activ and latnt failurs. 10 Activ failurs ar th unsaf acts committd by popl who ar in dirct contact with th patint or systm, and latnt conditions ar th waknsss in dfnc mchanisms cratd by dsignrs, buildrs or managmnt. Also govrnmnt agncis strss th importanc of adquat quipmnt managmnt In addition, quipmnt is an important factor to b considrd in OR schduling. 14 Equipmnt-rlatd incidnts ar listd among th most common causs of dlay in th OR, aftr th lat arrival of surgons or anasthtists Furthrmor, many intrruptions that wr found in prvious studis ar rlatd to quipmnt As intrruptions during surgry might lad to advrs vnts, stramlining all procsss involving quipmnt will rduc risks by rducing th numbr of intrruptions. W could not find any litratur rporting on prospctiv invntoris of quipmnt-rlatd incidnts, irrspctiv of natur or background, and its ffct on continuity and safty of th oprating room procsss. This study sought to dtrmin (1) th occurrnc of quipmnt-rlatd incidnts in th OR, (2) th ffct of ths incidnts on th continuity of th clinical procss and (3) th undrlying causs of ths incidnts. METHODS Rsarch stting This study was prformd in a larg, non-acadmic taching hospital in Th Nthrlands that prforms approximatly surgical procdurs a yar. Th hospital has two locations, and surgry is prformd in both. Th study focusd on clinical ORs, and procdurs prformd in day car wr not takn into account. Eightn clinical ORs ar availabl across both locations (8+10), and most ORs ar ddicatd to spcific spcialitis. Thr is just on OR ddicatd to mrgncy procdurs, which was includd in this study. Th OR nurss work at both locations in a circulating systm. Data collction All OR nurss wr askd to fill in on rgistration form (s annx 1) aftr ach surgry procdur during a 4-wk rgistration priod in JanuaryFbruary 2009 (1580 procdurs). Using this form, thy rgistrd th dat, patint numbr and whthr or not an quipmnt-rlatd incidnt occurrd. An quipmnt-rlatd incidnt is dfind as all activitis with quipmnt that did not go according to plan. Th combination of dat and patint numbr mad it possibl to rtriv additional data (spcialty, typ of surgry procdur, OR numbr) from a databas. Whn an incidnt was rgistrd, additional qustions wr answrd on th rvrs sid of th form. Hr, information about th incidnt (tim, typ of incidnt, typ of quipmnt involvd; s tabl 1), consquncs Qual Saf Halth Car: first publishd as /qshc on 16 Jun Downloadd from on 8 May 2018 by gust. Protctd by copyright. Wubbn I, van Mann JG, Van dn Akkr BJ, t al. Qual Saf Halth Car (2010). doi: /qshc of 7 Copyright Articl author (or thir mployr) Producd by BMJ Publishing Group Ltd undr licnc.

2 Quality improvmnt rport Tabl 1 Dfinitions of quipmnt catgoris and incidnt catgoris with illustrativ xampls Catgory and dfinition Illustrativ xampl(s) Mdical dvic: Equipmnt that is usd during th surgry procdur. Nds to b powrd and givs information and/or has moving parts. Rpairs and inspctions ar don by th dpartmnt of Mdical Tchnology. Instrumnts: Equipmnt that is durabl and dos not nd powr. Most instrumnts ar tratd by th strilisation dpartmnt. (Disposabl) Matrials: (Bulk) products that ar disposabl aftr us. Furthrmor, durabl products that do not nd to b stril or powrd ar dfind as matrials. Facilitating quipmnt: Equipmnt that has a supporting function in th OR Equipmnt not availabl: Equipmnt that cannot b found, that is in us alrady, or is not stril Failing quipmnt: Equipmnt that fails whil using or tsting it Misus: Using quipmnt in an impropr way by oprating room mploys Othr: All incidnts that cannot b placd in th catgoris unavailabl, failing or misus. (xtra work, dlay, patint rlatd) and probabl causs wr rcordd. Th rgistration form was draughtd and tstd in a pilot study in coopration with OR nurss to vrify th practical and thortical contnt; th mthodological charactristics of th forms wr not othrwis tstd. Th rgistration forms wr printd in a prominnt colour and wr prsnt in ach OR. Aftr th forms wr compltd, thy wr rturnd to th scrtary of th OR complx whr thy wr pickd up daily for procssing. For th forms that wr incomplt or unclar, mails or intrviws (by phon or fac to fac) wr usd to rtriv th missing data or to clarify th rgistrd incidnt. In addition, th OR nurss wr instructd to continu to rgistr incidnts in th blam-fr rporting databas in ordr to b abl to compar th numbr and typ of incidnts in this databas with th rsults of our study, as th managmnt flt that thr might b undr-rporting in this databas. Data analysis c 2 tsts wr usd to dtrmin whthr thr wr any statistically significant diffrncs in incidnts btwn th two locations, spcialitis, tc (p<0.05). Furthrmor, a PRISMA analysis was usd to analys th causs of incidnts that rsultd in a dlay of 15 min or mor. Ths incidnts wr considrd to b srious by th hospital managmnt. Th PRISMA analysis consists of thr stps: crating causal trs for th occurrd incidnts (using intrviws with th OR nurss), catgorising th root causs using th ECM modl 21 and suggsting intrvntions to rduc th occurrnc or consquncs of incidnts. Th PRISMA mthod was suprvisd by th main author. Th rsarchr did not follow any formal training but xtnsivly studid all rlatd litratur and an instruction DVD. Fil accss and staff intrviws wr usd to rtriv th rquird data, and conclusions wr vrifid by th involvd staff and on of th coauthors (BJvdA) with xtnsiv xprinc in quipmntrlatd issus in th OR nvironmnt. Vido carts, infusion pumps, x-rays Evrything in a st of instrumntsdfor xampl, scalpls, scissors and twzrs. Furthrmor, add-ons for mdical dvics for xampl, saws, drills and scops ar dfind as instrumnts. Bulk products such as ndls, plastrs and bandags. Furthrmor, th matrials catgory contains products such as implants and ECG cabls. Equipmnt such as spcialisd oprating room-doors, air-filtring systms, oprating room-tabls, oprating room-lighting, non-mdical computrs and tlphons Spcial implants wr snt to th hospital but arrivd at th wrong location. Surgry was postpond until transportation to th othr location was arrangd. During a minimal invasiv surgry procdur, imags on th vido cart wr no longr visibl. A brokn scop ndd rplacmnt in ordr to rgain visual contact. Whil lowring th oprating room tabl, a bdsprad was crushd btwn th sliding mchanism. This stoppd th oprating room tabl from moving, and a rplacmnt was usd. A barhuggr blankt for warming th patint was availabl, but could not b usd du to protocol issus Finally, th data wr compard with th data in th blamfr rporting databas to vrify th compltnss of th data in both this study and th databas itslf. RESULTS Occurrnc of quipmnt-rlatd incidnts Th final sampl (rprsnting a 57.7% rspons rat) includd 933 rgistration forms rprsnting 911 procdurs (multipl incidnts occurrd during 15 procdurs); 167 incidnts ar rgistrd on ths forms. Nintn of ths incidnts, howvr, wr xcludd, as thy wr not quipmnt-rlatd (5) or wr rportd rpatdly, as th problm (an air-conditioning systm blowing vry cold air) was not solvd within a wk (14; inclusion would distort th rsults). Th rsulting 148 incidnts ar includd in this study, rprsnting a rgistrd incidnt prcntag of 15.9% (tabl 2). Th c 2 tst did not show any significant diffrncs in th occurrnc of incidnts btwn location A and B. Th distribution of th incidnts ovr th two locations, rlatd to timing, quipmnt catgoris and incidnt typs, is shown in tabl 3. Th most common typs of quipmnt involvd in incidnts wr surgical instrumnts (46%), followd by mdical dvics (28%), facilitating quipmnt (16%) and matrials (10%; s tabl 1 for dfinitions). Concrning th typ of incidnt, 93% of th incidnts could b catgorisd as quipmnt unavailabl (45%; oftn instrumnts) or failing quipmnt (49%; oftn Tabl 2 Ovrall occurrnc of rgistrd quipmnt-rlatd incidnts (by hospital location) Hospital location A B Total Prformd surgry procdurs during study Rturnd rgistration forms 474 (65.9%) 933 (59.1%) (prcntag of total)459 (53.3%) Rgistrd incidnts Incidnts xcludd Incidnts includd (prcntag of total no of forms) 68 (14.8%) 80 (16.9%) 148 (15.9%) Qual Saf Halth Car: first publishd as /qshc on 16 Jun Downloadd from on 8 May 2018 by gust. Protctd by copyright. 2 of 7 Wubbn I, van Mann JG, Van dn Akkr BJ, t al. Qual Saf Halth Car (2010). doi: /qshc

3 Tabl 3 location) Occurrnc of rgistrd quipmnt-rlatd incidnts (by Location A no of incidnts Location B no of incidnts Total no of incidnts (%) Timing of incidnts During prparation (31.8) During surgry (68.2) Equipmnt catgory Mdical dvics (28.4) Instrumnts (45.9) Matrials (10.1) Facilitating (15.5) Typ of problm Equipmnt not availabl (44.6) Brokn quipmnt (48.6) Misus (3.4) Othr (i, procdural problms) (3.4) N¼148. mdical dvics). Finally, incidnt prcntags wr abov avrag for spcialitis using th most (advancd) quipmnt, such as nurology (26.4%), orthopadics (20.8%), urology (20.5%) and thorax surgry (17.9%) (not in tabl). Consquncs of quipmnt-rlatd incidnts Th 148 incidnts mntiond abov causd a total of 29 h and 45 min of xtra work for th OR nurss. Waiting tim is not includd in this numbr, dfind as th tim that OR nurss in th OR ar actually waiting, without prparing a latr phas of Tabl 4 PRISMA profil of th 15 srious incidnts * Root-causs idntifid in PRISMA analysis No Exampls from rlatd study th procdur. On avrag, this rsults in xtra work for th OR nurss of 12.1 min pr rcordd incidnt (SD¼16.9). Svnty of ths incidnts (47.3%) vntually ld to a dlay (dfind as th tim that th ntir procdur was haltd) for th clinical procss in th OR. Th total amount of dlay rgistrd in this study in th OR was 12 h and 9 min (on avrag 5 min pr incidnt, SD¼9.9). Th 15 srious incidnts (analysd using th PRISMA mthodology) rprsntd only 10% of th total numbr of incidnts but rsultd in 61% of th total rgistrd dlay (xplaining th high SD for th avrag dlay). According to th OR nurss, non of th incidnts dirctly rsultd in physical harm. Howvr, patints wr affctd indirctly by longr anasthsia as a rsult of 29 incidnts (19.6%) and postpond procdurs as a rsult of two incidnts (1.4%), so ths incidnts can b dfind as advrs vnts. In th sam priod, only 10 quipmnt-rlatd incidnts wr rportd in th blam-fr incidnt rporting systm, of which only on rlatd to a srious dlay cas. Six out of ths 10 wr also rgistrd for th prsnt study using th rgistration forms. Causs for quipmnt-rlatd incidnts Th caus of an incidnt was oftn unknown to th rsponding OR nurs (27.7%). Failing quipmnt (21.6%) and incomplt instrumnt sts (14.2%) wr th top catgoris for th incidnts whr th caus was dtrmind. Othr causs dtrmind by OR nurss ar misus (6.1%), non-stril quipmnt (5.4%), communication rrors (4.1%), planning rrors (1.4%) and causs that wr listd only onc (18.9%). Causal trs wr drivd for 15 incidnts that causd srious dlay (>15 min). Classifying all root causs rsultd in th Tchnical T-x (Extrnal) TD (Dsign) 2 Malfunctioning softwar in navigation quipmnt TC (Construction) TM (Matrials) 5 Scop mad of fibrglass is intrnally brokn Organisational O-x (Extrnal) 1 No intnsiv car bd availabl for patint that nds othr typ of surgry (intnsiv car and oprating room ar sparatly managd dpartmnt) OK (Transfr of Knowldg) OP (Protocols) 2 Multipl typs of vido carts ar availabl. Surgons prfr a crtain typ and us this on whn availabl, vn if thy can prform th surgry with an oldr typ. Now, anothr surgry that ndd this spcific vido cart was dlayd by th unavailability (lack of procdurs). OM (Managmnt prioritis) 13 Dcision to do fiv idntical procdurs in 1 day, whil only thr sts ar availabl. Dlay in strilisation procss causs dlays in th oprating room. OC (Cultur) Human H-x (xtrnal) 4 Surgical instrumnts ar missing in instrumnt st (human rror in strilisation dpartmnt) HKK (Knowldg) HRQ (Qualifications) HRC (Coordination) 2 Surgon dcids to prform othr typ of surgry whn patint is alrady in th oprating room (quipmnt was not availabl yt) HRV (Vrification) HRI (Intrvntion) 7 Wrong us of instrumnt rsultd in brokn scrws HRM (Monitoring) 2 Oprating room nurs rsponsibl for rfilling th stock, forgot to chck th numbr of matrials in a crtain oprating room, rsulting in a shortag HSS (Slips) HST (Tripping) Othr PRF (patint-rlatd factor) 2 First surgry procdur was prformd in anothr country whr othr typs of orthopadic matrials wr usd. Othr instrumnts wr ndd whn this was noticd. X (Unclassifiabl) *Each singl incidnt can hav multipl root causs; only incidnts ar usd that rsultd in mor than 15 min dlay. Quality improvmnt rport Qual Saf Halth Car: first publishd as /qshc on 16 Jun Downloadd from on 8 May 2018 by gust. Protctd by copyright. Wubbn I, van Mann JG, Van dn Akkr BJ, t al. Qual Saf Halth Car (2010). doi: /qshc of 7

4 Quality improvmnt rport profil shown in tabl 4. An xampl of such an analysis is providd in figur 1. Managmnt Prioritis is th catgory that is dtrmind most oftn (13), followd by Human intrvntion (7) and Matrials (4). This Managmnt Prioritis catgory as dscribd by van Vuurn Rfrs to failurs rsulting from managmnt dcisions in which safty is rlgatd to an infrior position whn facd with conflicting dmands or objctivs. 21 In this study, w found incidnts du to invntory capacity planning (8), schduling issus (3) and th configuration of instrumnt sts (2). In all ths cass, costs and productivity wr factors that wr prioritisd by managmnt abov th risk of incidnts. CONCLUSION AND DISCUSSION In this study, w hav found that quipmnt-rlatd incidnts in th OR ar a common phnomnon, occurring in up to 15.9% of surgry procdurs. Ths incidnts rsult on avrag in 12 min of xtra work and 5 min dlay pr incidnt, affcting th continuity of th clinical procss. Furthrmor, w hav found that dcisions mad by managmnt hav a considrabl influnc on th dlay causd by quipmnt-rlatd incidnts. Finally, w found a larg discrpancy btwn th numbr of incidnts rgistrd in this study and th blam-fr rporting databas, indicating srious undr-rporting. Th incidnt prcntag found in this study (15.9%) might not rprsnt th actual occurrnc du to th uncrtainty causd by th rspons rat (57.7%). For both locations, thr was a significant positiv corrlation (0.64 and 0.54, p<0.05) btwn this rspons rat and th numbr of rgistrd incidnts during a day. OR nurss wr probably mor motivatd to fill in a form for procdurs whn confrontd with an incidnt. Thrfor, th actual occurrnc is likly to b somwhat lowr than th prcntag of 15.9% that is found in this study but will b at last 9.4%. As only th xtra work for OR nurss was rgistrd, th consquncs in trms of xtra work ar probably undrstimatd. Additional work can b incurrd for various dpartmnts such as planning, th mdical tchnology dpartmnt and nursing wards. Although thr was no dip in rportd incidnts in th blamfr rporting databas during this rsarch, it showd that only 10 quipmnt-rlatd incidnts wr rportd during this study, confirming that currnt incidnt rporting systms ar usd inconsistntly. 7 It is undrstandabl that OR nurss wr rluctant to rgistr all incidnts by blam-fr rporting, as it consums a considrabl amount of tim, and many incidnts wr only minor intrruptions that did not harm th patint. Howvr, a srious undr-rporting was found for th srious incidnts as wll (on out of 15 was rgistrd). This suggsts a considrabl potntial for improvmnt; if propr incidnt rporting and follow-up ar ralisd this can rsult in a lowr occurrnc of incidnts. 25 For th 15 incidnts causing a dlay of 15 min or longr, multipl root causs wr drivd by conducting intrviws (PRISMA analysis). Although 15 incidnts is a rlativly low numbr for an aggrgatd PRISMA analysis, th profil of classifid root causs clarly distinguishd th most important factors (tabl 4). As a rsult of th PRISMA analysis, th hospital undr rviw is advisd to r-valuat its invntory capacity of quipmnt (spcially instrumnts). Furthrmor, thy ar advisd to r-valuat th procdurs for th strilisation dpartmnt, as many incidnts wr th rsult of incomplt (21) or non-stril (svn) instrumnt sts. Lastly, w rcommnd that th hospital should considr rnwing its procdurs for rporting dfctiv quipmnt, as two incidnts wr causd by dfctiv quipmnt that had alrady causd problms but was not rportd to othr OR nurss. Mthods to rduc incidnts, such as a chcklist including a tim-out procdur 26 and propr quipmnt maintnanc, 5 wr alrady in plac but did not sm to b watrtight. This study has som limitations. Assssing th rprsntativnss of our findings for othr hospitals rquirs furthr rsarch. Furthrmor, th rspons rat of 57.7% crats som uncrtainty in th data rsulting from th chosn mthod of rgistration by OR nurss. Dirct obsrvation by traind and indpndnt rsarchrs would hav constitutd an idal mthod to validat th OR nurss rports at th nd of ach cas. Howvr, this was not fasibl du to tim and cost Qual Saf Halth Car: first publishd as /qshc on 16 Jun Downloadd from Figur 1 Brokn scops lading to considrabl dlay and a canclld procdur. on 8 May 2018 by gust. Protctd by copyright. 4 of 7 Wubbn I, van Mann JG, Van dn Akkr BJ, t al. Qual Saf Halth Car (2010). doi: /qshc

5 rstraints. It can b prsumd that mor, possibly lss significant, incidnts would hav bn rportd, lading to highr figurs than thos prsntd hr. Also, a highr prcntag of misus would probably b rportd, as is th cas in othr studis. 5,8 It is also possibl that th choic of rgistration by OR nurss, instad of surgons or anasthtists, crats a profssional bias. Th validity of th masurmnts was not formally tstd; it is likly, though, that th instrumnt usd is valid for this rsarch purpos, as w ncountrd no qustions from th OR nurss, and missing itms in th qustionnair wr vry rar. Lastly, th PRISMA analysis of th most srious incidnts provids a rlvant ovrviw of causs; in viw of th scoring options, considrably largr numbrs ar, howvr, ndd to prsnt a stabl profil of root causs. Notwithstanding ths limitations, th findings of this study provid insight into th occurrnc and ffct of quipmntrlatd incidnts. Th ffcts of ths incidnts on xtra work and discontinuity of clinical procsss in th OR ar not ngligibl, undrlining th statmnt that this factor should b includd in risk assssmnts for quipmnt. 13 Futur rsarch should indicat if th rsults of this study can b confirmd in othr hospitals as wll. Rsarch concrning th xtra rsourcs that ar ndd du to quipmnt-rlatd incidnts might also b vry intrstingdnot only for th OR dpartmnt, but for th ntir organisation, as dlays and waiting tim sm to hav a knock-on ffct on othr dpartmnts. Furthrmor, rsarch is ndd into th most fficint and appropriat way to stimat th local risks concrning quipmnt failur, as incidnt rporting dos not sm to suffic. From a mthodological viwpoint, it is not yt clar whthr a prospctiv risk analysis will compltly covr th wid array of problms that can b ncountrd. 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6 Quality improvmnt rport ANNEX 1 REGISTRATION FORM Qual Saf Halth Car: first publishd as /qshc on 16 Jun Downloadd from on 8 May 2018 by gust. Protctd by copyright. 6 of 7 Wubbn I, van Mann JG, Van dn Akkr BJ, t al. Qual Saf Halth Car (2010). doi: /qshc

7 Quality improvmnt rport Qual Saf Halth Car: first publishd as /qshc on 16 Jun Downloadd from on 8 May 2018 by gust. Protctd by copyright. Wubbn I, van Mann JG, Van dn Akkr BJ, t al. Qual Saf Halth Car (2010). doi: /qshc of 7