Efficacy of safety catheter devices in the prevention of occupational needlestick injuries: applied research in the Liguria Region (Italy)

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1 J prev med hyg 2016; 57: E110-E114 Originl rticle Efficcy of sfety ctheter devices in the prevention of occuptionl needlestick injuries: pplied reserch in the Liguri Region (Itly) D. SOSSAI 1, M. DI GUARDO 1, R. FOSCOLI 1, R. PEZZI 2, A. POLIMENI 1, L. RUZZA 1, M. MIELE 3, L. OTTAGGIO 3, V. FONTANA 2 AND OCCUPATIONAL NEEDLESTICK INJURIES STUDY GROUP * 1 Prevention nd Protection Unit, IRCCS AOU Sn Mrtino, IST Geno, Itly; 2 Epidemiology, Biosttistics nd Clinicl Trils Unit, IRCCS AOU Sn Mrtino, IST Geno, Itly; 3 Mutgenesis Unit, IRCCS AOU Sn Mrtino, IST Geno, Itly * Occuptionl Needlestick Injuries Study Group: F. Copello, P. Dellcà, M. Dori, A. Onesti, G. Montecucco, F. Risso, M. Nelli, I. Benvenuti, M. Sntcroce, L. Giribldi, G. Picelli, S. Simonini, P. Venturini Keywords Helthcre workers Sfety ctheter device Needlestick injuries Summry Helthcre workers who use or my be exposed to needles re t risk of needlestick injuries, which cn led to serious infections by bloodborne pthogens. These injuries cn be voided by eliminting the unnecessry use of needles nd using sfety devices. The present study ws imed t evluting the impct of sfety-engineered device, with pssive fully utomtic needlestick protection, on the rte of needlestick injuries mong helthcre workers. The setting of the study ws network of five public helthcre institutions situted in Northern Itlin Region. Dt on the type of device, the number of employees nd the number of ctheter devices used per yer were collected through regulr meetings with helthcre workers over period of five yers. The most notble result of this study ws the huge risk reduction ssocited with sfety devices. Indeed, the risk of needlestick injuries due to conventionl devices ws found to be 25-fold higher thn tht observed for sfety devices. However, it is noteworthy tht considerble prt of this excess cn be explined by the different bckground number of devices used. Moreover, descriptive nlysis suggested tht individuls with poor/moderte trining level hd lower risk thn those with good/high trining, though the difference ws not sttisticlly significnt. In conclusion, there is convincing evidence of cusl connection between the introduction of sfety devices nd the reduction in needlestick injuries. This considertion should prompt the introduction of sfety devices into dily clinicl prctice. Introduction A shrp injury is penetrting stb wound cused by needle or other shrp object, nd my result in contct with blood or other body fluids. Needlestick injuries (NSIs) re mong the most prevlent occuptionl ccidents, with hollow-bore needles nd disposble syringes s the primry sources of injury [1-3]. In hospitls, helthcre workers (HCWs), prticulrly nurses nd physicins [4, 5], re t higher risk, but clening stff nd other workers my lso be exposed to NSIs, owing to the inpproprite disposl of shrp objects [6]. HCWs re t risk of shrp injuries nd subsequent infection by more thn 40 bloodborne pthogens or species [7]. The risk of HBV, HCV nd HIV infection ttributble to contct with infected blood hs been estimted to be bout 30.0%, 0.5%, nd 0.3%, respectively. In Itly, the estimted yerly number of HCWs t risk of bloodborne infections is bout 900,000, with nerly 96,000 NSIs [6, 8]. The importnce of monitoring nd preventing NSIs hs been recognized in U.S. nd Europen lws. In recent yers, helthcre uthorities, initilly in the U.S. (Public Lw, September 19, 2000), hve focused their ttention on identifying nd utilizing proper medicl devices to prevent NSIs nd other shrp injuries in the workplce [9]. In Europe, Directive 2010/32/EU, pproved on My 10, 2010, requires EU member sttes to implement globl strtegy to prevent occuptionl exposure to bloodborne pthogens in helthcre settings s result of needlestick nd shrp injuries, including the doption of devices incorporting sfety fetures, on the bsis of risk ssessment [10]. The use of needlestick sfety devices is n essentil men of protecting HCWs from NSIs [7, 11]. Severl new devices re rpidly entering the mrket. However, not ll devices re like or eqully effective. To significntly decrese the risk of injury, the design of sfety devices should tke into ccount specific fetures. In prticulr, they should be needle-less nd work pssively; if user ctivtion is necessry, the sfety feture should be ctivted by mens of one-hnded technique nd llow the worker s hnds to remin behind the exposed shrp point. Moreover, they should be esy nd prcticl; they should be sfely nd effectively usble for ptient cre nd should possess d- E110

2 Sfety ctheters nd prevention of needlestick injuries ditionl fetures, ccording to the Americn Nurses Assocition [12]. Severl studies hve reported tht pssive sfety devices offer better protection ginst ccidentl NSIs thn ctive devices [13-16]. However, certin uthors hve concluded tht there is very low qulity evidence tht NSIs re significntly reduced by the using of sfety devices [17]. In the present pper, we evluted the impct of sfety-engineered device on the prevention of NSIs in five public helthcre institutions in Northern Itlin Region (Liguri). This study, conducted t the Protection nd Prevention Deprtment of Sn Mrtino Hospitl in Geno, ws imed t ssessing whether reduction in the number of NSIs cused by ctheters could be observed s consequence of the introduction of the Introcn Sfety IV Ctheter Stright (ISCS IV). The ISCS IV is sfety device equipped with fully utomtic pssive sfety shield, nd ws investigted becuse it won the supply tender of Regione Liguri. This sfety ctheter requires no user ctivtion; with regrd to design nd hndling, it is identicl to the conventionl ctheter [18, 19]. This device ws phsed in over the study period, strting with replcement rte of 24% in 2006 nd reching full replcement in 2010 in lmost ll institutions, except for one in which only very low replcement rte (30%) ws reched. Methods The present study, designed s qusi-experimentl study, ws performed in order to evlute the impct of the ISCS IV (B. Brun Medicl Inc., Germny) on the number of NSIs mong HCWs over five-yer period ( ). The ISCS IV ws used for peripherl venipuncture nd possessed pssive fully utomtic needlestick protection. The setting of the study ws network of five public helthcre institutions locted in Liguri, Northern Region of Itly. The following helthcre institutions prticipted in the investigtion: Sn Mrtino Hospitl (SMH), Gllier Hospitl (GH), Locl Helth Agency 1 (ASL 1), Locl Helth Agency 4 (ASL 4) nd Locl Helth Agency 5 (ASL 5). SMH nd GH re hospitls locted in Geno, while ASL 1, ASL 4 nd ASL 5 represent locl levels of the Ntionl Helth Service, consisting of smll-sized hospitls nd outptient deprtments situted in Imperi, Svon nd L Spezi, respectively. To prticipte in the study, detiled informtion on the yerly number of NSIs nd the type of device involved ws required. Specificlly, through regulr meetings with HCWs, dt were collected on the type of device, its clssifiction s conventionl or sfety intrvenous ctheter, the number of users nd the number of ctheter devices used per yer by ech institution. As both conventionl nd sfety devices were used concurrently during the study period, it ws impossible to estblish, even pproximtely, the yerly number of HCWs who used ech type of ctheter. We therefore ssumed tht the sme number of HCWs were exposed to both ctheters. The verge number of yerly trining hours in occuptionl helth nd sfety per HCW in ech institution ws used s mesure of HCW expertise nd knowledge of the proper use of ctheters nd the prevention of shrp injuries. In this respect, HCWs were clssified s hving poor/moderte or good/high-level trining, with 2 hours per yer being set s threshold vlue. The reltive frequency of NSIs ws the min response vrible of this investigtion. For this reson, the overll number of employees per yer in ech helthcre institution ws ssumed to be the number of person-yers t risk of NSIs. Accordingly, the reltive frequency ws clculted s the rtio of the number of NSIs per personyer t risk, nd indicted s the NSI rte (NSIR). The distribution of the NSIR ws then nlyzed ccording to the ctegories of ech study chrcteristic or covrite (i.e., type of ctheter, helthcre institution, clendr yer, stff trining level). In ddition, 95% confidence limits (95% CL) were computed for ech rte, ssuming the number of NSIs s Poisson rndom vrible [20]. Clendr yer ws tken s continuous covrite (i.e., liner time trend) in order to estimte the men yerly percent vrition (MPV). The joint effect of ll covrites on NSIR ws ssessed by mens of the Poisson regression model, nd rte rtio ws used s mesure of reltive risk (RR). For ech RR, 95% CL were lso computed. Overll nd covrite-specific sttisticl significnce ws ssessed by mens of the likelihood rtio test. A two-tiled P-vlue < 0.05 ws considered significnt. All nlyses were performed by mens of STATA [21]. The Poisson regression nlysis ws pplied in order to estimte the reltive risk between NSIR nd corresponding 95% confidence limits (95% CL). All nlyses were repeted on using the yerly number of ctheters s denomintor (offset) of NSIR in the Poisson model [22]. Results The nlysis of NSIs ws performed on HCWs from five different Itlin helthcre institutions. Tble I shows the min fetures of ech institution. SMH nd GH re hospitls with yerly ctchment re popultions of 1,500,000 nd 100,000, respectively; while ASL 1, ASL 4 nd ASL 5 include 3 to 4 smll-sized hospitls, with yerly ctchment re popultions between 150,000 nd 217,000. Tble II describes the distribution of the number of medicl devices, person-yers t risk, NSIs, nd the reltive frequency of NSIR. During the study, the totl number of person-yers t risk ws 122,464, nd 286 NSIs occurred. These dt show n overll verge NSIR of 23.4 per 10 4 person-yers (95% CL = ). The totl number of ctheter devices employed ws 4,785,345, which corresponded to yerly verge of 39.1 devices per HCW. Tble II lso shows tht the risk of NSIs due to conventionl nd sfety ctheters ws 44.9 nd 1.8, respectively, while the rtio of the number of conventionl nd sfety ctheters used per person-yer ws 51.8 nd 26.4, respectively. Descriptive nlysis reveled three risk levels: lower E111

3 D. SOSSAI et l. Tb. I. Min fetures of ech helthcre institution. Helthcre Smll-sized Bed Bed Popultion institution hospitls b vilbility c occupncy rte d Admissions e SMH 1, GH 100, ASL 1 217, ASL 4 150, ASL 5 213, Yerly popultion of ctchment re b Number of hospitls included in ech ASLs c Number of vilble hospitl beds d Percent rtio of the number of occupied hospitl beds to the number of vilble beds per yer e Number of hospitl dmissions per yer SMH: Sn Mrtino Hospitl; GH: Gllier Hospitl; ASL: Locl Helth Agency Tb. II. Risk of needlestick injuries. Number Person-yers b Rtio c NSI d NSIR e 95%CL f Ctheter device Conventionl 3, , Sfety 1, , Helthcre fcilities GH 513,595 17, SMH 842,000 44, ASL 1 499,250 27, ASL 5 610,000 12, ASL 4 2, , Stff trining level Poor/moderte 609,250 24, Good/high 4, , Clendr yer ,750 24, ,900 24, ,900 24, , , , , Whole smple 4, , Totl number of ctheter devices; b Employees considered t risk of needlestick injuries per yer; c Rtio of totl number of ctheter devices to personyers t risk; d Number of needlestick injuries; e Occurrence rte of NSIs per 10,000 person-yers; f 95% confidence limits for NSIR; SMH: Sn Mrtino Hospitl; GH: Gllier Hospitl; ASL: Locl Helth Agency level (from 2.2 to 5.7 NSIR) for two hospitls (GH nd SMH), n intermedite level (from 13.7 to 19.9 NSIR) for ASL 1 nd ASL 5, nd higher level (101.6 NSIR) for ASL 4. Moreover, individuls with poor/moderte nd good/high trining level hd NSIR of 19.1 nd 24.4, respectively, while the NSIR clculted by clendr yer showed trend from 27.1 to Tble III reports the result of the Poisson regression. The number of medicl devices used during the study nd the person-yers t risk were considered in the model: the former s log-trnsformed continuous covrite, the ltter s n offset. A significnt difference ws found between RR clculted for conventionl devices nd tht clculted for sfety devices (RR = vs RR = 1; P- vlue < 0.001). All ASLs were found to be t higher risk of NSIs: these institutions showed RRs which were greter thn 1.80 when the NSIR of GH ws used s reference. By contrst, from the comprison between the two hospitls (SMH vs GH), quite smll difference in risk (RR = 1.16; 95% CL = ) ws observed. In ddition, sttisticlly significnt two-fold increse in risk emerged when the overll rte of ll ASLs ws compred with the overll rte of the two hospitls (RR = 2.00; 95% CL = ; P-vlue < 0.001) (dt not shown). Regression nlysis showed no significnt difference in NSIR between the two trining ctegories (good/high vs poor/moderte: RR = 0.88, 95% CL = ). Lstly, regression modeling confirmed the downwrd trend obtined in the descriptive context, even though in weker nd not sttisticlly significnt mnner (RR = 0.95, 95% CL = ). In prctice, 5% reduction in NSI risk ws expected to occur in the vrious institutions during the study period (MPV -5%, 95% CL = -13.1% / +4.5%). E112

4 Sfety ctheters nd prevention of needlestick injuries Tb. III. Effect of ctheter type nd stff trining on needlestick injury occurrence estimted through the Poisson regression model. RR 95%CL b P-vlue Constnt c Ctheter device < Sfety 1.00 Ref. d Conventionl Helthcre fcilities GH 1.00 Ref. SMH ASL ASL ASL Stff trining level Poor/moderte 1.00 (Ref.) Good/high Clendr yer Liner trend Needlestick injury occurrence rte rtio (reltive risk) djusted for the totl number of ctheter devices used; b 95% confidence limits for RR; c Bseline needlestick injury occurrence rte per 10,000 person-yers t risk in ll reference ctegories (yer 2006) evluted t the yerly medin vlue (16,500) of ctheter devices used; d Reference ctegory. MH: Sn Mrtino Hospitl; GH: Gllier Hospitl; ASL: Locl Helth Agency Discussion Assessment of the risk of HCW exposure to biohzrds is one of the min issues for occuptionl helth professionls. The present investigtion provides convincing evidence tht the implementtion of sfety ctheters is relted to the reduced occurrence of NSIs, confirming reported previously results [14, 16, 23]. Through this non-concurrent prospective investigtion, we ssessed the impct of sfety-engineered devices in five Ligurin public helthcre institutions, following specific regionl competitive tender tht offered the opportunity to strt dopting sfety needles. During the study, mrked downwrd trend in NSIR by clendr yer ws observed. Specificlly, the NSIR declined by pproximtely 47% from 2006 to 2010, which corresponds to men yerly reduction of bout 9%. Over the sme period, the number of medicl devices employed per HCW incresed by bout 15%. Notbly, conventionl ctheters were grdully replced by sfety ctheters, strting from replcement rte of bout 24% in 2006, nd reching full replcement in 2010 in lmost ll helthcre institutions considered in the study, except for ASL 4, which only reched 30% replcement. The most striking result of this study ws the huge nd sttisticlly significnt risk reduction ssocited with the use of sfety devices. Indeed, the risk of NSIs due to conventionl ctheters ws found to be 25-fold higher thn tht observed for ISCS IV. However, it is noteworthy tht firly lrge portion of this excess cn be explined by the different bckground number of devices used, in tht the number of conventionl ctheters used per person-yer ws lmost double the number of sfety devices used. Our nlysis suggested tht individuls with poor/ moderte trining level hd lower NSIR thn those with better trining, though the difference ws not sttisticlly significnt. This prdoxicl result could lso be explined by the lrge difference in the number of medicl devices per person-yer used in the study. The present study certinly suffers from some epidemiologicl limittions, the min one being due to the study design itself; substntil bis stems from the fct tht the exposure-disese reltionship ws only estimted on the vilble lumped dt (institution level) nd could not be extended to ech individul (HCW level). Indeed, we did not know whether worker who reported NSI hd previously received dequte trining in occuptionl sfety, since we only knew the yerly verge of trining hours per worker in ech institution. Unfortuntely, this drwbck, which is typicl of this type of study design, cn only be voided by conducting epidemiologicl investigtions bsed on individul records (i.e., cse-control study). A second limittion is the lck of informtion on helthcre personnel truly t risk of exposure to NSIs, in tht the concept of person-yers t risk included the time contributions of ll employees (helthcre providers, dministrtive nd mintennce workers), regrdless of their ctul jobs. All helthcre fcilities belong to the sme Regionl Helth Authority nd, ccordingly, re subject to the sme helth policy guidelines nd service stndrds, which set the priorities in clinicl cre, define the qulity of ssistnce, nd estblish the number of medicl nd llied helth professionls engged in the public helth sector. Considering the moderte extension of the regionl ctchment re, which definitely reflects smll vribility in the overll disese burden, it is resonble nd relistic to ssume tht the proportion of medicl nd helthcre professionls truly t risk of exposure to bloodborne pthogens ws constnt cross institutions. However, this does not gurntee tht ll helthcre providers within public institution hve homogeneous risk level. In this respect, moderte degree of extr-poisson vrition or over-dispersion, due to the lck of some importnt covrites, ws found. This ws properly ddressed by using specific extension of the Poisson model, nmely the negtive binomil regression, which did not yield importnt chnges. E113

5 D. SOSSAI et l. Conclusions This investigtion reveled tht the NSIR rtio ssocited with the use of the ISCS IV sfety device ws significntly lower thn tht of the trditionl device. It cn therefore be concluded tht, despite the limittions of the investigtion, there ws cusl reltionship between the introduction of the ISCS IV nd the reduction in NSIs. In conclusion, convincing evidence in fvor of the ISCS IV should prompt the introduction of this new ctheter device into dily clinicl prctice, especilly when fir trde-off between clinicl performnce nd HCW sfety cn be chieved. Acknowledgements This reserch ws prtilly supported by B. Brun Medicl Inc., Germny, with fellowship to M.D.G. We thnk J. McDermott for helping to correct the mnuscript. Authors contributions DS conceived, designed nd coordinted the reserch, nd prticipted in ll stges of the work. MDG, RF, AP nd LR collected dt nd performed the dt qulity control. RP nd VF performed the sttisticl nlyses. MM nd LO evluted the results nd drfted the finl mnuscript. All Authors revised the mnuscript nd gve their contribution to improve the pper. All Authors red nd pproved the finl mnuscript. References [1] Jgger J, Perry J, Prker G, Phillips EK. Nursing2011 survey results: Blood exposure risk during peripherl I.V. ctheter insertion nd removl. Nursing 2011;41:45-9. [2] Cho E, Lee H, Choi M, Prk SH, Yoo IY, Aiken LH. Fctors ssocited with needlestick nd shrp injuries mong hospitl nurses: cross-sectionl questionnire survey. Int J Nurs Stud 2013;50: [3] Riddell A, Kennedy I, Tong CY. Mngement of shrps injuries in the helthcre setting. BMJ 2015;351:h3733. doi: / bmj.h3733. [4] Workbook for Designing, Implementing, nd Evluting Shrps Injury Prevention Progrm, Centers for Disese Control nd Prevention. Avilble t: shrpssfety/pdf/workbookcomplete.pdf. Accessed October 3, [Accessed 15/02/2015] [5] Pruss-Ustun A, Rpiti E, Hutin Y. 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