Variations in aseptic techniques during preparation and administration of intravenous drugs—an observation-based study in the UK and in Germany

Variations in aseptic techniques during preparation and administration of intravenous drugs—an observation-based study in the UK and in Germany

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  hygiene of medical staff have a greater impact.Routine, uncontrolled use of disinfectants forenvironmental cleaning and decontaminationshould be avoided, given the risk of their use andbecause well-designed studies in support of thismeasure are lacking. 3 References 1. Wilcox MH, Fawley WN, Wigglesworth N, Parnell P, Verity P,Freeman J. Comparison of the effect of detergent versushypochlorite cleaning on environmental contamination andincidence of  Clostridium difficile  infection.  J Hosp Infect 2003; 54 :109—114.2. Allerberger F, Ayliffe G, Bassetti M,  et al.  Routine surfacedisinfection in health care facilities: should we do it?  Am JInfect Control  2002; 30 :318—319.3. Dettenkofer M, Wenzler S, Amthor S, Antes G, Motschall E,Daschner FD. Does disinfection of environmental surfacesinfluence nosocomial infection rates? A systematic review.  Am J Infect Control  2003; in press. M. Dettenkofer*, T. Hauer, F.D. Daschner Institute of Environmental Medicine and HospitalEpidemiology, Freiburg University Hospital,Freiburg, Germany E-mail address: *Corresponding author. Tel.:  þ 49-761-270-5483; fax:  þ 49-761-270-5486doi:10.1016/j.jhin.2003.10.008 Variations in aseptic techniques during prep-aration and administration of intravenousdrugs—an observation-based study in the UK andin Germany Sir,It is estimated that at any one time 9% of inpatientssuffer from a hospital-acquired infection; a con-siderable proportion of these seem to be related tothe administration of intravenous (IV) therapy. 1 Anecdotal evidence showed that a lack of asepticpreparation techniques resulted in septicaemia, 2 and that breaches in aseptic administration tech-niques contributed to microbial colonization ofcatheters. 1 Contamination can occur at any pointin the process from the production of IV medicationby the manufacturer to the completion of theadministration in the hospital. We have studied twosteps in this process: ward-based preparation andadministration of IV medication.A European study showed national variationsin the incidence of hospital-acquired infectionsin surgical patients receiving IV therapy, 3 butlittle is known about any underlying differencesin practice. Therefore, we chose to conduct aprospective ethnographic study on the use ofstandard aseptic techniques during ward-basedIV drug preparation and administration in the UKand in Germany.A purposive sampling strategy was used toselect study hospitals and study wards. Thisdeliberately non-random sampling method wasused to explore aseptic techniques in IV drugpreparation and administration in a range ofdifferent settings, including hospital types andward specialities. 4 Data were collected in threeuniversity teaching hospitals (one in the UK, twoin Germany) and two non-teaching, generalhospitals (one in the UK and one in Germany).Twelve wards were studied in the UK and sixwards in Germany. Specialities included inten-sive care, paediatrics, surgery, cardiology andnephrology. IV medication was prepared andadministered by nursing staff on the wards, butcytotoxic medications were prepared centrallyby the pharmacy departments. Data were col-lected on six to 10 consecutive days on eachward between June 1999 and June 2000. To berepresentative the study included weekends andall times of drug rounds were observed for eachward. Data collection methods have beenreported elsewhere. 5 Briefly, a trained andexperienced observer (K.T. or V.W.) accom-panied nurses during IV drug rounds. Details ofaseptic preparation and administration tech-niques were recorded on a standard form. Thestudy was approved by the nursing and pharmacydirectorates and the ethics committees of thestudy hospitals. As the German non-teachinghospital did not have an ethics committee,approval was gained from the quality assurancecommittee.We observed 196 nurses and four doctors over125 days. Two thousand, three hundred and forty-five doses of IV medication were prescribed on thestudy wards during the observation period. Ofthose, the preparation of 938 (40%) doses and theadministration of 762 (32%) doses were observed.These were shown to be representative. Wards ingeneral did not have dedicated preparation areas.IV drug preparations were carried out in a storageroom or on a desk at the nursing station near thepatient’s bedside. Drug preparation areas were notdisinfected before starting the preparation. Therewere 698 (74%) preparations that required amultiple step reconstitution of the drug from aLetters to the Editor 79  vial. Aseptic techniques such as disinfection of thetop of the vial were rarely followed in eithercountry (Table I). In the UK, decontamination ofexternal surfaces of catheter hubs and connectionports before drug administration were observed inabout a third of cases involving peripheral cath-eters. Slightly higher rates were observed whenhandling central catheters. Such decontaminationtechniques were not applied in the German hospi-tals (Table II).The majority of preparations were administeredwithin 1 h. While it is unlikely that micro-organismsgrow to a considerable extent within such shorttime, we also observed that, occasionally, prep-arations were stored at room temperature forseveral hours or overnight. Furthermore, breachesin aseptic technique were observed for 14 (74%) of19 observed preparations intended for continuousinfusion over approximately 24 h. There were 16(2%) failures in aseptic preparation techniqueinvolving drug admixtures with glucose solutions,which are known to support bacterial growth. 6 There were considerable differences in asepticadministration techniques between the study hos-pitals in the UK and in Germany. Currently there islittle evidence regarding whether or not deconta-mination reduces the risk of patients experiencingcatheter-related bloodstream infections. Further-more, the same evidence is interpreted differentlyin different guidelines. 1,7 This may partly explainthe variation we found between the UK and theGerman hospitals.We were not able to study all aspects of aseptictechnique, for example practices relating to disin-fection of hands were not included in our protocol.However, our observation-based study showedworrying variations in aseptic preparation andadministration technique. Standards regarding pro-duction of IV medication in industry and pharmaciesare high, and adherence to standards is monitored.In contrast, on the wards there is disagreementabout standards, and little adherence to them. Theclinical consequences of our findings are unknown;there is not the evidence base from which toextrapolate. Our study clearly highlights the needto establish an evidence base and guidelines foraseptic preparation and administration techniqueson wards. Acknowledgements We thank the staff in the participating hospitals.This study was funded by The School of Pharmacy,University of London and by the Central ResearchFunds, University of London. The study sponsors didnot have any role in study design, in the collection,analysis, and interpretation of data; in the writingof the report; and in the decision to submit thepaper for publication. References 1. Pratt RJ, Pellowe C, Loveday C, Robinson N, Smith GW, TheEpic Guideline Development Team. The Epic Project: devel-oping national evidence-based guidelines for preventinghealthcare associated infections.  J Hosp Infect  2001; 47 (Suppl.):S3—S67.2. Koerner RJ, Morgan S, Ford M, Orr KE, McComb JM, Gould FK.Outbreak of Gram-negative septicaemia caused by contami-nated continuous infusions prepared in a non-clinical area.  J Hosp Infect  1997; 36 :285—289.3. Nystro¨m B, Olesen Larsen A, Dankert J,  et al.  Bacteraemia insurgical patients with intravenous devices: a European multi-centre incidence study.  J Hosp Infect  1983; 4 :338—349.4. Bowling A.  Research methods in health , 1st ed. Buckingham:Open University Press; 1997.5. Taxis K, Barber N. An ethnographic study of incidence andseverity of intravenous drug errors.  BMJ  2003; 326 :684—687.6. Langford SA. Microbial survival in infusion fluids.  Hosp Pharm 2000; 7 :228—236.7. Robert Koch Institut. Pra¨vention Gefa¨ b katheter-assoziierterInfektionen.  Bundesgesundheitsbl-Gesundheitsforsch-Gesundheitsschutz  2002; 45 :907—924. Table I  Application of disinfection steps during multiplestep preparationsMultiple steppreparationsApplication ofdisinfection stepsUK 370 45 (12%)Germany 328 3 (1%) Table II  Decontamination of external surfaces of the catheter hub and connection ports during drug administration processesPeripheraladministrationApplication ofdecontamination techniquesCentraladministrationApplication ofdecontamination techniquesUK 293 89 (30%) 121 47 (39%)Germany 198 14 (7%) 150 0 Letters to the Editor80  K. Taxis*, V. Wirtz, N. Barber Department of Practice and Policy, The School of Pharmacy, University of London,London, UK E-mail address: *Corresponding author. Address: Pharmazeutische Biologie,Pharmazeutisches Institut, Auf der Morgenstelle 8, 72076Tubingen, Germany. Tel.:  þ 49-70712975483; fax:  þ 49-7071295250doi:10.1016/j.jhin.2003.10.006 Missing data and participation or non-partici-pation in a surgical-site infection surveillancenetwork Sir,Missing data reflect the quality of information andmay bias epidemiological studies, including thesurveillance of hospital-acquired infections (HAI).The method of data collection may contribute tothe frequency of missing data. Data on HAIsurveillance can be obtained through a network orfrom isolated surveillance performed by one unit.The objective of our study was to compare theproportion of missing data according to partici-pation or non-participation in a surgical-site infec-tion (SSI) surveillance network.A voluntary, patient-based surveillance networkwas started in 1993 with the objective of monitoringSSIinsurgicalunitsofsouth-easternFrance. 1 Dataoninfectedand non-infected patients werecollected ina standardized way and sent to the co-ordinationcentre for validation and analysis.For the purpose ofthis study, data from three units in Lyon UniversityHospitalwereavailable.Twoofthemwerepartofthenetwork: 1 an orthopaedic surgery unit (unit A) and agynaecology–obstetrics unit (unit B). The third, adigestive surgery unit (unit C), implemented its ownsurveillance programme. We identified 20 commonitems between the two surveillance methods [net-work(units A andB), and extra-network(unit C)] andmissing values were counted for these items duringcommon surveillance periods: January 1999, April toJune1999,andJanuarytoApril2000.Comparisonsofproportions of missing values were based on the Chi-square test or Fisher’s exact test.  P  , 0 : 05 valueswere considered to be statistically significant.The total sample size was 1781. The studypopulation was composed of 719 patients fromunit A, 322 from unit B, and 740 from unit C. Thenumber and percentages of missing values areshown in Table I.For unit C, the surveillance database containedseveral missing items. Only five items out of 20were complete, andknown or suspectedrisk factors Table I  Number and proportion of missing values according to participation in a surgical-site infection surveillance (SSI) networkVariables Unit A  ð N   ¼  719 Þ  Unit B  ð N   ¼  322 Þ  Unit C  ð N   ¼  740 Þ  P  a Age 0 0 0 –Sex 0 0 0Date of entry 0 0 0Date of discharge 0 0 9 (1.2%)  , 0.001Date of surgery 0 0 0 –Surgery code 0 0 0 –Multiple surgery 3 (0.4%) 0 30 (4.0%)  , 0.000001Emergency 3 (0.4%) 0 22 (3.0%)  , 0.00001Implant/prosthesis 5 (0.7%) 0 32 (4.3%)  , 0.000001Keyhole surgery 1 (0.1%) 0 28 (3.8%)  , 0.000001Contamination class 3 (0.4%) 0 41 (5.5%)  , 0.000001American Society of Anesthesiologist (ASA) score 7 (1.0%) 6 (5.0%) 37 (5.0%)  , 0.01Duration of surgery 39 (5.4%) 3 (0.9%) 88 (11.9%)  , 0.000001Antibiotic prescription for operation 23 (3.2%) 4 (1.2%) 33 (4.4%)  , 0.05Starting date of antibiotic prophylaxis b 0 0 15 (2.7%)  , 0.00001Duration of antibiotic prophylaxis b 0 0 117 (21.2%)  , 0.000001Surgical site infection (SSI): yes/no 0 0 5 (0.7%)  , 0.05Starting date of SSI c 0 0 5 (21.7%) 0.15Site of infection c 0 0 3 (13.0%) 0.55NNIS index 44 (6.1%) 19 (5.9%) 103 (13.9%)  , 0.000001 a Chi-square test or Fisher’s exact test between units participating in the network analysed together (unit A  þ  unit B)  versus  theunit not in the network (unit C). b Denominators were 666 in unit A, 129 in unit B, and 552 in unit C. c Denominators were 5 in unit A, 6 in unit B, and 23 in unit C. Letters to the Editor 81
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