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1、A STUDY OF ESTABLISHMENT AND EVALUATION OF A RISK PREDICTIONMODEL FOR STEAM STERILIZATIONName:Xin ZhaoAffiliation:Xuanwu Hospital Of Capital Medical University-Beijing.China Establised in 1958 National Center for Neurological Disorders National Clinical Research Center for Geriatric Diseases Amount
2、of Beds:1643 Amount of ORs:39 Steam sterilization is still the most preferred method in hospital Quality control of sterilization process:Professional competence of staffPerformance of sterilizerbackgroudA High level sterility assurance shall be achieved by effective combination of human and equipem
3、ent!Forced shutdownRe-SterilizationDelivery delayWork overtimeWaste resourcesSterilizer Unexpected Alarmbackgroudbackgroud 24 alarms of sterilizers in total were triggered in 2021.320 packs had to be re-packed and re-sterilizerd due to those alarms.AlarmNumber of Alarm(%of Total)ResolutionAlarm duri
4、ng Pre-Vac phase4(16%)Pressure sensor calibration Tighten pipingsAlarm during Sterilization phase10(42%)Temperature sensor calibrationAlarm during other phases10(42%)Replace PLC battery This experiment is an attempt to establish a sterilization risk prediction model,by applying criteria stricter tha
5、n the control system of sterilizer,to proactively intervene in the sterilization process at an early stage thus provide Early warning of the sterilization quality.It eliminates the risk of failure much earlier and allows CSSD to manage the sterilizer in a proactive and predictable manner.ObjectiveMa
6、terrials and Methods-Experiment Group Define stricter sterilization criteria than machine logicBatch Report BasedA Take additional 2 Theoritical Temp.into account.Batch Documentation System BasedB Inplement Safety Margin concepts for assessmentSafety Margin Concept BasedC Optimize our criteria by re
7、viewing the statisticsFinetune ThresholdsDMaterrials and Methods-A8 Object of evaluationSelected Sterilization ProgramMoment of evaluationParameter to be evaluatedP1(134,5min)At completion of every batchT1:Control temperatureT2:Record temperatureP1:Control pressure P2:Record pressureMaterrials and M
8、ethods-APhaseMachine Alarm CriteriaPre-VacVac Time 15minSterilization1 Control Temp T113 Deviation between P1&P2100mbarOtherPLC battery running 24monthsPhasePreventive Intervention CriteriaPre-VacVac Time 8 minSterilization1 T1 or T2 0.63 Deviation between P1&P260mbarOtherPLC battery running12 month
9、sStep 2:Understand alarm criteriaStep 1:Read batch report carefullyStep 3:Determine preventive intervention criteriaMaterrials and Methods-AControl GroupExperiment GroupPeriod2021.8-2022.4(9 Months)2022.5-2023.1(9 Months)Batches41154142Evaluation and ActionsEvaluate batch report against EN285Evaluat
10、e batch report against EN285Implement the new preventive intervention criteriaOnly contact service whenever an unexpected alarm is triggeredContact service whenever one of the preventive intervention criteria was reachedSterilizer still runs normally while waiting for preventive service action to be
11、 taken#Pre-Vac PhaseSterilization PhaseBatch No.(Sterilizer No.)Criteria triggered Preventive InterventionPreventive Service ActionTime for Preventive Service1752359(#2)1st Vac Pulse 8minReplace hose connection15min23011626(#4)1st Vac Pulse 8minCalibrate P sensor35min33011626(#4)1st Vac Pulse 8minTi
12、ghten hose connection5min4751357(#3)T1 0.6Calibrate T sensor45min6752329(#1)Deviation T1&T2 0.6Calibrate T sensor40min7752329(#1)T2 134.2(T2=134.1)Calibrate T sensor45minTotally 3h25minIntermediate Results of StudyIntermediate Results of Study-ACase#4T1 134.2(T1=134.1)MoreIntroduce 2 more parameters
13、 of sterilization phase into the preventive intervention criteriaMethods Optimization 1-BIntroduce T3 and T4Evaluate T3,T4 and T1,T2 all together agaisnt EN285Define the moment when sterilization phase starts:T1,T2,T3,T4 all 134Define the moment when sterilization phase ends:Any of T1,T2,T3,T4 134T3
14、 T4T=A+B(lnp+c)-1T is the saturated steam temperature in Kelvinp is the measured pressure in megapascals,time averaged to result in a time constant belween 1s and 2.5 sA is 42,677 6 KB is-3892,70 KC is-9,486 54Methods Optimization 2-CSafety Margin1SVSM%=ABS(Target Value Measured value)/Target valueS
15、terilization Temperature Band SVSM%(3Measured Sterilization Temperature Band)3100%Holding Time SVSM%(Measured Holding Time180s)/180s100%Sterilization Temperature Deviation SVSM%(2-Sterilization Temperature Deviation)2100%SPSM%=Min(all above 3 SVSM%)1 Yao Jinguo,Analysis of Safety Margins of Reactors
16、 in Tianjiawan Nuclear Power Plant,Reactor Thermal Fluid Dynamics Design and Experimental Research,July 2007Sterilization VariableSafety Margin(SVSM)Sterilization ProcessSafety Margin(SPSM)Results&Discussions In total 8257 batches have been evaluated Basic Fact of StudyControl GroupExperiment GroupN
17、umber of batches(134,5min)41154142Number of preventive interventions under Risk Prediction ModelN/A7Results&Discussions Qualification of Sterilization Pack Indicator of ResultControl GroupExperiment GroupImprovementNumber of sterilizaton packs processed3Number of unqualified sterilization
18、 packs3150Qualifaction rate of sterilization packs99.78%100%0.22%Indicator of ResultControl GroupExperiment GroupImprovementOperation Time(h)(A)3925.823489.70Proactive shutdown due to preventive intervention service(h)(B)03.41Passive shutdown due to unexpected alarm and service(h)(C)339.930Rate of s
19、terilizer proper operation%*(D)91.34%99.90%8.56%Sterilizer Operation EfficiencyResults&DiscussionsD=(A-B-C)/A x 100%5929273ST alarmPackrecontaminatedITS operationerrorLack ofinstrumentWD alarmResults&DiscussionsIndicator of ResultControl GroupExperiment GroupImprovementPercentage of delivery delay d
20、ue to sterilizer unexpected alarm*59%059%OT due to sterilizer unexpected alarm(h)279.500Percentage of OT due to sterilizer unexpected alarm%37%037%CSSD Work Efficiency*Percentage of delivery delay due to sterilizer alarm%=Delivery delay cases due to sterilizer alarmTotal delivery delay casesBreakdow
21、n of CSSD delivery delay(Control Group)100%Results&DiscussionsIndicators AnalysedEN285P ValueTemperature deviation during sterilization phase(T1,T2,T3,T4)20.05Temperature fluctuation during sterilization phase 180s0.05 We invited Dr.Zhang Jinxin and his team from Sun Yat-sen University to analyse tw
22、o groupsdata generated by 4 sterilizers by statistical method Possible ExplanationTolerance of parameter already rather smallMachine performance quite stable#1 Sterilizermin T1/T2/T3/T4 max T1/T2/T3/T4 T Deviation Rate of T Deviation(Deviation/2)T Fluctuation Rate of T Fluctuation(Fluctuation/3)Temp
23、erature PrecisionTemperature DistributionTemperature StabilityWithout new model(740 batches in total)134.2 135.2 0.6 29%1.0 33%Under new model(685 batches in total)134.4 135.0 0.5 26%0.6 21%Improvement0.20.20.13%0.412%Improvement of sterilization performance of one sterilizer is observedResults&Disc
24、ussionsResults&DiscussionsWas the root course correctly identified and removed by this service intervention?SPSM beforeService 65%SPSM afterservice 45%Case#4T1 134.2(T1=134.1)Results&DiscussionsIntroducing more process parameters from the batch documentation system could give more precision to the R
25、isk Preventive Model,and at the same time help to create a new quantitative tool for assessing the effect of every service interventionSPSM beforeService 48%SPSM afterservice 71%Case#7T2 134.2(T2=134.1)Conclusion1New Management Approach2Operate more independently3Feasibility and Promotion4Optimize Continuously-DAcknowledgementMs Liu Ting,Head nurse of OR and CSSD.(Xuanwu Hospital Of Capital Medical University)Dr.Zhang Jinxin and his team(Sun Yat-Sen University)CSSD branch of Chinese Nursing AssociationThanks for your attention!