影响器械清洁结果的因素-如何获得良好结果以及什么算是足够好.pdf

1、CleaningHow to do it?What is good enough?Dr.Gerhard KirmseSenior Expert Reprocessing and OR SupplyB.Braun -Aesculap Divisiongerhard.kirmseaesculap.deGoalHygienic SafetyValue PreservationReliabilityEfficiencyEverywhere inthe world?You can clean without disinfecting,but you cannot disinfect without cl

2、eaning!If it is not clean,you cannot sterilize it!Earle SpauldingDigital public library of AmericaDr.Earle Spaulding|DPLAWhy is cleaning so difficult?Why is cleaning so difficult?Multiple Process StepsMultiple manual FactorsIncluding Machine Cleaning(Loading,)Pre CleaningKontaminationPoint-of-Use-Cl

3、eaningTransportation Time/ConditionMachine Cleaning2nd CleaningVisualInspectionDifferent Philosophies Different Philosophies Different Ways to Rome Different Ways to Rome TextGraphics by Markus Auly,CHWhat is clean?What is clean?-Where is Rome?Where is Rome?Risk Based Approach:no harm below this lim

4、itFeasibility Based Approach:achievable with reasonable effortBiocompatibility ISO10993:2021:complex laboratory testPyrogens,Senzitation,Cytotoxicity,Haemocompatibility,Used by Medical Device Manufacturers ISO 15883 Part 1 Washer-Disinfector General Requirements(2020)Part 2 Requirements and Test Met

5、hods 2009 Part 5 Test Soils and Test Methods 2021Different AnalytesVisually clean3/6,4g/cm2Protein (Warning Level/Action Level)1/2,2g/cm2 Hemoglobin6/12g/cm2 TOC10/22fmol ATP.100g before Cleaning post cleaningVisually o.k.=sterilizationInsideInsideOutside surfaces arerelatively easy to clean!How to

6、Test?How to Test?Systematics Test Soil Test GeometryCrile Clampreactivatedsheep blood100lCleaningProcesssElution SDS 1%Recovery RateProteinBiuret-BCA-OPA-TestExampleGerman GuidelineMinimum detectable Limit(Concetration)Clinically usedInstrument(Recovery)Test MethodProtein Test by ElutionProtein Test