ASTM F1992-1999(2007) 与软性内窥镜一起使用的可重复使用的耐热内窥镜辅助仪器(EAI)再加工的标准实施规程

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【英文标准名称】:StandardPracticeforReprocessingofReusable,Heat-StableEndoscopicAccessoryInstruments(EAI)UsedwithFlexibleEndoscopes
【原文标准名称】:与软性内窥镜一起使用的可重复使用的耐热内窥镜辅助仪器(EAI)再加工的标准实施规程
【标准号】:ASTMF1992-1999(2007)
【标准状态】:现行
【国别】:美国
【发布日期】:1999
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.35
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:cleaning;endoscopicaccessoryinstrument(EAI);flexibleendoscope;heatstableinstrument;heatsterilization;reprocessing;reusable;ultrasoniccleaning;EAI(endoscopicaccessoryinstrument);Flexiblesurgicalimplantmaterials;Heatstableinstrumen
【摘要】:EAIsmayhavedesignfeaturessuchascoiledmetalsheaths,pivotingjoints,opposedsurfaces,andinternallumensorwireswhichmakevisualinspectionforcleanlinessdifficultifnotimpossible.Bynatureoftheirdesignrequirements,EAIsaremoredifficulttoreprocessthanmanyothertypesofmedicalinstruments.BecauseEAIsareusedtodiagnoseandtreatdiseaseinbothimmunocompetentandimmunocompromisedindividuals,caremustbetakentoensurethatonlypatient-readydevicesareusedforexamination.TheuseofEAIsinpatientshavingdiagnosedorsuspectedinfectionssuchashepatitisB,hepatitisC,orhumanimmunodeficiencyvirus(HIV)isnotcontraindicated.Further,EAIsneednotbededicatedforuseonlyinthesepatients.Personsresponsibleforreprocessingmustunderstandthespecifications,nomenclature,functionofcomponentparts,andinteriordesignofEAIsinordertorenderthempatient-ready.PersonsresponsibleforreprocessingEAIsshouldfollowthispracticeandassociatedlabelingandinstructionsfrommanufacturersaftereachendoscopicproceduretoensurethattheEAIwillbepatient-ready.ReprocessingofEAIsshouldbethespecificresponsibilityofappropriatelytrainedpersonnel.Temporaryemployeeswithouttherequisitetrainingshouldnotbegiventheseresponsibilities.TheresponsibilityforreprocessingofEAIsshouldnotbedelegatedfrompersontopersonunlesseachhastheappropriatetrainingfortheposition.Reprocessingpersonnelshouldhavetheabilitytoread,understand,andimplementinstructionsfrommanufacturersandregulatoryagenciesastheyrelatetoEAIreprocessing.Reprocessingpersonnelshouldhavetheopportunitytobecomecompletelyfamiliarwiththemechanicalaspectsofthedevices.Theymaygainthisknowledgethroughstudyofthemanufacturer''sinformationanddemonstrationbyrepresentatives.ReprocessingpersonnelshouldbemadefullyawareofthepotentialchemicalandinfectioushazardsforpatientsandhealthcarepersonnelassociatedwiththereprocessingofEAIs.Trainingshouldinclude:Athoroughbackgroundininfectioncontrolprinciplesandconceptsbasedonwrittenin-houseinfectioncontrolprocedures.Athoroughbackgroundregardingthepotentialfornegativepatientoutcomesresultingfromlapsesincompliancewithwrittenreprocessingguidelines,FamiliarizationwithOccupationalSafetyandHealthAdministration(OSHA)regulationsandin-housepoliciesregardingtheappropriateandsafehandlingofchemicalreprocessingagentsandequipmentusedduringreprocessingofEAIs,andInformationonthesafehandlingofEAIscontaminatedwithpatienttissueandfluidsafteruse,includingfamiliarizationwithprinciplesandpracticesofstandard(universal)precautions.Note18212;AlthoughhealthcareworkersandpatientsmaybenefitfromadheringtotheregulatoryguidelinesissuedbyfederalandstateOSHAagencies,theseguidelinesaredirectedonlytowardhealthcareworkersafetyandhealth.Theymaynotbesufficientlyinclusiveforoptimumsafetyandhealthofpatients.Therefore,contemporaryinfectioncontrolguidelinesshouldbeconsultedinadditiontoOSHAguidelines.ThispracticeisnotintendedtoreplacethereprocessinginstructionprovidedbythemanufacturersofEAIsorsuggestspecificequipmentorchemicalreagentstobeusedforreprocessing.Rather,itistobeusedtogetherwithmanufacturers''instructionsthatprovidespecificinstructionsforspecificproducts.SeeAppendixX1.1.Thispracticeisnotintendedtocoverendoscopictechniques,patientcare,orothermedicalaspectsofflexibleendoscopy.Thispracticedoesnotincludeinstructionforreprocessingflexibleendoscopes.1.1Thispracticeco......
【中国标准分类号】:C38
【国际标准分类号】:11_040_30
【页数】:6P.;A4
【正文语种】:英语