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FDA’s Human Factors Program for Medical Devices医疗器械FDA的人文因素计划

FDA’s Human Factors Program for Medical Devices医疗器械FDA的人文因素计划

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时间：2019-05-28

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1、FDA HumanFactors ofMedicalDevicesEnsuringasafe,userfriendlydevice-userinterfaceMedicalErrorsinU.S.eachYearResultIn:Upto98,000deaths5thleadingcaseofdeath:exceedsautoaccidents,breastcancerandAIDS$29BillionaddedcostFDAMedicalDeviceIncidentReports:100,000reportsperyearMorethan1/3involveuseerrorTipof

2、theIcebergFDARecallStudy44%ofmedicaldevicerecallsduetodesignproblems.Useerroroftenlinkedtodesign.MoreuserfriendlyDesignOperations-don’texceedusercapabilitiesInformation-Sufficient,legibleandintelligibleProcedures-logicalandintuitiveOperations-consistentwithconventionsDangerouserror-designedoutCo

3、nditionsofuse-consideredandaddressedKeysafetyconceptsindesignmakethingsvisiblesimplifytheoperationavoidrelianceonmemoryavoidrelianceonvigilanceusenaturalmappingsuseforcingfunctionsmakeiteasytoreverseanerrorFDA’sauthorityQualitySystemsRegulation/CGMP-DesignControls(1996)DesignControlsRegulatoryLa

4、nguage:“…designrequirements…intendeduse…needsoftheuserandpatient.”“…testingproductionunitsunderactualorsimulateduseconditions.”“…conductriskanalysis.”DesignControlsPreambleLanguage:“…conductappropriatehumanfactorsstudies,analyses,andtests…”“…humaninterfaceincludesboththehardwareandsoftwarecharac

5、teristics…”DesignControls-HumanFactorsEngineering(HFE)ProcessHFEappliedfromconceptstagetofinaldesignEarlyInvolvementoftypicalusersiscriticalTheprocessisiterativePerformStudies&AnalysesDevelopRequire-mentsDevelopSpecs.TestOutputAgainstInputTestAgainstPatient&UserNeedsConceptPhaseDesignInputDesign

6、OutputVerificationValidationHFElementsLiteratureComplaintsObservationInterviewsSafetyEnvironmentUsersPerformanceDrawingsMockupsComputerPrototypesProductionUnitsFullUsabilityTestRiskAssessment**DesignandDevelopmentPlanningImportantHereHumanFactorsEngineeringProcessAnalysesExpertEvaluationRapidPro

7、totypingHumanFactorsEngineering-SummaryofMethodologyStudytheuserpopulationanduseconditionsAnalyzefunction,tasks,andhazardsIncorporatefindingsinrequirementsTestandanalyzeprototypesagainstrequirementsTestproductionmodelsinsimu

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