Medical device use error : root cause analysis

Content: IntroductionOur Root Cause Analysis ProcessIntroductionStep 1: Define the Use ErrorStep 2: Identify Provisional Root CausesStep 3: Analyze Anecdotal EvidenceStep 4: Inspect Device for User Interface Design FlawsStep 5: Consider Other Contributing FactorsStep 6: Develop a Final HypothesisStep 7: Report the ResultsNext StepsThe Regulatory Imperative to Perform Root Cause AnalysisFDA RegulationsEuropean Union RegulationsOther RegulatorsApplicable Standards and GuidelinesU.S. Food and Drug Administration (Silver Spring, Maryland USA)Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design, Issued on June 22, 2011International Standards Organization (Geneva, Switzerland)ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposesInternational Standard Organization (Geneva, Switzerland)ISO 14971:2007 Medical devices -- Application of risk management to medical devicesInternational Electrotechnical Commission (Geneva, Switzerland)IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: UsabilityInternational Electrotechnical Commission (Geneva, Switzerland)IEC 62366-1:2015 Medical devices -- Part 1: Application of usability engineering to medical devicesSummaryThe Language of Risk and Root Cause AnalysisIntroductionRisk analysisHarmHazardHazardous situationIntended useUse errorLikelihoodSeverityRiskRisk evaluationRisk controlResidual riskTypes of Use ErrorsPerception, Cognition, and Action ErrorsSlips, Lapses, and MistakesErrors of Commission and OmissionSafety-Related and Non-Safety-Related Use ErrorsDetecting Use ErrorsDetecting Use Errors during Usability TestsDetecting Use Errors during Clinical StudiesDetecting Use Errors during the Device's Life CycleInterviewing Users to Determine Root CausesIntroductionInterview TimingInterviewing Participants during Formative Usability TestsInterviewing Participants during Summative Usability TestsInterview TipsPerils of Blaming Users for Use ErrorsDon't Blame the UserReporting Test Artifacts as a Root Cause of Use ErrorUser Interface Design Flaws That Can Lead to Use ErrorIntroductionGeneral User Interface Design Flaw ExamplesHardware User Interface Design Flaw ExamplesSoftware User Interface Design Flaw ExamplesDocument User Interface Design Flaw ExamplesPackaging User Interface Design Flaw ExamplesReporting Root Causes of Medical Device Use ErrorIntroductionResidual Risk AnalysisPresenting the Results of a Residual Risk AnalysisRoot Cause Analysis ExamplesAbout the root cause analysis examplesInsulin Pen InjectorDrug BottleAutomated External Defibrillator (AED)Handheld TonometerLancing DeviceTransdermal PatchElectronic Health Record (EHR)Syringe Infusion PumpSurgical Warming BlanketUrinary CatheterHemodialysis MachineUltrasonic NebulizerVentricular Assist Device (VAD)AutoinjectorStretcherSmartphone Application: Insulin Bolus CalculatorNaloxone Nasal SprayEnteral Feeding PumpMetered Dose InhalerDrug Patch PumpPatient MonitorJet NebulizerSyringeElectrosurgical Generator and HandpieceLarge-Volume Infusion PumpHospital BedPen InjectorBlood Gas AnalyzerDialysis Solution BagUltrasound ScannerGuide to Designing an Error-Resistant User InterfaceIntroductionPerceptionsText ReadabilityPushbutton FeedbackComponent VisibilityCognitionAction"Undo" ControlData EntryProtection against Inadvertent ActuationInstructional Content and FormatPackage DesignOther Root Cause Analysis MethodsIntroductionThe 5 WhysIshikawa DiagrammingAcciMapThe Joint Commission's Framework for Conducting a Root Cause AnalysisUPCARE ModelMatrix DiagramsCritical Decision Method (CDM)Systems-Theoretic Accident Model and Processes (STAMP)The Human Factors Analysis and Classification System (HFACS)Event Analysis for Systemic Teamwork (EAST)ResourcesBooksArticles and ReportsUS Food and Drug Administration (FDA) PublicationsStandardsWebsites