Lecture-1 Intro to ISO 14971 - Milan Meeting

InternationalIEC60601 1MedicalElectricalEquipmentISO14971RiskmanagementMedicalDevices April2009MilanItalyStanMastrangeloMassimoPolignano RiskManagementofMedicalDevices ThistwodayprogramisanoverviewforCBTL sofISO14971 ThisprogramdoesnotconferanycertificationontheattendeesAsthiscourseisintroductory furthereducationisrecommendedforpractitioners EnsuringSafetyandEfficacythroughISO14971 RiskManagementofMedicalDevices DevelopmentofISO14971RiskManagementbasicsISO14971 Whatdoesitsay EnsuringSafetyandEfficacythroughISO14971 RiskManagementofMedicalDevicesEnsuringSafetyandEfficacythroughISO14971 ISO14971 Whatdoesitsay ISO14971 MedicalDevices RiskManagement ApplicationofRiskManagementtoMedicalDevices ISO14971Published2000 2007 ISO14971 Medicaldevices Riskmanagement Applicationofriskmanagementtomedicaldevices ISOIECCENCENELEC 100 100 100 100 ISO14971ReferencesinMedicalDeviceStandards AFewExamples UtilizationISO14971inMedicalDeviceStandards ISO13485 qualitysystemsIEC60601 1 2 1999 PEMSIEC80001 1RiskManagementforNetworksIncorporatingMDIEC80002RiskManagementinSoftwareAAMI ISO10993 18 biologicalevaluationIEC60601 1 06 UsabilityAAMI ISO14155 01 clinicalinvestigationIEC60601 1 medicalelectricalequipmentISOCD5840 cardiacvalvesISO15198 Clinicallaboratorymedicine Invitrodiagnosticmedicaldevices Validation Also ISO IEC14971isreferencedinthecurrentdraftofICHQ9forPharmaceuticalQualityRiskManagement ICHistheInternationalConferenceforHarmonization WhatDoWeNeedtoKnow aboutISO IEC14971 World widestandardManagementstandardRiskmanagementprocessEstablishedriskmanagementconceptsLifecyclestandardAdoptioninregulationsIntegrationwithinstandards ISO13485 IEC60601 1 3rd ed IEC ISO14971 ISO14971 MedicalDevices RiskManagement ApplicationofRiskManagementtoMedicalDevices CoversallmedicaldevicesLifecycleofdeviceCoverssafetyandefficacyQUANTUMLEAP RiskManagement ISO14971 Whatdoesitsay IdentifyhazardsEstimateriskAcceptabilityMitigaterisk RiskManagementofMedicalDevicesStandardforManufacturers RiskManagementofMedicalDevicesEnsuringSafetyandEfficacythroughISO14971 OverviewAcceptabilityRiskManagementFileIntendedPurposeHazardIdentificationPostMarketInformation WhatistheDifferencebetweenISO14971andotherStandards ScopeofISO14971isallMedicalDevicesHorizontalStandardManagementStandardProcessandSystemStandardCompletelifecycleincludingdesign manufacture installation servicingNotaPerformanceorTypeStandard RiskManagementGeneralRequirementsISO IEC14971 Scope Clause1 RiskManagementProcess Clause3 2 ManagementResponsibility Clause3 3 RiskAcceptabilityAssignPersonnelResourcesManagementReviewQualificationsPersonnel Clause3 4 RiskManagementPlan Clause3 5 RiskManagementFile Records Clause3 6 Scope Clause1ISO IEC14971 ThisInternationalStandardspecificsaprocessforamanufacturertoidentifythehazardsassociatedwithmedicaldevices includinginvitrodiagnostic IVD medicaldevices toestimateandevaluatetheassociatedrisks tocontroltheserisks andtomonitortheeffectivenessofthecontrols Applicabletoallstagesofthelife cycleofthemedicaldevice RiskManagementProcessISO14971 simplifiedprocess Clause2 Definitions Somekeydefinitions Hazard potentialsourceofharmHazardoussituation circumstancesinwhichpeople property ortheenvironmentareexposedtooneormorehazardsRisk combinationoftheprobabilityofoccurrenceofharmandtheseverityofthatharm 19 Clause2 Definitions Page2 Somekeydefinitions RiskAnalysis SystematicuseofavailableinformationtoidentifyhazardsandtoestimatetheriskRiskEvaluation ProcessofcomparingtheestimatedriskagainstgivenriskcriteriatodeterminetheacceptabilityoftheriskRiskAssessment Overallprocesscomprisingariskanalysisandariskevaluation 20 RiskManagementProcessISO14971 simplifiedprocess 14971 GeneralRequirementsClause3 MusthavethatparticulardefinedanddocumentedRMProcessthataddressesriskanalysis evaluationandcontrol collectionofpost productionsafetyrelateddatatovalidateorchangepreviousriskdeterminations ManagementResponsibilities Themanufacturershall definehispolicyfordeterminingcriteriaforriskacceptability takingintoaccountrelevantInternationalStandards andnationalorregionalregulationsensuretheprovisionofadequateresourcesensuretheassignmentofqualifiedpersonnelformanagement performanceofworkandassessmentactivitiesreviewthesuitabilityofriskmanagementactivitiesatdefinedintervalstoensurecontinuingeffectivenessoftheriskmanagementprocessanddocumentactionstakenComplianceischeckedbyinspectionoftheriskmanagementfile ManagementResponsibilitiesISO IEC14971 Commitment PolicyfordeterminationacceptableriskProvisionofadequateresourcesAssigntrainedpersonnelReviewriskmanagementactivities PolicyonEstablishingRiskAcceptability Managementneedstodevelopariskacceptabilitypolicytodeterminecriteriaforriskacceptability guideproductdevelopment clause3 2ManagementResponsibility ApplicationofInternationalstandardsNationalorregionalregulationsAvailableinformationondevice s StateoftheartThatriskwillbebroughtdowntothebesttechnologicallevelavailable ManagementReview PlannedintervalsSuitabilityofRMProcessContinuingeffectivenessDocumentationofdecisionsandactions QualificationofPersonnelISO IEC14971 Appropriateknowledgeandexperiencefortasksofriskmanagement DeviceApplication useRiskmanagement RiskManagementPlanISO IEC14971 TheManufacturerShallPrepareaRiskManagementPlaninAccordanceWiththeRiskManagementProcess RiskManagementPlanISO IEC14971 ScopeoftheplanApplicablelifecyclephasesVerificationplanResponsibilitiesRequirementsforreviewCriteriaforacceptabilityCollectionofpostproductioninformationRecord CriteriaforRiskAcceptability Onceapolicyisadefined proceedwithdefiningtheacceptabilitycriterialevelusinginformationfrom thecompany shistorywithsimilardeviceorplatform informationgatheredaboutyourcompetitors currentindustrylevel meetthisataminimum andwhatarethealternativetherapies RiskManagementFileISO IEC14971 Thesetofrecordsthatarerequiredbythisstandard RiskManagementFileRecordsISO IEC14971 RiskManagementPlanIdentificationofHazardsEstimationofRisksRiskEvaluationMeasuresforControlEvaluationofEffectivenessRiskManagementReportVerificationResidualRisks WhatDoWeNeedtoKnow ISO IEC14971 World widestandardManagementstandardRiskmanagementprocessEstablishedriskmanagementconcepts RequirementsRiskManagementProcessISO IEC14971 Riskanalysis clause4 Riskevaluation clause5 Riskcontrol clause6 Riskacceptance clause7 Riskreport clause8 PostProductionInformation clause9 RiskManagementProcessISO14971 simplifiedprocess Clause4 RiskAnalysis IntendeduseIdentificationHazardsEstimationofRisksRecordinRiskManagementFile Hazard Apotentialsourceofharm 14971 RiskAnalysisClause4 Aparticularriskanalysisprocessshallbedevelopedthatcontainsrequirementsto Identifytheintendeduseofthedeviceincludingtheenvironmentinwhichitwillbeused andcharacteristicsthatareassociatedwithrisks i e inherenttothedevice Identifyhazardsandhazardoussituationsassociatedwiththedevice notethateachhazardmayresultinmultiplehazardoussituationsandpotentialharmsandeachpotentialharmmustbeidentified Hazard PotentialSourceof Harm Potentialsourceofphysicalinjuryordamagetothehealthofpeople ordamagetothepropertyorenvironment Causerelatedaspect Consequencerelated Hazard NaturalTechnologicalSocialLifestyle Hazard Areaofexposure impact NoRiskwithoutexposure FunctionalAnalysis FaultTreeAnalysis HACCP FMEA 14971 RiskAnalysis continued Clause4 Estimatetheriskassociatedwitheachhazardorhazardoussituationby Estimatingthelikelihoodthatagivenharmwilloccur Estimatingtheseverityoftheharmifitdoesoccur Clause5 RiskEvaluation CriteriaforRiskacceptabilityRiskAcceptabilityDeterminewhetherthecalculatedriskisacceptablebasedontheacceptancecriteriaestablishedbymanagementRecordinRiskManagementFile Clause6 RiskControl IsRiskReductionrequired InherentsafetybydesignProtectivemeasuresInformationforsafetyImplementriskcontrolVerifyimplementationVerifyeffectivenessResidualriskevaluationRiskbenefitanalysisOthergeneratedhazards CompletenessRecordinRiskManagementFile 14971 RiskControlClause6 EachmitigationshallbeevaluatedthroughtheapplicationofriskanalysisandcontroltodeterminewhetheranynewriskshavebeencreatedORwhetherpreviouslyidentifiedriskshavebeennegativelyimpacted Theprocessdescribedinclauses4 6shallbereiterateduntilallresidualrisksareacceptableandallriskshavebeenaddressed Anassessmentshallbeperformedtoassurethishasbeendone Clause7 OverallResidualRiskEvaluation AllriskcontrolinplaceImplementedVerifiedResidualriskacceptable RiskBenefit ifrequiredRecordinRiskManagementFile 14971 OverallRiskAcceptabilityClause7 Afterallriskshavebeenidentified analyzedandcontrolled thedeviceshallbeevaluatedtodeterminetheoveralllevelofresidualriskpresentedbythedevice Wheretheoverallresidualriskhasbeendeemedunacceptable theriskmaybeconsideredacceptablebasedonthebenefitsprovidedbythedevice Clause8RiskManagementReport ReviewofRiskManagementprocessRiskManagementPlanimplementedOverallresidualriskacceptablePostproductioninformationsysteminplacePartofRiskManagementFile Clause9 PostProductionInformation PostproductionSystematicProcedureIdentificationnewhazardsChangesacceptabilityFeedbackloopRecordinRiskManagementFile 14971 Post productionClause9 Themanufacturermustimplementasystemforthecollectionoffielddatarelatedtothesafetyofthedeviceandsimilardevicesoncereleasedforuse Thepost productionsystemshallbecapableofdetermining Ifpreviouslyunidentifiedrisksexist Ifpreviouslyestablishedrisklevelswereorhavebecomeunacceptable ISO14971AStandardforAllSeasons Lifecyclestandard notlimitedasadesignstandardUpdatefilewithpost productioninformation productchanges Iterativeprocess everydevelopmentcyclegetsmorequantitative lookfordifferences baselinedataisavailable ISO14971 2000 2007 Firsteditionin2000RevisionofallStandardsaRequirementRationaleto14971PublishedasAmendment1in2003Revisionto14971initiatedfor2005PublishedMarch1 2007 Revisionto14971 ManagementstandardNormativetextlittlechangedAnnexesprovideguidanceRationale Amendment1 isincorporatedinAnnexPublicationin2007 Revisionto14971 AnnexA RationaleAnnexB OverviewFigureRMProcessAnnexC CharacteristicsforSafetyAnnexD RiskConceptsAnn