Presentation on theme: "ISO/TS 19218 WHO Informal Consultation on Nomenclatures for Medical Devices March 23-24, 2011 Leighton Hansel Convener ISO/TC210 WG3 Symbols and Nomenclature."— Presentation transcript:
1 ISO/TS 19218WHO Informal Consultation on Nomenclatures for Medical DevicesMarch 23-24, 2011Leighton HanselConvener ISO/TC210 WG3Symbols and Nomenclature for Medical DevicesDirector, Regulatory AffairsAbbott Quality and RegulatoryAbbott Laboratories
2 1999 Proposed NWIPStandard for coding device failures suggested to ISO/TC 210 WG 3, Symbols and Nomenclature for Medical Devices by FDA/GHTF SG2To support adverse event information exchange between regulatory authoritiesManufacturer submissions of adverse event reports to regulatory authorities.Could also be used by end usersExcluded patient outcomesFor post market events, not for clinical studies
3 History of TS 19218 NWIP approved 2000 Background information gathered early 2002ISO/TC 210 WG 3, concluded that work should result in a Technical SpecificationWD Prepared mid 2002Consulted with GHTF SG2 in 2003DTS Voted on early 2004 and revisedAs result of preparing DTS2, WG3 concluded NWIP for introduction of hierarchical structure should be proposedDTS 2 Voted on, revised and published as TS 19218:2005NWIP for hierarchical structure approved 2005WG3 Decided to split into 2 Documents, Event Type Codes(-1) and Evaluation Codes(-2)Event Type Codes submitted for publication 2010Amendment 1 to coding examples under developmentWG3 will review draft of in 2011 with publication in 2012
4 Initial Version of TS19218 Development based on two documents FDA Coding Evaluation Report – An Evaluation of the Coding System for Device Problems and Patient Effects Used to Report Adverse Medical Device Events to the FDA MedWatch ProgramReport on Medical Device Fault Conditions (NKKN, Haukeland University Hospital)
5 Revised TS 19218 WG revised to consist of event types and cause codes DefinitionsThe adverse event type code characterizes the observed use/malfunction/failure of the medical device at the time the event occurred.The adverse event cause code characterizes the latest conclusions of a cause analysis of the adverse event.Number of codesAs Issued (2005) – 22 Type and 46 Cause
8 Code Development/Use Considerations Use of codesRegulatory authoritiesLevel of detail related to size of regulatory authority and number of adverse event reports receivedLevel of detail for data exchangeManufacturers“Buckets”Supplemental codingIT applications as support toolsMaintenance
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