ISO/TS 19218 WHO Informal Consultation on Nomenclatures for Medical Devices March 23-24, 2011 Leighton Hansel Convener ISO/TC210 WG3 Symbols and Nomenclature for Medical Devices Director, Regulatory Affairs Abbott Quality and Regulatory Abbott Laboratories

1999 Proposed NWIP Standard for coding device failures suggested to ISO/TC 210 WG 3, Symbols and Nomenclature for Medical Devices by FDA/GHTF SG2 To support adverse event information exchange between regulatory authorities Manufacturer submissions of adverse event reports to regulatory authorities. Could also be used by end users Excluded patient outcomes For post market events, not for clinical studies

History of TS 19218 NWIP approved 2000 Background information gathered early 2002 ISO/TC 210 WG 3, concluded that work should result in a Technical Specification WD Prepared mid 2002 Consulted with GHTF SG2 in 2003 DTS Voted on early 2004 and revised As result of preparing DTS2, WG3 concluded NWIP for introduction of hierarchical structure should be proposed DTS 2 Voted on, revised and published as TS 19218:2005 NWIP for hierarchical structure approved 2005 WG3 Decided to split into 2 Documents, Event Type Codes(-1) and Evaluation Codes(-2) 19218-1 Event Type Codes submitted for publication 2010 Amendment 1 to 19218-1 coding examples under development WG3 will review draft of 10218-2 in 2011 with publication in 2012

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 Program Report on Medical Device Fault Conditions (NKKN, Haukeland University Hospital)

Revised TS 19218 WG revised to consist of event types and cause codes Definitions The 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 codes As Issued (2005) – 22 Type and 46 Cause

Device vs. Drug Report Numbers

EU – Device Reports

Code Development/Use Considerations Use of codes Regulatory authorities Level of detail related to size of regulatory authority and number of adverse event reports received Level of detail for data exchange Manufacturers “Buckets” Supplemental coding IT applications as support tools Maintenance

Example FDA Hierarchical Structure

Global Vision of Harmonized Event Type Codes Manufacturer Codes (XXX) FDA Codes (476) TS 19218 Level Two Codes (82) TS 19218 Level One Codes (20)

19218-1 Event Type Codes Level 1

Example of Event Type Codes TS19218-1

Examples being developed for 19218-1

19218-2 vs. 19218:2005

Portion of Draft TS19218-2

Portion of Draft TS19218-2

Level 1 Terms – TS19218-2