ISOTS 19218 WHO Informal Consultation on Nomenclatures for

ISO/TS 19218 WHO Informal Consultation on Nomenclatures for Medical Devices March 23 -24, 2011 Leighton Hansel Convener ISO/TC 210 WG 3 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 SG 2 • 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 2

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 SG 2 in 2003 • DTS Voted on early 2004 and revised • As result of preparing DTS 2, WG 3 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 • WG 3 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 • WG 3 will review draft of 10218 -2 in 2011 with publication in 2012 3

Initial Version of TS 19218 • 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 Med. Watch Program – Report on Medical Device Fault Conditions (NKKN, Haukeland University Hospital) 4

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 5

Device vs. Drug Report Numbers 6

EU – Device Reports 7

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 8

Example FDA Hierarchical Structure 9

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) 10

19218 -1 Event Type Codes Level 1 11

Example of Event Type Codes TS 19218 -1 12

Examples being developed for 19218 -1 13

19218 -2 vs. 19218: 2005 14

Portion of Draft TS 19218 -2 15

Portion of Draft TS 19218 -2 16

Level 1 Terms – TS 19218 -2 17