1. 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

2. 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

3. 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)
Event Type Codes submitted for publication 2010
Amendment 1 to coding examples under development
WG3 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 Program
Report on Medical Device Fault Conditions (NKKN, Haukeland University Hospital)

5. 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

6. Device vs. Drug Report Numbers

7. EU – Device Reports

8. 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

9. Example FDA Hierarchical Structure

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

11. 19218-1 Event Type Codes Level 1

12. Example of Event Type Codes TS19218-1

13. Examples being developed for 19218-1

14. vs :2005

15. Portion of Draft TS

16. Portion of Draft TS

17. Level 1 Terms – TS