1. HUG HUG Auto-ID Data Work Team - Update Berlin, 1 st Feb 2007 Mark Hoyle, Tyco Healthcare & Mark Walchak, Pfizer

2. ©2006 GS1 2 GS1 HUG AIDC Data Work Team’s Objective “Because there are no Global Application Standards for the Automatic Identification of data related to Healthcare, this team will identify the Business Requirements and Data Requirements to be used for the development of a global standard for the automatic identification of vaccines, biological, pharmaceuticals, therapeutic nutritional products, medical devices, instruments and implants with the goal of improving patient safety.”

3. ©2006 GS1 3 GS1 HUG AIDC Data Work Team Problem Statement…..! Healthcare Provider The Patient The Manufacturer The Distributors The Wholesalers Local AIDC (S) Global AIDC

4. ©2006 GS1 4 GS1 HUG Calculated Check Digit Product Number GS1 Company Prefix (Manufacturer ID) Separator Digit – Always Zero Indicator Digit Application Identifier – GTIN (Global Trade Item Number) The GTIN – Fixed Information Expiry Date Application Identifier - Expiry Date Lot Number Application Identifier - Lot Number Other AI’s – Variable Information Localised Problem Self Built Systems Requiring Something Different to the Intended Solution Provided by Present and Future Standards. Imposed Limitation rather than Standardising on Data Structure, Data Content and Data Symbology or Carrier. Globally Unique Product Identification Problem Statement….! AI(10)? AI(01)? AI(02)? AI(21)? AI(37)? AI(17)?

5. ©2006 GS1 5 GS1 HUG Introduction – Work Teams versus Roadmap AutoID Data GTIN Allocation 200820072006 Packaging/ Direct Marking Serialisation Carriers AIDC Application Standards “AIDC Application Standards ” AutoID Data Work Team AutoID Data

6. ©2006 GS1 6 GS1 HUG AutoID Data Serialisation Carriers AIDC Application Standards Business & Data Reqmt’s* Application Standard AIDC Data Work Team Deliverables * Final report

7. ©2006 GS1 7 GS1 HUG AIDC Data Work Team Members Abbott Aexxdis Aesculap Baxter Behring B. Braun Boston Scientific Celesio FDA Pfizer GSG Northern University Hospitals Johnson & Johnson Medtronic Merck Germany NHS Chelsea & Westminster Novartis Procter & Gamble Sanofi-Aventis St. Jude Tyco Healthcare Australia Austria Canada China France Hong Kong Hungary Italy Japan New Zealand Spain Switzerland UK USA

8. ©2006 GS1 8 GS1 HUG Review Mission & Vision Establish Team Approve Objective & Scope Approve Business Requirements Approve Data Requirements Submit Final Report Sept Oct Nov Dec Jan Feb Mar Apr AIDC Data Work Team Project Plan physical meetings key task scheduled task complete 2006 2007 ParisPhiladelphiaBerlin

9. ©2006 GS1 9 GS1 HUG AIDC Data Work Team’s Scope The starting point on the supply chain will be at the manufacturer and the point of finished goods, because marking only starts at the point of finishing. Upstream from this point will be out of scope. Food services will not be included but therapeutic nutritional products will be included. Note: Therapeutic nutrition is defined as “Therapeutic Nutrition business means enteral and parenteral nutrition of products and services to treat patients who require feeding on that specific route because of a specific disease or to prevent a potential disease.” Adverse events related to data capture shall be considered within scope and used as an input to preparing the deliverable. Animal healthcare will not be in scope at this time, but input will be considered. Equipment used to transport patients is out of scope. A facility’s assets used by a patient such as tables, lights, etc. is out of scope.

10. ©2006 GS1 10 GS1 HUG Mfg Item Case Pallets Trucks Distributor Trucks Pallets Case Item Hospital User Scope Supply Chain Illustration – Packaging/Direct Marking Finished Goods To End of Treatment Looking for Common Ground Care FacilityManufacturingDistribution These are the boundaries From: Finished GoodsTo: End of Treatment

11. ©2006 GS1 11 GS1 HUG AIDC Data Work Team Business Requirements For this task the work team has: 1.Gathered Business Requirements 2.Compiled and Condensed 3.Agree upon Content (team consensus) Next Steps: The approved business requirements will be used to establish the DATA requirements.

12. ©2006 GS1 12 GS1 HUG Established Sub Teams By Product Areas Product AreaSub-Lead *VaccinesPeter Tomicki *Biologicals *Therapeutic nutritional PharmaceuticalMark Walchak / India Hardy Medical DevicesMark Hoyle InstrumentsVolker Zeinar ImplantsGunther Lamparter

13. ©2006 GS1 13 GS1 HUG AIDC Data Work Team Business Requirements Cont…. Hospital Survey VA Hospital Input by individuals

14. ©2006 GS1 14 GS1 HUG AIDC Data Work Team Business Requirements

15. ©2006 GS1 15 GS1 HUG OUR METHODOLOGY CREATE MASTER LIST KEY WORD GROUPING 3 PASS ANALYSIS ROLE GROUPING SUB TEAM AND OUT REACH LISTS

16. ©2006 GS1 16 GS1 HUG 3 Pass Analysis GOOD & APPROVED BY CONCENSUS OUT OF SCOPE – MOVE TO PARKING LOT NEEDS ADDITIONAL WORK

17. ©2006 GS1 17 GS1 HUG NEXT STEPS Finalise approval of business requirements Hospital survey analysis Master list analysis Start data requirements analysis and recommendations Leadership team GS1 Staff Present recommendations to full team Existing data available Gaps Close gaps Approve data requirements Prepare report

18. ©2006 GS1 18 GS1 HUG QUESTIONS ?