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Industry Adoption Roadmap Update

Industry Adoption Roadmap Update

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Industry Adoption Roadmap Update

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  1. Industry Adoption Roadmap Update Grant Hodgkins Alcon Laboratories, Inc. Former Co-Chair, EPCglobal Industry Adoption Task Force Current Co-Chair, GS1 Healthcare AIDC Standards

  2. Topics • IATF Roadmap Overview • GS1 Healthcare Standards Overview • Where We’re Going • Questions and Answers

  3. What is the IATF Roadmap • IATF – Industry Adoption Task Force (EPCglobal) • Tasked by EPCglobal HLS leadership team to create the first holistic strategy to meet California and other urgent compliance initiatives • Cross-functional team of 80+ participants, most representing global healthcare entities, mobilized from Jun-2006 to Oct-2007 • Worked closely with FDA and CA BOP to craft mutually agreeable solutions

  4. Around the time the IATF Roadmap was completed, EPCglobal HLS and GS1 HUG merged to form GS1 Healthcare • The IATF deliverable was used as input to new global standards using newly-created work teams Oct 2008 Oct 2007 Oct 2006 EPCglobal HLS Industry Adoption Task Force GS1 Healthcare Work Groups (AIDC, Traceability, GDSN) GS1 HUG Work Groups (AIDC, Traceability, GDSN)

  5. IATF Roadmap

  6. IATF: Team Members Supply Chain Partners • Abbott Laboratories • Ahold N.V. • Albertsons • Alcon Laboratories • Allergan • AmerisourceBergen Corp. • AstraZeneca • Baxter Healthcare Corp. • Bristol Meyers Squibb • Cardinal Health • CVS • Dai Nippon Printing • Genzyme Corporation • GlaxoSmithKline • Johnson & Johnson • Ken Traub Consulting LLC Supply Chain Partners • Kimberly-Clark • Matsushita Electric • McKesson Corporation • Merck & Co. • MetaBiz • Motorola Inc. • NEC Corporation • Nestle S.A. • Pfizer Inc. • Proctor & Gamble • Royal Philips Electronics N.V. • Target • The Dow Chemical Company • Unisys • Upsher-Smith Labs • Walgreens Company Trade / Regulatory • Auto-ID Labs (MIT) • CPhA • EPCglobal HLS Community • FDA • GS1 HUG Community • HDMA • NACDS • NCPA

  7. IATF Roadmap: Context • When this work group began in mid-2006, the world was a much different place… • California regulation set to become effective Jan. 1, 2009 • Much confusion and controversy about serialization, pedigree vs. track / trace, RFID vs. Barcodes, Inference, NDC Masking, etc. • High sense of urgency for answers, direction, and a plan • Virtually no standards were completed • No practical experience with mass serialization in any industry • The IATF was charged with bringing some clarity and direction to this confused space

  8. Overview of the IATF Roadmap • Serialization • e-Pedigree • Implementation and related guidance

  9. IATF: Serialization • Uniquely Identify – Pallets, Totes, Cases, Items. • Unique Identification should be based on Serialization. • Use current GS1 and EPCglobal serialization schemes appropriate for the chosen data carrier. • Synchronize serial numbers when using two or more data carriers: • SSCC: serial number ranges are the same for both Barcode and RFID. • SGTIN: serial number range for AI(21) when used as backup for SGTIN-96 should be limited to same range as SGTIN-96. • Avoid encoding of Lot Code and/or Expiry Date as an integral part of the serial number; instead, encode this data into RFID User Memory and/or into barcode Application Identifiers designed for this purpose. • Include backup human-readable text per GS1 standards. Answers one specific issue; now resolved

  10. IATF: Serialization • Other special-interest serialization topics: • Serialized Inference Inferring reads when less than 100% of data carriers are read. • NDC Masking Optional, interim practice to mask the Item Reference portion of the 10-digit NDC in RFID tags to avoid divulging product number for products with patient privacy concerns. • Barcode and RFID Co-Existence Synchronizing serial numbers when using two or more data carriers. This is NOT recommended and does not meet GS1 Stds

  11. IATF: e-Pedigree • There are two Options to provide a Pedigree: • Option 1 – Drug Pedigree Messaging Standard • Option 2 –Track and Trace • Drug Pedigree Messaging Standard available now. • Software available today with EPCglobal certifications. • Track and Trace in Requirements phase now. • Standards will follow at a later date. • Then software will be available. Update: Global Traceability Standard entering standards approval process

  12. IATF: e-Pedigree • Rx ASN (modified EDI Transaction Set 856, Advance Ship Notice) does not meet California requirements for pedigree. • Cannot support ‘certification under penalty of perjury’. • Does not exist in an ‘interoperable electronic system widely used…’ • Does not meet requirement for ‘manufacturer-initiated pedigree’. • Rx ASN’s could be used to facilitate supply chain transactions (receipts, shipments, etc.). • ASN’s support efficient receiving practices. • Use of ASN’s will not meet pedigree obligations for jurisdictions requiring the pedigree in an ‘interoperable electronic system’.

  13. IATF: Implementation Guidance Typical Activities For All Trading Partners • Engage with your Industry Trade Associations to ensure you have the most current information regarding policy and positions. • Work with EPCglobal and GS1 groups to obtain standards, education, and to learn from others. • Choose Serialization data carriers for every packaging level. • Choose Pedigree Option and software. • Develop scale-up and rollout-plans for Serialization and Pedigree (e.g., based on SKU counts or geographical rollout). • Work with all affected trading partners with sufficient leadtime on Serialization and Pedigree choices and options to facilitate efficient supply chain operations. • Convert operations to apply, commission and aggregate serial numbers.

  14. IATF: Implementation Guidance Typical Activities For All Trading Partners • Develop, implement, and adhere to effective Privacy standards to ensure appropriate use of these technologies. • Install capability to transact serial numbers and serialized pedigrees—based on specific local regulatory requirements. • Test serialized pedigree + serialized product final configurations with trading partners. • Start shipping serialized and pedigreed products. • Pallet, Tote, Case, Item Serialization. • Transact a manufacturer-initiated pedigree. • With sufficient lead time to load the supply chain with serialized products supported by a pedigree. • Execute your Scale-Up / Rollout Plans. • Retain Pedigree data according to regulatory data retention requirements. • Respond to requests for verification of Pedigree data.

  15. GS1 Healthcare:Standards Update

  16. GS1 Healthcare – Organization • GS1 Healthcare Leadership Team • Roadmap • Direction and resources for work teams • Active Teams related to IATF Work • Global AIDC Application Standards Team • Global Traceability Team • Global Data Synchronisation Network (GDSN) Team • Other Global work teams

  17. Membership around the world Local participation Members global user group And many more…

  18. GS1 Healthcare – Local Groups And more being developed…(Belgium, Japan, Mexico, Sweden, Turkey)

  19. GS1 Healthcare Roadmap • Phase 1 nearing implementation • Standard: AIDC • Standard: Traceability • Standard: GDSN Healthcare Extensions • Phase 2 to kickoff shortly • Work scheduled thru 2009

  20. GS1 AIDC Application Standard

  21. Excerpt of Direct Part Mark Standards Description of the product packaging Data Carrier recommendations Data to be encoded

  22. 2.1.5 Fixed Measure - Direct Part Marking – Brand Owner Marked Preferred AIDC Carrier(s): GS1 DataMatrix Optional AIDC Carrier: EPCglobal RFID tags (in addition to bar code) Supported AIDC Carrier: N/A Product Category: Medical Device Identification Level: Highest GS1 Key: GTIN-12, -13, -14 GS1 Key Attributes: Serial Number Important Application Standard Notes: Direct part marking (DPM) refers to the process of marking a symbol on an item using an intrusive or non-intrusive method. This does not include parts which are marked using labels or other indirect marking processes. Direct Part Marking is not required for Implantable Medical Devices. If a product that is required to marked at the Direct Part Mark level is contained in a Primary Package and that Primary Package obscures the DPM barcode, then the Primary Package is required to be marked with the required marks in this section. Specific GS1 DataMatrix rules & requirements apply, see GS1 Gen. Spec. for specific details / rules. 26

  23. Specific Phase 2 Activities are Being Defined

  24. GS1 Traceability Standard

  25. Just Published GS1 GDSN Standard

  26. Summary • The IATF Roadmap, although no longer completely current, remains a good one-stop source for understanding serialization and pedigree challenges • Those challenges are now being aggressively addressed at a global level by GS1 Healthcare • Virtually all key questions raised in the IATF Roadmap have been migrated into one or more GS1 Healthcare groups for resolution and action • Combining forces has accelerated activities, globalized the solutions, and enabled productive dialogue with regulators across the globe

  27. Questions?