Industry Adoption Roadmap Update Grant Hodgkins Alcon Laboratories, Inc. Former Co-Chair, EPCglobal Industry Adoption Task Force Current Co-Chair, GS1 Healthcare AIDC Standards
Topics • IATF Roadmap Overview • GS1 Healthcare Standards Overview • Where We’re Going • Questions and Answers
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
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)
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
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
Overview of the IATF Roadmap • Serialization • e-Pedigree • Implementation and related guidance
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
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
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
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’.
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.
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.
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
Membership around the world Local participation Members global user group And many more…
GS1 Healthcare – Local Groups And more being developed…(Belgium, Japan, Mexico, Sweden, Turkey)
GS1 Healthcare Roadmap • Phase 1 nearing implementation • Standard: AIDC • Standard: Traceability • Standard: GDSN Healthcare Extensions • Phase 2 to kickoff shortly • Work scheduled thru 2009
Excerpt of Direct Part Mark Standards Description of the product packaging Data Carrier recommendations Data to be encoded
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
Just Published GS1 GDSN Standard
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