Presentation on theme: "Industry Adoption Roadmap Update"— Presentation transcript:
1Industry Adoption Roadmap Update Grant HodgkinsAlcon Laboratories, Inc.Former Co-Chair, EPCglobal Industry Adoption Task ForceCurrent Co-Chair, GS1 Healthcare AIDC Standards
2Topics IATF Roadmap Overview GS1 Healthcare Standards Overview Where We’re GoingQuestions and Answers
3What 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 initiativesCross-functional team of 80+ participants, most representing global healthcare entities, mobilized from Jun-2006 to Oct-2007Worked closely with FDA and CA BOP to craft mutually agreeable solutions
4Around the time the IATF Roadmap was completed, EPCglobal HLS and GS1 HUG merged to form GS1 HealthcareThe IATF deliverable was used as input to new global standards using newly-created work teamsOct2006Oct2007Oct2008EPCglobal HLSIndustry Adoption Task ForceGS1 Healthcare Work Groups(AIDC, Traceability, GDSN)GS1 HUG Work Groups(AIDC, Traceability, GDSN)
7IATF Roadmap: ContextWhen this work group began in mid-2006, the world was a much different place…California regulation set to become effective Jan. 1, 2009Much 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 planVirtually no standards were completedNo practical experience with mass serialization in any industryThe IATF was charged with bringing some clarity and direction to this confused space
8Overview of the IATF Roadmap Serializatione-PedigreeImplementation and related guidance
9IATF: 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 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
10IATF: Serialization Other special-interest serialization topics: Serialized InferenceInferring reads when less than 100% of data carriers are read.NDC MaskingOptional, 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-ExistenceSynchronizing serial numbers when using two or more data carriers.This is NOT recommended and does not meet GS1 Stds
11IATF: e-Pedigree There are two Options to provide a Pedigree: Option 1 – Drug Pedigree Messaging StandardOption 2 –Track and TraceDrug 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
12IATF: e-PedigreeRx 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’.
13IATF: Implementation Guidance Typical Activities For All Trading PartnersEngage 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.
14IATF: Implementation Guidance Typical Activities For All Trading PartnersDevelop, 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.
16GS1 Healthcare – Organization GS1 Healthcare Leadership TeamRoadmapDirection and resources for work teamsActive Teams related to IATF WorkGlobal AIDC Application Standards TeamGlobal Traceability TeamGlobal Data Synchronisation Network (GDSN) TeamOther Global work teams
17Membership around the world Members global user groupLocal participationManufacturersAbbott LaboratoriesAlcon LabsAmgenAstra ZenecaBaxterB. BraunBoston ScientificCookCovidienEdwards LifescienceGlaxo Smith KlineJohnson & JohnsonKing PharmaceuticalMedtronicMerck & Co.Novartis PharmaPall MedicalPfizerPurdue PharmaSchering PloughSmiths MedicalSakura SeikiDistributors/Healthcare providers/GPOs/T&LCardinal Health (U.S.)CH Aulnay sous Bois (France)Comparatio Health (Germany)CVS (U.S.)DHL Exel Supply ChainErasmus MC Rotterdam (NL)UNI.HA (representing 17 French university hospitals)Hong Kong Hospital AuthoritiesMcKesson (U.S.)Novation (U.S.)Orthopädisches Spital Speising Wien (Austria)Premier (U.S.)Marienhospital Herne (Germany)UMC Groningen (NL)University Hospital Geneva (CH)University Kentucky Healthcare (U.S.)Wiener Krankenanstaltenverbund (Austria)Non-voting membersAHRMM CladimedInstituto Brasileiro de Ética Concorrencial – ETCOLIF – Swedish Association of Pharmaceutical ManufacturersPublic Health Agency of CanadaUS DoDUS FDA3MBayerBecton DickinsonBoehringer IngelheimColoplastDraeger MedicalGenzymeHospiraKimberly-ClarkNovo NordiskSt. Jude MedicalStrykerTeva PharmaceuticalsTerumoUCBUpsher-Smith…Distributors/WholesalersAexxdisAmerinetAmerisource BergenCH2DepolaboGalexisGAMMA WholesaleGeodisMcMahonOwens & MinorHealthcare providers/RetailersAlfred Hospital (Australia)Ascension Health (U.S.)Capital District Health (Canada)CHU de Québec (Canada)CHU Dijon (France)HUG Geneva (Switzerland)London Drugs (U.K.)Mayo Clinic (U.S.)Sisters of Mercy (U.S.)Sobeys Pharmacy (U.K.)UHCS Augusta VA (U.S.)Walgreens (U.S.)Wal-Mart (U.S.)AssociationsAHA (U.S.)CIP/ACL (France)CHeS (U.S.)EFPIA (Europe)Eucomed (Europe)FENIN (Spain)GIRP (Europe)HDMA (U.S.)International Hospital FederationJFMDA (Japan)Medical Industry Association of AustraliaNACDS (U.S.)Patient Safety Foundation (U.S.)And many more…
18GS1 Healthcare – Local Groups And more being developed…(Belgium, Japan, Mexico, Sweden, Turkey)1818
25Excerpt of Direct Part Mark Standards Description of the product packagingData Carrier recommendationsData to be encoded
262.1.5 Fixed Measure - Direct Part Marking – Brand Owner Marked Product Category: Medical DevicePreferred AIDC Carrier(s): GS1 DataMatrixOptional AIDC Carrier: EPCglobal RFID tags (in addition to bar code)Supported AIDC Carrier: N/AIdentification Level: HighestGS1 Key: GTIN-12, -13, -14GS1 Key Attributes: Serial NumberImportant 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
30SummaryThe IATF Roadmap, although no longer completely current, remains a good one-stop source for understanding serialization and pedigree challengesThose challenges are now being aggressively addressed at a global level by GS1 HealthcareVirtually all key questions raised in the IATF Roadmap have been migrated into one or more GS1 Healthcare groups for resolution and actionCombining forces has accelerated activities, globalized the solutions, and enabled productive dialogue with regulators across the globe