GS1 STANDARDS & UDI UPDATE SIOBHAN O BARA GS1US

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1 GS1 STANDARDS & UDI UPDATE SIOBHAN O BARA GS1US

2 AGENDA We have the standards. GS1 US Background and Update We have the framework. Unique Device Identification (UDI) We need to move forward. The clock is ticking ~ moving standards into action 2

3 GS1 IS BOTH GLOBAL & LOCAL GS1 Global Office Identification, creation, development and maintenance of standards and our foundational architecture, coordination with other international bodies, development of training programs...not-for profit organization GS1 Member Organizations Local offices in countries around the globe, such as GS1 US Implementation of standards, local regulatory adjustments, community management and relationship management with local governments and regulatory agencies... 3

4 RECOGNIZED, OPEN AND NEUTRAL SOURCE And many more August 2012

5 ABOUT GS1 US GS1 US serves more than 250,000 businesses across 25 industries in the United States. Leading industry initiatives in Apparel / General Merchandise, Consumer Packaged Goods / Grocery, Foodservice, Fresh Foods, and Healthcare Administrating the GS1 System of standards Providing support services, tools, education, and training Connecting communities through events and online forums GS1 US is the pioneer of the Universal Product Code (U.P.C.) and the Electronic Product Code (EPC ). 5

6 MOVING FORWARD IN HEALTHCARE 6

7 HEALTHCARE PROGRAMS / INITIATIVES FDA Unique Device Identification (UDI) for Medical Devices The proposed FDA UDI regulation aims to transform disparate medical identification methods into a standardized system. The GS1 GTIN provides the foundation for companies to meet these requirements Readiness and FDA Track and Trace Initiatives GS1 Healthcare US works with members of the U.S. pharmaceutical industry to help prepare companies for product serialization, 2015 state drug pedigree requirements, and FDA track and trace initiatives using GS1 Standards and 2012 Sunrise Dates To accelerate wide-scale adoption of GS1 Standards, "sunrise" dates were established by the industry: 2010 for location identification (Global Location Number GLN) 2012 for product identification (Global Trade Item Number GTIN, and Global Data Synchronization Network GDSN) 7

8

9 HEALTHCARE 9

10 THE FOUNDATION: GS1 COMPANY PREFIX Company Prefix Assigned to the Brand Owner Used to create globally-unique identification numbers for: Products (GTIN) Inner Packs, Cases, and Pallets (GTIN) Locations (GLN) Assets Services 10

11 UDI DATABASE (UDID) Listing of medical devices Includes all Class I, II, and III devices using the rollout plan Includes a base set of information for the identification of the item Includes information about how the item is controlled Does not include specific serial numbers. Specific lot numbers, or specific dates Populate FDA s UDI Database Web Portal SPL GDSN 11

12 WHAT IS A GTIN? GTIN is Global Trade Item Number A globally unique 8, 12, 13, or 14-digit number that uniquely identifies products and services An identification number of the GS1 System, therefore unique and unambiguous A global standard for collaborative commerce A 14-digit GTIN is encoded in a GS1-128/DataMatrix /Databar GS1-128 (14-digit GTIN) DataMatrix (14-digit GTIN) Databar (14-digit GTIN) 12

13 WHAT IS GDSN* *Global Data Synchronisation Network 13

14 THE UDI MECHANISMS USED Under the system to be established by proposed rule, two mechanisms would be used together to identify a device: UDI on the Label and Packaging of a Device or on the Device Itself (represented both in plain text and automatic identification and capture technology - AIDC) FDA Global UDI Database, containing device identification information for each UDI. 14

15 EXAMPLE OF UDI MARKING UDI = 2 Parts Static part = DI Product identifier (GTIN) Dynamic part = PI Production identifier (serial or lot number, & expiry date)

16 CONSTRUCT OF UDI = DI + PI Device Identifier (DI) - a mandatory, fixed portion of UDI identifies specific version or model and labeler of device, Production Identifier (PI) - a conditional, variable portion of a UDI included on the label of the device: (Lot, Serial No., UBD, etc.). However, PI not required for Class I devices. Each UDI must have a plain-text form and an AIDC technology, e.g. bar code. If the AIDC form is not visually evident, then the label must display a special symbol. 16

17 CURRENT UDI REQUESTED ATTRIBUTES Primary Device Identifier (DI) (no control information) Secondary Device Identifier (if applicable) Unit of Use DI (if different form DI) Manufacturer s Name, Address, and Contact Information GMDN Device Description Additional Product Description Trade Name/ Brand Name (of DI and if part of a device family) Model Number/Catalog Number (of DI and if part of a model family) Clinical Size (volume, length, gauge, etc) Storage Conditions Sterile? Sterilize prior to use, and method of sterilization Type of Control (serial number, Lot/Batch, Expiration Date, and/or manufacturing date) (not actual number or date) Can DI be reused? Contains Latex? Contains Human Tissue? FDA Numbers- Product Code Listing Number Premarket Authorization, 510K Supplement Number Direct Marking DI (if different from DI) Direct Marking Exemption Reason Marketing Status Is DI part of a Kit? Or a Combination Item? DI Discontinued Date (if applicable) Higher level information Parent DI, Child DI, Child Quantity 17

18 UDID HL7 SPL SUBMISSIONS Utilizes Health Level 7 (HL7) Structured Product Labeling (SPL) Release 5, DSTU Submit Device Information (DI) as HL7 SPL xml files Submitted via the FDA Electronic Submissions Gateway 18

19 FDA UNIQUE DEVICE IDENTIFIER (UDID) PILOT The FDA is conducting a pilot to test loading data into the UDID Beta environment 2 GDSN Data Pools are participating 1Worldsync, GHX Data will be loaded by manufacturers into the UDID Pilot ran for two weeks last month Since GDSN is a single point of entry system, the manufacturer can load all of their product information for GPO all types of recipients GDSN HOSPITAL/PROVIDER MANUFACTURER FDA UDID 19

20 GDSN PROCESS AND UDID Manufacturer loads all their product information into a Certified Data Pool Data for supply chain Data for UDID (elements which were found to be missing in GDSN have been added so all can be populated in GDSN) Manufacturer publishes the data to its intended recipients The manufacturer publishes each item to the applicable data recipient via GDSN as is appropriate Using GLN for the supply chain partner (Distributor, Provider, GPO) Using GLN for the FDA UDID When the FDA UDID GLN is chosen the source data pool will Construct an SPL message using the FDA list of attributes Send the SPL message to the FDA Electronic Gateway Receipt by the FDA The data is received and responses are sent 20

21 BASIC PLAN TO POPULATE UDID USING GDSN GS1 GDSN Manufacturer (Acme) Web based tool Bulk HL7 SPL Minimum Data Set For each Device Identifier: Manufacturer and model GMDN Code Other attributes HL7 SPL GSI GDSN HL7 SPL Business Rules FDA Managed FDA s UDI Database 21

22 SO, WHERE DO WE START? 22

23 UDI HAS A GLOBAL IMPACT ACROSS THE MANUFACTURER S ENTERPRISE MANUFACTURING Raw,Semi finished Materials REGULATORY Registration, Declaration release & submissions CUSTOMERS & DISTRUBITORS Orders, Cash, HCPs... PACKAGING & LABLELING Packaging materials, labels IFU. Barcodes, RFID, local languages UDI is more than Regulatory the impact is throughout SUPPLY CHAIN LOGISTICS Storage, EDI, ecommercer, purchasing QUALITY & COMPLIANCE Complaints, CAPA... LEGAL Legal requirements of countries, WHO BI & REPORTING Sales reports, Tax reports FINANCE VAT & Tax information, Finance classification IT, R&D, MDM New product dev, centralized data, IT

24 WE ARE HERE FOR YOU UDI Comments Workgroup (70+ members from across the community. Comments have been submitted, but that is just the start.) Web site resources (documents, webinars, videos) People (staff and community) 24

25 REFERENCE LINKS Healthcare Industry Sunrise Dates GLN and GTIN Industry Readiness Scorecards Industry Use Cases Healthcare Tools & Resources Education GS1 Healthcare US Initiative GLN Registry for Healthcare 25

26 BD / MERCY CASE STUDY Perfect Order and Beyond BD and Mercy/ROi Achieve Far-Reaching GS1 Standards Integration Learn how BD and Mercy/ROi implemented GS1 global standards from manufacturing plant to patient bedside illustrating ways the supply chain can impact patient safety and optimize healthcare operations with fully automated order processes and transactions. Download at Benefits Achieved 30% reduction in days payable outstanding 73% reduction in discrepancies (part number and UOM) Improved sourcing of products (right product/right order number) Less calls to customer service Fewer stock outs Better charge compliance POU) 26

27 CONTACT INFORMATION Siobhan O Bara MJ Wylie Sr. Vice President, Industry Engagement Sr. Director, Medical Devices GS1 US GS1 US TEL TEL WEB WEB Scott Brown Géraldine Lissalde-Bonnet Director, Global Standards Manager, Public Policy GS1 US GS1 TEL TEL WEB WEB Connect with the GS1 US community on 27

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