GS1 STANDARDS & UDI UPDATE

SIOBHAN O’BARA GS1US

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

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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 110 + 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...

GS1 IS BOTH GLOBAL & LOCAL

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RECOGNIZED, OPEN AND NEUTRAL SOURCE

And many more… August 2012

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®).

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MOVING FORWARD IN HEALTHCARE

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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.

• 2015 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.

• 2010 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)

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HEALTHCARE

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THE FOUNDATION: GS1 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

Company Prefix

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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

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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

DataMatrix (14-digit GTIN) Databar (14-digit GTIN) GS1 -128 (14-digit GTIN)

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WHAT IS GDSN*

13 *Global Data Synchronisation Network

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.

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UDI = 2 Parts

Static part = DI Product identifier (GTIN)

Dynamic part = PI Production identifier (serial or lot

number, & expiry date)

EXAMPLE OF UDI MARKING

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.

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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

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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 www.fda.gov/esg

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 all types of recipients

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GDSN

MANUFACTURER

GPO

HOSPITAL/PROVIDER

FDA UDID

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 1100001017041 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

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Web based tool

Business Rules

Manufacturer (Acme)

GSI GDSN

Bulk HL7 SPL

Minimum Data Set For each Device Identifier: • Manufacturer and model • GMDN Code • Other attributes

FDA’s UDI Database

FDA Managed

HL7 SPL

BASIC PLAN TO POPULATE UDID USING GDSN

GS1 GDSN

HL7 SPL

SO, WHERE DO WE START?

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MANUFACTURING PACKAGING & LABLELING

SUPPLY CHAIN LOGISTICS

REGULATORY QUALITY & COMPLIANCE

LEGAL

IT, R&D, MDM FINANCE BI & REPORTING

Raw,Semi finished Materials Packaging materials, labels

IFU. Barcodes, RFID, local languages

Storage, EDI, ecommercer, purchasing

Complaints, CAPA...

Registration, Declaration release & submissions

Legal requirements of countries , WHO …

New product dev, centralized data, IT

VAT & Tax information, Finance classification…

Sales reports, Tax reports…

UDI HAS A GLOBAL IMPACT ACROSS THE MANUFACTURER’S ENTERPRISE

“UDI is more than Regulatory – the

impact is throughout “ CUSTOMERS &

DISTRUBITORS Orders, Cash, HCPs ...

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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)

REFERENCE LINKS

• Healthcare Industry Sunrise Dates

– www.gs1us.org/hcsunrise

• GLN and GTIN Industry Readiness Scorecards

– www.gs1us.org/hcscorecard

• Industry Use Cases

– www.gs1us.org/hcstudies

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• Healthcare Tools & Resources

– www.gs1us.org/hctools

• Education

– www.gs1us.org/hcedu

• GS1 Healthcare US Initiative

– www.gs1us.org/healthcare

• GLN Registry for Healthcare

– www.gs1us.org/glnregistry

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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 (scanning @ POU)

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 www.gs1us.org/BDMercystudy

CONTACT INFORMATION

Siobhan O’Bara MJ Wylie Sr. Vice President, Industry Engagement Sr. Director, Medical Devices GS1 US GS1 US TEL +1 609 620 8046 TEL +1 303-961-7050 EMAIL sobara@GS1US.org EMAIL mjwylie@gs1us.org W EB www.GS1US.org/healthcare W EB www.GS1US.org/healthcare Scott Brown Géraldine Lissalde-Bonnet Director, Global Standards Manager, Public Policy GS1 US GS1 TEL +1 609 620 4681 TEL +32 2 788 78 87 EMAIL scott.brown@GS1US.org EMAIL geraldine.lissalde.bonnet@gs1.org

W EB www.GS1US.org/healthcare W EB www.GS1.org

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