Download pdf - UDI: Where Do We Go From Here?

Healthcare

Greg Bylo, GS1 US

UDI: Where Do We Go From

Here?GS1 US Supply Chain Visibility

June 15, 2016

© 2016 GS1 US All Rights Reserved

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http://www.gs1us.org/gs1-us-antitrust-compliance-policy


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Agenda

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• Anti-Trust Caution / Legal Disclosure• Standards in Action• UDI – The Basics• Holistic Approach to UDI• Leveraging Your Investment


Standards in Action

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GS1 Standards in Action

• The following link provides a basic review of the

GS1 standards for Healthcare and how they can

improve operational efficiency and patient

safety.

• http://www.gs1us.org/industries-

old/healthcare/standards-in-action-video

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http://www.gs1us.org/industries-old/healthcare/standards-in-action-video


The Global Language of Business

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Identify GS1 Identification Numbers

Companies, Products, Locations,

Logistics, Assets, and Services

Capture GS1 Data Carriers

Barcodes and EPC-enabled RFID

Share GS1 Data Exchange

Master Data, Transactional Data,

and Physical Event Data


GS1 Standards

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Implemented GS1 Standards in the Supply Chain

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GS1 Interface Standards for Electronic Commerce

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GS1 Interface Standards for Electronic Commerce

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Data Flow for the Global Data Synchronization Network

Select one data pool as a SINGLE point of entry to the GDSN

The GS1 Global Registry® is a single repository where basic data is registered. The GS1 Global Registry identifies the data pool location of source data.

Data Pools provide data that is standards conformant, and interoperable in the GDSN®. The data pool performs the transactions of sending and receiving validated product information between partners inside or outside the data pool.

Step 1 : Load Data

Step 2 : Register Data

Step 3 : Subscription Request

Step 4 : Publish Data

Step 5 : Recipient Confirmation

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FDA GUDID

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UDI Basics

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Meeting UDI Requirements

• Step 1 - The Device Identification

(DI)

- Identify your devices

- Adhere to one of issuing agencies –

GS1, HIBCC, or ICCBBA

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• Step 2 – Select Bar Code

(AIDC) and design label and

packaging

• Step 3 – Identify the

Production data

•GTIN – Global Trade Item Number

•Expiry Date

•Lot

Number

•Serial Number

UDI = Device Identifier (DI) + Production Identifiers (PI)

GTIN + Application Identifiers (AI)


Meeting UDI Requirements

Step 4 – The GUDID

• Global Unique Device Identifier Database (GUDID)

- Operated by the FDA to collect information on Medical Devices

- Will have public facing website to share data with anyone

- Some information submitted to the GUDID will be private (for FDA only)

• All medical devices which are regulated under the UDI regulations will be

required to be listed in the GUDID

- Sunrise for each class is the same for GUDID as assigning a UDI

• Class III devices- 1 year from final rule publication (September 24, 2014)

(complete with extensions)

• Class II “life sustaining” devices- 2 years from final rule publication

(September 24, 2015) (GUDID extended to October 24, 2015) (complete with

extensions)

• Class II remaining devices- 3 years from final rule publication (September

24, 2016)

• Class I devices- 5 years from final rule publication (September 24, 2018)

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Holistic Approach to UDI

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Implementation & Integration Implications to Consider

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1• MDM business process needed to maintain UDI attributes

• UDI Rule provides data definitions for each attribute

• Need BP Owners for each attribute

2• Incorporate UDI into it Labeling/Packaging process

• Address both global & local UDI requirements

• Impacts all product labels– unit of use through case

3• Create ECR BP to meet UDI Requirement

• 48 hour requirement for design change notification

• Product Design incorporate GTIN assignment process

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• Identify all SOPs which need to be updated & include in project plan

• Document integrated process in SOPs

• SOPs need to be completed before project is completed

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• Update the systems to utilize the UDI GTIN (DI)

• Map product attributes from source to GUDID

• Identify GUDID process & owner

• Validate automated GUDID transfer process

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• Determine sharing strategy–GDSN?

• Integrate ECR process with data update process

• Integrate data sharing with GUDID update process

• Global and Local Approach

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Leveraging Your Investment - Supply Chain Visibility using GS1 Standards

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Critical Tracking Events

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Critical Tracking Events

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CRITICAL TRACKING EVENT DEFINITIONS

TRANSFORMATION-TYPE EVENTS are those events that typically support internal traceability within the four walls of a supply chain company.

TRANSFORMATION INPUT (T1) EVENT: The event where one or more materials are used to produce a traceable product that enters the supply chain.(NOTE: Materials used to produce products for immediate consumption by consumers are reported as Consumption events)

TRANSFORMATION OUTPUT (T2) EVENT: The event where a traceable product is packaged and labeled for entry into the supply chain.

TRANSPORTATION-TYPE EVENTS are those events that typically support external traceability between supply chain companies.

SHIPPING (S) EVENT: The event where traceable product is dispatched from a defined location to another defined location.

RECEIVING (R) EVENT: The event where traceable product is received at a defined location from another defined location.

DEPLETION-TYPE EVENTS are those events that capture how traceable product is removed from the supply chain.

CONSUMPTION (C) EVENT: The event where a traceable product becomes available to consumers.

DISPOSAL (D) EVENT: The event where a traceable product is destroyed or discarded or otherwise handled in a manner that the product can no longer be used as a food ingredient or become available to consumers.


Key Data Elements

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Shipping Receiving Input Output Consumption Disposal

Event Type R R R R R R

Event Owner R R R R R R

Date R R R R R R

Time R R R R R R

Event Location R R R R R R

Item ID Type R R R R R R

Item ID R R R R R R

Batch/Lot/Serial# BP* BP R R BP BP

Quantity R R R R R R

Unit of Measure R R R R R R

Batch/Lot Relevant Date C^ C C C^ BP BP

Activity Type C C R R

Activity ID C C R R

Supplier Identity C C C C

Trading Partner Location R R

R = Required Data

BP = Best practice is to capture the batch/lot number for transport and depletion events whenever possible;

however, if not feasible, Batch/Lot Relevant date or Activity ID must be provided.

* Batch/lot/serial numbers should be reported by Suppliers for Shipping events.

Transport Transformation DepletionKey Data Element

C = Conditional Data; The need for this data would be determined by business circumstances;

^ Relevant Date should be reported by Suppliers for Shipping Events and for Transformation Output events.


GS1-128 barcode information for Visibility

• When using a GS1-128 barcode, Application Identifiers (AI’s) are

encoded for scanning purposes. AI’s are flags that precede each piece

of data in a barcode to identify its meaning and format.

• GS1-128 provides the ability to string together additional fields of

information:

− (01) precedes a GTIN ( 00614141987658 )

− (11) precedes Production Date (YYMMDD) (120715)

− (10) precedes Batch/Lot Number ( ABC123 )

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How do we Share this data?

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Visibility Data Content

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Visibility data consists of events,

each of which records something

that happened in the real world

triggered by reading a barcode

or an RFID tag.

An event has four dimensions:

- What: what physical objects were

involved (EPC)

- When: when the event took place

(timestamp)

- Where: where the event took place

(location identifier)

- Why: what business process step

was being carried out

Where and Why are what distinguish visibility data

useful to a business application from raw RFID

or Bar Code data


The “What” Dimension

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1732050807+

Company Code Product Code Lot/Batch or Serial Number

• Tells you:

- What product (GTIN / U.P.C.)

- What instance (lot/batch or serial number)


The “Where” Dimension

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• A location identifier that says

- Where the event took place; and/or

- Where things are following the event

• Understood by applications

- Master data synchronization important!

• Meaningful

- E.g., two rooms separated by a door, report which room,

not the location of the door

• Not necessarily the name of the reader

- E.g., for a bar code / RFID-enabled forklift, indicate into

which bin the load was dropped, not which forklift did it

• Location sensor, location tag, etc – not the reader

identity

Room 1 Room 2


The “Why” Dimension

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• Identify the business context of the visibility event:

- What business step was taking place at the time of the event

- What is true from a business perspective after the event

- Any associated business transactions

• Purchase Order, Invoice, BOL, etc

Ski #23Tue 10:05Rent Shop

CheckoutRented

Ski #23Tue 10:15Base Rack

Observe

Ski #23Tue 10:20

Lift #1

Observe

Ski #23Tue 10:23Summit #1

Observe


CheckinAvailable

Ski #23Tue 13:08

Repair

BeginRepair


DoneRepair

Ski #23Tue 13:06Base Rack

Observe


Problem


CheckoutRented

RentalContract#1235

John Doe

RentalContract#1325

Jane Roe


Visibility in the Supply Chain

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Pack Line

Ship Door

Ship Door

Rcv Door

Interior Door

Trash Compactor

R1 R2 R3 R4 R5

R6

R7

DC1 - Mfr DC2 - Retailer

Store1

Rcv Door Back Front

Promotion / NPI

Tracking

Supply Routes Analysis

Real-time Inventory Correction

EPCIS Visibility Data

Product Recall

Execution

Demand Planning Response


Visibility Architecture

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EPCIS Visibility Data

Business Applications

Data Capture Infrastructure

R

R

R

R

Single Most Important

Design Decision:

This Interface

Key “hinge” between

different worlds

Enterprise Software

Factory Automation

Overall Business Process

Single Material Handling

Step

IT/LOB

Operations/ Labor


Example – Forward Deployed Inventory

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Implant #1Tue 10:05

Mfg. Plant 1

GoodsReceipt

Implant #1Tue 1:05

Mfg. Plant 1

Shipment

Implant #1Tue 4:30DC #1

GoodsReceipt

Implant #1Wed 12:10ReplenishStore #2Goods

Receipt

Tray #10Thur 12:05Replenish Store #2

Aggregate

Implant #1Wed 8:30

DC #1

Shipment

Tray #10Thur 3:00ReplenishStore #2

Shipment

Tray #10Sat 9:00Hospital#1234

Shipment

Tray #10Fri 9:15Hospital#1234Goods

Receipt

Tray #10Tue 1:05Hospital #1234Goods

Receipt

Implant #1Fri 3:30Hospital#1234

Consumption


Scenario – Leveraging the Data

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Implant #1Tue 10:05Mfg. Plant

GoodsReceipt

Implant #1Tue 1:05

Mfg. Plant

Shipment

Implant #1Tue 4:30DC #1

GoodsReceipt

Implant #1Wed 1:05ReplenishStore #2

GoodsReceipt


Aggregate

Implant #1Wed 8:30

DC #1

Shipment


Shipment

Tray #10Sat 9:00Hospital#12345

Shipment

Tray #10Fri 9:15Hospital#12345GoodsReceipt

Tray #10Tue 1:05Hospital#12345GoodsReceipt

Implant #1Fri 3:30Hospital#12345

Consumption

Inventory Management

Supply Consignment Management

Accounts Payable


Data Sharing with Known Trading Partners

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Supplier Retailer

Factory Distribution Ctr Distribution Ctr

Retail Stores

EPCIS Database

EPCIS Database

1. Visibility data

collected during

tagging and shipping2. Visibility data

collected as product

moves3. Retailer data shared

with supplier via

retailer’s network

4. Combined data used

to gain business benefits


Focus on Data Interfaces –Maximum Flexibility

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Visibility-Driven Business Applications

Visibility Data Hub

Visibility Data Capture (1 or more sites)

Visibility Data

Definitions (matrix)

Govern

ance

Master Data

Configuration

http://www.prlog.org/10135910-uhf-rfid-reader.jpg





Macy’s Inc. - Driving Inventory Accuracy & Omni-Channel Fulfillment

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Macy’s, Inc. is one of the nation’s premier omni-channel retailers. As of February 23, 2016, the company operates about 870 stores in 45 states, the District of Columbia, Guam and Puerto Rico. Macy’s, Inc.’s diverse workforce includes approximately 166,900 employees.

macysinc.com

Situation Approach

In late 2011, Macy’s embarked on a 3-year omni-channel excellence journey. Looking to increase color/size inventory visibility and to drive sales in their high replenishment categories, They began using EPC-enabled RFID technology to execute more frequent cycle counts and improve sampling compliance in women’s and men’s shoes.

GS1 Standards support:• GS1 EPC Radio-Frequency Identity Generation-

2 UHF RFID Protocol (GS1 SGTIN-96 coding schema for these tags)

• GS1 US Apparel and General Merchandise Initiative membership

• Workgroup participants - Macy’s has collaborated with industry trading partners in developing industry best practices and driving industry adoption.

Since 2011, their adoption of RFID has evolved from a transformational technology to a foundational requirement for inventory optimization and has grown to all 800+ Macy’s and Bloomingdale’s stores.

They expanded RFID use from replenishment to fashion areas and saw their sales volumes increase more than 200%. In 2014, they completed their single view of inventory system upgrades. Macy’s now has one “view” of inventory— accurate inventory through RFID—with a focus on optimizing in-stock inventory to satisfy customer demand.

Converting to a single view inventory was enabled by leveraging many GS1 Standards including, but not limited to: GTIN, SSCC-18, EDI, and EPC/RFID.

Results & Benefits

3-Yr Results:• Inventory optimization in their omni-channel fulfillment processes (freeing up the last one (GTIN) for

sale … instead of working with thresholds and minimum units/location before making it available for sale via their e-com channel)

• Sustaining a 95% item accuracy at the size/color level (improved from 75%)• Selling floor shoe sample compliance growth (from 70% style representation to 95%+)• Sales trends increases in RFID tagged product categories (increasing in the high single digits to low

double digits vs the non-RFID comparable control groups)Benefits ~ Previously, store and online assortments were bought and marketed by separate organizations at Macy’s and at Bloomingdale’s. These changes enable Macy’s to:• Continue to support organizational growth & the enhanced unified shopping experience• Have an accurate inventory file to drive customer demand & better business decisions • Increase sales & customer satisfaction through improved in-store availability and enhanced omni-

channel fulfillment (e.g., buy online and ship from / pick up in store).


Macy’s Inc. - Driving Inventory Accuracy & Omni-Channel Fulfillment

• Their RFID-enabled departments outperformed controls by 10%

(between Sept. 2013 and May 2014) and their display rates

improved from 70% to 95%. 1

• Further, demonstrating that RFID enables better “last-item” visibility

and the ability to sell that item at the higher full margin price point,

Macy’s CEO, Terry Lundgren reported that their “buy online/pick-up

in-store results totaled 125% of intended order.” 2

1. Retail Touch Points Webinar, Sept 16, 2014, “Omni-channel Leaders Reaffirm The Value Of RFID”

2. Marketing Daily, Sept 3, 2014, “Macy's Focused On Mobile, Gen Y, Private Label”

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Wrap Up

• Determine what “challenges” visibility can solve in your

organization

- Inventory Utilization?

- Supply Management – shortages?

• Validate process flows are really what is happening

• Do a risk analysis of the events in the process flow to

determine when to capture the data and how long to

maintain it

• Are all systems enabled for the process?

• Apply learnings to other parts of your business

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Supply Chain Visibility Workshop

• The below link takes you to a GS1 US website dedicated to supply

chain visibility. Additional information and workshops are available

to support an organization who wants to pursue this further.

- https://www.gs1us.org/about-gs1-us/events/supply-chain-

visibility

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https://www.gs1us.org/about-gs1-us/events/supply-chain-visibility


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www.gs1us.org

GS1 US Corporate Headquarters

Princeton Pike Corporate Center

1009 Lenox Drive, Suite 202

Lawrenceville, NJ 08648 USA

Contact Information

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Greg Bylo

VP Healthcare

Office (609) 620-8073, Cell (609) 216-4346

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