Successful Implementation of GS1 Standards: Step-by-Step Approach

Successful Implementation of
GS1 Standards
Step-by-Step Approach
Salil Joshi,
Senior Director – Industry Development
GS1 US
October 19, 2016
Benefits of Standards
KEY BENEFITS
• Improving patient safety
• Lowering costs through increased efficiency
• Reducing medication errors
• Enabling supply chain visibility
• Facilitating effective product recalls
• Tracking of pharmaceutical products/medical devices
• Reducing introduction of counterfeit products
• Enhancing inventory management
• Linking critical product data to the patient record
• Supporting regulatory compliance
• Optimizing order, invoice, sales reporting, and chargeback/rebate
processes
© 2016 GS1 US All Rights Reserved 15

GS1 Standards in Healthcare

We envision a world where…
The supply chain delivers:

• the right product
• to the right place
• at the right time
Healthcare professionals spend their time providing care:
• to the right patient
• administering the right dose
• through the right route
Focus is on reducing error from the process with automation and the use of
standard, unique identifiers.
Regulatory efforts since the 1999 Institute of Medicine report

To Error is Human focused on marking products to enable automation and
further visibility to protect patients in the event of a product recall.
Regulations Driving Change

When Will We See Usage Increase?
“When should a Hospital Provider flus

h
DSCSA 2023
t o ry
begin preparing to meet upcoming Inv
en
CMS –
sI
regulations?” las
h DIC Reimbursement
y flus ar U
2021
o r sB
n vent ce ha
I I Dev i
sI DSCSA
Clas Med es Meaningful Use Stage 2 -
I f d 2019
UD rity o Co 2015 – 2017
jo ONC
Ma
2018 & UDI
h Class I Meaningful Use Stage -
lus 2018 & beyond
o ryf
t DSCSA
en
I Inv 2017
s II UDI Class II
las
IC 09/24/2016
UD
Today
“Backward
UDI Class III scheduling would
2014 suggest need to
start in late 2016 -
early 2017
Usage of standards assuming 12 to 18
increases
month timeline”
Build the foundation
for interoperability and
adoption
2016 - 2017

Regulations Driving Change
The FDA Unique Device Identification (UDI) Rule and Drug Supply
Chain Security Act (DSCSA) are being implemented
 Packaging Changes for Products

 Serialization Requirements for drugs
 Track and Trace Initiative in Rx
 EHR Regulation – Meaningful Use and EHR Certification Proposed
Rules from ONC

FDA Unique Device Identification (UDI)
• Label devices with AIDC (barcode)
MARK UDI=Device Identifier(DI)+Production Identifier(PI)

•
• UDI=GTIN in GS1 Standards
• Label plain-text ISO format date YYYY-MM-DD
• Publish UDI plus required data attributes to the Global
SUBMIT UDI Data Base (GUDID)

• GDSN is one mechanism to publish that data once to both
the FDA and customers
• Year 1 (2014):Class III and devices under PHS Act

• Year 2 (2015):Class II/I implants and life-
supporting/sustaining
COMPLY • Year 3 (2016):Remainder of Class II
• Year 5 (2018):Class I
• For Direct Marking - Compliance dates are extended by 2 years
except for FDASIA implants and life-supporting/sustaining
UDI Final Rule Posted to Federal Register Sept 24, 2013

GS1 US website: www.gs1us.org/hcudi FDA UDI Website: www.fda.gov/gov and click on “UDI Help Desk”

US FDA UDI General Rule
• The label* of EVERY medical device (including all IVDs) must have a
UDI.
• EVERY device package (contains a fixed quantity of a version or

model) must have a UDI.
• Any other approach is an exception to or

alternative from these requirements.
* Section 201(k) defines 'label' as a display of written,
printed, or graphic matter upon the immediate container of
any article...

GS1 US and UDI
GS1 has been accredited by the FDA as an Issuing Agency for the
assignment of UDIs in the context of the U.S. FDA Unique Device
Identification System, and GS1 US serves as the first point of contact for
the FDA.
As of February 2016, about 90% of the

products in GUDID have been assigned GTINs.
Global Unique Device Identifier
Database (GUDID) Website
• Operated by the FDA to collect information on Medical
Devices

GUDID
• Global Device Identifier Database (GUDID)

Operated by the FDA to collect information on Medical Devices
Public facing website to share data with anyone (
https://accessgudid.nlm.nih.gov)
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)
• Class II “life sustaining” devices- 2 years from final rule publication (September 24,
2015)
• 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)

GUDID Loading
• Data loading responsibility lies with the “Labeler”

FDA defines the “Labeler” as the entity responsible for the contents
of the label
In GS1 speak, this is the Brand Owner
• Data is loaded for the Device Identifier (DI) Only

UDI is a Device Identifier (DI) and Production Identifier (PI)
Only the DI is used in the GUDID
• Data provided is master data and is used for public consumption,

however there are some elements which are for FDA only

UDI Components
Device Identifier (DI) + Production Identifiers (PI)
UDI = GTIN + Application Identifiers (AI)
•GTIN – Global Trade Item Number

•Serial Number
•Lot
Number
•Expiry Date

How is UDI documented?
The product is scanned, the data is sent to the EHR, which parses the data
to the respective data fields

Benefits of UDI
• Helps providers identify patients implanted with recalled products using a

standardized identifier
• Enables patients and providers to submit more precise adverse event
reports
• Supports care coordination by providing physicians with precise
information on the devices implanted in patients
• Allows hospitals to perform analyses comparing devices used in that
facility
• Allows providers to submit information to device registries
• Provides a foundation to address counterfeiting of products
Source:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/Benefits
ofaUDIsystem/default.htm

Provider Steps for UDI Implementation
• Step 1: Establish Executive Support

• Step 2: Form a UDI Implementation Team (Clinical,
Supply Chain, IT)
• Step 3: Develop Project Communication
Internal and External with suppliers
• Step 4: Assess Information Systems (ERP and EHR)
• Step 5: Identify/Obtain UDI Product Data
Select source (GDSN, GUDID, GPO, Supplier)
• Step 6: Engage Suppliers for Pilot & Testing
• Step 7: Conduct Transactional Testing
• Step 8: Create Standard Operating Procedures

Successful Implementation of
GS1 Standards
What Does It Mean for
St. Joseph Health?
St. Joseph Health
ABOUT US
• Not-For-Profit Integrated Catholic Health
Care Delivery System based in Irvine,
California
• Founded by the Sisters of St. Joseph of
Orange
• First Hospital established in 1920 in Eureka,
California
• Health System established in 1982
St. Joseph Health
• Three Geographic Regions: Northern
California, Southern California and
Texas/Eastern New Mexico
• Total Revenue of $5.6 Billion
• 16 hospitals, as well as home health
agencies, hospice care, outpatient services,
skilled nursing facilities and physician
organizations
• Nearly 24,000 employees and more than
1,500 affiliated physicians
• Supply Chain spend is $850+ million
• Centralized Purchasing/AP
St. Joseph Health
Our Mission
To extend the healing ministry of Jesus in the tradition
of the Sisters of St. Joseph of Orange by continually
improving the health and quality of life of people in the
communities we serve
Our Vision
To bring people together to provide compassionate care,
promote health improvement and create healthy
communities
Why GS1
Standards Adoption?
Benefits of GS1 Standards
• Item Master standardization
• Analytics
• Patient Safety
• EMR
• Electronic transactions (EDI)
• Reform and Regulations
GS1 Healthcare House
What was our GS1 Standards
implementation process?
Engaging GS1US
In Jan. 2016, SJH asked GS1US to include us in a
GS1 implementation plan, including:
– Documenting the process of implementation

– Tracking ROI
Outside Consumtant
Outside consulting firm assisted us with implementing GS1 Standards
more quickly and seamlessly, so we can better support efficient and
safe patient care.
They assisted us in preparing for our GS1 Standards implementation

through:
– Cleaning up GLNs
– Boarding GLN with GHX
– Transacting using both GLN and GTIN
– Documenting Step by step business process form maintaining
GS1 Standards after go live.
GLN Clean-Up
SJH began the clean-up of our Global Location
Number (GLN) and boarding process with GHX:
• Clean-up of “ship-to” locations within PMM
• Request new GLN when needed
– Currently we must go through GPO, but we are working on
bringing our GLN maintenance in-house
GLN & GTIN Testing
• In May 2016, SJH began testing the Global

Location Number (GLN) and Global Trade Item
Number (GTIN) transaction with vendors Cook
Medical and Abbott
• By the end of May, we had our first complete
transaction (850, 855, 810)
What are the next steps?
Next Steps
1. Load GLN into PMM for all “ship-to” locations (not

including VL at this time) so that we can begin using
GLN to transact with both Cook Medical and Abbott
2. Load GTIN into PMM
3. Requesting GTIN information with new contract
price files
4. Identify data pool company
5. Begin testing process with Johnson & Johnson
6. Track progress
Communications
• Communication/education with Ministry Supply
Chain Directors
• Communication explaining GS1 Standards in The
Huddle for System Office and Ministries
• Management Minute article
• Communications to Exec Leadership, as needed,
including Momentum Newsletter & Chatter
• Conference Presentation
• White Paper
Glossary
• GLN - Global Location Number
• GTIN - Global Trade Item Number
• GDSN - Global Data Synchronization Network
• UDI - Unique Device Identification
• GUDID - Global UDI Database
Questions?
Drug Supply Chain Security Act (DSCSA)
Traceability in the Drug Quality and Security Act (DQSA)
JAN 2015 NOV 2017 NOV 2023

Transaction
• Transaction • Identifier- Information
• Capture Item
• Product Name
Statement* Package and Level • Strength,
Homogenous Traceability Dosage Form
• Capture Lot Case • NDC
Level • Container Size
Traceability • Mark Product • Sunset Lot Level • Number of
and ID as SNI with Traceability Containers
Verification of Lot # and • Lot #
Suspect or Expiry Date in a • Date of
Illegitimate 2D Data Matrix Transaction,
Product Barcode Date of
shipment if
• By July 2015 • Distribute by applies
• Business
for dispensers NOV 2019
Names of
Transacting
Parties
• Dispense by
NOV 2020
*Refer to the Rule for data storage requirements, exceptions (direct purchase, drop ship, returns, 3rd party solutions, 3PLs, repackagers,
effect on State laws)
FDA Draft Guidance will outline standards for Transaction Statement Information and History
SNI= Standardized Numerical Identifier – will require sunset of the 2004 FDA Bar Code Rule
DQSA (H.R 3204) November 27, 2013
http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/

GS1 Standards in Healthcare
GS1 Standards for identifying, capturing, and sharing

information— about products, business locations, and more —
make it possible for companies to speak the same language,
connect with each other, and move their business forward.

GS1 System of Standards

What Is The GS1 System?
• GLN Global Location Number – Location Identification
• GTIN Global Trade Item Number – Product Identification
• GDSN Global Data Synchronization Network – Data Sharing and

Attribute Accuracy

IDENTIFY: GS1 Identifiers
GS1 Standards begin with GS1 Identification Numbers

used to uniquely distinguish all products (trade items),
logistic units, locations, assets, and relationships across
the supply chain from manufacturer to consumer.

CAPTURE: GS1 Data Carriers
GS1 Data Carriers

are capable of
holding varying
amounts of data to
accommodate
different needs for
different products.
The appearance of the EPCglobal®

Seal is to inform that an EPC-Enabled
RFID tag is present on or within the
packaging of the product(s).

SHARE: GS1 Data Exchange
Interoperability, made possible by identification standards, data

capture standards, and data exchange standards, allows product
information to flow through the supply chain.

United Nations Standard Products &
Services Code® (UNSPSC®)
• An open, global, multi-industry standard used to classify products
and services
Provides a structure or framework for product classification

Provides a way to categorize products and services to help users
organize products for catalogs, databases and listings
• Owned by: United Nations Development Program (UNDP)

Managed by GS1 US since May 2003
• Designed to facilitate electronic commerce

• Help streamline the procurement process
• Help analyze spending
• Help customers find products
Global Location Number (GLN)

Location Identification in Healthcare
Too many identifiers for the same healthcare location = Confusion & inefficiency
• SAINT JOHN'S QUEENS HOSPITAL

1100004570208
• ST JOHN'S QUEENS HOSPITAL

100084547
• SAINT JOHNS QUEENS HOSPITAL

JAOE
• SAINT JOHN'S QUEEN HOSPITAL

50003000431
Many different names and
• SAINT JOHN'S QUEEN’S HOSPITAL location numbers for same
CA2053 hospital location
• ST. JOHN'S QUEENS HOSPITAL
OM 12345

Global Location Number Overview
• The use of standardized location identification not only ensures that

the right product arrives at the right place at the right time, it also
enables more efficient business practices and helps to drive down
supply chain costs
• Basically the GLN points to a number in a database that references

the following criteria:
Who, What and Where
Who controls the GLN; What qualifies or states the context of the
relationship of the related data; and Where is the physical address

What is a Global Location Number
(GLN)?
A globally unique 13-digit number that identifies:
• Legal entities (whole companies, health systems, divisions)
• Functional entities or specific department within a legal entity

(Pharmacy, receiving department, accounts payable)
• Physical locations (Clinics, units, warehouses, loading docks,

room/shelf locations)

GLN Hierarchies – Getting Started
• Organizations can assign GLN’s to various supply chain locations in

their organization to facilitate precise location identification in a
business
• Questions to consider
Who is the buying organization?
Where will the products be shipped/received?
Who will receive the invoice?
Who is the selling organization?
Where are the payments sent?

Provider GLN Assignment
• Assign a GLN to the main entity (DONE)

Check with GLN Registry to see if a GLN has been assigned to this
level
• Assign a number to each specific location within the company

(depending on your need) (DONE)
Requires a GS1 Company Prefix
Do NOT build intelligence into the number
• Use the GLN registry to communicate GLNs and structure to suppliers

Provider to set up Vendors
• Vendors (Manufacturers/Distributors) should be enumerated with

GLNs for use in
• Ordering
• Invoicing
• Payments
• Providers need to store these numbers in their Vendor Master files
• Communicate hospital GLN hierarchy and numbers to vendors

GLN Hierarchy

GLN Hierarchy

GLN Structure Example
Note: Use the Check Digit Calculator on the GS1 US website

http://www.gs1us.org/resources/tools/check-digit-calculator

How are GLNs USED?
A GLN may be encoded within a barcode for specific business

applications and placed on shipping labels (help users to ensure that each GLN is
specific to one unique location within the world instead of phone numbers, store
numbers, DUNS+4):
• “Ship to – deliver to” locations

• “Bill to – invoice to” locations
• “Purchased from” locations
• Shelf locations
GLNs are used in eCommerce

• EDI and XML
GLNs are required for Global Data Synchronization

• Identifies parties and locations in order to match records from a data pool

GLN Benefits for Providers
• Simplifies location identification with a single identifier used across all

supply chain partners
• Enables providers to define and manage their own account and

location information to ensure accuracy
• Provides an accurate view of the organization as a customer to

ensure correct contract pricing eligibility and to streamline rebate
processing
• Reduces mis-shipments and time spent resolving order and invoice

errors
• Provides the foundation for traceability to improve product recall

processes

Next Steps for GLN Implementation
• Register for GLN Registry Training
• Take ownership of your GLN Registry Records

Contact your GPO or GS1 US for your GLN hierarchy
• Review and Update your GLN Registry Records
• Synchronize GLNs with Trading Partners
• Conduct Pilot Project and Test GLNs in Transactions
• Repeat with next supplier
• Ongoing Maintenance

Global Trade Item Number (GTIN)

Issue #1 - Problem with Item Identification
Manufacturer Product # Distributor Product # Hospital Product #
383520 0723383520 1114985
(GTIN = 00382903835201)
Artwork Courtesy of GS1 and BD

Issue #2: Catalog Numbers Not Unique
Cat # BD Product Other Supplier

382268 382268 - 14 G x 3.25 in. BD
Angiocath™ peripheral venous
Dentsply 03-822-68 SS GLD 018X022
14IN PKG 10
catheter (2.1 mm x 83 mm) made of
FEP polymer. (10/sp, 50/ca)
381705 381705 - 18 G x 1.16 in. BD

Angiocath™ Autoguard™ shielded IV
Mallinckrodt 3817-05 CHEMICAL DRY
SODIUM PHOSPHATE DIBASIC
catheter (1.3 mm x 30 mm) made of
FEP polymer. (50/sp, 200/ca)
371073 371073 - BD E-Z Scrub™ surgical

scrub brush impregnated with 4%
Codman 371073 DEBAKEY BULLDOG
CLAMP RING HANDLE ANGLED 90?
CHG. Color coded red. (30/sp, 300/ca) STRAIGHT SHAFT 41MM JAW 4 3/4''
(120MM)
305905 305905 - 3 mL BD SafetyGlide™

syringe with 23 G x 1 in. shielding
CARL ZEISS 305905 FLOORSTAND S-1
COMPLETE, W/ARTICULATED ARM
intramuscular injection needle, SYSTEM FOR OPMI & ACCESS 2.5-7
regular bevel, regular wall. Detachable KG.
needle. (50/sp, 400/ca)

Issue #3: Trading Partner Numbers
(329461 - 1/2 mL BD Lo-Dose™ U-100 Insulin Syringe)
Business Name Item Number Type Item Number

BD Mfg Catalog Number 329461
BD GTIN 00382903294619
BD GTIN 30382903294610
BD GTIN 50382903294614
CARDINAL HEALTH PV Order Number BF329461
OWENS & MINOR PV Order Number 0722329461
OWENS & MINOR PV Order Number 0723329461
AMERICAN MEDICAL DEPOT Vendor Catalog Number 777127217
AMERICAN MEDICAL DEPOT Vendor Catalog Number 777127218
GOVERNMENT SCI SOURCE Vendor Catalog Number FSC1482679CS
GOVERNMENT SCI SOURCE Vendor Catalog Number FSC1482679PK
ALLIANCE JOINT VENTURE Vendor Catalog Number 888021932
THOMAS SCIENTIFIC Vendor Catalog Number 8938M25
THOMAS SCIENTIFIC Vendor Catalog Number 8938M28
VWR INTERNATIONAL Vendor Catalog Number BD329461

Solution – Global Trade Item Number
• A unique 8, 12, 13, or 14-digit number

identifies products and services of the GS1 System, as an
unambiguous global standard for collaborative commerce
• A 14-digit GTIN can be encoded as

a GS1-128 / GS1 DataMatrix / GS1 DataBar / EPC/RFID
GS1-128 (14-digit GTIN) DataMatrix (14-digit GTIN) Databar (14-digit GTIN)
EPC/RFID

GTIN Introduction
The Global Trade Item Number (GTIN) is an identification key in the

GS1 System of Standards. The GTIN is used for uniquely identifying
trade items, which includes both products and services that are
priced, ordered, and invoiced at any point in the supply chain
worldwide.
GTINs are placed on trade items as barcodes:

• GTIN = A pointer that identifies product characteristics
• Always numeric and to be stored as text
• Barcode = Symbology that carries the GTIN
• A non-intelligent number
• Allocated according to the GTIN ALLOCATION
RULES

GTIN for Each Packaging Level

Application Identifier Overview
Application Identifiers (AI) are:

• A two, three, or four digit numeric code that precedes each data element in a barcode
• Always shown in parentheses within the HRI (Human Readable Interpretation) and is
not part of the barcode’s encoded data
• Tell the application “what to expect next”
o For example, the AI for GTIN is 01 which means that when the GTIN is scanned,
the system understands that the next 14 digits comprise a GTIN
GTIN (Global Trade Item Number) Expiry Date Lot Number Serial Number

Application Identifiers provide the ability to string together multiple

fields of information to help solve a variety of business
challenges. The AIs are a finite set of specialized identifiers
encoded within barcodes like a “flag” that define:
• The nature of the data: what is it?
• The length of the data: how many digits/characters, or variable
to what length?
• The format of the data: numeric/alpha-numeric, particular
sequence (e.g., YYMMDD)
GS1 GTIN Batch/Lot Number

The most common AIs include those required in the

FDA DSCSA and UDI Rule:
(01) GTIN
(17) Expiration Date
(10) Batch or Lot Number
(21) Serial Number
GS1 AI GS1 AI GS1 AI for GS1 AI for

for for Expiry Batch/Lot Serial
GTIN Date Number Number

Implementing Standards – Provider
Systems
GDSN
Communicate/share your GLNs & Obtain trading partner GLNs &

Obtain GTINs & Product Location Master Data from the
Location Master Data with trading GLN Registry
Master Data from GLN Registry and store in Trading
partners using the GLN Registry
suppliers using GDSN Partner Master Database
Add a field for GTIN in

the Product Master
Add a field for
Database in your MMIS
GLN to
MMIS Location Trading
MMIS Product Master Partner MMIS Trading
Assign GLNs to locations Master Database EDI Interface
Database & define location data Master Partner Database
(GLNs & Location Database (GLNs & Location •Purchase Order
(GTINs & Product Master Data) Master Data) •Invoice
Master Data) Store GLNs & Location
Master Data in Location
Master Database and the
GLN Registry
EHR sends message with product GTIN to the EHR sends message with product GTIN to
Inventory System to update quantity on hand Claims/Billing System to add product to patient
bill and prepare claim
EHR
Inventory Management System
Enters product
Adds products to the
GTIN (& any
Inventory Management
additional data)
System using product
into EHR
GTIN
Products are delivered with barcodes Product barcodes are scanned Product barcodes are
for receiving and distribution scanned at POC
encoding GTINs & additional data

GTIN – BD example
00382903065073 = Each Level GTIN

30382903065074 = Shelf Pack GTIN
50382903065078 = Case GTIN

GTIN Implementation Steps from Use
Cases
• Step 1: Establish Executive Support
• Step 2: Form a GTIN Implementation Team
• Step 3: Develop Project Communication
Internal and External with suppliers
• Step 4: Assess Information Systems (ERP)
• Step 5: Identify/Obtain GTINs
Select source (GDSN, GUDID, GPO, Supplier)
• Step 6: Engage Suppliers for Pilot & Testing
• Step 7: Conduct Transactional Testing
• Step 8: Create Standard Operating Procedures
REPEAT ABOVE STEPS FOR NEXT SUPPLIER

Global Data Synchronization Network (GDSN)

Data Flow via 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.
Select one data pool as a SINGLE
point of entry to the GDSN
Step 1 : Load Data

Step 2 : Register Data
Step 3 : Subscription Request
Step 4 : Publish Data
Step 5 : Recipient Confirmation

GS1 Workgroups and Support
• Support supply chain standardization through adoption of

GS1 data standards
• Provide GS1 Standards support in your implementations
• Collaborate with stakeholders in our community and

connect the many colleagues standardizing and utilizing
AIDC solutions

Workgroup Activity at GS1 US
Medical Devices Community Group Calls

• Price Accuracy Initiative
• GTINs in Practice
(Beth Gibson bgibson@gs1us.org)
Held every two weeks

To join and receive meeting invitations, log into the GS1 Healthcare US Community room at
http://community.gs1us.org/apps/org/workgroup/transactions_action/
Healthcare Provider Advisory Group

(Salil Joshi sjoshi@gs1us.org)
Held monthly
To join and receive meeting invitations, log into the GS1 Healthcare US Community room at
http://community.gs1us.org/apps/org/workgroup/gs1stds_patcare/
Pharmaceutical Secure Supply Chain Group Call

(Peter Sturtevant PSturtevant@gs1us.org)
Held every other week
To join, just log into the GS1 Healthcare US Community room at
http://community.gs1us.org/apps/org/workgroup/rx_securesc/

Next Steps
• Engage with your suppliers
• Contact your IT vendors (ERP, Clinical, EHR) and

check functionality available in systems
• Develop Pilot Initiatives and Start Implementation
Any Questions Please Feel Free To Contact me at:

Salil Joshi
sjoshi@gs1us.org
609-620-4522

Questions

Contact Information
Salil Joshi
Senior Director, Industry Engagement – Hospital Providers
GS1 US Corporate Headquarters

Princeton Pike Corporate Center
1009 Lenox Drive, Suite 202
Lawrenceville, NJ 08648 USA
T 609.620.4522
E sjoshi@gs1us.org
www.gs1us.org

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Successful Implementation of

© 2016 GS1 US All Rights Reserved 15

© 2016 GS1 US All Rights Reserved 16

The supply chain delivers:

Regulatory efforts since the 1999 Institute of Medicine report

© 2016 GS1 US All Rights Reserved 18

“When should a Hospital Provider flus

© 2016 GS1 US All Rights Reserved 19

 Packaging Changes for Products

© 2016 GS1 US All Rights Reserved 20

• Label devices with AIDC (barcode)

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

• Publish UDI plus required data attributes to the Global

SUBMIT UDI Data Base (GUDID)

• Year 1 (2014):Class III and devices under PHS Act

UDI Final Rule Posted to Federal Register Sept 24, 2013

© 2016 GS1 US All Rights Reserved 21

• EVERY device package (contains a fixed quantity of a version or

• Any other approach is an exception to or

© 2016 GS1 US All Rights Reserved 22

As of February 2016, about 90% of the

© 2016 GS1 US All Rights Reserved 24

• Global Device Identifier Database (GUDID)

© 2016 GS1 US All Rights Reserved 25

• Data loading responsibility lies with the “Labeler”

• Data is loaded for the Device Identifier (DI) Only

• Data provided is master data and is used for public consumption,

© 2016 GS1 US All Rights Reserved 26

Device Identifier (DI) + Production Identifiers (PI)

UDI = GTIN + Application Identifiers (AI)

•GTIN – Global Trade Item Number

© 2016 GS1 US All Rights Reserved 27

© 2016 GS1 US All Rights Reserved 28

• Helps providers identify patients implanted with recalled products using a

© 2016 GS1 US All Rights Reserved 29

• Step 1: Establish Executive Support

© 2016 GS1 US All Rights Reserved 30

– Documenting the process of implementation

They assisted us in preparing for our GS1 Standards implementation

• In May 2016, SJH began testing the Global

1. Load GLN into PMM for all “ship-to” locations (not

JAN 2015 NOV 2017 NOV 2023

© 2016 GS1 US All Rights Reserved 48

GS1 Standards for identifying, capturing, and sharing

© 2016 GS1 US All Rights Reserved 49

© 2016 GS1 US All Rights Reserved 50

• GLN Global Location Number – Location Identification

• GTIN Global Trade Item Number – Product Identification

• GDSN Global Data Synchronization Network – Data Sharing and

© 2016 GS1 US All Rights Reserved 51

GS1 Standards begin with GS1 Identification Numbers

© 2016 GS1 US All Rights Reserved 52

GS1 Data Carriers

The appearance of the EPCglobal®

© 2016 GS1 US All Rights Reserved 53

Interoperability, made possible by identification standards, data

© 2016 GS1 US All Rights Reserved 54

­ Provides a structure or framework for product classification

• Owned by: United Nations Development Program (UNDP)

• Designed to facilitate electronic commerce

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• SAINT JOHN'S QUEENS HOSPITAL

• ST JOHN'S QUEENS HOSPITAL

Provides a structure or framework for product classification

Who, What and Where