Tips for Implementing

FDA UDI without Derailing

Production

Agenda

Welcome and Introductions

Gain an understanding of UDI in practical terms

Evaluate the benefits of implementing bar-coding using GS1

standards

Understand how labeling systems can remove the perceived

complexities of FDA UDI regulations

View the planned timeline for proposed FDA UDI regulations

Learn how to implement UDI with minimal impact on your

organization

Presenters• Jay Crowley, FDA

• Janice Kite, GS1 Global Office

• Chris Miller, PRISYM ID

PRISYM ID

Experienced

Experts in

21 CFR

Part 11

GAMP VGlobal

Customers

Printing

TechnologiesIntegration

Our Clients

FDA

Device Information Lifecycle

Distributor

Direct Hospital

Clinical Use Unit

AE Reporting

Population Databases

Postmarket

Surveillance

Hoarding

Off-master

purchase

Rentals

Recall

ManufacturerSold

Sales Rep

GPOs Clinical

Substitution

Device X

Lot Y

Exp Date Z

Reuse

Reorder

Registries

Physician

preference

Comparative

Effectiveness

EHR

Reimbursement

FDA’s Sentinel System

FDA

The History of FDA’s UDI

• 1999 IOM Report – To Err is Human• 2004 FDA Barcode Rule• 2005 and 2006 FDA/FDLI Meeting on UDI • 2005 FDA Contracted White Papers on UDI• 2006 FDA Public Meeting• 2006 Docket No. FDA-2006N-0292• 2007 FDA Amendments Act of 2007• 2008 GHTF Ad-Hoc Working Group on UDI• 2009 FDA Workshop on UDI• 2009 Docket No. FDA-2008-N-0661• 2009 GHTF AHWG submits recommendations

FDA

Current Device Identification

• Non-standard device identification systems; standards

used in different ways

• Not necessary unique or unambiguous

• Does not include all necessary levels of uniqueness

• Manufacturers’ own number/catalogue number

• Distributors’ – apply different, proprietary number; lot

or serial number not captured

• Hospital – yet different identification number/code• Information on use not usually captured

• Control numbers rarely captured

FDA

Current Device IdentificationBusiness 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

FDA

Medical Device Adverse Events

For 2007, we received ~ +100k reports

• ~ 15% lacked model or catalogue number

• ~ 50% lacked lot or other identifier

• ~ 10% lacked both

The face of things to come…

(01)00802526255410(17)080531(10)6062151

FDA

Medical Device Recalls (2007)

• 41 Class I recalls

• 931 Class II recalls

• 78 Class III recalls

• Class I – 28M units (devices by lots, kits, etc)

Range 4-27M (Moistureplus Solution)

• For March 2007 – 142 Class II recalls

35M individual units (just one month)

Range 1-33M (Lifescan one touch test strips)

FDA

UDI Can Improve… Visibility

• Medical device recalls

• Adverse event reporting and postmarket surveillance

• Tracking and tracing, supply chain security; and anti-

counterfeiting/diversion (location systems)

• Comparative effectiveness (e.g., registries)

• Disaster/terror preparation and shortages/substitutions

• Reduce medical errors

• Documenting medical device use in patient’s

EHR/PHR, hospital information systems, claims data

• Sentinel Initiative - strengthening FDA’s ability to

query data systems for relevant device information

FDA

Medical Device Identification

Develop a system to identify medical devices, which is:

• Consistent

• Unambiguous (differentiates among all dimensions)

• Standardized

• Unique at all levels of packaging

• Harmonized internationally

And facilitates the:

• Storage,

• Exchange, and

• Integration of data and systems

FDA

UDI Public Workshop

12 February 09 - 300 people attended; 4000

webcast

4 Panels addressed issues related to:

• Developing standardized UDIs

• Placing the UDI in human readable and/or AutoID

on a device, its label, or both

• Creating and maintaining the UDI Database

• Promoting adoption and implementation

Received 60 written comments.

FDA

GHTF UDI ADWG

• Formed October 2008

• EC Chair (Laurent Selles)

• Members US (FDA, AdvaMed), Europe (EC,

Eucomed, EDMA, Matthias Neumann), Japan

(Hiroshi Ishikawa), Canada (Chris Rose)

• AHWP recently joined (China)

• Public Document – available at:

www.ghtf.org/documents/AHWG-PD1-N2R1.doc

• Final guidance due for Nov 2010 SC meeting

FDA

FDA Amendments Act of 2007

September 27, 2007, the FDAAA signed into law:

The Secretary shall promulgate regulations

establishing a unique device identification system

for medical devices requiring the label of devices

to bear a unique identifier, unless the Secretary

requires an alternative placement or provides an

exception for a particular device or type of device.

The unique identifier shall adequately identify the

device through distribution and use, and may

include information on the lot or serial number.

FDA

Establishing a UDI System

Combination of 4 distinct steps:

1. Develop a standardized system to develop the

unique device identifiers (UDI)

2. Place the UDI in human readable and/or AutoID on

a device, its label, or both

3. Create and maintain the UDI Database

4. Adoption and Implementation

FDA

1st – Developing the UDI

• Develop UDI code according to ISO 15459 [GS1,

HIBCC]

• Created and maintained by the manufacturer

• Concatenating Device and Production Identifier

• Device Identifier (DI): [static] Manufacturer, make,

model [i.e., each catalogue number]

• Production Identifier (PI): [dynamic] if currently

serialized – serial number; if currently identified at

the lot, the lot number, and expiration date

• Risk based approach – DI; DI + lot; DI + serial (or

lot and serial)

FDA

2nd – UDI Application

• Applied at all levels of packaging, down to the

lowest level (the patient use level or unit of use)

• Human readable and/or encoded in a form of

automatic identification technology

• Direct Part Marking (DPM) for some devices

• No specific technology would be identified

(technology neutral)

• Identify a series of standards (linear barcode, 2-

dimensional barcode, RFID)

FDA

UDI Application Example

FDA

3rd - UDI Database

Development

• Device Identifier Type/Code [GTIN, HIBCC]

• Make/model; Brand/Trade Name; Description

• Device model number (or reference number)

• Size; Unit of Measure/Packaging level/quantity

• Control – Lot and/or Serial Number; Exp. Date

• Contact name, phone, email

• GMDN Classification code/term

• Storage condition; Single Use; Sterility; Restricted Use

• Contains known, labeled allergen (e.g., latex)

• URL for additional information – Web address

• Special Instruction for use

FDA

• Device Identifier: GS1 2081090010024

• Endopath Dextrus Finger Mounting Locking Forceps

• Ethicon Endo-Surgery Inc, Cincinnati, Ohio

• Jane Smith; 1-888-888-8888; JSmith@JNJ.com

• Controlled by Lot; Expiration Date

• Packaged sterile; Single Use; Prescription

• GMDN code: 12345; Manufactured in Israel

• Package of 1; Storage conditions: between 0-24º C

• Does not contain latex or PVC

FDA’s UDI Database

Distribution

HIBCC UPN

Business

Rules

Manufacturer

(Acme)

GSI GDSN

The label of Medical Device 123 Size 45:

Device Identifier (Device XYZ123)

Production Identifier (Lot #ABC)

Expiration date (MMDDYYYY)

Sterile; Latex free

FDA eList

Minimum Data Set

For each Device Identifier:

• Manufacturer and model

• GMDN Code

• Other attributes

or

or

FDA’s UDI

Database

Oth

er o

pti

ons

HL7 SPL

FDA

FDA Managed

Public User

Interface

FDA

4th – Adoption and

Implementation

• Resolve technology issues – barcodes, RFID, DPM

• Develop appropriate UDI Database

• Facilitate distributor uptake and use

• Facilitate hospital uptake and use

• Facilitate use of UDI throughout device lifecycle

• Develop medical error reduction (e.g., latex)

• Drive integration – MMIS-Clinical

• Drive appropriate use of UDI in EMRs

• Determine appropriate role in reimbursement

• Address privacy concerns

FDA

Limitations of UDI and UDID

• UDI is a foundational element – it unambiguously

identifies a specific device (at its unit of use).

• Benefits accrue only if used by all stakeholders.

• UDID contains only “static” identifying and product

information.

• UDID does NOT contain production information, such

as lot or serial numbers – and is NOT track/trace or

other similar purposes requiring the full UDI.

• UDID provides link to Better Product Information- not

a replacement for Recalls/Adverse Event Databases.

© 2010 GS1

GS1 and UDI

Where are they linked?

How are they linked?

26

© 2010 GS1

GS1 and UDI

GS1 Standards

will enable the effective and

efficient implementation of UDI

worldwide.

27

© 2010 GS1

GS1 Vision

GS1 is a leading global organization dedicated

to the design and implementation of global

standards and solutions to improve the

efficiency and visibility of supply and

demand chains globally and across sectors.

28

© 2010 GS1

108 Member Organizations - 150 Countries served

Neutral platform for all supply chain stakeholders

1.2 million members

30 years of experience

Countries with a

GS1 Member

Organization

Countries served on a

direct basis from GS1

Global Office (Brussels)

GS1 Around the World

© 2010 GS1

Global Reach

30

Driving standards development

and global harmonization

© 2010 GS1

Voluntary, Global

Healthcare User Group

To lead the healthcare sector to the successful

development and implementation of global standards by

bringing together experts in healthcare to enhance

patient safety and supply chain efficiencies.

© 2010 GS1

Leading Healthcare

Organizations Pave the Way…

32

Corporate members of the global user group

© 2010 GS1

Leading Healthcare

Organizations Pave the Way…

33

Healthcare providers and Group Purchasing

Organizations going global

France

France

SwitzerlandHong KongNetherlandsGermany

Netherlands

USAGermanyGermany USAAustria

Ireland USA

© 2010 GS1

UDI MarkStatic part

Product identifier (GTIN)

Dynamic part

Production identifier (serial or lot

number, & expiry date)

Example UDI

© 2010 GS1

UDI Mark

Static part

Product identifier (GTIN)

Dynamic part

Production identifier (serial or lot

number, & expiry date)

Example UDI (2)

© 2010 GS136

© 2010 GS1

European Commission & UDI

• Avoid the multiplication of national systems at the

EC level

• Develop an international approach

“A balance has to be found between

the potentialities of UDI and the feasibility of UDI”

37

© 2010 GS1

Eucomed position

• UDI is coming

• UDI must be developed in a harmonized and global

manner

• Country-specific requirements on UDI (e.g. numbering

systems) would have major impact on multiple country

device configurations

38

© 2010 GS139 16www.eucomed.org

Same Level of Identification for Every Medical Device?

Extreme diversity in size, materials, processing, use and criticality

– needs to be considered for any identification rules!

– some differences on UDI needed, at least on required information

Examples*:

– pacemakers, hip replacements : device ID + serial no. + lot no.

– catheters, needles : device ID + lot no.

– syringes, stopcocks : device ID

– Single use commodity devices : no UDI

*Examples vary on specific devices, usage, packaging levels,....

Risk-based approach

© 2010 GS140 21www.eucomed.org

What do we need from an industry perspective?

The industry

needs a Global

Standard system

Only global and open standards enable the realization of all healthcare and economic benefits related to UDI

© 2010 GS141 22www.eucomed.org

The Way to Move Ahead

► A global initiative - GS1 & GS1-Healthcare are currently developing and

enhancing standards, specifically for healthcare. Eucomed and ETF support

this initiative actively.

► Eucomed and ETF

– recommend introducing the use of global GS1 Standards at any opportunity deemed

appropriate for a cost-efficiency and quality point of view

– believe that companies implementing these standards will be best positioned to meet

customer expectations now and in the future

© 2010 GS1

Product Marking Grids An ID “landscape”

A risk-based approach is necessary

M

I

NPharmaceuticals

Distributed and/or Sold

Primarily Via

Retail Channels

Medical Devices

Distributed and/or Sold

Primarily Via

Retail Channels

Pharmaceuticals

Distributed and/or Sold

Primarily Via

Non-Retail Channels

Medical Devices

Distributed and/or Sold

Primarily Via

Non-Retail Channels

Medical Devices

Distributed and/or Sold

Primarily Via

Retail Channels

Medical Devices

Distributed and/or Sold

Primarily Via

Non-Retail Channels

Pharmaceuticals

Distributed and/or Sold Via

Retail and/or

Non-Retail Channels

Medical Devices

Distributed and/or Sold

Primarily Via

Non-Retail Channels

Direct Part Mark(AIDC marked

directly onto a

single,

unpackaged,

unlabeled item)

Primary Package(AIDC marked onto

the first level of

packaging, either

on the packaging

or on a label

affixed to

packaging. May

consist of 1 single

item, or a group of

items for a single

therapy such as a

Kit.)

Secondary

Packaging (AIDC marked onto

the next level of

packaging,

containing one or

more single items

in their Primary

Packaging)

Case / Shipper(AIDC marked onto

a shipping

container. May

contain one or

more items in their

Primary Packaging

and/or Secondary

Packaging.)

Pallet(AIDC marked onto

a pallet. May

contain one or

more Case /

Shippers.)

MINIMUM Level of AIDC Marking (Non-Retail)MINIMUM Level of AIDC Marking (Retail) ENHANCED Level of AIDC Marking HIGHEST Level of AIDC Marking

No Marking No Marking No Marking No Marking No Marking No Marking

GTIN

Serial No.

-Not for

Implants

Hospital:

-8003/8004

-optional

GTIN

Lot

Expiry

Serial No.

Potency (kits)

Hospital:

-8003/8004

-optional

Trade Item:

-GTIN

-Lot

-Expiry

-Serial No.

-Potency (kits)

Logistics:

-SSCC

Trade Item:

-GTIN

-Lot

-Expiry

-Serial No.

Logistics:

-SSCC

Trade Item:

-GTIN

-Lot

-Expiry

-Serial No.

Logistics:

-SSCC

Trade Item:

-GTIN

-Lot

-Expiry

Logistics:

-SSCC

Trade Item:

-GTIN

-Lot

-Expiry

Logistics:

-SSCC

Trade Item:

-GTIN

-Lot

-Expiry

Logistics:

-SSCC

Trade Item:

-GTIN

-Lot

-Expiry

Logistics:

-SSCC

Trade Item:

-GTIN

-Lot

-Expiry

Logistics:

-SSCC

GTIN

Hospital:

AI(01)+AI(21)

+AI(7003)GTIN

Lot

Expiry

[Need 2 marks]

GTIN

Lot

Expiry

Serial No.

Potency

Hospital:

AI(01)+AI(21)

+AI(7003)

No Marking

(mark with

GTIN if no

Secondary

Package)

GTIN

Lot

Expiry

GTINGTIN

12 Syringes 6 Catheters

GTIN

Lot

Expiry

GTIN

Lot

Expiry

GTIN

Lot

Expiry

Serial No.

Potency (kits)

Hospital:

-8003/8004

-optional

No Marking

(mark with

GTIN if no

Secondary

Package)

No Marking

(mark with

GTIN if no

Secondary

Package)

No Marking

Trade Item:

-GTIN

-Lot

-Expiry

Logistics:

-SSCC

2 Contact Lens

GTIN

No Marking

(mark with

GTIN if no

Secondary

Package)

Trade Item:

-GTIN

-Lot

-Expiry

-Serial No.

-Potency

Trade Item:

-GTIN

-Lot

-Expiry

Logistics:

-SSCC

Trade Item:

-GTIN

-Lot

-Expiry

Logistics:

-SSCC

Trade Item:

-GTIN

-Lot

-Expiry

Logistics:

-SSCC

Trade Item:

-GTIN

-Lot

-Expiry

Logistics:

-SSCC

Trade Item:

-GTIN

-Lot

-Expiry

Logistics:

-SSCC

Trade Item:

-GTIN

-Lot

-Expiry

Logistics:

-SSCC

Logistics:

-SSCC

Hospital:

AI(01)+AI(21)

+AI(7003)

GTIN

© 2010 GS1

GS1 Standards enable UDI

43

© 2010 GS1

GS1 System of Standards

44

Global reachAn integrated approach

•Standardized identification keys

•Products, locations, assets, …

•Standardized data carriers

•Bar codes & RFID

•Standardized sharing of static data

•Data on products & locations

•Standardized sharing of dynamic data

•Event data

•Standardized electronic communication

Open standards

Proven standards

© 2010 GS145

UDI

Unique Device Identification

Not IF…

But WHEN and HOW

Turning Regulations into Reality

• You know when

• You know about the

standards

• It’s now how to make

it a reality

Unique Device Identification

Design Exercise

Correct variables

Correct barcode

Application Labeling

PRISYM Medica

More than just print

time variables

Approval Management

Version Control

Audit History

Data Driven Printing

21 CFR Part 11

GMP based

Thin/ Thick Client

Summary

UDI can be implemented

without Derailing

Production

The right software

GS1Good

Design

QA

FDA – Jay Crowley

T + 1 301-980-1936

E jay.crowley@fda.hhs.gov

W www.fda.gov

GS1 Global Office – Janice Kite

T + 32 2 788 78 00

W www.gs1.org

PRISYM ID

T +44 1189364403

E hollypurchase@prisymid.com

W www.prisymid.com