Hoe voldoe ik aan wetgeving

voor Unique Device

Identification (UDI) en

Serialisatie?

Hans Lunenborg

Sectormanager healthcare

GS1 Nederland

© 2014 GS1

Agenda

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• Introduction to GS1

• Serialisation on Pharmaceuticals

• EDQM

• ESM

• Unique Device Identification (UDI)

• Global UDI Database (GUDID)

© 2014 GS1

Het zes-lagen model

Randvoorwaarden

Samenwerking

Informatie-inhoud

Softwarekoppeling

Infrastructuur

WET & REGELGEVING

ZORGPROCES

INFORMATIE

TECHNIEK

APPLICATIES

BELEID Richtlijnen

© 2014 GS1

GS1: The Global Language of

Business

GS1 is a neutral not-for-profit

organisation driven by its users, that

facilitates collaboration amongst

trading partners, to create more

efficient, safer and sustainable value

chains through global standards.

© 2014 GS1

Global reach, local presence

111 Member Organisations

1,500,000 member companies

150 countries served

2,000 people helping us

© 2014 GS1 6

GS1 has developed a full suite of standards to meet

the needs of the supply chain Standards in

Healthcare

© 2014 GS1

Interoperability

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© 2014 GS1

Recognised, open and neutral source

And many more… © Copyright GS1 AISBL, 2014. All Rights Reserved.

© 2014 GS1

The healthcare supply chain needs

global standards

• Medication errors result in additional treatments,

disabilities and even loss of life

• Counterfeiting is an increasing global threat

• Traceability from manufacturer to patient is

problematic

• Product recalls can be difficult to manage, in

particular for healthcare providers

• Manual interventions in the healthcare supply

chain decrease its efficiency and accuracy

© 2014 GS1

Transforming the Healthcare Supply Chain

Process to Improve Patient Safety and Care

GS1 Healthcare: Helping the

right patient get the right

medicine at the right dose in

the right route at the right time.

We bring together hospitals,

pharmaceutical companies, medical

device manufacturers, distributors,

associations, regulators, logistic

providers, and more to develop

standards that will help improve patient

safety and increase supply chain

efficiency.

© 2014 GS1 11

New McKinsey report “Strength in unity: The

promise of global standards in healthcare”

Highlights the cost savings and patient safety

benefits of adopting a single global supply

chain standard in healthcare

Available at:

http://www.gs1.org/healthcare/mckinsey or

http://www.gs1.org/docs/healthcare/McKinsey_Healthcare_R

eport_Strength_in_Unity.pdf

New McKinsey & Company report

quantifies supply chain issues in

Healthcare

Source: http://www.mckinsey.com

© 2014 GS1

Huge cost savings and patient safety benefits

when adopting a single global standard in

healthcare

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•“Implementing global standards across the entire healthcare supply chain could save 22,000-43,000 lives and avert 0.7 million to 1.4 million patient disabilities”

•“Rolling out such standards-based systems globally could prevent tens of millions of dollars’ worth of counterfeit drugs from entering the legitimate supply chain”

•[We] “estimate that healthcare cost could be reduced by $40 billion-$100 billion globally” from the implementation of global standards

•“Adopting a single set of global standards will cost significantly less than two” (between 10-25% less cost to stakeholders)

SOURCE: McKinsey report, “Strength in unity: The promise of global standards in healthcare”, October 2012

Serialisation on pharmaceuticals

© 2014 GS1

EU Commission proposal

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• The composition, format and carrier of the unique identifier will be fully harmonised across the EU. The unique identifier will be placed in a 2D barcode and contain the manufacturer code, a serialisation number, a national reimbursement number (if present), the batch number and the expiry date.

• Medicine authenticity will be guaranteed by an end-to-end verification system supplemented by risk-based verifications by wholesale distributors. Medicines will be systematically verified before being dispensed to patients. Medicines at higher risk of falsification (returns or medicines not being distributed directly by manufacturers) will be additionally checked at wholesaler level.

• The repository containing the unique identifiers will be set up and managed by stakeholders. National competent authorities will be able to access and supervise the database.

© 2014 GS1

Options for countries with national

numbering systems - adopting GTIN

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Option Description

1 Replace the national

number with a GTIN

If the GTIN can replace the national number, it should be considered. Only one code has to be

maintained and it will simplify packs, systems and processes. It is recognised that this migration

path is not always possible or necessary.

2

Put the GTIN on pack

and look-up the

national number in a

database

Place a GTIN on the pack in a data carrier such as a 2D GS1 DataMatrix and use enabled IT

systems to look up the NHRN/ national number. This will not be possible without system migration in

many instances but should be explored as a good option with many advantages. In doing so it needs

to be ensured that national integrity is assured and that there is a one to one relationship of both

numbers at the secondary packaging level.

3

Put both the GTIN &

national number (in

NHRN format) on the

pack

Put both the GTIN and National Number (in an NHRN format) into the data carrier on the pack. This

will allow either to be accessed and is a good solution . Over time as IT systems are updated the

NHRN could be removed from the pack and looked up as an attribute of GTIN. There are technical

considerations for manufacturers as this increases the amount of data held in the barcode.

4 Allocate national

numbers from the

GTIN pool

This is a more complex path and creates a type of code called an NTIN (National Trade Item

Number).

• 4 options have been identified to allow those countries with national

numbers use a GTIN

• The European Commission will decide the specifications for product

identification in “delegated acts” to be released by 2014

© 2014 GS1

EDQM Track and trace

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EDQM Track and trace

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EDQM Track and trace

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EDQM Track and trace

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European Stakeholder Model (ESM)

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European Stakeholder Model (ESM)

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European Stakeholder Model (ESM)

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European Stakeholder Model (ESM)

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European Stakeholder Model (ESM)

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Unique Device Identification (UDI)

© 2014 GS1

UDI number

• Develop UDI number based on ISO 15459 : US FDA accredited

GS1 as an issuing agencies.

• Created and maintained by the manufacturer

• Device Identifier (DI) Static : manufacturer, make, model,

catalogue number

• Production Identifier (PI) Dynamic : serial number, lot number,

expiration/manufacturing date

• Phase out national numbering system (NDC/NHRIC)

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© 2014 GS1

UDI: Scope

All products placed on the

market that fall within the

definition of a medical device

that appears within the

according GHTF document :

http://www.gs1.org/sites/default/files/d

ocs/healthcare/ghtf-sg1-n071-2012-

definition-of-terms-120516.pdf

Note: This is NOT the GHTF UDI

guidance!

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© 2014 GS1

What is Driving the Need ?

Current systems of product catalog numbers include duplicate

identifiers for the different products across manufacturers

Current system allows product re-identification by every stakeholder in

the supply chain, making product tracking efforts extremely difficult

Manufacturer

Product # 305905

Distributor

Product # MT305905

Hospital or Healthcare Provider

Product # M-5905

Manufacturer Catalog # Description

Medtronic 305905 Mosaic ® 305 Porcine Heart Valve ………….

BD 305905 3mL BD SafetyGlide ™ Syringe ………..

J & J 305905 Protectiv ® IV Catheter System ………..

Source, Jackie Elkin, Medtronic

© 2014 GS1

Which barcode do we scan?

© 2014 GS1

Issuing Agency

• FDA definition: Any organisation accredited by FDA to

operate a system for the issuance of UDI’s – multiple

issuing agencies are possible (GS1, HIBCC, ICCBBA) and

also FDA itself

• Must be private organisation or state agency

• Operates a system for UDI’s following international standards

• Provides description of processes, fees, data management

systems, policies and procedures for application

• Fee schedule needs to be acceptable and no undue burden

for users

• First accreditation for three years, to be renewed, next is for

seven years

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© 2014 GS1

Timeline for implementation

• Timelines based on premarket risk class after publication of final

rule – 24 September 2013:

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Class III & Devices licensed under PHS Act 1 year

Class II/I implants and life-supporting/sustaining 2 years

Rest of Class II 3 years

Class I 5 years

Direct part marking (except FDASIA devices: 2 years) + 2 years

© 2014 GS1

European Commission & UDI

Sept. 2012

EC proposals

on MD & on IVD

Regulations

Q3-4 2014

EC starts

drafting DA on UDI

Sept. 2013

EP vote in Committee on draft MD Regulation

Oct. 2013

EP vote in Plenary on draft MD

Regulation

Q2 2014

Final MD Regulation

adopted

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Discussions in

EP and Council

EC, EP, Council

meetings to reach

political agreement

EC:European Commission; EP:European Parliament; DA:Delegated Acts: implementing measures of regulatory requirements

…

© 2014 GS1

UDI in the GS1 system of standards …UDI in GS1 terms…

AIDC – Unique Device Identification (UDI)

Goal to be unambiguous identification of a specific medical device. From an

AIDC standpoint this identification has two (2) parts:

– Device Identifier (DI) – Meant to be the identification of the “generic”

medical device – GS1 GTIN enables this.

– Production Identifier (PI) – Meant to be whatever “control” numbers or data

a manufacturer uses in their process – GS1 Application Identifiers (AI’s

such as lot/batch number, serial number, expiry, in any combination with a

GTIN) enable this aspect.

GTIN + AI(s) = UDI

AIDC - Data Carriers ISO compliant machine-readable Data Carriers on the product (via label or

DPM… Direct Part Marking) or it’s packaging, which contain the UDI – 1D /

Linear & 2D / Matrix bar code symbols, RFID.

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© 2014 GS1

UDI in the GS1 system of standards …UDI in GS1 terms…

© 2014 GS1

All data carriers are for illustration only, not to scale and not in proportional size to one another.

Please refer to GS1 General Specifications for detailed & up-to-date GS1 System information.

UDI requirements may vary by geography -please refer to regional UDI regulations.

UDI in the GS1 system of standards …UDI in GS1 terms…

© 2014 GS1 36

Some (but not all) common reasons for a Device Identifier (DI =

GTIN) to change are:

• Change in quantity of a device package

• Change to package sterility

• Re-labeling of the original labeler’s (mfg.) device

• Change labeling languages for different global markets

• Change in certification mark, e.g., CE Mark

Refer to the appropriate UDI regulation in you area and the GS1

GTIN Allocation Rules for complete details on any regional

influence for DI / GTIN change.

Device Identifier / GTIN Allocation

UDI in the GS1 system of standards …UDI in GS1 terms…

© 2014 GS1 37

Placement – Bar code symbols are to be positioned to allow ready

access for scanning when the product is stored or stocked on shelves.

Packaging Levels –The DI

(GTIN) & PIs (AIs) should be in

the bar code & in human-

readable form on each

applicable package level as

defined by regulation. Each

designated package level must

have its own DI (GTIN).

NOTE: GTINs below for illustration only

Package Levels/Hierarchy, Kits & Placement

Kits – Medical Device “kits” have there own UDI. (NOTE: Refer to the FDA Rule for details. Additional definition & allocation rules for Healthcare

kits are being clarified through the GS1 GSMP.)

UDI in the GS1 system of standards …UDI in GS1 terms…

© 2014 GS1

UDI Bar Code

symbol Device Identifier (DI) “Static” portion

GTIN (product identifier)

Production Identifier (PI) “Dynamic” portion

Application Identifiers (e.g. serial,

lot number & expiry date)

UDI example - #1

© 2014 GS1

UDI example - #2

UDI Bar Code

symbol

Device Identifier (DI) “Static” portion

GTIN (product identifier)

Production Identifier (PI) “Dynamic” portion

Application Identifiers (e.g. serial,

lot number & expiry date)

Global UDI Database (GUDID)

© 2014 GS1

US FDA Global UDI Database (GUDID)

• Global Unique Device Identification Database (GUDID) • Operated by the FDA to collect information on Medical Devices

• Will have public facing website to share data with anyone (future)

• 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 release of GUDID web interface

– Class II “life sustaining” devices- 2 years from release of GUDID web interface

– Class II remaining devices- 3 years from release of GUDID web interface

– Class I devices- 5 years from release of GUDID web interface

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© 2014 GS1

UDI system… …Database components…

UDI

• DI (static

data)

• PI

•(dynamic data)

Static Data Elements

• DI = primary access key

Content

Structure

Data Relationships

Vocabulary

•…

AIDC

Machine

Readable Data

Carrier

•Linear Bar

Code

• 2D Bar Code

• RFID

• …

DI = Device Identifier

PI = Production Identifiers

UDID (database)

UDI/UDID - System

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© 2014 GS1

GUDID Loading

• Data should be loaded from by “Labeler”

• FDA defines the “Labeler” as the entity responsible for the

contents of the label

• In GS1 language this is the “Brand Owner” or “Authorised

Representative”

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

• Only the DI is used in the GUDID not the PI

• Data provided is master data and is used for public

consumption

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© 2014 GS1

GUDID Loading Mechanism

• 2 Options for Labelers to load data into the GUDID:

• Web Portal User Interface: Using a graphic user

interface on the FDA’s website data can be loaded

one device at a time

– Only recommended for small catalogs (i.e. less than 100

items)

• Machine to Machine: Structured Product Language

(SPL) developed by HL7 the SPL is a computer

language similar to XML GDSN: Certified Data Pools can establish a connection to the

FDA system to load data on behalf of the Labeler (using the HL7

SPL standard)

– The Data Pool will need access under the Labeler’s account to

accomplish the load.

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© 2014 GS1

Minimum Data Set

For each Device Identifier

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FDA’s Global UDI Database

Commercial

Distribution

HL7 SPL

Business

Rules

Manufacturer

(Acme)

Web based tool

The label of Medical Device 123 Size 45:

Device Identifier (Device XYZ123)

Production Identifier (Lot #ABC)

Expiration date (YYYY-MM-DD)

3rd Parties

or

FDA’s GUDID

FDA Managed

Public User

Interface Source: FDA presentation UDI conference, Sept 2013

© 2014 GS1

Manufacturers are able to provide data to all UDI databases and their

customers (hospitals, distributors, wholesalers, GPOs) simultaneously, with

one single connection.

One connection to UDI databases,

Providers and other data recipients

Data is

provided

to the

FDA

GUDID by

the

Source

Data Pool

© 2014 GS1

GUDID population using GDSN

• GDSN is a single point of entry for publishing an item’s

master data

• Supply Chain and Market data to GPOs and Providers

• GUDID data to the FDA and other similar UDIDs globally

• Benefits to the approach

• Single entry platform

• Population of data one to many

• Providers and other customers receive public GUDID

data elements

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GDSN

MANUFACTURER

GPO

HOSPITAL/PROVIDER

FDA UDID

© 2014 GS1

GUDID attribute areas

• Manufacturer’s Name, Address,

and Contact Information

• Primary Device Identifier (DI)

• Previous DI (if a new version or

model)

• GMDN code

• Clinical Size (volume, length,

gauge, etc)

• 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)

• Unit of Use DI (if different form

DI)

• 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)

• 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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© 2014 GS1

Data Quality and Master Data

Management

Data Quality • Refer to the FDA’s Data Quality Framework

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Roles and Responsibility

Data Management

Data Governance

The FDA

expects

every

manufacturer

to have a

Data Quality

and Master

Data

Management

process in

place

© 2014 GS1

How to get information on UDI

• GS1 Healthcare’s website: http://www.gs1.org/healthcare/udi

• UDI White Paper (already published): http://www.gs1.org/docs/healthcare/GS1_UDI_Position Paper.pdf

• New UDI collateral released: Are you ready for UDI - AIDC

perspective

• New UDI collateral in development: How Global Data

Synchronisation enables Unique Device Identification

• McKinsey Report – Strength in Unity

PUBLIC WEBPAGE

© 2014 GS1

NEW UDI webpage:

http://www.gs1.org/healthcare/udi

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The site will continue to be populated as more supporting

documents are developed

© 2014 GS1

A snapshot of the collateral:

Introduction to UDI and AIDC

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© 2014 GS1

Brochure for Unique Device

Identification (UDI) and GDSN (In review)

© 2014 GS1