Unique Device Identification Unique Device Identification

Marjolein Engelen

UDI: History and PlayersUDI: History and Players

US Congress mandates FDA

GHTF recognizes global relevance

GHTF ad-hoc WG for

www.ghtf.org

GHTF ad-hoc WG for guidance preparation ‘ensure global harmonisation’2007

2008

2008 - 2010Europe

• EU Commission

•MoH Germany

•Eucomed

• EDMA

North America

• US FDA

•Health Canada

•AdvaMed

Asia - Pacific

• China FDA

• JFMDA

• AHWP

ad-hoc WG

UDI: Rational, Purpose and ScopeUDI: Rational, Purpose and Scope

Rational

A common, worldwide system for product identification should eliminate

differences between jurisdictions and offer significant benefits to

manufacturers, users and/or patients, and Regulatory Authorities.

Purpose

Improve patient safety by :

• facilitating traceability of devices• facilitating traceability of devices

• enhancing the identification of devices in case of adverse events

• assisting in the event of a field safety correction

It is anticipated that a UDI System may facilitate the reduction of medical errors.

Scope

All products placed on the market that fall within the definition of a

medical device that appears within the GHTF document :

‘Information Document Concerning the Definition of the Term MEDICAL DEVICE’

Packaging Level HierarchyPackaging Level Hierarchy

The Device Identifier (DI) of the lowest

packaging level(*1) which is marked with

an AIDC carrier is the UDI which serves

as the Primary Key

of the UDI Database.

Hierarchy example :

• Device itself - without packaging

• Primary pack- e.g. pack with 1 unit

Important Definitions!

of the UDI Database.

The Identifiers of higher or lower

packaging levels (independent of AIDC

marking) are Alternative Keys.

• Secondary pack- e.g. shelf pack with 10 primary packs

• Tertiary pack- e.g. case with 50 secondary packs

Out of scope in terms of UDI

• Pallet - e.g. with 200 tertiary packs

(*1) can also be the device itself

UDI Database: Data Elements UDI Database: Data Elements

• Packaging Hierarchy (unlimited no.), per pack. level

• Device Identifier / Unit of Measure / Quantity

•Manufacturer Name

•Manufacturer Contact Information (address, email, phone)

• Nomenclature (e.g. GMDN code)

• Nomenclature Term (e.g. GMDN term)

• Trade Name

• Device Model Number (REF No./Catalog No.)

• Controlled by (e.g. expiry date, manuf. date, lot no. serial no., …)

• Size/Volume/Length/Gauge… (clinically relevant characteristics)

Intention

Collection of information

with Medical Device

•identification• Size/Volume/Length/Gauge… (clinically relevant characteristics)

• Product Description (additional clinically relevant info.)

• Special Storage/Handling Conditions

•Labelled as ‘single use’

• Sterility / Package sterile

• Need to be sterilized before use

• Restricted number of reuses

• Containing Natural Rubber Latex

• Authorized Representatives (list of countries and addresses)

• License / Marketing Authorization (e.g. registration no.)

• URL for additional information

• Critical warnings or contraindications

•identification

• and labelling

‘global core elements’

FDA statement (Dec 2010): data elements will change and grow over time (e.g. DEHP, but no specific plan)

UDI Carrier + Placement UDI Carrier + Placement

Classes B – D

DI + PI mandatory(techn. feasibility prerequisited)

Reusable Products, Kits, Multiple Part ProductsReusable Products, Kits, Multiple Part Products

Reusable products have to be marked

directly on the device • e.g. laser etched, dot peen, labelled, inkjet, …

• AIDC carrier readable throughout MD lifetime

• AIDC carrier should be accessible / visible

Kits / multiple part products Kits / multiple part products

are seen as ONE product• item with the highest risk-class defines the

risk-class of the kit / assembled product

• only one UDI

• only one database entry

• only one AIDC carrier

Out of scope or open issues :

• Spare parts / replacement components

• Software

• …

Implementation Implementation

The UDI The UDI -- System shall be implemented System shall be implemented stepwisestepwise..

Starting with Starting with highest risk class firsthighest risk class first, lowest risk class last., lowest risk class last.•• according GHTF riskaccording GHTF risk--classes (A, B, C, D)classes (A, B, C, D)

General agreements :

Between the steps Between the steps time to review time to review •• analyze achieved results, experiences, etc. analyze achieved results, experiences, etc.

••make system adjustments if necessarymake system adjustments if necessary

Introduction shall allow Introduction shall allow sufficient implementation time sufficient implementation time for for

manufacturers to maintain compliance with quality system requirements.manufacturers to maintain compliance with quality system requirements.

Risk-based implementation of Unique Device Identification (UDI) ETF Position Paper June 2009:

www.eucomed.be/~/media/45B95BF4CBEB400D94EE229E821D87A8.ashx

Milestones Milestones –– Timelines (1)Timelines (1)

US Congress

mandates FDA to

develop a UDI

guidance

US FDA

1. pilot

UDI-DB

US FDA

going to release

UDI legislation

(draft)

EU Commission

going to consider

UDI at

MDD recast

Milestones

in cooperation with

GHX + GS1

GHTF SC

established UDI

AHWG goal =

‘global

harmonization’

GHTF SC

published

1. UDI

discussion

paper

end of

public

comments

period

GHTF AHWG

presents UDI

guidance

draft to GHTF SC

Sept

2007

Oct

2008

Nov

2009

Sept

2009

Mar

2010

May - Sept

2010

Apr

2011

GHTF AHWG :

• comments

review

•‘UDI guidance

draft’

comments from :

Eucomed, AdvaMed, JFMDA,

EDMA, COCIR, GS1, …. (40+)

Nov

2010

end of public

comments

period

(5 months)

Q1

2011

GHTF SC

publishes

UDI

guidance

draft

AHWG closedAHWG closed new WG:

‘impl. issues’

new WG:

‘impl. issues’

Dec

2010

US :

UDI legislation

becomes a law

US : Implementation

deadline for Class 3

products

Implementation Schedule (expected)

US : Implementation

deadline for Class 2

products

US : Implementation

deadline for Class 1

products

Milestones Milestones –– Timelines (2)Timelines (2)

EU : ???

MDD recastUDI legislation

EU :

2 years

legislation

process(2012-2013)

2011

Q2 (3?)

2012

Q3

2013

Q3

2015

Q3

2017…….…

other

regions

world-

wide???

2016

EU :

at least 3 years

transition period for

implementation on

national level(2014 – 2016)

UDI will bring great benefits for:

� PATIENT SAFETY

� IMPROVED VIGILANCE & MARKET SURVEILLANCE

� GLOBAL TRADE

Eucomed’sEucomed’s PositionPosition

BUT it is essential that

� A pragmatic (risk-based) approach is adopted

� Healthcare providers are fully resourced to respond

� Regional authorities co-operate to ensure a truly

GLOBAL and HARMONISED UDI approach

���� otherwise much time and resources would be waisted!

Thank you very much for your attention!Thank you very much for your attention!

Marjolein Engelen

Email: nefemed@wispa.nl

Phone: 013-5944342