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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: [email protected]
Phone: 013-5944342