This document discusses the challenges medical device manufacturers will face in implementing Unique Device Identification (UDI). It argues that a step-wise implementation timeline is needed as UDI regulations will require adding variable data to automatic identification and data capture (AIDC) markings on individual medical device packages and products. This will be technically challenging due to limited space for small AIDC carriers, requirements to print variable data inline during high-speed packaging, and ensuring the quality and scannability of AIDC markings on different packaging materials. The document advocates for reviewing results between implementation steps to adjust systems as needed before expanding UDI to additional device classes.

1. Unique Device Identification
A Manufacturers View
Volker Zeinar Paul Geelen
B. Braun Melsungen AG B. Braun Medical BV
Global Coordination Auto-ID Affairs Pharmacist, QA&RA-manager
Amsterdam, 26 January 2011

2. B. Braun group, 2010
€ 4,450 m
3.573
3.026
Sales in Mio. €
2.175
1.528
1.023
507
10,7 102
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Volker Zeinar | Unique Device Identification 'UDI' | Seite 2

3. Importance of the Implementation Sequence, Medical Devices
Both in parallel : AIDC + UDID entries
UDI becomes law USA (Q2 2012??)
• Highest Risk Class 3 (Q2 2013??)
+ 1 year • review results 1
• system adjustments (?)
Step1 REVIEW !
achieved results
(experiences) need
• Medium Risk Class(es) 2a + 2b (Q2 2015??) to be analyzed
+ 3 years • review results 2
before the next step
Step 2 • system adjustments (?)
starts
• Lowest Risk Class 1 (Q2 2017?)
• review results 3
+ 5 years
• system adjustments (?)
Step 3
complexity will increase step-by-step
- diversity of MD product portfolio, no. of products, UDID entries, etc. -
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4. Key Challenge : Implementation timelines
Why do we need ‚so much‘ time ?
UDI regulations will mainly focus on
AIDC marking of the consumption unit level
inclusive variable data !
(primary pack or product itself)
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5. Key Challenge : Primary Pack
variable data within the AIDC carrier = in-line printing !
technical framework
• limited space means  small carriers + high data density
• e.g. DM size : 6x6 - 10x10 mm
• production/packaging line speed
• speed reduction by an additional print not acceptable
• packaging material (Tyvek, coated/uncoated paper, label, …)
• printing technology (inkjet, thermal transfer, etc.)
• often replacements necessary !
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6. Key Challenge : Primary Pack
quality issues
• DM quality verification : ISO/IEC 15415 (final grade 1,5)
• absorptive / translucent paper in use
• only validated ink permitted
• impact on contrast between ink and paper ?
DM through the camera of the
verifier
our experience :
verifier fails / low-cost image scanner reads
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7. Key Challenge : Multilingual labeling
sample
sample ‚secondary pack‘ ‚primary pack‘
UDI is an additional
labeling requirement !
AIDC Carrier
• globally harmonized
data content
16 • technology neutral
26
languages
One product presentation for many markets
(supply chain efficiency)
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8. Key Challenge : Direct Part Marking
no problem at
bigger devices /
machines 2.3 x 2.3 mm
but significant technical
• metal plates efforts at many other
• labels / stickers reusable products
• tags
•… • product characteristics
• carrier size
• DPM technology
• durability
•…
Volker Zeinar | Unique Device Identification 'UDI' | Seite 8

9. Pharma Labels Today
Carton (sales unit) Container (unit dose)
free space
for printing
HRI
(Human
Readable
Information)
xxxxxxxxxx xxxxxxxxxx
xx.xxxx xx.xxxx
Carton label
• pre-printed linear BC
• static data (product-ID) Container label (depends on size)
• often no BC
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10. Pharma Labels in Future
Carton (sales unit) Container (unit dose)
keep pre-
printed linear
BC
xxxxxxxxxx
xx.xxxx xxxxxxxxxx
both xx.xxxx
printing during production process
• HRI and DataMatrix incl.
• static data (product ID) +
• Serial No. (SN)
• variable production data (exp./manuf.date, lot/serial no)
Volker Zeinar | Unique Device Identification 'UDI' | Seite 10

11. Fact : AIDC implementation is time consuming
1. technical feasibility studies
- pack. material, print technology, ink, impact on production speed, …
2. investment planning + release
Sponsor  TOP Management
3. new hardware / software (for in-line printing)
Technical
Regulatory
4. label artwork / packaging paper Engineering
Label Design
- redesign to have space for AIDC carriers Quality Control
5. technical engineering efforts Production
- HW installation, lines 7 days/24h in use, …
IT
Marketing
6. perform test trials Finance
Sales
7. measurements to fulfill AIDC carrier quality requirements Controlling
- 100% control by camera systems vs. sample checks
- e.g. in full-autom. pack. lines, how to handle faults, sort-out/bypass
- define internal globally harmonized test methods
8. process qualification and validation
9. documentation
- drawings, process descriptions, notified bodies, …
10. …
cross-functional project teams + top-management support
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12. Key Challenge : UDI Database
Set of global core elements :
1. Packaging Hierarchy (unlimited no.), per pack. level manufact. need to ensure
2. Device Identifier / Unit of Measure / Quantity • data availability in e-format
3. Manufacturer Name
4. Manufacturer Contact Information (address, email, phone) • data quality / accuracy
5. Nomenclature (e.g. GMDN code) • up-to-dateness
6. Nomenclature Term (e.g. GMDN term)
7. Trade Name • proper processes
8. Device Model Number (REF No./catalog no.) (data maintenance + upload to 3rd-party)
9. Controlled by (e.g. expiry date, manuf. date, lot no., serial no., …)
10. Size/Volume/Length/Gauge… (clinically relevant characteristics)
11. Product Description (additional clinically relevant info.)
12. Special Storage/Handling Conditions
13. Labeled as ‘single use’
14. Sterility / Package sterile
15. Need to be sterilized before use
16. Restricted number of reuses
17.
18.
Containing Latex
Authorized Representatives (list of countries and addresses)
UDID
MD identification
19. License / marketing Authorization (e.g. registration no.)
+ labeling
20. URL for additional information
21. Critical warnings or contraindications
+ local elements ?
From how many sources do we have to collect this information ?
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13. Key Challenge : UDI Database
UDID
?? UDID
EU (?)
UDID network
US
UDID
AP (?)
UDID
??
manufacturers requirements :
• as less UDIDs as possible
• ideally a ‘single point of entry’ for data upload ?
 how to handle language issues ?
• avoid regional add-ons ?
• clarity regarding DB design / techn. details
 we are able to bring in our knowledge !
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14. Fact : UDI Implementation will be complex
B. Braun landscape
AIDC : many production lines affected at the same time
 Centers of Excellence concepts
UDID : processes for data collection, up-to-dateness + upload
 many people need to be sensitized !
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15. Thank you very much for your attention !
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