Unique Device Identification A Manufacturers View

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. -
Volker Zeinar | Unique Device Identification 'UDI' | Seite 3

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)
Volker Zeinar | Unique Device Identification 'UDI' | Seite 4

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 !
Volker Zeinar | Unique Device Identification 'UDI' | Seite 5

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
Volker Zeinar | Unique Device Identification 'UDI' | Seite 6

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)
Volker Zeinar | Unique Device Identification 'UDI' | Seite 7

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
Volker Zeinar | Unique Device Identification 'UDI' | Seite 9

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
Volker Zeinar | Unique Device Identification 'UDI' | Seite 11

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 ?
Volker Zeinar | Unique Device Identification 'UDI' | Seite 12

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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