Unique Device Identification A Manufacturers View

Amsterdam, 26 January 2011

Volker Zeinar

B. Braun Melsungen AG

Global Coordination Auto-ID Affairs

Paul Geelen

B. Braun Medical BV

Pharmacist, QA&RA-manager

Volker Zeinar | Unique Device Identification 'UDI' | Seite 2

Sales in Mio. €

10,7102

507

1.023

1.528

2.175

3.026

3.573

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01

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07

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09

€ 4,450 m

B. Braun group, 2010

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

Importance of the Implementation Sequence, Medical Devices

Step1

• Highest Risk Class 3 (Q2 2013??)

• review results 1

• system adjustments (?)

Step 2

• Medium Risk Class(es) 2a + 2b (Q2 2015??)

• review results 2

• system adjustments (?)

Step 3

• Lowest Risk Class 1 (Q2 2017?)

• review results 3

• system adjustments (?)

UDI becomes law USA (Q2 2012??)

+ 1 year

+ 3 years

+ 5 years

complexity will increase step-by-step- diversity of MD product portfolio, no. of products, UDID entries, etc. -

Both in parallel : AIDC + UDID entries

REVIEW !

achieved results

(experiences) need

to be analyzed

before the next step

starts

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

Key Challenge : Primary Pack

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 !

variable data within the AIDC carrier = in-line printing !

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

Key Challenge : Multilingual labeling

One product presentation for many markets

(supply chain efficiency)

AIDC Carrier

• globally harmonized

data content

• technology neutral

languages

16

26

UDI is an additional

labeling requirement !

sample ‚secondary pack‘

sample

‚primary pack‘

Volker Zeinar | Unique Device Identification 'UDI' | Seite

2.3 x 2.3 mm

8

Key Challenge : Direct Part Marking

no problem at

bigger devices /

machines

• metal plates

• labels / stickers

• tags

• …

but significant technical

efforts at many other

reusable products

• product characteristics

• carrier size

• DPM technology

• durability

• …

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

Pharma Labels Today

Carton label

• pre-printed linear BC

• static data (product-ID)

xxxxxxxxxx

xx.xxxxxxxxxxxxxx

xx.xxxx

free space

for printing

HRI (Human

Readable

Information)

Carton (sales unit) Container (unit dose)

Container label (depends on size)

• often no BC

Volker Zeinar | Unique Device Identification 'UDI' | Seite 10

Pharma Labels in Future

xxxxxxxxxx

xx.xxxx xxxxxxxxxx

xx.xxxx

keep pre-

printed linear

BC

Carton (sales unit) Container (unit dose)

printing during production process

• HRI and DataMatrix incl.

• static data (product ID) +

• variable production data (exp./manuf.date, lot/serial no)

both

• Serial No. (SN)

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

1. technical feasibility studies

- pack. material, print technology, ink, impact on production speed, …

2. investment planning + release

3. new hardware / software (for in-line printing)

4. label artwork / packaging paper

- redesign to have space for AIDC carriers

5. technical engineering efforts- HW installation, lines 7 days/24h in use, …

6. perform test trials

7. measurements to fulfill AIDC carrier quality requirements

- 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. …

Fact : AIDC implementation is time consuming

cross-functional project teams + top-management support

Regulatory

Label Design

Technical Engineering

Quality Control

Marketing

Sales

IT

Finance

Controlling

Production

Sponsor TOP Management

Volker Zeinar | Unique Device Identification 'UDI' | Seite

Set of global core elements : 1. Packaging Hierarchy (unlimited no.), per pack. level

2. Device Identifier / Unit of Measure / Quantity

3. Manufacturer Name

4. Manufacturer Contact Information (address, email, phone)

5. Nomenclature (e.g. GMDN code)

6. Nomenclature Term (e.g. GMDN term)

7. Trade Name

8. Device Model Number (REF No./catalog no.)

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. Containing Latex

18. Authorized Representatives (list of countries and addresses)

19. License / marketing Authorization (e.g. registration no.)

20. URL for additional information

21. Critical warnings or contraindications

+ local elements ?

manufact. need to ensure

• data availability in e-format

• data quality / accuracy

• up-to-dateness

• proper processes (data maintenance + upload to 3rd-party)

Key Challenge : UDI Database

12

UDIDMD identification

+ labeling

From how many sources do we have to collect this information ?

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UDID

US

UDID

EU (?)

UDID

AP (?)

UDID

??

network

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 !

UDID

??

Key Challenge : UDI Database

13

Volker Zeinar | Unique Device Identification 'UDI' | Seite 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 + uploadmany people need to be sensitized !

Volker Zeinar | Unique Device Identification 'UDI' | Seite

Thank you very much for your attention !