• Like
Unique Device Identification A Manufacturers View
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

Unique Device Identification A Manufacturers View

  • 1,052 views
Published

Unique Device Identification A Manufacturers View

Unique Device Identification A Manufacturers View

Published in Business , Health & Medicine
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Be the first to comment
No Downloads

Views

Total Views
1,052
On SlideShare
0
From Embeds
0
Number of Embeds
0

Actions

Shares
Downloads
27
Comments
0
Likes
1

Embeds 0

No embeds

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
    No notes for slide

Transcript

  • 1. Unique Device IdentificationA Manufacturers ViewVolker Zeinar Paul GeelenB. Braun Melsungen AG B. Braun Medical BVGlobal Coordination Auto-ID Affairs Pharmacist, QA&RA-managerAmsterdam, 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 1021948 1950 1952 1954 1956 1958 1960 1964 1966 1968 1970 1972 1974 1976 1980 1982 1984 1986 1988 1990 1994 1996 1998 2001 2003 2005 2007 1962 1978 1992 2009 Volker Zeinar | Unique Device Identification UDI | Seite 2
  • 3. Importance of the Implementation Sequence, Medical Devices Both in parallel : AIDC + UDID entriesUDI 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 samplesample ‚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 Markingno problem atbigger 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 TodayCarton (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 consuming1. technical feasibility studies - pack. material, print technology, ink, impact on production speed, …2. investment planning + release Sponsor  TOP Management3. new hardware / software (for in-line printing) Technical Regulatory4. label artwork / packaging paper Engineering Label Design - redesign to have space for AIDC carriers Quality Control5. technical engineering efforts Production - HW installation, lines 7 days/24h in use, … IT Marketing6. perform test trials Finance Sales7. 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 methods8. process qualification and validation9. 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 DatabaseSet of global core elements :1. Packaging Hierarchy (unlimited no.), per pack. level manufact. need to ensure2. Device Identifier / Unit of Measure / Quantity • data availability in e-format3. Manufacturer Name4. Manufacturer Contact Information (address, email, phone) • data quality / accuracy5. Nomenclature (e.g. GMDN code) • up-to-dateness6. Nomenclature Term (e.g. GMDN term)7. Trade Name • proper processes8. 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 Conditions13. Labeled as ‘single use’14. Sterility / Package sterile15. Need to be sterilized before use16. Restricted number of reuses17.18. Containing Latex Authorized Representatives (list of countries and addresses) UDID MD identification19. License / marketing Authorization (e.g. registration no.) + labeling20. URL for additional information21. 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 ! Volker Zeinar | Unique Device Identification UDI | Seite 13
  • 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 ! Volker Zeinar | Unique Device Identification UDI | Seite 14
  • 15. Thank you very much for your attention !Volker Zeinar | Unique Device Identification UDI | Seite