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Tips for Implementing
FDA UDI without Derailing
              Production
Agenda
    Welcome and Introductions

    Gain an understanding of UDI in practical terms

    View the planned timeline for proposed FDA UDI regulations

    Evaluate the benefits of implementing bar-coding using GS1
    standards

    Understand how labeling systems can remove the perceived
    complexities of FDA UDI regulations

    Learn how to implement UDI with minimal impact on your
    organization
Presenters
• Jay Crowley, FDA


• Janice Kite, GS1 Global Office


• Chris Miller, PRISYM ID
PRISYM ID


              Experts in
                                      Printing                    Global
Experienced    21 CFR      GAMP V                  Integration
                                    Technologies                 Customers
                Part 11
Our Clients
Device Information Lifecycle
                            GPOs                                          Rentals
                                                       Clinical
 Manufacturer                                        Substitution
                                                                            Sold
                                   Distributor
             Device X
  Reuse       Lot Y                  Direct               Hospital       Physician
            Exp Date Z                                                   preference
                                     Recall
 Reorder                                                                 Off-master
                                                                          purchase
            Clinical Use                                   Unit
                                    Sales Rep                            Hoarding
Reimbursement
                                           AE Reporting
                    EHR                                                Postmarket
   Registries                            Population Databases          Surveillance

                         Comparative                         FDA’s Sentinel System
                         Effectiveness
                                           FDA
The History of FDA’s UDI
•   1999 IOM Report – To Err is Human
•   2004 FDA Barcode Rule
•   2005 and 2006 FDA/FDLI Meeting on UDI
•   2005 FDA Contracted White Papers on UDI
•   2006 FDA Public Meeting
•   2006 Docket No. FDA-2006N-0292
•   2007 FDA Amendments Act of 2007
•   2008 GHTF Ad-Hoc Working Group on UDI
•   2009 FDA Workshop on UDI
•   2009 Docket No. FDA-2008-N-0661
•   2009 GHTF AHWG submits recommendations


                        FDA
Current Device Identification
• Non-standard device identification systems; standards
  used in different ways
• Not necessary unique or unambiguous
• Does not include all necessary levels of uniqueness
• Manufacturers’ own number/catalogue number
• Distributors’ – apply different, proprietary number; lot
  or serial number not captured
• Hospital – yet different identification number/code
  • Information on use not usually captured
  • Control numbers rarely captured

                             FDA
Current Device Identification
      Business Name            Item Number Type        Item Number
BD                       Mfg Catalog Number       329461
BD                       GTIN                     00382903294619
BD                       GTIN                     30382903294610
BD                       GTIN                     50382903294614
Cardinal Health          PV Order Number          BF329461
Owens & Minor            PV Order Number          0722329461
Owens & Minor            PV Order Number          0723329461
American Medical Depot   Vendor Catalog Number    777127217
American Medical Depot   Vendor Catalog Number    777127218
Government Sci Source    Vendor Catalog Number    FSC1482679CS
Government Sci Source    Vendor Catalog Number    FSC1482679PK
Alliance Joint Venture   Vendor Catalog Number    888021932
Thomas Scientific        Vendor Catalog Number    8938M25
Thomas Scientific        Vendor Catalog Number    8938M28
VWR International        Vendor Catalog Number    BD329461
                                 FDA
Medical Device Adverse Events
For 2007, we received ~ +100k reports
• ~ 15% lacked model or catalogue number
• ~ 50% lacked lot or other identifier
• ~ 10% lacked both

The face of things to come…
(01)00802526255410(17)080531(10)6062151


                       FDA
Medical Device Recalls (2007)
• 41 Class I recalls
• 931 Class II recalls
• 78 Class III recalls
• Class I – 28M units (devices by lots, kits, etc)
  Range 4-27M (Moistureplus Solution)
• For March 2007 – 142 Class II recalls
  35M individual units (just one month)
  Range 1-33M (Lifescan one touch test strips)


                          FDA
UDI Can Improve… Visibility
• Medical device recalls
• Adverse event reporting and postmarket surveillance
• Tracking and tracing, supply chain security; and anti-
  counterfeiting/diversion (location systems)
• Comparative effectiveness (e.g., registries)
• Disaster/terror preparation and shortages/substitutions
• Reduce medical errors
• Documenting medical device use in patient’s
  EHR/PHR, hospital information systems, claims data
• Sentinel Initiative - strengthening FDA’s ability to
  query data systems for relevant device information
                          FDA
Medical Device Identification
Develop a system to identify medical devices, which is:
• Consistent
• Unambiguous (differentiates among all dimensions)
• Standardized
• Unique at all levels of packaging
• Harmonized internationally

And facilitates the:
• Storage,
• Exchange, and
• Integration of data and systems
                          FDA
UDI Public Workshop
12 February 09 - 300 people attended; 4000
webcast
 4 Panels addressed issues related to:
 • Developing standardized UDIs
 • Placing the UDI in human readable and/or AutoID
   on a device, its label, or both
 • Creating and maintaining the UDI Database
 • Promoting adoption and implementation
 Received 60 written comments.
                       FDA
GHTF UDI ADWG
• Formed October 2008
• EC Chair (Laurent Selles)
• Members US (FDA, AdvaMed), Europe (EC,
  Eucomed, EDMA, Matthias Neumann), Japan
  (Hiroshi Ishikawa), Canada (Chris Rose)
• AHWP recently joined (China)
• Public Document – available at:
  www.ghtf.org/documents/AHWG-PD1-N2R1.doc
• Final guidance due for Nov 2010 SC meeting

                      FDA
FDA Amendments Act of 2007
September 27, 2007, the FDAAA signed into law:
 The Secretary shall promulgate regulations
 establishing a unique device identification system
 for medical devices requiring the label of devices
 to bear a unique identifier, unless the Secretary
 requires an alternative placement or provides an
 exception for a particular device or type of device.
 The unique identifier shall adequately identify the
 device through distribution and use, and may
 include information on the lot or serial number.
                         FDA
Establishing a UDI System
Combination of 4 distinct steps:
1. Develop a standardized system to develop the
   unique device identifiers (UDI)
2. Place the UDI in human readable and/or AutoID on
   a device, its label, or both
3. Create and maintain the UDI Database
4. Adoption and Implementation



                       FDA
1 st   – Developing the UDI
• Develop UDI code according to ISO 15459 [GS1,
  HIBCC]
• Created and maintained by the manufacturer
• Concatenating Device and Production Identifier
• Device Identifier (DI): [static] Manufacturer, make,
  model [i.e., each catalogue number]
• Production Identifier (PI): [dynamic] if currently
  serialized – serial number; if currently identified at
  the lot, the lot number, and expiration date
• Risk based approach – DI; DI + lot; DI + serial (or
  lot and serial)
                         FDA
2 nd   – UDI Application
• Applied at all levels of packaging, down to the
  lowest level (the patient use level or unit of use)
• Human readable and/or encoded in a form of
  automatic identification technology
• Direct Part Marking (DPM) for some devices
• No specific technology would be identified
  (technology neutral)
• Identify a series of standards (linear barcode, 2-
  dimensional barcode, RFID)
                         FDA
UDI Application Example




          FDA
3rd - UDI Database
                 Development
•   Device Identifier Type/Code [GTIN, HIBCC]
•   Make/model; Brand/Trade Name; Description
•   Device model number (or reference number)
•   Size; Unit of Measure/Packaging level/quantity
•   Control – Lot and/or Serial Number; Exp. Date
•   Contact name, phone, email
•   GMDN Classification code/term
•   Storage condition; Single Use; Sterility; Restricted Use
•   Contains known, labeled allergen (e.g., latex)
•   URL for additional information – Web address
•   Special Instruction for use
                             FDA
•   Device Identifier: GS1 2081090010024
•   Endopath Dextrus Finger Mounting Locking Forceps
•   Ethicon Endo-Surgery Inc, Cincinnati, Ohio
•   Jane Smith; 1-888-888-8888; JSmith@JNJ.com
•   Controlled by Lot; Expiration Date
•   Packaged sterile; Single Use; Prescription
•   GMDN code: 12345; Manufactured in Israel
•   Package of 1; Storage conditions: between 0-24º C
•   Does not contain latex or PVC
                            FDA
FDA’s UDI Database
                            The label of Medical Device 123 Size 45:
                              Device Identifier (Device XYZ123)
Manufacturer
                               Production Identifier (Lot #ABC)          Distribution
  (Acme)
                                Expiration date (MMDDYYYY)
                                        Sterile; Latex free

Minimum Data Set
                                                                           FDA
For each Device Identifier:
• Manufacturer and model
• GMDN Code                                       FDA Managed
• Other attributes

                GSI GDSN
                                    HL7 SPL           Business           FDA’s UDI
                                                       Rules              Database
Other options




                   or
                HIBCC UPN
                   or                                      Public User
                FDA eList                                   Interface
4th – Adoption and
          Implementation
• Resolve technology issues – barcodes, RFID, DPM
• Develop appropriate UDI Database
• Facilitate distributor uptake and use
• Facilitate hospital uptake and use
• Facilitate use of UDI throughout device lifecycle
• Develop medical error reduction (e.g., latex)
• Drive integration – MMIS-Clinical
• Drive appropriate use of UDI in EMRs
• Determine appropriate role in reimbursement
• Address privacy concerns

                       FDA
Limitations of UDI and UDID
• UDI is a foundational element – it unambiguously
  identifies a specific device (at its unit of use).
• Benefits accrue only if used by all stakeholders.
• UDID contains only “static” identifying and product
  information.
• UDID does NOT contain production information, such
  as lot or serial numbers – and is NOT track/trace or
  other similar purposes requiring the full UDI.
• UDID provides link to Better Product Information- not
  a replacement for Recalls/Adverse Event Databases.

                          FDA
GS1 and UDI
             Where are they linked?
             How are they linked?



                                      26
© 2010 GS1
GS1 and UDI


                     GS1 Standards
              will enable the effective and
             efficient implementation of UDI
                        worldwide.




                                               27
© 2010 GS1
GS1 Vision


    GS1 is a leading global organization dedicated
      to the design and implementation of global
       standards and solutions to improve the
        efficiency and visibility of supply and
     demand chains globally and across sectors.




                                                 28
© 2010 GS1
GS1 Around the World




     Countries with a
     GS1 Member
     Organization

     Countries served on a
     direct basis from GS1
     Global Office (Brussels)




                  108 Member Organizations - 150 Countries served
                   Neutral platform for all supply chain stakeholders
                                  1.2 million members
                                 30 years of experience
© 2010 GS1
Global Reach



             Driving standards development
                and global harmonization

                                             30
© 2010 GS1
Voluntary, Global
                           Healthcare User Group




                  To lead the healthcare sector to the successful
             development and implementation of global standards by
                bringing together experts in healthcare to enhance
                  patient safety and supply chain efficiencies.

© 2010 GS1
Leading Healthcare
                         Organizations Pave the Way…
             Corporate members of the global user group




                                                          32
© 2010 GS1
Leading Healthcare
                             Organizations Pave the Way…
             Healthcare providers and Group Purchasing
                     Organizations going global



      France       Germany     Netherlands    Hong Kong     Switzerland




    Germany        Germany          USA           Austria       USA




                 Ireland        Netherlands      France       USA
                                                                          33
© 2010 GS1
Example UDI




   UDI Mark                                         Dynamic part
                     Static part
               Product identifier (GTIN)   Production identifier (serial or lot
                                               number, & expiry date)
© 2010 GS1
Example UDI (2)




             UDI Mark
                               Static part                    Dynamic part
                         Product identifier (GTIN)   Production identifier (serial or lot
                                                         number, & expiry date)
© 2010 GS1
36
© 2010 GS1
European Commission & UDI



  • Avoid the multiplication of national systems at the
    EC level
  • Develop an international approach

          “A balance has to be found between
    the potentialities of UDI and the feasibility of UDI”



                                                          37
© 2010 GS1
Eucomed position


        • UDI is coming

        • UDI must be developed in a harmonized and global
          manner

        • Country-specific requirements on UDI (e.g. numbering
          systems) would have major impact on multiple country
          device configurations




                                                                 38
© 2010 GS1
Same Level of Identification for Every Medical Device?

   Extreme diversity in size, materials, processing, use and criticality
             – needs to be considered for any identification rules!
             – some differences on UDI needed, at least on required information

   Examples*:
             – pacemakers, hip replacements      : device ID + serial no. + lot no.
             – catheters, needles                : device ID + lot no.
             – syringes, stopcocks               : device ID
             – Single use commodity devices      : no UDI



         *Examples vary on specific devices,
             usage, packaging levels,....


       Risk-based approach

                                                                                      39   16
© 2010 GS1                                      www.eucomed.org
What do we need from an industry perspective?


         The industry
       needs a Global
       Standard system




      Only global and open standards enable the realization of all healthcare and
                          economic benefits related to UDI


© 2010 GS1                           www.eucomed.org
                                                                                40   21
The Way to Move Ahead

   ► A global initiative - GS1 & GS1-Healthcare are currently developing and
         enhancing standards, specifically for healthcare. Eucomed and ETF support
         this initiative actively.

   ► Eucomed and ETF
             – recommend introducing the use of global GS1 Standards at any opportunity deemed
                appropriate for a cost-efficiency and quality point of view
             – believe that companies implementing these standards will be best positioned to meet
                customer expectations now and in the future




                                                                                                 41   22
© 2010 GS1                                      www.eucomed.org
Product Marking Grids
                                                                                  An ID “landscape”                                         M
                                MINIMUM Level of AIDC Marking (Retail)             MINIMUM Level of AIDC Marking (Non-Retail)               I          ENHANCED Level of AIDC Marking                                         HIGHEST Level of AIDC Marking
                                                                                                                                            N
                               Pharmaceuticals            Medical Devices           Pharmaceuticals             Medical Devices                    Medical Devices                Medical Devices                    Pharmaceuticals                Medical Devices

                             Distributed and/or Sold   Distributed and/or Sold    Distributed and/or Sold    Distributed and/or Sold            Distributed and/or Sold        Distributed and/or Sold        Distributed and/or Sold Via        Distributed and/or Sold
                                  Primarily Via              Primarily Via             Primarily Via               Primarily Via                      Primarily Via                  Primarily Via                   Retail and/or                     Primarily Via
                                Retail Channels            Retail Channels         Non-Retail Channels        Non-Retail Channels                   Retail Channels             Non-Retail Channels              Non-Retail Channels              Non-Retail Channels
       Direct Part Mark                                                                                                                                                                                                                                     GTIN
       (AIDC marked                                                                                                                                                                                                                                         Serial No.
       directly onto a
       single,                                                                                                                                                                                                                                              -Not for
       unpackaged,                                                                                                                                                                                                                                          Implants
       unlabeled item)
                                          No Marking                 No Marking                 No Marking                     No Marking                         No Marking                     No Marking                        No Marking
                                                                                                                                                                                                                                                            Hospital:
                                                                                                                                                                                                                                                            -8003/8004
                                                                                                                                                                                                                                                            -optional
       Primary Package
       (AIDC marked onto
       the first level of
       packaging, either
       on the packaging
       or on a label
       affixed to                                                                                                                                                                                                               GTIN                         GTIN
       packaging. May                                                                                                                                                                                                                                        Lot
       consist of 1 single               No Marking                 No Marking              GTIN                              No Marking                          No Marking                                                    Hospital:                    Expiry
       item, or a group of                                                                                                                                                                                                      AI(01)+AI(21)                Serial No.
                                         (mark with                 (mark with                                                (mark with                          (mark with                                                    +AI(7003)                    Potency (kits)
       items for a single
                                         GTIN if no                 GTIN if no                                                GTIN if no                          GTIN if no                  GTIN
       therapy such as a
                                         Secondary                  Secondary                                                 Secondary                           Secondary                   Lot                                                            Hospital:
       Kit.)                                                                                                                                                                                  Expiry
                                         Package)                   Package)                                                  Package)                            Package)                                                                                   -8003/8004
                                                                                                                                                                                                                                                             -optional
       Secondary                                                                                                                                                                                                                [Need 2 marks]
       Packaging                                                                                              12 Syringes                        2 Contact Lens                 6 Catheters                                     GTIN                         GTIN
       (AIDC marked onto                                                                                                                                                                                                        Lot                          Lot
       the next level of                                                                                                                                                                                                        Expiry                       Expiry
       packaging,                                                                                                                                                                                                               Serial No.                   Serial No.
       containing one or                                                                                                                                                                                                        Potency                      Potency (kits)
       more single items
       in their Primary                GTIN                       GTIN                      GTIN                            GTIN                            GTIN                              GTIN                              Hospital:                    Hospital:
       Packaging)                                                                           Lot                             Lot                                                               Lot                               AI(01)+AI(21)                -8003/8004
                                                                                            Expiry                          Expiry                                                            Expiry                            +AI(7003)                    -optional


       Case / Shipper
       (AIDC marked onto
                                                                                                                                                                                                                                                             Trade Item:
       a shipping
                                                                                                                                                                                                                                                             -GTIN
       container. May                                             Trade Item:                                                                               Trade Item:                       Trade Item:                                                    -Lot
                                        Trade Item:                                          Trade Item:                    Trade Item:                                                                                         Trade Item:
       contain one or                   -GTIN                     -GTIN                      -GTIN                                                          -GTIN                             -GTIN           Logistics:                                     -Expiry
                                                                                                                            -GTIN                                                                                               -GTIN
       more items in their              -Lot                      -Lot                       -Lot                           -Lot                            -Lot                              -Lot            -SSCC             -Lot                         -Serial No.
       Primary Packaging                -Expiry                   -Expiry                    -Expiry                        -Expiry                         -Expiry                           -Expiry                           -Expiry                      -Potency (kits)
       and/or Secondary                                                                                                                                                                                       Hospital:         -Serial No.
       Packaging.)                      Logistics:                Logistics:                 Logistics:                     Logistics:                      Logistics:                        Logistics:      AI(01)+AI(21)     -Potency                     Logistics:
                                        -SSCC                     -SSCC                      -SSCC                          -SSCC                           -SSCC                             -SSCC           +AI(7003)                                      -SSCC


       Pallet                                                                                                                                                                                                                   Trade Item:                  Trade Item:
       (AIDC marked onto                                                                                                                                                                                                        -GTIN                        -GTIN
                                        Trade Item:               Trade Item:                Trade Item:                    Trade Item:                     Trade Item:                       Trade Item:
       a pallet. May                                                                                                                                                                                                            -Lot                         -Lot
                                        -GTIN                     -GTIN                      -GTIN                          -GTIN                           -GTIN                             -GTIN
       contain one or                   -Lot                      -Lot                       -Lot                                                           -Lot                              -Lot                              -Expiry                      -Expiry
                                                                                                                            -Lot
       more Case /                      -Expiry                   -Expiry                    -Expiry                        -Expiry                         -Expiry                           -Expiry                           -Serial No.                  -Serial No.
       Shippers.)
                                        Logistics:                Logistics:                 Logistics:                                                     Logistics:                        Logistics:                        Logistics:                   Logistics:
                                                                                                                            Logistics:
                                        -SSCC                     -SSCC                      -SSCC                                                          -SSCC                             -SSCC                             -SSCC                        -SSCC
                                                                                                                            -SSCC




                                                      A risk-based approach is necessary
© 2010 GS1
GS1 Standards enable UDI




                                        43
© 2010 GS1
GS1 System of Standards

  An integrated approach
                                          Global reach
 •Standardized identification keys
     •Products, locations, assets, …
 •Standardized data carriers
     •Bar codes & RFID                       Open standards
 •Standardized sharing of static data
     •Data on products & locations
 •Standardized sharing of dynamic data
     •Event data                          Proven standards
 •Standardized electronic communication




                                                         44
© 2010 GS1
UDI
             Unique Device Identification
                       Not IF…

                 But WHEN and HOW


                                            45
© 2010 GS1
Turning Regulations into Reality

 • You know when

 • You know about the
   standards

 • It’s now how to make
   it a reality
Unique Device Identification



 Design       Correct     Correct
Exercise     variables    barcode
Application Labeling
                                   More than
                                   just print
                                     time
                                   variables


                    Thin/ Thick                   Approval
                      Client                     Management




        GMP based
                                  PRISYM                         Version
                                                                 Control
                                  Medica



                21 CFR Part
                                                 Audit History
                    11



                                   Data Driven
                                    Printing
Summary

                GS1
 The right                 Good
 software                  Design

              UDI can be
             implemented
                without
               Derailing
              Production
Q    FDA – Jay Crowley
     T + 1 301-980-1936




 A
     E jay.crowley@fda.hhs.gov
     W www.fda.gov

     GS1 Global Office – Janice Kite
     T + 32 2 788 78 00
     W www.gs1.org


     PRISYM ID
     T +44 1189364403
     E hollypurchase@prisymid.com
     W www.prisymid.com

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Prisym UDI Implementation

  • 1. Tips for Implementing FDA UDI without Derailing Production
  • 2. Agenda Welcome and Introductions Gain an understanding of UDI in practical terms View the planned timeline for proposed FDA UDI regulations Evaluate the benefits of implementing bar-coding using GS1 standards Understand how labeling systems can remove the perceived complexities of FDA UDI regulations Learn how to implement UDI with minimal impact on your organization
  • 3. Presenters • Jay Crowley, FDA • Janice Kite, GS1 Global Office • Chris Miller, PRISYM ID
  • 4. PRISYM ID Experts in Printing Global Experienced 21 CFR GAMP V Integration Technologies Customers Part 11
  • 6. Device Information Lifecycle GPOs Rentals Clinical Manufacturer Substitution Sold Distributor Device X Reuse Lot Y Direct Hospital Physician Exp Date Z preference Recall Reorder Off-master purchase Clinical Use Unit Sales Rep Hoarding Reimbursement AE Reporting EHR Postmarket Registries Population Databases Surveillance Comparative FDA’s Sentinel System Effectiveness FDA
  • 7. The History of FDA’s UDI • 1999 IOM Report – To Err is Human • 2004 FDA Barcode Rule • 2005 and 2006 FDA/FDLI Meeting on UDI • 2005 FDA Contracted White Papers on UDI • 2006 FDA Public Meeting • 2006 Docket No. FDA-2006N-0292 • 2007 FDA Amendments Act of 2007 • 2008 GHTF Ad-Hoc Working Group on UDI • 2009 FDA Workshop on UDI • 2009 Docket No. FDA-2008-N-0661 • 2009 GHTF AHWG submits recommendations FDA
  • 8. Current Device Identification • Non-standard device identification systems; standards used in different ways • Not necessary unique or unambiguous • Does not include all necessary levels of uniqueness • Manufacturers’ own number/catalogue number • Distributors’ – apply different, proprietary number; lot or serial number not captured • Hospital – yet different identification number/code • Information on use not usually captured • Control numbers rarely captured FDA
  • 9. Current Device Identification Business Name Item Number Type Item Number BD Mfg Catalog Number 329461 BD GTIN 00382903294619 BD GTIN 30382903294610 BD GTIN 50382903294614 Cardinal Health PV Order Number BF329461 Owens & Minor PV Order Number 0722329461 Owens & Minor PV Order Number 0723329461 American Medical Depot Vendor Catalog Number 777127217 American Medical Depot Vendor Catalog Number 777127218 Government Sci Source Vendor Catalog Number FSC1482679CS Government Sci Source Vendor Catalog Number FSC1482679PK Alliance Joint Venture Vendor Catalog Number 888021932 Thomas Scientific Vendor Catalog Number 8938M25 Thomas Scientific Vendor Catalog Number 8938M28 VWR International Vendor Catalog Number BD329461 FDA
  • 10. Medical Device Adverse Events For 2007, we received ~ +100k reports • ~ 15% lacked model or catalogue number • ~ 50% lacked lot or other identifier • ~ 10% lacked both The face of things to come… (01)00802526255410(17)080531(10)6062151 FDA
  • 11. Medical Device Recalls (2007) • 41 Class I recalls • 931 Class II recalls • 78 Class III recalls • Class I – 28M units (devices by lots, kits, etc) Range 4-27M (Moistureplus Solution) • For March 2007 – 142 Class II recalls 35M individual units (just one month) Range 1-33M (Lifescan one touch test strips) FDA
  • 12. UDI Can Improve… Visibility • Medical device recalls • Adverse event reporting and postmarket surveillance • Tracking and tracing, supply chain security; and anti- counterfeiting/diversion (location systems) • Comparative effectiveness (e.g., registries) • Disaster/terror preparation and shortages/substitutions • Reduce medical errors • Documenting medical device use in patient’s EHR/PHR, hospital information systems, claims data • Sentinel Initiative - strengthening FDA’s ability to query data systems for relevant device information FDA
  • 13. Medical Device Identification Develop a system to identify medical devices, which is: • Consistent • Unambiguous (differentiates among all dimensions) • Standardized • Unique at all levels of packaging • Harmonized internationally And facilitates the: • Storage, • Exchange, and • Integration of data and systems FDA
  • 14. UDI Public Workshop 12 February 09 - 300 people attended; 4000 webcast 4 Panels addressed issues related to: • Developing standardized UDIs • Placing the UDI in human readable and/or AutoID on a device, its label, or both • Creating and maintaining the UDI Database • Promoting adoption and implementation Received 60 written comments. FDA
  • 15. GHTF UDI ADWG • Formed October 2008 • EC Chair (Laurent Selles) • Members US (FDA, AdvaMed), Europe (EC, Eucomed, EDMA, Matthias Neumann), Japan (Hiroshi Ishikawa), Canada (Chris Rose) • AHWP recently joined (China) • Public Document – available at: www.ghtf.org/documents/AHWG-PD1-N2R1.doc • Final guidance due for Nov 2010 SC meeting FDA
  • 16. FDA Amendments Act of 2007 September 27, 2007, the FDAAA signed into law: The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number. FDA
  • 17. Establishing a UDI System Combination of 4 distinct steps: 1. Develop a standardized system to develop the unique device identifiers (UDI) 2. Place the UDI in human readable and/or AutoID on a device, its label, or both 3. Create and maintain the UDI Database 4. Adoption and Implementation FDA
  • 18. 1 st – Developing the UDI • Develop UDI code according to ISO 15459 [GS1, HIBCC] • Created and maintained by the manufacturer • Concatenating Device and Production Identifier • Device Identifier (DI): [static] Manufacturer, make, model [i.e., each catalogue number] • Production Identifier (PI): [dynamic] if currently serialized – serial number; if currently identified at the lot, the lot number, and expiration date • Risk based approach – DI; DI + lot; DI + serial (or lot and serial) FDA
  • 19. 2 nd – UDI Application • Applied at all levels of packaging, down to the lowest level (the patient use level or unit of use) • Human readable and/or encoded in a form of automatic identification technology • Direct Part Marking (DPM) for some devices • No specific technology would be identified (technology neutral) • Identify a series of standards (linear barcode, 2- dimensional barcode, RFID) FDA
  • 21. 3rd - UDI Database Development • Device Identifier Type/Code [GTIN, HIBCC] • Make/model; Brand/Trade Name; Description • Device model number (or reference number) • Size; Unit of Measure/Packaging level/quantity • Control – Lot and/or Serial Number; Exp. Date • Contact name, phone, email • GMDN Classification code/term • Storage condition; Single Use; Sterility; Restricted Use • Contains known, labeled allergen (e.g., latex) • URL for additional information – Web address • Special Instruction for use FDA
  • 22. Device Identifier: GS1 2081090010024 • Endopath Dextrus Finger Mounting Locking Forceps • Ethicon Endo-Surgery Inc, Cincinnati, Ohio • Jane Smith; 1-888-888-8888; JSmith@JNJ.com • Controlled by Lot; Expiration Date • Packaged sterile; Single Use; Prescription • GMDN code: 12345; Manufactured in Israel • Package of 1; Storage conditions: between 0-24º C • Does not contain latex or PVC FDA
  • 23. FDA’s UDI Database The label of Medical Device 123 Size 45: Device Identifier (Device XYZ123) Manufacturer Production Identifier (Lot #ABC) Distribution (Acme) Expiration date (MMDDYYYY) Sterile; Latex free Minimum Data Set FDA For each Device Identifier: • Manufacturer and model • GMDN Code FDA Managed • Other attributes GSI GDSN HL7 SPL Business FDA’s UDI Rules Database Other options or HIBCC UPN or Public User FDA eList Interface
  • 24. 4th – Adoption and Implementation • Resolve technology issues – barcodes, RFID, DPM • Develop appropriate UDI Database • Facilitate distributor uptake and use • Facilitate hospital uptake and use • Facilitate use of UDI throughout device lifecycle • Develop medical error reduction (e.g., latex) • Drive integration – MMIS-Clinical • Drive appropriate use of UDI in EMRs • Determine appropriate role in reimbursement • Address privacy concerns FDA
  • 25. Limitations of UDI and UDID • UDI is a foundational element – it unambiguously identifies a specific device (at its unit of use). • Benefits accrue only if used by all stakeholders. • UDID contains only “static” identifying and product information. • UDID does NOT contain production information, such as lot or serial numbers – and is NOT track/trace or other similar purposes requiring the full UDI. • UDID provides link to Better Product Information- not a replacement for Recalls/Adverse Event Databases. FDA
  • 26. GS1 and UDI Where are they linked? How are they linked? 26 © 2010 GS1
  • 27. GS1 and UDI GS1 Standards will enable the effective and efficient implementation of UDI worldwide. 27 © 2010 GS1
  • 28. GS1 Vision GS1 is a leading global organization dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors. 28 © 2010 GS1
  • 29. GS1 Around the World Countries with a GS1 Member Organization Countries served on a direct basis from GS1 Global Office (Brussels) 108 Member Organizations - 150 Countries served Neutral platform for all supply chain stakeholders 1.2 million members 30 years of experience © 2010 GS1
  • 30. Global Reach Driving standards development and global harmonization 30 © 2010 GS1
  • 31. Voluntary, Global Healthcare User Group To lead the healthcare sector to the successful development and implementation of global standards by bringing together experts in healthcare to enhance patient safety and supply chain efficiencies. © 2010 GS1
  • 32. Leading Healthcare Organizations Pave the Way… Corporate members of the global user group 32 © 2010 GS1
  • 33. Leading Healthcare Organizations Pave the Way… Healthcare providers and Group Purchasing Organizations going global France Germany Netherlands Hong Kong Switzerland Germany Germany USA Austria USA Ireland Netherlands France USA 33 © 2010 GS1
  • 34. Example UDI UDI Mark Dynamic part Static part Product identifier (GTIN) Production identifier (serial or lot number, & expiry date) © 2010 GS1
  • 35. Example UDI (2) UDI Mark Static part Dynamic part Product identifier (GTIN) Production identifier (serial or lot number, & expiry date) © 2010 GS1
  • 37. European Commission & UDI • Avoid the multiplication of national systems at the EC level • Develop an international approach “A balance has to be found between the potentialities of UDI and the feasibility of UDI” 37 © 2010 GS1
  • 38. Eucomed position • UDI is coming • UDI must be developed in a harmonized and global manner • Country-specific requirements on UDI (e.g. numbering systems) would have major impact on multiple country device configurations 38 © 2010 GS1
  • 39. Same Level of Identification for Every Medical Device? Extreme diversity in size, materials, processing, use and criticality – needs to be considered for any identification rules! – some differences on UDI needed, at least on required information Examples*: – pacemakers, hip replacements : device ID + serial no. + lot no. – catheters, needles : device ID + lot no. – syringes, stopcocks : device ID – Single use commodity devices : no UDI *Examples vary on specific devices, usage, packaging levels,.... Risk-based approach 39 16 © 2010 GS1 www.eucomed.org
  • 40. What do we need from an industry perspective? The industry needs a Global Standard system Only global and open standards enable the realization of all healthcare and economic benefits related to UDI © 2010 GS1 www.eucomed.org 40 21
  • 41. The Way to Move Ahead ► A global initiative - GS1 & GS1-Healthcare are currently developing and enhancing standards, specifically for healthcare. Eucomed and ETF support this initiative actively. ► Eucomed and ETF – recommend introducing the use of global GS1 Standards at any opportunity deemed appropriate for a cost-efficiency and quality point of view – believe that companies implementing these standards will be best positioned to meet customer expectations now and in the future 41 22 © 2010 GS1 www.eucomed.org
  • 42. Product Marking Grids An ID “landscape” M MINIMUM Level of AIDC Marking (Retail) MINIMUM Level of AIDC Marking (Non-Retail) I ENHANCED Level of AIDC Marking HIGHEST Level of AIDC Marking N Pharmaceuticals Medical Devices Pharmaceuticals Medical Devices Medical Devices Medical Devices Pharmaceuticals Medical Devices Distributed and/or Sold Distributed and/or Sold Distributed and/or Sold Distributed and/or Sold Distributed and/or Sold Distributed and/or Sold Distributed and/or Sold Via Distributed and/or Sold Primarily Via Primarily Via Primarily Via Primarily Via Primarily Via Primarily Via Retail and/or Primarily Via Retail Channels Retail Channels Non-Retail Channels Non-Retail Channels Retail Channels Non-Retail Channels Non-Retail Channels Non-Retail Channels Direct Part Mark GTIN (AIDC marked Serial No. directly onto a single, -Not for unpackaged, Implants unlabeled item) No Marking No Marking No Marking No Marking No Marking No Marking No Marking Hospital: -8003/8004 -optional Primary Package (AIDC marked onto the first level of packaging, either on the packaging or on a label affixed to GTIN GTIN packaging. May Lot consist of 1 single No Marking No Marking GTIN No Marking No Marking Hospital: Expiry item, or a group of AI(01)+AI(21) Serial No. (mark with (mark with (mark with (mark with +AI(7003) Potency (kits) items for a single GTIN if no GTIN if no GTIN if no GTIN if no GTIN therapy such as a Secondary Secondary Secondary Secondary Lot Hospital: Kit.) Expiry Package) Package) Package) Package) -8003/8004 -optional Secondary [Need 2 marks] Packaging 12 Syringes 2 Contact Lens 6 Catheters GTIN GTIN (AIDC marked onto Lot Lot the next level of Expiry Expiry packaging, Serial No. Serial No. containing one or Potency Potency (kits) more single items in their Primary GTIN GTIN GTIN GTIN GTIN GTIN Hospital: Hospital: Packaging) Lot Lot Lot AI(01)+AI(21) -8003/8004 Expiry Expiry Expiry +AI(7003) -optional Case / Shipper (AIDC marked onto Trade Item: a shipping -GTIN container. May Trade Item: Trade Item: Trade Item: -Lot Trade Item: Trade Item: Trade Item: Trade Item: contain one or -GTIN -GTIN -GTIN -GTIN -GTIN Logistics: -Expiry -GTIN -GTIN more items in their -Lot -Lot -Lot -Lot -Lot -Lot -SSCC -Lot -Serial No. Primary Packaging -Expiry -Expiry -Expiry -Expiry -Expiry -Expiry -Expiry -Potency (kits) and/or Secondary Hospital: -Serial No. Packaging.) Logistics: Logistics: Logistics: Logistics: Logistics: Logistics: AI(01)+AI(21) -Potency Logistics: -SSCC -SSCC -SSCC -SSCC -SSCC -SSCC +AI(7003) -SSCC Pallet Trade Item: Trade Item: (AIDC marked onto -GTIN -GTIN Trade Item: Trade Item: Trade Item: Trade Item: Trade Item: Trade Item: a pallet. May -Lot -Lot -GTIN -GTIN -GTIN -GTIN -GTIN -GTIN contain one or -Lot -Lot -Lot -Lot -Lot -Expiry -Expiry -Lot more Case / -Expiry -Expiry -Expiry -Expiry -Expiry -Expiry -Serial No. -Serial No. Shippers.) Logistics: Logistics: Logistics: Logistics: Logistics: Logistics: Logistics: Logistics: -SSCC -SSCC -SSCC -SSCC -SSCC -SSCC -SSCC -SSCC A risk-based approach is necessary © 2010 GS1
  • 43. GS1 Standards enable UDI 43 © 2010 GS1
  • 44. GS1 System of Standards An integrated approach Global reach •Standardized identification keys •Products, locations, assets, … •Standardized data carriers •Bar codes & RFID Open standards •Standardized sharing of static data •Data on products & locations •Standardized sharing of dynamic data •Event data Proven standards •Standardized electronic communication 44 © 2010 GS1
  • 45. UDI Unique Device Identification Not IF… But WHEN and HOW 45 © 2010 GS1
  • 46. Turning Regulations into Reality • You know when • You know about the standards • It’s now how to make it a reality
  • 47. Unique Device Identification Design Correct Correct Exercise variables barcode
  • 48. Application Labeling More than just print time variables Thin/ Thick Approval Client Management GMP based PRISYM Version Control Medica 21 CFR Part Audit History 11 Data Driven Printing
  • 49. Summary GS1 The right Good software Design UDI can be implemented without Derailing Production
  • 50. Q FDA – Jay Crowley T + 1 301-980-1936 A E jay.crowley@fda.hhs.gov W www.fda.gov GS1 Global Office – Janice Kite T + 32 2 788 78 00 W www.gs1.org PRISYM ID T +44 1189364403 E hollypurchase@prisymid.com W www.prisymid.com