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Step-by-Step Approach of Unique Device Identification (UDI)


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Unique Device Identification (UDI)

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Step-by-Step Approach of Unique Device Identification (UDI)

  1. 1. Step-by-Step Approach of Unique Device Identification (UDI) UDI Implementation June 3, 2014 Arne  Briest  –  CEO  
  2. 2. History of UDI? •  2007 – US Congress passed legislation directing FDA to develop UDI System •  2013 – International Device Regulators Forum (IMDRF) established working group •  2013 – FDA published UDI Final Rule and draft GUDID guidance
  3. 3. Objective of UDI •  Global consistent system to improve visibility to UDI for patient safety through higher quality information used in post-market surveillance and in medical device reporting •  Fast identification of product issues and improved targeted field corrective actions •  Improved supply chain efficiencies (manufacturing, logistic) •  Reduce counterfeiting
  4. 4. Not just a Label Change •  Product Master Database per facility •  Labeling and Packaging •  Submission of UDI data to a FDA GUDID •  Direct Part Marketing
  5. 5. What is UDI? A unique numeric identifier composed of the device identifier and production identifier(s) that uniquely identifies a medical device through distribution and use.
  6. 6. What are the Benefits of UDI? •  Reduce medical errors •  Simplify the integration of device use information into data systems. •  Provide for more rapid identification of medical devices with adverse events. •  Provide for more rapid identification of solutions to reported problems. •  Provide more accurate, more efficient resolution of device recalls. •  Better focused and more effective FDA safety communication. •  Other benefits: -  Can be used in educational and informational materials. -  Can be used in inventory management. -  Can be used in the provision of high quality medical services. -  Can help identify alternative devices.
  7. 7. What makes up a UDI? •  Device Identification (DI) •  Product Identification (PI) Source: GS1
  8. 8. Device Identification (DI) •  DI is a static unique number assigned to all product model numbers at each packaging level. •  The number must use an accepted standard format. •  The accepted standard DI formats are currently provided by 3 companies. -  GS1 – Used by the majority of industry -  HIBCC – Health Industry Business Communications Council -  ICCBBA - International Council for Commonality in Blood Banking Automation
  9. 9. Product Identification (PI) •  PI is a dynamic number that identifies how the product is currently controlled. •  It can include one or all of the following: -  Serial Number -  Lot Number -  Expiration Date -  Manufacturing Date  
  10. 10. Product Label   •  UDI must be in plain human readable text and AIDC (Automatic Identification and Data Capture) •  UDI applies to all levels of packaging down to the lowest level (patient use/unit of use) •  UDI is not required on shipping containers (eg: brown corrugate box) •  The date format will be standardized: YYYY-MM-DD (eg: 2013-09-20 for September 20, 2013) YYMMDD for the GS1 bar code
  11. 11. Labeling for a Convenience Kit   •  The final rule does not require devices within a convenience kit to bear a UDI but does require the label and each device package of every kit to bear a UDI.
  12. 12.   Global Unique Device Identification Database (GUDID) •  Operated by the FDA to collect information on Medical Devices •  FDA has public facing website to share data with anyone (https:// •  Some information submitted to the GUDID will be private (for FDA only)
  13. 13.   What are the Challenges? •  Each Business must identify products •  Assign (Global Trade Item Number) GTINs where applicable •  Format Labeling •  Collect attribute data •  Upload existing data •  Develop process for future products •  Develop processes and procedures for overall system compliance
  14. 14.   How is data submitted to GUDID? •  Create an import file for all products •  Determine the method of submission -  Web – Secure on-line entry with an authenticated user account -  File Submission - HL7 Structured Product Labeling Standard for batch file submission -  Hybrid – Batch file submission and on-line update/correction
  15. 15.   Project Timing?
  16. 16.   Potential Project Resources? •  Marketing •  Quality •  Regulatory •  Manufacturing •  IT •  Logistic
  17. 17.   High Level Task List Select Standard and Request Account -  GS1 or HIBCC -  Request DUNS Number -  Request GUDID Account Assess Product Portfolio -  Assess device class and volume, packaging configuration (QTY, etc.) -  Identify internal and external products Assess Master Data -  Identify data source for all UDI data fields and correlate with current item master -  Establish Global Medical Device Nomenclature (GMDN) coding -  Determine how master data will be maintained accurately going forward Assess Packaging and Labeling -  Determine level of packaging an item will need to have a UDI -  Determine if Direct Part Marketing will be needed -  Select Technology Human and/or AIDC technology readable Assess Business Process -  Assess operational processes to determine if a process and/or system change is needed -  Determine if 21CFR Part 11 revalidation will be required
  18. 18. •  Prepare Master Productlist •  Identify Project Team •  Establish timeline based on product classification •  Present to Business Management •  Identify in detail products and need to up date master •  Set up processes and SOPs •  Modify Labels and related Process •  Implement Database and file submission system •  Perform Validation Activities •  File Submission to GUDID •  Up date SOPs based on test runs/ train user •  Go Live •  Process improvement and feed back High Level Task List