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Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
Prisym UDI Implementation
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Prisym UDI Implementation

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  • 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
  • 5. Our Clients
  • 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
  • 20. UDI Application Example 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
  • 36. 36 © 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

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