Ensure UDI Success!


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Slides from ID Technology's "Ensure UDI Success!" event covering the new Unique Device Identification rule from the FDA.

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Ensure UDI Success!

  1. 1. Welcome
  2. 2. Seminar Agenda Welcome and Introductions UDI – what is it all about? GS1 or HIBCC? Flexcon’s View on UDI GUDID Database Resources for moving forward Live demos and networking
  3. 3. Who We Are… Thanks to our sponsor… Alice Faile Peter Gallo Joe Simas
  4. 4. Who We Are… Thanks to our guest speaker… Ron Ducharme
  5. 5. Who We Are…
  6. 6. Who We Are… http://moteam.co/Mo-Technology
  7. 7. A Medical Device is… "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
  8. 8. What’s UDI All About? “The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use…”
  9. 9. What’s UDI All About? ”This rule requires the label of medical devices to include a unique device identifier (UDI)…” “The labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID)…”
  10. 10. What’s UDI All About? OK, so we have to identify things with some UDI thingy & send some info to a database? Sounds easy enough! Let’s look in a little more detail…
  11. 11. Know your DUNs No and D&B Address Ensure you have your company prefix from your chosen Issuing Agency Get all the data together for labeling and for the GUDID Database Have your GMDN account and get the nomenclature for your products Develop labels and package marking for each layer of packaging QA Plan to validate labeling and barcodes Test – Validate – Test some more! Sign up for GUDID access. Determine how you’ll upload data
  12. 12. What’s UDI All About? What Items Need UDI and When?
  13. 13. What’s UDI All About? UDI Acronyms Meaning DUNS D&B Number – needed for GUDID UDI Unique Device Identification GLN Global Location Number GS1 GTIN Global Trade Item Number GS1 GMDN Global Medical Device Nomenclature GUDID Global UDI Database DI Device Identifier PI Production Identifier AIDC Automatic Identification and Data Capture GS1 The GS1 Standards Organization HIBCC Health Industry Business Communications Council ICCBBA Bonus points if you know this one!
  14. 14. What’s UDI All About? What is a UDI? The UDI is defined as consisting of 2 parts: The company is called “The Labeler “ in the Rule Device Identifier – DI This identifies the company and the model of the device Production Identifier – PI Production data such as Lot number, Expiration Date, Serial Number The information must be provided in plain text and in AIDC form. The Rule is flexible on what AIDC technology is used!
  15. 15. What’s UDI All About? What is Device Identifier (DI)? DI = the static part of the UDI. Consists of: Company Prefix + Item Number These will depend on the Standards being used ?
  16. 16. What’s UDI All About? What is Production Identifier (PI)? PI = the dynamic part of the UDI. Consists of one or more of: Lot number Serial number Expiration date Manufacturing date
  17. 17. What’s UDI All About? Barcode Standards
  18. 18. What’s UDI All About? Barcode Standards
  19. 19. What’s UDI All About? Barcode Standards
  20. 20. What’s UDI All About? Barcode Standards + EXP DATE +LOT/BATCH +SERIAL NUMBER
  21. 21. What’s UDI All About? Barcode Standards
  22. 22. What’s UDI All About? Barcode Standards Expiration Date Data Identifier Data Identifier Supplier LIC & Part Number Data Identifier Lot Number Issuing Agency Code (RH) Data Identifier Data Identifier Packaging Level (0 = unit of use) Manufacture Date
  23. 23. What’s UDI All About? Barcode Standards Datamatrix Code QR Code Aztec Code Micro PDF Code
  24. 24. What’s UDI All About? Barcode Standards GS1 HIBCC Making inroads in medical Well established standard GTIN is numeric only Can use existing cat. #s Huge international presence Mainly in North America Annual fee One time fee Standard in many logistics chains ? If I were a betting man…
  25. 25. What’s UDI All About? RFID Standards FDA, GS1 & HIBCC all allow for RFID Note that HIBCC suggests 13.56Mhz
  26. 26. What’s UDI All About? ICCBBA ISBT 128 International Council for Commonality in Blood Banking Automation
  27. 27. Flexcon’s View AIDC in Modern Healthcare
  28. 28. What is a medical device? The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892. Three classes exist today. A very wide range of medical products such as: Traditional hospital based devices (beds, ventilator, monitors, infusion pumps) Implants (teeth, hips, etc…) Patient/home use devices (glucometers) Disposables, accessories (glucose test strips, catheters) In vitro diagnostic devices (IVDs) – both clinical lab and Point of Care (POC). Those used in alternative sites – e.g., homecare, dental Health Information Technology (HIT) Convenience kits, Combination products 28
  29. 29. Today’s view without UDI  Product tracking efforts and recall difficult  Current systems allow product re-identification by every stakeholder in the supply chain today  Healthcare Supply Chain will be able to use the same Unique Device Identifier! Manufacturer Product # 305905 Distributor Product # MT305905 Hospital or Healthcare Provider Product # M-5905 Courtesy of Jackie Rae Elkin of Medtronic, Inc. Global Process Owner - Standard Product Identification 29
  30. 30. Two FDA systems are UDI and SNI UDI: Unique Device Identification FINAL Rule!!! Medical devices Patient care, diagnostic or treatment devices Moving forward SNI: Standardized Numeric Identification Prescription drugs Pharmaceuticals Biologics Vaccines Stalled due to recent politics Guidance
  31. 31. Timelines of Final Rule Implementation (compliance) timeframes are generally the same from Proposed Rule: Year 1: class III and devices licensed under PHS Act Year 2: class II/I implants and lifesupporting/sustaining Year 3: rest of class II Year 5: class I Note For Direct Marking! Compliance dates are extended by 2 years Except for FDASIA (year 2) devices – still at year 2. The start date is 9/24/13
  32. 32. What Changed from Proposed Rule High Level? DIFFERENCES from the PROPOSED RULE: Combination Products and Kits topics ironed out Packaged Single Use Devices (SUDs) exempt with a common sense approach (the band-aid in the box issue) Direct Marking for direct patient reuse / sterilization equipment Direct part marking for organic implants not mandated is another common sense logical concession that was well received • • • • • • New Version or Model revised NDC/NHRIC Numbers UPC Exception for Class 1 more logical approach Definitions are clearer in the rule GUDID database has more quality attributes Issuing Agencies are now only private entities and not nonprofit, public, or government.
  33. 33. What does a possible UDI look like? E.g., The new GTIN that is purchased and linked to the Enterprises’ production information enables the benefits of the UDI initiative
  34. 34. Goals of the UDI Initiative Reduction of medical errors Identify compatibility issues Improve medical device reports (MDRs) Identify and reduce product counterfeiting More efficient purchasing, reimbursement, and supply chain management, thus lowering costs Enhance medical device asset utilization Enhance in post-market device surveillance Support recall of medical devices Enable chain of custody tracking Capture device information in Electronic Health Record
  35. 35. UDI Transactions are Three Parts Reformat your data using an approved registration authority Encode the data in AIDC format Print your label Label your product Register your UDI in the FDA data base Ship the Product
  36. 36. FDA’s UDI Database Database will be an open, public database, access shall be free of charge UDI Device Identifier will be primary key in the database with associated product data elements defined Manufacturers will be responsible for submitting and maintaining their own data in the database All data submissions will need to be in the HL7 Structured Product Labeling (SPL) format. Guidance Released 9/24/13
  37. 37. History of the UDI Regulation 1999 IOM Report – To Err is Human 2004 FDA Pharmaceutical Barcode Rule 2005 and 2006 FDA/FDLI Meeting on UDI with IOM Famous Quote 2006 Public Meeting and Docket FDA-2006N-0292 2007 FDA Amendments Act of 2007 (Congress Passes Law) 2007-2009 – UDI Database Pilots 2008 GHTF Ad-Hoc Working Group on UDI 2009 UDI Workshop and Docket FDA-2008-N-0661 2011 GHTF UDI Guidance published 2012 July 10th - UDI Proposed Regulation Publishes 2012 FDASIA provisions added and Congressional Law to Publish 2012 November 7th – comment period closes for Proposed Rule 2012 November 19th – FDASIA amendment (Dec 19) - “Med Tax” 2013 June– UDI Final Rule sent to OMB 2013 UDI Conference in Baltimore YOU ARE HERE on 9/24/13 2013 Final Rule Published
  38. 38. The Status as of 9/24/2013 Published Final Rule with comment period  http://www.fda.gov/MedicalDevices/Devi ceRegulationandGuidance/UniqueDeviceI dentification/ Courtesy FLEXcon 2013
  39. 39. FLEXcon® MedFLEX™ A series of polyester products UL-recognized 2 mil silver matte, clear and white Topcoat is more universally printable High performance acrylic adhesives Printable via UV, Emulsion and UV Ink jet Liner is suitable for optical scanning IEC compliance pending Overlaminates Choice of 1 mil clear and clear matte polyester films
  40. 40. Thank you
  41. 41. The Database
  42. 42. GUDID Interestingly, not a database of UDI’s Management of UDI’s with manufacturer !
  43. 43. GUDID
  44. 44. GUDID
  45. 45. GUDID – sending data Upload HL7 XML file Tools already exist to help Use the web tool Pay a 3rd party
  46. 46. Exemptions
  47. 47. Printing Your UDIs TTO – print on flexible packaging Zebra printers for durable labels Laser marking solutions for direct part marking IDT Labelers – cases and pallets
  48. 48. Printing Your UDIs GS1 Datamatrix
  49. 49. Printing Your UDIs ID Technology labels made from Flexcon Medflex materials
  50. 50. Know your DUNs No and D&B Address Ensure you have your company prefix from your chosen Issuing Agency Get all the data together for labeling and for the GUDID Database Have your GMDN account and get the nomenclature for your products Develop labels and package marking for each layer of packaging QA Plan to validate labeling and barcodes Test – Validate – Test some more! Sign up for GUDID access. Determine how you’ll upload data
  51. 51. Resources FDA’s UDI Site: http://idt.gs/fda-udi Draft DUDID Guide: http://idt.gs/dudid-guide GS1 Healthcare: http://idt.gs/GS1-Healthcare HIBCC UID & Standards: http://idt.gs/HIBCC-UDI Labeling News: http://www.labelingnews.com Contact me: dholliday@idtechnology.com
  52. 52. Thank you!!