![Product code
• Product code in GUDID must match the Product
Code assigned to the device in Registration &
Listing and premarket review
• Example:
• R&L - FGE [FGE - Catheter, Biliary Diagnostic]
• GUDID - MIR & MAF [MAF – Stent, Coronary]
[MIR - Shunt, Portosystemic, Endoprosthesis]](https://image.slidesharecdn.com/omtec-2016reedfda-udi-update-160620183426/85/FDA-Update-and-Q-A-UDI-35-320.jpg)
![GMDN Data Entry
• GMDN Code is a required element of DI record
• Term name and definition will be auto-populated
• DI Record will only accept active GMDN Codes
• It is the labeler’s responsibility to update obsolete GMDN
Codes in a DI record [21 CFR 830.330(b)]
• See Final GUDID Guidance](https://image.slidesharecdn.com/omtec-2016reedfda-udi-update-160620183426/85/FDA-Update-and-Q-A-UDI-36-320.jpg)
FDA Update and Q&A: UDI
- 2. Unique Device Identification (UDI) Clearly identifying a device to improve patient safety and healthcare efficiency 1 Terrie L. Reed, MS Industrial Engineering Senior Advisor for UDI Adoption Leslie Tompkins Steen, PhD UDI Lead, Standards and Vocabulary
- 3. Questions First • How does FDA recommend we direct mark screws and small implants? • How should we proceed as we await the guidance on the Convenience Kit exemption? • How is FDA enforcing UDI? • What are best practices for entering submissions to GUDID?
- 4. What is UDI? accessgudid.nlm.nih.govAn identifier that lets us all call the same product the same thing
- 5. What is UDI? 4 UDI = DI + PI
- 6. Establish a UDI System 5 Develop a standardized system to create the UDI Place UDI on label and (sometimes) the device Create and maintain the Global UDI Database Adoption and Implementation
- 7. What is UDI? 1st requirement …the label of every medical device shall bear a unique device identifier (UDI)… 2nd requirement…the labeler of a device must provide the information required … for each model or version required to bear a unique device identifier (UDI)…
- 8. UDI System Compliance Dates 7 Compliance Date Must bear a UDI & submit data to GUDID September 24, 2014 • Class III devices, incl. class III stand alone software • Devices licensed under the PHS Act September 24, 2015 • Implantable, life-supporting and life-sustaining (I/LS/LS) devices, incl. stand alone software • Direct Marking of I/LS/LS for certain intended uses September 24, 2016 • Class II devices • Direct Marking for class III devices and devices licensed under the PHS Act, for certain intended uses September 24, 2018 • Class I devices and devices not classified class I, II or III • Direct Marking of class II devices for certain intended uses September 24, 2020 • Direct Marking of class I devices and devices not classified into class I, II or III, for certain intended uses
- 9. Medical Specialties in GUDID (Data Current as of April 7, 2016) 8 Orthopedic 80% General & Plastic Surgery 4% Dental 4% Anesthesiology 3% Cardiovascular 3% All Other 6%
- 10. Most Frequent FDA Product Code Terms in GUDID (Data Current as of April 7, 2016) 9
- 11. 11 Companies =>10,000+ Records (Data Current as of April 6, 2016) 10 7. Synthes GmbH 8. Zimmer, Inc. 9. NuVasive, Inc. 10. Aesculap, Inc. 11. L&K Biomed Co., Ltd. 1. Biomet, Inc. 2. Smith & Nephew, Inc. 3. Medtronic, Inc. 4. Stryker Corporation 5. Globus Medical, Inc. 6. Smiths Medical MD, Inc.
- 13. UDI Goals for 2016 12 GUDID Accounts GUDID Records User Group Sessions, Helpdesk Standards, Guidances UDI integration in health information
- 14. Why is Unique Device Identification Important? What you see and hear depends a good deal on where you are standing; it also depends on what kind of a person you are. ~C.S. Lewis
- 15. Comparing Access to Performance Data Source: CDC/NCHS National Hospital Discharge Survey, 2010 Source: WardsAuto - 2010 New Vehicle Sales 2010 Hondas1,230,500 908,600 Nissans 358,500 Volkswagens Cardiac Catheterizations1,000,000 719,000 Total Knee Arthroplasties 332,000 Total Hip Replacements Medical Procedures New Cars Sold 1 2 1 2 2
- 16. UDI is important to… PATIENTS Care Providers Manufacturers Distributors Healthcare supply chain Risk Managers Value Analysts Government Agencies
- 17. First Focus: Implantable Devices 16
- 18. Patient Expectations 17 I don’t worry about my implants. My doctors take care of me and would let me know if there is a problem..
- 20. 19 Device Identifier Standard Data 1888TC
- 21. Office of National Coordinator for Health IT Create an Implantable device list UDI in Common Clinical Data Set
- 22. MR # 00000000000 Active Implantable Device List ……. ……. 21 DI Lot Serial Expiration Mfr Date DIC Description (GMDN or SNOMED) Company Name Brand Name Model MRI Safe Labeled as containing latex 05414734501743 Lot: 123456 Exp:12/31/2025 Endocardial pacing lead St. Jude Medical Inc. TendrilTM ST Labeling does not contain MRI Safety Information No Link Patient to Device Identifier
- 23. National Library of Medicine accessgudid.nlm.nih.gov Device Identification Data Available to you TODAY
- 25. How is UDI important to Public Health • Establishing a National Evaluation System for medical devices is one of FDA’s 2016-2017 strategic priorities. • Collaborative public private system that monitors, links, and analyzes real-world data from many different sources • Data Sources: clinical registries, electronic health records, and medical billing claims, GUDID • Goal: Better understanding of how medical devices perform to improve decision-making
- 26. Orthopaedics National Coordinated Registry Network (CRN) • Supports goals of National Evaluation System • Purpose: • Link registries together with diverse data sources to promote knowledge for regulatory and reimbursement decisions, best practice recommendations, patient information and innovation opportunities for manufacturers. • Partners: • American Joint Replacement Registry, FORCE TJR, and Kaiser Permanente; Two other registries expressed interest (Michigan State and Health East) • UDI: AccessGUDID and UDI on label could provide link to replace catalog number that is used now
- 27. What is the importance of Data Quality in GUDID? The value of UDI begins with data quality
- 28. • GUDID - Separated Labeler Hospital GUDID Other Request Registries • GUDID - Integrated Labeler Hospital Registries Other entities GUDID Role of GUDID
- 29. Start with GOOD data • Tools are provided in the GUDID to support data review • Published records are made available to the public, via AccessGUDID (after a 30-day Grace Period • Once public, records can be consumed by NES, registries, EHRs, hospital systems, etc.
- 30. GUDID and FDA Registration and Listing Product Codes in GUDID MNI MNH KWP NKB KWQ HWC HRS JWH OSH MAX Product codes in Registration and Listing MNI MNH KWP HWC KWQ GEI HRS JWH NKB HQY LPH JDI LZO DZE ITX GEX
- 31. Device Identifier is the Primary Key • GS1 Healthcare GTIN Allocation Rules • Indicator digit + GS1 Company Prefix + Item Reference + Check Digit • HIBCCs-Guide-to-GUDID-Device-Identifiers • Labeler Identification Code (LIC) + Product/Catalog Code + Unit of Measure • ICCBBA - Processor Product Identification Code • Facility Identification Number (FIN) + Facility Product (FPC) + Product Description Code
- 32. Brand Name • Brand Name must be limited to the name of the device • Including Size, Version, Model and other data that is collected in other fields in the database is not recommended • If the device does not have a Brand Name, refer to Data Elements Reference Table (DERT) for a recommendation
- 33. Model Number • Model or Version of a product is used to further help identify the product. • It should be a way to distinguish the product from its family • When entering data, do not repeat the word ‘Model’ or ‘Version’ • It should be easy to remember and use
- 34. DI Record Vocabulary • DUNS • FDA Classification Product Codes (Procodes) • GMDN • MRI Safety Information (ASTM F2503-13) • Sterilization methods (FDA Guidance) • Unified Code for Units of Measure (UCUM)
- 35. Product code • Product code in GUDID must match the Product Code assigned to the device in Registration & Listing and premarket review • Example: • R&L - FGE [FGE - Catheter, Biliary Diagnostic] • GUDID - MIR & MAF [MAF – Stent, Coronary] [MIR - Shunt, Portosystemic, Endoprosthesis]
- 36. GMDN Data Entry • GMDN Code is a required element of DI record • Term name and definition will be auto-populated • DI Record will only accept active GMDN Codes • It is the labeler’s responsibility to update obsolete GMDN Codes in a DI record [21 CFR 830.330(b)] • See Final GUDID Guidance
- 37. DERT = Data Element Reference Table • GUDID Data Elements Reference Table - May 1, 2015 (XLS - 104KB) – Data Element Name – Description – Data Entry Notes – Edit rule after Grace Period – Required – Data Type and Length – Entry List of Values – New DI Trigger
- 38. Data Element: Size • Designed to capture minimum data set • Use pull-down lists, when possible • Size Value cannot be entered as a range
- 39. Data Element: Sterilization • Designed to provide information to a healthcare professional or patient/consumer • Not intended to capture manufacturer’s sterilization procedures
- 40. Data Element: Single Use Definition • Device is intended for one use or on a single patient during a single procedure Implementation • If device does not meet the definition, Single Use = ‘No’ • Device may be reviewed as single use, but packaged as multiple single use • GUDID ‘Single Use’ does not affect pre-market review
- 41. Device Type: Unclassified • Unclassified ≠ Exempt • Unclassified devices may be reviewed by 510k or PMA process • All devices should have a FDA listing number
- 42. Device Type: Kit • UDI and DI record represent kit as a ‘device’ • Some data elements are confusing to answer when describing a kit vs single device: • Device Count • Device Description • GMDN • Size • Sterilization • Storage & Handling
- 43. Call to Action • Review and understand the GUDID data elements • Be sure to understand the DI record edit rules • Utilize the resources available on our website • Make data quality a priority
- 44. Compare your Data Source System Data Data submitted to GUDID
- 45. Consistency • Are related data elements such as GMDN and Product code consistent? • Does the data make sense?
- 46. Completeness • Device record should contain the same information that appears on the device label • Optional data elements add value: • Device Description • Catalog Number
- 47. Developing a Learning UDI Community
- 48. AHRMM – Leading a Learning UDI Community Device Labelers • Healthcare supply chain • Distributors • Value Analysis Professionals • Device users • Care providers • Patients • Device Surveillance
- 49. Linking Data across Data Sources 2015-06-16 48 Implantable Device List Care Documents FDA Adverse Event Reporting Incident Report Registry Record DI PIDI PI DI PI DI PI DI PI Point of Implant Item Master DI PI FDA Device Recalls FDA GUDID via NLM DI PI DI PI
- 50. Questions?