Your Morning Dose of UDI Fundamentals

Transcription

1 Your Morning Dose of UDI Fundamentals Presented by the AIM North America Healthcare Committee Slide 1

2 Slide 2 Overview Ardi Batmanghelidj, Innovatum

3 Advancing Identification Matters AIM is an unbiased, global industry alliance Education, advocacy, and standards Influence the industry Network with like-minded individuals There s strength in numbers! Slide 3

4 Automatic Identification Technology 1D Barcode 2-D Barcodes Contact Memory Buttons Passive RFID Tags Data Matrix QR Code MaxiCode Active RFID Tags PDF417 Bullseye Aztec Slide 4

5 Slide 5

6 Slide 6

7 About our presentation Slide 7

8 Slide 8 AIM North America Presenters Elizabeth Sinclair BarTender by Seagull Scientific Roger Peterson Arthrex, Inc. David Coons Zebra Technologies James Phillips FMOLHS

9 Slide 9 A UDI Primer Elizabeth Sinclair, BarTender by Seagull Scientific

10 10 Slide 10 Why UDI? Patient safety, visibility and analytics. Uniform system for identifying and cataloging medical devices Intended to improve reporting and enhance electronic tracking. Before UDI, analysis of device effectiveness and adverse event reporting was limited by the fact that specific devices used in treatment were often not known or not identified with adequate specificity. Standardized labeling and use of AIDC data carriers Before UDI, many medical devices lacked labels that could be automatically be scanned into electronic records systems, causing error-prone manual entry and incomplete recording of device details. Common product naming Without a common vocabulary for medical devices, meaningful analysis based on data from existing voluntary systems has been difficult. Reliable and consistent identification of medical devices will enable safety surveillance so that the FDA and manufacturers can better identify potential problems or device defects and improve patient care.

11 11 Medical Devices are Classified by Risk Level FDA Device Classification Examples Classification Risk Level Device Examples I II III Low Moderate High Tongue depressors, manual stethoscopes, dental floss, elastic bandages, examination gloves, nonprescription sunglasses. Electrical stethoscopes, electrocardiographs, dental cement, gas analyzers, x-ray systems, powered wheel chairs, fetal cardiac monitors. Implantable pacemakers, replacement heart valves, automated external defibrillators, heart pumps. Life Supporting / Life Sustaining is an additional flag for a device in any class, indicating a device that is essential to, or that yields information that is essential to the restoration or continuation of a bodily function important to the continuation of human life. Slide 11

12 12 Slide 12 FDA compliance schedule Implants, Life Supporting, Life Sustaining (All Dates are Sept 24 th ) Packaging ALL Devices Class 3 Class 2 Class 1 + Direct Part Mark For Reprocessed & Reused Class 3 Class 2 Class

13 13 What is UDI? FDA Regulation requiring: All medical devices must be assigned a unique identification number. This is the Device Identifier (DI) All medical devices must be registered in a federal FDA database All labels on devices and device packaging must include mandatory data elements printed in human readable form AND machine readable form (typically a bar code) Law applies to every medical device sold or distributed in the US, regardless of where it is manufactured. Slide 13

14 Barcode formats GS1 and HIBCC Same information, different formats 14 Slide 14

15 No mandatory symbology format 15 Slide 15

16 GUDID Required Data Fields 16 Slide 16

17 Required Label Data Elements Device Identifier (DI) Globally Unique, Static Identification number Must be Registered in the FDA Database Linked to a Single Manufacturer, Device Name, Model, and Packaging Level Linked to a Set of Static Product Attributes Production Identifier (PI) Describes one or more value(s) that tie to Production Lot, Production Date, Expiration Date, Serial #, etc. NOT registered in the FDA Database Both elements must be on the label in both human-readable and AIDC-readable format. (* PI is optional for Class I devices with UPC) Machine-readable format is not mandated could be barcode, RFID, or some other technology. 17 Slide 17

18 18 Slide 18 It s a little more complicated than that medical device label elements

19 Slide 19 From data to device Data sources Software Substrates and marking technologies Verification

20 From data to device: Data sources Slide 20

21 21 Slide 21 Gathering the Required Product Data Manufacturers must find and organize the required product information. Often, information doesn t exist or is scattered across multiple sites, servers and paper documents. Must be done at corporate level, but down to each SKU this is a challenge for companies that have grown by acquisition. Distinctions must be made between repair parts, accessories, kits, etc. Many companies do not have Product Data Systems Often there are conflicting data and no clear owner

22 From data to device: Software Slide 22

23 From data to device: Substrates and marking technologies Slide 23

24 From data to device: Verification Slide 24

25 Thank You Slide 25

26 Slide 26 Manufacturing Roger Peterson, Arthrex

27 Slide 27 Agenda UDI - Review Process GTIN allocation (Internal process of allocating and control) Sample package label (Illustration of UDI compliant label) Bar code verification (Review of production quality control options) Distribution and HCP AIDC requirements (AIDC structure requirements) Best Practice Compliant GTIN Indicator Digit (Package Hierarchy) Data Universal Numbering System, DUNS (Organizational naming requirements for GUDID account) Collecting UDI data DI Records Review UDI Project Plan Inclusions Odds & Ends

28 Slide 28

29 Slide 29 Global Trade Item Number, (GTIN) Join GS1 US to obtain a GS1 Company Prefix Allocate GTIN, (Device Identifier, DI) Document allocation and control process, (spread sheet, PLM interface or DataHub) Product Information Management Add GTIN to device master in enterprise resource management system, (ERP) Add GTIN to UDI database Add GTIN to Labeling database Document process Status Description GTIN-14 Level In Use Medical Device Each In Use Medical Device Each

30 Global Trade Item Number Anatomy Slide 30

31 Sample package label Unit of use label must bear a unique device identifier, (UDI) in both human readable and AIDC, (bar code) machine readable format Format of dates provided on a medical device label Slide 31

32 Slide 32 ISO / ANSI X3.182 Bar Code Quality GS1 bar code verification requirements are based on bar code print quality specifications of global ISO IEC 15416, Bar code Print Quality Test Specification and North American ANSI X3.182, Bar Code Print Quality Guideline, standards. Both standards harmoniously recognize that an acceptance criterion for bar code quality is 1.5/C or better.

33 Slide 33 ISO / ANSI X3.182 Bar Code Quality Bar code verification equipment must provide specifications in overall bar code print quality based on eight parameters defined in ISO and ANSI X The eight parameters of ISO / ANSI X3.182 single Scan Reflectance Profile, SRP are graded as follows: Parameters of a Bar code Scan Reflectance Profile Decode Minimum Reflectance (Rmin) Edge Contrast Minimum (ECmin) Edge Determination Symbol Contrast (SC) Modulation (MOD) Defects Decodability Quality Determination Pass/Fail X X X X Quality Determination Graded 4.0 (A) through 0.00 (F) X X X X

34 Bar code verification Slide 34

35 Slide 35 Distribution and HCP AIDC requirements The FNC1 in a GS1-128 bar code is always encoded in the first position following the Start character The symbology identifier (AIM ID) for a GS1-128 & GS1 2D DataMatrix bar code is ]C1 HRI (01) (17)180731(10) Decoded Value (Transmitted Message) ]C

36 Slide 36 Compliant GTIN Indicator Digit Package Indicator Digit Package Hierarchy 0 Single pack 1 Multi Pack (5 Units) 1 or 2 Multi Pack (10 Units) 3 or 4 Case Unit 4 or 5 Logistical Unit (Pallet) 6 through 8 As required

37 Slide 37 Current state: Data Universal Numbering System, DUNS What's our name?

38 Harmonized State: Data Universal Numbering System, DUNS Slide 38

39 Basic Process Collecting, Verifying and submitting UDI data Slide 39

40 Slide 40 DI Records - Review Verification for managing DI records Implementation timeline review Class III UDI implementation completed by 24th Sep 2014 GUDID Record Cycle: Class II, (Life Saving / Life Supporting) implementation by 24th Sep 2015 Remainder Class II by 24th Sep 2016 Class ~ 2020, (Direct Part Marking)

41 Slide 41 UDI Project Planning Project Plan Inclusions: Risk assessments, (dfmea & pfmea) Labeling application assessment Data System of Record, (SoR) repository, ERP, SQL, 3rd party solution etc. Labeling gap assessment, (AIDC, date format YYYY-MM-DD) Quality assessment, (assimilating conforming amendments) Production equipment assessment Data collection, data cleansing and internal process Regulatory QA review Device Identification records submission Labeling revisions change control Training Implementation

42 Slide 42 Odds & Ends Who is responsible as the labeler? Monitor GMDN code Process Failure Modes Effects Analysis, pfmea Data Integrity System of Record Not sure? Ask FDA UDI Help Desk

43 Thank You Slide 43

44 Slide 44 Putting UDI to Use in the Hospital: From Regulation to Opportunity David Coons, Zebra Technologies

45 Slide 45

46 Regulation Slide 46

47 Opportunity Automatically associate devices to patient records Improve analysis of clinical outcomes Reduced manual entry errors Reduce unproductive time Improve inventory visibility and efficiency Standardize terminology and naming Slide 47

48 Slide 48

49 Slide 49 UDI Feeds Clinical and Operations Systems MMS Item Master Inventory Common Clinical Data Set EHR Purchasing Billing

50 Slide 50 Eight Important Questions For Providers 1. Are our systems and people ready to consume this data? 2. How will we prepare our business practices for change? 3. Are our internal systems (financial, clinical and materials) ready to accept and share this data? 4. What will our costs be? 5. Do we have a long-term plan and budget? 6. Is our connectivity in place to receive the data? 7. How will our systems, people, and processes be prepared for the transition? 8. What is our timeline for conversion?

51 Slide 51 MATERIALS MANAGEMENT IN HEALTH CARE November 2009 Eight Years Later the Questions are the Same

52 Impediments To Adoption Variation in UDI Bar Code Application Three Issuing agency standards Multiple UDI Bar Code Formats and Arrangements Unrelated Bar Codes on Packaging UDI Bar Code(s) are often not differentiated Confusion around what to Scan Direct mark readability Very small Bar Codes Slide 52

53 Slide 53 Bar Code Formats: Different, but Fully Compatible HIBCC GS1 Device Identifier (DI) Production Identifier (PI)

54 The Industry is Moving to 2D DataMatrix Slide 54

55 Slide 55 Ok So which bar code do I Scan? SampleTech Medical

56 Technology Can help Slide 56

57 Slide 57 Technology Can help Device ID: Serial No: XX

58 Some Bar Codes Are Really Small Slide 58

59 Capturing Small Direct Part Marks Slide 59

60 RFID for Automatic Data Capture Low-cost RAIN RFID tags hold Device and Production identifiers Minimizes workflow changes and scanning compliance challenges Near real-time visibility to inventory Slide 60

61 Slide 61 RFID for Automatic Data Capture Low-cost RAIN RFID tags hold Device and Production identifiers Minimizes workflow changes and scanning compliance challenges Near real-time visibility to inventory SampleTech Medical

62 Slide 62 RFID for Automatic Data Capture Low-cost RAIN RFID tags hold Device and Production identifiers Minimizes workflow changes and scanning compliance challenges Near real-time visibility to inventory SampleTech Medical

63 Summary Minimal Mandates on Providers: UDI must be included in adverse event reports Certified EHR vendors must accommodate UDI field capture and include in Common Clinical Data Set. Hospitals must use Certified EHR technology capable of documenting UDIs for implants. The Rest is Up-Side Opportunity UDIs unlock multiple opportunities for better patient care, improved inventory management, error reduction, and clinician time savings. Technology providers are working to help you successfully capture the benefits. Slide 63

64 Thank You Slide 64

65 Slide 65 Consumption of the UDI James Phillips, FMOLHS

66 Agenda Who we are How we use UDI Where do scan What products we scan Why we scan How this data is used in the system and in downstream systems Challenges Upcoming Benefits Slide 66

67 6 Slide 67 UDI Components UDI= Device Identifier (DI) + Production Identifiers (PI) GTIN + Application Identifiers (AI) GTIN Global Trade Item Number Expiry Date Lot Number Serial Number *Another Production Identifier is Manufacture Date

68 UDI Components Slide 68

69 Where do scan now What products we scan Why we scan How this data is used in the system and in downstream systems Integrating data from GDSN & GUDID Slide 69

70 Challenges: Multiple barcodes per package Multiple standards per item No barcodes UOM Each don t always have barcodes/udi Education Slide 70

71 Upcoming Our vision Capital Asset Project Later this Conference Slide 71

72 Thank You Slide 72

73 Questions? Slide 73

74 Slide 74 Contact Us AIM North America Route 19 Suite 203 Cranberry Township, PA info@aim-na.org

75 Slide 75 Elizabeth Sinclair Roger Peterson David Coons James Phillips BarTender by Seagull Scientific SE 30 th Place Suite 100 Bellevue, WA Arthrex 6875 Arthrex Commerce Ave Maria, FL Zebra Technologies Agoura Road Agoura Hills, CA FMOLHS Little Cayman Baton Rouge, LA

76 Thank You Slide 76