Your Morning Dose of UDI Fundamentals Presented by the AIM North America Healthcare Committee www.aim-na.org Slide 1
Slide 2 Overview Ardi Batmanghelidj, Innovatum
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
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
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About our presentation Slide 7
Slide 8 AIM North America Presenters Elizabeth Sinclair BarTender by Seagull Scientific Roger Peterson Arthrex, Inc. David Coons Zebra Technologies James Phillips FMOLHS
Slide 9 A UDI Primer Elizabeth Sinclair, BarTender by Seagull Scientific
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 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 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 1 2014 2015 2016 2017 2018 2019 2020
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
Barcode formats GS1 and HIBCC Same information, different formats 14 Slide 14
No mandatory symbology format 15 Slide 15
GUDID Required Data Fields 16 Slide 16
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 Slide 18 It s a little more complicated than that medical device label elements
Slide 19 From data to device Data sources Software Substrates and marking technologies Verification
From data to device: Data sources Slide 20
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
From data to device: Software Slide 22
From data to device: Substrates and marking technologies Slide 23
From data to device: Verification Slide 24
Thank You Slide 25
Slide 26 Manufacturing Roger Peterson, Arthrex
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
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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 1 00812345678901 Each In Use Medical Device 2 00812345678902 Each
Global Trade Item Number Anatomy Slide 30
Sample package label 801.20.Unit of use label must bear a unique device identifier, (UDI) in both human readable and AIDC, (bar code) machine readable format. 801.18 Format of dates provided on a medical device label Slide 31
Slide 32 ISO 15416 / 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.
Slide 33 ISO 15416 / 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 15416 and ANSI X3.182. The eight parameters of ISO 15416 / 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
Bar code verification Slide 34
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)01234567123450(17)180731(10)01234567890 Decoded Value (Transmitted Message) ]C101234567123450171807311001234567890
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
Slide 37 Current state: Data Universal Numbering System, DUNS What's our name?
Harmonized State: Data Universal Numbering System, DUNS Slide 38
Basic Process Collecting, Verifying and submitting UDI data Slide 39
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 1 2018 ~ 2020, (Direct Part Marking)
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
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
Thank You Slide 43
Slide 44 Putting UDI to Use in the Hospital: From Regulation to Opportunity David Coons, Zebra Technologies
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Regulation Slide 46
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
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Slide 49 UDI Feeds Clinical and Operations Systems MMS Item Master Inventory Common Clinical Data Set EHR Purchasing Billing
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?
Slide 51 MATERIALS MANAGEMENT IN HEALTH CARE November 2009 Eight Years Later the Questions are the Same
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
Slide 53 Bar Code Formats: Different, but Fully Compatible HIBCC GS1 Device Identifier (DI) Production Identifier (PI)
The Industry is Moving to 2D DataMatrix Slide 54
Slide 55 Ok So which bar code do I Scan? SampleTech Medical
Technology Can help Slide 56
Slide 57 Technology Can help Device ID: 00884838047693 Serial No: XX01234567
Some Bar Codes Are Really Small Slide 58
Capturing Small Direct Part Marks Slide 59
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
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
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
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
Thank You Slide 64
Slide 65 Consumption of the UDI James Phillips, FMOLHS
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
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
UDI Components Slide 68
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
Challenges: Multiple barcodes per package Multiple standards per item No barcodes UOM Each don t always have barcodes/udi Education Slide 70
Upcoming Our vision Capital Asset Project Later this Conference Slide 71
Thank You Slide 72
Questions? Slide 73
Slide 74 Contact Us AIM North America 20399 Route 19 Suite 203 Cranberry Township, PA 16066 + 1.724.742.4470 www.aim-na.org info@aim-na.org
Slide 75 Elizabeth Sinclair Roger Peterson David Coons James Phillips BarTender by Seagull Scientific 15325 SE 30 th Place Suite 100 Bellevue, WA 98007 Arthrex 6875 Arthrex Commerce Ave Maria, FL 34142 Zebra Technologies 30601 Agoura Road Agoura Hills, CA 31301 FMOLHS 12100 Little Cayman Baton Rouge, LA 70809 +1 425.289.4146 esinclair@seagullscientific.com www.seagullscientific.com +1 239.598.4302 Roger.Peterson@arthrex.com www.arthrex.com +1 805.578.7122 dcoons@zebra.com www.zebra.com +1 225.526.4526 James.phillips@fmolhs.org www.fmolhs.org
Thank You Slide 76