UDI Roundtable Discussion - GS1

1 UDI Roundtable Discussion7 April 2011 2010 GS1 SpeakersChair Mike Wallace, Director Global Standards and Serialization, Abbott LaboratoriesPanelists Terrie Reed, Senior Policy Analyst, FDA Center for Devices and Radiological Health Joe Pleasant, Senior VP & CIO, Premier Inc. Mike Sarachman, Manager, International Data Standards Adoption, Johnson & Johnson Health Care Systems, 7, 2011 UDI Database Roundtable4 Agenda Abbott at a Glance What is Master Data? How does GS1 data fit with Master Data? What will the processes look like? The new paradigm The Panel5 Medical Devices is one of Abbott s Three Areas of BusinessMedical DevicesDiabetes CareLaboratory DiagnosticsMolecularPoint of CareAnimal HealthMedical OpticsVascular6 What is Master Data?

2 Master Data is the high valueinformation that an organization uses repeatedlyacross the enterprise and in many business processes. It describes the key business entities of a corporation, referred to as master records or data domains: Customer, Material, Vendor, Chart of Accounts and Employee It includes the data elements that help define the master records in support of transactional and reporting activity. Naming conventions and the adoption of industry standards are implemented where applicable. DomainData Element ExamplesCustomerAccount Number, Customer Name, Address, GS1 standard for GLNM aterialMaterial Number, adoption of UNSPSC codes for material classification (Material Group), GS1 standard for GTIN, Units of Measure7 Where does Master Data fit?

3 Transactional Data Data created during course of business operations such as sales orders, purchase orders, invoices, accounting postings are considered transactional data Supplemental Data Non-transactional data such as pricing conditions and product hierarchies that is not considered master data Master Data Corporate data assets such as customers, vendors, materials and chart of accounts Organizational Data ( Foundational Data) Essential elements such as company code, sale organization that should be in place for all other data to existEnterprise Data Pyramid (SAP Proprietary Model)How Master Data Fits8 ERPM aster DataAll GS1 Data is Master Data, but not all GS1 data is necessarily Enterprise Master Data.

4 Enterprise Master DataGS1 GDSN/UDID OVERLAP9D ATA TRANSFORMATION& VERIFICATIONINTERNALEXTERNALGOVERNANCE REQUIREDDATADATADATACUSTOMERSREGULATORSD ATA POOL?DATAGDSN/UDI Database processes mimic MDM Assign product GTINs Locate GTIN attribute data Identify data owners Modify/establish data governance process Assess attribute data v. GDSN/UDI Standards Complete and/or Transform attribute data as required Verify attribute data in correct formats for publication Publish data as appropriate to GDSN Data Pool/UDID Update GDSN/UDID as required for changes in products, attributes, customers, regulators 1011 Device Identification A Paradigm ChangeCURRENTPROPOSEDP roprietary Identification Manufacturers Catalogue NumberOpen Identification Manufacturers Standards-based UDINot Globally UniqueGlobally UniqueDistributors may apply different proprietary identification numberDistributors use Manufacturers UDI numberDistributors do not capture lot or serial numbersDistributors may use AutoID to capture lot or serial numbersHospitals may apply different proprietary identification numberHospitals use Manufacturers UDI numberHospitals do not capture lot or serial numbersHospitals use AutoID to capture lot or serial numbersNon-standardized device information available on a limited.

5 Ad hoc basisStandardized device information available in an FDA database12 UDI Panel Participants Mike Wallace Abbott (Moderator) Terri Reed FDA CDHR Michael Sarachman JNJ Standards Adoption Joe Pleasant Premier CIOFDA Center for Devices and Radiological Health: UDI Database & CDRH Informatics StrategyGS1 ConferenceBethesda, MD4/6/1114 Overview Informatics Strategy at CDRH UDI as Master Data Ties to HL7 Standards Data Exchange as a Team Sport15 CDRH Informatics Goal: Improve Data Quality Current data meets requirements of a particular regulation or business need StandardData exchange methods not used Some electronic data must be re-entered Data cleansed and linked after received and stored EXCEPTION: eMDR -standard vocabulary and data exchange format, 16 Focus on Fundamentals: Sharing and Reuse of Data Common Data Exchange Getting from A to B and back again (SYNTAX) Standard Terminology -Building Blocks -Allows Reuse of Data (SEMANTICS)17 Master Data Management Plan Compliments development of standard data exchange and vocabularies Identifies the agreed to, standard critical business data( , UDI info, device names, event codes, item codes, manufacturer names, GMDN codes) that can be shared across systems.

6 Creates policies and procedures for creation, access, update, and overall management of this central resource. Emphasizes Data quality, Integration, Single version of the truth, Data Master Data Management Multiple master No Authoritative dataInconsistent DataSemantic DifferencesData Duplicates Master DataData Hub- Single Master Harmonized Consistent DataSingle VocabularyGoverned by a single group 19 UDI as Master Data Core data for Regulatory product safety/effectiveness DEVICE Information Means to increase quality & consistency of DEVICE Information Applying UDI to label of device Requiring standardized electronic submission of UDI data20 Establishing a UDI SystemCombination of 4 distinct a standardized system to establish the unique device identifiers (UDI)

7 The UDI in human readable and/or AutoID on a device, its label, or and maintain the UDI Adoption and Implementation21 UDI: Ties to HL7 SPL r5HL7 Data Exchange Standard Global authority on standards for interoperability of health information technology with members in over 55 countries Individual Case Safety Report (ICSR) Adverse Event Reporting Structured product Labeling (SPL) -UDI - product Information (SPLr5)22 Agency Pre-Market DatabaseAgency Adverse Event DatabaseAgency Registration& Listing Sponsor Pre-Market DatabaseSponsor Complaint / Recall DatabaseSponsor Database of product on the Market RPSICSRSPLVISION: product DATAS ponsor UDI DatabaseSPL/CPMA gency UDI DatabaseSPONSOR product DATA SOURCES REGULATORY, QUALITY, MASTER DATAData Exchange Vision23 UDI Database Benefits of Adoption FDA/Manufacturer adoption -- Improves ability to link internal databases around product information Provides improved device information in regulatory submissionsHealthcare adoption - EHR as a rich data source for device-specific safety surveillance/observational studies Provides method to obtain real-world data for pre-market decisions (registries) Improves ability to link Healthcare databases24 Data Exchange/Reuse Efforts lead Improved Data Sharing with.

8 Regulated Industry Professional Organization Registries Healthcare IT Departments Materials Management Federal Health Partners25 Which leads Improved Patient Care Device Info Improved Public Health Improved Quality and Timeliness of Data Improved Information from Clinical Research Improved AE Reports (ASTER-D, PDRNet) Improved Signal Detection Improved Directed Inspections Improved Recalls26 Data Exchange is a Team SportTypeGroupUDI/Informatics RoleRegulated IndustryAdvaMed, GHTF, Coordinate FDA data standards with industry Educate and Facilitate SubmissionsStandards Development OrganizationsGS1, HL7, ISO, AAMICDISC, GMDNIHTSDO, (SNOMED), NCPDC, X12 CDRH advocate Apply Stds at Agency and Center Level Educate and Promote AdoptionSupply ChainGS1, HIBCCG roup Purchasing, Material Mgt, Hospitals, Distributors Promote UDI Device Identification Database:Managing UDI DataApril 2011 Michael SarachmanManager, Industry Standards AdoptionJohnson & Johnson Health Care Systems Inc.

9 | CUSTOMER & LOGISTICS SERVICESSUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000 Proprietary and Confidential | 29 Impact of Unique Device Identification (UDI) AdoptionManufacturer #742 GDistributor #003774 Health Care Provider #360013 Manufacturer 12345 Distributor 12345 Health Care Provider 12345 Current StateFuture StateCONFIDENTIAL30 Perceived Benefits of UDI Accurate sales orders Accurate and efficient recalls Accurate procurement Enable electronic health record usage Patient safety Efficient delivery of clinical care Foundational for track & traceCONFIDENTIAL31 UDI Benefits Standardized & consistent safety data Leverage common database Ensure positive product identification Standardized production data collection AutoID of Production Data Lot Code Serial Number Complements current data collection | CUSTOMER & LOGISTICS SERVICESSUBGROUP NAME.

10 REGION AND/OR PROJRCT | Confidential | Month 00, 0000 Proprietary and Confidential | 32 UDI Usage510K Notification No. K953442 UDI| CUSTOMER & LOGISTICS SERVICESSUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000 Proprietary and Confidential | 33 UDI System Components The identifier Global Trade Item Number + LOT Global Trade Item Number + Serial Number The carrier Bar code symbol The database Global Trade Item Number No LOT or Serial Number data Additional attributes Clinical size Brand Name Market authorization| CUSTOMER & LOGISTICS SERVICESSUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000 Proprietary and Confidential | 34 Data SourcesUDIM arketing Brand nameEngineering Clinical size Sterilization state Sterilization methodRegulatory FDA Market authorizationOthers Contents of concern GMDN CodeMaster Data| CUSTOMER & LOGISTICS SERVICESSUBGROUP NAME.