The What and the How - The UDID system Géraldine Lissalde-Bonnet GS1 Global Office

Transcription

1 The What and the How - The UDID system Géraldine Lissalde-Bonnet GS1 Global Office AHWP & RAPS Joint Conference 2-3 December 2013, Kuala Lumpur - Malaysia

2 Agenda 1. Introduction to GS1 Healthcare 2. The coding rules for identifying medical devices using a global standard 3. Databases, UDI and Data Synchronization 2

3 1. Introduction to GS1 Healthcare

4 GS1 an international standard organisation Not-for-profit 111 Member Organisations Over one million user companies (from SME to global companies) Member driven 150 countries served; 20 different domains 2,500 people helping us Over 6 billion transactions a day 4

5 GS1 Healthcare - a voluntary, global Healthcare User Group To lead the healthcare sector to the successful development and implementation of global standards by bringing together experts in healthcare to enhance patient safety and supply chain efficiencies.

6 Recognised, open and neutral source And many more

7 2. The coding rules for identifying medical devices using a global standard

8 Global system of standards to ensure visibility 8

9 Automatic Identification & Data Capture (AIDC) Automatic Identification and Data Capture (AIDC) refers to methods for automatically identifying objects, collecting data about them and entering that data directly into IT systems (i.e. without human involvement). - adapted from Wikipedia, 2009 Unique identification Products Logistics units 1 3 Links management Physical flow Information flow Locations & legal entities AIDC Components Etc. Building Blocks of Traceability Data capture Bar codes EPC/RFID 2 4 Data communication Share data Retrieve data

10 The Foundation GS1 Identification Keys Provide access to information held in computer files Information about company/location, package, product, price, etc. Unique Non-significant International Secure Foundational Global Trade Item Numbers (GTINs) uniquely identify items along the Supply Chain. Integrity of these numbers throughout the item s lifetime is a key to maintaining uniqueness for manufacturers, wholesalers, distributors, hospitals and regulatory bodies. A change to one aspect, characteristic, variant or formulation of a trade item may require the allocation of a new GTIN. 10

11 Anatomy of a GTIN-14 Assigned by GS1 Global Office Assigned by GS1 Malaysia Assigned by Brand Owner Calculated Assigned by Brand Owner I C C C C P P P P P C I = Indicator P = Item Number* 955 = GS1 Country code for Malaysia C = GS1 Company code* C = Check Digit GS1 Global Company code *This is an example the number of digits can vary depending on the assigning MO

12 Capture the identification key and more Keys (such as GTIN) provide access to information held in computer files. Key Attributes (such as Expiry, Lot / Batch, Serial Number, etc.) provide additional direct information. Item identifier Expiry date Batch number Serial number (21)123 12

13 UDI system AIDC components UDI/UDID - System AIDC Identifiers DI (static data) PI (dynamic data) Static Data Elements DI = primary access key UDID (database) AIDC Data Carriers Machine Readable 1D Bar Code 2D Bar Code RFID DI = Device Identifier PI = Production Identifiers (i.e. lot/batch no., serial no., expiry [use by] date, date of manufacture) 13

14 UDI in GS1 terms

15 Common industry practices Packaging Levels: The Device Identifier (GTIN) & Product Identifiers (AIs) should be in bar code & in human-readable form on each applicable package level Each designated package level must have its own Device Identifier (GTIN) Placement: Bar code symbols should allow ready access for scanning when the product is stored or stocked on shelves

16 Real UDI example - #1 UDI Bar Code symbol Device Identifier (DI) Static portion GTIN (product identifier) Production Identifier (PI) Dynamic portion Application Identifiers (e.g. serial, lot number & expiry date)

17 Real UDI example - #2 Production Identifier (PI) Dynamic portion Application Identifiers (e.g. serial, lot number & expiry date) Device Identifier (DI) Static portion GTIN (product identifier) UDI Bar Code symbol

18 3. Databases, UDI and Data Synchronization

19 The challenge : for regulators US Department of Defence* discovered that : product catalogues had problems matching the correct manufacturer name for 30% of the medical devices and 20-25% lack the product brand name the part number 8630 in the product catalogue of a leading GPO was linked to 9 different numbers from different distributors Different manufacturers use different standards in different ways if they use anything at all. Distributors apply their own. Hospitals apply their own. And we just sort of cascade into this series of events which means that we can t find devices. Jay Crowley, US FDA, FDA UDI Public Workshop, Feb In the US from 2005 through 2009, firms initiated 3,510 medical device recalls, an average of just over 700 per year. Regulators need to be able to ensure highest levels of market surveillance, to efficiently mange adverse event reports and to quickly recall devices not only in their country but also across borders * Source: US DoD Study 19

20 The challenge : for hospitals Product catalogues - current situation: Varying methods of communicating new items Supplier A printed catalog Supplier B price quote Supplier C PDF data Supplier D Excel tables Supplier E text data Supplier F link to website Varying methods of communicating updates/changes (or not communicating) Varying descriptions and levels of detail (product attributes) Varying levels of data accuracy and data quality Hospitals need single and integrated system of exchange of information on devices and adequately identified medical devices distribution and use 20

21 The challenge : for manufacturers Source: Volker Zeinar, B Braun, 2013 Manufacturers need cost optimisation and process synchronisation by submitting data to regulators and to customers through one connection 21

22 The future : a global network of regional UDID What will be needed: Global network of regional databases communicating with each other and providing a single point-of-access Allowing data providers to load their master data once for all geographies and data recipients have access to master data of all their data suppliers through one source Global Data Synchronization Network (GDSN) is already in use by manufacturers, distributors, GPOs and providers to share product data and will be leveraged by manufacturers as a data feed to the UDI databases as well as hospitals 22

23 UDI system Database components UDI/UDID - System UDI DI (static data) PI (dynamic data) Static Data Elements DI = primary access key Content Structure Data Relationships Vocabulary UDID (database) AIDC Machine Readable Data Carrier Linear Bar Code 2D Bar Code RFID DI = Device Identifier PI = Production Identifiers 23

24 UDI Databases: Global Core Data + Local Data FDA GUDID Core Data Local Data Additional local data elements defined by the FDA Global core data elements defined by IMDRF 24

25 GUDID Data Entry Options Labelers can to load Data for the DI (not PI) via: Web Portal User Interface: Using a graphic user interface on a website (eg. FDA s website) Data can be entered one device at a time Only recommended for small catalogs (eg. less than 100 items) Machine to Machine: Using the Structured Product Language (SPL) developed by HL7 The SPL is an HL7 XML data messaging standard GS1 GDSN: Certified Data Pools can establish a connection to the regulator s system (successfully piloted with the FDA GUDID) to load data on behalf of the Labeler, using the HL7 SPL standard The Data Pool will need access under the Labeler s account to accomplish the load. 25

26 A single connection to regulators and customers Manufacturers are able to provide data to all UDI databases and their customers (hospitals, distributors, wholesalers, GPOs) simultaneously, with a single connection.

27 Conclusions

28 The need to align on a global UDI framework It is crucial that regulators around the world align on the IMDRF Guidelines and ensure consistency when setting-up regional or national UDI system This would ensure : highest levels of patient safety beyond borders harmonised identification systems for medical devices globally allow for consistency in UDID across countries 28

29 The need for global standards Healthcare is local Healthcare providers are local Regulations are local Healthcare is global Healthcare supply chains often cross borders Country-by-country solutions are not sufficient nor effective A global harmonised approach and implementation is needed McKinsey report Strength in unity: The promise of global standards in healthcare Available at:

30 25 th Global GS1 Healthcare Conference Save the date: 1-3 April 2014, Seoul, South Korea How GS1 global standards get implemented worldwide and help to improve patient safety and supply chain efficiency About new regulations on UDI (Unique Device Identification) and traceability across the world Use cases and implementation at manufacturer, wholesalers and hospitals 5 th ThinkTank for regulatory bodies

31 Contact Details GS1 Global Office Brussels Géraldine Lissalde-Bonnet UDI webpage