Presentation on theme: "Unique Device Identification"— Presentation transcript:
1 Unique Device Identification Jay CrowleySenior Advisor for Patient SafetyFood and Drug Administration
2 Current Device Identification Non-standard device identification systems; standards used in different waysNot necessary unique or unambiguousDoes not include all necessary levels of uniquenessManufacturers’ own number/catalogue numberDistributors’ – apply different, proprietary number; lot or serial number not capturedHospital – yet different identification number/codeInformation on use not usually capturedControl numbers rarely captured
3 Future Device Identification Develop a system to identify medical devices, which is:ConsistentUnambiguous (differentiates among all dimensions)StandardizedUnique at all levels of packagingHarmonized internationallyAnd facilitates the:Storage,Exchange, andIntegration of data and systems
4 UDI brings… Global Visibility Medical device recallsAdverse event reporting and postmarket surveillanceTracking and tracing, supply chain security; and anti-counterfeiting/diversion (location systems)Comparative effectiveness (e.g., registries)Disaster/terror preparation and shortages/substitutionsReduce medical errorsDocumenting medical device use in patient’s EHR/PHR, hospital information systems, claims dataSentinel Initiative - strengthening FDA’s ability to query data systems for relevant device information
5 FDA Amendments Act of 2007September 27, 2007, the FDAAA signed into law:The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.
6 GHTF UDI ADWG Formed October 2008 EC Chair (Laurent Selles) Members US (FDA, AdvaMed), Europe (EC, Eucomed, EDMA), Japan, CanadaAHWP recently joined (China)Washington April 2010; Brussels June 2010; Ottawa September 2010Guidance submitted to Nov 2010 SC meetingPublic Document – available at: Comments due by 30 April 2011.
7 Establishing a UDI System Combination of 4 distinct steps:Develop a standardized system to develop the unique device identifiers (UDI)Place the UDI in human readable and/or AutoID on a device, its label, or bothCreate and maintain the UDI DatabaseAdoption and Implementation
8 1st – Developing the UDIDevelop UDI code according to ISO [GS1, HIBCC]Created and maintained by the manufacturerConcatenating Device and Production IdentifierDevice Identifier (DI): [static] Manufacturer, make, model [i.e., each catalogue number]Production Identifier (PI): [dynamic] however product is currently controlled – serial, lot number; expiration, manufacturing date
9 2nd – UDI Application• Unique UDI applied to all levels of packaging, down to the lowest level (patient use/ unit of use)• Human readable and/or encoded in a form of automatic identification technologyNo specific technology would be identified (technology neutral)Identify a series of standards (linear barcode, 2-dimensional barcode, RFID)Direct Part Marking (DPM) for some devices
13 Combination Products and Kits Like other devices – intended to facilitate identification:Combination product (device) has its own UDI; each device should have its own UDI.Each kit (devices only) has its own UDI; each device in a kit should also have its own UDI.
14 3rd – Global UDI Database Device Identifier Type/Code [GTIN, HIBCC]Make/model; Brand/Trade Name; Size; DescriptionDevice model number (or reference number)Unit of Measure/Packaging level/quantityControlled by – Lot and/or Serial Number; Exp. DateContact name, phone,GMDN Classification code/termStorage condition; Single Use; SterilityContains known, labeled allergen (e.g., latex)FDA premarket authorization (510k, PMA)FDA Listing Number
15 FDA’s UDI Database FDA FDA Managed Business Rules FDA’s UDI Database The label of Medical Device 123 Size 45:Device Identifier (Device XYZ123)Production Identifier (Lot #ABC)Expiration date (MMDDYYYY)Sterile; Latex freeManufacturer(Acme)DistributionFDAMinimum Data SetFor each Device Identifier:Manufacturer and modelGMDN CodeOther attributesFDA ManagedBusinessRulesFDA’s UDIDatabaseHL7 SPLGSI GDSNorWeb based toolorPublic User InterfaceBulk HL7 SPL
16 Implementation Based on premarket risk class: class III – 12 months after final ruleclass II – 36 months after final ruleclass I – 60 months after final ruleAllows stakeholders to jointly learn and for mid-course correctionsPhase out national numbering system (NDC/NHRIC)Robust alternate placement and exception processExpect manufacturers and groups of manufacturers to submit requests – results of which will posted.
17 4th – Adoption and Implementation • Facilitate distributor uptake and useFacilitate hospital uptake and useFacilitate use of UDI throughout device lifecycleDrive integration – MMIS-ClinicalDrive appropriate use of UDI in EHRs – and use of EHRs for registries and other postmarket activities
18 UDI Database PilotsPhase 3 – Purpose: Assess the feasibility of collecting, storing, and retrieving UDI data from initial creation (manufacturer) to point of use (hospital) .Phase 4 – Purpose: Assess how UDI data will impact FDA device information use in current systems