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Global Medical DeviceNomenclature (GMDN)GMDN – A Requirement for UDIMark Wasmuth – CEO, GMDN Agency
What we will be discussing Why is the GMDN neededGMDN data structureHow to find GMDN termsUnique Device IdentificationUDI & GMDN RelationshipExamples of GMDN in useQuestions?2
Why the need for Device names?Large variety of devices!3
Why is consistent naming important? Medical Devices are traded internationally Regulators need to approve devicesefficiently by identifying the product groupand the related hazards / risks Regulators need to identify ‘systematic’failures of medical devices Hospitals can identify the products theyneed and manage their inventory4
Why was the GMDN needed?Existing nomenclatures: ‘National’ systems (not suitable forinternational harmonisation) & Single language Unstructured / un-standardised Too vague / poor definitions Too rigid – difficult to include new technology Can’t keep up with volume of innovation Too many duplicates / overlaps Uncontrolled – no update method for usersNot meeting Regulator needs5
What is the GMDN?Global Medical Device Nomenclature (GMDN) The international standard (ISO 15225) fornaming Medical Devices Used by 65 national Medical DeviceRegulators - Backed by IMDRF Over 4000 Manufacturers worldwide Translated into 25 languages 22,000 Preferred Terms with Definitions Controlled distribution and updating International acceptance6
Global acceptance? GHTF (now IMDRF) proposes GMDN for UDI EC proposes GMDN for the EUDAMED (marketsurveillance database) EUCOMED supports the use of GMDN in meeting theneeds of European manufacturers EC has translated the GMDN into 20 languages WHO & MSF use GMDN in guidance for developingcountries Collaboration Agreement with IHTSDO (Snomed CT) US FDA are using GMDN in the first nationalimplementation of UDI7
GMDN Term StructureEach GMDN Term consists of 3 parts: Term Name: General-purpose syringe Definition: A sterile device that consists of a calibrated hollowbarrel (cylinder) and a moveable plunger intended to be used toinject fluids (e.g., medication) into, and/or withdraw fluids/gasfrom, the body or a medical device for various medical Code: 470178
How can you find GMDN Codes?www.gmdnagency.org9
Searching for GMDN Terms10
Review the Results11
How can you find GMDN Codes?12
More detail13
Reveal the GMDN Code14
Collective TermsGMDN uses Collective Terms to provide: Better navigation with variable hierarchies Compare common features: Materials (Inert, Latex, Animal)Invasiveness (Internal / External)Sterility (Supplied Sterile / non-sterile)Use Frequency (Single Use / Reusable)Powered by (mains, battery, air, etc.) Flexible to meet future needs15
Collective Terms16
Using Collective Terms to search17
What’s the process? Identify the GMDN Code for all of yourproducts, from the GMDN database Provide the GMDN Code to yourCustomers / Distributors / Data Pools Use the GMDN Code to register yourproducts with your MD Regulator Use with Unique Device Identification(UDI)18
Unique Device Identification Pack / product marking of ‘unique’ identifier Marking also includes production identifiers(e.g. Batch No., Expiry Date, Serial No ) Machine readable (e.g. bar code) andhuman readable Linked to other product data in a database(e.g. make, model, etc.)Hudson1234567890987419
UDI Database The GMDN code is one of the 25mandatory core data elements identified inthe IMDRF ‘UDI System for MedicalDevices’ draft Guidance Document. Data for each device is provided by themanufacturer to the UDI Database (UDID). The UDID data could be distributed by: Public access website Bulk data download (e.g. Hospitals)20
UDI requires a Carrier & Hardware Product Label (Carrier) Linear Bar Code 2D Bar Code (more data) RFID - Radio FrequencyIdentification (non-contact) Hardware to read labels123456789098741234567890987412345678909874 Bar code Reader Image Scanner RFID Scanner21
GMDN and UDI RelationshipPack / Device – Unique DeviceIdentifier(e.g. 12345678909874)Hudson1234567890987422
GMDN and UDI RelationshipPack / Device – Unique DeviceIdentifier(e.g. 12345678909874)Generic Device Group - GMDN Term(e.g. GMDN Code ks19876543218976Woods3234567890876523
When you can’t find a Term?If you can’t find a GMDN Term for yourproduct:1.Ask us for assistance2.Apply for a new Term: On-line Request ApplicationAttach your product datasheet / picturesWe discuss the draft Term with youTwo week public comment periodDatabase updated daily24
Modifying or Obsoleting Terms? We modify existing Terms To increase the scope Improve the definitions Make Terms Obsolete To remove inadequate Terms Reducing over time Notifications by email to Members25
Example of GMDN & UDI for Regulation Post Market surveillance Identify systematic (generic) product failure Support rapid product recall Better Regulation Speed up Pre-market approvalIdentify products quicklyDetailed information on imports and exportsQuickly identify trends about new equipmentuse and problems26
GMDN speeding up pre-market approvalNew ApplicantHudsonRegulator Device RegisterGMDNMake38501HudsonTest MethodDateApproval27
GMDN speeding up pre-market approvalNew ApplicantHudsonRegulator Device RegisterGMDNMakeTest MethodDateApproval38501Hudson38501WoodsISO 78862009 38501BrooksISO 78862008 38501JonesISO 78862010 JonesPreviously Approved Device28
GMDN speeding up product recallProduct FailureHudsonRegulator Device RegisterGMDNMakeUDI [GTIN]DateRecall38501Hudson123456789098742011 29
GMDN speeding up product recallProduct FailureHudsonRegulator Device RegisterGMDNMakeUDI Woods32345678908765 38501Brooks19876543218976 38501Jones58746528415424?JonesInvestigate this product too?30
Example of GMDN & UDI in Hospitals Asset Management Support equipment commissioning Help identify equipment location Support maintenance programmes Inventory Control Reduce wastage Translate product labels with poor descriptions Improve stock control31
Use the GMDN to find missing stockGMDNMakeUDI [GTIN]StockLocation38501Hudson123456789098741Ward CStock Control DatabaseHudson(01)1234567890987420 Needed in Ward C32
Use the GMDN to find stockGMDNMakeUDI [GTIN]StockLocation38501Hudson123456789098741Ward C38501Woods323456789087652Ward E38501Brooks19876543218976100Ward HStock Control DatabaseHudson(01)12345678909874Brooks20 Needed in Ward C(01)19876543218976100 Located in Ward H33
Nottingham University Hospital Clinical Engineering application34
Thank you for listeningAny nagency.org35
The GMDN code is one of the 25 mandatory core data elements identified in the IMDRF ‘UDI System for Medical Devices’ draft Guidance Document. Data for each device is provided by the manufacturer to the UDI Database (UDID). The UDID data could be distributed by: Public access website Bulk data download (e.g. Hospitals) 20File Size: 1015KBPage Count: 35
