GMDN An Introduction. Mark Wasmuth CEO, GMDN Agency

Transcription

1 GMDN An Introduction Mark Wasmuth CEO, GMDN Agency

2 GMDN An Introduction Some questions to answer: Why do we need GMDN? What is GMDN? GMDN and UDI? How do we use it?

3 It s a complicated world!

4 How can we sort all these products?

5 We need to group them

6 Can we rely on manufacturers descriptions? Example - A recent study to find all Peripheral Stents sold in the USA found Manufacturer s descriptions confusing: Self-Expanding Stent System Self-Expanding Peripheral Stent System STENT COMPLETE SE LONG US Self-Expanding Stent Trade name Stent System Or no description at all! We need a name we can all use

7 Can we use our existing naming system? Generally existing naming systems do not meet Regulator needs: National systems (not suitable for sharing) Usually in a single language Unstructured / un-standardised Too vague / poor definitions Too rigid in structure difficult to include new technology Can t keep up with volume of innovation Too many duplicates / overlaps Uncontrolled no method to contact and update users

8 How does the GMDN work?

9 How do we define the group? What is it?

10 We define the group with a precise Definition GMDN Term Definition: A mains electricity (ACpowered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to the patient; it also typically displays heart rate. The device is typically equipped with audible and/or visual alarms that are triggered when the patient's parameters drop below or exceed pre-set limits.

11 Give the group a Name GMDN Name: Electrocardiographic monitor GMDN Term Definition: A mains electricity (ACpowered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to the patient; it also typically displays heart rate. The device is typically equipped with audible and/or visual alarms that are triggered when the patient's parameters drop below or exceed pre-set limits.

12 Give the group a Code GMDN Code: GMDN Name: Electrocardiographic monitor GMDN Term Definition: A mains electricity (ACpowered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to the patient; it also typically displays heart rate

13 Device group = GMDN Term GMDN Code: GMDN Name: Electrocardiographic monitor GMDN Term Definition: A mains electricity (ACpowered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG)

14 Similar devices share the same GMDN Term

15 We publish the GMDN on our website

16 With lots of language options

17 Search using key words

18 GMDN is a Nomenclature & Hierarchy (for naming and searching) GMDN Term Collective Term Collective Term Collective Term GMDN Term GMDN Term GMDN Term GMDN Term Hierarchical structure - for searching / analysis Collective Term Collective Term Collective Term GMDN Term GMDN Term Nomenclature - for naming

19 Many to Many relationships = Flexible GMDN Term GMDN Term Collective Term Collective Term Collective Term GMDN Term GMDN Term GMDN Term Collective Term GMDN Term Collective Term

20 Search using Collective Terms Hierarchical structure - for searching / analysis

21 Analysis using Collective Terms Attribute structure - for analysis

22 When you can t find a GMDN Term? Our aim is to include all devices Free Enquiry process On-line application You provide product information Answer any questions About 2-3 weeks (or less time if it s urgent) We publish updates every day New product group Expanding Definitions Help to identify the correct GMDN Term

23 How about UDI? Unique Device Identification (UDI): Pack / product marking of unique number Marking also includes production identifiers (Batch No., Expiry Date, Serial No, etc) Machine readable (i.e. bar code) and human readable Linked to other product data in a database (Manufacturer, Make, Model, GMDN Code, etc.) Hudson of 35

24 GMDN is not the UDI! Device Type = Unique Device Identifier From a single supplier (e.g ) Device Group = GMDN Term (e.g. GMDN Code 47071) Hudson Hudson Brooks Woods

25 How do I use UDI & GMDN? Create a Database

26 Or use the US FDA Database?

27 UDI GMDN Term

28 We are working with the US FDA Analysing UDI data Over 1.3 million device records so far and growing, daily! Data is available from Search by UDI and GMDN Term Name We are checking GMDN allocations and feeding back to Members and improving GMDN Definitions US medical device evaluation system (MD EpiNet) Registry Assessment of Peripheral Interventional Devices (RAPID) - Building UDI into Longitudinal Data for Medical Device Evaluation (BUILD)-

29 Who is the GMDN Agency? The GMDN Agency is an independent, non-profit, UK Charity Responsibility for maintaining / distributing the GMDN License agreements to access the GMDN Regulators have free access for their use Manufacturers pay according to size (from 100 EUR) Governance Board of Trustees Policy Advisory Group Regulators Manufacturers Healthcare Providers

30 Global Acceptance? Over 80 National Medical Device Regulators use GMDN WHO publish guides that use GMDN IMDRF members only recommend GMDN Australia, Brazil, Canada, European Union, Japan, Russia & USA AHWP are supporting adoption by its members Adopted by Snomed International for Electronic Patient Records Working with Manufacturers Associations (GMTA, DITTA, etc) Over 7500 Device Manufacturers use GMDN

31 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 Apr-17 May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 Maybe all medium and large manufacturers? (> 100mEUR Sales) 160 GMDN total rolling membership - manufacturers >100m EUR

32 Why should I use the GMDN? The GMDN gives us: An international system, suitable for sharing Published in 20 languages Structured data to international standard ISO 15225:2015 Precise GMDN Names and Definitions Flexible structure, adaptable to include new technology Uses higher-level groups built-in (Collective Terms) Managing the volume of innovation by manufacturer request No duplicates or overlaps Responsive to change Controlled distribution all users are in contact with us

33 It s all about sharing information!

34 Thank you for listening Any questions now? Or later? Contact us at