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GMDN – An Introduction Mark Wasmuth – CEO, GMDN Agency
GMDN – An Introduction
Some questions to answer:
• Why do we need GMDN?
• What is GMDN?
• GMDN and UDI?
• How do we use it?
It’s a complicated world!
How can we sort all these products?
All Electrocardiographic
monitors (P35195)
We need to group them
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
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
How does the GMDN work?
What is it?
How do we define the group?
GMDN Term Definition: A mains electricity (AC-
powered) 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.
We define the group with a precise Definition
GMDN Name: Electrocardiographic monitor
GMDN Term Definition: A mains electricity (AC-
powered) 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.
Give the group a Name
GMDN Code: 35195
GMDN Name: Electrocardiographic monitor
GMDN Term Definition: A mains electricity (AC-
powered) 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…
Give the group a Code
GMDN Code: 35195
GMDN Name: Electrocardiographic monitor
GMDN Term Definition: A mains electricity (AC-
powered) bedside device designed to continuously
detect, measure, and display a patient's
electrocardiogram (ECG)…
Device group = GMDN Term
All Electrocardiographic
monitors (P35195)
Similar devices share the same GMDN Term
We publish the GMDN on our website
With lots of language options
Search using key words
GMDN is a Nomenclature & Hierarchy (for naming and searching)
Collective Term
Collective Term
Collective Term
Collective Term
Collective Term
GMDN Term
GMDN Term
GMDN Term
GMDN Term
GMDN Term
GMDN Term
GMDN Term
Collective Term
Hierarchical structure - for searching / analysis
Nomenclature - for naming
Many to Many relationships = Flexible
GMDN Term
GMDN Term
GMDN Term
GMDN Term
GMDN Term
Collective Term
GMDN Term
Collective Term
Collective Term
Collective Term
Collective Term
Search using Collective Terms
Hierarchical structure - for searching / analysis
Analysis using Collective Terms
Attribute structure - for analysis
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
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.)
23 of 35
12345678909874
Hudson
GMDN is not the UDI!
12345678909874
Device Type =
Unique Device Identifier
From a single supplier
(e.g. 12345678909874)
Hudson
Device Group = GMDN Term
(e.g. GMDN Code 47071)
19876543218976
32345678908765
Brooks
Woods
Hudson
12345678909874
How do I use UDI & GMDN? Create a Database
Or use the US FDA Database?
UDI
GMDN Term
https://accessgudid.nlm.nih.gov/
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 https://accessgudid.nlm.nih.gov/
• 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) -
http://mdepinet.org/rapid
• Building UDI into Longitudinal Data for Medical Device Evaluation (BUILD)- http://mdepinet.org/build
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
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
Maybe all medium and large manufacturers? (> 100mEUR Sales)
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GMDN total rolling membership - manufacturers >100m EUR
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
It’s all about sharing information!
Thank you for listening
Any questions now?
Or later?
Contact us at www.gmdnagency.org