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