global medical device nomenclature (gmdn)group of devices ct’s group/organize: by clinical...

Global Medical Device

Nomenclature (GMDN)

Dr Barry Daniels

Technical Lead

GMDN Agency

Apr 2019

Global use of GMDN

Background

GMDN was designed by Regulators for regulatory use

Brainchild of GHTF and adopted by IMDRF

Goal to have one global device nomenclature

Initial funding and in-kind support provided by EC, US FDA &

TGA (now membership funded)

Current IMDRF UDI Guidance (IMDRF/UDI WG/N7FINAL:2013):

“9.2 The core UDID data elements -

8. Global Medical Device Nomenclature…”

Current Operations

Charity (Non-profit) organisation regulated in the UK

Open and transparent◼ Board of Trustees (one industry representative)

◼ Policy Advisory Group (Regulators & manufacturers)

Changing to meet user needs◼ Free enquires from Dec 2016 at request of Users

◼ Free access from April 2019 at the request of WHO and EC

Operational capacity◼ 6 full-time technical authors

◼ 27000 terms, 1200 requests for new terms each year

Used by 90+ countries◼ Product registration in the USA, Australia, Russia, etc

◼ Translations in 30 languages

Get from this:

To this ?

Device Group

Naming and grouping – The role of GMDN

The GMDN term

GMDN Code: 35195

GMDN Term 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.

Products assigned to

35195

Electrocardiographic

monitor

• Names the group

• Defines scope of the

generic device group

• 27,000 currently

• Many Products assigned

to 1 GMDN term

The GMDN term

GMDN higher level grouping (CT’s)

CT1444 Patient monitors/monitoring systems

CT314 Electrically powered/operated

• Each GMDN term is linked to many higher level (broader) Collective terms (CT’s)

• CT’s arranged in a (multi-) hierarchy

• Therefore each Collective term creates a broader group of devices

CT’s group/organize:

◼ By clinical application (e.g., cardiovascular devices)

◼ By name (e.g., prosthesis, scissors, catheter)

◼ By attribute (e.g., Material, Invasiveness,

sterility, Use frequency)

A hierarchical categorisation …

GMDN higher level grouping (CT’s)

Nomenclature

GMDN termsHierarchical classification

Collective Terms

Collective Term

Collective Term

Collective Term

Collective Term

Collective Term

Collective Term

GMDN Term

GMDN Term

GMDN Term

GMDN Term

GMDN Term

GMDN Term

GMDN Term

GMDN Term

GMDN Term

GMDN Term

GMDN Term

GMDN Term

Collective Term

Collective Term

What does GMDN give the user

The GMDN data gives the user (Regulator, Registry, Hospital,

Manufacturer):

A name and definition that describes the device clearly and

succinctly without proprietary jargon (in up to 20 languages)

A way to group the device at many levels (e.g., for inventory

management, regulatory risk trending, recall analysis)

A global solution:

◼ Only one code needed worldwide

◼ Allows for global analysis of data

◼ Consistent communication of data across

borders

The Process for Manufacturer members

Logon to

GMDN

account

Search for

an active

GMDN

term that

accurately

describes

the device

Can you

find a

term?

Click – add to

shortlist and

purchase from

shortlist

Make an

Enquiry using

the Enquiry

wizard

Communicate

with GMDN

team until

enquiry finalized

Yes

No

Golden rule

A thought: If you have the device in front of you and

someone asked “What is that?” – would the GMDN term be a reasonable answer? Hopefully yes.

Every device (placed on the market

separately) should be assigned to a

single GMDN term that represents

that device.


Logon to

GMDN

account

Search for

an active

GMDN

term that

accurately

describes

the device

Can you

find a

term?

Click – add to

shortlist and

purchase from

shortlist

Make an

Enquiry using

the Enquiry

wizard

Communicate

with GMDN

team until

enquiry finalized

Yes

No

1) Simple word/part-word search

2. The Explorer: using the CT hierarchy

2. The Explorer – Finding a CT directly

Review terms under that CT

Select the CT

of interest

Use a single key

word/part-word to

search

2. The Explorer: Hide Sub-Group Terms

• The explorer allows you to use the power of the CTs to search for GMDN Terms

• NOTE: not every GMDN Term is linked to a CT at the lowest level of the CT tree

• In order to filter out the GMDN Terms that are described by more detailed Child

CTs click ‘Hide Sub-Group Terms’

3) CT links in term details

From a word search if you find a related term open ‘details’

At the bottom of the page you can see the CT tree for that term

Example for the term Bare-metal coronary artery stent (53616) the CT

links are:

• These hyperlinks to the Explorer

Example search:

Aortic valve bioprosthesis


Logon to

GMDN

account

Can you

find a

term?

Click – add to

shortlist and

purchase from

shortlist

Make an

Enquiry using

the Enquiry

wizard

Communicate

with GMDN

team until

enquiry finalized

Yes

No

Search for

an active

GMDN

term that

accurately

describes

the device

GMDN Website - Enquiry

Search first – if cant find suitable term use Enquiry.

Enquiry is the only way to get help from the GMDN Agency

for assigning Terms to products. The outcome will be:

◼ An appropriate existing Term.

◼ Modification of an existing Term to include the new product’s

characteristics.

◼ A new GMDN Term is created.

Enquiry - list

Enquiry - step 1

Enquiry - choice

Enquiry - software

Enquiry - IVD

Enquiry – similar term

Enquiry - details

Enquiry - end

Enquiry – purchase new term

Changes to GMDN data

Develop new Terms (average 2-3 day)

Modify existing Terms to increase the

scope / improve the definitions

(average 3-4 day)

We obsolete Terms (average 10/m or

0.5% per year) to remove ambiguity /

term overlap

GMDN is dynamic and current to keep

up with innovation

Members are notified about changes…

◼You will receive alerts relating to any changes

All changes will be seen at the alerts page on

your account

Notification e-mails will be sent out - ensure

these are received by the appropriate person

You also will receive a monthly newsletter by e-

mail detailing these changes

Notifications to manufacturers

Term details - amendments

My term has been made obsolete

Again from your ‘Alerts’ page open ‘Term Details’

Use the ‘Explorer Groups’ (aka

Collective Terms) to help you find

the term you need

How should you manage GMDN Term changes?

Who needs to receive notifications? (update your

account)

How is this communicated internally?

GMDN is a data element in the DI record that

can be edited after the Grace Period.

Labelers are required (per UDI Rule) to keep their

device information current and correct with any

data that may have changed.

◼Website download

o Monthly full and delta

◼FTP

o Daily full and delta

o Monthly full and delta

o Monthly CTs

◼All in English, French and Spanish

◼API in development

GMDN dataset availability:

GUDID

US FDA UDI

Database = GUDID

◼ GMDN code is mandatory field on record

submission

FDA GUDID April 2018

DI records: 1,623,452

Unique GMDN codes: 8,450

(Active GMDN = 8,239)

Therefore ratio = 1:192

Unique companies: 4705

DIs using GMDN (rather than FDA PT) = 83 %

Active implantable device records: 3,515 Non-active implantable device records: 638,623 IVD device records: 32,218

(2864 GMDN IVD terms used, therefore ratio = 1:11)

GMDN Agency working with the FDA

◼ ‘Learning UDI Community’

FDA initiated and participant

Managed by AHRMM – trade association for supply chain

Objectives

◼ Help stakeholders understand UDI

◼ Identify and explore non-regulatory uses for UDI

◼ GMDN involved in:

Device Categorisation

High Risk Implants

◼ Helping to improve GMDN definitions and user

assignment of terms.

LUC – Device Categorisation 1

Learning UDI Device Categorisation Requirements

▪ Includes a transparent change control and versioning process that

proactively communicates change details to allow effective use

of terms within downstream systems (Health IT, registries,etc.).

▪ Includes best practice guidelines that define unambiguous ways

to assign device categories

▪ Aligns with or improves existing device type code set.

▪ Has ability to include reference to regulatory requirements

associated with a particular model/version of a device.

▪ Includes representation of all existing device types and is

up‐to‐date with those in commercial distribution

◼ Use cases:

RAPID/VQI

Augmented UDI Data (AUDI)

Breast Implant registry

LUC – Device Categorisation 2

RAPID/VQI use case

◼ RAPID project (Pilot study MDEpiNet)

◼ Phase 2 completed

◼ Use GMDN to get data from GUDID for:

◼ Peripheral vascular stents

◼ Atherectomy/Angioplasty – 15 terms

◼ Vascular grafts

◼ Vascular guidewires

◼ Analysis by clinicians of match of GMDN terms to

level of granularity required.

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Device Identification

GMDN CTs GMDN Terms Devices

Poor assignment

◼ Multiple GMDN

◼ Systems/components

◼ Not using definition

◼ PT code finder

◼ Lazy?

Initial assessment (cardiovascular implants) ~ 20%

Issues

Multiple GMDN

Multiple terms assigned to a device ( often with kits, systems or implant sets)

Example (in GUDID):

Multiple GMDN - system

56284

Drug-eluting coronary artery

stent, non-bioabsorbable-

polymer-coatedA sterile non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel

smooth muscle cell proliferation. Disposable

devices associated with

implantation may be included.

Multiple terms assigned to a device ( often with kits, systems or implant sets)

Multiple GMDN - Kit

Systems/components

A GMDN term for a system term applied to a component of the system

47487Medical device electrical cable, reusable

60784Cardiac radio-frequency ablation system

Complete system

System

electrical

cable

Example:

Not using definition

Judging the term by the name without review of the definition

Ophthalmic use

33961

General surgical procedure kit,

non-medicated, single-useA general-purpose collection of various sterile surgical

instruments, dressings, and materials intended to

be used to assist a range of

surgical procedures across

multiple clinical specialities. It does

not contain pharmaceuticals. This is a single-use device.

Is this term more appropriate?

Ophthalmic surgical procedure kit, non-

medicated, single-use

Querying GUDID

◼ Access GUDID

Textural search – have to use ‘Advanced’

to get text search only on GMDN term

name.

No search by GMDN code available –

either by webpage or by API, by individual

or group.

No search by CT (category hierarchy)

available

61 of 35

A device has a new component – Shared Data

62 of 35

InformationFor Users (IFU)Document

Publically shared data

(inc. GMDN term

assignment) sent to

Regulators and Customers

(e.g., via GDSN)

data

GMDN 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 control

Replace existing inventory classification with an externally managed globally recognized nomenclature

GMDN in Hospitals - UK

• Use in a number of Hospitals for inventory management

• Example: Nottingham NUH Trust

13215

General-purpose

infusion pump,

line-poweredA mains electricity (AC-powered) device

designed to facilitate the accurate and consistent administration of drugs and

solutions which can be delivered via intravenous, subcutaneous, arterial,

epidural, and intracavital routes using a dedicated infusion set. It is used to supply

higher pressures than those provided by manually clamped gravity infusion sets or

infusion controllers. The device has a typical flow range of 1 to 999 ml/hour

and delivers solutions from a standard infusion bag or bottle of fluid. It typically

has internal batteries that enable operation for a short period when no

mains electricity is available (e.g., during transportation or a power outage).

GMDN in Hospitals - Scandinavia

• MTP-Reg• Central database of medical devices linked to GMDN Terms

• Updated and fed into local Hospital databases across Sweden + beyond

Journey of a GMDN coded device

Pre-purchase- Need/In-house expertise

- Communication/discussion

- Comparison

Purchase- Price

- Delivery managementUse- Repair

- Making replacements available

- Managing location

- Adverse event reporting

Decommission- Review its life

- Decontamination

- Scrapped/sold on

- Update inventory

- Start pre-purchase

£3499

P12345

GMDN is improving communication

GMDN is now the global language

Thank you for listening

Any questions now?

Website: gmdnagency.org

Enquiry – product/term

Contact us – anything else

Training/quiz

global medical device nomenclature (gmdn)group of devices ct’s group/organize: by clinical...

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