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
for
to be put in|A UDI ISSUING AGENCY| provides
|THE DEVICE|
with|THE MANUFACTURER| |A BARCODE|
What’s UDI?
|A UNIQUE NUMBER|
|A DATABASE|allowing accurate |DEVICE DATA| from|RETRIEVAL| of
|A DEVICE| is assigned to |A GMDN Term|
|A DATABASE|within
which creates |A GENERIC DEVICE GROUP|
and allows for |HARMONIZED NAMING|
What does the GMDN do?
|REGULATORS|for and
|THE GMDN Term| is assigned to |THE DEVICE| by |THE MANUFACTURER|
|HOSPITALS|
What’s the GMDN Process?
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.
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
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
The Process for Manufacturer members
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
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.
51 of 35
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