Transcript Document

IN THE NAME OF GOD
(G.M.D.N.(
Global Medical Device
Nomenclature
The Global Medical Device Nomenclature
(GMDN) is a comprehensive system of
internationally recognized coded descriptors
in the format of preferred terms with
definitions used to generically identify medical
devices and related health care products.
Ownership
The copyright for the GMDN is owned
exclusively by CEN: European Committee
for Standardization.
This also includes the Intellectual Property
(IP) of the nomenclature concept and the
content.
1991 – First international workshop on
harmonization of Medical Devices Nomenclature
between EU, EFTA, Canada, and USA.
 1997/2001 – The GMDN Project was undertaken
based on the structural standard (EN ISO 15225:2000,
Nomenclature – Specification for a nomenclature
system for medical devices for the purpose of
regulatory data exchange). It defined the general
structure of the nomenclature and provided the
required understanding of field lengths, data
relationships, etc.
2001 – The release of the GMDN Nomenclature as
the CEN Technical Report CR 14230, which is
identical to ISO Technical Specification ISO TS 20225.
To facilitate in the rapid production of the
GMDN 6 chosen existing nomenclatures
were adopted. These covered a wide
range of terms defining medical devices
and healthcare products and constituted
approximately 13,500 terms.
6 chosen nomenclatures
• CNMD Classification Names for Medical Devices and in Vitro
Diagnostic Products. Developed by Food and Drug
Administration (FDA) Is the USA official nomenclature.
• EDMA European Diagnostic Manufacturers Association in vitro
diagnostic product classification. Used in Europe.
• ISO 9999 Technical Aids for Disabled Persons Classification.
International use.
• JFMDA Japanese Medical Device Nomenclature. Used in
Japan and south East Asia.
• NKKN Norsk Klassifisering Koding & Nomenklatur, Norwegian
Nomenclature. Used in Norway and some use in Europe.
• UMDNS Universal Medical Device Nomenclature System.
Developed by ECRI. Is in use in the USA, some countries in
Europe and some countries worldwide.
Alternative nomenclatures Are there any that can be used?
No! Not for the purpose of registering Medical Devices
at a National and/or International Regulatory level.
The main reasons for this are:
1. In order to achieve the necessary capability for data
exchange required by the regulatory bodies the
nomenclature must be conform to the established
standard EN ISO 15225, otherwise data from one
system cannot be exported and imported to another.
2. No other nomenclature is comprehensive enough in
its coverage of the entire Medical Device market to
encompass all the devices covered by the European
Directives.
Runs and Updates the GMDN
All nomenclature systems must be kept
updated in order to reflect the current
technologies being applied. This will be done
by the GMDN Maintenance Agency
(GMDN MA), which has been set up
according to predetermined CEN rules and
is the legal entity under CEN charged with
this task.
The master copy of the GMDN will always be
available in an English version, (UK English).
It is anticipated that a number of countries
will require a translation of this for National
use. The GMDN MA will appoint licenses to
entities that apply for this task, and they will
then be recognized as the official translator
for the language of that country.
The GMDN is currently in use in 23 countries
and the data dictionary has been translated in
twelve languages with further translations in
progress.
Australia, Austria, Belgium, Brazil, Czech Republic
Denmark, Estonia, Finland, Germany, Ireland,
Japan, Mexico, New Zealand, Norway, Portugal,
Singapore, Spain, Switzerland,Sweden,Thailand,
Turkey, UK, USA .
A new revision of the GMDN
It is anticipated that a new revision of the GMDN
will be released once a year. The revisions will
be numbered with a version number that
corresponds to the year of production, e.g.
Version 2002.1
It is possible that, because of the inclusion of a
large amount of data in a particular year, that an
intermediate version will be released. This
would be seen by the increment of the decimal
numeral on the version number, e.g. Version
2002.2
THE USERS and applications
The primary users and applications for the GMDN are expected to
include the following:
Medical device manufacturers
! Product registration with public authorities.
! Tracking complaints and liaison with regulatory bodies.
! Responding to tenders from healthcare agencies.
Regulatory and conformity assessment bodies
! Product registration required by regulations.
! Post-market surveillance data collection and analysis.
! Information relating to death/serious injury incidents exchanged
between countries and trade blocs.
! Conformity assessment certification awarded to manufacturers.
! Safety and performance warnings and advice issued to medical device
users and patients.
continued
Healthcare agencies
! Specification of devices for purchasing.
! Medical device stock control systems.
! Asset registers (a regulatory requirement in some
countries).
! Service and maintenance registers.
Suppliers of data management systems
! Standard up to date listing of all medical devices for
integration into commercial systems
supplied to manufacturers and healthcare agencies.
Structure
The GMDN is a system, as defined in the ISO
15225 standard, having a general structure of three
levels. Each level differs in the breadth of the sets
of devices represented by the terms defined within
that level. The levels have a relational structure in
the following order:
Device Category
Generic Device Group
Device Type
Figure 1 shows the basic three level data
structure, which is the backbone of
the GMDN system. Each level carries
independent information that divides medical
devices into more refined groups. The three
levels are data relational, e.g. a Generic
Device Group can be linked to one or many
Device Categories. Likewise one Generic
Device Group can be linked to one or many
Device Types.
Device Category
The Standard allocates codes for a possible 20 categories.
Code Term
Code Term
01 Active implantable devices
02 Anaesthetic and respiratory
devices
03 Dental devices
04 Electro mechanical medical
devices
05 Hospital hardware
06 In vitro diagnostic devices
(IVD)
07 Non-active implantable
devices
08 Ophthalmic and optical
devices
09 Reusable instruments
10 Single use devices
11 Technical aids for disabled
persons
12 Diagnostic and therapeutic
radiation devices
13 Complimentary therapy devices
14 Biologically-derived devices
15 Vacant
16 Vacant
17 Vacant
18 Vacant
19 Vacant
20 Vacant
Generic Device Group
The generic device group is the generic
naming level of the GMDN nomenclature
and comprises three kinds of terms. These
are:
preferred terms
template terms
synonym terms
Preferred terms with their associated 5 digit codes
are the only terms available for the purpose of product
identification of medical devices. It is a term
representing a group of devices having the same or
similar intended uses or commonality of technology
allowing them to be grouped in a generic manner not
reflecting specific characteristics such as brand or
trade names. Each preferred term is supplied with a
definition that defines the most prominent
characteristics of the types of medical devices it
encompasses.
EXAMPLE:
Term: Bed, air fluidised
Definition: A bed designed for the treatment of severely
and extensively burned patients. It may also be used in
cases of decubitus ulcers of where the patient has little
remaining body fat and the displacement of the body
weight is vital for treatment. It employs the circulation of
filtered and temperature regulated air being forced through
large quantities of ceramic spherules (small round ceramic
beads), which become almost liquid (fluidized) in this
state, providing the patient with complete uplift over the
whole body surface. The combined effect of this process
provides other extremely beneficial results.
Code: 35921
Category: 04
Template terms are terms that are used to
collectively group all the preferred terms that have
an identical character string to that of the template
term up to the lastqualifier “<specify>”. They function
as a kind of heading and are added to the
nomenclature when the same character string occurs
in more than two preferred terms for the sole purpose
of presenting these in a subordinated hierarchy.
Each template term is also supplied with a definition
that defines the broader characteristics of the
preferred terms that are subordinated under it.
Synonym terms are purely navigational terms
providing many differing points of entry into the
nomenclature. Synonym terms do not need, nor do
they have a definition. They are usually based
upon an alternative term name or concept, or are
commonly used and known within the healthcare
environment.Or, in many cases within the GMDN
the synonym function has been set up to retain
original source nomenclature term names, as is
the case for many FDA terms, or to retain the
original source nomenclature code, as is the case
for the ECRI terms.
EXAMPLE
Fluidized bed is a synonym term directly linked to
the preferred term: Bed, air fluidized
Heartstarter is a synonym term that directs the user
to the template term Defibrillator, <specify>.
More term interactions using the group
of centrifuge terms as the example
Centrifuge, <specify>
Centrifuge, blood bank
Centrifuge, cell washing
Centrifuge, cytology
Centrifuge, general-purpose laboratory
Centrifuge, haematocrit
Centrifuge, ultraCytocentrifuge -see Centrifuge, cytology
Laboratory equipment, centrifuge cyto -see Centrifuge,
cytology
Tabletop centrifuge -see Centrifuge,
EXAMPLE of real time data relationships
------Code
10778
15115
35901
35881
30869
32933
37214
Term name
Centrifuge, <specify>
Centrifuge, blood bank
Centrifuge, cell washing
Centrifuge, cytology
Clinical centrifuge
Cytocentrifuge
Lab-equipment, centrifuge cyto
Synonym code
10778
35881
35881
The Device Type
The device type level is not part of the GMDN
nomenclature. It is, however, an essential part
of the GMDN general structure and it is
important for the GMDN user to understand
this level and its purpose.
The device type information is the concern of
the product manufacturer and is the level
considered specific enough to provide unique
product identification for the purpose of
declaration of conformity, product type
registration and traceability. This is the level
where the manufacturer assigns the product
its actual name. This is the place for the
make and model and any other accompanying
information, e.g., serial number, trade name,
etc.
Coding
All terms in the GMDN are assigned a unique code.
This code is an incremental, sequential cardinal
number comprising five digits starting from 10000.
Whilst, through the lifetime of the GMDN, the term
name and definition may be subject to revision
because of technological changes, the code will
always remain the same, being the unique
identifier.
Codes in the range of 1-9999
Codes in the range of 1-9999 are not represented in the
GMDN. These, as stated in the standard are
exclusively reserved for assignment by the end user
and may be used as desired in any user’s local
application.
NOTE: It is important for users to understand that
this range of codes should not be used for any kind
of official purpose, e.g. as temporary codes, as
national translated synonyms, where the data is
exchanged between users outside of the local
application. This would probably lead to ambiguity.
Codes in the range of 10000-30000
Codes in the range of 10000-30000 are
represented in the GMDN and have been reserved
to represent the original code used by the ECRI for
their UMDNS terms that has been adopted for use in
the GMDN. This will provide the GMDN user with
automatic mapping from the ECRI code representing
the UMDNS term to the identical GMDN code now
used to represent the GMDN term. This has been
done to
assist in the transition for users who had previously
used the ECRI UMDNS.
Codes in the range of > 30000
Codes in the range of >30000 represent all
other terms used in the GMDN whether these
terms have been imported from existing
source nomenclatures or have been created
as brand new terms.
Search
1-Alphabetical search
The terms are listed alphabetically and one can scroll
up and down the list until the
term or similar groups of terms are found.
2-Navigational search
The GMDN is supported by many synonym terms that
may direct the user directly to
the term being sought, or to a group of similar terms
subordinated under a template
term.
Continued
3-Category selection search
By knowing what the intended purpose of the product is, one
should have knowledge of what category the product belongs
to. A product made, for example, for dental use will be found
in Category 3. By selecting terms in Category 3 only, the listing
of terms will be considerably narrowed.
4-Word search
Searching by a chosen word can have two targets. This can be
done by either making a direct search at the term name level,
hitting a targeted qualifier, or by searching on a descriptor (a
semantic link) that has been purposely fitted into the
definition.
Product Identification/Registration
(1) Select most specific applicable preferred term.
(2) Check that the definition is adequate. If not, submit a
suggestion for improvement/correction.
(3) Check that the device category, or, at least, one of the
categories already indicated and linked to the selected
preferred term is applicable. If not, submit a proposal for an
additional category.
(4) Register the product with the following details:
Category code(s) (2 digits).
Generic device group code (5 digits).
No GMDN term available
If you cannot find an appropriate compatible
generic device group (preferred term) for the
identification/registration of your product you
will need to notify the GMDN Maintenance
Agency. The term Unclassified code 38442 has
been made available in the GMDN to use as a
temporary measure when no existing GMDN
term is found to be appropriate.
For more information about the
Global Medical Device Nomenclature
visit:
www.gmdn.org
or
www.gmdnagency.com
THANKS