Quality Assurance

Global Medical Device Nomenclature: The Concept for Reducing

Device-Related Medical Errors
Anand K, Saini SK1, Singh BK2, Veermaram C
Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Jodhpur National University,
Jodhpur, Rajasthan, 1Medical Affairs, Johnson and Johnson Limited, Gurgaon, Haryana, 2Department of
Pharmaceutical Sciences, Kumaun University, Nainital, Uttarakhand, India

Address for correspondence: Kaushik Anand; E-mail: [email protected]

ABSTRACT

In the medical device field, there are a number of players, having quite different responsibilities and levels of
understanding of the processes, but all with one common interest, that of ensuring the availability of sound
medical devices to the general public. To assist in this very important process, there is a need for a common
method for describing and identifying these medical devices in an unambiguous manner. The Global Medical
Device Nomenclature (GMDN) now provides, for the first time, an international tool for identifying all medical
devices, at the generic level, in a meaningful manner that can be understood by all users. Prior to the GMDN,
many nomenclature systems existed, all built upon different structures, and used locally or nationally for special
purposes, with unusual approaches. These diverse systems, although often workable in their own right, have had
no impact on improving the overall situation of providing a common platform, whereby, medical devices could
be correctly identified and the related data safely exchanged between the involved parties. Work by standard
organizations such as, CEN (European Committee for Standardization) and ISO (International Organization for
Standardization), from 1993 to 1996, resulted in a standard that specified a structure for a new nomenclature,
for medical devices. In this article we are trying to explain GMDN as the prime method to reduce medical device
errors, and to understand the concept of GMDN, to regulate the medical device throughout the globe. Here we
also make an attempt to explain various aspects of the GMDN system, such as, the process of development
of the GMDN-CEN report, purpose, benefits, and their structural considerations. In addition, there will be an
explanation of the coding system, role of the GMDN agency, and their utilization in the unique device identification
(UDI) System. Finally, the current area of focus and vision for the future are also mentioned.

Key words: CEN, coding system, device safety, ISO, medical errors, Unique device identification

DOI: 10.4103/0975-1483.71637

INTRODUCTION of users, who, when the devices initially arrive at the

place of intended use, struggle with an important task
Within all regulations concerned with medical devices, of correctly identifying and registering these devices in
there are a number of obligations placed upon the their local databases. This means that there are a number
manufacturer. In addition, the authorities are faced with of players, having quite different responsibilities and
the task of regulating the manufacturers and their devices, levels of understanding of the processes, but all with one
and there are the people involved in the trade of these common interest, that of ensuring the availability of sound
devices (e.g., the suppliers), before the devices themselves medical devices to the general public. To assist in this very
are brought into use. Finally, of course, there is the myriad important process there is a need for a common method
Journal of Young Pharmacists Vol 2 / No 4 403
 Anand, et al. J Young Pharm. 2010;2(4): 403-409
for describing and identifying these medical devices in an • Norsk Klassifisering Koding and Nomenklatur
unambiguous manner. The GMDN now provides, for the (NKKN), Norwegian Nomenclature.
first time, an international tool for identifying all medical • Universal Medical Device Nomenclature System
devices at the generic level, in a meaningful manner, which (UMDNS). Developed by ECRI, USA.
can be understood by all users.
On the 1st November, 2001, the Global Medical Device
Prior to the GMDN, many nomenclature systems existed, Nomenclature (GMDN) was published as a CEN Report
all built upon different structures, and used locally CR 14230 and as ISO.TS 20225. The first public release
or nationally for diverse purposes and with unusual on CD-ROM as GMDN version 2002.1 was in November
approaches. These diverse systems were CNMD, EDMA, 2002.[1]
ISO 9999, JFMDA, NKKN, UMDNS, and so on, and
furthermore these were used to develop global medical Development of GMDN-CEN Report CR 14230
device nomenclature systems. Although often workable
in their own right, they had no impact on improving the Medical Device experts from around the world
overall situation of providing a common platform whereby (manufacturers, healthcare authorities, and regulators)
medical devices could be correctly identified and the related compiled the initial GMDN nomenclature based on the
data safely exchanged between the involved parties. The standard ISO 15225. The study was mandated by the
advent of the European directives, initiated a new era, European Commission in order to provide the necessary
where national and indeed international bodies were given tool to carry out many of the obligations following the
the opportunity to cooperate and harmonize their efforts implementation of the Medical Devices Directives, and
in achieving the one thing that they all needed, namely, a also, to meet similar needs at the Global level, as identified
standardized method of identifying the products placed in the Global harmonization activities of GHTF by its
in the global market. members, notably USA (FDA), Canada, European member
states, Japan, Australia, and now by many other countries
Work by standard organizations like CEN and ISO, / regions.[2]
from 1993 to 1996, resulted in a standard that specified
a structure for a new nomenclature for medical devices. In 1991, the first international workshop on harmonization
This standard, now revised by ISO, is published as the of Medical Devices Nomenclature was held among EU,
ISO 15225 Nomenclature – Medical device nomenclature EFTA, Canada, and USA. However, there was no fruitful
data structure. Following this, a project was set up in 1997, outcome of this meeting. Consequently in 1993, as
by the CEN, with financial support from the European requested by the Commission, CEN established a standard
Commission (EC). The aim of the project was to create to define a structural basis for a device nomenclature.
a comprehensive nomenclature for all medical devices, Subsequently symbols, coding, and proposed nomenclature
suitable for use by all interested parties globally.[1] were developed by USA workgroups in 1994 and 1995; there
was a CEN recommendation for an interim nomenclature
To facilitate the rapid production of the GMDN, six system.[3] Adding to these, in 1996, a project proposal
existing nomenclatures of particular standing were for a device nomenclature system was submitted and it
adopted. These covered a wide range of terms defining was positively accepted by the European nomenclature
medical devices and healthcare products that combined, standard, through the Vienna agreement.[2] All this resulted
gave a total of 13,500 terms. in one single harmonized standard. There was also a license
agreement between ECRI and CEN for the use of their
The six chosen nomenclatures were: UMDNS (Universal Medical Device Nomenclature System)
• Classification Names for Medical Devices (CNMD) and as one component of the development process. From 1997
in vitro Diagnostic Products. Developed by the Food to 1999, the GMDN Project was undertaken, based on the
and Drug Administration (FDA), USA. structural standard. It defined the general structure of the
• European Diagnostic Manufacturers Association nomenclature and provided the required understanding
(EDMA) in vitro diagnostic product classification. Used of field lengths, data relationships, and so on. The project
in Europe. involved some 70 medical device experts from 16 countries,
• ISO 9999 Technical Aids for Disabled Persons a Project Council of 10 members, an Expert Advisory
Classification. International use. team of six members, and a secretarial / support team of
• Japanese Medical Device Nomenclature (JFMDA). six members. Finally in 2001, the GMDN Nomenclature
Used in Japan. as the CEN Technical Report CR 14230, was released,
404 Journal of Young Pharmacists Vol 2 / No 4
 GMDN: The concept for reducing device related medical errors

which was identical to the ISO Technical Specification Benefits of global medical device nomenclature
ISO TS 20225.[2] There was also the establishment of the
GMDN Maintenance Agency Policy Group, which was Internationally, it provides a common terminology, enabling
responsible for the future management of the GMDN global regulatory partners to efficiently communicate and
as also to develop and distribute the electronic version of share medical device details. If we talk about the national
the GMDN and all future versions of the data file. BSI benefits, it provides a common terminology, enabling the
(British Standards Institution) as delegated by CEN has federal entities and the industry to efficiently communicate
recognized the GMDN Agency to be the formal body for and share medical device data. DHHS promotes the work
the ongoing management and control of the GMDN on a on the GMDN and consolidates with UMDNS, which
global basis. The GMDN Agency has therefore exercised, anticipates a federal government standard in a few years.
and will continue to exercise, the sole rights to develop and As far as the Regulatory agency is concerned, the GMDN
distribute all versions of the GMDN and its associated provides guidelines for the appropriate and consistent
data, terminology, and supporting databases.[3] naming of the device groups and the creation of descriptive
definitions that are device-group specific. Specifically, their
Purpose of global medical device nomenclature utilization by regulators will help to improve nomenclature
practices, cross-generational consistency, and data
The foremost purpose of the GMDN is to provide a management, for post-market activities.[4]
single, global, nomenclature system by which the authorities
can regulate medical devices; this is also impacting upon Global medical device nomenclature structure
the healthcare providers, who are the mainstay users of
medical devices, the medical device manufactures, suppliers, The general structure of the GMDN is regulated by
conformity assessment bodies, and other affiliated parties, requirements stipulated in the standard ISO 15225
so that there is only one single system that provides generic Nomenclature – Medical device nomenclature data
product descriptors to support patient safety.[1] The GMDN structure. Figure 1 shows the basic organization of the
code represents the generic descriptor (this being the term GMDN data. The data is defined by three levels, associated
name along with its definition) in order to internationally with an external fourth level, each level containing data that
standardize device identification, for reasons of safe data differs in the degree of specificity.[5]
exchange between competent authorities and others,
exchange of post-market vigilance information, research, Device category
medical record keeping, e-commerce, and inventory
purposes.[4] The device category is the broadest level of the GMDN

GMDN Manufacturer’s name

Collective
Terms

Device Generic Device

Category Device Type
Group

20 < 20000
> 500000

Figure 1: General organization of GMDN data

Journal of Young Pharmacists Vol 2 / No 4 405

 Anand, et al. J Young Pharm. 2010;2(4): 403-409
data. It divides the entire medical device product market Preferred terms
into the highest-level groups based on device application,
technology, or other common characteristics. The standard Preferred terms with their unique five-digit codes are
allocates codes for possibly 20 categories; there are the only terms available for product identification. The
currently 16 established device categories.[6] These are: preferred term is the optimal name selected to represent a
Code Term group of devices (a collection of device types) that have the
01 Active implantable devices same or similar intended use or commonality of technology
02 Anesthetic and respiratory devices allowing them to be grouped in a generic manner, typically
03 Dental devices without reflecting the specialized characteristics, such as,
04 Electromechanical medical devices brand or trade names.
05 Hospital hardware
06 In vitro diagnostic devices Each preferred term has an associated definition that
07 Non-active implantable devices describes the most prominent characteristic of the device
08 Ophthalmic and optical devices types in the group [typically includes a physical description
09 Reusable devices and an intended use(s)]. It is the definition that determines
10 Single use devices the scope of the preferred term and code. The preferred
term type identifier is (P).
11 Assistive products for persons with disability
12 Diagnostic and therapeutic radiation devices
Template terms
13 Complementary therapy devices
14 Biological-derived devices The template term is a general device name added to the
15 Healthcare facility products and adaptations nomenclature when multiple preferred terms have identical
16 Laboratory equipment character strings forming a base concept, and functions
17 Reserved as a header term to create a simple hierarchy for lexically-
18 Reserved related preferred terms.
19 Reserved
20 Reserved Each template term has an associated definition that
is inclusive of all subordinated preferred terms. The
Generic device group template term type identifier is (T). The template term is
a navigational tool only and must not be used for product
The generic device group is the most specific level at which identification purposes.
products are aggregated, based on common technology or
intended use. There are four different types of GMDN If a template term code has been used to identify any
terms associated with the generic device groups. These products in the past, this code has been wrongly applied and
terms, with their alpha identifiers, include the: is not valid. A GMDN P term and code that is applicable
Preferred term P to the product must be selected and assigned instead. If no
Template term T current GMDN P terms are applicable, an application for
Synonym term S the creation of a new term or modification of an existing
Multiple-linked synonym term MS P term must be submitted.[5]

There are also terms within the main database called Synonym terms
‘Equivalent terms’. These are simply nonactive terms from
the original six source nomenclatures used to develop the The synonym term is the common use or a familiar name
GMDN and can be equal to a P, T, S, or MS term within used in the nomenclature. It is an alternative entry point
the database. They are identified with the alpha identifier E. in the nomenclature, used to locate the preferred term
or template term to which it is linked. It may or may
Using the GMDN search engine, or using some of the view not actually be synonymous with the term to which it is
possibilities provided by the database, E terms can be found linked. The synonym term type identifier is (S). Selecting
and viewed. The GMDN user is not to be concerned with a synonym term in the GMDN database will automatically
equivalent terms, as they are not active terms, they have no produce its linked preferred or template term. The
GMDN code allocated, and cannot be used by a user for synonym term is a navigational tool only and must not be
any practical application. used for product identification purposes.

406 Journal of Young Pharmacists Vol 2 / No 4

 GMDN: The concept for reducing device related medical errors

Multiple-linked synonym term For the ease of electronic transmission of data and code
recognition, each collective term is assigned a four-digit
The multiple-linked synonym term is a medical device name, incremental code, with the prefix ‘CT’ (Collective Term).
often from one of the GMDN source nomenclatures, that
is typically of a higher-order, and is therefore linked to Coding system for GMDN
more than one preferred term and / or template term. The
multiple-linked synonym term type identifier is (MS). This All terms in the GMDN are assigned a unique code. This
multiple-linked synonym term is a navigational tool only provides security in cases of misunderstandings, language
and must not be used for product identification purposes. barriers, or discrepancies in the data systems. The code is
an incremental, sequential cardinal number comprising of
Collective terms five digits starting from 10000. The codes in themselves
are not created with an integral hierarchical structure and
Collective terms are used to aggregate medical device are simply unique numbers. The codes are the carriers of
groups that have common features and are identified in the information to which they are linked and should always
the GMDN. Although the GMDN has been designed and be used and referred to in any reference to the GMDN or
developed for regulatory data exchange in areas such as data transaction. There are only three categories of ranges
vigilance reporting and tracking of medical device safety, that are used in the coding system for GMDN.[2]
there is a need for a set of terms that are more refined than
the GMDN category terms, yet broader than the GMDN They are:
generic device group terms, to be used in the application a. Codes in the range of 1 – 9999
of the medical device directives; the use of collective terms b. Codes in the range of 10000 – 30000
satisfies this requirement.[5] c. Codes above the range of 30000

Collective terms are intended to be used for a whole range Codes in the range of 1 – 9999 are not represented in the
of subject matters, for example: GMDN. These, as stated in the standard, are exclusively
• To illustrate the scope of certificates issued by Notified reserved for assignment by any end user and may be used
Bodies when assessing which groups, families or types as desired in any user’s local data system. It is important
of medical devices are covered within a manufacturer’s for readers to understand that this range of codes should
quality system not be used for any kind of official purpose, for example,
• To be used to identify the range of skills and general as temporary codes, as national translated synonyms, or
technological abilities for which a Notified Body has where the data is exchanged between users outside of the
been approved, and is so appointed by the relevant local data system. This will lead to ambiguity.
Competent Authority
Codes in the range of 10000 – 30000 are represented in
• For exchanges of information between Competent
the GMDN and have been reserved exclusively to represent
Authorities when general information on individual
the original code used by the ECRI organization for their
manufacturers capabilities is notified for inclusion in the
UMDNS terms that have been adopted for use in the
European Database for Medical Devices (EUDAMED)
GMDN. This will provide the GMDN user with automatic
mapping from the ECRI code representing the UMDNS
There were several means identified to aggregate the
term to the identical GMDN code used at present to
generic device group terms of the GMDN using collective
represent the GMDN term. This has been done to assist
terms. These were:
in the transition for users who have previously used the
• Devices covered by the application of common
ECRI UMDNS.
technology
• Devices manufactured using similar manufacturing Codes above the range of 30000 are all GMDN, created
procedures and common technical features for GMDN terms.[2]
• Devices manufactured for the application of similar
Medical Procedures Role of GMDN agency/governance
• Devices manufactured using common materials
requiring special skills The need for a Maintenance Agency was identified and
• Devices developed to meet specific risk-associated the structure was approved within the CEN. Therefore, in
considerations order to manage the GMDN, a maintenance agency was

Journal of Young Pharmacists Vol 2 / No 4 407

 Anand, et al. J Young Pharm. 2010;2(4): 403-409
set up to form the necessary legal entity. This non-profit commercial information
company, the GMDN Agency, acting as the Maintenance • To ensure that the GMDN is constructed with reference
Agency Secretariat (MAS), functioned as the hub in the to European and International standards, indicating the
running and maintenance of the GMDN. It also provided structure of such a medical device nomenclature (e.g.,
services and information for access to the GMDN data EN ISO 15225)
through the Internet site or other means. To ensure • To be responsible for adding, amending, and archiving
continuing permanency of the GMDN, revenues could be terms and definitions for medical devices and to assign
generated through the licensing or sale of GMDN Agency codes as required, to provide easy identification. Such
products and services, or by direct funding, allocated by codes will be consistent so that all translated versions
relevant global regulatory bodies or other parties.[5] of the nomenclature will carry an identical code for
each generic or other term as specified in the GMDN
Services provided by the GMDN agency are: • To liaise with standards bodies (e.g., CEN, CENELEC,
ISO, IEC), to be aware of the current standards
• Access to the GMDN data file and codes using the on medical device nomenclature (including any
Internet site through a license agreement and / or by additional levels of identification, e.g., collective terms,
direct credit card purchase identification of particular attributes, and links to other
• A link from the GMDN database to the user’s in-house nomenclatures as appropriate)
data system through a license agreement and a custom- • To coordinate and link with appropriate organizations
made software link for the translation of GMDN into other languages
• Application form for new terms or modification of
existing terms / definitions for the identification of Utilization of GMDN in unique device identification
the user’s product
• Access to GMDN terminology and information For the sake of patient safety, in the era of global economy,
• Guidance on how to use the GMDN it is desirable to address tracking and tracing of medical
• Access to Collective terms devices at a global level. One reliable way to achieve
• GMDN translational software tools the track and trace of medical devices is to develop a
Unique Device Identifier (UDI). The primary aim of a
A Maintenance Agency Policy Group (MAPG), now an UDI mechanism is to increase patient safety. It will also
entity of the GMDN Agency, ensures a globally recognized improve the work of market surveillance authorities in
representation that consists of delegates from authorities case of field safety corrective actions, for instance, the
and the industry, as well as other interested parties. Based fight against counterfeiting. In addition, the development
on the original Technical Report a vastly developed and of an international approach will make the trade of
enhanced GMDN is now available through the GMDN medical devices more secure for all the stakeholders (health
Agency. authorities, hospitals, manufacturers, distributors, etc.).[4]

The main role of the GMDN Agency is in accordance with This is why the introduction of GMDN in a UDI system
its Memorandum of Association as follows:[5] appears to many regional regulatory authorities and to the
• To carry out the functions of a Maintenance Agency industry at large, as an effective tool to protect public health
to develop and maintain the ‘Global Medical Device more efficiently. It is mainly for reasons of patient safety
Nomenclature’ for medical devices that all the actors of the sector advice development of
• To meet the needs identified by the European UDI for medical devices. Therefore, common worldwide
Commission when developing the European Directives UDI requirements would offer significant benefits to the
on Medical Devices, to establish a nomenclature for manufacturer, user and / or patient, and the Regulatory
medical device generic descriptors that will meet a global Authorities. In addition, eliminating or reducing differences
need for identification purposes. This identification between jurisdictions decreases the cost of gaining
will facilitate exchange of regulatory data and assist in regulatory compliance. Second, while developing a UDI
the identification of medical devices for commercial system, one important consideration which should be taken
purposes into account is the risk associated with the device. The UDI
• To ensure that the GMDN meets the needs of all mechanism should be implemented stepwise according to
national authorities, the industry, and other users the risk of the device — starting with the highest risk first
globally, as the primary reference and working generic (e.g., implants) and staggering the implementation, with
nomenclature for the exchange of regulatory and the lowest risk class (e.g., most disposables) implemented
408 Journal of Young Pharmacists Vol 2 / No 4
 GMDN: The concept for reducing device related medical errors

last. Furthermore, the introduction of the UDI should / registration, vigilance reporting, and product recall. The
allow sufficient implementation timeframes, to allow the foremost purpose of the GMDN is to provide a single,
manufacturers to comply with the requirements. Finally, global, nomenclature system, by which the authorities can
in order to achieve all the positive elements of a UDI regulate medical devices; this is also impacting upon the
mechanism, the use of the UDI should be promoted healthcare providers, who are the mainstay users of medical
among all stakeholders, including regulatory agencies, devices, the medical device manufacturers, suppliers,
medical device manufacturers, distributors, hospitals, and conformity assessment bodies, and other affiliated parties,
medical professionals. so that there is only one single system that provides the
generic product descriptors, to support patient safety.
A UDI for medical devices will consist of a unique Specifically, their utilization by all stakeholders will help
identification code using a globally accepted standard to improve nomenclature practices, cross-generational
format like the GMDN. In order to accommodate most consistency, and data management, for post-market
methods of labeling, marking, and identifying products, activities. To summarize, we can say that after adopting
the UDI should be technology neutral, that is, it should the GMDN concept there may be,
not be restricted to a particular method of Automatic • Common terminology for efficient data sharing and
Identification and Data Capture (AIDC).[4] The UDI communication
database shall allow the use of an existing globally accepted • Improved nomenclature practices and device group
data exchange process to harmonize the exchange of device identification
information, for safety purposes. It should utilize a globally • Potential for a system of unique device identification
accepted nomenclature such as the Global Medical Device that links device-group information with device-type
Nomenclature (GMDN). information
• Essentially there will be improved data management for
Current areas of focus with a vision for the future post-market activities, which will reduce medical device
errors
• There should be a continued efforts to consolidate
UMDNS and GMDN
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Source of Support: Nil, Conflict of Interest: None declared.
medical device groups primarily for product certification

Journal of Young Pharmacists Vol 2 / No 4 409