INTERBOR

 

Introduction to the INTERBOR Nomenclature©

 

The international market of prostheses and orthoses

The international harmonization of the market of external prostheses and orthoses develops slowly due to sector characteristics. The process is stimulated by the technological development or the normal market economics as such - that happens indeed mainly with the industrial production of components - but is hindered strongly with the orthopedic suppliers of the complete products as a consequence of topical issues, such as customized production and service, national and regional social and reimbursement policy, social and healthcare regulations, multidisciplinary approaches where languages, professional preferences, local history and tradition are dominant.

However the issue of international harmonization of the trade and industry is moving and speeding up. A number of issues is forcing that, like:

  • European legislation to stimulate trade and industry in the area of medical devices.
    Obvious is the role of the European Directive on Medical Devices which is guaranteeing safety to the users of medical devices, product conformity to buyers and open markets for manufacturers and suppliers. A consequence of that is the development of mandatory CEN-standards on products, components and services and European test methods. 
    Large buyers of equipment have to follow procedures with open call for tenders based on EU-procedures. It is no more a question if the market goes internationally, but the market is an international one due to European regulations
  • Trends with the users of prostheses and orthoses
    The European population is moving and getting older with more persons (absolutely and relatively) having some kind of disability due to chronic illness or age. Also is healthy changing into a value which people want to treat and to pay for. 
    The group of persons with "classical disabilities" is smoothly moving towards a consumer driven market model. More or less all countries in Europe implement new legislation based on rights of persons with disabilities based on equality, non-exclusion and non-discrimination. Social and healthcare legislation is adapting and stimulating persons to organize their life. Not cure or medical treatment is the standing issue but independence and participation in society are modern goals
  • Care should facilitate that social development. 
    A general accepted principle in developed markets is that clients have rights on transparency of the market mechanisms, the right on information on what is offered, the right on selection from the market offer
  • Changing role of the provider of medical devices 
    The traditional providers of medical devices such as local municipalities, healthcare insurance companies, sickness funds are moving into another role: facilitating care through maintaining structures for offering and organizing care, quality guaranteeing, budget watching, information provision, etc.
  • EU social policy
    The focus of the European Commission's social policy agenda for 2000 to 2005 is on modernization of the European social model. Through its proposals for action, the Commission aims to strengthen the role of social policy as a productive factor via positive and dynamic interaction among economic, social and employment policies. As concerns social protection, European-level co-operation will encourage joint reflection on the best way of meeting the challenges of modernization and improving the different social protection systems. Among that are actions foreseen aiming at ensuring the modernization and improvement of social protection, the promotion of social inclusion, the reinforcement of equality, the consolidation of fundamental rights and the fight against discrimination. 
     

What is the INTERBOR Nomenclature©

The INTERBOR Nomenclature© is a classification-based collection of descriptions of complete prosthetic and orthotic devices based on its functionality, incorporating international agreed classifications. 

Classification based means that all descriptions are connected together with a classification based on the functionality of the described types of prostheses and  orthoses. Functionality is defined as what the product does for the user, the so-called intended use of the product. Main classifications as used in the Nomenclature, are the International Classification of Functioning, Disability and Health (ICF; WHO, 2002), the International Classification of Technical Aids for persons with disabilities (ISO9999/CEN29999; Geneva/Brussels, 2002) and ISO standards related to prostheses and orthoses.

Descriptions are available in the Nomenclature of types of complete prostheses and orthoses and its functionality for the user. Components are only listed in those descriptions and not in the Nomenclature as stand-alone product-descriptions (excluding limb prostheses from which interfaces and construction/cosmetic are described independently. 

As specified only types of prostheses and orthoses are described in the Nomenclature and not all the commercial products as put on the market by individual manufacturers with different brand or product names. That includes that brand names are not mentioned. The descriptions are focussing on a higher level, the level that stands for a identifiable and particular product type seen from the user's perceptive. The descriptions include variants and different commercial versions coming from different companies and commercial sources.

The descriptions include a variety of data, presented in a record structure over a number of fields, including data on the product and its variants, drawings, the intended user and intended use, relevant classification codes, product related services, etc. 

The INTERBOR Nomenclature© is not a static product. The way the product types are described is time-related. Also completion of the Nomenclature is necessary due to new needs from the target group, market changes and technological developments and innovation. That makes that the INTERBOR Nomenclature© is a living tool, which is permanently in development and updated.
 

What can the INTERBOR Nomenclature© be used for 

The INTERBOR Nomenclature© contains information for all disciplines and target groups active in the field of prostheses and orthoses. Relevant disciplines are medical doctors/physicians, therapists, prosthetists and orthotists as well as other technicians, staff at health care insurance companies and other institutions responsible for the payment of the products, policy makers and national and regional level and of course user groups. 

The INTERBOR Nomenclature© can be used as:

  • an information source for appropriate, qualified and up to date information on types of orthopedic products and related services
  • a knowledge source: a standard for the identification, differentiation and description of product types, based on international agreed classifications
  • an educational tool for professionals as well as user groups
  • an international reference document for the design of new policy
  • an international basis for the creation of national files of products delivered by orthopedic workshops and orthopedic industries in relation to systems for the provision of orthoses and prostheses to individuals.
     

The 2003 issue of the INTERBOR Nomenclature© 

This version of the INTERBOR Nomenclature© has been finished by the Working Group in December 2002. A preliminary version (Beta-version) has been presented during a topical seminar on 22 and 23 February 2002. The INTERBOR Nomenclature© is delivered to interested parties on a CD-R with appropriate software to retrieve and access all the content. This CD-R is the 2003 version.

This version includes product types in all areas of prostheses and orthoses. It will be distributed on a restricted volume to interest persons and organizations, with the aim:

  • to introduce the Nomenclature and start communication on the content with the members of INTERBOR and related organizations
  • to enable feedback from the intended users of the Nomenclature to the working group which did the content development
  • to define a starting point for the national implementation of the Nomenclature through the members of INTERBOR. 

Together with this version, two updates of the Nomenclature per year will be launched, expected to start in 2003. Updates will be distributed on a subscription basis on CD-ROM and later on also through the INTERBOR website.

This version of the INTERBOR Nomenclature CD can been sponsored by 

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Experts involved in the development of the INTERBOR Nomenclature© 

The INTERBOR Nomenclature© has been developed by a Working Group of experts on request of the Board of INTERBOR. The members of the Working Group were nominated on personal title by the Board. An external consultant was contracted for the co-ordination of the work. 
Experts from ISO TC168/WG1 and WG2 have contributed to the correct use of ISO-standards in the INTERBOR Nomenclature©.

In the framework of the development, the members of the INTERBOR working group contributed to the work:

Co-ordinator and editor

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Representing the Board of INTERBOR

X...

Members of the working group

Michel Pierron, France,
Luc Thüer, Belgium, CPO
Marco Laineri, Italy,
Mario Cañamares, Spain, CPO,
Tom Sels, The Netherlands,
Frank Jüttner, Germany, CPO,
Giuseppe Caforio, Italy, CPO,
Leatitia Chiarelli, France, MBA

Angel Garcia, Spain, CPO
Rene Gastaldo, France, CPO
Gerd M. Ivanic, Austria, Medical Doctor
Sebastian Kaltenbach, Germany, CPO/Standardisation (till mid 2002)
Wilfried Knoche, Germany, CPO
Svein Sivertsen, Norway, CPO (from 2001 on)

Address of the co-ordinator of the INTERBOR working group

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Tel.   +
Fax.  +
E-mail:
 

Future developments of the INTERBOR Nomenclature © 

The INTERBOR Nomenclature © is developed by an international working group, composed of experts from different disciplines and with different experience. The working group will continue its work at least during 2002 and continue with the completion of the Nomenclature including reacting on feedback and comments. It is expected that the working group will be transferred into a standing committee to upgrade and to prepare updates of the Nomenclature twice a year.
 

How to receive the INTERBOR Nomenclature © 

This version will be distributed on the basis of an annual subscription, which includes two issues of the Nomenclature (one at the beginning of the subscription period and one half a year later).

The CD-R includes the database and the retrieval program. Installation is necessary on a PC with a CD-ROM player and which runs Windows 95 or a later version. For getting access to the Nomenclature is an hardware access key necessary. This piece of hardware has to be put in the Serial-port of the stand-alone PC on which the program runs. The access key is provided to subscribers 

Persons interested in a subscription can contact INTERBOR.
 

  Acknowledgement

INTERBOR thanks organizations who supported or provided material for this version, in particularly:

  • AOPA United States of America for the use of drawings
  • BIV Germany for the use of drawings
  • Austria and Italy for their offer to make use of their national Nomenclatures
  • Mr. Jacques van Rolleghem Belgium for the use of drawings coming from his private library
  • Support and co-operation is provided for upgrading the Beta-version towards this issue Upgrade 2002 by experts from the Standardization Committee ISO/TC168/WG1 and WG2 on the aspect of proper use of ISO standards on Prostheses and Orthoses. A standing co-operation is foreseen for the future. 

 

Publisher:
Disclaimer:

INTERBOR
All rights of exploitation in any form and by any means reserved worldwide for INTERBOR. No content of the publication may be reproduced or transmitted in any form or by any means without prior permission given in writing by INTERBOR.
No rights can be derived from the content of this digital product. 

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InterborCopyright 2003 INTERBOR.