Health Telematics (AIM) Final Report


	Updated: Feb 1, 97
BEAM

Biomedical Equipment Assessment and Management

Project Code: A2001

Project value: 4565 KECU

EC contribution: 2262 KECU

No of partners: 11

No of countries: 8

Duration : 36 months

Contact:
Prof. Nicolas Pallikarakis
Institute of Biomedical Technology
Patras Technological Park
Boukaouri 93
GR-262 25 Patras, Greece
Tel.: +30 61 22.36.75 /37.01
Fax: +30 61 27.23.46

Overview

The main objective of BEAM has been to develop a set of telematics applications assisting clinical engineers in dealing with the overall management of medical technology. The BEAM system aims to exploit the information produced continuously in different countries, to access and retrieve it from local and remote databases, to introduce new standards and tools for the effective management of medical equipment in the hospital environment, to provide effective communication means between clinical engineers, to promote quality assurance practices in the field and generally, to support the Clinical Engineer in the strive for improvement in the quality of daily work.

Purpose and objectives

The BEAM subsystems followed the typical S/W development life-cycle model, while active user involvement at all stages was ensured. The various applications were fully defined in terms of their requirement specifications and the interface areas between them were explored. The sub-systems were fully defined and designed, while gaps and overlaps between sub-systems, called clarification areas were identified and focused on. Demonstrators were developed illustrating selected key features of the sub-systems, their functionality as well as the general feasibility of the entire BEAM concept. After implementation, the prototype sub-systems were tested, prior to their instalment at several user sites for their verification. The evaluation results have been summarised in the Evaluation Report.

Results

The BEAM system incorporates the following applications:

The ECDB, database on Medical Devices contains information on the European Medical Device Marketplace, including data relating to equipment characteristics, standards and regulations. Biomedical Equipment management and Quality Assurance issues are handled by the MEMS and the PANDA subsystems, respectively. Both of these tools constitute aids for the planning and the overall management of procedures involving the clinical engineering department, as well as the handling of the large amounts of occurring data, in a systematic and standardised fashion. Databases developed within BEAM, but also other existing heterogeneous DBs, are accessed with the use of the Biomedical Interoperable Database or BIND. Communication between professionals, is aided by FINE, a Facility for Information Exchange. The FINE sub-system incorporates a Database (FDB) the contents of which are composed of general information related to biomedical technology aspects either in the form of a resulting interaction amongst them or in the form of users contribution, the Electronic Magazine and Bulletin Board Services. The interrelationships between sub-systems are specified in the BEAM Integration Architecture.

During the 3rd year of the project there has been a gradual shift of focus from the technical domain to the market place and plans for the exploitation of the BEAM sub-systems and/or their further development and evolution have been formulated. BEAMEX, the BEAM extension, is in fact, targeted to this exploitation by means of the development of a CD-ROM for broad distribution and early announcement of the eventual BEAM products. The CD-ROM is comprised of a BEAM demonstration, built on scenario of usage of the system, initiated by a selection of any given application or task by the user. The CD-ROM also incorporates the ECDB. which is a completed product. Since BEAMEX is regarded a key market penetration tool, a low pricing policy has been favoured. The remaining BEAM sub-systems are, at this stage, prototypes rather than finished commercial products. They generally need a large validation and/or data population before they can be marketed as end product. Therefore, a market oriented project with broad validation of BEAM sub-systems has been deemed necessary, before subsystems can become commercial products. In fact, BEAM is now continuing as one of the successful HC Telematics projects, under the 4th program, as BEAM 11. Within the life time of BEAM 11 the consortium aims to bring BEAM results through a successful commercialisation phase and ensure the successful commercial and user exploitation.

List of Deliverables

Year 1

Requirements of the medical Device Coding and Classification System workshop report (3/R/R)
Evaluation on selected existing systems - state of the art (3/R/L)
Design of the medical device coding and classification system (6/R/R)
Report on medical devices DB and on inclusion of other databases (6/R/R)
User and technical requirements for the BIND (6/R/R)
Review of software tools for medical equipment management (6/R/P)
Requirements and specification of the FINE system (6/S/R)
Quality control services requirements (6/S/L)
Integration - Architecture Demonstrator of a European medical devices database (9/P/L)
Demonstrator of a European medical devices database (9/P/L)
Design of the BIND system / Potential modification on selected system (9/R/I)
Requirements of the Medical Equipment Management System (9/R/R)
Design of the software components of the FINE system and configuration (12/R/I)
Final report - first year (12/R/P)

Year 2

Integration - Test plan (3/R/L)
Design of the Medical Equipment Management System (3/S/I)
Quality Control DB design and requirements for European QA Databases (3/S/L)
Demonstrator of the BIND subsystem, documentation and support (6/P/L)
Intermediate report on the status of the medical devices DB (9/R/P)
Demonstrator of MEMS (9/P/L)
FINE demonstrator (9/P/L)
First version of Quality Control prototype (9/P/L)

Year 3

Prototype BIND system (3/P/I)
Possible future inclusion and technical aspects for extensions. Tests (3/R/R)
European database for Quality Assurance data (3/P/L)
Prototype MEMS System (6/P/L)
Quality Control prototype (6/P/L)
Updated medical devices coding and classification system (9/R/P)
FINE integration, evaluation and system status (9/R/R)
Feasibility study of Quality Assurance and workshop report (9/R/R)
European database on medical devices (12/P/I)
Final report and integrated BIND (12/R/P)
Final report MDQAS (12/R/P)
Integration - Demonstrator (12/P/L)
Evaluation of the overall system (12/R/L)
Final report for MEMS (12/R/P)

List of Participants

Prof. Gianni Gnudi University of Bologna Dip. Elettronica e Informatica Viale Risorgimento 2 I-40136 Bologna, Italy Tel.: +39-51-644.30.09 Fax: +39-51-644.30.73	Prof. Elias Houstis First Informatics S.A. Kanakari 73'75 262 21 Patras, Greece Tel.: +30 61 62.21.29, 62.29.29 Fax: +30 61 62.27.21
Mr Mike Davis Directorate of Medical Physics and Clinical Technology Royal Hallamshire Hospital Glossop Road S10 2JF Sheffield, U.K. Tel.: +44 114 271.19.00 Fax: +44 114 271.34.03	Dr. Paolo Giribona Centro Ricerche E Studi Tecnologie Biomediche Sanitarie Area di Ricerca Padriciano 99 I-34012 Trieste, Italy Tel.: +39 40 22.68.12, 22.68.32 Fax: +39 40 39.89.78
Dr. Arne Talbot Danish Centre For Medical Technology MTA 5111 Blegdamsvej 9 DK-2100 Copenhagen, Denmark Tel.: +45-35-45.51.18 Fax: +45-35-45.51.47	Dr. Cees Zeelenberg TNO Centre for Medical Technology Zernikedreef 9 NL-2333 CK Leiden, The Netherlands Tel.: +31 71 518.17.89 Fax: +31 71 518.19.02
Prof. Niilo Saranummi Technical Research Centre Finland Medical Engineering Lab. PO Box 316 Kanslerinkatu 8 SF-33101 Tampere, Finland Tel.: +358-31-16.33.00 Fax: +358-31-17.41.02	Prof. Francisco Del Pozo Guerrero Universidad Politecnica Madrid Dept.Tec.Elec. & Bioengineering Cuidad Universitaria Ramiro de Maetzu 7 E-28040 Madrid, Spain Tel.: +34 1 549.57.00 ext 332 or 823 Fax: +34 1 336.68.28
Mr. Leif Rystrøm Jens Bisballe Planlaegning Havnevej 3 DK-4000 Roskilde, Denmark Tel.: +45-42-36.84.21 Fax: +45-42-36.84.21

[ BEAM II (4 FW, 1994-1998) ]



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