Status report: clinical engineering and the Clinical Engineering DivisionOver the last three decades, an exploding number of new technologies and applications have been introduced into the medical field, opening up new possibilities for diagnosis and therapy, but also raising questions of appropriateness, safety and effectiveness. The activity and the accelerated development in this area is often on the basis of an uncontrolled diffusion and use of medical technology, as well as of a non critical acceptance of new technologies. Additionally, the problem of the rising cost of health care, partly resulting from the new technological applications, is perhaps the most pressing issue for many governments today. This situation is expected to continue and by the year 2000 advances in biosensors, lasers, artificial organs, and also signal processing, imaging modalities and the application of telematics will change the shape of health care, resulting, however, in more pronounced side effects. New equipment is generally more complicated and often requires special handling, calibration and maintenance in order to function reliably and efficiently. Its technical support thus becomes a multidimensional task, requiring well defined structures and responsibilities at a local level and interactions amongst all involved parties on the national and international scene. At local level this task is covered by clinical engineering departments that constitute the basic infrastructure providing equipment support in hospitals. Their associated tasks address a broad spectrum of first level technology support and technology management activities. On the international scene, IFMBE recognised the importance of this branch of biomedical engineering and in 1979 set up a working group for clinical engineering, the primary aim of which was to support communication, training and common practices for the advancement of the field world wide. Since its beginning, the main activities of the group have been oriented towards bringing together professionals, facilitating exchange of ideas and experience, encouraging collaboration and promoting recognition. In 1985 the working group was transformed into a permanent specialised division of the Federation, the Clinical Engineering Division (CED). Since then the CED has organised, co-sponsored and supported many international events in the form of seminars, workshops, conferences or specialised sessions in world congresses. Early in the 1990s the division also prepared and published an international directory, containing names and addresses of more than one thousand clinical engineers in 36 countries. This directory is now being updated and a new version is expected to appear before the end of this year. Through these activities CED assists the profession to find its role and to open its scope in the sensitive area of medical technology management in the hospital environment for the final benefit of the patient. In fact, CE departments, established during the 1970s in many countries, have mainly dealt with repair and electrical safety of medical equipment. To these basic activities were, later on, added preventive maintenance, acceptance testing, quality control, risk management, follow-up of service contracts, user training etc. The shift toward these more managerial tasks, according to current trends in most developed countries, is also reflected in the following definition for clinical engineers which was adopted by the Division in 1992: A clinical engineer is a professional who supports and advances patient care by applying engineering and managerial skills to health care technology. From repair shops to technology managementThis new trend has already led many hospital clinical engineering departments to change their structure and to introduce quality systems in order to improve their services and monitor the outcomes. This also allows them to prove their cost-effectiveness and competitiveness against alternative solutions offered by third party service providers or manufacturers. The extended use of computer-based medical equipment management systems nowadays offers the possibility of monitoring equipment performance, cost, downtime or user errors, through the collection of appropriate data. This information, produced locally, is very useful for the management of the technologies involved, and at the same time it constitutes the basis for the evaluation of quality indicators concerning the clinical engineering department itself. In the field of risk management and medical device vigilance the role of clinical engineering departments is also essential. Although the new European Union (EU) directives and guidelines on medical devices place the responsibility for investigation of incidents with the manufacturers, in practice this cannot be effectively achieved without the participation of clinical engineers. Their role is equally important when implementing corrective actions. The critical information produced in this area of activity, requires careful handling and confidentiality. Appropriate communication networks can be used for quick and efficient dissemination of information, with the aim of avoiding reoccurrence of accidents with the same kind of device whenever possible. It is evident that all these activities relating to the development, assessment and use of medical devices world wide, are continuously generating an enormous amount of information, which is extremely important for the overall management of biomedical technology. This information is today processed by a number of national and international organisations and is rendered accessible through printed material or recently more and more through telematics means. The Clinical Engineering Division supports information exchange activities in many different ways. Apart from the organisation of meetings, which provide the opportunity for personal contact, the Division publishes quarterly its newsletter, Clinical Engineering Update. In addition, information exchange is expected to be facilitated with the implementation of a dedicated telematics tool for information exchange between its members. The FINE/BEAM@net facility, developed under the BEAM project of the EU Health Care Telematics program, will provide the possibility for communication on a person to person and society to members basis using modern telematics means and the Internet infrastructure. Despite these developments, the technical core functions of maintenance and risk control in clinical engineering departments still need to be strengthened, particularly in countries under development. It is thus a policy of the CED to support local initiatives world wide that are specifically focused on particular needs. Nicolas Pallikarakis | ||