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This paper presents the Higher Education in Clinical Engineering (HECE) program of the University of Trieste – Italy. HECE has been established since Academic Year 2003-04, following the long tradition and experience of the former post-graduate School in Clinical Engineering, started in 1991, with the cooperation of many Italian and foreign universities, hospitals, health ministries and biomedical industries. The paper focuses on the conceptual design and the educational structure which has been given to HECE’s extensive educational program in Clinical Engineering, specifically conceived to provide to the prospective Clinical Engineering professionals the appropriate education level and the related skill sets necessary to make them prepared for the future role of Clinical Engineers profession, according to the current and future developments of modern healthcare systems.

The clinical engineering staff including engineers and technicians is an important element in the use of medical technology in health care facilities. The clinical engineer is a member of the technology management team, which is involved in the selection of new technology and the design of facilities for the use of the technology. What is the impact on healthcare delivery as a result of certified Clinical Engineers and Biomedical Engineering Technicians (BMETs)? Can a certified clinical engineering staff improve accreditation of hospitals? Certification of staff is one measure of quality control for medical technology. However, no country requires that the BMETs and Clinical Engineers be certified in order to perform any functions with medical technology. The history of certification will be presented including how it differs in different countries. The recognition of certification of BMETs and Clinical Engineers by the healthcare community will be discussed. The first certification programs were initiated in 1972 in the United States. A clinical engineer may be called a biomedical engineer or medical engineer and different terminology is also used for the BMETs.

Despite the clinical engineering profession already exists in most parts of the world, one cannot say that its activities and profile are the same in each country. However, just a number of few countries have already conducted a survey to identify the characteristics of its clinical engineers. This survey, developed by the International Federation for Medicine and Biological Engineering, is the first attempt to identify the clinical engineer, the clinical engineering activities and the kind of employer worldwide. The results have shown significant differences according to the analyzed region.

Clinical engineering in Malaysia has received renewed interest as an engineering discipline. Growing interest about patient safety and the decision by the Malaysian government to privatize support services at all government hospitals beginning January 01, 1997 have pushed clinical engineering to the limelight and have opened up opportunities for local biomedical engineering graduates seeking jobs as clinical engineers. Clinical engineering flourishes as new approaches to healthcare technology are introduced to enhance the quality of services provided to the hospitals.

The healthcare system in Croatia is in transition. HTA can improve quality and increase its efficiency. In our feasibility study we analyzed the efficiency of Croatian healthcare system, and as a result we found out that the system is expensive and of low efficiency. Health technology assessment is a systematic evaluation of properties and effects of health care technology. It may involve the investigation of one or more of the following attributes of technologies: Performance characteristics that include sensitivity and specificity of diagnostic tests, and conformity with specifications of design, manufacturing, reliability, ease of use and maintenance. Safety, a judgment of risk acceptability (possibility of adverse health outcome and its severity) associated with using technology in a particular situation. Efficiency refers to the benefit of using technology in order to address a particular problem under ideal conditions (e.g., within the protocol of a carefully managed randomized controlled trial, involving patients meeting narrowly defined criteria, or conducted at a “center of excellence”). Effectiveness refers to the benefit of using technology for a particular problem under general or routine conditions (e.g., by a physician in a community hospital treating a variety of patient types).

The general problem of process control requires a big committment in terms of technologies and specific capacities about plenty of aspects that must be controlled, according to trial complexity and particularity of the health structure. This demand drove us to plan and define a methodological tool able to be applied to a general process in a health structure. Requirements for this kind of tools are related to the possibility to produce numerical, synthetic, and objective indexes, according to the idea that a numerical index has the intrinsic property to give a synthetic and comparable kind of information, especially when it’s linked to a qualitative definition. Hence, we propose a methodological tool based on QFD (Quality Function Deployment) approach and characterized by a “semi-quantitative” and at the same time objective approach to quality measurement in health care structures. Such an instrument may be applied to several processes of the health care area or, given a “target process”, more times to the same process in distinct moments (for example before and after particular changes on critical aspects), to assess the contribution supplied by this improvements on process performances.

This paper focuses on the e-learning experience in BME education of E-HECE (E-Higher Education in Clinical Engineering), an integrated distance learning system for education in Clinical Engineering at the University of Trieste (Italy). E-HECE is oriented toward providing to remote students many of the valuable aspects of the live classroom experience that are essential for learning. E-HECE has proven its successfulness in providing convenience to students who can actively participate in a class, whether they attend in person (physically, by videoconference or by video-streaming), and in making also available to the students recordings on-demand of classes synchronized with the lecture’s didactic material on the E-HECE e-learning platform. The E-HECE system made its debut in its current final version in September 2005, and since then it has been extensively used by the 340 E-HECE registered users for all the 150 courses in the Clinical Engineering program which have been delivered up to now. Its use has grown beyond Clinical Engineering including also courses in the health management and medical fields. The expansion of E-HECE’s capabilities continues to extend its utility and power as a distance education system.

European Commission funded virtual campus project EVICAB (European Virtual campus for Biomedical Engineering) was launched in January 2006. The idea is to develop a virtual environment for students to study biomedical engineering by means of e-courses. The transfer from contact teaching to e-courses gave rise to a need for web-based learning material. In order to face the challenge a new project was launched in Ragnar Granit Institute to produce video lectures and other supporting material to the Internet. The produced material has been evaluated and implemented as a part of ecourses in EVICAB.

A Curriculum on Biomedical Engineering is established to the Internet for European universities under the project EVICAB. The curriculum will be free access and available free of charge. Therefore it will be available worldwide. EVICAB will make high quality education available for everyone and facilitate the development of the discipline of Biomedical Engineering.

There is widespread recognition of the need for high quality Biomedical Engineering education, training, accreditation and certification throughout Europe. Many schemes are being developed or are awaiting implementation, but there has been little harmonization. The continuing national differences in the educational systems are a serious problem that can hinder and limit trans-national education, training, employment and cooperation. The BIOMEDEA project aims at changing this situation by establishing Europewide consensus on guidelines for the harmonization, not standardization, of high quality MBES programs, their accreditation and for the training, continuing education and certification or even registration of professionals working in the health care systems. Adherence to these guidelines, which ultimately should be recognized in all 45 Bologna signatory countries, will insure mobility in education and employment as well as proper management of health care technologies, an important aspect with regard to the necessary safety for patients. Targets for the dissemination of results will be the European universities, political decision makers at European and national levels, the European Accreditation Council as well as the accreditation councils of all European countries, European quality assurance and accreditation agencies, health care providers and students.