The Evolution of Clinical Engineering and the Development of Digital and Molecular Medicine: Cultural and Economic Effects

Improving the quality of social and healthcare services; positively influencing population’s health and quality of life; controlling and restructuring health expenditure in the technology sector. These are the daily challenges faced by the engineers and technicians who work within the twenty companies of the ITAL TBS Group. The Group, with headquarters in Trieste (Italy) but now established (with permanent organizational structures) in nine European countries, has chosen to pursue a strategy aimed at promoting a new generation of clinical engineering: this involves professional skills not only targeted at safe, efficient and effective management of technologies in medical and biomedical engineering, but also information technology and genetic engineering and, more generally, anything that falls under the banner of “life sciences”. The path leading to this goal (which will enable further growth of the company’s activities, services and consequently the value of its production) is a local and international scientific and cultural project that aims to resolve critical issues concerning the evolution of medicine (as increasingly costly and advanced technologies permeate services for social healthcare nationwide and in the industrialized world).

1. Clinical Engineering Services: International and Italian Contexts

1.1 The Market for Medical Equipment

A typical hospital in an industrialised country contains several thousand biomedical instruments for diagnosis, therapy and rehabilitation. Replacement costs are between 30 and 50 million Euros, a figure that could be as much as an order of magnitude or two lower in developing and underdeveloped countries (being directly proportional to gross national product in these locations). In developed countries such equipment should normally be under ten years old on average: as a consequence, a typical hospital should spend 3 to 5 million euros on new biomedical equipment as well as other medical equipment (reagents, radiographic films, prostheses, disability aids, etc.) in one year, for a total cost of at least 15-25 million euros.
Figure 1 illustrates that expenditure on medical equipment in industrialized countries (such as the USA, Sweden and Italy) is at least $100 per person, one order of magnitude greater than in developing countries (such as Argentina, Iran or Mongolia) and two orders of magnitude greater than in underdeveloped countries (such as Ethiopia and Bangladesh).
The graph below shows a clear correlation between expenditure per head on medical devices, and several economic parameters for the relevant countries (GNP/head and average annual health expenditure per head).

Figure 1: Expenditure for medical equipment compared to healthcare costs per head and the GNP per capita

1.2 Role of the clinical engineer and quantification of Clinical Engineering Services

In most countries the main task of clinical engineers and biomedical equipment technicians is to provide integrated management of biomedical equipment, which is just one component of the total market for medical devices (equal to 10-20% of this market according to Bostrom U. and others, 1993).
The attempt to arrive at an internationally recognised definition, based on precise and recognized criteria, of the roles and skills of the Clinical Engineer in managing biomedical equipment and medical devices in general has continued for more than 30 years. The International Federation for Medical and Biological Engineering (IFMBE) set up the “Working Group for Clinical Engineering” in 1979, which became the “Specialized Division in Clinical Engineering” (CED) in 1985.
CED’s work led to a precise definition of Clinical Engineering as well as a detailed specification of the role and areas of competence for the profession, which include the prudent, appropriate and economic use of technology in health systems. The CED has for a number of years promoted conferences and seminars as well as the continual analysis and monitoring of the worldwide growth in numbers of clinical engineers.
Data collected at the start of the 1990s from a sample of 28 developed and developing countries with a total population of around one billion, revealed that approximately two thousand clinical engineers were then employed in the hospital systems under examination.
At that time Italy was one of the countries in which Clinical Engineering was relatively uncommon, with one Clinical Engineer for every 8,300 hospital beds compared to the international average of one for every 3,500 beds. Furthermore, the presence of Clinical Engineering services in our country was limited to 5% of hospitals, while the figure was 95% in the USA and Northern Europe.
The international definition of clinical engineering had already been drawn up in 1992 by the IFMBE: “The Clinical Engineer has areas of competence covering the prudent, appropriate and economic use of technology relating to biomedical engineering applications in healthcare systems, and is supported in this work by biomedical equipment technicians.”
The areas of competence of the clinical engineer, as defined by IFMBE in 1992, were as follows:
•    to analyse the technologies available on the market;
•    to plan the replacement of obsolete equipment;
•    to provide technical consultancy on acquisitions and ensure the correct installation and testing of biomedical equipment;
•    to manage the maintenance of biomedical equipment and ensure its safety and effectiveness, making use of the hospital system’s internal maintenance facilities and maintenance contracts drawn up with producers or service companies;
•    to prevent dangerous situations, through the acquisition of equipment compliant with national and international standards, and through the dissemination of information and international reports on defects in equipment available on the market;
•    to lend direct support to medical staff using complex technology to perform clinical procedures and to coordinate the activities of health services support technicians modifying equipment or medical devices to improve their performance or safety;
•    to develop software programs and hardware interfaces between biomedical instruments and hospital information systems;
•    to organize educational sessions on biomedical technologies for the Clinical Engineering, medical, paramedical and administrative staff of health facilities;
•    to determine optimal technological solutions for resolving clinical problems with the possible development of prototypes of equipment or medical devices, and to run clinical trials on any such prototypes prior to their industrial production.
The specification of the biomedical equipment technician role quoted below was drawn up in the USA by the International Certification Commission (ICC, 1993): “The biomedical equipment technician is a person who is familiar with the functioning of biomedical equipment and the physiological conditions that it tests, and is competent to operate such equipment in a safe and practical manner. His/her responsibilities may include the installation, inspection, preventive maintenance, safety checks and repair of biomedical equipment. He/she may also be required to help operate biomedical equipment or to ensure correct functioning and periodically test and verify its performance”.
The roles of the clinical engineer and biomedical equipment technician in industrialised countries may differ significantly from those in developing or underdeveloped countries, since the presence of biomedical equipment – and hence the activities of these professionals in their respective hospital facilities – is closely linked to the economic strength of individual countries.
The prime indicators of the extent to which economic strength governs the organisation of such services are the gross national product per capita and healthcare spending per head, which are closely linked to the value and quantity of biomedical equipment in hospitals.
A study carried out in Germany by W. Irnich in 1989 suggested an organizational model for economically advanced countries, specifying that one biomedical equipment technician per 80-100 beds and one clinical engineer for each 5-6 technicians would serve as a correct and adequate number for clinical engineering services (CES). A similar Italian study by L. Mariani the same year recommended figures similar to those by Irnich but suggested an initial level of service could include one technician for every 200 beds and one clinical engineer for every 700 beds.
The Italian Association of Clinical Engineering (AIIC) was already attempting in 1994 to classify what a service should provide, analysing a set of indicators such as technology (e.g. quantity of autonomously functioning equipment), structure (e.g. number of hospital facilities) and organisation (e.g. number of purchasing administrators). The diverse methodologies used to determine the correct sizing of CE services are summarized in the table below.

Table 1: Sizing a CE service

Clinical engineer training began in Italy in the 1990s with the introduction of the first degree courses in biomedical and/or clinical engineering and specialised Masters degrees in leading Italian universities and specialist Schools. By 2007 there were over 300 clinical engineers working in Italy of whom 57% in the North, 20% in Central Italy and 23% in the South (Italian Association of Clinical Engineers, 2007).
In order to assess the need for clinical engineers and biomedical equipment technicians in Italy, the Ministry of Health analysed a representative sample of NHSs (local health units) or hospitals (comprising 16% of all Italian facilities).
The resulting projection is illustrated in the following table, which distinguishes technicians working internally from those in companies that outsource Clinical Engineering services.

Table 2: Estimated number of clinical engineers and biomedical equipment technicians needed in Italy for internal services and outsourced services

A similar result was found using expenditure on outsourced Clinical Engineering services (60 million euros in the cluster examined) as the reference parameter instead of bed numbers. This approach based on expenditure (or production value) also made it possible to estimate the number of personnel already employed in the Clinical Engineering sector in Italy, by extrapolating the figures to the total market for outsourced Clinical Engineering services for 2007 (a market which was monitored by the Industrial Association ANIE at the time). With the Association reporting that the entire Italian market for the maintenance of biomedical equipment was worth around 400 million euros that year (of which 230 were directly allocated to manufacturing companies and 170 allocated to outsourced Clinical Engineering services operating in collaboration with internal Clinical Engineering Services), it was possible to estimate not only the national requirements for clinical engineers (652) and biomedical equipment technicians (2,091) but also the number of clinical engineers (277) and biomedical equipment technicians (888) already operating.

Table 3: Estimated number of clinical engineers and biomedical equipment technicians required and already present in Italy

By projecting the detailed data of the first NHS sample onto the second, which refers to the entirety of outsourced Clinical Engineering Services, it was possible to categorize the figures for the same year showing the (estimated) respective numbers of technicians employed both internally and by companies outsourcing Clinical Engineering Services for the management of biomedical equipment.

Table 4: Subdivision between clinical engineers and biomedical equipment technicians needed for internal and outsourced services (Italy)

With regard to Clinical Engineers, these estimates are broadly confirmed by the membership figures of the Italian Association of Clinical Engineers (AIIC, 2007), given that around 10% of clinical engineers had not taken up membership in the Association.

Table 5: Clinical engineering by category according to the AIIC

Diego Bravar:Chairman and Managing Director of ITAL TBS, Trieste – Italy.

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