Clinical Engineering: From Devices to Systems

Engineers.

1

The Evolution of Clinical Engineering

History and the Role of Technology in Health Care

Saide Jorge Calil,    Faculty of Electrical Engineering and Computing, University of Campinas, Campinas, São Paulo, Brazil,    Clinical Engineering Division, IFMBE

Abstract

Clinical engineering faces today a great challenge to define the basic requirements a person must attend to be called clinical engineer. Its creation and evolution was totally dependent on the needs of the country that not always take as the patient safety as the paramount parameter. This chapter presents what is happening today with clinical engineering worldwide, how it evolved in some countries, the different activities developed by clinical engineers according to the world region he/she is working, and the resulting professional profile in relation to each country’s health system requirements.

Keywords

Clinical engineering evolution; clinical engineering responsibilities; clinical engineering situation; clinical engineering activities

There is today no precise data about how many health units are there in the world. As of 2014, the countries with the largest number of hospitals are China, India, Vietnam, Nigeria, Russia, Japan, Egypt, South Korea, Brazil, and United States. As of 2014, China alone had around 69,000 hospitals, according to Maps of the World (mapsofworld.com, 2015). Also, it is almost impossible to estimate how many clinical engineers are employed by health systems worldwide, since the requirements for this professional varies from country to country.

If one looks at professions such as civil, mechanical, and electrical engineering, for instance, the competences, activities, and the basic requirements are worldwide known. However, regarding clinical engineering, one of the major challenges to be dealt with is the definition of the basic requirements a person must attend to be considered a clinical engineer.

This chapter presents what is happening today with clinical engineering worldwide, how it evolved in some countries, the different activities developed by clinical engineers according to the world region he/she is working, and the resulting professional profile in relation to each country’s health system requirements.

Despite the lack of bibliography, probably medical equipment maintenance was born when the human warfare became more organized. By the time, doctors need help from technical people to sharpen instruments designed to withdraw arrow tips and amputate members from wounded warriors. Perhaps, they also needed some help to discuss and choose the best metal composition and shape to be used, without bending or loosing sharpness during surgery.

What is called today clinical engineering originated just after 1950, when more complex technology started to be developed and used in the health system (Dyro, 2004).

Clinical engineering evolved according to the improvement and additional needs of the health system environment. Around 1979, Scott and Caceres (Scott, 1976; Caceres, 1981) separately identified a number of clinical engineering responsibilities. The combined list of responsibilities includes development and management of medical systems, education, maintenance, safety, clinical research and development, and analysis and development for the more effective patient care systems (Dolan, 2004). Betts (1983), in considering the changing role of clinical engineering in the 1980s, emphasized the need for management skills in addition to the requisite technical knowledge.

In Europe 1992, clinical engineering was concentrated on technology management and advisory regarding acquisition, training, and technological evaluation for equipment incorporation (Bravar, 2010). Later, in 2003, to the former defined activities risk management was added. Also, to the task of technology management, the responsibility over financial management of technologies was included.

Table 1.1 summarizes, in general terms, the activities for clinical engineering in the seventies and the additional activities that were included from the nineties till the present days.

Table 1.1

Set of Activities Required to Clinical Engineering in the Seventies and in the Present Days

In 2005, the Clinical Engineering Division of the International Federation of Medical and Biological Engineering (CED/IFMBE) carried out a worldwide survey to identify clinical engineers and characterize their performed activities. This survey included questions regarding name, age, email address, academic background, and years of experience within the clinical engineering area. For the activities, the employer, job position, and job activities were asked. To avoid misunderstandings by the respondents, regarding the activities they were currently developing, a glossary about the meaning of each activity was included, using the same definitions adopted by the American College of Clinical Engineering (ACCE, 2001).

From the 559 questionnaires that were responded, 54% were from Latin America, 27% from Europe, 10% from the United States/Canada, 8% from Asia, and 1% from Africa (Figure 1.1).

Figure 1.1 Percentage of respondents from each one of the five selected regions.

The results for the question regarding the present developed activity (Figure 1.2) show that Technology Management (60.8%) and Service Delivery (60.6%) are the mainly practiced activities. Both results are quite similar analyzing the responses from the four regions. Importantly, to answer this question, the clinical engineer could choose as many answers that identified his/her kind of activity in the working place.

Figure 1.2 Activities that are practiced by clinical engineers worldwide.

Other activities, however, vary quite significantly according to each region (Figure 1.3). While in the Latin American, European, and US/Canadian regions the clinical engineers are very much involved with Education (around 53% in general), only 36.4% from the Asian region are involved with this activity, where the Academia is the second main employer (16%). The reason for such event is difficult to explain since the employer’s full address, for further explanation if necessary, was not asked in the questionnaire.

Figure 1.3 Activities that are practiced by clinical engineers within the five selected regions.

Around 70% of the clinical engineers from the US/Canadian region declared to be involved with Risk Management/Safety activities, while about 42%, 36%, and 26% of the respondents in the European, Asian, and Latin American regions, respectively, are involved with such activity.

Information Technology is other activity that varies quite significantly according to the regions analyzed. While in the European (35.3%) and US/Canadian (31.6%) regions several respondents declared to be involved with it, in the Latin American (12%) and Asian (13.6%) regions, just a few clinical engineers have such activity.

The analysis of this survey showed that complex clinical engineering activities, such as information technology and risk management, are concentrated on more developed regions. It does not mean that there are no needs for such activity in less developing regions as many hospitals acquire sophisticated medical technologies and indeed require the use of additional knowledge. However, the level of training courses (quality and contents) for clinical engineers on such less developing regions does not attend to such needs.

Another conclusion was that clinical engineering activities are still evolving in different ways and directions, not only according to the world regions but also to each country. As an example, while some European countries, as well as United States/Canada, are discussing the best way to implement information technology and the use of risk management tools within the clinical engineering activities, other regions are still discussing rules for equipment acceptance and installation and asking for training courses on the basic tools for medical equipment management.

The same can be said regarding the clinical engineering activities and the biomedical technician activities. While in some countries such differentiation is quite well defined, in several other countries clinical engineers work as the repair person for medical equipment. Hence, according to the country, even neighboring countries, the understanding of what is a clinical engineer is quite diverse. While in one country clinical engineers are known as the problem solver, the risk manager, the investigator, and the standard advisors, in other countries they are just recognized as the boys for maintenance.

One could think that clinical engineering evolution progressed according to the number of years it was created in the country. However, this is strongly subject to debate, and it is not confirmed. In many countries where you have maintenance groups for decades, clinical engineers are still the medical equipment maintenance managers and have little role in the processes for acquiring medical equipment or even involved on risk management. The majority of clinical engineers in several regions around the world have no knowledge about what tools can be used in the investigation of an adverse event.

The reason for such different evolution is still to be found but it may be possible to take some conclusions. Where the health system management is worried about patient safety programs, has a thorough cost control and quality control for medical equipment incorporations and bidding process, it is possible to notice a quite sophisticated set of activities for clinical engineers. In countries where most of the preoccupation is to have a cheaper maintenance, the clinical engineering activities go no further than medical equipment maintenance management.

It seems that the evolution of the clinical engineering as well as the sophistication of the tasks to be developed is highly dependent on the understanding of the health system about the priorities in the care its population. The more the health system cares about safety, equipment integration and interoperability, cost control, and technology evaluation, the more clinical engineers have to be prepared to face such requirement.

There is, however, another reason why in some countries clinical engineering is still developing basic activities. The paucity of scientific articles produced by clinical engineers is hardly found in other engineering professions. As a consequence, there are quite a few journals exclusively dedicated to clinical engineering. The consequence is that clinical engineers do not share their experience among themselves and do not feel compelled to learn or apply more complex activities. Most of them keep isolated in his/her work. Importantly, some biomedical engineering journals do not accept articles describing practical methodologies and results described by clinical engineers, regardless the merit.

Additionally, it is common knowledge that clinical engineers produce a reduced amount of articles. Such attitude does not improve the understanding about the role of clinical engineering in the health sector and, in general and consequently, hospital administrators have little information about the latent qualities and abilities of this profession.

Explaining What Is a Clinical Engineer

To explain clinical engineering for a person who is not familiar with the profession may be not so difficult. It can be said that it is the engineer who works in the healthcare service or in a hospital. However, explaining to this same person what are the activities of the clinical engineer and his/her role in the healthcare system may be a bit more complex matter and quite complicated to be described in a single phrase.

As already stated, the creation and evolution of clinical engineering was totally linked to the needs of the health area on each country. Also, depending on such needs at the time of its establishment as a profession, clinical engineering will carry a stigma for many years to come. To better explain such statement, let’s take the example of the United States where the original needs for its creation was basically patient safety (Bronzino, 2003). The clinical engineering model developed over there has a lot to do with risk and financial management, as well as contract management and internal operations. They even produced several guidelines on such subjects that are helping clinical engineers all over the world. Eventually, they can deal with the supervision of in-house maintenance staff (Grimes, 2012). Over there, a biomedical equipment technician (BMET) is a professional who develops the medical/hospital equipment maintenance.

In other world regions, such as Latin America, clinical engineering was developed basically to manage the maintenance of medical equipment. Hence, clinical engineers are seen as the person who either do the medical/hospital equipment maintenance and/or manage it. In fact, clinical engineering in these regions was originated basically due to the need of lowering the prices charged by external companies (service or vendors), to make repair and, sometimes, preventive maintenance. This is today the stigma carried by the majority of clinical engineers, mainly the ones who are frightened to stand up and present their skills to perform other tasks to the hospital administration.

Going to Japan, clinical engineers not only develop the maintenance of complex equipment but also work as an active health staff member during specific medical procedures. Such activity involves a direct participation, with doctors and nurses, on surgeries such as cardiac valve implants, cardiac catheterization, blood purifications, and several others. Importantly, his/her participation is not as a standby person waiting to solve some operational difficulty but actually is a member of the surgical team dealing and handling with the equipment, accessories, and even the part to be implanted in the patient.

Another example of the development of different clinical engineering models is in the European continent, where some countries use clinical engineers to monitor and manage external maintenance service companies, while in other countries most hospitals have their own clinical engineering group but developing different tasks. A German clinical engineer is quite dedicated to risk programs; in United Kingdom, there are clinical engineering groups dealing with rehabilitation developments as well as medical equipment maintenance. Some UK groups included services for the Ministry of Health regarding testing and conformity with standards.

Not only the mission of clinical engineers is different depending on the region but also the name. Biomedical engineers and hospital engineers are also used for the engineer that works within the healthcare system.

Requirements to Be a Clinical Engineer

Requirements to work as clinical engineers also vary according to the country. Some countries require certification of competence to work in this area, while others have a voluntary certification and most of them have no requirement at all.

The certification system is also different from country to country; some require the clinical engineer to be interviewed and approved in a set of written exams. Some require the filling of a form established (register) by the country’s clinical engineering society and the candidate has to attend a two years course plus a practical training in a certified hospital for several months.

There is no world standard or even basic requirements to be recognized as clinical engineer worldwide. Worst of all, there is no international entity that exclusively represents clinical engineering and where would be possible to discuss such matters, and perhaps reach a common sense regarding the recognition requirements.

All the recommendations regarding the responsibilities for clinical engineering are produced by isolated sources and strongly dependent on the countries’ healthcare system requirements and state of the art. However, such isolated efforts can demonstrate a clear evolution not only on the increasing number of responsibilities but also on the way such responsibilities must be dealt with. Table 1.2 shows a set of the clinical engineering responsibilities listed by the CED/IFMBE in 1992 (Bravar, 2010), and the responsibilities listed by the ACCE in 2012 (Grimes, 2012).

Table 1.2

Comparative Table Showing the Activities Established for Clinical Engineering by the Clinical Engineering Division/International Federation of Medical and Biological Engineering (CED/IFMBE) Defined in 1992 and the Ones Defined by the American College of Clinical Engineering (ACCE) in 2012