Management of Medical Technology: A Primer for Clinical Engineers

By Joseph D. Bronzino

Management of Medical Technology: A Primer for Clinical Engineers introduces and examines the functions and activities of clinical engineering within the medical environment of the modern hospital. The book provides insight into the role that clinical engineers play in the management of medical technology. Topics covered include the history, job functions, and the professionalization of clinical engineering; safety in the clinical environment; management of hospital equipment; assessment and acquisition of medical technologies; preparation of a business plan for the clinical engineering department; and the moral and ethical issues that surround the delivery of health-care. Clinical engineers and biomedical engineers will find the book as a great reference material.

• Language: English
• Publisher: Elsevier Science
• Release date: Jun 28, 2014
• ISBN: 9781483193908

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CHAPTER 1

CLINICAL ENGINEERING: EVOLUTION OF A DISCIPLINE

Publisher Summary

This chapter discusses the evolution of a clinical engineering as a new discipline. Biomedical engineering is an interdisciplinary branch of engineering with a foundation based in both engineering and the life sciences. It ranges from theoretical, nonexperimental undertakings to state-of-the-art applications. It can encompass research, development, implementation, and operation. Biomedical engineers apply electrical, chemical, mechanical, and other engineering principles to understand, modify, or control biological systems. When biomedical engineers work within a hospital or clinic, they are more properly called clinical engineers. However, this theoretical distinction is not always observed in practice as many professionals working in the U.S. hospitals today continue to be called biomedical engineers. In many hospitals, administrators have established clinical engineering departments to manage effectively all the technological resources, especially those relating to medical equipment, that are necessary for providing patient care. The primary objective of these departments is to provide a broad-based engineering program that addresses all aspects of medical instrumentation and systems support.

In the twentieth century, technological innovation has reshaped the field of medicine and the delivery of health-care services. Although the art of medicine has a long history, advances in medical technology, primarily in this century, have provided a wide range of positive diagnostic, therapeutic, and rehabilitative tools that are now routinely used in the cure of specific diseases and illnesses. In the process, the modern hospital in the United States has evolved as the center of a technologically sophisticated health-care system serviced by a technologically sophisticated staff.

With the dramatic role technology has played in shaping medical care, engineering professionals have become intimately involved in many medical ventures. As a result, the discipline of biomedical engineering has emerged as an integrating medium for two dynamic professions: medicine and engineering. Today, biomedical engineers assist in the struggle against illness and disease by providing materials, tools, and techniques (such as biomaterials, medical imaging, and artificial intelligence) that can be utilized for research, diagnosis, and treatment by health-care professionals. In addition, one subset of the biomedical engineering community, namely clinical engineers, has become an integral part of the health-care delivery team by managing the utilization of medical equipment within the hospital environment. The purpose of this chapter is to provide a broad overview of technology’s role in shaping our modern health-care system and to review the basic functions performed by clinical engineers within a hospital environment. This chapter also presents the status of the professionalization of clinical engineering (including certification), describes attributes of clinical engineering educational programs, and reflects upon the future of the discipline.

EVOLUTION OF THE MODERN HEALTH-CARE SYSTEM

Before 1900, medicine had little to offer the average citizen because its resources consisted mainly of the physician, his education, and his little black bag. In general, physicians seemed to be in short supply, but the shortage then had rather different causes than found today. Although the costs of obtaining medical training were relatively low, the demand for doctors’ services was also very small because many of the services provided by the physician could also be obtained from experienced amateurs in the community. The home was typically the site for diagnosis, treatment, and recuperation, and relatives and neighbors constituted an able and willing nursing staff. Babies were delivered by midwives, and those illnesses not cured by home remedies were left to run their natural, albeit frequently morbid, course. The contrast with contemporary health-care practices, in which specialized physicians and nurses located within the hospital provide critical diagnostic and treatment services, is dramatic.

The changes that have occurred within medical science originated in the rapid developments that took place in the applied sciences (chemistry, physics, engineering, microbiology, physiology, pharmacology, etc.) at the turn of the century. This process of development was characterized by intense interdisciplinary cross-fertilization, which provided an environment in which medical research was able to take giant strides in developing techniques for the diagnosis and treatment of disease. For example, in 1903, Willem Einthoven, the Dutch physiologist, devised the first electrocardiograph to measure the electrical activity of the heart. In applying discoveries in the physical sciences to the analysis of a biological process, he initiated a new age in both cardiovascular medicine and bioelectrical measurement techniques.

New discoveries in medical technology followed one another like intermediates in a chain reaction. However, the most significant innovation for clinical medicine was the development of X-rays. These new kinds of rays,― as their discoverer W.K. Roentgen described them in 1895, opened the inner man― to medical inspection. Initially, X-rays were used to diagnose bone fractures and dislocations. In the process, this "modern technology― became commonplace in most urban hospitals. Separate departments of radiology were established, and their influence spread to other departments throughout the hospital. By the 1930s, X-ray visualization of practically all organ systems had been made possible because of the inherent radiopacity of the body and the use of barium salts and a wide variety of radio-opaque materials.

X-ray technology gave physicians a powerful tool that, for the first time, permitted accurate diagnosis of a wide variety of diseases and injuries. Moreover, since X-ray machines were too cumbersome and expensive for local doctors’ clinics, they had to be placed in hospitals. Once there, X-ray technology essentially triggered the transformation of the hospital from a passive receptacle for the sick poor to an active curative institution for all members of society.

For economic reasons, the centralization of health-care services became essential because of many other important technological innovations appearing on the medical scene. However, hospitals remained institutions to dread, and it was not until the introduction of sulfanilamide in the mid-1930s and penicillin in the early 1940s that the main danger of hospitalization, i.e., cross-infection among patients, was significantly reduced. With these new drugs in their arsenals, surgeons were permitted to perform their operations with reduced morbidity and mortality due to infection. Furthermore, even though the different blood groups and their incompatibility were discovered in 1900 and sodium citrate was used in 1913 to prevent clotting, full development of blood banks was not practical until the 1930s when technology provided adequate refrigeration. Until that time, "fresh― donors were bled, and the blood was transfused while it was still warm.

Once these surgical units were established, employment of the available medical technology assisted in further advancing the development of complex surgical procedures. For example, the Drinker respirator was introduced in 1927, and the first heart-lung bypass was accomplished in 1939. By the late 1940s, medical procedures heavily dependent upon medical technology, such as cardiac catheterization and angiography (the use of a cannula threaded through an arm vein and into the heart with the injection of radio-opaque dye for the X-ray visualization of heart vessels and valves), were developed. As a result, accurate diagnoses of congenital and acquired heart disease became possible, and a new era of cardiac and vascular surgery was established.

Following World War II, the development of medical devices accelerated rapidly and the medical profession benefitted greatly from this rapid surge of technological finds throughout the next four decades.

Since it is impossible to cover all of the medical innovations that occurred during this period, consider just a few examples:

• Advances in electronics made it possible to map the subtle electrical behavior of the fundamental unit of the central nervous system–the neuron–and to monitor various physiological functions of patients in intensive care units (ICUs) by utilizing such diagnostic tools as the electrocardiogram (ECG) and the electroencephalogram (EEG). (Figure 1.1)

Figure 1.1 Modern bioelectric monitoring device used during surgery to monitor various physiological signals. (Courtesy of Space Labs Medical, Inc. Redman, WA)

• Nuclear medicine, an outgrowth of the atomic age, emerged as a powerful and effective approach to applying radioactive materials (tracers) to medical diagnosis and treatment. Activities in this area have included (a) the creation and use of radiopharmaceuticals; (b) the design and application of appropriate nuclear instrumentation to detect and display the activity of these radioactive elements; and (c) the determination of the relationship between the activity of radioactive tracers and specific physiological processes.

• "Spare parts― surgery became commonplace. Technologists were encouraged to provide prosthetic devices, such as artificial heart valves and artificial blood vessels, and the artificial heart program was launched to develop a replacement for a defective or diseased human heart (Figure 1.2).

Figure 1.2 Jarvik VII artificial heart (foreground) and surgical team preparing for implantation into a human patient

• Computers, similar to those developed to control the flight plans of the Apollo capsule, were used to store, process, and cross-check medical records, monitor patient status in intensive-care units, and provide sophisticated statistical diagnosis of potential diseases correlated with specific sets of patient symptoms (Figure 1.3).

Figure 1.3 Centralized computer monitoring of patients in an ICU. Physiological data from any patient in the ICU can be monitored by the duty nurses at this station.

• Medical imaging became a vital part of patient diagnostic systems. For example, diagnostic ultrasound based on sonar techniques has been so widely accepted that ultrasonic studies are now part of the routine diagnostic workup in many medical specialties. In fact, diagnostic ultrasound studies are often the method of choice because they provide information otherwise unavailable. For example, ultrasound images of the fetus are especially useful in evaluating the status of fetal development. Development of the first computer-based medical instrument, the computerized axial tomography (CAT) scanner has permitted the visualization of structures and masses in otherwise inaccessible regions of the body and has essentially revolutionized clinical approaches to non-invasive diagnostic imaging procedures. This technology has also served to stimulate the development of more recent medical imaging procedures such as magnetic resonance imaging (MRI) and positron emission tomography (PET).

The effect of these discoveries and many others has been profound. The health-care system that existed at the turn of the century, consisting primarily of the "horse-and-buggy― physician, has disappeared forever. It has been replaced by a clinical staff that consists of physicians, nurses, and other professional allied- health specialists and operates primarily in hospitals. The clinical staff now stands as the fundamental component of the American health-care system (Crichton, 1970; Knowles, 1973; Bronzino, 1977; Vogel, 1980; Bronzino, 1986; Bronzino et al., 1990).

WHAT IS CLINICAL ENGINEERING?

Many of the problems confronting health professionals today are of extreme interest to engineers because they involve the design and practical application of medical devices and systems–processes that are fundamental to engineering practice. These medically related design problems can range from very complex, large-scale constructs, such as the design and implementation of automated clinical laboratories, multiphasic screening facilities (i.e., centers that permit many clinical tests to be conducted), and hospital information systems, to the creation of relatively small and "simple― devices, such as recording electrodes and transducers that may be used to monitor the activity of specific physiological processes in either a research or a clinical setting. Furthermore, these problems often involve addressing the many complexities found in specific clinical areas, such as emergency vehicles, operating rooms, and intensive-care units. The American health-care system, therefore, presents significant challenges and opportunities to those members of the engineering profession called biomedical engineers.

Since the field of biomedical engineering involves applying the concepts, knowledge, and approaches of virtually all engineering disciplines (e.g., electrical, mechanical, and chemical engineering) to solve specific health-care-related problems, the opportunities for interaction between engineers and health professionals are many and varied. As a result, biomedical engineers may become involved in the design of a new medical imaging modality or the development of new medical prosthetic devices to aid the handicapped. Although what is included in the field of biomedical engineering is considered to be quite clear, many conflicting opinions concerning the field can be traced to disagreements about its definition. For example, consider the terms biomedical engineering, bioengineering, and clinical (or medical) engineering, which are defined in the Bioengineering Education Directory (Pacela, 1990). While Pacela defines "bioengineering― as the broad umbrella term used to describe this entire field, bioengineering is usually defined as a basic research-oriented activity closely related to biotechnology and genetic engineering; that is, the modification of animal or plant cells, or parts of cells, to improve plants or animals or to develop new microorganisms for beneficial ends. In the food industry, for example, this has meant the improvement of strains of yeast for fermentation. In agriculture, bioengineers may be concerned with the improvement of crop yields by treatment of plants with organisms to reduce frost damage. It is clear that bioengineers of the future will have a tremendous impact on the quality of human life; the full potential of this specialty is difficult to imagine. Typical pursuits include the following:

• Development of improved species of plants and animals for food production.

• Invention of new medical diagnostic tests for diseases.

• Production of synthetic vaccines from clone cells.

• Bioenvironmental engineering to protect human, animal, and plant life from toxins and pollutants.

• Study of protein-surface interactions.

• Modeling of the growth kinetics of yeast and hybridoma cells.

• Research in immobilized enzyme technology.

• Development of therapeutic proteins and monoclonal antibodies.

The term "biomedical engineering,― in my opinion, however, has the most comprehensive meaning. Biomedical engineering is an interdisciplinary branch of engineering with a foundation based in both engineering and the life sciences. It ranges from theoretical, nonexperimental undertakings to state-of-the-art applications. It can encompass research, development, implementation, and operation. Accordingly, like medical practice itself, it is unlikely that any single person can acquire expertise that encompasses the entire field. As a result, there has been an explosion of biomedical engineering specialists to cover this broad spectrum of activity. Yet, because of the interdisciplinary nature of this activity, there is considerable interplay and overlapping of interest and effort. For example, biomedical engineers engaged in the development of biosensors may interact with those interested in prosthetic devices to develop a means to detect and use bioelectric signals to power a prosthetic device. Those engaged in automating clinical chemistry instrumentation may collaborate with those developing expert systems to assist clinicians in making clinical decisions based upon specific laboratory data. The possibilities are endless. Biomedical engineers apply electrical, chemical, mechanical, and other engineering principles to understand, modify, or control biological (i.e., human and animal) systems. When biomedical engineers work within a hospital or clinic, they are more properly called clinical engineers. However, this theoretical distinction is not always observed in practice, since many professionals working in U.S. hospitals today continue to be called "biomedical engineers.― Unfortunately, this inconsistency within the profession has caused a great deal of confusion among clinicians, nurses, and hospital administrators.

In the field of biomedical engineering there are seven major career areas (Bronzino, 1991):

1. Application of engineering system analysis and modeling (computer simulation) to biological problems.

2. Measurement or monitoring of physiological signals.

3. Diagnostic interpretation via signal-processing techniques of bioelectric data.

4. Therapeutic and rehabilitation procedures and devices.

5. Prosthetic devices for replacement or augmentation of body functions.

6. Computer analysis of patient-related data.

7. Medical imaging—the graphic display of anatomical detail or physiological function.

Typical pursuits of biomedical engineers include these:

• Design of instrumentation for research in human physiology.

• Monitoring of astronauts and maintenance of life in space.

• Research on new materials for implanted artificial organs and prosthetic devices.

• Development of new diagnostic instruments for blood analysis.

• Computer modeling of human heart function.

• Writing software for analysis of medical research data.

• Analysis of medical device hazards for the United States government and consumers of medical technology.

• Monitoring of animal physiological functions.

• Development of new diagnostic imaging systems.

• Design of telemetry systems for patient monitoring

• Design of biomedical sensors for measuring multiple variables of human physiological systems.

• Research on artificial intelligence (AI) and development of expert systems for diagnosis of disease.

• Design of closed-loop control systems for drug administration.

• Modeling of the physiological systems of the human body.

• Design of instrumentation for sports medicine.

• Development of new dental materials.

• Design of computers and communication aids for the handicapped.

• Research in pulmonary fluid dynamics.

• Study of the biomechanics of the human body.

This list is not intended to be all-inclusive, but rather to illustrate the types of activities of interest to biomedical engineers. There are many other applications that utilize the talents and skills of the biomedical engineer. In fact, the list of activities of biomedical engineers depends upon the medical environment in which they work. This is especially true for the clinical engineer.

The universal acceptance of a definition for "clinical engineer― is important. In recent years, a number of organizations have attempted to provide an appropriate definition (Schaffer and Schaffer, 1992). For example, the AHA defines a clinical engineer as

• "a person who adapts, maintains, and improves the safe use of equipment and instruments in the hospital― (AHA, 1986).

The American College of Clinical Engineering defines a clinical engineer as

• "a professional who supports and advances patient care by applying engineering and managerial skills to health-care technology― (Bauld, 1991).

The definition which the AAMI originally applied to board certified practitioners describes a clinical engineer as

• "a professional who brings to health-care facilities a level of education, experience, and accomplishment which will enable him to responsibly, effectively, and safely manage and interface with medical devices, instruments, and systems and the user thereof during patient care …,― (Goodman, 1989).

For the purpose of internal certification, the Board of Examiners for Clinical Engineering Certification considers a clinical engineer to be

• "an engineer whose professional focus is on patient-device interfacing; one who applies engineering principles in managing medical systems and devices in the patient setting, (ICC, 1991).

Finally, the Journal of Clinical Engineering has defined the distinction between a biomedical engineer and a clinical engineer by suggesting that the biomedical engineer

• "applies a wide spectrum of engineering level knowledge and principles to the understanding, modification or control of human or animal biological systems, (Pacela, 1991).

For the purposes of this book, we will define a clinical engineer as

• an engineer who has graduated from an accredited academic program in engineering or who is licensed as a professional engineer or engineer-in-training and is engaged in the application of scientific and technological knowledge developed through engineering education and subsequent professional experience within the health-care environment in support of clinical activities.

The clinical environment is that portion of the health-care system in which patient care is delivered. Clinical activities include direct patient care, research, teaching, and public service activities intended to enhance patient care.

Engineers were first encouraged to enter the clinical scene during the late 1960s in response to concerns about patient safety as well as the rapid proliferation of clinical equipment, especially in academic medical centers. In the process, a new engineering discipline—clinical engineering—evolved to provide the technological support necessary to meet these new needs. During the 1970s, a major expansion of clinical engineering occurred, primarily due to the following events (Bronzino and Hayes, 1988):

• The Veterans’ Administration (VA), convinced that clinical engineers were vital to the overall operation of the VA hospital system, divided the country into biomedical engineering districts, with a chief biomedical engineer overseeing all engineering activities in the hospitals in that district.

• Throughout the United States, clinical engineering departments were established in most large medical centers and hospitals and in some smaller clinical facilities with at least three hundred beds.

• Clinical engineers were hired in increasing numbers to help these facilities use existing technology and incorporate new technology.

Having entered the hospital environment, routine electrical safety inspections exposed the clinical engineer to all types of patient equipment that were not being properly maintained. It soon became obvious that electrical safety failures represented only a small part of the overall problem posed by the presence of medical equipment in the clinical environment. This equipment was neither totally understood nor properly maintained. Simple visual inspections often revealed broken knobs, frayed wires, and even evidence of liquid spills. Investigating further, it was found that many devices did not perform in accordance with manufacturers’ specifications and were not maintained in accordance with manufacturers’ recommendations. In short, electrical safety problems were only the tip of the iceberg. By the mid-1970s, complete performance inspections before and after use became the norm and sensible inspection procedures were developed (Newhouse et al., 1989). Clinical engineering departments became the logical support center for all medical technologies. As a result, clinical engineers assumed additional responsibilities, including the management of high-technology instruments and systems used in hospitals, the training of medical personnel in equipment use and safety, and the design, selection, and use of technology to deliver safe and effective health-care.

Figure 1.4 illustrates the multi-faceted role played by clinical engineers. They must successfully interface with clinical staff, hospital administrators, regulatory agencies, etc., to ensure that the medical equipment within the hospital is safely and effectively utilized.

Figure 1.4 Diagram illustrating the range of interactions in which a clinical engineer may be required to engage in a hospital setting.

Hospitals that have established centralized clinical engineering departments to meet these responsibilities use clinical engineers to provide the hospital administration with an objective opinion of equipment function, purchase, application, overall system analysis, and preventive maintenance policies. With the in-house availability of such talent and expertise, the hospital is in a far better position to make more effective use of its technological resources (Jacobs, 1975; Bronzino, 1977, 1986). It is also important to note that competent clinical engineers, as part of the health-care system, can help create a more unified and predictable market for biomedical equipment. By providing health professionals with needed assurance of safety, reliability, and efficiency in using new and innovative equipment, clinical engineers can identify poor quality and ineffective equipment much more readily. These activities, in turn, can lead to a faster, more appropriate utilization of new medical equipment and provide a natural incentive for greater industrial involvement—a step that is an essential prerequisite to widespread utilization of any technology (Newhouse et al., 1989).

Typical pursuits of clinical engineers therefore include the following:

• Supervision of a hospital clinical engineering department that includes clinical engineers and biomedical equipment technicians (BMETs).

• Prepurchase evaluation and planning for new medical technology.

• Design, modification, or repair of sophisticated medical instruments or systems.

• Cost-effective management of a medical equipment calibration and repair service.

• Safety and performance testing of medical equipment by BMETs.

• Inspection of all incoming equipment (new and returning repairs).

• Establishment of performance bench marks for all equipment.

• Medical equipment inventory control.

• Coordination of outside services and vendors.

• Training of medical personnel in the safe and effective use of medical devices and systems.

• Clinical applications engineering, such as custom modification of medical devices for clinical research, evaluation of new noninvasive monitoring systems, etc.

• Biomedical computer support.

• Input to the design of clinical facilities where medical technology is used, e.g., operating rooms (ORs), intensive-care units, etc.

• Development and implementation of documentation protocols required by external accreditation and licensing agencies.

Clinical engineers thereby provide extensive engineering services for the clinical staff and, in recent years, have been increasingly accepted as valuable team members by physicians, nurses, and other clinical professionals. The acceptance of clinical engineers in the hospital setting has led to different types of engineering-medicine interactions, which in turn have improved health-care delivery. For example, clinical engineers serve as a significant resource for the entire hospital. They possess in-depth knowledge regarding available in-house technological capabilities and the technical resources available from outside firms. The availability of such talent enables the hospital to make effective and efficient use of all of its technological resources.

HOSPITAL ORGANIZATION AND THE ROLE OF CLINICAL ENGINEERING

In the hospital, management organization has evolved into a diffuse authority structure that is commonly referred to as the "triad model.― The three primary components are the governing board (trustees), hospital administration (CEO and administrative staff), and the medical staff organization. The role of the governing board and the chief executive officer are discussed in detail to provide some insights regarding their individual responsibilities and their interrelationship (Bronzino and Hayes, 1988).

Governing Board (Trustees)

The Joint Commission on the Accreditation of Healthcare Organizations summarizes the major duties of the governing board as "adopting by-laws in accordance with its legal accountability and its responsibility to the patient.― The governing body, therefore, requires both medical and paramedical departments to monitor and evaluate the quality of patient care, which is a critical success factor in hospitals today.

To meet this goal, the governing board essentially is responsible for establishing the mission statement and defining the specific goals and objectives that the institution must satisfy. Therefore, the trustees are involved in the following functions:

• Establishing the policies of the institution.

• Providing equipment and facilities to conduct patient care.

• Ensuring that proper professional standards are defined and maintained (i.e., providing quality assurance).

• Coordinating professional interests with administrative, financial, and community needs.

• Providing adequate financing by securing sufficient income and managing the control of expenditures.

• Providing a safe environment.

• Selecting qualified administrators, medical staff, and other professionals to manage the hospital.

In practice, the trustees select a hospital chief administrator who develops a plan of action that is in concert with the overall goals of the institution.

Hospital Administration

The hospital administrator, the chief executive officer of the medical enterprise, has a function similar to that of the chief executive officer of any corporation. The administrator represents the governing board in carrying out the day-to-day operations to reflect the broad policy formulated by the trustees. The duties of the administrator are summarized as follows:

• Preparing a plan for accomplishing the institutional objectives, as approved by the board.

• Selecting medical chiefs and department directors to set standards in their respective fields.

• Submitting for board approval an annual budget reflecting both expenditures and income projections.

• Maintaining all physical properties (plant and equipment) in safe operating condition. Representing the hospital in its relationships with the community and health agencies.

• Submitting to the board annual reports that describe the nature and volume of the services delivered during the past year, including appropriate financial data and any special reports that may be requested by the board.

In addition to these administrative responsibilities, the chief administrator is charged with controlling cost, complying with a multitude of governmental regulations, and ensuring that the hospital conforms to professional norms, which include guidelines for the care and safety of patients.

Clinical Engineering Program

In many hospitals, administrators have established clinical engineering departments to manage effectively all the technological resources, especially those relating to medical equipment, that are necessary for providing patient care. The primary objective of these departments is to provide a broad-based engineering program that addresses all aspects of medical instrumentation and systems support.

Figure 1.5 illustrates the organizational chart of the medical support services division of a typical major medical facility. Note that within this organizational structure, the director of clinical engineering reports directly to the vice-president of medical support services. This administrative relationship is extremely important since it recognizes the important role clinical engineering departments play in delivering quality care. It should be noted, however, that in the more common organizational structure, clinical engineering services fall under the category of facilities,― materials management,― or even just support services.

Figure 1.5 Organizational chart of medical support services division for a typical, major medical facility. This organizational structure points out the critical interrelationship between the clinical engineering department and the other primary services provided by the medical facility.

In practice, there is an alternative capacity in which clinical engineers can function. They can work directly with clinical departments, thereby bypassing much of the hospital hierarchy. In this situation, clinical departments can offer the clinical engineer both the chance for intense specialization and, at the same time, the opportunity to develop a personal relationship with specific clinicians based on mutual concerns and interests (Wald, 1989).

Establishment of a Clinical Engineering Department

The establishment of a clinical engineering department requires the following three major administrative steps. First, the hospital administration appoints a qualified individual as director. Directors of clinical engineering usually function at the department-head level in the organizational structure of the institution and are provided with sufficient authority and resources to perform their duties efficiently and in accordance with professional norms. According to the World Health Organization (WHO)(Issakov et al., 1990), the job title for clinical engineering director is as follows.

General Statement

The clinical engineering director, by his or her education and experience, acts as a manager and technical director of the clinical engineering department. The individual designs or directs the design of equipment modifications that may correct design deficiencies or enhance the clinical performance of medical equipment. The individual may also supervise the implementation of those design modifications. The education and experience that the director possesses enables him or her to analyze complex medical or laboratory equipment for purposes of defining corrective maintenance and developing appropriate preventive maintenance or performance assurance protocols. The clinical engineering director works with nursing and medical staff to analyze new medical equipment needs and participates in both the prepurchase planning process and the incoming acceptance testing process. This individual also participates in the equipment management process through involvement in the system development, implementation, maintenance and modification processes.

Duties and Responsibilities

The director of clinical engineering has a wide range of duties and responsibilities. For example, this individual:

• Works with medical and nursing staff in the development of technical and performance specifications for equipment required in the medical mission.

• Once equipment is specified and the purchase order developed, generates appropriate testing of the new equipment.

• Does complete performance analysis on complex medical or laboratory equipment and summarizes results in brief concise, easy-to-understand terms for the purposes of recommending corrective action or for developing appropriate preventive maintenance and performance assurance protocols.

• Designs and implements modifications that permit enhanced operational capability. May supervise the maintenance or modification as it is performed by others.

• Must know the relevant codes and standards related to the hospital environment and the performance assurance activities. (Examples in the U.S. are NFPA 99, UL 544, and JCAHO, and internationally, IEC-TC 62. See Chapter 5 for details of these codes and standards.)

• Is responsible for obtaining the engineering specifications (systems definitions) for systems that are considered unusual or one-of-a-kind and are not commercially available.

• Supervises in-service maintenance technicians as they work on codes and standards and on preventive maintenance, performance assurance, corrective maintenance, and modification of new and existing patient care and laboratory equipment.

• Supervises parts and supply purchase activities and develops program policies and procedures for same.

• Sets department goals, develops budgets and policy, prepares and analyzes management reports to monitor department activity, and manages and organizes the department to implement them.

• Teaches measurement, calibration, and standardization techniques that promote optimum performance.

• In equipment-related duties, works closely with maintenance and medical personnel. Communicates orally and in writing with medical, maintenance, and administrative professionals. Develops written procedures and recommendations for administrative and technical personnel.

Direction Received and Supervisory Responsibility

The director of clinical engineering functions with a minimum of supervision and often supervises or directs the work of biomedical equipment maintenance technicians and clinical engineers with less seniority.

Working Conditions

The work site is within the hospital and includes patient areas where the employee may be exposed to sick patients and to research projects.

Minimum Qualifications

A bachelor’s degree (four years) in an electrical or electronics program or the equivalent is required (preferably with a clinical or biomedical adjunct). A Master’s degree is desirable. A minimum of three years experience as a clinical engineer and two years in a progressively responsible supervisory capacity is needed. Additional qualifications are as follows:

• Must have some business knowledge and management skills that enable him or her to participate in budgeting, cost accounting, personnel management, behavioral counseling, job description development, and interviewing for hiring or firing purposes. Knowledge and experience in the use of microcomputers is desirable.

• Must be able to use conventional electronic trouble-shooting instruments such as multimeters, function generators, oscillators, and oscilloscopes. Should be able to use conventional machine shop equipment such as drill presses, grinders, belt sanders, shears, brakes, and standard hand tools.

• Must possess or be able to acquire a knowledge of the techniques, theories, and characteristics of materials, drafting and fabrication techniques in conjunction with chemistry, anatomy, physiology, optics, mechanics, and hospital procedures.

• Clinical engineering certification or professional engineering registration are required.

In the second step in the establishment of a clinical engineering department, the hospital administration, in conjunction with the director of clinical engineering, prepares a mission statement which defines the dimension and scope of responsibility of the clinical engineering department. The mission statement and list of objectives must conform to the overall strategic plan of the hospital. For example, consider the following (Simmons and Wear, 1988).

Mission Statement

It is the policy of the hospital clinical engineering department to provide technical and management professional clinical engineering support to hospital administration, hospital engineering department, medical, surgical, nursing, and other allied health professional departments, and staff medical professionals. The clinical engineering department will perform a primary role in the assurance of compliance to relevant laws, statutes, regulations, and standards by the establishment and implementation of effective instrumentation control programs. These programs will ensure the efficacious and safe use of medical instrumentation for the benefit of the patients and hospital employees alike. It is the policy of the clinical engineering department to augment this program by the continued development and presentation of educational materials through the use of in-service education and training sessions for clinical personnel.

Objective 1. To define, develop, and implement the hospital clinical engineering program which will provide scientific, technical, and management support to hospital administration, clinical departments, and medical staff.

Objective 2. To develop and issue all necessary programs, technical procedures, and documentation with the concurrence of appropriate personnel.

Objective 3. To determine and provide those professional scientific and technical consultation services that will be provided by the hospital clinical engineering department to the clinical and medical staffs.

Objective 4. To define program education and training needs for clinical department employees, medical staff, and clinical engineering personnel.

Objective 5. To establish communication methods for status reporting of program implementation both in management and in technical areas.

Objective 6. To optimize program costs in such a way so as to provide maximum improvement in patient care as a result of this program while attempting to minimize costs. No compromise will be made in the area of employee safety, as required by applicable laws, codes, and standards.

Finally, the clinical engineering department determines and requests adequate work space, personnel, test equipment, and supplies to accomplish its specified objectives in compliance with established codes and standards. A detailed discussion on how a clinical engineering department may be established is provided in Chapter 8.

Major Functions of a Clinical Engineering Department

The role of the clinical engineer in today’s hospital can be both challenging and gratifying because the care of patients requires a partnership between medical staff and modern technology. As previously discussed, this interchange has led to a close working relationship between the clinical engineer and many members of the medical and hospital staff. The team approach is key to the successful operation of any clinical engineering program. Figure 1.6 illustrates the degree of teamwork and interdependence required to maintain constructive interrelationships. In this matrix presentation, it is important to note that the health-care team approach to the delivery of patient care creates both vertical and lateral reporting relationships. Although clinical engineers report hierarchically to their hospital administrator, they also interact with hospital staff to meet patient requirements.

Figure 1.6 Matrix diagram illustrating the bi-directional interdependence and degree of teamwork required to maintain effective interaction between the members of the health-care delivery team.

As a result of the wide-ranging scope of interrelationships within the medical setting, the duties and responsibilities of clinical engineering directors are extremely diversified. Yet, a common thread is provided by the very nature of the technology they manage. Directors of clinical engineering departments are usually involved in the following areas:

• Developing, implementing, and directing equipment management programs. Specific tasks include evaluating and selecting new technology, accepting and installing new equipment, and managing the inventory of medical instrumentation, all in keeping with the responsibilities and duties defined by the administrator. The director advises the administrator of the budgetary, personnel, space, and test equipment requirements necessary to support this equipment management program.

• Advising administration and medical and nursing staffs in areas such as safety, the purchase of new medical instrumentation and equipment, and the design of new clinical facilities.

• Evaluating and taking appropriate action on incidents attributed to equipment malfunction or misuse. The director summarizes the technological significance of each incident and document the findings of the investigation. He or she submits a report to the appropriate hospital authority and, according to the Safe Medical Devices Act of 1990, to the device manufacturer, the Food and Drug Administration (FDA) or both.

• Selecting departmental staff and training them to perform their functions in a professional manner.

• Establishing departmental priorities, developing and enforcing departmental policies and procedures, and supervising and directing departmental activities. The director takes an active role in leading the department to achieve its overall technical goals.

The core functions of clinical engineers are as follows:

1. Technology management.

2. Risk management.

3. Technology assessment.

4. Facilities design and project management.

5. Quality assurance.

6. Training.

PROFESSIONAL STATUS OF CLINICAL ENGINEERING

Upon careful review of our definition of clinical engineering and the responsibilities and functions that clinical engineers assume within the hospital, it is clear that the term clinical engineer must be associated with individuals who can provide engineering services, not simply technical services. Clinical engineers, therefore, must be individuals who have a minimum of a four-year bachelor’s degree in an engineering discipline. They must be well versed in the design, modification, and testing of medical instrumentation, skills that fall predominantly in the field of engineering practice. Only with an engineering background can clinical engineers assume their proper role working with other health professionals to use available technological resources effectively and to improve health-care delivery.

By clearly linking clinical engineering to the engineering profession, a number of important objectives are achieved. First, it enables hospital administrators to identify qualified individuals to serve as clinical engineers within their institutions and to understand better the wide range of functions that clinical engineers can perform, while making it clear that this role cannot be assumed by technicians. Second, from this foundation it is possible for the profession of clinical engineering to mature. It has been pointed out that professional activities exist if "a cluster of roles in which the incumbents perform certain functions valued in the society in general― can be identified (Parsons, 1954; Courter, 1980; Goodman, 1989). Clearly, this goal has been achieved for the clinical engineer.

Professionals have been defined as an aggregate of people finding identity in sharing values and skills absorbed during a common course of intensive training. Parsons (1954) stated that one determines whether or not individuals are professionals by examining whether or not they have internalized certain given professional values. Friedson (1971) redefined Parsons’s definition by noting that a professional is someone who has internalized professional values and is to be recruited and licensed on the basis of his or her technical competence. Furthermore, he pointed out that professionals generally accept scientific standards in their work, restrict their work activities to areas in which they are technically competent, avoid emotional involvement, cultivate objectivity in their work, and put their clients’ interests before their