PREFACE

During the late twentieth century, technological innovation has progressed at such a
rapid pace that it has permeated almost every facet of our lives. This is especially true in
the field of medicine and the delivery of health-care services. Although the art of medicine
has a long history, the evolution of a health-care system capable of providing a wide range
of positive therapeutic treatments in the prevention and cure of illness is a decidedly new
phenomenon. Of particular importance in this evolutionary process has been the
establishment of the modern hospital as the center of a technologically sophisticated health-
care delivery system. From within the framework of this evolutionary process, the discipline
of clinical engineering has emerged to assist health-care professionals in the effective
utilization and management of the vast array of medical devices and technologies presently
available. We define clinical engineering as that subspecialty of biomédical engineering
that is devoted to the application of engineering methods and technologies in the delivery of
health-care. As a result, today's clinical engineers are responsible for the management of the
high-technology devices and systems used in modern hospitals, for the training of medical
personnel in the safe use of medical devices and equipment, and for the design, selection,
use, and maintenance of these devices for the safe and effective delivery of health-care
services.
Over the past two decades, many hospitals have established centralized
clinical/biomedical engineering departments to meet these responsibilities. In the process,
clinical engineers are called upon to provide the hospital administration with objective and
informed opinions regarding the assessment, acquisition, and utilization of medical
technologies. Consequently, today's clinical engineer plays an increasingly integral role in
the development and operation of a wide range of hospital programs, including quality
assurance, risk management, and strategic planning.
The purpose of this text is to introduce and examine the functions and activities of
clinical engineering within the medical environment of the modern hospital. The text is
intended for use by senior or graduate level students in engineering, and others in the health-
care community (administrators, clinicians, nurses, etc.) who are interested in technology
management in the modern health-care system. With this in mind, the text has been
organized to address those topics that will provide insight into the role that clinical engineers
play in the management of medical technology.
Chapter 1 begins with a historical perspective of the evolution of clinical engineering
as a specialized discipline, defines the job functions associated with this field, and reviews
the professionalization of clinical engineering within the evolving health-care system.
Chapter 2 discusses safety in the clinical environment. In the process, the role of
the clinical engineer in establishing and organizing electrical and medical device safety
programs is presented. Because clinical engineers are concerned with more than electrical
safety issues, an examination of radiation, laser, and infection control is also included.
One of the primary functions of clinical engineers is technology management.
Chapter 3 discusses this function in detail, highlighting the various types of equipment repair
and maintenance services and the calculation of costs associated with these services.
Technology assessment and acquisition are increasingly becoming functions of the
clinical engineer. Chapter 4 examines methods and rationale for the assessment of medical
technologies and provides detailed procedures for the establishment and operation of
programs for acquisition, distribution, and utilization of technologies in the health-care
environment.
 Chapter 5 covers a traditional, but important topic for clinical engineers—Codes and
Standards—and highlights the role of the federal government in regulating the development
and use of medical devices. Included are discussions of the Safe Medical Devices Act of
1990, and the presentation of particular codes and standards such as NFPA 70: The National
Electrical Code; NFPA 99: Standards for Health-care Institutions; NFPA 101 : The Life Safety
Code. Also discussed are the Joint Commission on Accreditation of Health Care
Organizations (JCAHO) requirements for the accreditation of hospitals.
In today's health-care environment, clinical engineers are often required to engage
in activities that closely involve facilities management (FM) and design. As a result,
Chapter 6 describes the fundamental operations of an FM department and presents, in some
detail, those activities that are of particular interest to the clinical engineer. The second
portion of this chapter presents concepts of particular significance to clinical engineers related
to facilities design, discussing issues of both new construction and renovation. Specific
examples include considerations for design of intensive care units, surgical suites, obstetrical
facilities, and imaging suites.
Clinical engineers are, by virtue of their profession, managers of both people and
machinery. Therefore, it is important that they be familiar with basic managerial concepts.
Chapter 7 presents a discussion of management concepts necessary to the operation of a
clinical engineering department. Significant emphasis is placed on the preparation of a
business plan for the clinical engineering department as a basis for organizing, leading, and
controlling the various aspects of departmental activities.
Chapter 8 illustrates how the basic principles developed in Chapter 7 can be applied
to develop effectively a clinical engineering program from the ground up. Processes related
to this development, such as how to conduct a review of existing equipment, how to
determine the services to be provided by the department, how to determine the resources
required to provide these services, and how to present these issues and requests to
administrators, are discussed in detail as are methods used to maintain continuous levels of
service on a day-to-day basis.
The computer revolution continues to have a significant impact on almost every facet
of human activity. Perhaps no single area illustrates the impact of computer technology
better than the health-care field. Chapter 9 reviews these computer applications of interest
to clinical engineers. Highlighted topics include computers in clinical laboratory applications,
computerized patient record systems, patient monitoring systems and diagnostic systems.
Examples of computer-dependent medical imaging systems (e.g., radiology; i.e., computed
tomography), ultrasound, and nuclear magnetic resonance are also presented. The use of
expert systems in clinical care, especially as adjuncts of clinical decision making is discussed.
Finally, the chapter reviews the use of clinical engineering management systems designed to
assist the clinical engineering department in the management of technical and personnel
resources, the scheduling and accounting of services rendered, and the documentation of
activities as required by federal and state regulations and accreditation agencies.
Clinical engineers must be aware of the moral and ethical issues that surround the
delivery of health-care in general, and the application of emerging medical technological
innovations in particular. Chapter 10 addresses these concerns, in terms both of the
individual and society at large, and reviews basic ethical theory. This review is followed by
a discussion of specific issues of importance to clinical engineers, including the definition of
death, concepts of euthanasia, research and experimental applications of technology, and
medical device use and regulation. Issues related to the allocation of medical care services
and technology are also discussed with reference to the future directions of health-care
delivery.
 Because health is a central concern of all human beings, health-care delivery and the
organization, management, and maintenance of systems required for that delivery process are
activities that are carried out throughout the world. It seems appropriate, therefore, that this
text end with a consideration of clinical engineering department functions in countries other
than the United States. Thus, Chapter 11 presents the results of an international comparative
survey of clinical engineering programs and functions in the U.S., Canada, the Western
European Community, and the Nordic countries and discusses these results in terms of the
cultural ideals that drive particular aspects of the health-care delivery system within these
countries.