Clinical Engineering

Clinical Engineering

Joseph F. Dyro
DOI: 10.4018/978-1-4666-0122-2.ch012
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Clinical engineering supports and advances patient care by applying engineering and managerial skills to healthcare technology. Since the 1970s, as medical device technologies have proliferated, increasingly impacting the cost and quality of healthcare, the clinical engineering profession has matured to play a significant role in healthcare technology management. It increases the cost-effectiveness, safety, and optimal utilization of medical devices. This chapter provides a comprehensive overview of the clinical engineer’s body of knowledge. It is addressed to international clinical engineering researchers, faculty, and students, as well as clinical engineering practitioners, medical device technology managers, hospital administrators, clinical and technology support personnel, regulators, and manufacturers. The chapter provides a solid foundation upon which healthcare systems can utilize methods for managing the ever-increasing number and complexity of medical device technologies and systems.
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12.2. Introduction

Clinical engineering emerged from the realization that engineering attributes, i.e., analysis and synthesis, are relevant and necessary to improve health care (Caceres, 1977). Some engineering aspects of the profession eroded over the years as hospital administrators and engineers themselves viewed the primary clinical engineering activity as medical device inspection, maintenance, and repair. Fortunately, the original concept of clinical engineering has reemerged, largely in response to the driving forces of cost-control, utilization optimization, regulatory requirements, patient safety and human error awareness, and increasing complexity of the technological environment. For example, among the forces of change were the revelations of inadequacies in the so-called healthcare delivery system (Kohn et al., 2000). Systemic ailments in this system cry out for reengineering. No longer can clinical engineering be content with following routine maintenance and repair procedures when the need is so great for making engineering changes in the healthcare arena; changes that will support and advance patient care.

The value of clinical engineering to the healthcare community is clearly recognized and enthusiastically embraced. The enormous potential of highly competent, well-educated, talented, and skilled clinical engineers is now tapped for inventions, technical development, and systems analysis. Clinical support, engineering at the bedside, healthcare delivery process improvement, enhanced technology utilization and patient care, and device design are at the core of the clinical engineering discipline. The listing of the many facets of the discipline of Clinical Engineering is shown in Figure 1.

Figure 1.

The discipline of clinical engineering


Key Terms in this Chapter

FDA: United States Food and Drug Administration Center for Devices and Radiological Health charged under Federal statute to regulate the medical device industry.

Healthcare Technology Management: The systematic process in which clinical engineers plan for and manage health technology assets to achieve the highest quality care at the best cost.

Clinical engineer: A professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology.

ACEW: Advanced Clinical Engineering Workshops presented around the globe by ACCE in collaboration with affiliated healthcare organizations.

Product Life Cycle: The introduction, growth, maturation, and decline of a medical device over time.

Maude: Manufacturer and User Device Experience database maintained by the FDA contains manufacturer and user reports of adverse incidents associated with medical devices.

Accident Investigation: Methodology of determining the cause of medical device related incidents and accidents.

ISO: Independent Service Organization offers clinical engineering and medical device management services to hospitals.

Medical Device Life Cycle: The stages of a medical device at a hospital from the initial planning, through acceptance and utilization, and finally to disposal.

Interoperability: Interoperability of medical devices and systems allowing them to communicate with each other with minimal effort in addition to sending their data to the electronic health record.

ACCE: American College of Clinical Engineering is the world’s leading organization committed to enhancing the profession of clinical engineering. Based in the United States, it is international in scope.

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