Introduction to Clinical Engineering

Samantha Jacques,Barbara Christe

• Publisher: Academic Press
• Year: 2020
• ISBN:
  9780128181041
• Topic: Technology & Engineering
• Subtopic: Engineering General
• Index: Technology & Engineering

Introduction to Clinical Engineering focuses on the application of engineering practice within the healthcare delivery system, often defined as clinical engineering. Readers will explore the fundamental concepts integral to the support of healthcare technology to advance medical care. The primary mission of clinical engineers is the utilization of medical devices, software, and systems to deliver safe and effective patient care throughout technology's lifecycle. This unique and interdisciplinary workforce is part of the healthcare team and serves as the intersection between engineering and medicine.

This book is aimed at practitioners, managers, students, and educators to serve as a resource that offers a broad perspective of the applications of engineering principles, regulatory compliance, lifecycle planning, systems thinking, risk analysis, and resource management in healthcare. This book is an invaluable tool for healthcare technology management (HTM) professionals and can serve as a guide for students to explore the profession in depth.

• Offers readers an in-depth look into the support and implementation of existing medical technology used for patient care in a clinical setting
• Provides insights into the clinical engineering profession, focusing on engineering principles as applied to the US healthcare system
• Explores healthcare technology, hospital and systems safety, information technology and interoperability with medical devices, clinical facilities management, as well as human resource management

Chapter 1

The profession

Abstract

This chapter details information on what clinical engineering is, the roles and responsibilities of clinical engineers, and how clinical engineering differs from other subfields of biomedical engineering. A historical perspective of the field is provided, as well as a discussion of how the profession is integrated into the healthcare system. Academic pathways on how to enter the field, how to become certified and credentialed, and potential employers and career pathways for clinical engineers are discussed. Clinical engineering societies and collaborations and codes of ethics are also covered. Finally, future opportunities for the clinical engineering field are discussed.

Keywords

Clinical engineering; healthcare technology management (HTM) profession; academic pathways; career paths; code of ethics

Introduction

Healthcare delivery has evolved to depend on technology, both simple and highly complex. A diverse group of professionals supports clinicians in the utilization of devices, software, and systems to deliver patient care. Broadly, these efforts are labeled healthcare technology management (HTM), a discipline that interweaves patient safety, medical technology, and financial stewardship. These relationships and activities are illustrated in Fig. 1.1.

Figure 1.1 The healthcare technology management profession. AAMI, used with permission.

Clinical engineers, as part of HTM, are one of the many contributors to the delivery of safe and effective healthcare. Possessing a unique skill set, clinical engineers collaborate with clinicians of all types, technicians, facility managers, administrators, information technology (IT) support staff, risk managers, and administrators, unified in a mission to enhance healthcare.

What is clinical engineering?

The American College of Clinical Engineering (ACCE) defines a clinical engineer as follows:

A Clinical Engineer is a professional who supports and advances patient care by applying engineering and managerial skills to health care technology.

About ACCE: Clinical Engineer (n.d.)

The Clinical Engineering Handbook describes the practice of clinical engineering as the application of engineering principles, such as analysis and systems principles, to improve healthcare (Dyro, 2004), acknowledging the highly complex systems of the healthcare environment featuring patients, technology, facilities, and users. Clinical engineers possess diverse knowledge and, thus, can bridge multiple domains of the environment of healthcare with technology, facilitating communication and understanding. The evolving nature of healthcare and the tools associated with patient care also drives clinical engineering as a profession. As the definition of physician has adapted and changed over the history of healthcare, in a parallel way so too has the definition of clinical engineer.

The term clinical engineer is not universally utilized and may be used interchangeably in healthcare settings with the term biomedical engineer. The confusion is exacerbated by academic institutions in the United States that do not grant undergraduate clinical engineering degrees, which can be obtained in other countries. Academic degrees are generally in biomedical engineering (BME). Many hospitals and other healthcare institutions title the position as biomedical engineer, although the responsibilities more closely align with clinical engineering. In addition, many departments are named clinical engineering but employ those with BME position titles. The converse is also true; hospital departments named BME also employ workers with a clinical engineering job title.

With this in mind, an exploration of the broad discipline of BME may be instructive. The Biomedical Engineering Society (BMES) offers a list of common focus areas of biomedical engineers:

1. 1. neural engineering;
2. 2. bionanotechnology;
3. 3. systems physiology;
4. 4. rehabilitation engineering;
5. 5. orthopedic bioengineering;
6. 6. medical imaging;
7. 7. clinical engineering;
8. 8. cellular, tissue, and genetic engineering;
9. 9. bionics;
10. 10. biomechanics;
11. 11. bioinstrumentation;
12. 12. biomechatronics; and
13. 13. biomedical electronics (FAQs about BME, n.d.).

The BME profession encompasses diverse specialties including artificial limbs and cellular-level research. The many applications of engineering principles associated with BME are far larger than the more narrowly defined area of clinical engineering. Thus, clinical engineering may be considered a focal area within the wide spectrum of the BME discipline.

The World Health Organization (WHO) also utilizes the term biomedical engineer as a broad label for a diverse profession. In their 2017 publication, the group noted the variations on the term:

“Biomedical engineering” includes equivalent or similar disciplines, whose names might be different, such as medical engineering, electromedicine, bioengineering, medical and biological engineering and clinical engineering.

World Health Organization (2017)

Complicating professional labels is a common job title within the clinical environment: biomedical engineer, often a position name provided to technicians and technologists who support devices and medical equipment. These technicians generally focus on the applications of technologies, while utilizing hands-on experience and providing services such as repair, performance assurance testing, and preventive maintenance. Academic preparation varies, but many technicians in these roles have earned an associate’s degree in electronics or other closely related discipline. The relationship among the technician, engineer, and leadership, as characterized by the professional society, the Association for the Advancement of Medical Instrumentation (AAMI), is shown in Fig. 1.2.

Figure 1.2 HTM career ladder.

Historical perspective

In the late 1960s, the profession of clinical engineering emerged as a BME specialty focused on broad issues in medical technology implementation beyond device maintenance and repair. Hospital safety awareness dramatically surged with the publication of an article written by Ralph Nader in Ladies Home Journal in March 1971. Nader claimed that there were a large number of hospital electrocutions each year. Also during this period, the community hospital system was expanding, and technology was increasingly utilized to monitor and image patients electronically. As a result of these converging events, several organizations such as the National Fire Protection Association (NFPA) and the American Hospital Association (AHA) sought to establish guidelines and regulations to promote patient safety. In 1973, AAMI developed a certification program for clinical engineers to supplement the biomedical equipment technician certification that has been available since 1970.

Hospital equipment inventories dramatically increased in the 1980s and coincided with a societal desire to decrease the cost of healthcare. This drove an expansion of hospital-based support staff for technical services as well as a desire for technology planning and broader thinking beyond “break-fix” technology maintenance. Regulations associated with medical devices dramatically expanded with the creation of healthcare facilities code NFPA 99 in 1984, a tool that sought to establish criteria based on risk to patients, staff, or visitors in healthcare facilities to minimize the harm caused by fire, explosion, and electrical hazards. As a result, clinical engineers moved into the realm of regulatory compliance and safety advocacy.

The Safe Medical Devices Act, which requires hospitals to identify and report serious problems with medical devices, was passed in 1990. The hiring of engineers to support medical technology expanded at that time. Driving this shift was the Veterans Administration (VA) hospital system that divided the country into BME districts and hired biomedical engineers with academic degrees in engineering to oversee engineering activities.

Throughout the early 2000s, leaders in the clinical engineering profession including Joseph Bronzino, Joseph Dyro, Malcolm Ridgway, Yadin David, and many others sought to differentiate clinical engineering as an engineering discipline with an engineering scope of practice, promoting attainment of baccalaureate and master’s level engineering degrees. Efforts included expansion of academic programs, improved professional publications in the discipline, and public advocacy. This drive sought to improve professionalization and status within society in general and the clinical environment in particular, defining educational requirements and differentiating the hospital technician from the engineer. Expansion of hospital roles in facilities management also occurred during this time.

A 2005 joint report from the National Acade...