Clinical Engineering
Clinical Engineering is a specialized field within biomedical engineering that focuses on integrating engineering principles with healthcare technology to enhance patient care. Practitioners, known as clinical engineers, play a crucial role in bridging the gap between advanced medical technology and clinical applications. Their primary responsibilities include monitoring the interaction between medical equipment and patients, training technicians, and troubleshooting to improve the efficiency and comfort of medical devices used in patient care.
Clinical engineers often engage in evaluating, installing, testing, and maintaining medical equipment, ensuring that it meets safety standards and provides optimal functionality. They also work closely with medical device manufacturers to suggest improvements, emphasizing redesign over new design to enhance patient outcomes. The profession has a rich history, evolving from early collaborations between medicine and engineering, and has gained formal recognition and certification processes over the years.
As healthcare technology continues to advance, the demand for clinical engineers is expected to grow, particularly as they help navigate the complexities of modern medical devices and systems. Their expertise is vital in the overarching goal of improving patient safety, quality of care, and efficiency in healthcare delivery.
Clinical Engineering
Summary
Clinical engineering is one of many subfields of biomedical engineering. In this subspecialty, practitioners support, monitor, and advance patient care by applying engineering and managerial skills to healthcare technology and delivery. A clinical engineer can function as a bridge between modern medicine and modern technology, interpreting and implementing sophisticated technology and complicated equipment to improve and enhance patient care and the delivery thereof. Possibly the most important characteristic of a clinical engineer is the ability to identify and solve problems, translating solutions into usable clinical care to improve patient outcomes.
Definition and Basic Principles
Clinical engineering is a field involving many aspects of biomedical engineering. It is a combination of technology and medicine that focuses on the practical side of implementing sophisticated medical technology in the clinical care of patients. A clinical engineer's job involves monitoring the interaction of humans and medical equipment to ensure that the machines or equipment provide service to the patient most comfortably or efficiently.
![US Navy Hospital Corpsman Wade Henry gives a passdown to the night shift in the Intensive Care Unit (ICU) aboard USNS Comfort (T-AH 20). Clinical engineers must understand all modern medical technologies and be able to train, troubleshoot, and design while managing clinical settings. By US Navy photo by Photographer's Mate 1st Class Shane T. McCoy. [Public domain], via Wikimedia Commons 89250394-78352.jpg](https://imageserver.ebscohost.com/img/embimages/ers/sp/embedded/89250394-78352.jpg?ephost1=dGJyMNHX8kSepq84xNvgOLCmsE2epq5Srqa4SK6WxWXS)
As part of their job responsibilities, clinical engineers may train and supervise other equipment technicians who handle biomedical equipment in a hospital-type setting. In a manufacturing setting, a clinical engineer may advise manufacturers of medical devices on how to improve the design of the equipment to function better in a clinical situation. Clinical engineering tends toward redesign rather than new design because it focuses on improving patient care.
Clinical engineers can be confused with biomedical equipment technicians (BMETs). The basic difference between the two jobs is that BMETs are usually responsible for the service and repair of medical equipment when it fails to function properly. Clinical engineers may supervise and even perform these functions, depending on the size of the hospital where they work, but typically, they are more involved in developing equipment or suggesting changes to existing equipment to improve patient care and delivery of healthcare services.
Background and History
Medicine and engineering have been partners for many years, nearly from the beginning of both fields. In the modern age, this relationship possibly started in the early eighteenth century with the work of English physiologist Stephen Hales, who invented a type of ventilator and developed the first procedure for quantitatively measuring blood pressure, among other achievements.
The first official meeting focusing on the collaboration between medicine and engineering is thought to have been held in 1948 by the Alliance for Engineering in Medicine and Biology. The term clinical engineer was first used in 1969 in a paper published by cardiologist Cesar Caceres, who is generally credited with coining the term.
The first formal accreditation process for clinical engineers was started in the early 1970s by the Association for the Advancement of Medical Instrumentation (AAMI). This body formed the International Certification Commission (ICC) for Clinical Engineering and Biomedical Technology to provide an avenue for clinical engineers to be formally certified. Another body, the American Board of Clinical Engineering (ABCE), started a similar program based on academic institutions offering graduate degrees in clinical engineering. The ABCE was dissolved in 1979, and those certified under its program were absorbed into the ICC. However, in the early 1980s, the ICC had certified only 350 clinical engineers, and in the late 1990s, it suspended its program.
In 2002, the American College of Clinical Engineering (ACCE) started a new clinical engineering certification program. This body awarded certification to several individuals previously certified under other programs and continued awarding certifications as the program grew in the following decades.
Clinical engineering as a subfield of bioengineering has a relatively rocky history. The delineation between the fields has always been hazy. Many of those who function as clinical engineers have a background in biomedical engineering or one of its subdisciplines.
The Healthcare Technology Foundation (HTF) offers an Excellence in Clinical Engineering Leadership Award (ExCEL), which identifies clinical engineering professionals demonstrating leadership in best practices in managing and advancing healthcare technology. The Journal of Clinical Engineering is an industry publication that provides articles about career development and innovations. Many journals cover the biomedical engineering field, including items of interest to clinical engineers.
How It Works
Clinical engineers focus on the interaction of medical technology and the human body. They may perform systems analysis to understand this interaction and suggest or implement changes to ensure the equipment provides the necessary service to each patient. For example, different types of equipment have certain sizes of tubing that enter a patient's body through various methods. A clinical engineer may examine how this tubing enters the body of a particular patient and suggest ways to incorporate larger or smaller tubing to ensure the device is functioning correctly and providing the patient with the best service.
Suppose the clinical engineer sees that a different type of delivery, such as different size tubing or any other equipment modification, makes a functional difference to many patients. In that case, they may be involved in decisions to modify equipment or suggest a different type of equipment or another manufacturer who would help consistently provide better patient outcomes.
A clinical engineer may also be involved in implants or prostheses and ensuring these devices are working correctly and providing the patient with the best possible outcome. They may suggest device modifications that may help the patient. Engineers may also be involved with manufacturers who make these types of equipment to help incorporate changes.
Applications and Products
Clinical engineers are necessary for safely operating diagnostic and therapeutic equipment necessary for optimal operation of healthcare facilities.
Evaluate. Clinical engineers evaluate equipment before it is purchased to ensure it meets current patient care and safety standards. They may recommend what equipment a healthcare system should purchase to provide patients with cutting-edge care. Some manage or coordinate service contracts or purchase negotiations and participate in strategic planning or systems analysis to ensure the recommended equipment is the best possible solution at the best price.
Install and Test. When new equipment is purchased, clinical engineers may be involved in the installation or in supervising the technicians who install the equipment. They ensure equipment meets the requirements of any regulatory agency and provide or supervise inspection, installation, and preventive or corrective maintenance.
Repair and Maintain. Clinical engineering departments oversee or coordinate maintenance and continued functionality of technological medical equipment. This extends beyond the mere functionality of the equipment itself and into the realm of ensuring that the equipment is functioning at the best level for patient care and comfort and suggesting any changes that would lead to improvement.
Improve. Clinical engineers are on the front lines of patient care and are charged with ensuring technological advances improve that care. As such, they may adjust equipment or suggest changes to device manufacturers to ensure the patient's needs are met. If incidents occur, clinical engineers investigate the cause and correct and improve the situation. They provide continuous quality assurance and control.
Careers and Course Work
A clinical engineer generally completes at least a bachelor's degree in engineering and then completes specific training related to clinical engineering. As an evolving field, few programs specifically relate to clinical engineering, so clinical engineers often have a background in biomedical engineering with further training in human-factors engineering or a similar field.
After completing coursework, clinical engineers often complete an internship in a teaching hospital that gives them a practical background in hospital functions. They may also become certified by the ACCE, which involves written and oral tests to demonstrate specific knowledge and a portfolio review to determine applicable experience.
A clinical engineer may then begin a career in any aspect of the medical field, including academia, design, or research, but usually, this type of engineer puts their skills to work in a practical clinical setting, where they assess, manage, and solve the problems that occur when complicated, technologically advanced medical equipment and the human body interact.
In a hospital, a clinical engineer may be the technological manager of medical equipment and related systems. This type of job requires knowledge of budget and finance, service agreements, data-processing systems, planning, assessing the effectiveness and efficacy of new equipment, quality control, incident investigation, training, and hospital operations in general. An executive-level job for a clinical engineer might be a chief technology officer position.
Another possible career for a clinical engineer is researching and developing new medical equipment. Clinical engineers may work in clinical trials developing new equipment to help evaluate and improve products or in medical equipment companies to develop and design equipment.
A clinical engineer may be asked to provide various consulting services, such as acting as an expert witness or serving on government commissions overseeing the rapidly changing world of medical technology.
Social Context and Future Prospects
When the term clinical engineering was coined in the late 1960s, many clinical engineers were predicted to be in demand in the coming years. However, fewer clinical engineering positions were created than expected. This lack of positions was partly due to confusion in the field and the role of clinical engineers in the medical system. The role of biomedical engineering and biomedical equipment technicians in medicine was particularly confused with clinical engineering.
As healthcare technology becomes more and more complex and complicated, a clinical engineer can act as a translator between information systems, medical equipment, and the patient. Clinical engineers bring creativity, curiosity, and analytical, communication, and problem-solving skills to the medical field. They may serve on healthcare-system-wide committees that relate to process and performance improvement, quality control and inspection, new technology purchases, and patient safety.
As evidence-based medicine becomes implemented into healthcare services, the convergence of information technology and medical technology becomes increasingly relevant to controlling healthcare costs and improving patient outcomes. Clinical engineers are perfectly positioned to bridge the gap between developing and implementing emerging technologies in the intricate web of interconnected machinery and equipment.
The American College of Clinical Engineering is a major professional organization that promotes clinical engineering as a career of the future. It has established a code of ethics, advanced workshops, and certification programs to pursue recognition of the field. This organization has committees and task forces to educate and improve the field of clinical engineering as it relates to different pressing issues such as quality control and medical errors. This committee and its members work internationally to improve knowledge of and education in this field.
At a 2011 AAMI-sponsored forum, a group of industry professionals voted to recommend that clinical engineering and biomedical equipment technology be united under a single field called healthcare technology management. In 2014, the AAMI recommended that during its planned revision of the Standard Occupational Classification (SOC) System for 2018, the US government add the category "Healthcare Technology Management—Engineers" under the "Architecture and Engineering Occupations" rubric. The category would include the job titles of clinical engineer and clinical systems engineer, neither of which had previously been listed by the SOC. Though the classification changed, certifications and roles in clinical engineering remained the same.
Bibliography
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Dyro, Joseph F. Clinical Engineering Handbook. Academic, 2004.
Enderle, John, and Joseph Bronzino, eds. Introduction to Biomedical Engineering. 3rd ed., Elsevier Academic Press, 2012.
Gallo, Jurex Cuenca. Handbook of Chemical and Biochemical Technologies. Arcler Press, 2019.
Jacques, Samantha, and Barbara Christe. Introduction to Clinical Engineering. Academic Press, 2020.
Joubert, Shayna. "How to Become a Field Clinical Engineer." Northeastern University, 19 Jan. 2023, graduate.northeastern.edu/resources/how-to-become-a-field-clinical-engineer. Accessed 15 May 2024.
"Life of a Biomedical Engineer." New Scientist Jobs, 16 Apr. 2019, jobs.newscientist.com/article/life-of-a-biomedical-engineer. Accessed 20 May 2024.
Miniati, Roberto, et al. Clinical Engineering: From Devices to Systems. Academic Press/Elsevier, 2016.
Saltzman, W. Mark. Biomedical Engineering: Bridging Medicine and Technology. Cambridge UP, 2009.
Stern, Gavin. "AAMI Urges Federal Recognition of Healthcare Technology Management, Clinical Engineers." Association for the Advancement of Medical Instrumentation, 22 July 2014, www.aami.org/detail-pages/press-release/aami-urges-federal-recognition-of-healthcare-technology-management-clinical-engineers. Accessed 15 May 2024.