Clinical engineering

Overview
Clinical engineering is a specialty responsible for applying engineering technology for the improvement and delivery of health services. While some trace its roots back to the 1940s, the term "clinical engineering" was first used in 1969. Over the years, the field has changed from an initial focus on research activities to its current emphasis on equipment maintenance activities. Attempts have been made to broaden the scope of clinical engineering activities to encompass activities such as pre-purchase equipment evaluation, incident investigation, equipment management, productivity, cost effectiveness, information systems integration, and patient safety activities; however, all of these have met with limited success.

History
Depending upon whom you are asking, the history of the application of engineering to medicine can be traced back decades or centuries. For example, Stephen Hales's work in the early 1700s which led to the invention of a ventilator and the discovery of blood pressure certainly involved the application of engineering techniques to medicine.

The first modern professional intersociety engineering meeting to be focused on the application of engineering in medicne was probably held in 1948, according to the Alliance for Engineering in Medicine and Biology

The first explicit published reference to the term "clinical engineering" appears in a paper published in 1969 by Landoll and Caceres. Cesar A. Caceres, a cardiologist, is generally credited with coining the term "clinical engineering."

In the early 1970s, clinical engineering was thought to be a field that would lead to a need for a substantial number of clinical engineers. Estimates for the US ranged as high as 5,000 to 8,000 clinical engineers, or five to ten clinical engineers for every 250,000 of population, or one clinical engineer per 250 hospital beds. . However, even then, according to this article, only 300 to 400 clinical engineers had found employment in hospitals. The following decades have shown no evidence of growth in the number of employed clinical engineers, and probable evidence of decline.

For example, the International Certification Commission for Clinical Engineers (ICC) was formed under the sponsorship of the Association for the Advancement of Medical Instrumentation (AAMI) in the early 1970s to provide a formal certification process for clinical engineers. A similar certification program was formed by academic institutions offering graduate degrees in clinical engineering as the American Board of Clinical Engineering (ABCE). In 1979, the ABCE agreed to dissolve, and those certified under its program were accepted into the ICC certification program. By 1985, only 350 clinical engineers had become certified. Finally, in 1999, AAMI after lengthy deliberation, and analysis of a 1998 survey demonstrating that there was not a viable market for its certification program decided to suspend that program, no longer accepting any new applicants as of July 1999.

A new clinical engineering certification program was started in 2002 under the sponsorship of the American College of Clinical Engineering (ACCE), and administered by the ACCE Healthcare Technology Foundation. In 2004, the first year that the certification process was actually underway, 112 individuals were granted certification based upon their previous ICC certification, and three individuals were awarded new certifications. By the time of the publication of the 2006-2007 AHTF Annual Report (approx. June 30, 2007), a total of 147 individuals were included in the ranks of HTF certified clinical engineers.

The Definition
A Clinical engineer is "a professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology." Cross-disciplinary activities are the norm, often involving physicians, nurses, medical technologists, information technology professionals, pharmacists, administrators, medical device manufacturer sales and engineering, and local and national regulatory authorities. Clinical engineers generally team with Biomedical Equipment Technicians (BMETs) to support and maintain the medical devices used at the point of delivery of care. This definition was first adopted by the ACCE Board of Directors on May 13, 1991.

There are at least two issues that this definition does not address that continue to cause some confusion. First, what is the difference between a "clinical engineer" and a "biomedical engineer?" Many times the terms are used interchangeably. Some hospitals refer to their medical equipment maintenance departments as a "clinical engineering department," while others call them a "biomedical engineering department." Indeed, as noted above, technicians are almost universally referred to as "biomedical equipment" technicians, regardless of the name of the department that they might work for. However, the term "biomedical engineer" is generally thought to be more all-encompassing, including engineers who work directly in the design of medical devices for manufacturers, while clinical engineers generally work in hospitals solving problems that are very close to where equipment is actually used in a patient care setting.

The second issue that is not addressed by this definition is the appropriate education background for a clinical engineer. Generally, the expectation of the certification programs is that an applicant for certification as a clinical engineer will hold a bachelor's degree in engineering, although there are some exceptions that will allow other individuals to qualify provided that they can demonstrate sufficient years of engineering practice. But, as a rule of thumb, it seems safe to say that the average clinical engineer will be trained as an engineer, and will hold the academic credentials to prove it.

The Future
The management of healthcare technology is becoming increasingly complex. The driving factors and opportunities presented are examined in The Future of Clinical Engineering, published in the IEEE EMBS magazine in 2003.