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Clinical engineering is responsible primarily for applying and implementing medical technology to optimize healthcare delivery. Roles of clinical engineers include training and supervising Biomedical Equipment Technicians(BMETs), working with governmental regulators on hospital inspections/audits, and serving as technological consultants for other hospital staff (i.e. physicians, administrators, I.T., etc.). Clinical engineers also advise medical device producers regarding prospective design improvements based on clinical experiences, as well as monitor the progression of the state-of-the-art in order to redirect hospital procurement patterns accordingly.

Their inherent focus on practical implementation of technology has tended to keep them oriented more towards incremental-level redesigns and reconfigurations, as opposed to "revolutionary" R&D or cutting-edge ideas that would be many years from clinical adoptability; however, there is nonetheless an effort to expand this time-horizon over which clinical engineers can influence the trajectory of biomedical innovation. In their various roles, they form a sort of "bridge" between product originators and end-users, by combining the perspectives of being both 1) close to the point-of-use ("front lines"), while also 2) trained in product and process design. Clinical Engineering departments at large hospitals will sometimes hire not just biomedical engineers, but also industrial/systems engineers to help address operations research, human factors, cost analyses, safety, etc.


History[]

While some trace its roots back to the 1940s, the actual term "clinical engineering" was first used in 1969. The first explicit published reference to the term "clinical engineering" appears in a paper published in 1969 by Landoll and Caceres[1]. Cesar A. Caceres, a cardiologist, is generally credited with coining the term "clinical engineering." Of course, the broader field of "biomedical engineering" has a relatively recent history as well. The first modern professional intersociety engineering meeting to be focused on the application of engineering in medicine was probably held in 1948, according to the Alliance for Engineering in Medicine and Biology[2]

The general notion of the application of engineering to medicine can be traced back 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 [3].

The recent history of this sub-discipline is somewhat erratic. In the early 1970s, clinical engineering was thought to be a field that would require many new professionals. 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.[4]. However, even then, 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. Nonetheless, some large hospitals do hire several clinical engineers, and some academic programs do concentrate in it.

The history of its formal credentialization and accreditation procedures has also been somewhat unstable. 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[5]. 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[6].

The new, current Clinical Engineering Certification (CCE) program was started in 2002 under the sponsorship of the American College of Clinical Engineering (ACCE), and is 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 the new certification.[7] 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[8].

The Definition[]

A Clinical engineer is defined by ACCE as "a professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology."[9] This definition was first adopted by the ACCE Board of Directors on May 13, 1991. Clinical Engineering is also recognized by the Biomedical Engineering Society (BMES), the major professional organization for biomedical engineering, as being a branch within Biomedical Engineering. [1]

There are at least two issues with the ACCE definition that cause some confusion. First, it is phrased so broadly that it's not readily evident that "clinical engineer" is but one subset of "biomedical engineer." Many times the terms actually get used interchangeably: some hospitals refer to their relevant departments as "Clinical Engineering" departments, while others call them "Biomedical Engineering" departments. Indeed, as noted above, the technicians are almost universally referred to as "biomedical equipment technicians," regardless of the name of the department that they might work under. However, the term "biomedical engineer" is generally thought to be more all-encompassing, including engineers who work in the primary design of medical devices for manufacturers, or in original R&D, or in academia -- whereas clinical engineers generally work in hospitals solving problems that are very close to where equipment is actually used in a patient care setting[10]. The other issue not evident from the ACCE definition is the appropriate educational background for a clinical engineer. Generally, the expectation of the certification program is that an applicant for certification as a clinical engineer will hold an accredited bachelor's degree in engineering (or at least engineering technology).

The Future[]

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

Eligibility Requirements[]

To be eligible for certification in clinical engineering (CCE), a candidate must hold appropriate professional or educational credentials (an accredited engineering or possibly engineering-technology degree) have certain relevant experience, and pass an examination. The Examination for Certification in Clinical Engineering involves a written examination composed of a maximum of 150 multiple-choice objective questions with a testing time of three (3) hours, and a separate oral exam. [11]. Particular weight is given to applicants for CE certification (CCE) who are already licensed as registered Professional Engineers (PE) -- which itself has extensive requirements (including an accredited engineering degree and engineering experience).

Some industry associations include:

References[]

  1. Landoll JR and Caceres CA, Automation of Data Acquisition in Patient Testing, Proceedings of the IEEE, Vol. 57, No. 11, November 1969, 1941-1953
  2. Zambuto RP, Clinical Engineers in the 21st Century, IEEE Engineering in Medicine and Biology Magazine, May/June 2004, 37-41
  3. Cartwright FF, A Short History of Blood Pressure Measurement, Proceedings of the Royal Society of Medicine, Volume 70, November 1977, 793-799
  4. Shaffer MJ, Clinical Engineering: An In-Depth Review of Its Economic Potential, Medical Care, July 1977, Vol. XV, No. 7, 552-567
  5. Shaffer MJ, Clinical Engineer Cost-Effectiveness Measurements in the USA, Medical and Biological Engineering & Computing, November 1985, 505-510
  6. Minutes and Report of USCC Task Force on Certification Clinical Engineering Conference Call December 2, 1999
  7. ACCE Healthcare Technology Foundation 2004/2005 Progress Report
  8. ACCE Healthcare Technology Foundation 2006/2007 Progress Report
  9. According to The American College of Clincal Engineering.
  10. BMES - Biomedical Engineering Society
  11. ACCE-Healthcare Technology Foundation

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