Clinical engineering is a speciality within HTM (Healthcare Technology Management) biomedical engineering 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, IT, etc.).[unreliable source?]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 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 close to the point-of-use, while also trained in product and process design. Clinical engineering departments at large hospitals will sometimes hire not just biomedical engineers, but also IT, industrial/systems engineers to help address operations research, human factors, cost analyses, safety, etc.
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 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. 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.
The general notion of the application of engineering to medicine can be traced back centuries; for example, Stephen Hales's work in the early 18th century which led to the invention of a ventilator and the discovery of blood pressure certainly involved the application of engineering techniques to medicine.
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.
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. Finally, in 1999, the 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.
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. By the time of the publication of the 2006-2007 AHTF Annual Report (c. June 30, 2007), a total of 147 individuals were included in the ranks of HTF certified clinical engineers.
New name for the profession
In 2011, AAMI arranged a meeting to discuss a new name for clinical engineering and/or biomedical equipment technology. After careful debate, the vast majority decided on "Healthcare Technology Management". Due partly to common confusion about the line between clinical engineers (engineers) and BMETs (technicians), the word engineering was deemed limiting from the administrator's perspective and unworkable from the educator's perspective. (An ABET-accredited college could not name an associate degree program "engineering".) Also, the adjective clinical limited the scope to hospitals. It remains unresolved how widely or officially accepted this change is or will be, and how this will affect Clinical Engineering Certification (CCE) or the formal recognition of clinical engineering as a subset of biomedical engineering. For regulatory and licensure reasons true engineering specialities must be definable in a way that distinguishes them from technicians with whom they work.
A clinical engineer is defined by the ACCE as "a professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology." 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. 
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 a subset of "biomedical engineer". Many times the terms are 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. The clinical engineers in some countries such as India are trained to innovate and find technological solutions for the clinical needs. 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 management of healthcare technology is becoming increasingly complex.
The University of Connecticut offers a two-year clinical engineering internship program where students work part-time as clinical engineers during the Fall and Spring semester at a hospital in New England. Clinical engineering classes are attended throughout the academic semesters in core and trending topics of the clinical engineering field.
The University of Toronto offers a two-year master of health sciences in clinical engineering program where students complete internships as clinical engineers in industry or at hospitals. In addition to internships, students are required to complete a research thesis. Clinical engineering classes are attended throughout the first year of the program in core and trending topics within the clinical engineering field.
To be eligible for certification in clinical engineering (CCE), a candidate must hold appropriate professional or educational credentials (an accredited engineering or 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 hours, and a separate oral exam. 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).
Clinical engineering in the UK
Clinical engineers in the UK typically work within the NHS. Clinical engineering is a modality of the clinical scientist profession, registered by the HCPC. The responsibilities of clinical engineers are varied, and can include providing specialist clinical services, inventing and developing medical devices, and medical device management. The roles typically involve both patient contact and academic research. Clinical engineering units within an NHS organisation are often part of a larger medical physics department. Clinical engineers, are supported and represented by the Institute of Physics and Engineering in Medicine (IPEM), within which the clinical engineering special interest group oversees the engineering activities. The three primary aims of Clinical Engineering with the NHS are:
- To ensure medical equipment in the clinical environment is available and appropriate to the needs of the clinical service.
- To ensure medical equipment functions effectively and safely.
- To ensure medical equipment and its management represents value for patient benefit:
Clinical engineering supports a broad range of healthcare activities, and therefore the specific person requirements for the role are equally varied. However clinical scientist must be able to work with patients, clinical staff and a range of other professionals, therefore being able to communicate often in complex situations appropriately is essential. As a scientist you will be required to keep up to date with advances in your area, and will often have the opportunity to communicate research and development to others. Clinical engineers will have a scientific first degree (often engineering or physics) before going on to train and register as a clinical scientist., and many also are educated to a doctoral level, either as part of their clinical engineering training, or prior to training.
Registration in the UK
Clinical engineers are registered as clinical scientists by the HCPC. Assessment of trainees prior to registration is provided by the Association of Clinical Scientists (ACS) and the Academy of Healthcare Science (AHCS). There are two programmes for attaining registration from the HCPC as a clinical scientist. The first is a Certificate of Attainment, awarded on successful completion of the NHS Scientist Training Programme (STP), and the second is through the Certificate of Equivalence, awarded on successful demonstration of equivalence to the STP. This second route is normally chosen by individuals that have significant scientific experience prior to seeking registration. In March 2017 IPEM published a policy document stating their position on the routes of entry to clinical scientist registration.
Clinical engineering in India
Healthcare has increasingly become technology driven and requires trained manpower to keep pace with the growing demand for professionals in the field. An M-Tech Clinical Engineering course was initiated by Indian Institute of Technology Madras (IITM), Sree Chitra Thirunal Institute of Medical Sciences and Technology, Trivandrum and Christian Medical College, Vellore (CMC), to address the country's need of human resource development. This was aimed at indigenous biomedical device development as well as technology management, and thereby contribute to the overall development of healthcare delivery in the country.
During the course, students of engineering are given an insight into biology, medicine, relevant electronic background, clinical practices, device development and even management aspects. Additionally, students are paired with clinical doctors from CMC and SCTIMST to get hands-on experience during internships. An important aspect of this training is simultaneous, long term and detailed exposure to clinical environment as well as to medical device development activity. This is aimed at making students understand the process of identifying unmet clinical needs and thus, contributing to the development of new medical devices in the country. A unique feature of the course is clinical attachment which exposes the students to the clinical environment. The program also trains engineers to manage and ensure safe and effective use of technology in health care delivery points.
The minimum qualification for joining this course is a bachelor's degree in any discipline of engineering except civil engineering and a valid GATE score in that field.
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- Zambuto RP, Clinical Engineers in the 21st Century, IEEE Engineering in Medicine and Biology Magazine, May/June 2005, 37-41
- Cartwright FF, A Short History of Blood Pressure Measurement, Proceedings of the Royal Society of Medicine, Volume 70, November 1977, 793-799
- Shaffer MJ, Clinical Engineering: An In-Depth Review of Its Economic Potential, Medical Care, July 1977, Vol. XV, No. 7, 552-567
- Shaffer MJ, Clinical Engineer Cost-Effectiveness Measurements in the USA, Medical and Biological Engineering & Computing, November 1985, 505-510
- Minutes and Report of USCC Task Force on Certification Clinical Engineering Conference Call December 2, 1999 Archived July 10, 2007, at the Wayback Machine
- "ACCE Healthcare Technology Foundation 2004/2005 Progress Report" (PDF).
- "ACCE Healthcare Technology Foundation 2006/2007 Progress Report" (PDF).
- According to The American College of Clinical Engineering.
- "About BME". 10 March 2009.
- BMES - Biomedical Engineering Society Archived 2007-09-08 at the Wayback Machine
- The driving factors and opportunities presented are examined in The Future of Clinical Engineering, published in the IEEE EMBS magazine in 2003.
- "MHSc in Clinical Engineering - IBBME, University of Toronto".
- 2014 Candidate Handbook, American College of Clinical Engineering, 5/15/2014, p.4. "Archived copy" (PDF). Archived from the original (PDF) on 2014-11-29. Retrieved 2014-11-17.CS1 maint: Archived copy as title (link)
- "ACCE-Healthcare Technology Foundation".
- Bronzino, Joseph D. (April 2006). The Biomedical Engineering Handbook, Third Edition. [CRC Press]. ISBN 978-0-8493-2124-5.
- Villafane, Carlos, CBET. (June 2009). Biomed: From the Student's Perspective, First Edition. [Techniciansfriend.com]. ISBN 978-1-61539-663-4.CS1 maint: Multiple names: authors list (link)
- Information related to biomedical engineering.
- Medical engineering stories in the news