Clinical Engineering: A Detailed Educational Resource

clinical engineering, biomedical engineering, healthcare technology, medical devices, certification

Explore the field of clinical engineering, its history, key responsibilities, and certification processes. Learn about the role of clinical engineers in healthcare settings and the educational pathways to becoming a certified professional.

Read the original article here.

Introduction to Clinical Engineering

Clinical engineering is a specialized field within biomedical engineering that focuses on the practical application of medical technology in healthcare settings to improve patient care and optimize healthcare delivery.

Biomedical Engineering: A multidisciplinary field that applies engineering principles and design concepts to biology and medicine for healthcare purposes. This field combines engineering expertise with medical and biological sciences to improve healthcare diagnosis, monitoring, and therapy.

Clinical engineers act as vital intermediaries within the healthcare ecosystem. They bridge the gap between complex medical technology and the clinical needs of healthcare providers and patients. Their responsibilities are diverse and crucial for the smooth and efficient operation of modern healthcare facilities.

Key Responsibilities of Clinical Engineers:

• Supervision and Training of Biomedical Equipment Technicians (BMETs): Clinical engineers provide leadership and technical guidance to BMETs, who are essential for the day-to-day maintenance and repair of medical equipment.
• Regulatory Compliance: They work closely with governmental regulatory bodies to ensure hospitals meet safety and performance standards during inspections and audits related to medical devices.
• Technological Consultation: Clinical engineers serve as expert consultants for various hospital staff, including physicians, administrators, and IT professionals, providing insights into the selection, implementation, and management of medical technologies.
• Medical Equipment Design Improvement: They provide valuable feedback to medical device manufacturers, leveraging their hands-on experience to suggest improvements in the design and usability of medical equipment.
• Hospital Supply Chain Management: Clinical engineers contribute to maintaining efficient and state-of-the-art hospital supply chains for medical equipment, ensuring timely access to necessary technologies.

Clinical engineers possess a unique combination of skills, blending product design knowledge with practical, point-of-use experience. This dual perspective allows them to effectively translate technological advancements into tangible improvements in patient care. While they are often focused on incremental redesigns and practical solutions for immediate clinical needs, there is a growing recognition of the importance of their role in influencing the long-term trajectory of biomedical innovation.

In larger hospitals, clinical engineering departments may also incorporate professionals from other engineering disciplines, such as industrial and systems engineers. This interdisciplinary approach allows them to address broader aspects of healthcare technology management, including:

• Operations Research: Optimizing workflows and processes within the hospital environment to enhance efficiency and reduce costs.
• Human Factors Engineering: Ensuring medical devices and systems are user-friendly, safe, and effectively integrated into the clinical workflow, considering the human-machine interface.
• Cost Analysis: Evaluating the economic impact of medical technology investments, ensuring cost-effectiveness and value for money.
• Safety Engineering: Implementing and maintaining safety protocols and procedures related to medical equipment to minimize risks for patients and staff.

History of Clinical Engineering

The formal recognition of clinical engineering as a distinct specialty is relatively recent, although the application of engineering principles to medicine has a much longer history.

Origin of the Term

The term “clinical engineering” was first introduced in a 1969 paper by Landoll and Caceres. Dr. Cesar Caceres, a cardiologist, is widely acknowledged as the individual who coined the term. This marked a crucial step in formally defining this emerging field.

Broader Context of Biomedical Engineering

The broader field of biomedical engineering itself is also a relatively modern discipline. The first inter-society engineering meeting specifically focused on engineering in medicine is believed to have taken place around 1948. This event signifies the growing convergence of engineering and medicine in the mid-20th century.

Historical Roots of Engineering in Medicine

However, the fundamental concept of applying engineering principles to solve medical problems dates back centuries.

Example: Stephen Hales (Early 18th Century)

Stephen Hales (1677-1761): An English clergyman, physiologist, and inventor who made significant contributions to the fields of botany, physiology, and chemistry. He is best known for his pioneering work in plant physiology and his invention of the ventilator.

Stephen Hales’ work in the early 18th century provides a compelling early example. His research led to the invention of the ventilator, a device to assist breathing, and the discovery of blood pressure measurement. Hales employed engineering techniques and innovative apparatus to study physiological processes, demonstrating the power of engineering approaches in medical advancements.

Ventilator: A machine designed to mechanically assist or control breathing by delivering breathable air into and out of the lungs. It is a critical piece of medical equipment used in intensive care units and operating rooms.

Blood Pressure: The pressure of circulating blood against the walls of blood vessels. Measuring blood pressure is a fundamental diagnostic procedure in medicine.

Early Projections and Growth

In the early 1970s, there was a widespread belief that the field of clinical engineering would require a significant influx of new professionals. Estimates in the United States at the time projected a need for 5,000 to 8,000 clinical engineers, approximating to one clinical engineer for every 250 hospital beds. This demonstrates the early recognition of the critical role clinical engineers were expected to play in the expanding healthcare landscape.

Credentialization and Certification

The development of formal certification processes has been an important aspect of establishing clinical engineering as a recognized profession.

Early Certification Efforts

In the early 1970s, the International Certification Commission for Clinical Engineers (ICC) was established under the sponsorship of the Association for the Advancement of Medical Instrumentation (AAMI). The ICC aimed to create a standardized certification process for clinical engineers, ensuring a level of professional competency and recognition.

Association for the Advancement of Medical Instrumentation (AAMI): A non-profit organization dedicated to advancing the development, management, and use of safe and effective health technology. AAMI plays a crucial role in setting standards, providing education, and advocating for best practices in the medical device industry.

Concurrently, academic institutions offering graduate degrees in clinical engineering formed the American Board of Clinical Engineering (ABCE) to create a similar certification program. This dual approach reflected the field’s growth in both professional practice and academic recognition.

Consolidation and Transition

In 1979, the ABCE dissolved, and individuals certified under its program were integrated into the ICC certification program. This consolidation aimed to streamline the certification process and unify standards within the field. However, despite these efforts, by 1985, only around 350 clinical engineers had achieved certification, suggesting challenges in adoption or awareness of the certification process.

Discontinuation and Re-establishment of Certification

A 1998 survey indicated a lack of sufficient market demand for the ICC’s certification program. Consequently, AAMI ceased accepting new applicants in July 1999, marking a temporary halt to this particular certification pathway.

However, the need for professional certification remained. In 2002, a new certification program was launched under the sponsorship of the American College of Clinical Engineering (ACCE) and administered by the ACCE Healthcare Technology Foundation (AHTF). This new certification, known as the Certified Clinical Engineer (CCE), aimed to revitalize and update the certification process to better meet the evolving needs of the profession.

American College of Clinical Engineering (ACCE): A professional society dedicated to the advancement of clinical engineering and healthcare technology management. ACCE provides leadership, advocacy, and resources for clinical engineers.

In 2004, during the initial year of the new CCE program, 112 individuals were granted certification based on their previous ICC certification, ensuring continuity for those already certified. Additionally, three individuals achieved the new CCE certification. By June 30, 2007, as reported in the 2006-2007 AHTF Annual Report, 147 individuals had become HTF-certified clinical engineers, indicating a gradual growth in adoption of the new certification.

Definition and Terminology of Clinical Engineering

Defining clinical engineering precisely and differentiating it from related fields, particularly biomedical engineering, has been a subject of ongoing discussion and clarification.

ACCE Definition (1991)

In 1991, the ACCE provided a formal definition of a clinical engineer:

Clinical Engineer (ACCE, 1991): “A professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology.”

This definition highlights the core functions of clinical engineers: applying engineering expertise and management skills to optimize the use of healthcare technology for the benefit of patient care.

Relationship to Biomedical Engineering

Clinical engineering is widely recognized by the Biomedical Engineering Society (BMES), the leading professional organization for biomedical engineering, as a distinct branch within the broader field of biomedical engineering.

Biomedical Engineering Society (BMES): A professional society for biomedical engineers and bioengineers. BMES promotes knowledge sharing, education, career development, and ethical practice in biomedical engineering.

Despite this recognition, there are common points of confusion regarding the relationship between “clinical engineer” and “biomedical engineer.”

Points of Confusion:

1. Overlap in Terminology: Hospitals sometimes use “Clinical Engineering” departments and “Biomedical Engineering” departments interchangeably. Similarly, technicians in these departments are almost always referred to as “biomedical equipment technicians” (BMETs), regardless of the department’s name.
2. Scope of Practice: The term “biomedical engineer” is generally considered more encompassing, including engineers involved in designing medical devices for manufacturers or conducting research in academia. In contrast, clinical engineers primarily work within healthcare facilities, directly addressing technology-related challenges at the point of patient care. However, in some countries like India, clinical engineers are also trained to be innovators and develop technological solutions for specific clinical needs.

Educational Background

Another point of consideration is the appropriate educational background for clinical engineers. Certification programs typically require applicants to hold an accredited bachelor’s degree in engineering or, at minimum, engineering technology. This requirement underscores the engineering foundation essential for the profession.

Potential Name Change: Healthcare Technology Management

In 2011, AAMI convened a meeting to discuss a potential name change for clinical engineering. After extensive deliberation, the majority consensus favored “Healthcare Technology Management” as a more encompassing and descriptive term.

Reasons for Considering a Name Change:

• Confusion with BMETs: The term “engineering” in “clinical engineering” was seen as potentially contributing to confusion about the distinction between clinical engineers (engineers) and BMETs (technicians), particularly from an administrative perspective.
• Educational Limitations: From an educator’s standpoint, the term “engineering” posed challenges. ABET-accredited colleges (Accreditation Board for Engineering and Technology) could not use “engineering” in the name of an associate degree program, which is often the entry point for BMETs.
• Limited Scope of “Clinical”: The adjective “clinical” was perceived as limiting the scope of the field primarily to hospitals, when healthcare technology management extends beyond hospital settings to various healthcare environments.

ABET (Accreditation Board for Engineering and Technology): A non-profit, non-governmental accreditor of college and university programs in applied and natural science, computing, engineering, and engineering technology. ABET accreditation is widely recognized as a benchmark of quality in engineering and technology education.

Unresolved Issues:

The adoption of “Healthcare Technology Management” as a replacement for “Clinical Engineering” remains unresolved. It is unclear how widely this change will be accepted, its impact on the existing Clinical Engineering Certification, and its implications for the formal recognition of clinical engineering as a subset of biomedical engineering.

Furthermore, for regulatory and licensure purposes, it is essential to maintain a clear distinction between engineering specialties and the roles of technicians who work alongside them. This distinction is crucial for professional identity, scope of practice, and accountability.

Certification in Clinical Engineering

Certification in clinical engineering is overseen by the Board of Examiners for Clinical Engineering Certification. This certification process is designed to ensure that individuals practicing as clinical engineers meet established standards of competence and professionalism.

Eligibility Requirements for Certification:

• Educational Credentials: Candidates must possess appropriate qualifications, typically an accredited engineering or engineering technology degree at the bachelor’s level or higher.
• Relevant Experience: Applicants are required to demonstrate specific and relevant professional experience in clinical engineering practice.
• Examination: Candidates must successfully pass a comprehensive examination process.

Examination Process:

The certification examination consists of two parts:

1. Written Examination: A three-hour written exam composed of up to 150 multiple-choice questions covering the breadth of clinical engineering knowledge.
2. Oral Examination: A separate oral examination to further assess the candidate’s practical knowledge, problem-solving abilities, and professional judgment.

Recognition of Professional Engineering License:

Weight is given to applicants who are already licensed and registered Professional Engineers (PE). Obtaining a PE license itself involves rigorous requirements, including education, experience, and examinations, signifying a high level of professional competence and commitment.

Professional Engineer (PE): A licensed engineer who has met specific qualifications in education, experience, and examination, and is authorized to practice engineering professionally and take responsibility for engineering designs. The PE license is a legal requirement for practicing engineering in many jurisdictions.

Canadian Context:

In Canada, the term “engineer” is legally protected. Therefore, in Canada, registration as a Professional Engineer (P.Eng.) is a prerequisite for becoming a Certified Clinical Engineer. This legal framework reinforces the engineering foundation of the clinical engineering profession in Canada.

Clinical Engineering in the UK

In the United Kingdom, clinical engineers primarily work within the National Health Service (NHS), the publicly funded healthcare system.

Clinical Engineering as a Clinical Scientist Profession:

Clinical engineering is recognized as a modality within the clinical scientist profession in the UK. Clinical scientists in the UK are registered by the Health and Care Professions Council (HCPC), ensuring professional standards and public protection.

Health and Care Professions Council (HCPC): A regulator in the UK that sets standards for training, professional skills, behavior, and health for 15 professions, including clinical scientists. HCPC registration is required to practice as a clinical scientist in the UK.

Responsibilities of Clinical Engineers in the UK:

The responsibilities of clinical engineers in the UK are varied and encompass:

• Specialist Clinical Services: Providing expert clinical engineering services directly to patients and healthcare teams.
• Medical Device Innovation: Inventing and developing new medical devices and technologies to address unmet clinical needs.
• Medical Device Management: Overseeing the management, maintenance, and safe use of medical devices throughout healthcare organizations.

Patient Contact and Research:

Clinical engineering roles in the UK often involve both direct patient contact and engagement in academic research, reflecting the multifaceted nature of the profession.

Integration with Medical Physics:

Clinical engineering units within NHS organizations are frequently integrated into larger medical physics departments, fostering collaboration and synergy between these related disciplines.

Medical Physics: A branch of physics that applies physical science principles to medicine and healthcare. Medical physicists work in areas such as radiation oncology, medical imaging, and nuclear medicine, ensuring the safe and effective use of physics-based technologies in healthcare.

Professional Representation:

Clinical engineers in the UK are supported and represented by the Institute of Physics and Engineering in Medicine (IPEM). Within IPEM, the clinical engineering special interest group specifically oversees and promotes engineering activities within the profession.

Institute of Physics and Engineering in Medicine (IPEM): A UK-based professional organization for physicists, clinical engineers, and technologists working in medicine and healthcare. IPEM promotes professional development, sets standards, and advances the application of physics and engineering in medicine.

Primary Aims of Clinical Engineering in the NHS:

The core objectives of clinical engineering within the NHS are:

1. Availability and Appropriateness: Ensuring medical equipment in clinical settings is readily available and appropriate to meet the specific needs of clinical services.
2. Effectiveness and Safety: Guaranteeing that medical equipment functions effectively and safely for both patients and healthcare providers.
3. Value for Patient Benefit: Ensuring that medical equipment and its management represent value for patient benefit, considering cost-effectiveness and clinical outcomes.

Registration Pathways in the UK

Clinical engineers in the UK can register with the HCPC or the Register of Clinical Technologists (RCT), depending on their specific roles and qualifications.

Register of Clinical Technologists (RCT): A voluntary register in the UK for clinical technologists and technicians working in healthcare. RCT registration demonstrates professional competence and commitment to standards.

HCPC Registration Programs:

The HCPC offers two primary pathways for clinical scientist registration:

1. Certificate of Attainment (NHS Scientist Training Programme - STP): Awarded upon successful completion of the NHS Scientist Training Programme (STP), a structured training program for clinical scientists.
2. Certificate of Equivalence: Granted upon successful demonstration of equivalence to the STP, typically chosen by individuals with significant prior scientific experience seeking registration.

Both programs are provided by the Academy for Healthcare Science (AHCS).

Academy for Healthcare Science (AHCS): A UK-based organization that sets standards for healthcare science professions, including clinical scientists. AHCS provides accreditation, education, and professional development resources.

Electronics and Biomedical Engineering (EBME) in the UK

Electronics and Biomedical Engineering (EBME) technicians and engineers are an integral part of clinical engineering in the UK, working in both the NHS and the private healthcare sector.

Role of EBME Professionals:

EBME professionals are responsible for managing and maintaining medical equipment assets in NHS and private healthcare organizations. Their role is crucial for ensuring the functionality, safety, and longevity of medical devices.

Professional Registration:

EBME engineers can achieve professional registration with the Engineering Council as Chartered Engineers (CEng), Incorporated Engineers (IEng), or Engineering Technicians (EngTech), depending on their qualifications and experience.

Engineering Council: The UK regulatory body for the engineering profession. The Engineering Council sets and maintains standards for engineering education, competence, and ethical conduct, and registers engineers and technicians.

EBME Community and Knowledge Sharing:

The EBME community in the UK actively shares knowledge and best practices through platforms like the EBME Forums, fostering collaboration and professional development.

EBME National Exhibition and Conference:

An annual 2-day National Exhibition and Conference serves as a significant event for EBME professionals in the UK. This event provides a platform for engineers to:

• Learn about the latest medical products and technologies.
• Attend a large conference (500+ seats) where academic and business leaders share their expertise in medical equipment management.

Founded in 2009, the conference aims to improve healthcare through the sharing of knowledge and experience among professionals involved in medical equipment management.

Clinical Engineering in India

In India, the healthcare sector is increasingly driven by technology, creating a growing demand for trained professionals in clinical engineering to manage and advance this technology.

M-Tech Clinical Engineering Program:

To address this need for human resource development in clinical engineering, an M-Tech Clinical Engineering course was jointly initiated by three leading Indian institutions:

• Indian Institute of Technology Madras (IIT Madras)
• Sree Chitra Thirunal Institute of Medical Sciences and Technology, Trivandrum (SCTIMST)
• Christian Medical College, Vellore (CMC Vellore)

M-Tech (Master of Technology): A postgraduate degree in engineering and technology, commonly offered in India and other countries.

Program Objectives:

The M-Tech Clinical Engineering program in India aims to:

• Promote Indigenous Biomedical Device Development: Foster innovation and development of medical devices within India to reduce reliance on imported technologies.
• Enhance Technology Management: Improve the management and effective utilization of medical technology in healthcare settings across the country.
• Contribute to Healthcare Delivery: Ultimately contribute to the overall advancement and improvement of healthcare delivery in India.

Curriculum and Training:

The M-Tech program provides engineering students with a comprehensive interdisciplinary education, including:

• Biology and Medicine: Foundational knowledge in biological sciences and medical principles.
• Relevant Electronics Background: In-depth understanding of electronics and instrumentation relevant to medical devices.
• Clinical Practices: Exposure to clinical practices and healthcare workflows within hospital settings.
• Device Development: Training in the principles and processes of medical device design and development.
• Management Aspects: Education in healthcare technology management, including regulatory compliance, safety, and cost-effectiveness.

Hands-on Clinical Experience:

A crucial component of the program is the integration of hands-on clinical experience. Students are paired with clinical doctors from CMC and SCTIMST for internships, providing them with:

• Direct Clinical Exposure: Long-term and detailed exposure to the real-world clinical environment.
• Medical Device Development Activity: Involvement in ongoing medical device development projects.

Understanding Unmet Clinical Needs:

This combined exposure helps students to:

• Recognize Unmet Clinical Needs: Develop the ability to identify gaps and challenges in current healthcare practices that can be addressed through technological solutions.
• Contribute to Future Medical Devices: Equip students to contribute to the creation of innovative medical devices that address these unmet needs.

Safe and Effective Technology Use:

The program also trains engineers to:

• Handle and Oversee Technology: Develop the skills to manage and oversee the safe and effective utilization of medical technology in healthcare delivery sites.

Admission Requirements:

The minimum qualification for admission to the M-Tech Clinical Engineering course is:

• Bachelor’s Degree in Engineering/Technology/Architecture: A bachelor’s degree in any engineering discipline, technology, or architecture.
• Valid GATE Score: A valid score in the Graduate Aptitude Test in Engineering (GATE).
• Interview Process: Successful completion of an interview process to assess suitability for the program.

GATE (Graduate Aptitude Test in Engineering): A national-level examination in India conducted by the Indian Institute of Science (IISc) and seven Indian Institutes of Technology (IITs). GATE scores are used for admission to postgraduate engineering programs and for recruitment in some public sector undertakings.

See also

• Biomedical engineering

References

[List of references from the original Wikipedia article - to be included here if needed for a full educational resource]

Further reading

• Villafane, Carlos, CBET. (June 2009). Biomed: From the Student’s Perspective, First Edition. [Techniciansfriend.com]. ISBN 978-1-61539-663-4.
• Medical engineering stories in the news School of Engineering and Materials Science, Queen Mary University of London

External links

• EBME website EBME website for Medical, Biomedical, and Clinical engineering professionals.