CLINICAL ENGINEERING

1. Definitions
Clinical Engineering is the use of scientific principles and technology to solve problems for
ensuring the safe and effective provision of healthcare. A clinical engineer is a professional who
supports and advances patient care by applying engineering and managerial skills to healthcare
technology. Clinical engineer can be also called healthcare engineer, hospital engineer,
biomedical equipment technician, equipment managers, technology manager, biomedical
engineer, maintenance engineer, or healthcare technologist. Clinical engineer responsible for
equipment such as infusion pumps, defibrillators, monitors, x-ray machines, cat scan, MRI,
ultrasound, ventilators, surgical table and lights, electrosurgical units, pulse oximeters, CT scan,
etc.
Different with clinical engineering, biomedical engineering is the use of scientific principles and
technology to solve problems in biology and medicine.
Different with clinical engineer, hospital engineer mainly responsible for equipment such as
HVAC, medical gases, electrical systems, medical compressed air, vacuum systems, elevators,
construction support, communication systems, vehicles, steam, hot water, etc.
Technology is a combination of systems, techniques, skills, procedures, and processes used to
perform a common function in the accomplishment of objectives. Technology life-cycle is a
process by which technology is created from basic and applied research and innovation, tested in
early diffusion stage, applied, and replace or abandoned.
Healthcare technology is technology that focus on medical equipment and hospital installation
and facilities. Healthcare technology includes the devices, equipment, systems, software,
supplies, pharmaceuticals, biotechnologies, medical and surgical procedures, organizational
structures used in the prevention, diagnosis, and treatment of disease in humans; for
rehabilitation; and for assistive purposes.
Healthcare technology is mainly purpose on maintain efficacy, effectiveness, and efficiency.
Technology efficacy is a benefit from a given medical technology under ideal conditions of use.
Technology effectiveness is a benefit from a given medical technology under average (real)
conditions of use. Technology efficiency is the lowest price when different technologies have
same efficacy and effectiveness.
2. Mission and Customers
The mission of clinical engineering is to ensure the safe and effective application of technology
to the patient care. The customers of clinical engineering are clinical staff and patients that use or
being used by the medical equipment.
3. Typical Engineering Responsibilities
 Supervision, coordination and technical orientation
 Studies, planning, projects and specifications
  Technical and economic feasibility studies
 Counseling and advisory services
 Manpower and resource management
 Inspections, audits, evaluation, survey, technical reports
 Technical functions
 Teaching, research, analysis, experimentation, tests
 Budget preparation
 Standardization, measurements, quality control
 Constructions
 Fiscalization of service execution
 Specialized technical production
 Technical evaluation of work conductions
 Management of installation, mounting, operation, repair or maintenance team
 Execution of installation, mounting, repair and remodeling
 Installations and equipment operations and maintenance
 Technical drawing
4. Function of Clinical Engineering
4.1. Technology Planning (Project Management)
A clinical engineer determines the most effective and efficient types of technology comply the
program needs of the healthcare facility. They must analyze and balancing the improvement of
patient outcome, cost and expense control, and productivity improvement. They need to have a
knowledge and insight of the future technology requirements, under development technologies,
technology resources, and the impact to the patient care by joining equipment control program.
This knowledge and insight can be obtained by continuing education and familiarized themselves
to read professional journals, newsletters, and internet, joining professional societies, seminars
and conferences. They also need to increase the awareness of program needs by frequent
communication with users and involvement with technology related committees.
4.2. Technology Assessment
Technology assessment is the assessment of medical technology such as devices, drugs,
procedures, and system in term of safety, clinical effectiveness, cost effectiveness, ethical, and
legal. A clinical engineer will obtain, analyze, process, and dissemination all information related
to the technology that will be applied.
4.3. Acquisition and Application of Technology
A clinical engineer needs to know all information of the equipment including the availability, the
suitable models, the cost to purchase and to operate, the required facility and environment, the
compatible user and the user training, the service requirement and frequency, and the expired
date. To obtain this data, they need to conduct an assessment, conduct environmental assessment,
translate clinical requirement into technical specifications, research, evaluate functional and
technical, give recommendation, purchase the equipment, conduct inspection, submit to
equipment control program, conduct installation, and train the user.
4.4. Equipment Control
A clinical engineer needs to obtain and control the data of the equipment including type, model,
serial number, location, user, safety, reliability, effectiveness, utilization, replacement date,
performed service procedures, performed preventive maintenance, assurance, testing and
calibration, and cost of operation and services.
4.5. Preventive and Corrective Maintenance
A clinical engineer need to conduct preventive and corrective maintenance including in-house or
external service determination, knowing the level of in-house service such as board or
component level, service procedures and reports, PM frequency and scheduling, warranty
management, service facility, manage and organize technical staff, conduct staff training,
knowing parts inventory, test equipment, equipment manuals and documentation, diagnostic
software, vendor support, and billing rate.
4.6. Service Contract Management
A clinical engineer manages the equipment service contract including determine in-house,
vendor, third-party, maintenance insurance or warranty, provisions of service contract,
negotiation, monitoring and documentation, and analyze cost.
4.7. Development of New Technology
A clinical engineer should be able to develop a new technology by conduct needs assessment,
research, develop design and specification, build prototype, conduct testing and evaluation,
construction, testing, and documentation of final assembly, submit for regulatory approvals, user
training, conduct clinical trials, modification, documentation and reporting, and submit to
equipment control program.
4.8. Facility Planning and Development
A clinical engineer must plan and develop the required facility for equipment appropriate
placement by specifying equipment requirements, knowing liaison between contractor and
hospital, project planning and management, and ensure conformance to relevant codes and
regulations.
4.9. Safety and Risk Management
A clinical engineer must remain current on all pertinent codes & regulations, interpret codes &
regulations, implement and enforce codes & regulations, maintain system for responding to
published equipment hazard reports, reviewing requests for new technology as to safety and
effectiveness, identify potential hazards, assessing degree of hazard protection required in
relation to size of risk, preventing technological change when risk unwarranted or effectiveness
not demonstrated, investigate and report incident, maintain incident database, develop safety
policy, develop safety education programs, represent hospital safety committee, liaison with
manufacturers, liaison with hazard reporting agencies (ECRI, Government).
4.10. Continuous Quality Improvement
A clinical engineer must improve the quality continuously by identify costumers, identify and
measure improvement needs such as critical processes and quality indicators, examines problems
and analyze the causes, determines solutions and action plans, implements proposed solutions,
measure, and evaluate, adopts and standardize improved processes.
4.11. Education
A clinical engineer must educate themselves and their technical staffs, clinical staff, patients, and
establish partnership with local clinical engineering technology programs. To educate themselves
and their technical staffs, they need to attend relevant conferences and seminars, attend vendor
service courses, participate in Clinical Engineering professional associations, read clinical
engineering magazines and journals, and remain current on developments in medical technology.
To educate clinical staff, an in-service education program need to be developed, conduct user
training on new equipment, conduct annual refresher courses for clinical staff, conduct informal
user assistance and training, provide documentation of user training, educate clinical staff on
new developments in medical technology. To educate patients, in-service education program
needs to be conducted to the patients that responsible for the operation of medical devices. A
clinical engineer also can establish a training partnership by advice local clinical engineering
technology programs on curriculum content, assist with training, and provide hospital internship
program.
4.12. Clinical Equipment Application
A clinical engineer aids the user with set-up and operation of technically complex medical
devices with application of medical technology in tertiary care areas (ICUs, Diagnostic areas,
and ORs) such as dialysis, intra-aortic balloon pump, and lasers and electrosurgery unit.
5. Evolution of Clinical Engineering
Level 1 Level 2 Level 3 Level 4 Level 5
(1970-1978) (1978-1984) (1984-1989) (1989-1993) (Future
Projection)
 Associated  Center for  Reports  Integration of  Technology
with Physical hazard and directly to CQI/RM into Assessment
Plant recall network administration technology  Strategic
 Electrical  Incident  Computerized management Technology
safety investigation equipment  Comprehensive Planning
 Corrective  Significant control service  Integration of
maintenance of involvement in program with contract Clinical and
basic acquisition productivity management Information
electromedical process and cost  Computerized Technologies
equipment  Initial analysis ECP with  Home Care
 Initiation of involvement in capability extensive technology
PM program outside service  Maintenance analysis management
 Equipment contracts of more capability  Increasing
Control sophisticated  Active clinical
Program technology participation in involvement
initiated including equipment
 Initial medical planning and
involvement in imaging and facilities
equipment clinical lab development
acquisition
process

6. Clinical Engineering Program Structure

A clinical engineering program should report directly to administration and have autonomy for
its own personnel, capital equipment, and budgets management. It must have political strength
with administration and clinical staff to keep the independency and the impartiality.
Clinical Engineering Program Subdivisions:
 Risk management/CQI
 Technology Planning and Assessment
 Technology Development
 Technical Support Services
 Clinical Laboratory
 Diagnostic Imaging
 Medical Instrumentation Group 1
 Medical Instrumentation Group 2
 etc.
Clinical Engineering Program is recommended to established under director of technology or
directory of engineering in healthcare facility organizational structure.
7. Engineer vs Technologist vs Technician
In administrative function, a clinical engineer will oversee technologist and technician. In
technical function, a clinical engineer will have incision scope of work with technologist and
technician. In education, a clinical engineer will have broader knowledge than technologist and
technician.
8. Centralized vs Distributed Service
Centralized Service Distributed Service
 Lower Cost  Higher Cost
 Higher Efficiency  Lower Efficiency
 Lower overlap probability  Higher overlap probability
 Common resource and knowledge base  Diverse resource and knowledge base
  Lower individual department control  Higher individual department control

9. Equipment specialist vs generalist

Equipment Specialist Equipment Generalist
 Staff are more capable  Staff are less capable
 More efficient  Less efficient
 Job gets done faster  Job gets done longer
 Staff are less flexible  Staff are flexible
 No cross-training  Cross-training
 Department is vulnerable  Department is sustained
 Uneven workload distribution  Even workload distribution

10. Single Team vs Multiple Team (Area Specialization)

Single Team Multiple Team
 Less efficient  More efficient
 Less familiarity with equipment and  Improved familiarity with equipment
users and users
 Unclear identification of responsibility  Clear identification of responsibility
by clinical staff and CE staff by clinical staff and CE staff
 Less ownership  Ownership (pride in work)
 Less accountability  Accountability
 Less communication between clinical  Improved communication between
staff and CE staff clinical staff and CE staff
 More sustained  More vulnerable
 Technologist have various range of  Technologist may become bored with
equipment same range of equipment
 Even workload distribution  Uneven workload distribution

11. Factor Causing Change in Clinical Engineering Program Structure

 Regionalization of Support Services
 Medical Program Rationalization
 Patient Focused Care
 Competition (private service organizations)
 Fee-for-service model