VALLEY VIEW UNIVERSITY

FACULTY OF SCIENCE

DEPARTMENT OF COMPUTING SCIENCES AND ENGINEERING

BMET 435
INTRODUCTION TO CLINICAL ENGINEERING
COURSE OUTLINE

SECOND SEMESTER: 2022 / 2023

MR. EMMANUEL PRAH

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 VALLEY VIEW UNIVERSITY
FACULTY OF SCIENCE
DEPARTMENT OF COMPUTING SCIENCES AND ENGINEERING
BMET 435 – INTRODUCTION TO CLINICAL ENGINEERING
SECOND SEMESTER 2022 / 2023

Lecture: Mr. Emmanuel Prah (BSc, MSc)

Office: Andrew Clark (AC) – 304
e-mail: ekaprah@engineer.com, eprah@vvu.edu.gh
Tel: 024 0103900
Office Hrs: By appointment

Credit Hours: Three (3)

Class: 10:00am – 12:30pm, Thursdays Room: MET 101
Lab: N/A Room: N/A

Course Description

The course provides the fundamental concepts involved in managing medical

technology, establishing and operating a clinical engineering (CE) department, and the
role of clinical engineering departments in the design of facilities used in patient care.
The course will examine the different aspects of engineering duties performed by
clinical engineers in a hospital, the functions and activities of clinical engineering within
the medical environment of the modern hospital, and provides insight into the role that
clinical engineers play in the management of medical technology. Students will gain
knowledge and understanding in areas such as in-service education, equipment
planning and acquisition, equipment control and maintenance, facility planning,
regulatory affairs, and technology assessment. Topics covered include: Overview of
Clinical Engineering, Safety in the Clinical Environment, Technology Management,
Technology Assessment, Technology Acquisition, Codes, Standards and Regulations,
Facilities Management and Design, Management and Supervision, Development and
Operation of a Clinical Engineering Department, and Moral and Ethical Issues in Clinical
Engineering Practice.

Prerequisites: None

Textbooks:

1) Anthony Y. K. Chan. (2003). Medical Technology Management Practice. Illi-

nois: Charles C. Thomas.
2) Binseng Wang. (2009). Strategic Health Technology Incorporation. New Jer-
sey: Morgan & Claypool.
3) Binseng Wang. (2012). Medical Equipment Maintenance: Management and
Oversight. New Jersey: Morgan & Claypool;.

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 4) Frank R. Painter and Mathew F. Baretich. (2011). Medical Equipment Mainte-
nance Programme Overview. Geneva: WHO Press.
5) Tania O’Connor. (2011). Introduction to Medical Equipment Inventory Man-
agement. Geneva: WHO Press.

Course Objectives

Upon successful completion of the course, students will be able to:

i. Examine the functions and activities of clinical engineering (CE)

departments.
ii. Discuss safety programmes in the clinical environment.
iii. Examine the role of the clinical engineer in establishing and organizing
electrical and medical device safety programmes.
iv. Plan, implement, and manage equipment repair and maintenance services.
v. Compute the costs associated with equipment repair and maintenance
services.
vi. Discuss the various types of equipment repair and maintenance services.
vii. Examine the methods used in the assessment of medical technologies.
viii. Discuss the design of healthcare facilities.
ix. Develop a clinical engineering programme.
x. Discuss the elements of a medical technology management programme.
xi. Examine the elements of the health technology assessment process.

Course Content

1) Overview of Clinical Engineering

i. Definition of Biomedical Engineering and Clinical Engineering

ii. Typical Pursuits of Biomedical Engineers
iii. Typical Pursuits of Clinical Engineers
iv. Clinical Engineering Departments: Mission, Vision, and Values
v. Activities of a Clinical Engineering (CE) Department

a. Medical Equipment Inventorying

b. Medical Equipment Planning
c. Medical Equipment Acquisition
d. Acceptance Testing
e. Training
f. Preventive Maintenance
g. Corrective Maintenance / Repair
h. Quality Assurance
i. Risk Management
j. Equipment Disposal

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 vi. Certification of Clinical Engineers

a. Registration
b. Certification
c. Accreditation
d. Credentialing
e. Licensing

2) Safety in the Clinical Environment

i. Hazards of Medical Devices

a. Electrical Hazards
b. Mechanical Hazards
c. Environmental Hazards
d. Biological Hazards

ii. Electrical Safety

a. Physiological Effects of Electrical Current

b. Protection against Electrical Shocks: Grounding and Leakage
Current Limits, Capacitive Coupling, Inductive Coupling, Isolated
Patient Connections, Isolated Power Systems, Ground Fault Circuit
Interrupters

iii. Electrical Safety at all Stages of the Equipment Life Cycle

a. Procurement and Commissioning

b. Maintaining Safety in Use
c. Specific Hazards from some Device Types
d. Interconnections
e. Computer Standards

iv. Electrical Safety Programs

a. Environmental Inspection: Anesthetizing Location, Critical Care

Locations, General Care Locations, Nonpatient Areas, and Wet
Locations
b. Equipment Inspection
c. Education of Clinical Staff
d. Model Program
e. Medical Device Safety Program
f. Hazard Alerts and Recalls: Class I, Class II, and Class III
g. Incident Investigation: Operator / Device Interface, Patient / Device
Interface, Consumable Supply / Device Interface

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 v. Radiation Safety Program

a. Atomic Structure and Emissions: Alpha Decay, Negatron Decay,

Positron Decay
b. Detection of Radioactivity

vi. Laser Safety Programs

a. Types of Lasers
b. Laser-related Hazards

vii. Infection Control Programs

a. Basic Infection Control Practices

b. Decontamination and Sterilization

3) Technology Management

i. Medical Equipment and its Life Cycle

a. What is a Medical Equipment

b. Equipment Management Processes

 Establishing Need
 Funding
 Specification
 Tendering, Evaluation, and Purchase
 Preparatory Work
 Delivering, Installation, Acceptance, Commissioning, and
Payment
 User Training
 Deployment
 Management in Use

ii. Definition of Technology Management

iii. Technology Management Program
iv. Equipment Control and Maintenance
v. Technology Planning, Acquisition, and Replacement
vi. Training in Equipment Use
vii. Quality Assurance
viii. Equipment-Related Risk Management
ix. Initial Inspection / Acceptance Testing
x. Maintenance Schedules

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 a. Scheduled Maintenance Services
b. Repair Services
c. Types of Maintenance Services
d. Cost Analysis for In-House Maintenance Service

xi. Service Contracts

xii. Repair Parts Management
xiii. Equipment Disposition
xiv. Managing Medical Equipment Over its Life Cycle

a. Life Cycle Management

b. Life Cycle Cost
c. Reviewing Maintenance Costs
d. Replacement Planning
e. Approaches to Financing the Life Cycle of Medical Equipment
 Traditional Capital-Funded Acquisition with Revenue-Funded
Support
 Funding Equipment through Consumable Purchases
 Renting Medical Equipment
 Leasing Medical Equipment
 Managed Equipment Service

f. Asset Management

4) Technology Assessment

i. Healthcare Technology - Definition

ii. Healthcare Technology Assessment - Definition
iii. Health Technology (HTA) Process
iv. Efficacy, Effectiveness, and Safety
v. Methods of Technology Assessment
vi. Technology Assessment Criteria and Tests
vii. Operational Aspects of Technology Assessment in a Hospital Setting
viii. Role of Clinical Engineers in Technology Assessment
ix. Technology Assessment in Hospitals: An Example

5) Technology Acquisition

i. Clinical Requirements
ii. Equipment Evaluation
iii. Incoming Inspection

6) Codes, Standards, Regulations

i. Definitions

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 ii. Standards Organizations
iii. Voluntary Accredited Organizations

7) Facilities Management and Design

i. Functions of a Facility Management Team

ii. Facilities Design

a. Design Issues
b. Design / Development Process
c. Intensive Care Areas\
d. General Patient Care Areas\
e. Surgical Suites\
f. Obstetrical Facilities
g. Imaging Suites
h. Case Study: Design of a Cardiac Catheterization Laboratory

8) Development and Operation of a Clinical Engineering Department

9) Moral and Ethical Issues in Clinical Engineering Practice

i. The Ethical Significance of Professionalism

ii. Code of Ethics
iii. The Nature of Moral Judgment
iv. Ethical Theory and Applied Ethics
v. Metaethics
vi. Normative Ethics
vii. Beneficence, Normaleficence, and Technological Process
viii. Defining Death
ix. Euthanasia

a. Active versus Passive Euthanasia

b. Involuntary and Voluntary Euthanasia
c. Should Voluntary Euthanasia be Legalized

x. Human Experimentation

a. Practice and Research

b. Nonvalidated Practice
c. The Ethics of Research on Humans
d. The Ethics of Nonvalidated Practices

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Course Evaluation Criteria

Item Percentage (%)

Assignment 20
Mid Semester Examination 20
End of Semester Examination 60

Course Grading

Marks (%) Grade

80 – 100 A
75 – 79 A-
70 – 74 B+
65 – 69 B
61 – 64 B-
56 – 60 C+
50 – 55 C
45 – 49 C-
40 – 44 D
00 - 39 F
Class Policies and Procedures

All students are required to note the following class policies:

1. The Head of the Department reserves the right to change the class schedule if
there are time table clashes.

2. Cell phones and other electronic devices must be turned off during class hours.

3. Academic Integrity: Valley View University believe in high standards of academic

excellence. In all matters of intellectual pursuit, VVU faculty, staff and students
must strive to achieve the best. In the classroom and in all other academic
activities, students are expected to uphold the highest standards of academic
integrity. Any form of scholastic dishonesty is a hindrance in the pursuit of
knowledge and jeopardizes the quality of education. Any student who commits
an act of scholastic dishonesty is subject to disciplinary action. Scholastic
dishonesty includes, but is not limited to, cheating, plagiarism, collusion, the
submission of any work or materials that are attributable in whole or in part to
another person, any act designed to give unfair advantage to a student or the
attempt to commit such acts. Proven violations of these guidelines may result in
sanctions ranging from disciplinary probation, to failing grades on the work in
question, to failing grades in the course, to suspension or dismissal, among
others.

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4. Exam/Assignments/Projects: All students are expected to arrive in class
prepared, i.e., assigned readings completed and homework ready to turn in for
grading. If there is a problem taking an exam at the assigned time, students
MUST contact the instructor PRIOR to the day of the exam or NO make-up test
will be allowed and the student will receive a zero for the missed exam. NO
projects or homework will be accepted after the due date and time. Project or
homework material left with the instructor at the end of the semester will be
retained only for two (2) weeks into the next semester, after which they will be
destroyed.

5. Class Attendance: Students are expected to attend classes regularly and on

time. Grade will be awarded for active participation in the classes. Only
exceptional reasons for absence (e.g., illness, death of a family member) will be
excused. If a student must miss a class, he/she must inform the instructor before
the class period. Students must take full responsibility when they miss class or
come to class late. If a student misses a class with permission, it is the
responsibility of the student to obtain class notes, announcements, handouts,
exercises and assignments from classmates and assistance from the instructor.

6. Sickness: If a student is sick and he/she misses the class, then the student must
inform the Head of Department and the class instructor in writing immediately.
Letters that are obtained from the doctors after the sickness without prior
information to the Head of Department will not be accepted.

7. Dress Code: Demonstrating professionalism is very important for students,

especially for future career development. Therefore, students are expected to
dress properly as executives when they are in class. Shorts, t-shirts, tight jeans,
sleeve-less tops, sandals, etc, are not acceptable attire while attending classes.

8. Quizzes: To ensure that students stay current with the assigned readings, the
instructor will give several short unannounced quizzes during the semester.
There will be no make-ups for missed quizzes.

9. Group Work: Students may be assigned to work in a group and submit group
work and therefore they are responsible for organizing themselves, dividing up
the work, and deciding how relative contributions should be measured. It is
responsibility of the student to promptly inform the instructor of any dysfunctional
group member and to solicit help. All group members must:

a) Participate in all group activities,

b) Participate in class discussions,
c) Strive to maintain positive working relationships with their group members,
d) Complete all assignments,
e) Freely express their ideas, thoughts, comments, and constructive
criticisms to their group members, the instructor, and the class.

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 f) Ensure that all members understand all concepts related to the completed
projects and presentations. The instructor may ask questions about any
completed project or presentation to any group member and any
incomplete or unsatisfactory answers will affect the group grade.

10. Quality of Work: The submitted work must be of professional quality both in terms
of content and presentation:

a) Spelling, grammar, punctuation, clarity of expression, and presentation will

count in every piece of work students do for during course. If students
have trouble with spelling, grammar or punctuation, they arrange for
someone to proof-read the material before submission.
b) Student grade will be based on what they say or write and how they
present it. A superior job may not be recognized as such if the
presentation is poor.
c) Good ideas poorly expressed will receive poor grades, as will flashy
presentations that lack content.
d) Students must read carefully all assignments. Students are responsible to
turn in ALL required assignments/projects/ exercises.
e) All work submitted for evaluation must be neat and clearly marked
indicating the question/case to which it relates. Students work should
clearly state the title of the work, student’s name (or the names of all the
group members, if it is group work), and the date of submission.

11. Grade Appeals: If a student believes that the grade he/she received on an
assignment, exam or other graded course component was an error or unfair, the
student can appeal within three weeks after the declaration of results by filling the
Grades Re-Checking Form that is obtained from the Head of the Department. Fill
the form and submit it to the Head of Department for processing. Grades Re-
Checking form submitted after three weeks will not be considered. After
confirmation of the grades through the Grades Re-Checking process and the
student still believe that the grade he/she received on an assignment, exam or
other graded course component was an unfair and student is interested in re-
marking of the paper, then the student must obtain the Re-Marking Form from
the Head of Department, fill it and submit to the Head of Department for
processing. A student is allowed to apply for Re-Marking within three weeks after
the declaration of Grades Re-Checking results. Re-Marking forms submitted after
three weeks will not be considered.

12. Sexual Harassment: If a student encounters unlawful sexual harassment or any

form of discrimination from instructors or students, please contact the Office of
Dean of Students Affairs, Valley View University, P.O. Box AF 595, Adentan.
Accra. Telephone Number: 0307011833/0244715373.

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Students with Special Needs

Valley View University is committed to providing a conducive learning environment,

which reasonably accommodates qualified persons with disabilities. If a student has any
disability that may impair his/her ability to study successfully, the student should contact
the instructor and the Head of the Department immediately for assistance. If the student
with disability feel that he/she has been unlawfully discriminated against on the basis of
disability, he/she should contact the: Office of Dean of Students Affairs, Valley View
University, P.O. Box AF 595, Adentan. Accra. Telephone Number: 0307011833 /
0244715373.

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