Chapter 1 CENG Introduction to Clinical Engineering

Question 1

What is clinical engineering?

Answer 1

A branch of biomedical engineering that manages the
deployment of medical technology and integrates it appropriately
with desired medical practices

Question 2

What are some career options for biomedical engineers?

Answer 2

Technology Transfer, Research & Development, Clinical Engineering, Sale & Service, Regulatory / Quality Assurance

Question 2

Why the need for clinical engineering?

Answer 2

The healthcare system is a very complex environment where
facilities, equipment, materials and human interventions are
involved. This can lead to unacceptable risk if it is not
integrated properly by qualified professionals

Question 3

Who is a clinical engineer?

Answer 3

A professional who supports and advances patient care by
applying engineering and management skills to healthcare
technology

Question 4

What is the purpose of Certification for clinical engineers

Answer 4

To promote healthcare delivery improvement by assessing the competency of engineering professionals who work in the healthcare industry.
1. Certificated Biomedical Equipment Technicians (CBET).
2. Certificated Radiology Equipment Specialists (CRES)
3. Certificated Laboratory Equipment Specialists (CLES)

Question 5

What are the functions of a clinical engineering department? Explain all 8.

Answer 5

1. Technology Management (manage equipment servicing matters, manage inventory of medical instrumentation and installation of new equipment)
2. Risk Management (Identify the hazards, assess the risks and control the risks related to medical equipment)
3. Technology Assessment (Evaluate and select new equipment.)
4. Facilities Design and Project Management (Assist in the design of new or renovated clinical facilities with medical equipment)
5. Quality assurance (Implement and track regulatory protocols for medical equipment)
6. Training (Manage instructional modules on the operation of medical equipment and provide training to other clinical staff)
7. Administration (Filing system for all documentations pertaining to medical equipment and Coordinate technical services rendered by vendors)
8. Others (Provide assistance in the application and management of any healthcare technologies that support patient care such as system integration and equipment connectivity matters)

Question 6

What are the roles of the Health Sciences Authority (HSA)?

Answer 6

1. Provide the scope of regulations on medical devices in
   Singapore
2. Regulate all medical devices in Singapore under the Health
   Products Act (HPA) and its Health Products (Medical
   Devices) Regulations 2010
3. Companies are required to obtain a dealer’s licence from
   HSA before manufacturing, importing or supplying any
   medical device. Only Class A low risk medical devices or
   those devices under specific conditions as approved by HSA, are exempted from product registration

Question 7

When must the HSA be notified by the medical device company?

Answer 7

1. Any change for registered devices.
2. Advertisement and sales promotion.
3. Adverse events reporting.
4. Field safety corrective actions reporting

Question 8

What is a medical device?

Answer 8

Medical device means any instrument for human beings, for one or more of the specific medical purpose(s)

Question 9

What are the 5 factors influencing risk classification?

Answer 9

1. The duration of medical device contact with the body.
2. The degree of invasiveness to the body.
3. If medicinal products or energy is delivered to the patient.
4. If there is a biological effect on the patient.
5. Local versus systemic effects on the patient.

Question 10

Why is Good manufacturing practice (GMP) for medical devices a vital component in the regulatory requirements and quality assurance?

Answer 10

Ensure that medical devices are consistently produced with the operating standards appropriate for their intended use

Question 11

What are the 2 common operating standards?

Answer 11

1. International Organization for Standardization (ISO) 13485
2. 21 Code of Federal Regulations (CFR) Part 820

Question 12

What are clinical trials for?

Answer 12

Clinical trials provide the basis for the development of new
drugs or medical devices. The data collected provides evidences
that the product is safe, effective and useful for better healthcare
outcome

Question 13

What is IRB and IACUC?

Answer 13

Institutional review board (IRB) is an independent body
consisting of healthcare and non-medical professionals. Their
responsibility is to ensure the protection of the rights, safety and
well-being of human subjects involved in a clinical trial, as well
as the suitability of any clinical trial

Institutional animal care and use committee (IACUC) is
responsible for the oversight and evaluation of animal care and
use in an institution for scientific purposes. The appointed
committee must be qualified to regulate animal care at that
institution and has an external professional trained in
experimental animals

Question 14

What are the four ethical codes for engineers?

Answer 14

Beneficence, justice, non-maleficence & autonomy

Question 15

What is the principle of beneficence?

Answer 15

Principle of beneficence guides on doing what is good. Specifically, this
can mean balancing of the benefits to individuals against the risks and
costs involved

Question 16

What is the principle of non-maleficence?

Answer 16

Principle of non-maleficence directs the need to avoid the cause of harm to individuals. This is similar to the first principle except that the choice to do the least harm possible and/or to do harm to the fewest people should be taken

Question 17

What is the principle of justice?

Answer 17

Principle of justice requires consistent actions such as distributing benefits, risks, and costs fairly to everyone at all times

Question 18

What is the principle of autonomy?

Answer 18

Principle of autonomy states that there must be an absolute respect to the decision-making capabilities of every individual in that people should have control over their lives as much as possible because they completely understand what they want

Question 19

What are the 5 things to report during adverse event?

Answer 19

1. Brief description
2. Device details
3. Investigation
4. Possible causes
5. Recommendations

Question 20

What is an adverse event?

Answer 20

An adverse event is defined as any occurrence that has unfavourable or unintended effects on patients, regardless of severity or study-relatedness

Question 21

Why is it important to report an adverse event?

Answer 21

1. Improve protection of health and safety of patients.
2. Minimise repetition of events.
3. Learning experiences for medical staffs including clinical engineers