topic 1 Flashcards
What is clinical engineering?
A branch of biomedical engineering that manages the deployment of medical technology and integrates it.
What are some career options for biomedical engineer?
- Technology transfer
- Research & Development
- Clinical Engineer
- Sale & service
- Quality Assurance
Why do we need clinical engineers?
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 professtionals.
What are the 3 certification for clinical engineers?
- Certificated biomedical equipment technicians (CBET)
- Certificated Radiology Equipment Specialist (CRES)
- Certificated Laboratory Equipment Specialist (CLES)
What does CBET compose of?
Electrical safety
bio-potential
Skin contact
What does CRES compose of?
Radiation exposure limit
Types of radiation sources
Radiation safety
What does CLES compose of?
Biosafety level
Sterilisation of equipment
Good Laboratory practices
What is the function of a clinical engineering department?
- Technology Management
- install, service and manage inventory of medical instruments - Risk Management
- identify hazards and risk of the equipment - Technology Assessment
- Evaluate and select new equipment - Facilities design and project management
- Quality Assurance
- Training
- teach clinical stuff how to use equipment - administration
- documentations pertaining to medical equipment
What does HSA stand for?
Health Sciences Authority
What is the role of HSA?
- Provide the scope of medical devices
- Regulate all medical devices in singapore in Singapore under the Health Products Act (HPA).
- Approval of dealer’s license before company can manufacture, import or supply any medical devices.
Which Class is exempted from product registration?
Class A (low risk)
In what event must medical device company report to HSA?
- Changes in registered devices
- Advertisement and sales promotion
- Adverse events
- Field safety corrective actions reporting
What is a medical device?
Medical device is any instrument, apparatus, machine, implant, reagent for in vitro use, software or material to be used in human being for medical purposes.
What are the various risk classes?
Class A: Low risk
Class B: Low to moderate risk
Class C: Moderate to high risk
Class D: High risk
What are the factors influencing risk classification?
- Duration of medical device contact with body
- Degree of invasiveness
- If medical products or energy is delivered to patient
- If there is a biological effects on the patient
- local effect or systemic effect
What are the 2 common good manufacturing standards?
- International Organization for standardization (ISO) 13485
- 21 Code of Federal Regulations (CFR) part 820.
What is the institutional review board (IRB)?
Institutional review board (IRB) is an idependent body consisting of healthcare and non-medical professionals that ensures the protections of rights, safety and well-being of human involved in clinical trials.
What is the institutional animal care and use committee (IACUC)?
Institutional animal care and use committee (IACUC) is responsible for the oversight and evaluation of animal care and use for scientific purposes.
What is beneficence?
The principle of acting with the best interest of the other in mind.
What is Justice?
A concept that emphasizes fairness and equality among individuals.
What is Non-maleficence?
The principle of not doing harm.
What is Autonomy?
The right for an individual to make his or her own choice.
What are the 7 code of ethics.
- Safeguard the safety and health of all
- Keep up-to-date of healthcare related information
- Manage healthcare resources responsibly
- Perform services only in areas of competence
- Maintain patient confidentiality unless due to legal obligation
- Not engage in any activity which has conflicts of interest
- Conduct honourably and legally in any activity
What is the purpose of reporting adverse events?
- Improve protection of health and safety of patients
- Minimise repetition of events
- Learning experiences for medical staffs including clinical engineers.
Who do we report adverse events to?
Health Science Authority (HSA)
What to report?
- Brief description
- Device details
- Investigation
- details with illustrations - Possible causes
- Recommendations
- preventive measures
- lessons learnt
What are the 7 common administrative measures?
- Is there any ownership to the equipment?
- Is the equipment regularly maintained?
- Are the staff trained to handle the equipment?
- Are there labels to remind staff?
- Is the staffing level sufficient?
- Is there access control?
- Are the staff equipped?
