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