Public Safety and Regulations Flashcards
6 cards from real CBET practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Public Safety and Regulations flashcards as text
What is an FDA medical device recall and what are the three recall classes?
Answer: Recalls correct or remove defective devices; Class I is most serious, Class II is less serious, Class III is unlikely to cause harm
Recalls address defective devices. Class I: serious health consequences/death. Class II: temporary/reversible. Class III: not likely to cause harm.
What is the purpose of risk-based preventive maintenance scheduling and how is equipment risk typically assessed?
Answer: Risk assessment evaluates equipment function, physical risk, and maintenance requirements to prioritize PM resources
Risk-based PM uses systematic assessment of function, physical risk, and maintenance requirements to prioritize resources.
What are the biomedical technician's responsibilities regarding infection control when servicing medical equipment?
Answer: Follow standard precautions, request decontamination, use PPE, and prevent cross-contamination between devices
Technicians must follow standard precautions, ensure decontamination, use appropriate PPE, and prevent cross-contamination.
What is the MAUDE database and how is it used?
Answer: An FDA database of adverse event reports used to identify device safety trends and problems
MAUDE is a publicly searchable FDA database containing medical device adverse event reports.
What requirements does CMS impose on hospitals regarding medical equipment management?
Answer: CMS requires maintaining, testing, and inspecting all equipment per manufacturer recommendations as conditions for Medicare/Medicaid
CMS Conditions of Participation require comprehensive equipment management including inventory, maintenance, and testing.
What is the significance of IEC 60601-1 for biomedical equipment technicians?
Answer: The international safety standard for medical electrical equipment defining essential safety and performance requirements
IEC 60601-1 is the foundational safety standard defining requirements that form the basis for safety testing.