CBET Public Safety and Regulations 3

Question 1

What is an FDA medical device recall and what are the three recall classes?

Accepted Answer

Recalls correct or remove defective devices; Class I is most serious, Class II is less serious, Class III is unlikely to cause harm

Answer

Recalls address defective devices. Class I: serious health consequences/death. Class II: temporary/reversible. Class III: not likely to cause harm.

Question 2

What is the purpose of risk-based preventive maintenance scheduling and how is equipment risk typically assessed?

Accepted Answer

Risk assessment evaluates equipment function, physical risk, and maintenance requirements to prioritize PM resources

Answer

Risk-based PM uses systematic assessment of function, physical risk, and maintenance requirements to prioritize resources.

Question 3

What are the biomedical technician's responsibilities regarding infection control when servicing medical equipment?

Accepted Answer

Follow standard precautions, request decontamination, use PPE, and prevent cross-contamination between devices

Answer

Technicians must follow standard precautions, ensure decontamination, use appropriate PPE, and prevent cross-contamination.

Question 4

What is the MAUDE database and how is it used?

Accepted Answer

An FDA database of adverse event reports used to identify device safety trends and problems

Answer

MAUDE is a publicly searchable FDA database containing medical device adverse event reports.

Question 5

What requirements does CMS impose on hospitals regarding medical equipment management?

Accepted Answer

CMS requires maintaining, testing, and inspecting all equipment per manufacturer recommendations as conditions for Medicare/Medicaid

Answer

CMS Conditions of Participation require comprehensive equipment management including inventory, maintenance, and testing.

CBET - Certified Biomedical Equipment Technician Practice Test