CBA Biomedical Equipment & Technology Assessment Flashcards
6 cards from real CBA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CBA Biomedical Equipment & Technology Assessment flashcards as text
The term 'incoming inspection' in biomedical equipment management refers to:
Answer: Inspecting equipment before it is placed into clinical service for the first time
Incoming inspection (also called acceptance testing) verifies that new equipment meets specifications and is safe before first clinical use.
Which organization publishes the AAMI TIR32 guidance used by biomedical auditors assessing medical device security?
Answer: AAMI (Association for the Advancement of Medical Instrumentation)
AAMI (Association for the Advancement of Medical Instrumentation) publishes TIR32, a technical information report addressing medical device security in healthcare networks.
During an audit, a biomedical technician states that equipment failures are fixed 'as time allows.' This MOST likely indicates a deficiency in:
Answer: Corrective maintenance prioritization and response time policies
An informal approach to corrective maintenance without defined priorities and response times is a systemic gap that risks patient safety and regulatory noncompliance.
What is the PRIMARY purpose of an equipment management plan (EMP) in a healthcare organization?
Answer: To define the processes for managing the safety and performance of medical equipment
An EMP establishes the policies, procedures, and criteria for maintaining the safety and effectiveness of all medical equipment within the organization.
Under The Joint Commission's Environment of Care (EC) standards, a medical equipment management program must include:
Answer: Criteria for identifying, evaluating, and taking inventory of equipment before use
TJC EC standards require that equipment management programs define criteria for evaluating and inventorying medical equipment prior to initial use.
A 'device history record' (DHR) as required by 21 CFR Part 820 MUST contain:
Answer: Complete production and quality control records for each device batch or unit
21 CFR Part 820.184 requires the DHR to contain the complete production history of each device, including dates, quantities, acceptance records, and labeling.