CBA CBA Biomedical Equipment & Technology Assessment 2 — Questions and Answers
Question 1: The term 'incoming inspection' in biomedical equipment management refers to:
- Inspecting equipment before it is placed into clinical service for the first time (Correct answer)
- Checking equipment returned from repair
- Annual safety testing of all devices
- Reviewing manufacturer invoices upon delivery
Correct 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.
Question 2: Which organization publishes the AAMI TIR32 guidance used by biomedical auditors assessing medical device security?
- FDA
- The Joint Commission
- AAMI (Association for the Advancement of Medical Instrumentation) (Correct answer)
- NIST
Correct 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.
Question 3: During an audit, a biomedical technician states that equipment failures are fixed 'as time allows.' This MOST likely indicates a deficiency in:
- Corrective maintenance prioritization and response time policies (Correct answer)
- Staff credentialing requirements
- Device labeling compliance
- Annual budget planning
Correct 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.
Question 4: What is the PRIMARY purpose of an equipment management plan (EMP) in a healthcare organization?
- To track purchasing costs of new equipment
- To define the processes for managing the safety and performance of medical equipment (Correct answer)
- To schedule staff vacation around equipment delivery
- To list all vendors approved for equipment purchases
Correct 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.
Question 5: Under The Joint Commission's Environment of Care (EC) standards, a medical equipment management program must include:
- Proof of device purchase from accredited vendors only
- Criteria for identifying, evaluating, and taking inventory of equipment before use (Correct answer)
- Mandatory biennial equipment replacement schedules
- Agreement with a single authorized service provider
Correct 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.
Question 6: A 'device history record' (DHR) as required by 21 CFR Part 820 MUST contain:
- Marketing materials and pricing history
- Complete production and quality control records for each device batch or unit (Correct answer)
- Staff training logs for device operators
- Insurance coverage documentation
Correct 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.
CBA CBA Biomedical Equipment & Technology Assessment 2
The term 'incoming inspection' in biomedical equipment management refers to: