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
Which standard provides the primary framework for managing medical device quality in the US and is enforced by the FDA?
Answer: 21 CFR Part 820
21 CFR Part 820, the FDA's Quality System Regulation, is the primary US federal standard governing medical device quality management.
A biomedical auditor reviewing preventive maintenance records finds no evidence of scheduled PM for a critical patient monitor for 18 months. The BEST immediate action is to:
Answer: Issue a major nonconformance and recommend device quarantine
A critical device with no PM for 18 months represents a major nonconformance and a patient safety risk requiring immediate corrective action including potential device quarantine.
IEC 62353 is the international standard specifically governing:
Answer: Recurring testing of medical electrical equipment
IEC 62353 specifies methods for recurring testing (after repair or servicing) of medical electrical equipment to ensure continued safety.
When auditing a hospital's biomedical equipment inventory, which attribute is MOST critical for traceability?
Answer: Unique device identifier (UDI) and service history
The UDI combined with complete service history enables full traceability of medical devices as required by FDA regulations and accreditation standards.
Which of the following BEST describes a 'risk-based' approach to biomedical equipment inspection frequency?
Answer: Assign inspection intervals based on device criticality, failure risk, and patient impact
A risk-based approach tailors inspection intervals to each device's clinical criticality, failure rate, and potential patient harm, optimizing resource allocation.
A biomedical auditor discovers that calibration stickers on infusion pumps have expired dates. Which standard is MOST likely cited as nonconformant?
Answer: 21 CFR Part 820.72
21 CFR Part 820.72 requires that inspection, measuring, and test equipment be calibrated at defined intervals, with records of calibration maintained.