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
Electrical safety testing of medical equipment in the US most commonly references which standard to determine leakage current limits?
Answer: ANSI/AAMI ES60601-1
ANSI/AAMI ES60601-1 is the US-adopted version of IEC 60601-1, specifying safety requirements and leakage current limits for medical electrical equipment.
A biomedical auditor finds that a hospital performs no electromagnetic compatibility (EMC) assessments when placing new wireless devices near existing medical equipment. This is a nonconformance because:
Answer: EMC assessments are required to prevent device interference that could compromise patient safety
EMC assessments are essential to ensure wireless devices do not interfere with nearby medical equipment, a requirement addressed in IEC 60601-1-2 and FDA guidance.
When auditing end-of-life (EOL) medical device management, the auditor's MAIN concern should be:
Answer: Whether EOL devices are identified, segregated, and disposed of per regulatory and environmental requirements
EOL management must ensure that retired medical devices are properly identified, removed from service, and disposed of in compliance with regulatory and environmental regulations.
Which metric is MOST useful for a biomedical auditor evaluating the effectiveness of a preventive maintenance program?
Answer: PM completion rate (percentage of scheduled PMs completed on time)
PM completion rate directly measures whether scheduled maintenance is being executed as planned, making it the primary KPI for PM program effectiveness.
A hospital biomedical department outsources service on complex imaging equipment to an OEM. During an audit, which document is MOST critical to review?
Answer: The service contract, qualification records, and access to service reports
When service is outsourced, auditors must verify that service contracts define scope, that service providers are qualified, and that service records are accessible to the hospital.
ECRI Institute's health technology assessment reports are most useful to a CBA auditor when:
Answer: Evaluating the safety, efficacy, and risk profile of medical technologies during procurement audits
ECRI Institute publishes independent, evidence-based technology assessments that help auditors and healthcare organizations evaluate device safety and effectiveness during procurement.