CBA CBA Biomedical Equipment & Technology Assessment 1 — Questions and Answers
Question 1: Which standard provides the primary framework for managing medical device quality in the US and is enforced by the FDA?
- ISO 9001
- 21 CFR Part 820 (Correct answer)
- ISO 13485
- IEC 62353
Correct 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.
Question 2: 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:
- Issue a major nonconformance and recommend device quarantine (Correct answer)
- Document a minor finding and schedule follow-up
- Retrain the biomedical technician
- Update the PM schedule going forward
Correct 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.
Question 3: IEC 62353 is the international standard specifically governing:
- Electromagnetic compatibility of medical devices
- Recurring testing of medical electrical equipment (Correct answer)
- Sterilization of healthcare products
- Software lifecycle for medical devices
Correct 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.
Question 4: When auditing a hospital's biomedical equipment inventory, which attribute is MOST critical for traceability?
- Device color and location
- Unique device identifier (UDI) and service history (Correct answer)
- Manufacturer's suggested retail price
- Number of staff trained on the device
Correct 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.
Question 5: Which of the following BEST describes a 'risk-based' approach to biomedical equipment inspection frequency?
- Inspect all devices on the same annual schedule
- Assign inspection intervals based on device criticality, failure risk, and patient impact (Correct answer)
- Inspect devices only after a reported failure
- Defer to the manufacturer's recommended schedule regardless of clinical use
Correct 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.
Question 6: A biomedical auditor discovers that calibration stickers on infusion pumps have expired dates. Which standard is MOST likely cited as nonconformant?
- NFPA 99
- 21 CFR Part 820.72 (Correct answer)
- ISO 14971
- ANSI/AAMI ES60601-1
Correct 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.
CBA CBA Biomedical Equipment & Technology Assessment 1
Which standard provides the primary framework for managing medical device quality in the US and is enforced by the FDA?