CBA CBA Biomedical Equipment & Technology Assessment 1

Question 1

Which standard provides the primary framework for managing medical device quality in the US and is enforced by the FDA?

Accepted Answer

21 CFR Part 820

Answer

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:

Accepted Answer

Issue a major nonconformance and recommend device quarantine

Answer

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:

Accepted Answer

Recurring testing of medical electrical equipment

Answer

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?

Accepted Answer

Unique device identifier (UDI) and service history

Answer

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?

Accepted Answer

Assign inspection intervals based on device criticality, failure risk, and patient impact

Answer

A risk-based approach tailors inspection intervals to each device's clinical criticality, failure rate, and potential patient harm, optimizing resource allocation.

(CBA) Certified Biomedical Auditor Practice Test

(CBA) Certified Biomedical Auditor Practice Test

CBA CBA Biomedical Equipment & Technology Assessment 1