CBA CBA Biomedical Equipment & Technology Assessment 3

Question 1

Electrical safety testing of medical equipment in the US most commonly references which standard to determine leakage current limits?

Accepted Answer

ANSI/AAMI ES60601-1

Answer

IEC 60601-1

Answer

NFPA 101

Answer

21 CFR Part 880

Question 2

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:

Accepted Answer

EMC assessments are required to prevent device interference that could compromise patient safety

Answer

Wireless devices are banned in clinical settings by FDA

Answer

All devices must be wired per NFPA 99

Answer

EMC is only relevant to laboratory equipment

Question 3

When auditing end-of-life (EOL) medical device management, the auditor's MAIN concern should be:

Accepted Answer

Whether EOL devices are identified, segregated, and disposed of per regulatory and environmental requirements

Answer

Whether devices were purchased at competitive prices

Answer

Whether the device manufacturer is still in business

Answer

Whether clinical staff prefer newer models

Question 4

Which metric is MOST useful for a biomedical auditor evaluating the effectiveness of a preventive maintenance program?

Accepted Answer

PM completion rate (percentage of scheduled PMs completed on time)

Answer

Total number of devices in inventory

Answer

Number of biomedical technicians employed

Answer

Total cost of replacement parts purchased

Question 5

A hospital biomedical department outsources service on complex imaging equipment to an OEM. During an audit, which document is MOST critical to review?

Accepted Answer

The service contract, qualification records, and access to service reports

Answer

The OEM's stock price history

Answer

The OEM's advertising materials

Answer

The department's annual budget variance

Question 6

ECRI Institute's health technology assessment reports are most useful to a CBA auditor when:

Accepted Answer

Evaluating the safety, efficacy, and risk profile of medical technologies during procurement audits

Answer

Selecting paint colors for the biomedical workshop

Answer

Calculating equipment depreciation for tax purposes

Answer

Determining staff overtime eligibility