CBET Public Safety and Regulations 4

Question 1

Under NFPA 99, which category of healthcare facility has the highest risk level requiring the most stringent electrical safety standards?

Accepted Answer

Category 1

Answer

NFPA 99 Category 1 applies to spaces where failure of equipment is likely to cause major injury or death to patients or caregivers, requiring the most stringent standards.

Question 2

A BMET discovers that a ventilator's power cord has a damaged third prong (ground pin). The BEST immediate action is to:

Accepted Answer

Tag the device out of service and remove it from clinical use

Answer

A damaged ground pin creates a shock hazard; the device must be immediately taken out of service, tagged, and repaired before returning to clinical use.

Question 3

Which FDA regulation class typically applies to life-sustaining devices such as pacemakers, requiring the highest level of regulatory control?

Accepted Answer

Class III

Answer

FDA Class III devices are life-sustaining or life-supporting devices subject to the most stringent regulatory controls, including premarket approval (PMA).

Question 4

A hospital's biomedical department receives a Medical Device Report (MDR) obligation. This obligation is triggered when a device:

Accepted Answer

Has caused or contributed to a serious injury or death

Answer

FDA MDR regulations (21 CFR Part 803) require facilities to report when a device has malfunctioned and caused or contributed to serious patient injury or death.

Question 5

The Joint Commission's Environment of Care (EC) standards require medical equipment management programs to include which of the following?

Accepted Answer

Risk-based selection criteria for preventive maintenance intervals

Answer

TJC EC standards require a risk-based approach to determine appropriate maintenance strategies and intervals for medical equipment.

CBET - Certified Biomedical Equipment Technician Practice Test

CBET - Certified Biomedical Equipment Technician Practice Test

CBET Public Safety and Regulations 4