CBET Public Safety and Regulations 4 — Questions and Answers
Question 1: Under NFPA 99, which category of healthcare facility has the highest risk level requiring the most stringent electrical safety standards?
- Category 1 (Correct answer)
- Category 2
- Category 3
- Category 4
Correct answer: Category 1
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:
- Tag the device out of service and remove it from clinical use (Correct answer)
- Tape the cord and return the device to service
- Use a two-prong adapter until repairs can be scheduled
- Continue using the device since the ground is a redundant safety measure
Correct answer: Tag the device out of service and remove it from clinical use
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?
- Class I
- Class II
- Class III (Correct answer)
- Class IV
Correct answer: Class III
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:
- Requires routine maintenance ahead of schedule
- Has caused or contributed to a serious injury or death (Correct answer)
- Fails a preventive maintenance inspection
- Is recalled by the manufacturer for cosmetic defects
Correct answer: Has caused or contributed to a serious injury or death
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?
- Risk-based selection criteria for preventive maintenance intervals (Correct answer)
- Mandatory daily inspection of all patient care equipment
- On-site repair of all devices within 24 hours
- Annual replacement of all Class II devices
Correct answer: Risk-based selection criteria for preventive maintenance intervals
TJC EC standards require a risk-based approach to determine appropriate maintenance strategies and intervals for medical equipment.
Question 6: According to OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030), which personal protective equipment is required when a BMET services equipment contaminated with blood?
- Safety glasses only
- Gloves only
- Appropriate PPE including gloves and face protection as needed (Correct answer)
- N95 respirator and full-body suit only
Correct answer: Appropriate PPE including gloves and face protection as needed
OSHA requires employees to use appropriate PPE—such as gloves, gowns, masks, and eye protection—based on the anticipated exposure when handling bloodborne pathogen risks.
Question 7: Which standard specifies that the maximum allowable leakage current for chassis-to-ground on patient care equipment (normal condition) is 300 µA?
- ANSI/AAMI ES60601-1 (Correct answer)
- NFPA 70
- IEC 62353
- OSHA 29 CFR 1910
Correct answer: ANSI/AAMI ES60601-1
ANSI/AAMI ES60601-1 (derived from IEC 60601-1) specifies chassis leakage current limits for medical electrical equipment, with 300 µA as the normal-condition limit for patient care equipment.
CBET Public Safety and Regulations 4
Under NFPA 99, which category of healthcare facility has the highest risk level requiring the most stringent electrical safety standards?