Public Safety and Regulations Flashcards
7 cards from real CBET practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Public Safety and Regulations flashcards as text
A hospital is evaluating whether to include a newly purchased infusion pump in its equipment management program. According to a risk-based approach, which factor is MOST important in making this determination?
Answer: The potential risk to patients if the device fails
A risk-based equipment management approach prioritizes patient risk upon device failure as the primary factor when deciding on inclusion and maintenance strategy.
A Safe Medical Devices Act (SMDA) requirement obligates hospitals to report device-related serious injuries to:
Answer: Both the FDA and the device manufacturer
Under the SMDA, user facilities must report serious injuries caused by medical devices to both the FDA and the manufacturer within 10 working days.
What is the primary purpose of a Ground Fault Circuit Interrupter (GFCI) in patient care areas?
Answer: To detect current leakage to ground and interrupt the circuit to prevent shock
A GFCI continuously monitors current flow and trips the circuit when it detects as little as 4–6 mA of ground fault current, protecting against electrocution.
Which NFPA 99 requirement applies specifically to wet locations in healthcare facilities such as hydrotherapy areas?
Answer: GFCI protection is required for all receptacles
NFPA 99 requires GFCI protection on all receptacles in wet procedure locations to reduce electrocution risk in areas where water is routinely present.
An alarm fatigue situation in an ICU poses a patient safety risk. According to The Joint Commission's National Patient Safety Goals, hospitals should address alarm safety by:
Answer: Establishing policies to manage alarm systems, including setting default parameters
TJC NPSG.06.01.01 requires hospitals to establish policies and procedures for managing alarms, including setting appropriate default alarm parameters for clinical areas.
Under the Health Insurance Portability and Accountability Act (HIPAA), a BMET who accesses patient data stored on a medical device must:
Answer: Access only the minimum necessary information and follow facility data handling policies
HIPAA's minimum necessary standard requires workforce members to access only the protected health information needed to perform their job function.
A BMET is performing electrical safety testing on a device and measures patient leakage current that exceeds allowable limits under ANSI/AAMI ES60601-1. The MOST appropriate next step is to:
Answer: Remove the device from service, document findings, and initiate repair before return to use
A device that fails electrical safety testing must be removed from service immediately, the failure documented, and the device repaired and retested before being returned to patient use.