BTC Safety & Regulatory Compliance 2

Question 1

Which federal agency enforces the Safe Medical Devices Act (SMDA) and requires hospitals to report device-related deaths and serious injuries?

Accepted Answer

FDA

Answer

The FDA enforces the SMDA, which mandates that hospitals and manufacturers report device-related deaths, serious injuries, or malfunctions.

Question 2

What is the maximum safe leakage current limit for chassis/enclosure current in a patient-care–related electrical appliance under NFPA 99?

Accepted Answer

300 µA

Answer

NFPA 99 specifies a chassis leakage current limit of 300 µA for patient-care–related electrical equipment.

Question 3

A biomedical technician discovers that a ventilator's manufacturer has issued a Class I recall. What is the correct immediate action?

Accepted Answer

Remove the device from service and notify clinical staff immediately

Answer

A Class I recall indicates a serious risk of harm; the device must be immediately taken out of service and clinical staff notified.

Question 4

Under OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030), what must be used when cleaning blood spills on biomedical equipment?

Accepted Answer

An EPA-registered disinfectant appropriate for bloodborne pathogens

Answer

OSHA requires use of an EPA-registered disinfectant effective against bloodborne pathogens for decontaminating blood spills.

Question 5

Which document must accompany a medical device returned to the manufacturer for repair to protect shipping personnel from biohazard exposure?

Accepted Answer

Decontamination/cleaning certificate

Answer

A decontamination certificate confirms the device has been cleaned and is safe to handle, protecting shipping and repair personnel.

(BTC) Biomedical Technician Certification Practice Test