CBET - Certified Biomedical Equipment Technician Public Safety and Regulations Questions and Answers 1

Question 1

A hospital discovers that a specific model of infusion pump may have contributed to a patient's serious injury. According to the Safe Medical Devices Act (SMDA), what is the user facility's primary reporting responsibility?

Accepted Answer

Report the event to the manufacturer within 10 working days.

Answer

The Safe Medical Devices Act (SMDA) of 1990 requires user facilities, such as hospitals, to report a medical device-related serious injury to the manufacturer. If the manufacturer is unknown, the report must be made to the FDA. The report must be filed within 10 working days of the facility becoming aware of the event.

Question 2

The FDA issues a recall for a medical device because its use presents a reasonable probability of causing serious adverse health consequences or death. How would this recall be classified?

Accepted Answer

Class I

Answer

The FDA classifies recalls into three categories. A Class I recall is the most serious type, used when there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Question 3

A CBET is working in a newly constructed critical care unit. According to the risk-based approach of NFPA 99, systems and equipment whose failure is likely to cause major injury or death to patients or caregivers would be designated as which category?

Accepted Answer

Category 1

Answer

NFPA 99 uses a risk-based classification system. Category 1 is assigned to systems and equipment where failure is likely to cause major injury or death. This category requires the most stringent design and testing standards to ensure reliability and safety.

Question 4

Which of the following is a key requirement of The Joint Commission's Environment of Care (EC) standards regarding a hospital's medical equipment management plan?

Accepted Answer

Maintaining a complete and accurate inventory of all medical equipment, regardless of ownership.

Answer

The Joint Commission's standard EC.02.04.01 requires hospitals to maintain a current, accurate, and separate inventory for all medical equipment in their medical equipment management program, including equipment that is owned, leased, or rented. This inventory is critical for tracking recalls, scheduling maintenance, and managing safety.

Question 5

A BMET is tasked with decommissioning several old patient monitors that contain ePHI. Under the HIPAA Security Rule's Physical Safeguards, which standard specifically addresses the proper handling of this task?

Accepted Answer

Device and Media Controls

Answer

The HIPAA Security Rule's Physical Safeguards include the 'Device and Media Controls' standard. This standard requires covered entities to implement policies and procedures for the secure movement, removal, disposal, and re-use of electronic media and hardware that contains electronic Protected Health Information (ePHI).

CBET - Certified Biomedical Equipment Technician Practice Test

CBET - Certified Biomedical Equipment Technician Practice Test

CBET - Certified Biomedical Equipment Technician Public Safety and Regulations Questions and Answers 1