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

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

Report the event to the hospital's risk management department only.

Answer

Report the event to The Joint Commission within 30 days.

Answer

Report the event directly to the patient's family and the FDA.

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

Class A

Answer

Class III

Answer

Class II

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

Category A

Answer

Category 4

Answer

Category 2

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

Performing preventive maintenance on at least 75% of life-support equipment annually.

Answer

Outsourcing all medical equipment maintenance to third-party vendors.

Answer

Replacing all medical devices every five years to comply with technology standards.

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

Facility Access Controls

Answer

Workstation Use

Answer

Contingency Operations

Question 6

A biomedical engineering department is developing an Alternative Equipment Maintenance (AEM) program. According to The Joint Commission, which of the following is a critical requirement for equipment included in an AEM program?

Accepted Answer

Scheduled maintenance completion for high-risk equipment in an AEM program must be 100%.

Answer

AEM programs can only be applied to non-medical, facility-related equipment.

Answer

The manufacturer must provide written approval before a device can be placed on an AEM.

Answer

All equipment on an AEM program must be less than two years old.

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?

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?