CABT Healthcare Technology and Regulations Questions and Answers

Question 1

According to the U.S. Food and Drug Administration (FDA), which of the following best describes a Class III medical device?

Accepted Answer

Devices that support or sustain human life, are of substantial importance in preventing impairment of health, and present the highest risk.

Answer

Devices with moderate risk that require special controls, such as infusion pumps.

Answer

Devices with the lowest risk that are subject to general controls, such as tongue depressors.

Answer

Devices used exclusively for clinical research under an Investigational Device Exemption (IDE).

Question 2

A biomedical technician is servicing a diagnostic imaging system and finds a spreadsheet on the desktop containing a list of patient names and their medical record numbers. According to the Health Insurance Portability and Accountability Act (HIPAA), what is the most appropriate immediate action?

Accepted Answer

Report the finding to their immediate supervisor and the facility's designated Privacy Officer.

Answer

Delete the file immediately to prevent unauthorized access by others.

Answer

Ignore the file, as the technician is not a clinical user of the system.

Answer

Make a copy of the file onto an encrypted drive as evidence of the breach.

Question 3

During a survey, The Joint Commission (TJC) is evaluating a hospital's Medical Equipment Management Plan. Which of the following is a critical performance metric TJC will review to ensure equipment safety and reliability?

Accepted Answer

The on-time completion percentage for scheduled equipment maintenance.

Answer

The brand of test equipment used for preventive maintenance procedures.

Answer

The average cost of repairs for each device category.

Answer

The number of new medical devices acquired in the last fiscal year.

Question 4

A hospital becomes aware that a patient's death may have been the result of a malfunction in a medical device. Under the requirements of the Safe Medical Devices Act (SMDA), the user facility must report the incident to:

Accepted Answer

Both the manufacturer and the FDA, within 10 working days.

Answer

The device manufacturer only, within 30 days.

Answer

The Food and Drug Administration (FDA) only, within 24 hours.

Answer

The hospital's legal department and insurance carrier only.

Question 5

A manufacturer releases a critical cybersecurity patch for a networked physiological monitoring system to address a newly discovered vulnerability. What is the best practice for the Healthcare Technology Management (HTM) department to follow?

Accepted Answer

Follow the facility's change control process to test the patch before deploying it in a planned manner.

Answer

Immediately disconnect all affected monitors from the network until they can be replaced.

Answer

Deploy the patch to all devices during peak hours to ensure it works under load.

Answer

Ignore the patch, as it might interfere with the clinical workflow.

Question 6

A new biomedical technician is looking for a comprehensive, consensus-based standard on recommended practices for electrical safety testing and medical equipment management in a healthcare facility. Which organization would be the primary source for this type of guidance?

Accepted Answer

The Association for the Advancement of Medical Instrumentation (AAMI).

Answer

The Occupational Safety and Health Administration (OSHA).

Answer

The Joint Commission (TJC).

Answer

The National Fire Protection Association (NFPA).

According to the U.S.Food and Drug Administration (FDA), which of the following best describes a Class III medical device?

According to the U.S.
Food and Drug Administration (FDA), which of the following best describes a Class III medical device?