CABT Healthcare Technology and Regulations Questions and Answers — 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?
- Devices with moderate risk that require special controls, such as infusion pumps.
- Devices with the lowest risk that are subject to general controls, such as tongue depressors.
- Devices that support or sustain human life, are of substantial importance in preventing impairment of health, and present the highest risk. (Correct answer)
- Devices used exclusively for clinical research under an Investigational Device Exemption (IDE).
Correct answer: Devices that support or sustain human life, are of substantial importance in preventing impairment of health, and present the highest risk.
The FDA classifies medical devices based on risk. Class I devices have the lowest risk, Class II have moderate risk, and Class III devices have the highest risk. Class III devices, such as pacemakers and heart valves, are typically life-sustaining or implantable and require a rigorous Premarket Approval (PMA) process.
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?
- Report the finding to their immediate supervisor and the facility's designated Privacy Officer. (Correct answer)
- Delete the file immediately to prevent unauthorized access by others.
- Ignore the file, as the technician is not a clinical user of the system.
- Make a copy of the file onto an encrypted drive as evidence of the breach.
Correct answer: Report the finding to their immediate supervisor and the facility's designated Privacy Officer.
The discovery of unsecured Protected Health Information (PHI) is a potential data breach under HIPAA. The technician's duty is not to independently decide how to handle the data (e.g., deleting or copying it) but to follow organizational policy by reporting the incident through the proper channels, which always includes their supervisor and the HIPAA Privacy/Security Officer.
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?
- The brand of test equipment used for preventive maintenance procedures.
- The on-time completion percentage for scheduled equipment maintenance. (Correct answer)
- The average cost of repairs for each device category.
- The number of new medical devices acquired in the last fiscal year.
Correct answer: The on-time completion percentage for scheduled equipment maintenance.
The Joint Commission emphasizes proactive risk management. A key indicator of a healthy Medical Equipment Management Plan is a high completion rate for scheduled preventive maintenance (PM). This demonstrates the hospital is actively maintaining its equipment to ensure it is safe and functions as intended, which directly impacts patient safety.
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:
- The device manufacturer only, within 30 days.
- The Food and Drug Administration (FDA) only, within 24 hours.
- Both the manufacturer and the FDA, within 10 working days. (Correct answer)
- The hospital's legal department and insurance carrier only.
Correct answer: Both the manufacturer and the FDA, within 10 working days.
The Safe Medical Devices Act (SMDA) of 1990 mandates that user facilities (e.g., hospitals) report device-related deaths to both the manufacturer and the FDA. The report must be submitted within 10 working days of the facility becoming aware of the event. This dual reporting ensures that both the regulatory body and the company responsible for the device are aware of potentially serious issues.
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?
- Immediately disconnect all affected monitors from the network until they can be replaced.
- Deploy the patch to all devices during peak hours to ensure it works under load.
- Ignore the patch, as it might interfere with the clinical workflow.
- Follow the facility's change control process to test the patch before deploying it in a planned manner. (Correct answer)
Correct answer: Follow the facility's change control process to test the patch before deploying it in a planned manner.
While urgent, applying any software patch to a medical device carries the risk of unintended consequences. The best practice is to adhere to a formal change control process. This involves risk assessment, testing the patch (if possible on a non-production device), and scheduling the deployment to minimize disruption to patient care, all while ensuring the security vulnerability is addressed in a timely fashion.
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?
- The Occupational Safety and Health Administration (OSHA).
- The Joint Commission (TJC).
- The National Fire Protection Association (NFPA).
- The Association for the Advancement of Medical Instrumentation (AAMI). (Correct answer)
Correct answer: The Association for the Advancement of Medical Instrumentation (AAMI).
While NFPA (specifically NFPA 99) and TJC are critical for regulations and accreditation, AAMI is the primary organization that develops detailed, consensus-based standards (like ANSI/AAMI EQ56) and technical information reports (TIRs) specifically for the testing, maintenance, and management of medical instrumentation.
CABT Healthcare Technology and Regulations Questions and Answers
According to the U.S.
Food and Drug Administration (FDA), which of the following best describes a Class III medical device?