Healthcare Technology and Regulations Flashcards
6 cards from real CABT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Healthcare Technology and Regulations flashcards as text
According to the U.S. Food and Drug Administration (FDA), which of the following best describes a Class III medical device?
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.
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?
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.
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?
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.
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:
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.
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?
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.
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?
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.