Healthcare Technology and Regulations Flashcards
7 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 7 Healthcare Technology and Regulations flashcards as text
When performing incoming inspection on a newly received infusion pump, a biomedical technician should FIRST:
Answer: Verify the device against the purchase order and check for shipping damage
Incoming inspection begins with verifying the received item matches the purchase order and inspecting for any physical damage from shipping.
Under 21 CFR Part 820, which document describes the overall design requirements that a device must meet?
Answer: Design Input Document
Design input documents define the physical, chemical, and performance requirements that form the basis for device design under 21 CFR 820.30.
A hospital is evaluating a new wireless patient monitoring system. From a cybersecurity regulatory standpoint, which FDA guidance is most relevant?
Answer: FDA Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
FDA's cybersecurity premarket guidance outlines expectations for manufacturers to address cybersecurity risks in medical device design and submissions.
The primary goal of a Computerized Maintenance Management System (CMMS) in a healthcare technology department is to:
Answer: Manage inventory, schedule PMs, and maintain service records for medical equipment
A CMMS centralizes equipment inventory, preventive maintenance scheduling, work order tracking, and service history documentation for biomedical equipment.
A Class I recall is initiated when a device has a reasonable probability of causing:
Answer: Serious adverse health consequences or death
A Class I recall indicates the most serious situation where use of or exposure to the device will cause serious adverse health consequences or death.
Which standard covers requirements for medical device software lifecycle processes?
Answer: IEC 62304
IEC 62304 specifies life cycle requirements for medical device software development, maintenance, and risk management processes.
What is the purpose of a Unique Device Identifier (UDI) on medical devices as required by the FDA?
Answer: To allow adequate identification and traceability of devices through distribution and use
UDI enables standardized device identification and traceability throughout the distribution and use chain, supporting adverse event reporting and recalls.