CABT Healthcare Technology and Regulations 4

Question 1

When performing incoming inspection on a newly received infusion pump, a biomedical technician should FIRST:

Accepted Answer

Verify the device against the purchase order and check for shipping damage

Answer

Incoming inspection begins with verifying the received item matches the purchase order and inspecting for any physical damage from shipping.

Question 2

Under 21 CFR Part 820, which document describes the overall design requirements that a device must meet?

Accepted Answer

Design Input Document

Answer

Design input documents define the physical, chemical, and performance requirements that form the basis for device design under 21 CFR 820.30.

Question 3

A hospital is evaluating a new wireless patient monitoring system. From a cybersecurity regulatory standpoint, which FDA guidance is most relevant?

Accepted Answer

FDA Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

Answer

FDA's cybersecurity premarket guidance outlines expectations for manufacturers to address cybersecurity risks in medical device design and submissions.

Question 4

The primary goal of a Computerized Maintenance Management System (CMMS) in a healthcare technology department is to:

Accepted Answer

Manage inventory, schedule PMs, and maintain service records for medical equipment

Answer

A CMMS centralizes equipment inventory, preventive maintenance scheduling, work order tracking, and service history documentation for biomedical equipment.

Question 5

A Class I recall is initiated when a device has a reasonable probability of causing:

Accepted Answer

Serious adverse health consequences or death

Answer

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.

(CABT) Certified Associate in Biomedical Technology Practice Test

(CABT) Certified Associate in Biomedical Technology Practice Test

CABT Healthcare Technology and Regulations 4