CABT Healthcare Technology and Regulations 4 — Questions and Answers
Question 1: When performing incoming inspection on a newly received infusion pump, a biomedical technician should FIRST:
- Perform a full safety test per IEC 60601-1
- Verify the device against the purchase order and check for shipping damage (Correct answer)
- Place the device immediately into service
- Update the CMMS with calibration due dates
Correct 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.
Question 2: Under 21 CFR Part 820, which document describes the overall design requirements that a device must meet?
- Device History Record (DHR)
- Design History File (DHF)
- Device Master Record (DMR)
- Design Input Document (Correct answer)
Correct 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.
Question 3: A hospital is evaluating a new wireless patient monitoring system. From a cybersecurity regulatory standpoint, which FDA guidance is most relevant?
- FDA Guidance on Mobile Medical Applications
- FDA Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Correct answer)
- NIST SP 800-53 exclusively
- IEC 62443 series
Correct 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.
Question 4: The primary goal of a Computerized Maintenance Management System (CMMS) in a healthcare technology department is to:
- Track employee work hours and payroll
- Manage inventory, schedule PMs, and maintain service records for medical equipment (Correct answer)
- Monitor network traffic on medical devices
- Store patient health records securely
Correct 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.
Question 5: A Class I recall is initiated when a device has a reasonable probability of causing:
- Minor adverse health consequences
- No health consequences but violates FDA labeling regulations
- Serious adverse health consequences or death (Correct answer)
- Only property damage with no human health risk
Correct 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.
Question 6: Which standard covers requirements for medical device software lifecycle processes?
- IEC 62304 (Correct answer)
- ISO 14971
- IEC 60601-1
- ISO 9001
Correct answer: IEC 62304
IEC 62304 specifies life cycle requirements for medical device software development, maintenance, and risk management processes.
Question 7: What is the purpose of a Unique Device Identifier (UDI) on medical devices as required by the FDA?
- To encrypt patient data stored on the device
- To allow adequate identification and traceability of devices through distribution and use (Correct answer)
- To certify the device meets ISO 13485 standards
- To assign a reimbursement code for insurance billing
Correct 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.
CABT Healthcare Technology and Regulations 4
When performing incoming inspection on a newly received infusion pump, a biomedical technician should FIRST: