BTC Quality Assurance & Standards 2 — Questions and Answers
Question 1: Which FDA regulation governs the quality system requirements for medical device manufacturers in the United States?
- 21 CFR Part 820 (Correct answer)
- 21 CFR Part 11
- 21 CFR Part 210
- 21 CFR Part 111
Correct answer: 21 CFR Part 820
21 CFR Part 820, known as the Quality System Regulation (QSR), sets forth quality system requirements for medical device manufacturers.
Question 2: A biomedical technician discovers that a defibrillator has been repaired using a non-OEM replacement part not listed in the device's approved parts list. The best immediate action is to:
- Tag the device out of service and notify the supervisor (Correct answer)
- Return the device to service if it passes functional testing
- Document the deviation and continue using the device
- Contact the manufacturer for retroactive approval
Correct answer: Tag the device out of service and notify the supervisor
Using unapproved parts may violate the manufacturer's specifications and FDA regulations, requiring the device to be removed from service until the issue is resolved.
Question 3: In ISO 9001 quality management, what is the primary purpose of a corrective action?
- To eliminate the root cause of a nonconformity (Correct answer)
- To prevent a potential problem from occurring
- To document all identified defects
- To retrain staff on standard procedures
Correct answer: To eliminate the root cause of a nonconformity
Corrective action targets the root cause of an existing nonconformity to prevent its recurrence, distinguishing it from preventive action.
Question 4: Which of the following best describes 'design validation' in the context of medical device QA?
- Confirming the device meets user needs under actual or simulated conditions (Correct answer)
- Verifying that design outputs meet design input specifications
- Reviewing engineering drawings for accuracy
- Testing the device in a laboratory environment only
Correct answer: Confirming the device meets user needs under actual or simulated conditions
Design validation confirms that the finished device meets the intended use requirements under real-world or simulated conditions, including user needs.
Question 5: An incoming inspection program for biomedical equipment should include:
- Verification of device labeling, safety checks, and performance testing before clinical use (Correct answer)
- Only a visual inspection of packaging integrity
- Functional testing only if the device is high-risk
- Review of the purchase order and delivery receipt
Correct answer: Verification of device labeling, safety checks, and performance testing before clinical use
Incoming inspection must verify labeling accuracy, physical condition, safety parameters, and performance against specifications before any device enters clinical use.
Question 6: The AAMI standard TIR45 provides guidance on:
- Applying IEC 62443 cybersecurity standards to medical devices (Correct answer)
- Cleaning and disinfection of reusable medical equipment
- Electrical safety testing intervals for patient-connected devices
- Maintenance documentation practices for HTM departments
Correct answer: Applying IEC 62443 cybersecurity standards to medical devices
AAMI TIR45 is a technical information report that provides guidance on applying the IEC 62443 series of cybersecurity standards to medical devices.
Question 7: When a medical device fails an electrical safety test, the technician should:
- Remove it from service, tag it, and initiate a repair and re-test cycle (Correct answer)
- Adjust the test equipment settings to obtain a passing result
- Notify clinical staff to reduce usage frequency
- Document the failure and retest after 30 days
Correct answer: Remove it from service, tag it, and initiate a repair and re-test cycle
A device that fails electrical safety testing must be immediately removed from service, tagged, repaired, and retested before being returned to clinical use.
BTC Quality Assurance & Standards 2
Which FDA regulation governs the quality system requirements for medical device manufacturers in the United States?