BTC Patient Assessment & Documentation 3 — Questions and Answers
Question 1: A biomedical technician receives a work order flagged 'STAT' for a ventilator in the ICU. The first action before touching the device should be:
- Power cycle the device to clear the alarm
- Consult with the bedside nurse about current patient status and device use (Correct answer)
- Replace the internal battery as a precaution
- Complete the work order paperwork before intervening
Correct answer: Consult with the bedside nurse about current patient status and device use
Before servicing any patient-connected device, the technician must communicate with clinical staff to assess patient status and coordinate safe handoff of care.
Question 2: In biomedical equipment documentation, the term 'out-of-service' means the device:
- Has been permanently retired from clinical use
- Has been removed from patient use pending repair or inspection (Correct answer)
- Is undergoing scheduled preventive maintenance only
- Has passed all safety checks and is cleared for use
Correct answer: Has been removed from patient use pending repair or inspection
'Out-of-service' designates equipment temporarily removed from patient use until it is inspected, repaired, or cleared as safe.
Question 3: When assessing a patient's bedside monitor for electromagnetic interference (EMI), which environmental factor should be documented in the service report?
- Patient's medication list
- Proximity to other active radiofrequency-emitting devices (Correct answer)
- Room temperature only
- Nurse-to-patient staffing ratio
Correct answer: Proximity to other active radiofrequency-emitting devices
Nearby radiofrequency-emitting devices (e.g., wireless transmitters, surgical equipment) are the primary environmental source of EMI and must be documented.
Question 4: Which document serves as the legal chain-of-custody record when a medical device is removed from service for failure investigation?
- Preventive maintenance schedule
- Device sequestration form or equipment hold tag (Correct answer)
- Annual capital equipment budget report
- Manufacturer's service bulletin
Correct answer: Device sequestration form or equipment hold tag
A sequestration form or equipment hold tag documents who removed the device, when, and why, preserving chain of custody for legal or regulatory review.
Question 5: During a pre-use safety check of a defibrillator, the biomedical technician finds the patient cable has a cracked insulator. The correct documentation action is to:
- Note it in the log but allow limited use with supervision
- Tag the device out-of-service, document defect, and remove from clinical area (Correct answer)
- Apply electrical tape and record the repair in the daily check log
- Inform the charge nurse verbally with no written record
Correct answer: Tag the device out-of-service, document defect, and remove from clinical area
A cracked cable insulator is a patient safety hazard requiring immediate out-of-service tagging, written documentation, and removal from patient care.
Question 6: The primary purpose of a 'device history record' (DHR) as defined by FDA 21 CFR Part 820 is to:
- Track capital equipment depreciation for finance teams
- Demonstrate that a device was manufactured in conformance with the device master record (Correct answer)
- Record in-hospital preventive maintenance schedules
- Log patient adverse events associated with the device
Correct answer: Demonstrate that a device was manufactured in conformance with the device master record
Per FDA 21 CFR Part 820, the DHR documents that each production unit was manufactured according to the device master record (DMR), ensuring manufacturing compliance.
Question 7: When completing biomedical equipment service documentation, which identifier is most important for traceability across multiple hospital systems?
- Department cost center number
- Manufacturer serial number
- Biomedical asset (inventory) control number (Correct answer)
- PM due date
Correct answer: Biomedical asset (inventory) control number
The biomedical asset control number is the hospital's unique identifier that links the device across CMMS, purchasing, and clinical department records for full traceability.
BTC Patient Assessment & Documentation 3
A biomedical technician receives a work order flagged 'STAT' for a ventilator in the ICU.
The first action before touching the device should be: