MDRAO Identification 3 — Questions and Answers
Question 1: According to MDRAO guidelines, which document is the primary reference for identifying correct reprocessing parameters for a specific device?
- The facility's general reprocessing policy
- The manufacturer's Instructions for Use (IFU) (Correct answer)
- A colleague's prior experience with the device
- The device's purchase invoice
Correct answer: The manufacturer's Instructions for Use (IFU)
Manufacturer IFUs are the authoritative source for device-specific reprocessing parameters and must be followed for safe identification and processing.
Question 2: A stainless-steel instrument has a matte finish on one half and a mirror finish on the other. Why is finish identification important in reprocessing?
- Finish determines the sterilization temperature only
- Finish has no bearing on reprocessing decisions
- Certain finishes may require modified cleaning techniques to prevent damage and ensure efficacy (Correct answer)
- Mirror finishes require high-level disinfection instead of sterilization
Correct answer: Certain finishes may require modified cleaning techniques to prevent damage and ensure efficacy
Surface finish can influence the effectiveness of cleaning agents and mechanical action, so correct identification guides appropriate technique selection.
Question 3: Which identifier on a biological indicator (BI) envelope is checked FIRST after incubation to interpret results?
- The incubation temperature log
- The color change of the growth medium compared to the positive control (Correct answer)
- The technician's name on the label
- The sterilizer's chamber pressure reading
Correct answer: The color change of the growth medium compared to the positive control
BI results are interpreted by comparing the test BI's medium color to the positive control; a color match indicates sterilization failure.
Question 4: When identifying devices with heat-sensitive components, which material property requires alternative sterilization method selection?
- High carbon steel alloy content
- Polymer or plastic components with low melting points (Correct answer)
- Chromium plating thickness
- Tungsten carbide inserts
Correct answer: Polymer or plastic components with low melting points
Heat-sensitive polymers and plastics cannot withstand steam sterilization temperatures and must be identified for low-temperature sterilization alternatives.
Question 5: A technician is uncertain whether a device is single-use or reusable. What is the regulatory standard in Canada regarding single-use devices (SUDs)?
- SUDs may be reprocessed if they appear undamaged
- SUDs are reusable if the facility has a validated reprocessing program
- Single-use designation by the manufacturer must be respected unless a licensed third-party reprocessor validates reuse (Correct answer)
- SUDs and reusable devices have identical reprocessing requirements
Correct answer: Single-use designation by the manufacturer must be respected unless a licensed third-party reprocessor validates reuse
Health Canada regulations require that SUD reprocessing be performed only by licensed reprocessors with validated processes; facility-level reuse without validation is prohibited.
Question 6: What information on a sterilization load record is used to identify which patients received instruments from a recalled lot?
- Autoclave operator shift time
- Load number, sterilizer ID, and date linked to patient procedure records (Correct answer)
- Chamber temperature graph only
- The color of the wrapping material
Correct answer: Load number, sterilizer ID, and date linked to patient procedure records
Traceability systems link load number and sterilizer ID to patient records, enabling rapid identification of affected patients during a recall.
Question 7: Which symbol on a medical device label indicates it is a single-use item according to ISO standards?
- A circle with an arrow
- The number 2 inside a circle with a line through it (Correct answer)
- A triangle with an exclamation mark
- Two interlocking arrows
Correct answer: The number 2 inside a circle with a line through it
ISO 7000-1051 defines the 'do not reuse' symbol as the numeral 2 inside a circle with a diagonal line, universally indicating single-use.
MDRAO Identification 3
According to MDRAO guidelines, which document is the primary reference for identifying correct reprocessing parameters for a specific device?