MDRAO - Medical Device Reprocessing Association of Ontario Instrument Assembly and Packaging Questions and Answers 1 — Questions and Answers
Question 1: A multi-level instrument tray is being prepared for steam sterilization. According to Canadian Standards Association (CSA) guidelines, where must an internal chemical indicator be placed?
- Only on the top level, in the geometric center.
- In the geometric center of each level. (Correct answer)
- In two opposite corners of the bottom tray only.
- Attached to the exterior of the wrapped tray.
Correct answer: In the geometric center of each level.
According to CAN/CSA-Z314-18, if a multi-layer container is being used, a chemical indicator must be placed on each level. This ensures that the sterilant has penetrated all layers of the set, which is critical for verifying the effectiveness of the sterilization cycle throughout the entire tray.
Question 2: When assembling an instrument set, what is the correct procedure for items with hinges, such as hemostats or scissors?
- Closed and locked to prevent damage during transport.
- Placed on a stringer or rack in an open and unlocked position. (Correct answer)
- Tightly packed together to maximize space within the tray.
- Dipped in an oil-based lubricant to ensure smooth operation.
Correct answer: Placed on a stringer or rack in an open and unlocked position.
Hinged instruments must be kept in an open and unlocked position during sterilization. This allows the sterilant (e.g., steam) to make direct contact with all surfaces, including the critical box lock and jaw areas, which would be obstructed if the instrument were closed.
Question 3: A Medical Device Reprocessing Technician is packaging a single, heat-sensitive, flexible endoscope for low-temperature sterilization. Which of the following packaging materials would be MOST appropriate?
- Woven textile wraps.
- Standard paper-plastic peel pouches.
- Tyvek (all-plastic) pouches. (Correct answer)
- Rigid, sealed metal container.
Correct answer: Tyvek (all-plastic) pouches.
Tyvek (a brand of flashspun high-density polyethylene fibers) is a breathable material compatible with low-temperature sterilization methods like ethylene oxide (EtO) and hydrogen peroxide gas plasma. Standard paper-plastic pouches are designed for steam sterilization, and the paper component may not be compatible with all low-temperature methods. Woven textiles and sealed metal containers are also primarily used for steam sterilization.
Question 4: During the assembly of a major orthopedic set, a technician notices the total weight of the instruments and container is 12 kg (approximately 26.5 lbs). What should be the technician's primary concern based on MDRAO and CSA standards?
- The set will require a longer drying time after sterilization.
- The weight exceeds the recommended limit, potentially compromising sterilization efficacy and posing an ergonomic risk. (Correct answer)
- The chemical indicators may not function correctly in such a dense set.
- The set must be split into three separate trays to be compliant.
Correct answer: The weight exceeds the recommended limit, potentially compromising sterilization efficacy and posing an ergonomic risk.
Most Canadian standards and guidelines recommend a maximum weight for instrument sets, often cited as 11.3 kg or 25 lbs, including the container. Exceeding this weight can hinder sterilant penetration and drying, and creates a significant manual handling and ergonomic risk for staff. The set should be reconfigured to fall within weight limits.
Question 5: Which of the following is an essential requirement for the 'clean assembly' or 'preparation and packaging' area of a Medical Device Reprocessing Department?
- Negative air pressure relative to the decontamination area.
- Positive air pressure relative to adjacent areas like decontamination and hallways. (Correct answer)
- Humidity levels maintained between 70% and 80%.
- The use of oil-based lubricants on all instrument moving parts.
Correct answer: Positive air pressure relative to adjacent areas like decontamination and hallways.
The clean assembly and packaging area must maintain positive air pressure. This ensures that air flows from the clean area to the less clean areas (like hallways or the decontamination area), preventing airborne contaminants from entering the space where clean instruments are being handled and packaged.
Question 6: A technician is preparing to package an instrument set using a sequential wrapping technique with two sheets of non-woven wrap. What is the purpose of using a Type 1 chemical indicator in this scenario?
- To confirm the internal contents have achieved sterility.
- To secure the final fold of the outer wrap.
- To distinguish between processed and unprocessed packages. (Correct answer)
- To verify that the correct temperature was achieved for the required time.
Correct answer: To distinguish between processed and unprocessed packages.
A Type 1 chemical indicator, often in the form of indicator tape, is an external indicator used on the outside of a package. Its purpose is to show that the package has been exposed to a sterilization process, allowing staff to easily differentiate processed from unprocessed items. It does not prove that the contents are sterile.
MDRAO - Medical Device Reprocessing Association of Ontario Instrument Assembly and Packaging Questions and Answers 1
A multi-level instrument tray is being prepared for steam sterilization.
According to Canadian Standards Association (CSA) guidelines, where must an internal chemical indicator be placed?