MDRAO - Medical Device Reprocessing Association of Ontario Instrument Assembly and Packaging 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?

Accepted Answer

In the geometric center of each level.

Answer

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?

Accepted Answer

Placed on a stringer or rack in an open and unlocked position.

Answer

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?

Accepted Answer

Tyvek (all-plastic) pouches.

Answer

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?

Accepted Answer

The weight exceeds the recommended limit, potentially compromising sterilization efficacy and posing an ergonomic risk.

Answer

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?

Accepted Answer

Positive air pressure relative to adjacent areas like decontamination and hallways.

Answer

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.

MDRAO - Medical Device Reprocessing Association of Ontario Practice Test

MDRAO - Medical Device Reprocessing Association of Ontario Practice Test

MDRAO - Medical Device Reprocessing Association of Ontario Instrument Assembly and Packaging Questions and Answers