MDRAO - Medical Device Reprocessing Association of Ontario Sterile Storage and Distribution 1

Question 1

During a pre-use inspection of a sterile package, which finding should prompt immediate removal of the item from service for reprocessing?

Accepted Answer

A puncture or small tear in the outer packaging wrap

Answer

Any breach of the sterile barrier—such as a puncture, tear, compression crease, or moisture stain—compromises the packaging and the sterile status of the item. The item must be removed from service and reprocessed before it can be used safely on a patient.

Question 2

Which type of shelving is recommended for sterile storage areas to promote air circulation and reduce the risk of moisture accumulation beneath packages?

Accepted Answer

Wire or perforated metal shelving

Answer

Wire or perforated metal shelving allows air to circulate freely around stored packages, helping to maintain a dry microenvironment and preventing condensation from forming under packages, which could compromise packaging integrity and event-related sterility.

Question 3

Why is positive air pressure maintained in the sterile storage room relative to adjacent corridors?

Accepted Answer

To prevent outside air from entering the room when doors are opened

Answer

Positive air pressure causes air to flow outward from the sterile storage area whenever a door is opened, preventing potentially contaminated corridor air from entering. This directional airflow is a key engineering control that protects stored sterile items from environmental contamination.

Question 4

What is the primary purpose of assigning lot control numbers to sterilized packages before they enter sterile storage?

Accepted Answer

To enable traceability and facilitate a targeted recall if a sterilization failure is identified

Answer

Lot control numbers link each sterilized package to a specific sterilization cycle record. If a sterilizer malfunction or biological indicator failure is discovered, lot numbers allow the facility to identify and recall all affected packages, minimizing patient risk through targeted traceability.

Question 5

A sterile package is returned unused from a patient care unit at the end of a shift. What is the most appropriate initial action?

Accepted Answer

Inspect the package for integrity and labelling, then follow facility policy to determine whether it may be returned to stock or must be reprocessed

Answer

Returned sterile packages must first be carefully inspected for any compromise to the packaging barrier, correct labelling, and known storage conditions. Whether the item can be returned to stock or must be reprocessed is governed by facility policy, but inspection is always the required first step.

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 Sterile Storage and Distribution 1