MDRAO - Medical Device Reprocessing Association of Ontario Sterile Storage and Distribution 1 — Questions and Answers
Question 1: During a pre-use inspection of a sterile package, which finding should prompt immediate removal of the item from service for reprocessing?
- A chemical indicator that has properly changed to its pass colour
- A puncture or small tear in the outer packaging wrap (Correct answer)
- A sterilization label showing today's date
- The package being stored at the back of the storage shelf
Correct answer: A puncture or small tear in the outer packaging wrap
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?
- Solid laminate shelving with a smooth surface
- Sealed wooden shelving
- Wire or perforated metal shelving (Correct answer)
- Cardboard shelving units
Correct answer: Wire or perforated metal shelving
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?
- To circulate chemical disinfectants throughout the storage space
- To prevent outside air from entering the room when doors are opened (Correct answer)
- To lower the humidity level to the required range
- To ensure temperature remains consistent throughout the room
Correct answer: To prevent outside air from entering the room when doors are opened
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?
- To indicate which sterilization method was used on the load
- To record the name of the technician who processed the load
- To enable traceability and facilitate a targeted recall if a sterilization failure is identified (Correct answer)
- To determine the maximum shelf life of the package
Correct answer: To enable traceability and facilitate a targeted recall if a sterilization failure is identified
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?
- Return it directly to sterile stock without further assessment
- Discard it immediately as it is no longer considered sterile
- Inspect the package for integrity and labelling, then follow facility policy to determine whether it may be returned to stock or must be reprocessed (Correct answer)
- Re-sterilize it immediately regardless of its condition
Correct 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
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.
Question 6: What minimum clearance must be maintained between sterile packages and ceiling-mounted sprinkler heads in the sterile storage area?
- 15 cm (6 inches)
- 30 cm (12 inches)
- 45 cm (18 inches) (Correct answer)
- 60 cm (24 inches)
Correct answer: 45 cm (18 inches)
Sterile packages must be stored at least 45 cm (18 inches) below sprinkler heads. This clearance ensures that sprinklers can distribute water effectively in a fire emergency and also reduces the risk of moisture from the sprinkler system reaching and compromising package integrity during routine storage.
MDRAO - Medical Device Reprocessing Association of Ontario Sterile Storage and Distribution 1
During a pre-use inspection of a sterile package, which finding should prompt immediate removal of the item from service for reprocessing?