MDRAO Sterile Storage and Distribution 2 — Questions and Answers

Question 1: What environmental conditions must be maintained in the sterile storage area to support event-related sterility maintenance?

Any room temperature is acceptable as long as packages are sealed
Temperature of 18–24°C, relative humidity of 35–70%, positive air pressure, and limited access to the area (Correct answer)
The sterile storage area must be refrigerated at 4°C to extend sterility
No specific environmental controls are required for sterile storage

Correct answer: Temperature of 18–24°C, relative humidity of 35–70%, positive air pressure, and limited access to the area

Sterile storage areas require controlled temperature (18–24°C), controlled relative humidity (35–70%), positive pressure relative to adjacent areas, and restricted access — all documented to support the event-related sterility model.

CSA Z314 and Ontario PIDAC guidelines specify environmental requirements for sterile storage areas to maintain package integrity and support the event-related sterility model. Temperature should be maintained between 18–24°C to prevent condensation on packages (from temperature fluctuations) and to avoid extremes that could affect packaging materials. Relative humidity of 35–70% prevents moisture that could wick through packaging and compromise sterility maintenance. Positive air pressure (relative to adjacent corridors and non-sterile areas) prevents the influx of contaminated air. The area must have restricted access (limited to authorized CSSD and clinical staff), be away from traffic, and have adequate shelving to store packages off the floor (minimum 20–25 cm), away from walls, and below ceiling sprinklers.

Question 2: What does 'first in, first out' (FIFO) mean in the context of sterile storage management?

The first staff member to arrive in the morning is the first to work in the sterile storage area
Older sterilized items are used first before newer ones to prevent items from remaining in storage indefinitely and potentially suffering a compromising event (Correct answer)
The first instruments sterilized each day are distributed first to OR for morning cases
New instruments are used before older ones to ensure the freshest possible sterility

Correct answer: Older sterilized items are used first before newer ones to prevent items from remaining in storage indefinitely and potentially suffering a compromising event

FIFO ensures that the oldest sterilized stock is used before newer items — preventing accumulation of old stock and ensuring items are not left in storage for excessive periods where the probability of a compromising event increases over time.

First In, First Out (FIFO) is a standard inventory management principle applied to sterile storage in the CSSD. Even under event-related sterility (where there is no fixed expiry date), items left in storage for extended periods are more likely to be subject to compromising events through repeated handling, transportation, physical wear on packaging, or environmental fluctuations. FIFO is implemented by: storing new stock behind or below existing stock so older items are retrieved first; using clear shelving labels or rotation cards; and conducting regular inventory audits to identify stagnant stock. Items that have not been used within a reasonable period should be inspected for package integrity and potentially reprocessed. FIFO is a basic component of sterile storage quality management under CSA Z314.

Question 3: What is the minimum height that sterile packages must be stored from the floor?

5 cm (2 inches)
20–25 cm (8–10 inches) (Correct answer)
50 cm (20 inches)
No floor clearance requirement exists

Correct answer: 20–25 cm (8–10 inches)

Sterile packages must be stored a minimum of 20–25 cm (8–10 inches) from the floor to protect against moisture from floor cleaning, contamination from foot traffic, and physical damage.

CSA Z314 and Ontario PIDAC guidelines require that sterile packages be stored at a minimum height of 20–25 cm (approximately 8–10 inches) from the floor. This requirement protects sterile packages from: (1) moisture and water from floor cleaning activities; (2) physical contamination from foot traffic, floor cleaning equipment, and splashes; (3) physical damage from floor-level contact; and (4) flooding risk. Additionally, packages must be stored away from exterior walls (to prevent condensation from temperature differentials), below ceiling sprinkler systems (to avoid wetting from inadvertent sprinkler activation), and with adequate spacing between items and groups to allow air circulation. All shelving must be solid-surface or perforated (not wire shelving for wrapped packages) and regularly cleaned.

Question 4: When transporting sterile items from the CSSD to clinical care areas, which type of transport container is most appropriate?

Open wire carts for easy visual inspection during transport
Closed, covered carts or rigid covered containers that protect sterile packages from environmental contamination and physical damage during transport (Correct answer)
Standard cardboard boxes reused from supply deliveries
Sterile items may be hand-carried by staff without additional protection

Correct answer: Closed, covered carts or rigid covered containers that protect sterile packages from environmental contamination and physical damage during transport

Sterile items must be transported in closed, covered, purpose-built carts or containers that physically protect packages from dust, moisture, handling damage, and environmental contamination during transit through hospital corridors.

The transport of sterile items from CSSD to clinical areas represents a critical point in the sterility maintenance chain. Open wire carts expose sterile packages to dust, airborne contamination, moisture from corridor cleaning, and physical damage from contact with corridor walls, elevator doors, and other equipment. CSA Z314 and Ontario PIDAC guidelines require the use of closed, purpose-designed transport carts or containers with: solid or covered sides and top to provide physical and environmental protection; cleanable surfaces that are regularly disinfected; separate compartments for sterile items (to prevent mixing with returns or other materials); and clear identification as sterile transport equipment. Sterile items should never be transported loose or in open containers through general hospital corridors.

Question 5: Before using a sterile package in a clinical procedure, what inspection steps must clinical staff perform?

Simply open the package and proceed with the procedure
Check the external chemical indicator colour change, inspect the seal and packaging integrity, verify the load control number is present, and confirm the package is dry and undamaged (Correct answer)
Only check that the package is not visibly torn
Clinical staff are not responsible for checking sterile packages — that is the CSSD's responsibility

Correct answer: Check the external chemical indicator colour change, inspect the seal and packaging integrity, verify the load control number is present, and confirm the package is dry and undamaged

Before using any sterile package, clinical staff must inspect: external CI colour change, package seal integrity, absence of moisture, absence of tears or damage, presence of a valid load control number — refusing any package that does not pass inspection.

Package inspection before use is a shared responsibility between CSSD and clinical staff under CSA Z314. Before opening and using any sterile package, clinical staff should: (1) verify that the external chemical indicator has changed to the appropriate colour indicating sterilization exposure; (2) inspect the package for intact seals on all sides (no peel-back, tears, or holes); (3) check for absence of moisture (wet packages must be rejected); (4) confirm the load control number is present and legible for traceability; (5) verify the package contents match the labelled description; and (6) inspect for physical damage (crushing, punctures, excessive compression). Any package that fails inspection must be removed from use, returned to CSSD for investigation, and documented in the quality system. Point-of-use inspection is the last line of defence before sterile items reach patients.

Question 6: How should single-use devices (SUDs) be handled in the CSSD when they are returned after patient use?

Single-use devices may be cleaned and resterilized up to three times if they appear undamaged
Single-use devices must NEVER be reprocessed or reused — they must be disposed of according to biohazard waste protocols after a single use (Correct answer)
Single-use devices may be reprocessed if the clinician determines they are still functional
Single-use devices can be reprocessed if the manufacturer approves reuse in writing for that specific device

Correct answer: Single-use devices must NEVER be reprocessed or reused — they must be disposed of according to biohazard waste protocols after a single use

Single-use devices (SUDs) are labelled by the manufacturer for single use only — they must never be reprocessed or reused in Canadian healthcare facilities, and must be disposed of as biohazard waste per provincial regulations.

Single-use devices (SUDs) bear a single-use symbol (a circle with the number 2) indicating the manufacturer's designation that the device is intended for one use only on one patient. In Canada, Health Canada does not authorize the reprocessing of SUDs in healthcare facilities, unlike some US regulatory pathways. Reprocessing SUDs can result in: device material degradation leading to failure during use; inability to verify cleaning efficacy in complex device geometries; increased patient safety risk from compromised device integrity or retained contamination; and legal and regulatory liability for the facility. After use, SUDs must be disposed of as clinical/biohazard waste in accordance with provincial biomedical waste regulations. CSSD must have policies prohibiting SUD reuse and training staff to identify and discard single-use items appropriately.

MDRAO Sterile Storage and Distribution 2

What environmental conditions must be maintained in the sterile storage area to support event-related sterility maintenance?