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What is the proper storage environment for wrapped items in sterile processing?

3 min read

According to the Centers for Disease Control (CDC), sterile items should remain sterile until used, unless an event compromises the package. Maintaining this sterility hinges on a meticulously controlled environment, making the question of what is the proper storage environment for wrapped items in sterile processing a critical concern for patient safety and infection control. The integrity of wrapped items depends entirely on protecting them from environmental factors and physical damage.

Quick Summary

The ideal environment for wrapped items in sterile processing involves controlled temperature, humidity, and air circulation to prevent microbial growth and contamination. Proper storage also requires dedicated, secure shelving, minimizing physical contact to prevent tears, punctures, or compression of packaging. Implementing strict handling protocols and following recommended placement guidelines are essential for maintaining sterility until the point of use.

Key Points

  • Controlled Climate is Crucial: Maintain temperatures between 72-78°F and relative humidity between 30-60% to prevent microbial growth and packaging damage.

  • Positive Air Pressure is a Must: Ensure positive air pressure in sterile storage areas to prevent contaminated air from entering when doors are opened.

  • Proper Shelving Prevents Damage: Use cleanable, non-shedding, solid-bottom shelving that is properly spaced from floors, ceilings, and walls.

  • Avoid Handling and Stacking: Minimize handling of sterile packages and never stack items to prevent crushing, bending, or puncturing the wrap.

  • Use Enclosed Storage: Opt for closed cabinets or covered carts to provide an extra layer of protection against dust and contaminants.

  • Follow Event-Related Sterility: Recognize that a package's sterility is maintained until an event (e.g., damage, moisture) compromises it, regardless of time.

  • Implement 'First-In, First-Out' (FIFO): Rotate stock to ensure proper inventory management, particularly if utilizing time-sensitive dating practices.

  • Inspect Packages Thoroughly: Always inspect wrapped items for integrity and dryness before use; reprocess any compromised packages.

In This Article

Key Environmental Factors for Sterile Storage

For wrapped items to remain sterile, the storage environment must be carefully controlled. Several factors, including temperature, humidity, and air pressure, play a crucial role in preventing microbial contamination.

  • Temperature: The temperature in a sterile storage area should be maintained within a specific range. Industry standards from organizations like the Association of periOperative Registered Nurses (AORN) recommend a temperature of no more than 75°F (24°C). Maintaining a consistent, cool temperature helps prevent the growth of microorganisms and the degradation of packaging materials over time.
  • Humidity: High humidity can compromise package integrity by wicking moisture through the wrapping material, allowing microorganisms to penetrate. A relative humidity level of 30-60% is typically recommended in sterile storage areas to prevent condensation and microbial growth. Low humidity, conversely, can lead to brittle packaging, which can also result in tears and compromised sterility.
  • Air Pressure: Positive air pressure is a critical component of sterile storage areas. This means air should flow from the clean sterile storage area to adjacent, less clean areas. This prevents contaminated air from being pulled into the storage room when the door is opened, protecting the integrity of the wrapped items. Minimum air exchange rates are also specified by standards like ASHRAE 170.

Best Practices for Physical Storage and Handling

Even with a controlled environment, improper handling and storage practices can easily compromise sterility. Standardized procedures for shelving, cart placement, and handling are essential for protecting wrapped items from damage.

  • Shelving: All shelving in the sterile storage area should be constructed of cleanable, non-porous, and non-shedding materials. Shelves must be solid to protect items on lower levels from dust and debris. Proper spacing is vital: items should be stored at least 8-10 inches from the floor, 18 inches from sprinkler heads, and 2 inches from outside walls. This spacing ensures adequate air circulation and prevents contact with potential sources of moisture or contamination.
  • Storage Units: The use of enclosed storage cabinets or covered carts is ideal for providing an additional barrier against dust and environmental contaminants. These units should also be cleanable and designed to prevent damage to delicate packaging.
  • Handling: Careful handling is paramount. Sterile packages should never be crushed, bent, or compressed, as this can create microscopic breaches in the packaging. Items should be lifted, not dragged, to prevent tears. Heavier items should be stored on middle shelves for easier access and to prevent packages on lower shelves from being crushed. Staff should avoid touching wrapped items unnecessarily, as each interaction increases the risk of contamination.
  • Stock Rotation: Facilities should follow a 'first-in, first-out' (FIFO) rotation to ensure older sterile stock is used before newer stock. This is especially important for facilities that still practice time-related shelf life, though many have transitioned to event-related dating.

Comparison Table: In-House vs. Manufacturer Sterile Item Storage

Feature In-House Wrapped/Sterilized Items Manufacturer-Provided Sterile Items
Shelf-Life Basis Often event-related, where sterility is maintained until an event (tear, water, etc.) compromises it. Set by the manufacturer, justified by accelerated aging and environmental testing.
Packaging Wrapped in sterilization wrap, which requires careful handling to prevent compromise. Often includes additional plastic or protective boxes for enhanced durability during transport and storage.
Storage Best Practice Store in controlled environment, ideally on non-porous shelving, without stacking or compressing. Store in designated areas, often within shipping containers until moved to sterile stock. Inspect outer packaging for damage.
Environmental Control The healthcare facility is responsible for maintaining the required temperature, humidity, and pressure in the sterile storage area. The manufacturer ensures the product's integrity will last for the stated shelf life under typical storage conditions.
Handling Risk Higher risk of contamination from handling, as the packaging is often less durable than commercially prepared items. Lower risk due to more robust, manufacturer-designed packaging for transport and storage.

Conclusion

Protecting the sterility of wrapped items in the sterile processing department is a multi-faceted process that combines rigorous environmental controls with disciplined handling practices. From maintaining optimal temperature and humidity to ensuring positive air pressure, every aspect of the storage environment is critical for patient safety. The physical arrangement of items, including proper spacing and using protective storage units, further minimizes the risk of contamination. By adhering to these strict guidelines, healthcare facilities can effectively manage the storage of wrapped items, ensuring that instruments and supplies remain safe and ready for patient use.

For more detailed guidance and standards, healthcare professionals can refer to the Association for the Advancement of Medical Instrumentation (AAMI) guidelines..

Frequently Asked Questions

The recommended temperature range for sterile storage is typically 72-78°F (22-26°C), with a relative humidity level of 30-60%.

Sterile items should be stored at least 8-10 inches from the floor and at least 18 inches from sprinkler heads or the ceiling.

Positive air pressure is important because it causes air to flow out of the sterile storage area and prevents potentially contaminated air from entering, thus protecting the integrity of wrapped items.

No, sterile packages should not be stacked unless specifically stated by the packaging manufacturer. Stacking can crush or compromise the packaging, leading to loss of sterility.

Event-related sterility is the principle that a wrapped item remains sterile until an event, such as a tear, puncture, or moisture, compromises the package, rather than being based on a specific expiration date.

Sterile packages should not be stored near sinks or outside walls because these areas are prone to moisture and condensation, which can wick through packaging and compromise sterility.

Closed cabinets or covered carts are ideal for storing sterile items as they provide an extra barrier against dust and contamination. If open shelving is used, items must be properly spaced and protected.

Any sterile package that is torn, wet, or otherwise compromised must be considered contaminated. Its contents must be reprocessed—rec-leaned, re-packaged, and re-sterilized—before use.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice. Always consult a qualified healthcare provider regarding personal health decisions.