Chapter 16: Sterile Storage and Transport PDF

# Chapter 16: Sterile Storage and Transport ## Learning Objectives As a result of successfully completing this chapter, the reader will be able to: 1. Review basic sterile storage requirements 2. Explain the concept of event-related sterility 3. Discuss protocols for sterile storage and transp...

# Chapter 16: Sterile Storage and Transport ## Learning Objectives As a result of successfully completing this chapter, the reader will be able to: 1. Review basic sterile storage requirements 2. Explain the concept of event-related sterility 3. Discuss protocols for sterile storage and transport ## Introduction A great deal of work goes into ensuring items are sterile and ready for patient use. Once items are sterile, they can easily become contaminated. Extreme caution must be used to keep each sterile item safe until it is used. While barrier packaging protects sterile items from contamination, it is not an impenetrable barrier. Sterile packages must be protected from events that can cause them to become unsterile. This is accomplished by keeping the items in a safe environment and consistently practicing good protocols when handling a sterile package. This chapter examines strategies to help keep items sterile until use. - **Barrier Packaging**: Packaging that provides a barrier from microorganisms and allows aseptic presentation of the product at the point of use. ## Sterile Storage Considerations After sterilization, or after purchased sterile items are received from an outside vendor, the items are stored until needed. The activities of personnel in the storage area and the environment itself affect the maintenance of item sterility. Just like at home, if items are not properly protected or something unexpected happens, stored items may become unusable. If the kitchen floods, for example, food items like flour or sugar in their original packaging could become ruined by the water. If water is present in sterile storage, some or all of the packaged items may become ruined. Healthcare sterile storage areas need to be well planned and continually maintained to keep items sterile until use. The sterile storage process starts as soon as the sterilizer door is opened at the end of a cycle or when purchased sterile supplies are received into the facility. ## Sterile Storage Sterile storage begins as soon as in-house items are sterilized and commercially sterilized items are received. ### Protecting sterile items from contamination begins with considering the environment where the items will be stored. Providing the proper environment is critical for maintaining sterility. The following are all considerations that must be addressed when determining an appropriate sterile storage area. ### Location The sterile storage area should be located next to or near the sterilization cooing area. This area should ideally be an enclosed room easily accessible from the sterilization, break out and case cart staging areas, while being out of the facility's main traffic areas. The storage location should be removed from general traffic flow patterns to minimize airborne contaminants and keep items away from untrained personnel. - **Break out**: The process of removing commercially sterilized items from their outer shipping containers in an area adjacent to the storage area to prevent contamination that is present on the containers from being introduced into the storage area. ### Appropriate storage space is important. The area should be designed and designated for storage of sterile items only. While it may be impossible to create a separate sterile storage area, every effort should be made to place items in a location that meets criteria for sterility maintenance. It must be noted that sterile items may be stored in other areas of the healthcare facility such as nursing units, clinics, special procedure departments, etc. ### Storage Conditions Sterile storage areas should have no exposed water, sewer or air conditioning lines that could leak and contaminate the items. Work surfaces should be made of easy-to-clean, smooth and durable material..There should be no exposed light fixtures, pipes or ducts that can collect and shed dust. The location should be physically separated from other areas of the department. If this is not possible, extra care is required so that air and traffic always flow from sterile to clean to dirty. No pass-through traffic should be permitted. Air supply to the storage areas should be as clean and free from dust as possible, and this usually requires filtration. Because this area stores sterile items, air pressure should be positive in relation to surrounding areas so air flows out of the area when a door is opened, reducing the chance of airborne contamination. Doors and dispensing windows should remain closed when not in use. The room should also have at least four complete air exchanges per hour. ANSI/ASHREA/ASHE 170 Ventilation of Health Care Facilities recommends that temperature in the sterile storage area may be as high as 75°F (24°C), with less than 70% relative humidity (RH). This recommendation depends on when the healthcare facility last installed or upgraded the heating, ventilation and air conditioning (HVAC) system. Very dry air can affect seals and cause plastic materials to become brittle. Excessive humidity can cause tape and labels to lose their adhesion, loosen seals or affect package content identification. It is important to keep packs at least two inches away from exterior walls, windows and window seals where condensation can form on interior surfaces of exterior walls. Temperature and humidity levels should be checked and recorded at least daily. ### Temperature, humidity and air pressure should be monitored in the sterile storage area. This area should have proper lighting so package labels can be easily read. There should be no dark corners or blind spots, which could lead to improper product identification and misplaced or forgotten inventory. Adequate lighting is also critical for personnel safety. Hand hygiene stations should be located in this area. ### Storage Shelving Many companies manufacture shelving that is appropriate for storing sterile supplies. Some facilities have custom-made shelving units to fit their allotted space properly. Regardless of the shelving type, there are several factors to consider when choosing or replacing shelving: - Storage shelving should be designed to protect the sterile product. - Shelving should be sized to properly fit the stored items, without product overhang. Trays that do not properly fit on the shelf pose a safety hazard to all who work in the area. Trays that overhang shelving may also become contaminated by people walking by and brushing against them. - Shelving must be designed to easily hold the total weight of the trays to be stored. - Shelving should also be ergonomically friendly to prevent injuries. - Shelving should also be clearly labeled. - Adequate space should be allocated to prevent package damage. - Shelving must be easily cleaned. Metal or plastic shelving is recommended for this reason. Porous materials, such as wood, should not be used because it cannot be properly cleaned and can harbor microorganisms. ### Closed Shelving Closed shelving is the preferred type of shelving because it protects the sterile packaging from dust, traffic and air flow as well as other environmental and physical challenges within the storage area. Shelves are usually constructed as solid units, allowing for secure storage and easy cleaning. Closed shelving is expensive, so many facilities do not use this system (or it is used only for the most delicate and expensive items.) Doors should always be kept closed unless items are being accessed. When opening the doors, they should be opened slowly to avoid causing swift air currents that could potentially contaminate the sterile product. ### Semi-Closed Shelving Semi-closed shelving is shelving with at least three solid sides (top and two sides) that forms a closed unit when the shelves are moved together; these units are usually on tracks or have independent wheels. This type of shelving is also expensive; however, it is very versatile, user friendly and offers good protection for shelved items. Shelves may be solid or open wire. The bottom shelf must be solid to protect the stored items from contamination. The units should be pushed to the closed position when not accessing sterile products. ### Open Shelving In open shelf storage systems, items are placed on shelves that are not enclosed. Shelves usually have open-wire racks to prevent dust accumulation; however, the bottom shelf must be solid to protect the stored items from contamination. Open shelving is convenient and less expensive than closed shelving; however, packages are more vulnerable to physical hazards (usually accidental) and environmental challenges from cleaning solutions and microorganisms. Regardless of the system in use, a few standards must be followed: - The bottom shelf of each unit must be between eight and 10 inches from the floor. This protects stored items from contamination due to floor cleaning and dust. - The bottom shelf must be solid to protect items from environmental cleaning. If the shelf itself is not solid, commercially purchased shelf liners may be used to line the bottom shelf. - Although not required, having solid top shelves will help protect sterile items from dust. - All shelves must be cleaned regularly. ## Receipt of Sterile Items into Storage As previously stated, the sterile storage process starts when the sterilizer door is opened after a cycle or upon receipt of purchased presterilized items. ### In-House Sterilized Items Once items are removed from the sterilizer, they should be moved to a designated cooling area. This area should be close to the sterilizers because moving the warm cart causes air currents to flow over the warm items. Since the room air is. cooler than the sterilized items, this movement can cause condensation, making the items unsterile. Air currents can also help microbes penetrate the warm packaging material, again contaminating the sterilized packages. ### Once items are properly cooled, they may be placed on the storage shelf. Carefully check each item prior to placing it on the shelf. Ensure the indicator tape, peel package seal or container locks are intact. Visible chemical indicators (CIs) should show appropriate color change. There should be no holes, visual moisture or tearing of the package material. Lift (do not drag) wrapped trays; dragging will cause holes or tears in the packaging material. Wrapped trays should not be stacked on top of each other because stacking causes the lower trays to compress. When the upper trays are removed, air will be pulled into the lower packages, causing contamination. Stacking wrapped trays may also cause holes in the wrapper of the lower trays. Rigid container systems may be stacked, if approved in the instructions for use (IFU). They should be stored in a way that protects them from damage or contamination and in accordance with the item and storage cabinet manufacturers' written IFU, Other LCS- or HLD-processed devices, like laryngoscope blades, must be stored in a manner that protects them from unintentional handling. Items that have undergone LCS and are intended to be used as critical devices should be used immediately after processing. If they are stored, they must be reprocessed immediately before use. The acceptable storage time for LCS or HLD items differs according to each facility and item. Each facility should have a policy that specifies acceptable storage times. ### Purchased Pre-Sterilized Items Sterile storage areas are also used to store pre-sterilized products from outside vendors. These products are typically received in shipping containers. These outer shipping containers should be removed in a controlled break out area because the outside box has been exposed to environmental challenges, including weather, insects and microorganisms. Sterile items should not be removed from their outside box on the receiving dock unless there is an area protected from the outside environment that has been designed for this purpose. ### Storage of High-Level Disinfected and Liquid Chemically Sterilized Items Storage of items that have undergone high-level disinfection (HLD) or liquid chemical sterilization (LCS) is an important aspect of processing to ensure the devices are safe for the patient. Identification of patient-ready devices is important because it distinguishes LCS- or HLD-processed devices from non-processed devices. Endoscopes must be completely dry and stored in a cabinet that is clean, dry, well-ventilated, and dust free to prevent exposure to potentially hazardous microbial contamination. Some items are shipped in shelf cartons. Shelf cartons are commonly contained within an outer shipping box and are designed to store sterile items in a sterile or clean storage environment. Shelf cartons can be removed from the outer shipping cartons in the break out area and placed onto a sterile storage shelf. Using shelf cartons to store sterile items on shelves reduces the handling of the sterile items and provides protection. Received items should be delivered to an area close to the sterile storage area, where the items can be removed from the outside box. Sterile items should be placed inside a clean, enclosed transport cart, tote bin, or container so the items can be delivered to the storage area. Outside shipping cartons should never be allowed in the storage area because they are a major source of contamination. Transfer bins and carts must be cleaned regularly to help keep the sterility of the items intact. Items should be handled gently when transferring them from the box to the transport cart or container. Place items loosely; packing items tightly may compromise the items' sterility. Transport items directly to the sterile storage area. Never leave sterile items unattended where others may have access to the items. Curious staff or visitors may handle items and unintentionally damage the packaging, causing the items to become unsterile. Carefully place items on the shelves. Do not pack items tightly, as doing so will compromise the package sterility and may damage items inside the package. Always follow proper stock rotation procedures. ## Event-Related Sterility Shelf life is related to events that may compromise the pack sterility. Event-related sterility is the concept that sterile products remain sterile until an event occurs to make them unsterile. This section describes events that may render a package unsterile. This is not inclusive, as there are many events that can compromise sterility. ### Type of Packaging Material Utilized Many packaging materials have a defined useful life. SP technicians must be sure to follow the manufacturer's recommendations for shelf life before and after sterilization because the product's ability to perform properly diminishes after the stated expiration date. One of the events that could occur after the expiration date is loss of microbial barrier protection of the packaging. When this occurs, items will not remain sterile. ### Condition of Package Package integrity is very important. Rough handling, poor storage practices, moisture, dust, and poor transportation procedures are some of the events that can occur and damage a package. Once a package is damaged, the items inside must be considered unsterile. ### Storage and Transportation Conditions Clean, dry shelving in the storage area or in the transportation carts is required to keep items sterile. Whether the shelving or carts are open or closed can affect item sterility. Open shelving allows for a greater chance of contamination from the environment or personnel working in the area. Temperature and humidity must be monitored, and ensuring the absence of dust and insects helps maintain package integrity. ### Handling The following are all considered events: handling items while they are still warm, handling items excessively, and personnel engaging in poor hygiene when handling sterile items. Below are techniques to reduce the opportunity for contamination: - Practice good hand hygiene when handling sterile packages. Hands must be clean and completely dry before handling packages. - Handle sterile packages gently. - Containerize items when possible. - Keep items in shelf cartons to reduce extra handling of the sterile packaging. - Maintain an appropriate inventory, and practice first in, first out (FIFO). All sterile items should be monitored for events that may render them unsterile. If any event occurs to jeopardize an item, the item in question must be removed and processed or disposed of according to the facility's policy. Whenever there is doubt regarding the sterility of a package, the item should be considered unsterile. - **First in, first out (FIFO)**: A stock rotation system whereby the oldest product (that which has been in storage the longest) is used first. ## Basic Storage Guidelines Once items are delivered to the sterile storage area, they need to be carefully placed in their designated storage space. Regardless of whether the items are processed in-house or purchased outside the facility; the guidelines for storage of sterile items remain the same. The primary conditions that can adversely affect a sterile package's ability to maintain its sterility until it is opened by the user at the point of use include: - Moisture and liquid/fluid contamination - Dirt and dust - Physical damage to the package, including abrasions, cuts, tears, punctures, broken seals and the breakdown of packaging material (e.g., some plastics become brittle). Holes should not be put into packages for hanging because it can affect the package seals. Storage environments should be clean, dry and easily accessible by authorized personnel. Stored items should be arranged so packages are not crushed, bent or compressed. If the air inside a package is forced out, it can potentially rupture closures and seams. As previously stated, by forcing the air out of the pack, a void is created. When the source of compression is released (i.e., the weight on its top is removed), a slight suction can be created by the void. This can potentially establish conditions for the packs to "suck in" contaminated air. Per fire codes, stored items should be placed at least 18 inches below the ceiling or the level of the sprinkler heads to allow for proper air circulation and for water to flow unimpeded during a smoke or fire emergency. Spacing must also be planned and maintained to prevent packages from being touched, bumped or leaned upon when the room is cleaned or when personnel are storing or retrieving packs. Sterile packages should not be stored near or under sinks, exposed water pipes, sewage lines or air conditioning drains. Always place sterile items on clean surfaces. Do not trust the package barrier to protect contents from soil. When placing items on shelves or when removing them from the shelf, always check package integrity, including the filter area of rigid containers, and ensure all external CIs have turned to the proper color. If sterilized in house, be sure the load (lot) control label is still intact and all seals are securely in place. If the item has an expiration date, ensure the item has not expired. Do not place anything on the shelf until the items have been checked and verified to be intact. ### Sterile items should fit on the shelf; they should never overhang the edge of the shelf. The shelf edge may cause damage to the item, and the overhang can create a safety hazard. Place heavy items on middle shelves to allow for safe lifting. Lightweight packages should be placed on the higher shelves. Always lift items across the shelf; dragging them will damage the packaging. Handle all items gently. Rough handling of sterile packages can damage the packaging, causing the items to become unsterile. ## Arrangement of Instruments and Supplies Storage areas for instruments and supplies must be carefully planned. The goal is to help ensure that items are easy to locate and are protected from events that may cause them to become unsterile. Proper use of stock rotation principles is also important to ensure that older items are used first and that supplies with time-sensitive expiration dates are used before they must be discarded. The logical arrangement of stock improves efficiency, decreases staff injuries and facilitates appropriate stock rotation. SP technicians should review the manufacturer's IFU to determine if there are any special storage requirements. - **Locator systems** help SP technicians manage large numbers of supplies and instruments. Sterile items should be arranged so they are easy to locate. This may be best accomplished by organizing them alphabetically by name, functionality or specialty (related items shelved together), or numerically, based on stock codes. Shelves should be clearly labeled, designating where items should be stored, and include pertinent ordering and dispensing information. - **Stock Rotation**: Sterile packages should be arranged and maintained to allow stock rotation with a FIFO system. This ensures that the oldest items are used first. The longer a sterilized item remains in storage, the greater the chance the item can become contaminated due to handling and environmental issues such as dust. Even if the item does not become contaminated, it may not be able to be opened aseptically. Practicing a FIFO inventory control system prevents a "neglected packs syndrome” where hard-to-reach packs remain in storage much longer than others and are more likely to become damaged or contaminated. Note: Items with expiration dates should be used in the order of their expiration dates, with newer items that will expire being used first. The goal of a stock arrangement system is to provide minimal pack handling, while allowing FIFO rotation. Many facilities use a left-to-right system: the newest item is placed on the left and the older items move to the right. The pack on the far right is the first to be picked up for use. Other facilities place the new packs in from the back of the shelf and pick up the oldest from the front of the shelf. ### Satellite Sterile Storage Many facilities store sterile items in user departments. Storage areas for sterile supplies located outside the SP department (SPD), such as in the Operating Room (OR), must follow the same guidelines as stated previously and be included in quality assurance and infection prevention audits conducted for the sterile storage area in the department. Regardless of where a sterile item is stored, it must be protected from events that can render it unsterile. If satellite storage sites are used, personnel responsible for the areas should be trained about requirements for sterility maintenance. ## Cleaning To maintain product sterility, it is important to keep the sterile storage area clean and free from dust and debris. Standards for environmental cleaning should be the same as those for an OR or Labor & Delivery suite. The floors should be damp mopped, and trash should be emptied at least daily. Walls and vents should also be on a routine schedule for cleaning. Shelving, racks and other storage devices should also be routinely cleaned. The frequency depends on several factors. Closed shelving usually does not need to be cleaned as frequently as open shelving. The air filtration system in the storage area is also a factor in determining cleaning schedules. The better the filtration system functions, the less frequently the area must be cleaned. ### Shelf Cleaning 1. Remove all items from the shelves and storage bins. 2. Wipe entire shelf, including sides and top, using a facility-approved solution. 3. Clean all bins and shelf organizers using a facility-approved solution. 4. After cleaning surfaces touched by sterile packages, clean the shelf base, under the bottom shelf, and wheels. 5. Allow to dry thoroughly. Note: Alcohol may be used as a drying agent, if approved by facility protocols. 6. Wait until shelves, bins and organizers are completely dry. 7. Place items back in their assigned location. Check items for package integrity, external indicator change, expiration dates and lot control numbers for in-house sterilized items. 8. Document cleaning per the facility's quality assurance requirements. When cleaning shelves, all items should be carefully removed from the shelf. Using a facility-approved solution, wipe the entire shelf, including the sides and top. Alcohol may be used as a drying agent, if approved by the facility's protocols. After the shelves, base and shelf bottom have been cleaned, the wheels should also be cleaned. Be sure the shelves are completely dry before placing items back onto the shelf. Also, clean and completely dry all storage bins before placing them back on the clean shelf. Carefully check each item for package integrity and ensure seals are intact. Look for proper external indicator color change and check expiration dates. Ensure the load control number is still on the in-house processed items. As with most processes, sterile storage cleaning should be documented, and the documentation maintained for use in the department's quality assurance program. The process for sterile storage shelf cleaning is outlined in Figure 16.17. ## Sterile Storage Hygiene All SP technicians should maintain a high level of personal hygiene, including clean hair, body, nails (no artificial nails) and clothing at all times. SP technicians should frequently perform hand hygiene. Fingernails should be short to reduce the microbial load under the nails, and to minimize the potential for rupturing packages and pouches. Jewelry of any kind (including wedding bands and wristwatches) should not be worn. If badge lanyards are worn, they should be cleaned on a regular basis. Personnel working in the sterile storage area must be trained properly in all aspects of the storage process. Authorized individuals entering a storage area must follow hand hygiene policies, wear proper attire, be in good health and maintain good personal hygiene. ## Transporting Sterile Items Transportation of sterile packages should be done in a manner that protects the sterility of the items. It is important to follow the department's established procedures to ensure the items are delivered intact and ready to use. There are several ways to transport sterile items. Regardless of the method used, it is important to protect the items from crushing, bending, falling or other damage. ### Hand Carry It is often faster and easier to carry small, lightweight items to the point-of-use area by hand. Items being delivered should be protected from the environment and air currents from hallway traffic. Carefully place the items to be delivered in a protective cover, or a clean closed bin. Keep items away from the body to avoid contaminating them. The sterile items should be held with both hands, while keeping the items flat so instruments and products do not shift and become damaged. ### Cart Transport Transporting items by cart is easier and safer than hand carrying items. As with shelving, transport carts can be opened or closed. The bottom shelf should be solid to protect the items from dirt and dust contamination. When transporting with open carts, including wheeled tables, items should be covered and protected against the hallway traffic. Items should be placed flat on the cart to protect contents. Trays and packs should not overhang the edges of the cart. Closed carts are the transportation method of choice because they provide the best protection for sterile items. Carefully place items inside the cart. Do not overcrowd the cart. The cart doors should close and latch without touching the sterile item. All carts should be kept in good working order, and cart doors should be free from damage. Wheels should be properly maintained so the cart will move easily and quietly. ### Vehicles Healthcare facilities today may transport sterile items between sister facilities and to offsite clinics and physician offices. Items should not be transported in the trunk of a car because temperature and humidity levels cannot be controlled properly. There must be clear separation of clean and soiled items within the transport vehicle. The vehicle must be completely enclosed and in good repair, with no holes in the walls that will allow outside contaminates to enter. Sterile items should be placed inside clean, protective bins or carts. Protect the items from movement within the device, as packaging and instruments can be damaged from movement during transport. The cart or bin must be properly secured inside the vehicle to keep it from shifting. Temperature and humidity levels should be monitored. When the vehicle is not running, items should not be left inside the vehicle for extended periods of time, as condensation may form inside the sterile packages, rendering them unsterile. The transport vehicle should be cleaned on a regular basis. ### Elevators and Lifts Many facilities have dedicated clean elevators for sterile product transportation. These elevators should be used for clean and sterile transportation only. Soiled items should be returned using an elevator designated for soiled items. When using a dedicated lift, items must still be contained because air currents from outside the lift can contaminate the sterile items. ## Conclusion Maintaining product sterility during storage and transport is one of the most important tasks for SP technicians. If unsterile instruments or supplies are used, patients could be put at risk. Carefully following written storage and transport procedures and keeping the area clean and maintained will help keep patients safe. ## Resources - ANSI/AAMI ST79:2017 & 2020 Amendments A1, A2,A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities. - ANSI/AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities. - Association for PeriOperative Registered Nurses. Guidelines for PeriOperative Practice: Guideline for Sterilization Packaging Systems. 2022. ## Sterile Processing Terms - **Barrier Packaging** - **Break out** - **First in, first out (FIFO)**