Sterile Storage And Transport Procedures PDF

moudule11 Sterile storage and transprt Learning Objectives:By the end of this module you will be able to * Clearly understand the concept of Sterile Storage in the CSSD  * Describe the requirements for safe sterile storage  * Understand the proper and required environment for the CSSD sterile...

moudule11 Sterile storage and transprt Learning Objectives:By the end of this module you will be able to * Clearly understand the concept of Sterile Storage in the CSSD  * Describe the requirements for safe sterile storage  * Understand the proper and required environment for the CSSD sterile  storage * Outline the types of sterile storage in the CSSD Understand the concepts  of shelf life, event related and date related * Understanding of potential damage to sterile items during the  transportation and the storageprocess * Descript the Stock Rotation System, Product Release and Product  Rejection * Defning the product recalls and its process  Learning Outcomes: By the end of this module the studentshould be able to * Explain the concept of Sterile Storage in the CSSD.  * Describe the requirements for safe sterile storage Describe the proper  and required environment for the CSSD sterile storage. * Define the types of sterile storage in the CSSD  * Understand the concepts of shelf life, event related and daterelated  * Understanding of potential damage to sterile items during the  transportation and the storageprocess. * Descript the Stock Rotation System, Product Release and Product  Rejection. * Explain the product recalls and its process  quality of sterilized packages are directly connected with the packagin materials, storage methods and conditions, handling practices, and methods of distribution. The storing process starts immediately once the sterilizers' doors opened. The Sterilized packages require proper HVAC that's monitored and documented daily. The CSSD staff should store the instruments in clean, dry and closed or covered Carts. Storin, sterilized items under tables or sinks must be avoided at all timesbecause such practices will Jeopardize the sterilized packages. Prior of dispatching all packages must be inspected for signs of defect such as moisture, holes or torn. Ifsterilizedpackagesare compormesdi, the umrsntetnsi must pass throw t h e complete process of sterilization Product Release Before we explore the storage, handling and  transportation of processed items we must ensure we have met the requirements for safe product release. There are key aspects that must be assured after the sterilization process before we can release for storage or patient use. Physical Inspections: Was a :physical inspection made of all packs to  ensure the following PARAMETERS  Items were correctly placed on sterilization  racks and shelves with small and lighter items on top and heavier on bottom? Correct packaging and sterilization methods  were used, for low temperature steam? * No residual moisture on outside of package?  * Tapes and identification labels   Cooling Was an adequate amount  of time given for the items to cool after sterilization before moving to storage? For most items a marked set of 30 minutes is allowed for cooling but longer times are required for larger and Chemical Monitoring 1-Have chemical indicators been  placed inside al packages and external indicators used on packages that can't be viewed, like containers and wraps?. 2-Was an additional process  challenge device (PCD) run with the 2cycle for assurance? 3-Did the PCD chemical indicator  pass and was this documented? 4-Do the users in your facility check  the indicator before using on a patient Biological Monitoring Monitoring must be carried out  according to you r local policy, but generally r you monitor with the firs t full load of the day and with all implant loads. Biological indicators require anywhere from 1/2-48 hours of incubation before release so it is important to know your IFU DID T H E BIOLOGICAL  MONITOR PASS AND WAS THIS DOCUMENTED ?  Product Rejection During the product release checks above ,all must be fully met or the item(s)will not be released for use.For all release check failures,the item must go through the full reprocessing starting from decontamination(no short cuts canbe made.) Product Recall There is alwaysa possibility that items have been released but later recognized as items that should have been rejected.Some reasons 1- BIOLOGICAL OR CHEMICAL INDICATOR 2- DOCUMETATION 3-MANUFACTURER RECALLEDAD EFECTIVEITE.  When any of these things occur, it is critical to use your process documentation to identify all items that are affected by the error and carry out an immediate recall. Your facility should have a procedure for recall that includes at minimum, notifying all users impacted and documenting all actions in an adverse occurrence report Sterile Storage Room CSSD Cssd requires multiple storage locations, one for storing sterile products and another for storing clean(unsterile) supplies that are used in production. For this module we will focus on the sterile storage room where the items we released from the sterilizer room will be kept until required or staged for later delivery RECEIPT OF STERILE ITEMS INTOSTORAGE 1-IN-HOUSE STERILIZED ITEMS  2-PURCHASEDPRE-STERILIZEDI T E M S KEY REQUIREMENTS FOR SAFE STERILE STORAGE: Temperature and humidity controls control the room temperature between18- .%30-70 and a relative humidity of 24 can reduce the %30 Humidity below barrier effectiveness of packaging materials while excess humidity and temperatures can allowmoisture to condense on package Positive air pressure TO prevent cross  contamination, this room must be maintained under positive pressure to keep contaminants out.At least 4 air exchanges Lighting although additional lighting  and magnification will not be required there must still be adequate lighting to ensure items can be easily identified.for use200-500LUX  Restricted accessonly authorized personnel have  access to this room to ensure items are handled appropriately and notcontaminated Shelves, transport carts and work stations must be washable, designed  to avoid damage to packaging, and allow for items to be stored without excess stacking STERILE STORAGE CONSIDERATIONS 1-Correct handling—do not drag or push items against surfaces causing friction or abrasion. This damages the packaging and compromises sterility. 2-Correct Shelving—shelving should be of correct size and design to hold items safely and ideally the top and bottoms shelves should be solid or covered to reduce or prevent dust accumulation. (Closed- Semi closed- open ) 3-Walls—packs must be at least 5cm)2 icc) from walls and windows to reduce condensation risks. 4-Floors packs should be kept at least25-30cm8-10 incabove the floor — to prevent contamination from floor cleaning products, spills and.inadvertent touching 5-Ceilings—there should be at least 45cm)18 inc) between the highest package and the ceiling or fire sprinkler heads 6-Removing items from a shelf lift the front of the package underneath with one hand, place the other hand midway under the package and lift the whole item freefrom the shelf. 7-Minimal handling this is a critical element as each time a package is handled it is considered an event. 8-Food or drinks never consume, store or transport food or drinks through a sterile supply room 9-Corrugated boxes Corrugated boxes—harbor  moisture, mold, mildews, insects and potentially contaminating micro- organisms. Do not use cardboard boxes  Don’t force or stack on shelves items when forced, stacked, bent or  compressed can force contaminated air inside or cause ruptures to closures and seams that me by difficult to detect  12-SUnlight items should not be exposed to direct sunlight and ideally not located near windows  13-Moisture packages must not be stored near or under sinks, pipes, sewage lines, drains or other items that could expose sets to moisture. 14-Ball pens only validated markers should be used for writing on packages as ink from pens may seep into packages and also physically damage the surface 15-RUBBER BANDS force or compress packages so should never be used for sterile items Type of Shelving *Closed Shelving * Semi-closed Shelving. * Open Shelving STERILE SUPPLY EXPIRATION (STERILITY SHELF LIFE) 1-Time Related Expiration 2-Event Related Expiration Time Related Expiration A PACKAGE REMAINS STERILE UNTIL A SPECIFIC EXPIRATION DATE IS REACHED Time Date THIS METHOD IS PARTICULARLY IMPORTANT FOR PERISHABLE ITEMS LIKE FOOD THAT CAN SPOIL OR GROW DANGEROUS LEVELS OF BACTERIA AND RELIES ON THE ‘FIRST IN - FIRST OUT’ PRINCIPLE WHERE ITEMS WITH THE SHORTEST EXPIRATION DATE ARE ALWAYS USED FIRST. FIFO A STOCK ROTATION SYSTEM IN WHICH THE OLDEST PRODUCT IS USED FIRST Event Related Expiration EVENT RELATED STERILITY IS DEFINED AS “ITEMS ARE CONSIDERED STERILE UNLESS THE INTEGRITY OF THE PACKAGING IS COMPROMISED OR DAMAGED, REGARDLESS OF THE STERILIZATION DATE.”EVENTS ARE THE INTERACTIONS THAT CAN CAUSE A NEGATIVE IMPACT ON STERILE PRODUCTS AND OCCUR FROM BOTH STORAGE AND HANDLING. EVENT-RELATED STERILITY -EVENTRELATED STERILITY IS THE CONCEPT THAT STERILE PRODUCTS REMAIN STERILE UNTIL ANEVENT OCCURS TO MAKE THEM UNSTERILE. THE FOLLOWING LIST DESCRIBES EVENTS THAT MAY RENDER A PACKAGE UNSTERILE. THIS LIST IS NOT INCLUSIVE, AS THERE ARE MANY EVENTS THAT CAN COMPROMISE STERILITY Event Related STERILITY -Product Life -Type of Packaging Material -Utilized Condition of Package -StorageTransportation Conditions -Handling PRODUCT LIFE Some products and packaging material will degrade over time. Using these items once they have expired is unsafe. As items begin to degrade an event has occurred that can affect the items sterility TYPE OF PACKAGING MATERIAL UTILIZED Many packaging materials have a defined useful life. CS technicians must be sure to follow the manufacturer's recommendations for shelf life before and after sterilization as the products ability to perform appropriately is diminished 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 happens, items will not remain steril 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 to damage a package. Once a package is damaged, the items inside must be considered unsterile STORAGE&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 opened or closed can affect item sterility. Open shelving allows for 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 Lack of proper handling can cause items to become unsterile. Handling items while they are still warm, over handling items and the hygiene of the personnel handling the items are all considered events. 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 TIME VERSUS EVENT RELATED STERILITY In most parts of the world, both time and event related sterility are used together to ensure safe items for patient use. In some countries there is a shift to using only event related expiration with the idea that as long ashanding is minimaland environmental conditions are stablethen items should never expire If you are considering using only event related sterility can you answer yes to the following questions ? 1-Is your storage appropriate? 2- Are you handling sets correctly? 3-Are quality assurance checks carried out each time items are handled? QUALITY ASSURANCE CHECKS Environmental Monitoring Monitoring the environment ensures the conditions have been maintained consistently and no events have occurred that could reduce package integrity. Are you measuring temperature, humidity and room pressure and documenting the results? Is there a regular schedule of environmental cleaning and is this documented? Safety checks when handling Like the environment, we can never assume our colleagues have always handled items correctly so we should always look for signs of events that may impact sterility: Tears or abrasions? Tracks, or fuzzy or worn areas from dragging ? Dents or punctures? Dirt? Moisture or evidence of moisture-like spotting ? Sterilization label with date? Chemical indicator inside set or view pack CONSUMABLE INVENTORY MANAGEMENT OR INVENTORY REPLENISHMENT SYSTEMS  Inventory: Reusable equipment and consumable items that are used to provide healthcare services for patients. CS Inventory Groups *Patient care supplies. *Operational Supplies For reusable items processed in CSSD we have a fixed number of items and rely on a ’first in - first out ’out method to ensure items are used on a rotational basis. Consumables are used and disposed of and require replenishment systems to ensure they are available when needed.A lack of consumables can pose a risk to patients. Consumables are also an additional cost to a facility so it is important to maintain correct levels so there isn’t an overstock or risk of waste if items expire before use Inventory Replenishment SystemsA variety of systems :used to replenish consumablesupplies in patient care areas  Case Cart Systems*  2 BINSystems Periodic Automated Replenishment (PAR)-Level OR*  Exchange Cart Systems*  Requisition Systems Case Cart System*  Case Cart System In many hospitals, a Case Cart system is used for the preparation of surgical procedures. This system uses a Pick List that lists all the specific CSSD sets, consumables and equipment needed for an individual surgical procedure. In most ”pick“facilities that use this system, it is CSSD that the case cart so this requires additional storage considerations for consumables  Periodic Automated Replenishment (PAR) or 2 binuses a defined minimum and maximum level of supplies, frequently with 2 bins so that an order is placed when one bin is empty This system is preferred as it is simple to use, and does not require manual counting of stock levels for re-ordering. Once a bin is empty, the amount needed to refill the bin is ordered Exchange carta cart with determined levels is exchanged at a regular interval with a new fully stocked cart. This system is commonly used for laundry or areas with high usage as it allows a cart to be filled in a central location and simply exchanged with the depleted cart. Requisition systems An inventory distribution where items are requested (requisitioned) by the user department and dispensed from a central storage location STERILE TRANSPORTATION we discussed how transport carts play a key role in protecting us and the environment from contaminated items during transportation. For sterile items, transport carts play an equally important role but instead they protect the sterile items from us and the environment as we move them through the hospital.THE SAME PRINCIPLES FOR CARTS APPLY Closed cart Ideally closed or at minimum covered, to  protect sterile items from contamination risk when travelling through public areas.Closed carts also reduce the chance of items falling out of the cart Correct size and weight The cart should be an appropriate size with adequate shelves to hold the items being collected without stacking, stuffing, or overfilling as this counts as an event that can negatively impact sterility The size must also be appropriate so users have safe visibility when moving them through corridors and be of an appropriate weight that allows them to be moved in a controlled manner. Larger and heavier carts may need two people to move safely. washable This cart is used for sterile items but will be travelling outside sterile areas so needs to be cleaned effectively before returning to use in CSSD. The cart should ideally be compatible with a cart washer if available, or be designed to facilitate effective cleaning and disinfection between use serviving The carts should be constructed from robust materials to withstand the rigors of daily use. Doors, shelves and wheels must be maintained to ensure safety and ease of use to the users transporting items in the facility. HANDLING : We discussed the key requirements for minimal handling to meet event related sterility but for transportation we must also consider: -Select the most appropriately sized cart for the collection process and ensure it is functioning correctly. -Bring any required documentation necessary to log items being delivered Perform hand hygiene before loading or unloading carts. -Before transferring items, move the transport cart as close as possible to the destination to reduce the distance you carry items and minimize the risk of dropping them. -Place heavier items on the middle or lower shelves and never on high shelves to reduce the risk of dropping Handling : When travelling through the facility make sure you: -Take care to follow correct hand hygiene to reduce the chance of contaminating items in the cart. -Do not leave sterile transport carts unattended if they cannot be locked as other staff or patients could open them and compromise sterility of the items -When deliveries are complete, bring your cart back to CSSD for decontamination. -Empty carts should be processed through a cart washer if available or manually cleaned and disinfected if not, as per local policy.