Module 11 content.pdf

Module 11 STERILE STORAGE AND TRANSPORT Index : 1. Learning Outcomes 2. Introduction 3. Pre-Module Quiz 4. Product Release 5. Product Rejection 6. Product Recall 7. Sterile Storage Room 8. Event Related Expiration 9. Sterile Supply Expiration 10. Quality Assurance Checks 11. Time Versus Event Relate...

Module 11 STERILE STORAGE AND TRANSPORT Index : 1. Learning Outcomes 2. Introduction 3. Pre-Module Quiz 4. Product Release 5. Product Rejection 6. Product Recall 7. Sterile Storage Room 8. Event Related Expiration 9. Sterile Supply Expiration 10. Quality Assurance Checks 11. Time Versus Event Related Sterility 12. Consumable Inventory Management 13. Sterile Transportation 14. EVENT-RELATED STERILITY 15. CONCLUSION 16. Exercises and Checklists Learning Outcomes By the end of this module you will be able to: > Clearly understand product release practices for processed goods > Describe environmental requirements for storage areas > Understand the need to segregate items produced in-house from commercially produced items 264 > Understand health and safety requirements for manual handling and movement > Describe the tracking and traceability requirements for medical devices > Demonstrate understanding of potential damage to sterile items when being transported > Outline procedures for product recalls Introduction This module will give you an understanding of Time related and Event related sterility practices and the elements that can impact these practices. We focus specifically on the importance of appropriate storage locations and conditions , maintenance of stock levels and technician handling. Pre-Module Quiz Keep these questions in mind as you go through the content and don't worry if you don't know the answers yet-that's what you're here to learn. Q: What does time related expiration mean? Q: What does event related expiration mean? Q: With your understanding of CSSD design, what do you think are the key environmental aspects that would need to be monitored for sterile storage? Q: Where do risks occur when transporting sterile sets? Q: What would you do if you dropped a sterile set on the ground or found one on the floor? Q: What PPE precautions need to be taken when transporting sterile items? Q: With your understanding of the sterilization process and its monitoring, what conditions must be met to release sterile products for use? Q: What are some important features of a transport cart? 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. As we explored in module 7, there are key aspects that must be assured after the sterilization process before we can release for storage or patient use, such as: Biological Monitoring Monitoring must be carried out according to your local policy, but generally you monitor with the first full load of the day and with all 265 implant loads. Biological indicators require anywhere from 1-48 hours of incubation before release so it is important to know your IFU Did the biological monitor pass and was this documented? Chemical Monitoring Have chemical indicators been placed inside all packages and external indicators used on packages that can't be viewed, like containers and wraps? Was an additional process challenge device (PCD) run with the cycle for assurance? Did the PCD chemical indicator pass and was this documented? Do the users in your facility check the indicator before using on a patient? 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 heavier sets. Physical Inspections Was a physical inspection made of all packs to ensure the following: 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? Identification labels are correctly attached? No residual moisture on outside of package? Tapes and identification labels are attached? 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 can be made. Product Recall There is always a possibility that items have been released but later recognized as items that should have been rejected. Some reasons for this include: Biological or chemical indicator wasn't used or didn't pass Documentation wasn't correctly completed Manufacturer recalled a defective item 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 266 recall that includes at minimum, notifying all users impacted and documenting all actions in an adverse occurrence report. Sterile Storage Room 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 267 where the items we released from the sterilizer room will be kept until required or staged for later delivery. 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. We identified the requirements for a safe sterile storage room above. some additional considerations include: reduced on hands to minimize contamination. Hand wash facilities should be available but segregated to prevent splashing on sterile sets. Correct handling - do not drag or push items against surfaces causing friction or abrasion. This damages the packaging and compromises sterility. 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. Walls - packs must be at least 5cm from walls and windows to reduce condensation risks. Floors - packs should be kept at least 25-30cm above the floor to prevent contamination from floor cleaning products , spills and inadvertent touching. Ceilings - there should be at least 45cm between the highest package and the ceiling or fire sprinkler heads. 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 free from the shelf. Minimal handling - this is a critical element as each time a package is handled it is considered an event. Food or drinks - never consume , store or transport food or drinks through a sterile supply room. 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. Dropped items - jarring and compression from landing , forces dust and airborne microorganisms into the package. Dirt from the floor can also be carried onto the shelf and contaminate the next pack placed in that 268 position. Dropped items must be considered contaminated and removed even if no damage is apparent. Sunlight - items should not be exposed to direct sunlight and ideally not located near windows. Moisture - packages must not be stored near or under sinks , pipes , sewage lines drains or other items that could expose sets to moisture. 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. Rubber bands - force or compress packages so should never be used for sterile items. Sterile Supply Expiration Time Related Expiration When referring to medical devices, time related sterility is defined as " 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. Quality Assurance Checks We explored the events that can negatively impact sterile items but since we can't watch items 24/7 we must carry out quality assurance 269 monitoring of our environment and safety checks each time we interact with the sets. 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 regularly and documenting the results? Is there a regular schedule of environmental cleaning and is this documented? Are heating ventilation and air conditioning (HVAC) units serviced regularly and 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? 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 as handing is minimal and environmental conditions are stable , then 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? 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 facilities that use this system, it is CSSD that "pick" 270 the case cart so this requires additional storage considerations for consumables. Consumable Inventory Management 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 For this module we will focus on the top three management systems : periodic automated replenishment ( PAR ) , exchange cart and requisition. Periodic Automated Replenishment ( PAR ) or 2 bin - uses a defined minimum and maximum level of supplies frequently with 2 bins so that an order is placed when one bin is empty. Exchange cart - a 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. Sterile Transportation In module 4 we discussed how transport carts play a key role in protecting us and the environment from contaminated items during transportation. For sterile ite transport carts play an equally important role but instea 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 271 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 manual cleaning and disinfection between uses. Servicing 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. 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 particularly 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. 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 272 until an event 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. 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 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 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. CONCLUSION Maintaining product sterility during storage and transport is one of the most important Central Service job tasks. If unsterile instruments or supplies are used, patients could acquire an infection. Carefully following 273 written storage and transport procedures, and keeping the area clean and maintained will help keep patients safe. Exercises and Checklists Exercise 1 Explore your sterile storage room. Check your log book for instructions and documentation. Exercise 2 Complete the competency checklist. Check your log book for instructions and documentation. Module 12 SAFETY AND RISK MANAGEMENT INDEX: 1. INTRODUCTION 2. RISK MANAGEMENT 3. COMMON WORKPLACE SAFETY HAZARDS 4. GENERAL PHYSICAL HAZARDS 5. AREA-SPECIFIC SAFETY CONCERNS 6. DISASTER PREPAREDNESS 7. EMPLOYEE ACCIDENTS AND INJURIES 8. PATIENT ACCIDENTS AND INJURIES 9. EMPLOYEE INFORMATION AND TRAINING 10. EMPLOYEE PREPAREDNESS 11. CONCLUSION 274