day 1.pdf

> 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 m...

> 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: what is most 3 reason of Biological or chemical indicator wasn't used or didn't pass recall RMD 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