MOD 9 Part 2 PDF

ratchet only, to ensure that steam can penetrate all surfaces. Spread devices evenly by weight over the tray surface to help prevent condensate flowing together. Evenly place plastic items in the tray; avoid collecting them in one area as this may also lead to moisture collection post-sterilization....

ratchet only, to ensure that steam can penetrate all surfaces. Spread devices evenly by weight over the tray surface to help prevent condensate flowing together. Evenly place plastic items in the tray; avoid collecting them in one area as this may also lead to moisture collection post-sterilization. Validated tip protectors (Figure M6–17) should be placed on delicate or sharp items. Tray liners (Figure M6–18) or silicone mats (Figure M6–19) may also be used to protect delicate devices but placing them in a manner that protects them, especially away from heavy devices, is also very important. Any missing or extra devices found while assembling the tray should be reported to the supervisor for further action and a non-conformance documented. This is an239 extremely important matter as an incorrect count may lead to long delays in the OR if an item is found to be missing before or after the case. Don’t create overcrowded or overweight trays as it leads to possible issues related to drying and sterility failure. Additionally, heavy trays can be ergonomic challenge for those who lift the trays during loading the sterilizers or transportation. ANSI/AAMI ST77 containment devices for reusable medical devices sterilization and ANSI/ AAMI ST79, comprehensive guide to steam sterilization and sterility assurance in health care facility, recommend that the maximum weight of surgical instrument sets trays is 25 pounds, this include the weight of the instruments and the instruments containers. When processing metal basin, make sure you position them in a way allows moisture to drain during sterilization. When steam touches metal it cools down allowing water droplets to form. This can be avoided by using wicking material such as surgical towels to facilitate drainage and drying. There should be 1 inch in size difference When processing multiple basins to avoid condensation accumulation. Packaging Let’s recap the steps completed—so far we have: Checked that the Washer-disinfector cycle has been successful and the load is released Removed the tray of devices from the washer carriage Placed the tray on a clean workbench surface Inspected each individual device for cleanliness and functionality Assembled the devices that were disassembled for washing Laid the tray out in a manner that ensures good presentation of the devices and that they are protected against damage in accordance with the tray list. So now we are ready to wrap or package the tray and prepare it for sterilization. The two main considerations here are the type of wrap or packaging chosen and the packaging techniques applied. The packaging material and packaging techniques are designed to hold and protect the devices in order to facilitate sterilization and to maintain sterility. As a barrier material used in the perioperative practice setting, packaging material must provide an effective barrier to microbial penetration, protect the packaged240 items from contamination during handling, and allow aseptic delivery of the contents to the sterile field. Re-usable linen is old practice and completely discouraged due to strike-through risk and also leads to linting which can be a serious risk for cross-contamination. Today there are many different types of packaging materials that are used but the most common are: 1/ Rigid containers 2/ Peel Pouches of plastic and/or paper 3/ Sterilization Wraps While most hospitals use all of these packaging options, the most commonly used method is sterilization wraps. Choosing the type of241 wrapping material will depend on the items to be packaged and the sterilization process to be used. As a minimum, materials used must comply with EN ISO 11607-1 and EN ISO 11607-2, 2006 and EN 868 parts 2-10, inclusive. Regardless of the type of packaging chosen the main requirements are that the packaging will: Provide an adequate barrier to microorganisms and particulates Be suitable for the items being sterilized Maintain the sterility of the contents until the package is opened Allow the sterilants to penetrate, and come into direct contact with the item and surfaces Permit removal of the sterilant Permit aseptic delivery of the contents to the sterile field with minimal wrap memory (when opened they stay open, without closing back along crease lines). Allow for complete and secure enclosure of the item(s) Protect the contents of the package from physical damage as far as possible due to stacking or compression Allow a method of sealing that results in a complete seal and provide adequate seal integrity Be resistant to tears, abrasions and punctures Ensure the seal is tamper-proof and able to seal only once Permit adequate air removal 1/ Sterilization Flat Wrap Is made of nonwoven Spunbond-meltblown-spunbond (SMS) fabrics and designed as single use product. They are available in a variety of sizes and weights. Flat Wrapping Technique: 1/ Sequential Wrapping Sequential wrapping refers to when two layers of wrap material are wrapped individually using a fold technique. A single layer is folded242 completely and then sequentially followed with a second sheet of wrap material and repeating the wrap sequence to form a package within a package. 2/ Simultaneous Wrapping Simultaneous wrapping refers to when both layers of wrap material are wrapped together simultaneously. Two single-layer wrappers or one bonded double-layer wrapper can be used. Both methods are acceptable but sequential wrapping is the most commonly used in CSSD. Square Fold Technique The items to be wrapped are placed on the table parallel to the wrapper. This method is generally preferred with heavier items. Figure M6–25 Envelope Fold Technique The items to be wrapped are placed on the table in a diamond shape to the wrapper. This method is frequently used for smaller items. Figure M6–26 Both square and envelope fold techniques are used with the sequential and simultaneous wrap method. 2/ Containers Rigid reusable containers are making a comeback recently. Very popular in the 70’s and 80’s they can be seen in many CSSDs today. The technology has improved significantly and containers are far more user friendly and can be very cost effective if used properly. As a barrier, rigid containers are almost indestructible, providing sterility and customer reassurance if handled and maintained as per the manufacturer’s instructions. Some things to consider when using containers are that they are: Easily disassembled for cleaning, drying and storage Suitable for the method of sterilization being used Compatible with the cleaning method and cleaning agent being used Suitable for the storage configuration Lockable, tamperproof and non-resealable Packed in a manner which allows for penetration of the sterilizing agent Able to remove contents without the risk of contamination of the contents Rigid containers have filter and/or valve systems that are secure and must be in proper working order before sterilization. Examine the filter plate for integrity both before use and after the sterilization process. If the filter is damaged or dislodged or has holes, tears, or punctures, consider the contents contaminated. Clean containers between each use;243 preferably in an automated process, and check the seal between the base and the lid for possible damage. Containers should be serviced regularly by the manufacturer as per the IFUs. Disadvantage of using containers 1/ Creates ergonomics challenge to those who will lift them due to heaviness. 2/ Requires additional space to store them as they are larger than wrapped trays 3/ longer cycle time may be required to avoid issues associated with excessively wet packs 4/ entails extra effort since the containers must be cleaned between uses. 5/potential risk of filter dislodge leading to instruments contamination. 3/ Pouches and Reels There are a variety of packaging materials available for individual surgical instruments, depending on the item to be packaged. Peel-apart pouches with a see-through front and paper backing are often used for single devices or small loads. They come in reels of various sizes where both ends need to be sealed or as single form of various sizes for self-seal. Sealing peel-apart pouches is essential to ensure that the product remains sterile after autoclaving. In self-sealing pouches, adhesive is manufactured into the open end of the bag or plain top and either a heat sealing machine or autoclave tape is then required to create a seal. The see-through peel packaging is a time-saving concept. It is fast and easy to pack an item into a pouch and to close it with a heat sealer (Figure M6–28) or self-seal. Recommended sealing temperatures and pressures and other technical advice should be followed carefully. The identification of packed device(s) is easy because of the transparent plastic film. Peel pouches are used to pack small lightweight single instruments. They can be made of medical grad (kraft244 type) paper/plastic or spunbond polyolefin- plastic (Tyvek pouch). The choice of what type of pouch to use depends on the sterilization method being used. Paper pouches are used for Steam and Ethylene Oxide sterilization methods while Tyvek pouches are used when sterilizing instruments by hydrogen peroxide. Peel pouches are available in rolls allowing the specialist to cut off the desired length for each packed instrument. They are also available in precut sizes. Peel pouches can be heat sealed or contain self-adhesive seal that does not require heat. The plastic side of the pouch allows for fast and easy identification of the packed item. Instruments should be packed inside the pouch with opened hinge to ensure complete sterilant contact to surfaces of the surgical instruments. Leave about ¼’’ space on each side of the package to facilitate air removal and sterilant penetration and avoid package rupture during any of the sterilization phases. It’s important to remove excessive air from the pouch before sealing since the trapped air interfere with proper sterilization. Pouch labeling must be only on the plastic side using approved pen for the sterilization. It is recommended to use tip protector to prevent instruments from puncturing the pouch during sterilization or normal handling. Double pouching is required for aseptic presentation of the items inside the sterile field. It is created by placing an item inside a proper pouch then sealed. This pouch is then placed inside another pouch that is slightly245 larger, then sealed. Avoid folding the inner pouch as it affects air removal and sterilant penetration. Make sure to use a proper temperature when sealing Tyvek or medical grade paper pouch. PACKAGE LABELING It is necessary that all packages be labeled before sterilization. Complete and accurate labeling helps the end user to select the correct pack. Label should include the following information: Package contents Lot number Sterilization date Pack complete name Assembler / packager name The requesting department Sterilizer number and used cycle Labeling information should be written on sterilization tape, commercially available adhesive labels or in the plastic side ofpeel pouches.