Module 9 Inspection, Assembly, and Packager (IAP) PDF

MODULE 9 INSPECTION, ASSEMBLY AND PACKAGER (IAP) Assembly area is a clean area of the CSSD where surgical instruments are inspected for intactness, cleanliness and functionality. The job in this preparation area is critical as the surgical instruments will be handled for the last ti...

MODULE 9 INSPECTION, ASSEMBLY AND PACKAGER (IAP) Assembly area is a clean area of the CSSD where surgical instruments are inspected for intactness, cleanliness and functionality. The job in this preparation area is critical as the surgical instruments will be handled for the last time before being dispensed to OR rooms or clinics. Therefore, this job must be carried out by trained decontamination specialists and technicians, in accordance with manufacturer’s IFU. The area where inspection takes place is designated and controlled to optimize the effect of the sterilization process and minimize the risk of contamination of the RMD sets. Environmental Requirements for IAP: Ventilation for the inspection, assembly and packing room meets clean room standards according to ISO 14644-1: 1999 Class 8 or other internationally accepted equivalent standard. This room must be maintained under positive pressure to ensure that the air flows outward instead of into the work area whenever the doors of the assembly place are opened to reduce the risk of airborne bacteria introduction to the IAP. As outlined in module 1, all rooms in the department are ventilated and controlled to provide a comfortable working environment of 20–23C and a relative humidity within the range 30–60%. Environmental cleaning must follow policies and procedures that have been approved by the hospital. infection control committee. All furniture in this area must be made of smooth non-porous easy to clean materials. Fine fibers that compose lint can be carried by air current and settle on the clean surgical instruments. When lint is introduced to the sterile field it can cause infection to the patients’ wounds. Hence, environmental cleaning must be carried out on daily basis in accordance to the hospital infection control policies and procedures. A dedicated cleaning room is located within the IAP room to clean this area—no outside areas should be cleaned from this location. Microbiological monitoring is carried out in this room according to hospital infection control policies. This monitoring is used as an early warning system to alert staff when environmental quality is drifting out of control. One method of monitoring234 involves placing contact or settle plates in pre-planned locations in the room and then sending them to the lab for culturing and analysis. The results of the analysis are then compared to baseline counts of microorganisms (accepted levels of contamination) predetermined by either the microbiologist or a contracted specialist. Testing results should be the same or better than this baseline. To determine how well the IAP room is being cleaned and give you a good idea of contamination during traffic flows and peak periods, part of the sampling program should be carried out when the facility is unoccupied to achieve a baseline contamination level prior to sampling when occupied. Dress Code Requirement: Staff movement, between dirty and clean areas is not possible without passing through a clothing change and hand-wash area. Protective clothing is worn by personnel entering the IAP room to reduce the risk of possible contamination of the clean reusable medical devices and the environment. Managers ensure that protective clothing is available and all personnel are responsible for correct use and disposal. Specialists working in the IAP wear: 1/A freshly laundered scrub suit Scrub suits (Figure M6–6) are low-linting attire that minimize bacterial shedding and provide comfort and a professional appearance. Freshly laundered attire is changed daily or whenever it becomes visibly soiled or wet. Appropriate clothing is used by anyone entering this area, including staff involved in the maintenance of reprocessing equipment, and visitors. 2/ Head/Hair Cover A clean, single-use, low lint surgical hat or hood that confines all hair is always worn in IAP. The hat or hood must be designed so that microbial dispersal is minimized with all head and facial hair confined as well as covered. After use, headgear and beard masks should be discarded in the appropriate waste stream. Stud earrings may be worn as long as they are totally confined within the head cover. Make-up and jewelry, apart from a wedding band, are not worn in the IAP. 3/ shoes Dedicated sturdy shoes should be worn inside the IAP and never be used out-side. Those shoes should be able to protect the feet from the items that may in an indeliberate manner fall from work area. Shoes cover should be worn even if the shoes235 are dedicated to department use only to protect shoes from contamination.  WASHER-DISINFECTOR (WD) TO STERILIZER Following on from module 5 we are now ready to unload the washer-disinfector containing clean, disinfected surgical instruments and accessories. Depending on your specific equipment this may be an automated process using conveyor belt-type unloading mechanisms. If not automated, the washer carriage can be manually removed from the chamber taking care to wear heat-resistant gloves if necessary— remember the temperature in the chamber can reach over 90c. Be careful with utensils like gallipots or kidney dishes that may have turned upside down during the washing process and contain hot water. When unloading, quality checks are carried out before any further processing. Quality checks consist of: Correct cycle—for example, if a container cycle was inadvertently used for instruments then the load should be rejected and sent back for reprocessing. Spray arms not blocked — If arms were blocked by RMD during cycle the load must be rejected as correct cleaning and disinfection may not have occurred. Soil or stain — any soil or staining seen on visual inspection is rejected and items must be sent back for reprocessing. Excessive wetness — excessive wetness could be caused by blocked arms, incorrect loading or problems with the WD settings so should be investigated. Damage due to configuration — for example if items were impacted by spray arms or the the RMD was not compatible for WD processing. Devices correctly disassembled — If items were not disassembled, adequate cleaning would not have occurred so the full set should be returned for reprocessing. Completed documentation — load contents and any non-conformances and rejected loads must be documented and reported to the line manager. For example, you may notice a device that was not properly disassembled in the wash area, so the entire tray must be considered contaminated and sent back to the wash area via the transfer hatch or chamber. A more serious issue may be where the specialist notices the spray arm rotation has been hindered and therefore the whole load has236 been compromised and must be returned for re-processing. These non- conformances must be documented and reported to the line manager immediately. Local Policy Checks After Unloading (MUST BE DELETED DUE TO REPETETION) What happens to the load next depends entirely on local policies, procedures and guidelines. These are some standard processes that should also take place: Check that the chart record for the cycle conforms to the information established during validation and that all recorded variables are within the parameters permitted. Check that the operating cycle selected is in accordance with the specification for the load e.g. surgical instruments or anesthetic equipment would need different cycle types. Make a visual inspection of the load in order to ensure that there is no obvious damage, staining or residue. If staining and/or residue are present, this may be due to the configuration of the load, overloaded cart or malfunction in the washing cycle. Make a visual inspection of the load for dryness. Unless there is clear indication why a small percentage of RMD in a load were not cleaned and/or dried effectively, the entire load should be returned for re- processing. Manually Cleaned Device Acceptance Quality checks must also be carried out when accepting items that were not processed in a WD. These quality checks consist of: Soil or staining—any visible soil or staining is rejected and items must be sent back for reprocessing. Excessive wetness—items that have been manually cleaned and disinfected must be dry before moving to the IAP room. Damage—if the item was handled incorrectly or immersed in fluid when it should not have been it must be reported immediately to the line manager. Correctly disassembled devices—if items were not disassembled, adequate cleaning would not have occurred so the item is returned for reprocessing.Documentation completed—manually cleaned items and any non- conformances and rejected items must be documented and reported to the line manager. Inspection and Function Testing All surgical devices unloaded from the washer-disinfector must be inspected for cleanliness, stains, corrosion, cracks, breakage, and stiffness of movable parts before being placed in device sets. Where possible, devices should be checked237 under magnification because small pieces of bioburden or debris can otherwise be difficult to see. Inspect each RMD from a set separately. Critically inspect all areas of the devices e.g., box joints, serrations and crevices, for cleanliness. Check hinges (such as artery forceps and clamps) for ease of movement. Check jaws and teeth (such as found on Kocker- Mosquito forceps, Figure M6–9) for alignment. Check ratchets (Figure M6–10) for easy closure and firm hold. Report any damaged, incomplete or malfunctioning devices immediately to the supervisor. Check cannulated devices to ensure channel is patent (clear). Function check telescopes and light cables as per the manufacturer’s instructions. Check each device set for completeness. Check cutting edges (such as scissors, rongeurs, chisels, curettes) for sharpness, see device sharpness testing, module 3. Devices that have an outer insulation coating, for example diathermy forceps (Figure M6– 11), require close inspection to ensure that the insulation remains intact. Check insulated devices using a diathermy pin point tester. Damaged surfaces allow dirt and bacteria to collect, and can also lead to a potential burn risk for the patient and/or the user. Check each device for free movement of all part and non-sticking joints. A water-based lubricant may be used if required (read IFU for dilutions and application). Check that the edges of clamping RMD meet with no overlap and that teeth mesh together properly. Check all screws on jointed RMD for tightness as they may become loose during the cleaning process. ASSEMBLY AND CHECKING Once the devices have been inspected and function-tested they are now ready to be assembled into their respective trays. Many CSSDs today areswitching to one of the many types of computerized track and trace systems on the market. These systems are now accepted as one of the most essential requirements in the modern CSSD. The system allows for the accurate tracking of the devices and device trays through the whole decontamination process. In the IAP room the track and trace system238 usually consists of handheld barcode readers (Figure M6–12) connected to PC’s that log and store the information for each tray. Once the barcode label is scanned by the specialist preparing the tray it automatically produces a packing list (Figure M6–13) and also generates a unique barcode label (Figure M6–14) which contains the serial number specific to that tray and process. Once a new processing cycle begins, a new unique unit number is produced each and every time. For those CSSDs that do not have such a computerized system in place, a manual system may be used. This usually consists of a pre-printed tray checklist and a manual label gun (Figure M6–15). There are some general rules when it comes to assembling devices into trays. Most often items are arranged from left to right in accordance to when they will be required in a procedure, for example, the scalpel handle used to make the initial incision is the first device on the left and the needle holders used to close the wound are on the far right. They can also be arranged by size so they don’t get tangled or from Surgeon and OR Nurses preferences, but the most important aspect is to have an accurate checklist that all specialists follow to ensure consistency. All contents of a specific surgical instrument tray must be checked and verified against it’s checklist. Forceps should be placed on instrument pins to hold them together and reduce tangling. (Figure M6–16A) This can also be done using a forceps but isn’t recommended. (Figure M6–16B) Follow the manufacturer’s IFU for devices that should be sterilized in a particular way or disassembled. This ensures that all surfaces are presented to the sterilants. Aim to leave all forceps with ratchets open but if stringers are not available close devices with ratchets on the first 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.