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 time before being...

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