IAP Zone PDF - Inspection, Assembly, and Packaging

INSPECTION, ASSEMBLY AND PACKAGING (IAP) MODULE 9 Presented by: Noha Almalki AS RESULT OF SUCCESSFULLY COPLETING THIS MODULE THE TRAINEES ARE ABLE TO: DESCRIBE ENVIRONMENTAL REQUIREMENTS FOR IAP. DEFINE THE DRESS CODE REQUIREMENTS FOR ENTRY INTO THE IAP ROOM. Identify possible sourc...

INSPECTION, ASSEMBLY AND PACKAGING (IAP) MODULE 9 Presented by: Noha Almalki AS RESULT OF SUCCESSFULLY COPLETING THIS MODULE THE TRAINEES ARE ABLE TO: DESCRIBE ENVIRONMENTAL REQUIREMENTS FOR IAP. DEFINE THE DRESS CODE REQUIREMENTS FOR ENTRY INTO THE IAP ROOM. Identify possible sources of chemical and physical damage to medical devices. Provide an overview of packaging materials Describe the importance of selecting the correct wrapping Describe wrapping techniques. Describe sealing methods for pouches and reels. Explain tracking, traceability and labelling methods to support. Identify basic procedures for handling loan instruments  Q: Can you describe the decontamination life cycle?  The IAP room is usually the central point of CSSDs and where the inspection, function testing and appropriate maintenance of cleaned reusable medical devices takes place. sometimes called the preparation and packaging ( prep and pack) area Assembly area is a clean area of the CSSD where surgical instruments are inspected for intactness, cleanliness and functionality. Rooms, Eqipments,and machines? Inspection, assembly and packing 1-(IAP) room 2-Gowning room 3-Materials transfer room 4-Environmental cleaner room 5-Sterilization room  Inspection, assembly and packing (IAP) r oom— this room is restricted only who inspect, assemble and package cleaned RMD to prepare for sterilization. Sterilizers are frequently located in this.room Gowning room— provides controlled entry and exit to the IAP zone, allows for changing into PPE, and a hand wash sink for hand hygiene to protect clean instrumentation from the risk of contamination Materials transfer room— maintains an air-lock to bring raw materials in and out of th e IAP zone Environmental cleaner room— dedicated to cleaning materials and equipm ent for use only in the IAP zone  Sterilization room— in newer CSSD designs sterilization equipment is located in a room separate from IAP and Storage to further reduce contamination risks to unwrapped RMD  Packing tables Tray liners Chairs Air guns Pass through hatchs Magnifiers Drying cabinets Additional task lighting Sterilizers—high temperature Wrappers and containers Sterilizers—low temperature View pack pouches Biological incubators Heat sealers Environmental monitors Surgical instrument temperature, humidity and tip protectors pressure  What should the air pressure AND Temperature be in the IAP room of a decontamination unit?  Positive (+) prevents air from entering the room Room temperature is controlled between 20-23C (68-73 F) and kept at a relative humidity of 30–60% Environmental Requirements for IAP Ventilation for the inspection, assembly and packing room meets clean room standards according to ISO 14644-1: 1999 Class 8  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. 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. CSSD professionals assigned to prep and pack area must understand the primary goals of creating an instrument pack The first goal is to create a pack that meets the users needs Acronym (FAN) Function Accurate Neat  Staff movement, between dirty and clean Dress Code areas is not possible without passing through a clothing change and hand- Requirement 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. - In the IAP wear a freshly laundered scrub suit. - Scrub suits are low-linting attire that minimize bacterial shedding and provide comfort and a professional appearance. Dress Code Requirement 1-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 covere 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 wo rn 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 shoes are dedicated to department use only to protect shoes from contamination. Washer-Disinfector (WD) to Sterilizer  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 ? QUALITY CHECKS CONSIST OF: Correct cycle Spray arms not for example, if a container blocked cycle was used for If arms were blocked by RMD instruments then the load during cycle the load must be should be rejected and sent rejected as correct cleaning back for reprocessing. and disinfection may not have occurred. Soil or stain Excessive wetness excessive wetness could be any soil or staining seen on caused by: visual inspection is rejected - blocked arms and items must be sent back - incorrect loading for reprocessing. -problems with the WD settings so should be investigated. QUALITY CHECKS CONSIST OF: 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. QUALITY CHECKS CONSIST OF: 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 tray must be considered contaminated and sent back to the wash area via the transfer hatch or chamber. Local Policy Checks After Unloading 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 damage, staining or residue. These are some standard processes that should also take place: 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: quality checks?  Soil or staining any visible soil or staining is rejected and items must be sent back for reprocessing. Excessive wetness Damage if the item was handled incorrectly or immersed items that have been manually cleaned and in fluid when it should not have been it must be disinfected must be dry before moving to reported immediately to the line manager. the IAP room. Correctly disassembled devices Documentation completed if items were not disassembled, adequate manually cleaned items and any non- cleaning would not have occurred so the conformances and rejected items must be item is returned for reprocessing. 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 checked under magnification because small pieces of bioburden or debris can Bioburden :The number of otherwise be difficult to see. microoranisms on a contaminated object Key parts of surgical instruments  Tip Key parts of Jaws surgical Box lock instruments Shank Ratchet Ring handle  Instrument categorization Accessory: An accessory is any instrument that does not fit into a category, but is an important part of the surgical procedure and has a specific function. Ex: mallets, harmonic scalpels and guide pins. Clamping and Occluding: Used to compress or close blood vessels for hemostasis or occlusion. Ex: Crile hemostatic forceps Cutting and Dissecting: Used to separate or incise, dissect or excise soft or compact tissue.Ex: scalpels, Iris scissors and curettes.  Grasping and Holding: Grasping and holding instruments are designed to grip, and stabilize body tissues. They may also be used to extract foreign bodies. Ex: Allis tissue forceps, and towel clamps. Dilating and Probing: These instruments are used to probe, expand, examine or create an anatomic passage; to enlarge or open a stricture or introduce another instrument. Ex: are uterine dilator, mini-dilators. Exposing and Retracting: Designed to pull aside or hold back wound edges and other tissues to gain access to the surgery or operation site. These instruments are usually called “retractors,” with blunt “blades” that may be curved or angled, or with sharp prongs.. Ex: bone hooks, Volkman retractors.  Aspirating and Suctioning: Aspirating and suctioning instruments are used to remove blood and other fluids and debris from the operating site. These instruments are hollow tipped and come in a variety of sizes and shapes for ease of access. Ex: cannulas, aspiration suction tubes. Stapling and Suturing: Used to align, secure and approximate the edges of soft or compact tissue for healing; they may employ implants like sutures, staples, clips wires or screws. Ex: needle holders, suture needles. Viewing: Viewing instruments allow to illuminate a cavity such as a nasal cavity. Examples include endoscopes, nasal specula, and lighted vaginal specula.  Accessory Ex: mallets, harmonic scalpels andguide pins  Clamping and Occluding Ex: Crile hemostatic and Kelly hemostat forceps Jaw features can consist of: Full serration (Crile hemostat) Partial serration (Kelly hemostat) Cutting and Dissecting Ex: scalpels, Iris scissors, curettes, Bone rongeurs, Kerrison rongeur, and bone cutters/nippers, osteotoms and chisel Most popular is Mayo scissors. Cutting and Dissecting Ex: scalpels, Iris scissors, curettes, Bone rongeurs, Kerrison rongeur, and bone cutters/nippers Most popular is Mayo scissors.  Grasping and Holding Ex: Tissue forceps, Dressing forceps, Allis tissue forceps, and towel clamps. Tissue forceps: have teeth. Dressing forceps: have serration.  Dilating and Probing Ex: uterine dilator, mini-dilators  Exposing and Retracting Ex: bone hooks, Volkman retractors and Zalkind retractors.  Exposing and Retracting Ex Handheld: Langenbeck, Morris, Deaver, Doyen, and army-Navy.  Exposing and Retracting Ex: Self-retaining: Weitlaner reatractor, Blafour retractor.  Exposing and Retracting Ex: Table mounted: Bookwalter retactor.  Aspirating and Suctioning Ex: cannulas, aspiration suction tubes, Frazier suction tube, pool sucker and Yunker suction. Stylet is used during surgery to unclog the suction. Stapling and Suturing Ex: needle holders  Viewing Ex: endoscopes, nasal specula, and lighted vaginal specula.  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 KockerMosquito forceps, ) for alignment. Check ratchets for easy closure and firm hold. Report any damaged, incomplete or malfunctioning devices immediately to the supervisor.  Check cannulated devices to ensure channel is (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 Devices that have an outer insulation coating, for example diathermy forceps , 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 parts 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. -Inspect blades and be sure they meet evenly -inspect for cracks and bioburden  Inspect for teeth and proper alignment Inspect for boiburden Inspect for cracks -Inspect jaw serrations for bioburden -Inspect for cracs  -Inspect for cracks -Push down and release should spring back up -Retractor like (richardson) inspect blade for burs -Inspect for dents -Inspect for boiburden  -Inspect screw -For chisels and osteotomes use plastic dowel rod test material  Scissors sharpness Rust or stain Scissors 4.5” and larger: red Pencil eraser test test material. Scissors 4” and smaller: yellow test material Bone curette, chisels and osteotoms Bone cutter, rongeur Plastic Dowle rod Index card  Instrument lubrication Surgical instrument with moving parts must be after each use or according IFU. Lubricants should be approved to be used a sa surgical instrument lubricant and for the type of sterilization method that will be used. Lubrication can be done manual or automated. The application point should be on the instrument hinge and any working component (moving part). 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 are switching 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 system usually consists of handheld barcode readers ) connected to PC’s that log and store the information for each tray. Once the barcode label is scanned preparing the tray it automatically produces a packing list and also generates a unique barcode label ( which contains the serial number specific to that tray and process.  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 There are some general rules when it comes to assembling devices into trays. 1- Arrange from left-Right. 2-Arrange by size. 3-Accurate cheeklist. 4-Forceps place on instrument pins to hold them togather. 5-Follow the manufacturer IFU 6-Leave all forceps with ratchets open but if stringers are not available close devices with ratchets on first ratchet only 7-Spread devices evnly by weight over tray surface help prevent condensate. 8- Evenly place plastic items in the tray. 9-Validated tip protectors should be placed on delicate or sharp items. 10-Try liners to aid in the drying of wrapped instrument sets 11-Validated silicone mats used to protect delicate devices but placing them in a manner that protects them. 12-Any missing or extra devices found while assembling should be reported  Tray liners Stringers Tip protectors Silicone mats Silicone mats Packaging Let’s recap the steps completed so far we have:  Checked that the Washer-disinfector Removed the tray of cycle has been devices from the successful and the washer carriage load is released Inspected each Placed the tray on a individual device for clean workbench cleanliness and surface 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. packaging material must: provide an effective barrier to microbial penetration protect the packaged items from contamination during handling. allow aseptic delivery of the contents to the sterile field. Re-usable linen is old practice and completely discouraged.  The choice and type of wrapping material will depend on: - the type of sterilization process used - the size of wrapping material needed to attain adequate coverage of the item. As a minimum, materials used must comply with EN ISO 11607-1 EN ISO 11607-2, 2006 EN 868 parts 2-10 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 Therr are tow baisic categoris of sterility packaging : -Reusable -disposable Reusable Sterilization Packaging Materials Woven Textiles Rigid Container  Woven Textiles - Muslin –Broad term describing awide variety of plain weave cotton or cotton/polyester fabrics Other Woven Textiles: - Duck Cloth. - Twills. Textile Packaging -Must be inspected for holes between uses using a light table. -Holes must be patched using heat sealed patches. -Textile packaging requires more labor than disposable packaging. Rigid Container Somethings to consider when using containers are that they are: Easily disassembled Suitable for the for cleaning, drying method of sterilization and storage being used Compatible with the cleaning method and Suitable for the cleaning agent being storage configuration used 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; 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. - The lid of gasket should be clean and free of crack and nicks. - The handle area should be checked to ensure that they are secure and not separation from the container. - Handle should move up and down easily.  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. Disposable Sterilization Packaging Materials Pouches Nonwoven warp Kraft-type Papers - Medical-grade paper approved by the FDA for use as Sterilization packaging. - Used for small items. Non-woven Packaging Material Spunbond - meltbiown - spunbond(SMS) - Available in a wide variety of sizes and weights. - Used for various items from small single item packs, to entire instrument  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 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.  Spunbond Polyolefin-Plastic Combinations: (Tyvek) - Allows visibility of pack contents and penetration of sterilant. - Contains no cellulosic materials and is therefore compatible with gas plasma sterilization processes.  Sterilization Wraps While most hospitals use all of these packaging options, the most commonly used method is STERILIZATION WRAPS. There are tow methods of using sterilization wraps.: 1-Sequential Wrapping Sequential wrapping refers to when two layers of wrap material are wrapped individually using a fold technique. A single layer is folded 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.  There are also tow techniques for wrapping packages and both are used with the Sequential and Simultaneous : 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. Envelope Fold Technique The items to be wrapped are placed on the table in a diamond shape to the wrapper. This method is frequenlty used for smaller items.  PACKAGE LABELING AND CSSD Electronic Tracking Systems  PACKAGE LABELING: It is essential that all package be labeled before sterilization. The label must be complete and accurate to ensure that the correct packs are selected and opened. label information should include the follwing: Description of package contents. Initial of package(packager) Lot control number Identification of sterilizer and cycle to be used. Date of steriliztion Assigned storage location The requesting department or the surgeons name may also be includedon label. Correct labeling is critical in the event of a sterilization load recall  CSSD Electronic Tracking Systems There are many IT tracking systems on the market, all with very different features and benefits. Each CSSD must evaluate its own requirements and purchase the system most closely matching their local needs. The IT system is an electronic documentation system also used to demonstrate compliance with the procedures in the QMS as long as they can be retrieved to show to an auditor. It is important to test the system internally to become familiar with how records can be accessed  As a minimum, the system records all items in circulation including surgical instruments and trays, and contain information on tray contents supporting the printing of tray lists for assembly. All devices must be uniquely marked in some way to allow scanning. This may be achieved using a number of different options including bar codes, matrix marks, laser etching and radio frequency identification (RFID). Below are some of these examples.  Most tracking systems will scan bar coded devices at each stage of the decontamination process, thereby logging the activity. Many systems will prevent items from moving to the next stage of the process before successful completion of the previous one; this is quality control. No device can easily miss a critical step in the process. Decontamination specialists can be provided with barcoded personal identification badges, that are scanned at various points within the department, marking an association between them, the devices they handle and the equipment used in the department. Thank you for listening! Don't hesitate to ask any questions!