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Added: Jul 24, 2024
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Instrument reprocessing
INSTRUMENT REPROCESSING Sort And Disassemble, Cleaning, Decontamination, Inspection, Assemble And Wrap/Pack Sterilization Storage, Distribution
CLASS USE INSTRUMENT/ EQUIPMENT REPROCESSING Critical/ high risk Enters body cavities, tissues and vascular system, in contact with break in the skin or mucous membranes. Surgical instruments, needles, catheters (cardiac) and prosthetic implants, intrauterine devices endotracheal and tracheostomy tube. Cleaning followed by sterilization Semi-Critical/ Intermediate risk Cleaning followed by sterilization Endoscopes, respiratory equipment including laryngoscope and blade, oropharyngeal and nasal airways, thermometers Li nen , ute ns i l s u se d o n p a ti en ts infected with highly virulent and infectious pathogens, e.g. Hepatitis B, Mycobacterium tuberculosis, Shigella Cleaning followed by sterilization/ high- level disinfection
CLASS USE INSTRUMENT/ EQUIPMENT REPROCESSING Non-Critical/ Low-risk In contact with intact skin Stethoscopes, blood pressure apparatus, bedpans, urinals, washing bowls, utensils, toilets linen Cleaning followed by low or intermediate level disinfection. Limited risk Not in close contact with patient, or in close proximity but with low contamination risk Walls, floors, sinks, bedframes, lockers. Cleaning with detergent and drying
Cleaning at the point of use The main purpose of cleaning at the point of use is to prevent blood and debris from drying on instruments or to soften and remove dried blood and debris. During surgery, instruments and equipment exposed to blood and body tissue are periodically wiped free of blood and debris to prevent caking and drying. Dried blood and tissue debris make instruments difficult to operate and create a film on the instruments that is difficult to remove later.
Cleaning at the point of use Also, dried blood and tissue must not be reintroduced into the surgical wound. A sponge moistened with water can be used for this purpose, or instruments may be placed in a basin of water. Suction tips should be periodically flushed with water. Saline is never used for cleaning or soaking instrument because it causes pitting, rusting, and corrosion. Equipment that is not immersible should also be wiped down periodically during surgery. This includes digital or electronic cameras, light cables, pneumatic drills, and other power equipment . Wiping instruments during surgery reduces biofilm and prevents buildup of organic debris.
Cleaning at the point of use At the close of surgery, sharp instruments are separated out to prevent injury. Other instruments usually are placed in a separate basin with the heavy ones on the bottom and lighter on top. The water used to soak the instruments is suctioned off before the equipment is transported out of the surgical suite; this prevents spills and contamination of the transport cart. The equipment is placed on a covered or closed transportation cart for transfer to the decontamination area.
MANUAL CLEANING STEPS OF CLEANING INSTRUMENTS MANUALLY Fill the washing sink with clean, warm water to which a noncorrosive, neutral pH, low- sudsing , free-rinsing detergent has been added. Liquid detergents are preferred. Do not pour the detergents directly on the instruments.
STEPS OF CLEANING INSTRUMENTS MANUALLY 2. Wash instruments carefully to guard against splashing and creating aerosols. Use a soft brush to clean serrations and box locks. A soft bristle toothbrush may be used to clean ophthalmic, microsurgical, and other delicate instruments. Keep instruments totally submerged while brushing to minimize aerosolizing microorganisms and chemicals. Use a soft cloth to wipe surfaces. A nonfibrous cellulose sponge will prevent damage to delicate tips. Remove bone, tissue, and other debris from cutting instruments. Never scrub surfaces with abrasive agents such as steel wool, wire brushes, scouring pads, or powders. These agents will scratch and may remove the protective finish on metal, thus increasing the likelihood of corrosion. The finish on stainless steel instruments protects the base metal from oxidation.
STEPS OF CLEANING INSTRUMENTS MANUALLY Rinse instruments thoroughly in distilled or deionized water at the temperature recommended by the manufacturer. Some enzymes can be inactivated by extreme temperatures. The water should not exceed 140° F (60° C) to prevent burns of the skin. Inadequate rinsing can leave a surface residue that can stain instruments.
Transport of soiled instruments to decontamination area Most surgical departments use a case cart system to collect and transport instruments and equipment for a surgical procedure. Sterile instruments and supplies are loaded onto the cart before surgery and transported to the surgical suite. Immediately after surgery, instrument trays, basins, and any other soiled equipment are placed on the cart, which has closed shelving units. The covered cart then is transferred to the decontamination area for processing.
Cont. If the health care facility has a cart decontamination system, basins and trays can be placed directly on the shelves at the point of use before transport to the decontamination area. If no such system is available, all soiled items must be contained in leak-proof bags to prevent gross contamination of the cart. Instruments and equipment are transported directly to the decontamination area by the scrubbed technologist or nurse.
Decontamination attire Protective eyewear (i.e., goggles with side shields) Face shield Gloves approved for contact with chemical disinfectants (surgical or patient care gloves are not permitted) Full protective body suit or gown with waterproof apron and sleeves Waterproof shoes and covers
1. Sort and disassemble The first phase of reprocessing is sorting . This is done to prevent damage to delicate items and prevent injury during reprocessing. It is also important to gather the small parts of instruments (pins, gaskets, screws) and keep them together to prevent their loss during reprocessing. Instruments and equipment must be cleaned before they are disinfected or sterilized.
Cont. Dried blood, body fluids, and tissue debris trap microorganisms and become contaminants. This debris can also cause instrument damage and malfunction. Cleaning is performed by hand, ultrasonic cleaner, and automated washer.
1. Sort and disassemble cont.. Items are removed from the transport cart and grouped together by category: Non-immersible equipment or instruments Instruments with sharp edges or points Small gaskets, screws, pins, and other small parts Heavy instruments Delicate instruments Heat- and pressure-sensitive instruments Instrument containers Basins and cups Tubing, suction tips, or other instruments with a lumen Instruments or equipment requiring repair or replacement
2. Cleaning After the instruments have been sorted, selected instruments are soaked and hand cleaned using cold water and enzymatic detergent. Cold water is superior to hot water as a solvent for blood and other body fluids. Also, some enzymatic detergents are deactivated at temperatures over 140° F (90° C). The instruments are submerged during cleaning to prevent the release of contaminated airborne droplets (aerosol effect).
Cont. Areas that are difficult to clean must be scrubbed with a small brush. Particular attention is paid to hemostats and other clamps, orthopedic rasps, and other instruments that contain bits of trapped soft tissue or bone. Items with a lumen (e.g., hollow tube) are cleaned with a soft, narrow brush. The correct size brush must be used to be effective. Brushes that are bent or have sections of missing bristles are not efficient in removing tissue and biofilm.
Cleaning cont. Suction tips are cleared with a stylet, a fine wire that can be passed through the instrument to push out debris. Instruments with channels and valves may require disassembly for complete cleaning. Equipment and specialty instruments that are not immersible, such as those with lenses or electronic parts, are cleaned according to the manufacturer’s specifications. After cleaning, instruments must be completely rinsed to remove all traces of detergent and debris. Some instruments require rinsing in distilled water. In this case the manufacturer’s guidelines should be followed.
3. DECONTAMINATION PROCESS. DECONTAMINATION: The combination of processes (including cleaning, disinfection and sterilization) used to render a re-usable item safe for further use on patients and handling by staff. Effective decontamination is essential in reducing the risk of transmission of infectious agents. OR The neutralization or removal of dangerous substances, radioactivity, or micro-organisms from an area, object, or person. OR The process of rendering (an area, building, object, etc.) harmless by the removal or neutralization of harmful substances. CONTAMINATION: The soiling or pollution of inanimate objects or living material with harmful, potentially infectious or unwanted material
De f . o f t e r ms CLEANING: The process that physically reduces the level of contamination(organic matter, dirt, grease) but does not destroy all organisms DISINFECTION: The partial removal or destruction of organisms except spores STERILISATION: The process used to render an object free from all organisms including spores SINGLE PATIENT USE Any device deemed unsuitable for re-processing
TE R M S The terms sterilization and disinfection are often used incorrectly, for example: it is not correct to refer to the immersion of baby bottles in a hypochlorite solution as sterilization. In fact, this is a disinfection procedure that destroys some but not all organisms present Spores: are single-celled microorganisms or microorganisms in the resting or inactive stage .
Cont. The usual steps in the decontamination process include sorting, soaking, washing, rinsing, drying, and lubricating. To ensure proper detergent concentration, it is advisable to obtain an exact measuring device for the detergent and to mark the sink with a piece of tape or a nontoxic, permanent marker to indicate the correct water level. Instructions for rinsing are also important. Some products call for multiple rinses.
3. DECONTAMINATION PROCESS cont … In most clinical settings, the four-bucket system is used: The first bucket – 0.5% sodium hypochrorite The second bucket- clean water The third bucket – soapy water The fourth bucket – clean water Thereafter, the instruments are air dried or using a clean towel
washer-sterilizer or washer decontaminator machine In advanced CSSD department, washer-sterilizer or washer decontaminator machine is used. The temperature of the washer-sterilizer ranges from 250° F to 280° F (121° C–138° C) and would cause coagulation and crusting of protein. The instruments should be thoroughly rinsed. At the end of the cycle the instruments may be safely handled without gloves. The sets can be assembled and prepared for routine sterilization. A cycle in a washer-sterilizer makes the instruments safe to handle with the bare hands, but it does not render instruments safe for immediate patient use or sterile storage.
Cont. Lubrication is done during decontamination Instruments are lubricated to ensure smooth mechanical action. This process is used on stainless steel instruments and other selected equipment according to the manufacturer’s recommendations. Only lubricants approved for use on medical devices are used. Oils are not used for lubrication, because the sterilization process may not penetrate oil. Steel instruments may be dipped in a combined lubricating and protective instrument milk as the final stage in cleaning and decontamination.
4. Inspection Before instruments are assembled and wrapped for sterilization, they are inspected for soil, stains, corrosion, proper function, and structural soundness. Instruments that are not properly cleaned before the sterilization process harbor tissue fragments in the hinge or other areas. Microbes can survive in tissue fragments and cause infection in the patient. The shanks of instruments such as hemostats, needle holders, and scissors should be straight. The instrument should be opened and shut several times. If the hinge is stiff during opening and closing, it can be treated with an approved instrument lubricant.
4. Inspection cont. Mineral oil and silicone must not be used on surgical instruments because they can interfere with the sterilization process. While examining the instrument, look for the conditions of the ratchets and hinges. With time, hemostats and needle holders may spring open unexpectedly. Cutting instruments such as scissors, curettes, osteotomes, rongeurs, and shears should be examined for pitting along the cutting edge. Sharp instruments should be inspected to ensure that the blade surfaces meet smoothly and properly. Forceps must be tested for spring. When the tips are compressed and then released, they should immediately return to the open position. The tips of forceps should close freely and align precisely.
4. Inspection and testing Microsurgical instruments are very expensive to purchase , repair, and replace . These instruments should never be mixed with heavier ones. The tips of microsurgical instruments should be inspected under magnification to ensure that the sharp points are smooth, sharp, and in proper alignment. Any instrument found to be malfunctioning should not be packaged and sterilized; rather, it should be sent for repair
Inspection and testing cont. The following essential points should be observed when inspecting an instrument after cleaning: Check hinged instruments for stiffness. Box locks and joints should work smoothly. Stiff joints are usually caused by inadequate cleaning. Lubrication eases stiffness temporarily. Test forceps for alignment. A forceps that is out of alignment can break during use. Check the ratchet teeth. Ratchet teeth are subject to friction and metal-to-metal wear by the constant strain of closing and opening. Test needle holders for needle security and precision. Clamp an appropriate-size needle in the jaws of the needle holder and lock it on the second tooth of the ratchet. If the needle can be turned easily by hand, the needle holder needs repair or replacement.
Inspection and testing cont. Test scissors for correctly ground and properly set blades. The blades should cut on the tips and glide over each other smoothly. Use tissue/operating scissors to cut through four layers of gauze at the tip of the blades. Electrical insulation should be intact on all reusable electrosurgical equipment. Inspect the edges of sharp and semi sharp instruments such as trocars, needles, chisels, osteotomes, rongeurs, and adenotomes for sharpness, chips or dents, and alignment Inspect microsurgical instruments under a magnifying glass or microscope to check alignment and detect burrs on tips and nicks on cutting edges
Inspection and testing cont. Check pins and screws of reusable staplers to be sure they are secure and intact. Flatten or straighten malleable instruments such as retractors and probes. Weakened or cracked items should be immediately replaced. Unclean or questionable instruments should be returned to the cleaning area for ultrasonic cleaning. Instruments in poor working condition should be removed from the processing area.
5. Assembly and wrapping/ packing After inspection, the instruments are ready for assembly and wrapping. Lists of all instruments and equipment usually are maintained in a computer database or hard copy file. Materials management systems allow CP personnel to track both individual instruments and instrument sets. Standardized trays are assembled so that staff members know what is included in an instrument tray at the point of use. Lists are printed out so that they can be checked at the time of tray assembly.
Guidelines on instrument assembly Instruments are assembled in a way that protects them and allows the sterilization method to reach all surfaces: Hinged instruments are opened (unlocked) and strung together with an instrument stringer or in racks designed to hold the instruments in an open position during the sterilization process When assembling instrument sets, make sure any sharp or pointed items are turned downward to prevent injury and sterile wrapper puncture. Sharp and pointed instrument tips may be covered with plastic tip protectors to protect them from injury.
Cont. Instruments that have movable parts intended for disassembly must be disassembled before sterilization. Any instrument that was not disassembled before disinfection may not be clean and should be returned for disinfection. Instrument trays have a perforated bottom that allows steam to circulate up through the tray and adequately cover all surfaces of the instruments. Make sure no instrument tips are caught in the perforations, where they could be damaged. A cloth towel may be placed on the bottom of the tray to prevent damage to the instrument tips during the sterilization process.
Cont. Heavy instruments are placed on the bottom of the tray, and the others are packed or nested so that they cannot shift and damage each other during processing. For items with a lumen, a small amount of sterile, deionized (distilled) water should be flushed through the item immediately before sterilization. This water vaporizes during sterilization and forces air out of the lumen. Any air that is left in the lumen may prevent sterilization of its inner surface. Remove stylets from suction tips for assembly so that the sterilant can freely circulate inside the lumen.
Cont. Instrument trays should not contain separate items wrapped in peel pouch packages. Air can become trapped inside the pouches and prevent steam from reaching all surfaces of the items inside. Rubber bands must not be used to group instruments, as these cannot be sterilized effectively. Do not use nonwoven disposable wrapping material to separate instruments inside the tray or for lining the tray bottom. The material may prevent penetration of the sterilant to the instruments.
Cont. Power-driven surgical instruments (e.g., drills and saws) should be disassembled before steam sterilization. Hoses can be coiled loosely during packaging, and all delicate switches and parts should be protected during preparation. Before sterilization, power-driven instruments should be lubricated according to the manufacturer’s specifications. Power driven instruments should be tested before wrapping. Finally, before processing, make sure that all switches and control devices are in the safety position.
Cont. Container devices that allow systematic organization and separation of specialty instruments such as ophthalmic and microsurgery sets must be safe for surgical use. Make sure that the specifications of the device meet AAMI and FDA standards..
Wrapping instruments All items to be sterilized by pressurized steam, ethylene oxide, ozone, or gas plasma methods must be wrapped according to approved methods. The purpose of wrapping an item before sterilization is to protect it from contamination after the sterilization process. Two broad categories of wrappers are woven and nonwoven paper or polymer material. Combination polypropylene-paper pouches are also used to wrap small items.
Wrapping instruments All items must be wrapped before sterilization. Wrapping helps prevent recontamination after sterilization and prior to the item’s use. Only wrapped or packed sterilized materials should be described as sterile.
Qualities of a wrapping material Allows the sterilant to penetrate the wrapper and reach all parts of the device Allows complete dissipation of the sterilant when the process is finished Contains no toxic ingredients or non-fast dyes All wrappers must be lint free (special type of cleaning cloth that does not give up any fluff when used). Does not create lint. Resists destruction by the sterilizing process (e.g., melting, delamination, blistering, and alteration of the chemical structure of an item)
Qualities of a wrapping material Permits complete enclosure of the package contents Produces a package strong enough to withstand storage handling. Is convenient to work with (i.e., pliable and easy to handle) Facilitates a method of opening and distributing the device that prevents contamination at the point of use. Is cost-effective. Matches the method of sterilization to be used.
Qualities of a wrapping material allow it to act as a barrier against dust particles, to repel water, and to provide an adequate seal of the contents. The wrapper should resist tears and punctures, and be free of holes and toxic ingredients. Wrappers have to completely enclose the instrument or item The edges need to be properly folded so the tool can be aseptically presented during a procedure. While the edges and corners of the wrapper need to be tucked in, there should not be excessive wrapping material on and around the item as this interferes with the sterilant penetration.
Packaging Materials and Methods Packaging materials must be compatible with the sterilization process. The following materials may be safely used to wrap items for steam sterilization because they permit steam penetration, adequate air removal, and adequate drying
Packaging Materials 1. Woven Fabrics. Reusable woven fabrics are commonly referred to as muslin or linen. This wrapper should withstand between 50 and 75 launderings before becoming too worn to be a microbial barrier. A laundering mark-off system is helpful to monitor the number of times a wrapper has been used. The manufacturer should provide information about the number of launderings and sterilization cycles the wrapper can withstand. Before use, the woven fabric is inspected for holes and patched with vulcanized patches if necessary. Fabric may create free-floating lint in the operating room .
2. Nonwoven Fabrics. Nonwoven fabrics are a combination of cellulose and rayon with strands of nylon randomly oriented it, or they are a combination of other natural and synthetic fibers bonded by a method other than weaving. These fabrics have the flexibility and handling qualities of woven materials and are available in several weights. Lightweight is used in four thicknesses ; medium weight is the most economical for wrapping items in two thicknesses ; and heavy-duty weight is used when a single wrap is used for wrapping supplies for sterilization.
2. Nonwoven Fabrics cont. Packages are wrapped in the same manner as wovenm fabrics. Nonwoven fabrics provide an excellent barrier against microorganisms and moisture during storage after sterilization. They are disposable and virtually lint free. Some manufacturers provide a recycling service for nonwoven wrappers.
3. Peel Packs or Pouches. Peel pouches and tubes made of a combination of paper on one side and clear plastic film on the other are satisfactory for wrapping single instruments, odd-shaped items, and small items. Double-sided paper pouches are commercially available. For sterile presentation, a peel-open seal may be preformed on one end. The open end is either heat sealed or closed with indicator tape after the item is inserted. All air is expressed from the package before sealing. Self-sealing pouches with adhesive flaps that do not require heat sealing also are available.
3. Peel Packs or Pouches cont. The sequential packaging of supplies in a smaller pouch into a larger pouch is not routinely necessary. However, this method may be useful for keeping multiple small items together, such as a set of bone screws. The aseptic presentation of tiny parts to the sterile field without dropping items on the floor can be accomplished with sequential packaging. The manufacturer’s instructions should be consulted if sequential peel pouches will be used. A peel pouch should not be processed flat, but positioned on its side.
3. Peel Packs or Pouches. The plastic side of the pouch can impede the flow of steam penetration through the package. Inclusion of plastic sided pouches within an instrument set can impair the process of steam through a tray. Obstruction of the steam flow can compromise the entire load. After processing, the peel pouch should be stored on its side to maintain integrity of the packaging.
Sealants and Labeling. Chemical indicator tape is used to seal packages such as peel pouches and wrapped items. Steam sensitive tape resembles tan masking tape and reveals dark stripes when exposed to steam sterilizing conditions. Gas-sensitive tape is light green and reveals dark stripes after exposure to gas sterilizing conditions. Peel pouches are usually heat-sealed or self-sealing and have an indicator area or dot that changes color in response to steam or gas exposure. They may be sealed with steam- or gas-sensitive tape.
Sealants and Labeling. These sealants are not indicators of sterility but are a visual means by which to validate exposure to sterilant conditions. The sealing tape on the outside of the package should be labeled with a dark marker that is nontoxic, and resistant to moisture, bleed through, or smearing. Preprinted labels may be used instead. The date of processing and a load number should be attached to each package. These forms of identification are helpful in tracking and locating items that have been processed in batches. A recall of items may be necessary if the sterility of a particular load is in doubt.
Packaging methods 1. Wrapped Trays . To allow steam penetration around instruments and prevent air from being trapped in the tray, trays cannot be solid. Therefore instruments are placed in open trays with mesh or perforated bottoms. Absorbent towels or foam may be placed in the bottom of the tray and over instruments to absorb condensate and protect instruments from snagging in the perforations. Trays are sequentially double-wrapped in woven or nonwoven wrappers.
Packaging methods 1. Wrapped Trays . They must be allowed to cool and dry at the end of the sterilizing cycle before they are handled. Hot packages should not be placed on cool surfaces. Condensation under the tray can generate strike-through , promoting capillary action of moisture between the warm sterilized tray and the shelving. The moisture can carry microorganisms to the inside of the package
Packaging methods 2. Rigid Closed Containers. A metal or plastic rigid closed container system may be used for sterilizing instruments singly or in sets. A stainless steel mesh or perforated basket lined with foam porous padding nests in the rigid container. The lid is affixed to the container base by metal snap locks. Plastic breakaway shrink bands secure the flip locks and act as chemical external indicators by changing color. The body of the container is labeled with the contents. A load-identifying label is affixed to the container before processing.
Packaging methods 2. Rigid Closed Containers. Most styles of closed containers have single-use unidirectional air filters in the lid and bottom. These filters are changed each time the container is processed. The closed container is placed into the steam sterilizer so the steam can penetrate through the bottom and lid. Some containers do not have vents in the bottom. The manufacturer of the closed container system should establish the processing temperature and time.
2. Rigid Closed Containers. After the sterilization process is complete, the container is placed on a firm, dry surface adjacent to the sterile table. The circulating personnel breaks the shrink band seal by flipping open the locks and then lifts the lid toward him or her. The outer rigid container is not considered sterile. The scrub person carefully reaches into the container without touching it and grasps the handles of the sterile inner basket, lifting it straight up and out. The sterile basket containing the instruments can be placed on the sterile back table.
Packaging methods 2. Rigid Closed Containers. Sterile supplies are not to be opened into the rigid container, because the edges are not considered sterile. Condensate in the bottom of the nonvented closed container is considered sterile because it is not permeable to the capillary action associated with other packaging methods.
3. Specialized Tray Sets. A manufacturer may supply a fitted case or rack for a set of instruments or implants, such as orthopedic devices. These cases or racks help protect the instruments and keep them separated for sterilization and use. These cases or racks are double-wrapped before sterilization; they are not the same as rigid closed containers.
Count Sheets. Count sheets are sometimes packed inside the instrument set for use in counting instruments in the OR. The inks and toner pose a questionable risk for depositing foreign matter inside the patient during the surgical procedure. Toner in the printer cartridge is fused to the paper by heat. The transfer of the toner from the paper to the instruments is of concern during thermal sterilization. Although no data exist to demonstrate harm from toner on count sheets, no data are available to prove that toner is harmless. It may contribute to the formation of adhesions in the same way any foreign body can stimulate an inflammatory response.
Count Sheets. Some facilities place the count sheet in a peel pouch. The plastic side of the pouch can obstruct the flow of steam if placed flat in the tray. A paper peel pouch is preferred. Another option is to place the count sheet in a separate labeled peel pouch and process it separately from the packed tray.