Chapter 17 After studying this chapter, the learner will be able to: • Describe the steps in decontamination. • List Spaulding’s classifications of patient care items. • Compare and contrast the three levels of disinfection. • Discuss how an instrument is rendered safe for handling. • Identify three safety issues associated with the use of chemical disinfectants. Kills gram-negative and gram-positive bacteria unless specifically stated to the contrary (adj: bactericidal). Action may be specific to a species of bacteria. Inhibits growth of bacteria. Degree of microbial load on an item before sterilization. Microbial load attached to a surface in a fluid environment. Microbes in slime adhere to surfaces of all kinds of moist material, such as implantable metals, plastics, and tissue, causing antibiotic resistance.8 Process by which chemical or physical agents are used to clean inanimate, noncritical surfaces. A specific contact time is not specified. A low-level disinfectant is commonly used for this purpose. If a known organism, such as HBV, Mycobacterium tuberculosis, or HIV, is present on the surface, an intermediate-level disinfectant should be used. Water that has been processed through synthetic cation-anion resins to remove the positively or negatively charged ions. Chemical or physical process of destroying most forms of pathogenic microorganisms except bacterial endospores; used for inanimate objects but not on tissue. The degree of disinfection depends primarily on the strength of the agent, the nature of the contamination, and the purpose for the process. Process that destroys all microorganisms except high numbers of bacterial endospores. Intermediate-level disinfection Process that inactivates vegetative bacteria, including M. tuberculosis, and most fungi and viruses but does not kill bacterial endospores. Process that kills most bacteria, some viruses, and some fungi but does not destroy resistant microorganisms, such as M. tuberculosis or bacterial endospores. The process of evaporating water and creating condensation from the steam that is collected for future use. Forms of bacterial classes clostridia and Bacillus that are generated when living conditions are not favorable. Protective capsule that forms inside specific bacterial species encircles and protects the genetic matter to resist destructive forces, such as disinfection or sterilization. Kills fungi. Not a method of sterilization. This heating process kills many pathogenic microorganisms that are found in biosubstances such as milk or wine. Kills endospores. Kills viruses. The CS decontamination personnel have specialized training in cleaning many types of instruments using several methods as described in later sections in this chapter. The decontamination process renders soiled instruments safe for handling, but not safe for patient use.4 After decontamination, the cleaned instruments are transferred via a pass-through door to the instrument set assembly room. Some facilities have a conveyor system that automatically sends the cleaned items to the clean assembly area after passing through the washer. When a tray is needed for a surgical procedure other CS personnel in the sterile storage area pack a case cart with the necessary sterile tray and needed supplies for the surgical team. The case cart exits the CPD through a separate door that has no communication with the decontamination area. Detailed information concerning sterilization is found in Chapter 18. Central service (CS) personnel entrusted with the care, cleaning, assembly, and processing of patient care equipment to the appropriate degree of safety require specific training and credentialing.5 Training entails learning thousands of surgical instruments and their care. CS personnel need to know and understand all methods of instrument processing such as decontamination, disinfection, and sterilization. The role of the CS technician requires attention to detail. New Jersey was the first state to pass legislature requiring certification for CS personnel. Personnel currently holding positions in CS are required to become certified. New hires will have 2 years from the date of hire to attain the credential as recommended by the Association for the Advancement of Medical Instrumentation (AAMI). Training programs take between 6 to 12 months to complete.2 As of 2011, 14 other states are seeking to require appropriate education and certification of CS personnel. The International Association of Healthcare Central Service Materiel Management (IAHCSMM) is driving the effort to require mandatory standardization of education and certification of all CS personnel. Information about CS certification requirements can be found at www.iahcsmm.org. Certification signifies that an individual professional has attained specific knowledge and skill in a specific professional practice. It sets a standard for performance and raises the bar for expectations in the profession. Information about certification of CS personnel can be found at www .sterileprocessing.org. Successful passage of the certification examination is designated by the title CRCST (certified registered central service technician) after the name of the CS employee. The IAHCSMM offers short-term 1-year certification at three levels: (1) technician, (2) instrument processing, and (3) leadership. AAMI sets the standards for instrument processing in the United States and recognizes both certifying bodies.2 Certified CS individuals are recertified through examination or by continuing education credits. Becoming certified encourages individuals to seek additional training that exemplifies certification-level knowledge. Periodic competency testing should be incorporated into performance assessment. (An example of central service personnel competency testing can be found at www.apic.org.) The relationship between CS staff and OR staff is complex and synergistic. The OR staff relies on the CS staff to provide complete instrumentation processed to the appropriate degree of safety for patient use. The CS staff relies on the OR staff to return used sets in a safe-to-process condition without the risk of concealed blades or other sharps that pose a risk for injury during preparation for processing. Each person has a stake in the intricate coordination of preparing for a surgical procedure. Mutual respect and cooperation between the two specialty areas is in the best interest of safe and efficient patient care.2,7 Decontamination of instrumentation is performed in a designated area by specially trained personnel immediately after completion of the surgical procedure. The scrub person can facilitate the instrument decontamination process by wiping instruments as they are used on the sterile field and then opening the instruments completely before placing in a tray for return to the processing area. Enzymatic foam or solution can applied to the instruments to prevent debris from drying during transport to the central service area. All instruments on the table during a surgical procedure require decontamination before processing to the required level of safety for patient use. The processing of endoscopes is discussed in Chapter 32. • A triple proteolytic enzymatic detergent. Proteolytic enzymes dissolve blood and debris, and the detergent removes dissolved particulate from the surfaces of instruments, including otherwise inaccessible areas such as lumens. Enzyme-impregnated tubular sponges are commercially available from companies such as Ruhof for cleaning endoscopes and tubular instruments used in adipose and greasy tissues. (More information is available at www.ruhof.com.) • An enzymatic agent diluted per manufacturer’s instructions. • Water with a low-sudsing, near-neutral detergent. The detergent should be compatible with the local water supply. • Plain, clean, demineralized distilled water. • Sodium hypochlorite (chlorine bleach) is corrosive; however, it is used as a presoak in suspected or potential prion disease such as transmissible spongiform encephalopathy (TSE). Instruments should not be soaked in any chlorine compound for more than 1 hour and should not be autoclaved with chlorine solution because of the formation of toxic chlorine gas. • Soaking in a phenolic, guanidine thiocyanate, or sodium hydroxide is an alternative, but chlorine bleach is the most reliable in reducing the prion titer within 1 hour. These chemicals are extremely corrosive and are not appropriate for use on endoscopes. • STERIS Corporation has developed Hamo 100. This is an alkaline prion inactivating and removal detergent that is a corrosive potassium hydroxide solution. It cannot be used with soft metal or anodized aluminum. Hamo 100 is not recommended for use with rigid or flexible endoscopes. This product has been released for use in Europe but is not currently approved for use in the United States. The following steps should be observed when cleaning instruments manually: 1. Fill the washing sink with clean, warm water to which a noncorrosive, neutral pH, low-sudsing, free-rinsing detergent has been added. a. Detergent should be compatible with the local water supply. The mineral content of water varies from one area to another; a water softener may be used in the system routinely to minimize mineral deposits. Regardless of the water content, the detergent should be anionic or nonionic and have a pH as close to neutral as possible. An alkaline detergent (pH more than 8.5) can stain instruments; an acidic detergent (pH less than 6) can corrode or pit them. b. Proteolytic enzymatic detergents dissolve blood and protein and remove dissolved debris from crevices. These detergents are effective in a wide range of water qualities. c. Liquid detergents are preferable because they disperse more completely than do solids. Dilute the concentration before contact with instruments to avoid corrosion and staining. Do not pour liquid or put solid detergents directly on instruments. 2. Wash instruments carefully to guard against splashing and creating aerosols. a. 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. b. Use a soft cloth to wipe surfaces. A nonfibrous cellulose sponge will prevent damage to delicate tips. c. Remove bone, tissue, and other debris from cutting instruments. d. 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. 3. 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. 4. Load instruments into the appropriate trays for terminal sterilization or containers for high-level disinfection. a. Put instruments back into sterilization racks or replace the protective guards as appropriate. b. Arrange instruments that can be steam-sterilized in sterilizer trays for the washer-sterilizer or washer-decontaminator. The unwrapped tray is terminally steam-sterilized to make it safe for handling. c. Unless an automatic cleaning, disinfecting, and sterilizing machine is available, immerse lensed instruments that are heat sensitive in a high-level disinfectant after manual cleaning. d. Follow the manufacturer’s instructions for the proper decontamination, cleaning, lubrication, and terminal sterilization of powered instruments. 1. Place heavy instruments in a separate tray or in the bottom of a tray, with smaller, lightweight instruments on top. 2. Turn instruments with concave surfaces, such as curettes and rongeurs, with the bowl side down; this facilitates drainage of the concave surface. Be certain that bone and tissue are removed from these surfaces during precleaning. 3. Open the box locks and pivots of hinged instruments to expose maximum surface area. 4. Disassemble complex instruments that can be disassembled without tools (e.g., stapling devices). 5. Position sharp or pointed instruments carefully on top of other instruments to prevent contacts that could damage the cutting edges or surfaces of other instruments. An alternative is to either place sharp instruments in a separate tray or terminally sterilize them after manual cleaning. Fine, delicate instruments should never be put in a washer-sterilizer or washer-decontaminator because the mechanical agitation will damage them. 6. Always arrange instruments neatly. They should not be randomly piled on top of one another. 1. Arrange heavy instruments at the bottom of the tray and lightweight instruments on top. 2. Open the box locks and pivots of hinged instruments. Disassemble instruments as appropriate. 3. Protect cutting edges from other instruments. Fine, delicate microsurgical and ophthalmic instruments may be damaged by vibrations or contact with each other. Some small units may be suitable for delicate instruments. 4. Separate dissimilar metals. Do not mix stainless steel instruments with other metals because electrolysis with resultant etching may occur. 5. Do not clean plated instruments in an ultrasonic cleaner. Cavitation will accelerate the rupture and flaking of plating. Plated instruments are not suitable for use in surgery. The surface coating of the instrument could potentially flake or peel during use and leave particles in the patient’s tissues. 6. Rinse instruments thoroughly in hot deionized water after the cleaning cycle to remove any surface debris and detergent residue. 7. Dry instruments promptly and completely before reassembling or storing. Instruments will corrode, spot, or stain if they are stored with trapped moisture. • Check hinged instruments for stiffness. Box locks and joints should work smoothly. Stiff joints are usually caused by inadequate cleaning. Lubrication eases stiffness temporarily. If box locks are frozen, leave the instruments in a water-soluble lubricant bath overnight, and then gently work the jaws back and forth. Reinspect the instrument for cleanliness and function. • Test forceps for alignment. A forceps that is out of alignment can break during use. Close the jaws of the forceps slightly; if they overlap, they are out of alignment. The teeth of forceps with serrated jaws should mesh perfectly. Hold the shanks in each hand with the forceps open, and try to wiggle them. If the box lock has considerable play or is very loose, the forceps will not hold tissue securely. If a surgeon continues to use it, jaw misalignment will occur and impair the effectiveness of the forceps. • Check the ratchet teeth. Ratchet teeth are subject to friction and metal-to-metal wear by the constant strain of closing and opening. Ratchets should close easily and hold firmly. To check this, clamp the forceps on the first tooth only. Hold the instrument at the box lock and tap the ratchet teeth lightly against a solid object. If the forceps springs open, it is faulty and should be repaired. A forceps that springs open when clamped on a blood vessel or duct is hazardous to the patient and is an annoyance to the surgeon. The ratchets must hold. • Check the tension between the shanks. When the jaws touch, a clearance of 1/16th to 1/8th inch (1.5 to 3 mm) should be visible between the ratchet teeth of each shank. This clearance provides adequate tension at the jaws when closed. The misalignment of hinged instruments is a common problem that occurs primarily as a result of misuse. The instrument needs to be repaired or replaced if the teeth or serrations do not mesh perfectly or the jaws overlap. • 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 ratchet tooth. If the needle can be turned easily by hand, the needle holder needs repair. Using a needle holder for placement of a blade on a scalpel handle can cause the jaws of a needle holder to loosen. • 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 (or through two layers if the scissors are less than 4 inches [10 cm] long). The scissors should cut with a fine, smooth feel and a minimum of pressure. Tissue scissors should not be used to cut dressings or tape. • Electrical insulation should be intact on all reusable electrosurgical equipment. Split insulation can cause inadvertent tissue damage during use. • Inspect the edges of sharp and semisharp instruments such as trocars, needles, chisels, osteotomes, rongeurs, and adenotomes for sharpness, chips or dents, and alignment. Remove any questionable items from service, and send for repair or replacement. Shards of metal could be deposited in the patient’s tissue during use. • Inspect microsurgical instruments under a magnifying glass or microscope to check alignment and detect burrs on tips and nicks on cutting edges. The exact alignment of teeth on fine-tooth forceps is an absolute necessity. Microscopic teeth are very easily bent. Be certain that these instruments are thoroughly dry. A chamois is useful for drying to prevent snagging delicate tips. • Check pins and screws of reusable staplers to be sure they are secure and intact. They can become loose or fall out during ultrasonic cleaning as a result of vibration. • Flatten or straighten malleable instruments such as retractors and probes. Weakened or cracked items should be immediately replaced. • Self-retaining retractors should provide free motion and sliding of the retracting blades. They should attach, slide, and detach easily. The tilts and ratchets should slide and hold as appropriate. All screws, wing nuts, and removable parts should be inspected for stripped threads. • Demagnetize instruments by passing them back through a magnetic field. Although this is not a common occurrence, instruments can become magnetized. • 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. A place is usually designated in the OR suite or the CS department for the collection of instruments for repair. A defective instrument should be tagged as unsafe for use and not be allowed to remain in circulation.
Decontamination and disinfection
Central processing department
Workflow in the processing areas
Central service personnel
Credentialing of central service personnel
Coordination of central service staff and operating room staff
Instrument cleaning and decontamination
Prerinsing/presoaking
Manual cleaning
Washer-sterilizer/washer-decontaminator
Ultrasonic cleaning
Inspecting and testing
Decontamination and disinfection
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