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The primary purpose of cleaning surgical instruments and scopes is to remove all inorganic and organic bioburden material from the internal and external surfaces of the surgical instruments. The secondary purpose of cleaning surgical instruments and scopes is to maintain and improve the “passive Layer” of surgical stainless steel. The passive layer is provided by the manufacturer of surgical stainless steel to resist (prevent) corrosion. Proper cleaning of surgical instruments will maintain and improve this passive layer. If the manual cleaning of surgical instruments, brushing and rinsing are not properly performed protein debris can harden and lead to formation of biofilm on the surgical instruments. The optimal cleaning surgical instrument protocol will break down bioburden and clean the surface. The inadequate cleaning surgical of instruments can result in material remaining on the surfaces of surgical instruments which prevent disinfection and sterilization fluids or gases from reaching all of the surfaces of potentially contaminated surgical instruments. Inadequate sterilization or disinfection may in turn result in transmission of infectious organisms when the surgical instruments are reused. The intricate design, delicate materials and susceptibility to damage of surgical instruments further complicate their decontamination.
Cleaning Surgical Instruments and Cleaning Endoscopes is the Prerequisite for Sterilization. If surgical instruments aren't clean they canot be sterilized. The sterilizing of surgical instruments can only be effective if cleaning is adequate. Sterilization of an inadequately cleaned instrument is not possible. Cleaning surgical instruments is the prerequisite for sterilizing surgical instruments.
Cleaning, whether done manually or automatically in a surgical instrument washer will be more effective if "pre-cleaning" is adequate. Presoaking with neutral pH enzymatic detergent surgical instrument cleaners will effectively remove debris and has proven to be an acceptable alternative to manually cleaning surgical instruments. During cleaning all surfaces of surgical instruments must be exposed to the cleaning process. The use of automated surgical instrument washers may reduce the risk of exposure to contaminants, improve turnaround time, and extend the life of surgical instruments. Delicate surgical instruments may be washed manually. Endoscopes should be cleaned with an enzymatic detergent compatible with the endoscope immediately after use and before manual or automated disinfection. Cleaning involves the entire endoscope, including valves, working channels, connectors and all detachable parts. High level enzymatic formulations (Enzymatic Surgical Instrument Cleaners), in combination with a high level surfactant chemical complex, have been shown to be more effective in removing stains, hard water deposits, and encrusted bioburden, while being safe to use for rigid or flexible scopes.
Manufacturers of surgical instrument cleaners recommend that Enzyme Surgical Instrument Cleaners should be discarded after each use as these products are not microbicidal and will not retard microbial growth. Some manufactures of "combination" or all-in-one Surgical Instrument Cleaner include a bacteriostatic agent which will prevent the growth of microorganisms. Some detergent complexes contain antimicrobial-microbicidal substances. Although these Surgical Instrument Cleaners do not replace disinfection they are designed to reduce the risk of infection to reprocessing personnel by rendering surgical instruments clean and safe to handle. The cleaning efficacy of enzyme Surgical Instrument Cleaners is determined by the ratio of enzymes to bioburden. The higher the proportion of enzymes the higher the efficacy. As a result, if the Surgical Instrument Cleaners become laden with bioburden from previous cleaning, the efficacy of the enzyme Surgical Instrument Cleaners is lower. When Surgical Instrument Cleaners states that is it "multi-tiered", the inference is that is contains: protease (enzyme) which break protein debris into smaller, more soluble subunits, amylase (enzyme) which catalyses the breakdown of starch, and lipase (enzyme) which breaks up fat-containing debris and carbohydrates. When a detergent cleaning concentrate states that is it "high-level", the inference is that is contains a high concentration of enzymes. When Surgical Instrument Cleaners state that it provides "enzyme activity" the inference is that is contains enzymes but this is often a misrepresentation of ingredients for a Surgical Instrument Cleaner that does NOT contain enzymes. Look for the terms "high" level" and "multi-tiered" as an indication that the Surgical Instrument Cleaner contains an optimal level of enzymes. Enzymes are costly but they are effective and their cost effectiveness has been shown to lower the costs of cleaning surgical instruments. As is true for all detergent Surgical Instrument Cleaners, the most effective test is against your most difficult cleaning challenge. The two most common tests for cleaning concentration efficacy that are commercially available are the "TOSI Test" and the "film test". Be aware that some manufacturers use advertising text and product names that imply enzymes as active ingredient but do not include enzymes, or the level of enzymes is inadequate to deliver adequate cleaning of surgical instruments. Refer to Surgical Instrument Cleaners label and ingredients for disclosure.
Enzyme Surgical Instrument Cleaners function more effectively at temperatures above room temperature. The optimal range begins as > 22C - 72°F with performance reaching it's peak at 58.3C - 137F. This is often referred to as the optimal temperature for the performance or activity of enzymatic action. The activity of Surgical Instrument Cleaners enzymes does not stop at higher temperatures but the level of performance does begin to decrease. Enzyme cleaning concentrates enzyme-detergents and all-in-one Surgical Instrument Cleaners, which include enzymes, should be used in accordance with the manufacturer's recommendations and the recommendations of the surgical instruments being cleaned.
The approach is the same if the presence of pathological prions (including the prions of vCJD Creutzfeld-Jakob disease) is suspected, however attention to detail is more important. It has been long known, that prions are unusually resistant to disinfection and sterilization by physical and chemical methods in common use for decontamination of infectious pathogens. It is a difficult task to gain a consensus opinion on what constitutes optimal and practical conditions for decontamination of prions. Numerous studies have been conducted, but they do not reflect the reprocessing procedures for surgery instruments in a clinical setting which are critical for iatrogenic transmission. The method of cleaning prion contaminated surgery instruments and scopes includes (1) decontamination by NaOH or NaOCl for 30 or 60 minutes followed by GL-autoclaving at 121°C for 30 minutes, (2) cleaning and (3) routine PL-sterilizing at 134°C. It is known that some surgical instruments cannot be decontaminated by heat and moisture. Disinfectants have been widely used for this purpose although practically ineffective. The most common practice suggest that the only completely safe way to prevent transmission of vCJD is to use single-use surgical instruments. Because of the pervasive distribution of these infectious proteins and the long incubation time of the disease, cleaning of surgical instruments and scopes has been identified as a risk factor for nosocomial transmission of vCJD. Research has shown that the agent of the vCJD disease, an infectious prion protein, is extremely resistant to today’s sterilization methods; therefore, the argument, “It does not matter if surgical instruments are 100 percent clean, as they will be sterilized,” is definitely no longer valid. Today, we understand the surgical instrument cleaning process is as important as the surgical instrument sterilization process. Today’s standard surgical instrument washing processes require increasingly sophisticated Surgical Instrument Cleaners. which are used in these processes. The Surgical Instrument Cleaners can be mild, with a neutral pH, or they may be more aggressive, with values in the alkaline range of the pH scale. A number of hospitals and surgery centers are effectively using neutral pH “combination” enzymatic-detergent Surgical Instrument Cleaners for reprocessing surgical instruments and scopes. The “combination” enzymatic enzyme detergent Surgical Instrument Cleaners provide optimal cleaning as well as the highest possible level of care for surgical instruments and scopes. The early prion inactivation approach, using a high concentrate of sodium hydroxide solution or sodium hypochlorite combined with long hold times, is generally lethal for surgical instruments and surgical instrument washers decontaminators disinfectors. Recently, researchers have been looking for less destructive methods to decontaminate surgical instruments potentially contaminated with prions. The use of “combination” enzymatic enzyme detergent Surgical Instrument Cleaners has offered the highest level of cleaning outcomes.
• a non-foaming detergent must used
• the labeling of the detergent should recommend the use of the product for ultrasonic cleaning
• the treatment cleaning time recommended by the medical device and detergent manufacturers should be observed
• avoid the inhaling of enzyme containing detergent aerosols (risk of anaphylactic reactions) by maintaining a cover over the ultrasonic cleaner when in use.
Ultrasonic cleaners are more effective when used with hot water, as per the manufacturer’s recommended temperature.
It is recommended that all visible debris and blood be removed from the instrument prior to ultrasonic cleaning. Sort instruments by similar metals to prevent corrosion due to the contact of dissimilar metals. (electrolytic deposition - galvanic corrosion) It is not recommended to clean plated instruments in an ultrasonic cleaner since the ultrasonic vibration and the presence of other sharp instruments may crack or rupture the plating. Because Ultrasonic Cleaners do not provide the complete "proper sequence of treatments" i.e. final rinse(s) that are purified, purged between treatments, and/or have temperatures elevated to disinfection levels, they are not considered to be as clinically effective as automated surgical instrument washers. Ultrasonic Cleaning can effectively remove: long term encrustation and surgical cements or glues that have dried onto instrumentation.
• surgical instruments being cleaned must be fully immersed
• hinged surgical instruments must remain open during treatment
• only use cleaning trays that do not obstruct the ultrasonic cleaning process or add mass (e.g. wire baskets)
• large surface bulky items such as kidney shaped bowls must be positioned not to create anechoic (shadow) zones that will block the efficacy of ultrasonic transducer waveform. Position such items vertically or put them on top of the other items.
• always sort surgical instruments by similar metals to prevent corrosion
• do not overload the ultrasonic cleaning tank with excessive mass as this will reduce the efficacy of cleaning
• the soil being removed from surgical instruments being cleaned adds to the mass within the tank and decreases the efficacy of the ultrasonic cleaner. Review the level of soil and renew the ultrasonic bath as needed
• ALWAYS follow ultrasonic cleaning with separate rinse treatments. Ultrasonic cleaning will fragment and loosen soil but will not necessarily remove the soil from the surface of the surgical instruments being cleaned.
Cleaning detergents with or without enzymes, and detergents containing antimicrobial substances may be used. Use of non-foaming detergents is recommended. Foaming can inhibit good fluid contact with device surfaces, and prevent a clear field of vision during the cleaning process with a risk of injury to personnel. Foaming Surgical Instrument Cleaners are valuable in that they create a thick layer of foam on the surface of surgical instruments. This prevents bioburden from drying and facilitates the cleaning of the soiled surgical instruments. Once applied the Surgical Instrument Cleaners should be non-foaming. Although foaming is valuable for hydrating debris and preventing encrustation on soiled eye surgical instruments foaming during the cleaning process is detrimental to the cleaning process and can present a risk to workers. This is especially important with Ultrasonic Cleaners and Automated Eye Surgical Instrument Washers. Surgical Instrument Cleaners without "foam control" require excessive rinsing. Residual foam can cause unwanted residue to be retained on the surface of the surgical instrument. The detergent selected should effectively loosen organic and non-organic material so that the flushing action of the detergent fluid and subsequent rinsing water removes the unwanted material. Combination all-in-one Enzymatic Surgical Instrument Cleaner detergent complexes have been shown to be highly effective.
surfactants which reduce surface tension thus facilitating removal of debris
activated H2O2 hydrogen peroxide which effectively loosens debris at room temperature
protease (enzyme) which break protein debris into smaller, more soluble subunits
amylase (enzyme) which catalyses the breakdown of starch
lipase (enzyme) which breaks up fat-containing debris
quaternary ammonium compounds, biguanidine, alcohols
enzymatic detergents
neutral pH detergents
amine compounds
glucoprotamine
peracetic acid
hydrogen peroxide
When using Surgical Instrument Cleaners which contain Aldehydes, be aware that they denature and coagulate protein. Detergents based on amine compounds or glucoprotamine in combination with glutaraldehyde for disinfection should not be used to clean surgical instruments as chemical reactions may result and result in the formation of colored residues. These residues can appear to be corrosion or rust. The use of a neutral pH, high level surfactant based enzyme detergent instrument cleaner can be used to remove the corrosion, stains, and further prevent corrosion or stains on surgical instruments.
John Temple
Product Development
will lower your cleaning costs and replace cleaning products for: