The all-in-ONE Surgical Instrument Detergent Cleaners
will lower your Surgical Instrument detergent cleaning costs and
replace multiple Surgical Instrument Care products
Creutzfeld-Jakob disease vCJD
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 flexible endoscopes. The secondary purpose of cleaning surgical instruments and scopes is to maintain and improve the “passive Layer” of 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. (for more information go to: Prevent Corrosion – Importance of Cleaning) If the manual cleaning of surgical instruments, brushing and rinsing steps are not properly carried out, protein debris can harden and lead to formation of biofilm on the biopsy channel of the endoscope. The optimal cleaning surgical instrument protocol will break down bioburden and clean the surface. Inadequate cleaning surgical of instruments can thus result in material remaining on the endoscope surfaces which prevents disinfection and sterilization fluids or gases reaching all parts of potentially contaminated surfaces. Inadequate sterilization or disinfection may in turn result in transmission of infectious organisms when the endoscope is reused. The intricate design, delicate materials and susceptibility to damage of flexible endoscopes further complicates their decontamination.
is the Prerequisite for Sterilization
The reprocessing decontamination process, whether done manually or automatically in a surgical instrument washer can only be effective if cleaning is adequate. Effective disinfection or sterilization: (Generic Sterilization with a Pre-Vacuum Sterilizer (HI-VAC): 270-272° F (132-134° C), 16-minute exposure time, with 4 pulses and a 30-minute dry time. Generic Sterilization with a Gravity Displacement Sterilizer: 270-272° F (132-134° C), 30-minute exposure time, with a 30-minute dry time.) Sterilization of an inadequately cleaned instrument is not possible. cleaning is the prerequisite for sterilization.
All disinfection processes, whether done manually or done automatically in a surgical instrument washer can only be effective if prior cleaning is adequate. Effective disinfection or sterilization of an inadequately cleaned surgery instrument or scope is not possible. 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.
Surgical Instrument Cleaners Enzymes are effective and they are costly
Manufacturers usually 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 instruments that are clean and safe to handle. The cleaning function 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 is provides "enzyme activity" the inference is that is contains enzymes but this is usually is a misrepresentation of ingredients for a detergent cleaning concentrate that does not contain enzymes. Enzymes are effective and they are costly for manufacturers to include in the formulation. 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 wordage and product names that imply enzymes are an active ingredient but do not actually include enzymes in their product formulation. Refer to Surgical Instrument Cleaners label and ingredients for disclosure.
Enzyme Cleaning Concentrates
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 medical devices 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 reprocessing 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 surgery instruments cannot be decontaminated by heat and moisture. Disinfectants have been widely used for this purpose although practically ineffective. The most common practice believes that the only completely safe way to prevent transmission of vCJD is to use single-use surgery instruments. Because of the pervasive distribution of these infectious proteins and the long incubation time of the disease, reprocessing of surgery 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 instruments are 100 percent clean, as they will be sterilized,” is definitely no longer valid. Today, we understand the washing process is fully as important as the sterilization process. Today’s standard washing processes require increasingly sophisticated Surgical Instrument Cleaners. Detergents, which are used in these processes, 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 surgery instruments and scopes. The “combination” enzyme-detergent cleaners provide optimal cleaning as well as the highest possible level of care for surgery 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 medical surgical instruments and washer-decontaminators- disinfectors. Recently, researchers have been looking for less destructive methods to decontaminate surgery instruments potentially contaminated with prions. The use of “combination” enzymatic-detergent Surgical Instrument Cleaners has offered the highest level of cleaning outcomes.
Ultrasonic cleaning of reusable endoscope accessories and components may be needed to remove material from hard-to-clean areas. The same detergent used for ultrasonic surgical instrument cleaning can be the same as used for manual cleaning. Recommendations for detergents used for ultrasonic cleaning are as follows:
• a non-foaming detergent must used
• the labeling of the detergent should recommend the use of the product for ultrasonic surgical instrument cleaner
• always use enzymatic detergent Surgical Instrument Cleaner for instruments soiled with bioburden (protein, fats, starch)
• use detergents with 'surfactant' Surgical Instrument Cleaners for removing stains and hard water mineral deposits
• the treatment cleaning time recommended by the medical device and detergent manufacturers should be observed
• avoid the inhalation of enzyme-containing detergent aerosols (risk of anaphylactic reactions) by maintaining a cover over the ultrasonic cleaner when in use.
Ultrasonic Surgical Instrument Cleaners are very effective when used with hot water per manufacturer’s recommended temperature and specially formulated detergents. 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 Surgical Instrument 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 Surgical Instrument Cleaning can effectively remove: long term encrustation and surgical cements or glues that have dried onto instrumentation. Always refer to the printed manufacturer recommendations prior to using Ultrasonic Surgical Instrument Cleaning.
Recommendations for Maximizing the Efficacy of Ultrasonic Surgical Instrument Cleaning
• items being cleaned must be fully immersed
• hinged 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 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 devices 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 the use of Ultrasonic Surgical Instrument Cleaners with separate rinse treatments. Ultrasonic Surgical Instrument Cleaning will fragment and loosen soil but will not necessarily remove the soil from the surface of the surgery instrument being cleaned.
For the cleaning of endoscopes, 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.
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.
Detergents may contain the following substances with properties supporting the cleaning action:
•
surfactants which reduce surface tension thus facilitating removal of debris
surfactants which reduce surface tension thus facilitating removal of debris •activated H2O2 which effectively loosens debris at room temperature
activated H2O2 which effectively loosens debris at room temperature •protease (enzyme) which break protein debris into smaller, more soluble subunits
protease (enzyme) which break protein debris into smaller, more soluble subunits •amylase (enzyme) which catalyses the breakdown of starch
amylase (enzyme) which catalyses the breakdown of starch •lipase (enzyme) which breaks up fat-containing debris
lipase (enzyme) which breaks up fat-containing debris •quaternary ammonium compounds, biguanidine, alcohols
quaternary ammonium compounds, biguanidine, alcoholsOther active substances recommended for cleaning include:
•amine compounds
amine compounds•glucoprotamine
glucoprotamine•peracetic acid
peracetic acid•hydrogen peroxide
hydrogen peroxideWhen using Surgical Instrument Cleaners which contain Aldehydes, be aware that they denature and coagulate protein.
Amine Compounds or Glucoprotamine in combination with Glutaraldehyde and Cleaning Concentrates
Detergents based on amine compounds or glucoprotamine in combination with glutaraldehyde for disinfection should not be used as chemical reactions may result in formation of colored residues. These residues can appear to be corrosion. The use of a high level cleaning surfactant "combination" enzyme detergent Surgical Instrument Cleaners can be used to remove the corrosion-stains, and prevent corrosion or stains.
John Temple
Product Development
The all-in-ONE Surgical Instrument Cleaners
will lower your Surgical Instrument cleaning costs and
replace multiple Surgical Instrument Care products
Creutzfeld-Jakob disease vCJD
