After being cleaned in a Surgical Instrument Washer delivering the "Proper Sequence of Washer Treatments", including ultrasonic cleaning (Washer Decontaminator, Washer Disinfectors) and a combination enzyme detergent cleaning concentrate: "evaluation of Surgical Instrument Washers Decontaminators Disinfectors confirmed that the efficacy of disinfection was 100%". "All instruments and utensils tested were sterile at the completion of the process."

Properly Designed Surgical Instrument Washer Decontaminators Disinfectors
Provide the Prerequisite for Sterilization

John Temple
Product Development
John Prohonic
Product Development

Summary : Properly Designed Surgical Instrument Washer, Decontaminators, Disinfectors, are designed to clean all surfaces thoroughly, thereby providing the critical prerequisite for the safe handling, disinfecting, and the sterilizing of surgical instruments.  

Critical cleaners, usually referred to as Washer Decontaminators Washer Disinfectors, perform pre-wash, ultrasonic (optional), detergent washing, purified water elevated temperature rinsing, lubrication and high temperature drying in such a manner as to provide thoroughly clean, stain free and lubricated medical devices. Surgical Instruments cannot be sterilized (be sterile) unless all exposed surfaces are properly cleaned, prior to sterilization, to remove soil (debris, bioburden) and properly rinsed to prevent staining.1,2,3  Not all Washer Decontaminators Washer Disinfectors provide adequate pre-rinsing, pre-cleaning, purified water rinsing, and thereby render higher rejection rates of processed surgical instruments. 4,5.

Proper Surgical Instrument Washer Decontaminator Washer Disinfector Design Secures Performance

The proper sequence of treatment and the correct choice of time, temperature and the components used are necessary to render surgical instruments that are critically clean, safe to handle, and have the prerequisite for sterilization. 6,7,8.

Washer Decontaminators Washer Disinfectors employ a cold water pre-wash to remove gross debris.  This removes proteins and lipids, preventing them from being baked onto devices during the high temperature treatments to follow. 9, 10.  Then, the ultrasonic process creates millions of micro implosions to loosen and free debris from lock boxes, hinge pins, serrations and other difficult-to-access surface areas. 

The Washer Decontaminators Washer Disinfectors detergent wash then applies high flow low pressure water with a cleaning concentrate (at ~ 135 degrees F) in such a manner as to evenly reach all areas of the load and strip bioburden from the surgical instruments.  The elevated temperature (at ~ 194 to 209 degrees F) purified water final rinse secures the biocidal process, removes mineral deposits from prior cycles and lubricates the instruments. The high temperature (at ~ 158 to 230 degrees F) dry cycle presents heated, forced air which dries each device.  The critical cleaned medical devices are now clean, safe to handle, have the prerequisite for sterilization, and are properly prepared for further reprocessing. 

Surgical Instrument Washer Decontaminator Washer Disinfector - Complete Removal of Pathogens

The Washington University School of Medicine at Washington University Medical Center examined the performance of a properly designed Washer Decontaminator Washer Disinfector (CESCO washer Decontaminator Model 520) and found that it removed all organisms from the surgical instruments tested.  11

The Surgical Instrument Washer Decontaminator Washer Disinfector was tested for its ability to complete remove pathological organism from surgical instruments. 

Pure cultures of the following organisms were grown on appropriate agar plates:

1. Staphylococcus aureus;
2. Pseudomonas aerations;
3. Escherichia coli;
4. Bacillus species

Kelly clamps, tweezers and scissors wee placed on these plates of organism, taking care to ensure that all serrated edges were packed with all the organisms.  Each contaminated instrument was then dipped into the tube of Thiogycolate medium before being placed in all the washer baskets.  The instruments were then processed through the complete Washer Decontaminator Washer Disinfector cycle.  At the end of the drying cycle, the instruments were allowed to cool and then dipped into another tube of Thioglycolate medium.     

Results

All tubes of the Thioglycoate medium tested before the wash grew the appropriate organism within six to 18 ours after testing.  All tubes tested at the end of the wash showed no growth after 14 days of incubation. This Washer Decontaminator Washer Disinfector removed all organisms from the instruments. 

Surgical Instrument Washer Decontaminator Washer Disinfector Efficacy of Disinfection 100%

Another evaluation of Washer Decontaminators Washer Disinfectors confirmed that the efficacy of disinfection was 100%.  In this study, L.P. Jette and N.G. Lambert used two test methods.12   One method (N) was to test the effect of heat only within the disinfection process and the other test method (G) was to test the efficacy of both heat and washing.  Each method gave reproducible results and confirmed the efficacy of the Washer Decontaminator Washer Disinfector.

Surgical Instrument Washer Decontaminator Washer Disinfector Critical Cleaners Will Work for You

Washer Decontaminator Washer Disinfector Critical cleaners demonstrated the ability to completely remove pathological organisms with effective repeatability.  There operation is automatic, reliable, labor saving and easy to use.  Central Processing departments rarely find the need to manually treat devices and report an  exceptionally low rate of rejected devices. 

Conclusion

The Washer Decontaminator Washer Disinfector sequence, cold water pre-wash, ultrasonic cleaning, detergent washing action, final rinse and drying treatment of a properly designed Washer Decontaminator Washer Disinfector Critical Cleaner will provide critical cleaning, the prerequisite for safe handling, optimal disinfecting, and sterilizing of medical devices.

_________________
References
1. Peggy Ryan, RN, “Concepts of Cleaning Technologies and Processes,” Journal of Healthcare Material Management, (Nov./Dec. ’87), pp. 20-27.
2. Marimargaret Reichert, RN, “processing Reusable Medical Devices, “Journal of Hospital Material Management, p. 40.
3. Training Manual for Central Service Technicians, American Society for Central Services Personnel of the American Hospital Association, (Chicago, IL, 1986), p. 69.
4. Ryan, op. cit.
5. Training Manual for Central Service Technicians, op. cit.
6.  Ryan, op. cit.
7. Interview with Charles A. Reed, Washington University School of Medicine, Washington University Medical Center, Dec. 1985.
8.  L.P. Jette’and N.G.Lambert, “Evaluation of Two Hot Water Washer Disinfectors for Medical Instruments, “ Infection Control Hospital Epidemiology, Vo.1 9, No. 5, (1988), pp. 194-199.
9. Training Manual for Central Service Technicians, op. cit.
10.  Ryan, op. cit.
11.  Ryan, op. cit.
12. L.P. Jette’and N.G.Lambert, op.cit.

NOTE:
The goal of cleaning (decontaminating reprocessing) surgical instruments is to deliver Clean Surgical Instruments that are safe for the Reprocessing Staff and have received the prerequisite for disinfecting and/or sterilizing surgical instruments. It is a recognized risk of exposure to unidentified microorganisms that reprocessing personal endure during the decontamination, reprocessing, and cleaning of surgical instruments. Our goal is to minimize the amount and degree of reprocessing personal exposure to this risk and provide reprocessed surgical instruments that are clean: safe to handle, safe for patient care, and are cleaned (decontaminated reprocessed) at the lowest cost. The optimal decontamination cleaning-reprocessing of surgical instruments will secure the prerequisite for disinfecting surgical instruments and/or sterilizing surgical instruments, deliver surgical instruments that are safe to handle, and reduce reprocessing costs.
NOTE:
Surgical Instrument Washers with Ultrasonic Cleaning used in this research study were manufactured by CESCO, Mercersburg PA. The Surgical Instrument Washers (Tunnel Washers with automated Ultrasonic Cleaners) are not currently available from CESCO. European Manufacturers have developed Surgical Instrument Washers with fully automated Ultrasonic Cleaning manufactured within the ISO/DIS 15883-1 Standard. Studies demonstrate the propensity for Surgical Instrument Washers with Ultrasonic Cleaning to deliver optimal cleaning results.
The surgical instrument cleaners used in these studies are currently available in the form of the all-in-ONE enzymatic enzyme detergent surgical instrument cleaners. A critical component for optimal cleaning is using the best possible "surgical instrument cleaners". Recent European studies have illustrated and concluded that combination enzymatic enzyme detergent surgical instrument cleaners are more effective than conventional surgical instrument cleaners. The research was initiated to deactivate prions deactivating prions within the objective to prevent CJD (Creutzfeldt-Jakob Disease).
The mechanical Surgical Instrument Washer treatments include:
cold water pre-wash, may include surgical instrument enzyme cleaner,
ultrasonic surgical instrument cleaning,
surgical instrument detergent wash,
purified water rinses,
and hot air drying.
The chemical Surgical Instrument Washer treatments include:
surgical instrument enzyme cleaner,
surgical instrument detergents,
surgical instrument surface conditioners,
and surgical instrument lubricants.
Studies have demonstrated how properly designed Tunnel Washers, Surgical Instrument Washers Decontaminators, Washer Disinfectors are able to deliver optimal cleaning using a combination of automated mechanical treatments and chemical treatments.

Enzymatic Enzymes Detergents Conditioners and Lubricants
in ONE  cleaning concentrate.
After being cleaned in a properly designed Tunnel Washer, Washer Decontaminator, Washer Disinfector using a combination enzyme detergent cleaning concentrate: "evaluation of Washer Decontaminators Washer Disinfectors confirmed that the efficacy of disinfection was 100%". "All instruments and utensils tested were sterile at the completion of the process."
After being cleaned in a properly designed Washer Decontaminator Washer Disinfector using a combination enzyme detergent cleaning concentrate:
“All instruments and utensils tested were sterile at the completion of the process.” 

APIC ABSTRACT
Paper accepted for presentation at APIC: 
Eighteenth Annual Conference and International Meeting
Nashville Tennessee

Oral Presentation 
Validation of the microbial safety of surgical instruments and utensils following automated cleaning by a properly designed Washer Decontaminator Washer Disinfector – Thermal Disinfection. A. Drake, RN and L. Ayers, MD., The Ohio State University Hospitals, Columbus, Ohio, 43210

The application of universal precautions to instruments/utensils handling became an issue in the selection of replacement decontamination equipment for Central Sterile supply at our hospital.  The new technology of an automated thermal disinfection Washer Decontaminator Washer Disinfector (TW)(CESCO TM, Mercersburg, Pa.) offered increased protection to our reprocessing staff due to decreased handling but raised concerns about the efficacy of thermal disinfection as opposed to traditional washer sterilization. Because of the limited scientific documentation of this new technology, a study was undertaken to establish the microbial safety of finished products and to identify any feature or function failure which could adversely affect outcome. The sequential functions of the Washer Decontaminator Washer Disinfector progress from flush/rinse, sonic bath, wash, rinse, lubricant/deionized water (DI) sprays to drying at 240°  F. for 4 minutes.  The Washer Decontaminator Washer Disinfector was challenged with selected instruments and utensils that are considered to be very difficult to clean.  Included were 30 each  of stainless steel non-perforating towel clips and stainless steel and glass medicine cups.  Each item was rinsed with a 10 5ml  suspension of Staphylococcus aureus, Pseudomonsaeruginosa, Enterococcus fecalis and Candida albicans in nutrient media and then dried. The instruments wee processed in the Washer Decontaminator Washer Disinfector 3 separate loads during times of high volume operation.  All products were tested for sterility.  Ten separate cultures were taken of the final rinse solution of instrument lubricant and de-ionized water prior to the drying cycle.  A separate culture was taken of the instrument lubricant fluid.  All instruments and utensils tested were sterile at the completion of the process.  The final rinse, however, was heavily contaminated with the saprophytic bacteria Flavobacterium  sp., Pseudomonas (P.) picketti and P. rubrisubalbicans.  The source of the contamination was determined to be resin gel in the DI tank and not the instrument  lubricant.  The contamination can be eliminated by the addition of a 0.22 u filter to the DI line.  Our findings support the practice of validating all features of new technologies that may compromise the expected final outcome.  The Washer Decontaminator Washer Disinfector is a valid replacement for the conventional washer-sterilizer.
 

Ann Drake
John Temple
Product Development

NOTE:
Surgical Instrument Washers with Ultrasonic Cleaning used in this research study were manufactured by CESCO, Mercersburg PA. The Surgical Instrument Washers (Tunnel Washers with automated Ultrasonic Cleaners) are not currently available from CESCO. European Manufacturers have developed Surgical Instrument Washers with fully automated Ultrasonic Cleaning manufactured within the ISO/DIS 15883-1 Standard. Studies demonstrate the propensity for Surgical Instrument Washers with Ultrasonic Cleaning to deliver optimal cleaning results.
The surgical instrument cleaners used in these studies are currently available in the form of the all-in-ONE enzymatic enzyme detergent surgical instrument cleaners. A critical component for optimal cleaning is using the best possible "surgical instrument cleaners". Recent European studies have illustrated and concluded that combination enzymatic enzyme detergent surgical instrument cleaners are more effective than conventional surgical instrument cleaners. The research was initiated to deactivate prions deactivating prions within the objective to prevent CJD (Creutzfeldt-Jakob Disease).

Washer Sterilizers Sterilizing Surgical Instruments
Washer Sterilizers Cleaning Surgical Instruments
Washer Sterilizers Decontaminating Surgical Instruments
Surgical Instrument Washers
Washer Sterilizers
It is widely understood that "Washer Sterilizers" do not sterilize surgical Instruments. Then why do we call them "Washer Sterilizers" ?

Surgical Instrument Washers (Washer Disinfectors) were referred to as "Washer Sterilizers" by manufacturers prior to the FDA regulations that require approval for a products marketing terminology is based on evidence of product efficacy. Products, such as Washer Sterilizers, that were manufactured prior to the the FDA Regulations can continue to call their products by their pre-regulation terminology. The only products that can be called "Washer Sterilizers" are those that were being manufactured prior to the enactment of the FDA Regulations.
It has been demonstrated that Surgical Instrument Washers ("Washer Decontaminators", "Washer Disinfectors") using the Proper Sequence of Washer Treatments can deliver surgical instruments that are sterile. Surgical Instrument Washers are not intended to be Washer Sterilizers. One research study states: "All instruments and utensils tested were sterile at the completion of the process."
After being cleaned in a properly designed Washer Decontaminator Washer Disinfector using a combination enzyme detergent cleaning concentrate:
“All instruments and utensils tested were sterile at the completion of the process.” 

APIC ABSTRACT
Paper accepted for presentation at APIC: 
Eighteenth Annual Conference and International Meeting
Nashville Tennessee

Oral Presentation 
Validation of the microbial safety of surgical instruments and utensils following automated cleaning by a properly designed surgical instrument washer – Thermal Disinfection. A. Drake, RN and L. Ayers, MD., The Ohio State University Hospitals, Columbus, Ohio, 43210

The application of universal precautions to instruments/utensils handling became an issue in the selection of replacement decontamination equipment for Central Sterile supply at our hospital.  The new technology of an automated thermal disinfection Washer Decontaminator Washer Disinfector (TW)(CESCO TM, Mercersburg, Pa.) offered increased protection to our reprocessing staff due to decreased handling but raised concerns about the efficacy of thermal disinfection as opposed to traditional washer sterilization. Because of the limited scientific documentation of this new technology, a study was undertaken to establish the microbial safety of finished products and to identify any feature or function failure which could adversely affect outcome. The sequential functions of the surgical instrument washer progress from flush/rinse, sonic bath, wash, rinse, lubricant/deionized water (DI) sprays to drying at 240°  F. for 4 minutes.  The surgical instrument washer was challenged with selected instruments and utensils that are considered to be very difficult to clean.  Included were 30 each  of stainless steel non-perforating towel clips and stainless steel and glass medicine cups.  Each item was rinsed with a 10 5ml  suspension of Staphylococcus aureus, Pseudomonsaeruginosa, Enterococcus fecalis and Candida albicans in nutrient media and then dried. The instruments wee processed in the Washer Decontaminator Washer Disinfector 3 separate loads during times of high volume operation.  All products were tested for sterility.  Ten separate cultures were taken of the final rinse solution of instrument lubricant and de-ionized water prior to the drying cycle.  A separate culture was taken of the instrument lubricant fluid.  All instruments and utensils tested were sterile at the completion of the process.  The final rinse, however, was heavily contaminated with the saprophytic bacteria Flavobacterium  sp., Pseudomonas (P.) picketti and P. rubrisubalbicans.  The source of the contamination was determined to be resin gel in the DI tank and not the instrument  lubricant.  The contamination can be eliminated by the addition of a 0.22 u filter to the DI line.  Our findings support the practice of validating all features of new technologies that may compromise the expected final outcome. The surgical instrument washer Washer Disinfector is a valid replacement for the conventional washer-sterilizer.
 

Ann Drake
John Temple
Product Development
Washer Sterilizers Sterilizing Surgical Instruments
Washer Sterilizers Cleaning Surgical Instruments
Washer Sterilizers Decontaminating Surgical Instruments
The Goal Purpose of a Surgical Instrument Washers
The purpose of an Instrument Washer is to deliver surgical instruments that are "clean and safe to handle" for reprocessing and are clean so that they can be sterilized. Surgical instruments that are not clean cannot be sterilized. Washer Disinfectors properly prepare surgical instruments for sterilization by Terminal Sterilizers. Clean is the "Prerequisite for Sterilization".
The "Proper Sequence of Surgical Instrument Washer Treatments"
includes a series of mechanical and chemical treatments. 

The mechanical Surgical Instrument Washer treatments include:
cold water pre-wash, may include surgical instrument enzyme cleaner,
ultrasonic surgical instrument cleaning,
surgical instrument detergent wash,
purified water rinses,
and hot air drying.

The chemical Surgical Instrument Washer treatments include:
surgical instrument enzyme cleaner,
surgical instrument detergents,
surgical instrument surface conditioners,
and surgical instrument lubricants.
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