The "Proper Sequence of Washer Treatments"
includes a series of mechanical and chemical treatments.
It is widely understood that "Washer Sterilizers" do not sterilize surgical Instruments. Surgical Instrument Washers (Surgical Instrument Decontamination Washer Decontaminators and/or 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 a Surgical Instrument Washer Surgical Instrument Decontamination Washers 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."
Click Here to review the APIC Abstract.
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Studies demonstrate that a Tunnel Washer Surgical Instrument Washer "Washer Decontaminator" "Washer Disinfector") that delivers the "Proper Sequence of Washer Treatments" including ultrasonic cleaner solution can deliver: the "complete removal of all pathogens" from surgical instruments and “surgical instruments sterile at the completion of the process". The "Proper Sequence of Washer Treatments" include a combination of mechanical and chemical treatments.

After being cleaned in a Surgical Instrument Washer using the proper sequence of washer treatments ultrasonic cleaner solution and a combination enzyme detergent cleaning concentrate: "evaluation of Washer Decontaminators Washer Disinfectors confirmed that the efficacy of disinfection was 100%". "All surgical instruments and utensils tested were sterile at the completion of the process."

The "Proper Sequence of Washer Treatments" includes a series of mechanical and chemical treatments.  The mechanical treatments include: cold water pre-wash, ultrasonic cleaner solution detergent wash, purified water rinses, and hot air drying. The chemical treatments include combination of enzymatic enzyme cleaners, detergents, surface conditioners and lubricants.
“All instruments and utensils tested were sterile
at the completion of the process.”

After being cleaned in a Surgical Instrument Washer using the
"Proper Sequence of Washer Treatments"

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

Oral Presentation - Automated Thermal Disinfection 
Validation of the microbial safety of surgical instruments and utensils following Automated Thermal Disinfection cleaning by a properly designed Tunnel Washer (Washer Decontaminator Washer Disinfector)
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 tunnel washer (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
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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. The Surgical Instrument Washer used in this research study were manufactured by CESCO, Mercersburg PA. Although these Surgical Instrument Washers   are not currently available, the studies demonstrate that  a Washer Decontaminator Washer Disinfector that uses the Proper Sequence of Washer Treatments with ultrasonic surgical instrument cleaner can deliver optimal cleaning results. The Cleaning Concentrates used in these studies are currently available in the form of the all-in-ONE combination enzymatic enzyme detergent cleaners and conditioners. A critical component for optimal cleaning is using the best possible cleaning concentrate. Recent European studies have illustrated that combination enzymatic enzyme detergent cleaners and conditioners are more effective than conventional cleaners. The research was initiated to deactivate prions deactivating prions within the objective to prevent CJD (Creutzfeldt-Jakob Disease).

The "Proper Sequence of Washer Treatments" includes a series of mechanical and chemical treatments.  The mechanical treatments include: cold water pre-wash, ultrasonic surgical instrument cleaner, detergent wash, purified water rinses, and hot air drying. The chemical treatments include combination of enzymatic enzyme cleaners, detergents, surface conditioners and lubricants.
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Surgical Instrument Decontamination: For Surgical Instrument Decontamination to be effective, the cleaning process must remove all forms of bioburden, minerals, and cleaning products prior to disinfection or sterilization. The Surgical Instrument Detergent 4 Enzyme Cleaner was originally designed for cleaning eye surgical instruments cleaner and rinsing surgical instruments clean.