“All instruments and utensils tested were sterile
at the completion of the process.”
After being cleaned in a Tunnel Washer using the
Paper accepted for presentation at APIC:
Eighteenth Annual Conference and International Meeting
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.,
Ohio State University Hospitals, Columbus, Ohio, 43210
The application of universal precautions to surgical instruments/utensils handling became an issue in the selection of replacing surgical instrument decontamination equipment for Central Sterile supply at our hospital. The new technology of an automated thermal disinfection tunnel surgical instrument washer(CESCO, Mercersburg, Pa.) offered increased protection to our reprocessing staff due to decreased handling but raised concerns about the efficacy of surgical instrument thermal disinfection as opposed to traditional surgical instrument 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 Decontaminator Washer Disinfector progress from cold water flush/rinse, sonic bath, wash, purified water rinses, surgical instrument lubricant within the final rinse, and hot air drying drying at 240° F. for 4 minutes. The Surgical Instrument 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 surgical instrument lubricant and de-ionized water prior to the drying cycle. A separate culture was taken of the surgical instrument lubricant fluid. All surgical 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 Decontaminator Washer Disinfector is a valid replacement for the conventional washer-sterilizer.
Ann Drake, APIC President, Director Sterile processing, Ohio Sate University
John Temple, VP Product Development
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 sterilizing surgical instruments, deliver surgical instruments that are safe to handle, and reduce reprocessing costs.
The Surgical Instrument Cleaning Concentrates referred to as "ultrasonic cleaning solution" used in these studies are currently available in the form of the all-in-ONE Surgical Instrument Cleaner with Conditioners (enzymatic enzyme detergent cleaners and conditioners). A critical component for optimal surgical instrument cleaning is using the best possible surgical instrument cleaning concentrate. Recent European studies have illustrated that combination enzymatic enzyme detergent surgical instrument cleaners with conditioners 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 Proper Sequence of Washer Treatments" includes a series of mechanical and chemical treatments. The mechanical treatments include: cold water pre-wash at less than 110 F, ultrasonic surgical instrument cleaner solution at 135 F, detergent wash at an elevated temperature of approx. 185 F, purified water rinses approximating the boiling point, and hot air drying above boiling point. The chemical treatments include the combination of enzymatic enzyme cleaners, surfactant detergents, passive layer surface conditioners, water conditioners, and lubricants.
John Temple, Product Development
John Prohonic, VP of Engineering
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