Surgical instrument washers are not washer sterilizers.
Medical instrument washers were referred to as washer sterilizers prior to the FDA regulations that now require approval, based on product efficacy.
An APIC study of a surgical instrument washer confirmed that the efficacy of disinfection was 100% and that all medical instruments tested were sterile at the completion of the process.
Products, such as washer sterilizers, that were manufactured prior to the FDA Regulations for medical instrument washers, 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 proven that surgical instrument washers using the proper sequence of washer disinfector cycle times and temperatures, for washing surgical instruments, using a cleaning concentrate consisting of neutral pH medical enzyme surgical instrument cleaners working with surface cleaning detergents can deliver sterile surgical instruments and utensils.
An APIC research study demonstrated that "all surgical instruments tested were sterile at the completion of the washing process".
The surgical instrument washer time and temperature cycles that rendered sterile surgical instruments used a series of mechanical and chemical cycles.
The mechanical surgical instrument washer cycles include: cold water pre-wash, ultrasonic cleaning, enzyme detergent washing, purified water rinses, and hot air drying.
Purpose of a Surgical Instrument Washer
The purpose of a surgical instrument washer disinfector is to decontaminate and clean medical devices so they are "clean and safe to handle" and can be sent to the "clean side" where they will be packaged, and then sent to terminal sterilization.
An APIC study has proven that surgical instrument washer disinfectors are able to deliver sterile surgical instruments, using the proper sequence of mechanical cycles with chemical cycles using surgical instrument cleaners that consist of enzymes that break down bioburden working with detergents that remove the debris from the surface.
After being cleaned in a properly designed surgical instrument washer disinfector using an enzyme detergent cleaner, the research study confirmed that the efficacy of disinfection was 100%. An additional study proved that all medical surgical instruments and utensils were sterile at the completion of the washing process.
Ann Drake, APIC President and Director of Sterile Supply, University of Ohio
John Temple, Product Development, CESCO
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