The evaluation of surgical instrument washer disinfectors confirmed that the efficacy of disinfection was 100% and that all instruments and utensils tested were sterile at the completion of the process.
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 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.
The Proper washing Surgical Instrument Washer Treatments include a series of mechanical and chemical treatments. The mechanical surgical instrument washer treatments include: cold water surgical instrument pre-wash, ultrasonic surgical instrument cleaning, detergent wash, purified water rinses, and hot air drying. The chemical treatments include: surgical instrument enzyme cleaners, surgical instrument cleaner detergents, surgical instrument surface conditioners, and surgical instrument lubricants.
The Purpose of a Surgical Instrument Washer
The purpose of a surgical instrument washer is to deliver instruments that are "clean and safe to handle" for reprocessing and surgical instruments so that they can be sterilized. Surgical instruments that are not clean cannot be sterilized.
Studies have demonstrated how a Surgical Instrument Washer is able to deliver optimal cleaning using a combination of automated mechanical treatments and chemical a surgical instrument cleaner. After being cleaned in a properly designed Surgical Instrument Washer disinfector using an enzyme detergent cleaner, the evaluation confirmed that the efficacy of disinfection was 100%. All instruments and utensils tested were sterile at the completion of the process.
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Washer Sterilizers do not sterilize. Surgical Instrument Washers were referred to as Washer Sterilizers prior to the FDA regulations that require approval based on evidence of product efficacy.