It is widely understood that Washer Sterilizers do not sterilize surgical Instruments. Surgical Instrument Washers 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 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.
Proper Sequence of Surgical Instrument Washer Treatments
includes 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 surgical instrument washer 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 is to deliver surgical instruments that are "clean and safe to handle" for reprocessing and surgical instruments that are clean so that they can be sterilized. Surgical instruments that are not clean cannot be sterilized. Surgical Instrument Washers properly prepare surgical instruments for sterilization by Terminal Sterilizers. Clean is the Prerequisite for Sterilization. Studies have demonstrated how properly designed Surgical Instrument Washer are able to deliver optimal cleaning using a combination of automated mechanical treatments and chemical treatments. Enzymatic Enzyme Detergents, Conditioners, and Lubricants in ONE surgical instrument cleaner concentrate. After being cleaned in a properly designed Surgical Instrument Washer using a combination enzyme detergent cleaning concentrate: evaluation of Surgical Instrument Washers confirmed that the efficacy of disinfection was 100%. All instruments and utensils tested were sterile at the completion of the process.