An evaluation of medical instrument washers 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 demonstrated that medical instrument washers using the proper sequence of washer cycle treatments can deliver medical instruments that are sterile. Medical instrument washers are not intended to be washer sterilizers, yer a research study demonstrated that "all medical instruments tested were sterile at the completion of the washing process".
The proper washing medical instrument washer cycle treatments include a series of mechanical and chemical cycles. The mechanical medical instrument washer cycles include: cold water pre-wash, ultrasonic cleaning, detergent wash, purified water rinses, and hot air drying. The chemical cycles included using; medical instrument enzyme cleaners, medical instrument detergents, surface conditioners, and a surgical instrument lubricant.
The Purpose of a Medical Instrument Washer
The purpose of a surgical instrument washer is to deliver instruments that are "clean and safe to handle" for reprocessing and cleaning medical instruments so that they can be sterilized. Surgical instruments that are not clean cannot be sterilized.
Studies demonstrate how medical instrument washers are able to deliver sterile medical instruments, using the proper sequence of mechanical cycles and chemical treatments that use a combination of enzymes and detergents (surface cleaning) surgical instrument cleaners.
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 medical instruments were sterile at the completion of the washing process.
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Washer sterilizers do not sterilize so why do we call the "washer sterilizers"?. Medical instrument washers were referred to as washer sterilizers prior to FDA regulations that require approval, based on product efficacy.