It is widely understood that "Washer Sterilizers" do not sterilize surgical Instruments. Then why do we call them "Washer Sterilizers" ?
Surgical Instrument Washers, Washer Decontaminators, and Washer Disinfectors were referred to as "Washer Sterilizers" by manufacturers prior to the implementation of FDA regulations that require FDA approval of a products marketing terminology 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 a Surgical Instrument Washer with Ultrasonic Surgical Instrument Cleaner (Washer Decontaminators and/or Washer Disinfectors) can consistently 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." Click Here to review the APIC Abstract. This study was initiated to discover a higher quality cleaning outcome and an acceptable replacement for the "Washer Sterilizer".
