The "Proper Sequence of Washer Treatments"
includes a series of mechanical and chemical treatments.
do not sterilize surgical Instruments.
Surgical Instrument Washers (Washer Decontaminators and/or Washer Disinfectors) were referred to as "Washer Sterilizers" by manufacturers prior to FDA regulations requiring premarket approval. The FDA Regulations require approval for a products marketing terminology based on evidence of product efficacy. Products, such as Washer Sterilizers, that were manufactured prior to 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 ("Washer Decontaminators", "Washer Disinfectors") using the Proper Sequence of Washer Treatments, including an ultrasonic cleaning treatment, can deliver surgical instruments that are sterile.
Surgical Instrument Washers are not intended to be Washer Sterilizers. One research study states: when surgical instruments were cleaned (with no manual pre-cleaning) in a Tunnel Washer (Washer Decontaminator Washer Disinfector "All instruments and utensils tested were sterile at the completion of the process."
