Peracetic acid is a highly biocidal oxidizer that maintains its efficacy in the presence of organic soil.  Peracetic acid removes surface contaminants (primarily protein) on endoscopic tubing.  An automated machine using peracetic acid to sterilize medical, surgical, and dental instruments chemically (e.g., endoscopes, arthroscopes) was introduced in 1988.  This microprocessor-controlled, low-temperature sterilization method is commonly used in the United States.  The sterilant, 35% peracetic acid, and an anticorrosive agent are supplied in a single-dose container.  The container is punctured at the time of use, immediately prior to closing the lid and initiating the cycle.  The concentrated peracetic acid is diluted to 0.2% with filtered water (0.2 μm) at a temperature of approximately 50°C.  The diluted peracetic acid is circulated within the chamber of the machine and pumped through the channels of the endoscope for 12 minutes, decontaminating exterior surfaces, lumens, and accessories. 

Interchangeable trays are available to permit the processing of up to three rigid endoscopes or one flexible endoscope.  Connectors are available for most types of flexible endoscopes for the irrigation of all channels by directed flow.  Rigid endoscopes are placed within a lidded container, and the sterilant fills the lumens either by immersion in the circulating sterilant or by use of channel connectors to direct flow into the lumen(s).  The peracetic acid is discarded via the sewer and the instrument rinsed four times with filtered water.  Concern has been raised that filtered water may be inadequate to maintain sterility.  Limited data have shown that low-level bacterial contamination may follow the use of filtered water in an AER but no data has been published on AERs using the peracetic acid system.  Clean filtered air is passed through the chamber of the machine and endoscope channels to remove excess water.  As with any sterilization process, the system can only sterilize surfaces that can be contacted by the sterilant. 

The manufacturers suggest the use of biological monitors (Geobacillus stearothermophilus spore strips) both at the time of installation and routinely to ensure effectiveness of the process.  The manufacturer’s clip must be used to hold the strip in the designated spot in the machine as a broader clamp will not allow the sterilant to reach the spores trapped under it.  One investigator reported a 3% failure rate when the appropriate clips were used to hold the spore strip within the machine. The use of biological monitors designed to monitor either steam sterilization or ETO for a liquid chemical sterilizer has been questioned for several reasons including spore wash-off from the filter paper strips which may cause less valid monitoring.  The processor is equipped with a conductivity probe that will automatically abort the cycle if the buffer system is not detected in a fresh container of the peracetic acid solution.  A chemical monitoring strip that detects that the active ingredient is >1500 ppm is available for routine use as an additional process control.

Microbicidal Activity.  Peracetic acid will inactivate gram-positive and gram-negative bacteria, fungi, and yeasts in <5 minutes at <100 ppm. In the presence of organic matter, 200-500 ppm is required.  For viruses, the dosage range is wide (12-2250 ppm), with poliovirus inactivated in yeast extract in 15 minutes with 1500 to 2250 ppm.  Bacterial spores in suspension are inactivated in 15 seconds to 30 minutes with 500 to 10,000 ppm (0.05 to 1%).

Uses.  This automated machine is used to chemically sterilize medical (e.g., GI endoscopes) and surgical (e.g., flexible endoscopes) instruments in the United States.  Lumened endoscopes must be connected to an appropriate channel connector to ensure that the sterilant has direct contact with the contaminated lumen.

See the complete recommendations on sterilizer and disinfection at www.cdc.gov “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008”.  ATS, Inc. also stocks a monitoring system using Geobacillus stearothermophilus spores to test the Peracetic Acid Sterilization equipment – see Supplies.

DID YOU KNOW?

§       Autoclave Testing Service, Inc. is one of the first companies nationwide to offer a Mail-In sterilizer monitoring service using biological indicators.  Serving the healthcare industry throughout the United States and Canada since 1986, we have thousands of satisfied customers.

§       We have on-line test results allowing you to access your results at your convenience!  Your Sterilizer Test Report (STR) is posted on-line upon completion of culturing, offering minimum turn-around time.

§       We have 24-hour test results for Steam sterilizers!

§       We have a comprehensive Glossary of Terms related to the sterile processing area (scroll below to view the Glossary).  This is invaluable information, assisting you with this important area of your facility.

ATS, Inc. now stocks sterilization pouches, sterilizer cleaners, chemical indicator products, sterilizers (new and used), ultrasonic cleaners, water distillers, and more!  (see Supplies).