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ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities is an essential reference document for healthcare facilities in the US conducting chemical high level disinfection or sterilization during device processing. This “How to … ” guide provides a quick reference for suitable quality assurance that is consistent with ANSI/AAMI ST58 for use of the SYSTEM 1E® Liquid Chemical Sterilant Processing System. The SYSTEM 1E® Processor is intended for liquid chemical sterilization of manually cleaned, immersible, reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

Quality Assurance Methods

ANSI/AAMI ST58:2013 recommends several quality assurance methods to help ensure effective liquid chemical sterilization of medical devices.

The recommendations for chemical sterilization in ST58 now include:

  1. Monitoring Every Load/Cycle –This routine testing includes the use of chemical process monitoring devices to verify an effective liquid chemical sterilization cycle. Physical monitors are defined by the system manufacturer and may include displays or printouts of cycle parameters (temperature, concentration, exposure time etc.), in some cases biological indicators (BIs) or spore test strips, and chemical monitoring devices or chemical indicators (CIs). This also includes correct use and monitoring of the device by the processing staff and/or the staff preparing instrumentation for patient use.
  2. Routine Testing – This testing should be conducted daily or weekly as recommended by the sterilization process manufacturer, and verifies that the process is operating properly. It includes defined diagnostic testing. Routine testing may also use a BI or spore test strip as defined by the manufacturer.
  3. Quality Testing After Installation or Major Repair – This includes running consecutive diagnostic, BI or spore test strip and CI tests to verify that the process is operating properly after a major event (such as a repair).
  4. Periodic Product/Load Quality Assurance Testing – This testing is performed to verify that the expected results are achieved when following the chemical sterilization process manufacturer’s IFU as well as the instrument manufacturer IFU. It includes testing for sterilant exposure with typically used devices and by using BIs or spore test strips and CIs.

Most facilities are familiar with the first three quality assurance methods above, with reference to the instructions for use (IFU) from the manufacturer of the chemical sterilization process selected and the instrument manufacturers. These monitoring methods help to provide confidence that the sterilization process is working as intended. However, many facilities are less familiar with the recommendation for periodic product and load quality assurance testing. While AAMI ST58 recognizes that the sterilization process manufacturer and the reusable instrument manufacturer are in the best position to make recommendations for sterilization parameters, it is also recommended that end users periodically test and verify processing of instrument sets/loads given their particular local utilities and load configurations.

Quality Assurance Monitoring with the SYSTEM 1E® Processor

The following Table provides a guide to recommended quality assurance monitoring with the SYSTEM 1E® liquid chemical sterilant processing system.

1
Monitoring Each Load
and Cycle
2
Routine Sterilizer Testing
3
Quality Testing after Installation or Major Repair
4
Periodic Product/Load Quality Assurance Testing
Physical (print-out) Monitoring:
Confirm Successful Cycle Completion
(temperature, concentration,
exposure time)
Physical (print-out) Monitoring:
Confirm Successful Cycle Completion
(temperature, concentration,
exposure time)
Physical (print-out) Monitoring:
Confirm Successful Cycle Completion
(temperature, concentration,
exposure time)
Not Required: Monitoring and control of critical parameters by the SYSTEM 1E electromechanical system ensures that process conditions during clinical use match those of the process validation. Therefore, load quality assurance testing is not required.
Load: Use VERIFY Chemical Indicator for S1E Processor (CI); confirm passing color change Load: Use VERIFY Chemical Indicator for S1E Processor (CI); confirm passing color change Perform Diagnostic Cycle:
Confirm “Passed”
Daily: Perform Diagnostic Cycle: Confirm “Passed” Perform daily Aspirator probe inspection, drain screen inspection, and printer inspection In an empty tray (no device) perform 3 consecutive cycles with a VERIFY Chemical Indicator for S1E Processor (CI) and (optional) a VERIFY Spore Test Strip for S40® Sterilant.
Weekly (or, preferred each day of use): VERIFY Chemical Indicator for S1E Processor (CI) and a VERIFY Spore Test Strip for S40® Sterilant. Perform testing in an empty tray (no device)

For more details refer to ANSI/AAMI ST58, the Operator Manual for the SYSTEM 1E® Liquid Chemical Sterilant Processor, and the instructions for use for VERIFY Chemical Indicator for S1E Processor (CI) and VERIFY Spore Test Strip for S40® Sterilant.