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Reprocessing Options for Flexible Endoscopes

Reprocessor Q&A

Helpful Hint



Charles Roberts, MS
Director of Research,
Microbiology &
Chemistry, ASP

Barbara Trattler,

Director of Clinical
Education, ASP

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The STERRAD® Sterility Guide is an easy-to-use online tool designed to help you identify devices that fall within STERRAD® Systems cleared claims for sterility. With a few simple clicks of the mouse, you can log onto the STERRAD® Sterility Guide from any computer with Internet access and determine whether a device can be sterilized in the STERRAD Sterilization Systems.

The STERRAD Sterility Guide is dynamic and constantly changing as new devices are added. Please check the guide frequently for any additions or updates. The STERRAD Sterility Guide is the first of its kind in the industry and is one more example of ASP’s leadership and continued commitment to its customers.

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For More Information
To learn more about ASP and the products featured in this issue, or to let us know what you’d like to see covered in future issues, please call 888–783–7723 or e-mail frontiers@aspus.jnj.com.

Healthcare facilities across the United Stated are faced with the challenge of finding acceptable alternatives for the STERIS System 1 sterile processing system for the reprocessing of flexible endoscopes and other heat-sensitive medical devices. This special issue of Frontiers in Infection Prevention was developed to provide information and resources to help healthcare providers evaluate alternative products and make the best decisions to meet their sterilization and high-level disinfection needs

Reprocessing Options for Flexible Endoscopes—What Facilities Need to Know

Healthcare facilities have been advised to transition to legally marketed alternatives to the STERIS System 1 peracetic acid sterilization system. In determining reprocessing options for flexible endoscopes and other heat-sensitive medical devices, facilities should assess their patient-care needs, currently utilized instrumentation, and sterilization and high-level disinfection requirements. Reprocessing options include liquid chemical sterilants/high-level disinfectants that may be used alone or with automatic endoscope reprocessor systems, or sterilizers for processing medical devices, including those that employ low-temperature processes.1 Advanced Sterilization Products (ASP) offers a range of low-temperature sterilization and high-level disinfection products that should be considered as facilities evaluate their needs.

Terminal Sterilization
The STERRAD® NX System from ASP is a compact terminal sterilization alternative that utilizes an advanced hydrogen peroxide gas plasma process to rapidly sterilize a wide range of instruments at a low temperature—including most flexible endoscopes. It offers a 28-minute standard cycle time (38 minutes for single-channel flexible endoscopes), and the flexibility of having dry, packaged, sterilized instruments available for use anytime. The STERRAD NX System’s compact size, easy mobility, and fast cycle time make it ideal for the OR environment, as well as ambulatory surgery centers, sterile processing departments, and specialty departments such as urology, where rapid instrument turnaround is crucial.

Automated Endoscope Cleaning & Reprocessing
The EVOTECH® Endoscope Cleaner and Reprocessor (ECR) from ASP is a high-level disinfection alternative that eliminates labor-intensive manual cleaning of endoscopes* and provides consistent endoscope reprocessing each time. It features integrated leak testing, an onboard minimum effective concentration monitor, built-in alcohol flush, and computer tracking of all cycle parameters. Automated cleaning occurs using CIDEZYME® GI Enzymatic Detergent Solution, followed by a single-metered dose of CIDEX® OPA Concentrate Solution (5.75% ortho-phthalaldehyde), which assures high-level disinfection. The EVOTECH ECR provides a consistent, high standard of care—its fast, cost-effective automated process ensures a clean and disinfected endoscope every time. (See the Fall 2009 issue of Frontiers in Infection Prevention to read about a study evaluating inconsistencies in manual endoscope reprocessing.)

High-Level Disinfection
For facilities utilizing manual reprocessing, there’s only one place to look for proven efficacy, safety, and value in high-level disinfection: CIDEX® OPA Solution (0.55% ortho-phthalaldehyde). CIDEX OPA Solution has been tested and cleared as a high-level disinfectant for use with the most widely utilized endoscopes, and provides high-level disinfection with a 12-minute soak time at room temperature (20°C). This glutaraldehyde-free solution has been proven effective against a wide array of microorganisms, and protects patients and staff with a demonstrated safety profile backed by the heritage of ASP. And, as the No. 1 brand in high-level disinfection,2 it helps facilities maximize their budgets with its rapid processing time and noncorrosive formula that is gentle on expensive instrumentation. (See the Spring 2009 issue of Frontiers in Infection Prevention for a case study about the successful use of CIDEX OPA Solution at Bryn Mawr Hospital.)

Key Steps in Identifying Alternative Reprocessing Methods
In determining reprocessing alternatives for flexible endoscopes and other heat-sensitive medical devices, facilities should assess their patient-care needs and sterilization and high-level disinfection requirements. Below are some recommended steps in the process:

  • List the manufacturers and models of flexible endoscopes and other devices processed in the peracetic acid system
  • Review the device manufacturer’s instructions for reprocessing each instrument
  • Identify and evaluate alternative processing methods, including:
    • Low-temperature sterilization systems such as the
      STERRAD® NX System, which provides terminally sterilized wrapped devices
    • Automated endoscope reprocessors, such as the EVOTECH® Endoscope Cleaner and Reprocessor, which eliminates labor-intensive manual cleaning of endoscopes and utilizes CIDEX® OPA Concentrate Solution for high-level disinfection
    • High-level disinfectants such as CIDEX® OPA Solution for use in manual reprocessing
  • Select the reprocessing option that best meets your facility’s needs
  • Contact the device manufacturers to confirm that the reprocessing method is compatible with the instruments to be reprocessed
  • For instruments that are not compatible with the selected reprocessing method, evaluate whether other compatible instruments could be substituted

For more information about ASP reprocessing alternatives, please contact your local ASP representative or visit www.aspjj.com.

1. Questions and answers about the Steris System 1 processor for healthcare facilities. U.S. Food and Drug Administration.  (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm192685.htm). December 3, 2009. Accessed January 6. 2010.
2. 2008 Healthcare Products Information Services (HPIS) data. HLD Market Assessment.

* Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH® ECR when selecting those cycles that contain a wash stage. Does not eliminate bedside precleaning.

What resources are available to help with the transition from peracetic acid sterilization of flexible endoscopes and other heat-sensitive instrument to legally marketed alternatives?

A number of resources are available to help with the research and evaluation of sterilization and high-level disinfection options:

How is high-level disinfection different from sterilization? (Reprinted from the Spring 2009 issue of Frontiers in Infection Prevention)

It is important for anyone involved in instrument processing to understand the different roles of high-level disinfection and sterilization. The Spaulding Classification System dictates that reusable medical devices that enter the bloodstream or normally sterile tissue—known as critical items—should be sterilized. Semi-critical devices, or reusable devices that touch mucous membranes or skin that is not intact, should be high-level disinfected.1

Sterilization of medical instruments means the use of a physical or chemical procedure to destroy all microbial life, including highly resistant bacterial endospores.2 Major sterilization agents used in healthcare facilities include hydrogen peroxide gas plasma, ethylene oxide gas, dry heat, and moist heat (steam autoclave). According to the Centers for Disease Control and Prevention, chemical germicides are rarely used for sterilization.2

Alternatively, high-level disinfection is achieved using chemical germicides that eliminate virtually all recognized pathogenic microorganisms on instruments, except high levels of bacterial spores. High-level disinfection can be accomplished via manual soaking or in automatic endoscope cleaner and reprocessor systems, such as the EVOTECH® ECR from ASP.

1. Grahs P. General guidelines for use of chemical disinfectants: cleaning and disinfecting—disinfection of bloodborne pathogens. Infection Control Today. Posted Jan. 1, 2001. Available at: http://www.infectioncontroltoday.com/articles/410/410_111clean.html Accessed Feb. 27, 2009.
2. Centers for Disease Control and Prevention. Sterilization or Disinfection of Medical Devices. Available at: http://www.cdc.gov/ncidod/dhqp/bp_sterilization_medDevices.html. Accessed Feb. 27, 2009.

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Do you have questions about transitioning away from STERIS System 1 for reprocessing flexible endoscopes?  
E-mail us at: frontiers@aspus.jnj.com.


© Ethicon, Inc. 2010
STERIS System 1 is a registered trademark of STERIS Corporation.
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