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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.

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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.

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.)

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

* 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:

• FDA Report: Questions and Answers about the STERIS System 1 Processor for Healthcare Facilities 
• FDA Report: Alternatives to Steris System 1: FDA-cleared Sterilization and Disinfection Products
  
• SGNA: Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes
  
• STERRAD^® Sterility Guide
• STERRAD^® NX™ System Overview
• EVOTECH^® Endoscope Cleaner and Reprocessor (ECR) Product Overview
  
• CIDEX^® OPA Solution White Paper
  
• CIDEX^® OPA Solution Technical Information
• ASP: How Do I Determine the Best Alternative?
  

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.

References:
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.