Sep 22, 2016

Sterilization Policies and Procedures for Vaporized Hydrogen Peroxide

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The tumultuous and devoted acceptance of our customers to our newest rapid biological indicator for vaporized hydrogen peroxide (3M™ Attest ™VH2O2 Biological Indicator 1295) has been remarkable. Now, we want to share some best practices to help your Central Sterile Processing department.

Do you know if your Vaporized Hydrogen Peroxide Sterilization Quality Assurance Policy and Procedure is correct, and up-to-date to current published standards and guidelines?

Healthcare accreditation organizations are paying close attention to medical device processing and are reviewing and verifying a department’s policies and procedures.  A facility’s policies and procedures are the foundation of the day-to-day operation of your sterile processing department. The document available from 3M, Quality Assurance for Vaporized Hydrogen Peroxide (VH2O2) Sterilizers, is a brief and concise summary of the quality assurance recommendations for vaporized hydrogen peroxide sterilizers to help you update your policies and procedures.

Here are a few questions about VH2O2 sterilization:

Do you know which professional standards and guidelines that contain the recommended practices for vaporized hydrogen peroxide sterilizers (i.e. gas plasma sterilizers)?  ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities and the 2016 Edition AORN Guidelines for Perioperative Practice, Guideline for Sterilization are the basis for best practices.

Did you know that monitoring vaporized hydrogen peroxide sterilizers are similar too, but not exactly, like steam and ethylene oxide sterilizers?  As with other sterilization modalities, a variety of monitoring tools are used as part of an effective VH2O2 sterilizer quality assurance program. These include physical monitors, chemical indicators and biological indicators.

Section 9.5.1 of AAMI ST58 discusses the use of physical monitors for monitoring gaseous chemical sterilization processes. The Key quotes are: “At the end of the cycle and before items are removed from the processing equipment, the operator should examine and interpret the printout to verify that cycle parameters were met and should initial it to allow later identification of the operator.”  Do you know how to interpret the printout from your hydrogen peroxide sterilizer?

AAMI ST58 states: “A PCD with the appropriate BI should also be used at least daily, but preferably in every sterilization cycle” (Section 9.5.4.3).  AORN’s Guideline for Sterilization is slightly more specific and states, “Routine sterilizer efficacy monitoring should be performed at least daily on each cycle type, preferably with each load” Recommendations XX.h.4 and XX.h.5). In U.S. hospitals, end-users typically place a BI and an internal CI in a peel-pouch indicated for use in VH2O2 sterilizers and then position the pouched BI in the sterilizer chamber as recommended by the sterilizer manufacturer. As a best practice and to provide optimal patient safety, 3M recommends that every sterilization load be monitored with a biological indicator.

To assure your policy and procedures align download here.

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