Tag Archives: Vaporized hydrogen peroxide sterilization

Feb 22, 2017

The value of a positive vaporized hydrogen peroxide sterilization monitoring biological indicator

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The value of a positive VH2O2 BI

Sterilization monitoring expertise 

Since the 3M™ Attest™ System was created, it has monitored over 850 million sterilization cycles worldwide for steam and ethylene oxide. That same scientific research and development is now applied to the vaporized hydrogen peroxide (VH2O2) sterilization modality, which to-date has monitored approximately 500,000 cycles and has since received industry recognition as a 2016 Excellence in Surgical Products (ESP) Award winner!  With all of the information collected over the past four decades from users, we have become experts when it comes to biological indicator sterilization monitoring in healthcare facilities.

Challenging sterilization practices

Asking questions and researching technologies are some of the most important things anyone can do to become better and more efficient – and that is how we work. Biological indicators (BIs) by definition provide a strong challenge – they are the only monitor containing viable microorganisms and are intended to demonstrate whether or not the conditions were adequate to achieve sterilization.  Over the past few months the 3M Monitoring Technical team has been having great conversations about vaporized hydrogen peroxide sterilization. Some users of the 3M™ Attest™ Rapid Readout Biological Indicator 1295 for Vaporized Hydrogen Peroxide have seen positive biological indicators (failed cycles). To some this was alarming, since they have never experienced a failed load with vaporized hydrogen peroxide sterilization – but to us, this was an opportunity to really look at what was happening inside these sterilizers. Working together we discovered some very interesting real world challenges. We found common errors that caused positive BI’s due to the following:

  • Improper loading of the sterilizer chamber
  • Overloading the sterilizer chamber
  • Use of  incompatible materials
  • Over filling rigid containers
  • And, even using the wrong type of packaging

Some of these issues can change the chemistry of the vaporized hydrogen peroxide sterilant resulting in decomposition – meaning the molecular bonds come apart and/or change making the cycle less effective/lethal for some items in the load.

The fact that these conversations are now happening in the industry, and throughout the world, is good news! This dialogue is now helping sterile processing departments learn more and raise the standard of safety they deliver to the operating room and patients. Speed will always be important, but there is also tremendous value with consistency across sterilization modalities, and the advantage of support beyond a single modality. These materials are some of the most common and useful tools we have been delivering users:

For more help and live support you can talk to a sterilization monitoring technical expert by phone (1-800-441-1922, option 2)or submit a question online.

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.