Author Archives: Larry Talapa, BS, MS, CQE

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.

Nov 1, 2016

Sterilization monitoring help is here! Get answers to your questions and learn best practices from experts.

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Sterilization Monitoring Technical Support

Are you a sterile processing manager or technician? Do you need a live technical support team to help troubleshoot undesirable events?

Over the past 30+ years, the 3M Sterilization Tech Line has received thousands of calls from sterile processing managers and technicians who need help or guidance on best practices. Time and time again, sterile processing departments have trusted the 3M team to provide the correct information referencing standard recommendations to help overcome challenges faced every day.

I take my job seriously. From healthcare facilities, to sterile processing departments, to patients, they all depend on us for answers. Each year our team completes many hours of CEUs, engage in national and local sterile processing chapter meetings, attend and participate in the national AAMI standard conferences, and travel globally to take part in the international ISO standards meetings. We stay current on sterile processing best practices, guidelines, and recommendations so we can tackle questions from across sterilization modalities (steam, ethylene oxide, and vaporized hydrogen peroxide).

Sterile Processing technical support; from cleaning to sterilization monitoring is free

We take a firm stance to make sure sterile processing departments get help when they need it. That means when you call one of us, you get support from all of us.

There are a several ways to get help when you need it

  • Submit your question online: a new feature that allows customers to ask a question and have a sterilization monitoring expert call back.
  • Call our 3M Sterilization Tech Line for live technical support: we have always had a technical helpline for quick access to answers. It’s easy to reach an expert at 1-800-441-1922 option 2.
  • We have experts in the field near you!  Typically for complex issues we may send out a Field Technical Consultant who can help troubleshoot at your facility on-site. We investigate at the source, conduct root cause analysis, and provide a solution or two to help your department to keep moving forward.
  • On demand best practice learning and education courses: one of the best things any sterile processing manager or technician can do is to continue to learn. We work hard to make courses convenient about topics that are relevant to issues we hear about.

Some recent interesting questions from sterile processing departments

I thought that I would share a few recent questions/answers 3M has received from sterile processing departments that I think are interesting and may be helpful to you.

Question: What type of BI PCD does AAMI ST-79 say to use for steam IUSS cycles?

Answer: AAMI ST79 10.7.4.1 A representative of the same type of tray to be routinely processed through by immediate-use steam sterilization should be selected to serve as the PCD (BI challenge test tray). Each type of tray configuration in routine use for IUSS should be tested separately.

Question: What Type or Classification of internal chemical indicator should I use for vaporized hydrogen peroxide sterilization monitoring?

Answer: AAMI ST58 2.14 under the note 1 definitions states Chemical indicators Class 2–6 are not applicable to monitoring the LCS/HLD/gaseous chemical sterilization processes described in this document.

Question: I heard ethylene oxide sterilization was banned in my state?

Answer: This is a very common misconception. All 50 states allow the use of ethylene oxide sterilization in healthcare facilities. The facility just needs to follow any state, local or regional regulations for installation and routine use.

For those of you who are reading this and I have had the pleasure of talking with you over the phone or during a visit I just want to say hi and keep monitoring!

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.