Tag Archives: AAMI

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.

Sep 14, 2015

Doing nothing is NOT an option: The case for a higher standard of care in flexible endoscope reprocessing

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Transmission of pathogens, including Carbapenem Resistant Enterobacteriaceae (CRE), by inadequately reprocessed flexible endoscopes is well documented in scientific literature as well as popular media and is recognized as a serious risk to patients. Healthcare providers and administrators in many roles, Gastroenterology, Infection Prevention, Sterile Processing, Surgical Services, Executive Management, Risk Management, and more, are wrestling with difficult questions—How confident am I that my facility has adequate processes in place? What are our quality control measures? Are there steps we need to take to minimize the risk of CRE or other pathogen transmission from inadequately reprocessed duodenoscopes or other similarly complex flexible GI endoscopes?

The “scope” of the issue
What is clear right now is that there is no single root cause and no single “fix” for the challenges of endoscope reprocessing. Studies show that even with the best of intentions, current reprocessing guidelines are not always followed to the letter. A study published online Aug 5 in AJIC1 provides evidence that contamination remains even when observers document that each and every step is completed properly. Not only that, but this study showed that contamination remains even after cleaning (or multiple rounds of cleaning and disinfection) on colonoscopes and gastroscopes, and thus is a concern not limited to the duodenoscopes that are currently the focus of concern.

Even the oft-cited microbiological culturing is only a small piece of a complex microbiological puzzle, according to Alex Kallen of the CDC in the latest from USA Today.

“A negative [duodenoscope] culture should not be relied on to rule out a scope as a source of an outbreak,” says Kallen, the CDC official. “There doesn’t necessarily have to be a positive duodenoscope culture; it is more of a preponderance of evidence. … If you have other epidemiological links, the scope might well be the source.”1

Based on what we know today and solutions that are currently available, there are two steps that facilities can take to help mitigate risk and safeguard their patients.

Cleaning verification
We know that adequate cleaning, physical removal of clinical soil/bioburden, is imperative to effectively perform subsequent reprocessing steps.  But how do you know whether an endoscope has been adequately cleaned? With the publication of AAMI ST91:2015 Flexible and semi-rigid endoscope processing in healthcare facilities, (recognized as a consensus standard by the U.S. FDA on 8/14/2015), new guidance is available related to cleaning verification. Section 12.4 – Verification and Monitoring of the Cleaning Process recommends that healthcare facilities:

  • Implement a defined, documented process for verifying the efficacy of manual cleaning–this should include the types and number of scopes tested and the frequency of testing
  • Routine monitoring should include visual inspection AND another method of cleaning verification (common methods available to healthcare facilities include ATP bioluminescence, protein, hemoglobin, carbohydrate)
  • Use rapid cleaning indicators to monitor cleaning efficacy—weekly, preferably daily for each endoscope processed

Developing a quality control program that includes routine endoscope monitoring with a rapid cleaning indicator will generate immediately actionable data. 3M™ Clean-Trace™ ATP Monitoring System is a rapid cleaning monitor validated against established manual cleaning benchmarks (protein, hemoglobin, and bioburden) for endoscope channels. In 30 seconds, the Clean-Trace System is able to quantify the cleanliness of a surface or lumen sample using Adenosine triphosphate (ATP) bioluminescence. With the integrated software, you can focus your quality improvement efforts for cleaning processes, for example:

  • Pinpoint individual endoscopes that are consistently failing to meet recommended thresholds.
  • Use generated data to identify potential cleaning process issues, such as missed or inadequate bedside flushes, or the need to modify cleaning solutions.
  • Document your quality assurance process and provide proof of adequately cleaned endoscopes to consistently deliver highest standard of care.

The case for sterilization
One recent CRE outbreak investigation revealed no lapses in reprocessing steps associated with cleaning and high level disinfection (HLD), leading investigators to the conclusion that the duodenoscopes had the “potential to remain contaminated with pathogenic bacteria even after recommended reprocessing is performed.”2

This and other evidence combine to cast doubt on the adequacy of high level disinfection for at least some types of flexible endoscopes. Despite the critical nature of the distinction between HLD and sterilization, there continues to be a great deal of confusion about, and misuse of, the two terms in discussions of endoscope reprocessing. Disinfection is defined by ANSI/AAMI ST58:2013 as a “process that kills pathogenic and other microorganisms by physical or chemical means. Disinfection destroys most recognized pathogenic microorganisms but not necessarily all microbial forms, such as bacterial spores.”

Today, the most common biocidal practice used for duodenoscopes and other flexible endoscopes is high level disinfection (HLD) using a liquid chemical disinfecting agent. Faster device reprocessing time and lower cost are the primary benefits of HLD.

In contrast, sterilization is defined as “a validated process used to render product free from viable microorganisms” (from ISO/TS 11139:2006 Sterilization of health care products — Vocabulary). Terminal sterilization and liquid chemical sterilization processes are required to kill all types of microorganisms including bacterial spores. Terminal sterilization cycles also include an extra margin of safety, referred to as the “overkill” process, which includes the time it takes to kill all spores and then doubles that time to create a sterilization cycle for a large margin of safety. A liquid chemical sterilization process does not have this margin of safety.

Terminal sterilization with ethylene oxide is validated and described in the IFUs for many models of endoscopes, including high-risk duodenoscopes. Ethylene Oxide (EO) is known to be gentle on instruments and is highly penetrating, making it ideal for complex devices such as long lumen flexible endoscopes. Modern EO sterilizers are engineered for safety and comply with occupational safety requirements.

The 3M™ Steri-Vac™ Sterilizer/Aerator GS series was introduced earlier this year. Though outdated concerns and misinformation continue to circulate, here are some facts about EO sterilization with the Steri-Vac Sterilizer GS series. It is:

  • Safe for staff and the environment:
    • Proven to be safe for staff when installed and operated according to instructions
    • Engineered safety features including 100% EO single-dose cartridges and cycles run entirely under vacuum and aeration performed in locked chamber
    • Available with a 3M™ Abator that converts EO exhaust into CO2 and water vapor with a conversion efficiency of 99+% – virtually eliminating emissions of EO to the environment
  • Highly efficacious—as a gas, it can penetrate medical devices with complex components including long, narrow lumens, with no restrictions on the length or inner diameter of endoscope channels
  • A traditional sterilization method that has been relied upon by healthcare, medical device, government and other industries for decades

Supplemental measures
As you know, the FDA, industry, professional organizations, and reprocessing experts are working diligently to understand the issues contributing to endoscope associated infections. In May 2015, a U.S. FDA panel convened to hear commentary on the topic. Dr. William Rutala, an internationally known expert in Infection Control and Epidemiology, presented the panel with a strong recommendation.

“To protect the public health we (FDA, industry, professional organizations) must shift endoscope reprocessing from HLD to sterilization. FDA should mandate that duodenoscopes (preferably all GI scopes) used in healthcare facilities be sterile by 2018.”4

As an outcome of that meeting, at the beginning of August, the FDA released FDA Safety Communication: Supplemental Measures to Enhance Duodenoscope Reprocessing which includes the use of Ethylene Oxide Sterilization as a listed supplemental endoscope processing measure. Although evidence is still being assembled, multiple facilities dealing with CRE outbreaks have reported adding Ethylene Oxide (EO) sterilization to their endoscope reprocessing protocol, and following the change, no further cases of CRE were identified (Illinois, Pennsylvania, California, Wisconsin3,5-7). Facilities with EO sterilizers can take action now. Facilities without on-site EO sterilizers should assess the feasibility of purchasing new equipment or consider outsourced EO sterilization.

Moving from HLD to sterilization is no small undertaking. The EO sterilization cycle time is much longer than the brief exposure time required for HLD. Additional endoscopes inventory may be required. When working with your leadership team, there are issues of risk assessment and cost that will require hard questions and diligent effort. Yet, your patients are counting on you to advocate on their behalf, to ensure they receive the highest standard of care, the care you would want for your own family.

Undoubtedly, this issue will continue to be discussed, studied, and debated because there are no easy answers. More data will help uncover the most effective modifications to current guidelines and design innovation may someday offer redesigned endoscopes or biofilm resistant surfaces. Until then, what we do know, and what should guide us, is the knowledge that doing nothing is NOT an option.

To learn more about this topic, download the white paper, “An Approach to Improving the Quality and Consistency of Flexible GI Endoscope Reprocessing.”

References:

  1. Ofstead CL, Wetzler HP, Doyle EM, et al. Persistent contamination on colonoscopes and gastroscopes detected by biologic cultures and rapid indicators despite reprocessing performed in accordance with guidelines. AJIC 2015;43(8):794-801. doi:10.1016/j.ajic.2015.03.003.
  2. Eisler, Peter. Deadly infections from medical scopes go unreported, raising health risks. USA Today. August 5, 2015. http://www.usatoday.com/story/news/2015/08/05/duodenoscope-infections-not-reported/29988165/. Accessed August 25, 2015.
  3. Epstein L, Hunter JC, Arwady MA, et al. New Delhi Metallo-β-Lactamase–Producing Carbapenem-Resistant Escherichia coli Associated with Exposure to Duodenoscopes. JAMA. 2014;312(14):1447-1455. doi:10.1001/jama.2014.12720.
  4. Rutala WA. ERCP Scope: A Need to Shift from Disinfection to Sterilization? Presented at: Meeting of the U.S. FDA Medical Devices Advisory Committee Gastroenterology-Urology Devices Panel; May 14-15, 2015; Washington, D.C.
  5. McCool S, Muto CA, Querry A, et al. High Level Disinfection (HLD) Failure in Gastrointestinal Scopes with Elevator Channels – Is it Time to Switch to Ethylene Oxide (ETO) Sterilization? Poster presented at: IDWeek; October 8-12, 2014; Philadelphia, PA.
  6. UCLA statement on notification of patients regarding endoscopic procedures. UCLA Health Web site. https://www.uclahealth.org/news/ucla-statement-on-notification-of-patients-regarding-endoscopic-procedures  Updated February 19, 2015. Accessed August 25, 2015.
  7. Smith ZL, Oh YS, Saeian K, et al. Transmission of carbapenem-resistant Enterobacteriaceae during ERCP: time to revisit the current reprocessing guidelines. Gastrointestinal Endoscopy. 2014;81(4):1041-1045. doi:10.1016/j.gie.2014.11.006.