Tag Archives: Endoscope Reprocessing

Jun 1, 2016

It’s Time for APIC 2016!

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It’s Time for APIC 2016!

It’s Time for APIC 2016! And it’s time to get inspired – the APIC 43rd Annual Conference is almost here! From June 11-13, the infection prevention community – some 5,000 strong – will gather in beautiful, historic Charlotte, North Carolina to share and take in the latest breakthroughs and best practices from around the world. This three-day event is filled with opportunities to listen, learn and recharge with some of the industry’s most innovative thought leaders on infection prevention and control. We’ll be there, and we wanted you to know about some of the highlights:

What to see at APIC 2016 Conference

Disinfection and Sterilization: The Good, the Bad, and the Ugly

Start this conference right with this plenary session featuring Dr. William Rutala, a professor in the Division of Infectious Diseases at the University of North Carolina School of Medicine. Dr. Rutala presents a “good” classification scheme, improved data, and new technologies; the “bad” noncompliance, with guidelines for reprocessing medical/ surgical devices; and the “ugly” endoscope reprocessing and infection risks that may expose patients. Don’t miss it!

Integrating Infection Prevention Control Programs into the Ambulatory Care Setting: An Evolving Model 

Get a quick dose of ambulatory care expertise in this 30-minute session with Faith Skeete of NYU Medical Center and Natalie Fucito of NYU Langone.

Duodenoscopy

Hear the latest on a procedure that presents formidable challenges in infection control, presented by Maroya Walters of the Centers for Disease Control and Prevention.

International Infection Prevention and Control (IPC) in Resource-Limited Settings

Here is a rare chance to attend a workshop on a globally vital topic, hosted by experts from the Liberian and Kenyan Ministries of Health as well as the Infection Control Africa Network and the US CDC.

Best Practices for High-Level Disinfection and Reprocessing Programs at Large Academic Health Institutions

Take the Emerging Science, Research, and Application track – this Concurrent Education session features the very latest information from experts from the Medical Center, Medical School and Health Department at the University of Minnesota.

Infection Prevention and Surveillance in Primary Care 

Explore the latest with officials from Thomas Jefferson University, Jefferson College of Nursing and the Hospital of the University of Pennsylvania.

What to see in 3M Medical booth 1503

This year we are focusing on two topics that we get a considerable amount of questions on:

Endoscope reprocessing

Cleaning endoscopes is critical because residual organic material can inactivate disinfectants, allowing potentially deadly bacteria to remain on the surfaces. Facilities that achieve the highest standard of care proactively monitor manual cleaning protocols for flexible endoscopes. Read how routine endoscope cleaning monitoring can contribute to a higher standard of care.

Reducing the risk of surgical site infections

Patient safety is a primary concern for the perioperative team. A lot of attention is focused on skin preps and ways to reduce the patient’s bacterial load. One method is to use a nasal antiseptic before surgery. Before the conference, read a summary of clinical evidence about the efficacy of nasal antiseptics.

These are just a few examples of what’s inspiring us at this year’s APIC conference. We look forward to seeing you!

Mar 9, 2016

Applying the Science of Human Factors Engineering to Medical Device Reprocessing

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Endoscope Reprocessing with elevator down

You may not have heard about human factors engineering. But without question, the underlying concepts lie at the heart of what you do every day in a busy Sterile Processing department.As you strive to manage and improve processes and procedures to keep your department running efficiently, human factors provides a new perspective, and, quite possibly, new inspiration. Put simply, human factors is the science behind how we as humans relate to our processes, work methods, and environments. Where do we operate at our most productive levels? Where do we make errors? Why, and how, do we improve? A slightly less general view involves engineers solving the problems that arise when humans integrate with devices and systems, using the scientific method – testing and gathering data, rather than depending on common sense or simple “gut feel.” The specifics are exciting. Beginning with medical device manufacturers, human factors can help to design and verify the processes used for medical device reprocessing. It can include how processes and procedures are communicated for maximum understanding and compliance. It can even include the design of the instruments themselves. In your department, applying human factors engineering can help you define processes that can be performed in your specific, real-world environment. It can also help you establish education, training, and competency verification tools to ensure staff have the necessary information and skills. 3M would like to invite you to learn more about human factors. Our educational webinar, How can Human Factors Engineering Concepts be Applied to Medical Device Reprocessing? explores how human factors affects the design of medical devices and processes. You’ll learn about:

  • How human factors engineering affects instrument and instrument set design
  • Proper design and content of Instructions for Use (IFUs)
  • Design of reprocessing procedures
  • Applying protocols
  • And much more.

Facilitated by 3M’s Christophe de Campeau and Dorothy Larson and featuring Susan Klacik, CSS Manager at St. Elizabeth’s Healthcare, Youngstown, OH and educational consultant to 3M Health Care, this presentation also features case studies that illustrate how human factors can make a difference in any department. View this webinar and other webinars about Sterile Processing at 3M Healthcare Academy.

Feb 12, 2016

If You Struggle With Sterile Processing, Then Read This

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Sterile processing department

Sterile processing is an important function that is vital to every health care facility. Sterile processing technicians need up-to-date, helpful information about standards, guidelines, and recommended practices. To make it easy for technicians to learn best practices, 3MSM  Health Care Academy created a full catalog of free self-study and live continuing education (CE) courses presented by technical experts. Here is a list of some of the most popular 1 hour sterile processing CE courses over the past 12 months.

Sterilization & Disinfection in an ASC Setting

Learning Objectives:

  • Identify the latest requirements and guidelines from accrediting organizations specifically relating to reprocessing of medical devices.
  • Describe key published standards and recommended practices for safe and effective reprocessing of reusable patient care items.
  • List available resources that can help an ASC comply with best practice related to reprocessing of reusable medical devices.

ST79 Essentials for ASCs

Learning Objectives:

  • Discuss AAMI ST79 and the need for the recommended practice.
  • Discuss the different types of steam sterilization processes and cycle parameters.
  • Describe the different types of sterilization monitoring devices, including PCDs.
  • Describe routine load release for implants and non-implants.

What a Gas: A Review of Today’s Low Temperature Sterilization Options

Learning Objectives:

  • List the low temperature sterilization technologies that are available in the industry today.
  • Describe how each of the low temperature sterilization technologies work.
  • Recognize the benefits and limitations of each low temperature sterilization technology.
  • Identify the factors to be considered for choosing a low temperature sterilization technology.

IUSS – Follow the Standards or Get Cited!

Learning Objectives:

  • Review the most current AORN and AAMI standards and recommended practices relating to IUSS.
  • Explain CMS’s Update of Survey and Certification Memorandum Regarding IUSS.
  • Identify The Joint Commissions’ standards related to IUSS.

Steam Sterilization Qualification and Troubleshooting: Process Failures and Wet Packs

Learning Objectives:

  • Discuss steam sterilization qualification testing.
  • Describe available tools to help guide an investigational process on sterilization process failures and wet pack/load assessment.
  • Identify common reasons for steam sterilization process failures and wet packs/loads.

Are you following me? A Surgical Instrument Tray Tracer

Learning Objectives:

  • Understand how tracer methodology applies to sterile processing.
  • Discuss how IFU’s, competencies and processes may be observed by surveyors.
  • Understand the importance of following manufacturers’ IFU.

Duodenoscopes: Are Current Reprocessing Guidelines Adequate?

Learning Objectives:

  • Explain why duodenoscope reprocessing is currently under scrutiny.
  • Summarize the clinical literature describing outbreaks following exposure to duodenoscopes.
  • Discuss the reprocessing challenges that are unique to duodenoscopes.
  • Outline available and proposed options for improving duodenoscope reprocessing.

The Nuts and Bolts of Washers and Disinfectors

Learning Objectives:

  • Describe the steps in a washer/disinfector cycle and the purpose of each step
  • Discuss thermal disinfection and the A0 concept
  • Review means to optimize the effectiveness of your washer/disinfector
  • Identify potential root causes of washer / disinfector monitoring failures

The Science of Speed – The Evolution of Biological Indicators

Learning Objectives:

  • Describe the design and function of biological indicators
  • Discuss how biological indicator incubation time is determined
  • Understand how rapid readout biological indicators work

Sterile Processing in the ASC Environment – Are you ready for a survey?

Learning Objectives:

  • Identify sterile processing standards and guidelines relevant to the ambulatory surgery setting.
  • Describe best practices for instrument processing in the ambulatory surgery setting.
  • Develop a check off list to determine readiness for an accreditation survey.

Need more sterile processing CE learning? View the full course catalog.

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.