Tag Archives: Quality System

Nov 23, 2015

The Chain of Infection: A Patient Journey

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The Chain of Infection

Passing Thru the Gauntlet of Healthcare Associated Infections

Meet Mary J, an incoming patient. She’s been referred to your hospital because of its reputation as a state-of-the art facility and one that has minimized healthcare-associated infections – HAIs. Mary’s OB/GYN insisted that yours is the best hospital for her to have her surgery. What began as a persistent pain in her pelvic region has been diagnosed as ovarian cancer and a complete hysterectomy has been ordered. The life of this otherwise healthy, 46 year old mother and elementary school teacher has taken a dramatic turn. She must put her care in someone else’s hands, something she’s unaccustomed to doing. With her family and her students relying on her, the last thing Mary needs is to come through the procedure successfully but encounter an HAI. HAIs can be harbored in virtually any place Mary will be transiting.  According to a recent HAI prevalence survey1 administered by the CDC, 1 in 25 hospital patients in the US have experienced at least one HAI. Read how ready this facility is to mitigate and minimize the occurrence of HAIs in its commitment to patient safety.

Arrival – Let the Battle Begin

Hands, the most common source of pathogen transmission, are a critical battleground in the fight to reduce healthcare-associated infections so naturally they are at the center of the challenge. One challenge is that in order for any product to be effective, it would also need to be gentle enough to promote repeated and frequent use. In any hospital, an effective antiseptic hand solution should also be latex glove and Chlorhexidine Gluconate compatible. It should also be dye and fragrance-free and available in versatile and convenient point-of-care locations to promote compliance. Because your hospital has initiated a comprehensive hand hygiene policy using awareness training, products and tools that are effective against infection yet gentle on skin, Mary’s admission will be less of a risk. Your hospital has also incorporated appropriate environmental cleaning programs with detailed instructions to ensure consistent cleaning based on industry standards and best practices. Because of this, Mary’s chance to contract HAIs as she passes through the hallways and contacts various equipment is reduced. The OR has been cleaned and disinfected using a variety of cleaning products and tools including chemical management systems that mix disinfectants and other products in exacting quantities. Additionally, the Infection Preventionist and Environmental Services Manager routinely review a hygiene-management-system sampling plan to validate the cleaning process and address problem areas. In all areas where Mary will pass, particular attention is paid to disinfecting high-touch surfaces. Cleanliness is verified using a hygiene management and testing system that provides real-time results. The analysis confirms that environmental cleanliness is at or above the goal benchmark for frequently touched surfaces – where the risk of cross contamination tends to be the highest. In addition to physical testing, data-driven assessment tools also help provide facilities managers with the ability to track the cost of HAIs to their facilities and justify investments in infection prevention programs.

Pre-op – Even up Your Nose?

As Mary is prepped for her procedure, she is impressed and reassured to see that all personnel who come in contact with her sanitize their hands using an instant hand antiseptic. They are obviously well trained and sanitize their hands without a second thought. She changes into a forced-air warming gown which will keep her warm as she waits prior to surgery, as well as maintain a comfortable body temperature throughout her procedure. Her nurse administers the hospital pre-surgical cleansing policy, which includes nasal antiseptic applied to her intranasal cavity and even an oral rinse – no opportunity for an HAI is left to chance. Mary’s nurse explains that this routine will help minimize the bacteria in her nasal and oral passages, bacteria that could easily spread to her surgical wounds or her airway while she is on the breathing machine. Her skin is prepared for surgery using specially developed 2% chlorhexidine gluconate rinse-free cloths that address multidrug resistant organisms on the skin and are another layer of defense against surgical site infections. Mary is then transported into the operating room. Other members of the surgical team begin to arrive into the OR. The surgical assistant puts on a high fluid-resistant surgical mask, disinfects her hands with an antiseptic hand prep and then gowns up. All surgical tools are effectively monitored using chemical and biological indicators. These indicators serve as release criteria in the Central Sterile Supply Dept. (CSSD). CSSD places chemical indicators into each set before sterilization and then are checked prior to use in the OR to verify sterilization conditions have been met. This last step is adopted by the World Health Organization, Safe Surgeries Check List to indicate that sterilization conditions exist inside the set (http://apps.who.int/iris/bitstream/10665/44186/2/9789241598590_eng_Checklist.pdf)

The indicators show a “pass”, which means they have met the parameters for sterilization and the instruments are ready. Just before she goes under anesthesia, as part of the patient monitoring process, pre-wired monitoring electrodes are placed on Mary and connected to her monitors. These electrodes use a gentle, conductive adhesive that is repositionable and won’t tear delicate tissues when removed. Mary’s IV  is inserted and secured using a transparent dressing so her IV can be monitored without removing the dressing and exposing the IV site to additional bacteria. Your hospital realizes the importance and cost saving benefits to using dressings that provide superior wear time, gentle removal, and excellent moisture management in the battle against HAIs.

In the OR Zone

While Mary’s forced-air warming gown is keeping her warm before surgery, another warming product will be used during her procedure – a full access underbody blanket. (Recent studies found that underbody blankets delivered significantly warmer patients than resistive warming devices or standard warming therapy).2-5 Maintaining normothermia helps reduce the risk of infections as well as the hospital length of stay. Warmed blood and fluids are also beneficial in an effort to maintain normothermia and they will be administered using a leading blood and fluid warming device. Once Mary is anesthetized, her skin previously clipped of hair, done in periop, is prepared for surgery using an iodine povacrylex and isopropyl alcohol surgical solution, which keeps bacteria counts below baseline for at least 48 hours. During this time, the rest of the surgical team disinfects their hands with an antiseptic hand prep. Mary is then draped using a surgical drape that has an antimicrobial incise film to create a sterile surface. This front-line barrier provides a sterile surface all the way to the wound edge, and provides continuous broad-spectrum antimicrobial activity to further reduce the risk of SSIs and HAIs. Before making any incision, the team conducts a “time out” to make sure they are doing the right operation on the right patient, have all of the appropriate instrumentation present and confirm that the correct pre-surgical protocols have been followed. The team also makes introductions and states the roles they have in the surgery, all part of your hospital’s head- to-toe patient safety attitude. Satisfied that all of the proper procedures have been followed, her gynecologic oncologist initiates the operation. After successfully removing her uterus, fallopian tubes, omentum and ovaries, fluid and tissue samples are collected and sent for testing. Mary’s skin incision is then closed using a disposable skin stapler. Closing the incision this way maintains wound edge apposition, allowing for appropriate edema to occur and facilitate proper healing. The final touch is dressing the incision. Your hospital stocks an all-in-one dressing that is highly conformable; one that flexes with movement and swelling and provides a better exchange of moisture vapor and oxygen to reduce skin maceration. The post-surgical dressing of choice protects the wound while absorbing drainage, all of which promotes healing and greater comfort. At last, Mary is transferred to the recovery room and then the ICU.

Post op Success and New Horizons

As the staff ushers Mary though recovery, a new set of pre-wired monitoring electrodes are placed on her and connected to the patient monitor. Oral care is started with an oral rinse (Chlorhexidine Gluconate 0.12%). This process is done every four hours while Mary is in the Post Anesthesia Recover Unit, or PACU. Because the staff at your hospital had the right processes and products in place, from the surgical prep station to the sterilization room to the OR and onto the ICU, they helped reduce the risk of Mary walking away with a healthcare-associated infection. Why subject patients to needless risk of a HAI when risk can be mitigated?


  1. CDC, Healthcare-associated Infections (HAIs), HAI Prevalence Survey, 2011, http://www.cdc.gov/HAI/surveillance/
  2. Tominaga A., Koitabashi T., et al. Efficacy of an underbody forced-air warming blanket for the prevention of intraoperative hypothermia. Anesth. 2007;107:A91.
  3. Insler SR., et al. An evaluation of a full-access underbody forced-air warming system during near-normothermic, on-pump cardiac surgery. Anesth Analg. 2008. 106(3):746-750.
  4. Teodorczyk JE., et al. Effectiveness of an underbody forced-air blanket in preventing postoperative hypothermia after coronary artery bypass graft surgery with normothermic cardiopulmonary bypass.  Critical Care. 2009. 13(1):P71.
  5. Engelen S, et al. A Comparison of under-body forced-air and resistive heating during hypothermic bypass. ASA Abstract. 2010. A075.
  6. World Health Organization, Health care-associated infections FACT SHEET, http://www.who.int/gpsc/country_work/gpsc_ccisc_fact_sheet_en.pdf
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.”


  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.