Gastroenterology and Endoscopy News - PRIORITY Report ( July 2020 ) by McMahon Group

Volume 2 â&#x20AC;¢ Summer 2020

Endoscope Reprocessing &Infection Control

Keeping It Clean Amid COVID-19

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From the Editors

elcome to the Summer 2020 issue of Priority Report: Endoscope Reprocessing & Infection Control, a special supplement to Gastroenterology & Endoscopy News. As we write this, nearly 3 million Americans are known to have contracted COVID-19, and more than 132,000 people in this country have died of the disease. Although the outbreak seems to have stabilized in some places, in other states, cases, hospitalizations and deaths are surging. In other words, we are far from through with the pandemic. At the same time, many parts of the country have begun the process of reopening, including the resumption of elective medical procedures such as colonoscopies. Although these efforts look different in different places—what’s true in New Jersey may not be the case in Louisiana—at least one thing is consistent: The jobs of health care workers involved in endoscopies have become much more complicated, with infection control practices now more crucial than ever. This issue of Priority Report takes a look at some of the ways the COVID-19 pandemic has affected endoscopy practices, from sterilization of instruments to use of personal protective equipment to keep staffs and patients safe from the virus. The issue provides additional articles covering topics including preparing for surveys, how to make sure clean really means clean, and tips to improve working conditions for techs. We hope it provides information to help you in your daily practice.

Adam Marcus Managing Editor

Sarah Tilyou Senior Editor

Disclaimer—The reviews in this issue are designed to be a summary of information, and they represent the opinions of the authors. Although detailed, the reviews are not exhaustive. Readers are strongly urged to consult any relevant primary literature, the complete prescribing information available in the package insert of each drug, and the appropriate clinical protocols. No liability will be assumed for the use of these reviews, and the absence of typographical errors is not guaranteed. Copyright © 2020 McMahon Publishing Group, 545 West 45th Street, 8th Floor, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

Endoscope Reprocessing & Infection Control

PRIORITY Report Volume 2 • Summer 2020

Endoscope Reprocessing &Infection Control 6

S Sterilization Had Been a Problem FFor Months—Then COVID-19 Hit

S Seeing Is Believing: Why Colonoscopy Remains the Gold Standard (CE/CME) R

W When a Cough Can Kill: How Hospital HVACs Fight COVID-19 H

D Disposable Scopes Are Likely to Play A Larger Role at Small-Volume Centers

I IDSA PPE Recommendations: A Practical Approach to Protect HCWs

M Mission Critical: Working Conditions FFor Reprocessing Techs

D DDW 2020: Model Evaluates Cost, Infection Risk With Various C Duodenoscopes D

D 2020: Infection Risk From DDW EEndoscopy Far Higher Than Previously Reported R

When Doing Laundry Isn’t Enough W

A Ambulatory Surgery Centers: How to Prepare for Your First Survey H ‘ ‘The Normalization of Deviance’: How One Hospital Cleaned Up H PPrecleaning and Transport

A Automated Cabinets Found SSuperior for Endoscope Drying

H Do You Know When ‘Clean’ How IIs Really Clean?

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Sterilization Had Been a Problem For Months—Then COVID-19 Hit

or months, officials had been

warning of a looming shortage

in the supply of a gas used in the sterilization of medical equipment. Now, that already stressed system has taken another massive hit from COVID-19. At the heart of the issue is ethylene oxide (ETO). Across the country, states have been shutting down plants that produce ETO in response to concerns from local communities that the chemical, a known carcinogen, could contaminate the local environment. These closures have raised fears of shortages of necessary equipment for many medical procedures. Now, the onslaught of COVID-19 has placed additional strain on the system, as medical providers ask for more protective gear and single-use instruments, which are often sterilized using ETO before initial use. “Everyone approves of eliminating the emissions to keep people safe,” Lawrence Muscarella, PhD, the president of LFM Healthcare Solutions LLC, in Lansdale, Pa., told Priority Report. “Taking ETO factories offline until enhanced safety goals could be achieved may have seemed smart at the time, but in hindsight with this pandemic, it may have inadvertently contributed to equipment shortages.”

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To Use or Not to Use The medical industry has been relying on ETO since the 1950s, as one of a handful of ways to sterilize medical devices and instruments that contain delicate materials, such as plastic, which can degrade in high heat, according to guidelines from the CDC (www.cdc.gov/infectioncontrol/ guidelines/disinfection/sterilization/index.html). According to AdvaMed, the medical technology trade association, more than half of all medical devices—over 20 billion per year—are sterilized using ETO. These devices include gowns and drapes, syringes, surgical kits, catheters and ventilators (www.advamed.org/issues/regulatory-affairs/ ethylene-oxide-sterilization-and-medical-devices). However, exposure to ETO can lead to a host of health problems, such as cancer and neurologic issues, according to the CDC guidelines. This, along with reports of leaks and explosions at ETO sterilization facilities (www.aidic.it/cet/13/31/078. pdf; bit.ly/2MAfSYZ), has put residents in areas close to ETO manufacturers on high alert, and facilities have been closing their doors. In October, the FDA warned that the recent closures of facilities in Georgia and Illinois could affect the supply of sterile medical devices (bit.ly/3eFMegP). When the health care system became engulfed by the pandemic, demand for sterilized medical equipment soared. Fortunately, in many fields, providers have rescheduled elective procedures, which eases the strain on the system, Dr. Muscarella said. But the demand for personal protective equipment (PPE) and single-use medical instruments—required to be sterile before first use, often requiring use of ETO— will remain high as long as the pandemic continues, he said. “You have a supply line that was already stressed because of efforts in some places to eliminate a process that’s commonly used in this country to sterilize this equipment,” Dr. Muscarella said.

Responding to a Crisis In late March, the EPA said the state of Georgia and the company BD had reached an agreement to temporarily increase the number of devices the company can sterilize at two ETO sterilization facilities during the pandemic. According to the agency, the company is installing new air emission controls to protect the local environment (bit.ly/302YRhF).

On March 27, the Illinois Environmental Protection Agency announced that Medline Industries could resume full commercial sterilization operations using ETO, after showing it had complied with local environmental regulations (bit.ly/3coFiTD). According to Medline, the facility in Waukegan, Ill., produces and sterilizes more than 16,000 sterile surgical packs every day, supplying nearly 80% of the state’s urban and rural hospitals (bit.ly/3ctzbNM). The EPA declined to comment, referring inquiries to other agencies, including the Illinois EPA (IEPA). A representative of the IEPA, Kim Biggs, told Priority Report the agency had been working with Medline to implement new protective measures. The facility has since been up and running, she said, and the state doesn’t have plans to increase capacity further. “Medline is the only remaining commercial medical sterilizer in the state of Illinois, and they are now authorized to resume normal operations,” Ms. Biggs said. “IEPA has not been provided with any other proposals to increase use of ETO for medical equipment sterilization.” Jesse Greenberg, a spokesperson for Medline, told Priority Report the Waukegan facility had been dark since late December, as it was working on the installation, testing and balancing of an updated emissions system to comply with the state’s new law that went into effect just before 2020. But now that it can resume normal operations, it is using the same process for surgical kit sterilization to decontaminate used face masks, including N95 respirators. “We just started this process and will be decontaminating 100,000 face masks per day, part of which will be handled in Waukegan,” he said. Soumi Saha, PharmD, JD, the senior director of advocacy at Premier, a group purchasing organization for health facilities and providers, said the company was immediately “concerned about ETO sterilization capacity” once the

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COVID-19 pandemic hit. Seeing facilities open up and ramp up production has been a big relief, Dr. Saha said. “That’s opened up tremendous capacity in the U.S. to help sterilize PPE and other medical supplies that are being used to care for COVID-19 patients.” Ideally, that will continue, she added. “Our hope is the reopening of the facilities in Illinois and Georgia are not temporary, and that going forward, the FDA, EPA and CDC work together to collaboratively define acceptable ETO emissions and sterilization techniques, which will help ensure continued availability of sterile medical supplies.” A spokesperson for the FDA told Priority Report that although most endoscopes do not rely on ETO for reprocessing, the gas remains a vital part of infection prevention as a sterilizer of PPE used in surgical and other interventional procedures.

‘ Taking ETO factories offline until

enhanced safety goals could be achieved may have seemed smart at the time, but in hindsight with this pandemic, it may have inadvertently contributed to equipment shortages.

’

—Lawrence Muscarella, PhD LFM Healthcare Solutions LLC

“We are committed to working with state and local officials and industry to increase the supply of certain essential medical devices needed for health care personnel to protect against COVID-19 and to provide the best care to patients with COVID-19,” the spokesperson said. For the long term, the FDA is working to reduce the system’s reliance on ETO to sterilize equipment. Last year, the agency issued two challenges designed to encourage innovators to develop alternative sterilization techniques and new ways to reduce ETO emissions (bit.ly/2ZY3gmh). “We stand steadfast in our commitment to reduce overreliance on ethylene oxide for medical device sterilization,” the FDA noted.

For providers who are seeking to reuse filtering facepiece respirators such as N95 masks to address shortages, the CDC has recommended the use of other techniques, such as vaporous hydrogen peroxide and ultraviolet germicidal irradiation (bit.ly/3gWSPWa). A group at Duke University, in Durham, N.C., has reported safely decontaminating N95 face masks using vaporized hydrogen peroxide (bit.ly/3drnbOp). The FDA recently issued an emergency use authorization to another decontamination system developed by Battelle that also uses hydrogen peroxide (bit.ly/2MpTFwm). “There was a whole science behind reprocessing multiuse instruments, and now there’s a science developing around reprocessing PPE for front-line medical staff to wear during this pandemic,” Dr. Muscarella said. And there is much still to work out, he noted. “This is the big elephant in the room: If you’re reprocessing a single-use device, how many times can you safely reuse it?” Many things keep Dr. Muscarella up at night lately, he said, one of which is how the sterilization landscape might be permanently changed by what happens during the pandemic. If providers are able to find ways to reuse single-use devices, why not keep doing it? “What I’m concerned about is that when this crisis ends, we may be incentivized to rewrite our policies in a way that tolerates lax practices,” Dr. Muscarella said. “We can’t let this become the new clinical norm. We need to assure we revert back when the crisis is resolved.” —Alison McCook Dr. Muscarella is the president of LFM Healthcare Solutions LLC, an independent safety and quality improvement company. His company has consulted for or received research sponsorship in the recent past from universities about endoscope-related infections, and from companies that market ETO and other low-temperature sterilization technologies, instrument cleaning products, disposable endoscopes and reusable equipment, among others.

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When a Cough Can Kill: How Hospital HVACs Fight COVID-19

t a hospital in Wuhan, China, a group of investigators swiped swabs over high-touch areas such as computer

mice, bed handrails and trash cans, all of which tested positive for the virus that causes COVID-19. Perhaps most concerning, traces of the SARS-CoV-2 virus were present in the air.

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Like influenza, COVID-19 is transmitted by respiratory droplets, which can linger in an enclosed space for more than 10 minutes. A patient who asks for a glass of water in a crowded hospital hallway can generate thousands of droplets per second. What happens to the person without a mask who steps into that air space? Fortunately, hospitals have spent centuries improving infrastructure to prevent airborne transmission of other potentially deadly pathogens, such as the virus that causes measles, which can float in the air for up to two hours after an infected person coughs or sneezes. That infrastructure includes an intricate web of air filters and strict practices when treating patients who have (or may have) a contagious disease, with special attention paid to where procedures can generate droplet-rich aerosols.

‘ There are unknown risks in surgery for

aerosolization of COVID-19–infected blood and body fluids, and some procedures may be higher risk, such as endoscopy.

’

—Amber Wood, MSN, RN Association of periOperative Registered Nurses

Preventing airborne transmission of deadly diseases in hospitals “is a huge concern,” said Michael J. McDavid, a technical sales representative for Professional Abatement and Remediation Technologies (PART) LLC. Although some hospitals are taking extra precautions because of COVID-19, he told Priority Report he is “cautiously optimistic” that the same techniques that reduce the risk for measles, tuberculosis and other contagious diseases will work for COVID-19. For companies like his, which have worked for years on air quality in health care settings, the new coronavirus is “just another pathogen we’re dealing with now. Nothing else has changed.”

Scope of the Problem For a symbol of the fight against airborne transmission in hospitals, look no farther than Florence Nightingale, who advocated in the

1800s that facilities should take steps to improve ventilation. Over the years, hospitals have gradually developed more sophisticated building designs, always finding ways to improve air quality. “It’s a science that is continually evolving,” Mr. McDavid said. Most facilities are now airtight, he said, bringing in 100% of their air from the outside, and exhausting any contaminants to the outside. Before COVID-19, their primary concern was mold. “You bring in a lunchbox or other materials from the outside, and that introduces mold,” Mr. McDavid said. “It’s everywhere all the time, even in the most sophisticated system in the world.” Hospitals have elaborate filtration systems in place, including several banks of filters in various locations. When air is taken in from the outside, it typically passes through a prefilter, which cleans the air before it hits any equipment in the hospital’s heating, ventilation and air conditioning (HVAC) system. The air then travels through a return fan, then the heating and cooling components, another set of pre-filters, and the final filters—which, in the OR, are often high-efficiency particulate air (HEPA) filters. These are not the one- or two-inch HEPA filters the average person can buy, Mr. McDavid said. “These things are three feet deep.” Air ducts are cleaned regularly, said Mr. McDavid, an instructor for the National Air Duct Cleaners Association’s Certified Ventilation Inspector certification training course. The NADCA’s Assessment, Cleaning and Restoration standard recommends annual inspections of airhandling units, supply and return/exhaust ducts in health care facilities. “Proper assessment, maintenance and cleaning of the HVAC system is important to ensure the system is operating properly and appropriate air exchange and filtration is maintained,” added Mr. McDavid, whose employer, PART LLC, is also a member of the NADCA. If a contagious patient must undergo a surgical procedure, it takes place in an airborne infection isolation room, which uses negative pressure to exhaust all air to the outside, passing through HEPA filters along the way, Amber Wood, MSN, RN, the senior perioperative practice specialist with the Association of periOperative Registered Nurses (AORN), told Priority Report.

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Negative pressure can increase the risk for surgical site infection, so facilities often operate in a positive-pressure OR and adopt additional protective measures, such as limiting staff (all of whom must wear higher level respirators, or N95 masks), using a portable HEPA filter or ultraviolet germicidal irradiation to clean the OR air and waiting for a 99% exchange of new air before using the space for other patients, Ms. Wood said. But even these extra precautions aren’t foolproof. Last year, the CEO of Seattle Children’s Hospital revealed that, since 2001, several children had died from Aspergillus mold, spread into ORs via contaminated air (www.seattletimes. com/seattle-news/times-watchdog/mold-infections-at-seattle-childrens-hospital-tied-to-14-illnesses-six-deaths-since-2001/).

What COVID Changed A bad HVAC system is bad for COVID-19. Earlier this year, researchers showed how one asymptomatic person likely infected nine others after all of them ate at the same restaurant, perhaps via strong airflow from the air conditioner, which spread virus-laden air between three tables (Emerg Infect Dis 2020 Jul. doi: 10.3201/ eid2607.200764). The virus is present in stool, so any traces in toilets can become aerosolized from a flush, Lidia Morawska, PhD, the director of the International Laboratory for Air Quality and Health at the Queensland University of Technology, in Brisbane, Australia, told Priority Report. Indeed, a recent study of two hospitals in Wuhan, China, found elevated levels of SARS-CoV-2 RNA in aerosols taken from patients’ toilet areas (Nature 2020. doi: 10.1038/s41586-020- 2271-3). Because much about the airborne spread of the new virus remains unknown, some experts are looking to another virus for clues: SARS-CoV-1, which caused outbreaks of severe acute respiratory syndrome in the early 2000s. Researchers have documented numerous cases when the virus may have spread through the air, including in hospitals (Indoor Air 2004;15:83-95). One outbreak occurred after a patient with diarrhea visited a Hong Kong housing complex and used the toilet; soon after, more than 300 residents were infected (J Epidemiol Community Health 2003;57:652-654).

Given the concerns about potentially high airborne levels in bathrooms, Dr. Morawska recommended that hospitals increase ventilation in infected patients’ bathrooms, and maintain regular cleaning of bathroom surfaces. Some hospitals are taking extra precautions to prevent airborne transmission of SARS-CoV-2, Ms. Wood said. For instance, when patients need to be intubated—a procedure that can generate droplets—facilities may perform the intubation in airborne infection isolation rooms before transporting patients to the OR, or use a plexiglass box or plastic sheeting if intubating in the OR. If a facility is short on N95 respirators, team members may remain outside the room during intubation and extubation, she said, and wait to enter until the air exchange has removed 99% of airborne particles. But it’s not just intubation that can be dangerous, Ms. Wood said. “There are unknown risks in surgery for aerosolization of COVID-19‒ infected blood and body fluids, and some procedures may be higher risk, such as endoscopy.” Modifying existing HVAC systems, which hospitals have been optimizing for decades to prevent airborne transmission of other pathogens, doesn’t make sense to Mr. McDavid. If anything, some facilities, such as the Johns Hopkins Hospital, in Baltimore, are adding more of what works, such as HEPA filters and negative-pressure rooms to create more space to isolate COVID-19 patients (www.hopkinsmedicine.org/coronavirus/articles/ all-hands-on-deck.html). The SARS-CoV-2 virus is not measles, Mr. McDavid said; most of the respiratory droplets that contain the new virus are likely large enough that they fall to the ground or other surfaces relatively quickly. In that scenario, protecting staff and patients in hospitals is mostly a matter of adequate protective gear and housekeeping, he said, using proper chemicals to wipe down surfaces. “Yes, the new coronavirus is something different, and we’re learning a lot about it,” Mr. McDavid said. “But, really, the same mitigation efforts are in place as for mold, asbestos and other types of mitigation [that have] taken place over the years.” —Alison McCook The sources reported no relevant financial conflicts of interest.

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IDSA PPE Recommendations: A Practical Approach to Protect HCWs any health care facilities in the United States

have been reporting shortages of personal

protective equipment (PPE) for health care workers (HCWs) and are developing strategies to stretch these precious resources. Among these strategies are extending the use of disposable PPE or reusing it. The Infectious Diseases Society of America released recommendations about using PPE for infection prevention among HCWs caring for patients with suspected or confirmed COVID-19. If equipment is going to be used for an extended period or reused, the guidelines emphasize the need for proper donning and doffing of equipment, as well as proper hand hygiene techniques. Because SARS-CoV-2 is a newly discovered virus, many of the recommendations in the guidelines are based on experience with other respiratory viruses, explained Allison McGeer, MD, a member of the guideline committee and a microbiologist and infectious disease consultant in the Department of Microbiology at Mount Sinai Hospital in Toronto. The panel wanted to determine the evidence for reusing PPE that is “designed to be used in a single-use way,” explained Dr. Lynch, the associate medical director of Harborview Medical Center, in Seattle. To extend the lifespan of such tools, the recommendations state that surgical masks and N95 respirators could be removed and kept in a breathable container, such as a paper bag, for four or five days to give any contaminating virus an opportunity to die. The respirators also can go through reprocessing steps, such as UV-C light sanitizing or vaporous hydrogen peroxide. The concern about reprocessing, according to Dr. McGeer, is that each time a respirator is reprocessed, parts—like the elastic straps—degrade

a bit. There are many different respirators, and “each type would have to be tested repeatedly by each reprocessing method in order to know how many times you can take them on and off before they might start to fail, and how many times you can reprocess them,” she explained. “The number of times you can reprocess an N95 respirator without impacting the integrity of the unit is unknown at this point, and likely highly dependent on the method used,” agreed Fred Massoomi, PharmD, a senior director at Visante. “After each reprocessing step, the respirator must be visually inspected for tears, wear of the nose-bridge seal, and the elastic loops.” Nebraska Medicine estimated that a disposable N95 respirator could be reprocessed three times (bit.ly/2N6klCL).

Concerns About Counterfeits The shortages and uncertainty in the supply chain mean that HCWs are being asked to use unfamiliar equipment, sometimes sent by vendors that they’ve never worked with before, noted Jim Jorgenson, RPh, MS, the CEO of Visante Inc. It is very important to inspect the new equipment, he suggested; it might be counterfeit. This is so concerning that the National Institute for Occupational Safety and Health and CDC have a website on counterfeit equipment (bit.ly/37I5ojJ). Dr. Massoumi said, “Any suspected counterfeit products should be quarantined and reported to the FDA, NIOSH or the CDC; and, more importantly, not used, since the protective nature of the equipment many not exist.”

Endoscope Reprocessing & Infection Control

—Marie Rosenthal, MS The sources reported no relevant financial conflicts of interest.

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Ambulatory Surgery Centers: How to Prepare For Your First Survey

he number of ambulatory surgery centers has exploded

in recent years, with one in five Medicare-certified single-specialty ASCs focusing on endoscopy, according to the Ambulatory Surgery Center Association. It can be hard to stand out in such a crowded landscape.

Give yourself enough time to prepare, and continually review the standards to be sure you can reasonably meet them, so you’re not setting yourself up for failure.

‘

’

—Lori Groven, MSPHN, RN, CIC TRIA Orthopaedic Center

“There are a lot of ASCs now. Consumers and patients really do have the option of [going] where they want to go,” said Lori Groven, MSPHN, RN, CIC, the infection preventionist at TRIA Orthopaedic Center, in Minnesota. As a result, although facilities are subjected to regular checks by the Centers for Medicare & Medicaid Services, TRIA and other ASCs choose to undergo surveys from the Accreditation Association for Ambulatory Health Care (AAAHC) and other accrediting organizations, to try to gain a competitive edge. For TRIA, the benefits have gone beyond attracting patients, Ms. Groven said. Their yearlong process to prepare for their May 2014 survey—their first by a third-party accrediting organization— gave the facility a chance to take a second look at its practices, she noted. “It was really good to go through all these standards with our leaders to understand what our gaps were and what we needed to work on.”

Getting to Work It wasn’t an easy process. As a first step, Ms. Groven and her colleagues brought together

every stakeholder—including the ASC director, clinic director, managers, information technology support, the CEO and the chief operating officer—for a weeklong meeting. “We spent a lot of time getting a good understanding of the standards during that Lean event, and assigning responsibility.” AAAHC organizes its standards into chapters, so TRIA assigned a leader to each chapter and priority levels for various tasks. To keep track of what everyone was doing, team members compiled a “crosswalk,” or Excel spreadsheet, with a tab for each chapter, listing the required standards, whether they were compliant, and deadlines for completing each task. Then, they got busy getting ready. Chapter leaders began conducting mock surveys, in which staffers wore badges and pretended to be AAAHC agents. “It was a … realistic pretend survey for [staffers], and we were able to do some honest, real-time education with them, so that was really helpful for us,” Ms. Groven said. TRIA spent extra time on environmental safety and infection prevention, such as hand-washing and securing sharps, and teaching staff why all

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of that is important. Chapter leaders identified deficiencies and noted them in a shared folder. They reviewed items with staff, sharing PowerPoint presentations and placing cards with bullet points listing key information to remember throughout the facility. A TRIA newsletter included quizzes about AAAHC standards with prizes—sports tickets—for correct entries. “Bribery helped,” Ms. Groven said. Another area of focus was the use of opioids at the facility—specifically, standardizing the type and quantity prescribed by TRIA physicians. Before 2014, some would offer patients 120 pills, some as few as 15. Standardizing opioid prescribing “took quite a bit of time, but we’ve done really well with that,” Ms. Groven said.

Tips for Survey Day •

• •

Expert Advice Angela FitzSimmons, the director of communications and marketing at HFAP, another accrediting organization, agreed that more and more ASCs are turning to these third-party surveys as an extra source of validation. “It distinguishes you from other organizations around you,” she said, adding that it’s also just good practice. “It’s always a good idea to have an independent set of eyes looking at what you’re doing.” According to the most recent HFAP Annual Quality Report, the most frequent citations given to ASCs relate to the environment, such as issues with testing and verifying the fire alarm system. But, in 2018, more than 20% of ASCs were cited for issues relating to infection control, such as conducting the sterilization process with closed ratchets and using expired cleaning supplies. Ms. FitzSimmons said HFAP uses these lapses as an opportunity for education, not punishment. If surveyors spot a problem, they discuss it with staff, presenting the safer approach. Standards are the same; focus is the same. “HFAP prides itself on being a very educationally focused survey experience,” she said. “It’s why we always call it a survey as opposed to an ‘inspection.’ We don’t think people learn well under stress. And if you are bringing a third party in to review your organization, you want to get the benefit of that.” The biggest piece of advice Ms. FitzSimmons could offer to ASCs undergoing surveys: Don’t think of the standards as items that each department works on separately. Everyone contributes

•

Book a conference room. If you don’t have one available, make sure an appropriately sized room is available for meeting with surveyors. Bring a laptop. Avoid the shortcuts of a busy practice. Make sure medication room doors are not propped open and showers are clear. Don’t provide surveyors with information they don’t ask for; saying too much could get you in trouble. If a surveyor tries to write you up for something that isn’t a violation, talk to them about it. When an AAAHC surveyor thought TRIA shouldn’t be using triclosan, a staff member explained that it had been OK’d by the FDA. Stay calm! You’ve been preparing for this. —A.M.

to quality, she said, and everyone needs to be working together to get there. “Treat the standards as a framework for continuous quality improvement, as opposed to a checklist of disconnected requirements to meet.” Ms. Groven’s advice: Give yourself enough time to prepare, and continually review the standards to be sure you “can reasonably meet them, so you’re not setting yourself up for failure.” That approach worked for TRIA. The ASC passed its 2014 AAAHC survey, with surveyors just recommending (not mandating) a few improvements, such as changes to the write-up of quality improvement studies to better fit the AAAHC format. They also passed two subsequent surveys and are in the process of applying for specialty certification offered by AAAHC. Getting ready had been extremely time-consuming, Ms. Groven said, but after all of the team’s hard work, she said she “felt pretty confident” on the day of the survey.

‘ Treat the standards as a

framework for continuous quality improvement, as opposed to a checklist of disconnected requirements to meet.

’—Angela FitzSimmons HFAP

—Alison McCook Ms. Groven described her facility’s experience at the 2019 meeting of the Association for Professionals in Infection Control and Epidemiology. Ms. Groven and Ms. FitzSimmons reported no relevant financial conflicts of interest.

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‘The Normalization of Deviance’: How One Hospital Cleaned Up Precleaning and Transport

few years ago, something about the infection prevention efforts at

her institution just didn’t feel right to Allison Folkerts, MPH. So, she and her colleagues decided to investigate. As the infection preventionist at AMITA Health, in Illinois, Ms. Folkerts had been working with staff on avoiding surgical site infections at the health system’s community hospital, AMITA Health Adventist Medical Center La Grange. But they had not yet tackled the issue of precleaning and transport of materials to the sterile processing department (SPD). So, in 2017, Ms. Folkerts and others decided to observe the process. They were unpleasantly surprised. They found multiple lapses, including instances of instruments not being precleaned. As a result, the instruments arrived at the SPD with dried blood and body fluids, forcing staff to spend extra time scrubbing off the debris. It’s a “huge time drain on sterile processing staff if they’re tied up doing that,” Ms. Folkerts, now the director of quality and patient safety at AMITA Health, told Priority Report. Although some of the lapses were surprising, “in a way, I think I was expecting them, because that’s why we set out to do the risk assessment,” Ms. Folkerts said. Still, she added, “we were surprised by the normalization of deviance that was occurring throughout our organization as it relates to instrument precleaning and transport. We had become so accustomed to our broken processes that we no longer recognized that they were broken.” Ms. Folkerts and her team knew they had to

tackle the problem. They did so in the expected way, buying more equipment and teaching staff the proper steps to take. But they added a step: an audit of the precleaning and transport of more than 1,000 trays and case carts.

Compliance Soared The strategy appears to have worked: Six months after implementation, compliance with the new standards exceeded 95% (2019 annual meeting of the Association for Professionals in Infection Control and Epidemiology; abstract ISR-73). Most of the mistakes—including skipping precleaning altogether—resulted from a lack of awareness of current best practices and regulations, Ms. Folkerts said. Education, along with regular check-ins and follow-ups through the audits, made all the difference. “Once our associates became aware of the deviance that was occurring, they were immediately willing to help solve the issue,” she said. As a first step to the process, Ms. Folkerts and her team purchased new bins to transport contaminated equipment that were leakproof, puncture-proof, and could be labeled as biohazardous. They also bought products intended to maintain moisture on the instruments until they could be cleaned during the decontamination step. Once they determined which departments

Endoscope Reprocessing & Infection Control

see Cleanup, page 20

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Automated Cabinets Found Superior for Endoscope Drying ow long should you dry an

endoscope to achieve a dry,

microbe-free device that is safe for prolonged storage before use on the next patient? The answer: possibly longer than you think.

A stud udyy co comp mppari arrin ing drr yi y ngg eff ffec ecti tive v neess ve s and microb micr obbiall le obia l ve vels ls bet e we ween en a staand n arrd st stor orag or agee cabi bine bi nett an nd an n aut utom omat ated ed dry r in i g an andd st stor o agge cabi ca b ne nett fo f un nd th that at int nter erna nall su surf r ac rf aces e wer es eree ssttil il n t ddrr y af no afte terr 244 hou ours rs in th the st stan anda d rd cab da abiinet, wh ne heereeas alll surfface cess weere dryy aft fter err thr hree ee hours in the aut u om omat ated ed cabin nett ussiing forrce c d in nst s rume m nt-grade d air de ir (Am m J Inf nfec nf ecct Co C nt ntro roll 20019 1 ;447[ 7[9]:1108 0833 10089 389). ) The st Th stud udy wa wass initiaateed as cli lini nici cian ans n s at UC CLA Hea e lth h we were re pre r paringg to mo move ve fro r m stan st a dard unventiila l tedd veert rtic i al sto tora rage ge cab abiin ts to ne ne n w automa maated teed drying ng and sto tora rage ge cabiine nets with h fo f rced fillteere r d air. “II sa said id,, ‘L ‘Let et’s seee if thi hiss thing real a ly works lik ikee th they ey say it do d es,,’” seni nior author V. Raman n Mut uthuusa samy my,, MD MD,, th the medi dica call di dire rect ctor or of en endo dosc scop sc opyy at op a UCL CLA A Health h, told l Priority Rep epor o t. “I was as a bit of a skeptical customer, but I di didd kn know ow w, ba base s d se on our pri r or research [Ga Gast stro roin inte test st Endos nddossc 2 18;88(2):33166-322], tha 20 h t a si size zeab able lee min inor orit ity of pra ract ctic ices e do noot use an es ny ki kind nd of en enha hanc ncedd

dr yiing aftter end dr ndos osscoope p repro eppro roce ceess s in ng. We allso s had co ha cond nduc nd u te tedd a bo bore r sc scop opee st stud uddy in whi h ch h we f un fo nd mo mois isture ree in so some m end me ndos o co os cope pee cha hann nnel es seveerall da days y aft fter rep epro roce cess ce ssin ss ingg wh in heen n for orce c d ai ce ar d ying was dr a not perrfo f rm medd aft fter err reppro r cessin in ng” g (Ga Gast stroin i teest st End ndos oscc 20118; 8;88 88[4 88 [4]: [4 ]:61 ]: 6122 619) 9).. 9) Foor th he stud stud udyy co com mpar mp a in ingg ca cabbineet ttyyppees,, Dr. Muth Mu thus usam us amyy an andd hi his co co -i - nv nves nves esti t ga ti gatoors r useed th hree brronch chosco cope co p s (O pe (Oly lymp ly mppus BFm F 3C C2200), thr hree colo co lono lo n sccop no opes ess (Ollym ympu p s C pu CF F-Q Q16 160A 0A AL) L), an nd tth hree re duuodden e os osco cope co pess (O pe (Oly lyymppuuss TJF JF-1 -160 60F) F). F) Two brronch Tw hosco oscoope os pes, s, two w col olon on nos osccoopees an andd ttw wo duod o en od nos osco coope pess we w re rep epro rooce roce cess sssed and dri r edd using tw wo di difff fferent ffer en nt dr dryi y ng yi n plaatf t orms: a stan a daard sto t ra r ge cabbin inet et (Ol Olym ympu ym pus) pu us)) tha hat doeess not o h ve ha ve com ompr pres pr essse s d or hig ighighh-ef -ef effi ffi fici cien cien ency par ency artti ticulaattee air (H HEP EPA A) fililte A) ters te rs,, wh rs whic ich ic h is com o monly usedd in manyy endos osco coopy py uni nits tss in th thee Un U ited itted ed Sta taate tes,, and n an aut utom om mat a ed dryin ryin ingg an andd sttor o agge caabi binet wi w th th f rc fo rced ed fililttere tere r d aiir (E End ndod odry od ryy Dr Dryi ying yi n and Sto t rage g ge Cabi Ca b ne bi nett, Meddiv ivat a or at ors) s. s) Beefo fore ree the end ndos ossco c pe pess we wer ere re plaaced in the hee

Endoscope Reprocessing & Infection Control

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drying cabinets, they were put through a highlevel disinfection (HLD) cycle in an automated endoscope reprocessor (AER). After one half-hour of drying, all the scopes in both cabinets still had residual moisture in both internal and external channels. At the one-hour mark, scopes in the automated cabinet had no remaining moisture in the internal channels but had moisture on external surfaces, whereas scopes in the standard cabinet retained moisture in the internal channels and external surfaces. By three hours, scopes in the automated cabinet were found to be completely dry in both the internal channels and external surfaces, but moisture remained in both internal channels and external surfaces of the scopes in the standard cabinet. At 24 hours, external surfaces of endoscopes in the standard cabinet were dry, but the internal channels still retained some moisture. In the second part of the study, the investigators inoculated each endoscope with Pseudomonas aeruginosa after it underwent HLD in an AER and compared rates of bacterial growth between the cabinets. Dr. Muthusamy and his team found significantly more colony-forming units (CFUs) in the endoscopes dried in the standard cabinets. “After 48 hours of drying, the automated cabinet resulted in 8 log, 7 log and 9 log fewer recovered organisms for bronchoscopes, colonoscopes and duodenoscopes, respectively,” compared with the standard cabinet, they noted. “For decades, failures in endoscope reprocessing have primarily been attributed to human error resulting in breaches of existing reprocessing protocols. It is becoming increasingly apparent that although human error can play a role, existing protocols for endoscope reprocessing may also be insufficient. If moisture remains after endoscope reprocessing, recolonization with bacteria during endoscope storage can occur. Without the drying step in endoscope reprocessing, fluid may reside within endoscopes for days,” according to the investigators. Savvas Pavlides, PhD, the scientific quality manager of technology assessment at ECRI, an independent, nonprofit organization focused on improving the safety, quality and cost-effectiveness of health care, praised the study’s design but noted that it had limitations. “The concept of this study is interesting, and it’s very important that

we recognize that endoscopes are not completely dried after having been subject to [HLD], meaning that any remaining viable microbes can proliferate and colonize the instrument,” Dr. Pavlides said. But he noted that CFUs are only a surrogate measure for infection rates. “Just because they’ve reduced CFUs doesn’t mean that they will also see a reduction in patient infection rates. That’s the ultimate end point that we would like to measure, although reducing CFUs is a starting point. It does seem that more evidence is needed before we can draw conclusions about the utility of automated drying cabinets in reducing infections in the clinical setting. I would like to see larger clinical studies comparing infection rates” in patients related to use of these cabinets. Dr. Pavlides also noted that the experimental procedure in the study differed from the way endoscopes are normally handled in the clinical setting. “Obviously, undergoing [HLD] and then inoculation with Pseudomonas is not something we’d see in standard practice,” he said. “I’d like to see a comparison with a more real-world approach.” Dr. Muthusamy acknowledged the study’s limitations. “In terms of the inoculation, we wanted to begin with a large amount of bacteria … to better measure the suppressive effect. With a tiny amount, it would be much more difficult to quantify a difference,” he said. “Although we used CFUs as a surrogate for infections, obviously the more bacteria that are present, the greater the potential for infection. A study directly comparing rates of endoscopically transmitted clinical infections would be very hard to conduct, given the low rates of the occurrences and the difficulty in detecting them.” The broader message of the study, he said, is about the significance of the last step of getting moisture out of scopes once they are reprocessed. “We spend a lot of time talking about making sure we clean these scopes properly, but this shows that even if you do everything right, if you fail to get moisture out, there is still a potential for environmental recontamination depending on how the scopes are stored.” —Gina Shaw Dr. Muthusamy reported a financial relationship with Medivators. Dr. Pavlides reported no relevant financial conflicts of interest.

Endoscope Reprocessing & Infection Control

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Cleanup continued from page 16 used which instruments and which instruments needed precleaning, infection prevention staff held a 20-minute session to educate staff on the steps they need to take. “We made sure to explain the ‘why’ behind the ‘do’ and that patient safety was truly at the heart of the process,” she said. Then, they began the audit. The checklist evaluated staff who were responsible for precleaning and transporting instruments; once each item arrived in the SPD, a sterile processing technician reviewed the checklist to ensure that all steps were taken. Erin Kyle, DNP, RN, If something was amiss, the leadership in the CNOR, NEA-BC operating room performed real-time coaching. All completed checklists were passed on to the infection prevention team; if the team noticed any trends, such as certain departments missing the same step, they would schedule an additional educational session with those departments. “Once we felt that the process was hardwired and we achieved a compliance rate that we were pleased with, we dropped the total number of audits down to a more manTake an organization-wide, rather ageable number,” Ms. than piecemeal, approach. Folkerts said. “We Make the goal clear: a safer system continue to monitor for patients and personnel. compliance on a regular basis and offer tarAssemble an interdisciplinary team geted interventions, as that relies on best practices based necessary.” on solid evidence. Although Ms. Folkerts said she was not Provide adequate equipment and aware of any patients supplies, and use an audit tool or who became infected another device to evaluate progress. as a result of the previConduct continuous monitoring and ous lapses, “we recogfeedback, which are critical to longnize the link between inappropriate preterm success. cleaning and transport [and] potential patient harm,” she said. “Each time an instrument is not appropriately precleaned or transported should be considered a near-miss event, and it is our obligation to learn from the event and prevent it from happening again.”

Quality Improvement In 5 Easy Steps

1. 2. 3.

Widespread Problem Ms. Folkerts said other hospitals likely are facing similar problems. “I think that every organization should build a mechanism for detecting failures with precleaning and transport into their normal processes,” she said. “An audit is a good way to do this,” she said, noting that tracking data and monitoring trends can allow hospitals to implement “focused interventions.” AMITA is not the only organization that struggles with maintaining best practices for point-of-use treatment and transport of contaminated materials to the decontamination area, said Erin Kyle, DNP, RN, a perioperative practice specialist at the Association of periOperative Registered Nurses. “Audits are a great tool that organizations can use in the form of a checklist or an outside observer to evaluate how well a new process is working for users,” Dr. Kyle said. “Evaluation of a new process of this magnitude is essential for its success.” To work, she said, auditors must be objective—ideally, not a close friend of the person being audited—and use the information from the review to provide feedback. “When personnel make mistakes performing a task, giving them that feedback helps them to correct and helps them to be successful with the new process,” she said. AMITA’s approach is a “shining example” of how this could work, Dr. Kyle added. Others can follow its lead by undertaking an organizationwide improvement project instead of addressing the issue in pieces, framing the goal in terms of making the process safer for patients and personnel, assembling an interdisciplinary team that relies on evidence-based best practices, purchasing adequate equipment and supplies, using an audit tool or some other device to evaluate progress, and continuing to monitor and provide feedback. “Any facility can replicate what AMITA” has done, Dr. Kyle said. “All it takes is interdisciplinary collaboration among personnel who are interested in improving health care using evidence-based practices in their organizations.”

Endoscope Reprocessing & Infection Control

—Alison McCook Ms. Folkerts and Dr. Kyle reported no relevant financial conflicts of interest.

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How Do You Know When ‘Clean’ Is Really Clean? ori Ofstead, MSPH, knows all too well that things

are not always what they seem. As the president

and CEO of Ofstead & Associates, Inc., based in St. Paul, Minn., she and her team have visited numerous reprocessing centers across the United States, trying to determine if the reprocessed scopes are as ready for patient care as the facility believes. She’s often disappointed.

When Ms. Ofstead and her team visited two institutions and examined 16 uretoscopes that were considered ready for patients—after they underwent manual cleaning and sterilization— they found visible problems on every scope, such as scratches, debris and residual fluid. Additional

‘ We are trying to figure out why endoscope reprocessing

doesn’t work. [Cleaning verification tests] are a great canary in the mine, and they tell us something is not right here.

’

—Cori Ofstead, MSPH Ofstead & Associates, Inc.

tests confirmed that every one of the scopes was contaminated and needed to be reprocessed again (Am J Infect Control 2017;45[8]:888895). The researchers reported similarly troubling findings in a study of bronchoscopes that had undergone high-level disinfection (Chest 2018;154[5]:1024-1034). In both studies, the authors also found live bacteria inside both types of scopes.

In another, more recent study, more than one in 10 duodenoscopes remained contaminated even after they were reprocessed following protocols established by the manufacturer (Digestive Disease Week 2019; abstract Sa2047). Furthermore, a second round of cleaning helped only a little: When researchers reprocessed the contaminated scopes again, nearly one in seven remained contaminated. Although manufacturers and federal health agencies have suggestions on how to reprocess scopes, including precleaning, manual cleaning, visual inspection, and disinfection or sterilization (www.cdc.gov/hicpac/recommendations/ flexible-endoscope-reprocessing.html), how well these instructions work is unclear. “Recommendations have been made and yet there’s really not a lot of data on how effective they are in clinical use,” said Jacob Mark, MD, the medical director of the Pediatric Pancreas Center at Children’s Hospital Colorado, in Aurora, and first author of the study presented at DDW. Even when facilities follow instructions to

Endoscope Reprocessing & Infection Control

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Cleaning verification test (top), with resulting swap showing remaining debris (bottom).

the letter, they often fail, Dr. Mark said. “This is important to know when considering procedures and discussing risks with patients.” In the study, Dr. Mark and his team followed the manufacturer’s reprocessing instructions for three types of Olympus duodenoscopes. These consisted of immediate bedside cleaning followed by manual cleaning, and two cycles of high-level disinfection, which the manufacturer stipulated should include automated reprocessing using 22% hydrogen peroxide and 5% peroxyacetic acid, 4.3% trisodium phosphate and detergent, then 70% isopropyl alcohol and drying. To test how well this approach worked, the researchers brushed for cultures from the scope’s distal tip, including the elevator mechanism, and flushed sterile water through the working channel; all scopes were quarantined for 72 hours until the results of the cultures came through. The culture result was considered positive if the scopes had at least 10 colony-forming units (CFUs) of low-concern organisms (coagulase-negative staphylococci, micrococci and gram-positive

rods) or any CFUs of more concerning organisms, such as yeast, Staphylococcus aureus, enterococci or gram-negative enteric bacilli. A scope with a positive culture was cleaned, tested and quarantined again; if it was positive after the third round of high-level disinfection, the researchers returned the device to the manufacturer for assessment. Most of the cultured organisms (98%) were gram-positive, which pose less of a risk to patient health. “That, I think, is somewhat encouraging,” Dr. Mark said. “But it’s also not zero, which is what we would really like.” The most likely reason bacteria persist, he said, is a “design issue” that most providers are aware of—specifically, the elevator mechanism, which is particularly difficult to clean and may put these devices at higher risk for contamination. Alternatively, he said it’s possible that skin flora from technicians who handle the scopes may contaminate the tools during reprocessing. The findings are worrisome, Dr. Mark said, because many facilities struggle to follow the manufacturer’s recommendations for reprocessing scopes. What’s more, larger centers perform more than 1,000 ERCPs per year, and cannot culture and quarantine each device for 72 hours to wait for results without significantly increasing inventory. “There’s significant costs associated with culturing the scopes after every use,” he said. The bottom line is that endoscopes aren’t getting sufficiently cleaned and there are realworld consequences, as numerous reports of outbreaks of infection attest (JAMA 2014;312[14]:1447-1455).

Need to Verify Cleaning Given how difficult it is to keep endoscopes pristine, Dr. Mark recommended that providers check them as often as possible, to catch contamination before it hurts patients. “The more surveillance that we can do, the more likely we are to identify problems earlier.” Ms. Ofstead and other experts are urging facilities to purchase tools that check for the presence of residual debris (see sidebar, page 26). These cleaning verification tests—which measure levels of adenosine triphosphate (ATP), protein, carbohydrate and hemoglobin—should be performed at the very least after manual cleaning and before

Endoscope Reprocessing & Infection Control

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Distal end (left) and inner distal end (right), showing scratches and brown debris.

high-level disinfection and sterilization, according to experts. Any remaining patient material (e.g., serum, blood, fecal residue) present on a scope after manual cleaning will serve as a barrier that can prevent the sterilizing agent or the highlevel disinfectants from making direct contact with the microbes on endoscope surfaces. “If an endoscope is not cleaned properly, neither sterilization nor high-level disinfection will work,” said Michelle Alfa, PhD, the CEO of AlfaMed Consulting. Although many guidelines—including those from the Association for the Advancement of Medical Instrumentation The more surveillance that we can and the Association of periOperative Regisdo, the more likely we are to identify tered Nurses—agree problems earlier. that facilities should be —Jacob Mark, MD using cleaning verificaChildren’s Hospital Colorado tion tests, a 2018 study by Ms. Ofstead showed that only 50% of facilities were using them. That has to change, she said. “We are trying to figure out why endoscope reprocessing doesn’t work.” Cleaning verification tests “are a great canary in the mine, and they tell us something is not right here.”

‘

’

Pros and Cons of Various Tests Because there are no rules about cleaning verification tools, each facility has to decide for itself which to use and how often, according to Marc-Oliver Wright, MT (ASCP), MS, CIC, a clinical infection control practitioner at the University of Wisconsin Hospitals and Clinics, in Madison. Mr. Wright said he would like to see facilities use some type of cleaning verification tests at least once a day on each scope. However, he said, given the lack of standards and the time pressures of the health care environment, “I would guess that’s not happening.” Even if facilities adopt cleaning verification tests and perform them on a regular basis, they may struggle to interpret the findings. Almost everything contains some ATP, so how much is too much? In the meantime, Ms. Ofstead has a suggestion for facilities: Try everything, get samples from companies, and see what works best for you. When she does research checking scopes for how clean they are, she uses multiple tests, such as ATP, protein and hemoglobin. But that may not be necessary for every facility. The most important thing, she said, is to determine which tests work best with the facilities’ processes and produce reliable ratings.

Endoscope Reprocessing & Infection Control

see Verify, page 26

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Verify continued from page 24

Methods of Verifying Cleaning Adenosine triphosphate tests: These tests, sold by a variety of companies, take samples with swabs. A luminometer indicates if any residual adenosine triphosphate (ATP), a sign of organic matter, is present. Taking a sample is fast and easy, and sampling materials are relatively inexpensive, but a luminometer can cost more than $1,000. The test measures the amount of light generated by the reaction between the liquid-stable luciferase/luciferin reagent and ATP, represented as relative light units (RLUs); the higher the reading, the more organic matter. The luminometer will not distinguish between the types of organic matter, nor whether the cells are living or dead. Chemical tests: These tests measure levels of protein, hemoglobin or carbohydrate using swabs or strips that include reagents. The reaction produces a color, which is rapidly displayed on a spectrophometer or interpreted by staff. The tests are relatively inexpensive and easy to use, but rely on a subjective reading, unlike the quantitative output of ATP tests. Visual inspection: Another easy way to see if an endoscope is clean, Ms. Ofstead said, is to look at it. “That visual inspection is really straightforward, but it’s generally not done.” Even something as simple as taking a white swab to rub different parts of a scope, such as the biopsy port, can be telling. “A [cotton-tipped stick] is cheap. If it can’t pass a visual [cotton-tip] test [by being free of visible residue], it’s probably not going to pass your ATP or protein test.” Checking cleaning at other stages of reprocessing makes sense, too, Ms. Ofstead added. Up to half of endoscopes can have residual fluid, which serves as a breeding ground for microorganisms (Am J Infect Control 2018;46[6]:689-696). Looking inside with a boroscope, or using a simple drying test that shoots air through the channel and changes color if moisture is present, is simple and easy to do, she noted. To help, Ms. Ofstead’s organization has created a series of webinars designed to teach facilities how to visually inspect endoscopes and perform cleaning verification tests (ofsteadinsights.com/webinars). —A.M.

Ms. Ofstead recommended subjecting several different types of scopes to messy, long procedures, and testing them with different products. “They should flag very positive,” she said. Clean the scopes using regular processes, test them and then repeat the process; “you should see a remarkable difference in test scores” after repeated cleanings. This should quickly reveal which tests are easiest for staff to use and which scopes and parts of the scope are dirtiest and need extra checking. “You’re looking for a continuum” of dirtiest to clean, she said. “After a few weeks, get a sense of what dirty and clean should be,” and you can interpret any subsequent readings accordingly. “In that pilot screening, it generally becomes really clear which tests you’re most comfortable with,” she said. “[It] isn’t one size fits all.” Overall, according to experts, the most important thing is to use some type of rapid cleaning verification test after manual cleaning as a way to check if things are not what they seem. “I don’t answer the question, ‘which cleaning verification test do you think is better?’” Dr. Alfa said. “The site needs to determine what frequency and which test method works best for their facility.” Stressing the importance of using the many tools available to reduce contamination, Lawrence Muscarella, PhD, the president of LFM Healthcare Solutions, based in Montgomeryville, Pa., told Priority Report: “The FDA has said you can’t eliminate the risk of contamination, but adopting supplementary measures—culturing, sterilizing or repeating high-level disinfection again” and verifying that scopes are clean “will reduce the risk of multidrug-resistant infections.” He added that “if the scope remains persistently dirty, the facility may have to remove it from clinical use.” —Alison McCook Ofstead & Associates reported financial relationships with 3M, Ambu/Invendo, ASP/Fortive, Auris, Boston Scientific, Cogentix/Laborie, Convergascent, Healthmark, Medivators, Nanosonics and Steris. Dr. Mark and Mr. Wright reported no relevant financial conflicts of interest. Dr. Alfa reported financial relationships with 3M, Ambu, ASP, Healthmark, Kikkoman, Novaflux, Olympus, Ruhof and TSO3. Dr. Muscarella reported financial relationships with Ambu and a gas sterilization manufacturer.

Endoscope Reprocessing & Infection Control

Earn CE/CME Release date: March 1, 2020

Expiration date: March 31, 2021

Seeing is Believing ACTIVITY DESCRIPTION

INTENDED AUDIENCES

Routine screening colonoscopy with polypectomy is the most effective strategy for the prevention and early detection of colorectal cancer (CRC). Advantages include direct mucosal inspection of the entire colon and the ability to detect and remove precancerous polyps during a single session. Widespread use of this technique has contributed to an accelerating rate of decline in both the incidence and mortality of CRC from peak levels in the mid-1980s. Recently, noninvasive, home-based CRC detection tests have become available. One of the most important motivators for patient compliance with CRC screening guidelines is a recommendation from a primary care physician (PCP). The PCP has a unique opportunity to facilitate evidence-based and individualized screening in appropriate populations during regular checkups, in collaboration with specialists, and through appropriate referral and patient education. In this activity, participants will review the advantages and disadvantages of various CRC screening modalities and ways to maximize the effectiveness of the interdisciplinary team in delivering appropriate colonoscopy screening.

The intended audience for this activity comprises gastroenterologists and other health care professionals interested in CRC screening, colonoscopy, and appropriate bowel preparation.

GOAL The goal of this activity is to educate health care professionals about the use of appropriate CRC screening methods, including the limitations and advantages of both colonoscopic and noncolonoscopic approaches.

LEARNING OBJECTIVES 1. Review data supporting the importance of visualization via colonoscopy in the detection of CRC and precancerous polyps 2. Discuss the benefits and risks associated with the use of noncolonoscopic screening tests in the detection of CRC and precancerous polyps 3. Describe the role of the PCP in providing/referring for guideline-recommended CRC screening via colonoscopy

FACULTY Douglas K. Rex, MD, MACG, FASGE, MACP, AGAF Distinguished Professor of Medicine Indiana University School of Medicine Chancellors Professor Indiana University Purdue University of Indianapolis Director of Endoscopy Indiana University Hospital Indianapolis, Indiana

David A. Johnson, MD, MACG, FASGE, MACP Professor of Medicine Chief of Gastroenterology Eastern Virginia Medical School Norfolk, Virginia

Bill H. McCarberg, MD, FABM Kaiser Permanente San Diego (retired) Adjunct Assistant Clinical Professor University of California San Diego, California

Jointly provided by Global Education Group and Applied Clinical Education

ACCREDITATION AND CREDIT DESIGNATION STATEMENTS Physician Accreditation Statement This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Global Education Group and Applied Clinical Education. Global Education Group is accredited by the ACCME to provide continuing medical education for physicians. Physician Credit Designation Global Education Group designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nursing Continuing Education Global Education Group is accredited with distinction as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. This educational activity for 1.0 contact hour is provided by Global Education Group. Nurses should claim only the credit commensurate with the extent of their participation in the activity.

FEES: Free METHOD OF PARTICIPATION To receive CME credit, participants should read the preamble, participate in the activity, and complete the post-test and activity evaluation at www.cmezone.com/CU201. CME certificates will be made available immediately upon successful completion.

DISCLOSURE OF CONFLICTS OF INTEREST Global Education Group requires instructors, planners, managers and other individuals and their spouse/life partner who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations. The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this activity: • David A. Johnson, MD, MACG, FASGE, MACP: Aries Pharmaceuticals, Avrio Health, CRH Medical, Medscape/ WebMD (consultant/independent contractor); CRH Medical (stock shareholder) • Bill H. McCarberg, MD, FABM: Adapt, Scilex (speakers bureaus); Collegium, Johnson and Johnson, Sellas Life Sciences (stock shareholder); Averitas, Lilly, Scilex (consultant/independent contractor)

Supported by an educational grant from Braintree, A Part of Sebela Pharmaceuticals.

• Douglas K. Rex, MD, MACG, FASGE, MACP, AGAF: Aries Pharmaceutical, Boston Scientific, Braintree Laboratories, Endokey, GI Supply, Lumendi Ltd, Medtronic, Norgine, Olympus Corporation (consultant/independent contractor); EndoAid Ltd, Erbe USA Inc, Olympus Corporation, Medivators Inc (grant/research support); Satisfai Health (ownership) The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity: • Kathleen Wildasin: Nothing to disclose • Jennifer Kulpa: Nothing to disclose • Andrea Funk: Nothing to disclose • Lindsay Borvansky: Nothing to disclose • Ashley Marostica, RN, MSN: Nothing to disclose

DISCLOSURE OF UNLABELED USE This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. Global and ACE do not recommend the use of any agent outside of the labeled indications. The opinions expressed in this activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

DISCLAIMER Participants have an implied responsibility to use newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or courses of diagnosis or treatment discussed should not be used by clinicians without evaluation of patient conditions, contraindications, applicable manufacturer’s product information, and the recommendations of other authorities.

GLOBAL CONTACT INFORMATION For information about the accreditation of this program, please contact Global Education Group at 303-395-1782 or cme@globaleducationgroup.com.

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28 2 I|

Seeing Is Believing: Why Colonoscopy Remains the Gold Standard Proceedings from a live event presented October 28, 2019 Introduction Colorectal cancer (CRC) is the third most common cancer in the United States and the third leading cause of cancer death in US men and women.1,2 Five-year survival is greatly affected by stage at diagnosis, ranging from 90% when localized to only 14% with distant metastases,3 underscoring the importance of early detection and treatment. Efforts to prevent CRC via screening colonoscopy have led to declines in incidence of approximately 3% per year during the last decade,2 and most professional guidelines recommend colonoscopy every 10 years in average-risk individuals starting at 50 years of age.4 Compliance with this guidance varies greatly by region in the United States, from a high of 76% in Massachusetts to a low of 58% in Wyoming.2,5 The advantages of colonoscopy include the ability to detect and remove precancerous lesions—including adenomas, the precursor to about 70% of CRCs,4 and serrated lesions—in the same procedure. Numerous improvements in colonoscopy have occurred over the past few decades, including the introduction of high-definition scopes, the development of techniques

to resect lesions throughout the entire colon, and the establishment of quality indicators. At issue for some patients is bowel cleansing in preparation for colonoscopy, which is an acknowledged challenge. Recently, noncolonoscopic screening modalities have been introduced and are being promoted to patients and physicians alike as screening alternatives to colonoscopy that do not require bowel preparation. This presentation covered approaches to CRC screening, including data for the benefits and risks of available screening tests; the important role that the primary care physician (PCP) plays in recommending the appropriate test for each patient; and strategies for maximizing the effectiveness of colonoscopy. Case studies were incorporated to elucidate key points. In addition, the session sought to gather feedback from attendees on effective messaging around this topic, namely the following: • Are you messaging your own PCPs about the value of screening colonoscopy? • What is your message about screening colonoscopy? About other screening modalities?

CRC Screening Tests: The PCP Perspective Bill H. McCarberg, MD, FABM Approaches to Screening Most national organizations, such as the US Preventive Services Task Force (USPSTF) and American Cancer Society (ACS), provide information about the various CRC screening tests without a ranking. In a busy primary care practice, this leaves the decision about which test to recommend up to the provider, who may be inclined to focus on the test that raises the fewest questions or issues from the patient. In contrast, the US Multi-Society Task Force (USMSTF) on Colorectal Cancer—which includes the American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE), and American College of Gastroenterology (ACG)—stratifies CRC screening

Table 1. US Multi-Society Task Force–Recommended CRC Screening Tests4 Tier 1

Test/Frequency

Frequency

Colonoscopy

Every 10 y

FIT

Every 1 y

CT colonography

Every 5 y

FIT-fecal DNA

Every 3 y

Flexible sigmoidoscopy

Every 10 or 5 y

Capsule colonoscopy

Every 5 y

CRC, colorectal cancer; CT, computed tomographic; FIT, fecal immunochemical testing.

tests into 3 tiers based on performance features, costs, and practical considerations (Table 1).4 This can help streamline the conversation. The setting in which the CRC screening process begins is important. Organized screening refers to a system-wide, organized approach in which screening is offered to an employee population or members of a health care plan, whereas opportunistic screening refers to screening that takes place during an interaction between a patient and health care provider in an office-based setting. Organized screening is dominated by fecal immunochemical testing (FIT); however, colonoscopy is often available in this setting as well.4 In the United States, most CRC screening occurs in the opportunistic setting and involves colonoscopy, FIT, or FITfecal DNA testing. Within the opportunistic setting, 3 different approaches can be used to offer screening to patients.4 The sequential approach involves first offering the provider’s preferred screening test (colonoscopy); if the patient declines the first option, a second test (FIT) is then offered. In the riskstratified approach, colonoscopy is offered to patients predicted to be at high risk for precancerous lesions based on factors such as older age, male gender, smoking, diabetes, and obesity; and other screening tests are offered to patients predicted to be at a lower risk. In the multiple-options approach, the benefits, risks, and costs of 2 or more screening options are discussed. Recent qualitative studies have shown that offering more than 2 options does not improve adherence but actually leads to confusion and nonadherence. In a cross-sectional study of 1,707 survey respondents, those who discussed more than 2 options for CRC screening with their physicians were 1.6 times more likely to be confused than those who discussed 1 option, and those who reported confusion were 1.8 times more likely to be nonadherent to screening than those who did not.6

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It is important to acknowledge the numerous barriers to CRC screening.7,8 Health-system barriers include lack of insurance or inadequate access to payment resources, lack of recommendation from a PCP to undergo screening, and lack of language interpretation services. Personal/cultural barriers include lack of knowledge or misconceptions about screening, poor understanding of bowel preparation instructions, distrust of the medical system or a fatalistic attitude about cancer, lack of transportation or inability to take time off from work, and embarrassment or fear of the procedure. Overcoming these barriers requires physician intervention, particularly on the part of the PCP. A recent review found that among adults who were not current with CRC testing despite having a PCP visit within the previous year, 90% cited lack of physician recommendation as the reason for lack of testing.8 This underscores the key role of a PCP recommendation in improving health-related behaviors. In a 2008 Cochrane Review of 41 trials, including more than 31,000 smokers, the most common setting for delivery of smoking cessation advice was primary care.9 Pooled data showed a significant increase in the rate of quitting among patients who received a brief intervention from a PCP. The authors concluded that, assuming an unassisted quit rate of 2% to 3%, the PCP can increase quitting by a further 1% to 3%.

“PCPs have many demands on their time and often don’t make the necessary recommendations for colonoscopy. Sometimes there is a note in the patient’s chart that goes unnoticed, and sometimes busy PCPs simply forget. What is important to acknowledge, however, is that when patients do not undergo colonoscopy at the appropriate time, it’s most often because the provider hasn’t informed them that it needs to be done. It’s very important that PCPs get the message across. In addition, readers may not be aware of the effect that gastroenterologists can have on PCPs by just advising them to mention and encourage screening. PCPs are always interested in doing the best for their patients. If colonoscopy is the best test as judged by providers opting for this test for themselves, then the providers should encourage this same best test for patients, even if they encounter resistance.” —Bill H. McCarberg, MD, FABM

Colonoscopy Colonoscopy provides direct visual examination of the entire colon as well as the removal of precancerous lesions. This procedure remains the gold standard for CRC screening and is the reference used to evaluate all other screening methods.10 Colonoscopy confers the longestlasting protection compared with other screening options. In fact, the protective effect of colonoscopy screening corresponds to an 89% reduction in CRC incidence (Table 2).12-16 Another benefit of colonoscopy is that lesions detected during the procedure can be removed immediately. A cost-effectiveness analysis also found that colonoscopy performed every 10 years is less costly and/or more effective than other CRC screening strategies commonly used in the United States.11 Disadvantages of colonoscopy include the need for complete bowel cleansing; the potential occurrence of procedural adverse events (eg, perforation); the need for and risks associated with anesthesia; operator dependence; and schedule interruptions due to procedural preparations.10,17

Fecal Immunochemical Testing FIT measures human hemoglobin (Hb) in stool as a marker for colon cancer. The chief advantage of FIT is that it is noninvasive, eliminating the need for bowel preparation. Instead, the patient provides a stool sample via a mail-in collection kit; this is more cost-effective than other methods of screening. A meta-analysis of 19 trials assessing the diagnostic performance of FIT for CRC detection in average-risk, asymptomatic individuals reported the sensitivity and specificity to be 79% and 94%, respectively.18 FIT is more effective at detecting cancers than polyps, but in a metaanalysis of 12 studies (N=6,204), the sensitivity of FIT for advanced neoplasia was just 48%.19 In the United States, FIT is reported as positive or negative based on a cutoff of 20 mcg Hb/g feces.20 Recent studies have examined the association between fecal Hb concentrations below the FIT cutoff value and the later development of colorectal advanced neoplasia (AN). In one study of 9,561 average-risk individuals aged 50 to 74 years, those with concentrations of 8 to 10 mcg Hb/g had a higher cumulative incidence of AN versus those with a concentration of 0 mcg Hb/g after 8 years of follow-up (33% vs 5%; P<0.001).21 Participants with 2 consecutive Hb concentrations of 8 mcg Hb/g had a 14-fold increase in risk for AN compared with those who had 2 consecutive concentrations of 0 mcg Hb/g (P<0.001). The chief disadvantage of FIT is the necessity of repeating it annually. This can be challenging in the opportunistic setting, as it lacks the

Table 2. Colonoscopy in the Literature11-15 Author/Study

Year

National Polyp Study

1993

1,418

vs Mayo Clinic, St Mark’s, SEER cohorts

Kahl et al13

2009

715

Jacob et al14

2012

Pan et al15

2016

11,12

SEER, Surveillance, Epidemiology, and End Results.

|I 3 29

Design

Incidence, %

Mortality, %

79-90

vs SEER data

1,089,998

Instrumental variable analysis

1,499,521

Meta-analysis of 11 studies

30 4 I|

structure and systematic navigation tools of the organized screening setting. On their own, only 1 in 5 patients gets an annual physical, for example.22 A recent retrospective cohort analysis of 1,122,645 patients found that only 14% of those scheduled for annual FIT actually completed the test in 4 of 5 years.23 In addition, FIT does not detect serrated lesions, and patients with positive results must undergo colonoscopy, for which insurance coverage likely will not be provided.

FIT-Fecal DNA Testing The FIT-fecal DNA test screens for occult blood measured by immunoassay as well as the presence of known DNA alterations in tumor cells during colorectal carcinogenesis that are shed into the stool.10,24 FIT-fecal DNA testing has been shown to have a 92% sensitivity for cancer and is more effective than FIT in detecting serrated lesions.25 The test is done at home, requires only a single stool sample, and does not require time off from work.24 The FDA has approved the use of FIT-fecal DNA testing at 3-year intervals for average-risk individuals aged 45 years and older. In the pivotal trial, a relatively high rate of false-positive results was noted, at 13.4%. Other disadvantages of FIT-fecal DNA testing are as follows: • It is less effective and less cost-effective than both FIT and colonoscopy. • Its specificity is lower than that of FIT (88% vs 95%, respectively) and decreases with age. • Long-term data are not available. • DNA testing adds limited sensitivity, increases the rate of false positives, and adds substantial cost. • Positive test results require follow-up colonoscopy with bowel preparation.

Flexible Sigmoidoscopy Flexible sigmoidoscopy provides visualization of the sigmoid colon. Data from several randomized controlled trials and meta-analyses have shown that flexible sigmoidoscopy reduces CRC incidence and

Discounted Mean Cost per Person, $

6,000 –

z 4,000 –

3,000 –

2,000 –

CT colonography (also known as virtual colonoscopy) produces 2- or 3-dimensional images of the colon. It is noninvasive, does not require sedation, and has a lower risk for perforation than colonoscopy.10,17,30 In a meta-analysis of 33 studies (N=6,393), the sensitivity and specificity of CT colonography were found to be 70% and 86%.31 Polyp detection rates varied by size, with poor detection of polyps smaller than 6 mm (48%). In addition, CT colonography is associated with radiation exposure; the need for full bowel cleansing; poor sensitivity for flat or serrated lesions; the potential for extracolonic findings that may require further investigation; and requirement of follow-up colonoscopy—including a second bowel preparation—in cases with positive findings.10,17,30

Capsule Colonoscopy Capsule colonoscopy is an imaging capsule approved by the FDA in 2014 for use in patients who are unable to complete a colonoscopy, refuse to undergo a colonoscopy, or are not candidates for colonoscopy or sedation. The advantages of capsule colonoscopy include minimal patient discomfort and minimal interference with daily activities.

FIT yearlya FIT q2yb MT-sDNA q3yb Colonoscopy q10yb FIT yearlyb

Computed Tomographic (CT) Colonography

z No screening z FIT q2ya z MT-sDNA q3ya

5,000 –

mortality.26-29 Other advantages include limited bowel preparation (ie, pre-procedure enema only), lack of a sedation requirement, and lower risk and cost versus colonoscopy. At present, however, this test is unpopular in the United States and rarely used for CRC screening. Disadvantages include the inability to examine the proximal colon; concerns about the lack of quality standards and limited availability; patient pain/discomfort (ie, low patient satisfaction); the need for further endoscopic examination if findings are positive; and the potential for additional out-of-pocket expenses associated with follow-up procedures.10,17 Of note, an indirect comparison of data from observational studies suggested a 40% to 60% lower risk for incident CRC and death from CRC after screening colonoscopy versus flexible sigmoidoscopy.29

1,000 –

Figure 1. Effectiveness (discounted QALYs per person) and cost (discounted dollars per person) for screening strategies. FIT with 100% consistent screening participation and without additional patient support costs was cost-saving compared with no screening. MT-sDNA testing achieved effectiveness similar to the other strategies given the same levels of patient participation, but it was more costly. Participation rates of 50% consistent screening and 27% intermittent screening are representative of successful organized screening programs, and the results for FIT with these participation rates include patient support costs of $153 per testing cycle. FIT, fecal immunochemical testing; MT-sDNA, multi-target stool DNA; QALY, quality-adjusted life-year. a

0 –ı 18.86

ı 18.68

ı 18.70

ı 18.72

ı 18.74

Discounted Mean QALYs per Person

ı 18.76

50% consistent, 27% intermittent screening. b 100% consistent.

Reprinted from Gastroenterology, vol 151(3), Ladabaum U, Mannalithara A, Comparative effectiveness and cost effectiveness of a multitarget stool DNA test to screen for colorectal neoplasia, pages 427-439.e6, Copyright 2016, with permission from Elsevier.

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A 2015 study of 695 average-risk patients 50 to 75 years of age demonstrated 88% sensitivity and 82% specificity for identifying adenomas of 6 mm or larger.32 Similar to CT colonography, however, positive findings require follow-up colonoscopy and repeat bowel preparation. At present, capsule colonoscopy is not approved for CRC screening and usually is not covered by insurance.33

Cost-Effectiveness of CRC Screening Strategies A recent study comparing the cost-effectiveness of available CRC screening strategies found that FIT-fecal DNA was only cost-effective versus no screening and not cost-effective versus the other 5 strategies.34 In the study, 3 microsimulation models were used to simulate previously unscreened 65-year-old individuals who were screened for CRC with 1 of 6 Centers for Medicare & Medicaid Services–reimbursed screening strategies: 1) fecal occult blood test every year; 2) FIT every year; 3) flexible sigmoidoscopy every 5 years; 4) flexible sigmoidoscopy every 10 years plus FIT every year; 5) colonoscopy every 10 years; or 6) FIT-fecal DNA every 3 years. The main outcome measures were discounted life-years gained,

|I 5 31

lifetime costs, threshold reimbursement, and threshold adherence. At its 2017 reimbursement rate, FIT-fecal DNA testing was found to be the most costly of the 6 strategies; furthermore, if adherence was 30% higher with FIT-fecal DNA than with other strategies, it would still not be a costeffective option. In another analysis, yearly FIT (without additional patient support costs) yielded the highest mean QALYs per person, followed by screening colonoscopy, FIT-fecal DNA testing every 3 years, and FIT every 2 years (Figure 1).35 Yearly FIT and colonoscopy every 10 years were more effective and less costly than FIT-fecal DNA testing every 3 years, when participation rates were equal across strategies.

Conclusion Primary care physicians play an important role in CRC screening and thus must be knowledgeable about barriers and approaches to screening in an opportunistic setting, the ranking of various available tests based on benefits and risks, and comparative cost-effectiveness across the range of CRC screening strategies.

Common Scenarios in CRC Prevention Douglas K. Rex, MD, MACG, FASGE, MACP, AGAF Introduction Dr. Rex presented scenarios commonly encountered in clinical practice and initiated a discussion about how best to evaluate the individuals described. Cases described: • Rectal bleeding in a 29-year-old man • Screening in 45- to 49-year-olds • Positive FIT and refusal of colonoscopy • Positive FIT and negative colonoscopy • Positive FIT-fecal DNA and negative colonoscopy • Positive FIT 2 years after negative colonoscopy

Case Study 1: Evaluation of Rectal Bleeding Presentation A 29-year-old man presents with rectal bleeding. What type of evaluation is most appropriate?

Commentary Rectal bleeding is the most predictive symptom of CRC. Bleeding symptoms, such as hematochezia, melena with a negative upper endoscopy, iron deficiency anemia, and a positive fecal occult blood test, also have positive predictive values between 2% and 12% for cancer. Other symptoms that patients may worry about—change in bowel habits, change in stool shape, and abdominal pain—do not have predictive value for CRC absent evidence of bleeding. A central area of medicolegal risk for PCPs is delaying the diagnosis of colon cancer by attributing rectal bleeding to hemorrhoids or some anal cause and not evaluating it. The details regarding bleeding are often poorly documented in a patient’s medical record; however, the record should describe the color of the blood, the frequency of bleeding, and the duration

of bleeding. Some experts will advise that any blood, including blood on the toilet paper, is an indication for colonoscopy; however, if the blood is only on the paper, it is reliably from the anus. The source is less clear if the blood is in the toilet bowl, in which case, the issue becomes whether to perform colonoscopy, anoscopy, or flexible sigmoidoscopy. Traditionally, if there is blood in the toilet bowl, most clinicians would recommend colonoscopy even in young patients based on the rising incidence of colon, and particularly rectal, cancer in individuals under the age of 55 years in the United States. Cost also plays a role in the decision-making process.

Takeaway In a relatively young patient presenting with rectal bleeding, the cause of bleeding should be identified and treated. If a test other than colonoscopy is used, the patient should be treated and followed to ensure resolution of bleeding.

Case Study 2 Presentation A 47-year-old white woman with no known family history of CRC and no symptoms is seeking CRC screening. She states that her father had a colonoscopy and may have had polyps; however, she does not know whether they were advanced polyps. Should this patient undergo colonoscopy?

Commentary Both family history and age should be considered in deciding whether screening is appropriate for this relatively young, asymptomatic patient. CRC screening recommendations based on family history are shown in Figure 2.4 The current guidelines vary in their recommendations for the age at which CRC screening should start.36 For example, the USPSTF recommends

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CRC Mortality Trends In the past 15 to 20 years, CRC mortality rates have increased in white and decreased in black people younger than 50 years of age. The ACG was the first group to recommend starting CRC screening at 45 years of age in black people; however, the mortality rates for white and black individuals younger than 50 years have since converged.

CRC Incidence Trends The incidence of colon cancer began to increase circa 1980 in individuals aged 20 to 29 years, with some experts speculating that the introduction of processed foods in the 1970s or changes in the microbiome may have been the source of the increase. Of note, from the mid-1980s through 2013, the rate of colon cancer incidence increased by 2.4% per year in that age group. Similarly, in the mid-1990s, the rate also began increasing in adults aged 50 to 54 years (0.5% per year).39 The increase in colon cancer incidence in individuals younger than 50 years was confined to tumors in the distal colon, with the exception of individuals aged 40 to 49 years, in whom the incidence also increased for tumors in the proximal colon.39 Incidence in the 50- to 54-year-old and 55- to 59-year-old cohorts now is very similar for colon cancer (only 12.4% lower for younger patients) and virtually equal for rectal cancer.39 The relative risk for CRC in individuals born in 1990 has increased dramatically versus those born in 1950—2.4-fold for colon cancer and more than 4-fold for rectal cancer (Figure 3).39 In addition, the percentage of all rectal cancers that occur in people under the age of 55 years has nearly doubled between 1990 and 2013, from 14.6% to 29.2%. About

Multiple FDRs with CRC or advanced adenomas at any age

Begin screening at 40 y or 10 y before age at diagnosis of youngest affected relative

“There is fairly good evidence to suggest that the increased risk for CRC in people younger than the age of 50 years is real. Between 2000 and 2013, the rate of colonoscopy in 40- to 49-year-olds more than doubled, from 6.4% to 13.6%.41 These data raise the question of whether the increased incidence is the result of an increase in screening.42 A real increased risk for CRC in young persons is supported by available evidence. First, the relative risk is higher in younger cohorts, that is, 20- to 29-yearolds have a greater increase in relative risk than 30- to 39-yearolds and 40- to 49-year-olds.39 Second, the increased incidence rates have been observed in both early- and late-stage cancers.39 Finally, CRC mortality rates are also increasing.43 In terms of screening 45- to 49-year-olds, risk stratification could be quite valuable. It would make sense to use colonoscopy in a 47-year-old man who is obese, diabetic, and a cigarette smoker. That person is almost certainly a better candidate for screening colonoscopy than a 47-year-old, thin, vegan, marathon-running female.” —Douglas K. Rex, MD, MACG, FASGE, MACP, AGAF

Individuals Born in 1990 vs 1950

Single FDR with CRC or advanced adenoma diagnosed at >60 y

Begin screening at 40 y

Rectal Cancers in Those Aged <55 y

4.33

29.2 25

Incidence Rate Ratio

Single FDR with CRC or advanced adenoma diagnosed at <60 y

50% of all cancers that occur in individuals younger than 50 years in the United States occur in the 45- to 49-year-old age group.40 Among 45- to 49-year-olds, 7,000 individuals were diagnosed with CRC in 2017 and 1,800 died of the disease.17 The actual burden in terms of all life-years lost due to premature CRC death is now similar, at 13% for those aged 50 to 54 years and 10% for those aged 45 to 49 years.17

Percentage

starting at 50 years in everyone,37 whereas the ACS recommends starting at 45 years of age in everyone.38 The MSTF recommends starting at 50 years of age in average-risk cases and at 40, or 10 years younger than the age at which the youngest affected relative was diagnosed, for high-risk cases.4 The MSTF recommends starting at age 45 in black patients.4

2.4

20 15 14.6 10

1 Colonoscopy q5y

Tests and intervals as in average-risk patients

5 0

CRC

Rectal cancer

1990

2013

Figure 2. CRC screening recommendations based on family history.4

Figure 3. Colon and rectal cancer incidence data.39

CRC, colorectal cancer; FDR, first-degree relative.

CRC, colorectal cancer.

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Cost-Effectiveness of Screening Younger Individuals A recent study estimating the cost-effectiveness of initiating CRC screening in average-risk younger individuals found that colonoscopy initiation at 45 years of age versus 50 years of age per 1,000 individuals screened averted 4 CRCs and 2 CRC deaths, gained 14 quality-adjusted life-years (QALYs), and cost $33,900 per QALY gained.44 The initiation of FIT at 45 years of age instead of at versus 50 cost $7,700 per QALY gained. The study also found that although CRC screening initiation at 45 years of age would likely be cost-effective, a greater benefit at a lower cost could potentially be attained by increasing CRC screening rates in unscreened older individuals and those at higher risk. At present, about 22 million Americans are between the ages of 45 to 49 years, so it is reasonable to ask whether CRC screening in this age group would shift resources. Indeed, the cost of CRC screening would be substantial—$10.4 billion over 5 years—but those being screened would not all present simultaneously. Furthermore, there is no evidence that colonoscopy resources have been exhausted in the United States,45 and screening rates have leveled off in individuals at least 50 years of age. Takeaway Colonoscopy screening in individuals aged 45 to 49 years is costeffective; however, a risk-stratified, organized approach should be considered to control costs.

Case Study 3 Presentation A 52-year-old woman with positive FIT results refuses colonoscopy. What should be done next?

Commentary According to USMSTF recommendations on quality in FIT programs, 80% of patients with positive FIT results should undergo a diagnostic colonoscopy.46 Unfortunately, a diagnostic colonoscopy requires a copay, which is often a factor in patient decision making.

|I 7 33

Takeaway Patients with negative colonoscopy results require no further screening for at least 5 or 10 years. Some clinicians might prefer to resume FIT screening after 5 years.

Case Study 5 Presentation A 54-year-old man has positive FIT-fecal DNA results and a normal colonoscopy. He has no symptoms, and his Hb level is within normal limits.

Commentary In such a scenario, no other tests (ie, upper endoscopy, small bowel evaluation, CT scans) are necessary. This approach is supported by a recent cohort study (N=1,216), in which patients with negative findings on high-quality colonoscopies had low incidence of aerodigestive cancers, regardless of discordant or concordant findings from multitarget stool DNA tests, after a median of 5.3 years of follow-up.47 In the study, aerodigestive cancers developed in 5 patients in the discordant group and 11 patients in the concordant group (adjusted risk ratio, 2.2; P=0.151). Furthermore, the incidence of aerodigestive cancers was lower in the concordant group than expected based on Surveillance, Epidemiology, and End Results Program data (risk ratio, 0.4; P=0.0008).

Takeaway In a patient with positive FIT-fecal DNA but discordant colonoscopy results, a reasonable approach would be to stop screening for 5 or 10 years and not perform FIT-fecal DNA testing again.

Case Study 6 Presentation A 72-year-old man has positive FIT results 2 years after a negative colonoscopy. What should be recommended to him?

Takeaway

Commentary

A reasonable approach with a patient who refused colonoscopy despite a positive FIT result would be to document the discussion and warn the patient of her risk for death from failing to undergo colonoscopy.

A positive FIT or FIT-fecal DNA test result is an indication for colonoscopy. However, many patients who have a positive FIT result will undergo a second FIT to confirm the result, and if the second FIT is negative, may decide not to follow through with the colonoscopy. An important message for PCPs is to avoid CRC screening during the interval after colonoscopy in order to avoid having to refer patients for further testing.

Case Study 4 Presentation A 54-year-old man has positive FIT results and a normal colonoscopy. He has no symptoms, and his Hb level is within normal limits. Should he undergo additional testing?

Commentary No further evaluation is needed. Although some clinicians might perform an upper endoscopy, current evidence suggests that such testing has a high yield for benign findings, but not for cancer.

Takeaway FIT and FIT-fecal DNA testing should not be recommended to patients during the guideline-recommended interval after a normal colonoscopy, as this can be confusing and expensive if the patient has a false-positive result on one of the home tests.

34 8 I|

Improving the Performance of Colonoscopy David A. Johnson, MD, MACG, FASGE, MACP Colonoscopy Preparation The optimal effectiveness of colonoscopy requires patient acceptance of both the procedure and the preparation.48 Inadequate bowel preparation, which occurs in 20% to 25% of patients in some series, leads to failed procedures, the need for repeat procedures, failed lesion detection, procedural adverse events, and patient no-shows. Furthermore, a failed screening colonoscopy due to inadequate bowel preparation is an indicator for repeat colonoscopy within 1 year—something most insurance companies will not cover. Several bowel preparations with different formulations and dosages are available and should be individualized to help facilitate tolerability and minimize no-shows on the day of the procedure (Table 3).49-58 The most recent introductions have aimed to reduce the volume of fluid the patient must consume and improve the taste of the formula, while maintaining safety.

Split Dosing for Bowel Preparation Split dosing, whereby the patient consumes the bowel preparation product in 2 doses—the first on the day before the colonoscopy and the second the morning of the colonoscopy—is endorsed as the standard of care over day-before dosing, in which the patient consumes the entire dose of bowel preparation the day before the procedure.48,59 The split doses are not necessarily equal in volume or composition; however, the morning dose is particularly important because it cleans out any remaining fecal material and especially the small bowel chyme that continues to enter the right colon. Of note, the same bowel preparation regimen can be used in patients planning a colonoscopy on the same day as the preparation (ie, an afternoon colonoscopy). Split dosing of bowel preparations is associated with higher adenoma detection rates (ADRs) than day-before dosing.60,61 In a randomized controlled trial in 690 patients who received a low-volume 2-L polyethylene glycol-ascorbate solution as preparation for a colonoscopy after positive FIT findings, a split-dose regimen increased the ADR for at least

1 adenoma by 22% and for at least 1 advanced adenoma by 35% over a completed day-before regimen (Figure 4).60,61 Split dosing was also superior to day-before dosing in the detection of sessile serrated polyps (8% vs 4%), the achievement of overall excellent colon cleansing (80% vs 55%), compliance (92% of patients vs 86% able to consume the full preparation), and tolerability reports (62% vs 50% described “no distress” with solution intake).60 Although the preponderance of evidence and guidelines from the ACG and USMSTF support split dosing,48 the adoption of this regimen remains suboptimal due to several identified barriers, including the timing and scheduling of anesthesia, difficulties associated with morning colonoscopies relative to eating, and the potential for fecal incontinence.61

Quality Indicators for Colonoscopy National guidelines recommend that patients ask prospective colonoscopists relevant questions pertaining to ADR, cecal intubation rate, and split-dose bowel preparations before colonoscopy to help enhance a high-quality examination (Table 4).4 A study examining quality indicators for colonoscopy found that ADR is an independent predictor of the risk for interval CRC after screening colonoscopy (Figure 5).62 In the study, which collected data from 186 endoscopists involved in a colonoscopy-based CRC screening program (N=45,026), a total of 42 interval CRC cancers were identified during a period of 188,788 person-years. A higher ADR was found to be significantly associated with a lower risk for interval CRC (P=0.008). Specifically, the hazard ratios for ADRs of less than 11.0%, 11.0% to 14.9%, and 15.0% to 19.9% were 10.94, 10.75, and 12.50, respectively, compared with ADRs of at least 20% (P=0.02 for all comparisons). Of interest, the rate of cecal intubation was not significantly associated with the risk for interval CRC (P=0.50). Another study—this one evaluating 314,872 colonoscopies performed by 136 gastroenterologists—found that ADR was inversely associated with the risk for interval CRC, advanced-stage interval CRC, and fatal interval CRC.63 In the study, ADR was highly variable among

Table 3. Available Bowel Preparations49-58 Active Ingredient(s) 49-52

Dosage Form(s)

Brand

Approved

Powder for reconstitution (4 L)

Colyte, GoLytely, others

1980s

Powder for reconstitution, SF (4 L)

NuLYTELY, Trilyte, others

1990s

Powder for reconstitution (2 L)

MoviPrep

2006

Liquid, tablet

OsmoPrep

2006

Liquid concentrate for dilution

Suprep

2010

Sodium picosulfate, magnesium oxide, citric acid56,57

Powder for reconstitution

Prepopik

2012

Oral solution

Clenpiq

2017

PEG-ELS, sodium ascorbate58

Powder for reconstitution

Plenvu

2018

PEG-ELS

PEG-ELS, AA

Sodium phosphate

Oral sulfate solution

AA, ascorbic acid; ELS, electrolyte solution; PEG, polyethylene glycol; SF, sulfate-free.

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“If we move the quality needle for colonoscopy by even small steps, we’re making demonstrable changes in strategic end points. Any improvement in colon cancer and colon cancer deaths makes a difference, which is the reason society guidelines have emphasized that colonoscopy is a tier-1 test. It’s the ‘gold standard’ test that can prevent, detect, and treat colon cancer all in the same procedure. Ideally the best purpose of CRC screening is prevention of cancer via recognition and removal of precancerous lesions.” —David A. Johnson, MD, MACG, FASGE, MACP

Quality Colonoscopy: PCP Responsibility The quality and safety of colonoscopy vary among clinicians, even among those with extensive training, experience, and certification.64 It is therefore critical that PCPs are able to identify clinicians who meet highquality standards to facilitate appropriate referrals. To that end, PCPs should rely on the actual performance of colonoscopy, not only the training and specialty of the clinicians who perform the procedure. A consensus statement from the Quality Assurance Task Group, a working group of the National Colorectal Cancer Roundtable, identified several indicators that PCPs can utilize to evaluate the quality of colonoscopy services.65 The main elements of quality recommended by the working group include a complete colonoscopy report, technical competence, and a safe setting for the procedure. The colonoscopy report should contain descriptions of 5 major elements: 1) depth of insertion, 2) quality of the bowel preparation, 3) patient tolerance of the procedure, 4) polyps, and 5) recommendations for follow-up and/or surveillance unless pathology is needed to

Table 4. Questions Patients Should Ask Prospective Colonoscopists4 Question What is your adenoma detection rate?

Expectation ≥25% overall ≥30% for men and ≥20% for women

What is your cecal intubation rate?

≥95% for screening colonoscopies

Do you use split-dosing of bowel preparations?

At least half the preparation should be ingested on the day of the colonoscopy

≥90% overall

determine follow-up schedule. The assessment of technical competence should focus on the ADR and cecal intubation rate achieved by the endoscopist and whether these rates meet quality standards. Characteristics of a safe colonoscopy setting include adequate disinfecting/cleaning of equipment, well-maintained equipment, well-trained staff and endoscopist, and the ability to react to emergency situations (eg, bleeding, perforation, cardiovascular events) that could potentially arise during the procedure. National guidelines recommend that the colonoscopy report include 1) photographs of the end of the colon, including the appendiceal orifice and ileocecal valve/terminal ileum, to demonstrate that the full extent of the colon was examined; and 2) a description of the bowel preparation quality, which must be adequate to ensure an effective examination.4

Management of Large Colon Polyps In the United States, more than 50% of segmental colon resections are performed on benign colorectal lesions that may not have required surgery. These often include polyps that are located in the right colon, non-pedunculated in shape, or large in size.65 However, considerable evidence and anecdotal experience now indicate that the overwhelming percentage of large colon polyps are amenable to endoscopic resection by experts. A recent single-center study (N=82) found, for example, that 74% of patients with benign difficult colorectal lesions referred for surgical resection were successfully treated endoscopically.66 Costs and complications also factor into the decision of how to manage large polyps. A prospective, observational, multicenter study of consecutive patients with large, laterally spreading colorectal lesions (N=1,353) found that endoscopic mucosal resection was significantly more costeffective than surgery and associated with a shorter hospital length of stay (LOS; Figure 6).67 Detection rates 60 50 40

Patients, %

gastroenterologists, ranging from 7.4% to 52.5%. During follow-up, 712 interval colorectal adenocarcinomas were identified, including 255 advanced-stage cancers; in addition, 147 patients died from interval CRC. In patients whose gastroenterologists had ADRs in the highest versus lowest quintiles, the adjusted hazard ratios for any interval cancer, advanced-stage interval CRC, and fatal interval CRC were 0.52, 0.43, and 0.38, respectively. Of note, each 1.0% increase in ADR was associated with a 3.0% decrease in the risk for CRC and a 5% decrease in the risk for a fatal interval CRC.

|I 9 35

P=0.002

Split-dose Prior-PM

41 P=0.047

30 26

P=0.053

10 8

Adenoma

Advanced adenoma

Figure 4. Adenoma detection rates.60

Sessile serrated polyp

36 | 10 I

A recent systematic review of 26 studies involving 139,897 patients found substantial postoperative morbidity and mortality after surgical resection for benign colon polyps.65 The 1-month pooled complication rate was 24%; the anastomotic leak rate ranged from 0.3% to 8.7%; the mean hospital LOS was 5.1 days; and the 1-month pooled mortality rate was 0.7%. The authors concluded that referral to an advanced interventional endoscopist for evaluation of polyps in difficult locations with no suspicion of submucosal malignant invasion may be an appropriate strategy to consider before referral for surgery. Gastroenterology experts are fairly unified in the notion that most polyps, with the exception of Kudo type V and Narrow-Band Imaging International Colorectal Endoscopic classification type 3 lesions, are endoscopically resectable. To that end, the current expert consensus is that referral to an advanced interventional endoscopist should be considered or discussed before referral of any benign precancerous colon lesion for surgical endoscopic treatment. The implications for the endoscopic management of colon polyps are far-reaching, affecting PCPs who assess colonoscopists, gastroenterologists who refer directly to surgery, and surgeons who choose to operate first, without discussion of endoscopic options.

12.5

CRC Hazard Ratio

11 10.94 10.75

Conclusion

9 <11%

11%-14%

The primary goal of CRC screening is the detection and removal of precancerous lesions in order to prevent cancer. The high-quality performance of colonoscopy, which prevents CRC and death, is the current gold standard for CRC screening. PCPs play a major role in recommending a screening test, preparation agent, and colonoscopy provider. Quality colonoscopy metrics include the use of a split-dose bowel cleansing preparation and high ADR.

15%-19.9%

ADR

Figure 5. ADR and risk for interval cancers in a Polish screening database.62 ADR, adenoma detection rate; CRC, colorectal cancer.

P<0.001 18

Cost per patient AUD $, thousands

16 15.5

14.3

12 10 8 6 4

5.4

5.9

EMR

EMR + anes

6.3

2 0

EMR + anes + recurrencea

Surgery

Surgery + complicationsa

Figure 6. Comparison of management costs for resection of large laterally spreading lesions.67 a

Estimated.

anes, anesthesiology; AUD, Australian dollar; EMR, endoscopic mucosal resection.

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|I 11 37

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Trilyte. Somerset, NJ: Wallace; 2013. https://dailymed.nlm.nih.gov/dailymed/fda/ fdaDrugXsl.cfm?setid=486598b1-0358-11e3-8ffd-0800200c9a66&type=display. Accessed January 17, 2020.

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de Neree Tot Babberich MPM, Bronzwaer MES, Andriessen JO, et al. Outcomes of surgical resections for benign colon polyps: a systematic review. Endoscopy. 2019;51(10):961-972.

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Robertson DJ, Lee JK, Boland CR, et al. Recommendations on fecal immunochemical testing to screen for colorectal neoplasia: a consensus statement by the US MultiSociety Task Force on Colorectal Cancer. Gastroenterology. 2017;152(5):1217-1237.

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48.

Berger BM, Kisiel JB, Imperiale TF, et al. Low incidence of aerodigestive cancers in patients with negative results from colonoscopies, regardless of findings from multitarget stool DNA tests. Clin Gastroenterol Hepatol. 2019 Aug 5. [Epub ahead of print]

CU201

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Vo l u m e 2 • S u m m e r 2 0 2 0

Disposable Scopes Are Likely to Play A Larger Role at Small-Volume Centers

he FDA approved the first disposable colonoscope in 2016, but one-time-use scopes have yet to enter the U.S. market.

A study by researchers at Johns Hopkins University suggests that the market best suited for these scopes is likely to be at smaller, lower-volume endoscopy centers.

“We found that the cost to use reusable scopes is volume dependent and also dependent on how many scopes you have,” study investigator Susan Hutfless, PhD, the director of Johns Hopkins’ Gastrointestinal Epidemiology Research Center, told Priority Report. “If, for example, an ambulatory surgical center is doing 3,000 colonoscopies per year and owns 20 colonoscopes, we estimate that it costs them just over $200 per use of that colonoscope to reprocess it. For that practice, the

break-even point on cost for a disposable would have to be around that point. In addition, if an infection is coming from mistakes that happen during the reprocessing of the scope, a disposable colonoscope in theory should decrease a practice’s infection rate.” Dr. Hutfless and her colleagues assessed the costs (cleaning, capital and operating) associated with current reusable scopes and found that these costs ranged from $189 per procedure at centers that perform at least 3,000

Endoscope Reprocessing & Infection Control

Vo l u m e 2 • S u m m e r 2 0 2 0

colonoscopies per year to $501 per procedure at centers performing 1,000 or less (Gut 2019. pii: gutjnl-2019-319108). The cost of treating postprocedural infections added an additional $20 per procedure in centers with low infection rates to almost $47 for centers with greater infection rates. In a 2018 study, Dr. Hutfless and her colleagues “found a direct correlation between the number of procedures performed at a particular center and the rates of infection, with highvolume centers having lower infection risks,” she said. The adjusted overall risk for infection was 0.86 for middle-volume centers and 0.77 for high-volume centers compared with low-volume centers (Gut 2018;67[9]:1626-1636). “In fact, the infection rates observed at some low–procedure volume ASCs were over 100 times more than the rates we would expect to see had patients received procedures at an average ASC,” Dr. Hutfless said. The association between lower procedure volume and higher infectionrelated unplanned visit rates persisted even after the researchers accounted for patient and procedure complexity.

Disposables Not Practical For High-Volume Centers So, for centers that perform a significant volume of colonoscopies, Dr. Hutfless said, the research indicates that moving to disposable scopes would not make sense, either financially or clinically. “Based on what we’re hearing in terms of cost estimates for disposables, it’s unlikely to make sense for most ambulatory surgical centers that are doing high volumes of colonoscopies to replace their entire unit with disposable scopes.” At Austin Gastroenterology in Texas, which performs between 35,000 and 40,000 endoscopies annually (about 150 per day), there have been no infections associated with colonoscopies over the past decade, according to gastroenterologist Harish Gagneja, MD. “Infection rates on colonoscopes are extremely low; indeed, the claims data in these studies don’t make clear whether these infections are truly related to the scope disinfection,” he said. “If you follow the manufacturer’s guidelines, have well-trained and experienced reprocessing staff and do not cut corners, then there is no need for a disposable

scope. And in this era of decreased reimbursement, disposable scopes are likely to cost more, not less, for most centers.” The prospect of disposable scopes also raises storage, supply chain and environmental issues. “Where would you store them? At 150 procedures a day, we would need to have storage [for] 3,000 scopes a month,” Dr. Gagneja said. “What if the scopes are manufactured overseas and you encounter an interruption in shipping, and you can’t do procedures? And when they’re discarded, where are these scopes going to go? Into a landfill?”

Niche for Smaller Centers With Higher Infection Risk But for small-volume centers, the inverse relationship between infection rate and procedural volume might make disposable colonoscopes a smart choice. “If you are a smaller-volume center, doing less than 100 colonoscopies a year, then you should absolutely buy disposables once they are available,” Dr. Hutfless said. “You won’t have to worry about reprocessing facilities and expertise.” Dr. Gagneja agreed. “Yes, for a smaller-volume center that is only doing one or two colonoscopies a week—perhaps in rural centers where there is limited staff available—that’s probably the best thing you can do. But that is the only type of setting where I could see the utility of disposable colonoscopes.” The only other circumstance in which a disposable scope might make sense is for patients who are at extremely high risk for infection, Dr. Hutfless added. “For example, if you suspect that patient may have a [Clostridioides] difficile infection, it would be advisable for any center to use a disposable scope.” “With the potential for disposable scopes to enter the U.S. market soon, we wanted to make this data available so that centers can start considering their options,” Dr. Hutfless said. “Of course, it could be that the disposable scopes come out and no one likes the design and they don’t want to use them. But assuming that quality and comfort for the provider are the same, this research provides an idea of what the numbers look like.”

Endoscope Reprocessing & Infection Control

—Gina Shaw

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Mission Critical: Working Conditions for Reprocessing Techs

re your reprocessing techs working in conditions that foster their best performance? In many facilities,

that’s not the case, said James Davis, MSN, RN, a certified health care environmental manager and senior infection prevention analyst at ECRI Institute, who spends much of his time auditing and consulting with gastroenterology practices across the country.

“I’ve seen a lot of facilities that do it right—and others that just make do with what they have,” Mr. Davis told Priority Report. “That may mean that if you get another reprocessing machine, you fit it in the closet in the back next to the two existing machines, with techs bumping into each other. Unfortunately, that’s fairly prevalent in the field; space is not well thought out, and there is little attention paid to ergonomics and technician comfort. People think, ‘Oh, this is just where we reprocess scopes, so it doesn’t require much attention,’” he said. But, he stressed, “these are mission-critical staff members, and they can’t do their best work in poorly designed environments.” see Mission, page 46

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Tips for Designing Reprocessing Spaces Mr. Davis listed several key principles for the design of a well-functioning reprocessing space, including: Optimize the layout of the overall space.

Do you have a one-way workflow that separates contaminated spaces from clean ones, and doesn’t require your techs to frequently regarb and resterilize? Consider placement of sinks and counters.

“If you are working an eight-hour shift and are hunched over a sink for hours at a time, you will develop back issues,” Mr. Davis said. “And if your back is hurting, you’ll be distracted when you’re cleaning the ports on that scope.” A number of vendors now supply adjustable-height reprocessing sinks that can be moved to the right height for each staff member. Ensure appropriate heating, ventilation and air conditioning (HVAC) design. “The

reprocessing space can get hot and humid,” Mr. Davis said. “Meanwhile, your staff is working in personal protective equipment that exacerbates those conditions. If you can’t control the HVAC environment because of building design limitations, you need to assess the kind of accommodations necessary to keep your staff comfortable, such as cooling vests.” Consider other ergonomic aspects of the space. What other things can you do to make

the standing, bending, reaching and repetitive movement less physically taxing? “We have pressure reduction mats both at the reprocessing sinks and machines, as well as in the procedure rooms for where we are standing next to the physicians,” said Laura Falcon, RN, a nurse manager for Rocky Mountain Gastroenterology, the largest GI group in Colorado, which has three endoscopy centers throughout the Denver metro area. “We do a lot of standing, and those mats

make it much easier on our legs and backs.” GI Associates Endoscopy Center in Wausau, Wis., uses similar pressure reduction mats in their reprocessing area, noted endoscopy technician Amanda Jensen. “We also have a ‘Scope Buddy’ flushing aid, so instead of having to manually push syringes of detergent and air through the scope, the machine does it all on its own,” Ms. Jensen added. “We just verify the water flow every morning to ensure the pressure is acceptable. That saves a lot of wear and tear on our wrists.” Consider scheduling factors. Beyond the physical conditions your reprocessing staff is working in, their schedules also are important to consider. “No matter how comfortable we make the environment for our reprocessing staff, they are working in conditions that are not always comfortable,” said Milton Smith, MD, an associate professor of gastroenterology at UC Health in Cincinnati. “You have to work out a reliable break schedule because it can be physically challenging to be in gown and mask doing these repetitive tasks for a long period of time. In our facility, when the scopes are in the reprocessing machine, [reprocessing staff ] only need to be gowned and masked when they are physically handling the scopes.” GI Associates has a “float tech” position that serves several purposes. The float tech is available to give the scope reprocessing tech several muchneeded breaks throughout the day. “While one tech is assigned as a scope reprocessor and others are assigned as assist techs, the float tech is available to help the entire tech team with room turnovers and lunch breaks as well as stepping in for the scope reprocessor,” said center director Shelly Hoffman, RN. “It would be backbreaking to do these tasks all day long; we try to be sensitive to the physical demands of the job.”

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DDW 2020: Model Evaluates Cost, Infection Risk With Various Duodenoscopes

duodenoscope with a disposable endcap is the most cost-effective option to use in endoscopic retrograde cholangiopancreatography (ERCP), and it

is associated with a low rate of infection transmission, according to a modeling study presented at the Digestive Disease Week 2020 online meeting. The sttuuddy wa The w s co cond nduc nd uccte t d am amid idd ong n oiing ng coon nce cern rn ns abou ab ouut po pote t nttiiaal tr tran ansm sm mis issi sion on of in infe fect fe ctio ct ious io uss ageent ntss by duuoodden nossccoope pess th hat a has ledd to th he deve deeve velo lopm lo pmen pm en nt of n ve no vell du duodden noossco cope pees wi with t dis ispo ispo posa s bl sa blee en e dc dcap apss as ap welllll as fu we f llllyy ddiisp spos osab able ab bllee duoode d no nosc sccop opes e . In Aug es ugus ustt us 220019 1 , th he F FD DA reeco comm mmen ende en dedd tr de tran ansi an siti si tiion to us usee off suuch deevvic vic ices es and nd awa w y fr from om reu eusa sabl blee fi bl fixe xedd en xe endc dcap dc ap duuoodden enos osco os coope cope pess to redduc ucee or o elilimi mina mi nate t the nee te eedd fo forr r proces re esssi s ng of th thee de devi vice cess (b ( it it.l.ly/ y/2y 2y6I 6I1D 1Dh) h).. As of h) Apri Ap ril,l, fiv ivee pr prod oduc ucts ts wer eree ap appr prov oved ed tha hatt we were re eit ithe herr fuullllyy di disp sppos o ab able le orr ha hadd di disp spos osab able le com ompo pone nent ntss (s (see ee sidebar). Although there have been some reports of malfunctions with products with removable endcaps, the FDA “continues to recommend that hospitals and endoscopy facilities transition to innovative duodenoscope designs” to reduce the risk for infectious transmission (bit.ly/2y6I1Dh). Table.

Cost-Effectiveness of Duodenoscope-Transmitted Infection Minimization Strategies

Infection Control Approach

Cost-Effectiveness Ranking

Estimated Infection Transmission Rate, %

Estimated Cost Per Use,a $

Reusable Duodenoscopes Needed, n

Disposable endcap

0.1-1

654

Disposable duodenoscope

2,903

Culture and hold

0.1-2

387

Ethylene oxide

0.1-2

644

Single reprocessing

0.1-5

131

Double reprocessing

0.1-3

188

Includes materials and labor.

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This modeling analysis compares the costs of different approaches for ERCP, taking into account the costs of the products per use as well as the costs associated with duodenoscope-transmitted infection (abstract 775). Investigators led by Monique Barakat, MD, PhD, an assistant professor of pediatrics (gastroenterology) and medicine (gastroenterology and hepatology) at Stanford University’s Lucile Packard Children’s Hospital, in Stanford, Calif., developed a Monte Carlo analysis model to assess the cost-effectiveness of various duodenoscopes disinfected through various methods (single high-level disinfection [HLD], double HLD, ethylene oxide [EtO] sterilization, and culture and hold) as well as duodenoscopes with disposable endcaps and fully disposable duodenoscopes. The investigators based the model on the following assumptions: an annual volume of 800 ERCPs; an average age of 60 years for patients undergoing ERCP; a post-ERCP life span of seven years; an overall multidrug-resistant organism (MDRO) infection rate of 11%; a 30% rate of transmission of an MDRO after an ERCP with an infected duodenoscope; a 50% rate of clinical symptom development in an MDROinfected patient; a $375,000 cost to manage cholangitis; a 70% rate of survival after MDRO infection; and a $100,000 value of qualityadjusted life-years (QALYs). They also assumed a triangular distribution with three parameters: minimum, maximum and most probable infection transmission rate (MPITR). They simulated QALYs lost by duodenoscope-transmitted infection and factored this into the average cost for each approach at variable rates of most probable infection transmission. They found that duodenoscopes with disposable endcaps were the most cost-effective option for performing ERCP, with an estimated MPITR ranging from 0.1% to 1% and an estimated peruse cost of $654 (Table). They noted that the fully disposable duodenoscope “eliminates the potential for infection transmission” at an estimated cost of $2,903, making it more cost-effective than single/double HLD at all MPITR, more costeffective than EtO for MPITR less than 0.22%, and more cost-effective than culture and hold for MPITR less than 0.49%. They found single and double HLD to be the most costly approaches

FDA Keen on Novel Duodenoscopes

he manufacturers of duodenoscopes with disposable endcaps—Fujifilm, Olympus and Pentax—have “submitted 10 reports of device malfunctions, such as removable caps or ends falling off during endoscopic retrograde cholangiopancreatography,” although only three of these instances occurred with models on the U.S. market (bit.ly/2y6I1Dh). The FDA “continues to recommend that hospitals and endoscopy facilities transition to innovative duodenoscope designs to help improve cleaning and reduce contamination between patients, including designs with disposable caps or distal ends.” Noting that it “is not aware of any patient injuries related to these innovative duodenoscope designs,” the agency reminds health care providers using these devices “to follow the manufacturer’s instructions for the assembly of the caps and distal ends.” As of April 2020, the FDA had cleared five duodenoscopes that are fully disposable or have disposable components that facilitate reprocessing: • Boston Scientific, Exalt Model D single-use duodenoscope (fully disposable duodenoscope) •

Fujifilm, ED-580XT duodenoscope (disposable endcap duodenoscope)

•

Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V (disposable endcap duodenoscope)

•

Pentax Medical, ED34-i10T duodenoscope (disposable endcap duodenoscope)

•

Pentax Medical, ED34-i10T2 duodenoscope (disposable elevator duodenoscope) —S.T.

at all potential infection transmission rates. The next two most costly approaches were EtO and culture and hold, both of which required more duodenoscopes and had higher costs related to transport and institutional infrastructure. see Model, page 50

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DDW 2020: Infection Risk From Endoscopy Far Higher Than Previously Reported he risk for infection associated with duodenoscopes may

be as much as 180 times greater than indicated by previous

estimates, Dutch researchers have found. A team at Erasmus Medical Center, in Rotterdam, reported that between 2008 and 2018, 21 patients in the Netherlands who had undergone endoscopic retrograde cholangiopancreatography (ERCP) became infected with bacteria linked to the duodenoscopes used for the procedure. During that time, Dutch physicians performed roughly 203,500 ERCPs, leading to an infection rate of 0.01%, the researchers reported. The new estimate is far greater than previous figures, which have ranged from a low of 0.00006% to 0.00036%, according to the researchers, led by Marco J. Bruno, MD, the director of endoscopy at Erasmus. “The risk of developing a [duodenoscoperelated infection] is at least 30 to 180 times higher than the risks that were previously reported for all types of endoscopy-associated infections. Importantly, the current calculated

risk of 0.01% constitutes a bare minimum risk … because endoscope related infections are underreported,” they noted. In addition to the direct risk for infection from endoscopy, Dr. Bruno’s group said, patients also may become colonized with bacteria via a contaminated endoscope but not develop symptoms of infection. “These data call for consorted action of medical practitioners, industry and government agencies to minimize and ultimately ban the risk of exogenous endoscope associated infections and contamination,” they wrote. “As a first step, the FDA recently recommended health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components.” The study was presented as part of the 2020 virtual Digestive Disease Week (abstract Tu1036).

Mission continued from page 43

much space it takes,” he added. “If you anticipate growth in the future, you’ll want to include space in the reprocessing room to accommodate additional techs. As we’re automating more and more processes and doing a lot more computerized tracking, do you have adequate space for the reprocessing staff to perform those tasks?” Dr. Smith stressed that “this job requires a person who has great attention to detail. One thing that should never happen in our environment is transmission of an infection from a scope to a patient. That is almost always the result of human error,” he said. “So we need to establish a working environment for our technicians that enables them to perform at their best.”

Consider Reprocessing Space On a Par With Procedure Rooms The best way to figure out the flaws in your reprocessing space design is to put yourself in your technicians’ shoes. “We take a lot of pictures when we visit a site, and explain to owners and administrators what they are asking their staff to do,” Mr. Davis said. “But it’s even better if you can walk through a day of their routine with them and understand what they are experiencing.” If you are either expanding existing space or building a new location, consider your reprocessing rooms to be as important as your procedure rooms. “You really have to think about how

—Priority Report Staff

Endoscope Reprocessing & Infection Control

—Gina Shaw

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When Doing Laundry Isn’t Enough Clean towels are clean, right?

everal years ago, a group of investigators set out to answer that

question. They collected three cleaned towels from each of 10

Arizona hospitals, submerging each towel in buffered peptone water to extract microbes. They wrung out each towel, collected the broth, and examined it for signs of potentially dangerous microbes.

The investigators found them. More than 90% of the towels contained viable microbes, including 3% with the potentially dangerous bacteria Escherichia coli. Furthermore, more than half of the buckets used to soak towels in disinfectants—the very containers designed to clean the towels—harbored viable bacteria, including those that form spores (Am J Infect Control 2013;41[10]:912-915). The results are among a body of research that points to a troubling trend: The products used to clean medical facilities may be contributing to their contamination. Now, researchers are asking themselves how to do a better job of cleaning hospital cleaning products. In the 2013 study, the researchers examined reusable cloths made of cotton and of microfiber, common materials used in cleaning products. Both were contaminated. Roughly 10 years ago,

microfibers came onto the market, promising to do a better job of picking up soil and weighing less than cotton, the typical material of cleaning products such as mops and rags (Am J Infect Control 2007;35[9]:569-573). Since then, hospitals rapidly added them to their roster of cleaning products. But then they came across a dilemma: The laundry techniques that kill microbes—bleach and hot water—also destroy the delicate microfibers. The gentle cleaning process that microfibers need doesn’t always destroy the contamination on the surface of used cleaning products. Now that the world is dealing with an ongoing COVID-19 pandemic, adopting the best products and practices for cleaning has become even more crucial. The situation has left facilities scrambling for solutions. “We’re finding lots of contamination in the very tools we are using to clean,”

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said K. Mark Wiencek, PhD, the lead microbiologist at Contec, Inc., a company headquartered in Spartanburg, S.C., that manufactures cleaning supplies. “As a result, we are faced with this conundrum of how to properly decontaminate these towels and mops without destroying the textile.”

A Fine Mess A microfiber mop that’s been used to clean a hospital floor is, simply put, pretty gross. “We’re cleaning up after people, and people leave behind a lot of stuff—everything from small bits of human skin and hair to bacteria, fungi and viruses,” Dr. Wiencek said. He and his colleagues have repeated the 2013 experiment, testing mops and towels from hospitals after laundering. “In some cases, the contamination level was too high to count with the traditional and molecular methods we were using,” he said. The microfiber textile consists of small synthetic fibers, with edges like blades that hold dirt and debris. But the qualities that make microfiber such an effective cleaning tool also render it difficult to clean after use. In addition, although microfiber initially works better than cotton, after multiple washes and if laundered improperly microfiber may not perform as well (Am J Infect Control 2010;38[4]:289-292), noted Karen deKay, MSN, RN, CNOR, CIC, a perioperative practice specialist at the Association of periOperative Registered Nurses. Most facilities likely use a variety of materials to clean between patients, she said. In the perioperative environment, for instance, most places employ single-use disinfectant cloths made of polyester to clean and disinfect the surfaces after each patient. At the end of the day, a facility will do a “complete clean” using disposable cotton or microfiber cloths, Ms. deKay said. The mops, too, could consist of cotton mop heads or reusable and/or single-use microfiber. Dr. Wiencek agreed that most hospitals still use laundered products, but more facilities are adding disposable products to their supply closet. The use of disposable cleaning products “has really exploded in the last five years,” he said. Unfortunately, some evidence indicates that despite laundering, contaminated supplies are resulting in infections. More than a decade ago,

researchers in Japan linked five cases of infection by spore-forming Bacillus cereus bacteria to reused towels that had been dried and steamed (J Hosp Infect 2008;69[4]:361-367). In 2015, six immunosuppressed patients developed infections from a spore-forming mold, Rhizopus microsporus, by inhaling and touching contaminated linens supplied by a designated laundry (Clin Infect Dis 2016;62[6]:714-721). A 2015 literature review uncovered 12 outbreaks of infectious diseases associated with laundered health care textiles over the previous four decades (Infect Control Hosp Epidemiol 2015;36[9]:1073-1088). These reports might only scratch the surface, according to Ms. deKay, who said other cases of infections related to laundered cleaning products likely haven’t been documented. What’s more, she said, infections are often hard to pinpoint, particularly in immunocompromised patients. “Even if it’s not been proven that the textile itself might make infections happen, we know we need effective cleaning and we know we need consistent cleaning,” Dr. Wiencek added.

Let’s Clean It Up However, switching back to all-cotton towels and mops is not a solution, Dr. Wiencek said. As a natural fiber, cotton can biodegrade; that’s good for the environment, but not for the sterile hospital room, where fibers break apart and cause lint. Cotton fibers are much bigger than microfiber, he said, so they can push particles along the surface instead of picking them up. Some facilities may want to consider including more disposable products with their cleaning materials, Dr. Wiencek said. Cost could become an issue because facilities would have to replace each mop pad after every use. But single-use pads are lighter and less expensive than reusable pads, which may not be effective after hundreds of washes. Plus “laundry isn’t free,” he added. “Cost is part of the story, but organizations have to look into their laundry contract to figure out how much they’re paying per use of the product.” So how can facilities clean microfiber materials properly? The best advice, Ms. deKay said, is to follow the manufacturer’s instructions. Even if the instructions eschew bleach and high heat, the laundry industry’s bug-killers of choice, “instructions from the manufacturers have been validated

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to show they will get rid of organisms,” she said. Another tip: Separate microfiber cloths from mops because contamination can spread from one to the other. For additional advice, facilities may want to join TRSA or the Healthcare Laundry Accreditation Council, which can audit organizations and help raise their laundry standards, Dr. Wiencek said. For now, no additional technology exists that can replace the physical action of rubbing a surface with a chemical disinfectant, but facilities with high rates of methicillin-resistant Staphylococcus aureus, Clostridioides difficile and other deadly pathogens may want to consider adjunct technologies, Ms. deKay said. Among those, ultraviolet radiation and hydrogen

peroxide mist can kill microorganisms and add another layer of protection, she said. However, they can be expensive and can’t do the job alone. “You can’t just use that technology without doing the cleaning, which is why it’s so important that we’re getting the cleaning materials clean.” Taking extra steps to ensure microfiber cleaning materials can get clean without being destroyed may seem like a hassle in the high-pressure health care environment, but if facilities establish a process and checklists to ensure compliance, it will start to feel automatic, Ms. deKay said. Every minute spent preventing infections is time well spent, she added. “We owe it to our patients.”

Model continued from page 45

pancreatic diseases program at Children’s Hospital Colorado, in Aurora, who has studied endoscope disinfection methods, told Priority Report, “this is an important topic to improve safety of ERCP in a cost-conscious manner. The sparsity of highquality data and multiple changes in duodenoscope design and differences in procedure volume and processing between institutions make this topic difficult to study well.” Calling the modeling study “interesting,” he underscored that it difficult to determine the validity of the assumptions the authors used. “If the true risk of infection for different approaches is different than the modeling assumptions, it could make a significant difference in the final results for this study.” In addition, he noted that it is not known whether the various disposable duodenoscope designs “all carry the same risks of infections.” He and his colleagues conducted a study recently and found “no infections with a culture and hold approach” (Gastrointest Endosc 2020;91[6]:1328-1333. doi:10.1016/j. gie.2019.12.050), but he acknowledged that it was a small study and it is not clear whether the results “would hold true” in larger studies. Dr. Mark pointed out that the modeling analysis did support the results of a prior study published in Gut (2019;68[11]:1915-1917), which “found that fully disposable duodenoscopes are likely to significantly increase the cost of ERCP.”

The investigators acknowledged several limitations of their model, including the assumptions they made and a possible inability to generalize the results to facilities with lower volumes than their center. Stressing that the data “underscore the importance of cost calculations” that take into account the “potential for infection transmission and associated patient morbidity/mortality associated with each approach,” they noted that “institution-specific cost analyses will become increasingly relevant as the FDA recommendation for transitioning to duodenoscopes with newer design features gains momentum.” Commenting on the study for Priority Report, Vivek Kaul, MD, a professor of medicine in the Division of Gastroenterology and Hepatology at the University of Rochester Medical Center, in New York, said, “The study does again bring into focus a very important topic nowadays, which is infection control in endoscopy—especially ERCP, which uses duodenoscopes that are at most risk. There is no doubt,” he added, “that between enhanced cleaning practices and novel endoscope and elevator/disposable cap designs, a new and different paradigm will eventually emerge and become mainstream in this realm.” Jacob Mark, MD, the medical director of the

—Alison McCook

Endoscope Reprocessing & Infection Control

—Sarah Tilyou

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GIEndoscopy.com

Gastrointestinal Endoscopy Procedure

Q&A with Dr. Mark Gromski Cross-Contamination and Patient Safety in ERCP The risk of infection from inadequate endoscope reprocessing is relatively low, but there is a risk nonetheless – which has sparked much discussion around endoscopic retrograde cholangiopancreatography and patient safety. Dr. Mark Gromski a gastroenterologist, advanced endoscopist, and assistant professor of medicine at IUHealth/Indiana University School of Medicine in Indianapolis, Indiana, where he personally performs about 400 endoscopic retrograde cholangiopancreatography procedures per year. He says research needs to drive future attention to cross-contamination.

See full article at GIEndoscopy.com

What is GIEndoscopy.com? Ambu created GI Endoscopy to explore topics in gastroenterology and the work being performed in hospitals and clinics. The content — including articles, videos and graphics — goes beyond the use of duodenoscopes, gastroscopes and colonoscopes to cover best practices in workflow improvements, cost-effectiveness considerations, and preventing cross-contamination. And it’s geared to a wide-ranging audience including physicians, nurses, infection-control specialists and purchasing executives.

Gastroenterology and Endoscopy News - PRIORITY Report ( July 2020 )

Articles inside

DDW 2020: Infection Risk From D Endoscopy Far Higher Than Previously E Reported R

Seeing Is Believing: Why Colonoscopy S Remains the Gold Standard (CE/CME) R

Disposable Scopes Are Likely to Play D A Larger Role at Small-Volume Centers A

DDW 2020: Model Evaluates D Cost, Infection Risk With Various C DuodenoscopesD

Mission Critical: Working Conditions M For Reprocessing Techs F