Gastroenterology and Endoscopy News - PRIORITY Report - Summer 2023 by McMahon Group

Volume 5 • Summer 2023

Endoscope Reprocessing &Infection Control

A Supplement to

THE TABLET CHOICE IN BOWEL PREPARATION

Packaging and tablets not shown actual size.

• NO SODIUM PHOSPHATE1 • SAFE AND EFFECTIVE1,2 • ACG-RECOMMENDED SPLIT-DOSE REGIMEN3 – Two SUTAB doses are required for a complete preparation1 Dose 1 consists of 12 tablets and 16 oz of water Dose 2 consists of 12 tablets and 16 oz of water Each dose is followed by two additional 16 oz of water ACG=American College of Gastroenterology

IMPORTANT SAFETY INFORMATION

SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. DOSAGE AND ADMINISTRATION: A low residue breakfast may be consumed. After breakfast, only clear liquids may be consumed until after the colonoscopy. Administration of two doses of SUTAB (24 tablets) are required for a complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose. Water must be consumed with each dose of SUTAB and additional water must be consumed after each dose. Complete all SUTAB tablets and required water at least 2 hours before colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any ingredient in SUTAB. WARNINGS AND PRECAUTIONS: , Ã v yÕ ` > ` i iVÌÀ ÞÌi >L À > Ì iÃ: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing; Colonic mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting V ÃV «Þ w ` }Ã «>Ì i ÌÃ Ü Ì Ü À ÃÕÃ«iVÌi` y> >Ì ÀÞ L Üi ` Ãi>Ãi° Suspected GI obstruction or perforation: Rule out the diagnosis before administration. Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. ADVERSE REACTIONS: Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. DRUG INTERACTIONS: ÀÕ}Ã Ì >Ì VÀi>Ãi À Ã v yÕ ` > ` i iVÌÀ ÞÌi L> > Vi° Please see Brief Summary of Prescribing Information on reverse side. See Full Prescribing Information and Medication Guide at SUTAB.com.

BRIEF SUMMARY: Before prescribing, please see Full Prescribing Information and Medication Guide for SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use. INDICATIONS AND USAGE: An osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. DOSAGE AND ADMINISTRATION: Split Dose (2-Day) Regimen: Dose 1 – On the day prior to colonoscopy: A low residue breakfast may be consumed. Packaging and After breakfast, only clear liquids may be consumed until after the colonoscopy. tablets not shown Early in the evening prior to colonoscopy, open one bottle of 12 tablets. Fill actual size. Ì i «À Û ì` V Ì> iÀ Ü Ì £È Õ ViÃ v Ü>ÌiÀ Õ« Ì Ì i w i®° -Ü> Ü each tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Ƃ««À Ý >Ìi Þ i ÕÀ >vÌiÀ Ì i >ÃÌ Ì>L iÌ Ã }iÃÌi`] w Ì i «À Û ì` V Ì> iÀ > ÃiV ` Ì i Ü Ì £È Õ ViÃ v Ü>ÌiÀ Õ« Ì Ì i w i® > ` `À Ì i i Ì Ài > Õ Ì ÛiÀ Îä ÕÌiÃ° Ƃ««À Ý >Ìi Þ Îä ÕÌiÃ >vÌiÀ w Ã } Ì i ÃiV ` V Ì> iÀ v Ü>ÌiÀ] w Ì i «À Û ì` V Ì> iÀ Ü Ì £È Õ ViÃ v Ü>ÌiÀ Õ« Ì Ì i w i® > ` `À Ì i i Ì Ài > Õ Ì ÛiÀ Îä ÕÌiÃ° Dose 2 – Day of colonoscopy: Continue to consume only clear liquids until after the colonoscopy. The morning of colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1), open the second bottle of 12 tablets. Fill the provided V Ì> iÀ Ü Ì £È Õ ViÃ v Ü>ÌiÀ Õ« Ì Ì i w i®° -Ü> Ü i>V Ì>L iÌ Ü Ì > Ã « v Ü>ÌiÀ > ` `À Ì i i Ì Ài > Õ Ì ÛiÀ £x Ì Óä ÕÌiÃ° Ƃ««À Ý >Ìi Þ i ÕÀ >vÌiÀ Ì i >ÃÌ Ì>L iÌ Ã }iÃÌi`] w Ì i «À Û ì` V Ì> iÀ > ÃiV ` Ì i Ü Ì £È Õ ViÃ v Ü>ÌiÀ Õ« Ì Ì i w i® > ` `À Ì i i Ì Ài > Õ Ì ÛiÀ Îä ÕÌiÃ° Ƃ««À Ý >Ìi Þ Îä ÕÌiÃ >vÌiÀ w Ã } Ì i ÃiV ` V Ì> iÀ v Ü>ÌiÀ] w Ì i «À Û ì` V Ì> iÀ Ü Ì £È Õ ViÃ v Ü>ÌiÀ Õ« Ì Ì i w i® > ` `À Ì i i Ì Ài > Õ Ì ÛiÀ Îä ÕÌiÃ° « iÌi all SUTAB tablets and required water at least 2 hours before colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any ingredient in SUTAB. WARNINGS AND PRECAUTIONS: Serious Fluid and Electrolyte Abnormalities: Ƃ`Û Ãi > «>Ì i ÌÃ Ì Þ`À>Ìi >ìµÕ>Ìi Þ Liv Ài] `ÕÀ }] > ` >vÌiÀ Ì i ÕÃi v -1/Ƃ ° v > «>Ì i Ì ìÛi «Ã Ã } wV> Ì Û Ì } or signs of dehydration after taking SUTAB, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. ÀÀiVÌ yÕ ` > ` i iVÌÀ ÞÌi >L À > Ì iÃ Liv Ài ÌÀi>Ì i Ì Ü Ì -1/Ƃ ° 1Ãi -1/Ƃ Ü Ì V>ÕÌ «>Ì i ÌÃ Ü Ì V ` Ì Ã] À Ü >Ài ÕÃ } i` V>Ì Ã] Ì >Ì VÀi>Ãi Ì i À Ã v À yÕ ` > ` i iVÌÀ ÞÌi ` ÃÌÕÀL> ViÃ À >Þ VÀi>Ãi Ì i À Ã v >`ÛiÀÃi iÛi ÌÃ of seizure, arrhythmias, and renal impairment; Cardiac arrhythmias: Use caution when prescribing SUTAB for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias; Seizures: Use caution when prescribing SUTAB for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia; Use in Patients with Risk of Renal Injury: Use SUTAB with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti y> >Ì ÀÞ `ÀÕ}Ã®° / iÃi «>Ì i ÌÃ >Þ Li >Ì À Ã v À Ài > ÕÀÞ° Ƃ`Û Ãi Ì iÃi «>Ì i ÌÃ v Ì i « ÀÌ> Vi v >ìµÕ>Ìi Þ`À>Ì Ü Ì SUTAB and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients; Colonic Mucosal Ulcerations and Ischemic Colitis: Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and SUTAB may increase these risks. Consider the potential for mucosal ulcerations resulting from the bowel preparation when ÌiÀ«ÀiÌ } V ÃV «Þ w ` }Ã «>Ì i ÌÃ Ü Ì Ü À ÃÕÃ«iVÌ y> >Ì ÀÞ L Üi ` Ãi>Ãi ®Æ 1Ãi *>Ì i ÌÃ Ü Ì - } wV> Ì Gastrointestinal Disease: If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering SUTAB. Use with caution in patients with severe active ulcerative colitis. Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, angioedema, dyspnea, rash, pruritus and urticaria have been reported with SUTAB. Inform patients of the signs and symptoms for anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur. ADVERSE REACTIONS: Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. Postmarketing Experience: Gastrointestinal: gastric ulceration, gastritis; Hypersensitivity: anaphylaxis, angioedema, dyspnea, rash, pruritus, urticaria. POTENTIAL FOR DRUG ABSORPTION: SUTAB can reduce the absorption of other co-administered drugs. Administer oral medications at least one hour before starting each dose of -1/Ƃ ° Ƃ` ÃÌiÀ ÌiÌÀ>VÞV i > ` yÕ À µÕ i > Ì L Ì VÃ] À ] ` } Ý ] V À«À >â i] > ` «i V > i >Ì i>ÃÌ Ó ÕÀÃ before and not less than 6 hours after administration of each dose of SUTAB to avoid chelation with magnesium. Pregnancy: There are no available data on SUTAB use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. No reproduction or developmental studies in animals have been conducted with sodium sulfate, magnesium sulfate, and potassium chloride (SUTAB). Lactation: There are no available data on the presence of SUTAB in human or animal milk, the effects on the breastfed child, or the effects on milk production. Pediatric Use: Safety and effectiveness in pediatric patients has not been established. Geriatric Use: Of the 471 patients who received SUTAB in pivotal clinical trials, 150 (32%) were 65 years of age or older, and 25 (5%) were 75 years of age or older. No differences in safety or effectiveness of SUTAB were observed between geriatric patients and younger patients. Elderly patients are more likely to have decreased hepatic, renal or cardiac function > ` >Þ Li Ài ÃÕÃVi«Ì L i Ì >`ÛiÀÃi Ài>VÌ Ã ÀiÃÕ Ì } vÀ yÕ ` > ` i iVÌÀ ÞÌi >L À > Ì iÃ° STORAGE: Store at 20º to 25°C (68º to 77°F). Excursions permitted between 15º to 30°C (59º to 86°F). See USP controlled room temperature. Rx only. Manufactured by Braintree Laboratories, Inc. Braintree, MA 02185 See Full Prescribing Information and Medication Guide at SUTAB.com. References: 1. SUTAB® [package insert]. Braintree, MA. 2. Di Palma JA, Bhandari R, Cleveland M, et al. Ƃ Ã>viÌÞ > ` ivwV>VÞ V «>À Ã v > iÜ ÃÕ v>Ìi L>Ãi` Ì>L iÌ L Üi «Ài«>À>Ì ÛiÀÃÕÃ > * > ` >ÃV ÀL>Ìi comparator in adult subjects undergoing colonoscopy. Am J Gastroenterol. 2021;116(2):319-328. doi:10.14309/ ajg.0000000000001020 3. Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; ACG. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009;104(3):739-750.

201-698-v2-A

June 2023

Facing the Environmental Impact Of Endoscopies

Endoscope Reprocessing & Infection Control Volume 5 • Summer 2023 EDITORIAL STAFF

Keeping Risk Assessments Up-toDate Makes for Safer Reprocessing

Do We Really Need All These Disposable Parts?

SARAH TILYOU Managing Editor smtilyou@mcmahonmed.com MEAGHAN LEE CALLAGHAN Deputy Managing Editor mcallaghan@mcmahonmed.com JAMES PRUDDEN Vice President, Editorial ELIZABETH ZHONG, KRISTIN JANNACONE Senior Copy Editors

SALES STAFF

WGO Releases New Guidelines For Safe Endoscope Reprocessing

Reduced Infection, Higher Turnover Decrease ERCP Costs Per Procedure

MATTHEW SPOTO Publication Director mspoto@mcmahonmed.com DONALD V. POPOWSKI Account Manager dpopowski@mcmahonmed.com CRAIG WILSON Advertising Manager, Classified Sales cwilson@mcmahonmed.com JOSEPH MALICHIO Vice President, Medical Education jmalichio@mcmahonmed.com

ART AND PRODUCTION

Single-Use Duodenoscopes: Where Do They Fit Into Practice? Single-Use Duodenoscopes Successful in Real-World Study

15-Minute Forced-Air Drying Removes Simethicone Droplets In Endoscope Working Channels

Tips to Reduce Turnaround Time For Savings in the Endoscopy Suite

Staff Education Improves Compliance With Infection Control Protocols

ICECAP Trial Findings: Disposable Endcaps Significantly Reduce Contamination of Duodenoscopes

MICHELE MCMAHON VELLE Creative Director JEANETTE MOONEY Senior Art Director JAMES O’NEILL Senior Systems Manager RON REDFERN Production Manager ROB SINCLAIR Circulation Manager

MCMAHON PUBLISHING VAN VELLE President, Partner MATTHEW MCMAHON General Manager, Partner LAUREN SMITH MICHAEL P. MCMAHON MICHELE MCMAHON VELLE Partners RAY & ROSANNE MCMAHON Co-founders

Endoscope Reprocessing & Infection Control

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Focused on Infection Prevention.

Together. • Cleaning & Disinfection • Education • Leak Testing • Reprocessing • Service & Support • Scope Drying • Scope Storage • Scope Transportation • Tracking Software

Infection prevention requires more than the right equipment— it requires the right partnership. We’re continually working to improve the next generation of endoscopy products and procedures, making them safer and easier to use and maintain. Olympus works with you to provide the tools, services, and information you need to deliver the highest levels of quality and safety in patient care. It’s how we work together. It’s our commitment to progress. Contact your Olympus Sales Representative or call 800-848-9024. ©2019 Olympus America Inc. Registered Trademark of Olympus or its affiliates.

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VOLUME 5 • SUMMER 2023

Facing the Environmental Impact of Endoscopies Waste, carbon emissions are high in the endoscopy suite. How do we reduce the impacts of these vital procedures?

ome 8.5% of total greenhouse gas emissions in the United States are generated by healthcare systems, with gastroenterology making an

outsized contribution to the healthcare sector’s impact on the environment. Some GI experts are beginning to sound the alarm about this problem and encouraging their peers to do something about it. Heiko Pohl, MD, a professor at the Geisel School of Medicine at Dartmouth, in Lebanon, N.H., has come to a painful understanding about the impact of his work on the environment. He has watched the waste bin in his

endoscopy suite fill up with debris from case after case, knowing the discarded materials would ultimately end up in a landfill or be incinerated. Day after day. It turns out that the medical waste that’s

Examining Global Factors and Their Effects on Endoscopy ould the war in Ukraine and the supply chain crisis affect access to single-use endoscopes and gastrointestinal endoscopy at large? That question has been posed by a group of researchers in Italy. Luca Elli, MD, PhD, the chief of the Center for Prevention and Diagnosis of Celiac Disease at the Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, in Milan, and his colleagues wrote a postscript in Gut (2023;72[2]:407-408), praising the paper by Heiko Pohl, MD, et al, on the environmental impact of GI endoscopy (see main story) and positing the question of what it means for endoscopy to be sustainable in the modern world.

Sustainability is a fluid concept affected by time and various inputs, such as the environment and the economy, Dr. Elli and his co-authors wrote. “For example, availability and the price of resources and, as a consequence, the social, environmental and financial impacts of a health product or intervention, are not static,” they noted. “Consequently, the sustainability of gastrointestinal endoscopy, as well as of all health products and interventions, may frequently change and the sustainable practices of today could become the unsustainable practices of tomorrow.” In an interview with Priority Report, Dr. Elli also noted a geographic element to endoscopy’s

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VOLUME 5 • SUMMER 2023

generated during an endoscopy has been estimated to be the third largest in hospitals (Gut 2023;72[3]:493-500). “Our world is in a very bad situation, and there is some urgency to act,” Dr. Pohl said. “Otherwise, we might have a situation where thresholds are overstepped that can’t be turned back.” He isn’t alone in this view. Madhav Desai, MD, MPH, an assistant professor at the University of Minnesota, in Minneapolis, has come to a similar conclusion about the amount of waste generated by endoscopic procedures.

Understanding the Impact To tackle the problem, “the first thing is to start tracking the numbers,” Dr. Desai said. “If we don’t examine it, we don’t know.” Spurred by their growing concern, both gastroenterologists have been researching this problem and potential ways to address it. In a recent study presented at Digestive Disease Week 2023, Dr. Desai and his co-investigators collected information on waste generation and energy consumption during 450 standard GI procedures over the two-month period from May to June 2022 (presentation 52). They found that every 100 routine endoscopies generates roughly 220 kg of landfill waste and 1,400 gallons of

‘ The first thing is to start tracking the numbers. If we don’t examine it, we don’t know.’

—Madhav Desai, MD, MPH University of Minnesota, Minneapolis

water waste. In addition, these 100 endoscopies lead to 1,980 kWh of energy consumption—the equivalent of about 1,200 miles traveled by an average fuel-efficient car, roughly the distance from Seattle to San Diego. The team also found that 72% of total waste goes to a landfill, while 24% is biohazard waste. The carbon footprint of 100 GI endoscopies is roughly 1,500 kg of carbon dioxide equivalents, an amount that requires 1.8 acres of U.S. forests to offset. In a study published last year, Dr. Pohl and a team of seven others aimed to measure the amount of waste generated during their endoscopic procedures to better understand the effect of changing from reusable to single-use endoscopes (Gut 2022;71[7]:1326-1331). Looking at two U.S. academic medical centers with low and high endoscopy volumes, the team found an average of 2.1 kg of disposable waste generated during one endoscopic

sustainability. “There’s the question of whether what’s sustainable in France could have a different impact in China, the U.S. or Italy,” he said. The interconnected, global aspects of supply chains— with North America and Europe depending on equipment, resources and even waste disposal in other countries—is not something that likely will change anytime soon, according to Dr. Elli. In light of global affairs—particularly climate change and war and strife in countries that may be part of the global supply chain—the authors wrote that GI endoscopy professionals should consider reducing the impact of interventions, including reexamination of the sustainability of single-use endoscopes. Dr. Elli and his co-authors pose some questions

to help the field fill in some information gaps: “Could we do more to improve the efficiency of the reprocessing of reusable endoscopes? What is the rate of clinically relevant contamination of reusable devices? Should we follow the recent [FDA] recommendation to transition to disposable duodenoscopes and caps or can we just select patients who can benefit most from the use of disposable devices?” The question of sustainability in endoscopies is still novel, with much still to be determined, Dr. Elli told Priority Report. At this point, “we are at time zero.” —N.S. Dr. Elli reported no relevant financial disclosures.

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procedure. Extrapolating that number across the United States, the total waste generated was calculated to weigh 38,000 metric tons, or the equivalent of 25,000 passenger cars, covering 117 soccer fields at a depth of 1 meter.

‘ We have to be more conscientious and take the environmental aspect into account when we approach procedures and interventions.’

—Heiko Pohl, MD Geisel School of Medicine at Dartmouth, Lebanon, N.H.

Another study published last year showed the CO2 equivalent of single-use endoscopes to be 24 to 47 times greater when compared with reusable endoscopes (Gastrointest Endosc 2022;96[6]:1002-1008). That said, reusable endoscopes still carry rates of infection higher than their single-use alternatives, Dr. Pohl said, so that is another factor that needs to be considered in the decision making. “It’s a moving goal and everyone is working toward it,” Dr. Desai added. “Single-use scopes may not be a viable option unless we have a recyclable material or bio-friendly material in the scope themselves.” Separately, an estimated 70% to 80% of the health system’s carbon footprint comes from the supply chain, as well as fossil fuels involved with the transport, use and disposal of supplies, material and equipment (Health Affairs 2020;39[12]:2071-2079), Dr. Pohl told Priority Report. A simple instrument like a snare, for example, is typically shipped in a package, used once, and then carried away to a landfill or classified as highly biohazardous material. (See related story on page 12.)

Making Workplace Changes Although gastroenterologists may have little impact on the carbon footprint produced or generated by the supply chain, it’s still possible for those in the endoscopy unit to affect change. Dr. Pohl said reducing use and increasing reusable efforts are key to aligning with sustainable economy principles and bringing the United States a step closer to its peers.

“We have to be more conscientious and take the environmental aspect into account when we approach procedures and interventions,” he said. “We cannot just wait for leadership but work together from the base, as physicians, nurses and health employees,” Dr. Pohl said. Similarly, Dr. Desai said he believes hospital leadership is required for successful efforts to reduce environmental waste generation and energy consumption. “If leadership sets an example, other departments will follow,” he said. Institutions should start tracking how much waste they’re generating and gain a better understanding of items that are potentially recyclable, Dr. Desai said. “They should come up with benchmarking numbers about how much waste generation is more than the limit and then implement programs institutionally,” he said. According to Dr. Desai’s calculations, recyclable bins on-site can possibly reduce waste by 20%, while implementation of energy-saving equipment—such as light sensors in the late afternoon and evenings— can go a long way toward helping, too. In 2022, the United Kingdom’s health system became the first to embed net zero into legislation through the Health and Care Act of 2022, aiming to reach net-zero emissions for its carbon footprint by 2040. Dr. Pohl said he believes it is feasible for the United States to do the same in its federal healthcare system by 2050. To address this issue, in March 2023, the Department of Health and Human Services published the Health Sector Climate Pledge, an invitation for hospitals to commit and pledge toward a net-zero path by implementing changes in their healthcare systems. Drs. Desai and Pohl consider efforts to make endoscopy more environmentally friendly just the beginning. They’ve set their sights more broadly—to surgeries, pulmonary medicine and beyond. “We have to go back to a regenerative approach of using resources,” Dr. Pohl said. “We can’t just take resources out of the earth and think they are infinite.” —Natalie Schachar Dr. Desai reported no relevant financial disclosures. Dr. Pohl reported financial relationships with Cosmo, InterVenn and Steris.

Endoscope Reprocessing & Infection Control

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Keeping Risk Assessments Up-to-Date Makes for Safer Reprocessing

PHOENIX—High-quality standards, ongoing risk assessment and communication with leadership are crucial to keep reprocessing activities running smoothly and safely in endoscopy units, according a presentation at the 2023 annual meeting of the Society of Gastroenterology Nurses and Associates. The cornerstone of safety management is risk assessment. It’s a “fundamental” aspect [of ] monitoring corrective measures related to high-level disinfection in the endoscopy suite,” said Jim Collins, BS, RN, CNOR, a practice manager at Cleveland Clinic’s Digestive Disease & Surgery Institute, in Cleveland. Risk assessment, which includes tasks such as gathering and interpretation of data to support high-level disinfection (HLD), can be combined with staff management techniques to help lower

‘ The process for performing HLD of endoscopes is a human process. It relies on a person to remember over 100 steps from point-of-care cleaning to storage. No one person can do that, and, as a result, workarounds occur with detrimental results.

’

—Laura Habighorst, BSN, RN, CAPA, CGRN, NPD-BC

infection rates across endoscopic procedures, Mr. Collins said. The main aspect of this approach, he explained, is to assess the current HLD process with a fine-tooth comb. “We want to look at any vulnerable HLD processes. Do you have highrisk endoscopes? Do you need to scope those elevator systems?” Mr. Collins asked. Staff should assess risk posed by a hazard and identify actions needed if current measures prove inadequate, he said. Risk can be graded by likelihood and severity with action plans developed in-house to address the hazard. He recommended grading from medium to high risk based on the likelihood of harm to patients. However, he pointed out that risk assessment can be subjective. To address this, more than one person should assess the risks. “I always ask when [risk assessments] are done, they’re done by two people,” Mr. Collins advised.

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VOLUME 5 • SUMMER 2023

He also recommended cautiousness when grading because it’s better to be safe than sorry. “I always score heavy,” he said. “It’s better to score something heavy and be told you’re [over]worried than to underscore and have a potential threat develop down the road.” Another tip, Mr. Collins said, is to keep a time line of different parts of the HLD process that includes expectations for when certain tasks will be completed. “If you don’t keep everyone on track, things move at glacial speed,” he said, and “they’ll never get done.”

Following Regulations And Protocols Regarding disinfection, a variety of guidelines need to be followed for the safety of the patient and healthcare workers who are disinfecting or handling the endoscopes. Regulations from the Occupational Safety and Health Administration call for personal protective equipment and certain vaccinations to limit disease spread. The Environmental Protection Agency has regulations for how to use chemicals in cleaning and disinfection. Staff members must follow manufacturers’ instructions for use, too, Mr. Collins said. “We have a hierarchy of documents to follow,” he said. “We have state and local governmental [regulations] to be met, too, and if you take CMS [Centers for Medicare & Medicaid Services] payments, you have to meet conditions set forth by the Department of Health and Human Services.” Being up-to-date on various regulations is very important, Mr. Collins said, and staff members not only need to be monitored but also need to know they are being monitored closely. “We want to ensure competent staffing for each model of industry,” Mr. Collins said. “They need to know HLD manual and automated processes and have ongoing education with competency skill verification, because when you watch your employees, the Hawthorne effect kicks in. Everyone does the right thing when being observed.” Laura Habighorst, BSN, RN, CAPA, CGRN, NPD-BC, an independent consultant and educator based in Kansas City, Mo., who was not involved with the presentation, agreed. “It’s important for them to understand they cannot take shortcuts in their jobs. We often use the

‘

Staff members need to know HLD manual and automated processes and have ongoing education with competency skill verification, because when you watch your employees, the Hawthorne effect kicks in. Everyone does the right thing when being observed.

’

—Jim Collins, BS, RN, CNOR Cleveland Clinic, Cleveland

sentence, ‘Would you want to use the scope you just cleaned on your mom?’ “The process for performing HLD of endoscopes is a human process. It relies on a person to remember over 100 steps from point-of-care cleaning to storage. No one person can do that, and, as a result, workarounds occur with detrimental results.” Because HLD depends on knowing the whole process inside and out, manual and automated, Ms. Habighorst recommended reaching out to scope manufacturers for specific training. “Bring your scope and equipment manufacturers in on a regular basis for training,” she said. “Develop a rapport with these companies, as they will help you. Most have clinical nurse educators who will do teaching as needed.”

Leadership and Your Team Both Mr. Collins and Ms. Habighorst suggested that keeping leadership apprised can help risk assessment at a high standard. “Leadership has the ultimate responsibility for the endoscopy unit and reprocessing areas,” Ms. Habighorst said. “Their role ensures manufacturers’ instructions for use are followed, [and that there is] appropriate orientation, ongoing education, and implementation of changes within endoscopy rules, regulations, guidelines and accreditation.” The disinfection and reprocessing team should be composed staff with various skill levels, Mr. Collins said, so that the labor can be divided among the members. Ms. Habighorst agreed that each member of the team brings his or her own expertise. “A multidisciplinary team,” she said, “can only make significant and meaningful changstaff with table and their concerns are listened to and built upon.” —Sherree Geyer Mr. Collins and Ms. Habighorst reported no relevant financial disclosures.

Endoscope Reprocessing & Infection Control

VOLUME 5 • SUMMER 2023

Do We Really Need All These Disposable Parts?

he single-use versus disposable debate continues in endoscopy, and it applies to

the many procedure-associated accessories in addition to the scopes themselves.

Endoscope Reprocessing & Infection Control

VOLUME 5 • SUMMER 2023

Many procedure accessories became single use a long time ago to reduce infection risk, said Lawrence Muscarella, PhD, the president of LFM Healthcare Solutions LLC, in Lansdale, Pa. “The single use [accessories] not only perform well, but eliminate the risk of cross-infection ... and then reduce all the reprocessing costs. That includes manual staff costs, device transportation costs and materials costs associated with the reprocessing,” Dr. Muscarella, an expert in healthcare infection control, told Priority Report. “The market [has] really carved out not even just a niche but a real presence for the single-use accessories.” “What’s more, it was almost impossible to clean the gunk from inside the shaft of reusable biopsy forceps or other types of accessories after a patient procedure,” said Michelle Alfa, MSc, PhD, FCCM, a certified clinical microbiologist and the CEO of AlfaMed Consulting, in Winnipeg, Manitoba. The single-use options “[reduce] the risk of having to reprocess a complex accessory device that really was never designed to be reprocessed.”

FDA Push Toward Single Use But what about the components that are part of the scopes themselves, such as distal endcaps? The FDA has reiterated their position that it’s just safer for these parts to be disposable. In a safety communication that came out just over a year ago as an update to an earlier safety communication released two years before, the agency drew a line in the sand on disposable components. “Given the cleaning concerns and contamination data with fixed endcap duodenoscopes and the increasing availability of duodenoscope models that facilitate or eliminate the need for reprocessing, hospitals and endoscopy facilities should complete transition to innovative duodenoscope designs that include disposable components, such as disposable endcaps, or to fully disposable duodenoscopes” (FDA Safety Communication; updated June 30, 2022). The agency is following accumulating data, which is starting to show reductions in the rates of infection with single-use scopes and components compared with reusable ones. For example, a study published in JAMA earlier this year found a nearly 5% reduction in the rates of infectious material in between uses when endoscopists used

duodenoscopes that had disposable elevator caps (JAMA Intern Med 2023;183[3]:191-200). (See related story, page 32.) Having disposable components and accessories eliminates human error, and “[takes] out that whole problem of trying to get adequate cleaning on a lever mechanism. They’ve removed that risk factor,” Dr. Alfa said.

‘ Be careful what you wish for because if every flexible endoscope becomes sterile, single use and disposable. ... The environmental impact would be far greater than what is currently happening.

’

—Michelle Alfa, MSc, PhD, FCCM AlfaMed Consulting, Winnipeg, Manitoba

Re-engineering the Future The lion’s share of the flexible duodenoscope manufacturers have already switched to making at least the endcap disposable, Dr. Alfa noted. “However,” she told Priority Report, “there has been little progress to change the complex design of the reusable duodenoscopes that would make their narrow channels easier to clean and highlevel disinfect or ideally sterilize.” Rather than designing sterile, single-use endoscopes, she said, “an option would be to re-engineer reusable endoscopes, thereby fully automating a reliable cleaning and sterilization process.” That point is one that Bret T. Petersen, MD, a professor of medicine in the Division of Gastroenterology and Hepatology at Mayo Clinic, in Rochester, Minn., echoed. “I’m sure a durable multiuse device could be designed and constructed that would work far better” than the older models.

Eliminating Costs, but Increasing Waste So, are there any disadvantages in using disposable accessories or components for these procedures? The answer comes in its usual forms: cost, disposal and labor. With the elimination see Disposable Parts, page 14

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VOLUME 5 • SUMMER 2023

Disposable Parts continued from page 13 of sterilization and reprocessing costs for these accessories, price considerations increasingly are not a factor. Even as far back as 2002, Dr. Petersen said, “in our huge practice, we were buying [disposable components] for equivalent or less than we could reprocess them.” Concerns about the effects on the reprocessing workforce have been raised, but the elimination of the need to sterilize and reprocess these devices doesn’t mean people will necessarily lose their jobs associated with those tasks, Dr. Muscarella said. “Just because you eliminate a reusable accessory and replace it with a disposable counterpart, you still have so much other associated instrumentation that’s still reusable, the notion that you’re going to lose jobs—I don’t see that as having a huge impact today.” Waste seems to be the biggest drawback. “Endoscopic procedures with disposable accessory devices, along with the accompanying reprocessing requirements for the endoscopes, in general, create more trash than most other

medical disciplines,” Dr. Alfa said. (See related story, page 6.) It makes sense to use sterile, single-use endoscopes for certain situations, she said, but if all flexible endoscopes were fully disposable, the waste stream would quickly exceed manageable levels. “Whenever you’re dealing with a disposable device, like a disposable plastic bag that you throw out as opposed to a reusable bag, there are going to be environmental issues that need to be addressed. There may be technology advances that mitigate the effect of single-use items on the environment,” she said. “However, be careful what you wish for because if every flexible endoscope becomes sterile, single use and disposable, there are published studies to show that the environmental impact would be far greater than what is currently happening.” —W. Harry Fortuna Dr Alfa reported financial relationships with HealthMark, Nanosonics and Olympus America. Dr. Muscarella reported a financial relationship with Ambu.

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VOLUME 5 • SUMMER 2023

WGO Releases New Guidelines For Safe Endoscope Reprocessing

on’t let your endoscope drip-dry, and

please, remember to wash your hands.

The World Gastroenterology Organisation’s updated endoscope reprocessing guidelines are full of practical strategies and advice for reducing infection risk. The update reiterates the importance of fighting biofilm and puts a spotlight on endoscopic retrograde cholangiopancreatography as the procedure most commonly linked to bacterial outbreaks. “Biofilm, or buildup of accumulated biofilm, does occur in flexible endoscopes. The prior expectation was that this would not happen because the endoscopes are supposed to be fully processed, disinfected and stored dry,” said guideline author Michelle Alfa, MSc, PhD, FCCM, a professor at the University of Manitoba, in Winnipeg. “The reality is that biofilm buildup does occur, in both the air–water channels and instrument channels.” Dr. Alfa and her co-authors, who hail from Australia, the United Kingdom, Chile and the Netherlands, propose several steps throughout the reprocessing journey, for all types of endoscopes (Table). The guidelines stress that when it comes to drying endoscopes, providers should never rely on drip-drying or passive drying of endoscope channels in standard storage cabinets. “You need to ensure that you do sufficient drying after the scopes have been processed, before they’re put

into storage,” Dr. Alfa emphasized. Sometimes technicians end up using insufficient manual forced-air drying during reprocessing, she said, due to demands to quickly return scopes to service and a lack of guidance on how to achieve adequate drying. The guidelines also note that a sample of patient-ready endoscopes should be regularly cultured to monitor bacteria, and endoscopes should be sent away for yearly maintenance. Consider replacing the instrument channel every two years, or sooner if the workload is sufficient to warrant replacement, the authors wrote.

More Clean Hands on Deck The guideline includes additional recommendations specific to duodenoscopes. Before even purchasing the scopes, clinics should first consider whether their ERCP volume is sufficient to warrant offering the procedure, the guideline authors suggested. If so, clinic leaders should invest in dedicated duodenoscope reprocessing staff, offering rigorous training and ongoing assessment that includes a focus on the importance of personal hygiene for preventing contamination; perform

Endoscope Reprocessing & Infection Control

VOLUME 5 • SUMMER 2023

monthly bacterial cultures; and replace duodenoscope O-rings at least yearly, per manufacturers’ instructions. “At all times, it is crucial to maintain a prudent eye on our own hand hygiene practices,” said Jim Collins, BS, RN, CNOR, who helps oversee endoscope reprocessing at Cleveland Clinic’s Digestive Disease & Surgery Institute, in Cleveland. Mr. Collins commended the WGO authors for including a focus on hygiene in the guidelines, which he finds to be concise and easy to digest. The WGO is not the only organization with a recent focus on flexible endoscopes. Last fall, the Association of periOperative Registered Nurses (AORN) released a manual about all aspects of flexible endoscope management, from evaluating which devices to purchase to precautions against prion disease transmission. AORN’s offering is more comprehensive than the relatively brief WGO document. Mr. Collins foresees a smaller readership for the complete AORN guideline, mainly among facility administrators and not so much among front-line reprocessing technicians. Although attention to preventing endoscope contamination is very similar between the WGO and AORN documents, AORN includes a focus on device transportation—both transportation to the decontamination area, and to the point of use—that is not in the WGO document. Mr. Collins said that safe handling of endoscopes back and forth between procedure and decontamination areas can reduce bacterial contamination as well as physical damage to endoscopes. “Manually cleaning some of these scopes— particularly the duodenoscopes, in which a lot of the outbreaks have occurred—can take a full 20 minutes,” noted V. Raman Muthusamy, MD, MAS, the director of endoscopy for UCLA Health, in Los Angeles. Given that complexity, Dr. Muthusamy applauded the WGO’s focus on training and ongoing competency assessment for duodenoscope reprocessing staff in an interview with Priority Report. Dr. Muthusamy echoed the call for forced-air drying cabinets rather than drip-drying, pointing to research he led—which the WGO cited— showing forced-air drying is better at preventing contamination. He fully endorsed the WGO’s call for ongoing microbial surveillance, as well as

its other recommendations. That said, he believes that bacterial sampling remains an imperfect art. “Microbial surveillance is not perfect. If you can’t reach it, you can’t sample it, and if you can’t sample it, you can’t culture it,” Dr. Muthusamy said, calling for continued research into more reliable sampling techniques. Early reactions to the WGO guidelines reflect the somewhat competing agendas of various stakeholders. “There’s been pushback from some of the gastroenterology clinics about the cost of implementing these procedures, which could drive some clinics to use single-use sterile scopes for everything,” Dr. Alfa said. However, that total conversion to sterile single-use scopes would have a significant negative environmental toll, she said. Table. WGO-Recommended Steps for Reprocessing 1.

Preclean immediately after use.

Clean manually or with an automatic flexible endoscope reprocessor within 30 minutes of precleaning, following current manufacturers’ cleaning instructions.

Disinfect by machine or manual high-level disinfection.

Flush with alcohol and ensure the channels are as dry as possible using forced-air drying.

Store in forced-air drying cabinets until next patient use. Never rely on “drip dry” of endoscope channels in standard storage cabinets.

Regularly culture some patient-ready endoscopes to monitor for the presence of high-concern bacteria.

Send endoscopes for yearly maintenance, and consider replacing instrument channels every two years, or sooner if the workload warrants this.

Alternatively, “the infection prevention and control experts are very supportive of the guidelines,” Dr. Alfa said. Slightly higher costs associated with implementing these more rigorous—and safe—standards, she explained, would pale in comparison with those costs in responding to an outbreak of multidrug-resistant bacteria transmitted via contaminated endoscopes. —Marcus A. Banks Dr. Alfa reported financial relationships with 3M, Johnson & Johnson, Novaflux and Olympus. She receives royalties related to a patent licensed to Healthmark through the University of Manitoba. Mr. Collins reported financial relationships with Boston Scientific and Steris. Dr. Muthusamy reported a financial relationship with Boston Scientific.

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Reduced Infection, Higher Turnover Decrease ERCP Costs Per Procedure CHICAGO—The total costs for a single endoscopic retrograde cholangiopancreatography procedure at a large-scale endoscopy center are essentially half of those at smaller centers, and a 0.2% increase in infection rate added nearly $100 per ERCP, regardless of location, according to a new study.

Table. Effects of Varying Infection Rates on ERCP Procedure Cost Procedure volume, n

Scopes, n

Procedure cost, $ 0.7% Infection rate

1.1% Infection rate

1,810.42

2,004.79

100

1,191.54

1,385.91

150

985.25

1,179.62

250

820.22

1,014.59

500

787.99

982.36

750

784.44

978.81

1,000

774.45

968.82

1,500

752.05

946.42

ERCP, endoscopic retrograde cholangiopancreatography. Based on Digestive Disease Week 2023 (abstract Mo1478).

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VOLUME 5 • SUMMER 2023

The researchers analyzed capital costs, fixed equipment costs and varying infection rates associated with reusable duodenoscopes during ERCPs. The infection rate across the published studies in the analysis averaged 0.9%. In a simulation of different infection rates, they found that a drop in infections of 0.2% decreased costs by the same amount—$97.19 per procedure—regardless of the volume of the center. In addition, procedure costs at different-sized centers ranged from approximately $1,900 per ERCP at centers that perform 50 procedures per year to approximately $850 at centers that perform 1,500 ERCPs annually. The combination of higher infection rates and lower procedure volume led to the highest costs per procedure in a sensitivity analysis, reported the investigators at Digestive Disease Week 2023 (abstract Mo1478) (Table).

Study Conducted by Ambu “These numbers are a bit less than we expected,” said study investigator David Hoffman, MSPH, MBA, a health economist for Ambu, a single-use duodenoscope manufacturer with U.S. offices in Columbia, Md. (Mr. Hoffman said he has analyzed the financials of more than 150 facilities in which ERCP is performed and has found costs that, in general, were marginally higher than those reported at DDW.) The DDW analysis relied on published estimates of ERCP costs and expert consultations. Both Mr. Hoffman and his co-investigator Christina Cool, MPH, Ambu’s senior director of health economics, outcomes research and market access, cautioned that many costs related to ERCP are not publicly available. Using data that are available, Mr. Hoffman and Ms. Cool found that costs per ERCP often dipped below $1,000 once a center did more than 200 procedures per year. After that point, there is a modest further decline as organizations reach 1,500 procedures annually, to a per-procedure cost of $849. They collaborated on the study with David Diehl, MD, a gastroenterologist at Geisinger Medical Center, in Danville, Pa.

‘ Among our low-volume centers, there

are less duodenoscopes available, which in turn translates into overall more use of each scope and potential risk of scope damage and, thus, repair.

’

—Olaya Brewer Gutierrez, MBBS Sibley Memorial Hospital, Washington, D.C.

Similar Findings at Johns Hopkins The higher per-procedure cost at lower-volume centers aligns with the experience at Johns Hopkins Medicine, said Olaya Brewer Gutierrez, MBBS, the director of endoscopy for Sibley Memorial Hospital at Johns Hopkins Medicine, in Washington, D.C. “We have noticed that among the lower-volume centers across our enterprise, the cost of the procedure is higher. Among our low-volume centers, there are less duodenoscopes available, which in turn translates into overall more use of each scope and potential risk of scope damage and, thus, repair,” Dr. Brewer Gutierrez told Priority Report. Dr. Brewer Gutierrez noted that there are always more than two reusable duodenoscopes available at the higher-volume centers she oversees, reducing the risk for damage and need for repair, and thereby lowering the cost per procedure. At this time, Johns Hopkins does not purchase single-use duodenoscopes, Dr. Brewer Gutierrez said, noting that insurance reimbursement rates for ERCPs performed with single-use scopes currently tend to lag behind those for reusable scopes. “Once there is more adoption of single-use technology, we will know the true cost and economic impact,” Dr. Brewer Gutierrez said. But, she added, whether endoscopy centers choose single-use or reusable devices, it will always be necessary to keep infection rates as low as possible. —Marcus A. Banks Dr. Brewer Gutierrez reported no relevant financial disclosures. Ms. Cool and Mr. Hoffman are employed by Ambu.

Endoscope Reprocessing & Infection Control

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Single-Use Duodenoscopes: Where Do They Fit Into Practice? CHI HICAG HICAG AG AGO— A GO Sinc ince nce nc n c the introdu in introduction int nt duction du of single-u single-use e-use d duode duodenoscopes denoscop d e op in opes ope n2 2019, end endoscopists nd ndoscop n dosco copists t ha have av b been en wo working wo orking kin to o find nd the e optima optimal pti a al role ole fo forr thes the devices these devices. d vic . Wh While th tthat hat is h is st sti still tiill illl being be ei determ etermined, etermined ete errm ed ed, e d there e is increasing sing reco recognition cognition c og n that tth these es scopes sc s are a h here herre to st stay. tay. ay y.

“The key is to figure out where they’re best utilized,” said Raman Muthusamy, MD, MAS, a professor of clinical medicine at the David Geffen School of Medicine at UCLA and the medical director of endoscopy for UCLA Health, in Los Angeles.

‘ First, it was felt that it would be impossible, then there were concerns that a device could be made but wouldn’t be any good, then it was that we can’t afford it. Now, I think most concerns center on the environment.

’

—Raman Muthusamy, MD, MAS UCLA Health, Los Angeles

In a presentation at Digestive Disease Week 2023, Dr. Muthusamy explored some settings in which single-use scopes have a role. He said they can facilitate logistics and operations, such as in small low-volume centers where adequate reprocessing equipment and expertise are lacking; streamline weekend/night cases or act as a backup fleet on busy days; and protect the fleet

in cases with known multidrug–resistant organisms. They also can be used for at-risk patients who would not be able to withstand a scopeacquired infection, such as transplant patients, hospitalized patients and for procedures associated with a high risk for infection transmission, such as cholangioscopy, biliary radiofrequency ablation and stent placement.

Evidence for Single-Use Scopes Although there is a learning curve with such devices, Dr. Muthusamy discussed research that he and his team conducted showing that expert endoscopists can complete endoscopic retrograde cholangiopancreatography of varying complexity using a single-use duodenoscope for nearly all cases (Clin Gastroenterol Hepatol 2020;18[9]:2108-2117). A larger real-world study, presented at this year’s DDW meeting, lends support to the idea that endoscopists with varied levels of experience can perform ERCP successfully with these devices, with a high level of satisfaction (see page 22). Furthermore, some issues raised by users early

Endoscope Reprocessing & Infection Control

see Single-Use Scopes, page 31

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More visual drying status indicators More control of the drying process More information regarding system maintenance More data for monitoring More flexibility to configure drying parameters for individual endoscopes

The right choice for instrument channel drying after the AER.

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VOLUME 5 • SUMMER 2023

Single-Use Duodenoscopes Successful In Real-World Study

ndoscopists with varying experience had high levels of procedural success and reported high levels of satisfaction

performing endoscopic retrograde cholangiopancreatography using a single-use duodenoscope, including in a significant number of high-complexity cases, according to a multicenter, global prospective case series presented at Digestive Disease Week 2023.

Although a disposable duodenoscope virtually eliminates the problem of scope contamination, other questions about these devices remained. Would endoscopists be comfortable with the disposable designs, and would they find that they performed the same? This new study, led by Adam Slivka, MD, PhD, an associate chief of clinical affairs for the Division of Gastroenterology, Hepatology and Nutrition at the University of Pittsburgh Medical Center, answers that question in the affirmative.

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In the study, 61 endoscopists at 22 academic centers in 11 countries performed 551 ERCP procedures in adults using the EXALT singleuse duodenoscope (Boston Scientific) (abstract Su1456). Outcomes included the ERCP completion rate for the intended indication, mean cannulation attempts, rate of crossover to a reusable endoscope, device performance ratings, median ERCP completion time, and device- or procedure-related serious adverse events (SAEs). A total of 529 (96.0%) ERCPs were completed, including 503 (91.3%) using only the single-use duodenoscope, and 26 (4.7%) with crossover to a reusable endoscope. Of the 4% of ERCPs not completed, half included a crossover and the other half were aborted cases with no crossover. The ERCP completion rate did not differ significantly for expert (>2,000 lifetime ERCPs) or less-experienced endoscopists (96.3% vs. 94.4%; P=0.382) or by American Society of Gastrointestinal Endoscopy grade (P=0.444). Endoscopists’ median satisfaction with the single-use duodenoscope was 8.0 overall on a scale of 1 to 10, with 10 being the best. Median ERCP completion time was 24.0 minutes, with significantly longer time for higher ASGE grade (35.5 minutes for grades 3-4 vs. 20.0 minutes for grades 1-2; P<0.001). One or more SAEs related to the ERCP and/ or the scope were reported in 7.8% of patients, including pancreatitis (16 mild or moderate and two severe), pain (n=5), GI bleed (n=4), sepsis (n=3), cholangitis (n=2), cholecystitis (n=2) and perforation (n=2). Three patients died after ERCP. One patient died from acute pancreatitis occurring 16 days after ERCP that was fatal on day 70, another patient died from a fatal hemorrhage due to papilla after balloon dilation, and one death was associated with sphincteroplasty.

When to Choose Disposable

and that they are indeed good enough,” said Deepak Agrawal, MD, MPH, MBA, the chief of gastroenterology and hepatology at Dell Medical School at The University of Texas at Austin, who was not involved with the research. “The manufacturers have done a good job in making these scopes feel, look and behave very similar to the reusable duodenoscopes people are used to using. In normal use, in real life, these scopes work well.”

‘ A disposable scope may be convenient for me and for the

hospital, but if I’m using it not because it decreases infection but because it increases convenience, I’m damaging the environment for my convenience.

’

—Deepak Agrawal, MD, MPH, MBA Dell Medical School at The University of Texas at Austin

But that’s not the only question associated with the potential adoption of single-use scopes, he said. “The bigger question is this: Do we need to use them? That issue remains unsettled in my mind. Yes, if a patient has a known case of multidrug-resistant bacteria, these scopes should probably be used. But with normal cases, I don’t believe we should, especially since there is the alternative of scopes with disposable caps. “The environmental impact of disposable endoscopes will be significant, while the footprint of a disposable cap is much smaller. A disposable scope may be convenient for me and for the hospital, but if I’m using it not because it decreases infection but because it increases convenience, I’m damaging the environment for my convenience.” —Gina Shaw

The results show high procedure success rates and endoscopist satisfaction, but does this mean providers should ditch their reusable duodenoscopes for the single-use version? “This study indicates that clinicians are using these scopes

Dr. Agrawal reported no relevant financial disclosures.

For more on Single-Use Scopes, see page 20.

Endoscope Reprocessing & Infection Control

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15-Minute Forced-Air Drying Removes Simethicone Droplets In Endoscope Working Channels

CHICAGO—Endoscopists might not have to give up their simethicone. Extended automated drying for 15 minutes eliminated residual moisture within endoscope working channels even in the setting of up to 3% (high concentration) simethicone use, according to a new study presented at Digestive Disease Week 2023.

Although the use of simethicone to decrease air bubbles in the gastrointestinal tract and improve visualization during endoscopy has become common practice in recent years, the three major endoscope manufacturers now discourage its use in light of studies demonstrating that simethicone residue and associated moisture persist even in endoscopes that have been fully reprocessed and manually dried according to current guidelines.

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Table. Fluid Residue After 10-Minute Drying by Simethicone Concentration Simethicone concentration

Median number of droplets (range)

Low

2 (0-4)

Median

5 (2-10)

High

12 (4-28)

“However, simethicone can be highly advantageous during endoscopy due to its bubble dissolution capability and enhanced mucosal visualization/lesion detection,” noted investigator Monique Barakat, MD, and her co-investigators. Noting that the team previously “demonstrated that 10 minutes of automated drying is sufficient to eliminate moisture from all endoscope working channels without simethicone use,” the group sought to assess whether there is an automated drying duration at which all moisture would be removed even after simethicone use. For the study, colonoscopy was performed using water or standardized amounts of varied simethicone concentrations (0.5%, low, 1%, moderate, 3%, high) for flushing. After high-level disinfection, automated drying was accomplished using DriScope (Tricor). The investigators then conducted blinded borescope inspection of endoscope working channels to assess for retained fluid droplets under each condition. After 10 minutes of automated drying, some rare fluid retention persisted (Table). But after 15 minutes of automated drying, no visible fluid droplets remained for any of the three concentrations. “This warrants further study, but suggests that prolonged automated drying may mitigate the fluid retention associated with simethicone use during endoscopic procedures,” according to Dr. Barakat, an assistant professor of pediatrics (gastroenterology) and medicine (gastroenterology and hepatology) at Stanford Healthcare, and her co-investigators.

Air–Water Channels Need Further Study

of AlfaMed Consulting Ltd., in Winnipeg, Manitoba, told Priority Report. “It’s interesting to me that 15 minutes can remove even 3% concentration of simethicone. It must have to do with the idea of it being hydrophobic, so that air flushing pushes the droplets of simethicone through and out the endoscope.”

‘ It’s interesting to me that 15 minutes can remove even 3% concentration of simethicone. It must have to do with the idea of it being hydrophobic, so that air flushing pushes the droplets of simethicone through and out the endoscope.

’

—Michelle Alfa, MSc, PhD, FCCM AlfaMed Consulting Ltd., Winnipeg, Manitoba

She raised the question of whether consideration also was given to the drying adequacy of the air–water channels. “It is great to have data demonstrating that 15 minutes of forced-air drying eliminated residual droplets in the instrument channel, but published data show that the air–water channels are a lot harder to dry than the instrument channel. I agree with Dr. Barakat that additional studies would be of value to determine if 15 minutes drying is OK for the air–water channels as well.” —Gina Shaw

“The instrument channel data look solid,” Michelle Alfa, MSc, PhD, FCCM, the president

Dr. Alfa reported financial relationships with Healthmark, Nanosonics and Olympus. Dr. Barakat reported no relevant financial disclosures.

Endoscope Reprocessing & Infection Control

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Tips to Reduce Turnaround Time For Savings in the Endoscopy Suite PHOENIX—Focusing in on standardization, consistency and communication in the endoscopy suite can help staff reduce turnaround time and ultimately have a positive effect on the bottom line, according to a presentation at the 2023 annual meeting of the Society of Gastroenterology Nurses and Associates.

‘ Our costs, from disposables to salaries, are off

the chain. Our reimbursements are reduced. So, it’s imperative to study anything that improves productivity.

’

—Jeanne Greer, BSN, RN, CGRN Cooper University Hospital, Camden, N.J.

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“Now, more than ever, we have a clinical need to provide cost-effective care,” said presenter Jeanne Greer, BSN, RN, CGRN, the director of GI operations at Cooper University Hospital, in Camden, N.J. “Our costs, from disposables to salaries, are off the chain. Our reimbursements are reduced. So, it’s imperative to study anything that improves productivity.” To improve turnaround time (TAT), Ms. Greer recommended that GI techs standardize room setup and bedside cleaning, and nurses practice “consistent and succinct” pre- and post-op handoffs. To improve workflow, physicians should complete documentation in the procedure room. With these tips, strong team buy-in and consistent communication helped to see the team to a 10% increase in patient volumes. TAT went from 15 to 11 minutes, which allowed one to two cases more per procedure room and five to six more cases per day—all without additional staff or overtime. Patient, physician and staff satisfaction increased—along with revenues—while lag time and costs decreased, she said. “By increasing volumes and reducing lag time, we increased patient and physician satisfaction,” Ms. Greer said. “That’s really important because physicians are driven by reviews. They were very happy and patients were very happy.”

Lag Time Is Money Asked to comment, Laura Habighorst, BSN, RN, CAPA, CGRN, NPD-BC, an independent consultant and educator based in Kansas City, Mo., agreed with the importance of evaluating procedures to reduce TAT. “Time is money in the procedure room. A room that is not running is eating resources from staff to supplies,” she told Priority Report. “With the average cost running $50 per minute in a procedure room, unused time adds up quickly and becomes a loss for the facility. When we decrease inefficiencies in the daily routine, the schedule runs smoother and delays decrease.” Lag time presented a barrier at Cooper University Hospital, Ms. Greer said, peaking at 46 days in September 2022 before going down to 25 days in March 2023. “Before COVID-19,

our lag time was 14 days. We were up to 65 days at one point,” Ms. Greer said. “It starts when the tech leaves the room with the scope after precleaning and room cleaning and the next patient enters. TAT needs to be a well-oiled machine. When everyone on the team knows their responsibilities and works together, it will flow with minimal lag time.”

‘ With the average cost running $50 per minute in

a procedure room, unused time adds up quickly and becomes a loss for the facility.

’

—Laura Habighorst, BSN, RN, CAPA, CGRN, NPD-BC Kansas City, Mo.

Other barriers that the team faced included first case on time starts (FCOTS). For the hospital, the percentage of FCOTS was as low as 50% in January 2022 before rising to nearly 80% by March 2023. “FCOTS impact the daily schedule for the unit and physician, so starting on time is important,” said Ms. Habighorst, who was not involved with the research. Ms. Habighorst noted that low FCOTS also can generate other problems. Mistakes happen when teams take shortcuts to get back on schedule, she said. “Does the gastroenterologist intubate the cecum or take a quick look and remove the scope? Does the tech do a thorough bedside cleaning before taking the scope to decontamination? Does the nurse make a mistake when labeling specimens without confirmation? “When cases are scheduled, not only should procedure time be taken into account but also little things that must happen before and after the actual procedure time,” she said. “This gives an accurate and reality-based idea of how long it takes to turn a room and prepare for the next procedure.” —Sherree Geyer The sources reported no relevant financial disclosures.

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Staff Education Improves Compliance With Infection Control Protocols PHOENIX—Increasing infection control compliance with staff education can benefit patients and staff members alike, according to research presented at the 2023 annual conference of the Society of Gastroenterology Nurses and Associates.

‘ We all know to wash our hands, but does

everyone do it? Most people do it when they leave a patient, but how many times do they do it before seeing a patient?

’

—Kelli Beecher, DNP, APRN, FNP-BC University of Cincinnati

In efforts to lower healthcare-associated infections (HAIs) and increase infection control compliance, researchers at the University of Cincinnati Medical Center introduced new education sessions between January and June 2021. After the sessions, they found in adherence to hand hygiene with soap and water increased by 20% and compliance with room turnover cleaning standards increased by 14%.

Narrowing Education Gaps More than 20% of U.S. endoscopy units have infection control gaps (Gastrointest Endosc 2018;87[5]:1167-1179), with hand hygiene practices being notable place to improve standards, according to lead researcher Kelli Beecher, DNP, APRN, FNP-BC, an instructor in nursing at the University of Cincinnati. “Approximately 2.5 million HAIs occur annually in the U.S.,” she said. “Hand hygiene adherence can reduce new HAIs. We all know to wash our hands, but does everyone do it? Most people do it when they leave a patient, but how many times do they do it before seeing a patient?” It wasn’t just these statistics that pushed Dr. Beecher and her colleagues to improve infection control at their facilities. She also see Infection Control Compliance, page 30

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Infection Control Compliance continued from page 28 shared a personal connection to her study. “The purpose of my project was to increase infection control compliance, [but] another thing that drove my project was that I was personally affected,” Dr. Beecher said. “Around January 2021, I got norovirus twice in three months.” To mediate this for her colleagues and patients, Dr. Beecher developed a multimodal approach to improve infection control compliance, one that included training and more than 2,000 observations. “I put a PowerPoint in their mailbox and discussed safe and effective [hand hygiene] protocols,” she said. “I didn’t just mark if they were compliant. I wanted them to figure out where they were not compliant—which step in the process they were missing, so I could properly educate them.”

‘ It’s the human element, and people make mistakes. If a hospital says they have 100% handwashing, doubt it. Absolutely no one is perfect.’

—Laura Habighorst, BSN, RN, CAPA, CGRN, NPD-BC Kansas City, Mo.

The six-month project improved overall infection control compliance. The full endoscopy staff completed the education sessions, which reviewed the fine details of hygiene, such as appropriate times to clean, appropriate cleaning agents and management of biohazardous waste. After the project, compliance with hand sanitizer improved from 74% to 83%, soap and water hygiene improved from 64% to 77%, and procedure room turnover hygiene standards improved from 81% to 92%. Compliance in certain areas improved more than others because there was more need for improvement. For instance, more staff members needed to wash their hands for the full 20 seconds, with compliance starting at only 45% before the education project. That number improved to 65% after the sessions. Staff also needed to keep disinfectants on surfaces for longer periods to properly sanitize them. Before the interventions, only 55% were compliant, but 90% of staff were compliant with the standards afterward. “Before COVID-19, you washed your hands

for 15 seconds. Now, that has increased to 20 seconds,” Dr. Beecher said. “We’re moving to a safe and effective turnover using hydrogen peroxide versus bleach. … We like to be fast but efficient in our cleaning. Disinfection should be done between procedures, and a deep cleaning at the end of the day. “You use hydrogen peroxide green and whites between 30 seconds and five minutes. A television takes five minutes for hydroperoxide whites. Then bleach for three minutes. It’s about making sure staff adhere to proper kill tonics.”

It’s Human to Make Mistakes Laura Habighorst, BSN, RN, CAPA, CGRN, NPD-BC, an independent consultant and educator based in Kansas City, Mo., told Priority Report that gaps occur for “a multitude of reasons.” Some are due to the individual, like having a sloppy technique, being forgetful or misunderstandings, such as the belief that gloves obviate the need for handwashing. Others are institutional, like inadequate and poorly located handwashing stations and time constraints. “It’s the human element, and people make mistakes. If a hospital says they have 100% handwashing, doubt it. Absolutely no one is perfect,” she said. Ms. Habighorst compares step-by-step compliance to a preflight checklist. “Each item is assessed for thoroughness and completeness. When the steps for handwashing are followed, we can be assured minimal bacterial spread will occur,” she said. Ms. Habighorst also added that staff members should also stay up to date with other infectious disease precautions in a post-pandemic era. “Seek out the CDC to see what information they have about ongoing infectious disease. Know what type of PPE [personal protective equipment] to wear and when. Know proper donning and doffing techniques. If there are step-by-step instructions, follow them. They were designed to prevent infection transmission,” she said. “Ensuring proper use of PPE is all important to prevent infection, as is proper cleaning with the right chemicals.” —Sherree Geyer The sources reported no relevant financial disclosures.

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Single-Use Scopes continued from page 20 on have been addressed in more recent versions of the devices, according to Dr. Muthusamy: that the single-use device used was stiffer, which hindered gastric passage; that image quality and stability were not equivalent to that of the reusable endoscope; and that air/water button functionality was not optimal. Factors that led to the development of single-use devices after outbreaks of infections—difficulty in processing conventional endoscopes because of the complexity of their distal tip, reprocessing protocols with a narrow safety margin, and the potential for errors to occur, such as incomplete drying and incorrect brushing and flushing of endoscope channels during manual cleaning— have not gone away, despite ongoing efforts to improve reprocessing protocols (Gastrointest Endosc 2021;93[1]:11-33).

Questions Remain Nevertheless, some gastroenterologists maintain there is still not enough available information on the incidence of infections directly attributable to reusable duodenoscopes and that some level of infection should be acceptable, in light of concerns surrounding disposable devices (Gastroenterology & Endoscopy News, July 2022. Duodenoscopes: Throw Them Out? Or Put Them in the Wash?). Among the frequently noted cons of these devices are lack of durability, high cost and increased medical waste. Le et al performed a life cycle assessment evaluating environmental and human health effects of single-use and reusable duodenoscopes (Gastrointest Endosc 2022;96[6]:1002-1008). They found that single-use devices release between 36.3 and 71.5 kg of carbon dioxide equivalent, which is 24 to 47 times greater than that generated with reusable duodenoscopes. In a 2022 review, Kihyun Ryu, MD, from Konyang University in South Korea, and Sunguk Jang, MD, from Cleveland Clinic, in Ohio, argued that proper methods for safe collection, disassembly and redistribution of components should be mapped out (Clin Endosc 2022;55[2]:191-196). “As it stands, healthcare institutions determined to use this technology are also subjected to the mercy of the supply and

distribution channel (pre and post use) of the manufacturer,” they wrote, noting that “this may cause additional financial burden to the enduser, namely the healthcare institutions.” They urged clinicians “at the forefront” of efforts to incorporate these devices into practice to establish appropriate indications for their use, “given the current state of production capability and environmental considerations.” Harish Gagneja, MD, FACG, FASGE, the chief medical officer at Austin Gastroenterology, in Texas, acknowledged that single-use devices potentially can help workflow given staff shortages and can help prevent infections, but he said the reduction in infection has not been “proven beyond the duodenoscope,” and he has some major reservations with the shift to disposables. He is concerned about the “huge environmental impact,” (see related story, page 6) as well as supply chain issues and questions the feasibility of storing all the scopes that are needed. “A busy facility will need thousands of scopes. If the supply chain is disrupted, imagine what can happen.”

Harish Gagneja, MD, FACG, FASGE

Stages of Opinion On Single-Use Devices Despite the ongoing logistical and environmental concerns, opinions about single-use duodenoscopes are evolving. Dr. Muthusamy compared uptake of these scopes to the Kübler-Ross grief cycle. “The stages of grief include denial, anger, depression, bargaining and acceptance, and in my five years of being involved with this, this is where I feel that the opinion cycle has moved from,” he said. “First, it was felt that it would be impossible, then there were concerns that a device could be made but wouldn’t be any good, then it was that we can’t afford it. Now, I think most concerns center on the environment,” he said. “Perhaps one day, with additional technical advancements, refinements regarding indications and further efforts to promote sustainability, it will ultimately achieve acceptance.” —Natalie Schachar and Sarah Tilyou Dr. Gagneja reported no relevant financial disclosures. He is a member of the Gastroenterology & Endoscopy News editorial board. Dr. Muthusamy reported financial relationships with Boston Scientific, Capsovision, EndoGastric Solutions, Medtronic and Motus GI.

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ICECAP Trial Findings

Disposable Endcaps Significantly Reduce Contamination of Duodenoscopes

isposable elevator cap duodenoscopes exhibited reduced contamination after high-level disinfection compared with standard scope designs, without affecting the

technical performance and safety of endoscopic retrograde cholangiopancreatogaphy, according to results from the multicenter randomized ICECAP trial.

In the wake of a series of outbreaks of multidrugresistant infections associated with ERCP in the United States and Europe between 2012 and 2013, the FDA ordered the three manufacturers of reusable duodenoscopes currently marketing in the United States—Fujifilm, Olympus and Pentax— to conduct postmarketing surveillance studies to determine rates of contamination after clinical use and reprocessing of their fixed endcap duodenoscopes. The final results of those studies found that as much as 6.6% of samples tested positive for highconcern organisms even after reprocessing.

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The agency “recommended that the industry should migrate to scope solutions that either have disposable components, where the elevator cap of the duodenoscope is disposable, or where the endoscope itself is a single-use, disposable scope,” said Klaus Mergener, MD, PhD, MBA, MASGE, an affiliate professor at the University of Washington School of Medicine, in Seattle, and a past president of the American Society for Gastrointestinal Endoscopy. Over the past several years, manufacturers have phased out their legacy reusable duodenoscopes with fixed endcaps and replaced them with disposable endcap scopes. “I don’t know about every single hospital in the U.S., but it’s fair to say that if your hospital has not replaced their entire duodenoscope fleet already, they will be doing so soon. The primary question that remains, which the ICECAP study and others are addressing, is whether or not it is advisable to go one step further and pursue general adoption of the fully disposable scopes now offered by Boston Scientific and Ambu,” Dr. Mergener said.

There were no differences between groups in adverse events and other secondary outcomes. “The findings of our study support the FDA recommendation to transition to duodenoscopes with novel designs,” wrote the authors, led by Nauzer Forbes, MD, MSc, FRCPC, an assistant professor of medicine and the director of the therapeutic endoscopy training program in the Division of Gastroenterology and Hepatology at the University of Calgary, in Alberta. “Although entirely disposable duodenoscopes offer the ability to completely eliminate persistent microbial contamination, the high costs, lower technical performance and environmental effects all limit the widespread use of these devices. Duodenoscopes with a disposable elevator cap offer a potential solution for substantially reducing persistent microbial contamination that is scalable, with an incremental cost of approximately $50, or 3% to 7% of overall procedural costs.”

‘A Potential Solution’

‘ I don’t know about every single hospital in the U.S., but it’s

The ICECAP, or Infection Control in ERCP using a Duodenoscope with a Disposable Cap, trial, which was conducted at two tertiary ERCP centers in Canada, enrolled 518 patients between December 2019 and February 2022, 259 undergoing ERCP with disposable elevator cap duodenoscopes and 259 with standard duodenoscopes (JAMA Intern Med 2023;183[3]:191-200). The scopes used in both study arms, all from Pentax Medical, were required to have been in clinical use for more than 12 months but not more than 24 months, and they underwent two cycles of high-level disinfection followed by steam sterilization before sample collection. Persistent microbial contamination was detected in 24 of 214 (11.2%) standard duodenoscopes and 8 of 208 (3.8%) duodenoscopes with disposable elevator caps (P=0.004), corresponding to a relative risk of 0.34 (95% CI, 0.16-0.75), and the number needed to treat to avoid persistent contamination was 13.6 (95% CI, 8.1-42.7). Technical success using the disposable cap scope was noninferior to that of the standard scope (94.6% vs. 90.7%; P=0.13).

fair to say that if your hospital has not replaced their entire duodenoscope fleet already, they will be doing so soon.

’

—Klaus Mergener, MD, PhD, MBA, MASGE University of Washington School of Medicine, Seattle

Dr. Mergener noted that these results are consistent with those of a trial conducted by Fujifilm of its own disposable endcap scopes (FDA. 522 Postmarket Surveillance Studies Database). “With the Fuji scope, the contamination rate was 1.1%, down from a baseline contamination rate of over 5%,” he said. “In addition to that study and this investigatorinitiated trial, Pentax and Olympus are also completing FDA-mandated studies of their disposable endcap scopes, and I expect that those will produce similar results.”

High Performance, Low Infection Risk These findings lead to the question of how low the contamination rate needs to be for a reusable scope to be acceptable. “If we reuse see ICECAP Trial, page 34

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ICECAP Trial continued from page 33 instruments in medicine, there will never be a 0% rate of contamination,” Dr. Mergener said. “But you are weighing the non-zero contamination risk against the advantage of using a much more high-quality and detailed reusable scope rather than a one-time disposable product. With a single-use scope, the infection rate may be zero, but the trade-off is that you are using a scope that is, by necessity, made of cheaper products and may not perform quite as well as the more expensive reusable scopes.” Dr. Mergener said that based on his conversations with colleagues, he believes that most of them feel the residual risk for transmitting an infection with a disposable endcap scope is within a quite low and acceptable range. “I believe the majority of the physician community is of the opinion that these modifications are sufficient to address the issue of infection transmission in duodenoscopy,” he said. That’s the conclusion of Harish Gagneja, MD, FACG, FASGE, a gastroenterologist with Austin Gastroenterology, in Texas. “I would like to see zero contamination, but that is not possible with a reusable scope. When you combine the extremely low risk of contamination with the disposable endcap with the fact that we know that not all contamination causes infection, the actual risk of infection to patients becomes extremely small—something like 0.0005%,” he said. “At the same time, after having used the disposable endcap scopes for more than a year and a half, I have not seen any difference in the performance of these scopes compared with legacy scopes. On the other hand, when I use a disposable scope, I feel like I’m holding a toy. There’s clearly a decrease in performance. The disposable endoscopes also have a significant environmental impact and added cost. Taking all that into account, for the vast majority of ERCP cases, reusable scopes with disposable endcaps make sense.” Single-use disposable duodenoscopes may still have niche applications with certain highrisk patients, however. “For example, if I had a patient who was profoundly immunosuppressed due to high-dose chemotherapy or an immunologic disorder, I would choose a single-use scope,”

Dr. Mergener said. “Or if a patient already had a known infection with an antibiotic-resistant organism and then required ERCP, I would not want to employ a reusable scope and take the risk of transmitting that organism to the next patient. Those high-risk patients are a small group, probably significantly less than 5% of all the ERCPs that I do, but in that group, single-use scopes might have an application.” Dr. Gagneja agreed with these scenarios, and added one more: “In very low-volume centers, where they may do a handful of ERCPs a year and may not have good reprocessing capabilities, disposable scopes may make sense.” When asked about potential drawbacks to partially disposable endoscopes, Dr. Mergener told Priority Report, “all in all, I agree that in coming up with better solutions to reduce the number of contaminated ERCP scopes, the new endcap scopes are providing such a solution, but they come with a new set of potential downsides, specifically the need to be diligent in assembling the removable cap with the tip of the endoscope. Provided this is done correctly, mishaps such as unintentional detachment of the tip can be minimized if not completely avoided, and the overall benefit of these scopes probably outweigh their downsides. But it behooves us to continue to look for even better solutions.” To that end, he expects all scope makers will continue to work on other solutions to further reduce infection risk, shifting focus to the reprocessing side. “There are many steps in the cleaning of endoscopes that are quite error-prone because they are done by humans, such as precleaning and insument channel brushing. “A number of companies are trying to automatize the currently manual steps of endoscope cleaning, and this is where attention needs to be focused in the coming years. On the scope side, I don’t think there is much more that needs to be done.” —Gina Shaw Dr. Gagneja reported no relevant financial disclosures. Dr. Mergener reported financial relationships with Boston Scientific, Kate Farms, Pentax Medical and Sebela Pharmaceutical. Drs. Gagneja and Mergener are members of the Gastroenterology & Endoscopy News editorial board.

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