Gastroenterology and Endoscopy News - PRIORITY Report - Winter 2023

Volume 6 • Winter 2024

A Supplement to

FLAVOR CHOICE IN W E BOWEL PREPARATION N

RESULTS FROM A PHASE 3 CLINICAL TRIAL

94% of patients achieved successful* bowel cleansing with SUFLAVE 87% of patients found SUFLAVE tolerable to very easy to consume 79% of patients found the taste of SUFLAVE neutral to very pleasant

1,2

3

4

THE MAJORITY OF PATIENTS SAID SUFLAVE TASTES LIKE A SPORTS DRINK3 *Success was defined as an overall cleansing assessment of excellent or good by the blinded endoscopist; scores were assigned following completion of the colonoscopy; P<0.001 in this noninferiority clinical trial.

IMPORTANT SAFETY INFORMATION SUFLAVE™ (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) 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 on the day before colonoscopy, followed by clear liquids up to 2 hours prior to colonoscopy. Administration of two doses of SUFLAVE are required for a complete preparation for colonoscopy. Each bottle must be reconstituted with water before ingestion. Each bottle and one flavor enhancing packet are equivalent to one dose. An additional 16 ounces of water must be consumed after each dose. Stop consumption of all fluids at least 2 hours before the 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 SUFLAVE. WARNINGS AND PRECAUTIONS: Risk of fluid and electrolyte abnormalities: 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; Colonic mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease; Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration; Patients at risk for aspiration: Observe during administration; Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. ADVERSE REACTIONS: Most common adverse reactions (* 2%) are: nausea, abdominal distension, vomiting, abdominal pain, and headache. DRUG INTERACTIONS: Drugs that increase risk of fluid and electrolyte imbalance.

Please see Brief Summary of Prescribing Information on reverse side. See Full Prescribing Information and Medication Guide at SUFLAVE.com.

Scan the QR code to learn more, or visit SUFLAVE.com

BRIEF SUMMARY: Before prescribing, please see Full Prescribing Information and Medication Guide for SUFLAVE™ (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution).

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) Recommended Dosage: The Day Prior to Colonoscopy: A low residue breakfast may be consumed. After breakfast, only consume clear liquids until after the colonoscopy.

Day 1, Dose 1 - Early in the Evening Prior to Colonoscopy: Open 1 flavor enhancing packet and pour the contents into one bottle. Fill the provided container (bottle) with lukewarm water up to the fill line. After capping the bottle, gently shake the bottle until all the powder has dissolved. For best taste, refrigerate the solution for an hour before drinking.

Do not freeze. Use within 24 hours. Drink 8 ounces of solution every 15 minutes until the bottle is empty. Drink an additional 16 ounces of water during the evening. If nausea, bloating, or abdominal cramping occurs, pause or slow the rate of drinking the solution and additional water until symptoms diminish. Day 2, Dose 2 – The Morning of the Colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1): Continue to consume only clear liquids until after the colonoscopy. Repeat Step 1 to Step 3 from Day 1, Dose 1. Drink an additional 16 ounces of water during the morning. Stop drinking liquids at least 2 hours prior to colonoscopy. If nausea, bloating, or abdominal cramping occurs, pause or slow the rate of drinking the solution and additional water until symptoms diminish. 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 SUFLAVE. WARNINGS AND PRECAUTIONS: Serious Fluid and Electrolyte Abnormalities: Advise all patients to hydrate adequately before, during, and after the use of SUFLAVE. If a patient develops significant vomiting or signs of dehydration after taking SUFLAVE, 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.

Correct fluid and electrolyte abnormalities before treatment with SUFLAVE. Use SUFLAVE with caution in patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment; Cardiac arrhythmias: Use caution when prescribing SUFLAVE 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 SUFLAVE 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 SUFLAVE 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-inflammatory drugs). These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration with SUFLAVE 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 SUFLAVE may increase these risks.

Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease; Use in Patients with Significant Gastrointestinal Disease: If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering SUFLAVE. Use with caution in patients with severe active ulcerative colitis.

Aspiration: Patients with impaired gag reflex or other swallowing abnormalities are at risk for regurgitation or aspiration of SUFLAVE. Do not combine SUFLAVE with starch-based thickeners. Observe these patients during administration of SUFLAVE. Hypersensitivity reactions, including anaphylaxis: SUFLAVE contains polyethylene glycol (PEG) and other ingredients that may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs and symptoms occur. ADVERSE REACTIONS: Most common adverse reactions are: nausea, abdominal distension, vomiting, abdominal pain, and headache. POTENTIAL FOR DRUG ABSORPTION: SUFLAVE can reduce the absorption of other co-administered drugs. Administer oral medications at least one hour before starting each dose of SUFLAVE. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of each dose of SUFLAVE to avoid chelation with magnesium. Pregnancy: There are no available data on the use of SUFLAVE during pregnancy to evaluate for a drugassociated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not conducted with polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride (SUFLAVE). Lactation: There are no available data on the presence of SUFLAVE 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 have not been established. Geriatric Use: Of the 460 patients who received SUFLAVE in pivotal clinical trials, 125 (27%) were 65 years of age or older. No differences in effectiveness of SUFLAVE were observed between geriatric patients and younger adult patients. In geriatric patients, decreases in blood pressure on the day of colonoscopy were reported more frequently in SUFLAVE patients than with the active comparator in Study 1 (6% vs 0%) and Study 2 (3% vs 0%). Geriatric patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities. STORAGE: Store SUFLAVE at room temperature between 20°C to 25°C (68°F to 77°F). Excursions permitted from 15°C to 30°C (59°F 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 SUFLAVE.com.

References: 1. Bhandari R, Goldstein M, McGowan J, et al. A safety and efficacy comparison of new BLI4900 bowel preparation to oral sulfate solution. Poster Sa1024 presented at: Digestive Disease Week Annual Meeting; May 21-24, 2022; San Diego, California. https://www.emedevents.com/medical-hybrid-events-2022/digestive -disease-week-ddw-conference-2022. 2. SUFLAVE [package insert]. Braintree, MA: Braintree Laboratories, Inc. 3. Bhandari R, Goldstein M, McGowan J, et al. The new flavor enhanced bowel preparation BLI4900 provides a superior patient experience. Poster Mo1024 presented at: Digestive Disease Week Annual Meeting; May 21-24, 2022; San Diego, California. https://www.emedevents.com/medical-hybrid-events-2022/digestive-disease-week -ddw-conference-2022. 4. Data on file, Braintree, MA: Braintree Laboratories Inc.

For additional information, please call 1-800-874-6756 ©2023 Braintree Laboratories, Inc.

All rights reserved.

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August 2023

Volume 6 • Winter 2024

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Study Explores Best Methods d For Reprocessing Tricky Scopes

EDITORIAL STAFF SARAH TILYOU Managing Editor smtilyou@mcmahonmed.com MEAGHAN LEE CALLAGHAN Deputy Managing Editor mcallaghan@mcmahonmed.com

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Artificial Intelligence Aims to Standardize Endoscopy Inspection

DAVID BRONSTEIN Group Editorial Director ELIZABETH ZHONG, KRISTIN JANNACONE Senior Copy Editors

SALES STAFF

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Simethicone Alternative Performs Well During GI Procedures

MATTHEW SPOTO Publication Director mspoto@mcmahonmed.com DONALD V. POPOWSKI Account Manager dpopowski@mcmahonmed.com CRAIG WILSON Advertising Manager, Classified Sales cwilson@mcmahonmed.com

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New Scope Cleaning Brush Linked to Lower Contamination

JOSEPH MALICHIO Vice President, Medical Education jmalichio@mcmahonmed.com

ART AND PRODUCTION MICHELE MCMAHON VELLE Creative Director

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Common Methods Don’t Fully Dry Endoscopes During Reprocessing

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

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4

Disjointed Protocol Leaves Scopes Vulnerable to Contamination

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3 Studies Support the Role Of Single-Use Devices in ERCP

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Study Finds No Differences In Turnover Time Between Reusable, Single-Use Duodenoscopes

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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POSTMASTER: Send address changes to: Gastroenterology & Endoscopy News 545 West 45th Street, 8th Floor New York, NY 10036 Commentaries and opinions do not necessarily reflect the views of the publication.

Disclosure Statement: We endeavor to obtain relevant financial disclosures from all interviewees and rely on our sources to accurately provide this information, which we believe can be important in evaluating the research discussed in this publication.

Copyright © 2024 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.

The OER-Elite™ Endoscope Reprocessor: Automated Endoscope Reprocessing Technology Smart Navigation Technology is Designed to Reduce Human Errors1 We’ve simplified the reprocessing experience with easy setup and touchscreen guidance.

These upgrades are designed to make it easy to train new staff and help keep your infection prevention program running smoothly.

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Improper use of the OER-Elite Endoscope Reprocessor may pose an infection control risk to patients and/or operators.

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Medical devices listed may not be available for sale in all countries.

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WINTER 2024

Study Explores Best Methods For Reprocessing Tricky Scopes

L

inear echoendoscopes may pose as big an infection risk as duodenoscopes used for endoscopic retrograde

cholangiopancreatography, according to a new real-world study by researchers at the University of Pittsburgh.

Few studies have directly compared contamination rates of linear echoendoscopes with ERCP duodenoscopes, according to the researchers. The new study went a step further and characterized the contamination risk of each type of scope under different reprocessing conditions (Infect Control Hosp Epidemiol 2023;44[9]:1485-1489).

‘Linear echoendoscopes represent a contamination rate similar to ERCP duodenoscopes and should be part of a microbiological surveillance program.’

—Ashley Ayres, MBA, BS, CIC University of Pittsburgh Medical Center

The team evaluated samples from 127 linear echoendoscopes and duodenoscopes that were reprocessed at the University of Pittsburgh Medical Center (UPMC) during a 15-month period. Partway through the study, the hospital

6

had a planned shutdown of equipment for maintenance, so the scopes went from their standard reprocessing with high-level disinfection (HLD) and ethylene oxide gas sterilization to reprocessing with double HLD for a one-month period.

Overall, ethylene oxide sterilization was used to reprocess 63% of samples and double HLD was used for the rest. During the study period, UPMC also started to use disposable tips on duodenoscopes, which allowed the researchers to compare contamination rates before and after the switch to disposable tips.

Small Differences To collect samples, the team swabbed both the channels and elevator mechanisms of each scope.

If at least one of these swabs came back positive for pathogens, the scope was considered positive for contamination. Of the 127 samples, 45 (35.4%) were taken from linear echoendoscopes and 82 (64.6%) from duodenoscopes, 27 (21.3%) of which had disposable tips.

Overall, six of 127 samples (4.72%) contained

Endoscope Reprocessing & Infection Control

WINTER 2024

According to Aaron Preston, RN, BSN, pathogenic contamination. Although the investigators found that ethylene oxide gas steriliza- CIC, the senior infection prevention coordition was associated with a numerically lower nator at Emory University Hospital Midtown, in Atlanta, the findings infection rate than double were not surprising, but HLD, the difference was the research emphasizes not statistically significant ‘More is not always better. A lot the importance of fol(ethylene oxide, 2.5% vs. of departments focus on the type lowing each cleaning step double HLD, 8.5%; ethylor frequency’ of their HLD, but the closely and using manual ene oxide risk ratio [RR], Association for the Advancement techniques, rather than 0.29; 95% CI, 0.06-1.54; focusing on the overall P=0.12). They also found of Medical Instrumentation method used. that linear echoendorecommends ‘a quality program “More is not always betscopes had a numerically that looks at key performance ter,” said Mr. Preston, who but not statistically higher indicators for precleaning, cleaning, was not involved with contamination rate than drying, storage and [HLD].’ the new study. “A lot of duodenoscopes—8.9% departments focus on the compared with 2.4% (RR, —Aaron Preston, RN, BSN, CIC type or frequency” of their 3.64; 95% CI, 0.69-19.1; Emory University, Atlanta HLD, Mr. Preston said, P=0.10). but the Association for the Linear echoendoscopes Advancement of Medical reprocessed with double HLD had the highest risk for contamination Instrumentation recommends “a quality program (2/18; 11.1%). None of the 53 duodenoscopes that looks at key performance indicators for prereprocessed with ethylene oxide gas sterilization cleaning, cleaning, drying, storage and [HLD].” nor the 27 with a disposable tip contained conNo Perfect Solution tamination after reprocessing.

The most common bacterial pathogens were The intensive reprocessing practices required Klebsiella pneumoniae, Pantoea species and for lumened endoscopes makes reprocessing Staphylococcus aureus. In addition, the investiga- vulnerable to missed or incomplete steps, Ms. tors also noted that small amounts of fungi spe- Ayers said. It might not make sense to choose cies were present. A Candida species was found ethylene oxide gas instead of double HLD if in 6.4% of cultured endoscopes, which led the there is not an overwhelming disinfection benresearchers to include fungi in microbial scope efit. “Potential safety concerns, costs and prosurveillance. cessing time may all disfavor ethylene oxide gas Although the study was small, primary inves- sterilization if it does not significantly reduce tigator Ashley Ayres, MBA, BS, CIC, said the contamination rates compared to double highfindings indicate that “linear echoendoscopes level disinfection,” she said. represent a contamination rate similar to ERCP For now, a perfect solution doesn’t exist, she duodenoscopes and should be part of a micro- added. “The only way to 100% protect against biological surveillance program.” The elevator possible contamination of endoscopes would be mechanism in linear echoendoscopes is likely what to move to a fully disposable model, but these puts them on par with ERCP duodenoscopes models may remain cost-prohibitive and may for infection risk, said Ms. Ayres, the director of not yet be sufficient for all clinical applications,” infection prevention at UPMC. This finding Ms. Ayers said, adding that disposable equipadds to a growing body of evidence showing lin- ment in healthcare goes against sustainability ear echoendoscopes present a substantial risk for objectives. contamination she told GEN Priority Report, not—Kaitlin Sullivan ing that a prospective study published in 2017 Ms. Ayers and Mr. Preston reported no relevant financial disclosures. showed similar results (Gastrointest Endosc 2017;85[2]:390-397.e1).

Endoscope Reprocessing & Infection Control

Ashley Ayres, MBA, BS, CIC

Aaron Preston, RN, BSN, CIC

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WINTER 2024

Artificial Intelligence Aims to Standardize Endoscopy Inspection VANCOUVER, B.C.—A novel artificial intelligence algorithm could help standardize and improve the evaluation of endoscope instrument channels with borescopes, according to data presented at the 2023 annual meeting of the American College of Gastroenterology.

Analysis of the algorithm showed effective detection and classification of defects in endoscope channels compared with manual review.

“Manual inspection of endoscope working channels with borescopes currently lacks standardization and is a time- and focus-intensive process,” lead investigator Sagar Shah, MD, told GEN Priority Report. “Future advancements in this technology could improve quality control of inspections and augment decision making pertaining to endoscope reprocessing,” added Dr. Shah, an internal medicine resident at UCLA Health, in Los Angeles.

‘The problem is that much today is unknown about what specific internal endoscope defects ... indicate a true safety risk, and which can be reasonably ignored.’

—Lawrence F. Muscarella, PhD LFM Healthcare Solutions, Lansdale, Pa.

Although several studies have demonstrated that borescopes can effectively detect defects such as scratches, stains, crimps, fluid droplets and foreign objects, current practices for post-reprocessing inspection lack standardization, Dr. Shah noted. In addition, he said inspection quality is

8

highly dependent on the technician, demonstrating considerable interobserver variability.

Dr. Shah and his co-investigators hypothesized that AI could aid in borescope image interpretation and facilitate the standardization of this process. The researchers reviewed the test characteristics of a novel automated AI algorithm on borescope (FIS-007 Flexible Inspection Scope, Healthmark) videos of the working channels of endoscopes used at a single tertiary center between August 2022 and May 2023.

They then analyzed the AI algorithm ( WatchDog Endo Alm, BH2 Innovations) against manual reviews of the video recordings, which served as the gold standard. The researchers evaluated the sensitivity, specificity and accuracy for each type of defect on a per-inspection basis and constructed receiver operating characteristic (ROC) curves.

AI Integration Yields Promising Results For the pilot program of the study, the AI system was used to perform 51 borescope inspections of 48 endoscopes, producing promising results when compared with an expert reviewer (abstract P3406).

Endoscope Reprocessing & Infection Control

see AI Evaluation, page 10

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AI Evaluation continued from page 8 The Al system detected a median of 36 scratches (IQR, 74.6), one area of peeling (IQR, 5.5), 16 stains (IQR, 32.5), five droplets (IQR, 14.5) and seven crimps (IQR, 12) per inspection. The overall accuracy for identifying different defects varied and was highest with scratches (80%) and peeling (75%). Crimps and stains were detected 65% of the time. Droplets were the hardest for the program to identify.

The AI system was accurate a little less than half of the time (47%). However, the ROC stats were very close for detecting each defect, except for identifying droplets (0.60). The ROC was highest in identifying peeling (0.79), followed by scratches (0.78) and then crimps and stains (0.76 for both).

‘Future advancements in [AI] could improve quality control of inspections and augment decision making pertaining to endoscope reprocessing.’

—Sagar Shah, MD UCLA Health, Los Angeles

The researchers emphasized that Al systems have the potential to standardize borescope inspection and potentially reduce the risk for infection associated with working channel defects. “Improving standardization in endoscope inspections is crucial for infection control and functionality,” Dr. Shah concluded. “The application of artificial intelligence in borescope image interpretation could be a game changer in achieving that goal.”

According to Dr. Shah, future research should be directed toward understanding the extent to which borescope findings affect decisions made during endoscope reprocessing.

Addressing Challenges In AI Application

primary question regarding the application of AI to endoscopy “involves how to design, teach and validate the AI to ensure its results are reliable, sensitive and accurate, no matter the AI’s manufacturer.

“The problem,” Dr. Muscarella added, “is that much today is unknown about which specific internal endoscope defects ... indicate a true safety risk and which can be reasonably ignored.”

According to Dr. Muscarella, AI algorithms will make judgment calls, at least at first, and such subjectivity could bring providers back full circle to a lack of standardization.

“Subjectivity is what we are trying to eliminate, so it could prove fruitless and costly to simply exchange one judgment call—a reprocessing technician’s assessment about a defect’s infection risk, for example—with that of an AI platform’s. [It’s] Peter for Paul,” he said. “We will need to watch and see how the designers of the AI address and mitigate these concerns, which would be necessary to prevent the AI from yielding false-negative and/or false-positive results.

“We do not want one AI platform sounding an ‘alarm’ for a defect inside an endoscope’s working channel that another AI platform/database concludes poses an entirely inconsequential risk,” he added.

As Dr. Muscarella explained, such differences between platforms are theoretically possible and would depend partly on the data used to train the AI and, again, those data can be error prone.

“If the AI is wrong and cries wolf too often about defects that pose no reasonable risk, hospitals will abandon the technology,” Dr. Muscarella observed. “The AI must prove to reliably discriminate between real infection risks and negligible ones. This is the challenge.”

Nevertheless, Dr. Muscarella remained confident that AI will ultimately “teach itself how to optimize its finding and assessments” and that “virtually all platforms, no matter the manufacturer, would ... yield the same meaningful results, but this may take some time.”

Lawrence F. Muscarella, PhD, an independent medical device safety expert and the president at LFM Healthcare Solutions, based in Lansdale, Pa., told GEN Priority Report that his

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Endoscope Reprocessing & Infection Control

—Chase Doyle Drs. Muscarella and Shah reported no relevant financial disclosures.

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WINTER 2024

Simethicone Alternative Performs Well During GI Procedures

water-soluble, ginger-based solution that clears bubbles

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from the gastrointestinal tract during GI procedures allows

endoscopists to fully visualize the GI tract during colonoscopies and esophagogastroduodenoscopies, according to a study.

98% of patients had improved GI tract visibility, with no adverse events

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Although simethicone is the most common defoaming solution used to enhance GI tract visibility, primary investigator Teri S. Mallard, BSN, RN, noted that its use is not recommended because it prevents the evaporation of moisture, creating a haven for bacterial growth and biofilm formation. The findings show that options other than simethicone are viable, said Ms. Mallard, the nurse manager for perianesthesia and endoscopy at Providence Swedish Medical Center, in Seattle. “My hope is that endoscopists move away from simethicone,” she told GEN Priority Report.

Ms. Mallard and her co-investigators analyzed the results of 114 routine colonoscopies that required a defoaming agent (Am J Infect Control 2023;51[10]:1192-1195). Instead of simethicone, endoscopists used a water-soluble GI supplement with ginger as the active ingredient (GI-Ease, Advanced Health Solutions). Endoscopists compared the number of bubbles flattened in the GI tract before and after flushing with GI-Ease. Most patients required three or fewer GI-Ease flushes, although the number of flushes was as high as 19 for one patient.

Before flushing, every patient’s GI tract had some impaired visibility, and 29% of patients had

bubbles obscuring their mucosa. After using the supplement, 89% of GI tracts were fully clear and another 10% had significantly improved visibility, although as much as 50% of bubbles remained on the luminal diameter. In all, 98% of patients had improved GI tract visibility, with no adverse events.

Ms. Mallard also noted that the ginger formula could have other benefits, albeit ones that have not been studied during endoscopy. “Besides its aid with visibility during colonoscopies, ginger can also support digestive health and has antibacterial and biofilm inhibition properties,” Ms. Mallard added.

Data Lacking Whether Alternatives Are Removed During Reprocessing Presumably, it should be possible to remove water-soluble products such as GI-Ease from endoscopes during standard cleaning processes, Michelle Alfa, MSc, PhD, FCCM, told GEN Priority Report. “Simethicone is insoluble in water, so it’s not surprising that current endoscope channel cleaning processes, which are based on water and detergent, do not remove simethicone,” said Dr. Alfa, a certified clinical

Endoscope Reprocessing & Infection Control

see Simethicone Alternative, page 14

WINTER 2024

New Scope Cleaning Brush Linked to Lower Contamination anually cleaning duodenoscopes with a brush capable of more thoroughly sweeping the channel may better prevent contamination by microorganisms within duodenoscopes, according to a new study.

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“Duodenoscope contamination remains a critical concern, as shown by several outbreaks in recent years,” said primary investigator Koen van der Ploeg, MD, a PhD candidate in gastroenterology and hepatology at Erasmus University Medical Center, in Rotterdam, Netherlands.

“Standard duodenoscope cleaning methods may not be able to achieve a zero contamination rate.”

Erasmus Medical Center conducts microbe surveillance of its Pentax ED34-i10T2 duodenoscopes monthly, Dr. van der Ploeg told GEN Priority Report. The new study compares contamination rates at Erasmus Medical Center before and after the introduction of the new brush, Endoss Push&Pull Brush, which uses a distal sweeper (Endoscopy 2023 Oct 17. doi:10.1055/a-2193-4481). Previously, cleaning was performed with an older duodenoscope cleaning brush with bristles at just one end.

When reviewing the surveillance cultures, Dr.

‘We hypothesize that the new brushes are better able to remove biofilms that adhere to the surface of the channel.’

—Koen van der Ploeg, MD Erasmus University, Rotterdam, Netherlands

van der Ploeg and his co-investigators defined contamination as the presence of one or more colony-forming units of gastrointestinal or oral microorganisms.

Over the study period, the researchers saw a 28.2% reduction in contamination in their duodenoscopes. Of 176 cultured samples collected from March 2018 to Dec. 15, 2020, before the medical center changed to the new brush, 45.5%

(95% CI, 38.3%-52.8%) were contaminated.

Analysis of 81 samples from scopes cleaned using the new brush found a contamination rate of 17.3% (95% CI, 10.6%-26.9%).

“We hypothesize that the new brushes are better able to remove biofilms that adhere to the surface of the channel,” Dr. van der Ploeg said.

However, he noted that this study is retrospective, not a head-to-head comparison of different duodenoscope cleaning techniques. “There appears to be a very strong association here, but it is still an association and not causation,” Dr. van der Ploeg said. “We encourage other researchers to conduct randomized prospective trials.”

‘A Significant Finding’ Even with that limitation, Michelle Alfa, MSc, PhD, FCCM, who was asked to comment, said the study’s findings were relevant. “I think that the clear reduction in high-concern organisms is a significant finding,” said Dr. Alfa, a certified clinical microbiologist and the CEO of AlfaMed Consulting, in Winnipeg, Manitoba.

However, Dr. Alfa noted that low-concern microorganisms actually increased when the scope channels were cleaned using the new brush compared with the levels after cleaning with the old brush, although this increase was not statistically significant. Even so, ideally the proportion of low-concern organisms would not have increased. “Even if you only introduce low-concern organisms, that’s not a good thing because they could form biofilm and protect other organisms,” Dr. Alfa said.

Dr. Alfa added that the culturing method used at Erasmus Medical Center was very thorough,

Endoscope Reprocessing & Infection Control

see New Brush, page 14

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WINTER 2024

Simethicone Alternative continued from page 12 microbiologist and the CEO of AlfaMed Consulting, in Winnipeg, Manitoba.

However, endoscope manufacturers have not provided data to show this product could be efficiently removed by their existing cleaning protocols. “We still need to know more about the efficacy in terms of the cleaning process, but this [study’s] focus was on the clinical efficacy of a ginger-based product in improving visibility of the gut mucosa. There is no doubt that it did so, which is exciting,” Dr. Alfa said. “It would seem to me that something like GI-Ease should probably be removed by the existing cleaning processes, but that’ s speculation until we have published data.”

This is not the only alternative to simethicone being researched. Similar studies of alternatives will be published in the near future, Dr. Alfa said.

She suggested that endoscope manufacturers could facilitate the transition to new alternative products to replace simethicone by undertaking clinical evaluation studies confirming that existing endoscope cleaning protocols can effectively remove these new alternative products.

Without transitional supports like this and evidence that current cleaning protocols can remove the new alternative products better than simethicone, adoption of any alternatives to simethicone might be low, Dr. Alfa said. “You can’t tell people not to use something anymore, and then not help evaluate the new alternatives.”

—Marcus A. Banks Dr. Alfa and Ms. Mallard reported no relevant financial disclosures.

New Brush continued from page 13 spurring confidence in the accuracy of the analysis.

“They filtered the entire sample for culture.

I’m impressed, because that way you’re picking up all the organisms in the sample compared to

‘I think that the clear reduction in highconcern organisms is a significant finding.’

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

culturing just a small portion of it,” Dr. Alfa said.

One practical impediment to moving to a newer type of endoscope channel cleaning brush, Dr. Alfa noted, is that these products could be more expensive. The older type of brush first used at Erasmus Medical Center is more common in flexible endoscope reprocessing units, Dr. Alfa said.

With this financial drawback, Dr. Alfa also noted that there is little to no information about the manufacturer’s instructions for how the new brush is to be used during manual cleaning of endoscope channels. This information would help determine whether the new brush cleaning process would be more or less labor-intensive compared with that used with the existing brushes, she said.

“I certainly think their finding is a step in the right direction toward reducing infection risk,” Dr. Alfa said, “but I wish there was more information in the methods section about how the brush is intended to be used.”

—Marcus A. Banks Drs. Alfa and van der Ploeg reported no relevant financial disclosures.

14

Endoscope Reprocessing & Infection Control

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WINTER 2024

Common Methods Don’t Fully Dry Endoscopes During Reprocessing early half of the channels of reprocessed endoscopes

N

retained water after use of common drying methods,

leaving opportunities for the equipment to harbor bacteria, a new study has found.

Air flush cycles are commonly used in the final steps of automated endoscope reprocessing, but the new research shows even prescribed flushing methods may not adequately dry narrow endoscope channels. According to Casey Czarnowski, BA, CRCST, CSPDT, CIS, CER, a perioperative consultant in Rochester, Minn., who specializes in sterile processing, the biggest risk residual moisture poses is facilitating the growth of biofilms. “Once that starts, it’s going to be really hard to mitigate,” Mr. Czarnowski, who was not involved with the new study, told GEN Priority Report.

‘What we are really seeing is gross moisture. Even if we reduce that significantly and not entirely, that is a win.’

—Mohamed Yassin, MD University of Pittsburgh

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Endoscope Reprocessing & Infection Control

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Comparing Methods The study, conducted by researchers from the University of Pittsburgh and the Cleveland VA Medical Center, evaluated two air flush lengths: three and 10 minutes. They also evaluated scopes that had been hung to dry ambiently in a cabinet for one week (Am J Infect Control 2023;51[5]:527-532).

‘Even if you don’t have an active drying cabinet, it’s incredibly important to hang your scopes in a cabinet, rather than lay them coiled in a drawer.’

—Casey Czarnowski, BA, CRCST, CSPDT, CIS, CER Rochester, Minn.

a 10-minute air flush was effective at drying the biopsy and suction channel but not the narrower air and water channels. Hanging with no air flush had limited effect on drying, with its main benefits seen in the wider biopsy and suction channel.

Primary investigator Mohamed Yassin, MD, the director of infection control at the University of Pittsburgh Medical Center–Mercy, was not surprised by the findings.

“These cycles work, but not fully. The guidelines from the AAMI say we don’t have a perfect solution for that problem yet,” he said, noting that while older data showed an alcohol flush effectively dried scopes, it was clear to him that was not the case and that alcohol flushes should be revisited with more research.

“This area of research is behind, and we need people to realize that more,” Dr. Yassin said.

Mohamed Yassin, MD

An Elusive Solution While the researchers inspected the scopes using a borescope, which can catch water droplets as well as wear and tear in large scope channels, these devices cannot evaluate smaller inner channels. To get a more comprehensive look at every channel within a scope, the investigators used a stripped endoscope model. They took apart each layer of the endoscopes to determine how much moisture was present between layers as well as inside the scopes’ inner channels.

The researchers found that overall, 37 of 77 scopes (48%) showed evidence of residual moisture after drying. The scopes also retained moisture even after an alcohol flush, which research already has demonstrated to be an ineffective way to improve channel drying (Am J Infect Control 2023;51[7]:772-778).

All endoscopes were wet after a three-minute air flush cycle that included an alcohol flush.

The Association for the Advancement of Medical Instrumentation (AAMI) recommends that flexible endoscopes with channels be dried for a minimum of 10 minutes, preferably with pressure-regulated forced instrument air, otherwise a minimum of HEPA-filtered air. The study found

According to Mr. Czarnowski, a designated active drying cabinet, which also should be cleaned regularly, is the best method for drying reprocessed endoscopes. The second-best known method is a 10-minute air flush cycle with hospital-grade air.

“Most scope instructions for use have a maximum psi [pounds per square inch],” Mr. Czarnowski explained. “You have to be careful that the air pressure has a gauge and can be manipulated to a certain psi, or you can be wrecking your scopes.”

Despite its lack of forced air, a hang-drying cabinet that does not have active drying is still the most common method used to dry reprocessed endoscopes, he added. “Even if you don’t have an active drying cabinet, it’s incredibly important to hang your scopes in a cabinet, rather than lay them coiled in a drawer,” Mr. Czarnowski said.

Dr. Yassin noted the new findings highlight the need for improvements, even imperfect ones, in the methods used to dry endoscopes during reprocessing. “What we are really seeing is gross moisture,” he said. “Even if we reduce that significantly and not entirely, that is a win.”

Casey Czarnowski, BA, CRCST, CSPDT, CIS, CER

—Kaitlin Sullivan Mr. Czarnowski and Dr. Yassin reported no relevant financial disclosures.

Endoscope Reprocessing & Infection Control

17

WINTER 2024

Disjointed Protocols Leave Scopes Vulnerable to Contamination A new study emphasizes the need for education among reprocessing staff

lack of reprocessing protocols tailored

A

to individual endoscope models is

leaving equipment open to contamination, a new study by Brazilian researchers found.

‘The most powerful tool here is education.’

—Chris Lavanchy ECRI, Plymouth Meeting, Pa.

Chris Lavanchy

In the study, the researchers examined reprocessed scopes and interviewed staff about reprocessing protocols. They uncovered several weak points in the reprocessing steps due to variability in the way staff handled the scopes. These vulnerabilities highlight the need for consistent education, the researchers said.

The cross-sectional study included data from a single visit to a healthcare clinic that performed between 140 and 530 scope-related examinations per month (Gastroenterol Nurs 2023 Sep 23. doi:10.1097/SGA.0000000000000767). The final results included 13 devices—eight gastroscopes and five colonoscopes—that had channels that were more than 2.4 mm in diameter and had been stored after undergoing high-level disinfection. The scopes were inspected using a borescope. see Disjointed Protocols, page 20

18

Endoscope Reprocessing & Infection Control

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Disjointed Protocols continued from page 18

Naiara Bussolotti Garcia, MSc

20

After reprocessing, 85% of scopes had stains and grooves, 69% contained residual moisture, and 46% harbored debris. There was also at least one noncompliance issue associated with each of the channels the team inspected.

“There will always be some blemishes in a scope that is used for many years,” but “it shouldn’t be so commonplace to see moisture in processed scopes,” said Chris Lavanchy, the engineering director of the device evaluation group of ECRI, in Plymouth Meeting, Pa., who was not involved in the new research.

The reprocessing equipment in the study was cleaned manually, mostly using a pressure pistol to rinse or clean and in one case using a lumen irrigation adapter, as recommended by the scope manufacturer. All equipment was dried with either a compressor or an oxygen source, but the pressure was not controlled. Only one protocol had a defined minimum air time for the channels.

Two protocols used an alcohol flush before the equipment was hung vertically in a conventional cabinet, without filters and with natural ventilation, to finish drying. However, all equipment included in the study underwent forced-air drying before being stored vertically.

Primary investigator Naiara Bussolotti Garcia, MSc, and her co-investigators determined the absence of specific drying guidelines—such as those that require air infusion time for each channel, controlled pressure, proper handling of auxiliary channels, and the use of a suitable device to irrigate all channels while preventing air from escaping—facilitated the presence of residual humidity in reprocessed scopes.

They also found that some staff members reused cleaning brushes, even those that were meant to be disposable or were damaged. Other aspects—like misunderstandings about the structural knowledge of the equipment—moved the researchers to conclude that more education is needed.

Although Brazil created legislation that outlines minimum guidelines for endoscope reprocessing in 2013, individual providers are responsible for creating their own protocols.

These unstandardized protocols lack detailed guidelines for validation, monitoring, drying

procedures, the use of irrigation devices and brush care, noted, Ms. Bussolotti Garcia, the nurse supervisor of sterilization services for hospital and dental medical materials and a PhD candidate in the School of Nursing at the Federal University of Minas Gerais, in Belo Horizonte, Brazil.

The same disconnect exists around the world, leading to lingering water and debris in endoscope channels—“both of which pose substantial threats,” Ms. Bussolotti Garcia said. Other recent studies have shown that moisture, in particular, is a serious issue in reprocessed scopes and can facilitate the growth of biofilm (see “Common Methods Don’t Fully Dry Endoscopes During Reprocessing,” page 16).

Continuing Education Short of resorting to disposable equipment, “a definitive solution for the safe use of reprocessed endoscopes is still lacking,” Ms. Bussolotti Garcia said. “However, several measures can enhance the proper reprocessing of these instruments.” This includes helping people understand why each step in the reprocessing protocol is necessary and why procedures are different for different scopes.

Protocols should be written down and include specific inspection times and points to be examined, clearly assigned responsibilities, documentation procedures for maintaining records, and protocols for addressing nonconformities, as well as regular inspection with equipment such as borescopes, Ms. Bussolotti Garcia said. “Adequate training for the assessor is also pivotal in this context.”

Mr. Lavanchy also stressed the importance of proper training so that staff follow proper protocols. Based on the results, he said, it’s likely the staff responsible for reprocessing the scopes in the study had not been fully educated on the procedures. “If endoscopes are being handled properly in terms of the reprocessing steps and are being serviced regularly, I wouldn’t expect to see a high degree of what these researchers reported,” he said. “The most powerful tool here is education.”

Endoscope Reprocessing & Infection Control

—Kaitlin Sullivan Ms. Bussolotti Garcia and Mr. Lavanchy reported no relevant financial disclosures.

WINTER 2024

3 Studies Support Use of Single-Use Devices in ERCP

VANCOUVER, B.C.—A trio of studies presented at the 2023 annual meeting of the American College of Gastroenterology add support for the role of single-use duodenoscopes in endoscopic retrograde cholangiopancreatography.

High Overall Success Rates in Meta-Analysis A systematic literature review revealed that single-use duodenoscopes are associated with a high success rate and promising safety profile in performing endoscopic retrograde cholangiopancreatography procedures (abstract P3717).

‘We concluded that single-use duodenoscopes had high overall success rates for completion of procedure with seemingly acceptable rates of adverse events and crossover.’

—Sujani Yadlapati, MD Indiana University School of Medicine, Indianapolis

Data from the 634 patients included in the meta-analysis showed an adjusted pooled procedural completion rate of 94%, which was statistically significant and higher than the American Society for Gastrointestinal Endoscopy threshold of 90% (P<0.001). Of note, there were no recorded cases of aspiration or perforation.

“Based on this analysis, we concluded that single-use duodenoscopes had high overall success rates for completion of procedure with seemingly acceptable rates of adverse events and crossover,” said lead researcher Sujani Yadlapati, MD, a visiting clinical lecturer in medicine at Indiana University School of Medicine, in Indianapolis.

In the systematic literature review, the

Endoscope Reprocessing & Infection Control

21

WINTER 2024

researchers included all studies published by the end of October 2022 that were in English and involved patients 18 years and older.

After screening 132 articles, Dr. Yadlapati and her co-investigators chose six studies for their final analysis. The primary outcomes measured were procedure completion rate, crossover rate (switching from a single-use to a reusable duodenoscope during the procedure due to technical difficulty), adverse event rate and safety.

‘Better characterization of this learning curve is needed to ensure safe adoption of these innovative devices.’

—Iyiad Alabdul Razzak, MD St. Elizabeth’s Medical Center, Boston

Results of the analysis showed a full procedure completion rate of 95.5%, with an adjusted completion rate of 94%. In addition, adverse events recorded in the study were low and included post-ERCP pancreatitis (2.7%) and post-sphincterotomy hemorrhage (1.1%).

These rates were well within the reported ranges for average-risk patients, Dr. Yadlapati told GEN Priority Report.

However, Dr. Yadlapati acknowledged that the study is limited by the nature of available studies, with only one having a comparative control.

Any differences in sample patient population characteristics may have led to differences in outcomes and cannot be accounted for, she added, and other long-term outcomes, such as infection, were not available to be analyzed.

Dr. Yadlapati and her co-investigators underscored the need for more studies to confirm these findings and suggested that comparative groups with variables such as similar case complexity, native papilla and other factors should be considered in future studies.

Single-Center Study Showed High Efficacy A single-center study has demonstrated similar efficacy and safety with a single-use duodenoscope compared with a reusable duodenoscope (abstract P3708).

The retrospective cohort study of patients

22

undergoing ERCP using either the EXALT Model D single-use duodenoscope or Olympus TJF-Q180V reusable duodenoscope showed similarly high completion rates of 88% and 93.7%, respectively (P=0.30). Complication rates also were similar between study arms.

“We conclude that the EXALT Model D single-use duodenoscope has a similar clinical performance and safety profile compared to conventional reusable duodenoscope,” said lead investigator Iyiad Alabdul Razzak, MD, a resident physician at St. Elizabeth’s Medical Center and Boston University School of Medicine.

For this study, Dr. Razzak and his co-investigators included all ERCP cases attempted with single-use duodenoscopes since their adoption at a tertiary care center ( January 2020 to February 2023). For comparison, the researchers randomly selected 80 ERCP cases performed with reusable duodenoscopes.

The primary outcome was clinical success rate.

Secondary outcomes included reported technical difficulty, the rate of crossover from single-use to reusable duodenoscopes, complications and 30-day readmission rate.

Results of the study showed no significant differences in clinical success rates between patients with the single-use duodenoscope and the conventional reusable model.

In instances where the ERCP procedure could not be accomplished with the single-use model, a crossover was made to the conventional reusable duodenoscope, with a success rate of two out of three cases.

Reported complications were post-ERCP pancreatitis, bleeding and perforation, said Dr. Razzak, who noted that 85% of complications with the single-use duodenoscope occurred during the first six months of its adoption.

“The introduction and adoption of single-use duodenoscopes could reduce the infection risks associated with reusable scopes,” Dr. Razzak said. “However, our findings also indicate a learning curve for single-use duodenoscopes, even in the hands of experienced advanced endoscopists.

He said that “better characterization of this learning curve is needed to ensure safe adoption of these innovative devices.”

Endoscope Reprocessing & Infection Control

see 3 Studies, page 24

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3 Studies continued from page 22 Third Study Showed Scopes’ Economic Viability Finally, a study conducted on the economic implications of single-use duodenoscopes has shown that these devices are not only practical but may generate a modest profit within a community healthcare setting (abstract P0843).

Among 68 outpatient procedures evaluated, researchers found that 55 cases were reimbursed over a 16-month period.

“Our analysis showed that reimbursement ... at least reached a break-even point and actually allowed for a very mild profit for the institution when using the single-use duodenoscope,” said Robert S. Dean, MD lead investigator Robert S. Dean, MD, a gastro‘If device reimbursement were to be included, single-use duodenoscopes may prove to not only enterologist at Premier Medical Group in Poughbe a viable option in lower-use or medium-use keepsie, N.Y. settings, but also more efficient, higher-volume For this study, Dr. Dean and his co-investigators institutions as well.’ examined the financial —Robert S. Dean, MD Premier Medical Group, Poughkeepsie, N.Y. viability of single-use duodenoscopes for ERCPs between Jan. 1, 2022, and April 20, 2023. Their primary objective was to evaluate whether insurance reimbursements, including cases that were un-reimbursed, would allow for use of these devices without financial loss.

During the 16-month study period, the researchers considered 68 outpatient procedures involving various insurance plans. A total of 55 cases were successfully reimbursed, offsetting the initial expense of using the single-use devices.

The average reimbursement was $3,223 per case.

Even with 13 unreimbursed cases, the study demonstrated that the cost of using single-use duodenoscopes was not just economically feasible but could result in a minor economic gain for healthcare institutions.

Of note, the research did not account for potential savings from additional factors typically associated with the maintenance and use of reusable duodenoscopes, Dr. Dean said. These factors include costs associated with purchasing and maintaining equipment, managing potential infectious complications, reprocessing expenses,

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and addressing equipment malfunction and repair, among others.

According to Dr. Dean, prior estimates of an economic “break-even” point for single-use duodenoscopes fall in the range of 150 to 250 ERCPs per year, assuming a 0.4% infection rate. However, these estimates assume no device reimbursement (Tech Innov Gastrointest Endosc 2022;24[1]:16-24).

“If device reimbursement were to be included, single-use duodenoscopes may prove to not only be a viable option in lower-use or medium-use settings, but also more efficient, higher-volume institutions as well,” Dr. Dean concluded.

Assessing the Need to Switch However, even if single-use scopes are viable, they may not be necessary in all cases, according to Harish K. Gagneja, MD, FACG, AGAF, FASGE, the chief medical officer of Austin Gastroenterology, in Texas.

Dr. Gagneja told GEN Priority Report that the main reason for switching (infection control) has been significantly overstated. “We have started on a journey that is inherently flawed, ” Dr. Gagneja said. “The assumed infection rate is closer to 0.04%, not 0.4%. Infection control is out of control and outstrips actual, data-backed risks.”

In addition to the detrimental environmental impact, Dr. Gagneja underscored the high costs associated with switching from reusable to disposable duodenoscopes, including environmental costs. “Just because the device is reimbursed by insurance doesn’t mean that it is economically feasible,” he said. “Medicare is paying for it, which means that you and I are paying for it, too.”

According to Dr. Gagneja, there are two settings where single-use duodenoscopes potentially make sense: very low-volume centers, where knowledge about optimal reprocessing techniques may be lacking and high-volume centers for cases involving severely immunocompromised patients.

—Chase Doyle Dr. Dean reported a financial relationship with Boston Scientific. Drs. Gagneja, Razzak and Yadlapati reported no relevant financial disclosures. Dr. Gagneja is a member of the Gastroenterology & Endoscopy News editorial board.

Endoscope Reprocessing & Infection Control

WINTER 2024

Study Finds No Differences in Turnover Time Between Reusable, Single-Use Duodenoscopes VANCOUVER, B.C.—Using single-use duodenoscopes in place of reusable scopes does not affect turnover time, according to a new study presented at the 2023 annual meeting of the American College of Gastroenterology.

Little is known about the potential differences in turnover time between disposable and reusable duodenoscopes, according to Adrian Pona, MD, a gastroenterology fellow at Prisma Health-Upstate, in Greenville, S.C., and his co-investigators.

To investigate the potential differences, the team conducted a retrospective cohort study evaluating all procedures that involved a side-viewing duodenoscope performed in September and October 2022 at a single tertiary center (abstract P0846). The researchers recorded procedure type and times, including patient in room, patient out

Endoscope Reprocessing & Infection Control

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WINTER 2024

of room and type of scope. Differences in turnover time, defined as the time from one patient leaving the room to the next patient entering, were calculated using a two-sample t-test.

Over the two-month period, the researchers found no statistically significant difference in turnover times between traditional reusable duodenoscopes and the disposable ones. Mean turnover time was 36.9 and 33.37 minutes for disposable and reusable scopes, respectively (P=0.64).

“There was really no difference between the two approaches,” in their single-center study, Dr. Pona told GEN Priority Report.

Although the turnover times were similar, Dr. Pona emphasized that other factors may more strongly influence the choice to use disposable or reusable duodenoscopes.

“Moving towards a more disposable approach prompts the need to explore cost and, importantly, environmental impact,” Dr. Pona explained. “If we were to completely switch to disposable scopes, then our waste would go up by 40%. “We need to figure out an environmentally friendly way of disposing these scopes,” he added.

Dr. Pona and his co-investigators are continuing to collect data at their center comparing single-use and reusable duodenoscopes. The

researchers noted that additional collaborative studies, including multicenter studies, are needed to explore this topic further.

Harish K. Gagneja, MD, FACG, AGAF, FASGE, the chief medical officer of Austin Gastroenterology, in Texas, remained unconvinced about the need to transition from reusable to single-use duodenoscopes. “The focus on infection control outstrips actual, data-backed risks,” Dr. Gagneja told GEN Priority Report.

“The detection of bacterial growth on the tip of a scope does not mean that there will be a viral infection. It does not indicate anything about potential outcomes.”

Dr. Gagneja also underscored the potential for negative environmental impact of a switch to single-use duodenoscopes. “The environmental impact due to increased production, shipping and the effect on the carbon footprint could be detrimental,” said Dr. Gagneja, who noted that 80% of the carbon footprint is in the supply chain. “Unless manufacturers figure out a way to reduce their output of carbon dioxide, we are potentially spoiling the planet.”

—Chase Doyle Drs. Gagneja and Pona reported no relevant financial disclosures. Dr. Gagneja is a member of the Gastroenterology & Endoscopy News editorial board.

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Endoscope Reprocessing & Infection Control

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