Gastroenterology and Endoscopy News - PRIORITY Report - July 2021 by McMahon Group

Volume 3 • Summer 2021

Endoscope Reprocessing &Infection Control

Shining a Light On Safety AS Supplement Su upp upp pplle eme men ment ntt tto o

THE TABLET CHOICE FOR BOWEL PREPARATION

• 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

92% OF PATIENTS IN TWO PIVOTAL TRIALS ACHIEVED SUCCESSFUL BOWEL CLEANSING WITH SUTAB1,2* 91% OF PATIENTS IN ONE PIVOTAL TRIAL RATED SUTAB AS TOLERABLE TO VERY EASY TO CONSUME2† • 52% of all SUTAB and MoviPrep® patients reported at least one selected gastrointestinal adverse reaction1,2‡ r /QTG 576#$ RCVKGPVU TGRQTVGF GZRGTKGPEKPI PCWUGC CPF XQOKVKPI VJCP EQORGVKVQT YKVJ Ű QH VJGUG TGRQTVU considered severe2‡

78% OF PATIENTS IN ONE PIVOTAL TRIAL WOULD REQUEST SUTAB AGAIN FOR A FUTURE COLONOSCOPY2† * -ÕVViÃÃ Ü>Ã Ì i «À >ÀÞ i `« Ì > ` Ü>Ã `iw i` >Ã > ÛiÀ> V i> Ã } >ÃÃiÃÃ i Ì v Î } `® À { iÝVi i Ì® LÞ

the blinded endoscopist; scores were assigned following completion of colonoscopy. Patients completed a preference questionnaire following completion of study drug to capture their perceptions of the preparation experience. This questionnaire has not undergone formal validation. ‡ Patients were queried for selected gastrointestinal adverse reactions of upper abdominal pain, abdominal distension, nausea, and vomiting following completion of study drug, rating the intensity as mild, moderate, or severe.1,2 ACG=American College of Gastroenterology Packaging and tablets MoviPrep® is a registered trademark of Velinor AG. †

not shown actual size.

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. 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; Suspected GI obstruction or perforation: Rule out the diagnosis before administration. ADVERSE REACTIONS: Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. DRUG INTERACTIONS: Drugs that increase risk of 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.

From the makers of SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution for adults—

THE #1 MOST PRESCRIBED, BRANDED BOWEL PREP KIT4

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 Packaging and consumed. After breakfast, only clear liquids may be consumed until after the tablets not shown colonoscopy. Early in the evening prior to colonoscopy, open one bottle of actual size. £Ó Ì>L iÌÃ° Ì i «À Û ì` V Ì> iÀ Ü Ì £È Õ ViÃ v Ü>ÌiÀ Õ« Ì Ì i w i®° Swallow each tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Approximately one hour after the last tablet 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

Ãi £®] «i Ì i ÃiV ` L ÌÌ i v £Ó Ì>L iÌÃ° Ì i «À Û ì` V Ì> iÀ Ü Ì £È Õ ViÃ v Ü>ÌiÀ Õ« Ì Ì i w i®° -Ü> Ü i>V tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Approximately one hour after the last tablet is ingested, 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 > -1/Ƃ Ì>L iÌÃ > ` ÀiµÕ Ài` Ü>ÌiÀ >Ì i>ÃÌ Ó ÕÀÃ Liv Ài V ÃV «Þ° CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention. 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 } À 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. Correct 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 v Ãi âÕÀi] >ÀÀ ÞÌ >Ã] 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 i âÞ i L Ì ÀÃ] > } Ìi Ã ÀiVi«Ì À L V iÀÃ] À ÃÌiÀ `> > Ì y> >Ì ÀÞ `ÀÕ}Ã®° / iÃi «>Ì i ÌÃ >Þ Li >Ì À Ã v À Ài > ÕÀÞ° Advise these patients of the importance of adequate hydration with 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 Õ ViÀ>Ì Ã ÀiÃÕ Ì } vÀ Ì i L Üi «Ài«>À>Ì Ü i ÌiÀ«ÀiÌ } V ÃV «Þ w ` }Ã «>Ì i ÌÃ Ü Ì Ü À ÃÕÃ«iVÌ y> >Ì ÀÞ bowel disease (IBD); 1Ãi *>Ì i ÌÃ Ü Ì - } wV> Ì >ÃÌÀ ÌiÃÌ > Ãi>Ãi: 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. ADVERSE REACTIONS: Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. POTENTIAL FOR DRUG ABSORPTION: SUTAB can reduce the absorption of other co-administered `ÀÕ}Ã° Ƃ` ÃÌiÀ À> i` V>Ì Ã >Ì i>ÃÌ i ÕÀ Liv Ài ÃÌ>ÀÌ } i>V ` Ãi v -1/Ƃ ° Ƃ` ÃÌiÀ ÌiÌÀ>VÞV i > ` yÕ À µÕ i antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours 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 -1/Ƃ « Û Ì> V V> ÌÀ > Ã] £xä ÎÓ¯® ÜiÀi Èx Þi>ÀÃ v >}i À ìÀ] > ` Óx x¯® ÜiÀi Çx Þi>ÀÃ v >}i À ìÀ° ` vviÀi ViÃ safety or effectiveness of SUTAB were observed between geriatric patients and younger patients. Elderly patients are more likely to >Ûi ìVÀi>Ãi` i«>Ì V] Ài > À V>À` >V vÕ VÌ > ` >Þ Li Ài ÃÕÃVi«Ì L i Ì >`ÛiÀÃi Ài>VÌ Ã ÀiÃÕ Ì } vÀ yÕ ` > ` i iVÌÀ ÞÌi abnormalities. STORAGE: Store at 20º to 25°C (68º to 77°F). Excursions permitted between £x¨ Ì Îäc x ¨ Ì nÈc ®° -ii 1-* V ÌÀ i` À Ìi «iÀ>ÌÕÀi° ,Ý Þ° > Õv>VÌÕÀi` LÞ Braintree Laboratories, Inc. Braintree, MA 02185 See Full Prescribing Information and Medication Guide at SUTAB.com. References: 1. SUTAB® [package insert]. Braintree, MA; 2020. 2. Di Palma JA, Bhandari R, Cleveland M, et al. A safety and ivwV>VÞ V «>À Ã v > iÜ ÃÕ v>Ìi L>Ãi` Ì>L iÌ L Üi «Ài«>À>Ì ÛiÀÃÕÃ > * > ` >ÃV ÀL>Ìi V «>À>Ì À >`Õ Ì ÃÕL iVÌÃ undergoing colonoscopy. Am J Gastroenterol° ÓäÓ£Æ££ÈÓ®\Î£ ÎÓn° ` \£ä°£{Îä É> }°ääääääääääää£äÓä 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. Óää Æ£ä{Î®\ÇÎ Çxä° 4. IQVIA. National Prescription Audit Report. May 2021.

201-289-v2-A

June 2021

PRIORITY Report Volume 3 • Summer 2021

Endoscope Reprocessing &Infection Control

L Latest Multi-Society Reprocessing Guidelines Aim to Follow the Evidence G

D DDW 2021: Study Finds DisposableAAnd Fixed-End Cap Duodenoscopes EEqually Safe

Culture Club: What Gold-Standard Sampling, Culturing W PProtocols Mean for Your Center

D DDW 2021: Studies Explore Financial, EEnvironmental Costs of New Duodenoscopes

W PPE Practices in Endoscopy Will Change Permanently After COVID-19? C

I Improving Duodenoscope-Related Infection Control Requires a Multipronged Approach C

Hot Topics in Scope Reprocessing H

AACG Updates CRC Screening Guidelines

Can Infection Prevention Go Green? C

D DDW 2021: Duodenoscope Contamination Rates Vary Widely by Measurement Approach R

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Disclaimer—The reviews in this issue are designed to be a summary of information, and they represent the opinions of the authors. Although detailed, the reviews are not exhaustive. Readers are strongly urged to consult any relevant primary literature, the complete prescribing information available in the package insert of each drug, and the appropriate clinical protocols. No liability will be assumed for the use of these reviews, and the absence of typographical errors is not guaranteed. Copyright © 2021 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.

SUMMER 2021

Latest Multi-Society Reprocessing Guidelines Aim to Follow the Evidence Valuable updates but some areas of potential confusion ulti-society guidelines for reprocessing endoscopes date

back to 2003, but the latest iteration released in January

provides more evidence-based recommendations than before. Increased research on reprocessing of endoscopes triggered by infectious outbreaks related to contaminated duodenoscopes since 2014 provided data for the guidelines authors to develop a comprehensive document.

“There’s probably been more research into the area of endoscope reprocessing in the last five years than in the entire history of GI endoscopes,” said V. Raman Muthusamy, MD, MAS, the medical director of endoscopy at the University of California, Los Angeles Health. “Traditionally, there’s been this perception that if you follow the manufacturer’s reprocessing instructions, everything will be fine, but the outbreaks happened at very experienced, highvolume centers where they were following protocol and doing all the steps. They weren’t fine,” said Dr. Muthusamy, a co-author of the recently published guidelines (Gastrointest Endosc 2021;93[1]:11-33e6). “What we wanted to do [with this update] is provide evidence, as much as possible, to answer four key questions and provide guidance in many other areas.” see Guidelines, page 8

Endoscope Reprocessing & Infection Control

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SUMMER 2021

Guidelines continued from page 6 Emphasis on Training Emmanuel S. Coronel, MD, an assistant professor of medicine at The University of Texas MD Anderson Cancer Center, in Houston, said the new guidelines have some major improvements over the 2016 guidelines. “While the basic recommendations have not changed,” he said, “the new guidelines do a better job at explaining their recommendations and providing the best available evidence.” Dr. Coronel said he also appreciates the emphasis on staff training and competency, as well as the overall transparency of the guidelines. Noting that Table 3 of the guidelines is devoted to acknowledging areas that need more research, he said this underscores the recognition “that a lot of these recommendations are not final.” Despite the need for more data, he called the guidelines document “very comprehensive,” saying “if you study this guideline with your team, you should have a pretty good direction in how to manage your infection control team and your reprocessing steps for your scopes.” Lawrence Muscarella, PhD, the president of LFM Healthcare Solutions, agreed that the new guidelines contain a vast amount of important updated information, but he pointed out some specific changes he thought could be perceived as a rollback or can be misinterpreted.

Question About Intermediate-Level Disinfection Although the multi-society’s update defines what “semi-critical devices” are and recommends that they be sterilized or treated with a high-level disinfectant if sterilization is not feasible, it includes a clause stating that “some semi-critical and non-critical devices may undergo intermediate-level disinfection,” Dr. Muscarella said. “But this clause appears to be new—it’s not in any of the prior multi-society guidelines—and there’s no reference given for it and no description of the specific semi-critical devices the guidelines are referring to,” he added. “Guidelines are updated all the time, but if the rationale for the change is not provided, it can lead to some confusion in the context of reprocessing GI endoscopes.” The FDA advises thorough cleaning followed by intermediate- or low-level disinfection for non-critical items, not for semi-critical devices such as GI endoscopes, he added.

4 Key Questions 1.

Is it necessary or beneficial to repeat high-level disinfection?

There has been some debate about whether to run endoscopes through two rounds of cleaning, and even about what repeat cleaning means—is it going through both manual cleaning and the automated endoscope reprocessor (AER) twice, or just AER twice? “We specifically defined it as just running it through the machine twice, but found that [in a non-outbreak setting], there is no additional benefit compared with single high-level disinfection for reducing contamination rates for duodenoscopes, and not enough data to even comment on other endoscopes,” Dr. Muthusamy said.

Is ethylene oxide (EtO) sterilization better than a single round of high-level disinfection? At sites where outbreaks have occurred, EtO may be useful, but otherwise it’s not better than high-level disinfection. “Based on the evidence, EtO [sterilization of duodenoscopes] is not better for your patients’ safety than doing high-level disinfection well, and there’s not enough data on other types of endoscopes,” Dr. Muthusamy said.

How long can you store an endoscope before it needs to be put through a fresh cleaning cycle?

Especially in 2020, when elective procedures were put on pause, physicians worried about endoscopes becoming recontaminated while not in use. “The studies that investigated this were so variable we could not offer a blanket recommendation,” Dr. Muthusamy said. “So, we recommend assessing your own risks and benefits and developing a specific unit policy.”

What’s the best way to assess for contamination?

Although the use of microbiological testing of endoscopes is not clearly defined, it is the most commonly recognized technique for detecting bacterial contamination and probably is the best option available, Dr. Muthusamy said. “We recommend using proper technique defined by the FDA and the CDC.”

see Guidelines, page 10

Endoscope Reprocessing & Infection Control

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SUMMER 2021

Guidelines continued from page 8 Explaining the rationale for this guidance on semi-critical devices, lead author of the guideline Luke Day, MD, the chief medical officer of Zuckerberg San Francisco General Hospital, said several members of the group felt it was necessary to include some semi-critical devices. Dr. Day noted that the information “was taken from the CDC guidance document on disinfection and the Spaulding classification that states, ‘Some items that may come in contact with nonintact skin for a brief period of time … should be treated with intermediate-level disinfection.’ While the CDC states that this ‘brief period of time’ makes it a non-critical device, some debated that this meets the definition of critical,” Dr. Day said. “Hence, we said some semi-critical devices.” Dr. Muscarella observed that this confusion could have been eliminated if the new guideline had explicitly identified GI endoscopes as semi-critical devices. “All three of the earlier versions—2003, 2011 and 2016—clearly stated this, but not the 2021 guideline, paving the way for the confusion that ‘some’ semi-critical devices can be intermediate-level disinfected.”

Sterilization Versus High-Level Disinfection In a discussion of the use of EtO sterilization instead of high-level disinfection, the guidelines state that the former should be considered in selected settings (e.g., outbreaks) and patient populations. But this could appear to stray from the longstanding concept that all patients should receive the same standard of care, Dr. Muscarella said. “Ideally, we want one standard of care; we want it to be consistently high for all patients. We don’t really want to start choosing between disinfection or sterilization depending on what we think may be the status of a patient’s immune system, at least not without sound supporting evidence,” he said. “Otherwise, we can start getting into variations in care.” Dr. Muthusamy said there are no trials of patients in a non-outbreak setting in which the use of EtO has been shown to be better than high-level disinfection done properly. “But there are data showing that several institutions that had an outbreak were able to contain and stop

the outbreak when they switched to EtO.” He also noted that it is hard to recommend EtO because of issues of availability, toxicity, flammability and cost that make it unfeasible for some institutions.

Role of Alcohol in Drying Another area of potential confusion Dr. Muscarella discussed relates to drying of endoscopes. The new guidelines point out two benefits of using an alcohol flush in the drying process but ultimately conclude that the data to “strongly support or refute the use of alcohol flushes for the drying of endoscopes” are scarce. However, the 2016 guidelines endorsed the use of a 70% to 90% ethyl or isopropyl alcohol rinse followed by forced-air drying and cited several references to support that advice, Dr. Muscarella said. “Some other countries’ guidelines do not recommend using alcohol because of concern that it could present potential protein fixation risks,” he added. “I think it’s possible the 2021 guideline may be deferring to another country’s guidelines and practices. The protein fixative properties are valid, but I am unaware of any published reports linking those properties directly to a specific case of infection involving a GI endoscope, while many reports support the use of an alcohol flush and forced air to reduce the risk of an endoscope transmitting waterborne microorganisms.” Dr. Muthusamy agreed with Dr. Muscarella’s point that the potential problem of protein fixation is largely theoretical but said the evidence to support using alcohol in the drying process is not overwhelming. “We’re not arguing that you should or shouldn’t use alcohol, but [we] don’t see irrefutable benefit one way or the other,” he said. “Ultimately, given this uncertainty, we recommend individualizing your response based on what the manufacturer of your device advises. We would be happy to see further research in this area to make a more definitive recommendation in future guidelines.” —Monica J. Smith Dr. Coronel reported a financial relationship with BS. Dr. Muscarella reported current and/or recent financial relationships with companies that market single-use flexible endoscopes and/or products for low-temperature sterilization of reusable endoscopes. Dr. Muthusamy reported financial relationships with Boston Scientific (BS) and Medivators.

Endoscope Reprocessing & Infection Control

SUMMER 2021

Study Finds Disposable- and FixedEnd Cap Duodenoscopes Equally Safe

study comparing two new duodenoscope models with disposable end caps and a device with a fixed end cap

found the newer models do not present notable safety concerns. In the study, researchers led by gastroenterologists Thomas E. Kowalski, MD, and David E. Loren, MD, at Thomas Jefferson University Hospitals, in Philadelphia, compared the performance of the Olympus TJF-Q180V, a fixed-end cap device, and the Olympus TJF-Q190V and Fujifilm ED-580XT, two devices with disposable end caps, over 169 consecutive procedures. Reporting their findings at the 2021 virtual Digestive Disease Week (presentation 137), the researchers said endoscopy staff noted that devices with disposable end caps were easier to clean and that the Fujifilm’s device was cleaned 16 seconds faster than the Olympus disposable-end cap device. In four instances, clinicians were unable to complete a procedure using a device with a disposable end cap. The researchers deemed three of these instances to be the result of occlusive or obstructive duodenal strictures, not device failure. In the fourth instance, clinicians used the fixed-end cap TJF-Q180V device to complete the procedure. The researchers noted that the disposable end caps never dislodged during any procedure in which they were used. “The disposable-end cap duodenoscopes have adequate ergonomics without compromise of clinical performance in this initial experience,” they said. The results provide encouraging information about the overall safety and effectiveness of duodenoscopes with disposable end caps. But, in general, “whenever you have a new design,” you need to consider “what new risks could it be introducing that we need to become aware of and mitigate,” said Lawrence F. Muscarella, PhD, the

president of LFM Healthcare Solutions, who analyzes the causes of health care–associated infections. Recent reports in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database (bit.ly/3pJuFmy), “suggest two possible concerns here: dislodgement of the component and laceration of the mucosal tissue,” Dr. Muscarella told Priority Report, pointing to reports of tissue ending up in the disposable end cap. A related risk is that the bite block patients use during endoscopies can disappear temporarily, sometimes to be found later and other times not, he said. Laceration is perhaps the most serious issue with disposable end caps, according to Dr. Muscarella. “It could be that the distal end cap is more abrasive than we anticipated, compared to the fixed end cap,” he said, noting that more work is needed to test this hypothesis. Some evidence for it comes from the fact that Olympus issued a recall of the TJF-Q190V earlier this year and is investigating reports of mucosal injury with the device (bit.ly/3gg3k8y). (see related story, page 33). Dr. Muscarella offered straightforward suggestions for mitigating these potential risks. “During and at the end of the procedure, confirm that the cap is attached and that no tissue is within the single-use distal cover.”

Fujifilm ED-580XT

Olympus TJF-Q180V

—Marcus A. Banks Dr. Kowalski reported a financial relationship with Boston Scientific (BS). Dr. Loren reported financial relationships with BS and Olympus. Dr. Muscarella reported current and/or recent financial relationships with companies that market single-use flexible endoscopes and/or products for low-temperature sterilization of reusable endoscopes.

Endoscope Reprocessing & Infection Control

Olympus TJF-Q190V

SUMMER 2021

Will PPE Practices in Endoscopy Change Permanently After COVID-19? ill endoscopists keep their new habits when it comes to personal protective equipment (PPE) once the COVID-19 pandemic has ended? A survey of Canadian clinicians suggests they will.

A totall off 7777 respondents d ffrom across Canada, the majority of them gastroenterologists (70.1%), completed the survey, which was published in the Journal of the Canadian Association of Gastroenterology (2021;4[suppl 1]:31-32). The investigators found that most endoscopists (91.0%-93.9%) wore gowns in the prepandemic era and all wore gloves, but generally less than one-third wore surgical masks (20.9%-31.3%) and face shields (13.4%-33.9%). Even fewer wore eye protection (13.4%-21.3%) or hair protection (11.1%-12.5%), and a tiny minority used N95 masks (1.5%-3.2%).

Increased PPE Use Will Continue However, the surveyed endoscopists reported that they planned to continue with the more rigorous PPE practices they adopted during the pandemic when things return to a “new normal.” All endoscopists said they would fully gown and glove, with the majority indicating they will continue wearing surgical masks (87.7%-90.5%), face shields (57.8%-75.0%), and hair protection (50.8%-53.8%). Universal use of N95 masks will decrease, although it still will be far more common than before the pandemic (6.5%-23.7%), as will eye protection (36.5%-40.0%). “Over half of the respondents reported changing their practice from no masking prepandemic to implementing routine masking,” the investigators said. “Ongoing studies comparing the rates of transmission of hospital-acquired infections in the setting of endoscopy are needed to develop a new post-pandemic PPE consensus.” Many clinicians expected endoscopists in the United States to make the same long-term PPE changes as their northern neighbors. “For many practices, this was a wake-up call,” said Partha Nandi, the president and chief medical officer

off Michigan-based Pinnacle “We Mi hi b d Pi l GI GI Partners. P would always use surgical masks before, but now we universally use N95 masks. We all used gowns, but now we specifically provide uniform staff training in donning and doffing. We didn’t uniformly double glove, nor did we always use shoe covers, and now we are. At least for the rest of this year, and probably until next spring, I anticipate continuing with this level of PPE.” Industry expert Scott Fraser, the founding partner of the consultancy Fraser Healthcare and a board member at Pinnacle GI Partners, said many GI practices used a relatively minimal level of PPE before the pandemic started. “Given the fact that GIs are around blood, bile and stool every single day, it was somewhat alarming,” he said. “They would wear gloves and some form of gown, but not usually a level 3‒type OR gown that fluids can’t permeate, and very rarely face shields or masks.” At Austin Gastroenterology, in Texas, all staff—including physicians, technicians, nurses and CRNAs—always have worn level 3 gowns, and the technicians and physicians always have worn gloves, gastroenterologist Harish Gagneja, MD, told Priority Report. “But relatively few employed a surgical mask and even fewer any kind of face shield. At the beginning of the pandemic, we instituted a 100% strict rule of N95 masks for everyone in the practice, and since last March, we have completed over 15,000 procedures with no known transmissions of COVID-19.” With the entire practice now vaccinated, clinicians and staff members are permitted to return to using surgical masks, but Dr. Gagneja predicted that everyone will continue to use N95 masks for the foreseeable future. “At some point after we are much more sure the pandemic is waning—perhaps in five or six months—some

—Gina Shaw What PPE Protocols Are You Planning at Your Center? Please let us know. Email smtilyou@mcmahonmed.com

see PPE, page 16

Endoscope Reprocessing & Infection Control

SUMMER 2021

Hot Topics in Scope Reprocessing

hould you invest in forced-air drying cabinets for your surgical center? What’s the current status of simethicone use? Does sending your scopes

off-site for sterilization add a layer of protection against infection? These and other hot topics in reprocessing were on the agenda of a webinar on infection control for duodenoscopes, featuring experts Gregory Cote, MD, a professor of gastroenterology and hepatology at the Medical University of South Carolina, in Charleston, and Michelle Alfa, PhD, FCCM, a clinical microbiologist and professor in the Department of Medical Microbiology at the University of Manitoba, in Winnipeg.

What’s the Benefit of Forced-Air Drying Cabinets?

‘ The handheld air pistol

that flushes each channel independently takes 50 minutes to complete drying of all channels. ... You can’t do a fiveto 10-minute air flush and think you’ve got all endoscope channels properly dried.

’

—Michelle Alfa, PhD, FCCM, University of Manitoba

Forced-air drying cabinets push air through all endoscope channels to ensure that thorough drying occurs. Does that cut the risk for patient infection—which is, of course, the primary goal of reprocessing? Published clinical studies to date haven’t demonstrated that, Dr. Alfa said. “What they have shown is that this type of endoscope storage cabinet reduces the ability of any residual microbes to replicate within channels. If there are no microbes in the channels of an endoscope and it’s totally dry, that’s a pristine scope that can be used with confidence that it is not going to transmit exogenous microorganisms to the patient it is used on. Even if low levels of environmental organisms get into a reprocessed endoscope and it’s dry, they won’t replicate either, thereby reducing the risk of biofilm formation,” she added. Channel-purge drying cabinets help ensure there is no biofilm formation within endoscope channels, she explained, noting that several studies confirm there is no microbial replication or biofilm formation in endoscope channels that are properly dried or stored in a channel-purge drying cabinet. “There are also studies that have shown that if endoscopes are stored with moisture in the channels, then low levels of residual bacteria can form biofilm formation over time,” Dr. Alfa said. A 2018 survey of 249 U.S. endoscopy centers found that less than half of these sites used forced air to dry reprocessed endoscopes before storage

(Gastrointest Endosc 2018;88[2]:316-322.e2). “The authors commented on the widespread lack of compliance with endoscope drying guidelines, noting that it was shocking to see so few sites using forced-air drying,” Dr. Alfa said. Clinicians and reprocessing staff may believe that the alcohol flush and forced air drying at the end of an automated endoscope reprocessor (AER) cycle is adequate to meet manufacturers’ instructions for use [IFU] requiring thorough drying. However, the evidence shows otherwise. “Both Ofstead and colleagues and Barakat and colleagues have shown that endoscope channels have “widespread residual moisture … despite the use of an AER with an alcohol flush and dry cycle and being allowed to hang in a regular storage cabinet overnight,” Dr. Alfa said, referring to studies published in 2018 and 2019 (Am J Infect Control 2018;46[6]:689-696; Gastrointest Endosc 2019;89[1]:124-132.e2). “The data from these clinical studies awakened me and many others to the fact that adequate drying is not being achieved by the AER cycle.” Some centers may have their own individualized setups for forced-air drying, such as Rocky Mountain Gastroenterology (RMG), in Colorado. “When our centers were configured, we had a line put in for some nitrogen along with the oxygen piped into our cleaning room, so the staff is able to shoot some of that forced air through and dry the equipment,” Laura Falcon, BSN, RN, the administrator for RMG’s North Denver and Lakewood endoscopy centers, told

Endoscope Reprocessing & Infection Control

SUMMER 2021

Priority Report. “We did recently discuss whether we needed forced-air drying cabinets and it was determined that we did not because of what we already have in place.” But Dr. Alfa said automated drying equipment offers more protection. “The Barakat 2019 study found that automated drying with an air flushing pump is more effective than a staff person with a forced-air gun drying each channel for 10 minutes,” she said. “It’s clear that automation of drying improves the quality of the drying process. The channel-purge storage cabinets provide ‘engineered safety’ into the drying process, as it is automated and doesn’t rely on human factors.” If you are using handheld drying methods, time is of the essence—more time, not less. “Studies have found that when you use a handheld air pistol to flush each channel individually, it takes at least 25 minutes to get all channels dry with a multichannel connector,” Dr. Alfa said. “For the handheld air pistol that flushes each channel independently, it takes 50 minutes to complete drying of all channels. The bottom line is this: You can’t do a five- to 10-minute air flush and think you’ve got all endoscope channels properly dried.” She pointed to FDA postmarketing clinical findings from April 19, 2019, showing that up to 5.4% of properly collected samples tested positive for high-concern organisms despite full reprocessing. “Based on this data, it behooves all of us to ensure endoscope drying is done properly,” Dr. Alfa said. “Reprocessing personnel can do everything correctly up to this stage, but if the endoscopes are stored with moisture in their channels, then this will undo all their good work.”

How Vital Is Bedside Precleaning? Bedside precleaning is an absolutely critical step in reprocessing, according to Dr. Alfa. “In fact, precleaning and manual cleaning are the most crucial steps, according to a 2020 review from Marya and Muthusamy [Gastrointest Endosc Clin N Am 2020;30(4):665-675]. It’s the best opportunity to remove organic material and to reduce the microbial load on and in the endoscope before it has a chance to adhere. If the bedside cleaning is not done properly or not done at all, this makes the manual cleaning step more difficult and increases risk that it may not be done adequately. The downstream implication is that

the ability of organisms to survive high-level disinfection is enhanced if they are embedded in organic material.” This shouldn’t be new information to anyone in practice. Two of Dr. Alfa’s older studies, dating back as far as 1999, showed how the protein and bacterial levels were dramatically reduced by bedside cleaning (Am J Infect Control 1999;27[5]:392-401; Am J Infect Control 2013;41[5 suppl]:S56-S59). “The level of colonyforming units (CFUs) per square centimeter in clinically used endoscopes will vary somewhat based on the type of clinical procedure and the duration of the procedure,” she said. “Before the bedside clean, there was an average of 37 mcg/cm2 in colonoscopes and 11.3 mcg/cm2 in duodenoscopes; the highest protein level was 115 mcg/cm2. The bacterial load ranged as high as 7 logs/cm2. After the bedside clean, there was over 90% reduction in protein levels and at least a 2-log reduction in microbial levels. It is clear that the bedside preclean is an ideal opportunity to get rid of most of the organic material and microbes present in endoscope channels after a patient procedure.” In a busy practice, it can take some time to get to the high-level disinfection step. “Bedside precleaning is so important to begin the removal of bioburden and microorganisms,” Ms. Falcon said. “We’ve always done that in our practice.” Precleaning should be done in the procedure room, with the patient still on the table. “That means that I, as the physician, represent the primary challenge to completing this step well,” Dr. Cote said. “A doctor is in the middle of a procedure and needs to switch from one endoscope to a second and is anxious to continue with the process. That can sometimes put pressure on the technician or the nurse working with you at the table. It all comes down to teaching in the unit and empowering nurses and technicians to ‘take over the room’ at this juncture. They are the principal in this procedure and should feel that they have the authority to remind the physician of the importance of precleaning.” In Dr. Cote’s practice, technicians are required to take a minimum of one minute for bedside precleaning of a scope. “We don’t want them to feel like they have to rush. In fact, they can’t rush. It’s important for them to feel like they have that dedicated time to complete this essential task.”

Endoscope Reprocessing & Infection Control

After the bedside clean, there was over

90% reduction in protein levels and

at least a 2-log reduction in microbial levels. Sources: Am J Infect Control 1999;27(5):392-401; Am J Infect Control 2013;41(5 suppl):S56-S59.

SUMMER 2021

What’s the Impact of Simethicone?

‘ It all comes down to

teaching in the unit and empowering nurses and technicians to “take over the room” at this juncture. They are the principal in this procedure and should feel that they have the authority to remind the physician of the importance of precleaning.

’

—Gregory Cote, MD, Medical University of South Carolina

The antifoaming agent simethicone commonly is used in endoscopy practices to break up bubbles on the surface of mucosa, making visualization of polyps and abnormalities easier. “There is great clinical value in this, as it improves the detection of abnormalities in gut mucosa,” Dr. Alfa said. Although it is used more commonly for lower GI procedures and not as commonly for upper ones, simethicone residuals can be found in all types of scopes. That’s a problem because it is insoluble in water and alcohol. “Because its use flew under the radar for quite some time and it was not recognized as something routinely being introduced into endoscopes, the manufacturers’ IFUs and validation studies on cleaning and disinfection of scopes did not take into account the fact that simethicone residuals may be present,” Dr. Alfa said. “Simethicone isn’t going to be removed by current bedside clean, not by manual cleaning, or by processing through an AER and high-level disinfection. And when you are using forced air to dry endoscope channels, simethicone residuals [that are] present interfere with the efficacy of drying. In addition, if the simethicone concentration is high, it can cause blurring of the image seen through the endoscope lens.” The lower the concentration of simethicone used, the less residuals there are (Gastrointest Endosc 2019;89[1]:115-123), but even at the lowest concentration, droplets still remain. “There is clinical value in using simethicone to improve visualization of mucosal surfaces, but it is important to make sure to use at lowest effective concentration,

which is about 0.15%,” Dr. Alfa said. “I’m hopeful that we’ll find either cleaning methods that will remove simethicone or alternatives that are as effective as simethicone but can be removed by existing cleaning methodologies.” Fortunately, Dr. Cote said, most scenarios in which simethicone is preferred are those that do not involve more complex endoscopes. “It never occurred to me that use of simethicone would result in any issues with reprocessing, so my threshold to request it was extremely low,” he said. “There was a time when we routinely added simethicone to the flush for all colonoscopies because it was nice to have, but we’ve stopped doing that. We need to educate physicians that it is reasonable to use when necessary to improve mucosal visualization, but they should be mindful that it does add some issues with reprocessing, and technicians should be cognizant of reminding the doctor of the ability to dilute it while still retaining its effectiveness in getting rid of bubbles.” At RMG, they’ve largely cut out use of simethicone, Ms. Falcon said. “We have recommended instead that our patients take over-the-counter Gas-X [GlaxoSmithKline], to try to prevent the formation of the bubbles systemically. We haven’t yet done a study as to whether that has improved visualization.” —Gina Shaw The webinars were sponsored by Olympus. Dr. Alfa reported financial relationships with 3M, ASP, Kikkoman, Olympus, Ruhof and STERIS. She stated that the information provided for the Olympus webinar was based on published scientific data and her own opinion, not that of any company to which she provides consulting services. Dr. Cote reported financial relationships with AbbVie, Cook and Olympus.

PPE continued from page 13

Economic Considerations

of the techs and nurses may return to surgical masks, but most physicians I talk to say they will stick with the N95 masks for now.” Rajiv Sharma, MD, a gastroenterologist at Digestive Health Associates in Terre Haute, Ind., agreed. “We need to drive home the point that you have to be more careful protecting yourself in every way. I think everyone is now more cognizant of the importance of PPE in GI procedures and will continue to use appropriate gowns, masks and gloves aggressively to be safe.”

Increased consistent use of PPE is a trend that will add to operational costs for ambulatory surgery centers, Mr. Fraser noted. “If I’m a physician owner, what level of PPE do I feel safe with that’s not going to break the bank, and can I work with my commercial payors to get some type of supplemental coverage or relief ? I haven’t heard about being able to do this so far, but I hope that the economics and reimbursement structure will support continued improved PPE practices in a postpandemic world.”

Endoscope Reprocessing & Infection Control

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doscop e Repr ocessin g & In fectio n Con trol

, page

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SUMMER 2021

Can Infection Prevention Go Green?

ndoscopes are dirty—and not just from an infection standpoint. They’re dirty

because of how much their use and reprocessing contribute to hospitals’ waste and carbon footprints.

Each endoscopy bed generates nearly 7 pounds (3.09 kg) of waste every day, putting it in the top three of all hospital departments (Lancet Gastroenterol Hepatol 2020;5[7]:636-638). It’s easy to see where the waste comes from: disposable tools and protective gear, high-throughput caseloads, and use of large amounts of water and disinfectants during reprocessing. Some experts fear the waste problem in endoscopy could worsen, as the field moves more toward disposable products to reduce the risk for infection. The trend toward disposables is creating some tension between infection control and environmental protection, where emphasizing one may put the other at risk, said Nitin K. Ahuja, MD, MS, an assistant professor of clinical medicine and the codirector of the program in neurogastroenterology and motility at the Perelman School of Medicine at the University of Pennsylvania, in Philadelphia.

“I’m sympathetic to the thinking of people concerned with infection control, but it’s hard for those of us who are concerned about waste,” he said. “Is the disposable duodenoscope just another thing that’s going to end up in the ocean?”

Flying Blind When he first heard about the disposable duodenoscope, Bu’Hussain Hayee, MBBS, PhD, a consultant gastroenterologist at King’s College Hospital London, was very concerned. “A hospital like King’s, where I work, performs 1,000 procedures using duodenoscopes per year. This is a huge demand for disposable equipment, which I just cannot see being realistic,” he told Priority Report. “I have also yet to hear a convincing argument that this is sustainable at all.”

Endoscope Reprocessing & Infection Control

see Green, page 20

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Green continued from page 18 But there’s no way of knowing whether the alternative—reusable scopes that need reprocessing—has any less environmental impact, because of the lack of data comparing the footprint of reusable and disposable tools, Dr. Hayee said. Cleaning one endoscope uses between 90 and 100 L (22 gallons) of water, filtered using reverse osmosis to ensure purity, which consumes a lot of energy, he said. “Obviously single-use scopes do not need water to reprocess them, so there is that. But we can only incinerate used scopes; they can’t be recycled, so the impact is high.” The bottom line, Dr. Ahuja said, is that there needs to be more research about the environmental impact of the waste associated with endoscopy: disposable materials such as packaging, single-use instruments and personal protective equipment versus the water, detergents and decontamination employed during reprocessing of reusable instruments. “Certainly, more could be done to understand what percentage of resources in any given endoscopy [is] contributing to the global carbon footprint.”

Ideas for Reducing Waste Although the top contributors to carbon emissions are companies (https://bit.ly/3gVbYsh), individual providers and facilities can reduce waste, Dr. Ahuja said. He recommends that providers think deliberately about their use of accessories during procedures—such as using only one for a small and large polyp in the same colon—so there are fewer things to throw away or reprocess. Dr. Hayee’s practice has installed energy-efficient light bulbs and infrared faucets to control water flow in sinks and started emailing reports and digitizing information, rather than using paper. They also are recycling all noncontaminated waste, and using thermal compaction machines to deal with personal protective equipment and aprons that otherwise would be incinerated, creating an inert plastic “flock” they can sell to plastic manufacturers for reuse. The biggest step providers can take is to simply cut back on unnecessary procedures, Dr. Ahuja said—a particular problem for practices in which doctors are paid according to the number of procedures they perform. But, if a patient comes to him for a second opinion, he should not need to repeat the procedure that would inform his opinion. When seeing a new patient, some providers may redo a procedure instead of going through the administrative work of seeking out the patient’s medical records, he added. “That’s a cultural attitude that could probably change within gastroenterology,” Dr. Ahuja said. “Substantive change with regard to the carbon footprint of not just endoscopy, but medicine at large, would probably entail moving away from productivity as a primary incentive, and towards outcomes instead. And we would need to include environmental outcomes as part of the shared set of things we all care about as a professional community,” Dr. Ahuja added. “Green endoscopy ought to become a phrase that becomes a more common refrain within the practice of gastroenterology at large.”

Garbage generated in the reprocessing of one scope. Image courtesy of Ofstead & Associates Inc.

Endoscope Reprocessing & Infection Control

—Alison McCook Drs. Hayee and Ahuja reported no relevant financial disclosures.

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* As deﬁned by the American Society for Gastrointestinal Endoscopy ** Success rate based on number of procedures completed without having to change to a reusable duodenoscope.

Images owned by Boston Scientific. All trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France. Rx Only. Results from clinical studies are not predictive of results in other studies. Results in other studies may vary. © 2021 by Boston Scientific Corporation or its affiliates. All rights reserved. ENDO-1032501-AA

SUMMER 2021

Culture Club:

What Gold-Standard Sampling, Culturing Protocols Mean for Your Center

n 2018, a joint working group released new protocols for duodenoscope surveillance sampling and culturing, offering the first truly comprehensive, authoritative guide to sampling a scope to detect bacterial contamination after reprocessing. Why are these protocols such a big deal?

‘ If you’re not monitoring, you don’t

know for sure what’s going on inside the scope channel. By doing scope cultures periodically, it can help you rectify the problem before it becomes a persistent issue affecting a lot of people.

’

—Michelle Alfa, PhD, University of Manitoba, Winnipeg Michelle Alfa, PhD

The protocols—developed by the FDA, CDC and American Society for Microbiology (ASM) Working Group on Duodenoscope Culturing incorporating input from gastroenterology professional societies, reported experiences from U.S. hospitals and additional testing by duodenoscope manufacturers—are meant to provide a framework that facilities can use to measure the quality and adequacy of reprocessing (https://www.fda. gov/media/111081/download).

Inconsistencies in Culturing, Or No Culturing “If you look at the literature prior to 2018 and the culture positivity of patient-ready scopes, the ranges were all over the place,” said clinical microbiologist Michelle Alfa, PhD, who provided expert consultation to the FDA/CDC/ASM working group. “Many centers were testing and saying they found no contamination whatsoever, while others had 35% of their scopes growing organisms of concern.” In addition, “there was no standard approach see Culture, page 24

Endoscope Reprocessing & Infection Control

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Culture continued from page 22 to sample collection or to the culture methodology,” said Dr. Alfa, a professor in the Department of Medical Microbiology at the University of Manitoba, in Winnipeg. “Some sites were just using fluid flushing to collect samples; others used fluid flush and brush methods. The fluid used to collect scope samples could be a culture medium or it could be a buffer. There was a wide mix of approaches taken to obtain samples for culture, and no validated extraction protocol,” Dr. Alfa said during a webinar series on infection control of conventional duodenoscopes sponsored by Olympus.

‘ A sampling and culturing program is a

strong quality control check. If you can report back that X number of organisms were identified and Y number were pathogenic, that’s important for reference, especially in the context of a potential outbreak that could occur at your center.

’

Gregory Cote, MD

—Gregory Cote, MD, Medical University of South Carolina, Charleston

Beyond that, many facilities did not do any culturing. A 2016 survey of 249 U.S. health care facilities that use duodenoscopes showed only 53% conducted any form of surveillance microbiological culturing (Gastrointest Endosc 2018;88[2]:316-322). The working group protocols are meant to help address these gaps and inconsistencies that exist across health care facilities with respect to the sampling and culturing of duodenoscopes.

Putting the Protocols Into Practice The working group report provides an extensive list of materials required for sampling, as well as a highly detailed, step-by-step outline of the precise process—including post-sampling neutralization, transport, handling of the duodenoscope after sampling and documentation. “Neutralization is an important step,” Dr. Alfa said. “Organisms that go through high-level disinfection and sterilization are stressed and go

into a viable but nonculturable mode. You can collect them in the sample, but they often won’t grow in culture because they are damaged. Neutralizer inactivates any trace amounts of disinfectant, and also stimulates the growth of these organisms. Many protocols used in the past did not incorporate neutralization.” Sampling per the protocols calls for two staff members with duodenoscope experience, such as endoscope reprocessing technicians or endoscopy staff. The “sampler” maintains aseptic handling and conducts brushing steps, while the “facilitator” opens packages and handles the unsampled portions of the endoscope. A minimum of two scope sites should be used for the sample. For example, an instrument channel sample and an elevator recess sample could be combined into one sample, with a separate sample derived from the elevator wire channel for duodenoscopes with an open (unsealed) channel. The culturing guidance recommends that the entire sample should be concentrated for culture, with filtration as the preferred method, to ensure optimal sensitivity. The guidance clarifies that the culture protocol is not meant to identify all possible microbes that could be found on a duodenoscope. “[It is] intended to detect the most common high-concern organisms on reprocessed duodenoscopes, but these methods will not culture all microbes that could potentially contaminate a duodenoscope and cause infections … such as Haemophilus or Mycobacterium species,” the working group noted, adding that culture conditions may need to be revised for the sampling of additional types of endoscopes, such as bronchoscopes. In addition, if an outbreak of infection is linked to reprocessing endoscopes, the culturing method may need to be tailored to the suspected agent of infection.

Responding to Culturing Results After culturing, the protocols include a table of potential responses based on the quantity and types of organisms that have been isolated from the scopes, including removing a particular scope from use, conducting a risk/safety management response such as potential patient notification and follow-up, reviewing reprocessing practices

Endoscope Reprocessing & Infection Control

SUMMER 2021

and retraining staff, repeating reprocessing and sampling, and additional investigative activities. Isolation of a high-concern organism from a reprocessed endoscope warrants immediate removal of that endoscope from use, the working group warned, and it should be returned to use only after additional reprocessing, sampling and culturing return negative results and identify no breaches in reprocessing. Implementing the new protocols is a big plus for an endoscopy program, said Gregory Cote, MD, a professor of gastroenterology and hepatology at the Medical University of South Carolina, in Charleston. “A sampling and culturing program is a strong quality control check. It quantifies the job you’re doing in terms of reprocessing your scopes. If you can report back that X number of organisms were identified and Y number were pathogenic, that’s important for reference, especially in the context of a potential outbreak that could occur at your center. It’s also great feedback for your reprocessing team and your whole unit. And obviously, if you identify a contaminant, that scope would be reprocessed, recultured and retested, and you would, in theory, prevent the duodenoscope from being used on a patient with a pathogenic organism in it.”

Time and Resources Are Required But undertaking such a program is not without drawbacks. Beyond the added costs of sampling and culturing, it requires a sufficient inventory of scopes that can be pulled from use for the duration of the culturing process. “It adds personnel, as well,” Dr. Cote said. “You consistently have to engage infection control experts, who should be part of this, in addition to your internal endoscopy unit staff. And with all that effort, it’s very likely that you will identify some contaminants that actually came about as part of the reprocessing and culturing process itself. So, the impact on preventing patient infection—which is the goal—remains not clearly proven in my mind.” Dr. Alfa conceded that a good sampling and culturing program requires time and resources, along with dedicated training for the individuals collecting samples. “This can’t be done every day on every patient-used endoscope,” she said. “Sites need to be selective about taking realistic steps.” Many endoscopy centers are still undecided

Testing the Protocols

he working group had the three primary manufacturers of duodenoscopes in the United States test the new protocols by depositing small amounts of Staphylococcus aureus and Escherichia coli into specific areas of their scopes—the elevator recess, instrument channel and elevator wire channel (where applicable)—then sampling and culturing using the filtration and plating approach. Adherence to the protocols recovered between 65% and 100% of microbes placed on a duodenoscope, suggesting that the protocols can extract most—but not necessarily all—microbes on the device, according to the working group. (They emphasized that this intentional contamination of scopes to validate sampling and culturing methods is not an approach that should be used in facilities that treat patients.) —G.S.

about implementing such a process. At Rocky Mountain Gastroenterology (RMG) in Colorado, for example, “it was discussed and then sidelined for a bit, but this year we are going to be reevaluating putting it into place,” said Laura Falcon, BSN, RN, the administrator for RMG’s North Denver and Lakewood endoscopy centers. “Because we do not reprocess duodenoscopes in the ASC [ambulatory surgery center], that decreases the risk of potential transmission of bacteria.” But Dr. Alfa stressed the importance of such monitoring. “What I always say about this process is ‘you don’t know what you don’t know.’ Everybody involved in reprocessing believes they are following the manufacturer instructions and doing the best job possible,” she said. “But if you’re not monitoring, you don’t know for sure what’s going on inside the scope channel. By doing scope cultures periodically, it can help you rectify the problem before it becomes a persistent issue affecting a lot of people.” —Gina Shaw Dr. Alfa reported financial relationships with 3M, ASP, Kikkoman, Olympus, Ruhof and Steris. She reported that the information she provided for the Olympus webinar was based on published scientific data and her own opinion, not that of any company to which she provides consulting services. Dr. Cote reported financial relationships with AbbVie, Boston Scientific, Cook and Olympus. Ms. Falcon reported no relevant financial disclosures.

Endoscope Reprocessing & Infection Control

SUMMER 2021

Studies Explore Financial, Environmental Costs of New Duodenoscopes ew single-use duodenoscopes could have higher financial and

environmental costs than the reusable standbys at high-volume

endoscopy centers, according to two studies presented at the virtual 2021 Digestive Diseases Week (DDW). A third study found that improving provider awareness of the costs of the equipment they use is not easy.

In 2020, the FDA recommended that gastroenterology practices switch from entirely reusable to partly or wholly disposable scopes for endoscopic retrograde cholangiopancreatography (ERCP) to guard against infections. Now, manufacturers offer scopes with disposable end caps, fully disposable models, and even one that has a disposable elevator mechanism. The studies presented at DDW start to answer some of the myriad questions facing providers and health care systems about the newer scopes. “Disruptive technologies always make physicians and providers stop and think about the best way forward,” Vivek Kaul, MD, the Segal-Watson Professor of Medicine in the Division of Gastroenterology and Hepatology at the University of Rochester Medical Center, in New York, who was not involved in the studies, told Priority Report. Many unknowns remain—the pros and cons of disposable scopes for low-volume ERCP centers, the effectiveness of scopes with disposable end caps in reducing infections, the logistics involved in storing all these disposable scopes, and more, Jennifer Higa, MD, who also was not involved in

the studies, told Priority Report. “Overall, what we’re needing very desperately is more information on financial and logistical viability for implementing these technologies and the environmental impacts,” said Dr. Higa, an assistant professor of medicine in gastroenterology at Fox Chase Cancer Center at Temple Health, in Philadelphia.

A Financial Comparison Switching to entirely disposable duodenoscopes could be economically costly. At the University of California, Irvine (UCI), researchers compared the costs of ERCP performed with reusable versus single-use duodenoscopes at their high-volume academic center (presentation 135). In the analysis, UCI clinical research fellow Anastasia Chahine, MD, calculated the cost per procedure with a reusable duodenoscope by looking at scope price and cost for repairs and reprocessing over a two-year period. The researchers then compared that cost with the price of singleuse duodenoscopes.

Endoscope Reprocessing & Infection Control

see New Scopes, page 32

SUMMER 2021

Improving Duodenoscope-Related Infection Control Requires A Multipronged Approach Vivek Kaul, MD, FASGE, FACG, AGAF Seth A. Gross, MD, FACG, FASGE, AGAF

rug-resistant infections associated with duodenoscopes can occur during endoscopic retrograde cholangiopancreatography (ERCP), despite current reprocessing protocols. Advanced endoscopists perform more than 500,000 ERCP procedures annually in the United States, often for urgent, life-threatening conditions.1 Thus, minimizing or eliminating the risk for contracting infections from these procedures is critical.

Even when all guidelines are followed, reprocessing does not guarantee 100% removal of all organisms from duodenoscopes, and, thus, contamination from patient-ready duodenoscopes remains a concern. Preliminary findings from postmarket surveillance studies mandated by the FDA reveal that 9% of duodenoscopes remain contaminated after reprocessing.1 Subsequent studies demonstrate that even higher contamination rates are possible in this setting.2 The extent to which high-concern organisms on patient-ready duodenoscopes result in patient harm is not known, but outbreaks of multidrugresistant, carbapenem-resistant Enterobacteriaceae have been traced back to inadequately reprocessed duodenoscopes.3 After these outbreaks, in 2015, the FDA convened an expert panel from across the infection control, endoscopy, and medical device communities to devise effective strategies to reduce duodenoscope-related infections.4 Since then, the FDA has asked device manufacturers to collect and analyze postmarket data on reprocessing and develop

potential alternatives to traditional duodenoscopes. There is no simple answer to eliminating the risk for duodenoscope-associated patient infections. An all-encompassing solution is preferred but may not be realistic for gastroenterologists across various clinical settings with varying resources. To ensure patient safety remains a top priority, gastroenterologists will need to assess which reprocessing strategies or emerging technologies work best to minimize the risk for duodenoscope-related infection in their patients. Solutions will vary for gastroenterologists across clinical settings, but a multifaceted approach to patient safety is required for duodenoscope-associated infection to become a thing of the past. All physicians and clinical staff must adopt a strict, forward-thinking culture of safety that considers duodenoscope-associated infection to be possible but preventable.

Limitations of Reprocessing Flexible endoscope reprocessing includes 7 essential steps: manual precleaning, leak testing,

Endoscope Reprocessing & Infection Control

SUMMER 2021

manual cleaning, high-level disinfection (HLD), rinsing, drying, and storage. What is involved in these steps varies by the type of flexible endoscope, the manufacturer instructions for use, and society guidelines for infection control adopted by an institution. Reprocessing can take up to an hour or more to complete, whether it is a duodenoscope, a colonoscope, a bronchoscope, or other type of flexible endoscope. Reprocessing is driven by humans, who may not be able to comply with these complex processes for a variety of reasons, including inadequate training and lack of stringent protocols or supervision. Thus, there is an opportunity for human error, and quality assurance protocols should be in place to measure the success of reprocessing for each endoscope. How closely are reprocessing personnel following manufacturer recommendations for cleaning and disinfection? Are facilities culturing endoscopes after reprocessing to check for pathogenic bacteria? The CDC recommends that training for reprocessing personnel include explanations as to why each of the 7 essential steps—precleaning, leak testing, etc—are so important to reprocessing success.5 Staff also should be able to demonstrate the ability to adequately reprocess each specific type of endoscope they may be presented with in the reprocessing suite, according to CDC recommendations. It is well recognized that training for reprocessing personnel can be inadequate in some instances. In a 2018 survey conducted by Ofstead & Associates and the International Association of Healthcare Central Service Materiel Management, 70% of more than 2,300 surveyed sterile processing professionals reported they had received less than a week of training when starting their position.6 Despite these survey results, we believe most endoscope reprocessing units follow proper training protocols and provide supervision for this demanding work. For example, in large academic medical centers and hospital systems, rigorous protocols are in place in endoscope reprocessing rooms, which represent a significant investment on the part of these centers. Reprocessing personnel in these facilities undergo thorough training over many months and understand how important their job is in keeping endoscopes clean and patients safe. In addition to lengthy training by

device manufacturers and senior staff members, surveillance by internal infection control teams and external surveying bodies, such as the Joint Commission, help root out cleaning- and disinfection-related deficiencies. That does not, however, remove the potential that other human factors will affect the adequacy of reprocessing. We know there are times when a high volume of cases will demand unrealistic speed from reprocessing technicians, leading to the potential for errors or substandard cleaning. Reprocessing technicians in busy hospitals may be charged with cleaning up to 30 flexible endoscopes of varying design and complexity in a single shift, according to a recent study.7 The physical challenges inherent to this work and time demands may lead technicians to inadvertently skip steps, especially if there isn’t a full understanding about why every reprocessing step is essential to the procedure’s success.8 In addition to juggling these multiple tasks, technicians must keep track of various guidelines and instructions for use for the various types of endoscopes being cleaned.9 Based on the literature, it appears that most of the missteps likely occur during the manual cleaning step. Manual cleaning shortcomings could lead to inadequate HLD, even in an automated endoscope reprocessor (AER). In the United States, manual cleaning more often is done outside of an AER, with the machines reserved for HLD. Recent studies suggest the use of an AER can be as efficient as manual cleaning.7 However, as long as manual cleaning is done by endoscope reprocessing personnel, we believe regular retraining should include updated refresher courses on the proper procedures for manual cleaning to ensure continued compliance.

Problems Inherent to Design There also remains the issue of duodenoscope design. After all, it’s the unique and complex design of duodenoscopes that makes ERCP possible and effective as a therapeutic procedure. But the duodenoscope’s narrow channel, distal end cap, and elevator mechanism can potentially harbor pathogenic organisms. Debris or biofilm may be retained in these components, even when cleaning instructions are followed meticulously, potentially exposing patients to infectious agents. Studies have revealed contaminants in the working and suction

Endoscope Reprocessing & Infection Control

Vivek Kaul, MD, FASGE, FACG, AGAF Segal-Watson Professor of Medicine Division of Gastroenterology and Hepatology University of Rochester Medical Center Rochester, New York

Seth A. Gross, MD, FACG, FASGE, AGAF Professor of Medicine Clinical Chief Division of Gastroenterology and Hepatology NYU Langone Health New York, New York

SUMMER 2021

channels of duodenoscopes, including Escherichia coli cultured from a biopsy channel after a lethal outbreak.10 One study shows higher bacterial culture rates from a biopsy channel brush than from the elevator,11 although positive cultures do not always translate into clinical infection or patient harm, and vice versa. Advances in duodenoscope design that simplify cleaning and eliminate the need to reprocess endoscope components that are prone to contamination are essential to reduce infection risk. The FDA recommends that hospitals and endoscopy facilities transition away from fixedend cap duodenoscopes to those with newer design features that include disposable components or even fully disposable duodenoscopes.

Innovative Technologies Offer Multiple Solutions Several device manufacturers have updated duodenoscope designs, with the aim of limiting the risk for infection. The FDA cleared duodenoscopes with disposable end caps from Fujifilm, Olympus, and Pentax. In addition, Pentax also received clearance on a model with a fully disposable and replaceable elevator. Ambu and Boston Scientific released fully disposable duodenoscopes, designed for single use. Single-use end cap and elevator modules and single-use duodenoscopes help reduce the risk that contaminants remain lodged in the end cap and elevator mechanism. The impact of these novel devices on patient safety will become clearer with further use, study, and analysis. Preliminary research into these new disposable options is promising. Abstracts from the 2020 Digestive Disease Week point to cases in which disposable duodenoscope components greatly reduce contamination rates12 after reprocessing and potentially lower costs for hospital systems.13 Single-use duodenoscopes offer financial benefits. Although there is a need to purchase a new duodenoscope for every ERCP procedure, they eliminate all associated reprocessing and maintenance costs.14 Readily available and sterile endoscopes also can benefit smaller facilities that may lack reprocessing personnel and resources. In addition, disposable endoscopes potentially are useful in emergency department and ICU settings to facilitate urgent/emergent procedures

without the need to transport traditional reusable endoscopes and towers to those units. Gastroenterologists also must weigh the performance capabilities of these new options when assessing which developing infection control measures will be best for their practice. Since ERCP can be a technically challenging procedure in the best of circumstances, any design innovations to prevent cross-contamination after reprocessing also need to account for the procedure’s complexity. The duodenoscope functionality, image quality, performance characteristics, and handling are going to be very important to get the job done safely and successfully. As any gastroenterologist who has performed ERCP can attest, the functionality of the duodenoscope is essential for procedural success. Navigation to the major papilla needs to be atraumatic, seamless, and efficient. Then, during and subsequent to cannulation of the desired duct, the duodenoscope must be able to respond adequately to the fine movements required to avoid papillary trauma and procedural complications. Most studies on the performance of fully disposable duodenoscopes have been conducted at high-volume ERCP centers, with highly trained and experienced expert endoscopists using this new technology. Initial results suggest that fully disposable duodenoscopes intended for onetime use can be effective for ERCP. However, it remains to be seen whether these disposable duodenoscopes perform as well with less experienced/low-volume endoscopists at smaller facilities and in more complex procedures. Hospital systems and outpatient clinics will need to undertake extensive due diligence on the technological capabilities of these endoscopes, including image quality and functionality, as well as their financial and environmental impacts, before making a switch. Disposable endoscopy can offer many infection control and financial benefits, but gastroenterologists must explore the applications that make the most sense for their practice and facility as the technology continues to evolve.

Creating a Culture of Safety Despite strict reprocessing protocols, thorough training programs, and hardworking staff, errors do occur in the endoscope reprocessing pathway. We have discussed the various aspects relevant

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to this issue, including the importance of proper training, human factors related to compliance, and novel endoscope design/disposable endoscopes, each of which are important considerations in this realm. New technology should be evaluated in carefully conducted trials and adopted where it has transformational impact on patient care. Infection control related to ERCP should be a multifaceted approach, with hypervigilance and a culture of safety at its core. When using reprocessed duodenoscopes, facilities must adopt the strictest surveillance measures related to reprocessing, including optimal training of reprocessing personnel, while following FDA guidance. We believe institutions that have a culture of safety will be the most successful. In those institutions, it is less likely there will be clinically significant errors or negative outcomes that can be traced back to the reprocessing suite. All health care personnel working with duodenoscopes need to be hypervigilant and ensure maximum safety precautions are employed. Leadership is vital in making this message clear to staff, and all facilities should ensure that patient safety—not procedure volume—is the highest priority, always.

References 1. FDA. The FDA is recommending transition to duodenoscopes with innovative designs to enhance safety: FDA Safety Communication. Accessed January 31, 2021. https:// www.fda.gov/medical-devices/safety-communications/fdarecommending-transition-duodenoscopes-innovative-designsenhance-safety-fda-safety-communication 2. Mark JA, et al. Gastrointest Endosc. 2020;91(6):1328-1333. 3. CDC. CDC Statement: Los Angeles County/UCLA Investigation of CRE transmission and duodenoscopes. July 10, 2015. Accessed January 31, 2021. https://www.cdc.gov/hai/ outbreaks/cdcstatement-la-cre.html 4. FDA. Infections associated with reprocessed duodenoscopes. Accessed February 1, 2021. https://www.fda.gov/ medical-devices/reprocessing-reusable-medical-devices/ infections-associated-reprocessed-duodenoscopes 5. CDC. Healthcare Infection Control Practices Advisory Committee (HICPAC). Essential elements of a reprocessing program for flexible endoscopes, December 27, 2018. Accessed January 31, 2021. https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html 6. Ofstead CL, et al. PROCESS. 2019;July/August:61-71. 7. Alfa MJ, et al. Am J Infect Control. 2006;34(9):561-570. 8. Ofstead CL, et al. Gastroenterol Nurs. 2010;33(4):304-311. 9. Hildebrand EA, et al. Proc Hum Factors Ergon Soc Annu Meet. 2011;55(1):748-752 10. Snyder GM, et al. Gastroenterology. 2017;153(4):1018-1025. 11. Rauwers AW, et al. Gut. 2018;67(9):1637-1645. 12. Rao HB, et al. Gastroenterology. 2020;158(6):abstract Su1509. 13. Barakat M, et al. Gastroenterology. 2020;158(6):abstract 775. 14. Das A, et al. Gastroenterology. 2020;158(6):abstract Tu1963. Dr Kaul reported a financial relationship with Ambu. Dr Gross reported financial relationships with Ambu and Olympus.

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New Scopes continued from page 26

Jennifer Higa, MD Fox Chase Cancer Center

In total, the cost of one ERCP procedure using a reusable duodenoscope was $228.83. Meanwhile, the quoted price of a single-use duodenoscope was eight times more expensive at $1,950. One of the biggest limitations of the study is that it does not include the cost of duodenoscope-related infections. “That’s where the money adds up quickly,” Dr. Higa said. A 2017 modeling study found the cost of one carbapenem-resistant enterobacterales (CRE) infection ranged from $22,484 to $66,031 for hospitals, $10,440 to $31,621 for third-party payors, and $37,778 to $83,512 for society (Clin Microbiol Infect 2017;23[1];48.e9-48.e16). How much of the cost of the disposable scopes will be covered by insurance is an open question that could make the switch to the newer devices more or less feasible for centers, said Jason Samarasena, MD, a gastroenterologist and associate professor of medicine at UCI and a co-investigator on the study. In addition, Dr. Kaul said the results of this study are specific to a high-volume center, and the economic realities could be different for a center that only does a few ERCPs a year.

Environmental Impact Disposable duodenoscopes, by definition, can only be used once and don’t require the harmful chemicals involved in reprocessing, but they still carry real environmental trade-offs.

CO2 emission, kg

15 ■ Electricity during use ■ Infection treatment

■ Cleaning and disinfection ■ Disposal ■ Transportation

■ Duodenoscope manufacturing

Single-use duodenoscope

Reusable duodenoscope

Duodenoscope with disposable end cap

Figure. Comparison of the CO2 emission of an ERCP procedure using three types of duodenoscope, showing the contribution of different life cycle stages.

In a preliminary life cycle analysis (LCA), Lyndon Hernandez, MD, a gastroenterologist with GI Associates in Kenosha, Wis., worked with LCA expert Oliver Jolliet, PhD, a professor of environmental health sciences at the University of Michigan School of Public Health, in Ann Arbor, and a group of Dr. Jolliet’s students to evaluate the environmental impact of each major type of duodenoscope. In the study (presentation 479), the researchers estimated the carbon dioxide (CO2) emissions from the manufacturing, running, cleaning and disinfecting, transporting, and disposing of a reusable scope and a duodenoscope with a disposable end cap. They compared the results with the estimated emissions associated with the manufacturing, use and disposal of a single-use duodenoscope. They also included the carbon emissions of the number of ICU stays associated with a baseline infection rate of 0.09% for the reusable duodenoscope, and theoretical infection rates of 0% for the single-use option and 0.0045% and 0.0022% for duodenoscopes with disposable end caps. The model showed that using one completely disposable duodenoscope for one ERCP released 29.3 kg of CO2 (Figure). This is 20 times more than that released if a reusable duodenoscope (1.55 kg) or a duodenoscope with a disposable end cap (1.37 kg) is used. Nearly all of the emissions associated with a disposable scope (96%) are generated in the production of the device, including its largely nonrecyclable electronic parts, Dr. Jolliet said. These data are intended as a starting place to be followed up with a full life cycle analysis. Still, Dr. Jolliet said he thinks the general findings are applicable because the emissions from manufacturing one scope are so substantial. “This is a good starting point to raise the conversation about what impact single-use duodenoscopes and other disposable devices will have on the environment and the planet long term,” Dr. Kaul said.

Knowledge of Pricing To address a lack of awareness of many practicing gastroenterology providers at academic medical centers about about the cost of the equipment they use every day, researchers at University of North Carolina at Chapel Hill School of

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Duodenoscope Contamination Rates Vary Widely by Measurement Approach

new analysis evaluating rates of duodenoscope contamination,

ordered by the FDA and conducted by Olympus, found illness-causing bacteria, including “high-concern” organisms, in some reprocessed duodenoscopes.

The researchers noted that processes for determining duodenoscope contamination rates vary widely, making the results of different analyses hard to compare. The FDA order came in response to many reports, in 2015, of contaminated duodenoscopes produced by multiple manufacturers. Besides Olympus, Fuji and Pentax also were required to study contamination rates of their scopes (https://bit.ly/3zSP6SH). For this analysis, presented at the virtual 2021 Digestive Disease Week (presentation 134), Olympus studied contamination rates for more than 1,700 of its TJF-Q180V and TJF-160F/VF duodenoscope models. The study analyzed 859 TJF-Q180V scopes and 850 older model TJF-160F/VF devices. To control for the effects of age on contamination rates, every device was specially manufactured for this study. continued on page 34

Medicine tried a series of quality improvement interventions to boost price knowledge. Reasoning that the increased knowledge would lead to better choices of devices that providers use during endoscopic cases, Lisa Gangarosa, MD, a professor of medicine in the Division of Gastroenterology and Hepatology, and gastroenterology fellow Cary Cotton, MD, MPH, selected 20 devices and asked 38 GI fellows, attending physicians and endoscopy staff members to guess the cost the university system paid for each (presentation Sa104). At two locations, Dr. Gangarosa and her colleague posted pictures of the devices with their prices for 60 days. At the third site, they had hospital staff tell providers the cost of a device every time they asked for it over a 60-day period. Dr. Gangarosa then resurveyed the study participants. “Unfortunately, it was not a huge improvement,” she said. Nineteen people completed the

follow-up questionnaire, due largely to pandemicrelated delays and staff relocations. Participants guessed within 15% of the actual cost for 2.4 of the 20 devices at baseline and 4.6 devices at follow-up (P=0.01). They found that participants were within 30% of the actual cost for a mean of 3.8 devices at baseline and 6.1 devices at followup (P=0.04). The group that improved the most was endoscopy staff, Dr. Gangarosa said. Thinking about ways to improve the knowledge and awareness of the cost of medical care is a step in the right direction, Dr. Kaul said. “I think the era of cost-conscious, fiscally responsible medicine is upon us.” —Jillian Mock Drs. Gangarosa, Hernandez, Chahine, Higa and Jolliet reported no relevant financial disclosures. Dr. Kaul reported a financial relationship with Ambu. Dr. Samarasena reported financial relationships with ConMed, Cook Medical, Docbot, GI Supply, Mauna Kea, Medtronic, MicroTech, Motus, Neptune Medical, Olympus, Pentax and Steris.

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After the scopes were reprocessed, at 16 different medical facilities, investigators sampled and cultured them to determine if at least one bacterial colony had formed in any part of the scope. They followed FDA and CDC specifications during this step. Investigators especially looked for highconcern bacterial organisms or those associated with increased risk for disease. The investigators found that 35 TJF-Q180V devices (4.1%) Table. High-Concern Organisms and 56 TJF-160F/VF devices The guidance document defines high-concern organisms as those “that are more often associ- (6.6%) contained high-concern ated with disease.” They include the following: bacterial colonies and were considered contaminated. Gram-negative rods Lead researcher Ross David • Escherichia coli Segan, MD, MBA, the chief • Klebsiella pneumoniae or other medical officer at Olympus, Enterobacteriaceae • Pseudomonas aeruginosa suggested that improvements in instructions for use can help Gram-positive organisms ensure that duodenoscopes are • Staphylococcus aureus as free from contamination • Beta-hemolytic streptococci as possible. In a conversation • Enterococcus species with Priority Report, Dr. Segan Yeasts noted that Olympus has made Source: https://www.fda.gov/media/111081/download several changes to its newestgeneration duodenoscope, the TJF-Q190V, including simplifying the instructions for use and providing more visual aids for reprocessing staff. Noting that elevator channels are especially prone to contamination, Dr. Segan said Olympus also added a disposable end cap for the TJF-Q190V. Dr. Segan said Olympus plans to conduct a sampling and culturing study with the new TJFQ190V scopes, to see whether the changed design and enhanced instructions reduce contamination rates. However, the company issued a recall in January, after several reports of mucosal injuries associated with the TJF-Q190V duodenoscope’s distal cap (bit.ly/3gg3k8y). At press time, the recall—which did not result in the TJF-Q190V being removed from the market—was ongoing. As part of its recall notice to customers, issued on Feb. 5, Olympus provided instructions for safe use of the TJF-Q190V scopes.

Standardization Crucial For Validation Dr. Segan stressed that duodenoscope contamination rates vary widely in published studies, from

0.2% to 15% (Surg Endosc 2017;31[12]:51355142; Gut 2018;67[9]:1637-1645). This variation could indicate differences in stringency in defining high-concern organisms, as well as different sampling and culturing methods, he said. “Interpretation and comparison of literature reporting contamination rates should be done with caution. A simple change in definition or method may yield significantly different results, all other conditions being equal,” Dr. Segan said. Lawrence F. Muscarella, PhD, the president of LFM Healthcare Solutions, underscored the importance of standardizing these definitions and sampling methods when evaluating scopes for contamination. “If three different people perform the same study using the same methods, ideally all three have to get the same or comparable results. Otherwise, it’s not reliable,” Dr. Muscarella told Priority Report. He said the current FDA and CDC definitions of a high-concern organism (Table) are too nebulous, and that the culturing and sampling methods endorsed by the agencies make it possible for a scope to appear uncontaminated even if bacteria are present. He pointed out that an older duodenoscope might have tears or pockets that have collected illness-causing bacteria, which acceptable sampling and culturing methods might miss. Dr. Muscarella also noted that, to his knowledge, one of the organisms that the CDC classifies as high-concern—Staphylococcus aureus—has never been linked to any cases of patient-to-patient infection via a duodenoscope. One researcher might plausibly exclude S. aureus as an organism of high concern based on its lack of association with patient-to-patient infection, Dr. Muscarella said. Someone else could just as plausibly include it as a high-concern organism, based on the CDC’s imprimatur, he added. Such discrepancies will necessarily yield different contamination rates. “Just clearly define ... what are high-, moderate- and low-concern organisms,” Dr. Muscarella said, “and we all just stick to that.” —Marcus A. Banks Dr. Segan reported that he is an employee of Olympus. Dr. Muscarella reported current and/or recent financial relationships with companies that market single-use flexible endoscopes and/or products for low-temperature sterilization of reusable endoscopes.

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