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

Volume 3 â&#x20AC;˘ Winter 2021

Endoscope Reprocessing &Infection Control

Striving for Scope Safety

A Supplement to

COMING SOON

FROM THE MAKERS OF

201-28-v1

December 2020

WINTER 2021

EDITORIAL STAFF ADAM MARCUS, Managing Editor amarcus@mcmahonmed.com SARAH TILYOU, Senior Editor smtilyou@mcmahonmed.com JAMES PRUDDEN, Group Editorial Director ELIZABETH ZHONG, Senior Copy Editor KRISTIN JANNACONE, Copy Editor

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

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

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

McMAHON PUBLISHING Sales, Production and Editorial Offices: 545 West 45th Street, 8th Floor New York, NY 10036 Telephone: (212) 957-5300 Subscription: $95 for 1 year ($120 outside USA); Single Copies $15 ($20 outside USA) Copyright © 2020-2021 McMahon Publishing, New York, NY 10036. All rights reserved. Gastroenterology & Endoscopy News (ISSN 0883-8348) is published monthly by McMahon Publishing. Periodicals postage paid at New York, NY, and at additional mailing offices. POSTMASTER: Send address changes to: Gastroenterology & Endoscopy News 545 West 45th Street, 8th Floor New York, NY 10036

Letter to Editor To the editor:

“A

re the Towels in Your Hospital Really Clean? Investigators Find Dangerous Microbes” (Priority Report 2020;2[Summer]:48) might have better qualified its conclusions, included more details on quoted towel research, and covered the variety of factors that When en Doing oing Lau oi aund ndrry ry Isn n’tt Eno oug u h affect the cleanliness of mops and Wh Clean Cl Clea ea an tto tow o owe wels we lss ar are e clean, cle c an an, n, ri right? ight? ight ht? t? towels when they are used. The article states, “The situation S has left facilities scrambling for solutions,” implying they are compelled to curb the use of reusable mops and towels. No professionals from any such facilities are identified/quoted; thus, no such discontinuation is reported. The quoted towel study quantified heterotrophic, total coliform, aerobic spore-forming bacteria and fungi but didn’t list amounts of specific bacteria or fungi, except for Escherichia coli on one of 30 tested towels. Whether quantities found presented potential harm was not judged, although the absence of methicillin-resistant Staphylococcus aureus and Clostridioides difficile was noted. Researchers observed “significant differences among hospitals in the numbers and types of microorganisms recovered,” possibly explained by “substantial variation in laundering and cleaning among the hospitals.” The research did not address this variation at the sampled sites, revealing they may not have followed best laundry practices, such as the use of chemicals with high antimicrobial effectiveness. A more balanced article would have included the perspective of an expert in the laundering of health care textiles. Vo l u m e 2 • S u m m e r 2 0 2 0

everal years ago, a group of investigators set out to answer that at question. They collected three cleaned towels from each of 10

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

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

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

Endoscope Reprocessing & Infection Control

—Ken Koepper Director of Membership/Industry Outreach TRSA Alexandria, Va.

Disclaimer—The reviews in this issue are designed to be a summary of information, and they represent the opinions of the authors. Although detailed, the reviews are not exhaustive. Readers are strongly urged to consult any relevant primary literature, the complete prescribing information available in the package insert of each drug, and the appropriate clinical protocols. No liability will be assumed for the use of these reviews, and the absence of typographical errors is not guaranteed. Copyright © 2020-2021 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.

Endoscope Reprocessing & Infection Control

PRIORITY Report Volume 3 • Winter 2021

Endoscope Reprocessing &Infection Control 6

Checklists Pare Procedure Delays C

Q Q&A EErgonomics in Endoscope Reprocessing: Why It’s So Important

F Farming Out Sterilization Can Work FFor Some Physician Practices

TThe View Inside: 25

New N ‘Test Article’For Visualizing Scope Drying Shows Flaws in Usual Practices D

E Endoscopic Accessory Disposal: TToo Conservative, Too Costly?

A 2020: Novel Scope ACG With Disposable Elevator Cap W Might Be Answer to Infection Risk M

G Gaps Seen Between Confidence AAnd Knowledge Among Endoscopy TTechs, Nurses

A 2020: Video Capsule Endoscopy ACG FFor GI Bleeding Reduces Need FFor Invasive Procedures

I Infection Control in Endoscopy Centers in the Time of COVID-19 C

A 2020: Study Finds Check ACG Of Assembled Scopes Warranted O

A Quality Systems Approach TTo Scope Reprocessing

A 2020: Survey of GIs Indicates ACG Receptiveness to Single-Use Scopes R

Cause of Death: Unknown C TThose due to infections often are undercounted.

Sterile. Single-Use. Problem Solved. Ambu® aScope™ Duodeno For decades, interventional endoscopists have used duodenoscopes to perform lifesaving ERCP procedures. There is, however, growing concern that even with the most stringent cleaning procedures, patient cross-contamination can occur with reusable duodenoscopes. The new Ambu® aScope™ Duodeno is a single-use duodenoscope for ERCP procedures. The aScope Duodeno is familiar in form and function, delivering reliable performance for you. With the aScope Duodeno, you get a brand-new, sterile duodenoscope straight from the pack every time. Our single-use endoscopes are trusted by more than 3,800 hospitals worldwide.

To learn more or schedule a product demo, visit ambuUSA.com/single-use-duodenoscope

496 5205 31 - V01 - 11/2020 - Ambu Inc. - Technical data may be modified without further notice.

US: Rx only

WINTER 2021

Checklists Pare Procedure Delays

preprocedure checklist written collaboratively

by charge nurses from Mayo Clinic’s gastrointestinal endoscopy and medical care units significantly reduced the number of canceled and rescheduled procedures and enhanced staff communication and satisfaction during a pilot study.

The Mayo Clinic team compared procedure cancellations and other factors before and after implementation of the checklist in a study published in Gastroenterology Nursing (2019;42[1]:79-83). They found that of 25 endoscopy procedures scheduled during the prepilot period, six were rescheduled and five were canceled, leaving only 14 procedures completed. In the comparative post-pilot period, 42 of 51 scheduled procedures were performed, with 10 not completed (eight rescheduled, two canceled). Nineteen more procedures were added to the schedule and completed during the pilot period, for a 21% total increase in endoscopy procedure completions.

Of the 14 charge nurses who completed a survey after the pilot study, 79% agreed that the checklist helped reduce procedural delays, 71% agreed that it improved communication and 57% agreed that it contributed to safe patient care. “Initially, this project stemmed from staff voicing ideas for quality improvement and keeping the patient flow consistent throughout the day. We had many applications that weren’t interfaced between the procedural area and the inpatient units, so we were struggling with patients being appropriately prepped for GI procedures,” explained Susan Wittren, MSN, RN, the nursing supervisor at Mayo Clinic in Rochester, Minn. “Patients would come down see Checklists, page 8

Endoscope Reprocessing & Infection Control

VERIFY THAT YOUR ENDOSCOPE LEAKAGE TESTER IS WORKING PROPERLY. TEST THE FUNCTIONALITY OF AUTOMATED & HANDHELD ENDOSCOPE LEAKAGE TESTERS WITH HEALTHMARK’S NEW LEAK TESTER TESTER.

THE LEAK TESTER TESTER IS OFFERED FOR THE FOLLOWING LEAKAGE TESTERS: • • • •

Olympus Automated Leak Tester Olympus Handheld Tester Pentax Handheld Tester Karl Storz Handheld Tester

The Leak Tester Tester assists in reducing ƚŚĞ ƉŽƚĞŶƟĂů ĨŽƌ ĐƌŽƐƐͲĐŽŶƚĂŵŝŶĂƟŽŶ͕ ĚĂŵĂŐĞ ĂŶĚ ĐŽƐƚůǇ ƌĞƉĂŝƌƐ ƚŚĂƚ ƌĞƐƵůƚ ĨƌŽŵ using an endoscope with leaks.

^ŝŵƉůǇ ĂƩĂĐŚ ƚŚĞ ĚĞƐŝƌĞĚ >ĞĂŬ dĞƐƚĞƌ dĞƐƚĞƌ ƚŽ ǇŽƵƌ ĨĂĐŝůŝƚǇ͛Ɛ ĞŶĚŽƐĐŽƉĞ ůĞĂŬ ƚĞƐƚĞƌ͕ ƚƵƌŶ ŝƚ ŽŶ Žƌ ƉƌĞƐƐƵƌŝǌĞ ƚŚĞ ďƵůď͕ ĂŶĚ ƌĞĂĚ ƚŚĞ ƉƌĞƐƐƵƌĞ ŽŶ ƚŚĞ ŐĂƵŐĞ͕ ǁŚŝĐŚ ŐŝǀĞƐ Ă ƋƵŝĐŬ ĂŶĚ ŽďũĞĐƟǀĞ ƌĞƐƵůƚ ŽĨ ƚŚĞ ĂŵŽƵŶƚ ŽĨ Ăŝƌ ďĞŝŶŐ ĞǆƉĞůůĞĚ ĨƌŽŵ ƚŚĞ ůĞĂŬ ƚĞƐƚĞƌƐ͘

INTELLIGENT SOLUTIONS FOR INSTRUMENT CARE & INFECTION CONTROL HMARK.COM | 800.521.6224

For more innovative tools to help effectively manage the proper reprocessing of endoscopes, visit

HEALTHMARKGI.COM

WINTER 2021

Checklists continued from page 6 to the procedural area having eaten breakfast, or with a heparin drip still going.” During the pilot process, the charge nurse in the GI endoscopy unit would initiate a morning report telephone call to the charge nurse in the inpatient unit, during which the RNs would verify that patients met the essential requirements for their upcoming procedures. Items on For example, if a patient is the checklist included scheduled for a colonoscopy, critical laboratory valthe questions will include: ues, nothing-by-mouth (NPO) status and antiDid the patient take full prep?  coagulation therapies What are the results of the prep?  ordered by physicians. “The weekly pilot sumIs the patient oriented times three?  mary reports incorHave they signed consent?  porated statements of positive reinforcement, What is their NPO status?  which were given when What is their oxygen status?  the units achieved stated Have you checked recent lab work?  outcomes,” Wittren and her co-authors wrote. Have medications such as insulin  Since the original pilot or anticoagulants been held? study, the checklist has been fine-tuned to be even more GI specific, and has been expanded from the original single inpatient unit for use hospital-wide. “It originally took about 10 minutes to go through the checklists, but with experience, it has become a fairly quick process and only takes a couple of minutes per unit first thing in the morning,” Wittren said. Working with administrative staff at St. David’s Medical Center, in Austin, Texas, clinicians at Austin Gastroenterology have implemented a similar checklist system based on the SBAR (situation, background, assessment, recommendation) approach for facilitating communication, and found it advantageous, said gastroenterologist Harish Gagneja, MD, of Austin Gastroenterology. “While we have not published anything, we do know that our cancellation rate for procedures has gone down, and we have excellent communication with nurses from different parts of the hospital.”

If, for example, a patient is scheduled for a colonoscopy, the questions will include whether or not the patient took full prep, the results of the prep, whether the patient is oriented times three, and whether they have signed consent. It also includes NPO status, oxygen status, recent lab results, and whether medications such as anticoagulants or insulin have been held. “If a patient is in isolation, we will also discuss related arrangements, such as terminally cleaning the room after their procedure or scheduling that patient as the last case of the day,” Gagneja told Priority Report. The checklist process typically is done between 6 and 7 a.m., allowing enough time to change the sequence of procedures, if necessary, to prevent cancellations. “If the patient’s prep was not done right, or is unclear, then we can intervene to complete the prep in the morning and do the procedure four hours later, rather than having to reschedule for another day,” Gagneja said. At ProHealth Care Associates, in New York, booking sheets are incorporated into the electronic health record, and the checklists begin with a nursing call to the patient two days before a scheduled procedure. “For colonoscopy preps, a lot of patients think they know what to do but don’t realize when they need to start— kind of like kids leaving their homework until Sunday night,” said Matthew McKinley, MD, the co-chief of the Division of Gastroenterology at ProHealth Care Associates’ facility in Lake Success. “The nurse ensures that the patient has started their two-day prep, or if they are ready to start their one-day prep tomorrow. Do they have the prescriptions? Do they have their instructions?” Going over such a checklist with patients ahead of time also improves the quality of prep and decreases cancellation rates, McKinley said. “We noticed a tremendous improvement in completed preps once we instituted this process, and if we ever notice problems with scheduling, no-shows and cancellations, it’s almost always because we’re a little short-staffed and those twoday calls weren’t carried out.”

Endoscope Reprocessing & Infection Control

—Gina Shaw

Complete archives Web-only content Multimedia And more â&#x20AC;Ś

WINTER 2021

Farming Out Sterilization Can Work For Some Physician Practices Process efﬁcient for many y instruments but not endoscopes

n increasing number of patients are seeking care at physician-based practices, which use

many of the same instruments hospital practices use—including reusable endoscopes and surgical equipment such as forceps, which must be sterilized. But these busy practices often lack the training and resources to properly sterilize these tools. Sensing the potential risk, an infection preventionist and her colleagues at Thomas Jefferson University Hospital took action. Working with six physician-based practices under Jefferson’s license, the researchers created a program that enabled the clinics to farm out sterilization to the hospital, with a strict turnaround time of 48 hours. It wasn’t easy, admitted Kelly Zabriskie, CIC, the director of infection prevention at Thomas Jefferson University Hospital, in Philadelphia. Physicians were understandably concerned about sending away their equipment, trusting it would return on time; all six clinics had to purchase additional instruments to cover the gap. But now, Zabriskie said, it feels good knowing the materials are being properly reprocessed in a centralized hospital setting, with dedicated staff. “Centralized sterilization takes the responsibility away from the practices and utilizes the resources at the hospital,” she told Priority Report. Physician-based practices “should be concentrating on patient care. They shouldn’t be worrying about reprocessing instruments, unless they have the proper setup and the properly trained people to do that job.”

Endoscope Reprocessing & Infection Control

WINTER 2021

The idea for the program came about after various specialty clinics came under the Jefferson license several years ago. When Zabriskie and her colleagues evaluated the reprocessing practices at the clinics, they realized that decentralized reprocessing, with small autoclaves present at each office, was difficult to oversee. Although she wasn’t aware of any infections that directly resulted from problems with reprocessing, she said the team believed they “needed to keep a better handle on” how the clinics were cleaning reusable equipment. “I want to feel confident saying that I’m comfortable with the processes in place,” she said. Although no agency systematically tracks infections from outpatient practices, there have been reports in the literature (JAMA 1991;265[18]:2377-2381); between 1998 and 2008, 33 outbreaks of hepatitis B and C occurred in health care settings outside the hospital (Ann Intern Med 2009;150[1]:33-39). So, Zabriskie and her team decided to centralize the sterilization process (2019 meeting of the Association of Professionals in Infection Control and Epidemiology; abstract ADS-51). They removed all tabletop autoclaves and sterilization practices from the physician-based practices, provided the practices with locking biohazard bins, and bought a temperature-controlled truck with clean and dirty areas that transport the instruments between the practices and the hospital. Infection preventionists met with the leadership team at each clinic to set up times when the truck could feasibly pick up and drop off the instruments. This part was less challenging than Zabriskie had anticipated: “I thought the scheduling would be the hardest part,” she said. Of course, parking such a large vehicle in the city was always an issue. In the end, the hospital always met the 48-hour turnaround time, despite bad weather, power outages and other unplanned events, Zabriskie said.

Endoscopes Required A Different Approach Transporting endoscopes in the truck proved too challenging, given their delicate nature and the quick turnaround time, so the clinics ended up having to hire two technicians and purchasing a low-temperature sterilizer that was appropriate for their scopes and did the reprocessing on site.

Centralization Is Not for Everyone “Do we expect everyone to do it? No,” said Sylvia Garcia, MBA, RN, CIC, the infection prevention and control director at the Joint Commission. “In some cases, it just doesn’t work.” Some sites may be too far from a central reprocessing location, or have so few instruments that they cannot afford to send them away for any period of time. Some physicians are also very possessive of their instruments, and don’t like the idea of sharing with others or sending theirs away. “There are ways around that,” Garcia said, such as adding labels to individual pieces. Physician-based practices considering whether or not to centralize should think about all these factors, including the cost of disposables and training a person to do the job in-house. “Whatever works for the organization is what we want the organization to do,” she said. Physician-based practices “need to look at the risk. They need to be aware of the risk, and they need to make sure they have solid practices and solid staff.” Zabriskie said she believes farming out instrument sterilization to a central location is a good idea, particularly when clinics are clustered around a central hospital, and sites are relatively close to each other. “This helps us to keep a tighter control over the reprocessing at the practices that are not located at the hospital proper,” she said. “I think we are very fortunate that we had such a great team between the hospital, the sterile processing department and the practice leaderships to be able to make this model work. It may not be as feasible for practices that are not associated with a hospital or within a close proximity, but I do think it is a great model.” “I think centralization is a great idea,” Garcia told Priority Report. She noted that she’s seen more companies embracing the idea, which has been used in Europe, with facilities under a public health care model sending their equipment to a centralized reprocessing area. In the United States, some large companies in the sterilization industry are providing fee-forservice sterilization; facilities can send their own equipment or rent items that are reprocessed at a central location. —Alison McCook Zabriskie and Garcia reported no relevant financial conflicts of interest.

Endoscope Reprocessing & Infection Control

WINTER 2021

re you disposing of your endoscopy unit’s medical waste properly? A study from Gastroenterology Nursing

suggests that the answer is probably no. A survey of more than 1,000 endoscopy professionals showed that 58% of staff members and 65% of gastroenterologists handled simple endoscopy accessories as regulated medical waste (RMW) instead of regular trash, while 27% of respondents discarded endoscopic accessories as sharps—although they are not considered sharps (Gastroenterol Nurs 2017;40[1]:13-18).

The Occupational Safety and Health Administration Defines RMW as: •

liquid or semiliquid blood or other potentially infectious materials (OPIM);

•

contaminated items that would release blood or OPIM in a liquid or semiliquid state if compressed, such as blood-soaked gauze;

•

items that are caked with dried blood or OPIM and could release these materials during handling;

•

pathologic and microbiological wastes containing blood or OPIM; and

•

sharps, such as needles, syringes with needles attached and scalpels, which should be disposed of in designated sharps containers.

see Disposal, page 14

Endoscope Reprocessing & Infection Control

e-Newsletter

In Your Inbox

OPT IN

to receive your

free e-newsletter from the best-read* t l gastroenterology

publication in the country

Articles from the current monthâ&#x20AC;&#x2122;s issue Articles ahead of print Web-exclusive content

GastroEndoNews.com/enews *Based on data from Kantar Media, December 2019

WINTER 2021

Disposal continued from page 12 There are three primary categories for medical waste disposal: regular trash, RMW to be disposed of in red biohazard bags, and RMW to be disposed of in sharps containers.

‘ Our endoscopy unit is almost a needleless division; we

very rarely use needles. But probably about half of providers and nurses would just throw needleless syringes into the sharps container.

’

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

So what’s the problem with erring on the conservative side, categorizing more items as regulated waste? The cost and environmental impact of disposal. According to the investigators, it is estimated that RMW should make up no more than 7% of total medical waste, but it accounts for 50% to 70% of waste for many hospitals. They noted that RMW disposal costs 10 to 20 times more than less regulated waste, primarily because further steps—incineration or autoclaving—“are taken to render this waste noninfectious.” In addition, they pointed to the “significant environmental impact” of incineration due to the generation of “ash and exhaust gases, which may contain very toxic chemicals.” Lead author Deepak Agrawal, MD, MPH, an associate professor of gastroenterology and hepatology at Dell Medical School at the University of Texas at Austin, investigated waste disposal practices in endoscopy units after observing gaps at his own institution. “Someone would pick up an ERCP [endoscopic retrograde cholangiopancreatography] wire, and I would watch where they would throw it,” he said. “More often than not, it would be in the sharps container. When I asked why, I would be met with a quizzical look and a response to the effect of ‘This is what I’ve always done.’ But what is sharp in an ERCP wire? The definition of a sharp is that it can draw blood, and a wire cannot.” The survey found that significant percentages of gastroenterologists, nurses and endoscopy technicians would dispose of endoscopic

accessories such as snares, dilating balloons and sphincterotomes, as well as wires, in the sharps container, although none of those meet the definition of sharps. Asking up the chain of command and in different departments—such as the nursing supervisor, housekeeping staff and sustainability staff—he learned that there was no consistent or comprehensive education on disposal of these items, a finding that was later reflected more broadly in the survey results, with only seven respondents (0.6%) having a good understanding of disposal costs and all but 23 (2%) saying medical personnel should be better informed about medical waste. “Where there is education, it mostly defaults to being extremely conservative,” Agrawal said. “Syringes are a perfect example. Our endoscopy unit is almost a needleless division; we very rarely use needles. But probably about half of providers and nurses would just throw needleless syringes into the sharps container.” The costs to a health system of improper waste disposal can be astronomical. Agrawal’s study reported that while regular trash disposal costs approximately “$0.03 to $0.1 per pound,” the cost of sharps disposal can range up to $2 per pound. Citing a 2012 issue brief from the Commonwealth Fund, the investigators noted that if hospitals nationwide adopted recommended waste management interventions, the five-year net cost savings would exceed $700 million. Harish Gagneja, MD, a gastroenterologist with Austin Gastroenterology, in Texas, said the survey’s findings were consistent with what he sees in practice. “When I read the whole study, I learned a few things myself—not about what goes where, but about the cost of disposal,” he said. “I was not aware that there is so much difference between disposal costs among different categories. I think that waste disposal education, both on infection risk and cost, is a must in all gastroenterology departments. We should all be very cognizant of this as we focus on cost and resource utilization.”

Endoscope Reprocessing & Infection Control

—Gina Shaw Agrawal and Gagneja reported no relevant financial conflicts of interest.

DESIGN YOUR OWN

ENDOSCOPY SINK

We know one size doesn’t fit all. That’s why TBJ will work with you to customize a sink to fit your specific space and equip it with the options and features you need to process scopes safely and efficiently.

Notable optional features include: - Integrated Scope Buddy™ Plus Flushing Aid - Automatic push-button sink filling - Water temperature monitoring - Overhead lighting and task lighting/inspection options - Numerous faucet and fixture options - Push-button height adjustment - Storage and shelving options - Single, double and triple bowl configurations

More Choices · More Features Visit www.tbjinc.com or call 717-261-9700

WINTER 2021

Reports From ACG

Novel Scope With Disposable Elevator Cap Might Be Answer to Infection Risk

duodenoscope with a disposable elevator cap performed well in a multicenter prospective study,

bringing this device, with the promise of reduced risk for endoscope-related infection outbreaks, a step closer to routine applications. “Most endoscopists with varying level of experience could easily complete various complex ERCP [endoscopic retrograde cholangiopancreatography] tasks with the DEC duodenoscope,” reported Nirav Thosani, MD, the director of advanced endoscopy at the University of Texas Health Science Center, in Houston. This study, called the DECap trial, did not determine the extent to which the cap reduces the risk for duodenoscope contamination or, more importantly, the infectious Table 1. ERCP Maneuvers outbreaks related to incompletely sterEvaluated by Endoscopists ilized duodenoscopes after ERCP. The study simply confirms that a device Biliary or pancreatic tissue sampling with a disposable elevator cap perCholangioscopy or pancreatoscopy forms well. Ease of attempting cannulation In this prospective multicenter Electrohydraulic or laser lithotripsy trial, which was presented at the Large balloon sphincteroplasty 2020 annual meeting of the American College of Gastroenterology (abstract Mechanical lithotripsy 52), 200 consecutive ERCPs were Metal stent placement performed for various indications. FelPlastic stent placement lows performed more than one-third Sphincterotomy of the procedures. Stone removal with balloon sweep On the basis of the ASGE scoring, 134 of the procedures were of grade

2 complexity; 33 were grade 3; 30 were grade 4; and three were grade 1. The average cannulation time was 5.2 minutes (range, 1-60 minutes), and the average time to complete the procedure was 26.1 minutes (range, 5-92 minutes). Although the devices were not compared with conventional duodenoscopes, the endoscopists appeared to find the performance characteristics comparable to those observed during past experiences with other devices. For 10 specific maneuvers (Table 1), the endoscopists rated the scope’s performance as “met expectations,” “improvement needed,” or “unsatisfactory.” Evaluating the scope during the most performed maneuvers, such as ease of attempting cannulation or stone removal with balloon sweep, 100% of participating endoscopists reported that the device met expectations. In a few cases, such as tip control and ability to examine the mucosa, fewer than 1% advised that improvement was needed, but no one considered performance to be unsatisfactory. Plastic stent placement was associated with the lowest level of satisfaction. For this maneuver, 3% of the endoscopists graded the device as “improvement needed.” Although this meant that 97% considered the device to have met

Endoscope Reprocessing & Infection Control

WINTER 2021

expectations, the figure was lower than the 99% traditional duodenoscope or one with a disposto 100% who concluded that expectations were able cap (BMC Gastroenterol 2020;20:64). The primary end point consists of persistent bacterial met for the other nine maneuvers. Nurses and technicians rated the overall perfor- contamination after traditional automated repromance of the modified duodenoscope for various cessing and ERCP technical success. “Persistent microbial contamination rate is, preprocedural, intraprocedural and postproceat this point, the best end point we have in predural tasks as 97% to 99% (Table 2). Ultimately, experts hope that the disposable dicting the potential infection transmission risk elevator cap will help reduce the vexing outbreaks of a duodenoscope,” said Nauzer Forbes, MD, of infection associated with contaminated duo- the director of the therapeutic endoscopy traindenoscopes. These outbreaks have been reported ing program at the University of Calgary, in even after duodenoscope processing had been con- Alberta, and lead investigator on the ICECAP trial. He acknowledged that persistent microsidered adequate. The source of the contamination, according bial contamination is “by no means a definitive to multiple studies and evaluations, has been end point,” but it is a practical end point. parts of the device that are difficult to fully —Ted Bosworth sterilize. The problem is significant. In a recent Thosani reported financial relationships with AbbVie, meta-analysis of 15 studies investigating con- Boston Scientific, Medtronic and Pentax. Forbes reported no relevant financial conflicts of interest. tamination rates of reprocessed duodenoscopes, the rate of contamination was 15% (EClinicalMedicine 2020;25:100451). The rate of associated outbreaks was Table 2. Nurse/Technician Evaluation of Selected much lower, but the FDA, among oth- Measures of Scope Performance ers, has considered the risk to be unac- Measure Meets Improvement Unsatisfactory ceptably high and has been working Expectations Needed to encourage scope manufacturers to Preprocedural and intraprocedural tasks resolve the problem. Overall functioning of the 99.5 0 0.5 Of duodenoscope parts that are sus- instruments, % ceptible to contamination, the elevator Removal of the instruments, % 99.5 0 0.5 mechanism is among the most com99.5 0 0.5 monly implicated, according to a report Removal of disposable tip, % 99 0.5 0.5 issued by the FDA in November 2019 Attachment of disposable (https://www.fda.gov/media/132187/ elevator cap to the tip, % 99 0.5 0.5 download). The goal of the dispos- Passage of instruments able elevator cap is to eliminate this through biopsy channel, % vulnerability. Immediate postprocedural 98.5 1 0.5 Although the innovative design of manual cleaning the scope tested in the DECap trial Postprocedural tasks “has the potential to reduce ERCP- Leak testing, % 99.5 0 0.5 related infectious outbreaks,” accord- External surface cleaning, % 99.5 0 0.5 ing to Thosani, this study provides only Elevator link and distal end 99.5 0 0.5 the first step toward the goal of reduccleaning, % ing infection outbreaks associated with Cylinder and port cleaning, % 99.5 0 0.5 contaminated duodenoscopes. 99.5 0 0.5 More trials are coming. One, called Channel brushing, % 99.5 0 0.5 ICECAP that is enrolling more than Channel flushing, % 500 patients, will randomly assign Overall manual cleaning, % 99.5 0 0.5 participants to undergo ERCP with a Adapted from 2020 annual meeting of the American College of Gastroenterology (abstract 52).

Endoscope Reprocessing & Infection Control

WINTER 2021

Reports From ACG

Video Capsule Endoscopy for GI Bleeding Reduces Need for Invasive Procedures

s an alternative to traditional diagnostic protocols for finding the source of unexplained gastrointestinal

bleeding, video capsule endoscopy is faster and less invasive than conventional scoping and may help minimize physician exposure to the SARS-CoV-2 virus, according to a study conducted to address this issue during the early stages of the COVID-19 pandemic. Unlike conventional endoscopy, which is typically performed by a gastroenterologist working with a nurse, a technician and an anesthetist, capsule endoscopy can be performed by a single clinician, and it does not produce aerosols, according to Shahrad Hakimian, MD, a gastroenterology fellow at the University of Massachusetts Medical Center, in Boston. “In hemodynamically stable hospitalized patients, this is a superior triaging tool. It limits the need for additional imaging. In some cases, you can find the source of bleeding within a few minutes,” he added. The new study, which Hakimian’s group presented at the 2020 annual meeting of the American College of Gastroenterology (abstract 6), builds on previous research that has associated capsule endoscopy with accuracy in the diagnosis of nonhematemesis GI bleeding. In a randomized trial published last year by some of Hakimian’s co-investigators, the technique was found to be about twice as likely as standard-of-care endoscopy to identify the source of GI bleeding (64.3% vs. 31.1%; P<0.01) (Gastrointest Endosc 2019;89[1]:33-43.e4). “In the COVID era, one advantage of video capsule endoscopy is that it requires very little patient contact,” Hakimian told Priority Report.

For the study, Hakimian and his colleagues enrolled 50 hemodynamically stable hospitalized patients with suspected GI bleeding between March and May 2020, a time when high COVID-19 infection rates were having a major impact on delivery of hospital care. When the 50 patients evaluated with capsule endoscopy were compared with a control group of 57 patients who were evaluated with standard care before the COVID-19 pandemic, invasive procedures were used less frequently (44% vs. 96%; P<0.001), Hakimian reported. In the controls, 82% underwent upper endoscopy as a first diagnostic test. Most of the others underwent colonoscopy. In the capsule group, endoscopy was used only when bleeding was localized, and then for treatment. “The disadvantage of video capsule endoscopy is that it does not permit a therapeutic intervention when the source of bleeding is identified, but more than half of these patients do not have a source of bleeding identified, even with invasive tests,” Hakimian said. Once the source of bleeding is localized, the invasive procedure “can then be targeted,” he added. With current technology, capsule endoscopes send real-time images to a monitor. By watching the images as the capsule descends into the

Endoscope Reprocessing & Infection Control

see Capsule, page 38

Breakthrough Device Designation AmbuÂŽ aScopeâ&#x201E;˘ Duodeno We received Breakthrough Device designation from the FDA for our Ambu aScope Duodeno. You will receive a sterile, single-use duodenoscope that will eliminate patient cross-contamination.

Sterile. Single-Use. Problem Solved. To learn more or schedule a product demo, visit ambuUSA.com/single-use-duodenoscope

496 5206 31 - V01 - 11/2020 - Ambu Inc. - Technical data may be modified without further notice.

US: Rx only

WINTER 2021

Reports From ACG

Study Finds Check of Assembled Scopes Warranted sing a high-resolution inspection scope, investigators found superficial scratches, stains and debris in the working channels of new, unused endoscopes. Many of these defects persisted after initial high-level disinfection and processing, according to a presentation at the 2020 virtual meeting of the American College of Gastroenterology.

In the first study to quantify the baseline defects in endoscopes before they have been used, Tara Keihanian, MD, MPH, from the University of Miami Health System (UHealth), and Mohit Girotra, MD, FACP, from UHealth and Swedish Medical Center in Seattle, evaluated and inspected the inner working channels of 17 brand-new endoscopes, using a novel flexible inspection endoscope (abstract P2574). There were five colonoscopes, four esophagogastroduodenoscopy scopes, three endoscopic retrograde cholangiopancreatography scopes, four echoendoscopes and one enteroscope. The investigators evaluated the scopes before and after initial highlevel disinfection in an anterograde-retrograde fashion, reviewing video recordings for scratches, light and dark debris, stains, fluid, burns, perforation and adherent peel. They compiled the results according to recommendations by Barakat et al (Gastrointest Endosc 2018;88[4]:601-611). Keihanian and Girotra conducted 68 inspections on the 17 endoscopes. They found superficial scratches in seven scopes (41.2%) before reprocessing and persistent scratches in five (29%) after initial disinfection. They noted that the burden of these persistent scratches was minimal. They detected stains in 14 scopes (82.5%) at baseline; the stains persisted in 12 scopes (70.6%) after processing (all single stain). They also found minimal dark-colored debris in 14 scopes (82.4%), which was observed in 10 scopes (58.8%) after initial processing. Four of eleven scopes had persistent light debris after high-level disinfection. The investigators did not find any

channel perforations, burns or adherent peel. Noting that “at least one of these findings was seen in all of the 17 scopes” before they were ever used, they recommended that manufacturers use high-resolution flexible endoscopes to conduct video inspection of endoscope working channels after scope assembly “to ensure integrity of inner working channels, prior to their release.” Emmanuel S. Coronel, MD, the associate clinical medical director of the endoscopy center at the University of Texas MD Anderson Cancer Center, in Houston, told Priority Report that although “the integrity of inner working channels has been studied in endoscopes that had been used, this study looked at the inner channels of unused endoscopes. Interestingly, stains and persistent scratches were found in a significant proportion of endoscopes before clinical use.” Coronel noted that “endoscopic examination of the inner channel of endoscopes has been proven to be useful in determining the integrity [of ] the inner channel and it may improve reprocessing efficacy, as debris or residual humidity may be related to microbial growth or biofilm formation.” However, he added that “the data supporting the routine use of this technology is still scarce” and that since this study was performed on a small number of endoscopes, “larger studies should be performed to confirm these findings.” —Sarah Tilyou Keihanian and Girotra reported no relevant financial conflicts of interest. Coronel reported consulting work for Boston Scientific.

Endoscope Reprocessing & Infection Control

WINTER 2021

Reports From ACG

Survey of Gastroenterologists Indicates Receptiveness to Single-Use Scopes U.S. gastroenterologists surveyed by an endoscope manufacturer expressed interest in using single-use duodenoscopes for approximately half of their endoscopic retrograde cholangiopancreatography procedures, according to a report of the findings at the 2020 virtual annual meeting of the American College of Gastroenterology. this survey was conducted only three months after the first single-use duodenoscope was approved by the FDA, before the vast majority of the market has access to single-use duodenoscopes” and “any additional reimbursement has been considered” for these devices. “This technology is a welcome new addition to the market,” said Emmanuel S. Coronel, MD, the associate clinical medical director of the endoscopy center at the University of Texas MD Anderson Cancer Center, in Houston. Referring to a study by Rex et al, he said data suggest “that in a best-case scenario, close to 5% of duodenoscopes may still have positive cultures despite intensive disinfection protocols” (Endoscopy 2018;50[6]:588-596). Coronel pointed to a recent trial by Muthasamy et al, of 60 ERCPs performed by expert endoscopists in which “the disposable duodenoscope performed well amongst expert endoscopists,” with see Survey, page 38

Change in use, %

Sara Larsen, MSc, and her colleagues from Ambu Inc, which manufactures the aScope Duodeno single-use scope for ERCP, surveyed the physicians to assess their willingness to use single-use duodenoscopes in their endoscopy practices (abstract P1857). Between Feb. 17 and March 16, 2020, 70 gastroenterologists who perform ERCP answered an electronic survey about using single-use scopes instead of reusable ones. The investigators collected the data using the online survey tool QuestionPro, de-identifying the respondents. Larsen’s team found that the surveyed gastroenterologists would convert to single-use devices for an average of 50% of their ERCP procedures, with those who owned all their duodenoscopes converting a slightly larger portion than those who leased some or all of their duodenoscopes, but the difference was not significant (54% vs. 43%; P=0.182) (Figure). Gastroenterologists who reported having a duodenoscope contamination rate greater than 10% would, on average, convert 54% of their ERCPs to be performed with a single-use duodenoscope, whereas those who reported a contamination rate less than 5%, on average, reported they would switch to single-use devices for 49% of their procedures (P=0.679). The clinicians ranked “cost transparency” as the most important feature associated with single-use duodenoscopes (24%), followed by “eliminated risk of cross-contamination” (22%) and “minimized risk of cross-infection” (18%). The survey results showed no significant difference in conversion rate based on which features were selected as being most important. The researchers considered it “noteworthy that

50 40 30

20 10 0

Physicians Physicians owning all leasing all duodenoscopes duodenoscopes

Physicians Physicians Physicians owning and reporting reporting leasing contamination contamination duodenoscopes rate <5% rate >10%

Figure.

Average reported conversion rates from reusable to single-use duodenoscopes.

Endoscope Reprocessing & Infection Control

WINTER 2021

Ergonomics in Endoscope Reprocessing:

Why It’s So Important o the reprocessing technicians who clean the scopes in your endoscopy center ever complain about back pain, sore wrists or aching shoulders? Priority Report spoke with Jim Davis, MSN, RN, and Amanda Sivek, PhD—experts with the independent nonprofit health care safety and quality organization ECRI— about some ways to optimize ergonomics in reprocessing spaces.

Why is ergonomics such an important issue for endoscope reprocessing?

Davis: We do a large number of consultations in sterilization and disinfection focused on reprocessing workflow, and when we interview the technicians and ask, “What could be better here?” they almost always have something to say that relates to ergonomics. We often find that work areas are not optimized for the task at hand. They often are small, dark, hot, humid and in locations such as basements lacking windows. The staff must wear a lot of personal protective equipment because of the nature of what they are cleaning, and they must move around in that PPE within areas that often are cramped and not designed to adapt to individuals of different sizes. For example, if you’re 6 feet, 5 inches tall and hunched over a 35-inch sink, in full PPE, all day, you’re at risk for back injuries from that repetitive activity. Or, conversely, for someone who is 5 feet, 3 inches tall, the sink is at shoulder level for them. If you’re not comfortable doing your job, how well are you going to be able to perform

‘ We often find that work areas are not optimized for the task at hand. They often are small, dark, hot, humid, in locations such as basements lacking windows … [and] are cramped and not designed to adapt to individuals of different sizes.

’

—Jim Davis, MSN, RN

intricate, mission-critical tasks of cleaning and high-level disinfection of instruments with channels, bores and grooves? Your main focus can’t be on the equipment when you’re in pain.

One of the biggest things that puts any worker at risk is repetitive tasks. The Occupational Safety and Health Administration has reported that repetitive tasks are the cause of most workplace injuries. If someone has to do a repetitive task, as do endoscope reprocessing technicians, the space should be designed so that a person of any physical stature can perform the tasks comfortably.

Why are so many reprocessing spaces not designed with proper ergonomics?

Davis: Endoscopy centers have gone from perhaps 100 procedures per week a decade ago to perhaps 500 or more per week today because of advancements in technology and procedures. They have invested in advanced scopes, more staff and more exam rooms, but often they have not made similar investments in reprocessing. Designing these areas effectively from an ergonomic workflow and safety perspective, to make it easy for people to do their jobs, can take months to get right in the design phase, and that is frequently neglected. We typically do not see people who understand how reprocessing should work while doing walk-throughs of the spaces. I’ve seen endoscopy suites that have been designed to consider these issues, and they are beautiful. They have natural lighting and are easy to move around in. Then, I have been in some sites where you have essentially what used to be a large janitor’s closet with a sink on one wall for cleaning and then the reprocessing equipment on the other wall. The folks cleaning and those running automated reprocessors are back-to-back and running into each other. That’s common.

Endoscope Reprocessing & Infection Control

see ECRI, page 24

From the IFU to ASGE and everwhere in-between, drying is a requirement. How are you going to automate yours?

www.driscope.com

Help keep your scopes dry and patient safe with one of our Dri-Scope Aid Products!

The most advanced system to inspect the internal channels both pre and post HLD.

WINTER 2021

ECRI continued from page 22

Q Jim Davis, MSN, RN Senior Infection Prevention Analyst Risk Management Group

What key elements of a reprocessing space are ergonomically healthy for staff?

Davis: The first is simply allotting the reprocessing room enough space so that everyone who needs to be working in there can move around comfortably. You can’t stuff it in an oversized closet. The next most important element is the sink or sinks. You need height-adjustable sinks that can be moved up and down to be at the correct height for each reprocessing technician. Another key factor is storage of supplies. Are supplies such as detergents stocked overhead or under the sink, which requires repetitively having to reach up or down for them, as opposed to moving them horizontally? Sivek: There also are manual flushing aids available for staff who perform manual cleaning. Doing that flushing manually is quite onerous— think about flushing a scope with a syringe over and over. It can result in issues with the wrist, hand and thumb, especially for anyone who has arthritis.

Amanda Sivek, PhD Principal Project Officer for Health Devices

If you are interested in participating in the ECRI survey on reprocessors of reusable duodenoscopes, contact ECRI at duodenoscopes@ecri.org.

Davis: Providing reprocessing staff with sufficient magnification and illumination that makes it easier to visualize areas such as channels and ports facilitates their examination of scopes to determine whether they are clean before disinfection. There are lighter, smaller LED magnifiers available; there are borescopes that can be hooked up to a computer screen so you can visualize them clearly and ensure you got them clean before high-level disinfection or sterilization. And this isn’t exactly ergonomics, but there also are methods to document the borescoping, such that the pictures are tagged right into the program with the scope number, patient information and other data. This makes the process easier and less time-consuming for the technician.

How can endoscopy centers plan their reprocessing spaces for improved ergonomics? Davis: At ECRI, we can mock up a room and have someone conduct a virtual “walk-through” of the space with a headset, understanding where

everything is in terms of spacing. Looking at a floor plan versus exploring it in virtual reality is very different. If you’re not using virtual simulation, we just urge you to be aware of these issues so that you take them into consideration when you do a refresh or a renovation. These technicians work insanely hard on a mission-critical job for patient safety, and they’re not comfortable doing their jobs. They are almost doing the impossible.

How is ECRI advancing research on this issue?

Sivek: We are in the process of developing and pilot testing two surveys for reprocessors of reusable duodenoscopes. One is for people who perform the precleaning in the procedure room directly after a procedure, and the other is for those who are working in sterile processing on the manual cleaning of duodenoscopes. We’re extremely interested in duodenoscope reprocessing workflow and the ergonomics of the procedure room and sterile processing environments. If it’s too onerous for people to complete their tasks in the time allotted, then patient safety might be at risk. The pilot phase for both of the surveys is underway, with final versions expected out in December. We seeking respondents (box) are trying to cast a wide net of target health care workers. As far as we know, there have not been any previous surveys on this topic focused on the people who do the work of duodenoscope reprocessing. We want to hear from the people who are directly affected by reprocessing ergonomics. Davis: This is an essential issue for patient safety. We know what happens when these scopes—especially duodenoscopes, because they are so difficult to work with, but really any reusable scope—are contaminated and used in patient care. There are outbreaks associated with that. What can we do to get these reprocessing technicians as comfortable as they can be in their daily tasks so the environment poses no obstacles to their work? That’s a main component of patient safety in reprocessing.

Endoscope Reprocessing & Infection Control

—Compiled by Gina Shaw Davis and Sivek reported no relevant financial conflicts of interest.

WINTER 2021

The View Inside:

New ‘Test Article’ for Visualizing Scope Drying Shows Flaws in Usual Practices he common method of flushing an endoscope with alcohol and hanging it in an ambient storage cabinet does not dry endoscope channel systems effectively, according to a recent study from scientists in the Advanced Sterilization Group at Steris Corp.

“This result suggests that endoscopes must be dried with compressed air prior to storage, or may benefit from storage in an endoscope cabinet that provides compressed air directed into the endoscope channels,” lead author Michelle Nerandzic and her colleagues reported. A 2016 survey found that more than 50% of U.S. endoscopy centers flush endoscopes with alcohol and then hang them to dry in cabinets that do not have ventilation or directly compressed air (Gastrointest Endosc 2018;88[2]:316-322.e2). But the Steris researchers noted that the most

common method of determining endoscope dryness—examination of the large diameter channels using a borescope—does not permit visualization of the narrow diameter air, water, elevator and auxiliary water channels. Most studies have evaluated the large-diameter channels, but several others have shown biofilm or higher microbial density to be more common in these narrow-diameter channels, the researchers noted (Am J Infect Control 2014;42:12031206; Infect Dis Health 2018;23:189-196). These studies emphasize the need for alternative methods to monitor dryness in smallerdiameter channels of endoscopes.

Test Device Allows View Of Narrow Channels

ith a ‘ This study may provide us with

gold standard by which future drying protocols can be compared in order to resolve this issue.

’

—Venkataraman Muthusamy, MD UCLA Health, Los Angeles

By stripping an endoscope of its outer sheath, fiber optics and actuation systems, and replacin replacing rep placin ng opaque channel systems with equival equivalent lent transparent channels, the Steris groupp developed a skeleton “test d article” thatt al allowed for direct visualizainside tion in ns these narrower channels. The investigators tested ttheir method on three different en nt endoscopes, following the manufacturer’s instructions for manmanufac act ual final water rinse and alcohol flush w steps (Am (Am J Infect Control 2020 Sep 3. [Epub ahead aahea of print]. doi: 10.1016/j. ajic.2020.08.034). They then used the ajic.202 ajic 20220 0 novell test article to visualize retention of alcohol and water in endoscope channel systems after final water rinse and alcohol flush, before and after hanging for

Endoscope Reprocessing & Infection Control

WINTER 2021

five days in an ambient endoscope storage cabinet. They found that all three of the test article models contained a similar quantity of residual alcohol and retained most of that alcohol throughout the five-day storage process, with alcohol retention highest in the narrow-diameter channels (Figure). When compressed air was applied to the channels at 15 psi, 10 minutes’ drying time was not sufficient to dry all the channels systems, whether applied through all of them at once using adapters or applied to each one independently using a rubber-tipped nozzle. The first method took an average of 19.6 minutes to dry all the channel systems, while the second took an average of 43.1 minutes. “This result suggests that endoscopes must be dried with compressed air prior to storage, or may benefit from storage in an endoscope cabinet that provides compressed air directed into the endoscope channels,” the authors wrote. “In particular, the narrow diameter channel systems (i.e., air, water, elevator, and auxiliary water) showed that vertical hanging was not sufficient for removing either residual alcohol or water,” they added. “The purpose of this study was not to provide users with detailed instructions for how to effectively dry endoscopes, but to understand the impact of various parameters on drying,” Nerandzic told Priority Report.

Figure. Alcohol remains in the test article after final water rinse and alcohol flush (per manufacturer’s instructions) before and after hanging for five days in an ambient endoscope storage cabinet.

‘When Is Dry Dry Enough?’ “I really liked the idea of the skeleton model that they’ve described in this paper,” said Michelle Alfa, PhD, a professor in the Department of Medical Microbiology and Infectious Diseases at the University of Manitoba, in Winnipeg, whose research focuses on hospital-acquired infections derived from exogenous sources, such as the patient care environment or contaminated medical devices. “It allows you to see all of these smaller channels and shows the difficulty of drying them. We went through a long period of time when the question in endoscope reprocessing was, ‘When is clean clean enough?’ and now the question is, ‘When is dry dry enough?’ We still don’t really know that at this point, but studies like this one help us focus on what the issues are, and give manufacturers of cabinets and novel drying methods an approach by which they can assess their air pump.” The study also pokes a hole in the common assumption that alcohol flushing allows endoscopes to dry more quickly. “We see here that that is not the case,” said Venkataraman Muthusamy, MD, the medical director of endoscopy at UCLA Health, in Los Angeles. “Instead, you need to use compressed air for more than 10 minutes, and even that duration is not always effective, and the force of the compressed air matters. This study may provide us with a gold standard by which future drying protocols can be compared in order to resolve this issue.” He predicted that Steris will commercialize the test article dummy endoscope as a research tool for manufacturers of drying solutions. “I believe this will be useful for coming up with procedures that we know can then be validated as adequate,” he said. “This isn’t something you’re going to use after every single scope reprocessing to assess dryness, but to use it in a trial—to know that if you use this process for this amount of time, 99% of the time these channels will be dry—that could be useful information for designing future reprocessing and drying protocols with confidence.”

Source: Steris Corp.

Endoscope Reprocessing & Infection Control

—Gina Shaw Nerandzic is an employee of Steris. Alfa reported financial relationships with 3M, Healthmark, J&J, Olympus and Steris.

WINTER 2021

Gaps Seen Between Confidence And Knowledge Among Endoscopy Techs, Nurses

ndoscopy technicians and nurses often lack key information about infection control in endoscope reprocessing, according to a

survey of education, training and knowledge of nurses and techs in the endoscopy unit presented at the 2020 virtual Digestive Disease Week.

Investigators at the University of Texas MD Anderson Cancer Center and Baylor College of Medicine, both in Houston, conducted a paper survey of endoscopy technicians and nurses who attended Texas Interventional Endoscopy Group’s fourth annual training course in Houston in November 2019. The 10-question survey assessed each respondent’s formal education, endoscopy experience and knowledge of infection control. A total of 34 technicians and 54 nurses completed the survey. Although the median experience in health care of the group was fairly long, at 20 years, median experience in endoscopy was significantly shorter, at 6.5 years.

The survey findings highlighted a significant disconnection between respondents’ confidence in their reprocessing skills and their actual knowledge of the subject (abstract Tu1105). For example, the majority of technicians rated themselves a 10 out of 10 in their ability to reprocess an endoscope, while 65% of them recognized that precleaning a soiled endoscope must be done immediately after a procedure to prevent the buildup of biofilm. Only a small minority of endoscopy technicians who responded to the survey had previous training either as surgical technicians (15%) or

Endoscope Reprocessing & Infection Control

see Gaps, page 30

IBD Help Center Resources for Nurses and Advanced Practice Providers The Crohn’s & Colitis Foundation can help you guide your patients as they learn to live with inflammatory bowel disease (IBD). Connect them to our IBD Help Center, which provides information and resources to patients, caregivers, and healthcare providers about IBD. Our team of Masters-level information specialists can provide patients with the tools needed to become effective partners in their care by connecting them to support programs and educational resources. • Our helpline is available Monday through Friday from 9 a.m. to 5 p.m. EST • Call us: 1-888-MY-GUT-PAIN (888-694-8872, extension 8) • Email us: info@crohnscolitisfoundation.org • Chat live with a specialist. Available Monday, Tuesday and Thursday from 9 a.m. to 5. p.m. EST Healthcare professionals can order free educational publications for their offices on a wide range of topics relating to IBD including: surgery, diet and nutrition, and possible complications.

For more information visit: www.crohnscolitisfoundation.org/IBD-nurses

WINTER 2021

Gaps continued from page 28 sterilization technicians (13%). Even while working in an endoscopy unit, only about one of three of the techs (35%) became certified to reprocess endoscopes; half began reprocessing endoscopes independently after one month of supervised training. Only 2% of nurses became certified to reprocess endoscopes. “It was surprising to us that so many of the people who were doing the job more regularly were so confident in the way they did it and their knowledge of the process but that this confidence didn’t necessarily correspond to whether they actually knew the content,” said lead author Sanjivini Suresh, MEd, a curriculum development specialist at MD Anderson. “I think this is largely an infrastructure problem. If we’re not giving our personnel the training they need, how can we expect them to know what they don’t know?” In general, no real formal training exists related to infection control for endoscopy technicians, said co-investigator Gottumukkala S. Raju, MD, the John Stroehlein Distinguished Professor in the Department of Gastroenterology, Hepatology, and Nutrition at MD Anderson. “You just come and get trained on the job, and institutions do not necessarily require certification. The American

‘ It was surprising to us that so many of the people who were

doing the job more regularly were so confident in the way they did it and their knowledge of the process but that this confidence didn’t necessarily correspond to whether they actually knew the content.

’

—Sanjivini Suresh, MEd University of Texas MD Anderson Cancer Center, Houston

Gastroenterological Association’s statement about infection control in endoscopy does talk about the need for certification, but so far that has not led to the creation of formal certification programs.” Raju has spearheaded efforts to create a comprehensive two-year training program for endoscopy technicians at Coleman College for Health Sciences of Houston Community College (bit.ly/3fmDlt0). Originally slated to enroll its first class in January 2020, the program’s launch was delayed first by financial constraints and then by the COVID-19 pandemic. “Our goal is now to open in 2021,” Raju said. “With

a hands-on program such as this, you really don’t want to begin it while there is still such extensive social distancing required.” Raju also suggested that if such gaps between confidence and knowledge exist among endoscopy technicians in Houston, most of whom were affiliated with major academic health centers, even larger educational deficits are likely in smaller community hospitals. “We don’t have the resources to reach out and assess those institutions, but my guess is their endoscopy technicians will be at the same knowledge level or lower than the individuals we surveyed.” Current hospital-based training in infection control for endoscopy technicians may focus on process without explaining the underlying rationale, said Venkataraman Muthusamy, MD, the medical director of endoscopy for UCLA Health, in Los Angeles. “Sometimes we train people in what to do, but not why to do it,” he said. “Without a fundamental understanding of the rationale behind the steps and their clinical relevance—like the need for immediate precleaning to avert biofilm formation—people may be more likely to skip steps. While some scope-transmitted infections can still occur even when the cleaning process is done perfectly, a key potential source of transmission lies in [inadequate] reprocessing and manual cleaning.” After an outbreak of infections related to duodenoscopes several years ago, the UCLA system undertook an overhaul of its educational process for endoscopy technicians, which incorporated components on the underlying reasons for each step in reprocessing and the risks if those steps are not fully completed. They also established ongoing competency assessments and more frequent audits. “Reprocessing of these devices is a critical step in the flow of the endoscopy unit,” Muthusamy said. “It must be understood and it cannot be rushed. There is often pressure to move faster, as hospitals try to minimize inventory to save costs on capital equipment, but the reality is that we have to take the time to do reprocessing right in order to achieve optimal patient outcomes.”

Endoscope Reprocessing & Infection Control

—Gina Shaw

WINTER 2021

Infection Control in Endoscopy Centers in the Time of COVID-19

s ambulatory surgery centers returned to providing elective procedures starting in the late spring and early summer, one of the biggest challenges

they faced—one they continue to face—was adapting reprocessing and infection control procedures to prevent the transmission of SARS-CoV-2. After months spent trying to understand how this novel virus is transmitted, a scientific consensus has emerged that the primary means of transmission is via aerosols and droplets. “The primary issue for each surgical center, endoscopy centers included, is determining what they consider to be ‘aerosol-generating procedures [AGPs],’” said Sylvia Garcia-Houchins, MBA, RN, the director of the infection control program at the Joint Commission. AGPs are “more likely to generate higher concentrations of infectious respiratory aerosols than sneezing, talking, or breathing,” notes a guidance document from the CDC on COVID-19 and infection control. However, the CDC has not provided a comprehensive list of procedures that it considers to be AGPs, according to Garcia-Houchins. “They have provided some guidance but have said that there is no consensus on what is an [AGP], so it’s up to each organization to make their own determination,” she said. “The Joint Commission is an accrediting body, not regulatory, so we don’t make those rules either. We survey to state and federal requirements and to Joint Commission standards.” The Table lists commonly performed procedures that often are considered to be AGPs. For patients with known or suspected COVID19, it’s recommended that appropriate personal protective equipment (PPE) for health care workers includes N95 or other respirators, such as a

powered air-purifying respirator, eye protection (goggles or a disposable face shield that covers the front and sides of the face), gloves and a gown. Table.

Commonly Performed Procedures Often Considered to Be AGPs Bronchoscopy, including mini bronchoalveolar lavage Cardiopulmonary resuscitation Colonoscopy Endotracheal intubation and extubation Filter changes on the ventilator High-flow oxygen Manual ventilation before intubation Nasal endoscopy Noninvasive ventilation (e.g., BiPAP, CPAP) Open suctioning of airways Sputum induction Swallowing evaluation Tracheal intubation and extubation Tracheotomy Upper endoscopy, including a transesophageal echocardiogram

AGPs, aerosol-generating procedures; BiPAP, bilevel positive airway pressure; CPAP, continuous positive airway pressure Sources: CDC, UpToDate September 2020.

Endoscope Reprocessing & Infection Control

WINTER 2021

The CDC also recommends that AGPs for patients with COVID-19 should take place in an airborne infection isolation room, when possible.

‘Make Their Own Determinations’ But what about in an ambulatory surgery center performing elective gastrointestinal endoscopic procedures on patients who are not known or suspected to be COVID-19–positive? What preventive measures are required in procedure rooms and in the reprocessing areas? “Each organization is left to read what their professional societies recommend, what their state accrediting bodies require, There needs to be additional and make their own determinaattention to staff safety outside tions,” Garcia-Houchins said. “Do you consider scope reprocessing to of processing activities—such as be an AGP? If not, then wear what staggering hours, not bringing a you always wear, which is generally bunch of people into a locker room considered to be heavy-duty gloves, at the same time, and separating fluid-resistant gowns or aprons, and eye and face protection. That’s typiworkspaces so people are not on cal of endoscopy centers. But if you top of each other. consider it to be an AGP and you are —Gail Horvath, MSN, RN in an area where there is substantial ECRI community spread, then it would be prudent to switch to a respirator.” Recommended practices for endoscope reprocessing have not changed because of COVID-19, according to Gail Horvath, MSN, RN, a patient safety consultant with the health care safety nonprofit organization ECRI. “But it’s become more important than ever not to deviate from them, not to employ shortcuts or workarounds, to do manual cleaning the way it’s intended and to use PPE as intended,” Horvath said. “Cleaning, disinfecting, sterilization should be conducted strictly according to instructions for use by the device manufacturer, and that hasn’t changed. We also emphasize that there needs to be additional attention to staff safety outside of processing activities—such as staggering hours, not bringing a bunch of people into a locker room at the same time, and separating workspaces so people are not on top of each other.” Shortages of PPE and other infection control supplies are no longer in the headlines, but the Joint Commission’s weekly Q&A sessions with hospitals and ambulatory surgery centers have revealed that they persist around the country. “We have heard that many centers are having

‘

’

difficulties getting their normal disinfectants and having to switch to other products,” she said. “We heard from one center that no longer meets a vendor’s requirements for volume, so they will no longer provide them with the necessary drapes or disinfectant wipes. The smaller organizations are suffering from not being able to compete for the supplies that larger organizations can get more easily.” Some smaller centers have grouped together for buying power, she noted, while others who have affiliations or partnerships with larger organizations have sought to add their orders to those hospitals’ contracts. “People have gotten creative developing alternative sources for what they need,” she said, “but when it comes to specialty items, there really is a limited vendor market. And being able to get those is becoming a challenge, especially as elective procedures continue to ramp up, and we are also concerned about [the] surge of COVID in the fall and winter.”

Navigating PPE Shortages ECRI has been working with surgery centers and hospitals to address PPE shortages and navigate purchases of imported products they are using as substitutes for what cannot be purchased domestically, Chris Lavanchy, the engineering director of ECRI’s Health Devices Group, told Priority Report. “We’re most commonly asked about isolation gowns, KN95 and surgical masks,” he said. “We are able to do a lot of testing for facilities if they have questions about the quality and efficacy of what they are buying, and that’s something we have ramped up over the past six months.” The FDA has issued a number of emergency use authorizations (EUAs) for PPE decontamination systems so health care personnel can reuse the protective items. Horvath cautioned surgery centers and hospitals to be on the alert for unscrupulous vendors of these solutions. “One of our members was approached by a vendor with a so-called ‘heat sterilization unit’ to reprocess their masks and put out a purchase order for three of these units,” she said. “Fortunately, they thought better of it and contacted us. This vendor had no EUA from the FDA, nor did the manufacturer of the N95 mask endorse its use. The organization was able to cancel the purchase order for three units and get more

Endoscope Reprocessing & Infection Control

see COVID-19, page 35

WINTER 2021

A Quality Systems Approach To Scope Reprocessing ou don’t know what

“Y

you don’t know.”

That’s the take-home message from a new review article on quality systems approaches to endoscope reprocessing by Michelle Alfa, PhD, who has done extensive research on hospital-acquired infections derived from exogenous sources, including contaminated medical devices (Gastrointest Endosc Clin N Am 2020;30[4]:693-709). “In terms of reprocessing flexible endoscopes, endoscopy clinics cannot keep doing the same thing and expect a different outcome,” wrote Alfa, a professor in the Department of Medical Microbiology and Infectious Diseases at the University of Manitoba, in Winnipeg. “The key question is, ‘What needs to change?’ It is difficult to identify effective changes in endoscope reprocessing because currently there is no monitoring being performed!”

She cited an April 2019 interim FDA statement, which found that up to 5.4% of collected samples tested positive for organisms such as Escherichia coli and Pseudomonas aeruginosa, with an additional 3.6% contaminated with organisms of low to moderate concern. The agency had expected contamination rates to be less than 1%, Alfa noted. To make reprocessing easier and reduce the risk for infection, the FDA recently recommended that endoscopy centers transition to duodenoscopes with innovative designs, such as disposable or removable endcaps, that allow them to be reprocessed more effectively. The agency also recommended that centers institute quality assurance programs that include sampling and culturing of duodenoscopes as well as other monitoring methods.

Endoscope Reprocessing & Infection Control

WINTER 2021

3 Things You Can Do Right Now To Improve Reprocessing Quality 1. Facilitate dialogue between clinical and reprocessing personnel to identify what lubricants, defoaming agents and other items are being used in clinical practice that might affect reprocessing. 2. Establish a weekly process for sampling scopes and evaluating the efficacy of their cleaning. “Even if you only check a few scopes a week, that will give you some idea of what’s going on,” Alfa said. “I think it will surprise you.” 3. Take steps to monitor whether or not moisture is retained in the channels of endoscopes that are stored in regular cabinets. “One simple way to do this is using cobalt chloride paper. Blow air through the channel onto the paper, and just like a baby’s diaper, the color will change if it’s wet,” she said. “If water remains after overnight storage, the chance is that your scope might have developed biofilm, and you might then want to culture to find out if you have a contaminated scope.” —G.S.

“One of the driving forces behind this article was the fact that multiple recent studies have drawn attention to problems with endoscope drying efficacy and the value of the alcohol flush,” Alfa told Priority Report (see related article, page 25). “Many people believe automated endoscope reprocessors are doing an adequate job, but the data shows that is not the case. That led my coauthor Dr. Harminder Singh and myself to recognize the need to put all of the latest information about endoscope reprocessing together into one review that emphasizes the need for quality systems approaches, and the fact that right now we fall, sadly, very short of that goal. The data is out there, but people hadn’t really put it all together.”

Communication Gaps Affect Reprocessing Effectiveness One key failing in quality systems, Alfa said, is communication about clinical procedures. “There is often a lack of dialogue between the staff in the clinical procedure room and the reprocessing

room,” she reported. “For example, many of the reprocessing personnel would never have realized that things like simethicone, tissue glue and dyes were being used during clinical endoscopic procedures. It’s important for the clinician to understand that these adaptations in clinical practice can detrimentally affect the ability to reprocess scopes.” She urged endoscopy centers to establish regular avenues for communication between reprocessing personnel and clinical staff, who often work in separate locations. “There is a lot of pressure on reprocessing technicians from the clinical side,” she said. The “main goal [of clinicians] is patient care and getting the procedures done that patients need, which is as it should be, but they may not consider the repercussions of what they do on the reprocessing side. This lack of dialogue is a key contributing factor to failures in endoscope reprocessing.” Another critical take-home lesson, Alfa said, is the need for regular monitoring of manual cleaning and drying processes in endoscopy centers. Her review noted that despite the established value of monitoring manual cleaning with rapid tests for organic or ATP residues, a recent survey of 249 endoscopy clinics indicated that only 33.7% in the United States had implemented such monitoring practices (Gastrointest Endosc 2018;88[2]:316-322.e2). “Staff think they are following the manufacturer’s instructions so everything is good, but no one is testing to see how well that manual cleaning is being done. You don’t know what you don’t know,” she said. “We need to recognize that the manufacturers’ instructions are meant to accommodate the routine of clinical practice, but there are many things that aren’t routine. If a procedure is complicated, if there is excessive bleeding, if it’s an emergency procedure and the bowel isn’t prepped, the load of organisms is high and the scope may come back with a much higher organic and microbial load than the manufacturer’s cleaning instructions were designed to address.”

Empowering Technicians Routine monitoring of scope reprocessing should not be framed as a negative “enforcement step” for reprocessing staff. “You’re giving them a tool to help them recognize when a scope hasn’t reached the level of cleaning you’d expect,” Alfa said. “You don’t want to have

Endoscope Reprocessing & Infection Control

WINTER 2021

negative things happen to the technicians when you find gaps in scope cleaning. The goal is to empower them to know when a scope hasn’t been cleaned adequately and correct that before high-level disinfection [HLD].” (Performing these tests after HLD or sterilization is not useful, since these processes fix organic residues to the surface and make them harder to remove in subsequent cleaning.) The review noted that data collected via regular monitoring of quality management systems can facilitate important changes to a center’s processes, such as: • reducing the use of off-label products that cannot be removed effectively by the cleaning steps specified in manufacturers’ instructions; • improving transit time between patient use and cleaning; • optimizing efficacy of manual cleaning before HLD; • culturing to reduce the risk for infection transmission due to contaminated scopes; and • ensuring adequate drying before storage. This last point, Alfa said, is another key gap for many institutions. “It continues to go unrecognized that automated endoscope reprocessors do not have adequate drying before scopes go in the storage cabinet,” she said. The Gastroenterological

Society of Australia (TGA) recommends that endoscopic equipment be stored in TGAapproved forced air-drying cabinets, which provide proven additional protection from bacterial biofilm, and Alfa said she believes that North American programs should do the same. There may be particular gaps in the monitoring of reprocessing at smaller endoscopy units that do fewer procedures, said Harish Gagneja, MD, a gastroenterologist with Austin Gastroenterology, in Texas. “In our endoscopy unit, we don’t allow corners to be cut in reprocessing or monitoring,” he said. “There has been a lot of discussion of disposable scopes, and while it would be financially and environmentally prohibitive for large programs like ours to adopt these, maybe these smaller-volume centers should consider disposable scopes or disposable caps.” Gagneja called for the FDA, manufacturers and gastroenterology societies to agree on best practices related to scope reprocessing. “Right now, everybody has their own [approach],” he said. “Even though they say similar things, I think it would be extremely helpful to have a consensus document that’s endorsed by everyone, with clear step-by-step instructions rather than variables.” —Gina Shaw Alfa reported financial relationships with 3M, Healthmark, J&J, Olympus and Steris. Gagneja reported no relevant financial relationships.

COVID-19 continued from page 32 than $100,000 back. A lot of people are taking advantage of COVID to market products that are not cleared for what they’re being sold as.” An analysis ECRI released in September found that as many as 70% of KN95 masks imported from China do not filter 95% of aerosol particulates, contrary to what their name suggests. “Using masks that don’t meet U.S. standards puts patients and front-line health care workers at risk of infection,” said Marcus Schabacker, MD, PhD, ECRI’s president and CEO, in a release. “As ECRI research shows, we strongly recommend that health care providers going forward do more due diligence before purchasing masks that aren’t made or certified in

America, and we’re here to help them.” Part of the challenge with establishing clear infection control processes for COVID-19 in surgery centers or anywhere else, Horvath said, is the lack of a national strategy. “Almost every state has had to make up its own mind about how to manage the pandemic. It’s been very difficult. We need a more cohesive national approach,” she stressed. “Hopefully this is a wake-up call, because this pandemic is not going to be the last one.” —Gina Shaw Alfa reported financial relationships with 3M, Healthmark, J&J, Olympus and Steris. Gagneja and Schabacker reported no relevant financial relationships.

Endoscope Reprocessing & Infection Control

WINTER 2021

Cause of Death: Unknown Those due to infections often are undercounted.

t’s an age-old question in medicine: What killed my patient?

The answer isn’t always easy. For example, HIV doesn’t kill; an infected patient typically dies of a complication or infection stemming from their impaired immune system. Often, deciding what was to blame becomes a judgment call by the physician completing the patient’s death certificate. Consider the case of a patient who develops drug-resistant bacteria such as methicillin-resistant With COVID, we may be getting Staphylococcus aureus (MRSA) a fairer representation on death during treatment for another certificates, at least in theory. With serious medical condition. The superbugs, we probably aren’t. death certificate likely would list —Lawrence Muscarella, PhD as the cause of death the underlyLFM Healthcare Solutions ing health issues that brought the patient to the hospital, not the deadly infection. “Cause of death is rarely coded as a drug-resistant pathogen,” said Ramanan Laxminarayan, PhD, MPH, the director and a senior fellow of The Center for Disease Dynamics, Economics & Policy and an affiliate professor of global health at the University of Washington, in Seattle.

‘

’

This practice raises concerns that the number of deaths from superbugs is likely to be undercounted, which can have profound policy impacts. If officials don’t see the full scope of a problem, they may not allocate the resources it deserves. To avoid the same problem with COVID-19— the disease caused by the new coronavirus SARS-CoV-2—the CDC has instructed physicians to list COVID-19 on death certificates, even if the patient could not be tested for the virus (reporting it as “probable” or “presumed”), as long as they believe the virus contributed to the patient’s demise (www.cdc.gov/nchs/data/ nvss/vsrg/vsrg03-508.pdf ). This guidance makes sense during a pandemic, experts say, but it has left some asking a follow-up question. “If accurately counting the number of deaths from COVID-19 is important to public health, and it surely is, then so too, should counting of the total number of deaths from superbugs,” Lawrence Muscarella, PhD, the president of LFM Healthcare Solutions LLC, in Lansdale, Pa., said. “With COVID, we may be getting a

Endoscope Reprocessing & Infection Control

WINTER 2021

fairer representation on death certificates, at least in theory. With superbugs, we probably aren’t.”

‘An Art and a Science’ Determining a patient’s cause of death is complex. Jason Burnham, MD, an assistant professor of medicine at the Washington University in St. Louis, who studies multidrug-resistant organisms, said the person signing the death certificate may not have known the patient well or may be genuinely unsure of what was to blame. “So if someone has advanced-stage cancer, but dies in the hospital with a MRSA infection that was acquired during chemotherapy, do they write that the death was due to the cancer because they never would have been on chemo and gotten the infection without having cancer, or the MRSA infection?” Burnham said. Hardly any death is straightforward, Laxminarayan said. “There is an immediate cause of death—for instance, a patient may die of heart failure, but the underlying cause could be a gunshot wound,” he said. “Accurately attributing the cause of death is both an art and a science.” The requirements for reporting deaths from superbug infections vary from state to state, Burnham said. “Most states do not require it,” he told Priority Report. Death certificates contain International Classification of Diseases (ICD) diagnosis codes for various conditions, but these codes do not provide a “simple way to code for an antibiotic-resistant infection,” according to a 2019 CDC report (www.cdc.gov/drugresistance/pdf/ threats-report/2019-ar-threats-report-508.pdf ). “There are ICD codes to cover antibiotic-resistant infections, but my understanding is that they are not used widely,” Laxminarayan said. In its most recent official tally, the CDC estimated that more than 2.8 million antibioticresistant infections occur each year, killing more than 35,000 U.S. residents. Since the agency could not rely on data from death certificates, it turned to a variety of other methods to track the burden of each drug-resistant pathogen individually, described in a 20-page technical appendix of the 2019 report (www.cdc.gov/drugresistance/ biggest-threats.html). A representative of the CDC did not respond to requests for comment.

A Similar Approach for Both In recent months, Americans watched the official U.S. tally of COVID-19 cases tick steadily higher, reaching nearly 13.5 million people and killing more than 267,000 by the end of November. Because the CDC asks providers to list COVID-19 on death certificates, obtaining a provisional number of deaths is relatively straightforward. The agency simply follows death certificate data received and coded by the National Center for Health Statistics, and updates official counts in near real time. In the midst of a pandemic that clinicians and researchers are desperSuperbugs jeopardize the entirety ately trying to understand, standardof modern medical care. Not ization and transparency are essential, cataloging the problem only lets it Laxminarayan said. “The only way in fester undetected until it tears the which we can understand where we have a growing COVID problem is whole system apart. by tracking deaths.” —Jason Burnham, MD Washington University in St. Louis But does the same logic apply to antibiotic-resistant infections, a growing and still misunderstood threat that kills at least tens of thousands of people every year in the United States alone? Muscarella said he is asking himself that very question and hasn’t yet come up with a clear answer. “What I would like to see, what makes sense, is our trying to reduce the gap between the standards for reporting deaths from COVID-19 and those for superbugs and related pathogens,” he said. “They should probably be treated more similarly. We probably should be observing better consistency and less confusion about how we are treating pathogens that cause morbidity and mortality, whether it’s COVID-19 or superbugs.” For Burnham, the answer is more obvious: In his opinion, providers should be required to list antibiotic-resistant infections on death certificates. “Superbugs jeopardize the entirety of modern medical care,” he said. “Not cataloging the problem only lets it fester undetected until it tears the whole system apart.”

‘

’

—Alison McCook Burnham and Laxminarayan reported no relevant financial conflicts of interest. Muscarella is the president of LFM Healthcare Solutions LLC, an independent safety and quality improvement company that has financial relationships with companies that market low-temperature sterilization technologies, instrument cleaning products, disposable endoscopes, reusable equipment and more.

Endoscope Reprocessing & Infection Control

WINTER 2021

Capsule continued from page 18 stomach, the source of bleeding can sometimes be identified in minutes, Hakimian explained. If the source of bleeding is lower, the video can be checked at intervals. In other words, the source of active bleeding typically can be identified before the capsule completes the journey.

Hands-off Approach Appealing During Pandemic Amid the COVID-19 pandemic, protecting clinical staff from the need to perform invasive procedures is a major potential advantage of capsule endoscopes. Avoiding invasive procedures in the GI tract is considered particularly important for infection control, because SARS-CoV-2 virus invades cells in the GI tract and can be detected in the feces for up to 30 days after infection, Hakimian said. Yet, the data might be relevant beyond the pandemic. Hakimian said the findings are in line with other evidence that capsule endoscopy is both more effective and faster for localizing the source of GI bleeding. He said the technology deserves to be considered earlier in the diagnosis of unexplained GI bleeding for at least some patients, even in the absence of a viral pandemic. In hospitalized patients who are hemodynamically stable and not in need of urgent evaluation, capsule endoscopy substantially reduces the number of diagnostic procedures needed, Hakimian said. “Patients evaluated with video capsule endoscopy were spared invasive tests but had no greater need for transfusions or readmissions,” he reported. A larger randomized trial is being planned to evaluate whether capsule endoscopy should become the routine strategy for evaluating GI

Survey continued from page 21 just two patients crossing over to the standard duodenoscope arm (Clin Gastroenterol Hepatol 2020;18[9]:2108-2117). However, although the Ambu survey shows that “close to 50% of endoscopists seem to be optimistic about this technology, most endoscopists still do not have access to disposable duodenoscopes,” Coronel said. Noting that some endoscope manufacturers “are

bleeding in hemodynamically stable hospitalized patients, said Hakimian, who performed this work in collaboration with the senior author, David R. Cave, MD, PhD, the director of clinical research at the UMass Memorial Medical Center, in Worcester. That study will also look at cost, a variable with the potential to favor capsule endoscopy over usual care if invasive procedures are reduced with no difference in outcomes. A relatively simple technique, capsule endoscopy “can be performed by a single member of the clinical staff,” Hakimian said. For managing patients potentially infected with COVID-19, that feature offers a clear potential advantage. John R. Saltzman, MD, a professor at Harvard Medical School and the director of endoscopy at Brigham and Women’s Hospital, both in Boston, said the new data are useful for validating capsule endoscopy as a tool for evaluating GI bleeding in the time of COVID-19. Outside of COVID-19, the role of the technology might be more limited, according to Saltzman, who has published extensively on upper GI bleeding. “During a surge of COVID-19 in areas where COVID-19 testing is not rapidly available or PPE [personal protective equipment] is in short supply, and since upper endoscopy is an aerosol-generating procedure, it makes sense to initially manage patients with suspected GI bleeding with video capsule endoscopy,” he said. “However, if COVID-19 testing and PPE are readily available, I would continue to perform upper GI endoscopy as the initial test and reserve [video capsule] for patients with suspected or known acute COVID-19 infections.” —Ted Bosworth Hakimian reported no relevant financial conflicts of interest. Saltzman reported financial relationships with Cook Medical and Iterative Scopes.

moving to a ‘partially disposable’ solution,” such as devices with disposable endoscope tips (with or without the elevator) (see story, page 16), Coronel said “it will be interesting to see if larger prospective studies can establish that the performance of these scopes is similar to that of standard duodenoscopes and if there is any variability in performance according to the degree of ERCP complexity.” —Sarah Tilyou Larsen and her colleagues reported employment by Ambu. Coronel reported consulting for Boston Scientific.

Endoscope Reprocessing & Infection Control