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

Volume 4 • Winter 2022

Endoscope Reprocessing &Infection Control

Illuminating Scope Safety A Supplement to

THE TABLET CHOICE IN BOWEL PREPARATION

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

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

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

3 (good) or 4 (excellent) by the blinded endoscopist; scores were assigned following completion of the colonoscopy. Patients completed a preference questionnaire following completion of study drug to capture their perceptions of the preparation experience. This questionnaire has not undergone formal validation. ‡ Patients were queried for selected gastrointestinal adverse reactions of upper abdominal pain, abdominal distension, nausea, and vomiting following completion of study drug, rating the intensity as mild, moderate, or severe.1,2 ACG=American College of Gastroenterology Packaging and tablets MoviPrep is a registered trademark of Velinor AG. †

not shown actual size.

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

BRIEF SUMMARY: Before prescribing, please see Full Prescribing Information and Medication Guide for SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use. INDICATIONS AND USAGE: An osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. DOSAGE AND ADMINISTRATION: Split Dose (2-Day) Regimen: Dose 1 – On the day prior to colonoscopy: A low residue breakfast may be Packaging and consumed. After breakfast, only clear liquids may be consumed until after the tablets not shown colonoscopy. Early in the evening prior to colonoscopy, open one bottle of actual size. £Ó Ì>L iÌÃ° Ì i «À Û ì` V Ì> iÀ Ü Ì £È Õ ViÃ v Ü>ÌiÀ Õ« Ì Ì i w i®° Swallow each tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Approximately one hour after the last tablet Ã }iÃÌi`] w Ì i «À Û ì` V Ì> iÀ > ÃiV ` Ì i Ü Ì £È Õ ViÃ v Ü>ÌiÀ Õ« Ì Ì i w i® > ` `À Ì i i Ì Ài > Õ Ì ÛiÀ Îä ÕÌiÃ° Ƃ««À Ý >Ìi Þ Îä ÕÌiÃ >vÌiÀ w Ã } Ì i ÃiV ` V Ì> iÀ v Ü>ÌiÀ] w Ì i «À Û ì` V Ì> iÀ Ü Ì £È Õ ViÃ v Ü>ÌiÀ Õ« Ì Ì i w i® > ` `À Ì i i Ì Ài > Õ Ì ÛiÀ Îä ÕÌiÃ° Dose 2 - Day of colonoscopy: Continue to consume only clear liquids until after the colonoscopy. The morning of colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting

Ãi £®] «i Ì i ÃiV ` L ÌÌ i v £Ó Ì>L iÌÃ° Ì i «À Û ì` V Ì> iÀ Ü Ì £È Õ ViÃ v Ü>ÌiÀ Õ« Ì Ì i w i®° -Ü> Ü i>V tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Approximately one hour after the last tablet is ingested, w Ì i «À Û ì` V Ì> iÀ > ÃiV ` Ì i Ü Ì £È Õ ViÃ v Ü>ÌiÀ Õ« Ì Ì i w i® > ` `À Ì i i Ì Ài > Õ Ì ÛiÀ Îä ÕÌiÃ° Ƃ««À Ý >Ìi Þ Îä ÕÌiÃ >vÌiÀ w Ã } Ì i ÃiV ` V Ì> iÀ v Ü>ÌiÀ] w Ì i «À Û ì` V Ì> iÀ Ü Ì £È Õ ViÃ v Ü>ÌiÀ Õ« Ì Ì i w line) and drink the entire amount over 30 minutes. Complete all SUTAB tablets and required water at least 2 hours before colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any ingredients in SUTAB. WARNINGS AND PRECAUTIONS: Serious Fluid and Electrolyte Abnormalities: Advise all patients to hydrate adequately before, during, and after the use of SUTAB. If a patient ìÛi «Ã Ã } wV> Ì Û Ì } À Ã } Ã v ì Þ`À>Ì >vÌiÀ Ì> } -1/Ƃ ] V Ã ìÀ «iÀv À } « ÃÌ V ÃV «Þ >L ÌiÃÌÃ i iVÌÀ ÞÌiÃ] creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and Ài > «> À i Ì° ÀÀiVÌ yÕ ` > ` i iVÌÀ ÞÌi >L À > Ì iÃ Liv Ài ÌÀi>Ì i Ì Ü Ì -1/Ƃ ° 1Ãi -1/Ƃ Ü Ì V>ÕÌ «>Ì i ÌÃ Ü Ì V ` Ì Ã] À Ü >Ài ÕÃ } i` V>Ì Ã] Ì >Ì VÀi>Ãi Ì i À Ã v À yÕ ` > ` i iVÌÀ ÞÌi ` ÃÌÕÀL> ViÃ À >Þ VÀi>Ãi Ì i À Ã v >`ÛiÀÃi events of seizure, arrhythmias, and renal impairment; Cardiac arrhythmias: Use caution when prescribing SUTAB for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias; Seizures: Use caution when prescribing SUTAB for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia; Use in Patients with Risk of Renal Injury: Use SUTAB with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, > } Ìi Ã V ÛiÀÌ } i âÞ i L Ì ÀÃ] > } Ìi Ã ÀiVi«Ì À L V iÀÃ] À ÃÌiÀ `> > Ì y> >Ì ÀÞ `ÀÕ}Ã®° / iÃi «>Ì i ÌÃ >Þ Li at risk for renal injury. Advise these patients of the importance of adequate hydration with SUTAB and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients; Mucosal Ulcerations and Ischemic Colitis: Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. In addition, gastric ulceration or gastritis may occur. Concurrent use of stimulant laxatives and SUTAB may increase these risks. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy w ` }Ã «>Ì i ÌÃ Ü Ì Ü À ÃÕÃ«iVÌ y> >Ì ÀÞ L Üi ` Ãi>Ãi ®° Ã ìÀ Ì i « Ìi Ì > v À ÕV Ã> Õ ViÀ>Ì ÀiÃÕ Ì } from the bowel preparation in patients undergoing esophageal gastroduodenoscopy; 1Ãi *>Ì i ÌÃ Ü Ì - } wV> Ì >ÃÌÀ ÌiÃÌ > Disease: If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering SUTAB. Use with caution in patients with severe active ulcerative colitis. ADVERSE REACTIONS: Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. Postmarketing experience: gastric erythema, gastric ulceration, gastritis, hypersensitivity reactions. POTENTIAL FOR DRUG ABSORPTION: SUTAB can reduce the absorption of other co-administered drugs. Administer oral medications at least one hour before starting each dose of SUTAB. Administer ÌiÌÀ>VÞV i > ` yÕ À µÕ i > Ì L Ì VÃ] À ] ` } Ý ] V À«À >â i] > ` «i V > i >Ì i>ÃÌ Ó ÕÀÃ Liv Ài > ` Ì iÃÃ Ì > È hours after administration of each dose of SUTAB to avoid chelation with magnesium. Pregnancy: There are no available data on SUTAB use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. No reproduction or developmental studies in animals have been conducted with sodium sulfate, magnesium sulfate, and potassium chloride (SUTAB). Lactation: There are no available data on the presence of SUTAB in human or animal milk, the effects on the breastfed child, or the effects on milk production. Pediatric Use: Safety and effectiveness in pediatric patients has not been established. Geriatric Use: Of the 471 patients who received SUTAB in pivotal clinical trials, 150 (32%) were 65 years of age or older, and 25 (5%) were 75 years of age or older. No differences in safety or effectiveness of SUTAB were observed between geriatric patients and younger patients. Elderly patients are Ài i Þ Ì >Ûi ìVÀi>Ãi` i«>Ì V] Ài > À V>À` >V vÕ VÌ > ` >Þ Li Ài ÃÕÃVi«Ì L i Ì >`ÛiÀÃi Ài>VÌ Ã ÀiÃÕ Ì } vÀ yÕ ` > ` electrolyte abnormalities. STORAGE: Store at 20º to 25°C (68º to 77°F). Excursions permitted between 15º to 30°C (59º to 86°F). See USP controlled room temperature. Rx only. Manufactured by Braintree Laboratories, Inc. Braintree, MA 02185 See Full Prescribing Information and Medication Guide at SUTAB.com. References: 1. SUTAB® [package insert]. Braintree, MA. 2 Di Palma JA, Bhandari R, Cleveland M, et al. A safety and ivwV>VÞ V «>À Ã v > iÜ ÃÕ v>Ìi L>Ãi` Ì>L iÌ L Üi «Ài«>À>Ì ÛiÀÃÕÃ > * > ` >ÃV ÀL>Ìi V «>À>Ì À >`Õ Ì subjects undergoing colonoscopy. Am J Gastroenterol. 2021;116(2):319-328. doi:10.14309/ajg.0000000000001020 3. Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; ACG. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009;104(3):739-750.

201-289-v3-A October 2021

2022

Endoscope Reprocessing &Infection Control Volume 4 • Winter 2022

D Droplets That Can Transmit SARS-CoV-2 AAre Expelled During GI Procedures

I Instructions for Use: IImportant Tools for Reprocessing

H Water Pressure Cleans High Duodenoscope Elevator Mechanism D

P Project Tracks, Improves Hospital-wide IInfection Control Procedures

S SGNA Scholarships Help GI Nurses Expand Their Skills G

W to Do With Your What Microbiology Lab Report M

B Borescope Inspection Process IIdentifies Damaged Endoscopes

I Foam Spray Useful When Scope Is Reprocessing Is Delayed? R

N Navigating PPE Waste Disposal During a Pandemic D

D Don’t Overlook Infection Control IIn Community Clinics

EDITORIAL STAFF

ART AND PRODUCTION

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

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

SALES STAFF

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

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

McMAHON PUBLISHING

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 © 2021-2022 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

Commentaries and opinions do not necessarily reflect the views of the publication. Disclosure Statement: We endeavor to obtain relevant financial disclosures from all interviewees and rely on our sources to accurately provide this information, which we believe can be important in evaluating the research discussed in this publication. Copyright © 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.

DRIVING INNOVATION IN GI TOGETHER Designed in close collaboration with experts like you

With aScope Duodeno, we’ve built on a decade of Ambu single-use endoscope innovation and continue to work closely with ERCP physicians to deliver the product that you need. Explore the possibilities at www.ambuUSA. com/single-use-duodenoscope

SINGLE-USE

Ambu® aScope™ Duodeno

2022

Droplets That Can Transmit SARS-CoV-2 Are Expelled During GI Procedures

he droplets patients expel during

upper endoscopy and colonoscopy

procedures could pose a risk for transmission of SARS-CoV-2 to health care workers involved in performing these procedures, according to a study from Beth Israel Deaconess Medical Center.

Researchers created a unique portable device capable of identifying the airborne droplets that can carry SARS-CoV-2 and other viruses from one person to another. They then used the device to measure the presence, size and number of droplets in the room during two common GI procedures. “When we think of patients producing droplets, we think of them emanating from the mouth and nose; we don’t really think about droplets being expelled from other orifices,” said investigator Mandeep Sawhney, MD, MS, a gastroenterologist with the Center for Advanced Endoscopy at Beth Israel Deaconess and an associate professor of medicine at Harvard Medical School, both in Boston. see Droplets, page 10

Endoscope Reprocessing & Infection Control

family of products provides HEPA-filtered air through all internal channels of your endoscope. th

Convert your existing scope cabinett into m. an automatic scope drying system.

Also available pre-installed in new cabinets. (1840 Series Wall Pump pictured)

Available in 5, 8, 10 or 16 scope configurations. (23 Series 5 port Manifold pictured)

Available for use with ambient, medical or instrument strument air air.

The right choice for instrument channel drying after the AER. Simultaneously process one or two endoscopes. Automatic pressure adjustments from Cystoscope to Colonoscopes.

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

www.driscope.com

2022

High Water Pressure Cleans Duodenoscope Elevator Mechanism

novel cleaning device using high-pressure water can

significantly and consistently reduce biofilm residue on a duodenoscope’s elevator mechanism after endoscopic retrograde cholangiopancreatography better than standard-practice manual preprocessing, according to a presentation at the 2021 annual meeting of the American College of Gastroenterology.

A team of researchers at Cedars-Sinai Medical Center, in Los Angeles, developed the device as part of ongoing efforts to avoid endoscoperelated infections of carbapenem-resistant Enterobacteriaceae (CRE). “My inspiration behind this entire water jet was water floss,” said Kapil Gupta, MD, an associate professor of gastroenterology at Cedars-Sinai, and lead The high-pressure water approach removes investigator on the study. “We use the human element from … cleaning, that to clean our teeth … and crevresulting in low variability and precision. ices behind molars and gums. Can we —Kapil Gupta, MD take that same principle and use it to Cedars-Sinai Medical Center clean the duodenoscope and elevator mechanism?” After working with a local design firm to create the device, Dr. Gupta and his colleagues launched a pilot study to determine

‘

’ ’

Endoscope Reprocessing & Infection Control

2022

the tool’s efficacy (poster 2129). To clean a duodenoscope, the scope tip is inserted into the box-like device and then high-pressure jets circulate water inside the scope’s elevator mechanism and hard-toreach areas; the device releases 1,400 pulses of water per minute at a pressure of 100 psi. In this prospective study, researchers tested 30 duodenoscopes. Ten of the duodenoscopes went through the standard-of-care manual cleaning process, 10 were cleaned by the high-pressure water system, and 10 scopes went through the high-pressure water system with water and cleaning fluids. (Five were cleaned with 200 mL of soap solution and then 500 mL of water, and five were cleaned with 200 mL of soap and then 1,000 mL of water.) The researchers used relative light unit (RLU) scores to assess the bioburden in the scopes’ elevator mechanisms before and after cleaning. The baseline RLU scores before cleaning were not significantly different between the group treated with the high-pressure water jet and the control group (RLU scores of 240,431 and 171,177, respectively) (Table). After cleaning, the scopes cleaned with the high-water pressure device had significantly less bioburden—measured as the absolute RLU score and percentage decrease in the RLU score—compared with the control group. The RLU scores were 584.5 and 1,0425, respectively (P=0.001), and the percentage decreases in RLU score were 98.7% and 78.9% (P=0.001). The researchers found no significant difference in the percentage decrease in RLU score when they compared the scopes cleaned with the high-pressure water system alone versus those cleaned with high-pressure water and soap. The high-pressure water system also is more consistent in how well it cleans the scopes compared with manual cleaning, Dr. Gupta said, noting that the effectiveness of manual cleaning varies greatly depending on the person doing the cleaning. The high-pressure water approach removes “the human element from … cleaning,” he said, resulting in “low variability and precision,” which he called “a big plus.” Still, the system did not reach the less than 200-RLU threshold that duodenoscopes are required to reach after reprocessing, he said.

Table.

RLU Scores Before and After Cleaning

Cleaning Approach

Baseline RLU Score

RLU Score After Cleaning

High-pressure water

240,431

584.5

Standard cleaning

171,177

1,0425

P value

P=0.001

NS, not significant; RLU, relative light unit

Step in the Right Direction “We are in an era of trying to understand and manage the CRE infection phenomenon related to duodenoscopes,” said Vivek Kaul, MD, the Segal-Watson Professor of Medicine in the Division of Gastroenterology and Hepatology at the University of Rochester Medical Center, in New York, who was not involved with the study. Disposable endoscopes have emerged as one option for dealing with this problem, but they carry significant costs and are not yet widely adopted, he said. “With this novel device, [Dr. Gupta and his coinvestigators] are able to demonstrate the RLU bioburden, or biofilm burden, is reduced The unique device attempts to create a nearly 20-fold compared to relatively simple, yet effective and potentially the standard approach,” at the low-cost, solution to a complex problem. distal end of the endoscope, —Vivek Kaul, MD Dr. Kaul said. The unique University of Rochester Medical Center device could appeal to gastroenterologists because it represents an attempt to create a relatively simple, yet effective and potentially lowcost, solution to a complex problem, Dr. Kaul said, and “this is a step in the right direction.” The research group at Cedars-Sinai plans to continue developing and studying the device to refine it further, Dr. Gupta noted. If they can tweak the device and get it to the point where this system alone can clean the elevator mechanism more thoroughly during the preprocessing phase, he said it could become “a very powerful tool.” —Jillian Mock

Endoscope Reprocessing & Infection Control

2022

Droplets

continued from page 6

At the start of this project, Dr. Sawhney and his colleagues could not find any studies that quantified the droplets produced during endoscopy. Noting the difficulty of counting droplets, he explained that droplets are small and fly through the air rapidly, and it can be challenging to distinguish a droplet from other particulate matter suspended in the air. In addition, existing commercial devices capable of this type of measurement are too large to incorporate into a typical endoscopy suite, he said. To tackle this problem, Dr. Sawhney and his co-investigators, including Lev T. Perelman, PhD, who studies light scattering systems at Beth Israel Deaconess, developed a novel device that is portable and capable of identifying those elusive droplets (Gastroenterology 2021;161[5]:1702-1704.e3). The device is a small box with an opening at one end that allows air, particles and droplets to move through it. Once inside the box, droplets and other particles cross through a red laser beam, scattering the light in a unique pattern, depending on size and makeup. For example, the scattered light pattern from a large droplet would look unique compared with that of a small dirt particle, “leaving almost a fingerprint,” Dr. Sawhney said. When the device was ready, Dr. Sawhney and his colleagues tested it in 10 upper endoscopies and 10 colonoscopies performed in the same room over two days. During each procedure, the device was positioned either by the patient’s head, for an endoscopy, or anus, for a colonoscopy. The researchers took measurements before and after the procedure as controls. The researchers found significantly more droplets in the air during both endoscopy and colonoscopy procedures compared with the control measurements. The researchers determined approximately 500 droplets could be produced during a single upper endoscopy, estimating that approximately 6,500 viral copies of SARS-CoV-2 could be produced per procedure. To Dr. Sawhney’s surprise, they also found more droplets were measured during colonoscopy procedures compared with upper endoscopies,

partly because those procedures last longer. After adjusting for the length of the procedures, they found more droplets were produced per unit of time during upper endoscopies, but the difference was not statistically significant. These results suggest droplets emitted during these procedures could reach nearby health care workers and that transmission via droplets during a colonoscopy is, therefore, possible, the researchers concluded. They also found that some patients emitted far more droplets than others, and that the majority of droplets were not necessarily expelled at expected times, such as during the insertion or removal of the endoscope. “I think this is really important for every endoscopy practice to be cognizant of,” said Emmanuel Coronel, MD, a gastroenterologist and an advanced therapeutic endoscopist at The University of Texas MD Anderson Cancer Center, in Houston, who was not involved with the study. “Any endoscopy procedure could be high risk, and we should all still be very careful; in addition to that, we should only have essential staff in the room during the procedure to avoid unnecessary transmission.” Noting that the study is one of only a few studies that has measured droplet production by real patients, Dr. Coronel said, “I think it’s a pretty novel instrument they developed.” The main limitation of the study is its small size of just 20 total procedures, Dr. Coronel added. But it is a preliminary study, and future research will allow researchers to build on these findings, he said, adding that it would be helpful to use this technique to understand the production of droplets in other types of procedures, such as endoscopic retrograde cholangiopancreatography, endoscopic ultrasound and small bowel enteroscopy. Dr. Sawhney and his colleagues plan to refine the device to make it more portable and use it to test possible interventions, such as having upper endoscopy patients wear an oxygen mask, to determine whether those protocols protect workers from possible virus transmission. —Jillian Mock

Endoscope Reprocessing & Infection Control

2022

SGNA Scholarships Help GI Nurses Expand Their Skills

hanks to $50,000 in scholarships awarded by the Society of Gastroenterology

Nurses and Associates (SGNA), six GI nurses are getting a boost to help them fulfill their academic aspirations and advance their careers. The scholarships are meant to increase diversity and inclusion within the GI profession and provide funding for nurses pursuing academic degrees and registered nursing program certificates.

Janet King, BSN, RN, the 2021-2022 president of SGNA and a registered nurse at Massachusetts General Hospital, in Boston, was impressed by this year’s scholarship recipients who strive to enhance collaboration with health care teams to improve patient care.

Pursuing a Nursing Leadership Role Award recipient Emily Salisbury, BSN, RN, the director of clinical operations for the University of Utah Health’s Endoscopy Services, in Salt Lake City, is pursuing her Master’s in Nursing (MSN) see Scholarships, page 14

Endoscope Reprocessing & Infection Control

Complete archives Web-only content Multimedia And more …

2022

Scholarships continued from page 12

Janet King, BSN, RN

after working as a GI nurse for 25 years, primarily in procedural areas such as endoscopy and surgical oncology. She hopes her clinical work and leadership experience within GI clinics and endoscopy units, and now an advanced degree focusing on nursing management and leadership, will pave the way to an executive position in nursing endoscopy or quality and patient safety at her institution. “One thing I want to do if I become executive director of nursing is develop a collaborative approach that allows nurses to maximize [their] patient care skill sets,” she said.

‘ [Patients] are often scared and aren’t

sure of what a certain diagnosis means, and we should all be caring for them in a holistic way.

’

— Vicki Purpura, BSN Southern Hills Hospital, Las Vegas

Emily Salisbury, BSN, RN

Ms. Salisbury also wants to deepen the interdisciplinary nature of GI patient care at her institution—something she said will be important as the COVID-19 pandemic continues and both nurses and technicians face work and life stresses and possible burnout. In case of a shortage of skilled technicians, which Ms. Salisbury said she has anecdotally seen at her institution, she would like to offer training for nurses at her institution so they can assume some of the work that technicians typically perform. “There are a lot of opportunities for nurses to do more hands-on work,” she said, noting

that as a nursing executive, she also wants to help her institution meet increasingly stringent scope reprocessing requirements and tackle other challenges. Scholarship awardee Vicki Purpura, BSN, the endoscopy charge nurse at Southern Hills Hospital, in Las Vegas, recently completed her BSN with the help of the SGNA funds and is looking forward to cultivating a greater focus on patient needs at her institution. “My hospital just started a GI fellowship, and I plan to help teach the GI fellows as much as I can about being a patient advocate,” Ms. Purpura said. “I want the doctors to see that their patients are more than a disease or a procedure. They are often scared and aren’t sure of what a certain diagnosis means, and we should all be caring for them in a holistic way.”

Diversity in Nursing Is Critical Ms. King noted that partly with the assistance of an SGNA scholarship, another recipient, a recent immigrant to the United States, is pursuing an associate degree with a focus on GI endoscopy nursing—an opportunity not available to her in her native country. Ms. King said ensuring diversity, inclusion and equity in the nursing workforce “is a necessity if we want to improve patient outcomes and provide optimal health care. Underrepresenting different groups in nursing limits the awareness of patients’ needs and a true understanding of a patient’s culture and how it influences their behavior and thinking,” she said. “When patients see a culturally diverse workforce, they feel safer, more comfortable and confident in their care and have more trusting relationships.”

Vicki Purpura, BSN

Endoscope Reprocessing & Infection Control

—David Wild The 2021 SGNA scholarships are sponsored primarily by Boston Scientific.

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

2022

Borescope Inspection Process Identifies Damaged Endoscopes

lthough a borescope inspection process for duodenoscopes

used in endoscopic retrograde cholangiopancreatography (ERCP) procedures added to the cost of endoscope repair and maintenance, it helped identify damaged endoscopes and scopes with residual debris after reprocessing, mitigating the risk for patient exposure and infection, according to investigators from Ochsner Health.

“Our organization lacked a process for visualizing internal lumens during and after the cleaning process,” noted the authors, led by Diana Sierra, MSN, RN, CGRN, an endoscopy clinical coordinator for Ochsner Health, in Louisiana. Ms. Sierra and her colleagues focused on endoscopes through which a device, such as a band clip or stent, had been deployed or removed through the instrument channel, as well as endoscopes in which compromise was suspected and those that needed to undergo routine inspection post-culture. In 2018, after reports in the literature indicated that video inspection of the endoscope reprocessing channel could be useful to audit reprocessing performance and identify damaged endoscopes

(Gastrointest Endosc 2018;88[4]:612-619), Ochsner’s Endoscopy Department acquired six borescopes, with four mounted in reprocessing areas and two stored for post-culture inspections.

Standard Processes Developed The department collaborated with the infection prevention team to create standard operating procedures and train staff on incorporating the new borescope channel inspection process into their customary reprocessing steps, as well as on how to handle, clean and disinfect the borescopes themselves. Under the new procedures, after standard bedside cleaning but before the endoscopes are transported to the reprocessing area, technicians label endoscopes requiring

Endoscope Reprocessing & Infection Control

2022

borescope inspection—those that have had a device deployed or removed through the instrument channel and those in which compromise is suspected—with a yellow sticker. After manual cleaning, scopes with yellow stickers have their internal lumens inspected with the borescope; duodenoscopes also have the elevator and distal tip inspected. Findings and interventions are then documented. Presenting a review of their findings at the 2021 annual meeting of the Society of Gastroenterology Nurses and Associates, the investigators reported that one year after implementation of the process, 100% of endoscope reprocessing staff were trained, with competency validated (poster R01). Over that time, 1,490 inspections were performed: 187 post-culture inspections, 722 inspections on endoscopes in which a device was deployed/removed through an instrument channel, and 787 duodenoscope distal tip/elevator inspections. Of those inspections, 79 displayed abnormal findings including debris, retained foreign bodies, discoloration, scratches and tears. According to the investigators, “100% of those abnormal findings were addressed prior to next patient use, including repeated manual cleaning with repeated inspection to ensure removal of debris.” Their finding could not be remedied or the scope required repair in 17 cases; these scopes were sent to the manufacturer. In the second quarter of 2019, after implementation, average quarterly endoscope maintenance and repair costs were up by 53% compared with the first quarter of 2018, before implementation. However, given the debris remaining after cleaning, the investigators underscore the patient safety benefits of the inspection process. “Despite manual cleaning of all endoscopes prior to automatic endoscope reprocessing [AER], through implementation of our borescope inspection process, we continued to identify debris behind duodenoscope elevators, warranting further cleaning steps and reinspection before AER high-level disinfection,” they noted. “Our health system’s Performance Improvement and Infection Prevention teams appreciated the potential patient safety implications and value our new process added and mandated borescope implementation system-wide.”

Borescope Approach Useful For Hospitals, Ambulatory Centers Harish Gagneja, MD, FACG, FASGE, a gastroenterologist with Austin Gastroenterology, in Texas, praised the study as highly useful for hospital endoscopy centers. “This demonstrates that you can effectively incorporate this process in the hospital setting, which is where most of these therapeutic procedures involving stents and other devices are performed. The question has been posed recently with regard to endoscopic ultrasound and ERCP scopes, which can have a high risk of biofilm formation, as to whether you use the borescope inspection process or move to disposable scopes. In my opinion, disposable scopes are more expensive and have a negative environmental impact—not to mention potential supply chain issues—so I think the borescope approach has much more utility.”

‘ Once you get trained to use [borescopes],

you know what to look for; it could cut down on the amount of water intrusion into scopes, and [you could] send them out earlier for repair [to avoid] more damage.

’

—Rob Puglisi PE GI Solutions

Although they may have their greatest utility in the hospital endoscopy setting, borescopes could be useful in ambulatory surgery centers as well, according to Rob Puglisi, a vice president of operations for PE GI Solutions, which oversees operations at 60 gastroenterology surgery centers in 15 states. “Once you get trained to use it, you know what to look for; it could cut down on the amount of water intrusion into scopes, and [you could] send them out earlier for repair [to avoid] more damage,” he said. “But you would have to do a cost–benefit analysis as to how much damage is done via small tears that you don’t pick up versus the cost of acquiring the borescope unit.” —Gina Shaw

Endoscope Reprocessing & Infection Control

2022

Navigating PPE Waste Disposal During a Pandemic

he increased need for personal protective equipment (PPE) and its use during the COVID-19 pandemic has produced a rise in

medical waste as institutions dispose of gowns, gloves, masks, face shields and shoe covers that have been exposed to the virus. “There definitely is more regulated medical waste being generated, and a lot of it is derived from PPE,” said Rudy Vingris, the health care business development manager at Waste Management Sustainability Services. The challenge, he noted, “is that there isn’t a national standard that applies across the board to determine what types of COVID-19–related PPE should be regulated as medical waste. It’s up to individual states.”

Category B Infectious Waste The Occupational Safety and Health Administration and the CDC released guidance specific to COVID-19 waste, which determined that the virus is a Category B infectious substance. This means PPE and other medical waste generated in the treatment of patients with COVID-19 can be managed in the same way as other waste related to Category B infectious substances, in contrast to the more hazardous Category A infectious waste generated in the management of diseases such as Ebola. “This classification means that, unless the PPE is grossly contaminated with blood or bodily fluids to the extent it could lead to an infection, it is technically just trash and can go to the solid waste stream,” Mr. Vingris said. However, given that COVID-19 is a highly communicable disease, treating exposed PPE as ordinary waste rather than hazardous medical waste gives some people pause. “The University of Nebraska Medical Center has done studies on surface and air contamination associated with the virus, and has found measurable concentrations in the air and on surfaces where patients have been,” said Fred Massoomi, PharmD, the senior director at the pharmacy consulting firm Visante (Sci Rep

2020;10[1]:12732). “We know this is a virus that likes to linger. So, while some systems are managing COVID-related PPE as routine waste, others are treating it as biohazard waste that gets autoclaved or incinerated, depending on how they classify it.”

Clues From the States Many states have issued their own guidance statements on managing PPE exposed to the coronavirus. New Jersey, for example, clarifies that “PPE and cleaning materials (e.g., wipes, rags) contaminated with blood, excretion, exudates, or secretions from humans who have COVID-19 are considered regulated medical waste,” whereas materials that are not contaminated in that way can be disposed of as ordinary waste. California allows for some discretion in its regulations on PPE: “If the facility determines that any PPE should be disposed of [as solid waste], used gloves, face masks, coveralls, etc., should be placed in a lined container, preferably with a lid/cover. Tightly close off the bag before disposing the solid waste items into the ... waste bin for pickup by the waste management company.” Disposal of regulated medical waste is, of course, much more costly than solid waste. “It’s more expensive by probably an order of magnitude of 10 times or more, although not as expensive as something like RCRA [Resource Conservation and Recovery Act] waste that we would see in an oncology pharmacy,” Mr. Vingris said. “So is it breaking the budget? No, but it is definitely something that folks have had to adapt their planning and budget for as part of overall waste management.”

Endoscope Reprocessing & Infection Control

—Gina Shaw The sources reported no relevant financial disclosures.

DRIVING INNOVATION IN GI TOGETHER Designed in close collaboration with experts like you

With aScope Duodeno, we’ve built on a decade of Ambu single-use endoscope innovation and continue to work closely with ERCP physicians to deliver the product that you need.

Explore the possibilities at www.ambuUSA. com/single-use-duodenoscope

SINGLE-USE

Ambu® aScope™ Duodeno

2022

Instructions for Use: Important Tools for Reprocessing he instructions for use (IFUs) for a medical device detail for clinicians and sterile processing technicians exactly how that device should be used, cleaned and reprocessed. At the 2021 virtual meeting of the Association for Professionals in Infection Control and Epidemiology, Delores O’Connell, LPN, detailed best practices for using IFUs.

One of the most important principles for working with IFUs is to ensure that the current instructions are always at hand, said Ms. O’Connell, the senior clinical education specialist for the sterilization and surgical equipment supplier Steris. This can be harder than it seems, she noted. One challenge arises when a manufacturer slightly alters an existing device and the IFU that applies to the new device is not readily available. “We need to go

510(k) and Medical Device Approvals

edical devices can range from bandages to x-rays, and in most cases, will require FDA clearance and a determination of classification before they can be sold. But if an entrepreneur develops a new type of bandage, which is a product that is very well understood and which would not cause great harm if misused, that new bandage likely can be sold without needing specific FDA clearance. Low-risk devices, such as bandages, are Class I devices; these types of devices have the lowest barriers to entry into the market, explained Delores O’Connell, LPN, in a presentation at the 2021 virtual meeting of the Association for Professionals in Infection Control and Epidemiology. Class II and III medical devices are managed by different regulatory schemes than Class I,

explained Ms. O’Connell, the senior clinical education specialist for the sterilization and surgical equipment supplier Steris. A Class II device, such as an infusion pump or steam sterilizer, would cause moderate harm if misused and, thus, requires a higher degree of regulatory oversight. For a manufacturer to obtain approval to market most Class II devices, they must submit a 510(k) application to the FDA at least 90 days before they intend to begin selling it. This application must show that the new device is “substantially equivalent” to a similar “predicate device” that’s already on the market. One way to do this, Ms. O’Connell said, is to show that the new device has the same intended use and technological characteristics as a device

Endoscope Reprocessing & Infection Control

2022

6 Criteria for IFUs for Reprocessing Medical Instruments back to the device manufacturer, not only to make sure An indication of the intended use Technically feasible reprocessing that we have the right IFU of the device instructions that only rely on legally but also to clarify if the new marketed devices and accessories A requirement to thoroughly clean IFU covers the old device,” the device Comprehensive reprocessing Ms. O’Connell said. instructions If two different IFUs apply A statement of the appropriate way to the two different devices, to kill microbes on the device Understandable reprocessing Ms. O’Connell said, a medical instructions system’s inventory management system must be robust enough to ensure that clinicians and sterile processing technicians are using the right IFUs for the right part of what the FDA considers when deciding device. This might feel cumbersome, or “very whether to clear a new medical product for marlumpy,” Ms. O’Connell said, but the stakes are keting, and the FDA has the authority to request high. “We’ve got to stand up for patient safety changes to IFUs before clearing a device. and high reliability,’’ Ms. O’Connell said. Sometimes IFUs are lengthy, which is another New 510(k) applications for reprocessing medi- reason to produce visual aids. Chris Lavanchy, cal devices must include IFUs, which must meet the engineering director in the Device Evaluation six criteria related to reprocessing medical instru- Group at ECRI, an independent analyst of the ments (box). safety and usability of medical devices, said the Ms. O’Connell noted that manufacturers can reprocessing instructions for some flexible endoproduce diagrams or other visual aids that make scopes are at least 100 pages. an IFU easier to understand and follow, as long —Marcus A. Banks as everything in the visual aid matches what is Mr. Lavanchy reported no relevant financial disclosures. Ms. O’Connell is an employee of Steris. in the written IFU. These visual aids become

1. 2. 3.

that’s already on the market. Or if the new device uses different technology, the manufacturer must show that it presents no new safety concerns. “A claim of substantial equivalence does not mean the new and predicate devices need to be identical,” Ms. O’Connell said, but they must be able to achieve the same outcome in similar ways. A Class III device, such as a pacemaker or an automated external defibrillator, could cause grave and immediate harm if misused and has the highest regulatory burden. Drawing on FDA estimates, Ms. O’Connell reported that approximately 10% of medical devices fall into Class III, and getting approval to market a new Class III device generally requires a premarket approval. Chris Lavanchy, the engineering director in the Device Evaluation Group at ECRI, an independent analyst of the safety and usability of medical devices, noted that the FDA’s 510(k)

4. 5. 6.

process is “a shortcut to obtaining market clearance. Unless there’s a significant risk associated with the device, say, for example, it’s used for lifesaving support, … it probably isn’t warranted to go through a full [premarket authorization]. The 510(k) shortcut seems to work pretty well,” Mr. Lavanchy said, noting that this process often enables a new medical device to enter the market in as few as three months, rather than taking a year or sometimes longer and costing hundreds of thousands of dollars. Balancing safety with speed will always be a concern, but Mr. Lavanchy offered assurance that safety is still a priority within the 510(k) framework. “To get a 510(k) cleared,” he said, manufacturers “have to show that they’ve tested their product and demonstrated that it works and that it’s safe.” —M.A.B.

Endoscope Reprocessing & Infection Control

2022

Project Tracks, Improves Hospital-wide Infection Control Procedures pera pe rati ting ti ng roo oom m sttaf aff ff ar are e lilik kely kel ly to get prompt feedback from sterile processing colleagues if they do not properly preclean or spray a medical instrument before sterilization, but such feedback edback db bac ck is s lless es ss likely ikely kely to o occur ccur cc curr for employees ployees ploy oyee yees es s in in u units nits nit ts fa fart farther arther from arther arth f tth he e OR, su such suc ch as tthe h women’s health or endoscopy dosco doscop dosc cop units, according to infection prevent rev reventionist eve vent nt Jill Holdsworth, CIC, CRCST, T,, of E of Emo y Hospi Emory p tal Midtown,, in Atla Atlanta. a.

‘ We had so many inconsistencies

throughout the hospital with transportation of soiled instruments. I see that in a lot of facilities right now, so we set out just to standardize everything.

’

—Jill Holdsworth, CIC, CRCST Emory Hospital Midtown

At the 2021 virtual meeting of the Association for Professionals in Infection Control and Epidemiology (APIC), Ms. Holdsworth described Emory’s ongoing strategy for standardizing infection control procedures throughout her facility. “We had so many inconsistencies throughout the hospital with transportation of soiled instruments,” Ms. Holdsworth said, noting that sometimes these instruments are carried in Tupperware-type storage containers. “I see that in a lot of facilities right now, so we set out just to standardize everything.” When Ms. Holdsworth began this

Endoscope Reprocessing & Infection Control

effort in 2018, she and her colleagues noticed that OR employees had a consistent process for managing soiled instruments that involved spraying them with surfactant gel and transporting them in closed carts that reduce the risk for contamination. OR employees also received regular training on how to avoid contaminating surgical equipment. In contrast, within procedural or clinical areas outside of the OR, practices were much more inconsistent. Infection control training by sterile processing staff occurred less frequently or not at all in see Procedures, page 24

Free CME now available! 1.5 AMA PRA Category 1 Credit™

Diagnosing and Managing EoE: Evolving Guidelines, Emerging Treatments RELEASE DATE: DECEMBER 1, 2021 EXPIRATION DATE: DECEMBER 1, 2022

Faculty Kristle L. Lynch, MD (Chair) Associate Professor of Clinical Medicine Director, Gastroenterology Physiology Laboratory Director, Advanced Esophagology Fellowship The University of Pennsylvania Perelman School of Medicine Philadelphia, Pennsylvania

Evan S. Dellon, MD, MPH

This continuing medical education activity is provided by MedEdicus LLC.

Professor of Medicine Division of Gastroenterology and Hepatology Adjunct Professor of Epidemiology Director, Center for Esophageal Diseases and Swallowing University of North Carolina at Chapel Hill School of Medicine Chapel Hill, North Carolina

This continuing medical education activity is supported through an educational grant from Takeda Pharmaceuticals USA, Inc. Distributed by Gastroenterology & Endoscopy News and CMEZone.com

Professor of Medicine Division of Gastroenterology & Hepatology Co-Director Northwestern Eosinophilic Gastrointestinal Disease Program Feinberg School of Medicine Northwestern University Chicago, Illinois

Emily C. McGowan, MD, PhD Associate Professor of Medicine Division of Asthma, Allergy, and Immunology University of Virginia School of Medicine Charlottesville, Virginia

Access today at www.cmezone.com/MM212

Esophagus photo credit: K Lynch MD

Nirmala Gonsalves, MD

2022

Procedures continued from page 22 3 Easy Steps For Precleaning

1. 2. 3.

Place soiled instruments into tray after ensuring they are open and were wiped down at the point of use. Spray instruments thoroughly with surfactant gel before transport. Safely transport instruments in biohazard bins.

these areas, and proper equipment was not always on hand. Unlike within the OR, which used an electronic system to audit compliance with infection control procedures, there was no consistent way to document whether staff in other units followed proper protocols. Ms. Holdsworth’s first step was to develop a documentation form to track other units’ compliance with best practices for infection control, using a biohazard container for transport of soiled instruments to the sterile processing unit and precleaning and spraying instruments before taking them away. Staff in the various units must fill out this form manually, a limitation that Ms. Holdsworth said means that some data are regularly missing. With the available data, Ms. Holdsworth determined that units outside the OR were compliant with best infection control practices less than 20% of the time when the project began. This intake stage also revealed that staff in many units were not aware of which infection control supplies they had on hand or which supplies could be disposed of and which needed to go to sterile processing. In a joint effort involving nursing, infection prevention and sterile processing leaders encompassing every unit of the hospital, Ms. Holdsworth said, “we figured out what was there, what needed to be there and what maybe didn’t need to be stocked anymore.” After taking this inventory, Ms. Holdsworth and her colleagues proactively listed exactly which infection control supplies a given unit needed, so there would be no waste when ordering. “We didn’t want them to buy a bunch of biohazard bins that didn’t fit their instruments,” Ms. Holdsworth said, noting that this inventory support effort was one major achievement of the initiative. In addition to the inventory support, in April 2018, Ms. Holdsworth’s team launched an intensive education campaign about infection prevention best practices throughout the hospital. One aspect of this effort was simple, engaging flyers, including one that highlighted the “three easy steps” involved in precleaning medical instruments (box). As of February 2019, audits of the units outside the OR showed an increase in compliance

from 20% to 91%. In June 2019, compliance reached 100%. These efforts earned Emory Midtown the 2020 Georgia Hospital Association Josh Nahum Award of Achievement in Infection Prevention. Commenting on the Emory project, Casey Czarnowski, CRCST, CSPDT, CIS, CER, the sterile processing educator at Stanford Health Care, in the San Francisco Bay Area, said the initiative points to the fact that infection control will always be crucial. “There’s no time constraint when it comes to patient safety,” Mr. Czarnowski told Priority Report. He said he promotes the idea that any member of a hospital staff, regardless of their role or the unit they work in, should feel empowered to speak up if they think any medical instrument might be contaminated. Mr. Czarnowski likens this to the “stop the line” philosophy of automobile manufacturing, in which any employee can request a production halt if they think something dangerous happened somewhere along the line. Mr. Czarnowski also recommended other critical infection control practices, such as never deviating from the manufacturer-provided instructions for use (IFU) when it comes to reprocessing instruments (see story, page 20). For example, it might seem expedient to wash a given instrument on a faster washing cycle so it can be recirculated and used for the next patient as soon as possible, but if the IFU specifies longer washing times or some other setting, then that is what must be followed. Besides the need to maintain best practices for infection prevention at already established facilities, new medical enterprises open all the time. If someone is opening a new clinic or hospital and needs to ensure that their sterilization facilities are optimal, Mr. Czarnowski suggested they consult sterilization guidelines by the Association of periOperative Registered Nurses or Association for the Advancement of Medical Instrumentation to hit the ground running by following best infection control practices. For her part, Ms. Holdsworth is not resting on the laurels of hitting 100% compliance in managing soiled instruments, saying that the work of optimizing infection control at Emory Midtown will always be ongoing.

Endoscope Reprocessing & Infection Control

—Marcus A. Bank

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

2022

What to Do With Your Microbiology Lab Report

our endoscopy center has initiated a sampling and culturing program,

you’ve just gone through your first round of sampling, and you’ve received

a report back from the microbiology laboratory. How do you make sense of that report and turn it into something actionable that helps you minimize the risk for infections transmitted via your endoscopes?

“Digging into the lab report can really be confusing when a facility has just started with a sampling and culturing program,” said Gregory Cote, MD, a professor of gastroenterology and hepatology at the Medical University of South Carolina, in Charleston. Dr. Cote and clinical microbiologist Michelle Alfa, PhD, discussed the intricacies of digging in and interpreting microbiology lab reports during a webinar sponsored by Olympus.

Focus on High-Concern Organisms Noting that the 2018 guidance on Duodenoscope Surveillance Sampling and Culturing, jointly released by the FDA, CDC

Table.

High-Concern Organisms

The guidance document defines high-concern organisms as those “that are more often associated with disease.” They include the following: Gram-negative rods

• Escherichia coli • Klebsiella pneumoniae or other Enterobacteriaceae • Pseudomonas aeruginosa Gram-positive organisms

• Staphylococcus aureus • Beta-hemolytic Streptococcus • Enterococcus species Yeasts Source: https://www.fda.gov/media/111081/download

Endoscope Reprocessing & Infection Control

2022

and American Society for Microbiology (ASM), categorizes organisms as either high, moderate or low concern, Dr. Alfa said, “As you review the lab report, your primary focus should be on high-concern organisms” (Table). “These are the ones that have been most associated with outbreaks of disease,” said Dr. Alfa, a professor in the Department of Medical Microbiology at the University of Manitoba, in Winnipeg. “Gut-derived gram-negative rods in particular are quite worrisome,” with the potential for isolates from a patient to remain in the scope channel and be transmitted to the next patient. Even 1 colony-forming unit (CFU) from any of these high-concern organisms requires action, she stressed. Moderate-concern organisms include those commonly found in the oral cavity (e.g., saprophytic Neisseria, viridans group streptococci and Moraxella). “These species occasionally might be able to cause infection in humans and have been involved in endocarditis and things like that, but the reality is that they haven’t been associated with any of the outbreaks linked back to contaminated scopes,” Dr. Alfa said. Low-concern organisms include many species of gram-positive bacteria such as Micrococcus, coagulase-negative staphylococci (excluding Staphylococcus lugdunensis), and Bacillus and diphtheroids or other gram-positive bacilli. “These organisms are very seldom associated with disease. Mostly, they’re introduced accidentally at the time of sample collection,” Dr. Alfa said. If these low- or moderate-concern organisms show up in your lab report, most of the time no action is required; but if you start seeing an exceedingly high number of CFUs for any organism—no matter its level of concern—the FDA/ CDC/ASM 2018 guidelines require that you take action. “If you have greater than 100 CFUs, it doesn’t matter what organism it is. You just shouldn’t have that. Something is seriously wrong,” Dr. Alfa said. “If there are 11 to 100 CFUs for low- to moderate-concern organisms, that’s an ‘alert’ category, although no action is specifically required.” Assuming that you do not have a microbiology lab on-site and are sending samples out to a private laboratory, Dr. Alfa noted that it’s important to be aware of what kind of assays the lab uses

and how fast they can respond. “MALDI-TOF [matrix-assisted laser desorption/ionization timeof-flight] mass spectrometry is preferred, if available, because it can identify most high-concern organisms very rapidly,” she said. “Traditional biochemical assays, like Vitek [bioMérieux] and Microscan [Omron], can take days to identify microorganisms, while DNA sequencing can also take days to weeks; for most high-concern organisms, you really don’t need DNA sequencing to identify these types of isolates.”

‘

After an actionable culturing result, you may need personnel adjustments or retraining, the problem may have something to do with handling, or it may be the equipment itself, such as a damaged scope.

’ —Gregory Cote, MD

Medical University of South Carolina, Charleston

If your report identifies any gram-negative gut organisms, Dr. Alfa recommended considering antibiotic susceptibility testing. “That would be the only time where this testing might be needed, because if you do have a multidrug-resistant organism, the implications are different.” She described a few organisms your facility might encounter in a microbiology lab report, including the following: • Acinetobacter, a gram-negative rod. Example species include A. baumannii, the most common cause of Acinetobacter infections in humans, and A. calcoaceticus. These organisms typically come from water or the health care environment. “Acinetobacter is one of the few gram negatives that can survive well for long periods of time in the environment, and it certainly is concerning,” Dr. Alfa said. • Enterococcus, such as E. faecalis and E. faecium, are gram-positive cocci that typically come from the gastrointestinal tract or health care environment. • Escherichia, such as E. coli, are gram-negative rods typically coming from the GI tract. • Klebsiella, such as K. pneumoniae and K. oxytoca, are gram-negative rods that typically come from the GI tract. “The

Endoscope Reprocessing & Infection Control

2022

presence of either of these two organisms after full reprocessing is a problem because it suggests that organisms from a prior patient survived the process and remain in the scope, which shouldn’t be happening,” Dr. Alfa said. • Pseudomonas species, such as P. aeruginosa and P. stutzeri, are gram-negative rods from the health care environment or water. • Staphylococcus species, such as S. aureus and S. lugdunensis, are gram-positive cocci that typically come from the skin or mucous membranes. “If you culture Staphylococcus species, or high numbers of low-concern organisms, you should question whether the handling of your fully reprocessed scope was done improperly—for example, no gloves used to handle fully reprocessed scopes—or whether skin organisms were introduced into the sample during collection,” Dr. Alfa said.

‘ If you have greater than 100 CFUs, it doesn’t matter what organism it is. You just shouldn’t have that. Something is seriously wrong.

’

—Michelle Alfa, PhD University of Manitoba, Winnipeg

Time to Take Action When you get an actionable culture result on your microbiology report, what happens next? First, the scope from which the organism was cultured should be removed from use. Then, said Dr. Cote, notify your infection control to help interpret the significance of the finding, along with your endoscopy directors, endoscopy nurse management and risk management team. Next, conduct a root cause analysis to identify the source of the organism(s) found. “The objective of your culturing program is to identify the gaps in your process,” he said. “You may need personnel adjustments or retraining, the problem may have something to do with

handling, or it may be the equipment itself, such as a damaged scope.” To find the potential source for the organism, look to its type. “For example, pseudomonads are notoriously water-oriented, so if you had 50 CFUs of P. aeruginosa that grew on your plate, one of your first steps should be examining how the sink in your reprocessing area is being used,” Dr. Alfa said. “Is it being decontaminated after each use? Also assess if the submicron membrane filter on your [automated endoscope reprocessor] is damaged such that it’s allowing waterborne Pseudomonas to pass through the filter and it’s showing up in the final rinse water.” After identifying what you think is the source of the contamination, the FDA/CDC/ASM 2018 guidance calls for repeat reprocessing of the affected scope and a repeat sampling and culture process. “If you have repeated positive cultures from the same scope or multiple scopes, it might indicate that some kind of unrecognized, lowlevel outbreak is happening, at which point you have to make a decision about initiating a more expanded follow-up,” Dr. Alfa said. “If a scope is repeatedly growing high-concern organisms, that is, if you have two such reports after consecutive patient uses, send it back to the manufacturer immediately for assessment and repair.” Dr. Cote stressed that it is important to keep the overall level of scope-related outbreaks in perspective. “Endoscopy centers do more than 600,000 of these procedures per year, and the reported infection case numbers are in the double digits in the worst of years, with a reduction in recent years,” he said. “Although these infections are rare, they are a horrible and preventable complication, and it is incumbent upon endoscopy providers to do an excellent job of keeping them to an absolute minimum. A good sampling and culturing program, along with a plan of action for what to do if something is found, can help you achieve that.” —Gina Shaw The webinars were sponsored by Olympus. Dr. Alfa reported financial relationships with 3M, ASP, Kikkoman, Olympus, Ruhof and Steris. She stated that the information provided for the Olympus webinars was based on published scientific data and was her own opinion and not that of any company to which she provides consulting services. Dr. Cote reported financial relationships with AbbVie, Cook and Olympus.

Endoscope Reprocessing & Infection Control

2022

Is Foam Spray Useful When Scope Reprocessing Is Delayed?

se of foam spray on flexible endoscopes that have

not been reprocessed immediately could serve

as an alternative to the delayed reprocessing protocol involving prolonged soaking, suggested authors of a study presented at the 2021 annual meeting of the Society of Gastroenterology Nurses and Associates. But other experts who spoke to Priority Report were unconvinced, noting that this approach doesn’t fall within endoscope manufacturer instructions for use. Endoscopes must proceed to reprocessing within one hour after patient use to prevent biofilm formation, but delays in precleaning can occur due to inadequate staffing or in after-hours emergency cases, when the endoscopes are left for proper reprocessing the next business day. When this happens, most manufacturer instructions for use stipulate a six- to 10-hour prolonged soaking as part of a delayed reprocessing protocol. But the investigators, from the Department of Endoscopy at Ng Teng Fong General Hospital in Singapore, noted that this process can be difficult to employ during off hours. see Foam Spray, page 34

Endoscope Reprocessing & Infection Control

Free CME now available! 1.0 AMA PRA Category 1 Credit™

RELEASE DATE: NOVEMBER 1, 2021 EXPIRATION DATE: NOVEMBER 1, 2022

An Update on the Unmet Needs in the Care of Patients With Ulcerative Colitis And Emerging Treatment

Faculty William J. Sandborn, MD (Chair) Professor of Medicine University of California, San Diego La Jolla, California

Laurent Peyrin-Biroulet, MD, PhD

This continuing medical education activity is provided by MedEdicus LLC.

This continuing medical education activity is supported through an educational grant from Arena Pharmaceuticals, Inc. Distributed by Gastroenterology & Endoscopy News and CMEZone.com

Head of Team 2 INSERM U1256 NGERE University of Lorraine Professor of Gastroenterology Nancy University Hospital Vandoeuvre-lès-Nancy, France

Bruce E. Sands, MD, MS Chief, Division of Gastroenterology Dr Burrill B. Crohn Professor of Medicine Icahn School of Medicine at Mount Sinai New York, New York

Séverine Vermeire, MD, PhD Professor of Medicine Catholic University Leuven, Belgium

Access today at www.cmezone.com/MM213

2022

Don’t Overlook Infection Control In Community Clinics

ealth systems are increasingly relying on

community-based clinics that perform

many of the procedures offered in hospitals, but infection prevention efforts at those clinics may be less rigorous than hospital-based infection prevention programs due to a lack of oversight, training and supplies, according to a presentation at the 2021 virtual meeting of the Association for Professionals in Infection Control and Epidemiology (APIC).

Some community clinics do not even have a formal infection prevention program, said Fozia Steinkuller, MPH, CIC, an infection preventionist at UT Physicians, in Houston, noting that such programs are not always required before a clinic opens its doors. However, in most states, ambulatory surgery centers need to be available for on-site inspections that would include evaluation of infection control practices, and all health entities must adhere to infection prevention standards from governing and accrediting bodies, such as the CDC and the Joint Commission.

Active Training Program At the APIC meeting, Ms. Steinkuller offered strategies for ensuring that infection prevention programs at non-hospital facilities are as rigorous as those in hospitals. She said a key ingredient for success of such programs is active, participatory training for anyone involved in infection prevention at community clinics. When Ms. Steinkuller trains staff, she ensures that they hear information about infection control practices, repeat the information back to her, see the practices being done and take a quiz on the information. She covers the distinction between low-level disinfection, high-level disinfection and sterilization, noting that only sterilization removes all forms of microbial life from a surgical

Endoscope Reprocessing & Infection Control

2022

instrument. High-level disinfection, she said, might leave small numbers of bacterial spores. “Sterilization is the best—it obliterates everything,” Ms. Steinkuller said. But not every medical device or instrument needs to undergo the lengthier and more rigorous process behind full sterilization, she said. Pointing to the Spaulding Classification for determining which level of disinfection is appropriate (https://bit.ly/3BXYYuB), Ms. Steinkuller said a blood pressure cuff requires low-level disinfection because its only contact is with intact human skin that is less vulnerable to infection. In contrast, an endoscope that will touch a mucous membrane always requires high-level disinfection or better, Ms. Steinkuller said, whereas any surgical instrument requires complete sterilization between each use. Ms. Steinkuller said she covers this information at every training because the medical assistants who attend her training sessions generally receive only a cursory overview of infection prevention principles during their schooling. Knowing that steps frequently are missed in reprocessing (bit.ly/2ZYkNwo), Ms. Steinkuller developed a training program that includes an overview of infection prevention concepts along with an extensive demonstration of how to properly clean and reprocess medical equipment. She tailors specific examples to different devices used in different clinics. After the demonstrations, Ms. Steinkuller asks students to take a quiz and reviews questions they answered incorrectly. Next, she has the new students apprentice with experienced staff at various clinics. After two months, she observes and assesses the students as they demonstrate different levels of disinfection and sterilization, using the CDC’s “Guide to Infection Prevention for Outpatient Settings” for the assessments (bit.ly/3BP4uj0). After completion of the program, the students receive certificates of competence they can present to potential employers.

Systemwide Approach Needed Ms. Steinkuller’s efforts are one way to address the reality that, even if institutions do not prioritize training in infection prevention, they are still accountable to regulatory bodies for ensuring a sanitary and safe environment for patients. This

is particularly true when reprocessing endoscopes, given well-publicized instances of endoscopic cross-contamination (bit.ly/3GVq9d6). “The Joint Commission educates our surveyors on the appropriate cleaning process and reprocessing of endoscopes. Then when they are on survey, they are required to go to any area where they are reprocessing endoscopes, as part of the survey process,” Sylvia Garcia-Houchins, MBA, RN, CIC, the Joint Commission’s director of infection prevention and control, told Priority Report.

‘ The expectations of the Joint Commission are that a health care

organization has an infection control program—not an employee, not a department, but a program—that everyone in the organization participates in based on their role, be it a secretary, a physician, a contractor, a patient or a visitor.

’

—Sylvia Garcia-Houchins, MBA, RN, CIC The Joint Commission

Beyond the details for managing endoscopes, Ms. Garcia-Houchins pointed out that infection control is an organization-wide responsibility that encompasses all personnel, hospitals and clinics within a health system. “The expectations of the Joint Commission are that a health care organization has an infection control program—not an employee, not a department, but a program—that everyone in the organization participates in based on their role, be it a secretary, a physician, a contractor, a patient or a visitor,” Ms. Garcia-Houchins said. She stressed that this infection control program is binding on any facility within a health system, whether a flagship hospital or an ambulatory care clinic hundreds of miles away. If any practice in a clinic or hospital presents an infection risk, there must be strategies in place to mitigate those risks. In the most egregious cases, Ms. Garcia-Houchins said, the Joint Commission could deem a medical facility to be an “immediate threat to health and safety” and require mitigation plans to be produced on the spot. Ms. Steinkuller’s efforts describe one strategy to help ward off such a result. —Marcus A. Banks

Endoscope Reprocessing & Infection Control

2022

Foam Spray continued from page 30 They undertook a mini prospective study on the effect of a foam spray (Intercept, Cantel) on flexible endoscope microbiological surveillance culture (MSC) in Ng Teng Fong’s endoscopy unit from August 2020 to March 2021 (poster I04). In the “spray arm” of the study, the scopes (gastroscopes, double luminal therapeutic endoscopes, duodenoscopes and linear echoendoscopes) were encapsulated in the foam within one hour after patient use. The control arm used a delayed reprocessing protocol with extended soaking. Scopes in both arms subsequently underwent extensive channel brushing and were flushed with detergent, rinsed and put through automated high-level disinfection. Scopes that had been used in infectious cases underwent double high-level disinfection. After culturing, the investigators found similar rates of contamination (10 or more colony-forming units or any gram-negative rods) between the two groups. Three of 65 scopes in the spray arm (5.34%) were positive for contamination, compared with three of 61 scopes in the control arm (5.69%).

‘ Delayed reprocessing is something you should

avoid at all costs. But if that isn’t possible, using a spray doesn’t cut out any of the steps you have to follow in terms of the manufacturer’s protocols for delayed cleaning.

’

—Amiee Mingus, RN, BSN PE GI Solutions

However, some differences were noted when the data were broken down by scope category. Although contamination rates in linear endoscopes were similar in both arms (14.3% for spray vs. 13.6% for control; odds ratio [OR], 1.17), contamination was more likely in the spray arm for nonlinear scopes (3.57% vs. 0%; OR, 1.64).

This finding “could be associated with the small sample size in this study,” the authors noted. “Non-linear scopes are more frequently used than linear scopes, which might increase positive MSC results and biofilm formation.” The investigators noted that as expected, the foam was “able to break down biofilms,” but they stressed the importance of endoscopes being reprocessed “immediately after patient use.” Amiee Mingus, RN, BSN, a vice president of clinical operations at PE GI Solutions, which oversees operations at 60 gastroenterology surgery centers in 15 states, told Priority Report that whether or not an endoscopy facility uses Intercept or one of the other foam spray products available, manufacturer instructions for use must still be followed. “First and foremost, delayed reprocessing is something you should avoid at all costs. But if that isn’t possible, using a spray doesn’t cut out any of the steps you have to follow in terms of the manufacturer’s protocols for delayed cleaning,” she said. “Foams and gels have been around forever and have been commonly used in surgical procedures for surgical instruments that have to sit around waiting for the surgery to be completed. It’s a natural progression that this would come around to scopes.” If you follow the “instructions for delayed reprocessing, that has been demonstrated to work equally well whether or not you use the foam. And if you follow the instructions for use as written, you’re not only performing the right steps to do the right thing for patient safety; you’re also not voiding your warranty and exposing yourself to liability,” Ms. Mingus said. “If this or another product got manufacturer support, we would use it,” noted Rob Puglisi, a vice president of operations for PE GI. “But, if any of our centers felt they had to take an interim step like this, I would caution them to slow up the processes of the day to ensure they could follow protocols.”

Endoscope Reprocessing & Infection Control

—Gina Shaw

NEED SCOPE TRACKING?

WE TRACK IT ALL

ABOUT SCOPECYCLE® A complete end-to-end scope tracking solution offering step-by-step customized scope reprocessing workﬂows to guide your staff through the cleaning process. ScopeCycle provides detailed reports of usage statistics, reprocessing records, and cleaning protocol compliance.

Scope History

Task Management

Custom Workflows

Quickly run reports on scope history, expiring hang times, and usage forecasting.

Automate the management and tracking of daily, weekly, and monthly tasks such as replacement ﬁlters and chemicals.

Step-by-step workﬂows are customized to meet the needs of your facility’s policies and procedures.

866.578.5713

www.ScopeCycle.com

EXALT ™ Model D

Single-Use Duodenoscope

One patient. One duodenoscope. One essential step forward in endoscopic care.

The only single-use duodenoscope with peer-reviewed, published data in three human clinical trials: 1,2,3,4

• 368 patients from four trials, across all ERCP

complexity grades.* 1. Bang et al. Equivalent performance of single-use and reusable duodenoscopes in a randomized trial. Gut 2020;0:1-7. 2. Muthusamy et al. Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography. Clinical Gastroenterology and Hepatology 2020:1-10. 3. Napolean et al. Evaluation of the performance of a single-use duodenoscope: Prospective multi-center national study, Digestive Endoscopy 2021:1-7. 4. Slivka A et al. Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity. Gastrointest Endosc. 2021 Jun 26:S0016-5107(21)01464-4. doi: 10.1016/j.gie.2021.06.017. Epub ahead of print. PMID: 34186052.

• Resulted in a 93% success rate with a single-use

duodenoscope alone.** • In three of the four trials, patients were

consecutively enrolled allowing for a wide range of challenging ERCP procedures. Let us show you how EXALT Model D with new ergonomic features can become a part of your everyday ERCP practice.

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

Images owned by Boston Scientific. All trademarks are the property of their respective owners. CAUTION: U.S. Federal law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device. Results from clinical studies are not predictive of results in other studies. Results in other studies may vary. 2021 Copyright © Boston Scientific Corporation or its affiliates. All rights reserved. ENDO-1032501-AB

To learn more, use the QR code to visit the Boston Scientiﬁc case studies page.