Gastroenterology and Endoscopy News - PRIORITY Report - July 2022

Volume 4 • Summer 2022

One Problem Solved The scrutiny around cross contamination of duodenoscopes remains high with the FDA stating in their most recent safety communication that “disposable FRPSRQHQWVb LQ GXRGHQRVFRSHV PD\ ORZHU EXW QRWbHOLPLQDWH ULVNV RI LQIHFWLRQ Ŗ

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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 MoviPrep is a registered trademark of Velinor AG. Packaging and tablets †

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 ingredient in SUTAB. WARNINGS AND PRECAUTIONS: , à v yÕ ` > ` i iVÌÀ ÞÌi >L À > Ì iÃ: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing; Colonic mucosal ulcerations\ à `iÀ « Ìi Ì > v À ÕV Ã> Õ ViÀ>Ì Ã Ü i ÌiÀ«ÀiÌ } V ÃV «Þ w ` }à «>Ì i ÌÃ Ü Ì Ü À ÃÕëiVÌi` y> >Ì ÀÞ L Üi ` Ãi>Ãi° Suspected GI obstruction or perforation: Rule out the diagnosis before administration.

Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. ADVERSE REACTIONS: Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain.

DRUG INTERACTIONS: ÀÕ}Ã Ì >Ì VÀi>Ãi À Ã v yÕ ` > ` i iVÌÀ ÞÌi L> > Vi° Please see Brief Summary of Prescribing Information on reverse side. See Full Prescribing Information and Medication Guide at SUTAB.com

BRIEF SUMMARY: Before prescribing, please see Full Prescribing Information and Medication Guide for SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use.

INDICATIONS AND USAGE: An osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

DOSAGE AND ADMINISTRATION: Split Dose (2-Day) Regimen: Dose 1 – On the day prior to colonoscopy: A low residue breakfast may be consumed.

After breakfast, only clear liquids may be consumed until after the colonoscopy. Early Packaging and in the evening prior to colonoscopy, open one bottle of 12 tablets. Fill the provided tablets not shown V Ì> iÀ Ü Ì £È Õ Vià v Ü>ÌiÀ ­Õ« Ì Ì i w i®° -Ü> Ü i>V Ì>L iÌ Ü Ì > à « v actual size. water and drink the entire amount over 15 to 20 minutes. Approximately one hour after Ì i >ÃÌ Ì>L iÌ Ã }iÃÌi`] w Ì i «À Û `i` V Ì> iÀ > ÃiV ` Ì i Ü Ì £È Õ Vià v Ü>ÌiÀ ­Õ« Ì Ì i w i® > ` `À Ì i i Ì Ài > Õ Ì ÛiÀ Îä ÕÌið Ƃ««À Ý >Ìi Þ Îä ÕÌià >vÌiÀ w à } Ì i ÃiV ` V Ì> iÀ v Ü>ÌiÀ] w Ì i «À Û `i` V Ì> iÀ Ü Ì £È Õ Vià v Ü>ÌiÀ ­Õ« Ì Ì i w i® > ` `À Ì i i Ì Ài > Õ Ì ÛiÀ Îä ÕÌið 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 { ÕÀà vÀ ÃÌ>ÀÌ } Ãi £®] «i Ì i ÃiV ` L ÌÌ i v £Ó Ì>L iÌð Ì i «À Û `i` V Ì> iÀ Ü Ì £È Õ Vià v Ü>ÌiÀ ­Õ« Ì Ì i w i®° -Ü> Ü i>V Ì>L iÌ Ü Ì > à « v Ü>ÌiÀ > ` `À Ì i i Ì Ài > Õ Ì ÛiÀ £x Ì Óä ÕÌið Ƃ««À Ý >Ìi Þ i ÕÀ >vÌiÀ Ì i >ÃÌ Ì>L iÌ Ã }iÃÌi`] w Ì i «À Û `i` V Ì> iÀ > ÃiV ` Ì i Ü Ì £È Õ Vià v Ü>ÌiÀ ­Õ« Ì Ì i w i® > ` `À Ì i i Ì Ài > Õ Ì ÛiÀ Îä ÕÌið Ƃ««À Ý >Ìi Þ Îä ÕÌià >vÌiÀ w à } Ì i ÃiV ` V Ì> iÀ v Ü>ÌiÀ] w Ì i «À Û `i` V Ì> iÀ Ü Ì £È Õ Vià v Ü>ÌiÀ ­Õ« Ì Ì i w i® > ` `À Ì i i Ì Ài > Õ Ì ÛiÀ Îä ÕÌið « iÌi > -1/Ƃ Ì>L iÌà > ` ÀiµÕ Ài` Ü>ÌiÀ >Ì i>ÃÌ Ó ÕÀà Liv Ài V ÃV «Þ° CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any ingredient in SUTAB. WARNINGS AND PRECAUTIONS: Serious Fluid and Electrolyte Abnormalities: Advise all «>Ì i ÌÃ Ì Þ`À>Ìi >`iµÕ>Ìi Þ Liv Ài] `ÕÀ }] > ` >vÌiÀ Ì i ÕÃi v -1/Ƃ ° v > «>Ì i Ì `iÛi «Ã à } wV> Ì Û Ì } À à } à v `i Þ`À>Ì >vÌiÀ taking SUTAB, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to ÃiÀ Õà >`ÛiÀÃi iÛi Ìà V Õ` } V>À` >V >ÀÀ ÞÌ >Ã] Ãi âÕÀià > ` Ài > «> À i Ì° ÀÀiVÌ yÕ ` > ` i iVÌÀ ÞÌi >L À > Ì ià 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 Õà } i` V>Ì Ã] Ì >Ì VÀi>Ãi Ì i À à v À yÕ ` > ` i iVÌÀ ÞÌi disturbances or may increase the risk of adverse 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 à V ÛiÀÌ } i âÞ i L Ì ÀÃ] > } Ìi à ÀiVi«Ì À L V iÀÃ] À ÃÌiÀ `> > Ì y> >Ì ÀÞ `ÀÕ}î° / iÃi «>Ì i Ìà >Þ Li >Ì À à 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; Colonic Mucosal Ulcerations and Ischemic Colitis: Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization.

Concurrent use of stimulant laxatives and SUTAB may increase these risks. Consider the potential for mucosal ulcerations resulting from the L Üi «Ài«>À>Ì Ü i ÌiÀ«ÀiÌ } V ÃV «Þ w ` }à «>Ì i ÌÃ Ü Ì Ü À ÃÕëiVÌ y> >Ì ÀÞ L Üi ` Ãi>Ãi ­ ®Æ Use in Patients with Signifcant Gastrointestinal Disease: If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering SUTAB. Use with caution in patients with severe active ulcerative colitis. Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, angioedema, dyspnea, rash, pruritis and urticaria have been reported with SUTAB. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.

ADVERSE REACTIONS: Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain.

Postmarketing Experience: Gastrointestinal: gastric ulceration, gastritis; Hypersensitivity: anaphylaxis, angioedema, dyspnea, rash, pruritus, urticaria.

POTENTIAL FOR DRUG ABSORPTION: SUTAB can reduce the absorption of other co-administered drugs. Administer oral medications at least one ÕÀ Liv Ài ÃÌ>ÀÌ } i>V ` Ãi v -1/Ƃ ° Ƃ` ÃÌiÀ ÌiÌÀ>VÞV i > ` yÕ À µÕ i > Ì L Ì VÃ] À ] ` } Ý ] V À«À >â i] > ` «i V > i at least 2 hours before and not less than 6 hours after administration of each dose of SUTAB to avoid chelation with magnesium. Pregnancy: There are no available data on SUTAB use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. No reproduction or developmental studies in animals have been conducted with sodium sulfate, magnesium sulfate, and potassium chloride (SUTAB). Lactation: There are no available data on the presence of SUTAB in human or animal milk, the effects on the breastfed child, or the effects on milk production. Pediatric Use: Safety and effectiveness in pediatric patients has not been established. Geriatric Use: "v Ì i {Ç£ «>Ì i ÌÃ Ü ÀiVi Ûi` -1/Ƃ « Û Ì> V V> ÌÀ > Ã] £xä ­ÎÓ¯® ÜiÀi Èx Þi>Àà v >}i À `iÀ] > ` Óx ­x¯® ÜiÀi Çx Þi>Àà v >}i À older. No differences in safety or effectiveness of SUTAB were observed between geriatric patients and younger patients. Elderly patients are more i Þ Ì >Ûi `iVÀi>Ãi` i«>Ì V] Ài > À V>À` >V vÕ VÌ > ` >Þ Li Ài ÃÕÃVi«Ì L i Ì >`ÛiÀÃi Ài>VÌ Ã ÀiÃÕ Ì } vÀ yÕ ` > ` i iVÌÀ ÞÌi abnormalities. STORAGE\ -Ì Ài >Ì Óä¨ Ì Óxc ­Èn¨ Ì ÇÇc ®° ÝVÕÀà à «iÀ ÌÌi` LiÌÜii £x¨ Ì Îäc ­x ¨ Ì nÈc ®° -ii 1-* V ÌÀ i` À 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 à v > iÜ ÃÕ v>Ìi L>Ãi` Ì>L iÌ L Üi «Ài«>À>Ì ÛiÀÃÕà > * > ` >ÃV ÀL>Ìi V «>À>Ì À >`Õ Ì subjects undergoing colonoscopy. Am J Gastroenterol° Óäӣƣ£È­Ó®\Σ ÎÓn° ` \£ä°£{Îä É> }°ääääääääääää£äÓä 3. Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; ACG. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. Óää Æ£ä{­Î®\ÇÎ Çxä°

For additional information, please call 1-800-874-6756 ©2022 Braintree Laboratories, Inc.

All rights reserved.

201-289-v4-A February 2022

Endoscope Reprocessing &Infection Control Volume 4 • Summer 2022

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S Staffing, COVID Mental Health Impact TTop Safety Concerns for 2022 A AAMI Releases New Scope PProcessing Guidelines; GI Societies Decline Endorsement D Reports of Endoscope Contamination Rose Significantly Since 2014, New Analysis Says S Study Finds Fully Automated Beats Manual Cleaning for Reusable Scopes M

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McMAHON PUBLISHING

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E Endoscopy Tech Training Program Graduates Move Into Workforce G

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PProtocols, Practices for Duodenoscope Reprocessing Need a Long Hard Look R

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D Ditching Pre-Colonoscopy Appointments Reaches More for Screening, R With Few Drawbacks W

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D Droplet Dispersal Study Draws Mixed Reviews D

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E Extended Shift Staffing in Endoscopy Units Linked to Fatigue, Work–Life U IImbalance

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SUMMER 2022

Staffing, COVID Mental Health Impact Top Safety Concerns for 2022 taffing shortages and COVID-19’s effects on

S

healthcare workers’ mental health head the list

of patient safety concerns for 2022, according to a compilation released in March by ECRI, the nation’s largest nonprofit patient safety organization.

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Endoscope Reprocessing & Infection Control

SUMMER 2022

This annual ranking usually is dominated by clinical issues—for example, topping the 2020 list (finalized before COVID-19 came to the forefront) were missed and delayed diagnoses, maternal health across the continuum, and early recognition of behavioral health needs. But ECRI researchers say this year’s leading concerns have their roots in long-developing crises that have been dramatically exacerbated by the pandemic (Table).

“Shortages in the healthcare workforce and mental health challenges were broadly known and well documented for years,” said Marcus Schabacker, MD, PhD, the president and CEO of ECRI, in a statement accompanying the list’s release. “Both physicians and nurses were at risk of burnout, emotional exhaustion, and depression prior to 2020, but the pandemic made both issues significantly worse.”

In early January 2022, the ECRI report noted, it was estimated that 24% of U.S. hospitals were critically understaffed, while 100 more facilities anticipated facing critical staff shortages within the following week. More than 60% of hospital executives reported a shortage of medical and laboratory technicians, even before the pandemic had reached its peak, according to a 2020 white paper from the American College of Healthcare Executives.

of the precautions for COVID, and doing so with typically being short-staffed, as a lot of our centers are,” Ms. Mingus said. “The staff at our centers are constantly working to maintain the proper processes with less staff and under difficult circumstances. In some cases, our centers have had to cut down the number of rooms that are operating or the number of patients seen in a day. Sometimes they have had to do extended days, which adds to the fatigue. I don’t know if you’ve ever worked all day in an N95 mask, but it’s exhausting.”

‘ When we are paying double the amount for traveling nurses, that shows us that the wages and salary structure of our staff need to be looked at. This is a real area of opportunity.

’

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

“I can say I see the stress on everybody’s face,” said Patricia Graham, BSN, CGRN, an administrator at the Endoscopy Center of Western New York, in Buffalo. “There are constantly people in my office with concerns. ‘I can’t call in sick again, but my child might have COVID. If I stay home with my child, am I letting the team down?’ It’s a constant worry. I do a lot of listening.”

‘In the Thick of It’ The ECRI report hit home for many physicians, nurses and administrators in GI endoscopy units, in both hospitals and ambulatory surgery centers.

They described working harder than ever to ensure patient safety and infection control and to provide quality care in the endoscopy suite. “We are in the thick of it,” said Harish K. Gagneja, MD, FACG, AGAF, FASGE, a gastroenterologist with Austin Gastroenterology, in Texas. “Every day you hear about people resigning. At our meetings, the biggest concerns that come up are always staffing issues. This will, of course, impact patient safety and produce delays in procedures.”

Amiee Mingus, RN, BSN, the vice president of clinical operations at PE GI Solutions, in Jamison, Pa., which oversees operations at 60 gastroenterology surgery centers in 15 states, underscored these concerns. “The No. 1 challenge today is trying to maintain all of your normal processes while also keeping up with all

Table.

2022 ECRI List of Patient Safety Concerns

1.

Staffing shortages

2.

COVID-19 effects on healthcare workers’ mental health

3.

Bias and racism in addressing patient safety

4.

Vaccine coverage gaps and errors

5.

Cognitive biases and diagnostic error

6.

Non-ventilator healthcare–associated pneumonia

7.

Human factors in operationalizing telehealth

8.

International supply-chain disruptions

9.

Products subject to emergency use authorization

10. Telemetry monitoring

Endoscope Reprocessing & Infection Control

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SUMMER 2022

Overtime, Supply-Chain Disruptions Add to Stress Everyone at the Buffalo center has worked overtime to ensure that all infection control rules are followed and reprocessing remains a top priority, said Linda Hubbard, RN, the center’s director of nursing. “We made sure we overbought our PPE at the beginning so that we can provide everyone with a safe environment and safe equipment to work with.”

“We wouldn’t operate if we couldn’t maintain safe reprocessing,” Ms. Graham said. “In the The staff at our centers are constantly working beginning, if we didn’t to maintain the proper processes with less staff have enough techniand under difficult circumstances. In some cases, cians for reprocessing, our nurses would then our centers have had to cut down the number jump in for the techs of rooms that are operating or the number of in the procedure room patients seen in a day. to do things like take —Amiee Mingus, RN, BSN, PE GI Solutions polyps off, so that the trained techs could reprocess the scopes.”

International supply-chain disruptions were identified as another top patient safety concern in the ECRI report, and managing those shortages is another challenge weighing on endoscopy center staff. “Everyone is trying to order the same things, whether it’s PPE or IV fluids,” said Melissa Watson, the center’s front office supervisor. “Everything is on back order, or you can’t get it for at least a week and you have to find replacement items to get the job done the way you need to, at twice the price.

It’s so stressful.”

Ms. Graham said she and Ms. Hubbard strive to maintain a close-knit team that can support one another during times of crisis. “We pick each other up and carry each other through,” she said.

“Linda constantly has her door open for staff who need an ear. When someone is short on nurses, we work the floor. We put supplies away, put linen away. Everyone chips in to make it work, but everyone is really, really tired.”

‘

’

Revisiting Salaries and Other Forms of Compensation See related story on Work–Life Balance on page 32.

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Deepak Agrawal, MD, MPH, an associate professor of gastroenterology and hepatology at Dell Medical School at The University of Texas at Austin, called the situation a nationwide vicious

cycle. “When you are short-staffed, then the people who are left take a little bit more of the brunt of the work, and obviously there’s a burnout rate.

Then there are even fewer people and they work harder, and then they burn out.”

He called for hospital and surgical center leadership to consider this an opportunity to break the cycle and change the way things are done.

“For example, during the staffing shortage, many institutions have found themselves having to pay traveling nurses and technicians much more money than they had been paying staff nurses just to have coverage,” Dr. Agrawal said. “When we are paying double the amount for traveling nurses, that shows us that the wages and salary structure of our staff need to be looked at. This is a real area of opportunity.”

Dr. Gagneja agreed. “I think it’s high time to look at how we can address issues such as compensation and what else we’re providing to our staff so we can make them happy, make them whole, so that they want to come to work rather than resign in desperation. We need to find as many creative ways as possible to take care of our people.”

Rob Puglisi, PE GI Solutions’ vice president of operations, said its centers have been increasing salaries and hourly rates to try to retain people.

“We’re also buying a lot of lunches, trying to let people know that we understand what they’ve been going through and want to say ‘thank you’ for hanging on through the pandemic. We want to do more team-building events.”

At his center, Dr. Gagneja said, they’ve pursued a variety of strategies. “We’ve given retention bonuses twice in the last six months. We have a day where we provide free massages during breaks, a ‘Coffee Day’ where a gourmet coffee service comes to the center. We do an ‘Employee Appreciation Day’ with gift cards for stores like Target and Starbucks. We do team-building exercises, offer more breaks and a lot of these small things. Is it enough? I don’t know, but we have to keep trying. For our organization, we have a ‘three P’s’ mantra: Take care of your Patients and Practice, and Profits will flow. It is high time to add a fourth P: Take care of your Patients, Practice and People, and Profits will flow.”

—Gina Shaw The sources reported no relevant financial disclosures. Dr. Gagneja is a member of the Gastroenterology & Endoscopy News editorial board.

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SUMMER 2022

AAMI Releases New Scope Processing Guidelines; GI Societies Decline Endorsement

n March 2022, the Association for the Advancement

I

of Medical Instrumentation issued its long-awaited

update to its guidance on cleaning and storing flexible and semirigid endoscopes.

‘ We cannot endorse the guideline, but it is a published standard, and it can be utilized.’

—Michael Kochman, MD, AGAF University of Pennsylvania Center for Endoscopic Innovation, Research and Training, Philadelphia

10

In a statement announcing the new guidance, AAMI noted that it “has been updated to reflect the consensus of industry, clinicians, and sterilization professionals from around the world.” But a response from seven leading gastroenterology societies, all of which participated in the AAMI Endoscope Reprocessing Working Group’s discussion process for the new guidelines, called that consensus into question.

“Changes to ST91 for flexible and semi-rigid endoscopes create obstacles to implement standards and offer impractical, inappropriate, or conflicting guidance,” said a joint statement from the American Association for

Endoscope Reprocessing & Infection Control

SUMMER 2022

the Study of Liver Diseases, American College of Gastroenterology, American Gastroenterological Association (AGA), American Society of Colon and Rectal Surgeons, American Society for Gastrointestinal Endoscopy (ASGE), Society of American Gastrointestinal and Endoscopic Surgeons, and Society of Gastroenterology Nurses and Associates, first published online in Gastrointestinal Endoscopy on March 11, 2022 (doi:10.1016/j.gie.2022.02.004).

Recommendations Lack Evidence “We believe the document fails in three main areas,” explained Lukejohn Day, MD, FASGE, a professor of medicine at the University of California, San Francisco and the chief medical officer at the Zuckerberg San Francisco General Hospital, who served as ASGE’s representative to the AAMI working group for the past three years.

“First, it is not data-driven and does not have a great deal of evidence to support some of the recommendations that are made, which is in contrast to the Multi-Society Task Force reprocessing guidelines” released last year (Gastrointest Endosc 2021;93[1]:11-33.e6), Dr. Day told Priority Report.

Dr. Day, who was a lead author of those guidelines, noted that AAMI did not employ the commonly accepted GRADE (Grading of Recommendations, Assessment, Development and Evaluations) framework, a widely adopted tool for grading the quality of evidence and making practice recommendations.

“GRADE includes a clear scan of the environment for all of the relevant papers, recommendations, and has levels of meaning associated with them, along with the significance of the evidence supporting that recommendation,” said Michael Kochman, MD, AGAF, the director of the University of Pennsylvania’s Center for Endoscopic Innovation, Research and Training, in Philadelphia, and the AGA’s representative to the working group. “Quality is graded along with the importance of the recommendation itself.

That was completely lacking in the AAMI process,” Dr. Kochman added.

A second problem area cited by the GI societies was the impracticality of some of the implementation strategies, which Dr. Day said were infeasible and not considered standard best practices.

2022 ANSI/AAMI ST91 Guidelines Overview he new guidance, ANSI/AAMI ST91:2021 Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities, which replaces the 2015 version, took an unusually long time to develop, with the process originally beginning in 2017. It includes: • classification for high-risk scopes, such as bronchoscopes and ureteroscopes; • updated guidance for drying of scopes, as well as proper storage and handling; • recommendations against manual high-level disinfection after washing, as opposed to in automated endoscope reprocessors (AERs); • guidance for testing water in AERs to avoid the final-rinse water recontaminating the endoscopes; and • guidance for determining the length of storage, or “hang time,” that a scope can withstand before needing to be reprocessed.

T

AAMI, Association for the Advancement of Medical Instrumentation; ANSI, American National Standards Institute.

“One example is the recommendation that end users should bring together the biopsy caps, air and water buttons, and endoscopes to form one collective set that would undergo reprocessing, or if not possible, label each of these devices and accessories in order to track them throughout the reprocessing pathway,” he said. “There is no evidence to suggest that this is a best practice, reduces infection risk or improves overall patient outcomes. Furthermore, it’s also not practical to implement these practices in endoscopy centers. Tracking scopes is definitely done from start to finish, but accessories like buttons and biopsy caps that go through reprocessing are not tagged/labeled as a scope is. There are no data or studies to suggest that implementing this practice would change overall patient outcomes or minimize infectious risks to patients.”

Another problematic recommendation, the multi-society statement said, is the use of cleaning verification tests after each use for all high-risk endoscopes, pointing out that these tests aren’t approved for this use by the FDA and have not

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demonstrated clear outcome metrics. “The FDA has not made any determination that any of these cleaning verification tests can do anything that is claimed in the AAMI guideline. We shouldn’t make such a recommendation to the end users when the data is not there,” Dr. Day said.

The guidelines also recommend the use of borescopes in endoscope inspection. “Borescopes can detect certain findings. The significance of those findings is not always clear. The manufacturers don’t recommend it, and we have to be It is not data-driven and does not have careful about implementing techniques that don’t have a great deal of evidence to support some clear levels of evidence supof the recommendations that are made, porting their use, as we also which is in contrast to the Multi-Society need to be fiscally and pracTask Force reprocessing guidelines tically responsible to society released last year. with solutions that are data —Lukejohn Day, MD, FASGE proven,” Dr. Kochman said.

University of California, San Francisco Finally, the societies also raised concerns about the transparency of AAMI’s process. “We felt that there were some conflicts of interest, and that many members of the working group represented for-profit industries whose devices could potentially benefit from some of the recommendations made in the guideline,” Dr. Day said.

‘

’

Lack of Transparency Those potential conflicts were an issue from the beginning, said Bret Petersen, MD, MASGE, a professor of medicine in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester, Minn., who preceded Dr. Day as ASGE’s representative to the working group. “There was not much transparency around the table, nor acknowledgment of conflicts when discussing specific issues.

That did improve over time, but not to the degree that most medical practitioners are familiar with, wherein conflicts are clearly disclosed and individuals must often recuse themselves from some discussions based on those conflicts. It’s fair to say that the participation of the physicians’ organizations instilled some ongoing discussion of these issues, which did improve the process. Of course, some would argue that the medical societies are also conflicted, but I hope that our stake in the process is the outcomes for our patients.”

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In the press release announcing the new version of ST91, working group co-chair Garland-Rhea Grisby, an endoscope service manager for Kaiser Permanente in Northern California, said sterilization professionals often ask for more stringent requirements. “When they want to introduce change in their facility that can improve safety, they might get pushback from leadership because there are few guidelines out there that say what they should do or how to do it,” he said. “That’s why they need this document to back up and outline what needs to be done.”

AAMI Maintains Process Was Valid AAMI provided a written statement to Priority Report for this article. “Our standards are developed in accordance with our American National Standards Institute-accredited procedures, ensuring due process, openness and transparency,” wrote Amanda Benedict, the vice president of standards. “The process for ST91:2021 considered and responded to the views of all stakeholders involved in developing the document, and the final standard reflects consensus among experts and stakeholders that the requirements will improve patient safety. Patient safety is our north star, and we collectively stand behind the process that delivers needed change.”

Dr. Kochman stressed that the GI societies are not telling any organization not to follow the AAMI guideline. “We cannot endorse the guideline, but it is a published standard, and it can be utilized.”

“There are multiple guidelines related to scope reprocessing. Some institutions follow the multisociety guidelines, some follow AAMI, and others may implement more than one, with their own selected differences between them, which should be explicitly delineated,” Dr. Petersen said. “The requirement for any single institution is to identify which guidelines they intend to follow, and then to demonstrate that they are doing so for their Joint Commission reviews and accreditation.”

—Gina Shaw Dr. Day reported financial relationships with 3T Biosciences, Boehringer Ingelheim and Pfizer. Dr. Kochman reported financial relationships with Applied Clinical Intelligence, Boston Scientific, Dark Canyon Labs, Medtronic, Novella, Olympus, Pentax and Virgo Systems.

Dr. Petersen reported financial relationships with Ambu, Boston Scientific, Olympus and Pentax.

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Reports of Endoscope Contamination Rose Significantly Since 2014, New Analysis Says Enhanced vigilance and more procedures likely contributed to the increase

A

dverse event reports submitted to the FDA, describing the actual or potential

contamination of a reprocessed flexible endoscope, have increased significantly over the past seven years, according to a review and analysis.

‘ Precleaning starts immediately after each procedure is finished,

and manual washing begins within one hour. We’ve been quite pleased with our processes, and I think having qualified techs who are dedicated to each procedure room and making sure there is no lag time have really helped us.

’

—Linda Hubbard, RN, Endoscopy Center of Western New York

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The report, released in January

by Lawrence Muscarella, PhD, the president of LFM Healthcare Solutions and a national authority on the causes and prevention of healthcare-related infections, included more than 10,000 adverse event reports describing contamination of a flexible endoscope submitted to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database between 2014 and 2021. Dr. Muscarella focused on three GI endoscopes (colonoscopes, duodenoscopes and gastroscopes), as well as bronchoscopes, otorhinolaryngologic endoscopes and urologic endoscopes.

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Although duodenoscopes have received particular scrutiny for their association with transmission of carbapenem-resistant Enterobacteriaceae (CRE) and other superbugs, the 804% increase in adverse event reports submitted to the FDA for these endoscopes was lower than for any other type of endoscope except bronchoscopes, which increased from 52 in 2014 to 259 in 2021 (or by 398%).

“Although FDA and others in recent years have diligently worked to reduce the contamination and infection risk of reprocessed duodenoscopes and other endoscope types, the findings of this analysis suggest that use of a duodenoscope remains a risk factor for patient exposure to multidrug-resistant organisms including CRE, warranting continued vigilance and care to ensure patient safety,” Dr. Muscarella wrote. “That said, this analysis found that the number of reports submitted to FDA linking a duodenoscope to patient deaths was significantly less in 2021 than just a few years ago.”

The analysis’s recommendations included the suggestion that healthcare providers consider “sterilization of gastroscopes (when feasible), or the use of a single-use gastroscope (when available and as warranted) to improve patient safety.”

Dr. Muscarella recommended performing a risk assessment to help guide this consideration. He also recommended that health experts evaluate whether the issuance of a letter or alert informing healthcare providers of the risk for “reprocessed” gastroscopes transmitting multidrug-resistant bacteria, along with providing evidence-based practices that reduce this risk, is now warranted.

More Procedures, More Testing Led to Some Reports In an interview with Priority Report, Dr. Muscarella acknowledged that at least some of these increases in adverse event reports associated with endoscopes could be attributable to more procedures being performed and a higher level of vigilance that began in 2014 after U.S. health officials, for the first time, linked a duodenoscope at a single facility to multiple infections of CRE at a hospital in northern Illinois.

“On the heels of this and other outbreaks, the FDA ordered manufacturers to perform surveillance testing of duodenoscopes, and we’re seeing this type of testing being performed more now on other types of scopes, too. There also may be

Increased Adverse Event Reports for All Scope Types ll six types of endoscopes had a significant increase in adverse events reported over the study period. Examples of adverse events Dr. Muscarella identified as satisfying his analysis’s inclusion criteria included: • contamination of the reprocessed endoscope with microorganisms, patient fluids and/or biofilms; • a documented association between use of a flexible endoscope and patient infection; • failure to clean or otherwise reprocess the endoscope correctly according to the manufacturers’ instructions; and • use of a damaged, cracked or otherwise broken endoscope (e.g., a loose component) that could pose an infection risk.

Gastroscopes, including endoscopic ultrasound endoscopes, had the most significant increase in adverse event reports of any of the six endoscope types—from 13 to 1,135 reports—or by approximately 8,630%, when comparing 2014 with 2021.

Adverse event reports associated with colonoscopes also increased substantially, from 23 to 820, or approximately 3,465% when comparing 2014 with 2021.

A

better compliance with medical device reporting regulations, so an increase in submitted reports does not necessarily translate into an increase in the contamination and infection risk,” he said.

“Surveillance testing, in which endoscopes are randomly sampled and cultured after reprocessing without there necessarily being an infection or an outbreak, is more commonly being performed in hospitals today compared to years ago. If we don’t put something under the microscope to examine it, then we may never see its fine details. Now there’s closer examination of what’s going on.”

Potential Factors Impeding Cleaning and Disinfection

‘ Before we pursue

something like sterilizing scopes or going to disposable scopes, which are cost-prohibitive and environmentally damaging, we should work further to mitigate risk with consistent reprocessing.

’

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

Dr. Muscarella described a few factors that he identified in reviewing the MAUDE reports that could interfere with the effectiveness of high-level disinfection and even sterilization.

“With duodenoscopes, we learned that the complexity of their design can impede cleaning,” he said. “But another issue has to do with limited

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‘ High-level disinfection

of endoscopes is effective, provided certain criteria are satisfied, but the process can be challenging to achieve if the endoscope is damaged, a component becomes loose, the endoscope is particularly complex in design, or the endoscope is not sufficiently serviced and maintained.

’

—Lawrence Muscarella, PhD LFM Healthcare Solutions

staff and financial resources and the problem of continuing to use a damaged endoscope unwittingly, or not maintaining, repairing and servicing instruments according to the manufacturers’ instructions and maintenance schedules.”

His analysis noted that several relatively recent adverse event reports discuss the deterioration of an adhesive, sealant or glue used at the distal end of some flexible endoscope types, causing a gap or crack to form in the adhesive and resulting in the potential for microbial contamination and an increased infection risk due to ineffective reprocessing. “In November of 2021, a duodenoscope model was recalled in part for this ‘adhesive deterioration’ phenomenon, but I found the problem is not unique to that one scope,” Dr. Muscarella said.

“There are stresses occurring at the distal end of the scope, which can be due to a number of factors including mishandling—like banging the endoscope inadvertently on a hard surface. This can cause cracking, chipping and gapping, almost like eating something hard and chipping an acrylic filling on your tooth, and then there’s a gap where bacteria could invade and accumulate. High-level disinfection of endoscopes is effective, provided certain criteria are satisfied, but the process can be challenging to achieve if the endoscope is damaged, a component becomes loose, the endoscope is particularly complex in design, or the endoscope is not sufficiently serviced and maintained.”

Need to Consistently Follow Manufacturers’ Guidelines Dr. Muscarella’s findings with regard to gastroscopes are “troubling,” said Deepak Agrawal, MD, MPH, an associate professor of gastroenterology and hepatology at Dell Medical School at The University Texas at Austin. “If this is true, we would need to change what we are doing. But there are a few things that remain to be clarified.

First, the MAUDE reports do not necessarily correlate contamination with infection, when patients are actually getting sick. Those things are very difficult to objectively prove with case reports, except for well-published case studies where they can trace one [type of ] bacteria arising from the scope and see the same bacteria in other patients. In our practice, we do not see this.”

Dr. Agrawal also cited lapses in following manufacturers’ reprocessing guidelines. “It’s clear that

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there were breaches in protocol for some of these events,” he said. “What would these numbers look like if reprocessing guidelines were consistently followed the way they are written? Before we pursue something like sterilizing scopes or going to disposable scopes, which are cost-prohibitive and environmentally damaging, we should work further to mitigate risk with consistent reprocessing.”

Harish K. Gagneja, MD, FACG, AGAF, FASGE, a gastroenterologist with Austin Gastroenterology in Texas, agreed. “With gastroscopes and colonoscopes, we know that not much has been reported with regard to passive infections,” he said. “ERCP [endoscopic retrograde cholangiopancreatography] scopes are a different story because of the complex design, but this is an issue that can be addressed with more due diligence in cleaning and disinfection, and adequate storage. You must ensure that your reprocessing staff are adhering to manufacturers’ instructions and that you have proper storage units in your facilities.”

Dr. Muscarella agreed, recommending that GI endoscopy units routinely perform internal audits of staff practices to ensure infection prevention competency and endoscope reprocessing acumen.

Centers that maintain such strict protocols say they have not needed to pursue either sterilization or single-use endoscopes. “We are purchasing new colonoscopes shortly, and we are not going disposable,” said Linda Hubbard, RN, the director of nursing for the Endoscopy Center of Western New York. “We log every scope that is reprocessed and regularly review all of those logs, and ... have not had any infections for a number of years. Michelle Velez, our lead endoscopy technician, ensures that all of our reprocessing staff is up to speed on those competencies, and they are reviewed constantly. Precleaning starts immediately after each procedure is finished, and manual washing begins within one hour. We’ve been quite pleased with our processes, and I think having qualified techs who are dedicated to each procedure room and making sure there is no lag time have really helped us.”

—Gina Shaw Drs. Agrawal and Gagneja and Ms. Hubbard reported no relevant financial disclosures. Dr. Gagneja is a member of the Gastroenterology & Endoscopy News editorial board.

Dr. Muscarella reported a financial relationship with Ambu, which sponsored the MAUDE study.

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SUMMER 2022

Study Finds Fully Automated Beats Manual Cleaning for Reusable Scopes LAS VEGAS—A fully automated process for cleaning duodenoscopes after clinical use far outperformed manual cleaning conducted by trained technicians adhering to manufacturer specifications, according to a new comparative study.

Although larger validating trials are needed, these results suggest that a fully automated cleaning process might be a viable replacement to manual cleaning.

‘

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’

—Michael O’Donnell, MD, MBA NYU Langone Health, New York City

Cleaning—the step taken before high-level disinfection—is widely regarded as a weak link in preventing transmission of pathogens when scopes are reused. Automated processing using turbulent flow technology might be the answer, according to researcher Michael O’Donnell, MD, MBA, a fellow in the Division of Gastroenterology and Hepatology at NYU Langone Health, in New York City.

In this study, conducted with Olympus TJF-Q180V duodenoscopes, 21 of 48 scopes were cleaned manually after endoscopic retrograde cholangiopancreatography (ERCP). The remainder were cleaned with the automated proprietary cleaning system called MACH I (Parametrik).

The instrument channels and distal elevator areas were then sampled for residual protein and carbohydrates.

After cleaning, two of the 21 manually cleaned duodenoscopes had protein levels exceeding the FDA safety threshold. In addition, three of the manually cleaned duodenoscopes exceeded the FDA threshold for carbohydrates. In contrast, none of the duodenoscopes that underwent automated processing exceeded either threshold.

Despite the limited size of the study, the difference for these outcomes combined was significant (P=0.03).

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The difference was reflected in the average residual contaminants. After processing, the residue levels in scopes cleaned automatically were a fraction of the levels in scopes cleaned manually for both protein (0.16 vs. 4.88 mcg/cm2) and carbohydrates (0.14 vs. 1.09 mcg/cm2).

Perfect Adherence Is Difficult “As seen in this study, manual cleaning can be prone to error,” said Dr. O’Donnell, who presented the data at the 2021 annual meeting of the American College of Gastroenterology (oral paper presentation 17). He said perfect adherence to the many steps of manufacturer cleaning instructions is “difficult to achieve.”

Failure to adhere to the steps, which can be tedious, is considered a major obstacle to cleaning success.

After several outbreaks of infection linked to duodenoscopes that remained contaminated after standard cleaning and high-level disinfection, numerous non–outbreak-initiated studies found that contamination rates were substantial, whether due to human error or persistent bacterial colonization resistant to standard cleaning. In one meta-analysis of these studies, the estimated contamination rate after cleaning was 21.5% (EClinicalMedicine 2020;25:100451).

The solutions proposed to reduce or circumvent the risk of contaminated scopes have included redesigns to facilitate cleaning, singleuse endoscopes that eliminate reuse and automated cleaning technology. Several automatic processors have been showing promise, according to a report issued by the American Society for Gastrointestinal Endoscopy (Gastrointest Endosc 2016;84[6]:885-892).

Addressing Bioburden Biofilm formation has proven to be one of most significant challenges in effective reprocessing of duodenoscopes, according to several sources, including the 2016 ASGE review. Notoriously difficult to eliminate during standard cleaning, it is not necessarily overcome by highlevel sterilization if it is not removed during the manufacturer’s protocol for cleaning.

The turbulent flow technology used in MACH I automated cleaning systems tested in the study presented by Dr. O’Donnell creates

shearing forces that appear to be more effective for removing biomatter overall and biofilm specifically, he said. His data suggest that an effective automated system is better than manual cleaning both in achieving complete or near-complete elimination of the bioburden during scope reprocessing, and reducing or eliminating the potential for human error.

The FDA approved the For decades, ineffective manual cleaning MACH I cleaning system for sale, but it is not yet “available has repeatedly been identified as a factor for purchase by hospitals,” Dr. in endoscope-related infections due to the O’Donnell said. Until it is, the complexity and operator dependence of the company has a processing center in the New York City area manual cleaning steps.

—Adarsh M. Thaker, MD and offers a pickup and delivery University of California, Los Angeles service, which he said will be expanded to other cities.

Although larger validating trials are needed, these results suggest that a fully automated cleaning process might be “a viable replacement to manual cleaning,” Dr. O’Donnell said.

‘

’

Automation to Reduce Chance of Human Error Numerous studies are leading to the conclusion that meticulous adherence to the cleaning protocols are unlikely to be the answer to this long-standing problem, commented Adarsh M. Thaker, MD, an advanced endoscopist within the interventional endoscopy service of the Vatche and Tamar Manoukian Division of Digestive Diseases at the University of California, Los Angeles.

“For decades, ineffective manual cleaning has repeatedly been identified as a factor in endoscope-related infections due to the complexity and operator dependence of the manual cleaning steps,” said Dr. Thaker, who has written frequently on this topic, including in a survey study three years ago on duodenoscope reprocessing practices in the United States (Gastrointest Endosc 2018;88[2]:316-322.e2). “Automation of these steps,” he said, “can minimize the opportunities for human error in endoscope reprocessing.”

—Ted Bosworth Dr. O’Donnell reported no relevant financial disclosures.

Dr. Thaker reported a financial relationship with Boston Scientific.

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SUMMER 2022

Endoscopy Tech Training Program Graduates Move Into Workforce

SAN DIEGO—This May, 12 newly trained endoscopy technicians became the first to graduate from a model certification program designed to address one of the workforce challenges seen in gastroenterology practices—technician shortages. The new technicians have already taken on roles in various practice settings, armed with the knowledge and skills to jump in and help their endoscopy suites run more smoothly.

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In a presentation at Digestive Disease Week 2022, G.S. Raju, MD, who spearheaded efforts to get the program off the ground, discussed the impetus behind it. Pointing to the evolution of the endoscopy team over the past few decades, with shifting responsibilities and high staff turnover, Dr. Raju stressed that better training and retention strategies for technicians and nurses are essential. Endoscopy services have “exploded, and the team is at risk of implosion if we do not make some changes,” said Dr. Raju, the John Stroehlein Distinguished Professor of Medicine at The University of Texas MD Anderson Cancer Center, in Houston.

Current Workforce Can’t Meet Demand “In 2020, in the United States, we performed nearly 22 million endoscopies,” Dr. Raju said. In addition, the recent recommendation that screening for colorectal cancer should begin at age 45 years means “20 million more lives [that need] to be covered. That’s a huge amount of work to be done. I’m not sure whether we can meet the demand with the current workforce.”

Another problem with the current technician pathway is that technician skills and abilities don’t always correlate with their potential career paths and salaries. “Unfortunately,” he said, “human resources does not have a system to recognize what they bring to the table, and this leads to job dissatisfaction, a lot of turnover of staff—and it does impact endoscopy service.”

To try to address these problems, Dr. Raju and his collaborators

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Better training and retention strategies for technicians and nurses are essential. Endoscopy services have exploded, and the team is at risk of implosion if we do not make some changes.

‘

’

—G.S. Raju, MD The University of Texas MD Anderson Cancer Center, Houston

developed a structured endoscopy technician training program through the Texas Medical Center and Houston Community College (HCC) Coleman College of Health Sciences.

However, the pathway from conception of the program to graduation of the first crop of students in May was challenging and took seven years. It involved discussions with educators and administrators at HCC; curriculum development with an advisory board consisting of physicians, nurses and technicians from the Houston area and industry representatives; and arrangements with MD Anderson, Baylor St. Luke’s Medical Center

and other local hospitals to establish practicum experiences.

The arrival of COVID-19 delayed the start of the program, but the students began their coursework in August 2021.

Currently, the one-year program consists of 35 credit hours (19 credit hours for the training classes and the rest for prerequisites covering basic biology, medical terminology and a practicum). Dr. Raju, along with the program director Melissa Bruton, BSHCA, AA, LVN, CST, and faculty members, including Benjamin Diaz

Above: The first graduating class of the Houston Community College Endoscopy Technician Training Program.

see Technician Training, page 34

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Protocols, Practices for Duodenoscope Reprocessing Need a Long Hard Look ndoscopy providers need to upgrade their

E

duodenoscope precleaning and reprocessing

methods, facilities and equipment, and devote more resources to ergonomics, proper training and worker retention for those who perform this work, according to a recent survey of reprocessing staff.

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Noting that no studies in the existing literature included information from technicians and other staff who do reprocessing, investigator Amanda D. Sivek, PhD, told Priority Report, “It’s really important to get the feedback of the actual people who are doing the work and see what they think affects their workflow, or what’s going on in their work environment that could be improved.”

To bridge the gap in knowledge, Dr. Sivek the principal project engineer at Plymouth Meeting, Pa.–based ECRI, a nonprofit organization that specializes in evaluating the safety of health equipment and practices, and her co-investigators developed the Duodenoscope Reprocessing Workflow and Ergonomic Design Human Factors Survey. The survey asked about the demographics of respondents, and the facilities and processes under which reprocessing takes place.

Dr. Sivek’s team incorporated feedback from two experts at the FDA and pilot-tested the survey with 11 healthcare workers who regularly perform endoscopy cleaning and reprocessing (Am J Infect Contr 2022:S0196-6553[22]00055-4).

The researchers—a multidisciplinary team comprised of endoscopy, engineering, human factors and infection control experts from ECRI and Rowan University, in Glassboro, N.J.—emailed the survey to 76 acute care facilities, 245 outpatient endoscopy centers and 264 health systems in the United States, as well as 35 international healthcare organizations, to reach healthcare workers who are regularly involved in precleaning or reprocessing reusable endoscopes.

They received 341 completed surveys (82.7% from acute care facilities and 58.4% from urban centers; 44.9% of workers had been doing the task for less than five years).

Under Pressure for Fast Turnover Dr. Sivek and her team uncovered some trends that she considered alarming, including increased time pressures and shortages of trained staff. For Jim Collins, BS, RN, CNOR, a practice manager for Cleveland Clinic in Cleveland, the most concerning finding is the percentage of respondents who indicated they were operating under increased pressure to work more quickly, and 65% felt that increased time pressure added difficulty to the task at hand.

That pressure, the authors of the survey wrote,

“is consistent with a 2019 endoscope reprocessing survey study of International Association of Healthcare Central Service Materiel Management [now the Healthcare Sterile Processing Association] members, which reported that 70% of the respondents felt pressure to work quickly, and 17% of the respondents routinely skipped endoscope IFU [instructions for use] steps due to time pressures” (Am J Infect Control 2020;48[1]:119-121).

‘ Please invest in your

endoscope reprocessing people and work environments.

’

—Amanda D. Sivek, PhD ECRI, Plymouth Meeting, Pa.

Mr. Collins told Priority Report that he found that data point to be very troubling. “There’s always the pressure to do more procedures more quickly. But each step of reprocessing is built upon another step, so if we don’t complete all the steps that are necessary, we place our patients in jeopardy.”

One thing providers could do in the short term, he said, is to increase their scope inventory.

“Do they have enough scopes on hand? Their inventory needs to be the right size for their practice.” He also said communication among team members about what’s involved in the cleaning and reprocessing process can help to manage their expectations. “When physicians are educated on what’s involved to provide for them an instrument that is safe for their patient, they tolerate the process being as long as it is.”

Investment in People and Spaces Another area of concern is difficulty retaining healthcare workers who specialize in this task.

Almost half of them had been doing it for less than five years, which indicates a high turnover rate. In addition, many workers reported that they believed they hadn’t received appropriate training.

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According to the survey responses, nearly 50% believed the training, certification and mentoring they received was moderate at best, with about 10% of respondents saying they had received none at all.

Beyond that, Dr. Sivek said, “over 75% of the people performing duodenoscope reprocessing experience fatigue in one or more of their body parts,” which she noted can result in musculoskeletal disorders. This is especially true at reprocessing centers that are exceedingly small. “My colleague has seen basically three people in a closet,” she noted.

‘ There’s so much innovation, but nobody

knows what solution is going to dominate. ...

It is one of those things where you know change is coming, but you don’t know exactly what the change is going to be.

’

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

Historically, facilities failed to place much importance on, or investment in, reprocessing workspaces, Mr. Collins explained. “Reprocessing stations had been very, very small. They didn’t allow for good workflow [between] dirty to clean. Often, they did not provide unidirectional travel, so there was a high potential to cross-contaminate.”

Endoscopy centers face an inability to recruit, train and retain workers who are knowledgeable and proficient in the proper procedures required to minimize harm to patients. Both Mr. Collins and Dr. Sivek urge all providers to dedicate themselves to regularly update their protocols for reprocessing, invest in reprocessing facilities that provide ample, ergonomically sound and specifically designed spaces to do this work efficiently and effectively. As Dr. Sivek put it succinctly: “Please invest in your endoscope reprocessing people and work environments.”

Change Is Coming Finally, there are the scopes themselves. The FDA has urged facilities to transition to scopes with disposable endcaps or parts, and Dr. Sivek from ECRI said the group recommends that

24

“facilities make a plan to transition to single-use duodenoscopes or the models with single-use components as soon as they can.”

But, at this point, most providers continue to use older scopes with no disposable parts. Mr. Collins and Dr. Sivek said the reason for this failure to change is the lack of will or resources to fund the effort. “There is very limited reimbursement for the items,” Mr. Collins said. “It’s a technology that people want to adapt to, but the cost–benefit ratio may not be clear to all facilities.” He added that it must also be considered that these scopes are tools to perform very delicate work, and there is much to be said for working with an instrument that is already familiar to the care provider.

However, according to V. Raman Muthusamy, MD, MAS, the medical director of endoscopy at UCLA Health, in Los Angeles, these factors are changing. For one, he told Priority Report, you can’t buy a new fixed end cap reusable duodenoscope from any of the three major U.S. manufacturers (Fujifilm, Olympus and Pentax); they are only selling duodenoscopes with disposable parts. Furthermore, he said, several manufacturers, including Olympus, are basically doing swap-outs akin to cellphone swaps. Providers can bring in their old reusable fixed end cap duodenoscope and get a new duodenoscope with a disposable tip and/or elevator.

As for whether providers are hesitating because of lack of familiarity with the newer devices, Dr. Muthusamy said that also may be old news. “There have been several studies, and what we’ve basically learned is that the technical success rates and adverse event rates in roughly 400 patients split among four studies, is essentially comparable. The overall endoscopist satisfaction was also nearly equivalent to [that for] the reusable devices.”

To Dr. Muthusamy’s thinking, the problem of early adoption is twofold. One, while the FDA is strongly recommending a rapid transition to the newer equipment, “they still haven’t set a date.”

And two, at this moment, the field is stuck in a VHS-or-Betamax moment. “There’s so much innovation, but nobody knows what solution is going to dominate,” he said. “One can’t say for sure, but it is one of those things where you know change is coming, but you don’t know exactly what the change is going to be.”

—W. Harry Fortuna The sources reported no relevant financial disclosures.

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Ditching Pre-Colonoscopy Appointments Reaches More for Screening, With Few Drawbacks

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o capture patients who find the traditional two-visit colonoscopy process too onerous, some practices have implemented

“fast-track” colonoscopy programs. Such programs can save patients and practices time and money and open the door to a new group of patients who’ve never been screened.

‘ Most people want to go the traditional route, [but] almost all the patients in the fast track have never had a colonoscopy.

’

26

—Mitchell J. Rubinoff, MD Valley Medical Group, Paramus, N.J.

“The whole reason Valley Hospital embarked on this fast-track colonoscopy program is to increase access to colorectal screening,” Mitchell J. Rubinoff, MD, the chief of gastroenterology at Valley Medical Group in Paramus, N.J., told Priority Report. From inception, the idea behind the program, Dr. Rubinoff said, was “to get people in who weren’t seeing primary care doctors, didn’t know about colonoscopy [or] didn’t know how to get it done.”

Fast-track, direct or open-access (OA) colonoscopy screening programs streamline the procedure by eliminating one or both pre-procedure office visits. In Valley Health’s program, Dr. Rubinoff

Endoscope Reprocessing & Infection Control

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explained, “the first time patients will meet the physician performing the colonoscopy will be right before their procedure.”

Valley Health started planning its fast-track colonoscopy screening program in 2016. Screening patients for eligibility was the most challenging aspect of the planning process. Valley Health convened panels of doctors within its system to develop a screening questionnaire and then hired a nurse practitioner to field the calls generated from the team’s initiatives to spread the news— community health board talks given by doctors, pamphlets and even a billboard marketing sign along a local highway.

After the screening questionnaire, which confirms the patient is of age and has no disqualifying complications, an appointment is booked with one of the participating providers, usually within a month, and the nurse goes over preparation. “Once they’re admitted to endoscopy, everything else is the same as traditional-track colonoscopy procedures,” Dr. Rubinoff said.

Since it started, Valley Health’s fast-track program has screened 626 patients, a fraction of its total volume of these types of screenings, which number in the thousands per year. “Most people want to go the traditional route,” Dr. Rubinoff said, but “almost all the patients in the fast track have never had a colonoscopy.”

Fewer Copays, Less Traffic, Less Wasted Time The direct colonoscopy program at KelseySeybold Clinics, a group of nonhospital, freestanding ambulatory surgery centers in Houston, is not fully OA. It still requires at least an initial consult with an affiliated, in-network primary care physician. That provider performs the initial screening and then refers the patient directly to the hospital for admission for the procedure.

Akshay Tavkar, MBA, CMPE, CASC, the director of operations for Kelsey-Seybold, said around half of the patients referred for direct colonoscopy had one scheduled. “This is Houston,” he told Priority Report. “It’s a big thing that you don’t have to make a second appointment, don’t have to pay that second copay [and] don’t have to sit in traffic. The clear benefit is getting people in for that screening colonoscopy when they might not have scheduled that appointment.”

Similar Outcomes to Traditional Path These obvious time and cost savings seen when appointments are eliminated have no ill effect on patient health, according to research. Investigators analyzed the data of a random sample of 1,000 patients who underwent outpatient colonoscopy at an academic medical center in 2013 (Dig Liver Dis 2016;48[8]:940-944). They found “no clinically meaningful differences between groups with respect to outcomes such as polyp detection (35.6% non-OA vs. 39.5% OA, P=0.54), postoperative call to GI practice (5.5% vs. 2.5%, P=0.41), or [quality indicator] metrics such as documentation of prep quality (99.8% vs.

98.8%, P=0.24).”

Other studies have found similar results.

Investigators at Policlinico Tor Vergata, the hospital of the University Tor Vergata, in Rome, analyzed OA colonoscopies in the vein of the Kelsey-Seybold model, where patients visited with their primary care provider first but not a gastroenterologist, and found no greater risk for complications or quality of assessment between traditional and OA procedures (Intern Emerg Med 2021;16[5]:1197-1206).

One single-center analysis even found that patients receiving OA colonoscopy had better returns on bowel prep than the traditionaltrack patients. “Adequate [bowel prep] was more frequent in 86% (18/21) of OA patients compared to 60% (21/35) in the GI group (P=0.043),” the researchers wrote (JGH Open 2021;5[5]:563-567).

Another analysis, this time a large population-based study in Eastern Canada, found that patients were slightly more likely—1.3 times— to undergo a complete colonoscopy if it was an OA procedure compared with traditional colonoscopy (95% CI, 1.2-1.4; P<0.0001) (Can J Gastroenterol 2013;27[6]:341-346). However, the rates of incomplete colonoscopy were low in both groups (5.3% in OA and 6.7% in non-OA).

Percentages of patients with endoscopic findings and CRC diagnosis also were similar between both groups.

Mitchell J. Rubinoff, MD

Akshay Tavkar, MBA, CMPE, CASC

Screening Is a Must Providers looking to establish fast-track or direct-access programs should ensure they have see Fast Track, page 30

Endoscope Reprocessing & Infection Control

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SUMMER 2022

Droplet Dispersal Study Draws Mixed Reviews

V

isible droplets were produced during almost every activity in a recent simulation of decontaminating

reusable medical instruments and equipment, with droplets sometimes traveling as much as 5 feet from a sink, according to a new study.

In addition, the personal protective equipment technicians used during the simulation did not prevent liquids from splashing onto skin, even when donned and doffed properly.

high-quality PPE due to COVID-related supply-chain issues. They were having to reuse PPE and attempting to use components that were not fluid-resistant or did not fit properly enough to provide protection,” lead investigator Cori L. Ofstead, MSPH, the president and CEO of I am really skeptical overall about these kinds Ofstead & Associates, a research group based in of studies using models rather than real-life St. Paul, Minn., told Priority Report.

Ms. Ofstead and her co-investigators affixed situations. droplet detection paper onto various surfaces in —Harish K. Gagneja, MD, FACG, AGAF, FASGE a hospital’s sterile processing department, adjaAustin Gastroenterology, Texas cent to sinks and at varying distances from sinks “We had heard that sterile processing depart- (Am J Infect Contr 2022;50[2]:126-132). They ments were not being prioritized for supplies of also affixed droplet detection paper to single-use

‘

’

28

Endoscope Reprocessing & Infection Control

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PPE, such as head covers, gowns, face masks, shoe covers and gloves. Sterile processing technicians simulated medical instrument reprocessing tasks, such as filling the sink, placing a ureteroscope into water, brushing the lumen, rinsing a stainless steel basin with a power sprayer, and using a sonication system within a multiple-basin sink.

Technicians donned new PPE as needed whenever their garments were splashed. Before any work began, Ms. Ofstead’s team reported, technicians had thoroughly disinfected all work areas and medical instruments.

Power spraying generated the most splash, with substantial splatters 5 feet from the sink. But almost every task generated detectable droplets, often more than 3 feet away from where the activity occurred and on multiple surfaces, as well as on the PPE and skin of technicians. Using the sonication sink did not produce any detectable droplets.

“Droplets were generated by every activity no matter how carefully it was done,” Ms. Ofstead said. “I was surprised to see so many droplets on so many surfaces several feet from the sink.”

Although Ms. Ofstead noted that this was a hypothesis-generating project that needs to be validated, she suggested the data are already strong enough to encourage sterile processing leaders to think about ways to reduce the potential of splash exposure, such as installing clear plastic barriers or a sink hood.

Translating to Real-World Scenarios “I am really skeptical overall about these kinds of studies using models rather than real-life situations,” said Harish K. Gagneja, MD, FACG, AGAF, FASGE, a gastroenterologist with Austin Gastroenterology, in Texas. “These aerosols don’t mean much as they are not coming directly from the patient.” The aerosols could originate from the scope but also from the washing fluid, he said.

In Dr. Gagneja’s view, the only way to know if the droplet dispersal measured in the study leads to sickness is to compare rates of infection between healthcare personnel who routinely reprocess scopes and those among other healthcare workers.

“There are people who are processing the scopes day in and day out. Are they getting sicker than those who are not?” Dr. Gagneja asked.

‘ Droplets were generated by every activity no matter how carefully it was done. I was surprised to see so many droplets on so many surfaces several feet from the sink.

’

—Cori L. Ofstead, MSPH Ofstead & Associates, St. Paul, Minn.

Ms. Ofstead responded that symptomatic illness may not be the best measure of exposure. It could be that sterile processing technicians have stronger immune systems due to more frequent exposure to diverse microbes, and end up hosting pathogens that can infect other people with less robust immune systems. This is a hypothesis that needs further research, she added.

Better Than It Used to Be “I’ve been in GI and endoscopy nursing for about 20 years, so I see how much more we do than we used to,” said Emily Salisbury, BSN, RN, the director of clinical operations for Endoscopy Services at University of Utah Health, in Salt Lake City. When her career began, Ms. Salisbury said, using full PPE was not common during reprocessing but has long since become routine.

Ms. Salisbury also noted that there are some safeguards in place in endoscopy units, such as marks in a sink to indicate how high to fill the basin. Some of the splashing seen in this study would likely not happen in everyday reprocessing units, she noted.

“I think there needs to be a realistic view,” Ms. Salisbury said, adding that sink hoods would be much more feasible than adding plastic barriers to a crowded sterile processing suite.

Ms. Salisbury agreed with Ms. Ofstead that PPE for sterile processing technicians was an afterthought during the worst of the COVID-19 pandemic. “I thought that was a very valid point,” she said. “Maybe the people who do reprocessing weren’t considered when we were distributing PPE.” —Marcus A. Banks Dr. Gagneja and Ms. Salisbury reported no relevant financial disclosures. Dr. Gagneja is a member of the Gastroenterology & Endoscopy News editorial board.

Ms. Ofstead’s study was supported in part by an unrestricted research grant from Healthmark Industries, which also provided study supplies including PPE and moisture detection paper.

Endoscope Reprocessing & Infection Control

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SUMMER 2022

Fast Track continued from page 27 good screening questions and a strong, fully integrated records system, Mr. Tavkar said. Strong screening is key at Kelsey-Seybold, he noted, because with it they never have to turn away a patient who isn’t a viable candidate on the day of the procedure. Without that screening, if the patient ends up unable to undergo the colonos-

‘ It’s a big thing that you don’t have to make a second

appointment, don’t have to pay that second copay [and] don’t have to sit in traffic.

’—Akshay Tavkar, MBA, CMPE, CASC Kelsey-Seybold Clinics, Houston

copy, “you’ve wasted their time,” he said.

Dr. Rubinoff agreed that the screening process is crucial. Not only is it inconvenient to the patient, but inappropriate prescription of OA procedures could have poor candidates taking slots from patients in imminent need.

The Italian study mentioned previously underscored the need for strong screening in OA programs. In the study, nearly 50% of the 180 OA procedures performed were deemed inappropriate (50 early, 20 late), according to local guidelines. Only 18 of the 233 (8%) traditional-track colonoscopies were deemed inappropriate.

What’s more, the researchers found that nearly one-fourth of the patients scheduled for an OA procedure failed to make their appointments, which is significantly larger than the just under 6% who failed to show in the traditional track.

Although no provider can guarantee a patient will show up to their scheduled appointment, Dr. Rubinoff and Mr. Takvar said only patients who fall within clinical guidelines for preventive screenings are candidates for the OA route, which goes a long way to addressing the possibility of performing procedures on poorly qualified patients.

No Great Change to Volume Means Same Workflow With these increases in new patients being screened, do OA colonoscopies effect patient

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volume and procedure workflow?

Although no two OA or fast-track programs are exactly alike, in the case of Kelsey-Seybold, the patients don’t choose to participate in the OA colonoscopy. They are assigned depending on their eligibility and the judgment of their primary care physicians. The patients aren’t aware of which track they will be assigned to and are not initially seeking the exam specifically, so any increase in volume is negligible. Afterward, scheduling, pre-procedure and post-procedure processes remain the same.

In Valley Health’s case, patients are coming to the program specifically for fast-track colonoscopy, and the intent of the program, Dr. Rubinoff said, is to bring care to more patients and bring more patients into the health system.

Consequently, there is the possibility of a sudden increase in volume. However, when a patient calls into Valley Health seeking an OA procedure, they are screened for eligibility by a nurse practitioner according to guidelines refined over years by committees of Valley Health’s gastroenterology team. “After a patient is found eligible,” Dr. Rubinoff said, “their experience, from the scheduling to the procedure, is the same as any patient on the traditional track.” It’s a program that already accounts for staffing and equipment processing needs. No allowances need to be made for these patients beyond standard operating procedures.

The benefits of OA programs with good screening are clear. Programs like this increase patient participation, and in the age of COVID-19, even one less visit per cycle means these programs require less provider resources— conserving personal protective equipment and providers’ time during the pandemic (Dig Dis Sci 2021;66[8]:2578-2584), benefiting patients not even in the program, Mr. Tavkar said. “If we get 850 to 1,000 referrals a month, that is nearly 10,000 visits saved a year. So, you’ve got better access for people who are truly ill that need to see that specialist,” he added.

“Over the past two years, so many people have put off or neglected proper healthcare screenings,” Dr. Rubinoff stressed. “The fast-track program is a way that people can quickly access [care] .”

—W. Harry Fortuna The sources reported no relevant financial disclosures.

Endoscope Reprocessing & Infection Control

SUMMER 2022

Extended Shift Staffing in Endoscopy Units Linked to Fatigue, Work–Life Imbalance

E

xtended shift staffing models have become common in

hospital-based endoscopy centers, especially in facilities that are not open 24 hours a day. But what does that mean for endoscopy staff in terms of fatigue and work–life balance?

According to results of a new survey presented at the annual meeting of the Society of Gastroenterology Nurses and Associates last year, lack of recovery between shifts and chronic fatigue are harming staff. “It is important that staff be aware of the need for rest between shifts,” wrote the researchers, led by Heather Thompson, MSN, FNP-BC, RN-BC, at Memorial Sloan Kettering Cancer Center, in New York City.

“Staff educators could provide ongoing education related to the responsibility staff bear for ensuring they are adequately rested so that they can provide quality care to patients.”

Quantifying Effects On Work–Life Balance Past research found connections between extended shift staffing models, fatigue and other negative effects. “Among staff working traditional units with 24/7 staff coverage, the extended shift staffing models have been reported to present adverse effects related to fatigue,” the researchers noted. “These effects include worker injury, errors, decreased health and well-being, and decreased critical thinking.”

Seeking to better understand the relationships among fatigue, intershift recovery and the quality of work–life balance (QWLB) in staff working in units open fewer than 24 hours a day, the investigators conducted a survey of registered nurses and

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Endoscope Reprocessing & Infection Control

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surgical technologists employed in non–24-hour units with extended day shifts (10 and 12 hours).

A total of 84 staff members completed the survey (abstract R07), which included a demographic questionnaire; the Walton Quality of Work Life survey, a questionnaire that has long been used to measure work–life balances and imbalances, as well as other aspects of a person’s life; and the Occupational Fatigue Exhaustion/Recovery (OFER) scale, which measures the differences between acute fatigue, chronic fatigue and intershift recovery related to a person’s work.

The Walton survey asks participants to rate their work–life satisfaction in eight dimensions, including salary and compensation, working conditions, opportunities at work, social integration, and the space that work occupies in their life, on a 5-point scale ranging from very dissatisfied (1) to very satisfied (5). The OFER scale has 15 items on a 7-point scale, with responses ranging from strongly disagree (0) to strongly agree (6), and statements such as “I use a lot of my spare time recovering from work,” “I have plenty of reserve energy when I need it,” and “I don’t get enough time between work shifts to recover my energy fully.”

Evidence of Impaired Quality of Life The researchers found chronic fatigue, acute fatigue and intershift recovery were significantly correlated with quality of work life in various behavioral and social areas, including social integration (e.g., relationships with colleagues, discrimination in the workplace, value of individual ideas and colleagues’ commitment to work); constitutionalism (e.g., fairness and equity in the workplace, respect for rules, respect for individuality, and ability to give opinions); and QWLB total life space (i.e., work’s influence on family life and leisure, and a work/rest schedule).

Chronic fatigue, acute fatigue and intershift recovery, as measured by OFER, were most strongly correlated with the QWLB total life space section of the Walton survey (P<0.001 for all). Of the OFER scales, chronic fatigue had the strongest correlations with the three QWLB scales (P<0.001 for all).

“Findings from this study clarified the knowledge that nurses who work extended shifts in

procedure units are at risk for a reduced QWLB related to chronic fatigue and poor intershift recovery. Staff working in units operating less than 24 hours demonstrated that personal QWLB is directly influenced by chronic fatigue and a lack of recovery between shifts,” the researchers noted. “This quantitative data can provide evidence for managers and schedulers that adequate rest between shifts should be a priority when scheduling staff and that staff fatigue should be a factor in unit coverage.”

Staggering Staff Could Help The issue of extended shifts, fatigue and recovery has become even more of a challenge in hospital endoscopy centers recently, as COVID-19 has contributed to staffing shortages, said Harish K. Gagneja, MD, FACG, AGAF, FASGE, a gastroenterologist with Austin Gastroenterology, in Texas.

“We have tried to overcome this in our medical center by implementing staggered shifts,” said Dr. Gagneja, who was not involved with the study.

“For example, if you have 10 nurses in your endoscopy unit, you start with six on shift early in the morning, then start two more two hours later, and two more two hours after that,” Dr. Gagneja explained. “Then the early-morning nurses leave first, when you have fewer procedures left. Then you have two more nurses leave two hours later, leaving the two who started latest to stay to the end of the shift, which should be adequate to do any add-on cases that may present.”

Although extended shifts are used more in the hospital-based endoscopy setting, where emergency cases are more likely to present, fatigue and inadequate recovery are significant challenges in the ambulatory surgery center setting as well.

“We have to be diligent about scheduling appropriately, not overscheduling, and giving breaks,” said Rob Puglisi, who oversees operations at 60 gastroenterology surgery centers in 15 states as the vice president of operations at PE GI Solutions, in Wayne, Pa. “We also encourage our staff to speak up when they need a break—no harm, no foul.

Everybody has to be on guard and look out for each other.”

‘ We have to be diligent

about scheduling appropriately, not overscheduling, and giving breaks. We also encourage our staff to speak up when they need a break. ...

Everybody has to be on guard and look out for each other.

’

—Rob Puglisi PE GI Solutions, Wayne, Pa.

—Gina Shaw The sources reported no relevant financial disclosures.

Dr. Gagneja is a member of the Gastroenterology & Endoscopy News editorial board.

Endoscope Reprocessing & Infection Control

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SUMMER 2022

Technician Training continued from page 21

Acknowledgments: Dr. Raju noted that teaching material for the Endoscopy Technician Training Program was developed with the help of philanthropy support from the John Stroehlein Distinguished Professorship, Mr. Charles Butt & HEB Grant, and the Boot Walk Program of The University of Texas MD Anderson Cancer Center. The teaching material was developed with the help of an educator (Sanji Suresh) and medical illustrator (Angela Diehl) and donated to Houston Community College.

In addition, he stated that the program would not have been possible without help from: Cesar Maldonado, Phil Nicotera, Ramon Villeagas, Jeff Gricar, Melissa Bruton (Houston Community College); Sophia Reyes, Laura Romero, Liben Mahometano, Denise Barringer, Selvi Thirumurthi, Joseph Zhang, Brian Bednarski, George Eapen (MD Anderson endoscopy team); Kal Patel, R.J. Sealock (Baylor College of Medicine); Tom Slocum (Boston Scientific); John Stroehlein, Mehnaz Shafi, Suresh Chari, Lisa Sauer, Gladis Shuttlesworth, Regina Sherrod, Carol Cox, Patrice Davis, Felicia Hancock, Diane Bodurka, James Cavalier, Karen Hagberg, Peter Pisters (MD Anderson Support); and Cancer Fighters of Houston.

Special thanks to Kal Patel, Tom Slocum and Marcela Romero.

and Rachel Breland, put the curriculum into practice. Their lesson plans included teaching slides developed by a medical illustrator and 175 videos with narration that Dr. Raju created for students to watch before class using a flipped classroom approach. (Dr. Raju makes the videos available on YouTube for technicians or nurses at youtu.be/vf1n3DWXn14.)

In addition to the didactic material, the technicians-in-training take part in practical, hands-on practicum training opportunities at various medical facilities in the area. Because most of the first student group, whose median age is 32 years, had jobs, the lectures were online, and labs were scheduled in the evenings (Tuesdays and Thursdays from 4 to 8 p.m.), with additional hands-on training days in hospital settings. The cost of the program for the students was approximately $4,000.

Although Mr. Diaz said they started with minimal resources and it was slow going initially, things eventually fell into place, and the students ultimately were able to get training in esophagogastroduodenoscopies, colonoscopies and many therapeutic procedures. They used snares and biopsy forceps, and collected various samples.

In an interview with Priority Report, one of the graduates, Cydnie Brown, shared how that classroom learning supported her when she was in clinical settings for the practicum component of the program. She said some of the doctors and technicians she and her classmates worked with on their practicums were “impressed” with their knowledge.

“They’ve asked us questions—and those techs have been there for a while, working two to three years— and they don’t know the answers. So, they’re kind of shocked that we know those answers.”

Expanding on the Program Currently, the Houston program is set up as a one-year certificate, but Dr. Raju said the hope is to expand that so, for example, techs could come back for a second year and learn more specialized skills. With such a two-year pathway, technicians could be working toward a nursing degree. After earning a two-year associate’s degree, they could

finish two more years of nursing and become an endoscopy nurse. In addition, Dr. Raju said the team would like to incorporate an additional pathway whereby currently employed technicians could access the certification pathway, obtaining credit for their knowledge and expertise. Through this process, technicians working for several years could get certification with the approval of their endoscopy director and completion of the prerequisites.

He also noted that the American Society of Gastrointestinal Endoscopy (ASGE) is working on developing an online program, and he said he is hopeful that in the next two years, the society will establish a national endoscopy certification for nurses and technologists. He said the process has started, and he and other endoscopists have been developing question banks for nurses and techs.

Ed Dellert, RN, MBA, the ASGE’s Chief Publications and Learning Officer, told Priority Report that ASGE plans to offer the certification option to GI endoscopy technicians as part of their ASGE membership benefits from.

In the meantime, Mr. Dellert noted that ASGE “continues its efforts in providing membership options and benefits to the entire endoscopy team, inclusive of GI endoscopy technicians. Currently we have a membership option that includes a growing number of training resources for professional development in GI Leap” (learn.asge.org/Users/Catalog.aspx), with modules on GI anatomy, pathophysiology, infection control, equipment and accessories, fundamental and advanced procedures, regulations and safety, and other areas.

With the idea of a national endoscopy technician certification option on the horizon, Dr. Raju and his team want other centers to share in their knowledge about technician training and develop similar programs across the country. “Houston Community College is keen on collaborating with other community colleges,” he said. “What we did at Texas Medical Center, you could do the same thing in your own place.”

—Sarah Tilyou

For more information about the HCC endoscopy technician certificate program, visit hccs.edu/programs/areas-of-study/health-sciences/endoscopy-technician/.

34

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