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How to Handle Violence During Outpatient Procedures
Nurse-led initiatives help to increase workplace safety
Although the majority of violent acts toward healthcare providers occur within the acute care setting, with security teams in place and a variety of colleagues available to help, outpatient clinics also are exposed to violence. Developing a plan and having well-trained staff are necessary to ensure the safety and preparedness of clinic teams, according to a presentation at the 2024 SGNA Annual Course.
T Turning an Incident Into Opportunity
Jeanne Greer, RN, BSN, CGRN, the director of g astroenterolog y operations at Cooper University Hea lthcare, in Mt. Laurel, N.J., recog nized the need for violence prevention training af ter her staff was attacked by a patient post-anesthesia due to a propofol reaction. In recovery after a procedure, the patient—a 32-year-old man with no history of reactions or drug misuse— jumped off his stretcher, pulled out his IV and beg an punching nearby staff members. He also attempted to hurt other patients. Luckily, Ms. Greer said, two technicians who formerly worked in security were able to restrain the patient. However, several staff were injured, and those who were involved entered a “shock state” for weeks after the incident, she told GEN Priority Report
see Outpatient Violence, page 8
Test the Functionality of Endoscope
Leakage Testers with the Leak Tester Tester
Healthmark’s Leak Tester Tester is designed to check the accuracy of air pressure provided by automated and handheld endoscope leakage testers
The Leak Tester Tester assists in reducing the potential for cross-contamination, damage and costly repairs that result from using an endoscope with leaks.
Simply attach the desired Leak Tester Tester to your facility’s endoscope leak tester, turn it on or pressurize the bulb, and read the pressure on the gauge, which gives a quick and objective result of the amount of air being expelled from the leak testers.
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
Reports From SGNA 2024 From SGNA 2024
Nurses Improve Bowel Prep Standards
Although the patient is responsible for completing bowel prep before a colonoscopy, it is often up to a nurse to provide clear instructions and guidelines to the patient and their family about how to successfully complete the prep. As bowel prep can make or break a colonoscopy, many clinics are finding that standardization, enhanced staff education and improved patient education materials can facilitate improved prep, according to two new studies presented at the 2024 SGNA Annual Course.
Providing Education to Staff
Junabelle Gamble, DNP, MSN, BSN, RN, a gastroenterology nurse at Baylor St. Luke’s Medical Center, in Houston, tested St. Luke’s nurses before and afterabowel preparation education course based on the most recent American Society for Gastrointestinal Endoscopy (ASGE) guidelines. She recruited participants from a variety of nursing units, including nurses working on different shifts and in different roles. A total of 134 participants completed the education course and the before-and-after tests.
Dr. Gamble found uniform results across the nine subtopic areas in the tests, which ranged from knowledge of types of bowel prep to understanding the repercussions of poor prep. Nurses scored consistently low before the education course but tested high after the course. To Dr. Gamble, the results confirmed that after proper education, the staff was able to recall and implement current bowel prep standards.
Providing Education to Patients
Like Dr. Gamble, Stephanie Rollo, BSN, RN, CGRN, a gastroenterology nurse at Glens Falls Hospital, in Queensbury, N.Y., has been working to improve bowel prep at her facility. Instead of staff education, her focus has been on standardizing bowel preparation practices since 2007 through patient and family education.
In her work, she has found that the materials provided by hospitals and clinics were very limited and that patients often expressed to staff members that they were confused and anxious before the procedure. She and the Gastrointestinal Unit-Based Council at her facility have been developing materials that are clear and easy to understand for those involved in the prep. These materials are supplemental to the pre-procedure instructions given by physicians.
A good bowel prep educational pamphlet, Ms. Rollo said, must include medication instructions, duration of NPO (nothing by mouth) and scenarios that would prompt a patient to call the doctor.
According to Ms. Rollo, improved patient education can help endoscopy centers avoid two main groups of complications: administrative complications—such as scheduling challenges, delays in anesthesia, and staffing challenges—and procedural complications—such as limited exam visibility resulting in delayed or missed diagnoses and treatments, increased electrocautery risks, and prolonged procedure times.
‘ Changing the culture from what we are used to doing to a better and new way can be a hurdle that can be overcome.’
—Seth Gross, MD
NYU Langone Health, New York City
“Patient compliance increases with education and understanding,” Ms. Rollo told GEN Priority Report. She said her goals for providing clear reference materials are to improve inpatient prep, decrease confusion, and improve communication and quality of care for everyone involved. Dr. Gamble also noted that education can benefit both the patient and the healthcare team by
Seth Gross, MD, the clinical chief of the Division of Gastroenterology and Hepatology at NYU Langone Health, in New York City, has found that the biggest challenge to implementing a standardized practice is implementing the change itself. “Changing the culture from what we are used to doing to a better and new way can be a hurdle that can be overcome,” he said.
‘ Patient compliance increases with education and understanding.’
He said he believes the best way to implement change is to support “champions” in the hospital to aid in implementing best practices. He said tools to implement change may include educational modules, routine knowledge checkins (i.e., audits) and replication of standards of practice. Each healthcare organization has its own policies and practices, and it can be difficult to streamline a standard of practice for every organization, he said. However, one can replicate the successes of other organizations’ bowel prep standards by:
• using current guidelines, such as referring to the ASGE guidelines to educate staff members;
• developing instructions that are presented in both oral and written forms to those completing the prep; and
• providing ongoing education that applies to a variety of staff and their differing shift times. Follow the societies, Dr. Gross advised. “Strong medical evidence leads to medical societies educating their members on best practice,” he said, “which leads hospitals to adopt these standards.”
—Ronni Benson, RN, BSN
The sources reported no relevant financial disclosures. Dr. Gross is a member of the Gastroenterology & Endoscopy News editorial board.
Outpatient Violence
continued from page 4
In response to the event, Ms. Greer worked with stakeholders to develop a violence council to ensure the staff was prepared if another incident arose. Her main goal was, “How do we build confidence in our staff and patients?”
The violence council developed a protocol for their facility. First, they started ongoing violence drills for staff, assigning roles staff members would take during a crisis. For example, one nurse would be assigned to call 911, another to protect other patients, and a third to prepare medications. Second, they installed signage instructing patients about what to do in case of a violent outburst and installed panic buttons in the front office and in several clinic rooms. Finally, they met with local police to discuss their role during a violent outburst.
In the initial incident, the police were hesitant to intervene because they weren’t sure what the patient’s psychiatric status was and what type of intervention was appropriate. Because of this, staff had discussions with the police, and it was determined that if a situation arose that was called a “post-anesthesia outburst,” that wording would allow them to assist appropriately with subduing the patient alongside the healthcare team.
Multifaceted Approach To Prevention
Emily Salisbury, MSN, RN, CGRN, the director of clinical operations in endoscopy services at the University of Utah Health, in Salt Lake City, has developed and implemented several methods in preparing her staff to face violence confidently within the clinic space. In an interview with GEN Priority Report, Ms. Salisbury agreed that installing panic buttons and planning out scenarios are good starting points.
Apart from assigning roles for staff members, she also recommended designing a “system of escalation,” she said, that delineates who staff should contact and what steps to take when faced with aggressive patients or visitors.
Training can be augmented with the help of an
Replicating a Successful Prevention Program
How can other outpatient facilities replicate these success stories and provide their clinics a wider safety net? Jeanne Greer, BSN, RN, CGRN, of Cooper University Healthcare, in Mt. Laurel, N.J., and Emily Sailsbury, MSN, RN, CGRN, of University of Utah Health, in Salt Lake City, both recommend the following:
• Advocate for a safe work environment by communicating with stakeholders and key members of the organization, including leadership and union leaders, and implementing a violence council.
• Communicate clearly withmembers of the healthcare team during an incident.
• Meet with local law enforcement to establish the role they will take during an incident.
outside training company, she said, noting that BERT Workplace Safety Solutions worked well for her healthcare team. One detail her staff learned in training for these events is to practice safe distances from patients and visitors at all times, she said. It’s important to remember to never place yourself in a position with no access to an exit, she explained.
Finally, she recommended performing precalls with upcoming patients to determine a patient’s mindset and training staff in verbiage to de-escalate aggressive patients. Ms. Salisbury said she believes that a great tool in de-escalation is simplylisteningto patients and visitors. “It allows them to vent their frustrations,” she said. “Many of these individuals are going through difficult times and may just need a space to express their frustrations.” However, she encourages enforcing firm boundaries with patients and visitors and following up any aggressive event with thorough documentation.
“Continued practice and good communication,” she said, “can empower staff and improve their confidence going forward.”
—Ronni Benson, RN, BSN
The sources reported no relevant financial disclosures.
—R.B.
Expert Picks From the 2024 SGNA Annual Course
In this installment of Expert Picks from the 2024 SGNA Annual Course, Cynthia M. Friis, MEd, BSN, RN, NPD-BC, the associate executive director of clinical affairs at SGNA, discussed four of her favorite abstracts from the meeting.
Fostering sustainable improvement: a test of change demonstrating new process effectiveness (So et al)
Given the benefits of timely esophagogastroduodenoscopy (EGD) after upper gastrointestinal bleeding (UGIB), investigators assessed whether a team triage system could expedite appropriate follow-up care in patients who present to the emergency department (ED) with UGIB. Specifically, the team aimed to improve the proportion of UGIB patients who underwent EGD within six weeks of presenting to the ED.
As part of the triage system, GI endoscopy nurses reviewed daily admission reports to identify patients with UGIB and worked to expedite consultations with gastroenterologists and scheduling of EGD. During the program, the proportion of patients who underwent timely EGD increased to 63%, from 56% before the program.
To the investigators, this improvement shows that “dedicated resources and workflow justification are essential for timely intervention for UGIB patients” and that it may be beneficial to “establish” a dedicated GI “nurse navigator position” to facilitate timely EGD.
Ms. Friis: The incidence of acute UGIB in the United States varies but ranges from 48 to 68 cases per 100,000 annually. Recognizing that effective processes and workflows are tantamount to safe and effective patient care, the authors sought to increase the level of communication among key stakeholders and enhance the role of nurses in managing patients with UGIB. The results indicated the need for a nurse navigator in this setting.
see Expert Picks, page 10
EXPERT PICKS
Point of Use
Cleaning
‘Reprocessing...can be an arduous process resulting in compliance issues. ... Sharing the results and steps of this study can benefit others as they seek to improve their compliance.’
On-Time Starts
‘Lags in the start of the first procedures of the day wreak havoc on the rest of the day’s procedures ... which is not only inconvenient but also can be costly.’
Cynthia M. Friis, MEd, BSN, RN, NPD-BC
Expert Picks
A clean you can trust: transforming point of use treatment at a military treatment facility through an evidence-based bundle (Atwood
An interdisciplinary team of investigators from a military medical center implemented a series of audits aimed to improve pointof-use (POU) treatment of reusable medical devices.
Based on the Plan-Do-Study-Act framework, each audit included promotion of evidence-based strategies for improving POU treatment performance and compliance, including “workflow analysis, policy development, competency assessment creation, training development and infection prevention grand rounds.”
Over 10 months and four audits, overall POU treatment compliance increased 15.6% from baseline. For flexible endoscopes and
et al)
endocavity probes, specifically, improvements were 12% and 9%, respectively.
Ms. Friis: Reprocessing reusable medical devices can be an arduous process resulting in compliance issues. One of the most important steps in flexible endoscope reprocessing is the removal of gross bioburden during the pre-cleaning or POU step. The authors of this study developed a multifold evidence-based practice plan to address the issue and increase compliance with this step. Sharing the results and steps of this study can benefit others as they seek to improve their compliance.
On time starts are within our scope (Acosta et al)
Given that late case starts can cause a ripple effect, resulting in delays for both patients and clinic staff, investigators aimed to assess reasons for delays and improve the proportion of days that the first endoscopy case started on time.
For six months, the investigators tracked whether the first case of the day started on time and, if it did not, the reason for the delay. Late staff arrivals, equipment malfunctions and lack of standardized processes were found to be the largest contributors to delayed starts.
To improve the proportion of on-time starts, the investigators implemented education and accountability measures, such as sending messages to clinic staff to summarize their adherence to timeliness.
The investigators “saw a marked increase” in the proportion of first cases that started on time with the implementation of these strategies.
Ms. Friis: Lags in the start of the first procedures of the day can wreak havoc on the rest of the day’s procedures and cause delays for the staff and patients, which is not only inconvenient but also can be costly due to overtime. This study sought to improve first case on-time starts (FCOTS). Through a rigorous plan focused on the various reasons for delays, the authors were able to create a deeper recognition and appreciation for the impact of the delays and, ultimately, increase FCOTS.
A novel magnet traction device for endoscopic submucosal dissection in an ex vivo porcine study (Deters et al)
Researchers assessed the efficacy and safety of endoscopic submucosal dissection (ESD) using an internal magnet traction device (MTD) compared with conventional ESD.
The internal MTD ESD involves the use of two neodymium magnets: one placed at the proximal edge of the lesion and the other on the wall across from the lesion. In the study, the endoscopist created a circumferential mucosal incision using a 30-mm diameter template, and when the two magnets met, the lesion was lifted up toward the opposite wall.
Overall, 20 lesions were dissected from ex vivo pig stomachs using either MTD ESD or conventional ESD. Lesions were on the anterior and posterior walls, as well as the greater curvature of the stomach. MTD ESD procedures had shorter submucosal dissection times than conventional ESD procedures. In addition, for lesions
on the posterior wall and greater curvature, those dissected with MTD had shorter overall procedure times than those dissected with conventional ESD. Muscularis propria injuries also were less common in lesions dissected with MTD ESD.
Ms. Friis: ESD, a minimally invasive procedure to examine and remove growths from the lining of the GI tract without surgery, is facilitated by devices or methods that enable lesion traction during submucosal dissection, enhancing the safety and efficiency of the procedure. The MTD ESD device the investigators used was deployed easily, and the resultant traction allowed for a clear view of the submucosal layer, resulting in shorter dissection times.
—Compiled and written by Natasha Albaneze, MPH Ms. Friis reported no relevant financial disclosures.
“My nurses rarely have to turn a patient on their back or apply pressure. They love it! They love being in my room because they know they are going to be the nurse, take the vital signs, do the interventions, and that’s it. They love it!”
Dr. Sandi Fields
Should States Require Certification For Endoscopy Technicians?
In the absence of federal certification mandates, societies have developed their own programs to better prepare technicians
Only six states require endoscopy technicians to complete sterile processing technician certification training. Experts say the disconnect between states has created a need for clinics and programs to incentivize technicians to receive formal training.
Connecticut, Delaware, New Jersey, New York, Pennsylvania and Tennessee have laws that require certification. Three more states—Florida, Massachusetts and Minnesota—are considering enacting similar laws. But the vast majority of states leave training up to endoscopy clinics.
‘ There has always been a push for more nationwide standards.’
People who work in cosmetology need to be certified. ‘ If those trades require certifications, why shouldn’t we?’
—Garland Grisby, CFER, CSPDT
Kaiser Permanente, San Francisco
“Depending on the local policy, a technician may train for four to six weeks on the job before they are on their own,” said Gottumukkala Subba Raju, MD, the John Stroehlein Distinguished Professor of Medicine at The University of Texas MD Anderson Cancer Center, in Houston.
Cynthia M. Friis, MEd, BSN, RN, NPD-BC, an associate executive director of clinical affairs
at the Society of Gastroenterology Nurses and Associates (SGNA), agreed that the expectations of endoscopy technicians vary greatly between clinics, and not just formal certification requirements. “Sometimes they are a scope reprocessor. Sometimes they play a more active role during the procedure,” she said. “It really depends on the facility.”
At baseline, managers in charge of training should teach all new endoscopy technicians to follow the manufacturers’ instructions for use, said Garland Grisby, CFER, CSPDT, an endoscope service manager at Kaiser Permanente, in San Francisco, and the co-chair of the Association for the Advancement of Medical Instrumentation’s Working Group 84, which focuses on endoscope reprocessing.
“We always want to go off of manufacturers’ instructions. However, some facilities might have a mixed fleet, and some of those instructions for use are different,” he said, noting that this can cause discrepancies in how endoscopes are being processed.
Moving Toward Standardized Training
“There has always been a push for more nationwide standards,” Mr. Grisby said. Pointing out that people in fields such as cosmetology need to be certified, he said, “If those trades require certifications, why shouldn’t we?”
Ms. Friis said she has noticed a concerted effort to standardize reprocessing technician training in recent years.
To that end, several industry groups have created training programs for endoscopy and sterile processing technicians. The Certification Board for Sterile Processing and Distribution and Healthcare Sterile Processing Association tests can be taken by anyone in the country. In addition, SGNA has two continuing education gastroenterology technician specialist programs that are tailored based on experience.
Ms. Friis said the focus of both SGNA programs is on allowing students to ask questions throughout the courses and providing them with context about the purpose of each stage. “It gives a reason for why someone is doing a step and helps the information stick more,” she said.
Incentivizing Formal Training
Dr. Raju has taken another approach to increase technician education. He partnered with the American Society for Gastrointestinal Endoscopy (ASGE) and Houston Community College to design a new kind of endoscopy technician training course that is flexible and easily tailored to people who are new to the field and those with prior work experience (GEN Priority Report 2022 July;20-21,34).
One of the goals of developing the training programs was to create a pipeline of qualified technicians who are ready to work. Another was to ensure people who took on extra schooling, outside of on-the-job-training, had an incentive to do so. This includes opportunities to expand their careers.
A person without prior experience can take 35 credit hours through Houston Community College. Students at Houston Community College also will complete two semesters of parttime on-the-job training.
Alternatively, an experienced technician working in an endoscopy unit can access 19
credit hours of endoscopy course subjects online through ASGE.
Students in the community college program also will have the chance to take a final exam designed by Dr. Raju and ASGE to ensure competency before graduating. If a technician already has work experience, they can opt to “test out” of the program. If they pass the test, they will receive 19 credit hours from the college without needing to take those classes. If they want to go for Level II training, they can complete another 16 credit hours, which can be applied toward a Level II certificate at Houston Community College where they later can go for an associate degree.
A Model to Replicate
Dr. Raju acknowledged that each clinic runs a bit differently, but a standardized training program like this will better prepare new technicians to enter the workforce with a good understanding of how to complete tasks, as well as the knowledge needed to ask questions to clarify each clinic’s process. There would be baseline knowledge so that training for a new technician doesn’t need to start from scratch.
‘ Ultimately the goal is to freely share that information. If a community college in Chicago or Denver wants to start this program, they can use the material and have somebody locally teach it.’
—Gottumukkala Subba Raju, MD
The University of Texas MD Anderson Cancer Center, Houston
Another important aspect central to the training was designing it in a way that can be replicated by other community colleges across the country, creating a new normal where people are incentivized to complete formal endoscopy technician training.
“Ultimately the goal is to freely share that information,” Dr. Raju said. “If a community college in Chicago or Denver wants to start this program, they can use the material and have somebody locally teach it.”
—Kaitlin Sullivan
The sources reported no relevant financial disclosures.
Reports From DDW 2024
An increasing number of tissue-cutting ablations that generate smoke may pose risks to healthcare personnel, according to new research presented at DDW 2024.
“While surgeons in the operating room have regulations and guidelines to mitigate smoke exposure, there are no comparable rules for gastrointestinal endoscopy,” explained principal investigator Christopher Thompson, MD, the director of endoscopy at Brigham and Women’s Hospital, in Boston.
Dr. Thompson and his co-investigators used measurement devices to quantify the level of smoke that surgeons, nurses and technicians are exposed to during these procedures (abstract Mo1121). The procedures ranged from stopping bleeding, to removing cancerous or precancerous polyps, to reducing the opening of the small intestine during a gastric bypass.
The results were alarming, he said. Every procedure produced measurable smoke, but the smoke level generated during argon plasma coagulation was more than for any other procedures, with a smoke level comparable to that produced when smoking a cigarette.
smoke during the procedures themselves, he said.
“This is a useful study, as we are moving toward the beginning of an environmentally and ergonomically conscious endoscopy era,” said Madhav Desai, MD, a gastroenterologist at UTHealth Houston, who was not involved with the research.
Dr. Desai said smoke generation during endoscopic procedures has been understudied, but it’s an important area of research as the number of smoke-generating procedures increases. Although this study suggests that argon plasma coagulation is especially smoke-intensive, Dr. Desai said more research is needed to defini-
The peak level of volatile organic compounds in the smoke reached twice the maximum level deemed safe by the EPA.
“Over the course of a career, endoscopic smoke may pose significant health risks,” Dr. Thompson said, especially to technicians and nurses who are in endoscopy suites every day.
He and his team placed smoke measurement devices approximately 1 meter away from where the various endoscopic procedures occurred. Based on a sample of 27 procedures in all, the peak level of volatile organic compounds in the smoke reached twice the maximum level deemed safe by the Environmental Protection Agency. Furthermore, ultrafine or fine inhalable particles that can enter the lungs were always floating about in the procedure room.
“Possible solutions that could be adopted would be using devices to remove smoke or wearing different types of masks,” Dr. Thompson said. Future research also should explore how to produce less
tively understand which endoscopic methods produce the most smoke. Most endoscopists use argon plasma coagulation and electrosurgery, daily or weekly, especially during third space endoscopy procedures, Dr. Desai said, which according to this research would result in cumulative health risks to all staff.
“GI physicians will need to understand and be aware of the concept of surgical smoke exposure, similar to ergonomic injuries, as these are collateral damages of doing GI endoscopy. We need to gain more knowledge regarding this problem first, and the solutions will follow. Surgeons learned this [about smoke] a long time back and they were able to fix this,” Dr. Desai said, predicting that the same will be true for endoscopists.
—Marcus A. Banks
The sources reported no relevant financial disclosures.
How to Fix the 2 Achilles’ Heels
Of Reprocessing
Despite progress in cleaning techniques and guidelines, flexible endoscope reprocessing remains inconsistent, putting patient safety at risk and bolstering the argument for single-use scopes.
Addressing two “Achilles’ heels” could drastically reduce discrepancies and ensure reprocessed scopes are safe, said Michelle Alfa, PhD, MSc,FCCM, a certified clinical microbiologist (retired) and the CEO of AlfaMed Consulting, in Winnipeg, Manitoba. Solutions do exist, she said. The challenge is getting sites to implement them.
‘ Break down that IFU into a chart, a graph or something that is very usable for the people reprocessing the scopes.’
“Every time you add to the cost, it has an impact on the bottom line and, therefore, there’s a lot of hesitancy when it comes to trying to proactively comply with these types of issues,” Dr. Alfa said. But it’s ultimately worth that cost, she explained to GEN Priority Report
Inconsistencies in Manual
Reprocessing
Neglecting IFU
The first hurdle is inconsistencies in manual reprocessing steps. The fact that this part of the process is manually controlled leaves ample room for error, she said, especially when there is a lack of adherence to manufacturers’ instructions for use (IFU).
“In some sites, it takes them less than five minutes to manually clean the scope,” Dr. Alfa said, despite the correct process taking 15 to 20 minutes. “They don’t even know they’re not getting it clean.”
A Brazilian study published last year investigated eight gastroscopes and five colonoscopes used at sites that perform between 140 and 530 scope-related examinations per month (Gastroenterol Nurs 2023;46[6]:455-464). After reprocessing, 46% still harbored debris.
Casey Czarnowski, BA, CRCST, CSPDT, CIS, CER, a perioperative consultant in Rochester, Minn., who specializes in sterile processing, said facilities should review each device’s IFU and post clear, easy-to-follow instructions in the rooms in which cleaning takes place. “[The IFUs] will go down to the minute for how long each task is going to take, whether it’s brushing or flushing. Break down that IFU into a chart, a graph or something that is very usable for the people reprocessing the scopes,” Mr. Czarnowski said.
Correcting Errors
Two important ways to handle inconsistencies—monitoring regularly and correcting any errors—can work in tandem.
“We know there are lots of sites that are taking shortcuts because there’s no monitoring,” Dr. Alfa said, noting that monitoring by using testing strips to test for moisture and debris should be a step in reprocessing.
Mr. Czarnowski said people, not just equipment, should be monitored. If a facility does not opt for third-party accreditation through an organization such as The Joint Commission, which will conduct competency evaluations for reprocessing, or through scope manufacturers, which sometimes offer on-site assessments, Mr. Czarnowski said at the very least, monitoring evaluations should be done by a clinical educator or manager—“someone who is knowledgeable but doesn’t do the procedure every day.”
An initial competency assessment will reveal how a technician was trained. (See related article on tech certifications, page 12.) “If I look at how a new tech cleans a scope, then I know how a new tech was taught to clean the scope,” Mr. Czarnowski said. If there are errors, “then I can go back to the whole team to address everyone on the team to ensure everyone is on the same page.”
The Drying Dilemma
Scope storage and drying is the second major hurdle in endoscopy reprocessing, but it’s one that may not be solved with closer adherence to IFU.
“The manufacturer says you must store the scope totally dry, but they don’t tell the site how to do that or how to measure the adequacy of drying,” said Dr. Alfa, adding that finishing cleaning a scope in a reprocessor that has an alcohol rinse and drying cycle is not enough.
Instead, the best option is to invest in an active drying cabinet that pushes medical-grade air through the scopes, Mr. Czarnowski said.
“If the choice is made to not do that, ensure that everyone at the very least is hanging scopes to dry in a cabinet made for flexible scopes, and not storing them coiled laying on their side,” he said.
‘ In some sites, it takes them less than five minutes to manually clean the scope,’ despite the correct process taking 15 to 20 minutes. ‘ They don’t even know they’re not getting it clean.’
—Michelle Alfa, PhD, MSc, FCCM Winnipeg, Manitoba
Some observers worry that without the threat of legal ramifications there won’t be enough incentive for hospitals to make costly investments in scope reprocessing equipment and training.
“In my mind, a lot of these things will only be fixed by very strict regulation. If you don’t [follow the regulations], you will be in trouble,” said Mohammad Yassin, MD, PhD, an associate professor of infectious diseases and microbiology at the University of Pittsburgh School of Public Health.
Dr. Alfa pointed to the Association for the Advancement of Medical Instrumentation’s new scope reprocessing guidelines as an example of industry leaders outlining what healthcare facilities should be doing.
“We’re getting some practical advice on how to do this,” she said. “We need to start integrating it.”
—Kaitlin Sullivan
The sources reported no relevant financial disclosures.
UV-C Lights Greatly Reduce Bioburden
In High-Touch Areas in Endoscopy Units
Automated ultraviolet-C light decontamination significantly decreased bioburden in high-touch areas in the endoscopy unit during a recent study.
“The endoscopy unit is a hub of care, with a multitude of outpatients cared for in this area and upwards of 15% of patients coming to the endoscopy unit at some point in the month surrounding [a] hospitalization. Awareness of sources of bioburden and the potential for infection transmission within an endoscopy unit is important for all patients and providers in the hospital,” according to the study investigators, from the Stanford University School of Medicine, in California.
Noting that previous research has shown that high-touch areas may contribute to healthcare-associated infections (HAIs) (JAMA 2002;287[11]:1400-1401; Infect Control Hosp Epidemiol 1997;18[9]:622-627), the team explored the potential benefit of remediation of bioburden in various areas of the endoscopy suite.
“There’s been tremendous focus on the risks associated with duodenoscope-transmitted infections, but we open the dialogue in this area to include other potential sources of infection
‘ Awareness of sources of bioburden and the potential for infection transmission within an endoscopy unit is important for all patients and providers in the hospital.’
transmission in the GI endoscopy unit, including pathogens on high-touch surfaces,” noted lead investigator Monique Barakat, MD, PhD, and senior investigator Timothy Angelotti, MD, PhD, in a joint statement to GEN Priority Report.
A Safe Way to Use UV-C
For the study, the investigators identified the top three high-touch surfaces within their endoscopy rooms by tracking staff movements in three observation windows lasting four hours (Am J Infect Control 2024;52[3]:331-336). They found high levels of bioburden on anesthesiologist, endoscopist and nursing computer keyboards as well as in common spaces where physicians, nurses and technicians interact and take breaks. Of the contaminated surfaces, the keyboards were amenable to implementation of disinfection using UV-C lights, which have long been recognized as an effective decontamination method.
The lights were installed above the keyboards and programmed to turn on 90 seconds after the last use. The lights, which measured 3.2 cm deep by 30.5 cm wide, remained active through an 18-minute decontamination cycle. To mitigate risk and prevent direct UV exposure to staff and patients, the devices included multiple safety features, including sensors and accelerometers that could detect motion, at which point the UV-C element would be turned off.
The investigators tested this decontamination system in the endoscopy unit for 96 hours. Beyond standard cleaning, no other further strategies were implemented to reduce bioburden during the analysis.
Decreasing CFUs With UV-C
At baseline, more than 80% of the keyboards had bacterial contamination, with the nursing and anesthesiologist keyboards having an average of 41.67 and 50 colony-forming units (CFUs), respectively, and the endoscopist keyboard having an average of 78.99 CFUs.
After implementation of UV-C lights to decontaminate these surfaces, bioburden was
reduced by more than 91%. The anesthesiologist keyboard samples dropped to an average of 1.25 CFUs, nursing keyboard samples decreased to 2.86 CFUs and endoscopist keyboard samples decreased to 11.25 CFUs.
Although the investigators hypothesize that the reduction in bioburden on high-touch areas in the endoscopy unit from UV-C lights would result in fewer HAIs, the study did not evaluate this, and the authors note it would be difficult to do so as well as to tease out the effect of potential confounders, such as masking, isolation procedures and variable cleaning intervals.
‘ There is a definite decrease in the CFU on cultures after UV radiation exposure, but it remains to be seen if it translates into any clinically meaningful reduction in the infection rate.’
—Harish
Gagneja, MD Austin Gastroenterology, Texas
Harish Gagneja, MD, a gastroenterologist with Austin Gastroenterology, in Texas, said he was skeptical that decontaminating high-touch surfaces with UV-C lights in the endoscopy unit would make a meaningful difference in infection rates. “There is a definite decrease in the CFU on cultures after UV radiation exposure, but it remains to be seen if it translates into any clinically meaningful reduction in the infection rate,” he said.
“I am not sure bioburden by itself lends to any meaningful conclusions in an endoscopy suite where we deal with contaminated patients all day long,” he said. “If that’s the case, the most important areas would be surgical suites, PACU and ICU, where patients with open wounds are present.”
—Ashley Welch
The sources reported no relevant financial disclosures. The company UV Partners Inc. funded the microbiological testing and installation of test devices. Dr. Gagneja is a member of the Gastroenterology & Endoscopy News editorial board.
Scope Companies Work to Reduce Endcap Dislodgment
Disposable endcaps solved one patient safety issue but opened the door to another—albeit rare—problem
Removable, disposable endcaps have significantly reduced the risk for infection from duodenoscopes. However, user error in securing the parts can present a new patient safety issue.
The FDA started recommending that healthcare facilities move away from fixed endcaps and adopt the use of disposable endcaps in 2019 as one strategy to reduce the risk for infection. But if disposable endcaps, including distal covers and elevator endcaps, are damaged or not properly placed before a scope is used, the caps can dislodge during a procedure.
“It’s mostly an error of how they are placed rather than their inherent design,” Manol Jovani, MD, MPH, a therapeutic endoscopist at Maimonides Medical Center, in Brooklyn, N.Y., said of the parts.
In addition to improper placement, using damaged or expired products also could be part of the issue, said Nauzer Forbes, MD, MSc, an associate professor of medicine in gastroenterology and advanced endoscopy at the University of Calgary, in Alberta.
Recalls and Retraining
The FDA has expressed concern over incidents involving endcaps made by each of the three largest manufacturers—Fujifilm, Olympus and Pentax—and has pushed manufacturers to initiate several endcap recalls since 2021 in an effort to mitigate the risk of the caps dislodging in patients.
The most recent manufacturer recall was initiated by Olympus in December 2023 after the FDA expressed concern that the company’s Single Use Distal Cover MAJ-2315 devices could dislodge and cause mucosal injury, tissue damage, bleeding, perforation or gastrointestinal tract obstruction. The recall also stated that an uncovered duodenoscope distal end could burn patients and noted the possibility that a dislodged cap could restrict the airway if it comes loose in a patient’s throat.
“Olympus sent a letter to its customers in December 2023 reinforcing the instruction for use for the Single Use Distal Cover. Furthermore, Olympus representatives scheduled on-site, inservice training at customer facilities reinforcing the instructions for MAJ-2315 distal cover attachment and user verification of
distal cover attachment. Since that time, Olympus representatives have completed more than 1,000 in-services with customers,” said Jennifer Bannan, a spokeswoman for Olympus Corporation of the Americas, adding that the company is continuing to monitor user feedback on the model of endcap.
This latest recall came after two earlier ones. Earlier in 2023, the FDA had issued a warning letter to Olympus citing “160 complaints describing the ‘distal end cover’ model number MAJ-2315 ‘dropped out.’” Olympus issued an initial recall for the endcaps in April 2023, which resulted in a redesign of the caps and a request for users to stop using the old model. In the December recall, Olympus initiated endoscopy staff retraining on how to properly secure and remove endcaps at the end of a procedure.
Several FDA Manufacturer and User Facility Device Experience (MAUDE) reports since 2019 have reported distal covers on Fujifilm ED-580XT scopes detaching, although the issues were determined to be user error. The company sent a safety notification to all existing customers in April 2020 and provides education to those who purchased the scopes after that period.
“The health and safety of patients is Fujifilm’s number one priority, and duodenoscopes, like our Fujifilm ED-580XT, are critical, necessary tools for performing lifesaving endoscopic retrograde cholangiopancreatography (ERCP) procedures,” Danielle Brown, the director of corporate communications at Fujifilm, said in a statement. “We remain committed to investing in educational, training, and scope maintenance resources to support healthcare professionals with the safe and effective use of all our products.”
Pentax issued a recall on its OE-A63 distal endcaps in 2021 over concerns that dislodged endcaps could cause aspiration. The company updated its instructions for use to include language about the risk of the endcaps unexpectedly detaching during a procedure as well as the immediate actions an endoscopist should take if this occurs. The company did not respond to GEN Priority Report’srequest for comment.
Support for Disposable Endcaps Remains
“There have been events, but the events are few and the companies have done a good job at immediately reacting to those events,” said Mohammad Bilal, MD, an assistant professor of medicine and associate program director of the gastroenterology and hepatology fellowship programs at the University of Minnesota, in Minneapolis.
Training remains key, he said. “There is a little bit of a learning curve if you were trained in the older duodenoscopes.”
For its part, the FDA continues to support the use of disposable endcaps despite the incidents. Recent studies have shown the disposable devices have been found to reduce scope contamination rates.
In a 2023 randomized clinical trial, Dr. Forbes and his co-investigators tested contamination in reprocessed duodenoscopes used in 518 patients who underwent ERCP. After high-level disinfection, the rate of contamination in disposable elevator cap duodenoscopes was 3.8% compared with 11.2% of standard duodenoscopes (JAMA Intern Med 2023;183[3]:191-200). Some centers perform sterilization with ethylene oxide to reduce the risk of duodenoscope infection, but that has its own issues.
Infrequent Harm
A study of four years of MAUDE reports found that although all three major brands reported patient injury from a dislodged endcap, the injuries were still very rare (Gastrointest Endosc 2022;96[1]:67-72).
Retrieving a Dislodged Endcap
anol Jovani, MD, MPH, a therapeutic endoscopist at Maimonides Medical Center, in Brooklyn, N.Y., experienced two incidents since his team moved to disposable endcaps. He caught the first, an endcap that wasn’t properly secured, before it dislodged from the scope. In the second, he needed to retrieve the device from the patient.
To do so, he used a clean scope and pair of forceps to remove the cap and was able to complete the procedure seamlessly
“An endcap retrieval is not particularly complicated because we remove foreign bodies all the time,” said Mohammad Bilal, MD, an assistant professor of medicine and associate program director of the gastroenterology and hepatology fellowship programs at the University of Minnesota, in Minneapolis.
Endcaps are neither big nor sharp, meaning they pose little threat, but endoscopists should try to retrieve a detached endcap from the body using forceps or a retrieval net or snare.
“Remove the scope, send it for reprocessing,” Dr. Bilal said. “Do the procedure with another scope and retrieve the endcap as soon as possible.”
The course of action may depend on the site of the dislodgment.
In a 2024 MAUDE report that involved a Fujifilm DC-08D distal endcap used for an ERCP procedure, the endoscopist and anesthesiologist decided to not retrieve the dislodged cap. The patient reportedly coughed up the endcap about 45 minutes after arriving in recovery.
“Even if you don’t pull it out and it goes through the intestines,” Dr. Jovani said, “it will go out by itself, and I don’t expect it to create any issues whatsoever.”
The study included 185 reports that included 201 device issues and 118 patient adverse events reported to the FDA between June 2018 and June 2021. The reports included 125 issues that occurred in devices that had detachable disposable caps. Of these, just 25 were related to detachment.
“Overall, the use of duodenoscopes with detachable or disposable endcaps appears to be largely safe, with clinically significant patient adverse events being rare relative to their overall use,” Dr. Forbes said.
Dr. Jovani agreed, adding that even if an endcap detaches, the risk that a patient will suffer injury is slim. “It’s very soft. It doesn’t have an acute angle, so the probability that it will cause damage to the intestines is very low,” Dr. Jovani said.
Dr. Bilal said he believes the field—both endoscopists and manufacturers—has made significant strides in patient safety in the last few years.
The “recalls for the endcaps is a good message that in medicine you can never be [too] cautious. The newer iterations seem to have less issues but will need more data and time before a final verdict can be made,”
Dr. Bilal said.
—K.S.
“We identified that duodenoscope-related infections were an issue and made changes to address that,” he said. “While further iterations of these devices and things like safety, cost and environmental impact still need to be evaluated, we are moving in the right direction.”
—Kaitlin Sullivan
Dr. Bilal reported financial relationships with Boston Scientific and Cook. Drs. Forbes and Jovani reported no relevant financial disclosures.
Single-Use Scopes Continue to Show
Good Outcomes in Multinational Study
Single-use duodenoscopes were associated with good endoscopic retrograde cholangiopancreatography outcomes and were rated highly by endoscopists with a range of experience levels in a new analysis.
“The current study supports the safe and effective performance of the first single-use duodenoscope among endoscopists with varying levels of experience in multiple countries,” the investigators wrote in the study published in Endoscopy (2023;55[12]:1115-1117).
The study included 551 patients and 61 endoscopists at 22 academic centers in 11 countries. Most endoscopists were considered expert (46/61), and each performed a median of seven endoscopies. The ERCP procedures included all American Society for Gastrointestinal Endoscopy grades of complexity, with 10.2% being grade 1, 51.5% grade 2, 28.5% grade 3 and 7.1% grade 4. The ERCP procedures were completed in 96.0% of cases, with a single-use duodenoscope sufficient in 91.3% of cases and crossover to a reusable endoscope required in 4.7% of cases. Of the 4.0% of procedures that were not completed, 2.0% included a crossover attempt to a reusable duodenoscope and 2.0% were aborted.
On a scale of 1 to 10, the mean rating for single-use duodenoscopes was 8.0. Expert endoscopists rated single-use duodenoscopes more highly than endoscopists with less experience did (mean, 8.0 vs. 7.0; P<0.001).
Expert and less experienced endoscopists had similar completion rates (96.3% vs. 94.4%; P=0.38), median procedural completion times (23.0 vs. 27.0 minutes; P=0.15), mean number of cannulation attempts (2.7 vs. 3.1; P=0.24), crossover rate (6.5% vs. 7.8 %; P=0.65) and proportion of cases with high complexity (36.4% vs. 31.1%).
Serious adverse events occurred in 7.8% of patients, 3.1% of patients developed post-ERCP pancreatitis and 0.5% of serious adverse events were fatal. These percentages are similar to others reported in the literature for reusable scopes (Am J Gastroenterol 2007;102[8]:1781-1788), according to the investigators.
The Role of Single-Use Scopes
The FDA recommended the use of disposable duodenoscopes or duodenoscopes with disposable components in 2020. “New iterations of these duodenoscopes are likely to improve procedural performance and safety, as shown in this study,” Nasir Saleem, MD, an assistant professor of clinical medicine at Indiana University School of Medicine, in Indianapolis, told GEN Priority Report.
He noted that his group “recently presented data assessing the learning curve for these duodenoscopes among experienced pancreaticobiliary endoscopists.” That study found an 87% completion rate of ERCP procedures in 31 patients using the EXALT Model D duodenoscope (Boston Scientific) (Dig Dis Sci 2024 Mar 11. doi:10.1007/s10620-024-08305-z). For experienced endoscopists, cannulation success and procedure times improved at about 10 ERCP procedures, and there was no apparent relationship between the learning curve and need to cross over from a single-use to reusable duodenoscope.
The larger, multinational study is a “high quality” study that provides “useful insight into how these devices perform in realworld clinical settings,” Dr. Saleem said.
Focus on High-Risk Patients
Despite the positive findings, he said he doesn’t believe the takeaway should be switching all reusable scopes to those that are fully disposable. “Given cost and environmental factors, widespread adoption of single-use disposable duodenoscopes at most institutions is likely reserved for patients at the highest risk of infection. Manufacturers have created options for entering the medical waste into recycling systems, but this process will also create an environmental impact downstream,” Dr. Saleem said.
“This remains an active field and area of ongoing research,” he said. “However, for most medium- and high-volume ERCP centers, a selective approach of using a single-use duodenoscope in high-risk patients is likely to remain in effect for the foreseeable future.”
—Jim Kling Dr. Saleem reported no relevant financial disclosures. The study was funded by Boston Scientific.
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