Priority Report: Reprocessing, Infection Control & Operations in the Endoscopy Suite
Reprocessing, Infection Control Operations in the Endoscopy Suite
Recycling in GI Endoscopy
Infection Control and Safety, Improving Bowel Prep, Water Quality in Reprocessing, and More
We’ve simplified the reprocessing experience with easy setup and touchscreen guidance. These upgrades are designed to make it easy to train new staff and help keep your infection prevention program running smoothly.
1. Data on file with Olympus, September 1, 2020.
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Improving Communication to Enhance Colonoscopy Follow-up
Improving patient–provider communication after outpatient colonoscopy procedures can reduce the risk for complications and admissions, according to results from two studies presented at ACG 2024. These studies offer gastroenterologists and clinic managers practical insights into methods that can enhance patient communication while optimizing clinic resources.
‘ Previously, only about 1 in 3 patients responded to a phone call. Now we are reaching close to 2 in 3 patients with text messages/emails. … It allows us to prioritize those patients who do need to speak to us.’
“Communication in medicine between healthcare providers and patients is critical,” said Seth Gross, MD, a gastroenterologist at NYU Langone Health, in New York City, who was not associated with either study. “Most patients undergoing endoscopic exams will have an uneventful post-procedure course. However, there will be a small group of patients who will have symptoms and need timely advice, especially those patients who might be experiencing a real complication, such as bleeding post polyp removal. Being able to timely communicate allows for high-quality, timely care, which benefits both patient and provider.”
see Improving Communication, page 6
“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
Improving Communication
continued from page 4
Automated Methods for Post-Procedure Follow-up
The first study, conducted by the Ohio Gastroenterology Group, in Columbus, assessed whether text messages and email better facilitate communication after an endoscopic procedure than phone calls (oral abstract 36).
Investigator Shail Govani, MD, and his team partnered with Orbita, an artificial intelligence company, to develop and deploy an automated outreach system for five ambulatory surgery centers (ASCs).
‘ Being able to timely communicate allows for high-quality, timely care, which benefits both patient and provider.’
—Seth Gross, MD NYU Langone Health, New York City
More than 80% of people ignore calls from unknown numbers, according Dr. Govani and his co-investigators, and automation offered a structured, multimodal approach to reach patients without relying solely on phone calls. The team sent a one-question survey via email and text message and used a three-step automated sequence for follow-up:
1. Morning survey link: Patients received a survey link via email at 9 a.m. the day after their procedure, which reduced the chance of missed follow-up, according to the investigators.
2. Midday text reminder: If the survey link was not accessed by 11 a.m., a reminder was sent via text message, a communication channel preferred by many patients.
3. Afternoon automated call: A final attempt was made at 3 p.m. through an automated phone call, encouraging patients to connect with the clinic if they had postprocedure concerns.
If a patient affirmed a need for follow-up, they were given a direct line to connect with a nurse, who was alerted to expect the call.
“We wanted to prioritize response rate and minimize intrusiveness to our patients,” Dr. Govani said. “Physician and nursing staff leadership together crafted … a yes or no question and covered our major post-procedure concerns.”
This sequence was tested on nearly 4,000 patients starting in May 2024, and investigators reported that the process was highly effective. More than 60% of patients engaged with the survey through email or text messaging, a significant improvement over the 32.7% engagement rate seen with only manual phone calls.
The nurses and office staff at Ohio Gastroenterology Group, who across the five ASCs perform roughly 40,000 procedures annually, were dedicating about 16 hours per week to phone calls that could be spent on patient care or necessary paperwork, Dr. Govani said.
“Our study showed that previously, only about 1 in 3 patients responded to a phone call,” he said. “Now we are reaching close to 2 in 3 patients with text messages/emails. This is really critical for a large organization like ours, which receives more than a thousand phone calls a day. It allows us to prioritize those patients who do need to speak to us, reducing their wait times.”
The study found only 4.8% of patients indicated they needed a follow-up. By flagging only symptomatic patients for direct follow-up by staff, this automated approach reduced workload and ensured high-risk patients received personal outreach, Dr. Govani said.
“We were previously using nursing staff to make phone calls,” he explained. “Our nursing staff worked on these calls while performing a variety of tasks, including stocking supplies, [and] preparing and recovering patients after endoscopy. By removing this task, we are able to allow them to focus on their other tasks.”
“A post-procedure phone call is … timeconsuming for staff,” Dr. Gross said, and “most patients have an uneventful course. Any strategy that automates part of this process is a win for staff and patients.”
Before the new approach was implemented, the nursing staff also frequently left messages asking patients to call back if they had questions or concerns, Dr. Govani added, but if a patient called the office, they faced long wait times because the nurse was occupied with other phone calls.
Although the automated system integrated easily with their electronic medical record, reducing staff burden while enhancing patient outreach, the team encountered some hurdles to effective communication, he said. “It’s critical to find a technology partner with expertise in this area. There are privacy concerns in addition to technical issues with deploying an automated text message/email system and getting that information back to our staff in a timely manner.”
He also stressed that “we have to ensure correct contact information for patients, including cellphone numbers.” Dr. Govani noted that it is “helpful to share with patients prior to discharge that they should expect a brief survey to improve the response rate.”
Fellow-Initiated Quality Improvement Project
For the second study, Dongmin Shin, MD, an internist at BronxCare Health System, and his team initiated a quality improvement project to improve accessibility to healthcare providers post-procedure, aiming to reduce unplanned hospital visits within seven days of colonoscopy, one of the quality indicators reported to the Centers for Medicare and & Medicaid Services.
This fellow-led project focused on providing direct support to patients by setting up an on-call phone line and scheduling “emergent ambulatory follow-up” slots to promptly address postprocedural concerns (poster 3635).
The investigators assessed an intervention composed of adding an on-call phone number in discharge instructions, allowing patients to directly reach a nurse if they had any concerns after their procedure. The team looked at the charts of 473 patients, 228 before and 245 after the intervention.
Their retrospective analysis showed that providing the phone number in discharge instructions improved patient reachability, increasing communication success from 57.4% pre-intervention to 66.5% post-intervention. The idea behind the intervention, according to the investigators, was
that creating same- or next-day appointment slots for post-colonoscopy concerns could help clinicians address issues before they escalated, reducing unnecessary emergency visits.
Although the communication may have improved slightly, the outcomes remained the same. In both study arms, post-procedure pain and discomfort were managed equally. Also, each arm saw only one patient visit the ER in the seven days post-procedure.
Although the post-procedure communication did not significantly affect readmission rates, Dr. Shin acknowledged the study was underpowered to precisely assess the impact of their intervention.
“These two studies show there is certainly more than one way for patients to communicate with their provider,” Dr. Gross said. “One is passive, where the patient must call the number, versus a more active approach by receiving a text message. The text message to the patient ensures all patients have been contacted and it’s automated.” He said he favors a proactive communication strategy because it has the highest likelihood of reaching all patients.
—Jordan Davidson
Dr. Govani reported financial relationships with AbbVie, Bristol Myers Squibb and Orbita. Dr. Gross reported no relevant financial disclosures. He is a member of the Gastroenterology & Endoscopy News editorial board. Dr. Shin reported no relevant financial disclosures.
Trends in Endoscopic Sterilization And Disinfection Techniques
A Q&A with Garland-Rhea Grisby, CER, CFER, CSPDT
GEN Priority Report recently sat down with Garland-Rhea Grisby, CER, CFER, CSPDT, the endoscope service manager for Kaiser Permanente in East Bay, Calif., to discuss sterilization and high-level disinfection of endoscopes. Mr. Grisby, who has been with Kaiser for more than 20 years, also is the interim assistant director for sterile processing for Kaiser in Oakland, Calif. Below, he shares his perspectives on scope reprocessing, double disinfection and training staff to optimize patient safety.
GEN Priority Report: What is your hospital like? You’re part of a bigger system, but how does that all flow together?
Mr. Grisby: We have a regional practice and regional policies that we follow. And I have the privilege of sitting on committees where we create the policies, and I’m the co-chair of the Northern California endoscopy group for Kaiser. That’s how we make sure that we’re as close to
being on the same page as possible. Not all facilities are created equally, and we have to understand that. If you have seen one hospital, you’ve seen one hospital. I manage three facilities, and they’re all different. It’s having a consistent practice that can work even when it’s different.
see Grisby Q&A, page 10
Grisby Q&A
continued from page 8
GEN Priority Report: How many people are on your staff?
Mr. Grisby: For my scope staff, I have 18 across the three facilities, and they just do flexible scopes, ultrasound probes, and high-level disinfection and some sterilization of flexible scopes.
It is just me who manages them, and I have some strong lead techs. For the sterile processing department, there’s about a good 45 to 50 techs and three supervisors.
GEN Priority Report: Can you walk us through scope reprocessing at your facilities?
Mr. Grisby: That’s the question most folks ask. What is the process? What is the workflow? Initially, when a patient procedure is completed, a point-of-use treatment takes place immediately after the scope is withdrawn. You definitely want to make sure the case is finished because you don’t want to do point-of-use treatment and then try to introduce the scope back into the patient.
Then, you follow what’s in the manufacturer’s instructions for use, and also what’s in your policy, regarding point-of-use treatment for instruments and scopes. From there, you take that scope into the soil room or processing area, and that’s when the visual inspection, the leak testing, the manual cleaning, the rinsing, the purging, the brushing, all of that takes place. Then, it goes over to the sterilizer or automated endoscope reprocessor.
Once those cycles are finished, if it’s sterile, you take it and store it appropriately. If it’s highlevel disinfected, then you take it and store it in the scope cabinet until it is ready for the next patient to use.
There are tons of different storage hangtime durations—I’ve heard everything from 12 hours to 60 days, as far as hang time. The
risk assessment for high-level disinfected scopes is something each facility needs to perform because everybody’s risk is different. Where’s your scope cabinet stored? Who has access? Have they been trained? All of that plays a part in how long your scope should be stored before you reprocess or use.
A factor that plays an important role is volume. You want to consider how many rooms are going to be doing procedures. It’s also important to consider the volume on worst-case days because you want to make certain that you have sufficient inventory and staff to handle the volume of cases.
Here’s an example. Specialty cases are done in one of my facilities, but there is a need to increase the current inventory to accommodate the volume and needs. This will avoid constantly overusing scopes, which could cause damage at a faster rate. Another key factor is making sure the inventory you have is being utilized and not being stored unused. Having sufficient inventory allows for proper processing time, allowing staff to avoid cutting corners and avoid patient delays. We never want to be in a situation where we have to cancel a patient or a patient has to wait.
GEN Priority Report: Which flexible scopes do you sterilize, and which do you high-level disinfect?
Mr. Grisby: At this point, we use lowtemperature sterilization for our cystoscopes and ureteroscopes. Those are scopes that are considered high risk. Although guidelines are now saying that flexible scopes should be sterilized, that is easier said than done. Yes, we want the best for our patients, but a move to 100% sterilization of all scopes requires planning, not just on the part of the facility, but will require the scope manufacturers to provide sterilization parameters as well. That will require more equipment—sterilizers, containers, storage space, etc.
GEN Priority Report: How do you handle high-level disinfection?
Mr. Grisby: The whole double-disinfection process came about years ago when there was a breach with duodenoscopes. Initially, we all looked to the FDA, and the end result was double disinfection of certain scope models, in addition to soil marker tests to make sure that the scopes are actually clean before you highlevel disinfect them twice. But double disinfection has since been retracted, and rightly so, because at the end of the day, when you look at
high-level disinfection, it’s supposed to do what it’s supposed to do the first time. It’s been said that double disinfection is like taking two showers back-to-back. Some facilities still adhere to double disinfecting, and they’re comfortable with it. But it has been noted that double disinfecting also can break down your scope faster because now you’re running two cycles of chemical when it technically could have used the one.
GENPriority Report: How do you dry your scopes?
Mr. Grisby: We have the scope cabinets that have the tubing and connectors that allow for air to purge, and you can adjust the time that it purges. You can have it on for 30 minutes, and it’ll go off for 30 minutes or an hour. You can have it come back on, so it’s a continuous flow however you lay it out. Not everybody has
those. Some facilities have the older ones, where you just hang and let gravity do its thing. Those are the ones where they’re finding that there’s still moisture inside scopes days later. Facilities have been trying to upgrade, slowly but surely, but cost and real estate factor into decisions to upgrade.
GENPriority Report: How do you train the new employees about your processes and make sure all staff members are following protocols?
Mr. Grisby: I learned years ago that if I want the training done consistently, I need to do the training. That’s been my practice. I perform the training for all new staff who come in and are going to process scopes from start to finish, so the information they’re receiving is consistent. I sit with the employee, and we go over every page of the policy and procedure [manual], and I tell them, this is not the competency. This is just so you see what’s in our policies and what we should do. If a surveyor, quality control or infection preventionist comes into our area, they
want to make sure that we’re doing what’s in our policies.
Some facilities train differently, but I start with the basics and go into the more difficult scopes to process as time goes on and the employee becomes confident and competent. By time we get to the more difficult scopes (e.g., duodenoscopes), they already have the concept in their head of how it should be done. Yes, it’s time-consuming, but it allows me to sleep at night knowing that our patients are receiving the best care as far as our scopes are concerned.
This interview has been edited for brevity and clarity.
Recycling in GI Endoscopy:
A Path to Lower Emissions and Cost Savings
PHILADELPHIA—A structured recycling initiative in a high-volume gastrointestinal endoscopy center cut greenhouse gas emissions by more than 3 metric tons and reduced procedural costs by nearly 29%, according to data presented at ACG 2024. The research may provide a framework for other endoscopy centers working to reduce their effect on the environment.
‘ Recycling is definitely feasible in a high-volume [advanced endoscopy center] and requires, in our experience, no additional time expended during each procedure.’
—Immanuel Ho, MD Pennsylvania Hospital, Philadelphia
To determine the best ways to recycle, gastroenterologists and facilities “need to work with manufacturers” and develop plans for “how green endoscopy is going to look in the future,” said Immanuel Ho, MD, the director of interventional endoscopy at Pennsylvania Hospital, in Philadelphia, and a clinical professor at the University of Pennsylvania who led the research. This study moves the field in that direction, providing “a blueprint for integrating recycling practices in GI endoscopy [and] demonstrating that sustainable practices can significantly reduce the carbon footprint associated with healthcare activities,” Dr. Ho said. see Endoscopy Recycling, page 14
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Endoscopy Recycling
continued from page 12
Dr. Ho initiated the study after learning that Boston Scientific already was running a rudimentary recycling program. He proposed that his team at the University of Pennsylvania and Penn Medicine would work with Boston Scientific on an endoscopy recycling program and collect data the company could use to improve its own recycling program.
This study ‘ addresses something that seems so obvious, and it’s great to finally see data on it. You can literally drive around the world with the amount of savings.’
—Mark B. Pochapin, MD
NYU Langone Health, New York City
“Medical plastic is very complex. Nobody knows where to put it,” said Swapna Gayam, MD, an associate professor of gastroenterology and hepatology at the West Virginia University School of Medicine, in Morgantown, who was not involved with the research. “We definitely need industry to take the lead on this. I don’t think clinics can do it on their own.”
Healthcare Is a Huge Source of Waste
Dr. Gayam said of the three major ways to address waste—reduce, reuse and recycle— decreasing the amount of materials healthcare facilities are using is the most important but, unfortunately, not always possible because reusing materials is difficult in a medical setting.
“It’s important to recycle as much as we can because that often is the only thing we can do to eliminate at least some of the plastic going into landfills,” she said, adding that specialized recycling programs for endoscopy waste would be particularly helpful for hospitals in areas without access to any type of recycling.
In GI endoscopy, there’s much room for improvement. A 2023 systematic review estimated that there are more than 18 million GI endoscopy procedures performed in the United States every year, with each procedure generating as much
as 3 kg of waste. While most of this waste is not recyclable, according to the review, about 20% of the waste that ends up in landfills can be recycled (Gut 2023;72[3]:493-500).
In the University of Pennsylvania study, which earned an ACG Outstanding Research Award (abstract 32), Dr. Ho and his co-investigators evaluated 3,063 endoscopy procedures conducted between Jan. 15 and June 15, 2024. The investigators placed a canister for recyclables in each of the hospital’s three endoscopy rooms and trained all technicians to recognize which items could go in the canisters. This included gauze, certain valves, air/water cleaning keys and suction tubing. Representatives from Boston Scientific helped identify what materials could be recycled. At the end of each day, the contents of the canisters were packaged into boxes to be shipped to Sharps Medical Waste Services, in Texas, where 99% of the materials eventually were recycled.
Over the course of six months, the hospital was able to recycle more than 1,708 kg of waste and avoided more than 3 metric tons of carbon dioxide emissions—the equivalent of driving about 9,000 miles, or about half the energy an average home uses per year, according to the Environmental Protection Agency’s Greenhouse Gas Equivalencies Calculator.
“Recycling is definitely feasible in a high-volume [advanced endoscopy center] and requires, in our experience, no additional time expended during each procedure,” Dr. Ho said during his presentation, noting that it did require extra staff time to collect, box and ship the recyclables.
A major strength of this study was its emphasis on integrating recycling with minimal disruption to daily operations, he added, as each procedure used a single endoscopy kit, which was then recycled in its entirety.
A secondary benefit of the recycling initiative was a slight reduction in red bag waste—the regulated medical waste that is costly to dispose of and cannot be recycled. Although the decrease from 28.2 to 27.1 kg per day was not statistically significant, Dr. Ho said, it reflects a gradual shift in waste disposal practices and offers potential cost savings as green initiatives in endoscopy continue to gain traction.
Challenges of Widespread Implementation
The study showed significant waste reduction, but Dr. Ho said the system is not perfect. There is a carbon footprint associated with shipping—about 1,708 kg of carbon dioxide over the six-month period—and recycling is not free. Although the University of Pennsylvania realized a cost savings of nearly 30% per case, “there is still a cost that is associated with recycling, and in our study, the cost was borne by the manufacturer,” Dr. Ho said.
Frequent waste removal is essential, he added, noting that daily pickups could better serve highvolume centers. In addition, the initiative required ongoing staff support to manage and track recyclable materials, which may pose a resource constraint for some facilities.
It’s not yet clear who would be responsible for absorbing any extra costs in the future, whether that be providers, the government or manufacturers. With an estimated cost of $160,000 over six months, Dr. Ho said the expense of maintaining a comprehensive recycling program may be prohibitive for some centers, particularly without external funding or subsidies.
“Recycling offers a practical solution for reducing the carbon impact of GI endoscopy without compromising workflow, but expanding this model will require coordinated support from healthcare systems, industry stakeholders and policymakers,” he said. Nevertheless, “as a proof-of-concept study,
we showed that recycling can be done.”
Mark B. Pochapin, MD, the director of the Division of Gastroenterology and Hepatology at NYU Langone Health, in New York City, commended the study, highlighting that “it addresses something that seems so obvious, and it’s great to finally see data on it. You can literally drive around the world with the amount of savings.”
‘ Medical plastic is very complex. Nobody knows where to put it. We definitely need industry to take the lead on this. I don’t think clinics can do it on their own.’
—Swapna
Gayam, MD West Virginia University School of Medicine, Morgantown
However, Dr. Pochapin also raised concerns about the potential danger of recycling tubing contaminated with infectious material, asking whether the tubing selected had been kept clear of exposure to organic waste.
Dr. Ho clarified that the tubing used was generally not heavily contaminated and said the study received approval from infectious disease authorities to proceed.
—Kaitlin Sullivan and Chase Doyle
Dr. Ho reported financial relationships with Merck and Novartis. Dr. Pochapin reported no relevant financial disclosures.
Endoscopy Room Incidents Shine Spotlight on Safety, Once Again
Three incidents during scope procedures at three separate U.S. hospitals potentially have exposed some patients to HIV and hepatitis, reigniting the discussion around scope safety in endoscopy units.
Vanderbilt University Medical Center (VUMC) has released scant information on an incident that occurred in its Gastroenterology Endoscopy Lab but confirmed the situation involved an issue with how a solution was administered through an endoscope during some procedures. Local media reported the story in October after a patient who was potentially exposed came forward.
‘ Any facility can have problems with reprocessing incidents. … We need to make sure that everyone, whatever role they play in caring for patients in GI care, makes sure they are constantly vigilant.’
“We have determined this issue was limited in scope, and the risk to patients is very low. The number of affected patients is less than 4% of endoscopy patients over the last six months,”
John Howser, the chief communications officer at VUMC, in Nashville, Tenn., told GEN Priority Report in an emailed statement.
“When such an infection control breach is identified, we generally want to know the details of what happened and how the error was corrected,” wrote healthcare-associated infection expert Lawrence Muscarella, PhD, on his website. However, the “disclosure of the risk of infection from exposure to potentially contaminated medical equipment is often discretionary and neither a foregone outcome nor necessarily an established policy or law,” despite the fact many experts and organizations, including the American Society for Gastrointestinal Endoscopy, have advised that institutions have an ethical duty to inform affected patients in a timely manner when a breach is discovered or an infection is suspected.
Published cases and data analysis suggest that patient exposure to inadequately cleaned, potentially contaminated endoscopes is both underrecognized and underreported, Mr. Muscarella said. He told GEN Priority Report that “FDA has not advised the public of the risk of ‘reprocessed’ gastroscopes exposing patients to infectious materials, including multidrug-resistant organisms, which I think is a significant omission and mistake by the FDA to the potential detriment of public health and patient safety.”
In another incident at Legacy Mount Hood Medical Center, in Portland, Ore., 2,200 patients were potentially exposed to hepatitis B and C and HIV. The health system did not indicate whether a scope was involved but said that infection control practices may not have been followed by an anesthesiologist. The provider was immediately suspended, an investigation was launched and patients were notified, hospital representatives told local media in July, adding that the provider was contracted by the Oregon Anesthesiology Group for approximately six months beginning in December 2023.
A hospital spokesperson told GEN Priority Report they are unable to discuss the matter because it’s currently being litigated.
A third incident reportedly occurred at Salem Hospital, in Massachusetts. The hospital’s parent company, Mass General Brigham, did not respond to GEN Priority Report’s request for comment as of press time. In that alleged incident, reported by the hospital in November 2023, about 450 endoscopy patients were potentially exposed to HIV and hepatitis B and C over a two-year period due to incorrect IV administration.
“Any facility can have problems with reprocessing incidents, even elite facilities. We need to make sure that everyone, whatever role they play in caring for patients in GI care, makes sure they are constantly vigilant,” said Casey Czarnowski, BA, CRCST, CSPDT, CIS, CER, a perioperative consultant in Rochester, Minn., who specializes in sterile processing.
With little information about what went wrong, experts can only speculate. “Ultimately, it is a learning opportunity,” said Harish Gagneja, MD, the chief medical officer at Austin Gastroenterology, in Texas.
Technology May Provide Solutions
Since the major outbreaks of infections related to duodenoscopes in 2013, safety conversations have centered on whether disposable models are imperative to patient safety.
According to Klaus Mergener, MD, an affiliate professor of medicine at the University of Washington, in Seattle, disposable models may provide superior patient safety, but the cost and amount of medical waste fully disposable scopes would create makes the option “unrealistic.”
However, new designs likely do have a place in
eliminating rare incidents of scope-related infection, he said. “Technology could be the answer,” Dr. Mergener explained. “Not fully disposable but something in between, such as just a disposable tip, which is hard to clean.” Some scope manufacturers are also exploring the possibility of lining the interior parts of scopes, especially the difficult-toclean channels, with antimicrobial films, he added.
“Even under the best scenario, the margin of error for cleaning these endoscopes is quite low,” Dr. Mergener said, adding that low pay and high turnover of scope reprocessors make solving the problem with ongoing training an uphill battle.
Another approach could be automating humanled parts of cleaning, which could significantly reduce potential infection incidents since most contamination occurs as a result of human error.
“Replacing mechanical cleaning with automated cleaning is one of the holy grails of improving the reliability of endoscopy reprocessing,” Dr. Mergener said. “The machine does not take shortcuts. It does things the same way every time. It does away with human error.”
Potential Consequences
Dr. Gagneja agreed that moving to fully disposable scopes is not the answer but said he worries that with each scope-related incident that occurs, the chorus calling for single-use scopes will grow louder. “Single-use endoscopes are impractical due to extreme cost and a never-ending supply of medical waste,” he said.
In addition, Dr. Mergener fears incidents that sacrifice patient safety also may cause people to shy away from procedures. “No one is saying we should ignore the issue of infection transmission, but when you talk about it, in the same breath you also have to remind everyone that endoscopy is lifesaving and overall, extremely safe,” he said.
Although scope procedures are not sterile procedures, treating them as such could also reduce errors that occur in the endoscopy room, whether those incidents involve a scope or not, Mr. Czarnowski said. “We can take universal precautions in how we set up the room and how we set up the scope itself, as if we are going to be doing a sterile procedure, as much as possible.”
Kaitlin Sullivan
Drs. Gagneja and Mergener are members of the Gastroenterology & Endoscopy News editorial board.
Lawrence Muscarella, PhD
Harish Gagneja, MD
Klaus Mergener, MD
What Endoscopy Staff Should Know About Endoscope-Associated Infection Prevention
The entire endoscopy team should recognize the importance of the procedures and protocols involved in reprocessing endoscopes and related infection prevention strategies, experts underscored during the 2024 annual meeting of the Society of Gastroenterology Nurses and Associates.
“We must respect reprocessing [of] reusable scopes,” said Mark Gromski, MD, the director of advanced endoscopy at Indiana University School of Medicine, in Indianapolis. “Reprocessing is a complex set of steps that all need to be followed closely to adequately decontaminate a scope,” he said. “The team you have in place can’t do it poorly, as the patient’s life can very much be affected.”
the adaptation of best IP practices promote and improve patient and caregiver safety.”
Multidrug Resistance And Systemic Infections
Dr. Gromski emphasized the potential for patient-to-patient contamination with improperly sanitized scopes and described research-backed infection prevention methods endoscopy staff can employ.
Jim Collins, BS, RN, CNOR, a practice manager at Cleveland Clinic’s Digestive Disease & Surgery Institute, in Cleveland, also underscored the importance of the entire endoscopy team in promoting safety in the endoscopy suite. “Caregivers play a crucial role in the infection control and prevention activities in their endoscopy unit,” he told GEN Priority Report. “Educating caregivers on trending, current and evolving IP [infection prevention] practices, analyzing the unit’s current IP practices, and prompting
He presented data from a study he and coinvestigators conducted analyzing the types of pathogens found in 615 patients suspected of having biliary infections who had undergone endoscopic retrograde cholangiopancreatography procedures (Endoscopy 2022;54[11]:1045-1052). Multiple species were found, with Enterococcus species being the most common (Table).
“We also found a substantial percentage of those cases had drug resistance, and those percentages of multidrug resistance were higher than what we had previously seen,” Dr. Gromski said.
These bacteria and fungi can result in dangerous and potentially fatal outcomes for patients, he added. Table. Microbes in Patients
Infection Prevention, page 26
Preventing Prion Disease Infection in Endoscopy
Researchers from Mayo Clinic have illustrated a novel way of handling endoscopy procedures in patients suspected to have Creutzfeldt-Jakob disease.
Although the CDC publishes infection control guidelines for CJD, no best practices exist for endoscopy procedures in these patients, investigator Yara Salameh, MD, a postdoctoral research fellow in the Division of Gastroenterology and Hepatology at Mayo Clinic, in Rochester, Minn., told GEN Priority Report.
Dr. Salameh and her team collaborated with other specialists, including infectious disease and surgical reprocessing experts, and experts at the CDC, to develop a comprehensive protocol for the handling and disposing of endoscopes used for a patient suspected to have CJD.
The specific tissue involved in the endoscopy procedure was a huge factor in determining the potential for transmission, reported Dr. Salameh, presenting the findings at ACG 2024 (poster 2387).
Biopsies and procedures that involve neurological tissues are considered high risk for putting equipment in contact with tissues that house prions in an infected person. However, during routine GI procedures— including endoscopic ultrasound, fine-needle aspiration of the lymph nodes or pancreas, and endoscopic retrograde cholangiopancreatography (ERCP) of the liver and liver channels or pancreas—scopes come into contact with tissues that are not likely to harbor prions, Dr. Salameh said. “It’s extremely unlikely that a scope that was used in a routine GI procedure would carry the risk of prion transmission,” she noted.
Nevertheless, she and her co-investigators recommend using a disposable scope in both low- and high-risk procedures and incinerating the scope after the procedure. If disposable scopes are not an option, reusable scopes should be sequestered in a sterilization container and tested for prions. If the scope tests positive, it should be incinerated, and if the test is negative, the scope should undergo full reprocessing.
Dr. Salameh and her co-investigators at Mayo Clinic have not had to use the protocol yet, she said, “but we want to be prepared. When you do encounter an endoscopy patient with CJD, you need to act fast and not take chances with such a scary disease.”
Klaus Mergener, MD, an affiliate professor of medicine at the University of Washington, in Seattle, emphasized that the risk for CJD infection from an endoscopy procedure is rare. A 2020 review found no recorded evidence of endoscope-related CJD infections (J Hosp Infect 2020;104[1]:92-110).
see Prion Disease, page 26
DDW Studies Address Poor Bowel Prep
Multiple studies presented at DDW 2024 evaluated risk factors for poor prep or methods to improve prep. Below are highlights from three studies.
Digital, Personalized Platform Improves Prep
Implementation of a “personalized, patient-engaging digital platform” can significantly improve bowel prep quality (abstract 478). Adjusted for age, sex, prep protocol and morning/afternoon colonoscopy, use of a digital platform link resulted in an independent 30% reduction in inadequate prep (Boston Bowel Preparation Scale [BBPS] score <6) compared with controls (P<0.001).
“The improvement was consistent across subgroups, including traditionally more resistant groups of patients,” according to Liat Deutsch, MD, a clinical senior investigator at Tel Aviv University, in Israel.
A link to the digital system was randomly sent to 913 patients scheduled for colonoscopy. The platform included conventional reminders plus unique patient-tailored videos and text. Patients selected their own avatars for personalized animated videos. The control group of 1,534 patients received written instructions.
More than 80% of the digital group opened the link, and 60% played the video and watched 91% of it on average. For these “full users,” the rate of inadequate prep was 19.2%, compared with 27.6% for controls. In addition, the cecal intubation rate was higher in the digital group (96.5% vs. 94.5%), and no-show rates were markedly lower (11% vs. 23%).
Meta-Analysis Identifies New Risk Factors for Poor Prep
A meta-analysis conducted at Indiana University School of Medicine calculated odds ratios (ORs) for sociodemographic, medication-related and procedure-related factors that greatly increase the risk for inadequate bowel prep (abstract 203). Azizullah Beran, MD, a fellow in gastroenterology and hepatology, and coinvestigators identified 132 studies involving 237,832 adults. They
focused on adjusted risk factors only, excluding conference abstracts and studies that reported only unadjusted risk factors.
The study found a host of risk factors with ORs indicating a high level of risk. Among the sociodemographic risk factors were Medicaid insurance (2.1), body mass index of 30 kg/mg2 or higher (1.42), low education level (1.37), age 65 years and older (1.32), current tobacco use (1.28), and Black race (1.28). Highest risk comorbidity-related factors included cirrhosis (2.44), poor functional status (2.17), gastrointestinal motility disorders (2.05), stroke/dementia (2.00), diabetes (1.97), constipation (1.84), prior abdominal surgery (1.80) and American Society of Anesthesiologists physical status class of III and higher (1.56).
Medication-related risk factors included use of tricyclic antidepressants (2.28), opioids (1.61) and calcium channel blockers (1.54). The highest risk procedure-related factors included lack of split-dose prep (2.38), increased prep-to-defecation interval (2.17), prior inadequate prep (1.99) and inpatient status (1.70).
Poor Glycemic Control Linked to Poor Prep
Investigators in New Zealand assessed bowel prep quality in a study of 169 patients with hemoglobin A1c of 48 mmol/mol or greater (=6.5%) undergoing elective outpatient colonoscopy (abstract 204).
“We found that poorer glycemic control was associated with increasingly inadequate bowel preparation quality and aborted procedures,” said Ho Nam Lee, MD, of Christchurch Hospital, Te Whatu Ora Health.
Colonoscopies were more likely to be completed in patients with lower median hemoglobin A1c levels: 54 versus 62 mmol/mol (P<0.026). Total median BBPS scores were 9 for a hemoglobin A1c range of 30 to 49, 8 for 50 to 69, 7.5 for 70 to 89, 6 for 90 to 119, and 5.5 for 120 to 139 (P=0.007). Similar differences were noted for left, right and transverse segments, Dr. Lee reported, suggesting that providers should attempt to better prepare patients with poor glycemic control.
—Caroline Helwick
Drs. Behran, Deutsch and Lee reported no relevant financial disclosures.
Is Your Organization Managing Its Water Quality to Support Flexible Scope Reprocessing?
David L. Taylor III, MSN, RN, CNOR
Water quality matters in endoscope reprocessing.
San Antonio, Texas
Principal Resolute Advisory Group LLC
The water that is safe for drinking may not be suitable for reprocessing flexible and semirigid endoscopes in healthcare settings. The purity of water is crucial. Impurities such as dissolved organic and inorganic solids, microbial contaminants, and chemical substances can significantly affect the reprocessing of reusable medical devices if they are not properly managed.
Given that water quality varies widely from one location to another, it is essential for endoscopy reprocessing personnel to understand how their organization manages water quality issues. Poor management can adversely affect their work and potentially contribute to shorter lifespans of the equipment, and even cause negative patient outcomes.
On Jan. 1, 2022, The Joint Commission introduced new water management standards (EC.02.05.02, Eps 1-4). These standards aim to enhance the quality and safety of care provided to immunocompromised patients, incorporating water management measures that influence medical device reprocessing.
Table 1. Consequences of Poor Water Quality
Hard water deposits and scaling
Increased microbial load and endotoxin levels
Corrosion and pitting of devices
Reduced life expectancy of equipment
Decreased effectiveness of cleaning agents
Deterioration of the water system
Increased workload and longer reprocessing times
Delays in patient care
Extended procedure durations
Risk for infections
Exposure to toxic substances
In addition, the Association for the Advancement of Medical Instrumentation provides a technical information report TIR34:2014/ (R)2021, which offers guidelines for the quality of water required at each stage of medical device reprocessing—cleaning, rinsing, disinfecting, and sterilizing. This resource also addresses water distribution, storage, quality control measures, and bacterial control, making it helpful for central sterile processing personnel and facilities maintenance teams involved in water treatment.
For municipal water systems, water is a finite resource that is recycled over time. Public water systems often contain additives from that recycling process, such as chlorine and dissolved salts, along with naturally occurring minerals and, in some cases, harmful contaminants, such as heavy metals, synthetic organic chemicals, and biological parasites.
Municipal water left untreated by a healthcare system can lead to the buildup of hard water deposits, which are difficult to dissolve and can cause corrosion and damage to medical devices (Table 1). Moreover, untreated water can promote the growth of opportunistic pathogens, including Escherichia coli, Legionella, and nontuberculous mycobacteria.
Managing Your Water
Healthcare organizations typically treat their water in some way—whether through distillation, reverse osmosis, or deionization. The treatment methods employed can have a significant impact on device integrity and patient care. It is essential to monitor water quality to confirm that control strategies are effective.
Document all actions and maintain accurate records
must include an evaluation of the physical and chemical conditions for each step in the water flow diagram. The plan also must be reviewed annually and revised as needed.
Stakeholders in Water Management
Developing a comprehensive water management plan is now a requirement under The Joint Commission’s new standards. Using this plan, facilities should assign individuals or teams to oversee and implement water management protocols. Essential components of the plan include risk assessments, testing protocols, and acceptable ranges to minimize pathogenic biological agents in various water systems.
Responsibilities for water management include creating diagrams mapping water supply sources, treatment systems and end-use points. This plan
A multidisciplinary team is critical for effective water management. This team may include representatives from areas such as building management, facilities engineering, infection prevention, and microbiology, as well as experts from specific clinical areas. Clear roles and responsibilities, along with a mission statement, will guide the team in effectively managing water quality and mitigating unnecessary costs (Table 2). Effective water management is essential for healthcare organizations to ensure the safety and quality of patient care. By adhering to established standards, understanding the intricacies of water treatment, and collaborating across disciplines, organizations can mitigate risks associated with poor water quality. This proactive approach not only enhances device reprocessing efficacy but also safeguards patient health, ultimately leading to better healthcare outcomes.
Is Ethylene Oxide a Go-To
Or Does It Have to Go?
Ethylene oxide has long been a mainstay in sterilizing medical equipment. It is widely used at commercial sterilization facilities, and on a smaller scale, EtO has qualities that make it ideal for delicate precision instruments. The problem with EtO is that it has been shown to be toxic to humans.
for Reprocessing?
Citing a body of research dating back to the 1980s, the Environmental Protection Agency called EtO a “potent cancer-causing air pollutant” in a 2024 report in which it vowed to cut emissions from large-scale commercial EtO facilities by 90% in just a few years.
In anticipation of these findings by the EPA, the FDA, in turn, held a town hall last January to tackle this complex subject. In the discussions, it was clear the FDA recognized that because of EtO’s effectiveness and its outsized role in the medical device supply chain (accounting for 50% of commercial sterilization), phasing it out entirely presents a real potential for “medical device shortages due to the lack of alternatives to EtO.”
‘ The method of sterilization that you’re using, you have to ask yourself, what is it doing to the user?’
—Garland-Rhea
Grisby, CER, CFER, CSPDT
Kaiser Permanente, Oakland,
Calif.
The possible negative effects of large-scale off-gassing of EtO from commercial plants into communities is clear, but what is less known are the dangers it presents to patients and providers
when used on a smaller scale.
Garland-Rhea Grisby, CER, CFER, CSPDT, an endoscope service manager at Kaiser Permanente, in Oakland, Calif., and the cochair of the Association for the Advancement of Medical Instrumentation’s (AAMI’s) working group that focuses on endoscope reprocessing, has his concerns. “The method of sterilization that you’re using, you have to ask yourself, what is it doing to the user?”
There is not much literature on the subject. To date there have been few, if any, studies on the effects of EtO on the people performing the sterilization, those using the instruments and those treated by them.
Despite the lack of data, the potential risks led the American Hospital Association to caution its members to find alternatives as far back as 2019. The organization listed a few options, including hydrogen peroxide vapor, which was recognized by the FDA in January as a class A sterilant that could be considered an alternative to EtO, as well as e-beam and gamma radiation. However, none of these modalities is as advantageous as EtO, and all parties involved—the FDA, EPA and providers—acknowledge that there are not many
options to replace EtO, especially when it comes to sterilization of delicate precision instruments.
Mr. Grisby noted that AAMI’s working group recommends sterilization practices that are approved by the FDA, but said the choice really depends on what instruments and scopes a practice or clinic is using. “The key is to find out if the scope is compatible with the sterilization methods that are available. The choice of sterilization method could depend on the outcome, the cost and the effects on the users,” he said. “AAMI does not endorse one sterilization method over the other. There are a few different compatible sterilization processes out there, such as EtO, hydrogen peroxide with or without plasma phase, and hydrogen peroxide–ozone sterilization systems.”
How We Got Here
What drove healthcare “toward EtO years ago was the fact that it was a low-temperature sterilization method that was extremely effective,” Michelle Alfa, PhD, MSc, a certified clinical microbiologist (retired) and the CEO of AlfaMed Consulting, in Winnipeg, Manitoba, told GEN Priority Report. Although the safer technique of “steam sterilization is the best option that can be used in healthcare,” she said, “there are no flexible endoscopes that I’m aware of that actually can withstand steam sterilization.”
It’s for these reasons, Bret Petersen, MD, a professor of medicine at Mayo Clinic in Rochester, Minn., told GEN Priority Report, that in an era when there is this push by some to move away from EtO, Mayo Clinic and other centers continue to use the modality.
Back in 2014 and 2015, around the same time the EPA began to reevaluate EtO, outbreaks of a multidrug-resistant organism occurred in hospitals across the globe. The FDA suggested sterilization with EtO as one of a few processing modalities capable of having a positive effect.
“At that time, we had a very underutilized EtO processing facility in the basement of our clinic in Rochester, Minnesota,” Dr. Petersen recounted. “We have continued with high-level disinfection as has been used for many years across the country in most sites, and for duodenoscopes only, we then send them to EtO sterilization.” It is what he referred to as a belt-and-suspenders type of approach. “We know that EtO has been the one
modality that has been employed to break each of the outbreaks.”
Other centers take this approach too, relying on high-level disinfection only, according to Dr. Alfa, or they choose to use a mix of scopes including single-use scopes, which eliminate the need for reprocessing.
Rigorous Protocol
Regarding the dangers to those who work with EtO or are treated with instruments sterilized by it, Dr. Petersen said he has not seen literature to support what may be an outsized fear and noted that Mayo’s methodology is rigorous. “You can’t start the machine without the room being locked down and sealed. [The instrument] is put under an intense prolonged vacuum to ensure clearance of any residual EtO on the devices.”
EtO also is expensive and time-consuming to use, experts agreed. The overall process takes almost a day to minimize the dangers to providers and patients, Dr. Petersen noted. “With most EtO facilities, the treatment itself is fairly brief, but the cycle of treatment is [17-20 hours] because of the evacuation component” needed for the EtO to dissipate.
However, “when so much of the procedure is allowing the instrument to sit so that it can be safely handled,” Mr. Grisby remains concerned about EtO’s residual toxicity.
Coordination With Scope Makers Required
Moving away from EtO as the go-to means of sterilization is a long-term process. “Transitioning from one sterilization modality to another is a complex challenge,” commented AAMI Vice President of Sterilization Amanda Benedict, MA, CStd, in a press release from the organization. Ms. Benedict underscored that “for any medical device, the device manufacturer needs to be sure that the sterilizing agent is compatible with the materials that comprise the device to ensure no negative impact on device functionality.”
Currently, when it comes to full sterilization at low temperatures, there really is no best second choice, Dr. Alfa said, and until there is one, on a small scale, EtO will still remain the go-to option.
—W. Harry Fortuna
The sources reported no relevant financial disclosures.
Infection Prevention
continued from page 18
‘ Reprocessing is a complex set of steps that all need to be followed closely to adequately decontaminate a scope. The team you have in place can’t do it poorly, as the patient’s life can very much be affected.’
—Mark
Gromski, MD, Indiana University, Indianapolis
Jim Collins, BS, RN, CNOR, a practice manager at Cleveland Clinic’s Digestive Disease & Surgery Institute, in Cleveland, agreed that care providers need to be aware of the potential dangers of these organisms. “While rare, it’s possible for these bacteria to travel through the bile ducts to the liver where the bacteria may enter the bloodstream and be spread throughout the body, resulting in a life-threatening systemic infection or septicemia,” he noted. “Caregivers must be cognizant of these events to be able to promote a safer environment and assist in the reduction of the threat of an infection.”
Preventive Strategies
Such infections can be prevented by effective reprocessing strategies, Dr. Gromski said. He and his co-investigators found that both double high-level disinfection and liquid chemical sterilization resulted in a low rate of positive surveillance duodenoscope cultures and a very low rate of high-concern/pathogenic organism growth (Gastrointest Endosc 2021;93[4]:927-931).
Education and training are additional crucial components of infection prevention programs. Linda Curtin, MSN, RN, CGRN, CER, the clinical nurse manager of endoscopy at Brown Medicine, in Providence, R.I., called her center’s
Prion Disease
continued from page 20
However, Dr. Mergener stressed that endoscopy suites should be prepared. He agreed disposable scopes should be used in these instances, if possible, since endoscopes cannot hold up to most of the sterilization techniques used for other medical equipment.
“There are now FDA-approved disposable GI endoscopes for upper endoscopy, colonoscopy and for ERCP,” he said. “This will cover most
highly trained reprocessing staff “the heart and soul of our infection prevention program.”
Ms. Curtin stressed the importance of recognizing the endoscopy staff as valuable team members and providing them “with the time, the education and the support they need to perform their job expertly 100% of the time.” She told GEN Priority Report that the basics of prevention of transmittable diseases, such as hand hygiene, personal protective equipment and sharp safety, are a big part of education of reprocessing staff, and play a big role in keeping patients safe.
Another way to prevent these infections is using a disposable or partially disposable scope. “The benefits of the reusable scope with the disposable cap is that it’s similar to prior generations of scopes that we’ve been using for many, many years,” Dr. Gromski said. “The potential downside is that data today tells us that it probably will not completely eliminate the contamination rate, but it will hopefully improve it. There’s also the risk of the cap dislodging within the GI tract.” (See related story, GEN Priority Report, July 2024.) Fully disposable scopes eliminate the risk for contamination from patient to patient, but researchers have observed a learning curve with these tools, and Dr. Gromski noted that it takes about 10 cases to obtain the performance characteristic of a reusable scope. He also pointed to the environmental impact that needs to be considered with single-use scopes.
—Ashley Welch
clinical situations where urgent endoscopic evaluation of such a patient is needed.”
Although CJD infections are rare—about 600 reported cases in the United States every year— they have been rising in recent years (JAMA Neurol 2024;81[2]:195-197), Dr. Salameh noted, adding, “No matter how rare the disease is, it should be on our minds. People die within a year of getting Creutzfeldt-Jakob disease, and we want to be at a low threshold of suspicion when it comes to CJD.”
