Welcome back, everyone! I hope you enjoyed that short lunch break after those stellar presentations this morning. We trust you will find the afternoon's talks equally engaging. If the public health emergency has taught us anything, it is that infections can affect endoscopy and operations by more ways than just contaminating the devices. While PPE, hand hygiene, and environmental hygiene have always been fundamental to discussions around infection control and GI endoscopy, the dialogue is largely focused on mitigating endoscope-associated infections. The pandemic highlighted the need to establish and maintain a culture of safety in the unit. So, let's run a few polling questions before we dive into this afternoon's presentations. Okay, first question. Have you ever had to deal with a potential case of endoscope-related patient-to-patient transmission of infections in your unit? Yes or no? That's really high. Almost half of you have actually had to deal with this. So, I think that the talk to come by Dr. Day is going to be very relevant for a lot of you. Okay, next question. So, if such an event were to occur, would you be actively involved in the investigation or response? Yes or no? Wow, every single person would be involved in that response. So, that's great. Okay, next question. Do you do ATP or blood-slash-protein testing in your unit to assess the quality of manual cleaning or reprocessing? Yes or no? Pretty even split. Yeah, so these quality indicators are out there. I think that there is some uncertainty as to how effective they are at assessing the quality of reprocessing. So, I'm not surprised that there's a relatively even split there. Okay, next question. For those of you performing ERCP in your units, which is the primary method of enhanced duodenoscope reprocessing that you perform in your unit? Double HLD, peracetic acid or liquid chemical sterilization, ethylene oxide sterilization, culture and quarantine, or not applicable to you? Let's see. So, of those who are doing enhanced reprocessing, it's about two to one double HLD versus LCS. So, that's interesting, and I'm really surprised that nobody's doing culture and quarantine. Okay, next question. For those of you performing ERCP in your units, do you see a role for disposable duodenoscopes? Yes, no, or not applicable? Yeah, it's almost two to one yes to no, and I think disposable duodenoscopes definitely have a lot of focus on them right now, but while they definitely have some advantages, they also have some disadvantages. So, yeah, very interesting. All right. So, with that, it's now my pleasure to introduce Dr. Luke John Day, who is a professor of medicine at the University of California, San Francisco, and the chief medical officer at Zuckerberg San Francisco General Hospital. Dr. Day currently serves as the chair of the ASGE Quality Assurance and Endoscopy Committee, and he is the lead author of the Multi-Society Guideline on Reprocessing Flexible GI Endoscopes and Accessories. Luke, the proverbial floor is all yours. Good afternoon, everyone. I hope you've been enjoying today's course and all the outstanding presentations so far. My name is Luke John Day, and I'd like to thank the course directors, Anne and Rahul, for such a wonderful course and for the invitation and opportunity to present today. Today, I'd like to address a topic that has been present in endoscopy since its inception, and something that all our endoscopy units must address, and that's the risk of infection transmission during endoscopy. This topic has been addressed by many guidelines and countless studies, but recently has received more attention with duodenoscope-related infections. My goal today is to provide an update on this critically important topic by reviewing the current evidence and outlining best practices on how to reduce infections in the endoscopy unit. There are multiple objectives I'd like to accomplish in today's talk. First, I'd like to provide a little background on this topic and help provide some context for why it's important. Second, I want to discuss the framework for how we think about infections in endoscopy units, looking at both endogenous and exogenous endoscopy-related infections. Third, and what I'm going to spend the bulk of the presentation on, is what's the risk to patients and staff for contracting an infection during endoscopy, and how can we prevent or minimize this risk? Lastly, I'll provide some concluding thoughts. Why is this topic important? First, there is a great deal of data that shows there is variation in infection control and reprocessing within endoscopy units. This table here highlights data from a study that examined 68 ambulatory surgical centers in four states to assess adherence to recommended infection control practices. Adherence to recommendations for reprocessing of endoscopic equipment was not uniform in over a quarter of ASCs surveyed. More concerningly, ASCs demonstrated deficiencies in other areas of infection control, such as 20% did not comply with hand hygiene, and nearly a third were not employing safe infection practices. Second, variation has been observed across all endoscope reprocessing steps, as well as several occupational hazards have been associated with reprocessing. Finally, we know that infectious outbreaks within an endoscopy unit can be disastrous on many fronts and may not shine a positive light on infected units. This body of literature illustrates that additional work and attention is needed to help reinforce and standardize our reprocessing and infection control guidelines in endoscopy. To understand infection risk in endoscopy, it is critical to have a framework. This illustration provides a conceptual outline for how infection transmission can occur within endoscopy units. There are two modes of transmission. First, patient to patient, and second, staff to patient or vice versa. Within these modes, there can be endogenous or exogenous infections that can develop. In the case of endogenous infections, one can become infected with their own bacteria, one's own microflora. On the other hand, exogenous infections involve a pathogen entering a patient's body from their environment. These pathogens can be introduced through a contaminated device, healthcare worker, surface, or other vector. Let's look more closely at each of these modes of transmission of infection during endoscopy and see how we can prevent such risk from occurring. Let's start with endogenous infections and answer the question, what is the risk of endogenous infections to patients undergoing endoscopy? Bacterial translocation of endogenous microbial flora into the bloodstream may occur during endoscopy because of mucosal trauma related to the procedure. The table here summarizes data we know as it relates to an endoscopic procedure, as well as types of interventions performed during endoscopy and the risk of a patient developing bacteremia as a result. From this data, we note several factors that can increase bacteremia in patients undergoing endoscopy. These include performing multiple therapeutic maneuvers, patients with underlying malignancy, incomplete biliary or pancreatic drainage, patients with immunocompromised states, patients on peritoneal dialysis, interventions on mediasinal cysts or cystic lesions, and patients with underlying cardiac conditions. Overall, we see bacteremia rates of about 4 to 23% in patients who undergo endoscopy. Now, it's important to put this information in the context of routine daily activity risk for bacteremia. For example, we know that common activities such as brushing our teeth or chewing food have high reported rates of developing bacteremia in patients. Now, this bacteremia is transient and doesn't result in poor clinical outcomes for patients. Since endoscopy related bacteremia is minor compared to the frequency of bacteremia in routine daily activities, this provides a strong rationale against the administration of antibiotic prophylaxis during most endoscopic procedures. How do we prevent endogenous endoscopy related infections? For this type of infection, we can consider antibiotic prophylaxis during endoscopy. The goal of antibiotic prophylaxis during GI endoscopy is to reduce the risk of significant endogenous infectious complications. Highlighted here are the most recent guidelines on this topic. In general, these guidelines do not recommend the use of prophylactic antibiotics during endoscopy. But rather to use antibiotics more judiciously and in high risk situations or patient populations. For example, it is recommended to administer prophylactic antibiotics in patients undergoing PEG2 placement, cirrhotics with GI bleeding, patients with incomplete biliary drainage, and patients who are undergoing fine needle aspiration on mediastinal or pancreatic cysts. Now let's pivot to exogenous infections during endoscopy and first look at patient-to-staff transmission of infection. There are a number of modalities by which staff can be exposed to infections, such as needle stick injuries, blood splashes to the chondroctyva, inhalation of aerosolized microorganisms, or transfer from direct handling of patients. Also, we know in endoscopy unit personnel are at higher risk for some types of infections in comparison to other health care workers or the general population. In particular, there is a higher prevalence of helicobacter pylori infection in endoscopy unit personnel. Finally, health care workers are at a risk for encountering a number of bacteria, fungi, parasites, and viruses within the endoscopy unit. However, it is important to understand this risk is not limited to endoscopy unit personnel. However, it is important to understand this risk is not well documented, and in most cases when it is reported, the risk of transmission is low. Much of the infectious risk to staff from patients is not quantifiable, but in some cases we do have such information. I want to illustrate some of the data that we do have in this area. I highlight here the risk of contracting some of the most concerning blood-worn pathogens within health care, such as HIV, hepatitis B, and hepatitis C. I showed this data to highlight that much of this risk is low, or not well known, or not quantifiable. It is important to know that several factors influence the risk of these blood-worn pathogens. This includes the route of transmission, the type and source of bodily fluid the staff was exposed to, and the volume of fluid transmitted during the exposure. What are best practices for preventing patient-to-staff transmission of infections? Key to this prevention are universal precautions. Universal precautions refer to the practice of avoiding contact with patients' bodily fluids by means of wearing non-porous articles such as medical gloves, goggles, and face shields. Let's review best practices for minimizing patient-to-staff transmission of infection in endoscopy units. This can be accomplished by consistent rigorous hand hygiene, adequate appropriate personal protective equipment, safe medication administration practices, safe handling of potentially contaminated equipment or surfaces, adequate ventilation and isolation precautions are followed when necessary, maintenance of a clean and sanitary environment, staff are up-to-date on all immunizations for vaccine-preventable diseases, and if staff are exposed to an infectious organism, then monitoring of staff after the exposure and providing and offering post-exposure prophylaxis if indicated. On the other hand, exogenous infections can also occur from one patient to another. This can occur by endoscopic or non-endoscopic methods. Potential areas during endoscopy where patients could develop exogenous infections include inadequate reprocessing of endoscopes and accessories, design limitations or damage of equipment, contaminated endoscopes, accessories, or equipment, and inadequate drying, transport, or storage of endoscopes. In terms of non-endoscopic areas, these include improper handling of IV sedation tubing, use of multi-dose vials, and the reuse of needles. Let's look a little more closely at what the risk of exogenous infections are from patient to patient, especially those who are undergoing endoscopy. There have been reported infectious outbreaks of bacteria, viruses, fungi, and parasites, as well as a possible risk of contracting prion disease during endoscopy, as I outline here in this table. In the majority of cases, we see the transmission of infection was due to a lapse in reprocessing of endoscopes or using contaminated equipment. Reassuringly, high-level disinfection can and does terminate these infectious outbreaks. Now, what have we seen over the last few decades is a difference between standard forward-viewing endoscopes, such as colonoscopes or upper endoscopes, versus side-viewing endoscopes, such as duodenoscopes. Let's look at both of these areas a little bit more carefully. First, this graph shows both published and reported infectious outbreaks related to standard endoscopes. We see a large peak in the 1980s with a significant decline afterwards. This dramatic drop is largely due to standardizing reprocessing protocols, as well as the publishing of reprocessing guidelines. How do we prevent endoscopy-related infections for our standard forward-viewing endoscopes? There is no one solution. However, key to success in this area is to identify several domains and develop countermeasures in each of them to strengthen infection control practices. There are a number of critical domains that need to be considered. These include examining and developing standards around a strong infection control leadership team, documentation, inventory control, education and training and reprocessing staff, physical setting, and quality assurance. This slide here provides a broad overview of all the steps involved in reprocessing of endoscopes. It's divided in three buckets, pre-reprocessing, reprocessing, and post-reprocessing. We know that when all of these sequential steps are correctly followed, infectious outbreaks associated with standard endoscopes is nearly eliminated. Key takeaways from endoscope reprocessing, especially with standard endoscopes, is that infectious outbreaks occur in settings where lapses in reprocessing steps have taken place or universal precautions are not followed. High-level disinfection is an effective modality for reprocessing of endoscopes, and when high-level disinfection is followed correctly, this terminates infectious outbreaks attributed to the use of standard endoscopes. What about more specialized endoscopes, such as a side-viewing endoscope, like duodenoscopes or echoendoscopes? Using a similar model of examining the literature and reported outbreaks for specialized endoscopes, we see a much different story. Interestingly, we have observed a spike more recently regarding this category of infections and these specific endoscope design models. This observation is likely multifactorial, but represents an increase in the frequency and use of these specialized procedures in GI, and also greater transparency in reporting of infections associated with their use. What do we know about infections related to duodenoscopes? Beginning in 2010, there was a sharp uptick in reported infections from multidrug-resistant organisms pertaining to duodenoscope use. Alarmingly, site-specific investigations of these infectious outbreaks revealed that infectious transmission was occurring despite adherence to manufacturer's reprocessing standards. Outbreaks predominantly were occurring in high-volume endoscopy centers in the United States and Europe. Taken together, the available evidence has allowed us to provide some estimates of patient risk as it pertains to them undergoing duodenoscope usage. First, the risk of contracting a low moderate concern organism during an ERCP is low and ranges from about 0.3 to 4.4 percent. Second, this risk increases slightly for high concern organisms to about 4 to 5 percent. Finally, using all of this data, the risk of a patient contracting a high concern organism during an ERCP ranges from about 1 to 106 to 1 in 2,632. In looking more closely at infectious outbreaks attributed to duodenoscopes, we see some trends with respect to clinical characteristics that are different from infections we have seen with other endoscope design models. These clinical characteristics include organisms detected are mostly gut flora. Infections are often distal from the site of colonization and include urinary tract infections, pneumonia, and sepsis. There is a long lag time that exists before clinical symptoms develop. There's usually a silent carriage of the infection by patients. Duodenoscopes are often culture negative and no failures in duodenoscopic processing have been identified in most of these outbreaks. Why might we be observing more infections associated with duodenoscopes? Multiple contributing factors may explain this observation. First, the distal end of the duodenoscope, as shown here on the right, has a complex design potentially making it challenging to disinfect or clean. Second, the internal working channels of duodenoscopes might be areas where damage could occur and be not only difficult to reprocess, areas where debris and organisms could collect over time. Third, reprocessing duodenoscopes is a complex process and is ripe for human error or missteps. Fourth, prolonged storage of duodenoscopes in a non-controlled environment might be a factor. And lastly, the rinsing water used to reprocess duodenoscopes can contain waterborne bacteria. Thus, we see a number of either separate but also interrelated factors that can contribute to duodenoscope contamination. Where might there be opportunities to improve or enhance the reprocessing of duodenoscopes? There are several key areas to consider when thinking about eliminating the infectious risk of patients who undergo endoscopy with these specialized endoscopes. Areas to consider are new technologies or techniques for endoscope reprocessing, better methods to identify contaminated duodenoscopes early on, considering duodenoscope redesign, and improving staff training and competency. Let's explore each of these areas a little bit more. Infectious outbreaks that have occurred within endoscopy units associated with duodenoscopes have prompted the FDA to issue advice on possible supplemental measures to consider. Outlined here are several of those supplemental measures that the FDA has recommended endoscopy units employ if they are using duodenoscopes. One question that arises is what are endoscopy units currently doing in terms of duodenoscope reprocessing to help combat this category of infections? This data here shows results from a nationwide survey of endoscopy units performing ERCP, about 250 institutions. We see that nearly 90% of endoscopy units across the country implemented one of the four recommended FDA enhanced techniques for duodenoscopes, with the majority choosing to use double high-level disinfection. Now, let's look a little bit more closely at how effective some of these supplemental enhanced reprocessing measures are. Lastly, what does the data tell us in terms of if any of these methods are effective at reducing infectious outbreaks within endoscopy units? Let's look at only repeating high-level disinfection, or what is called double high-level disinfection. Research in this area has been limited to non-outbreak settings in randomized trials, with results showing no benefit of double high-level disinfection versus other interventions. What about repeating all of the reprocessing steps a second time? Here, data has been limited to only outbreak settings, and while this process terminates outbreaks, there continues to be a low rate of concerning organisms observed on endoscopes. Some endoscopy units have transitioned to sterilized endoscopes. In non-outbreak settings, recent randomized controlled trials show no difference in detecting bacterial contamination rates between sterilization and other reprocessing interventions. However, sterilization has been effective in outbreak settings at terminating infectious outbreaks, although this has been in non-randomized studies. Another area that is getting a great deal of attention is frequent culturing on several areas of the duodenoscopes, and then removing devices from use if there is a positive culture detected. Such a culture and quarantine program is effective at reducing positive cultures, but the long-term impact of this intervention is unclear. Finally, there's been a move to using single-use duodenoscopes. Early data here suggests favorable performance characteristics, operator experience, and safety profile of single-use devices. However, more research is likely needed in this area. And lastly, much of this risk can be mitigated by improving staff training and competency, and is focused on employing automation at all steps in creating understandable, clear, and consistent reprocessing instructions for reprocessing teams. In summary, we have covered a number of topics around infection transmission in endoscopy. We see that variation is noted among the adherence of endoscopy units to recognize infection control practices and reprocessing protocols. There are a number of modalities by which patients may develop endoscope or endoscopy unit-related infections. Preventing infections in endoscopy units requires a multidisciplinary team and systematic approach. Looking more closely at infection transmission, we see that endogenous-related infections are rare in endoscopy units, and prophylactic antibiotics are recommended only in select circumstances. Additionally, infectious risk can occur between endoscopy unit staff and patients undergoing procedures. This risk can be significantly reduced by adhering to universal precautions. Much of the work around reducing infectious risk within endoscopy units has focused on patient-to-patient transmission of infection as it pertains to the endoscope. Infections associated with standard forward-viewing endoscopes have greatly declined in recent decades. This decline is the result of compliance with rigorous standardized reprocessing guidelines that include high-level disinfection. On the other hand, specialized side-viewing endoscope-related infections are on the rise and pose a much more complex and challenging problem. To address this problem, a multi-faceted approach is required, and more work and research are needed in this area. Thank you again for participating in today's course and for your attention.

infection transmission

endoscopy procedures

duodenoscopes

infection control practices

reprocessing guidelines

patient-to-patient transmission