So, I have actually a really fun topic, and I'm hoping that we can, you know, touch on this a little bit in the Q&A as well, because I think this is one of those areas that's very gray for, you know, GI and, quite honestly, medicine in general, is how we bring new technology into our units. So these are my disclosures, and those are always relevant, especially when we talk about a topic like this. So we're going to start with a polling question. So which of the following best characterizes your unit's approach to implementing new technology? For example, if you're bringing in a LAMS or a suturing, so do you have no formal process in place? You know, I say I can do it, I just start doing it one day. Do you have an internal expert watch or proctor the endoscopist perform their initial novel endoscopic procedure, or you actually bring someone external in to watch your endoscopist perform their, you know, novel procedure? So how do you actually implement this sort of new technology into your unit in that regard? All right, there you go. So this is actually really impressive. So this would say a little bit over, around actually two-thirds of people will have someone, either internal or external, watch someone who says they can do something new. I would gather that that is higher than the national average, because my experience is a doctor comes in with a lot of bravado, says I can do this, and everyone says, okay, go ahead and do it, and no one actually pays attention to whether they're actually credentialed or competent to do it. So we're going to talk a little bit about the equipment and also that piece. So our objectives today are to sort of outline an approach to bringing new equipment and devices into the endoscopy unit, talk about staff training on new endoscopy techniques and devices, and then go into physician privileging for new endoscopic techniques. So why do we want to adopt new equipment and techniques? You know, we might have a lot of reasons, and I think it's important for us to be really upfront early on of what that reason is. One is we might just say that this device that I'm bringing in has increased efficacy or safety, often compared to a surgical option, but sometimes compared to another endoscopic option we previously had. So an example in our historical past was radiofrequency ablation. Before that, esophagectomy was the standard of care for patients with dysplastic barotissophagus. It should be very clear that this is a good reason to bring technology in, to replace a high-risk procedure. There's also cost savings. So if you're going to sort of say that I'm going to bring some technology in that's going to allow me to perform resect and discard, meaning I take the polyp out and don't have to send it to pathology, there's cost savings to the healthcare system. There's also quicker, easier ways to do things. So luminoposing stents, as we all know, have revolutionized the way we manage a lot of diseases, but for things like pseudocyst drainage, it really just makes it easier. It doesn't necessarily make it safer. And then might increase our referrals and volume. So back in the day, everyone was really excited that they could do cholangioscopy and they all assumed that we bring this expensive technology in, we're going to actually get more referrals from the community. Unfortunately, sometimes it's also because the device company markets directly to the physician and that sort of puts pressure to bring new equipment and devices in. So what about new equipment specifically? So you stock esophageal stents from two major manufacturers. However, a friendly physician comes to see you and says, you know, I really like this new esophageal stent and I want us to bring it into the unit. Or another scenario, your physician comes in and says, you know, I really like this new thing that you've never seen before. This is how we felt about over the scope quips about 10 years ago. Like, I love this, we got to get this. It's not replacing a product, it's a new product. So you need to have different approaches for each of these scenarios. So how it used to happen, and we hope this is past tense for all of us on this call, but it may still be happening somewhere, is a manufacturer representative presents the new product to the physician. So I'm doing my ERCP, I come out of the case and my rep is there and is like, wow, I got this great product, Dr. Kaswani, you're the most talented doctor in the entire country and you're going to do such a great job with this product, you really need to get this in your unit. And I obviously, flattery works on all GI physicians, as you know, and I'm really excited about it. And I say, let's bring that product into the unit, they bring it on the day of the procedure, we do some quick hands-on training right at the beginning, I'm like, okay, what does this button do? What does that do? I'm like, okay, I'm ready to do this in a human, because that's how normal things happen. And we perform the procedure in a human, we hope it goes well, I'm like, that was amazing, we need to get 3000 of those in our unit, whatever cost. And then we'll ask the unit manager, can we stock them? And they're like, of course, doctor, we'll do anything. That is, as I hope we can all agree, not necessarily the optimal approach to bringing in new technology. So what's wrong with this scenario? There's undue influence by the company selling the device. There's no systematic review of efficacy, quality or safety. All the stakeholders that need to be involved are not involved in decision making. And there wasn't really great preparation or training of the staff and physicians. So there is an optimal standard operating procedure for new equipment, right? We want to remove the bias and conflict of interest from the decision to use a new product. Carefully weigh the risks and costs versus the benefits of the new stent, a manner that is transparent, fair and efficient, meaning that if you have a bias, if I have a conflict of interest, at the minimum, this should be disclosed so that everyone understands what's happening. And then accountability, really understanding, you know, what has happened after we implement the product so we can understand long-term outcomes. So we need to develop a policy. A policy must be developed for dealing with new product requests, right? And this needs to be a person or committee designated for product review. I would argue that in most large places, this is always a committee, right? You need to have a panel of your peers. So Northwestern, it is gastroenterologists, but also people in interventional radiology and other interventional procedural fields. Include physicians, non-physicians, administrators, subjective and data-driven. And the way this should be modeled is similar to what an IRB is like, very regimented and transparent the whole process. So all requests for new devices are proposed to the committee, and the requesting physician or vendor provides efficacy, safety, and cost data to the committee, right? So it's on me as the requester to say, okay, this is what I want. This is why I want it, whether it's an effectiveness or a safety reason. And then the cost data on our centers is usually pulled together by the committee, right? They look at the current products, the new product, what potential new revenue will come out of the product, what potential reduction, second procedures, other things that might be important to consider. What new business might come in, which is important for the committee as well. All of that is put together through that formal written request. And then the committee, if successful, will have the ability to respond in a timely manner and then tell you specifically why it's saying yes or no, let's bring this product in. Most committees will bring things in for a trial period, look at the financial implications, and then adopt it more permanently, especially when it's a high-ticket item. So this, you can see here, is an example of a new product form at Northwestern. This is a few years old. It's been modified a little bit, but there's things that the physician needs to put in. You know, how many of these cases do I expect to do? What devices is this going to replace? Again, what new business will this bring in? All of that is really from the clinician perspective. And so we require this to be put in by our physicians before we request new products. So we want to develop that process, right? If the committee agrees that the device has merit, the contract is made with the vendor for a trial period, and then all trial devices must be purchased. We don't like to do this idea that the vendor comes by, sort of slips 10 free snares under your door, no one is aware of it, you use it, and sort of then you want to then take it to the committee to say, I love this, I need to bring it in. We'd like to have even trials go through the committee for evaluation. We need to make sure that the staff are trained on the device, especially when it's a very new procedure. Obviously, if it's a similar type of device we're bringing in for cost savings only, generally, any new training isn't required, but we like to have the vendor on site to train the nurses and techs if need be. And then we need to have a mechanism to report, review safety and efficacy data for the new item. So what about training? Who is responsible for all this training, right? Is it the vendor? Is it the physician? Is it some outside group? Is it a national society or international society like ASGE? Who can get us trained for these things? How much in-servicing is needed to get started? You need to think about that before you bring the product in, right? Don't have the product hit your shelf and you're like, oh, who's going to train the techs on this new device? Often a refresher, of course, is needed to train on the device. And then different techniques and devices are variable with regard to the training necessary. Some of the devices we bring in now, it's actually quite a bit of a challenge because we may have all the nurses get trained on it. We don't do the procedure for another couple of months, and then there's a whole new set of nurses on that day who have never seen this device because they weren't available on the day they got trained. And so this idea that you can train everyone consistently is a challenge, and that's what we work on a lot in terms of making sure that we have a control plan on training for all of our nurses and techs. I do want to emphasize that we want to be very careful in this idea that what is the vendor's role in the training? This was a study we did almost a decade ago with the SG&A when we talked to nurses and asked them who's doing the actual procedure itself and all the cognitive parts for the nurses and techs. And if you look in places that are low volume, we often saw that the nurses and techs were very insufficiently trained in what's a relatively basic procedure now, ERCP. They didn't get much hands-on experience, didn't really shadow. And a lot of them who were low volume didn't feel super comfortable with ERCP. But the biggest thing is that they frequently asked the device representative to be available for the procedure for assistance during the ERCP, meaning that even though they said they were trained, they really didn't feel comfortable. So if you look at this, 25% of them were asking in a low volume unit to make sure that the rep was available to make sure that they could feel comfortable during that ERCP procedure. And I would argue those numbers get astronomically higher when you bring in a new device where everyone is unfamiliar with it, including the endoscopist. And so you really want to do your training before the procedure itself so that the nurse or the tech feels really empowered to do the procedure because it is very inappropriate to be relying solely on the vendor to sort of tell you what to do during the procedure. And I'll save those slides for you can review later. So what about training and maintaining skills? You know, the committee approves, for approving new equipment should also provide guidelines for training. Once the equipment is in use, a unit manager determines a need for periodic in-service for seldom used devices. So again, I want to emphasize, just because it hits the shelf when I trained you five months ago, it's not fair for me to expect you that now five months and one day later, when I say, okay, we're going to do this, you know, procedure we haven't done in a half a year, that you have to remember everything that happened on that training. We need to think about that consistent periodic in-service process. And to be fair, we do that more on a once a year basis for sort of all of our devices, you know, even simple things like banders and things of that sort, because we have such high nurse turnover, we want to make sure that everyone, you know, with all the new nurses that come in who haven't done this as much, that they feel comfortable learning this in a time that isn't a stressful time in the, you know, in the middle of the night in the ICU. So how do you set up an in-service for training? You really want to make sure that you tell people how to prepare the device, deploy anything and then what to troubleshoot, right? So if you're using hemostatic sprays or you're using over-the-scope clip, what can go wrong and what you should do when it goes wrong. So anticipate those possible adverse events. So finally, what about privileging for new techniques? This is really challenging as well for a lot of us. And you all, again, we're, I think, far ahead of where most people are in the United States on this. So here's a common scenario, a young, energetic and well-liked doctor. There must be some of them out there, energetic. Everything else is like all of us. Returns from DDW where she has seen expert endoscopists from around the world perform a new procedure called POEM. And this doctor, she says, it is inconceivable that a leading institution like ours does not provide this service for our patients. A friendly neighborhood competitor has already performed a POEM procedure at the hospital and received excellent press. So they, you know, they feel like the marketing push, like, wow, we are falling behind. And I saw at least three videos at DDW that tell me how to do a POEM. I'm gonna start doing them. So what do you do here, right? Conditionally and privileging are very challenging things, right? We need to first understand is there competence, which is a minimum level of skill, knowledge and or expertise required to safely and proficiently perform a task or procedure. So competence is a accumulation of hands-on and cognitive training where I now should be able to perform the procedure. That's different than credentialing. So I can be credentialed to do something, but not competent to do that. I'm sure, unfortunately, all of us have seen that in some procedural field. Credentialing is a process of assessing and validating the qualifications of a licensed practitioner to perform a particular procedure and privileging is authorization by a local institution perform a particular procedure. So I may be privileged to do a POEM procedure, but I may not actually be competent to do a POEM procedure. And those are some of the things that we need to really think about. So you have optimal standard operating procedure for new techniques. We want to remove or minimize as much as possible the bias and conflict of interest from the decision, carefully weigh the risks, costs and versus benefits and make sure that it's in a manner that is transparent, fair and efficient. And ultimately we wanna assure accountability, right? We wanna make sure that we bring all these things in, that we are understanding really what the outcomes are and what we would do based on sort of predetermined outcome metrics. So if we're gonna bring in the POEM procedure, we wanna understand what is a successful implementation before we actually bring it in. And we wanna make sure that we understand this is what we wanna do as an institution. Not every institution needs to do every procedure. The volumes aren't there and it's impossible to maintain competency and a procedure that you do too infrequently. So privileging, how do you develop a policy? You have accrediting bodies specify that there needs to be a privileging process, but they don't specify the privileging criteria to be used. So each endoscopy unit must have a privileging policy and that committee that is in charge of privileging needs to make decisions on whether a physician's training experience is adequate, right? So again, at your institution, you wanna have that committee to say, okay, we have five doctors who wanna do ERCP. Two of them have been doing it for 10 years and have volumes of 300 a piece. And one of them lasted in the ERCP five years ago and was doing five a year before that. A privileging committee needs to understand that all of these people are not the same and figure out which of the physicians training experience is adequate. And as you can rely upon the ASG for guidelines on privileging in those regards. So here are the ASG guidelines for privileging, credentialing and proctoring to perform GI endoscopy. This is some light reading for you to enjoy, but really goes through this process, which again is really important to bring in a new technology. So you finally wanna think about whether it's a major skill or minor skill, right? So if it's a major skill with high complexity, like EUS, ESD, all these sort of things that you're hearing about, that everyone's excited about, that really needs to be thought of differently than a minor skill, right? So I think that there's certain things that are just extensions of what we already do. And that doesn't require privileging. If I'm already privileged to do ERCP, do I need to be privileged to do a needle knife sphincterotomy? I would argue not. We would like to put that rolled up underneath the idea that I'm competent to do an ERCP. And that differentiation can be a bit challenging. It can get murky to where people say, well, I do EMR, so now I also do ESD. Is that really the same? Most of us would argue no. So for major skills, you wanna have a preceptorship, formal education required. And you can see here, you wanna really dedicate time to this and make sure there's a rigorous curriculum. You might need to go to short courses or workshops. Again, this is why ASG has really moved from the idea of, oh, let's do a quick weekend course where everyone's a winner and everyone passes to really rigorous courses that are longitudinal to say, okay, we're gonna work you through this acquisition of a skill and make sure you achieve competency by the end. This is the idea of mastery learning where through deliberate practice, you keep doing something over and over again until you learn how to do it. This is needed for the major skill acquisition. Again, minor skills, you might just watch a quick YouTube video. It's already what you already know how to do. You watch it, you're like, okay, that's what I already thought to do. And you just do it. So you're really not the same kind of duration of training. They thought the same kind of addition to your current portfolio of knowledge. So how do you implement new techniques? What I would say the process are, step one, set the goal, determine what is efficacious and what's the adverse event rate that you would be acceptable. Utilize published literature and guidelines. So do that before the procedure implementation has begun. Figure out how much training is needed. And as a unit, support the person to get that much training. If someone says, I need to learn how to place lumen opposing metal stands for pain relief, opposing metal stands for pancreas fluid collections. I already am trained in EUS, but I need to learn this. As a unit, work with that physician to understand what kind of training is needed and ideally support them in that process, including if it needs to be financially supported to do extra training, to go somewhere else, to watch someone who does a lot of these, et cetera. Figure out who will do the procedure and make sure we're privileging the right people and make sure the nurses are appropriately trained. Think about potential collaborators. Make sure that you get buy-in from surgeons, right? If you're gonna do something like gallbladder drainage and you think that you need to privilege someone to do that, then make sure the surgeons are on board because what you don't want is to work in a sort of your own lane and then have a bunch of people come at you and say that you were not really collaborative in your approach. Make sure there's institutional support and buy-in. Is there medical legal reasons for this as well as reimbursement? Although we all are here about patient care, don't bring in a new procedure that has zero financial reimbursement and a lot of costs. That's a recipe for disaster. And a lot of our people in here who do bariatric endoscopy can talk a lot about how you need to have the right balance of training, but also reimbursement to make a bariatric endoscopy program work. And then figure out if your unit can get enough volume to be good at it, right? So it takes a lot of things, a lot of volume of procedures. They say effectiveness or competency for PULM is achieved after 40, mastery after 60, but that's for the average physician. Some people might need 100, 150. Are you gonna see three of these a year? Then are you ever gonna get good enough? So what's the point of trying to bring this into your unit? So I'd say the last thing I've talked about is just really be careful as an endoscopy unit of who's doing the quote unquote credentialing and privileging. There was this really interesting trial that came out in 2013 where Intuitive, who I think you all know, is in terms of robotic surgery, one of the leading companies in robotic surgery. The plaintiff's attorneys argue that Intuitive failed to provide the attending surgeon with sufficient training and oversight to properly perform the operation using the da Vinci robot. The plaintiffs also alleged that the company failed to adequately warn the surgeon about risks, contraindications, and decision-making involved using the device. This all occurred because a surgeon went to some training with the da Vinci robot company, got some hands-on training, did their simulation, and then the patient had a really awful outcome. And instead of just suing the physician and the hospital, they tried to sue the company and said, listen, you did bad training on this doctor. And it was very clear that the company was like, no, no, we don't privilege a credential. That's the job of the hospital. We're going to provide some education, but this is not our job to tell you that this physician is competent to this procedure. And the jury agreed. They agreed that Intuitive was not negligent, that the companies are not responsible for the training. Who is responsible for the training are us on this call. We are responsible for ensuring competency, ensuring that the physician gets the right amount of training, and then when it comes time to it, privileging them for it. So be very wary of relying too much upon the companies to tell you that the doctor is ready to do this procedure, because first of all, they're conflicted. And second of all, they're taking no medical legal responsibility. So key points, we want to do a careful assessment of efficacy, safety, costs, and training about new equipment and techniques before implementation comes in. And endoscopy units must have a clear, defined policy delineating the process. Have a designated responsible person or committee, document all the steps, and then continue to make sure you actively train and retrain physicians and all staff members, especially with the turnover that's been referenced before. You know, we want to make sure that when that day comes that everyone feels comfortable with implementing this new technology and that they're not just relying on that rep to tell them what to do next. Thank you and look forward to the case studies.

medical technology

gastroenterology

endoscopic procedures

training and competency

equipment evaluation

patient safety