Hello and welcome to our DME course entitled Patient Education and Training, the safe and effective use of DME for athletic trainers. My name is Scott Hartel and I appreciate the opportunity to speak with you about an important aspect of our role in patient care, which is the direct education and training surrounding durable medical equipment, which we'll refer to from now on as DME, specifically in the physician practice setting. As athletic trainers, your insights and interventions play a vital role in patient recovery and rehabilitation, and understanding how to effectively educate your patients on DME can significantly enhance their outcomes. The proper use of DME can prevent complications, promote healing, and also facilitate a return to daily activities or sports and physical activity. However, the effectiveness of these devices not only depends on their design and manufacture, but also on how well patients understand their proper use, their safety, and their role in their recovery. Before we get into the specifics of the course, I'd like to first briefly define what we will be talking about, as well as provide you with the learning objectives that we'll be looking for throughout the course. So sometimes there can be a confusion between what's known as HME, or home medical equipment, and DME, durable medical equipment. Sometimes those terms are interchangeable. Sometimes people feel DME falls under the umbrella of HME. I'm not here to discuss one way or the other. For purposes of this course, I'm going to define HME, or home medical equipment, as oxygen equipment, diabetic supplies, things like hospital beds, or commodes, whereas DME, and I refer to that will be what we typically think of crutches, boots, splints, all the multiple braces that we see in the physician practice setting. The reason I'm differentiating this is because down the road in this course, I will be talking about recalls and adverse effects. When I'm talking about those, I'm really specifically just talking about the bracing and the boots and the crutches. I'm not going to be addressing diabetic supplies, or hospital beds, and troubleshooting those types of medical equipment. So it's important to distinguish between those two, but it is also important to remember that there is a great overlap with these products. So you cannot ignore them completely and should have at least a cursory or general knowledge of what those products are, because what if you have a patient in a post-operative knee brace locked in extension, but they have oxygen, and the tubing is coming out? Or if they're in a hospital bed at home, but they're in an abduction pillow, how does that transitioning up and down affect the pillow? Is it fitting properly? And finally, one of the more obvious ones we see is diabetic patients who are in boots. Are they in the correct boot? Do they know what to look for as a diabetic? What to sense for? Do their family members know? So while I'm separating them for purposes of this conversation, please know these are not separate, and there is overlap with the two categories. So what are the learning objectives? Number one, to understand the importance of proper DME usage. Now, this may seem obvious, but we need to remember that we are there to help prevent complications and to enhance treatment efficacy. We are there to help our patients out, and we are there to help them by making sure they understand how to use their equipment, which falls into our next objective of communicating efficiently while still educating your patients. Let's be honest, we are always under a time crunch with a provider or just the patient. Many times DME is the last thing on the patient's list, and they've already been there an hour and a half, and they want to get out, and they're not necessarily in the best mood. Our role is to educate, and we need to do that efficiently to make sure that our patients are learning. With that, we need to develop plans for those common questions or concerns and issues that come up. We know that 90% of the knee braces we're going to give out, someone's going to come back to us and say, hey, this thing slips. I just can't get it to stay up. OK, that's a common question. How do you develop plans for this? And if you have a plan already in place, it will help you communicate efficiently because you can already educate the patient on what they're speaking of. Finally, analyzing recalls and making sure that adverse effects are minimal. This can be skin breakdown, strap wear and tear, a simple rash from the product. So it's very important, again, to notice these things and to be able to discuss them and talk with the patients. And you need to be that trusted resource for your patients. In order to best educate your patients on the proper fitting and usage of their DME, you must first understand the role of DME in physician care and patient recovery. So these three questions that you see here are the three questions that I feel are the base of that pyramid that's going to build up that DME knowledge that you're going to use to translate to your patients. But you must first have that really good understanding of what the braces do and how they work and the differences and the little nuances between each one of the braces. So I suggest for each piece of inventory you have, you ask, why would this brace be used? What does the brace do, meaning mechanically and functionally, what does it do? And then how does it fit? And that's both from your standpoint as the athletic trainer fitting the brace, as well as the patient replicating that fitting and being able to put it back on themselves. To illustrate this point, I like to use the walking boot, then transitioning to a rigid style ankle brace, and then moving to a lace-up ankle brace. Now I'm not going to go through each question and answer with you, but you can see where if you ask the question, why this brace? And you have, let's say, a short boot versus a tall boot, or a rigid style ankle brace, or that lace-up ankle brace, you're going to have different indications for that brace, or you can use them all three in a transitionary period during the entire patient's recovery. This obviously will be based on the practice that you work in and the physicians that you work for, but what I want to drill home on this is, I want your answers. What's your opinion? Why would you use each one of those braces? Then what does the brace do? Again, let's look at the boot, a tall versus short, compared to a rigid style ankle brace with, say, one to two straps, and then compared to a lace-up ankle brace, and then how do those three fit differently? And the reason it's important is because what if you have a patient that a lace-up ankle brace would work for, but they do not have that finger dexterity, so they might have to go into that rigid style ankle brace, but that only has a one or two Velcro strap. It's much easier to get on and off. If you give that patient a lace-up ankle brace, their compliance is just not going to be there because they just can't get it on and off, so maybe you are giving them a little bit extra brace, but you want them to wear it and to actually be functional with the brace. So that's why having a knowledge of all three of these and a good understanding of why this brace, what does it do, how does it fit, that will help you when you are educating your patients. My real-world example I like to use in this is we had a patient. He was an early 60s gentleman. He had grade 2 medial compartment osteoarthritis, so he was in a single-hinged, a push style OA knee brace. He came to us saying that about two weeks prior, he had been wearing this ankle brace for a good six months, but about two weeks prior to him coming in, he slipped on some ice and he had some medial joint pain. Well, it turned out he was using his push style medial OA brace to support an MCL strain. Now, what that means is he was putting stress on that MCL every time he put the brace on. He was actually better to not wear the brace. What he told us was that he thought if he turned it up higher, he would get better relief, but he was coming to us because that relief never happened. Again, if you know why this brace, what the brace does, and how the brace fits, you'll be able to instruct this patient, kind of understand why he was stressing his MCL instead of relaxing it. So what we did is we shifted him into a bilateral-hinged, a simple bilateral-hinged wraparound knee brace and explained to him why this brace, what the brace does, and how it fits compared to his OA brace. So that is a little case study in why this is so important. Now that you've learned about your inventory and have a better understanding of what is in your closets, why is it so important to instruct your patients on the correct usage of these braces? It might seem like common sense and it's fairly obvious, but when we actually break it down, this way we can give you some evidence to support the fact that spending time with these patients on the front end should hopefully decrease some of the issues that you might have on the back end. So this all comes full circle. You're building that relationship in the beginning so that if issues do arise, which I'll talk about later or questions come up, you've built that trusted relationship with the patient in the beginning so that you can address those and you have that confidence in each other. So first, you're looking to enhance treatment and compliance. That is the number one goal. The providers want positive outcomes for their patients, regardless if it is a simple sprain or if it is a post-operative patient. You're looking for a successful outcome for this patient. So what you're trying to do is increase that patient trust and satisfaction. If the brace fits properly, again, they will be trustworthy of you, which in turn you hope goes to the provider, and you will increase their satisfaction. This in turn will lead to improved outcomes and decreased recovery times. I'm speaking in generalities, of course. It's not always going to work. But if we can get our patient trust and satisfaction high, we're also looking to get our outcomes high and our recovery times lower or within that normal range. We do not want to extend this patient's injury at all. Then finally with this, you're going to reduce your liability and you're going to improve best practices. So when you're there and you're instructing these patients, again, you're gaining their trust, you're hopefully getting their customer satisfaction, you're going to hopefully help them improve their recovery, you're reducing your liability, and you are providing best practices to these patients. So you've got all of these things combined, and this is simply from fitting a brace properly. Now, next we want to prevent complications from improper use. So if we're instructing these patients properly, we're hoping that they're listening and that they do not have complications. That is the last thing we're looking for. Your informed patients are more likely to adhere to their treatment plans. And when they understand how to use their equipment correctly, they're less likely to experience setbacks, injuries, or complications from the brace or from the injury in general. Also, effective education, it empowers your patients. It gives them a sense of control over their recovery and hopefully gives them a positive, more positive attitudes towards their rehabilitation. And then lastly, in this section, we believe well-informed patients, they just communicate better with their health care providers and with you as the athletic trainers or the staff. When patients are informed about what's going on with their injury and where they're at in their rehabilitation process, it definitely benefits that patient. Two things you can do to, I guess, better get your patients on board is, whenever possible, demonstrate the brace in front of them first and then allow them to feel that brace. Allow them to kind of get a hold of that brace. I'll get more into detail on this later, but just let them hold that brace. And then also, what you really want to do to enhance their treatment and to prevent their complications is tailor that education to meet the individual needs of each patient. You need to consider their age, their physical capabilities, and their lifestyle. A younger athlete is much different than an older adult. Again, I mentioned before, someone with less dexterity in their fingers, using a lace-up ankle brace is not going to work. So you need to be able to understand the products and your patients. And you're going to personalize this to each one of those patients. Along with this then becomes maintaining those physician protocols. If you're in a practice who has multiple physicians, my guess is they're not all on the same page with bracing or even the same braces. So by personalizing the instruction to the patient and then pulling in their physician protocol, now, again, you're increasing their trust. You're increasing their satisfaction, and you're hoping to increase their compliance. Now that we understand the braces in our inventory, and we also understand the extreme importance of proper fitting and the education of the patient on the proper fit, so now let's move into the education phase of donning and doffing the DME for the patient. For those of you that might not know, donning simply means to put something on. Doffing simply means to take it off. So we're teaching the patient to take the brace on and off. Because I will just be discussing general strategies, I'm not going to speak about any specific fitting guidelines. But what I do want to provide you with are the tools to promote confidence in yourself while you're fitting and educating the patients. But also, you'll be building that confidence in the patient that you're working on. You want, again, we're building that relationship, that trust, so that you're spending time now, you're building equity within that patient and that relationship. So down the road, when there's issues, because there always are, you're going to be that trusted contact or your provider and physician. That patient's going to have trust in that provider and your practice in general. So the first thing I do from a proper application standpoint is I take out the instructions and just lay them on the table. Not everyone agrees. Some believe it shows weakness or a lack of knowledge. Now, I've been doing this for a long time. I do not know all of it, but I do know a decent amount. I can tell you that I use these braces all the time and I will lay out the instructions. It's simply a visual aid for the patient. It also shows them a place where they can refer back to once they are at home. That is sort of my main purpose for laying those out there. You don't have to use them, but you can at least show them to the patient. However, if this is a brace that is new to you, it's newer to your inventory or simply a newer brace. Do not be afraid to look at those instructions. Tell the patient, hey, this is their newest brace. You're getting their newest brace they have. I'm just new to it as well. They've added a few tricks. So what I'm going to do is dig into these instructions as well while I'm showing you. There's absolutely nothing wrong with that if you feel comfortable doing that. So now that we've laid that out there, what are we going to do with the brace? First thing you're going to do, simply show and tell. You're going to show the brace to the patient, talk briefly about it. You do not want to overwhelm them and you want to tell them how it's going to relate to their injury and then exactly what it does. Now while you're showing them this brace, you are inspecting and examining the brace to see if there are any mechanical errors. So if it has a hinge, bend that hinge. While you're showing the patient, you're saying, look, the hinge bends the whole way. But at the same time, you're making sure that the hinge is not clunky. There's no catching. There's a smooth transition from flexion to extension all the way up. Then you can take the brace. If there's any tricks, some of the post-op knee braces or some of the abduction pillows have almost hidden pieces where the patient's going to need to know and be able to adjust. So it's easier to show the patient before it's on them. You don't want to show them every detail, but you do want to just show them what might be functional to those patients. So once that part is done, let's put the brace on the patient. So make sure you're fitting this brace in a conversational manner and make sure you're relaxed. Tell the patient, hey, you know, patient X, this is a process, especially if you're using some of those more complicated braces that use a lot of education. Say an OA knee brace, an abduction pillow, a post-operative knee brace. Those are going to be a little bit more complicated. Tell the patient, sometimes this is a trial and error process. We're going to have to make some adjustments. And talk the patient through everything that you're doing. And while you're talking them through the brace, show them any anatomic landmarks you're using or show them any bony prominences. So if you see the cervical collar here, what are we looking at? We're looking at the chin and we're looking as the brace sit in relation to the chin, the ears, kind of the base of the skull, and then we're also looking at how it sits on the sternum and on the thoracic spine. So if you feel like you're not going to overwhelm your patient with too much information, feel free to discuss what you're looking for because if there's a family member with them, you can provide them with these tricks or if they're doing this in a mirror. So again, we're just giving our patients as many tools as they can have to build their own confidence while you're confident in fitting their brace. This then leads right into the patient-allowed adjustments. So what you want to do is educate your patients on self-monitoring of the brace. So this means both from a proper placement standpoint, but as well as for mechanical issues or straps breaking or let's say a buckle breaks or Velcro, the Velcro starts to wear. These are very important things that fall under the maintenance of the equipment that the patient needs to continually look at while they're donning and doffing this brace. As athletic trainers, we understand we have to fit these braces properly. We have to educate our patients. We have to educate patients' family members, their parents, their children, whomever's going to be touching this brace. We understand that fact, but let's go into the risks of improperly fitting that patient. Why is it so important? Number one, patient compliance. All I speak about is building that trust between the patient, the provider, yourself, the brace. Trusting the process. If the brace does not fit, that brace will end up on the patient's floor or remain in a closet or will remain in the trunk of their car. They're not going to use the brace. So they're going to come back and they're going to tell you that the brace doesn't work. And there's no way for you to know if they've actually worn the brace or not worn the brace. But in general, patients are non-compliant if that brace does not fit or if the brace is causing some sort of irritation. One of the things you need to remember that I did not mention on a previous slide is that what if this is a post-operative patient and they have post-operative bandages or they have an incision in the brace because of a poorly fit brace or if we did not educate that patient in the beginning on how to adjust the brace around those incisions or those sutures or staples, that patient's going to take that brace off. We cannot afford for a post-surgical patient to not be compliant because what do we do? We're increasing their chance of additional injury to that patient. We must remember we are here to help. We are not here to hinder. So discussing something like post-operative bandaging, post-operative suturing, stapling, again we need to make sure that the patients understand the importance of keeping that brace on and keeping it fitted properly. In addition, once those sutures come out, once those staples are removed, we need to be able to re-educate the patient because now we can possibly readjust their straps, readjust their abduction pillow, or readjust things to make it even more comfortable for our patients. So we need them to make sure that the brace will work. We are not here to hinder their recovery and we are here to make them better, but the brace and rehab is a living, breathing thing. This will continue to change. So again, going back to building that trust, being that resource for the patient. Let them complain to you. Let them complain to you about the brace. We don't want them to lose trust in the provider or practice. If the patient feels that the brace doesn't work and it's simply because they are not compliant, we are at risk of them losing trust in our provider, our practice, ourselves in general, and we cannot afford that. So we need to be able to analyze what this patient is saying and know, is this a true complaint or is the patient simply non-compliant? The answer is irrelevant, but what you need to do is then address that concern or complaint from the patient. Some things to remember briefly are sometimes some of our patients are going to struggle to understand the information we're giving them due to either cognitive issues, language issues, so maybe try simplifying your language. Use analogies if you need to. Try and get to that patient's level. Whatever that patient's level is or their family members, and talk to that patient. This might, this will allow you to figure out, is this a complaint or is the patient just being non-compliant and doesn't really want to wear the brace? Finally, it could be just a motivational thing. Sometimes patients just get discouraged or frustrated with their recovery, so you need to be able to notice the emotional needs of the patient. Give them that positive reinforcement that they're potentially looking for. You might say, wow, all of this goes around a brace. Yes, it does, because this brace is touching that patient on a daily basis, probably for multiple weeks at a time, so we need to make sure that that brace fits, because otherwise we will risk the success of a surgery or the success of that patient, and we do not want to do that. We are now going to shift gears, and we've already fit the patient. Now, how do we handle any patient queries, concerns, questions regarding the brace, questions regarding their recovery, their rehabilitation? There's many questions these patients are going to have. Sometimes you'll have time for these. Sometimes you'll feel a little bit rushed, but as I mentioned in the beginning, if you have an efficient plan, and you're able to clearly communicate about the purpose and the usage of your DME, it will enhance your compliance and hopefully enhance your outcomes. So, what do we mean by this? I suggest making a cheat sheet of each brace, and this might sound like a lot, but trust me, it does work. Make a cheat sheet for each brace you have. Let's say abduction pillow, post-operative knee brace, as you see on the screen, or an osteoarthritis brace. Some of the more complicated braces, and then on that cheat sheet, what are the frequently asked questions regarding that brace? What do patients ask the most? So, do they ask, do I have to wear this to bed? Do I have to wear this when I'm sleeping? Can I shower in the brace? Can I bear weight? What is my weight-bearing status? There's going to be many, many questions these patients have, which is again why you need to understand which physician that patient is seeing, and what is that protocol that the physicians are using. This way, you can address their concerns, patient-specific and provider-specific. Another thing to understand is that these patients aren't always going to be in front of you, so you're not going to be able to in-person troubleshoot for these patients. You might have to do it over the phone. In fact, you may more not have to do it over the phone. So again, understanding the brace, understanding the patient's question, having those instructions for use, that IFU that I discussed earlier, if you have that out in front of you while you're on the phone, you've already introduced that IFU to the patient, so they're at home or wherever they are, they may have it in front of them. Now, if they forgot it or if they lost it, you can either email it to them, send them another one. You want to be able to provide those to the patients as easily as possible. But let's say you're talking on the phone about the brace. You're going to have to communicate very complex information effectively and simply, and you're going to have to make sure that the patient also is comprehending what you're saying. It's not like you have to test them, but follow-up questions, making sure they repeat back to you what you have said or making sure that they understand what you're saying and have a general understanding of it. If you can see here, the picture on the left has the knee brace slightly lower than it should be, and it is off of the hinge site, so it's off from where that range of motion is needed. But on the picture on the right, you can see the hinge is then lined up. It is not too far anterior. It is back on the joint space where it needs to be. This is a simple way to communicate complex information effectively. If you do this, as well as that cheat sheet, if you have pictures, visual aids, if you can show an anterior-posterior shot and a lateral shot, it's kind of a bilateral shot of what could happen and where the brace needs to be. And if you can provide these, again, for those abduction pillows, post-operative knee braces, as you see here, OA braces, ACL functional braces, if you can provide very simple one sheet of pictures of X and green check mark, that will go a long way in handling your patient questions. I've said it many times already, and I will continue to say it for the rest of my professional career, but as athletic trainers in this DME space, you must be a trusted resource for your patients. You will be that person where these patients are going to follow up with questions, concerns, issues that they have. And I'll be honest, that's what you want, because this way you can build a positive, successful DME program. You do want to be that go-to person. It sounds like I'm giving you much more work. I promise you I'm not. If you use these strategies of developing frequently asked questions, of developing one sheets with pictures or videos, as you see here on the bottom of the slide, all of these things combined will help build your DME program and build your efficiency so that your patients understand their role in their own recovery and what that brace does for their recovery as well. Now you can see on here I wrote, do not be afraid to discuss financial information. To be clear, you are not only a trusted resource for financial information, but as an athletic trainer myself and being friends with many athletic trainers, we aren't great about the finances. We tend to shy away from that. I am telling you from a DME standpoint in the DME world, you need to understand the financial information, at least the financial implications of the braces you are providing. You do not need to be an expert in insurance or Medicare. You just need to understand that patients will have a concern about the finances and their potential out-of-pocket costs. If your practice allows it, you can develop a fee schedule. Now, some practices say these are private. You don't want the information getting out there. But when a patient receives an EOB or an explanation of benefits, the charge for that brace is going to be on there anyway. So these dollar amounts are not secrets and we shouldn't treat them as secrets. We need to be open with our patients. And as athletic trainers, you need to be comfortable in discussing financial information. It could be as simple as if the patient has a Blue Cross Blue Shield plan and there's a number on the back of their card, you could suggest, hello, patient X, if you really need that dollar amount or want to know you're out-of-pocket, we can sit here, wait, I'll fit this other patient while you call your insurance and get that information. Now, this is not ideal. I completely understand that. I'm just simply providing you a reasoning behind why you need to feel comfortable with the financial information. To move on, while you're fitting the patient and always while you're talking to the patient, you want to encourage those questions to foster just a better understanding. Again, we can tie it back to the financial information in those questions. But more importantly, I want you to determine what are the patient's issues? What potential issues will the patient have? What do you see yourself as the athletic trainer, but then you're also asking the patient, what do you see as your biggest issue or complication with the brace? Now, it could be, I live on a fourth floor apartment building with no elevator and you're putting me in this post-operative knee brace. That's a question that we'll go back to the provider for. But if it's something simple or something you hear frequently, you'll be able to answer that. Now, my most important thing that I stress is active listening. Listen to the patient that is speaking to you. Do not have a preconceived notion of what they're asking and don't ask a question that you've been asked in the past. Do not anticipate what that patient's going to ask you. Even if you're right in anticipating it, don't do it because that patient may see that as you sort of not validating their question. Sometimes if you already have an answer or if you look frustrated, that patient will lose trust in you. You want to be confident. You want to be the person to give them the best answer possible. It might seem counterintuitive that I've said, make a frequently asked question sheet, but then also speak individually to that patient. What I'm trying to get across or the point that I'm making is that we need to be sure that we're treating patients as individuals and we're not treating them as products or commodities. So by actively listening to that patient, even if you've heard that question a hundred times that week, you're treating that patient as an individual, not as a commodity. And that is the most important thing or one of the most important things we can do in building that trust is because we want that patient to feel wanted, not to feel like a dollar sign themselves. Finally, if you can see, we have the shoulder pillow education video. It is similar to the post-operative knee video that I included earlier. So please give it a watch. It is just another strategy for trying to address the most common questions your patients are going to ask. And it gives them a tool. So if they're not on site, it gives them a tool to use at home or wherever they are so they can pull from that and they can continue to learn in their recovery and their rehabilitation process. Let's change gears and now discuss our equipment safety standards. So you've already fit the brace and you've answered the questions. Now we're going to talk about the exact safety standards that are out there for your braces and products on your shelves. DME itself is subject to regulations to ensure patient safety. The FDA or Food and Drug Administration has a very strict FDA or Food and Drug Administration classifies all medical devices into three categories based on their risk levels. And you can see that here. We have class one, which is the low risk, which is crutches, ace wraps, and those don't follow too many standards. They have the least regulatory control. Next is the medium category, which is where most of the bracing will fit that we're discussing. These do fall into rigorous standards and they must fall in compliance with very specific guidelines set out by the FDA. Finally, the high risk level is implants. So you're looking at total joints, hips, knees, those kind of things, spinal implants. Those are the most intense standards, but they do not apply to this course specifically. So what you want to do is be compliant with the safety regulations that you see here and the sizing. When you're fitting your patients, you want to make sure that that equipment is appropriately sized for the patient because a poorly fit brace can lead to skin irritation, can lead to decreased or impaired circulation or ineffective support in general. So making sure that sizing while you're fitting and that you're following those guidelines is extremely important and we've addressed why in previous slides. Now let's provide written instructions and educate our patients on proper handling. Oh, this is what we had already done in the past. We've already gone over those IFUs, the instruction for use. We've given them to the patients. Now most times on those IFUs, they will have care instructions for your equipment. And by this I mean, is it machine washable? Should you wash it by hand and let it air dry? Do you use a hypoallergenic detergent? Some things of those nature. So on those IFUs, a lot of times, especially if these are high contact braces, let's say cervical collars or spine bracing that's going directly on the skin or some of those osteoarthritis knee braces where that padding is going directly on the skin and patients are wearing these during exercise, during physical activity and they want to be able to clean them. You need to understand what is safe for the equipment you're providing and be able to provide that to your patients. Finally, the regular maintenance checks and inspections of all equipment. I mentioned previously that as you take it out of the bag and are putting it on the patient, you should be examining it at the same time. You should also be regularly inspecting your DME when it gets to you. So when you're pulling it out of the box from your vendor and putting it on your shelves take a look at it Make sure everything is okay Look for any sort of signs of damage or any signs of undue stress on that brace sometimes you can see a buckle that might have a little wear and tear to it just from shipping in the process, but Do not skip this step. Make sure you are inspecting all of the equipment at all times because you do not want to be liable for putting an improper or poorly mechanically made brace on a patient. As mentioned the FDA is the one that sets out those guidelines, but two other websites I'd like you to be aware of CMS.gov that is Medicare's website and they have a huge amount of information regarding DME Regarding the braces that they're looking at and all of their rules and regulations are on there including all of their safety standards There are even about I think it's around 30 to 32 Supplier standards and this document must be provided to all of your Medicare patients. So again CMS.gov has a lot of good information for you. The last website on there is DME PDAC Now PDAC stands for the Pricing Data Analysis and Coding of Bracing. So what CMS does is they approve the brace then the brace goes to PDAC to make sure that it is financially viable Meaning that CMS will approve the brace for a code. Let's say in L1832 then it is sent to PDAC for pricing and verification and for definition. So in 2025 CMS is really stepping up their PDAC approval or Making sure that the braces that are being dispensed to Medicare patients have that PDAC letter So this is something if you're not familiar with please make yourself aware of PDAC because currently in 2024 there are Denials coming across for some of the more common braces your ACL functional braces that do not have PDAC letters. This is something to look out for. It's not with the big vendors All of your bigger vendors will have PDAC letters for all of their products But if you do go to a less expensive option, which is completely understandable just make sure that the braces and the vendors that you're using have those PDAC letters because it could affect the financial viability of your DME program down the road It is rare with the DME that we use for it to be recalled but there are instances where there are recalls and You need to be aware of how to handle these recalls How it affects your patients and how it affects your specific DME program The first thing to do is to stay informed about all medical device recalls You can see I placed the website here on the FDA and It will give you all of the current medical device recalls that are out there You just input the information into the system and it will kick it out for you. So this is a huge resource For you to use when you are not sure if there is a PDAC letter If there is, it will be on this fda.gov website Now, if you're able to see that there is a recall or If you've signed up for an email list from your vendors from manufacturers and you get the newsletters and are alert What steps do you take? What do you need to do to make sure that this Is sound and that your procedures are solid? You need to make sure number one patient communication If a device is used by your patient and it becomes recalled you must communicate this information clearly You need to provide details about the recall to the patient including the reason and any potential risks with Continued use and you need to make sure that you have the right information for continued use Once you've notified these patients you need to work with them To get those recall devices returned to you promptly You need to ensure that the patients understand how to transition To any alternative equipment or to any new braces that you may give them Finally, then you must document this document document document We hear this all the time in athletic training and it applies in this as well for dme and for recalls You need to document each individual step you've taken So you need to keep thorough records of any recalls and document all communication that you've made with the manufacturers manufacturers vendors or reps As well as your patients and you must note or at least make the provider aware so that they can note Any changes in their treatment or in their bracing? now sometimes The easiest thing you can do is contact your manufacturer your vendor if They don't seem to care or if you have a rep who is not responding in a good proper way Feel free to change vendors or reps Any recalls need to be stressed with the utmost importance And if a company is not willing to help you To solve the problem to solve your patient's issues because ultimately that's what you're trying to do Solve the patient issue and not add to their problems or add to their length of recovery If the vendors are not going to do that, please search for another vendor Now also if you use an inventory management system, you might be able to Pull, let's say an l1832 Is part of the recall process? In your inventory management system, you might be able to pull by that HCPCS codes or you can pull by the manufacturer But the reason I bring in the HCPCS codes Let's say it's an l1832 brace or that's the most common code that you use You need to understand the braces that have the split codes or the dual codes so that you can pull Not only your custom fit braces, but your off-the-shelf braces as well So if you have a an l1843 osteoarthritis knee brace, but you also bill out L1851 You need to look in your inventory management system and make sure you're pulling all of those braces So this is just one final piece to be aware of in your recall protocols Now let's delve into the very important topic of reporting adverse effects related to DME usage So first off Why report these things? Number one because we need to be able to identify trends And prevent any future issues with the bracing so Just like having a cheat sheet with frequently asked questions. We need to be able to identify Where do our braces affect patients the worst? What are problems? Hopefully they are not but if you can identify Trends that are occurring Maybe it is in the brace so you can talk to the manufacturer or the rep Maybe it's on your application. So maybe it's something that you need to correct Internally when you're educating patients or when you're fitting the brace and the only way to know that is to have Patients report these things and to take them seriously again Similar to the recalls we need to take these adverse Effects seriously because they can contribute to patient safety and overall quality control What you need to do is to be vigilant for signs of these adverse effects And these include skin breakdown any excessive swelling any persistent pain Any patient that potentially could develop a rash under that brace And when you're fitting these you need to educate patients to report any issues you don't need to say hey look out for this specifically because You're just going to get into an endless conversation but What you should say is hey if you notice anything different if something feels weird Or if you just don't feel right, please let us know. Please report that to us so we can take a look at it This also is where a great relationship with your rep similar to that recall Is important because let's say it's a manufacturing issue or it's a brace issue Your reps or vendor Should be able to stand behind their products And if it's a brace issue, it should not be the financial responsibility of your DME program or your practice So a good working relationship with your reps and your vendors is very important for this adverse effect section as well Now, how do we report? You definitely want to use the proper external channels and i'll get into those in a little bit and again document document document So from a reporting standpoint, you need to familiarize yourself With whatever procedures your DME program and your practice Use for reporting adverse effects This can involve documenting your patient's experience Submitting a report internally or submitting a report to the manufacturer To the FDA or to CMS or to any other regulatory body out there Again, encourage your patients to keep a log of their experiences with the equipment Noting if they have any discomfort or any issues the reasoning is they can bring this log in and it can be valuable for both the Patient as well as the provider as well as your DME program again in helping you to identify any trends or potential complications down the road Finally from a follow-up standpoint After any sort of adverse effect is reported. You need to ensure that the patient receives the proper appropriate follow-up care Do you need to make adjustments to the device? Do they need additional support? Do they need a phone call from your provider? Do they need alternative equipment or Some sort of adjustment that you need to do that brace this all comes from Having that trusted relationship with your patient the patient Being able to come to you and know that you're going to take their Complaints seriously and then you reporting it now as far as the proper external channels and who to report to number one You're going to make sure that Internally you have a process that the patient comes to you You then go to that patient's provider and you document and this is put in the chart Sometimes some of the EMR systems will allow photos Everyone nowadays has a a phone on them so if there's a skin irritation or a breakdown or If you can note the placement of a strap that caused that skin breakdown and take a picture of that And upload it to the patient's chart. That is hugely important So you have that internal chain then next the next external channel would be the representative of that manufacturing company To contact them see if other patients in the area are having issues other patients across the country if they're having issues then Finally if the rep doesn't listen you want to go to that manufacturer in that vendor and find out. Hey, what is going on? but again To take it one step further You can then go to the cms.gov or fda.gov and find out how serious this is Again, if your vendor manufacturer is not responding you must take things to the next level In order to ensure your patient's safety It is important to note that some examples of adverse effects like skin breakdown excessive swelling or persistent pain Can just be part of the patient's injury and part of their recovery So the important thing is to differentiate with the patient That it is either an adverse effect from the brace or it is just a normal effect That is happening throughout the process You you must get with your provider Obviously to discuss this with the patient and to make sure that you are all on the same page but my point similar to Differentiating is it a complaint or is the is the patient just non-compliant? You need to make sure it is an adverse effect and not just something that occurs Post-operatively or let's say the patient just has extensive swelling They've had a tibia fracture and their ankle is just hugely swollen we need to be able to educate our patients and differentiate between normal anatomic body physiological responses Versus an adverse effect. So from a skin breakdown, is it a friction blister? Are you getting some rubbing in that area? Why is that skin breaking down? We were in the process of developing a brace a hip brace with a manufacturer And we had five Test patients who were fully aware of what we were doing And they were five female runners in their mid to late 20s, and they were all distance runners so they had limited body fat on them and what was happening on their Anterior superior iliac spine on their asis They were all getting a somewhat of a friction blister and what we found was because their asis was so prominent and the strapping On the pad that went over that asis was toggling it was toggling a very little bit But that's what it was doing and it was developing that so there was getting skin breakdown on that asis spot So we corrected that obviously changed the toggling of the bracing but The point is that is something that came directly from the brace and we could figure out why it was happening Excessive swelling again. Are there pockets of swelling? Is this normal or is this abnormal and then persistent pain the patients will know or they'll be able to feel their injury and know You've heard patients before where they'll say Something just isn't right Something is off where this pain is different than my usual knee pain or my usual ankle pain And that's when you need to be aware Hey, maybe this is the brace. Let's figure out what we're doing what i've included in here because many Dme coordinators dme programs are unaware of is that there is a medicare quality of care complaint form now this form Should be must be in your dme Policy and procedure manual and it must be available to your medicare patients if they have a complaint It is used for complaints regarding providers, but it is also a catch-all document For any sort of problems or adverse effects you do need to be aware that this document exists You do need to add it to your policy and procedure manual And if you have a medicare patient who has an adverse effect Please fill out this form and follow the instructions. I only have one page on here, but it is a three-page form Finally to sum up. I have two case studies one A we had a knee brace a patient came in And reported some skin irritation and this was over the phone. So we had the patient come in We saw that the brace was too tight and this patient he was just getting some pressure pressure sores And we we couldn't determine if it was An educational issue. So did we mess up or was the patient just pulling the brace too tight? I'll be honest It's irrelevant what where the problem came from because we addressed it as if it was both our fault As well as the patient doing too tight. So what we did is we Showed the patient we adjusted the fit on his brace Re-educated him on proper usage and this resolved the issue the The only caveat to this was that he did have some blood a blister had popped So some fluid had ended up on these straps. So we just went and Uh replaced his brace at no cost for him because of that We couldn't have him leaving with any of that on the brace the ankle brace recall we were using uh this ankle brace for years and then Out of nowhere got an email and it said the brace had a manufacturing defect So we quickly pulled all of those from our shelves. Our rep actually took the braces back. They were very good about it We did provide all of our patients with an alternative brace An alternative ankle brace so they they were still getting the same care, but we gave them a different brace Educated them on that brace and everything was at no cost to that patient and done At the patient's convenience while also alerting them that the brace did have that recall In summary We've learned the importance of proper DME usage and how this affects both our patients And the practices that you work in also Communication is key We're using communication to develop the trust in relationships within our patients so that you can build a Strong DME program that not only works efficiently But works to ensure that your patient's rehabilitation protocols Are followed and that your patients have the most successful outcomes possible Also, we learned how to handle patient concerns effectively this includes taking any adverse effects Seriously, although we might hear the same complaints a hundred times. We must treat each individual patient and their complaints Seriously because that is our commitment to safety and to quality care I thank you for your time today, and I wish you happy brace fitting

Patient Education

Durable Medical Equipment

Athletic Trainers

Rehabilitation

Proper Usage

Compliance

Patient Safety

Communication Strategies

Device Recalls

FDA Regulations