>>KOPELOW: Hello, I’m Murray Kopelow the chief executive of the Accreditation Council for Continuing Medical Education.
>>MARQUIS: Hi my name is Damon Marquis, I’m the Director of Education and Member Services of the Society of Thoracic Surgeons.
>>KOPELOW: Hi Damon.
>>KOPELOW: Thanks for joining me today.
>>MARQUIS: Happy to be here.
>>KOPELOW: Excellent. We want to talk a little bit about your organization as an accredited provider and some of the programming that it does and some of the approaches to programming that it does. Tell me a little bit about your organization.
>>MARQUIS: Well, The Society of Thoracic Surgeons is a membership organization, we have over 5,900 members from around the world, most of them are from the United States, Cardiac thoracic surgeons, so, cardiac general thoracic and congenital cardiac surgeons and we do have some allied health members. We offer a variety of educational programs; our major program is our annual meeting, held every year in January. And then, we do standalone meetings, for instance, we have a thoracic endografting program we offer periodically. And we also offer online journal CME it’s completely online you have to use the journal online to claim the credit. So, that’s what we’re doing right now, we’re expanding in the next year to include point-of-care CME activities, as well as, performance improvement using the STS National Database.
>>KOPELOW: And who’s we? How many of you are there in the CME unit, specialty society?
>>MARQUIS: Well, interestingly, dedicated staff, we have including myself, I have four other staff that are working full or part time on CME. And then, staff of the rest of the office from the different departments, when they’re involved in putting on educational programming. For instance, if we’re putting on a session on patient safety, we have a department that has a focus of patient safety. So, we’ll utilize their staff, particularly in the planning.
>>KOPELOW: staff the grows to manage the activity
>>KOPELOW: Excellent. Now, it’s a surgical specialty, procedure oriented, utilizing devices.
>>KOPELOW: And that, that presents some special challenges, because devices are developed, devices are new, people have ownerships, interests in devices, devices are marketed, devices have to be turned on and off – people have to know how to use them – that makes it very complicated and the issues of independence from commercial interests makes it, comes to bear in. So, let’s try to work through some of these issues about how you wind up being an organization as Accreditation with Commendation and facing all of these challenges. So, first, is there any truth to my statement that that in your specialty society education on devices is an important part of what you do?
>>MARQUIS: Yes. Education on procedures using the devices
>>MARQUIS: and that is a core part of what we do, in fact, the last part of our annual meeting, rather than being talking heads or even being open debate, is called, what we call STS University, which is all procedures. We offer 12 wet labs at the same time utilizing products from over 40 companies. So, it is a huge undertaking.
>>KOPELOW: OK. So, what’s your starting point in deciding about an educational activity that has a device as part of it what’s your, where do you begin?
>>MARQUIS: We have a task force conveniently called, the STSU Task Force, that looks at the specialty across the subspecialties and identifies procedures that are new or are not being done at the level that they should be, not enough people are doing it or there are products are out there now that can help do the procedure. And the surgeons decide, these are the courses, these are the topics that we really want to address for the upcoming STS University. At that point, we identify course directors. We try to have two course directors for each wetlab, so that they can team up. They’re going to have different perspectives for the course. And they will also, quite frankly, most likely, have experience with more than one product. We really do try in any wetlab to incorporate all the products or as many of the products as we possibly can that are available for that procedure.
>>KOPELOW: What’s the role of Industry in that committee that decides what devices should get talked about?
>>MARQUIS: Now, Murray, you know better than that. They don’t have a role in that. We, it becomes a little bit problematic. Clearly Industry knows, what’s the latest; I mean they’re constantly in the process of developing new products. They don’t get brought in until we’ve identified course directors and the course directors have fleshed out what that wetlab is going to be. So, there’ll be a certain amount of didactic to present the content to the attendees. And then, what do the stations need to look like? How are we teaching this procedure? And at that point
>>KOPELOW: no that’s good and I want to come back, right back to the beginning again, because these are critical points for people who are listening to this, about how you ensure independence. So, you’ve talked about the fact that you start with professional practice gaps.
>>KOPELOW: You start with understanding under use or overuse or misuse
>>KOPELOW: that are identified by your members, by the surgeons
>>MARQUIS: by surgeons, yes.
>>KOPELOW: And the surgeons say, these are the gaps that we’re going to fill. The University addresses whether it’s a knowledge need, or a strategy, or hands-on performance, but the basis is decided. So, the curriculum of your University is not determined with input from Industry.
>>MARQUIS: Industry has no role.
>>KOPELOW: Profession decides. So, you bring together that group, then you get your course directors and they’re going to do content.
>>KOPELOW: That’s the idea is that they’re for those 12 sessions, is there 12 of those course directors?
>>KOPELOW: each one of them is
>>MARQUIS: no, actually we try to have 24, two for each one.
>>KOPELOW: OK. A little balance, a little…
>>MARQUIS: There’s a benefit to doing that. If, if you work in one hospital setting, that hospital setting may only use a certain device and we want several devices if there are several devices for the same procedure. So, having two course directors you’re more likely to have people who are truly familiar with a variety of devices. So, it works really well that way.
>>KOPELOW: OK. And, you mentioned that there’s the input of Industry isn’t sought until those course directors are identified?
>>KOPELOW: Right. Did I hear you say that? So, tell me about that, these two people decide what’s going to be learned and where do they bring in Industry or how do they bring in Industry in that process?
>>MARQUIS: OK. The course director doesn’t bring in Industry. The course director will identify what product we need in order to teach that procedure. We also ask the course director to identify a staff member that works in their hospital with them, who may have more familiarity about what need to be in the OR when you’re practicing that or when you’re performing that procedure.
>>KOPELOW: So, that’s interesting. So, many people would think that you need to go to Industry as the expert on the device, but you’re saying that you can find a professional in a healthcare institution that can be an expert on the device that doesn’t work for Industry or doesn’t have a relationship with Industry, that’s why
>>MARQUIS: Correct. We will eventually get to Industry
>>MARQUIS: but, it’s not until after we’ve vetted through the surgeon, and one of their staff members be it a nurse practitioner, a perfusionist, a physician assistant, we talk to them about OK., in the OR, what will he or she have available for this procedure?
>>KOPELOW: And this helps you what to plan to make available?
>>KOPELOW: So, the other advantage is, is it brings the team together.
>>KOPELOW: It brings another member of the healthcare team to the discussion.
>>KOPELOW: So, now this triumvirate of the two course directors and this other expert have are informing what should be the curriculum. What’s the next stage in your planning, because so far independent of Industry.
>>MARQUIS: Correct. So, the next step is, my staff generates a list of the product that’s going to be used to teach the procedure. We then contact the various companies that have the product that we need. And tell them, here’s the course that’s being offered. Here’s – we don’t really go into a lot of detail of the didactic – but here’s the procedure we’re going to be teaching and here’s the product that we’re requesting from you. Can you provide this product? And they will tell us, yes or no. And more and more, they’re moving to applications online and so we don’t even speak to somebody when we’re asking for a product.
>>KOPELOW: Because, it’s like commercial support, it’s in kind commercial support
>>MARQUIS: it’s being treated very much, more like the pharmaceutical world has moved, the device world is moving in that direction now as well. When we are talking to Industry there are times when they know that there is a product that is missing on that list that needs to be used with their device in order to teach this procedure. We will write that down, we do not ask the Industry rep to contact the company, the course director; there is no communication between the course director and Industry. We write it down. We contact the course director and their staff to ask if indeed the product is needed.
>>KOPELOW: So, this is like cables, power supplies, monitors?
>>MARQUIS: Do we have the right suture? Do we have the right forceps? Do we have all the right product? If the surgeon
>>KOPELOW: for the procedure?
>>MARQUIS: for that
>>KOPELOW: it’s not the device, it’s for the procedure?
>>MARQUIS: it’s 100% for the procedure. If the surgeon says, Yes, I do need that. Then we’ll request it of the company. If the surgeon says, Really, I don’t. We tell the company, Thank you, but no thank you.
>>KOPELOW: And then, now it’s implementation day. It’s now the wetlab day, it’s the day after your meeting and you’re starting the University sessions. What is Industry the people donated, are they there? Are they around? Do they looking over the shoulders? What’s going on here?
>>MARQUIS: It’s changing with the times. For the set up of the wetlab we will assign the tables for where the product belongs. So, the companies don’t get to say, I’m going to be next to this company or I want to be as far away form this company. We assign them table, this is where your product is being set up. Industry will come in and set up their devices and their materials. We don’t know how to set that up; they do, they have the technical skills. But, the moment seven o’clock hits and the course starts all but one Industry representative must leave the room. So, each company who has an Industry has product in there will have an Industry representative. There are exceptions to this, when you have a, a device that needs a expert tech to actually run it, not teach how to do it. It’s something the surgeon will never be doing
>>KOPELOW: like a perfusion pump or something
>>MARQUIS: Correct. That person will be there, not talking, not teaching.
>>KOPELOW: What you’re teaching is not the device, but the cannulation, how to put the
>>KOPELOW: How to put that into the blood vessel.
>>KOPELOW: That’s where the procedure is happening.
>>MARQUIS: Correct. But, we got to have this person over here making sure
>>KOPELOW: the blood, the liquid is flowing
>>MARQUIS: correct. Other than that, the Industry rep is available; they can stand by the station so they can see what’s being done. We actually take the step so my staff knows who’s who in the room. The instructors are wearing a certain color gown; the attendees are wearing another color gown and Industry reps are wearing a certain color gown. So, we can look across a large room and tell, who’s doing the talking, who’s doing the teaching, and if it looks like an Industry representative has stepped to the table we immediately go to that table and make sure that they are not teaching or not showing anybody how to use the product.
>>KOPELOW: What do you do about that? Do you explicit roles, limitations, scope of practice in the room, what do you do about that?
>>MARQUIS: well, there’s a couple things we do. Before we even get on site we have already sent to the Industry representatives our contacts, our rules of what the industry reps can do, should do, and they cannot do. And we also tell them what the course directors are doing and what the staff’s role, our staff’s role is. We then, also, have a meeting on site because often times our contacts at the national headquarters are not the people who are showing up at STS University. So, we set up a meeting either the night before, or two nights before STS University with all of the Industry representatives that are going to be in the room and with our staff and we go over the roles again. And we also, to reinforce what we’re doing, we’ll distribute the Standards for Commercial Support to underscore, this isn’t just we’re feeling like we want to be mean guys. Here’s some of the explanation for why we want this separation and more and more there’s a real appreciation for this. I think when we first started there was less appreciation for it. An interesting scenario this year, I didn’t really have a problem with Industry representatives going up to the tables and trying to teach; I ran into something I hadn’t prepared myself for, and that was a surgeon who went up to an Industry rep and started asking for contact information and lead information and I had to intercede. And the interesting thing was the Industry rep pointed out that she had made it very clear that she could not talk to him. So, the Industry representatives are getting it and we need to make sure that we’re teaching our learners now, about the appropriate roles.
>>KOPELOW: That’s, that’s consistent with regulatory theory and background where you don’t really need oversight and compliance when people share the same values.
>>KOPELOW: So, in that situation the Industry person understood the values set that you had established and worked with you, with that physician, to talk about maybe later or another time or not at all.
>>KOPELOW: there’s another way for you to do it. You touched on, that’s monitoring, you’re watching, you’re oversight. You’ve got jackets, but monitoring of the proper behavior and outcome, it would, might be important? Do you do anything else, other than watching the room and watching the interactions? Do you do any evaluation or question asking or reporting at the end?
>>MARQUIS: Naturally, we do surveys. The evaluation at the end of the program we do ask about undo Industry influence in the program. We definitely want to know that. And I’m please to say that we very rarely get anybody saying that there’s been Industry influence. We also ask them what they’re planning on doing now that they’ve learned
>>MARQUIS: something, what are you going to do when you go back to your practice? And some people say, quite frankly, I just wanted to make sure I was doing this the way the experts, the true leaders, are doing it and I feel reinforced that I’ve got this landed. Other people will tell us, I need to get additional training. Now that I’ve practiced this in this, it’s a very short amount of time to practice a procedure if you’ve never done it before this is not, you’re not going back to the OR and doing it. But, they will identify that they need additional education. And that’s a great thing.
>>KOPELOW: And it’s an interesting approach that it brings together the idea that you can, you can identify an under use or a misuse that’s present in the population that can drive your education; you can do the education and you can have two sets of learners in the room, the, the group who learns I can technically do this if I, if I get taught properly. I’m comfortable with this procedure. This is something that I want to go do. I intend to go and get more learning about it. But, you can also have a group of people who say, that gap isn’t my gap. That this is the expert way to do it and I knew that from the literature and I knew, and I’ve had somebody observe and I do know how to do it. People have talked about that as affirmation, but this is more than affirmation. This is like verification.
>>MARQUIS: This really is verification.
>>KOPELOW: It’s at a higher, higher level.
>>MARQUIS: You’re, you’re talking to people who are true leaders, they’re true experts in the procedure. You know, it, it not to bring it home to CME, but if I were wanting to know if am I doing the best I can in the CME world I’d go to an expert and say, OK, here’s what I do, what do you think? Well, it’s, you ramp that up to the surgical level, well, what do you do and how do you do it and am I doing it as well as you are? Are you doing anything different that I should learn? And it also gives you an opportunity, quite frankly, if you’re learning from a table instructor who’s using a product that you’re not accustomed to, is this something you should be looking at? Is this something your hospital should be looking at, because you can do something different in the procedure with a different product? Without Industry selling you on it; you’re seeing by a peer using it.
>>KOPELOW: Damon, one of the things that you’ve mentioned is that , is the, the getting the commercial support, getting these devices in the model of commercial support in kind commercial support and one of the things ACCME requires is, is that you put a value, a dollar value on this commercial support (UPDATED: See NOTE below). On this donation of equipment for a period of time and of the person who comes along. What other kinds of models and methods do you use or have you seen used to attach a value?
>>MARQUIS: There’s a variety of models that people use, and we have evolved and I’m not certain we’ve landed on the right solution yet. On our letter of agreement we list out every product and the quantity of the product. Now, there are some products that cannot be reused and so when Industry provides us with a price on that it is the cost of that product. Other products can be reused, they’re probably not going to go into an OR, but they can be used for education and that’s where we get tripped up because some companies will say, the cost of that device is X and we don’t rent these devices so,
>>KOPELOW: that’s the purchase price
>>MARQUIS: here’s the purchase price. So, that’s the dollar amount we get. Others will say, Well, OK, it’s going to cost you this much, this is how much it would cost if we were lending it out. So, we get a variety of answers for how much it is. And I don’t go back and challenge them because it’s what they’re giving us. Most of the companies have not added in to there the staff time that they, they literally donate for setting the product up on site because they bring people off of the exhibit hall floor put them there. So, they think well they’re going to be there already. It makes sense to me that we should be calculating that in because that is time, but we haven’t, quite frankly. So, it’s kind of all over the place how people report what the dollar amount is.
>>KOPELOW: Damon, thank you very much.
>>MARQUIS: More than welcome.
In March 2011, the ACCME modified the requirement for reporting in-kind commercial support, in response to feedback from accredited CME providers. For activities taking place in 2011 and beyond, providers no longer estimate the dollar value of in-kind support, but instead they report the nature of the support in the Program and Activity Reporting System (PARS). For more information, please visit http://www.accme.org/ask-accme/how-do-we-report-kind-support.
This is a transcript of Planning CME Activities that Utilize Medical Devices.
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