U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES + + + + + FOOD AND DRUG ADMINISTRATION + + + + + MEDICAL DEVICE USE IN THE HOME ENVIRONMENT GUIDANCE WORKSHOP: IMPLICATIONS FOR THE SAFE AND EFFECTIVE USE OF MEDICAL DEVICE TECHNOLOGY MIGRATING INTO THE HOME + + + + + BREAKOUT SESSION: POSTMARKET + + + + + MONDAY, MAY 24, 2010 The session came to order at 1:00 p.m. in room Chesapeake I of the Hilton Washington DC/Silver Spring, 8727 Colesville Road, Silver Spring, Maryland. Suzanne Gardner, Ph.D., presiding. P R O C E E D I N G S 1:02 p.m. DR. GARDNER: Okay. So, everybody put away your BlackBerrys or whatever else you're doing. And this is the session that we want to discuss again what's called post market, which is really about the devices that are on the market and how do we as an FDA, and certainly that means having everybody get better information about the hazards that are out there? And, you know, along with that, we can have some discussion about how we can think about minimizing some of those hazards. Right before lunch I talked to Lisa and one of the things I recommended to her, if you're not very familiar with our guidance world well, let me just ask, how many of you are sticking around for the infusion pump work shop? That's great. That's great. Because if you are and you're familiar with what FDA is doing with infusion pump right now, you will see the guidance document that we've put out. And in that document are really what we do is outline our expectations for industries and for users. So, as we develop this guidance document that we're here to talk about today, that's one of the things that we want your help with in thinking about what we can do for the guidance document and understanding that that has a fairly big impact on how folks do business. We have Jeanette back there who's taking notes, and we're going to take some of our major points and we'll get to talk about them when we go back into the big session. So, let me also get a sense, how many are manufacturing folks here? Okay. And what else do we have? Marsha, we heard from you, so I don't know how you'd characterize what you represent. MS. NUSGART: Representing the manufacturing folks and providers. DR. GARDNER: Okay. MR. BECK: We're a distributor in home health care and service customers' devices. DR. GARDNER: Okay. MS. NUSGART: What might be interesting is knowing the different devices that are represented here in the room. You know, that might play a part. DR. GARDNER: Well, let's take a quick go around. Why don't you give us your name and tell us just you know, we can spend a few minutes doing that, because I only have a sense of what our environment is here and who's represented. So, let's start here. MR. BECK: Well, my name is Jim Beck and on behalf of this row here, we're with Medical Specialties out of Stoughton, Massachusetts. We're a national distributor for home health care focused in on primarily the infusion market. But we have how many different devices? MR. MILOSTAN: We have over 30,000 devices that we currently own and we're tracking over 100,000 right down to the patient level, our customers. MR. BECK: So, 130,000 devices that we track with our fixed asset systems. MR. WARD: We track every event from how often they get washed to when they break to what parts we put into them when they break. DR. GARDNER: First of all, can everybody hear? If I had designed this session, I would have us in a circle and not sitting the way you are all right now. But please be aware that you have colleagues here that can't hear you in the background, because this is important information. And maybe we'll get back to that, but go ahead and tell them what you just said. MR. WARD: Yes, so we have a software system that is designed to take a pump from when it's born in a manufacturing facility to when it goes to a health care provider, all the way out to the patient, back in for service. So, we track every preventative maintenance activity, every part that's being put into it, every type of breakdown a pump might experience. And we do that for over 100,000 devices in the industry. It's all real time and it's across the whole country. And we track for all the largest infusion companies like Walgreen's. We track every single device they have. DR. GARDNER: Okay. Thank you. What about, Marsha, your row? MS. NUSGART: Marsha Nusgart, executive director for a number of different coalitions representing wound care, respiratory care, enteral nutrition and also the Alliance of Wound Care Stakeholders. MR. VIERLING: I'm Philip Vierling of Kalypto Medical, manufacturer of negative pressure wound therapy. MR. KHOROWSHASHI: Hamid Khorowshashi with Prospera Negative Pressure Wound Therapy. DR. GARDNER: Okay. MS. McDONALD: Michele McDonald with Abbott Nutrition, oral pumps and nutrition products. MR. BURKHOLDER: I'm Jay Burkholder. I'm with DEKA R&D. We do engineering, research and development. DR. GARDNER: Okay. And way over here? Really, you're going to stay over there? You need to be plugged in. MS. ST. ONGE: Karen St. Onge with NxStage Medical, hemodialysis. DR. GARDNER: Okay. Go back and forth this way. MS. RODRIGUEZ: Dana Rodriguez with Newport Medical Instruments, ventilators. MS. TODD: I'm Joan Todd, nurse consultant. I'm review adverse events with physical devices. MR. SAMEC: Robert Samec, CareFusion, home care ventilation. MR. POSEY: Ernest Posey with the Posey Company. We make rehab products. DR. GARDNER: I'm sorry. You make what? MR. POSEY: Rehab products. DR. GARDNER: Oh, okay. Good. MS. THOMAS: I'm Debbie Thomas, West Pharmaceutical Services, primary and secondary components, medical devices, manufacture safety system, reconstitution systems, mostly class II devices like bio adapters and things like that. DR. PURPURA: Joe Purpura, medical director of medical device safety, Baxter Healthcare. I'm also an assistant professor at Northwestern University Med School and I teach the patient safety curriculum. MS. SKEENS: Lisa Skeens of Baxter Healthcare specifically focused on renal dialysis, both peritoneal dialysis in the home, as well as hemodialysis. MR. MOSKOWITZ: Aaron Moskowitz with the Biomedical Research and Education Foundation. We're a nonprofit involved with patient safety. DR. GARDNER: Okay. It's your turn. MS. NAPOLOTINO: Jenny Napolotino for the FDA. I'm with the CDRH. COURT REPORTER: I'm sorry, I can't hear. MS. LYNDEN GREEN: I'm Maureen Lynden Green. I'm with Fresenius Medical Care, home dialysis as well, both peritoneal dialysis as well as the home hemodialysis. MS. BIERMAN: Beth Bierman. I'm with Morgan Lewis. We represent manufacturers of medical devices. DR. GARDNER: I'm sorry. MS. BIERMAN: We represent manufacturers of medical devices. DR. GARDNER: Okay. MR. YOUNG: Brian Young, KCI, manufacturer of negative pressure wound therapy devices. MR. PAPADOPOULOS: Daniel Papadopoulos. MS. HOFFMAN: My name's Laurie Hoffman. DR. GARDNER: Okay. So, I guess one opening question would be, and we also when we first started this conversation let me just ask those of you that are responsible for the manufacture and then subsequent oversight of your devices; and you know the large percent of it's going into the home, how do you monitor the safety of these devices as they move out of the home into the manufacturing community, or into the home use community? I guess you could tell your story again. MR. WARD: Oh, sure. We monitor the devices because we are connected to everyone of our customers and they use our system because it helps them. Their primary incentive is that they don't lose devices as often. But their secondary benefit is that they get much more efficient use out of the devices. So, they might be able to get 80 percent utilization if they use our system. What we get is the ability to give them early warning. There was a device that needed a software grade immediately this year, actually last year. We were able to identify all of the devices for our customers in a matter of three hours to the patient level and mark them for software upgrade. And they were able to turn that around in, you know, about a tenth of the time it would have taken them if they didn't have our system. Yes? MS. TODD: Question. Is this all dependent on your consumers registering with you once they buy your product, or how do you get that list to have that contact? MR. WARD: You know, it's kind of taken a life of its own. We supply a service that is used quite frequently and we have a lot of market share, but we added the software system that we believe is exactly what we're all talking about. And so, if they sign up with us, they get the software system and then we track their pumps on everything from when there's a defect in a product, when a manufacturer makes a change on a certain capacitor. We can tell which serial numbers in the field require the upgrade all the way to the patient level. MS. McDONALD: Do you then communicate to the manufacturer if there's any complaints or adverse events? Or how does that MR. WARD: We do communicate frequently with the manufacturers and we are being brought in more and more to do a lot of the repairs. But with adverse events, we right now are leaving that up to the health care providers to communicate that. MS. McDONALD: To the manufacturer? MR. WARD: Yes. MS. McDONALD: Okay. MS. TODD: So, you don't feel an obligation that you should report adverse events back to the manufacturer that you're aware of that information and are contracting with you? MR. WARD: An obligation? No, I think we don't even know of all of the adverse events. We know when there's a default with the product or when it breaks and what's wrong with it, but by the time we get it in our hands, we're repairing it. MS. McDONALD: Are you 1345 certified? MR. WARD: Yes. MS. NUSGART: Sue, I was going to say also that that's difficult, depending on what you're talking about. All the different durable medical equipment, prosthetics, product supplies, the whole DME, you know, range of things, depending upon what the actual distribution chain is, and that's what so different because all of these different devices have different methods of distribution. In some instances you have the manufacturer that also serves as the supplier and will ship it, you know, to the patient's home. But dependent again whether it's durable medical equipment, whether it's a supply, it may go from the manufacturer to a distributor, primary distributor, secondary distributor, then perhaps a durable medical equipment supplier and then to the patient, or any variation of this. So, that's what's always been very difficult to figure out. From the manufacturer's point of view, you know, there may be two or three different types of distribution networks before it actually gets, you know, to the patient, the caregiver and then you kind of lose track of those types of things. That's where, you know, the UDI is probably going to very, you know, important down the road. DR. GARDNER: Yes, actually it will. Yes? MR. SAMEC: I can touch on our experience with our CareFusion home care ventilation. We have an install base worldwide of probably 50,000 devices. Essentially, in the U.S. the home care use of ventilation, it's a tracked device, so we do have very good records of the location at least to the home care dealer, which would be the primary distributor. And the dealer then obviously maintains its own records of actually where the device is located at any given time. We track all the maintenance, all the requests for service, anything that fits into the complaint reporting system. And essentially with that data obviously our first priority is to take care of the initial concern or issue, but then all that data is trended monthly. We basically have upper and lower control limits that we look at for different issues. Certain things that are particular just, if you will, known things that would flag for a safety issue and provide investigation. And obviously then follow through with that is the medical device reporting or any of the European or Canadian or Japanese reporting requirements. So, we have a comprehensive system to basically enter the data, track the data, manipulate the data and try to look for any type of trend regardless if it's user error or product issue. DR. GARDNER: Yes? MS. SKEENS: One issue we're having I think we have a similar But one of the things we're struggling, if it's not just getting all of the initial data, but meaningful data, and not that you can actually do a proper investigation and have, you know, assignment of cause to one particular device. And if there's a system of devices, our recent interaction with OSB has indicated if you don't have enough information, you really need to go ahead and report that against all the devices that are DR. GARDNER: Yes, you do. MS. SKEENS: potentially implicated. But then it goes to a lot of information, but not really meaningful information. So, it's not just getting, you know, enough reports, but they have to have enough data in them that they actually are meaningful and can help you understand DR. GARDNER: Right. That's obvious. I mean, if you're not getting it, we're not getting it. DR. PURPURA: I want to ask you a question. You made a comment that your feedback from home users produced poor quality data. Is that because you don't have denominator data, or why is that qualitatively DR. GARDNER: Well, I mean, it's not necessarily worse than our other problems. Well, it's a little worse, but not necessarily worse. First of all, as manufacturers; and I would like to talk about this more, I'm assuming that in spite of your systems that you struggle to get information to you. And you struggle. I know you struggle even in hospitals, because I know how many of you have come back and said to us I can't get the hospital to give me the device, therefore I can't evaluate it. Or we get back to you and you say I can't get back to the user, no one will talk to me, or they've thrown way the whatever, and so whatever. So, you take those everyday problems and then you magnify them, right, because with home care you've now stepped out of an environment that has a risk manager, may have processes and procedures or whatever that will help get you some of that information. So, to my way of thinking, you take the normal problems that we or you have in getting the information that we want and then you move it to an environment that is infinitely more difficult to have the information flow up. That's my assumption of how it works. And as I said, we have in HomeNet, where we have 26 organizations that came in enthusiastically and had been on the phone with us and had Webinars and whatever, they're not reporting to us. DR. PURPURA: Do you see that the manufacturers are when you do get the reports from home users that they do put in the reports that you've also received from manufacturers? And then the follow up question is, is the quality the same in terms of the richness of the data that you're getting? DR. GARDNER: I don't know that I can tell you that we've done a study, that I can give you a systematic answer; and maybe Joan can fill in on this. I would say we see great variability. And sometimes manufacturers are bad reporters. Sometimes they can't get the information and sometimes, you know, the people reporting to them aren't very good. So, we see all that across our reports. Joan? DR. PURPURA: I can see manufacturers making home users better reporters through efforts that we could undertake. DR. GARDNER: Well, that I'd love to hear. DR. PURPURA: Yes, it just popped into my head right now, so give me a month and I'll send you an email. But I think that's something that would be useful. We can teach them that, you know, we're all in this together and here are some of the things that we need to help improve products. MS. McDONALD: Well, and two things and then I want to follow up on that, because I agree. If you know your home user, they're captive. I mean, you're more likely to be able to get to first hand information, retain the product or the disposable, which a lot of times is the tricky piece to get. That is part of the system evaluation that is elusive. But I think what I would wonder is if FDA has data that suggests that there's a different experience in the home user than there is in the institutional user that's driving, you know, this initiative other than just the pure migration of the devices. DR. GARDNER: Right. Right. And I think again, and Joan's one of our analysts, so she can weigh in; this is fine. Most of my information comes from MedSun in terms of the comparison. And that is where we have been able to get into the hospitals and we have been able to get much improved information that comes from the hospitals and some of our other sort of networks. And let me take an example. The laboratories, prior to MedSun, laboratories didn't report to us. They had no idea they were supposed to report as a matter of fact. So, with MedSun came LabNet and we got we actually have quite a few laboratories into the program and they're actually reporting adverse events. So, we have some successes for a non reporting group and in HomeNet we have not yet been able to do that. So, that's kind of my information. MS. SKEENS: And it might be interesting if this especially for some of these diseases that have a lot of co morbidities and are maybe serious life threatening illnesses to have people understand what is an adverse event related to a medical device versus what is related to an underlying disease or what may be perceived to be, you know, just therapy related. DR. GARDNER: Yes. MS. SKEENS: And I think that's something where reporters, whether it's patients or healthcare providers, really may need additional guidance in trying to differentiate that. And I saw that on one of the slides, but I do think that is interesting if we could, you know, help people kind of make that differentiation and know maybe when to report. DR. GARDNER: Yes. I mean, and we tend to, when asked that question, talk in very regulatory language. And I think we need to move out of that and talk about sort of more concrete things that, you know, is related to whatever. MS. TODD: We do get volunteer reports, the consumers, the non mandatory reports that come into us. And it's sort of a different variety, but they tend to report one is they sometimes don't know how to report or the words are just out there enough to say we want your reports, you know, as a consumer. But also, when they tend to report, it's just that a lot of times they put in missing data or they won't have they get the brand name wrong or they'll mis assign the product to the wrong manufacturer. And so it's hard for us sometimes to match up the report to the manufacturer report when they submit that in. But we find the voluntary report is very rich in the event description of what happened. Sometimes not, but more times it is. And a lot of times when the manufacturer does find what matches up, they'll just send that along, you know, too, with it. And then the other thing was that a lot of times the consumer doesn't want to have their identity known to the manufacturer, and that's sort of what we our effort. I think what we tend to do is try to make that aware. Say, you know, go ahead and send it into the manufacturer because that way they can do adequate follow up, because there's a lot of education out there to users to say report and then, you know, let your identity be known. MS. McDONALD: What's the basis of the identity concern? I guess I would be curious, so we could learn to give them whatever if it's a privacy issue or something. But, I mean, in the end they're missing out on getting either compensation or at least giving us information that could help improve the product. MS. TODD: Well, I think on our part we've always protected the identity of the individual unless they want to be known. Some people feel they may be retaliated upon, or maybe, you know, they feel like if they've gotten a product from a manufacturer that they've used and they have to go back to them, especially smaller towns, they feel like, oh, that they upset them or they're not going to be able to get the thing PARTICIPANT: The distributor might be his brother in law. MS. TODD: But there's an whole list of those of those which DR. PURPURA: There's an analogy to that on the pharmaco vigilance side where providers are very hesitant to report adverse events because they know they'll get a blizzard of faxes and, you know, sort of this never ending MS. McDONALD: For the investigation team you mean, the manufacturer? Yes, I think that's the problem, I think, again trying to balance. You're trying to say what prevents us? It's sort of a double edged sword, you know, and that's one of the things we used to feel like we were having to pit ourselves against our customers and threaten to get stuff saying, well, the FDA you know, there's this regulation, you know, and figure out the best model. But from the home user, I think if there's a privacy issue of a disease state or something, we can work with that. We're not subject to comply with HIPAA, I don't believe, the manufacturers. DR. PURPURA: Yes, if you have the information. MS. McDONALD: We are? Okay. Wasn't sure, because I brought this up before and DR. PURPURA: Well, we do and we believe we are, but I guess I'm MS. McDONALD: You know, it's funny, I don't disagree with it, but I think the point is because we've submitted things to the FDA with details, and then I've raised that and I've been told that we don't fall under the scope as a manufacturer of who's supposed to comply with HIPAA. And, you know, if you look at tick and tie, it's like, duh, you're right. But in the end, it's kind of like well the purpose is to protect people's privacy. So, it's kind of like, you know I mean, we can get picky, too. But the point is, so I was just curious. And really if there's something that you know for certain that we could better understand, get in the head of the customer, because, you know, it's frustrating for us, too, to not understand that they've got an issue. MS. TODD: You know, I think it's good customer service is that we want to hear from you. MS. McDONALD: Yes. MS. TODD: We want to, you know, share what your problems are with the product, we want to make you happy. But I think a lot of times people just are hesitant, as you were saying, to feel like they're going to be identified, feeling something may come back to them that they MS. McDONALD: Or the hassles maybe? DR. PURPURA: Right. And a lot of times they don't understand that we are HIPAA compliant. I mean, I've even seen that from the risk managers at hospital levels. They just don't understand, you know the they don't understand the purpose of HIPAA. MS. McDONALD: Yes. DR. PURPURA: Right. I think that sometimes people don't understand that, you know, everyone has to be compliant. MS. McDONALD: Yes, I guess I get that actually I think sometimes people don't understand that, because I used the example what if it were, you know, you were the one sending in the information? How would you like to be handled? But what I think about the hassle piece, as I've heard, and I'm one of these people who tries to get more information and improve the product, but a lot of times we point back to the FDA. This is what we have to do and that just kind of instigates this, what a hassle. And people avoid. So, I think we got to figure out the middle ground and, you know, capturing the information that's so less regulatory, but more customer service. DR. GARDNER: So, I want to continue this. Again, I want to go back to our MedSun experience because we had the same push back, you know? How come you don't report it to us? Well, because all our reports go into a black box and I've got a billion people to report to, and so I can't bother reporting to the FDA. What good is it for me to do that? And I'm really worried about confidentiality because no one really understands it. So, then it's much easier not to do it than to sort of get our way through that. So, we did a pilot to sort to see whether we could get more reports by addressing some of these barriers. And so, I'm just sharing this little bit of wisdom. And I think this is a real challenge for us in dealing with home care. How do you get to the people that you need to hear from and tell them and let them know that, yes, it is a regulatory thing, but it's important for patient safety to have this information. I care a whole lot about what happens to you and what happens to your family and I need to know this so that we can make a better product. Or, you know, bring it down to a level that people everyday can feel is not regulatory, but actually, you know, a concern about them. And it's hard probably from your level, but then there's something I'm imaging that you need to push down into your staff. MR. PAPADOPOULOS: Are you working at all with any of the home health agencies that are out there? Are they part of the home health agencies? Are they part of home reporting or something? DR. GARDNER: Yes. Yes. Yes. MR. PAPADOPOULOS: So, you are working with them? DR. GARDNER: We are, yes. And they don't get the information, so they can't give it to us, so MR. PAPADOPOULOS: They're not getting it from the patient, you're saying? DR. GARDNER: Right. Right. MR. PAPADOPOULOS: I think that's our duty. I think that should be the first thing that a patient sees when they open a box of whatever, that here's our mission and this is our duty and here's how you can help us. MS. McDONALD: Is that labeling though? Yes, you know what I'm saying? MR. PAPADOPOULOS: Yes. MS. McDONALD: I mean, this is where again I mean, I think we all DR. PURPURA: Yes, I know. MS. McDONALD: Yes. DR. PURPURA: And it's sort of regulatory, can get I don't want to say common sense, but, you know, it can interfere. MR. YOUNG: But I just wanted to say that from our perspective as a manufacturer, it's kind of like putting together the pieces of a puzzle. The data streams come from a number of sources. I just jotted down a few while we were sitting here. And I would think it's rare that we get the whole story from just one source of information. So, for us, we have the home health organization, we have the prescribing clinician, we have the patient or patient's relative providing care. We have our COURT REPORTER: I'm having trouble hearing him. MR. YOUNG: organization. DR. GARDNER: Can you speak up for us? MR. YOUNG: We have our 24/7 call center, a global clinical account manager, and we have a medical safety department that also takes information. So, we could have up to 10 data streams for one event. And that's really not until you put all those together that you have a complete picture. And there can be occasions where just talking to the patient does not in any sense give a clear people of what happened. Sometimes patients are motivated by financial interests. Maybe there's a concern there of payment. You don't get to the bottom of that talking to just one person. You have to speak with many people to get the complete picture. DR. GARDNER: Over here? MS. RODRIGUEZ: Yes, I was just going to say I think one of the things that we DR. GARDNER: Speak up a little. MS. RODRIGUEZ: We deal, like you were saying, with many different avenues of getting information, because you've got the actual patient user information, but they're frequently with a home care agency. There's also usually a service entity that's involved. And the one thing that I've learned in trying to deal with the complaints is, you know, you guys are saying help the patients or help them to tell us to make the product better. Quite frankly, I don't think they really care about making the product better. What they want is they want their problem to go away. It's like the lady said this morning, these people are tired, they're hassled, they've got a bajillion things on their plate, and the last thing they really care about is answering our hundred questions and making our product better. They actually assume our products should be good when they get it and it should have worked the way it should have. And they're really quite frustrated that it didn't meet their needs and they just want that frustration to go away. So, one of the things that we have sort of learned over the last couple of years is to utilize those multiple streams of information to train our people, our clinical people that are taking that first call at midnight or 2:00 in the morning and solving the problem. We're trying to train those people to say, okay, look, be aware. Listen for the keys and the clues that tell you this might have been an malfunction, this might have been a user error. Try to get as much information as you can as unobtrusively as you can while you're solving the problem so that we can get as many pieces of information so we can put it together. And then we work with our tech support that then had to help the home care agency to fix the problem. We try to put all the pieces together to make it as seamless for our customers as we can, because quite frankly, they're irritated that they have the problem to begin with. They really don't want the hundred questions. So, if we can try to gather it without creating more of a hassle for them, that makes their life a heck of lot better. And it is a real challenge and it takes training a lot of people in our organization. We can't rely just on my two complaint handlers to do it, because quite frankly, if my complaint handlers call a customer, they've got their checklist. They're going to go down their hundred questions. They're going to say was it this, was it this or this? And they're going to end up irritating the person. But if I give it to my clinical specialist who's a nurse, she's much more empathetic, she takes time, she's concerned about how the patient was, a much softer touch. And yet, if she's well trained and knows what to go after, then afterwards I can interface with her and I can get a lot more information. So, it's training a lot of people internally to help me gather all those pieces so my guys can put the puzzle together on the back end. It's a lot of effort, but that's the way I think works actually better. MS. RODRIGUEZ: But that's a lot of effort, like you said, you said puzzle. You said a lot of things that are, you know, defining our environment. What you just said, I mean, I totally appreciate. The customer wants us to make their problem go away, yet we're burdening them with our problem of I got to have all these questions asked. And I think this is what the balance has to be and maybe this is where in looking at FDA guidance is how do we minimize the intrusion and get that narrative that is more the stream that's going to tell you the story and then we figure it out and not have to worry about you have to say the magic words so then I can code it appropriately? MS. McDONALD: Right. Because they're not going to say the magic words a lot of times. MS. RODRIGUEZ: Yes, and that's the struggle I have in trying to develop better systems myself. And especially if you're in a larger organization, you know, you've got a script and you're looking for consistency. MS. McDONALD: And checklists. MS. RODRIGUEZ: Yes. But the narrative is the piece that a lot of people are not able to manage. And then when we go to manage the narrative, we end up like, you know, losing the data stream that I think we're all trying to get. MS. McDONALD: Yes. DR. GARDNER: Other comments, folks? I'm curious about whether any of you use Internet types of for, I don't know, training, tracking, whatever, but also if you have thoughts I mean, it's early yet, but patient health records are sort of here and coming big time, and electronic health records. And I'm wondering if you have any thoughts about communicating with your customers that way or sending information to them that way, or whatever? MS. SKEENS: Yes, well, we're already doing that. In fact, we're doing it some for adverse events where we're giving the option being able to fill out the information electronically through the Web site as opposed to, you know, spending a lot of time on the phone. They can follow up electronically at their convenience, again in the hopes of getting more meaningful data, you know, giving them those options to report online or even to, you know, do follow up information online in addition to other things, information through the Web and Web based training and things like that. MS. RODRIGUEZ: We have the same thing. We have a portal on our Web site that they can go to and they can enter either product suggestions for improvement, which sometimes is linked to, gee, I had this problem and I wish it would have done this, and that gives us another trail to go follow. So, they can either put product suggestions or they can put complaints in. And then we can screen those to see if they are actual device complaints. MR. BECK: Susan? DR. GARDNER: Yes? MR. BECK: We do online customer input satisfaction servicing, et cetera. We also do training vignettes. So, there's a secure log on. Some of our customers have the ability for a new device launch, as an example. We might even have a vignette that helps the manufacturer put that device out there for certain customers in a manner that educates how do to use it. It sort of capitalizes and stands upon that the customer capability to outreach to a number of different users. DR. GARDNER: Very interesting. MS. MILOSTAN: And I can tell you that in using our systems we also still have, because we've been doing this for 25 years, where the customers will call in and state that they've had a problem with a device that they're renting, that they're owning that we're going to service. And when they called in that information, we've gotten a certain bit of specificity, but people have actually engaged and use our system that have that same access, but they're allowed to do it on the Internet at their off hours, at their break time or maybe at home. We're getting much more detailed information. So, when those devices arrive back in my door, I know a lot more about what happened to that device and what I'm going to be seeing then when it gets there, rather than somebody calling me and saying the pump is broken. MR. WARD: The other thing about that is it's a permanent note on that device down to the serial number level and it's attached to the repair ticket. So, you'll see what the true outcome was from what either a patient complaint or the health care provider's complaint was, and it never goes away. And then all of the parts and the true outcome is attached to the original complaint that was given by the patient or health care provider. DR. GARDNER: Very interesting. MR. YOUNG: Yes, you raised a good point with respect to new products, the requirements, at least in Europe for post market surveillance. When we launch something new, we're very proactive about collecting data from use of the product. And so, in the first six months we might be reaching out to all the customers that got that product. We collect a lot of information and that's very useful to establish an early baseline in terms of issues that are occurring. Then we make corrections of course and at some stage in the life cycle of the product, it turns into more of a monitoring event that we're trying to discuss in that way. DR. GARDNER: That's really interesting. You took the idea of doing the training and the everything that you could get back to each time. You don't have to keep where's that piece of paper that I had, you know, these instructions in French on whatever, right? I can just get on it's like going to YouTube, right? And here's the instructions again. MR. WARD: One of the big things we're doing now as well is we're starting to look at the data logs that come in from the devices, you know, so much great information. That's why was thinking about your situation. MS. SKEENS: Yes, we do that too actually, is to look at data logs and analyze those for trending and complaints. MR. WARD: Since we do patient level tracking, the data log is associated by date to every patient. So, when you go back, you can get a great retrospective look at the conversation you had and the interview you had and then apply by day the real story once you get the device back. MS. SKEENS: Right. Right. Exactly. MS. McDONALD: And that compensates for where you have little or no information? It's a broken type of thing and then you can sort of reconstruct possibly what the malfunction was and MR. WARD: Exactly. MS. McDONALD: Okay. MR. WARD: And the other thing is it helps you learn how to ask better questions over time. DR. GARDNER: Good point. Anything else? MR. SAMEC: I'd just add on that we've had data logs for about the last eight to ten years and they can be tremendously valuable as a piece of information. You'd never want to use it independently, but it can trigger questions and essentially get the person who's reporting the event to get more involved because we can, you know, politely and professionally challenge what the report is by saying, you know, review of the data log indicates this is what may have occurred and that may trigger another thought to say, well, you know, you're right, on second thought. And we'll have the ability to reevaluate the event again. DR. GARDNER: Any other examples or comments? We're moving toward new availability of information. Someone mentioned UDI and I will tell you UDI is coming; not fast enough for us, but we are working on it. It's extremely complicated, as you might imagine, but it's a key component I think for all of us of really how we understand what's going on with the products once they're out of your manufacturing plant and sort of how we recognize them and how people track and keep information on them. Electronic health records and patient health records again is going to be sort of another new world, I think, in our ability to understand and keep track of information. Phil, you were telling me an interesting story before we started, and do you mind sharing that, because it's sort of MR. VIERLING: I actually introduced myself as a medical device manufacturer. As a consumer I also have experienced the complexity of this issue having a 23 week old premature grandson born who came home to live with us with all the equipment; the ventilator, the oxygen, the respirator, the GI tube. We had two incidences where he coded in the house. And looking at it as a device manufacturer, the equipment performed to specification. The DME company had a respiratory therapist who trained us. Should we have a power failure, here's how to use the Ambu Bag to resuscitate your child. But it wasn't power failure in the middle of winter in Minnesota. It was a nursing error. And we were able to resuscitate him. But as I thought about this from us that sell equipment now to a DME company, I thought the FDA's asking the right question this morning of saying there are specifications that we need to be building our device to make it use the KISS principle or sixth grade/eight grade, all those types of standards for safety. They acknowledge the complexity between we sell it to the device or the DME company, they're training the consumer, they're also training the home health agency on the use of the device. And the question that I'm still wrestling with is how do we try to, since it's a class II device and we're the manufacturer, ensure competency and compliance down that distribution channel once we sell the device? And I'm all for the UDI labels, but you know, we lose that tracking unless we ask our distribution channels now to make sure that they're follow up systems are as robust as yours, that they're able to track everything back to us. And I don't have an answer to the gentleman in the middle of the table; give me a month to think about it and maybe I'll come back, but I don't know if that's more different types of training manuals. I don't know if we try to tie our distribution into ensuring that our DME channels have to be some sort of you know, follow the Medicare certification, that they need to be Medicare certified, knowing that that's a little different than the home health agencies who may be under a different certification, but how do we also you could have competing regulatory bodies here. And we're ultimately responsible to the FDA trying to ensure that and say I don't know how you're going to get that complexity. But as a grandfather, I get it. You see a blue child and you say, okay, I get it. DR. GARDNER: The baby's fine, by the way. MR. VIERLING: Yes, the baby's fine. DR. GARDNER: He has pictures. DR. PURPURA: Must have had a good CPR. But to go back to the root issue there, I mean, the nurse error, I suppose it was a use error of some type and maybe that's, you know, our duty is to go and I know that this isn't the human factors breakout, but you know, why did that happen? Why was the safe thing not the simplest thing for that nurse to do? MR. VIERLING: Well, it's even more frustrating. This example, it was a training night. The nurse who was training the trainer and the trainer froze. It was a 19 year old daughter that came in and saw it and says I'm taking over, and was told by a doctor that you do have the right to make that medical call, right? So, I don't think you'll ever be able to regulate user error. You know, that's the problem we have to realize with the device. DR. PURPURA: Is the agency going to go to use error as opposed to user error in accord with some of the other standards? DR. GARDNER: Yes, I think probably. DR. BRADY: I think that's the plan, yes. And I know that's global harmonization as well. DR. GARDNER: So, any more comments about this problem? I mean, you make your product, you may do a lot of human factor testing, you may do a lot of everything you're supposed to do, but then it's this distribution chain. And how do you get that information, that oversight, that tracking, whatever, down to the place where you want it to be? Or is that the key question? MR. VIERLING: It's a good dialogue. I would say the one side of this says what we should do as industry is have a different type of IFU, whether it's for the patient, whether it's for the clinician, if we know there's going to be a clinician, and whether it's going to be our durable medical or our distribution channel. One side says that would be helpful. You know, it's the right thing to do. The fear that brings it up is how would the agency then come back and say, Philip, how are you going to ensure compliance on all three of those entities? Because just listening to these people, you have 130,000 devices from how many different endpoints that go into that and it's exponentially a real tough matrix. And that's where I don't have an answer for you. One part would be easy to do, might be the right thing, but the enforcement of it, I'm not sure yet. DR. GARDNER: Other thoughts? Some heads nodding. MS. SKEENS: I do think there's a parallels with risk management on the drug side and just really again making sure that manufacturers have done everything they can in providing, you know, not just something that, you know, one training manual, etcetera, but really doing everything they can to, one, having an intuitive design as risk management, but then through our materials and even our training materials that we provide the trainer, just making it as easy as possible and as clear as possible so that there's less risk involved. It's all about risk minimization and really trying to reduce that as much as possible. MS. McDONALD: Is there any assumption here that some devices can't go into the home care environment? I mean, this is where the assumption here is everything is migrating to home care, but maybe the data, if we get enough of it, would say clearly and whether it's FDA and the manufacturer, but at some point maybe some tough decisions are going to have to be made that these types of devices just absolutely can't go into home care and you have to label them for those restrictions. Because right now it seems like so, but that's why I think we need that feedback also in the guidance that something that might be a trigger, whether, you know, from a risk management perspective or even up front that just says there's got to be some sort of limit to protect both the home user and the manufacturer from an assumption that everything is capable of going in the home for home care use. DR. GARDNER: Right. Mary, do you want to comment on that as our home care expert, because this is the question about a good question, I mean, should everything go into the home? And, I mean, FDA's answer to that would be no, by the way. Everything shouldn't go into the home unless it's indicated and there's proper labeling and proper indications. But do you have anything else you want to say? DR. BRADY: No, I do believe that everything eventually will end up in the home in some way or another, if not temporarily, then I believe permanently. If you're looking at X rays, things in the home, you're going to be looking at CAT scans and MRIs probably very soon, little affordable machines going into home. Who would have thought that a hyperbaric chamber would go into the home? So, I think we have to operate under the assumption that everything will find a way into the home. If it's even approved or cleared for home use, that it could migrate into the home and we need to be aggressive in that. And not probably in the guidance, but that would be in the regulatory guidance and we could provide some possible limitations saying, we know that this poses a danger here and we are now going to tell you that you either have to label this for home use and go through the guidance process, or specifically state that this is not for home use. MS. McDONALD: So, really if a manufacturer wants to if there's a foreseeable risk that they know will be in the home care and they want to make it clear it's up to them, it's incumbent on them to put that in their labeling? DR. BRADY: Yes. MS. McDONALD: And that way then, it's really if you're going to make any change right now and you know your devices aren't suitable for home, you should at least make that labeling change, given like what you're saying, the migration is just it's inevitable is what you're saying. DR. BRADY: It is, yes. DR. GARDNER: Okay. So, let me get back to I mean, our overall question was how can we get better information, and we've sort of explored that through a number of different channels. But before I are there any other thoughts about that? I mean, you all have given us some of the ideas that you have, but I don't want to this is sort of the core post market question. Do you have any other ideas, other suggestions? How can we help you get better information would be really good. MR. WARD: I mean, in the future we foresee talking to the data logs of all these pieces of equipment and then putting an exception report together that would analyze which patients are compliant, which ones need help, which ones are not educated and hitting the wrong buttons, and having that in real time. And that's really where we're going anyway with it. And it's totally connecting the data log and understanding what the prescription is. DR. GARDNER: And again, sort of another challenge that yes, this device can go in the home. It's labeled to go into the homes, whatever. There are certain homes probably that never should have whatever they're unfortunately going to equipped with because, you know, that's just sort of the sorry state of whatever that situation is. MS. SKEENS: But it's interesting who makes that risk/benefit decision around having access to care. I mean, for someone to deny access to care at home, especially if they don't have funding to have it in the hospital, I mean, it's just a very interesting question around who makes that decision around denying access to care versus MR. WARD: You know, we could be more objective if you do it like Jim is saying; that is, having for the more critical pieces of equipment that are a little more difficult or complex, having a training program that does give you a score, that does show competency, instead of just a sheet of paper that has good instruction on it. But you actually are to a degree certifying people in the home to use the equipment. Then you're covering yourself and you're doing the right thing and you're forcing people to take the time to be able to score out on a competency. MS. McDONALD: Well, you should be able to just take a score already with the clinical user, the highly trained person to see how well they're doing to determine what's your coefficient for likelihood of success in the home market. I mean, you know, this is one other thing. That's what I'm saying. Is there maybe already data that suggests certain either environments or devices aren't suitable for home use. And I think we ought to, you know, almost segregate those and then focus on those that are more likely to, you know, have success. Because then from there we'd glean probably a good set of principles that seem to make these devices more useable and then apply it to those other high risks. It seems like we're kind of we're all in right now. MR. WARD: Well, what if someone scores out well on a competency and you're saying it's not a device that should be used, but yet obviously there's people in that home that can use that device well? MS. McDONALD: Well, I'm just saying in general for devices versus the devices that are because it is. We get very discreet down the line. The distributor might be a great distributor and training people, but then again it's always at that you know, it's almost like you want to create an FMEA for the home use and get to that score of likelihood of no adverse or, you know, of hazards. MR. MOSKOWITZ: What if the FDA found devices that cause problems at home at a higher rate and made registration required? And it's still good for the home, but the user is in contact with the manufacturer or the FDA? DR. GARDNER: So, you're saying before a product moves into the home, they would have to have some MR. MOSKOWITZ: Maybe not all of it, but DR. GARDNER: I mean, it would end up actually being a registry that we control? PARTICIPANT: What does that get you? DR. GARDNER: I mean, that's all right. That's a suggestion. MR. MOSKOWITZ: Well, or the manufacturer. I mean, they do we have requirements for other devices the manufacturer has to keep track of, so maybe some just need greater oversight. I'm not sure. DR. GARDNER: Okay. Anything else? DR. PURPURA: Do you segregate data. When you're trending stuff, do you segregate home use, clinical use? And how transparent is that and how can people get it? MS. TODD: Yes, we certainly look at those factors when we look at them, because we'll do an aggregate across all device types and then we'll look and say is this happening in the home, is this happening in a user facility, hospital, or, you know, which particular one? DR. PURPURA: Yes. MS. TODD: So, that certainly is a factor, yes. DR. GARDNER: I mean, and typically when we're doing these things, I mean, most of you know this, we get back to you, to the manufacturer. You guys know this better than we do. Hopefully you have better information somewhere than we do. Sometimes you can't have them, but, you know, we do. DR. PURPURA: But in terms of looking at the overall migration into the home, you know, just looking at general trends that might be useful in terms of the design devices down the road. DR. GARDNER: I don't think I mean, our information is not necessarily better than MS. TODD: It's limited whatever's been checked, like they check the box that it was home use or the manufacturer tells us that, you know, it was used at home, because we're just depending on what you tell us because we're, you know, not actively going after each of the event reporters. DR. GARDNER: And there's a class of products here that we tend to we, FDA, now thanks to the vendor/home use umbrella that I think people classically don't. And that happens to be for example with implants. That was part of what Don Witters was trying to point out. And even our center director, we have this conversation as well, you know, really talking about, you know, hips or cardiac, you know, pacers or whatever. Well, at some point you do have to talk about those things because the home environment is the different environment and you still have to worry about the electronic magnetic interference and, you know, the dog eating, whatever else is going to happen. So, the home use question is much broader I think than we tend think of the home care nurse coming in and setting up the infusion pump. Anything else? (No audible response.) DR. GARDNER: So, this is good, because we're at 2:00 and there's about 15 minutes until we start again. I need to put my head together with my scribe and give a brief report out, which I will do. And then hopefully if you guys think I miss something big, you'll raise your hand and participate. Thanks very much. (Whereupon, the above entitled matter went off the record at 1:55 p.m.)
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