MS. GARVIN: Okay. Next on our agenda will be the public comment section and we're going to be using a lighting system here that you see at the end of the table. And please keep your comments as succinct as possible and related to the topic as possible. I'm going to start off by calling up the first name, and forgive me if I mispronounce your names. The first person is Mr. Prabku Ambatipudi. MR. AMBATIPUDI: I wasn't on the list. MS. GARVIN: Okay. How about Bernie Barbour? (No audible response.) No? Christopher Blagg? (No audible response.) MS. GARVIN: Dennis Cook? (No audible response.) MS. GARVIN: This will go quickly. Okay. Another name I'm going to mispronounce, Parakash Deedwania? (No audible response.) MS. GARVIN: Robert DiTullio. MR. DiTULLIO: That's me. MS. GARVIN: Okay, step right up. MR. DiTULLIO: So, that means I have plenty of time, is that correct? MS. GARVIN: We're going to cut you a little break then. MR. DiTULLIO: So, good morning. My name is Robert DiTullio and I'm with Inverness Medical Innovations. We're a major global developer, manufacturer and marketer of advanced rapid professional point of care and consumer diagnostic products. And such near patient testing has immense untapped utility in the home and increasing the availability of safe and effective diagnostic products into the home will enable through greater participation of the individual and, under medical supervision, better medical outcomes than are available today. We believe that in order to truly address the vitally important issue of continually rising health care costs, FDA must allow greater accessibility of home health care devices. Doing so will lead to a reduction in the number of unnecessary hospital admissions. With the advance of device connectivity via internet enabled diagnostics, such a reduction could easily be obtained without sacrificing safety and effectiveness of patient diagnostic testing. All of these possibilities will represent the most definitive step in the direction of reducing the cost of health care. Inverness Medical Innovations lauds the agency for holding this workshop and hopes that it begins to hasten the availability and utilization of safe and effective diagnostics into the patient's home and challenges FDA to consider novel and resourceful means of achieving this goal. Thank you. MS. GARVIN: Thank you. Okay. Next, Ms. Loretta Dorn? (No audible response.) MS. GARVIN: Michael Eckstein? (No audible response.) MS. GARVIN: Brenda Edin? (No audible response.) MS. GARVIN: Michael Flessner? (No audible response.) MS. GARVIN: Okay. Mr. Konstantin Goranov? (No audible response.) MS. GARVIN: Mike Griffiths? (No audible response.) MS. GARVIN: Rod Kinley? (No audible response.) MS. GARVIN: Hey, you guys are just making me pronounce these names for fun. Okay. Hamid Khosrowshashi? (No audible response.) MS. GARVIN: Okay. Nancy Kramer? MS. KRAMER: Hi, I'm Nancy Kramer. I'm with the National Home Infusion Association and we're a trade association that represents providers of infusion therapy, primarily licensed retail pharmacies as well as manufacturers who make the equipment that our nurses and pharmacists use in the home. As we were listening this morning to the incredibly well informed presentations; and thank you so much for pulling all of this together and giving us this opportunity to address this very critical issue, one of the challenges that we have in the home infusion setting, particularly around infusion pumps and devices, is not only the longevity of the devices in the marketplace, that many of them have been in use for 20 years or more, great reliable devices, but opportunities always arise for improvement. We've had historically a great relationship from an industry perspective between manufacturers and users and a lot of the issues that come up are resolved fairly quickly and collaboratively. And we want to make sure that as the improvement process goes forward, that ability to communicate provider to manufacturer and to facilitate improvement continues and that we have a really open process for that type of communication. But in addition, from a patient perspective, from an education perspective, much of what we do is very customized and very tailored from a patient specific perspective. So, one given infusion pump or infusion device may have a set of instructions that work for a patient, but another patient may not be given quite the same level of training or understanding because their use of the device may be different from the therapy that's being administered. So, asking the manufacturer to come up with the specific instructions that meet every patient's needs will be a challenge and has been a challenge. So, we really need to have partnership there with the industry, the clinicians that use the device and train the device and the manufacturers that come up with the technology. So, that's my thoughts. MS. GARVIN: Thank you. Michele McDonald? (No audible response.) MS. GARVIN: Aaron Moskowitz? MR. MOSKOWITZ: I am Aaron Moskowitz of the Biomedical Research and Education Foundation. Thank you for putting this on. I wanted to emphasize that, really it was in the last presentation, the use of post market analysis and reports that come into MAUDE and MedSun, and really the value to patients when they're able to hear about other user experience with their device. And hopefully those experiences and reports could be incorporated into future consumer education beyond just labeling on how to use it correctly. Because troubleshooting and things to look out are really valuable. Thanks. MS. GARVIN: Thank you. Joseph Murnane? MR. MURNANE: How do you do? My name is Joe Murnane. I work for Underwriters Laboratories. I guess most of you associate that with testing, certification, product evaluation. I was one of the members of Joint Working Group 6 that helped develop the 1 11 standard that Dave has talked about quite a bit, and I do think it is a very valuable document. By the way, this is essentially a firm. One of the lesser known aspects of UL is that they operate various councils. The one that has a remarkable overlap with the work at hand today is the Consumer Advisory Council. I'll read you a brief synopsis of what that does. "This council, which was established in 1967, is composed of representatives of academia, insurance, government agencies, along with home economists, public safety officials, retailers and individuals associated with consumer oriented media. The group advises on establishing levels of safety for consumer products, user experiences, product failures and educating the general public on the limitations and safe uses of specific consumer products." Certainly, the medical equipment for home use is a definable specific user product. By utilizing or cooperating with this consumer council, you can really extend the reach of the aims that FDA is trying to put forth today. I think there is every indication that this is the future. This is the way things are trending. We've mentioned the Baby Boomers, we've mentioned a lot of things. This council in '67 at that point in time; frighteningly enough, I still worked for UL at that time; don't do the math, I would have said for medical equipment that's ridiculous. Even 10 years ago I might have said, no, this is absurd. But today, definitely. These are now consumer products. Thank you. MS. GARVIN: Thank you. Okay. Ms. Anna Nowobilski Vasilios? MS. NOWOBILSKI VASILIOS: Close. I'll give you credit for that. MS. GARVIN: Okay. Thank you. MS. NOWOBILSKI VASILIOS: Hello, my name is Anna Nowobilski Vasilios, and I'm an independent health care consultant. I'm also a member of the American Society of Health System Pharmacists, the National Home Infusion Association, the American Society Parenteral and Enteral Nutrition, and also a surveyor for ACHC. I really want to commend you for putting this initiative together. Not only will it address the issues of migrating the technology from the inpatient to the outpatient setting, but as was briefly mentioned earlier; and I do want to underline it, there is a grave problem within the inpatient setting of this technology migrating back from the home environment back into the hospital environment. And specifically, your initiative to create a Web enabled resource for the labeling of these products will not only help the home environment, but also help significantly the inpatient environment. So, thank you so much. MS. GARVER: Thank you. Marcia Nusgart? MS. NUSGART: Good morning. My name's Marcia Nusgart and while I'm a pharmacist by education, I now serve as the executive director for three distinct medical device coalitions that represent products for use in the home; enteral nutrition, respiratory care and wound care, as well as the Alliance of Wound Care Stakeholders, which is a multidisciplinary clinical organization. It's a pleasure to be here today. I've been involved in FDA conferences on human factors and home care devices. That's where Suzanne and I met in the late 1990s, I believe, when I served as vice president for Home Care for the Health Industry Manufacturers Association, which is now AdvaMed. Over the past decade I've had the pleasure to serve on the FDA Home Care Committee chaired by Mary Brady and participate in the 2007 FDA Home Care Meeting in Houston, and most recently the National Research Council's Role of Human Factors in Home Care. We've really had the pleasure of working with Mary over the past few years and I have to say that she's come to our meetings, we've given her feedback on that definition of home care, and we wanted to talk about some of those issues today. Since so may of the devices are being brought from the acute care area to the home, which is why we're really here today, we believe that this is a very important and timely issue and compliment the FDA for launching the Medical Device Home Use Initiative and bringing it to the forefront. And we also appreciate Mary Brady's dedication and really transparency, because she has reached out, she's been at MedTrade, she's been at wound care meetings and she has reached out to physicians, clinicians and other folks, as well as though here today to be able to get this done. We will be submitting written comments, but I just wanted to mention two items which really did peak our members' interest. One was one that Dave had mentioned already, which was the topic of unique risks in the home care environment that needed to be factored into device design. And electrical risks really do need to be emphasized, especially for those respiratory patients that many of the devices that need to be used have to be on their own electrical circuit. Also the unique characteristics then users in the home environment need to be factored into device design was also an area of interest to my members. They don't believe enough information was contained currently that addressed the type of testing that needs to be put into the new product testing, want to see further information contained in that. And also the issue of usability testing in particular. Who can they use like the companies for usability testing? While labs do usability tests in product design to factor in the characteristics for the device to qualify for use in the particular environment, are there other entities that can be utilized? And this could be certainly a topic for further discussion. We appreciate the fact of what the FDA is doing in putting this information really in a guidance document, then and a regulation. I think that everybody in this room really agrees with that. And we look forward to working with you both as a resource today; there's a number of our members in the audience today, and also in the future. Thank you so much. This is a very important conference. MS. GARVIN: Thank you. Is Mary Rodgers here? (No audible response.) MS. GARVIN: Okay. Susan Rolih? (No audible response.) MS. GARVIN: Beth Rossheim? (No audible response.) MS. GARVIN: Ms. Aguta Smieja. MS. SMIEJA: Great job on the name, but I don't have any comments. MS. GARVIN: Okay. Molly Story? MS. STORY: I'm Mary Follett Story. I work at the National Research Council, which is part of the National Academies, and there I am a study director of the study of the role of human factors in home health care. I also have done a lot of consulting to the medical device industry and I've tested hundreds of people on dozens of products, everything from light switches and fire extinguishers to blood glucose monitors, PT/INR devices and radiology equipment. I've also worked primarily with people with disabilities, so I want to underscore the importance of user testing really and often. I want to make the point since there are some many manufacturers here today that the earlier in the process you do it, the fewer people you need to uncover some really big problems. It's diminishing returns. The better your device, the more polished it is. The more people it takes, but the fewer problems you find. I just think it's incredibly important. No matter how much I think I know about a device, when I go and test it with real people, they tell me things I could never imagine. So, I just wanted to underscore that. Thank you. MS. GARVIN: Thank you. Lawrence Wasserman? (No audible response.) MS. GARVIN: And finally, Stephen Wilcox? (No audible response.) MS. GARVIN: Okay. Mary has an email comment she's going to read. DR. BRADY: I'm just going to read portions of this, but this lady asked if we could do it because she couldn't be here today. "Because I am the primary caregiver for my aged, ill and disabled husband for over 13 years and I'm in charge of all his medications and devices, I will be unable to take part on the workshop. Had I been able to speak, I would have outlined to you the three areas in which I continually take a responsibility not far different from his primary care physician. Of course I make decisions on my own after consultation with his own doctors, but time is always a problem and often I need to make decisions immediately without a consultant. These include: (1) Monitoring, irrigating and changing a suprapubic urinary catheter at all times of the day and night in circumstances of clogging or infection; (2) informing technologists who are performing imaging studies as to whether his implanted intrathecal pain pump will interfere with the study or damage the pump or him; and (3) observe his vital signs, daily general health, noting if there is increased weakness, fatigue, inability to regulate his body temperature, dehydration, adequate food intake, bowel regularity, mental status, sufficient sleep, depression and anxiety and reporting these to the primary care doctor if something seems amiss to me. This method has saved his life on several occasions. These are tasks I perform 24 hours a day. I have tried to convey to you that caregiving is not only the ability to manipulate and manage medical devices, but the need to create a safe and creative environment where life can continue in a quasi stable atmosphere. It takes patience, love and loyalty, intelligence, assertiveness and unspeakable energy. Help is needed. It is critical. Thank you for your opportunity to record my experiences. I hope my comments will inform your workshop." This is signed by Beth Ann Rossheim, Ph.D., M.E.D. from Williamsburg, Virginia. MS. GARVIN: Actually, since we have additional time, we're going to open up the session for any comments or questions that you might have about post market surveillance, since we skipped that initially. Okay. Go to the microphone. MS. McDONALD: Susan, you had mentioned that there is no home use box to check on the current 3500(a) forms and with the new infusion pump guidance there's a post market discussion. Do you anticipate that there will be any changes specific to home use tracking for the medical device? DR. GARDNER: Actually, there is a box that indicates that it was used in the home. It's just that when we see that and we look at the reports, we often find that we don't get the information that we need. And so, if I were to tell you, you know, we have X, I think, Mary, what is 19,000 or something reports with those boxes checked, I will also tell you that from that information we have learned just very little about what the real needs are and what the real problems are. But let me just expand. I mean, one of the things that we could do in the guidance, for example, is to give better definitions about what to report. I mean, I think you'd see this in the infusion pump guidance. I mean, when you are reporting something about an infusion pump, you should include whatever information. So, that is something that we could talk about in terms of the guidance document. DR. ZIONE ALALE: Good morning. My name is Dr. Rhoda Zione Alale. I'm a Ph.D. nurse and I'm a health physicist. My concern is what manufacturers are doing about monitoring the non ionizing radiation in your sleep apnea monitors and your CPAP machines and your oxygen machines, because anything that gives off or that uses electricity, can also converge when you have these devices within 12 inches of each other. Just one case I want to bring to the table. I became a nurse health physicist after I bought a home and found out it was built on nuclear waste that was not that far from a radio station antenna. I had a son born with left brain encephalopathy who was able to overcome a number of things, went on to become a world class athlete and was on a 29 nation tour. When he came home to this house, within three weeks he lost 60 percent of his brain theta wave and ended up in the hospital for a year. I also at the same time had a baby that had Sturge's lethal dwarfism who was in the hospital every five days and we couldn't figure out why he was so unstable at home. When we went to look at his home situation, he had a oxygen intake, he had his sleep apnea machine, he had his tube feeding machine, all of them were within a foot of each other. He was in a steel baby crib that was within 10 inches or so of wall. And when we measured the radiation convergence of that; your body is not supposed to be exposed to more than 50 hertz, this little baby that was 19 months was being exposed to over 4,000 hertz of radiation that was causing a massive radiation assault. And so, as I've gone on to study other equipment like the TENS units. Whenever you use a TENS unit within two feet of a wall and you have a patient within two feet of wall, that TENS unit, instead of working therapeutically for the patient, works adversely and can actually dehydrate the intercellular fluid. So, there has to be in the home with all this wireless and everything's electronic in bedrooms, it has made home care for nurses overwhelming. The little home care safety eval that we do now is not adequate because we must begin to look at patients with all this electronic stuff in their bedroom, because it can contribute to stroke, heart attack, fibromyalgia. It can contribute to autism, etcetera. Thank you. MR. GARVIN: Are there any additional questions or comments? (No audible response.) MS. GARVIN: Okay. DR. BRADY: Sandy Berman will let you know where your breakout sessions are for the afternoon. So, when you come back from lunch, please go straight to your breakout sessions. If you haven't signed up for one yet, please do so and remember to fill out your questionnaires. There is a box out there. MS. BERMAN: The human factors will be meeting in the Maryland Room, which is the room you're in now. Wireless discussion will be in Chesapeake Room 2, and that's down the corridor there to my left. Post market breakout, Chesapeake Room 1. Potomac Room is with patient labeling. All of those are on this floor. The discussion on the environment is in the Assembly Room, and that's downstairs. So, you can either take the steps down, or you can take the elevator to M. And then you take a left out of the elevator and you're going to see the Assembly Room written there right above the door. And we will be starting on time at 1:00. Thank you. (Whereupon, the hearing was recessed at 11:52 a.m. to reconvene at 2:33 p.m. this same day.) A F T E R N O O N S E S S I O N 2:33 p.m. DR. GARDNER: Okay. So, over the last hour and 15 minutes or so everyone broke out into particular work groups. Some of the areas of focus were looking at human factors in the user. We've had one group look at the environment of use. Patient labeling. Also we've looked at wireless and also looking at post market concerns. So, what we're going to do is one person from each one of these breakout sessions is going to come. They were all doing their notes electronically, so we're going to share that with the entire group. We're going to rotate every 15 minutes or so, based on how much information. If they're getting closed to being finished, we'll let them run just a little bit over. And then afterwards we will actually have question and answer, because you might hear something from the labeling section and you were in the wireless group and you might need confirmation or you might need to add a little bit where you wouldn't have had the opportunity because you were in the wireless group or the human factors. So, we're still going to be taking your information from your questions in the question and answer session as well. So, we're going to start with environmental. Step on up. MR. OSBORN: While Sandy's bringing that up, the highest level conclusion that the group came to was that the home health care standard from IEC addressed the environmental issues quite fully and quite well. Clearly that standard is focused on electrical equipment and systems, but in fact other than the electrical parts the standard is a whole risk management standard. It addresses all of the related hazards and is completely applicable to all medical devices insofar as they're covered. So, for things like cleaning and disinfection and temperature and pressure and humidity and all those sorts of things, completely relevant and certainly the usability section is completely relevant to anything that has a human interface. How you doing, Sandy? MR. WEININGER: Well, it's MS. BROOKS: He's having a human factors issue here. MR. WEININGER: It's slower than I am. MR. OSBORN: Ooh. And for Mary, of course, we would hope that the future guidance document will be structured along the lines of 1 11 and reflect its content. MR. WEININGER: All right. Can everybody hear me? AUDIENCE MEMBER: Can you see it though? MR. WEININGER: No, I got bifocals on. I can't see a thing. MR. OSBORN: I resemble that remark. MR. WEININGER: So, our group was about the physical hazards associated with the home use environment. And I'm going to run through these in no particular order. We really didn't have time to digest and analyze them. So, it can stimulate some further conversation about them. So, we started really with the 60601 1 11 standard as an all hazard standard. It took several years with a lot of effort going into trying to understand what the whole use environment is. It's not just an electrical hazard standard. It's a whole hazard standard. And so, whereas it was built as a 601 family standard, which means it's designed for electro medical devices, it's principles are applicable for all the devices that would go into home use. So, things like dropping and shock and vibration and labeling, those are principles which are applicable to all medical devices. And so, an awful lot can be gained by understanding the essence of 601 1 11. So, there was some discussion about whether it covers integration with cell phones and what is a particular medical device? And what are the hazards introduced, for example, with cell phones with electromagnetic interference. And again, those issues were addressed. I'm trying to be too specific here. There was some discussion about generation of patient IDs and names and how you link them up to your device, and some of those things kind of got off topic as from a physical environment perspective, but are certainly important about how you go about making that association. There was discussion about electrical supply mains, what happens when the voltage dips or sags or gets noisy in either blackouts or brownouts or extended periods of time. We had some discussions about which standards addressed them. And those of you familiar with the IEC standards, there are significant numbers of standards which try to address those types of hazards. We talked about whether the medical device industry can interact more with the building infrastructure industry to try to perhaps prevent or present a safer environment. And of course, we always talk about the FDA and what the FDA can do and who the FDA actually regulates, which is on the medical device manufacturer and not any infrastructure type folks. We talked about 60601 1 2, which is the electromagnetic compatibility standard. And while it doesn't currently adequately address home care, there's a new work item for I guess it's actually underway within the next few years to try to incorporate the appropriate requirements for electromagnetic compatibility. And I'll tell you that it's quite the struggle, because the more rigorous your requirements are, the more expensive it is to build the particular product. And of course fewer people want you to have those, or fewer manufacturers want you to have those types of restrictions, because it just gets very expensive and time consuming to produce your devices. And in the case of some devices, they might not work anymore just because you've hardened them so much. Like pulse oximeters which require a very sensitive front end will not work if you shield them too much. All right. We talked about some power consumption issues. For example, is there a requirement that a certain amount of time for battery backup should be there should be a requirement for that. 601 1 11 has a disclosure requirement, but no particular times. The discussion was that it's, if you will, use dependent, so you can't have a horizontal requirement that covers all devices. We talked about the use of compact florescent lights and how those are adding electromagnetic noise to the environment if they're not used properly. Some of them have filters; some don't. We talked about the coming wave of LEDs which will replace the compact florescent lights. We talked about the potential for device injury due to emissions from medical devices and particularly if you have large groupings of medical devices, the possibility for injury rises. We talked a little bit about the process of the development of the guidance document and whether the guidance document can leverage 60601 1 and 601 1 11 and its collaterals. It would seem logical that those proceed as siblings as opposed to individual devices. And we in the FDA, we have some guidance documents which heavily leverage recognized standards and it's actually much easier to maintain that way because the standards group is already maintaining it and FDA can come along periodically and say, well, here's the extra things which we want to add onto that. There was some discussion, as I said before, about FDA's oversight of home health care agencies. It would be nice if home health care agencies had recommended practices, and they may; I'm just not aware of them, so I don't want to say bad things about that. But the issue is that it's an environment that all the different stakeholders should know what all the other stakeholders are doing and you shouldn't sub optimize. And one group can go off and do great and wonderful things, but it might turn out that in the long run that's hurting the whole group. So, knowledge of the regulatory environment and the safety environment is important. Let's see. So, we talked about different characteristics of the physical environment, which is the name of our committee, so we talked about temperature and pressure. And clearly if you use your ventilator in Denver, well, then that barometric pressure is going to be quite a bit different than at sea level. And actually had some devices that they didn't bother to do that in the early days. And 601 does a pretty job of addressing those types of broad horizontal basic safety aspects. Again, more reason why it can act as a foundation for any guidance documents we go off and build. We talked about some of the deficiencies of 601 1 11, which are the EMC immunity levels and how those are currently being worked on. And one of the issues that came up, as I mentioned before, was the convergence of multiple devices and either from a physical hazards/electromagnetic energy perspective, or even from an information perspective. How you get devices to play well together needs to be addressed. Particularly in the home I could imagine if you have multiple devices that are calling for the attention of the caregiver, that can lead to its own human factors issues and I presume those will be handled in the Human Factors Committee. Dave, you have any comments that I left out? MR. OSBORN: There was one specific question that I had addressed in my presentation, which was here the environmental limits for pressure or altitude, and in fact they're there. There are 700 to 1060 hectopascals, the same numbers that had been in the second edition of 601. Otherwise, I think you did a great job. MR. WEININGER: Thank you. Questions? Comments? Help to make this better? You're welcome. MS. BROOKS: Great. Thank you. Thanks, Sandy. Appreciate it and appreciate the breakout session looking at the environment of use of medical devices. We're next going to move to human factors. MS. WINSTEL: Okay. I would like to thank everybody who was in this session with me. It was fascinating working from the caregiver side to hear the multiple perspectives. We were talking about when the user is other than the well, I should say patient. And I turned some questions to the group and then we did a breakout into four different breakout groups. We wanted to talk about the industry's need to identify the appropriate patient population and whether or not the device needed to be disability friendly as well as caregiver friendly. And we had four different breakout groups. One that was tasked to list the barriers that face family caregivers as they are becoming familiar with a device. What are the appropriate sources of training, whether that's going to be manufacturer, a train the trainer model in a health care setting, or whether it's going to be a train the trainer model of one family member to another family member to the school nurse to the home health aid and so. What does the training need to look like given some of the barriers that face the family caregivers? And we did some work on the identity of the user groups as they move forward in the guidance document, talking about who are the family caregivers, who are going to be these user groups other than health care professionals and home health for these devices? There are 17 slides for Mary to take away and work with, and we're going to try and go through some of this feedback very quickly. But some of the barriers that we really wanted to bring to your attention was what we tasked here is that the mental strength, because as the caregiver is suddenly given this device, where are they in their life? What are they able to absorb about the disease state, about their change in life and so on? And you can look through this as we go through. And we also talked a lot about some of the financial and insurance burdens that the caregivers are facing. Where is there going to be reimbursement? Where is there not, especially around training time from the medical institutions? Are the caregivers overwhelmed by technology? This is a serious concern. In some of the research done at National Family Caregivers, we have learned that many family caregivers are not using a computer, are not on the Internet. This is a significant concern as manufacturers are putting user manuals online. We also talked about delivery model coordination so we could have some cohesive delivery. Another group was talking about the sources of training. We're talking about training material that's coming from the manufacturer, but then where does it go? It can go to the sales force where we have the health care professional being trained by the sales force. We have a nurse. In an ideal situation, a nurse then would train a family caregiver or another health care professional. Then one family member training another. Sometimes there's a sales force to the patient, and sometimes that caregiver is picking up the equipment on eBay with no training. The materials can come over the customer service line. There can be online chat or video/audio over the Internet. That gives us some nice interactive models, but it doesn't address the situations of the family caregivers who do not have computers. We talked a little bit about how the industry sometimes might feel a little stymied by the fact that they cannot determine the exact specific who is receiving and using the device. There might need to be a feedback loop on that. And how should and can the non medical professional labeling be developed? So, there are lots of FDA guidelines that are not user friendly to the non medical professional. So, how can we segregate that noise from the stressed caregiver and what they need to learn? Okay. What does the training look like? This was fascinating. I wish I had spent more time listening in on this group. They talked about four different vectors that they were exploring and a four dimensional cube model. Sounds great. They were talking about the nature of the device. Some devices are cognitively complex; some manually complex. There's the cube of the delivery of care. We are of course focusing on that which is home, although a lot of the in transit of course is what we're talking about here. The nature of the user. And then the training itself, and that can either be self directed or facilitated. And both of those can either be static or interactive. Ideally, of course you would have a multiple training session with lots of follow ups. But then again that would be the ideal. Then we talked a lot about who is the user? What's the actual division between the patient and the caregiver? We have to note that the caregiver is not a single person necessarily. That person can be in flux. One of the examples given is a child with Type I diabetes. At the home the caregiver is probably mom and then they go to school and it's the school nurse. And then the go the after school setting and the camp setting. Lots of different caregivers happening. It can change from one family member to the other. In an ideal situation there will be a family member getting respite help from a home health agency. So, lots of different people can be interacting with this device. There's a range of ages, education, nationalities, languages, technical literacy, language literacy, numeric literacy, all sorts of factors affecting any one given caregiver's understanding and adaptation of this device. Please remember, as Suzanne mentioned earlier, and I think everybody in our session embraced and understood, the caregivers are stressed. So, this is not a situation where you can pull somebody in off the street and say let's test and see if you understand these directions. You really have to do it with somebody who is walking in those shoes at the moment. The other thing that the group brought out, which I thought was a lovely point, is to remind us all that the direct emotional relationship that exists between a caregiver and their patient is very different than that between the medical professional and the patient. And also that caregivers are not trained as problem solvers. They never took differential diagnosis. They can't solve the problems in the same way. We then separated out some general comments. One is that we needed to say that certain devices need to be active in order to determine if the patient can really use the device and that this might affect some validation studies. So, the device actually has to be on and working in order for us to determine if a validation study can happen. That might be a challenge. We were taking consideration of who the user you want to use the user groups earlier in the design phase and consistently in the design phase. So, it becomes a very iterative process. Bring the caregivers in very early in the design phase as you're going through it, see how it's going, bring them in again, bring them in again, bring them in again. Solve the problems before they happen. We talked about segmenting devices. Not everything's the same. The difference between an infusion pump and a breast pump. Okay? It's not going to necessarily require the same type of training. Should they indeed be treated in the same type of way in the guidance? Is there any way to separate things out and have different classes? The question that we came up with was, you know, when does an iPhone become a medical device? And they told us there is an app right now that will walk you through compression only CPR and at the end of the app they're working it out so that the app will dial 911. Well, at what point is that a medical device? When we start to think about there being multiple classes or degrees of home medical devices, we also have to consider that there would be a different level of training that should be required for different types of devices. And, not just a different level of training, but different methods of training. Now, also when we're talking about different methods of training, there are so many different paths for the device to get into the user's hands. The labeling can be missing. Well, that's one scenario. The labeling can also be the wrong labeling. Maybe it's the labeling that was intended for that nurse who was going to be trained by the distributor's sales rep. And then that winds up being the labeling in the hands of the family caregiver and it's a vocabulary they can't understand. So, we talked about several different issues of the path of the device actually getting into the hands of the family caregiver and making sure that the right labeling and training is getting to the right person, and that those need to be perhaps at different levels. We did have some discussion; no offense intended, that we did not have necessarily all the right partners in the room for this discussion. We wanted to have this conversation with home care agencies, home medical equipment organizations. We wanted to have pharmacies here, some clinical pharmacologists, hospice agencies, the insurance companies and CMS. We talked quite a bit about reimbursement. For example, I opened with the simple fact and the wonderful brochure that's in your packet that says if you've got home health equipment, one of the things you should do is talk to your doctor and ask your doctor the following the questions. Well, if you're on Medicare or Medicaid, and with most private insurance, you're doctor will not be reimbursed to have that conversation. So, that would be a serious issue. Another comment on labeling from the manufacturing side, they would like some FDA guidance on specificity and the industry is willing to help with developing some classifications and degrees of those home use devices. I think that would be a consistent theme throughout. Of course, we did know that we need to be mindful of the cost, but sometimes there need to be a few extra steps to make sure we're saving a few extra lives. We also need a direct line to realize that sometimes the device is going to go directly from the manufacturer to me, the neophyte. I know nothing. Nobody will be stepping in in between. It will go right from manufacturer to caregiver and what can be in the place in the middle to help me? We did, as I said, talk about reimbursement and training. We have to assume that no one is going to retain more than half of what they're taught, and it is important that the materials that go home are both useful and something the user can refer to. And that's where we were getting into separating out some of the regulatory language from the user guides. There we go. It's right there. Separated out. Device classification again. Sometimes the manufacturers are saying that they need to use words that are good for the user, but they're required to use language that is designed for the physician, and where and how can they use both? There are some questions around social media. How can we leverage the user base of collective experience? How can a manufacturer use and interact with that information? Not in a marketing sense, but in reaching out to that home user through social media, through forums and so on. We did look a little bit at what do we do with those older devices that are out there in the field, the ones that are not meant to be used in the home? But we all go, yes, they're out there. They're being used. They don't have the right label on them. Who's responsible for that? Who can step up to protect the patient in that case? And again, differentiating between devices. And that's what we came up with. MS. BROOKS: Thank you, Lisa. Appreciate it. A lot of good information came from the working group. Okay. Next we're going to let's see, is our wireless group available to talk? MR. WITTERS: Good afternoon again. I'd like to thank all the folks that were in our session. There was a really good discussion, I think. And thank Terri for taking some copious notes. We have several points, but obviously we weren't alone in getting a lot of feedback. Our group had about 20 participants in it, including myself and Terri. About 13 of these were related to medical device manufacturers directly. Some were wireless industry or wireless vendors. Some were other organizations, another government person, and some were in the sort of academic and entrepreneurial type of organizations loosely associated with medical device work. There was quite a bit of discussion about the wireless guidance that I mentioned this morning, which is available and being finalized now, and how that applies and how this may differ in the guidance for the home care devices. And we were trying to talk about that a little bit more focused on home care and what might be in the home care guidance as opposed to something that's more general on specifically the wireless medical device systems. And of course, there was a lot of commonality. Should we define the term "medical device" in particular for the home care, because in wireless technology, as the last speaker talked about, what about these new platforms, these new smartphones, this new mobile health drive? Where does that enter into the picture and how much of that? We spent awhile figuring out how much of that might be actually in such a guidance, particularly since is there a distinction between the medical device and pieces that are simply transmitting some information, or somehow transmitting patient information? Where do they fit in? If there's a cutoff, would it be particularly with the part that has a very specific or well defined medical device type of function, an algorithm or center that's actually on the patient as opposed to something that's somewhere in between sending the data. One of the examples that we were talking about was the cellular network and how that fits into it, which is carrying information, but how much of that may or may not fit into it? Talking about, well, burden of proof. I'm not sure we were trying to get at that particular one, but where these aspects come in, who's responsible for what portion of this? Is it the medical device manufacturer that has developed this that connects to say the Internet wirelessly? Is it the Internet provider? Is it a global network? How much of that? One point that was made by one of the audience was about validating or verifying the communication, something that was related to this Part 11 about electronic signatures. I wasn't quite clear how much of that might apply here, but the idea is making sure that the system works properly, that it gets the signals that need to get across in the timely fashion they need to get across in. I mentioned about cognitive technology just to sort of lob a few things at the audience and the cognitive radio is a newer technology that's coming out now. It's still in the relatively formative stages, but it will dramatically change wireless technology. It will have the capability of basically thinking for itself, determining where the frequencies that it can use in the spectrum that it's designed to be used in, where there are free places for perhaps only a millisecond or so, and sneak some signals in there and in other places, and how that might affect these systems. Is there a possibility of establishing a test environment for home care and how might that be different from other devices? We spoke about that because there are some standards for electromagnetic compatibility that are being developed right now that increase some of the immunity testing; that is, the immunity of the device to outside signals. And some of those higher levels of immunity are much more difficult and much more expensive to perform testing to and much more rigorous to do that to. And how would this set in if we have an environment in the home that's particular? Getting a handle on that is going to be difficult. Should we define some of these in terms of the wireless, what should they be? Should this information be in a separate guidance, particularly for particular devices? Say for example, more direct specific things on the wireless that may be for particular kind of devices, say for monitors or ventilator equipment, or something like that, or dialysis. Should we define what should be in the guidance by the level of risk? We spoke about that. I spoke a little bit about that this morning. It's not an entirely linear type of approach necessarily, but maybe there's a whole group of home care devices that have low risk that don't need quite as much testing as rigor in their approach to this. We also spoke about the devices and the alerts or alarms that are in there. Should they be built in so they monitor the wireless working in transmitting data? Your cell phones are polling constantly, depending on the technology. It's once every second, once every sub second, perhaps every couple of seconds or more. Should medical devices particularly in the home have that capability? Again, getting back to risk, maybe that needs to be looked at in terms of particular kinds of devices. We talked about the cellular systems. There was a lot of talk about cellular as sort of a backbone that devices in the home could be built to connect to and the Internet. And we spoke about other wireless setups. A lot about distinctions between monitoring and using the device, simply checking to see that the device is actually working and then perhaps creating a methodology or a process by which some central unit some distance away can have control over that and perhaps troubleshoot it wirelessly or in parts of it wirelessly. We spoke about some of the mandatory standards, regulations, requirements that FCC, Federal Communication Commission had, because this falls under their authority, the air waves and how that's protected. And if the device causes interference of products, that should be in the labeling of course. Wasn't clear about what we need to do about that one, because FCC does have a requirement about that interference, but there may be situations where that could be exacerbated perhaps in the home environment. Future possibilities. I threw out a couple of questions just off the top of my head to these people in the audience because many of them there were manufacturers. And this is more on the technical side, if you were given by the FCC a portion of the spectrum, which right now would be billions of dollars worth, what would you do with it? Would you create these systems on your own? And we had some discussion about that. It takes a long time to create these systems and create the process and the technology, and it's not cheap. One comment was you could do something and create a thermometer that now is way too expensive to market because it has all these capabilities, but it's just too costly to make and make a profit on. There are those aspects of course. One of the things that we talked about, and I think I wanted to wind up with this one, should we revisit some guidance or any of these guidances in a set period of time because this technology, the wireless technology is changing so rapidly, so dramatically? Perhaps in two years this may be totally out of date. It may not be. Portions of it may be, but it needs to be perhaps re looked at on a regular basis, sort of like the way the standards are supposed to be, but many cases don't quite get there. That's a real issue that needs to be addressed. Is it worthwhile putting up some kind of standard time frame in this guidance, something that puts a handle on re looking at it and updating it, especially with the wireless technology where it does change so rapidly? Is there another process? Are there other groups that this could be worked in? And there was quite a bit of discussion about a few groups that do have interest in the wireless technology that go beyond home care. And there was some discussion about whether or not the home care is a subset of that and necessarily should be focused on that, or whether another entire document that aims at some of these particular lines of communication should be developed, and who might do that. One last question. There was some question about whether wireless technology in and of itself in a system would necessarily ever have a component that would require clinical testing. And there was a bit of discussion, and at least from my perspective, I could see possibilities in that realm depending on how far one goes into the technology. Body area networks are being developed now. Some of them may be implants or partially worn. That may require, just because of what it is and how it works, some sort of clinical aspect or clinical trial. Another issue was security. We touched on that quite a bit about the security of the wireless signals themselves and how could that be done. We also touched upon lost power. If you lose power in these systems, because here we just had a little bit of snow a few months ago and that kind of damaged our power and it took awhile for some of us to get back. And some people in other parts of the country were not quite attuned to that particular aspect, but they saw the real concerns about losing power in these systems. Because if you're depending on a cell system for part of the system and the cell power goes down for whatever reason, or parts of that system, say a hurricane or something, then that is a real issue that needs to be dealt with. Testing and other things, and of course this thing about the mobile apps, mobile applications on such platforms as smartphones and how do deal with those. This is a very quick summary of the questions and discussions which I thought was very rich, very good, very interactive. And of course, we could have spent a lot more time to do that, but I think we got some really good ideas for things in this area. MS. BROOKS: Thank you, Skip. Okay. So moving right along, we're going to look at patient labeling breakout session and Pat's going to speak for us. We're just going to try to increase the font size a little bit. We love the technology, but I know people in the back might have a little bit of trouble seeing that. Is that a little bit better? Yes? Good. Okay. Thank you, Pat. MS. PATTERSON: I'd like to thank the Potomac Group who participated in the labeling and the training. I thought it was a really interesting discussion. And it's also one of the things that I think is so worthwhile about this kind of workshop, and I thank for the opportunity to be here, is to really hear from different points of view, people who are doing different things and see the world from different vantage points. I think it's really been an enriching experience for me, so thank you for allowing me to participate. We talked obviously about the labeling and the training. There were a couple of major themes that seemed to be consistently expressed throughout the session. The beginning one was one size doesn't fit all model. This notion that labeling has to address different devices, some relatively easy, some relatively complex, various users, some professional, some novice, some who are, you know, computer savvy, some people who, you know, don't know anything about technology, and that the labeling needs to address the users and we just can't assume that one size is going to do it for everyone. The fact that the less complex devices are lumped with the more complex devices, the same regs might not be applicable. That was expressed not only in the context of the infusion pump guidance, but also in terms of sort of a cautionary word with any labeling and training kinds of guidance documents is just recognizing that you don't need to build an elephant all the time if an ant will do, and that we just need to be aware of that. The suggestion that we would like guidance to be less prescriptive, more user friendly regulations to make it easier for the industry to comply. I think this was addressing a couple of different things. One is sometimes the regulations or the guidance documents do make us feel like we have to put stuff in there that users don't need, users don't want. At the same time, manufacturers feel concerned that they need to have information in there to protect themselves. You know, when that was being expressed, just in my head I was recalling the McDonald's and the hot coffee. You know, do we need a 50 page manual about how to extract hot coffee from the little drive through window. And we had some discussion about that. Labeling that was described as pedantic, it should be practical but it should describe the performance characteristics needed. Again, this whole issue of how do we make the labeling appropriate for the user and how they are going to interact with the device? Again, some conflict with what some of the guidance documents say and what we think the labeling needs to say. In some cases the guidance documents themselves are pretty hard to understand, so how are we going to apply them? So, we would like to have labeling documents that speak English, that speak to us as you're asking us to speak to others. There was a little bit of discussion about grade reading level. And being the curmudgeon that I am, and one guidance document that did talk about grade reading level, I did a grade reading analysis on it and it wasn't even close to sixth or eighth grade. But I'm a curmudgeon like that. That CDRH needs to have more guidance on the labeling and the safety standards. We talked a little bit about too much focus relying on clinicians to train on the device. And I'm not sure if this is where we did it or the person who said this, but it was raised a couple of times, and it was the manufacturers will do the best they can, including validating testing their labeling. And then that labeling gets handed off to a clinician of some sort, and then the clinician will modify it, customize it. And then you have absolutely no idea what it was that the end user actually got trained on. And what the end user got trained on may work, may not work. It may have been validated. It probably wasn't validated. So, there seems to be more than a few gaps along the process. Customers want simple labeling materials versus the manufacturers feeling the need to perhaps include more information because of this liability. And where you can get so much in that domain, so much of the liability, you know, warning, warning, warning, caution, caution language, that they're just not going to use it. They're just going to say, hey, I'm not even going to be bothered with this. It's too intimidating. It's too scary. We talked a little bit about the contradiction. Since everyone likes the simplified version for the patient, but the manufacturers, again wanting to protect themselves for the liability, so there seem to be these kind of two ends fighting each other. Maybe was there a possibility where we could include the labeling for the actual user and then include all the other stuff for everybody else someplace else. There was some discussion about that. Again, too many warnings. It won't protect the patient because they're not using it, which I think I see a lot of that. The multifaceted approach was needed. Different training instructions again for the patients, clinicians, train the trainer for the nurses, and going beyond the user guide. I think a lot of that was boiling down to if you've got different users who are interacting with the device differently, it kind of stands to reason you're going to have to have instructions and labeling that will reflect that. The complication of labeling in institutional versus home care settings may require a multifaceted training approach. Again, I think if we're looking at different users, different environments, different contexts, the training and the labeling needs to address what the users are actually going to be. Again, those outcomes of value, how they're going to be interacting with the device. A lot of discussion about what we wanted to see in labeling guidance and what we didn't. The FDA can't be too prescriptive. General guidelines with generally accepted methodologies. Again, I guess this gets back to a little bit one size fits all. It's this balance of being not too prescriptive, but yet giving enough information so that people can understand what it is the FDA is looking for, what it is that the FDA wants to see. The infusion pump information, that was discussed again as sort of an example. Needing to define perhaps different components for each of the particular therapies. One person talked about that in a clinical environment, hospitals for example like to see using the example of an infusion pump, they like to see one pump that does 1,000 different things so that 1,000 different users can interact with it. Where when you migrate that to the home environment, you know, Mrs. Smith might only want it to do one or two things and, you know, Mr. Peters only wants it to do two or three things, and if we have to keep including all of these different things, we are making the devices very, very complex for people. And we talked about segmentation, and I believe that same term was used in your session as well, and I think that's a really important one. Labeling probably including who to call when the device doesn't work. And then Mary Brooks talked about having lock out modes. Access codes should be readily available. Again, the topic here was you really got a lot of conversation. You're going to have an interesting next two days, Mary. That'll teach you. Again, this notion of wanting the pump to be easy to use, reliable, durable, being important issues. And that the FDA; and we're very happy about that, the agency listening to all viewpoints was great. I think everybody appreciated that you have had this meeting here. It's been fabulous. Again, the dilemma for the industry. Simple instructions at a sixth grade level versus product liability. That came up repeatedly over and over and over again, is how do we balance that? And I think if we can have some further discussion on that, and there can be at least some discussion of that in a guidance document, I think a lot of people would be very happy with that. This was an interesting discussion. We started talking about users in terms of age. There is no simple device even I didn't say that this time, so don't blame me for that one even for single use devices, especially for pediatric age population. Does the FDA have product labeling standards for pediatric populations since peds actually may need to know how to use the device and have to understand the instructions? I think that's really becoming an interesting topic of discussion as not only are more devices migrating into the home environment, but the users are now becoming that much more complex and that much more diverse. And instructions for kids, wouldn't that be interesting what that would look like? I'm guessing that the adults would probably prefer them, too, but that's just me. Difficulty in writing a label for a particular group involved in care versus a label for the actual patient. Again, I think we're talking about similar to what your group found. You've just got so many different users and how do we address the needs of those various users? A discussion came up with combination products. Clinicians need to decide who is appropriate. This I thought was a really important point and a really useful point, that maybe part of this home use labeling/training, one of the early on decisions that needs to be made is is this person appropriate for this device? Maybe they're not appropriate for the device, either because they have a very complex health care state like perhaps Alzheimer's or whatever the thing is. And I think the group in your said it was interesting, a lot of the same things came up. Clearly, we're just the two smartest groups in the room. I mean, wow, Sue. Guidance was requested from the FDA on font size. I actually think that guidance does exist, but it's usually never employed. It's always, you know, how small can we make this user guide in 27 languages. Talked a little bit about older users. We talked about the younger users. Talked about the older users and their needs and that the older users tend not to play and tinker with a complicated device. They don't. Younger people will tend to. Older people, if they're finding the instructions difficult to understand, they're likely to just put them down and then abandon the device and then nobody wins. The manufacturers don't win and they don't get the benefit of the therapy. We talked about audio instructions within the device itself, the talking meter that I think Molly Story may have mentioned to us earlier. The notion of imbedding the instructions audibly so that someone can turn on and actually get audibly walked through. First do this, then do this, then do that. There was some discussion that, you know, gee, that sounds like it would be expensive. Gee, that sounds like it might be complicated. Some companies are doing it. Some companies are thinking about doing it. In the same vein we talked about imbedding the instructions onboard in the display, something referred to as electronic performance support systems. It's a methodology that's quite prominent in most other industries, but for some reason not in our industry. Where you have essentially the quick start guide on the device itself could be useful. I asked the question what would like the FDA not to pursue? You know, stay away from this. Don't give us any instructions on this. And it was basically give us the minimum requirements. Give us the objective, but don't be prescriptive. Again, something else that came up that I thought was interesting because I'd never heard it before, again the benefit of being part of this workshop, how to update older product instructions that are not very clear. Can the FDA tell us how to do that without requiring us to resubmit a 510(k), which would be great, wouldn't it? Some instructions are just really, you know, wretched, and you know who you are. And you'd like the opportunity to improve them, but you're concerned about having to possibly resubmit a new 510(k), because the first question, as some pointed out, one of the existing guidance documents is have you changed the labeling? You know, there you go. We talked about software and the version of the software. There was some discussion about wouldn't it be great if we use electronic instructions instead of having all this paper stuff, have it available online. There was some discussion about, you know, not everybody has access to it. Maybe there's away around that. Maybe again going back to one size doesn't fit all. Then part of the discussion was the version of the software that would be needed and how to update it. And then the usability of the Web site itself, because then how do you download the correct instructions for your particular product? And I guess I already mentioned that one. I just thought that was so interesting. How to update the labeling without having to resubmit a 510(k). I think if there was some guidance about that in the guidance document, you would make a lot of people happy. And, let me see. We had a lot of really good discussion. Qualification of users needed for the devices. Again, that notion of not everybody should be just simply say if you're a home person, you know, here, granny, you know, take the device home and go have it, that there should be some criteria for selecting. New 510(k)s shouldn't have to be needed again for the new labeling. And then I asked the question if I had said anything in my presentation that either didn't make sense or that they didn't agree with. And they were too chicken to admit, because nobody said anything, and I don't believe that. And I think that was it. Thank you. (Applause.) MS. BROOKS: All right. Thank you, Pat. And lastly, we're going to have Dr. Susan Gardner come and speak with us about the post market breakout session. DR. GARDNER: Well, for some reason we didn't get the message about our electronic presentation here. I'm not sure why, but Jeannette took notes for me and I'm going to tell you what we were doing, and we'll be able to do that later. That also will save us five minutes of changing computers and setting it up and all of that stuff which, you know, again towards the end of the day. In going over the notes and sort of thinking about what the discussion was, there were a couple key things. One is we would agree, there were some key people that were missing that we would have liked to had at the table. I would liked to hear much more from the people that really are on the caregiving end of the situation. The second thing is, the group actually was in violent agreement that we have a really hard problem to solve here. And then reflecting on this, it reflects the problem that we as FDA have in general about what is virtually a passive surveillance system, which means that we rely on the people outside of us getting the information and giving it back to us. And as we turn more towards looking to become a more surveillance system, I think this will also be something that impacts the home health care industry. Again, all the problems that we have normally getting device information just get magnified by home care because you're one step further into that sort of passive surveillance system. So, we talked about, you know, some of the problems. I mean, why is it so difficult? And I think there's no big a ha moments here. Again, sort of a lot of agreement. People aren't very good reporters and frankly the FDA form is not a very user friendly form, even if we should get that far to do it. We all know there's lots of missing data and it's hard to get really good explanation and it's hard to get back to the reporter to find out what really went on. But we talked more about also the reluctance on the part of the patient perhaps or the caregiver to give that information because they may worry or tied into real privacy issues, which I think people will become increasingly concerned about. And perhaps if you're sick, you worry about that might impact somehow your insurance and they worry somehow that might impact their ability to get reimbursed for, you know, their disease and for the equipment that they have. And so once again, what are sort of the usual problems we have in getting information get magnified in the home care setting. There was a request, and we get these requests often, and it certainly will be part of the guidance document, to make it as clear as we can about what really is reportable to the FDA. So, the other thing that was talked about is the fact that there's multiple data streams for folks that are in the business of manufacturing home care products. And I believe someone named 11 different data streams of places where information could come and how do you cover that and how do you get people to give you the right information or the best information, given the multitude of folks out there that are interacting between perhaps the manufacturer and getting right down into the patient level? And I think that although we didn't say this, certainly looking over the notes; and I hope the folks would agree, that, you know, if we're going to think that we're going to rely on the patient and we're going to rely on the home caregiver to give us really good information about adverse events and what's going on, we probably are not going to move a whole lot further than we are now, with the exception of the fact that we started to talk about, you know, this electronic age, and there's sort of two pieces about this. And I would certainly agree that not everybody in the world has the Internet or uses it. Nonetheless, we have a very low bar right now, so, you know, if we can start using more electronic age to step it up, I think we're still ahead of the game. But one has to do with folks whose business it is actually to track devices. And I believe they said that originally this was set up because no wanted to lose them, which was sort of a, you know, what happened to that device? Now I can't account for it. But in doing that, they actually acquire a fair amount of information and that information becomes a good source of looking across the data, looking at trends, using data logs to get information. So, you're relying against the individual adverse event. You're actually relying on what I refer to as no longer a passive system, but a more active data source to get that. Also, those kind of systems, it was pointed out, gives you permanent information. You have the record available. You can look back in time and can establish an early baseline for what you may see in the future. So again, those type of systems have some hope for getting better information. During this discussion we also briefly I think I mentioned, because I may know more about this right now, because sitting in my office is unique device identifiers. And if you are in the business of trying to track medical equipment or get information about medical equipment or whatever, you know we are badly hampered by the fact that we don't have a unique device identifier. Yes, we have bar codes and yes that can be used, but bar codes are meaningless to anybody except perhaps the person that invented the bar code. So, I will assure you that that's very high on our list and we're working hard on what's really a very difficult problem, but one that we absolutely understand that we have to solve to make this better for everybody. And let me back up, because I forgot to say something that was really important that someone talked about. Although acknowledging the difficulty of getting to the caretaker and the patient, someone gave some very good discussion points about things that the manufacturer can and has considered in this case about collecting information about problems. And that is, that the patient really could care less about the fact that you have to report to FDA. They've got a problem. They need to have that problem fixed. So, being sensitive to that and training the person who is on the phone taking this call is really important. And if you do this really well, you may be able to both meet your customer needs and get the information that you need to really understand what's going on. But in doing that, it means that you have to be sensitive and thoughtful ahead of time about the person. They're not just picking up the phone and sort of blindly recording little check boxes. You really need to spend some time talking to this customer/complaint person to get good information. So, then we talked briefly about more sort of moving into the electronic age. And again, I was talking to you about sort of existing data sources and data logs that you may not have thought could be valuable in giving you the information, but also thinking about what's coming very quickly, which you all know about or is here in a lot of cases, is electronic health records and the patient health record. So, we will be seeing a day and age where again, it's already happened in lots of places, but increasingly where the patient has access to their own health care record and they're communicating very directly with their physician or physician's assistant. And so, as that happens we need to be attuned to the fact of what are the opportunities here? As the Internet gives us opportunities to do training videos opposed to just having the little paper and audible languages, the electronic patient health records may give us opportunities to get feedback from the patient and the caregiver, again get better information about what's happening. One of the ways that electronic health records are used for the drug people, or they're looking into, is to have cues in the electronic health records. So, when a physician discontinues a drug, something pops up quickly and says did you do this, because there's an adverse event? That's nice, really good information for drugs. Really much more difficult, but not impossible for the device industry. Because we have some many products, you know, it's hard to get one solution that fits all. But again, as we go down this path we can think about how we can use these records and how we might be able to build in algorithms or cues that might give us information, or at least let us know that there has been a problem and maybe we can go back and try to figure out what that is. And then the other discussion was maybe there are devices that just shouldn't go into the home. And while we certainly acknowledge that that seems to be the direction that everything is going, it is certainly up to us, and I think in doing our guidance document, that we need to talk about some of those parameters and what they might be. Okay. If anyone in the group has more to add, please raise your hand and jump in. Thanks. (Applause.) MS. BROOKS: Thank you, Dr. Gardner. Appreciate it. We've received a tremendous amount of feedback from the breakout sessions. And right now we're going to open it up for question and answers. So, if you've heard something in one of the breakout sessions and you would like to respond to that particular group, or you have a question, please feel free. Remember this is interactive and we want everyone to participate. Okay. We also have a mic in the middle of the room and we'll be passing one around. So, you can ask directly to the panel members up here and you can also ask directly back to the breakout session group. MR. WELSH: Actually, I think it's probably directed at you, and it has to do with the labeling repository and MS. BROOKS: Speak directly into the mic. MR. WELSH: whether or not any thought has been given to how it would address single use devices where generally the labeling is there with the device. Is it really within the intent to gather information on all home use devices, or only those devices that are durable? You know, how far down is that going? DR. BRADY: I think I can answer that. We're still in the process of developing this labeling repository and trying to figure out what it is we need and don't need. That's why we're doing the pilot, to see what kind of information comes in and what really is necessary. What do people want to see when they're trying to find labeling on the Web. Is it really a disposable device, or is it something that they want to have information on their legacy device, or something that's new that the manufacturer no longer has on their Web site? We're trying to gather this, and that's what we'll do during that pilot period. In addition to that though, to answer your question, I think we will probably end up going in a direction of there will probably be some devices that will be excepted from having their labeling up on the Web site. We haven't gone that far to address that yet and we will more than likely have a public workshop on that one as well, because we want to get your feedback on what we think is essential. But it will be information. It will be instructions for use. It will be graphics. What it will not be, it will not be the technical manual, it will not be the big user manual and it will not have the lock out mechanisms on there. That's the plan right now, because we believe that that's something that goes between the health care professional and the manufacturer unless we hear something different from the public. But that should be something that stays separate at this point. Does that answer your question? MR. WELSH: Yes. MR. DiTULLIO: So, this is directed to Susan on the post market group. So, your comments about, I guess it's FDA's displeasure on the MDR or the reporting system in terms of it not being active, in terms of it being passive and not really fulfilling what it was intended to do, your not the first person I've heard from the FDA publicly talk about this. I know the FDA is displeased about it. And so, in terms of how the partnership between the agency and the manufacturers and the people who train the users, in terms of that whole partnership, how could that be, because I actually see that being a key point in whether you believe that we could further move into the home in a safe manner knowing that there might be underreporting or what have you, right? DR. GARDNER: Well, I don't know MR. DiTULLIO: That's not on. Before you answer, let me say this: Being in manufacturing now for 36 years, I believe manufacturers do a good job of reporting. And there's a quality system mechanism that actually leads you to reporting starting with the knowledge of the customer complaint and how you handle that customer complaint and then going through the checklist of exactly how you evaluate it from a safety point of view and so on. And that leads to a decision and the decision is auditable. So people find the information, they evaluate the information and report the information or they don't and they document it otherwise. So, it must be that the user facilities are the ones that are underreporting in your mind, or are you disagreeing with the premise that I was making? DR. GARDNER: You know, in some respect you don't know what you don't know. But, first of all, let me sort of re characterize the MDR system. It is say for the best, it is primarily a passive reporting system. In the world of surveillance, that is not where you would like to be. And anybody that's doing any kind of surveillance would want to move from a passive system where people just are sending in things sort of because they have recognized it to a more active surveillance system where you actually either encourage or directly get information, or have it in registries or clinical trials, or whatever. So, I think we realize the limitations of the system. At the moment though it is also the key way that we get information. And despite its shortcomings, every single day we see signals that we act on. So, it's key and yet we know it could be so much better than that. I would love to say that I think all manufacturers are good reporters; they aren't, but I'm not condemning the industry as a whole. Please, don't take it as that. But I can also tell you from experience, you know, there are folks that could do better. But I think my overall opinion is that industry is concerned about their customers and their patients, and they're trying very hard to do a good job. Is your information limited by user facilities and users? Absolutely it is. And I think there's a whole bunch of reasons why that is true also. Some of the fears that I talked about, the liability fears, you know, are pervasive in many different aspects. I know in MedSun, a lot of the hospitals, we always encourage them to give the device back to the manufacturer. And we say, look, they know the device better than we do. If you want to understand what happened, you have to give it back to the manufacturer. And they often say, well, our risk manager, our lawyer; you know, you know this story, won't let us do it because there's liability concerns. Again, there continues to be lack of recognition that an incident is related to the device. And, you know, all those things are just one more reason why sort of the current state of affairs with this passive system doesn't give any of us the information that we would really like to have to look at these products. We do see the coming of UDI. We see the coming of electronic health records. We see the increased interest in registries as being a boon to all of us that are concerned about patient safety, because I think we will get better information. I'm sure we'll get better information. And, you know, I don't think that means that MDR then becomes unimportant. I think it actually will stay important, but I think it will move from being the biggest thing we have right now to one way of looking at getting signals. And that will be then merged in or looked at with other available information. And that's really similar to the way we use MedSun right now. We get 90 percent of our reports in MDR from the manufacturing community, but we have this core of hospitals that are giving us really good information, too. So, we get to look at those systems together. Again, as we start developing registries, we'll have the other information to put in. And so, we're not sort of worried about whether we're really seeing something or not. Does that answer your question? DR. BRADY: Susan, I'd like to add onto that. I thought that was a very good response. I also wanted to add, one of the things that we're trying to do with the Home Use Initiative is to really reach out to the health care professional in the home and the caregivers and care recipients. And as I said, one of the earlier things that we were doing was educational outreach. And we want them to know what a medical device is, number one, and number two, your reporting responsibilities. Not obligations necessarily, but responsibilities. That you need to take charge of your medical device and how you're interacting with it. And if there are problems, you need to let the manufacturer know so that they can remedy it, because it's unfair to the manufacturer as well. And secondly, I'd like to say too, I think manufacturers can help us out and probably in their decision making tree is this reportable or not? Can I develop a couple of extra questions in my decision making tree? When I find out where that event occurred, what are some of those other things that I need to be looking for that we talked about today? How were you interacting with that device? Who was interacting with that device? What was going on in the environment around you? I'm not telling you to get a whole tome on it, but maybe ask a few more probing questions on that. The section where we ask for the location of the 3500(a), on the reporting form, is not a mandatory thing. So if you don't fill that out, we don't send it back to you and dun you for it. So, we end up with a lot of blank pages or we end up with something that's a little bit obscure, because we see the word "home" or "school" or "hospital," but we don't know anything more than that. We don't even know where in the hospital sometimes. So, having the manufacturer maybe probe a little bit more when you're getting a complaint and then we will work on the side with the users to educate them on what a device is and what they need to do to report problems. Maybe we can do a little bit better together. MR. DiTULLIO: Susan, you addressed it very well, very articulately. I was bringing it up in the context of, well, you're here for this meeting, so clearly post market is very important in the home use environment, probably way more so than it is in the professional environment because we're maybe even more concerned about being further away from a professional or a manufacturer who would facilitate a report. Okay? So, knowing that there's this issue in the better world, in the professional world, we clearly not only need to resolve that by understanding it and fixing it, but we actually have to increase the veracity of it because going into the home is going to be yet a more stringent environment, a more difficult environment for the enforcement. If it's passive now, it will become even more passive. Although, if my mother were at home using a medical device by herself, she'd be the first to complain, I'll tell you that. That's the reason I brought that up. DR. GARDNER: Okay. Yes. Well, I mean, by agreeing with you, and all of you, about the challenges of getting good information from home care, that certainly doesn't mean that and I don't think anyone has done this, it is still the manufacturer's job to do the best that you can and think as cleverly as you can to get the information. I mean, you have to monitor your products and know what's safe out there. But, we do agree that you face formidable challenges. As Mary said, we will do the best we can on our part to inform the user that this is an important piece of information. Again, that's an important piece of our MedSun Program, to continually remind users who have said to us, well, I don't want to tell the manufacturer. And our response is, well, you have to tell the manufacturer because that's the only way we can get this fixed. Part of the home use group, and again part of MedSun is we've developed materials, we have posters to put in the hospitals, we have things that we send around, and we have brochures, again to try to do outreach to encourage reporting. So, the acknowledgment mostly is this is a particularly difficult place to do it, but we all need to try and get there. And I do think that the future offers more hope through electronics and whatever. MR. WILCOX: I just have a technical question. I'm sure that various people in the room as they go home will have some brilliant idea about what needs to go into this guidance. What's going to be the most efficient way to send you additional ideas? DR. BRADY: Where you registered online for the meeting there's also a section now open for electronic comments, and we'll have that open for another month. So, please feel free to use that and we will take those and they will be part of this whole transcription process. DR. ZIONE ALALE: I'd like to address my question to the gentleman that had the wireless group. And my concern as a registered nurse and a professor of nursing is that is the FDA prepared to provide guidance in how strong the wireless frequency can be? This is my concern. Our communities, especially in our urban communities, are increasing in radioactive frequencies by the rate of 100,000 percent per year. Some of our North American cities have enormous, with cell phone towers, radiation. And CDC has reported that we've moved in autism from one child in 10,000 20 years ago to one child in 150 two years ago. And now the latest report is that in some communities like Arkansas one child in 60 is autistic. And the scientists have documented that this non ionizing radiation that's coming from electronics and wireless is contributing to the loss of a vital function of immunity called apoptosis. In other words, when your body makes an abnormal cell, you have a built in mechanism to destroy that cell. The radiation arrests that in the body because the magnetic polarity of wireless and of radiation electronics causes cells to spin backwards. There is limits that have been established by National Institute of Health and they're telling us that anything above a half a milligauss of radiation can become highly assaulted through DNA and stop apoptosis. My concern as a nurse with wireless telemedicine is that when you send a digital pulse to the patient's house to zap them, if they've got wireless from their computer in the home, if they've got a digital TV or a plasma flat screen, and they've got their cell phone charger and lamps and stereos at the head of the bed, and then if they're in a Zone 1 that the EPA has defined a radioactive environment like Ohio, we're 80 percent Zone 1, meaning that we are post World War II with a lot of radioactive ground. And you send a digital pulse there, you could actually hyper stimulate them and throw them in a heart attack. And so, there has to be some kind of way of regulating this. This is not just a figment of my imagination. This is happening in Chicago right now, because Con Edison has digitalized the electronic meters. And a company flew me to Chicago and we went to a mansion. People's hair was walking around in the air from the convergence. The mother couldn't kiss her children anymore because they were shocking each other. And we had to put mitigations in that home to lower it. And this is a real concern. I am one of thousands of women in American with radiation dermatitis to my breasts. I fight breast cancer every day. My breasts got fired, charred with radiation and turned black. And I got passionate about this because I had to go to Frankfurt, Germany to meet doctors and to learn how to restore when the doctors gave up on my breast tissue after eight months of suffering. MS. BROOKS: Okay. So, the question that you're asking the FDA then, because we're way behind schedule here DR. ZIONE ALALE: Okay. MS. BROOKS: is you're asking the FDA are we going to put limits on wireless? DR. ZIONE ALALE: Yes. MS. BROOKS: Skip, do you feel comfortable speaking to that? MR. WITTERS: I am not a human exposure expert, so no. MS. BROOKS: Okay. DR. ZIONE ALALE: Okay. Thank you. MS. BROOKS: But we will take your comments. We're taking everyone's comments. And we got time for one more quick little one. We see a couple people here who've been holding on for awhile. AUDIENCE MEMBER: Hi, I had a quick question regarding a shift towards telemedicine. Clearly, there's going to be cases where the caregiver would want total access to all the information that would be provided by a device. But I was also wondering if there would be some guidance provided for cases where due to liability reasons possibly the patient would not be allowed to have full access to the information to prevent say self diagnosis or something along those lines, where the data would be delivered directly to a physician. So, I'm thinking primarily telemedicine on this one. Is that something that could be addressed in the guidance? MR. WITTERS: Yes. I think we spoke about the remote readout and monitoring of patients. And I think I mentioned about the remote capabilities that might be planned for actually remotely turning on various functions of medical devices over some piece that may have wireless technology to it. Telemedicine is a big issue, particularly in rural and areas that are outside of the urban and suburban. Several countries have a big portion of that. The U.S. has a large effort in the Indian Health Organization, for example. Canadian government has a large effort in that area as well that has a lot of lessons that we are hoping we've heard some of and we'll learn more about. So, yes, that's a big issue. I think a lot of it will be hopefully learned and used in this document that we're trying to develop. MR. DESAI: In the guidance document, the 6061 1 11 one, is that a primary document that is going to be mentioned for environmental factors for non electrical systems? Thank you. DR. BRADY: You mean MR. DESAI: For non electrical. DR. BRADY: For non electrical. There are oh, I should probably let Dave answer that. MR. OSBORN: As to what the FDA does, we'll find out over time and perhaps we can have some influence to that. It is certainly true that 1 11 has in it many requirements that are equally applicable to non electrical medical devices as medical devices. As I was listening to several of the issues that have been raised in the area of labeling, I didn't speak to the labeling section because they asked me to speak to the environmental section, but I lost count, but well over a dozen of the issues that were raised are explicitly covered in the labeling section. I see some shaking heads from the other experts who were involved. So, Brody or Joe, did you keep count as to how many were covered? (No audible response.) MS. BROOKS: So, we are doing the wrap up session right now. And I just had one comment back from all the great comments from the breakout session. It seems like there's a lot of concern about updating your labeling and whether or not it requires a new 510(k). How many people, a show of hands, are going to be here tomorrow and Wednesday for the infusion pump? Okay. Great. I'm pretty sure I know the answer, but I don't have enough stripes on my shoulders yet or on my sleeves to answer that, so I'll get that answer tonight and update the group tomorrow, because I will be speaking a couple times tomorrow morning. And we'll make sure that we also can post that information hopefully on the Web site. DR. BRADY: I just have one favor to ask manufacturers. Has anybody ever used the self checkout at Giant or another grocery store? They're probably the most evil invention I've ever seen. I tried to use one yesterday and I always try to fool that thing. I think this time I'm going to get through without somebody having to come and help me. And yesterday I bought a card and it was it the first I buzzed through. And I put it on the rolling thing and it went down to the bottom, but it didn't make it quite to the bottom. So, the lady stopped me, the little voice, and she says move your card to the bottom. And I didn't want to move it to the bottom. I just wanted to get everything else down there, too. She would not let me do anything else. So, when you're designing your devices, please, in the future, keep these in consideration. Please do not use a self checkout thing as an idea how you want to do this, because they're evil. I don't know how that went through my mind. I think when I was sitting up here it was like, oh, gosh, what is not user friendly that people thing is great? I want to spend just a few minutes going through some take home notes that I have. I feel we got just a wealth of information today. I thought this was a really good group of people who really initiated a lot of discussion, a lot of questions. Areas where we thought we were going in the right direction like with the labeling definition and the home medical device labeling definition may be not so good. And that's why you ask other people, because you know you get involved in things and you're thinking I'm heading in the right direction. And then somebody tells you, no, you're not. And then multiply that times ten or fifteen, no, you're not. So, this has been just tremendous for us and we are going to take what you've said to heart. And the things that we can't agree with, we will tell you when we can't agree with them and the other things we will try to incorporate. I personally really appreciate this. This is going to be a very difficult guidance document to write, or I thought it was, but with a lot of the help of you, I think it's going to be a lot better. We had a lot of really good take home notes from the breakout sessions, but what I do hear is that we need to seriously consider the existing standards for devices and adopt them where we can. All of the international standards, ignore that place. We're not there today. And use the existing guidances that FDA already has in place for other pieces like the patient labeling and our human factors, or update those as necessary to be incorporated into the home use labeling guidance. In the area of the caregiver and care recipient, we need to look at the barriers that they face, which we pretty much confirmed in the breakout session that there are a lot of barriers, and I think we got a really good list today during the breakout session. There are a lot of sources of training and we need to look at the type and the source of training. Training needs to be geared toward the end user, whether it's self directed or facilitated, but it needs to be geared toward the end user. I think that confirmed some of our thinking as well. Know the user. It can be multiple people interacting with a device, especially when people are out in an ambulatory mode or children are going to school. A lot of people are interacting with that device and we need to keep that in mind. Keep the user involved throughout the design process. Separate the types of training depending on the complexity of the device. And I think I heard that numerous times. There are different paths that devices get into homes and we need to take that into consideration and be appreciative of that when the manufacturer's designing something, because they don't know every direction it's going to go. But there are many different ways that devices do get into homes. With manufacturing labeling, I heard we need a classification or degrees of home use devices possibly by risk. That's the first I've heard of that. So that was a very interesting point. We need to address the legacy devices that are out there and we need to work with reimbursement. As much as I don't like that word, we do need to work with that. In the area of wireless, there is a difference between medical devices and ones that just transmit data. And we're going to need to be pretty clear on that, if not in this guidance, in a subsequent guidance or ones that we revise with the wireless. We need to validate the communication, both the outgoing communication and the feedback. And we need to find out what's the best way to get validation for communication? We need to address interference, and we kind of knew that one as well. That validated something we were thinking. And we need to look about the emerging technologies and the existing ones and how quickly they're changing, and do we want to incorporate potential obsolescence into our guidance document? Or what do we do with that information knowing that in two years which it usually takes us three years to write a guidance, right? Do we really want to have something like that in there? So, I thought that was a very important point. Also, the different areas of security and power and dedicated bandwidth or spectrums need to be addressed, and that will be addressed. In the area of patient labeling, labeling cannot be standardized. It has to be kind of general. It cannot be prescriptive. We can't be too prescriptive for the manufacturers so that all of sudden it just becomes such a horrible burden to even try to follow this guidance, but the guidance needs to be general enough so that it will cover a bunch of different users in a bunch of different environments. But it also needs to make sure that it's not too general, yet not too prescriptive. So, we have a little bit of an area to work with in there, but we need to balance that. We need to balance the level of simplicity and the level of training that people get to. We had a lot of discussion about the eighth grade level of education and sixth grade and Alzheimer's and people with other cognitive problems. So, that is something we need to really try to work on and probably try to figure out a way to help the manufacturers get some good user testing there. In the area of post market, the privacy issues, insurance issues, reimbursement issues, all lead to no reporting, so how do we get around that? We need to make the reporting requirements very clear in the guidance document. And we have to make sure it's getting to all the people who I don't know what I wrote there. So, let's see. The methods to track the devices must be used whether it's UDI or bar codes. I know radio frequency is another popular way, but there are ways to track devices and we need to address that some way, probably in a more general sense. If you are tracking your device, how are you tracking your device versus being prescriptive and saying this is how you must track your device. Customer service came up over and over again. Customer service has to be good. I would even submit it has to be excellent. That is the contact that you have with that patient or caregiver and that is the contact that caregiver or patient has with you. You want that to be the best it possibly can be and it will eliminate a lot more problems in the future, I believe. And that there are opportunities in the electronic health records area and we should be looking at ways to build in algorithms to help with that problem. Two things I didn't hear from the breakout sessions, but I did hear earlier today, is that we need to think about, and maybe not in this guidance, but somewhere along the line, the devices that are going from home to hospital and how that needs to be addressed. I don't know that that is an FDA issue, but it is something we need to at least talk and either rule out or decide that we're going to do something about it. The other big area is the purchasing of prescription devices on the Internet. Huge problem. That really is a worse problem for the manufacturers than it is for us, because you are losing out on some good customers. So, that's a compliance issue. We weren't addressing compliance today, but it is something we need to really be thinking about in this area of home use. And if there aren't any other questions, I really, really thank you for coming today. This has been so beneficial. And we will try to get back to you as soon as possible. We're going to get the slides up hopefully on our Web site by the end of the week, if not sooner. I'm going to trust Ian to work with our Web people. And the transcription services takes about two weeks, but everybody will get a copy. That will go up on our Web site as well. If you gave us your email, we will inform you by email that that information is up, so you don't have to be looking for it all the time. Okay? Thank you very much. (Applause.) (Whereupon, the meeting was adjourned at 4:12 p.m.)
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