Medical Device Use in the Home Environment Workshop: Implications for the Safe and Effective Use of Medical Device Technology Migrating Into the Home, May 24, 2010 (Transcript Part 1)
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES + + + + + FOOD AND DRUG ADMINISTRATION + + + + + MEDICAL DEVICE USE IN THE HOME ENVIRONMENT GUIDANCE WORKSHOP: IMPLICATIONS FOR THE SAFE AND EFFECTIVE USE OF MEDICAL DEVICE TECHNOLOGY MIGRATING INTO THE HOME + + + + + MONDAY, MAY 24, 2010 + + + + + The meeting came to order at 8:00 a.m. in the Maryland Room of the Hilton Washington DC/Silver Spring, 8727 Colesville Road, Silver Spring, Maryland, Mary Brady presiding. PRESENT: MARY BRADY, RN, MSN, OSB/CDRH/FDA MARY BROOKS, BSN, MS, OSB/CDRH/FDA SONNA PATEL, PhD, OSB/CDRH/FDA JANETTE COLLINS MITCHELL, MS, RN, OC/CDRH/FDA SUZANNE MINTZ, President and CEO, National Family Caregivers Association DAVE OSBORN, Standards Coordinator, Philips Healthcare PAT PATTERSON, CPT, Human Factors Expert, Agilis Consulting DON WITTERS, OSEL/CDRH/FDA SUSAN GARDNER,PhD, OSB/CDRH/FDA TERRI GARVIN, ESQ., OCER/CDRH/FDA LISA WINSTEL, NFCA SANDY BERMAN C O N T E N T S Our Charge, Mary Brady. . . . . . . . . . . . .4 General Overview of Pre Market and Post Market, Mary Brooks . . . . . . . . . . . . . 22 Discussion of the HHC Definition and Feedback, Sonna Patel . . . . . . . . . . . . . . . . . 37 PRE MARKET Unique Characteristics of the Environment Dave Osborn . . . . . . . . . . . . . . . . . 59 Human Factors and the Unique Characteristics of the User, Susan Mintz. . . . . . . . . . . 74 Caregiver and Patient Labeling Pat Patterson . . . . . . . . . . . . . . . . 94 Wireless Issues in the Home, Don Witters. . .110 Questions and Answers . . . . . . . . . . . .126 POST MARKET Post Market Issues Susan Gardner . . . . . . . . . . . . . . . .145 Public Comment Robert DiTullio . . . . . . . . . . . . . . .159 Nancy Kramer. . . . . . . . . . . . . . . . .163 Aaron Moskowitz . . . . . . . . . . . . . . .165 Joseph Murnane. . . . . . . . . . . . . . . .166 Anna Nowobilski Vasilios. . . . . . . . . . .168 Marcia Nusgart. . . . . . . . . . . . . . . .169 Molly Story . . . . . . . . . . . . . . . . .173 Questions and Answers . . . . . . . . . . . .177 C O N T E N T S Reconvene with Reports by Breakout Groups Environment of Use, Sandy Weininger . . . . .186 Human Factors, Lisa Winstel . . . . . . . . .195 Wireless, Don Witters . . . . . . . . . . . .208 Patient Labeling, Pat Patterson . . . . . . .220 Post Market, Susan Gardner. . . . . . . . . .235 Additional Questions and Comments . . . . . .245 FDA Summary, Action Items, Future Work. . . .266 Adjourn P R O C E E D I N G S 8:13 a.m. DR. BRADY: Good morning. I'm going to get started. I apologize for the delay. Apparently there are a lot of traffic issues around here, and there are a lot of parking issues that we weren't aware of. So this is the first time we've really used this building for a public workshop, so we're kind of learning the ropes. Anyway, I wanted to welcome you today and thank you for spending your time and money to come to this FDA workshop. It's our first public workshop we've had on the Home Use Initiative. I'm going to make sure everybody can hear me. You're all good? Okay. I see some familiar faces, and I see some new faces out there, and I know that we're all here for one purpose and that's to assure that medical device use is safe in the home environment. Today is jam packed. I have allotted a little bit of extra time at the end of the day so in case we're running behind, like we are already, and we'll just keep plugging along, and hopefully we can get things done. I am Mary Brady. I've chaired the Home Health Care Committee at CDRH, at the Center for Devices and Radiological Health, since 2001. I've been with FDA for over 20 years. I bring a nursing background with a lot of clinical in the hospital, long term care, public health, the Peace Corps, and FDA. I also have done home care. I have a master's in nursing and a post it's an early doctorate in international nursing. I started FDA reviewing adverse event reports, and I looked at infusion pumps. That was my job for almost two years, just looking at infusion pumps. Then I moved to supervising the nurses who were reviewing the adverse event reports, eventually going to interpreting the regulation for adverse event reporting to industry and to user facilities. And now I'm working in a global atmosphere for global harmonization, international standards, and also with the Home Use Initiative. I'm going to give you actually I'm going to ask you to please look through your folders briefly. When you look on the right side, you're going to have the agenda, you're going to have logistics for today, and you'll have the white paper on the right side. The white paper is what was released to the press on April 20th of this year. When you have some time, just take a look through it. And that's all of the initiatives that we're going to be doing with home use and medical devices. I'm going to go through the agenda in just a couple of minutes. The left side has information just for you. There's a couple of different sheets of web sites. They're different sheets, so don't throw one away thinking we have duplicated it. They're very informative and quite handy to have because navigating an FDA web site can be difficult at times. There are some brochures in there that the Home Health Committee has done, and you will also find some MedSun information. There's also a questionnaire in the back. So if you can take five or six minutes sometime today and fill that out. We're going to have a box in the back where you registered and got your badges, and if you could just throw that in there. We don't need your name. We just need some information, if you could do that for us, please. So now I'm going to go on. I'm going to give you a brief history of the committee. Back in 2001, our then center director Dr. David Fiegal asked us were we looking at everything that we needed to be looking at? If we weren't looking at everything, what were we missing? And at that point I wrote a paper and I said we need to be looking at the safe migration of medical devices going into the home environment. This is a burgeoning industry, and we need to take a look more closely at that, given that most of our devices are cleared or approved for use in a clinical environment by clinical people. So, at that point, Dr. Fiegal said, please, go ahead and let's start looking at that. We formed a committee, and we spent a year looking at what FDA had been doing on the inside, what the outside, the public was doing, and what were the gaps in between. In September of 2002, we held a public meeting where we asked people, we said this is where we're thinking that we should be going. Do you have any suggestions? And that was a very helpful meeting because at that time we were then able to identify what we felt were the seven different stakeholders that are necessary for safe medical device use in the home. And we were also able to start gearing where we wanted to start focusing our work. The seven stakeholders that we believe are important for home use are manufacturers, distributors, human factors experts, professional organizations, health care professionals, other government agencies, and, of course, the main person, the caregivers and the care recipients. One thing that everybody asked us to do was they said, please, you're the government. Please don't write new regulations for this. Can you look and see what you already have existing in your regulations and help us that way? So we spent the next few years focusing on what we had in our regulations and what we didn't. What we had in guidances and what we didn't. What standards had and what they didn't have. And we started to really narrow down where we wanted to go. We spent time at this point doing a lot of educational outreach, trying to teach people what a medical device was. We ended up having exhibits down at Medtrade, we went to different conferences that pertained to home care and spoke at those. We wrote many different articles, and we also put together some brochures that you have to educate people about medical devices and their safety. All of these activities then led to the Home Use Initiative that came out last month in April. All of those different focus activities led us to those five areas. So these are the five areas for the Home Use Initiative which you'll see in your white paper. The highlighted one is the one we're working on today, and that is guidance for pre and post market design, testing, and monitoring. Mary Brooks is going to explain to you what guidance is, but basically pre market is geared towards manufacturers. I just want you to know there's people other than manufacturers here, so, and we need to explain that. Pre market is geared toward manufacturers. And post market surveillance is geared towards manufacturers, home care agencies, and other user facilities, and also the health care professionals and the lay users of these devices. We're also going to be working with accrediting bodies. There are three main accrediting bodies for home health care agencies. We're going to be working with them, developing agreements to find out where we can put medical devices into their standards. We're going to enhance surveillance. And it's not one that we're focusing in depth on today, however, Susan Gardner will be presenting what we looked at for enhanced surveillance activities because surveillance will be in our guidance document for the post market area. We're looking at developing a labeling repository. And what I mean by this is it's something very similar to what if you've only been on DailyMed, you can see you can pull out any medication that you want and get all of the information that you want on that medication. So what we're trying to do here is eventually get all medical device labeling out there for both old and new devices. This is a very, very long term project. We are starting with home use labeled devices. Okay? And we're going to ask manufacturers to voluntarily submit their labeling, and we're going to work with those manufacturers to get it submitted to us electronically. We had the 60 day notice went out last Tuesday. Some of you might be aware of that, and that's the notice saying that we are going to be asking for this, and we'll be getting comments back. We'll respond to those comments, and then we will go ahead with a final 30 day notice. Okay? And then whoever volunteers, and we do have one so far, we will work with them closely to pass the information on electronically into FDA's site. Finally, there's outreach to the public. And here we are, we're going to be developing videos. And the first ones that we develop are going to be educational videos for lay care people and for health care professionals. A lot of people tend to think of medical devices as being lifts and scooters and wheelchairs, which of course they are, but there's many other things out there, and we want people to be aware of what it is that FDA does regulate. We're going to be increasing our presence at the different conferences and exhibits and working with manufacturers who want to become compliant with the law, or if they are already compliant with the law, that we can work with them to talk about the home use guidance area. And we're also going to be working with the Healthy Homes Initiative at the Centers for Disease Control. Today's assignment, okay, help us make a good guidance document. The first thing is please listen to the speakers. We are going to have four pre market areas. Before that, though, we will have Mary Brooks; like I said, will explain what guidance is and give you an example so you have an idea. Sonna Patel is going to spend some time on our definition, and we're going to ask for a little bit of feedback during that time. As you know, in the federal government, definitions are very important. We put our definition together based on feedback from the stakeholders and now we're looking at you to say are we going in the right direction? We have received some feedback from some groups, but we're asking all of you today to just take a look and see if you understand what we're trying to tell you what a home medical device is. Then we will cover our current thinking based on all of this feedback over the years. Our current thinking is from the information from the stakeholders, and we are going to share with you what we want to be writing in a guidance for pre and post market. In the pre market area, if Suzanne Mintz comes, we're still looking for her, she will tell you about the unique characteristics of the user in the home. Okay? Dave Osborn will be telling you about the physical environment and how it is unique to the home versus the hospital environment. He's going to use the newly developed International Standard for Home Medical Equipment as his foundation for his talk. Pat Patterson will tell you about the importance of labeling and training for the caregiver, the care recipient, and for the health care professional who is going to be doing the training in the home. Don Witters is going to tell you about the issues surrounding wireless technology and devices in the home. I'm not forgetting Susan. Susan Gardner, as I said before, will tell you about the many ways that we can enhance surveillance of devices that are used in the home. After the pre market session, there will be a question and answer period. It's going to be for about 20 minutes. Please ask questions during that time that are pertinent to the talks of the people who have just given them. If you don't get a chance during that session, please attend the breakout session for that particular area and ask your question then. We're asking for a lot of feedback today. Susan will also have a question and answer session after the post market area, so just keep that in mind. There's also a session for public comments. We had asked people ahead of time if they had a public comment to make. We have approximately 30 people who have asked to make a public comment. We're going to ask you to keep your comments short. We have the list, and we will call your name. When you hear your name, please feel free to come up and make your public comment. As I said, I built in some time this afternoon, so if we end up having more people who would like to make a public comment, please let me know at lunch time, and I'll see if we can accommodate you this afternoon. During the breakout sessions this afternoon; and you're going to choose from one of the five different areas from the presenters, please participate. Please. This is your time to tell the federal government what we are missing, what is good, what is bad, at that point. Please participate. And I ask you, if you haven't signed up, sign up before lunch. We need to have a breakout of the number of people going into each room because each room is a different size. So when you come back from lunch, I want you to just take a look, and then we'll tell you where to go. But you'll meet in here first. I just want to warn you that lunch is very short. It's 50 minutes. There are places across the street. There are places downstairs where you can eat. If you need to bring your food back with you, please bring your food back in with you to the breakout session. We're fine with that. And I apologize, we are unable to provide you with food. And you should have all of your badges. And then finally, if you forget what session you are attending, there's a little line on your badge, and you can write it in there and then put it back in there. Some people tend to forget where they wanted to go. And I see Suzanne has come. What we will do after the breakout session then is we will ask for salient points to be brought back to the main group. Each of the facilitators of these breakout sessions will bring back those salient points and share with everybody else so that everybody knows where everybody else is coming from during that point. And then we'll have time to discuss those this afternoon. So that's the plan for the afternoon. If you end up thinking of something after today is over, we do have a place for electronic comments on the docket, and that will be open through the end of June. What we should not focus on today. Other portions of the white paper. Even though they are very interesting, we don't have time to look at the other portions of the white paper today, so I ask that you continue to focus just on the pre and post market guidance portion of the white paper. As for marketing any product today, during the question and answer session or public comment section, I ask that you not try to market your product. If you want to market your product, please talk to us separately. If you're having issues with marketing your product, please talk to us separately. This is an FDA meeting on developing a guidance document. It is not about reimbursement. And surprisingly, some people who are just not real familiar with the government tend to think of FDA as also a reimbursement place. We are a device approver, clearance and surveillance and compliance regulatory agency. Our sister agency, CMS, Center for Medicare, is the one who does the reimbursement. So if you could keep your questions away from reimbursement, we wouldn't be able to answer them anyway. If you have problems with FDA and you're unhappy with the way we do different things, please take us aside separately and talk to us about that, or we can set up a separate meeting. The question and answer session and the public comment session should be geared towards the guidance today and not towards any problems you might be having with FDA. So what we will do is we're going to take your comments into consideration and we're going to provide feedback on our thinking. We'll provide some of that today, this afternoon after we hear all of the salient points. We're going to provide the transcript on our web site. We have a transcription person here today; he's going to be helping us with this, and we should have that up within a couple of weeks. We're going to try to issue a draft of the guidance for public comment in 10 to 12 months. That is the plan right now. We have a lot of things already in place thanks to a lot of feedback over the years, so we're hoping that today will confirm what we've been thinking and add probably a couple other things that we hadn't been thinking about. So with that, I'm going to introduce Mary Brooks, and I'm going to say a little something about Mary here. Mary has been with FDA for five years. She has a BSN, and she also has a master's in science quality systems management. She has clinical experience in the Army, at Walter Reed and in home health. She also has had 30 years of caregiver experience, having cared for a family member with a chronic illness. I also have cared for a member with a chronic illness for eight years, so this is near and dear to our hearts. So with that, I'm going to give you to Mary. (Applause.) MS. BROOKS: Thank you, Mary. I really appreciate the nice introduction and I apologize for being late. I was probably on the toll road with Susan. MS. MINTZ: I have no excuse. I live 10 minutes away. MS. BROOKS: Oh, okay. Well, I'm down in Loudoun County, Virginia, so that's a trek for me on a rainy Monday morning. Even leaving early and preparing can be a challenge at best. Okay. Good morning. Again, my name is Mary Brooks. I'm in the Office of Surveillance and Biometrics with Susan Gardner. And just like Mary Brady, at the current I am reviewing adverse event reports for the agency. I've been part of the Home Care Committee when I was in the pre market ODE part of the FDA. Today I'm going to speak just briefly, very, very briefly. Just like a lottery ticket, we're going to scratch the surface of a few offices here in CDRH and hopefully at the end of the day we'll be all big winners because we're going to develop a guidance document. And as Mary said, guidance documents are very time consuming, so we really do appreciate your input and it's very valuable today. Under HHS we have several offices and FDA is one of the offices under HHS. Within FDA, we have several centers. The center that is going to be developing the guidance document for you today is for the Center for Devices and Radiological Health. Within CDRH we have several more offices, and that is Office of Device Evaluation and Office of Surveillance, Office of Compliance, Office of Engineering and Laboratories, and OCER. So, an overview of device regulation, again this is the 10,000 foot level. CDRH is responsible for regulating firms which manufacture, repackage, relabel and import medical devices sold in the United States. CDRH regulates radiation emitting medical and non medical electronic products such as lasers, X ray systems, ultrasound equipment, microwave ovens and color televisions. Medical devices are classified in three categories. We put them in Class I, Class II and Class III. FDA regulatory control increases as we move up the classes. So, Class I devices are mostly exempt from the pre market review process which is known as the 510(k). Most of the Class II devices do require pre market 510(k) clearance. And most Class III devices require pre market approval where they have to prove safety and effectiveness. Under the device classification, in order to get the various classes, there's lots of things that are taken into consideration. Those considerations depend on the intended use of the device, the indications for use of the device, the risk to the patient and also the risk to the user. Class I devices generally include devices at the lowest risk. And as you move up the classifications, the risk becomes higher. We know as of today roughly 74 percent of all Class I devices are exempt from the pre market notification. Under the Office of Device Evaluation, responsibility for the evaluation of the pre market submissions from the medical device industry, ODE plans, coordinates and renders agency decisions regarding marketing medical devices in the United States. Under the Office of Device Evaluation, again there are four types of pre market submissions. The pre market notification submissions is 510(k)s, pre market approvals; more or less known as PMAs, product development protocols, and those are your IDEs and your pre IDEs, and your humanitarian device exemption applications, those are HDEs, and those are devices that are for a very, very small group of the population. Again, there is the Office of Surveillance and Biometrics. And big picture is the responsibility for the overall evaluation of post market device safety and effectiveness once the device is on the market. And again, Susan Gardner will be talking more about OSB this morning. Again, OSB receives and evaluates adverse event reports. These reports come from manufacturers under the 3500(a) and also from the user facilities and the hospitals under the 3500(a). And we also receive voluntary reports under the MedWatch voluntary document. All of these adverse event reports are put into a system called MAUDE. We love her dearly. And the MAUDE database is a searchable database. It's also available on the FDA's website for the public, along with MedSun reports. OSB also has post market safety communications responsibilities. Some of these responsibilities include working with the MedSun newspapers to MedSun hospitals providing newspapers, newsletters to the country. And also, the FDA provides patient safety news broadcasts. And again, all of this is available on the Internet. OSB also works with pre market and the post approval studies, making sure the post approval studies are completed. And OSB also has a 522 post market surveillance studies. So if a device is acting or having unknown adverse events post clearance, OSB has the authority to ask for a 522 study to try to answer some of the concerns that they're seeing post market. OSB also works with OCER, Office of Communications, and we help support them in communications to health care professionals. So, today we're here to get your input on developing a guidance document. So, what is a guidance document? A guidance document represents the FDA's current thinking on a topic. It does not create or confer with any rights for or on any person, it doesn't not operate to bind the FDA or the public, and we do allow alternative approaches. Guidance documents in general. There's two categories. We have general control. These are non binding recommendations to manufacturers. And special control guidance documents are a little more prescriptive. This is a guidance document that I have worked on pretty intensely for the last two years. It just came out for public comment, and tomorrow and Wednesday we're actually going to have a workshop on this guidance document. So, now I'm just going to very quickly go to the guidance document and we're just going to flip through it so that you have an idea as to what a guidance document is itself. So, this is the total product life cycle for infusion pumps. And within this document, as you can see, and this will be the same for the guidance document that we develop today, there is going to be an opportunity for public comment, and it will be available on the Internet. We will take the public comments and incorporate it back into the guidance document. There's an introduction period in the guidance document itself, so we're actually introducing what products that we want to cover. So, our charge is looking at the homecare environment. So, that would be our introduction and our scope. As you can tell, they're very lengthy and long and we do cover lots of different aspects. We talk about risk to the health of the patients that are using them, and also to the operators. In this particular guidance document for infusion pumps we're asking for assurance case studies. Alarms are concerning for us in this particular guidance document, so we've asked manufacturers to consider alarms. So, as you go through the day, think about what you have concerns of for a device that's in the home environment, because you get to help make up all of the various elements. These elements that are in this particular guidance document are from the pre and post market, and also the post market adverse event reports we've been able to incorporate back into the pre market guidance. And that whole process is called TPLC, which is the total product life cycle. You know, people wonder what comes first, the chicken or the egg. Well, when it comes with device, we know that it's in the lab with device design. So, we want to make sure that once that device has been cleared, or if it's a Class I and it just needs registration and listing, that the manufacturer looks at how that device operates once it's in the home environment. And whatever happens to that device, whether it's an adverse event or a component failure, they take that information and they put it right back into device design to create the next generation or an improved model. So, in the guidance document here, we've asked them to look at various components that have been part of the post market device failures, putting it back into the pre market design. So, we've asked them to look at alarms and also for warnings, we've asked them to look at other safety mechanisms and also reliability. We also asked them to look at operational hazards. And for infusion pumps, we know some of the operational hazards are air in line, occlusion, free flow, reverse flow, are just a few, in addition to leakage and also flow rate accuracy. And there's the flow rate accuracy. We also asked them to look at environmental hazards. And having been on the Home Health Committee with Mary and working on the guidance document, I was able to make sure that some of the components for home health was also brought into the infusion pumps, because we know that infusion pumps are widely used in the home setting. So, we've asked them to look at for the environment hazards to look at electricity, to look at cleaning, to look at labeling. Again, we've asked them to look at electrical hazards. Hardware hazards, software hazards. So, if you know that this medical device that you're concerned with that's going to be in the home environment and it has software, that we might want to think about putting some sort of warning in there for software. We've asked them to look at mechanical hazards, biological and chemical hazards. We've asked them to look at reuse. How do you clean your device if you know that it's going from one patient to another patient. So, if it's not a single use device, if it's a reuse device, we've asked them to consider cleaning. And when you have a medical device in the home, does the home environment have the proper cleaning solutions available? Can they use something from the local grocery store to clean the device, or does it have to be a medical grade cleaner that you would receive from the hospital or the DME company? We also asked them to look at the shelf life. How long is your device intended to be used in the home environment, for example, for homecare devices? We also asked manufacturers to look at use hazards in relationship to the infusion pumps. And a big component is human factors. How does the device operate? We've asked that manufacturers actually test the device in the environment in which it's intended to be used by the people who is intended to use them. So, if you're marketing a medical device that's going to be used in the home environment for patients and caregivers, like an insulin pump, then it needs to be tested with those same people, so lay people in the home environment. And for infusion pumps we actually ask for clinical evaluation. And risk management. So, these are just a few, a few, quite a few. It's an infusion pump. And these are critical care devices and Class II devices. And this is a component. We did ask them to look at home use labeling, making sure that the pump is labeled specifically for the environment in which the pump is intended to be used. And also, with the TPLC process, looking at the total product life cycle. We actually asked manufacturers to consider how the device operates once it's been cleared. In this particular device classification, we're actually asking for inspections prior to the 510(k) approval and also to be looking at their reportability protocols. So again, this is a guidance document. As you can see, this particular one is 34 pages long. It's as long as it needs to be. So, it can be five pages; it can be 100 pages. This is a guidance that we our current FDA thinking. We're going to take your input today, put it into the guidance document and it will be as long as it needs to be to get the point across to manufacturers and to the public on how we get safe devices in the home. So, as you go through your day, like, Mary Brady had just said earlier, make sure that you keep in mind what our purpose is today. We are going to be developing a guidance document. And I know this was a little much for early morning; we probably still need some more caffeine, but this is what our charge is today. We're developing a document so that it incorporates home use environment. Thank you. (Applause.) DR. BRADY: Thank you, Mary. I want to introduce Sonna Patel. She is in our Office of Device Evaluation. Sonna has been with FDA for four years. She is a biomedical engineer and she joined the Home Health Care Committee almost as soon as she got to FDA. She has a vested interest in this as well, and we're very grateful to have somebody in our pre market area working with us on the Home Health Initiative. And Sonna is going to go through the home use definition with you. So this is a chance for you to provide some input during this time, and there's a microphone in the middle. I'll let Sonna take it from here though. DR. PATEL: Thank you, Mary. So, good morning. As Mary mentioned, I'm on the pre market side, so I do a lot of the evaluations in the division of cardiovascular devices. If you have any beef with us on the pre market side, please save it for later. So, as Mary stated, the purpose of this session is to discuss the home health care definition and get your comments and opinions on what you think it means to you and how it can be improved. I would like to point out that we do have a transcriptionist who's here today, so I was planning on taking some notes by hand for everyone to see, but since we'll have such an accurate account of your comments, I'll probably refrain from doing that and I think just sort of to facilitate the discussion moving forward. So, if you look at your white paper that was in your folder on page 3, it's the second paragraph, this definition is what FDA has come up with so far to define a home health care device. A home use medical device is a device intended for users in a non clinical or transitory environment which is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a licensed health care professional in order to be used safely and effectively. So, this is what FDA has come up with feedback internally and some feedback externally; although, Mary, I think you can confirm, this is the first time we've really asked for the public's comment. So we would appreciate anyone who has something to say about it, to come up to the microphone and introduce yourself and let us know what you think. DR. BRADY: Or I can pass this to you as well. DR. PATEL: If there are no comments, we're happy to go with this definition. MS. MINTZ: I think it's important to mention that it is managed partly or wholly by the user, but also by a family member, or friend, or somebody who is not part of the professional environment who is working with that person. Those aren't the exact words obviously, but the intent. DR. PATEL: So, would it be helpful to include the definition of "the user?" MS. MINTZ: Yes, you could do it that way. DR. PATEL: I think this definition and then somehow incorporate a user definition. MS. MINTZ: Perfect. MR. OSBORN: In fact, I would think that it needs to be the lay user. The critical issue here from a use viewpoint is who's using it and the differences between the lay user and the trained health care professional. Notwithstanding that, when we look at the environment, who's using it is not the critical factor for home health care. It's where it's being used, because there are many physical attributes that are independent of who is using it. So, I would strongly recommend that you look at the definition in the Home Health Care Standard where we had people for six years working on this, and I believe it covers exactly what you want. And Mary certainly has a copy. I will be showing that in my talk. DR. PATEL: So, Dave, you're saying "non clinical" or "transitory" is not sufficient for the environment? MR. OSBORN: Absolutely not. If a visiting nurse brings a piece of equipment into the home to use, and for instance it has a three wire plug, and it's a home that was built before the late '60s, there's going to be no safe place to plug it in. DR. PATEL: Any other comments? AUDIENCE MEMBER: I suggest you'll probably also need a definition for "labeling." MS. JOHANNSON: I see that you focus on the words "recover" and "rehabilitate," but there are certainly devices that we have that are for life long monitoring such as with ICDs. AUDIENCE MEMBER: I just want to add my name to Suzanne's comments redefining or defining the definition of "user" to include a family member or caregiver, because I think in some instances it may be someone other than the person directly in need of the device and might need assistance and help. DR. PATEL: So, I would like to emphasize that we certainly were intending "the user" to indicate a patient or someone who is receiving the device in addition to the individual who would be administering care and may be using the device who was also not the patient. But I do understand the point about defining specifically who the user is. AUDIENCE MEMBER: I would suggest that we need to clarify "licensed" and potentially look at "qualified" or "other measures" to define "licensed." DR. PATEL: Okay. MS. MINTZ: And this is about devices that are going into a home to be used by everyday people. And I think your language needs to reflect that, because it sets a tone for everything that you're doing. So, somebody had mentioned about the terminology here about "non clinical" or "transitory environment." For the user, it's where they live, whether it's transitory or not, so we have to think about in those terms. DR. PATEL: That's a good point. MR. OSBORN: We need to remember that patients sometimes are in their automobile or on the bus. DR. PATEL: Yes. MR. OSBORN: They might be at work. So really, from an environment viewpoint we're talking about any environment that's not a professional health care facility or emergency medical service. Emergency medical service is an interesting bridge, because that equipment can be anywhere for a very temporary period. Remember, in the U.S. we have a scoop and go philosophy. So, that will be in the home on occasion, but that stuff tends to be battery powered and even if it were say to interfere with your TV for the five minutes they were there, you really wouldn't care. So, in the development of the Home Health Care Standard, we realized by the time we got done there are really three environments of use. There's the professional health care facility, there's the home health care environment and emergency medical services. And the home health care environment includes transportation, work places, the home, going on a walk. We have a lot of people on ventilators who take their wheelchairs or scooters outdoors. These are all home health care environments. And I'll be talking about that in more detail. AUDIENCE MEMBER: I apologize. I arrived late, so I missed the discussion on the scope. But in terms of the definition for "medical device," it seems to me you're talking a lot about equipment, primarily electrical type things rather than simple medical devices. So, I just wanted to get some clarification on that in that definition such as an injector, auto injector, something on that lines. DR. PATEL: So, our interpretation of the language "medical device" is as it's written in the CFR. And so, unfortunately I don't know it off the top of my head, but I think the injectors, anything that's considered a medical device would fall into this category. Just the medical device definition, obviously not the home part. MS. HOSTE: I was just wondering if the emphasis might be more on safety and efficacy rather than on labeling and training. So, the goal is that they're safe and efficacious and ideally that would be because they're intuitive to use. So, it could be the usability and then it may be enhanced with labeling or enhanced with further required training. I'm not sure if it's something to think about. DR. PATEL: Can you clarify what you mean? So, we have "safely and effectively" as the last part. Are you saying that in order to emphasize safety and effective use, to make it earlier in the definition? MS. HOSTE: Well, what I think is "it's managed partially or wholly by the user in a safe and efficacious manner. In order to ensure that, it could be intuitive design or labeling or training, or all of them." AUDIENCE MEMBER: I'd like to mention too as a home care nurse for 15 years, we had a lot of patients that were on electronic pumps, home care pumps, but they'd go to the hospital. They'd leave the home care pump in place, and actually they would continue to care for the pump just because it was such a specialized therapy that was 24/7. So, and the hospitals a lot times didn't have the types of pump that were needed for the small dosages. So, I'm not sure where that would fit, having that transition from home to hospital, hospital to home, keeping the same pump with the layperson continuing to care for it. DR. PATEL: So, you're asking about where device that's used or transferred from the hospital to the home, if that would fall into this type of definition? AUDIENCE MEMBER: Or what would be you know, I guess where the definition would be when you are making that transition back and forth and they're using a home care device in the hospital environment and how that training goes. MR. OSBORN: There's sort of two issues there as I see it. One is that many hospitals don't allow the home care devices back into the institution primarily for liability reasons. If we look at the physical requirements, typically the home use devices have a more severe set of requirements than the hospital use devices so that in terms of the environment of use a home use device will work just fine in a hospital because it's a less severe environment. But that doesn't necessarily mean that the institution will permit it. DR. PATEL: So, just from my personal experience on the pre market side, my expertise is in ventricular assist devices; and some of you in the audience may work with them or are familiar with them, and these are devices that are essentially implantable hearts. And we have started to ask for extensive testing for these devices to be used in the home because they are implanted in the hospital. The patients are in the hospital for several days with the devices and the devices are intended to go home with the patient. They're permanent implantables, and there's also an external component, which is the controller. So, we tend to ask for the more extreme testing knowing that the devices will be going in transition from home to hospital and often back. I don't know if that answers your question. AUDIENCE MEMBER: The definition include device managed partially and wholly by the user, however, there is some devices not managed by the user, as monitors, for example, but used in user environment. So, do you want to include that in the definition, or would you like to exclude those devices? DR. PATEL: So devices that are not AUDIENCE MEMBER: Devices managed fully by the physician, like a monitor set up on the patient but used in the user environment. DR. PATEL: So, my understanding is because those devices are still used in the home, that we'd still want to include them. And the user in that case would then be the doctor, but there would still need to be environmental considerations, for example, if not necessarily the medical aspect of it. MR. OSBORN: We'll spend some more time on this topic when I get up, because I think that there's an entirely different approach we can take to this definition that will work a lot better. MR. WELSH: The language appears to be geared toward prescription devices, and I would ask that if this is intended to not overlap the existing guidance on devices that are cleared for OTC use that that somehow be established in the guidance. I'm not sure if that's the intent, but DR. PATEL: Okay. Thank you. DR. BRADY: It is prescription in OTC, but we'll take that into consideration. Thank you. AUDIENCE MEMBER: Your definition says "licensed" in your PowerPoint, but on the guidance it doesn't say "licensed health care professional," and there are a lot of training that's done by non licensed people who are dispensing a device. Would you clarify why you went to "licensed" in your DR. PATEL: That may have been a typo. I'm sorry, are you talking about the white paper? AUDIENCE MEMBER: Yes, the white paper doesn't say "licensed," and here you say "licensed health care professional." DR. PATEL: I'm sorry, that was a typo. AUDIENCE MEMBER: Which way is the typo? DR. BRADY: We were considering "licensed health care professional," and we would like your feedback on that if you believe "licensed" should be removed. It was removed in the white paper. I believe that was a typographical error. It should be "licensed" as what we're showing up here. But we need your feedback if you feel that that is something that needs to be addressed here. AUDIENCE MEMBER: I think there's a lot of devices that are dispensed and trained by non licensed personnel that are still going to the home. If you're trying to restrict it to only licensed devices, that's fine, but I think you would want to broaden it by removing that restriction to cover more devices that are going into the home. DR. BRADY: Just a comment on that, too. It was something that we did discuss and so we did change it to "may require training for the user by a licensed health care professional." So, we did qualify that. However, if that's still confusing, then we will need to address that more. AUDIENCE MEMBER: I would just say "may require training in order go into the home," so that it says someone has to train. So, my wife has a glucose meter. She got trained on it. I don't know if that person was a licensed health care professional or just a representative of the industry that trained her on it. So, if you want to broaden it, take away "licensed" to say it's only a professionals. AUDIENCE MEMBER: On that same line, instead of saying "licensed," maybe "a qualified health care professional," because I am a respiratory therapist and there are some states that do not require licensure at this time. But we would hope that they would be qualified, whoever that health care professional is. MR. OSBORN: We handled that one in the standard by saying "trained health care personnel." And again, this is an international standard, so our concept of both prescription and licensing doesn't translate well to all countries. But I agree with the comment from the floor that need to very careful with licensure. It varies by states, sometimes even less than a state. And really, the issue is the level of training on the specific kind of device. So, a surgeon might be a trained or licensed health care provider, but has no idea how to run a ventilator. AUDIENCE MEMBER: I just wanted to add my voice to the comment that was made by this woman right here in the black, which I very much appreciated. In terms of a definition, it seems to me that we should truncate it, "partly or wholly by the user safely and effectively," eliminating everything else that comes afterwards. All of that it seems to me is not part of a definition of a home care device. It is a part of what would be in the guidance and it just further narrows and makes it confusing I think to understand what devices you're talking about. You've got "may" in there. That "may" should not be part of a definition. So, all of that stuff I think should be removed. MS. JOHANNSON: It would be helpful to understand what you mean by "permanent implants" and if that excludes any type of permanent implants, or if you're intending to mean all permanent implants that go into any patient. DR. PATEL: Go ahead, Mary. DR. BRADY: Oh, I was going to say the intent was also with permanent implants. DR. PATEL: And the reason for that I think is because there are environmental considerations. MS. JOHANNSON: I was just wondering if there are boundaries or limitations with that. I mean, you have knee implants, you have stents, you have, you know, spinal implants. Are you meaning everything that goes home into the body of a patient, or are you meaning, you know, a subset of that? DR. PATEL: Well, I think a good point was raised, and two people have echoed this, about the safety and the effectiveness of the device. And I think what we're going to take back and consider certainly is the fact that if the device can be used safely and effectively and doesn't require labeling, like a knee implant or a spinal implant, for example, then although it still may be considered a home use device, it may not require the additional training or labeling that we're talking about in this definition. Mary, is that appropriate? DR. BRADY: Yes. AUDIENCE MEMBER: With the definition that you just used about an implantable device such as the spinal devices or knees, etcetera, I don't understand why that would be a home use medical device. It's permanently in your body. There's nothing you have to do with it. It either works or it doesn't work. And if it doesn't work, you're going to see a qualified physician. So, I see home use device as something where the user has to interact with the equipment. DR. BRADY: What we also have to take into consideration is how the environment might act/react with that implant. You think of aneurysm clips and some other of the devices that could be affected by electromagnetic interference. So, we were taking all of these into account, however, we will take your comment into account as well. MR. OSBORN: Yes, to follow up on that, I think there are two issues that you need to be focused on. One, whether or not there is a human interface to the device. If there's no human interface, then a whole raft of the issues in home health care go away, like an orthopedic implant. If, on the other hand, it's an active implantable where the environment is likely to have a potential impact on it; for instance, EMC, then there are very significant concerns. But there are devices that have no human interface and have no real interaction with the outside; a typical orthopedic implant, and I wouldn't think you would be caring about those in this particular guidance document. AUDIENCE MEMBER: With the electrical equipment, I understand there will be EMC to consider, but that should be part of the approval or clearance process, which is really part of design controls. And so hence, I don't that is really part of this definition of home use devices. DR. PATEL: Were there any other comments? (No audible response.) DR. PATEL: If there are no other comments, I'll turn it over to Mary to introduce the next speaker. Thank you, everyone. Oh, Suzanne? MS. MINTZ: Since we are on this topic, maybe it would be good for him to present next instead of me. MS. COLLINS MITCHELL: Good morning. I would like to introduce Dave Osborn from Phillips Healthcare. Dave is the manager of international standards for Phillips Healthcare in Andover, Massachusetts. He represents Phillips at standard organizations on matters affecting medical device industry. He serves as secretary to the International Standard Organization, the ISO. He's the secretary of several joint working groups such as the Usability, Home Care and Respiratory Gas Monitoring Groups. He particularly is active in the development; he was active, that is, in the development of the third edition of the IEC 6601 1 and now with the amendment A1. Please join me in welcoming Dave Osborn. (Applause.) MR. OSBORN: So, I should start some disclosures. Not only do I manage Phillips Healthcare Standards Program, I'm the chair of the AME Standards Strategy Committee and I'm on the AME board of directors. Would like to point out to everyone that the June 2010 Horizons will be a special issue devoted to home health care. And I was the secretary to the joint working group that produced the Collateral Standard to 601 for Home Health Care. So, we're proud to announce that just last month the Collateral Standard to 601 for Home Health Care was published. The FDA was significantly involved. Now, this standard is only for equipment, things with electricity. But nonetheless, many of the concepts in it are directly applicable to all medical devices. So, what is the home health care environment? We struggled for many meetings over several years to try to figure that out, because it's very complicated. And where we ended up is here, and there are a couple of very important things to understand. I'm going to start from the bottom and work up. Regardless of whether the equipment is operated by a lay operator and throughout this standard we have an adjective "lay" meaning someone who's not skilled in the art. And we didn't say "licensed" on purpose, because that doesn't work everywhere. But equipment, whether it's used by the lay operator or a trained health care professional, if it's in the patient's home, it's home health care equipment. And we'll go over some of the reasons why here in a couple of minutes. So, what is the home health care environment? Well, it's not a professional health care facility, because in a professional health care facility you have trained operators available when patients are available. That's a key distinction. And then there's this emergency medical services, which we're treating today in the world of 601 as part of the professional health care environment. However, I can tell you that a proposed new work item hit my in tray in the last month or two and there's a request from Northern Europe and also from the United States to begin work on a collateral standard for emergency medical services as an environment, to bring all of those requirements into one place. So, just a never ending battle. So, what's different about this environment? The electrical supply is different. You don't have a hospital bio med, you don't have backup generators, you don't have the kind of control that you have in a professional health care facility. And what does that mean? Well, believe it or not, we believe, or actually the power company is allowed to go minus 10 percent. The wiring of the building is allowed to absorb four percent. So, in the home you could go minus 14 percent. We therefore set the requirement at minus 15 percent, and that's more severe than in the hospital. And if it was a life supporting device, we tacked on a little bit more, because here in the Northeast and certainly in California in the summer time, we get things called brownouts. And if you're on the ventilator or dialysis or anything else, you really don't want the equipment to stop working while you're being treated. No protective earth. Older homes in the United States do not have three wire plugs. Or if they do, that third pin isn't connected to anything, as I found out when I moved into my house. And my youngest child was born with respiratory problems and needed a nebulizer and we brought it home and there was no place to plug it in safely. And, yes, you can go down to the hardware store and get one of those nice little cheaters, but you've just lost half of your electrical safety protection when you do that. And now a single electrical failure will electrocute you. Not a good solution. In many countries; Japan, Denmark, Norway, there is no earth ground. Norway's a big hunk of granite. You can't get it. Doesn't exist. So, if you're a worldwide manufacturer, you put a three pin plug on your device, there are a whole raft of places it can't be used safely. And even in a country like Germany, where all outlets are three wire outlets, the people who do home care work there will tell you it's a lot more than 10 percent of those outlets that actually aren't connected. Three pin plugs are dangerous in the home unless it's a brand new home. Temperature and humidity. We know about professional health care facilities here in the United States. They're like 100 percent air conditioned. Well, that's not true in the home health care environment. As Pat will tell you, it's already hit triple digits in Arizona this year. The dark days have begun. If it's the winter in New England or Minnesota, it gets really cold and you kind of expect the equipment to work as you carry it from the car in. And in fact, the standard has a thermal transition or thermal shock test for things that are transit operable. What is transit operable? It's a new term that we invented in the standard for devices that are intended to work while moving. A lot of the home health care devices are transit operable. You wear them on your belt or they're bolted to the wheelchair or the scooter. They're not just a patient in a bed like they are in the ICU. This stuff moves around, and that has an impact both in the temperature and humidity, and also in the shock and vibration. Patients are going to put some of this equipment in the car. And if they're not in it 24/7, it might actually stay in the trunk for a few hours and get to the outside temperature, which in Tucson in the summer is really hot and; I see Brody out there, in Minneapolis, Minnesota is really cold. And if the device isn't going to work after that, it's not going to be very useful in the home health care environment. We also have a term called "body worn," because in addition to transit operable, there's a body worn category which has yet some different characteristics. Now, for those of you who are familiar with electrical equipment, we do an accessibility test in 601. We have this articulated finger that you poke around the holes and openings to look for leakage current, and it's an adult finger. Well, an adult finger is not the only finger that may be around the equipment in the home. So, for home health care, we've added in the child finger, which is also available in the IEC test suite. So, home health care equipment also has to be examined with a child's finger for accessibility for things like shock hazards and leakage current. We also require that all applied parts be floating applied parts. Remember, you can't rely on the basic safety of a protective earth connection that isn't there. So, you need the higher dielectric capability of a floating applied part to keep from electrocuting someone. Usability. Pat's going to talk about that, that we have an international standard for usability, IEC 62366. And the home health care standard has as whole list of attributes that need to be evaluated to that usability standard. And you got to remember that the operator isn't a well educated health care professional. The standard requires that your operator profile includes something with only an eighth grade education. Some would argue that's too high and it ought to be a sixth grade education. It's got to be easy. You can't have a huge long complicated instruction book and be successful and safe in the home health care environment. So, here are some of the attributes written into 601 1 11 for the home environment, things that you have to specifically look at and do usability analysis on. Give you a chance to look at that list. And when you get to a specific device, you can expect that the specific or particular standard for that device is going to add to this list. These are just sort of the general ones that most devices have. And this one here on the bottom is rather important. And if you've got little parts, you're going to have a problem, because little kids are going to try to eat them. Some equipment can become contaminated in use. And it can, you've got to be able to clean, disinfect and/or sterilize as is appropriate in the home. So, that means you need to have validated processes for that and those processes have to be capable of being performed in the home. No ethylene dioxide, please. Or, you're going to have to label the equipment for professional reprocessing between uses or between patients, as might be applicable. You think for instance of a home care ventilator. It might make a fair amount of sense to professionally reprocess it between patients. Nonetheless, there are cleaning and disinfections required while in use because it's going to be used for a long period of time. And nosocomial infections are a problem in home ventilation just like they are in critical care ventilation. Dust and water protection. Even inside the house, this is not a super controlled environment. And so, the minimum requirement that the committee felt was appropriate for home health care is IP21, and that of equivalent to a light rain. And that's for things that are reasonable stationary and not moved around. If on the other hand, it's transit operable or body worn or hand held, it's going to see more than light rain. People go for walks, and as it did this morning, it started raining rather hard while you were outdoors. And if you're on a ventilator, you really don't want it to stop working when that happens, or an infusion pump on your belt. And there are a lot of people walking around every day with devices and going to work and riding on the bus, and such. So, we consider these enclosure protection levels normal condition for those of you who know about 601. What you're going to see in normal use in the home health care environment. Mechanical strength. Home operators are not as gentle as the folks in the hospital who get a bad review if they break things. So, there are shock and vibration requirements for all devices. And these are survivability tests, so they're much more severe than you expect to see in use, but it's very hard to test equipment effectively on the shock and vibration table. A drop test only lasts for a few milliseconds. And it's extremely difficult to evaluate that the device is working while you do that, so we up the levels and look at these as survivability tests. Again, for things that are transit operable, things that are intended to work in everyday movement, the levels are higher. And for portable equipment or things on wheels; again, go back to that ventilator that's bolted to the wheelchair or bolted to the scooter, you have a drop test as well. And of course, little hand held things drop all the time. And for those are familiar with 601, there's an additional test in 601 for hand held things onto a wooden floor at one meter. Right, Brody? So, these are in addition to that. The electromagnetic environment. This is a class B emissions environment. Home health care equipment is intended for domestic establishments. That means you have to have very small emissions so that you don't mess up radio and TV signals. If you're in an apartment building, your next door neighbor is not going to be real happy with you if they can't use their radio or use their television. Immunity. At the moment we've defaulted to the levels that are in 6601 1 2. However, that committee is hard at work on a new addition that will very clearly have more severe limits in it than the limits that are currently in that standard. And there's a good reason for that. Think of a typical GSM cell phone. That's a two watt transmitter. So, if you're half a meter away from it and do the calculations that are in 601 1 2, that says you need a 20 volt per meter immunity level. Now, how many people in this room really think that patients are going to keep their cell phone 18 inches away from their medical device? I certainly don't. So, higher levels are going to be necessary or you're going to have problems and your patients are going to have problems, and somebody from compliance is going to come visit you. Lastly, the joint working group considered issues 1, 2, 3 and 5 from the call to this workshop and the development of 6601 1 11. And I believe that the standard very effectively controls the risks associated with those issues. So, I certainly challenge the FDA to write that standard into the guidance document as a suggestion, as an adequate special control for home health care devices for the issues covered. Now, if you have a particular device, there's going to be some other issues as well, but I think an overwhelming majority of the horizontal issues have been very well addressed by this standard. Thank you and are there any questions? (Applause.) DR. BRADY: We'll go and hold the questions until after everybody in the pre market area speaks, so in the interest of time we'll just keep moving on. MS. COLLINS MITCHELL: Allow me to introduce Susan Mintz. Susan is a social entrepreneur who took the personal experience of her husband's diagnosis of MS and built a national organization for the benefit of family and caregivers, and that organization is the National Family Caregivers Association. Ms. Mintz is recognized as a forward thinking leader on family caregivers and related policy issues. She has provided testimony to Congress, written extensively and is often quoted by popular press. She's the author of several books including, "A Family Caregiver Speaks Up: It Doesn't Have to be This Hard." This was published in 2007. Please welcome Susan Mintz. (Applause.) MS. MINTZ: Good morning. I have to tell you all the things Dave said scared the hell out of me. I don't want to have to worry about any of that. I just want things to work easily, and easily is a word that you really need to keep in mind during all of this. How many people here are from out of town? (No audible response.) MS. MINTZ: Okay. Well, on behalf of Washington, I will apologize for the weather. It's supposed to rain in April and we're supposed to have glorious Mays, but it's been very screwed up this year. But people will say that about everything in Washington, so maybe it is appropriate. I'd like to get a sense of who is here. I don't work in your world, so who here is an equipment manufacturer? Who's with FDA or other government agencies? Okay. Minor. DME providers? Okay. Clinicians? Did I leave anybody out? Okay. So, mainly manufacturers. Great. Let me just give you a bit of background about NFCA. It is an organization for family caregivers. We define family caregivers as a person who is providing care for a family member or friend who has a chronic illness or disability. This can happen of course anyplace across the life span and the specific disease is irrelevant, as is the actual relationship, because there are common issues that all family caregivers share, and that is what we focus on as we provide them with education, community and advocacy. So, you've been looking at this for too long. Let's move forth. I hope everybody can see this cartoon. I love it. It says, "You can get dressed now. The doctor saw you when you weren't looking." And it really does speak to so much of what is going on in health care today, because everybody's asked to do things so quickly. But not everybody of course can do things all that quickly. People with chronic illnesses and disabilities and just the frailties of old age dance to a different tune, and you need to think about that in terms of the equipment you design for use by them and us. Equipment makes our lives possible in this day and age. You know, years ago people just died when they had some sort of a problem. That's not the case at the moment, and I think a great example of course is Chris Reeve who never would have survived for eight years without the ventilator that helped him until he was eventually actually able to get off of it. And I tell people that I drive a Mercedes Dodge. There is the cost of the minivan and then there's the cost of the conversion. So, by the time you put the two together, you've bought yourself a small Mercedes. Doesn't look like it, doesn't drive like it, doesn't have the resale value. Nevertheless, it is a Mercedes Dodge. And you may not think of that as a piece of equipment, but it enables our life to have life, and so we definitely do. And so, actually on behalf of all of us who need the equipment that you create, I just want to say thank you for doing what you do, because you make our lives possible. So, let me tell you what characterizes equipment and medical devices for me. It can be as simple as a transfer belt, because for me, equipment replaces body parts that no longer function as they should, or it augments abilities that have declined. And so, as you know, it comes in all shapes and sizes and some of it's real simple, and some of it is extraordinarily complex. And I think that's more and more the case with all the things that happen in the home. And I think, you know, a lot of those particular issues were really just addressed, whether it's something that needs a lot of maintenance or, you know, it's maintenance free, whether it's got lots of little parts or it's just, you know, one thing. And so, what you really need to be thinking about is that you need to develop a mind set that helps you understand to the extent possible how we use the products that you create and under what conditions. And ultimately it's all about communications. You need to know your audience, your target market. And I'm a great fan of the TV series "Criminal Minds". Does anybody else watch that? I've become addicted to this show. And what it's about is a special FBI unit whose members are all profilers. They study human behavior so that they can come up with a description that will help them and local law enforcement find the people who have created this most horrendous, horrendous, horrendous acts. And so, they develop a profile of these people they call "unsubs," which stands for unknown suspects. And so, what I'm saying is that you need to become profilers. You need to understand the nature of the patients and family caregivers who are going to use your product. And the term "patients" of course is a health care term. To us, the people who need your equipment aren't patients. They're parents, they're spouses, they're kids, they're friends. And it's not really just semantics. It's a different approach to who the people are. And so, again some of these things were touched on. What kind of training are we going to need? Most often people get very little training. It certainly isn't repeated. It's hard for you to know whether we're actually using it correctly. And so, everything needs to not only come with instructions that are easy to understand and I firmly believe that means pictures as well as words that the two together are that much more powerful. And you have to understand that doing business to business transactions are extraordinarily different from transactions with consumers. And although you as the manufacturer may not be selling directly to us, you are still responsible for that product. So, think BP. A place none of us really want to be. So, who needs equipment and medical devices? I think it's just good to get some sense of the demographics. There are between 40 to 50 million people in this country with a disability. And people on Medicare, not all of them are over 65. Seven million of them are younger than that and they're there because they have disabilities and need products and services. And then of course, there's a whole bunch who are 85 and over. And people over 85 are the faster growing cohort in this country. With a marketing hat on, I would say to you there definitely is money in them there hills because of the population. Boomer. First Boomer turns 65 next year, and I must admit I am one of them, barely. I was born on the sixth day of the second month of the first year of the Boom, so I kind of like that because, you know, there will still be a lot of things around before the peak hits unless we really change the way we're doing things. But, I do think that Boomers as consumers are going to be very different than our parents. You know, I grew up in the '60s and we were all thought of as change agents, people who weren't going to put up with the status quo. We were spoiled brats. We wanted things to be our way. Well, I'm not sure that we should expect anything different going forward, especially when we see what our parents and grandparents have had to go through. We really are living in a time that didn't exist before. People never did live this long before. We didn't save premie kids, babies the way we do now and the fact that we can do that has created so many more children in this country with disabilities and developmental delays. So, the wonders of medical science are indeed wonderful, but they also create situations that then need addressing. And so, who cares for people with disabilities, with chronic conditions? Most of the care in this country is done by people like me, not professionals, not in medical settings. And so, more and more things are going to be coming home, not because the system wants to save money only, but because that's where people really want to be. It is actually the law of the land and there is an additional $50 million in the president's budget for home and community based services. It really is where the action is. So, let me tell you a little bit about family caregivers. We're a mess. We're overworked and we're exhausted. We're working women. A typical family caregiver still has at least one kid at home and all of this takes a toll on family caregivers. The extreme stress levels of family caregivers are so high that it causes us to have conditions and illnesses at much higher rates than the rest of the population. Depression is extremely high in the caregiving community, twice as high for children of aging parents, four times as high for spouses. I've been there four times. And so, sometimes you have to wonder who's needing the care and who's giving it. So, another thing I think that's important to recognize is that family caregivers tend not to ask for help. I'm an anomaly; I always ask for help and I never turn it down. But because most people are going to keep trying and trying to do something by themselves, you need to take that into account when you are creating equipment. And you've got to remember above all else that we didn't go to medical school, we didn't go to nursing school, we're not PTs. And even those people who are in the medical profession, when they're dealing with their only family member, everything they've ever learned goes out the window. There is a reason that surgeons do not operate on their own family members. So, I want to read some things to you to give you a real life understanding of what actually happens with equipment. My husband says I make things complicated because I'm always doing things twice, like not bringing it over with me initially. So, I want to read you something actually from my book. My friend Eve, who was a highly resourceful caregiver for her husband before he passed away, says she reached her frustration limit when equipment broke or didn't function the way it was supposed to. She tells the story of the company sales rep who told her over the phone that the lifts his company manufactured to help transfer a non mobile person from bed to wheelchair never break. Well, she stood there in her bedroom with a broken bolt in her hand and the lift in pieces on the floor. "My first reaction was to scream at the guy," she said, "but then I realized I'd get more help if I didn't rant and rave, but rather told him in no uncertain terms how I needed him to fix my problem." Not everybody would have been like Eve. They would have ranted and raved, and you need to deal with that as well, but customer service is critical. That's pretty laughable. And then I want to read you something else. This is from an amazing book called "Rough Crossings: Family Caregivers' Odyssey Through the Health Care System." It was put out by the United Hospital Fund of New York. I'm not sure if it's still available. But, a woman whose husband returned from the hospital after a stroke had difficulty monitoring a feeding tube which had confusing computer settings. She'd seen it in the hospital, but received little training on how to use it at home. "I was terrified of it," she said. "It's broken twice. When we left the hospital, they showed me one, two, three and that's it. They said, 'Don't worry. You'll learn it.'" Enough said. And so, my advice to you is to design with a KISS. I'm sure everybody's familiar with the statement keep it simple, stupid, and this indeed is critical. I went into an Apple store yesterday actually to look at the iPad because it struck me, it might be the perfect thing for my 93 year old mom who is not online yet. And it really is so intuitive and, you know, you just move your finger over the whole thing. It struck me this might be the way that she could get on email and converse with her grandkids and her great grandkids and see pictures of them. And so, you need to think that way to make it as easy as possible. Most of the people who are going to use this are in their mid 40s or above; at least from the caregiver perspective, so no small print, please. And to me, one of the most critical things is what I'm calling a feedback loop. If you're going to somebody's house for the first time and they give you directions and, you know, you're driving along and you think you should have gotten somewhere already and you're a little nervous, but then you see, you know, the gas station on the right that she mentioned and you know you're going in the right direction. Well, I would say that patients and family caregivers need sign posts along the way as well. They need to know that they're doing it right as they progress in the steps to get something working. And so, these are my overall recommendations for the agency and for the industry. In the patient safety movement and in the disability movement there's an expression: Nothing about me without me. Don't design in a vacuum. Bring us in. Have panels of family caregivers and patients to be with you during the design process, to test things out. What makes sense to you may make absolutely no sense to us. And quite frankly, if you haven't walked in our shoes, if you haven't had a chronic illness and disability, if you haven't been a family caregiver, there are things that you just can't understand. And so, I would advise you definitely to do that. You need to know us. That's really what it comes down to. And, you know, pictures speak louder than words and together they're that much more powerful. So, I do think instructions need to be graphic. Even something like the transfer belt, which is something that Steven and I use all the time because he's in a chair. Well, I bought it from a professionals catalog; it didn't come with any instructions. And Steven's PT showed me how to use it, but everybody has a PT. And so, even something as simple as this belt should come with instructions. And, you know, as I mentioned before, the whole concept of customer service is absolutely critical. There is an apocryphal story about Nordstrom's, the retailer who is just known for their service, and it's a story that a man came into a store with a tire and he brought it over to a salesperson and wanted to return it. And she said, oh, yes, sir, absolutely. And guy gave her the tire and he walked away. But Nordstrom's doesn't sell tires. So, that is the ultimate in customer service. I want to leave you with one final thought which I think will give you a sense of the emotion that is involved in this for all of us. And of course the piece of paper I had in that one little part is no longer there, so bear with me. Well, as I'm looking for the poem, let me give you the background of it. I went to the beach one weekend by myself for a respite. And Steven had recently gotten his first wheelchair, because the scooter he had been using was no longer adequate. And so, it was a pretty sad time for us. And so, you know, a lot of emotions I had to deal with and he did as well. And so, while at the beach sitting on the sand and soaking up the warm rays of the sun alone with my thoughts and feelings, I wrote a poem that was inspired by of all things a beach chair. The poem erupted out of my brain in only a few minutes and poured onto the writing pad that was propped up against my thighs. It was a very dark poem reflecting all the painful emotions the purchase of the wheelchair engendered. I expressed my fears and my anger. It was the visible representation of the pain that I held inside. It was a poem written by a woman who definitely saw her glass has half empty. But the sun was shining. I was enjoying a respite and I decided to think about Steven's need for the wheelchair in a different way. I ripped up the first poem and began again. The poem that came from my inner core the second time around was more upbeat. It looked at the doors that the wheelchair opened for Steven and me, not the ones that had been closed. This is the poem that I called, "The Chair," but wonder now if I should rename it, "Life Depends on Your Point of View." "It sits there at the crest of the hill on the rise just before the sand dips towards the water's edge, a lone beach chair, seemingly abandoned. It's a jaunty chair with it's yellow striped canvas seat and sailboats floating on its blue and yellow back support. It lists just a bit to the left, almost rakishly as it nestles in the sand surveying the sea. It's a chair made just for sitting, and sitting on the sand at that. It has no legs to get in the way of stretching out, relaxing and letting the sun seep into your bones and warm your soul. It's so unlike another chair I know, a black chair with wheels, a chair that does not survey the vastness of the ocean with a jaunty air, but rather a chair that defines a narrower kingdom. And yet, I think this other chair is a happier chair than the one that sits and stares out to sea, for it is a chair with wheels that take the place of legs no longer able to propel their owner forth. The other chair is not made for sitting and looking at the world. It's a chair built for exploring, for meeting life face to face and tasting of its spirit. Perhaps this chair should have a seat of yellow and white stripes and a back support adorned with sailboats, a far better statement of its adventurous and joyous possibilities." Thank you. (Applause.) MS. COLLINS MITCHELL: Thank you, Susan. Our next speaker is Pat Patterson. Pat is a certified performance technologist and president of Agilis Consulting Group. She's a contributor to the documentation chapter of the recently published standard HE75, the human factors design for medical devices. And this is by the Association for the Advancement of Medical Instrumentation, the AAMI. And she's a member of AAMI's Medical Device and Systems in the Home Care Application Committee. Join me in welcoming Pat Patterson. (Applause.) MS. PATTERSON: Good morning and thank you for being here. Susan, please don't apologize for the weather. When you live where it's terminally sunny, I actually enjoy seeing clouds, but some people think I'm weird, and they're right. (Whereupon, a video was played.) MS. PATTERSON: For the next few minutes I'm going to talk to you about labeling and training. Before I do though, I'd like to set it in the context. Labeling and training is actually part of a much larger field called human factors. And as some of you know, human factors deals with the interaction between the user and the device. And we look at the user, we look at what's their abilities, what are their limitations, what mental model do they bring to you with your device, what does it remind them of? And then we look at the device to see how does it support user performance; the alarms, the displays, the controls and the labeling and the training, because that's part of how the user interacts with your device. So, while we're talking about a very small portion of human factors, it is part of a much larger field. Because this is the initiative workshop kick off, so to speak, I thought it might be useful to have some assumptions. You might agree with them, you might not agree with them. Perhaps we can talk about them this afternoon or even after this workshop is over. But these are some assumptions that I thought would be worth noting. The first assumption is that labeling and training can never substitute for a well designed device. I can see Darrell's head. Yes, Darrell. I've been learned well, Darrell. It can't. It can sometimes help and it can oftentimes actually make it worse. Can never substitute for. We want to maximize the effectiveness of our labeling and training, but we want to minimize the cost. We don't want to spend $100 when $10 would suffice. Most of us have budget limited resources. If we can describe the performance, the user performance in sufficient detail, we can teach it to other people. And then finally, the overall purpose of labeling and training is to support safe and accurate user performance to produce outcomes of value. Outcomes of value. What do I mean by that? Take a look at these three statements and tell me which is the most valuable to you? I understand aerodynamics. I can do these tasks. I can perform a preflight check. I can land a plane in bad weather. Passengers arrive safely at destination. Now as a frequent flyer, I can tell you which statement I think is more valuable. Let's take a look at a medical example. I understand the importance of administering the right dose of medication. I can do these tasks. I can set up the pump. I can set the correct dose at the correct flow. Mrs. Jones is medicated per doctor's orders with no adverse events. Last one. I know how to adjust the respiration settings. I can do these tasks. I can set respiratory rate, set tidal volume, adjust flow rate. Following a low pressure alarm, baby Chris is receiving oxygen at the correct flow rate and at the correct pressure. When we talk about labeling and training, we're usually talking about them in the context of user performance. It's one of those words we kick around a lot. What do we mean by performance? Performance is actually a summary term and a part of that incremental summary term has to do with the knowledge. I understand, I know. But it goes beyond that to incorporate the skills, the tasks that the user needs to perform. I can set, I can adjust. But even that's not enough. Working a medical device correctly and safely is more than just button pushing. It's about producing those outcomes of value. What is it that the user wants to achieve that matters to them? The medicated patient. The following the alarm. Receiving the correct oxygen. And at some level we can step back even farther and say for what purpose? What are we trying to accomplish? Safe and accurate use, improved health and lower costs. What's important to recognize is that performance unfolds in this direction. I think something, I can do something, I get the results I want, and there's some greater good. But we analyze performance in the opposite direction. We begin looking what are we trying to accomplish? Now, given our users, what are the outcomes of value that they need to produce with this device? Then we step back and say, okay, now what are the tasks that they're going to have to perform in order to produce those outcomes of value? And we do what's called a task analysis. We get way more detail than that is. And then we back up again and we say, okay, now what are the knowledge increments that they will need to know in order to intelligently perform those tasks? One of the things that has a huge, huge, huge influence on performance is memory. There's long term memory, short term memory, working memory. Some people define long term memory as anything longer than 18 seconds and my time is already up. Does anybody remember in the second outcomes of value example what the second statement was? It's okay. You didn't hurt my feelings, because I'm not training; I'm talking. There's a difference. When we look at the different ways to achieve performance, and again that performance being safe and accurate user performance, we talk about training. We talk about training. And do we ever ask what is the definition of training? These are not approved definitions; these are our definitions, but I think it's a place to start. Wouldn't it be wonderful if at some point we shared the same nomenclature? Training is a planned experience when there is a lack of skills and knowledge that enables the user again to produce those outcomes of value; it's more than button pushing, that is often associated with long term memory. I often hear people complain, I don't know why they screwed up. I don't know why they made the mistake. We trained them. As though that somehow is descriptive of actually what went on. We have this assumption that because they were in training, that somehow they're supposed to remember stuff. Eighteen seconds ain't a long time, guys. The other way we can achieve performance is the ubiquitous user guides, quick start guides, those sorts of things. I like to call those performance aids, because in reality that is exactly what they're supposed to do. They are supposed to be aiding the performance of the user. Here's another definition; again, not an official definition, but one that we found particular useful. A storage place for information other than long term memory. Because it's so complex and the consequences of error are so severe, we don't want you to try to memorize it. We want you to use an aid of some sort. It gives direction on when and how to perform the task and it is written so that it is accessible while the person is doing the task. Accessible real time. What does that mean? It means that they're able to use that performance aid while they're actually doing the task. That means two things: (1) is we eliminate the problem of the 18 second long term memory; but (2), it also means that it suggests how we have to actually produce the instructions and format the instructions so they are useable. We also want it to be written at a level of detail to minimize trial and error. Trial and error might be just plain frustrating when you're learning how to use your new smartphone, or in my case, my new computer. It can be downright dangerous when we're talking about a medical device. The third way to achieve performance, training plus the user guides, in which case now we have a partial. We want some information in long term memory and we want some to be accessible outside of the brain power. What's important to note here is that the decisions of what we're using should be overt decisions. There are algorithms that will enable you to make a decision that says is this a user guide only? Is this a training only? Is this a both? And if it's a both, how do they fit together? I've seen situations where you have one team do the user guide, another time do the training, and they don't even look like they belong to the same device. So, it can happen, but it needs to happen as a coherent whole. (Whereupon, a video was played.) MS. PATTERSON: So, this gentleman is saying the user guide didn't take the user by the hand enough. How do we know? These are three excerpts I pulled off the Internet. I can't even tell you what the devices were; I don't remember, but I can tell you that they were all from user guides that were intended to be used by laypeople in a home environment. First one. Prior to each use inspect product for damage. Do not use if any damage is found. Thank you. Does that sound like it's supposed to be minimizing trial and error? Yes, I don't think so. Parents should carefully inspect electrodes, lead wires, power cords and plugs. Work for you? No. Open to interpretation. Open to accessibility. You know, that instruction is clearly not intended to be used as they're actually doing the instruction. The third one. A simple five step setup process; and that's how the user guide described it, simple, is followed by one warning and four notes including this one: A mask should not be used in the pulse dose delivery mode as it might not fit to the face well enough to allow the conserving device to sense inhalation efforts. Also, the therapeutic effect of the oxygen conserving device would not be realized as the dose of oxygen would be diluted in the mask prior to inhalation. Does it work for you? One of the benefits of having good definitions is that you don't even have to have a clue what this device is and you don't have to really be an expert in the device. The definition of accessible real time is, the persons performing the task minimize trial and error. We know it doesn't work. The only way you can really know for sure; and even then it's still open to, you know, what happens after it gets in the hands of real users, but the only way you have a snail's bit of hope if your training and labeling truly is effective is doing something called human factors testing. The excerpts, the video excerpts that you have been seeing are actually excerpts taken from a human factors study that we did a couple of weeks ago, clearly on a user guide. What makes human factors testing different is that it is a very systematic process of observing and recording members of the target audience. These are not the product development team people. These are not your relatives. These are people who actually have whatever the condition is that this device is intended to serve performing real tasks with either a real or simulated device. You don't want to wait two weeks before your FDA submission to do this. You can do this with prototypes. In fact, you should be doing it with prototypes. But what you're doing is you're setting as real world condition and giving the user whatever it is that they would be expected to have in real world, and just let it happen, and videotape it. One of the things that I think makes human factors medical devices so different than the human factors for that smartphone and for your new computer is something called use error. Use error can be defined as an act or an omission of an act that something bad happens when that user's interacting with the device. The manufacturer did not intend it and the user did not expect it. It's one of those, oh, my gosh, who could have thunk? I have seen user guides go through literally nine review steps, nine people reviewing it, redlining the dickens out of it. Not one reviewer has the device in their hand. They're reading the instructions as though they're reading the front page of the New York Times, and they're all quibbling about is this word the right word? I think the comma should belong there. Then you put in the hands of an actual real user and it blows up and no one can figure out why. Because only the user can identify these things. If you want to shorten your process for getting labeling and training out there, knock down the reviews and increase the number of users. I would hire Susan in a heartbeat, by the way. MS. MINTZ: I do consulting. MS. PATTERSON: So, that's what we're looking for. We're looking for those opportunities that can either cause harm to the patient, to the user, sometimes to the device, or that cause the person not to get the therapy that your device is intended to provide. You guys work hard on these things, I know, so we want this to happen. If you're interested, I would invite you to take a look at AAMI's newest human factors standard, HE75, Human Factors Design for Medical Devices. There are people in this room who spent years of labor and love producing that document. It is beautiful. It is a rich resource. There is a chapter in there on documentation. Some of this stuff is covered in there. But if you don't have it, get it. Well, I've been talking about users kind of assuming maybe lay users; and caregivers certainly can be lay, as Susan told us. If this Home Health Care Initiative and the system is going to work, we have to begin to bring in the caregivers in a really formal and a really systematic way. These are the folks who have to meet the challenge, whether they be lay caregivers or professional. We don't have time to go into it right now, but I would invite you to look at this performance model in terms of how do we develop caregivers? What is an outcome or outcomes of value that a caregiver provides? It's more than knowing how to put somebody in and out of a wheelchair. It's much more than that. It's important. What we do in this room is important. (Whereupon, a video was played.) MS. PATTERSON: Thank you. MS. COLLINS MITCHELL: Thank you, Pat. Our next speaker is Don Witters. Don is a biomedical engineer with the Office of Science of Engineer Laboratories. He leads CDRH/FDA Electromagnetic Compatibility and Wireless Work Group that develops information recommendation guidances and coordinates the EMC and wireless standard efforts. He has worked at CDRH and its predecessor the Bureau for Radiological Health for over 30 years. He is the primary author of the draft wireless medical device guidance. Please help me in welcoming Don Witters. (Applause.) MR. WITTERS: Thank you. Good morning. It's getting a little late in the morning. I know we're a little bit behind schedule, but if you bear with me for a few minutes. How many of you actually I bet you all have cell phones, right? Some of you probably have some really smart phones and things like that. How many of you actually have passwords on your cell phones? A few. Now, that's great. Security is an issue with wireless. Since these signals are going out into the ether basically, anybody can pick them up. In fact, you can buy little products that you can sniff them out very easily. They're $20 or so. And with those kinds of products, you can find out who has wireless and perhaps how you can get into it. I just wanted to show you very quickly an example of electromagnetic interference. These right here are coming from this BlackBerry in this person's pocket. So, there are issues with electromagnetic compatibility and interference that we need to be well aware of. We've all heard of in the last few years things about cell phones and pacemakers and other sorts of issues with electromagnetic compatibility. I'm going to speak mostly about the wireless issues. That's the technology, how it's used, what it's used for. In home health care, this can be safe, effective and secure, but it requires designing it properly, it requires testing, deploying and really managing that for the wireless risks and hazards associated with that. So, my purpose very quickly this morning is to go over what some of these wireless technologies are, how they can be used, how they are being used, what sort of things are the risks involved with this and how you can address that, and give you an idea about some of the challenges and opportunities that are in this area right now. And wireless is increasing not only in our hands in every day life, but it's going more and more into the home use environment. Go over the technology very quickly, some of the issues in home here, addressing these issues and the challenges. Well, wireless is everywhere. Everything under the sun uses wireless. Wireless goes back about 120 years or plus in terms of that technology, but only in the past few years have we really started to grasp it again. All of these different kinds of technologies are available right now and many more. We have products such as monitoring systems used in the home that are wirelessly sending signals perhaps through a cellular network or other ware. We have implanted devices that both use wireless to connect to the outside, but also from the outside locally to something perhaps distant. We have glucose meters and devices that can attach or work directly with cell phones. You have smartphones that now can display various types of physiological signals. Here's one that I like to point out. This is actually an RFID, radio frequency identification chip that can be implanted. And now they're much smaller than this. We actually reviewed this and it went through five or six years ago. So, what are some of the issues in the home environment? It's uncontrolled, as Dave mentioned. Very uncontrolled. You have many wireless emitters both in and out of the home. In fact, if you were to go home and you had some kind of wireless computer system in your home, you could probably pick up several, perhaps your neighbors' and you might find that those aren't even protected. There have been people who have exploited that in nefarious ways, but just know that there are many sources both in and out of the home. Your wiring is a source of electromagnetic energy. Your motors. Perhaps you have a microwave oven. Perhaps you have an induction range. Perhaps you have many different things in your house that are using electric energy and these create electric and magnetic fields that can potentially interact with some of these. You have things outside of the home that you can't control. You may be living near a broadcast or TV station. You may be living near an airport that has radars. You may be in the vicinity of a cellular tower. All of these create energy levels that fall off with distance of course, but they're still there. They're everywhere. And in fact, if you didn't have them, your cell phone wouldn't work. You probably wouldn't be carrying it. There's little oversight, in some cases no oversight. As we've just seen in several demonstrations of technical knowledge, you can probably expect that to be pretty close to zero generally. Rapid changing technology. How many have had cell phones you've changed in the last year? In the last two years? Right. This changes very rapidly and it's changing as we speak. And the wireless technology we're using now today in two years will be completely different. It's both a source. It actually emits energy. That's it's sending a signal back to the cell site or wherever. It's going between your printer or your company say. It also is a victim for electromagnetic. That signal can be disrupted. It can be interfered with. These are some of the hazardous situations that lead to the risks that are specific to wireless, although they do have applications in networks and other areas, but these are things that we look at for wireless. Quality of service. QOS, quality of service. When you think about that, perhaps on your cell phone you might think about that related to but not entirely encompassed by the number of bars that you have. If you're in an urban or suburban area, this is generally not a problem. But when you get out of those areas; or if you see the commercials one vendor versus another, we have more coverage, we don't, how do you protect against that or how do you make sure that in the environment that you want to use these devices, or anywhere in between, it's going to work. Data integrity means just that, the data is going to be correct, it's going to be timely. Coexistence is another issue. There are so many of these systems wirelessly now, millions, hundreds of millions. How do they all coexist, because most of them are operating on a handful of frequencies. There's only one protected frequency for medical systems in the U.S., and really I'm not sure if that's applicable worldwide. Security. Security is an issue. Starts with simple things like passwords, but it goes well beyond that. Most of your computer systems that you have at home probably don't have any security and you've never enabled it. It doesn't come enabled. Unless you do it yourself, it won't be there. Things like Bluetooth do have some security, but Bluetooth has a nice little function called Discovery. If you're walking down a hall and you discover something, you might want to see what it is. Well, what if you're walking down the hall of a hospital or in a home and you discovered now a dialysis machine? Oh, that's interesting. Maybe I'd like to change that. Most of them that we look at, obviously we ask that question, how are you making sure that that security is enabled and adequate for the use of that device? Risk. Obviously it goes up as it gets closer to critical life functions. High priority alarms. If you want somebody to react immediately and that system doesn't go through your wireless system or the various parts of the system that it's connected to, that could be a problem. If it's delivering therapy, a drug or something like that, there are things that we even want to go to remote control. And that's now more and more advancing on actual use situations. This is a shared risk environment. Everybody has to share in this. If you don't into it looking as a shared risk environment and only protecting or dealing with one part of that risk, you may be overlooking other places. It's related to the system. What's an intended use? What's the technology? Some are much more adapted to certain things than others. And the data that's transmitted. It's not just a matter of data. It's a matter of the system, looking at the entire system as our last speaker talked about. Low priority. Well, what happens if it doesn't get there five minutes from now, ten minutes from now, two hours from now, today? Maybe it's not that important. It'll get there eventually or you'll make some sort of follow up to get it to you. Those are lower priorities. The consequences of not getting that data across that link correctly, timely and securely, these are the issues that really need to be looked at. When we look at wireless technology in submissions, I'll go through just a few of the questions that we're typically asking about this. A good description. That is, what is the actual wireless technology? People say Wi Fi. That's not all that well defined. What exactly is the technology? The quality of service needed. So, you understand how these can go across the ether, what the parameters that you need to have for that to happen correctly, timely and securely within the system that you have. Coexistence. Unfortunately there's not a good test for this, and I'll explain in a couple of minutes why. Data integrity, data security and electromagnetic compatibility. These are all aspects of questions that we have. These are all out of the draft wireless guidance that you can get it. It's been up since 2007. We're finalizing it now. Took into account many different comments and many different experiences that we've had. We think this is an excellent document. Let me speak just a minute for coexistence. This is what we're talking about. Here is your device, whatever it happens to be; not going to look like this in most cases, and here's the link that you're trying to make sure is the secured link, the one that your system needs to operate. And then you introduce all of these other emitters that are working, some of them on the same frequency, some of them nearby frequencies, some of them different frequencies. You also have another one of your devices. How close can they get? As we heard about the cell phone on top of a device, you would expect that two devices will possibly be on top of each other literally. Maybe they were intended that way; maybe they weren't. You may have some reason that these have to be separated by certain distances, or these kinds of things. Microwave ovens. Most of the popular wireless technology; in fact, the biggest group uses the same frequency microwave ovens use. Microwave ovens are well known, have been documented to cause problems with these if the oven is leaking badly. If it's even in the next room, it could go right through the wall if it's leaking badly. Most ovens don't. That's another area that we actually deal with. We do oversee microwave ovens. And by and large they don't leak very much, but people do things to the oven like taking off the doors or taking the glass out of the door. Unfortunately that's happened. Challenges and opportunity. More home care, more functions, less on sight management. Perhaps less management at all. Maybe it's a phone call. Maybe it's a call center. Maybe it's a Web site. Who knows? You have the situation of the bolt breaking. What happens when you get very complex systems that are supposedly simple and something doesn't go right? I know I've had to call up the call center just to get my Internet working properly. Changing wireless technology. Wider integration, more use of wireless resources. It's a much wider use of wireless technology. Everybody wants to go wireless. They want to get rid of the wires. Well, we know how that worked with Toyota. Toyota isn't wireless, but it went from a wired, basically a hard wire system, a mechanical system, to something that was electronic through a computer. And there were issues potentially about electromagnetic compatibility with that. These are potential issues that need to be dealt with. Greater needed for shared risk. Everybody shares in this. The broadcasters with television may share in this. Ten years ago or so we found that there were telemetry systems in hospitals, not in the home of course, that were taken off the air by a new television technology, digital TV, which we've all switched over to, because the old system allowed hospitals and everybody else to use vacant TV channels. And guess what, there weren't any more. Need for information and standards. Definitely. And safe, secure and reliable medical systems are really dependent on some of these. This leads us to the opportunity. We can create it, like we're here today to create a document that really does try to start to answer some of these questions, pose some more questions and develop a framework by which this kind of technology can be used wider, safely and securely. I'll just summarize real quickly. The home environment presents challenges and opportunities. It's rapidly increasing and it continues to change and evolve. It's risk management that has to be dealt with; that's what we're really talking about, in a shared risk environment. There's a lack of adequate tools and clear pathways for this. We need to have more engagement by all the parties, and this is a wonderful opportunity for that. Addressing wireless should include these kinds of issues which are in our guidance: A good description of the characteristics, a good quality of service, data integrity, coexistence and the rest of these, and labeling of course. But we've all heard about how much labeling needs to be addressed in most of these kinds of systems. I'll leave you with this thought basically: Making this work requires a lot of research, a lot of risk awareness and management overall by all parties involved in this. Everybody has a piece. Stakeholder engagement, like these meetings, but more so, intense to develop the real tools and a proactive approach to safe, secure, reliable deployment. I'll leave you with this one this is my information with this one thought. (Whereupon, a graphic was shown.) Now, you think this is funny. These are the kind of things that can happen. This is why wireless and wireless issues are important as we go forward. There have in fact been things that aren't too far from this, but you hope that things like the clapper aren't involved in them, but you can never tell. Thank you very much. (Applause.) MS. COLLINS MITCHELL: Thank you, Don. For almost two hours you have heard some very thought provoking information related to unique characteristics of the environment, caregivers and patient labeling, and wireless issues in the home. We're going to open the panel for some questions and answers for about 15 minutes. DR. PURPURA: Hi. I represent industry, but as a former health care provider I know one thing that I would never ever want to do is ask a patient to get rid of a beloved pet. And I was wondering if, I guess, today if I would pose the question if you considered that as part of the environment, because I know of situations where pets do interact with medical devices? MR. OSBORN: There's no question that that can be part of the environment, particularly for things that need cleaning and disinfection. The equipment standard didn't explicitly mention that much other than I think there's one bullet point and a note that says you need to consider that. DR. BRADY: I think we called it the pets, pests and vermin or children MR. OSBORN: Yes. In fact, it's not just pets. It's cockroaches and other things. MS. McDONALD: I had a question about the pre market. During one of the discussions the infusion pump guidance was brought up. The definition for that regulated device specifies it's a device used in the health care facility, yet the home care labeling and definition is going to possibly change that. The question I have is, is the regulation going to change for each home care device to include if the device is going to be used in health care facilities and in home use, or are there going to be separate new regulations for those devices? MS. BROOKS: I can speak to that. We are going to change the regulation to better define the environment of use for infusion pumps, so I can make comments to that for the infusion pump guidance. We're in the works. Takes time. DR. BRADY: Any other questions? AUDIENCE MEMBER: I had a question for Don on the definition of the shared risk environment. Typically we would be doing risk assessment with regards to a particular device. When you say shared risk environment, where are the boundaries, because environments can be very different as far as different people having different types of interfering sources? Where do we draw those lines to do a shared risked environment assessment? MR. WITTERS: Well, that's an excellent question. I don't know at this point. It really depends on the device and the device system. For example, we've had devices relatively recently that depend on a cellular network for communication. In this particular case, we asked questions about how are you going to make sure that this patient is going to have the quality of service they need? They in fact reached out to the vendor and the wireless carrier and were able to come to some arrangement about what sort of service they needed, where it was and the vendor of the wireless would be the one would help determine that this particular product would be needed in order to make that cellular connection in this particular location. It's not well defined at this point, but there are many parties that can play in this. It depends on how wide the system is and what's involved in it. AUDIENCE MEMBER: Excuse me, I have a question on electromagnetic compatibility. I have an antique diathermy machine that I just acquired on eBay. I'm just playing with it. And it wipes out my cell phone, computer; it even triggers my paper shredder, and it probably takes out a two or three block radius in my neighborhood. And I'm wondering what about devices that are designed to produce lots of RF energy, electrosurgical generators, diathermy machines, things of that nature? Is it acceptable to just say that you can't use certain devices with this device? MR. OSBORN: The home environment is a class B environment. That kind of equipment is industrial equipment and it's not permitted by law in many jurisdictions, and certainly in the United States for use. The FCC can come knocking on your door using that in a home environment because it's against the law. AUDIENCE MEMBER: Well, this new technology that produces RF energy, there's lots of stuff in the home that's designed to produce RF energy. This was a medical device from the 1940s, but I'm sure you can still get devices like this in the home today. This is not an industrial device at all. MR. WITTERS: Yes, unfortunately that's true. You can get practically anything on eBay. Intercontinental ballistic missile, I'd guess you could probably get, too. Medical devices unfortunately are readily available. Explants like pacemakers have been on there. Those are definitely prescription devices. The electromagnetic compatibility is only as good as what that device may have met at some point, and even after that is not so clear. I don't know how one would go about a priori understanding that or even finding a solution for what you're talking about, but it sounds like you've got one that definitely wouldn't meet class B. And it would be a perfectly legitimate device. For example, diathermy devices don't have to meet any of this. They in fact were intended to radiate energy to do something, heat muscle, heat tissue, et cetera. They're well known radiators. Unfortunately we've had adverse events, some of them very serious that were related to things like that. Electrosurgical units, well known problematic for almost any other device because they do generate such a large amount of energy. But there is a standard specifically for that in each standard iteration; the newest one was last year or two, I think, improves on that and offers more information. Unfortunately your example is all too common, that these kinds of things can happen and they do happen. Just points out how uncontrolled these environments tend to be. MR. DESAI: Hi, I represent the industry. Every talk here I'm listening is all related to electromechanical systems, IEC 6061. How are you thinking about simpler products which do not use electromechanical components associated with? Thank you. MR. WITTERS: As far as the human interface goes, the Usability Standard 62366 is for all medical devices, as is HE75. So, the usability aspects are covered there, and I think covered quite well. When you start looking at other devices, if they don't have a human interface and they don't use electricity, the number of issues begin to go down a great deal. But most devices, unless they're implants, have a human interface. MS. PATTERSON: Can I add something to that? I always get a little bit nervous when someone uses the word simple in the context of a medical device. We've worked with devices that don't have so much as a battery in them, different kinds of EpiPen kinds of drug delivery devices, and bad things can happen. They're can be things like people accidently stick themselves in really, really bad places and they weren't expecting to get the drug. We've worked with lancing devices that are used in conjunction with a blood glucose meter and I've seem people rocket the lansing device across a room by accident. So, I think that even though those devices would certainly be considered simpler than the electromechanical kinds of things that you're talking about; and I would invite Susan to add to this, devices that don't have so much as a battery can cause some real difficulties for users. DR. BRADY: I would like to add to that as well. We did talk a little bit; Suzanne in her talk, about a few things that seem to very simple devices. They help lift somebody up that no longer can lift themselves up. If there are no instructions for use or the instructions for use are so complicated that that person can't use that, it doesn't matter how simple that device appears. It is complex to that ultimate user. The example of the Hoyer lift I thought was incredible. Somebody who thinks this is just going to function on a regular basis every day, it breaks. What do they do? They call the company. The company says, well, our devices don't break. Well, there she stands. Now she is in an emergency situation. What is she supposed to do? So, I feel that devices, whether they appear to be complex or simple, I put them all in the same category at this point, depending on the user and the environment. MS. MINTZ: And I think, you know, in a home environment until somebody gets so completely comfortable with something, there is an emotional impact, a stress level. So they're not necessarily thinking as clearly as they might. You know, if somebody needs help doing it, then you get the interaction between the ultimate user and the family caregiver, whoever is helping them and that, you know, gets in the way as well. So, I know Pat doesn't like the word simple, but take it in the context of make it easy. Don't add to the stress, I think is the way to say it. And I really do believe that you can't do it alone. It doesn't make any sense. I remember my dad had had a stroke and so there was like an apartment set up in the hospital to help him learn some navigation and how to get in and out of bed. It's totally irrelevant, because it's not like your own home. And I think that's really critical. MS. JOHANNSON: I have a question for you regarding the guidance document. Has there been or will there be global collaboration to allow for one design that works globally, particularly for traveling patients? MR. OSBORN: Well, certainly for equipment IEC 6601 1 11 had that in mind. And we looked at worldwide issues, but there are many devices that don't involve electricity that aren't covered. And the usability issues I think are very, very significant. If the device has a user interface, if it's for home health care, it needs usability work full stop. AUDIENCE MEMBER: A couple questions for Dave. Right that the FDA put out a couple many years ago said sixth grade education, yet you said eighth grade education in your standard. And do you expect us to find eighth grade educated people to test the IFUs with? And has our education level decreased so much that you're moving from sixth to eighth grade for what we're looking for in the country? And do we take it from a demographic across the country, or eighth grade in a specific area, because I think eighth grade may change as we move across the country and the world? MR. OSBORN: Certainly as one moves around the world that's an issue. There was a fair amount of debate over whether we should even mention a level of education. And at one point it was sixth grade and at one point it was eighth grade. It ended up eighth grade at the end. Usability studies need to be performed with operators that meet all of our operator profiles. I'll let Pat speak to that. She's much more the expert. And there's a German expert who kept talking about the eighth grade ADD boy which barely is sixth grade, and this was a German speaking, it's a relevant issue in terms of that. There are many tools that you can use in terms of looking for instance at instructions for use to determine, if you will, the English level of writing, and there are similar tools in other languages. But you need to do usability studies with the intended operator or they're not valid. MS. PATTERSON: Right. I would add to that, when I started out in the medical field transferring from Fortune 500 stuff, it was very typical that the labeling was subjected to nothing more than comprehension tests and they stuck to that sixth grader, they depended upon that sixth grade. And they would run them through computerized programs to see if it was at a sixth grade reading level, and they would artificially pick a paragraph that didn't have words in it like hypoglycemic, because obviously that ain't no sixth grade reading level. And I think one of the things that his changing, and again I think one of the benefits of HE75 is the recognition that the labeling and instructional material needs to be hands tested. It needs to be can they read it, can they understand it, but more importantly can they do it, can they follow those instructions? It matters not to me. And I saw this once where someone was testing the labeling by having matching columns. Can you match the word to the right definition? I almost fell off of my chair. It needs to be tested in that way. So, while I think it's appropriate, okay to have some kind of grade level reading, I would be cautious about thinking that that's the one criterion that you really need to strike for. It was a shot in the dark; I think it's where we were 30 years ago, but I think that we've gotten beyond that today. DR. BRADY: Okay. We're going to take one more question here. And I would say we're running out of time, so we want to stay on track. But during the breakout sessions this afternoon, make sure that you ask these questions that you're holding right now. Write them down so you don't forget, because we really want to know what your thoughts are. So, just hold them right now. And we have one more question. MS. YOUNG: I just wanted to make a couple quick comments. One is that certainly I would agree with Pat that don't rely on that grade level, because I could write you sixth grade instructions that still would be completely and totally incomprehensible and not able for people to follow. But I wanted to make another comment about the idea of simple devices and where issues are. I'm involved with Western Michigan University and we ran a tele health study recently where people were asked to take their blood pressure. And these were older folks, between 60 and 90 actually. And we found that a third of them either could not use the traditional blood pressure cuff to take their pressure or they could not interpret it. And so, if you think there are not problems with simpler devices, simpler devices are not simple and blood pressure is a tough concept for somebody who's oxygen deprived, who doesn't know anything about blood pressure, etcetera. And I think you have to consider those things. Finally, I would make a plug for better and diverse training materials from manufacturers, and I would make that plug on behalf of the nurses who are often the folks who have to do the training, and we do not give them very good tools to use with patients. MS. COLLINS MITCHELL: Thank you so much. We have heard the comments and we'll take these comments back as we prepare these guidances. We'll have a 10 minute break and then we'll return to this room. Thank you so much. MS. MINTZ: I just wanted to say I'm not going to be here for the breakout sessions but Lisa Winstel; if you would stand, from NMCA will be. (Whereupon, the above entitled matter went off the record at 10:57 a.m. and resumed at 11:14 a.m.) MS. COLLINS MITCHELL: Okay. There has been a slight change in our agenda. After the next speaker we're not going to have the question and answer period. We're going to allow you to ask those questions in the breakout session. But today, it's my honor to introduce Dr. Susan Gardner and I hope that everyone is enjoying and finding the conference informative and enjoyable. The next speaker is Dr. Gardner. Dr. Gardner joined the FDA in 1995 as the deputy director of the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health. In 2002, Dr. Gardner became the director of the Office of Surveillance and Biometrics. The responsibilities of the Office of Surveillance and Biometrics include the monitoring and review of post market studies, post market signal detection through the monitoring of adverse event databases and other data resources. Prior to joining the FDA, Dr. Gardner was the associate director of health studies at Westat, a social science research firm. Dr. Gardner received her nursing degree from the Johns Hopkins School of Nursing, a bachelor's or arts in sociology from Boston University and a doctorate in medical sociology from Catholic University. Please join me in welcoming Dr. Susan Gardner. (Applause.) DR. GARDNER: All right. It's almost no longer morning. I'm going to give you a crash course in post market surveillance. And for those of you who are not students of the regulatory system, post market actually means the products are on the market, not post market. So, go figure how the terminology got where it is, but that's what we intend to call it. And unlike the speakers ahead of me, I probably am not going to bring you to tears or make you laugh through this talk. We really had some wonderful talks, but regulatory stuff tends to be a little drier than that. All right. The objectives of our surveillance program of course are to first of all ensure some reasonable safety and effectiveness of the medical devices which we regulate and we want to be able to identify and if possible prevent the occurrence of adverse events related to the products. When harm does occur, we want to figure out the cause of those problems and we want to capture that information and use that information to better inform decision makers. And you can think of decision makers in the broadest terms. It's both the day to day work that FDA does, it's those of you working in the homes taking care of your loved ones, it's people in the hospitals, all the way up our Congress. We have a number of information sources, and I will give you the punch line right now. In spite of this, we do not have very good information of the problems going on in the home. We have our Medical Device Reporting Program, we have our MedSun Program, we have epi research, post market studies and our important collaborations with our partners. And I'm going to briefly talk about each of these. Medical device reporting. Manufacturers are required to report device related deaths, serious injuries and certain malfunctions to the FDA within 30 days, and the regulation says of becoming aware of those events. We receive over 200,000 individual reports a year of adverse events. That number continued to increase since the mid '90s. We also receive about 200,000, and sometimes more, reports that are in a summary format. These reports come from devices that are well known and the adverse events are well known. So, instead of filling out an entire individual report, they come in summary format which allows us to trend them. Over 90 percent of the reports we have under MDR are from the manufacturers. We have a small number of reports from the clinical community; which I'm going to tell you about, and we also have voluntary reports. MDR reports are reviewed by a group of staff that are primarily nurses, but we also have biomedical engineers, and we have some people with other specialized backgrounds such as radiation physiology. We look for unexpected events, something that we hadn't anticipated, and either we're seeing that as something new or we're seeing it at an increased risk level. I will tell you that we do not have denominators in most cases without a lot of extra work, and because we have a lot of underreporting, we know we don't have good numerators. So, when I'm talking to you about increased risk level, I will tell you that that is a very, very difficult thing to find. On the other hand, there are some adverse events that should never occur; in that case, it makes it easy. We also look for user error. We've already talked this morning about human factors issues. That's extremely important. We do think it's the responsibility of the manufacturer to address human factors and user errors when we see them. We're able to look at problems that are happening across device types, such as the infusion pumps that Mary Brooks talked about earlier this morning, and we look for problems that are not corrected by the manufacturer. Under the law, the Safe Medical Device Act, user facilities are also required to report deaths related to medical devices to FDA and deaths and serious injuries to the manufacturer. However, we have only traditionally received a very small number of reports from user facilities. By user facilities, we include hospitals and nursing homes, home health care agencies, dialysis units and the like. And I'm going to tell you about the MedSun Program and what we found out about user facility reporting. When I got to FDA in the mid 1990s and into the 2000s, I was actually surprised that we had such few reports from the clinical users. These are the people that are on the ground using the devices and why weren't they talking to us and telling us what was going on? So, we created the Medical Device Surveillance Network. This is a program that started with 25 hospitals that has grown to a network of 350 user facilities now. This gives us real time reporting from the clinical users. And in fact, some days it's very real time. We really have formed a partnership with these hospitals who feel free to pick up the phone and call us and not wait whatever period of time it takes us to get the report. We go to these sites and they're specifically trained to report medical device adverse events to us and to recognize medical device adverse events. The core of the program is really a robust and ongoing sharing of patient safety information to these facilities so they realize that reporting to us has a benefit and giving as much information as we can to improve safety in their hospitals. They emphasis is on prevention, and we also have a lot of focus on human factors. Once again, these people are the direct line to us from the user community. In addition to giving us reports, the MedSun people give us some real time information that's valuable for our decision making. We are able to go to them if we see an event and ask them if this is happening in their hospitals. Because of our Paperwork Reduction and OMB rules, we usually can only ask that question to nine facilities, but you can get a very quick read of whether we're seeing something very unusual or whether they're also having that problem. We also are able to go to them and ask them about information that we're putting out in communications that we're putting out, whether it makes sense to them, whether it's something that's going to be applicable to their facility. We do get reports of near misses and close calls. And in fact, the bulk of the reports are near misses and close calls. And we have been able to take a lot of regulatory actions on that information, again receiving it before somebody is actually hurt. What we've done in the last couple of years is tried to go deeper into the reporting community. We really want to hear, really want to hear from the users. So, we have put together what we call sub networks. We have one called KidNet that operates in the PICUs and the ICUs. LabNet operates in the laboratory environment. HeartNet in cardiac cath and we also have HomeNet, which I'll tell you more about in just a minute. Right now we're piloting yet another program which is our Regional Rep Program. We actually have people on the ground in the field who are going into the hospitals and helping the MedSun hospitals with their reporting and other activities related to the program. For HomeNet we have 26 sites enrolled. The very sad news is that from September 2008 to essentially today, we've only received 14 reports from seven different sites. They're probably the usual culprits you might expect; infusion pumps, pulse oximeters, beds, syringe pumps. In fact, we've talked about more things here than we actually have reports on that we know are problems. We do have ongoing efforts to increase the reporting on HomeNet and we're also considering other strategies for getting additional post market information. We know and have recognized some of the barriers to this kind of reporting, because we've actually gone out and talked to people about it. If you are at all familiar with the reporting form we use, the 3500(a), you know that it is not a particularly user friendly form. And in fact, the form was designed for drugs and biologics and devices. And that's handy, so the user doesn't have a lot of forms to go through. But if you were going to design a form that really got the information that we needed for things like home care, that probably wouldn't be what you would use. So, in our MDR database, although we have a fair number of reports, it's very difficult to tell if it really is a home use issue. There is a box that you check. As I mentioned before, we have a lot of underreporting and we're very well aware of that. And frankly, the reports are not very complete. People are not inherently good reporters and they're looking at the problem from their perspective, and that often doesn't include the information that we need to make a good assessment. It's sometimes a challenge to go back to the reporter, and again that is particularly true in the home care environment. A lot of people don't have the knowledge, the skills, the ability to really recognize that an incident might be device related, and we run into this all the time. For example, years ago we had a catheter that was coated with a particular chemical and people were having allergic reactions. But if you have a very sick person who's going bad, it takes a lot of skill to think about the fact that it might be this catheter that's contributing to that. Other barriers include a knowledge gap between recognizing the device related event and then taking action to report. Again, particularly in the home care situation, you're several steps removed from the hospital environment, so you have to see the event, recognize that it's happened, get the information to the right person to be able to report it and get back to you. There's a fair amount of home care and nursing assistant turnover, so training may happen for some group and then most of those people turnover and they aren't available when something else happens. And again, the benefits of reporting are not always apparent. If we get the report and if we take action, it may be something that actually the person giving the report knows nothing about. And as I say, we realized when we set up the MedSun Program that the core and the key to the program is to make the reporter realize their reports are not going into a black hole and that we are taking action and improving the safety. And home health care agencies all have different policies and procedures, so again it's hard to get a coordinated effort from that. Other sources of information, yes we do have post approval studies. Those are condition of approval studies, so if a high risk device, which we call our PMA device, is approved and we know it's to go into the home care environment and is labeled, and that's one of the indications, we may get information. We may order a post approval study as part of the condition of approval study and get information from that. We also have the ability to order post market studies in something that we call our 522 Program. So, if we see problems and we need additional information, we can order the company to do a study for us. There are some limitations to that particular ability, because these studies are limited to three years. And obviously, if it's something that we need to take regulatory action, we don't bother doing the study. But if we really see something where we need to gather more information, we do have the ability to order that study. We do have a robust Epidemiology Program in the Office of Surveillance and Biometrics who do studies in real world situations. We're becoming more adept at using registries, observational database and other surveillance systems. It is not so often however that these are available to the home care type of population and the home care devices that we are concerned about. Again, getting the information flow from the home back up to where we need it or into these databases or studies is really quite challenging. Finally, I think of utmost importance and I think the place that we need to go and really look closely is our partnerships and collaborations with academic partners, certainly professional organizations or other government agencies such as the VA, for example, or DoD, and these active targeted consumer groups such as Suzanne is heading up now. People who have headed up or have formed their own groups and their own consumer group because they have a child or somebody in their family that they're really interested in helping really can be important sources of information. So, we're looking closely at how we can connect better to those organizations also. Okay. That's it.