U.S. Food and Drug Administration
transcript Event ID: 2087834Event Started: 1/11/2013 1:35:35 PM ETPlease stand by for realtime captionsPlease stand by for realtime captions Thank you for standing by. All lines will be listen only. To ask a question, press *1. Today's call is being recorded. If you have any objections, please disconnect. Please begin. Thank you for joining us for today's talk on medical devices in the home -- what FDA is doing. If you have any technical questions or experience difficulties, these see the e-mail in the lower left corner of your screen and we will respond to your e-mail. For questions at the end of the presentation, please press *1 and the operator will take questions in the order they were received. As a reminder, we are recording this session. It will be available for those not able to join today or if you would like to review. If you're not comfortable being recorded, please log out now. Today is my pleasure to introduce Mary Weick-Brady, the Senior Policy Advisor at FDA. After graduating college she began her career as a registered nurse in Rochester, Minnesota. She joined -- for about two years. Our interpreter, she worked as a clinical supervisor in a long-term care facility as a public health nurse. She obtained her masters degree in nursing while working as a nurse. She joined the FDA in 1990 where she worked in [indiscernible]. She was analyzing adverse events in medical devices. She later became a the director in the office of bio methods regarding adverse event reporting and reporting regulations. She initiated the work on medical devices in 2009 by establishing a home care committee. The purpose is to identify stakeholders for devices going into the home. And identify the problems and gaps in devices in the home and establishing [indiscernible] to become involved. The initiative was announced to the public in April 2010. I will now turn it over to Mary. Thank you, Andrea. Thank you again for taking the time this afternoon to listen to what FDA is doing with medical devices in the home. This is a big topic of interest for me and I do appreciate the interest you have in this as well. I have a little bit of a cold -- please forgive me. A lot of people ask why we focus on the home? What's the big deal with this environment? Besides many things, some of the bitter critical issues are having to do with people who come home from the hospital or who are developing comorbidities why they stay well. The areas I am looking at -- there are faster discharges as people are going home quicker and sicker. You have a lot of outpatient surgeries that used to be inpatient surgeries years ago and people are given instructions and discharged to the home with instructions on how to use medical equipment with minimal training and sometimes with a different device once they are in the home. You have the elderly population and we are getting more of the elderly population and they don't have just one or avidity -- a lot have comorbidities -- at least two or three different types. You also have individuals with chronic diseases -- 15 to 20 years ago, there were diseases that people were not living long within now things like cystic fibrosis, diabetes, HIV, are living long full life and yet they have these chronic diseases and they need to maintain that in the best way possible by staying well and independent in their homes. The big question is -- what is considered home? Fax we defined this broadly and it covers a large number of devices. Here is one area that I will ask your help in. What we consider home is any environment outside of a clinical facility which would be a hospital, rehab facility, long-term care facility, or someplace where there is 24/7 healthcare available. You're looking at environments outside of that that we would consider a home. This is where I will ask you to think about this as you listen to the presentation. We are trying to think of a different term or terms to use instead of the word home. Should we use community? Alternate site? Nonclinical environment? Think about that throughout the presentation. If you have thoughts, share them in the session. As a reminder, home use devices are brought. They cover a large gamut of devices. You have your disposables, accessories, -- oxygen and therapy. There are catheters, to be, syringes, needles, gloves. These are all what we consider to be home use devices. Implantable are devices -- such as defibrillators -- and inactive which would be the joint implants or intraocular lenses. There are computerized medical systems out there. This will be the majority of the devices in the home environment. These can be things like infusion pumps or dialysis. You can be talking about tele-monitors, ventilators, things like that that all have some sort of computerized environment. Reagents -- in vitro diagnostic products. When you do a screening, you do a self test in the home environment and determine whether you need to see a doctor or not. Things like a cold blood, Lyme disease, PTT test, pregnancy tests, are all considered home use devices. Another large area is the durable medical equipment. This is wheelchairs, patient lifts, scooters, walkers, anything like that -- hospital beds, etc. In 2010 we did establish the home use medical device initiative announced in April. At that point we said we were going to do five different things. The first thing was to establish guidelines for manufacturers of home use devices. I will talk more in depth about that letter on. That is something that came out with the update on the initiative last month. We also talked about developing a home use device labeling repository and we have been doing leveling research in the last couple of years and I will share that information, too. We going to partner with home health accrediting bodies and that is still an area we are building on. We have been in contact with all of the accrediting bodies for home healthcare agencies. We also talked about enhancing post-market oversight which means when their are problems in areas that are nonclinical, are they being reported to us? How do we encourage this? Finally, we wanted to increase public awareness and education to everyone to know that FDA does regulate medical devices and this is what is considered a medical device and this is what your responsibility as a user of the device should see. I will talk about that next. Now, in 2013, this initiative came out last month -- 2012. We came up with some different ideas for consumer information and we are slowly building on this. These are live links that you can look at later on. We have a 5.5 min. YouTube video CPAP on. If you have one, take a look at this later Rienzi at this is useful. We also did a consumer update in the magazine online and you can link to that and read the article. It talks more about the home use initiative there. The third thing that we worked on over the last couple of years -- a brochure on how to prepare for and handle power outages. These are becoming the norm now and they last anywhere from 24 hours to a couple of weeks -- given the hurricane a few months ago. We felt this was important for people to know what they can do with their medical devices in the event of a power outage. You don't want to be thinking about it at the moment of the outage. This brochure is also on the website. You can download it. It is about 20 pages. We also have it in hard copy, so if you want a copy, we can mail it to you. The information is there and you can stick it on your refrigerator and it is there so you don't have to think about it later on and you can pull it out when you need it. Also in the area -- last month, we were doing a lot of labeling research. Two years ago we started to ask healthcare practitioners and focus groups what it is they want in tabling and how they accessed labeling and what they thought about it? Was easy to read? Easy to understand? What portions did they use? They gave us some pretty good feedback. They told us that they wanted easy access to labeling because they couldn't find it -- it was in a file somewhere -- someplace where they couldn't find it. They wanted it to be easily accessible and preferably electronic. They also said they wanted a shortened version tough labeling -- something in relation to a quick guide or quick reference that they could look at and have access to full product labeling if they needed it. They also said that they wanted a standard content and format of labeling. If you have indications and warnings and precautions -- when you look at the labeling, it will be in the same place every time that you look for it in on every type of device you are looking at. This does not exist. Manufacturers are allowed to put information about warnings anywhere in the labeling that they want -- contraindications or indications. They said they would like to have a standard format. With this in mind, we did a web-based survey of over 600 but -- practitioners. We developed a shorter version of labeling. We did one for infusion. We figured that every healthcare provider has worked with one of these. We have three templates of this and they reacted to one of the templates. We are compiling the feedback now. The study ended last month and they are in the process of looking at the feedback. We had over 100% spot rate and that was wonderful. Then we were given a small amount of money -- a very small amount -- we were able to do a web-based survey of some consumers through the national family caregivers Association and we asked various caregivers to respond to the survey as to how they used labeling and accessed labeling them what they wanted. Hundred and 20 people responded. Surprisingly or maybe not, they said the same thing -- we want easy access and it would be nice to have an electronic. We need a shortened version because we don't have the time to look through all of the labeling. And we would like to know were all the information is is in the same place every time that we look for it. The information from consumers and healthcare professionals was coming up consistently to us. What was different was what they were asking for in the wake guide or the short version of labeling. Consumers are caregivers were asking for things like how to maintain the device and how to clean the device and the warranty and were to go to get it repaired. These were things that healthcare practitioners didn't have to ask because they typically don't have to worry about this. That was a big difference that we notice. I will also ask at this moment for you to think about if you were to have a shortened version of the labeling, what type of wording you would want. Would be the quick guide for quick reference or patient reference guide or a highlight section X we are trying to find out the best word for that, too. This is so people will know what they are looking for. In the area labeling, we are still looking at a repository of all labeling where people can access it and download it and do different searches on different types of labeling. We did a pilot test with five manufacturers in 2011. As we worked on this, we found a few problems. I would call that a success of the pilot -- we found it it was working. There are different ways to look at it, I think. Now, we are looking at what you didn't work and trying to make it work. So, that is still something we are thinking about. It will just take a little longer than what we thought. Again, we are very much considering a standard content and format of labeling where we would standardize the vocabulary and define it and also standardize the sections of labeling. This would be similar to what you would see in your drug labeling. They do have a standard content requirement. We are holding a public workshop April 29-30 and I am asking you now to register. I will show you the resources of the into the talk. If you are interested, you can attend virtually or in person. The final area of labeling we are looking at is called a Cooperative research and development agreement -- this is a company called Kwikpoint. They develop things -- we are asking them to look at problem areas that are high use devices -- patient lifts and sharp containers. We are asking them to do usability testing to see if we can have visual language instead of worse for people to understand how to use these things. We are also doing things with industry -- there is an organization -- the Association for the Advancement of Medical Instrumentation. One of the first things they are doing is they have a journal in the spring that is focused only on home use. They will have that out of the spring. In the fall they are planning on having a large meeting of manufacturers to discuss issues with home use of medical devices. The other thing we did that I will not go into detail about is the draft guidance for industry and FDA staff called Design Consideration for Devices Intended for home use. There are five areas of focus -- environment, user, device, human factors which is the interaction of the environment user and device, and finally the labeling. In this guidance document, we asked the manufacturer to consider all of these areas as they design their device if it is intended to be used outside of the clinical environment. These are some areas we are looking at in the environment. We are looking at the location. Is the device going to be used in an urban or rural area? What type of physical location will be used in and how will that impact the user and the ability of the device to function? Will it be used in schools in transit on planes? Outside? They need to think of all the different things. The idea is to keep people independent and functioning with the device with them and not having to function because of the device. They also have to think of the electromagnetic interference. There are a lot of things outside of the clinical environment that can possibly affect the device. It could be a radio transmitter or a radar or powerline. These have to be taken into consideration if they want to have the device functioning safely. Now we have to look at the physical location. How crowded is the location? Can it move from place to place? Can it move from room to room in the house or do you have to accommodate the device? For example, if you have a large oxygen concentrator that you can't move from room to room, do you now have to have tubing to follow you around X does a get caught on things? This is one thing they have to consider when they design these things. They also have to look at wireless signals. Here is an example -- somebody I know who had an Holter monitor was being monitored for a week and the signal was supposed to go from here in Silver Spring down to Texas. She lives in the first floor of an apartment building and the apartment building is like in a bowl. She thought she was translating her signal to Texas and they did not receive it because the signal was not getting down to the bottom of the apartment building. She would have to leave her apartment and go to the top of the hill and transmitter information. This is something the manufacturing needs to think about. Where the location will be when you are using these things. Contaminants -- to me there is no place outside of a clinical environment that can be considered sterile. These are not sterile environments and there are many things that can happen or antitrade a device. You need to think about Berman. There are cockroaches and ants around. You need to think about pets and how their firm I get into your device. You need to think about tobacco and smokers and dust and household chemicals. Anything that might affect the functioning of the device or get into the device. Also, the water supply is important in the home. Is it well water? City water? Distilled water? What type of water is the consideration here. More environmental considerations -- temperature. This time of year, especially, in the northern areas you can go from -30 degrees to a 70&#?°; office space in a matter of minutes. Does this affect the device itself or something used in the device? You need to think about that. Could it cause condensation -- could that be a problem X Manufacturers think about This and humidity. In this outfit is very humid. Does that affect anything that would bother the device? Here we have less humidity and we have problems with static. That generates an electrical charge. Will that affect the device? Atmospheric pressure changes. People live in the mountains or goal that an airplane. Is the pressure going to change out the device functions? Or below sea level. Airflow was also important. If it is a durable medical equipment that needs airflow, can you put it up against a wall? Does it need to be pushed out? What needs to be done? Make sure that the user knows. With childproofing, there needs to be minimal detachable parts and minimal parts to manipulate and minimal parts that can be manipulated around. This happens quite frequently with children playing with these devices. Then there is the area of tampering. Intentional or not intentional. Some people need to be able to adjust the volume or pressure or whatever it is that the device has and some people should not do this. You need to think about -- doesn't need to be tamperproof? Is there a lock mechanism necessary? The final areas for the environment that a manufacturer could should consider is that it should be assumed that people will travel. They should design this as such. People need to know if there is a converter they can take with them for the product. What are the voltage rates? Backup batteries? Access to backup batteries somewhere while I am traveling or should I take one with me? Going through security -- will that be a problem? Finally, you need to think about fluid exposure. Not just spills, but submersion. How much could a device withstand it was dropped in the water or a pool? Can you spill something on it wax what types of things are okay? How quickly do you need to wipe it up -- what should you look for if something goes wrong? These are all environmental considerations that a manufacturer has to put in the guidance document. The next one is very important -- user considerations. I am not sure that this is been thought about so much in the past as much as now since it is the lay user using the things. We are asking manufacturers to please consider these particular areas for the user. You need to think of the physical characteristics -- a caregiver or the care recipient or both. What size are they? Are they mobile enough to handle something like this? Are they coordinated enough? You have some elderly out there that are very uncoordinated. If you are fresh out of surgery and you have been sent home, you will not have a lot of stamina or strength. Are you able to operate the device? Think about the sensory and perceptual things and hearing and vision abilities. Sensitivities -- any problem with lighting? As you can see in the picture here, this gentleman told the person taking the picture -- I have no problem with Mike glucose meter. I can read it just fine. He was using a flashlight to see it. It was not fine. He should not have to use a flashlight to read the meter. Think about how visible the alarm is -- and if you can hear it. Is it something that you would know around the other noises in the home? Other considerations -- cognitive and literacy level and is English their first language packs are there any other cognitive impairments? Are they on a lot of different medications? Can they understand what is told to them? Can they understand what is written and can read it wax Finally, a big one is the emotional area. Whether you are the caregiver or the care recipient, you are taking care of someone you care about. You might have a new diagnosis or a new morbidity and you have to think about what is going on with that person and now you are being introduced with a device that you may not have used before. There will be a lot of anxiety and possibly fear of hurting the person. Therefore, I do not think that learning will take place well. A lot of it will sink in. Training for 10 min. is probably not going to be a big help there. This is what we have asked any factors to take into consideration. I want to show you this person -- Wendy. She is a home care recipient. She considers herself healthy with some problems. She has comorbidities. Pulmonary fibrosis and rheumatoid arthritis. She is in her early 50s. She recuperates from surgery about twice a year because her spine is crumbling. This has to be taken into consideration. These are typically outpatient surgeries. She is on full disability and cannot drive but she does self-monitoring and she does her own infusion therapy. She is on 19 medications, two of which are very strong -- one is morphing. -- Morphine. Her cognition can sometimes be impaired. She can walk about 20 feet without assistance. She gets monthly home visits and I have to say she is now eight years with a PIC line with no infection. I am showing her to you because I believe that people can function at home with ethical devices when they are monitored well and when they have something they can understand and use, even with disability. The third area that we have asked manufacturers to look at are called device considerations. I mentioned this earlier -- lockout mechanisms. Do you need to have a lockout mechanisms so someone cannot tamper with the device? You need to think about that -- if it is this very. Another area in home uses calibration. It is better not to have it calibrated, but if you do need to have a calibration in there, it should be minimal and they should be easy to follow and tell you that you have done something to tell if it has been calibrated correctly. They also need to think about the mechanical strength if something is portable. If someone is walking around with that device -- you have to understand that it will be dropped, moved around, in crowded conditions, banged up against something. Can that device withstand a lot of interference with that? Again you need to think about the electromagnetic compatibility. There is a term called coexistence. Can that device coexist with another device with an electrical pathway? Can they exist in the same room? If so, how close can they be without causing interference? I mentioned wireless technology. They need to think about that when they designed a device and I can't mention that enough. Many things are wireless now. Also, alarm systems. There is a lot of noise inside and outside the home and this is similar to the clinical environment except it is different. You have TVs, games playing, cars going by, or talking. There are many different noises going on outside that need to be thought about and what the alarm would sound like so it doesn't sound the same as something else. People have hearing impairments and visual impairments. I recommend that the manufacturer have at least 43 different types of alarm signals on all of the devices -- whether it is visual, auditory, tactile, I don't care as long as someone doesn't have to watch and wait for the alarm to go off so they can go up out their daily work and still no that they will hear the alarm. I won't go through all of these, but these are all of the electrical issues that manufacturers need to consider when designing their device. There could be a corruption of power supply. They have to know where the power source is. If someone needs to recharge their product, they need to know how often to recharge it or do they have to replace it every so often -- the power source? If you have permanently installed devices, you need to make sure that there is protective grounding and that somebody else can't assure that there is grounding. Outlets and adapters -- a lot of three-pronged outlets for two-pronged homes. Can you put it into a two-pronged outlets with adapter and be sure that the device will function correctly? I can, power outages and battery life. How long the battery should last -- the fourth area is human factors. The interaction between the environment, the user, and the device. These are all human factors. They need to look at elevation studies and think of the end user when they design their device from the beginning to the end. They need to do usability testing with the end-users throughout the product design and make sure that they are designing out any potential problems during the design, not after it is on the market. If there is user training and certification, they need to let people know that they have to be trained -- sometimes certified as in the case of home hemodialysis. There is a certification program. This program also goes with the care partner or caregiver. If there is responsibility of the care partner or caregiver, they need to be there as well in the human factor testing. Also, we certification and retraining. What needs to be done there to make sure that the interaction between the user and the device and the environment is done well. The final aspect that we asked manufacturers to look at is the labeling. I can't emphasize this enough. I think the best labeling is no labeling -- were it is intuitive enough not to have labeling. I don't think that will happen. So, it should be simple and concise and easily understood. At is what we heard. Make it simple. Make it even more simple so that we have a simple guide to use and if we need to referred to a local version, we have that, also. It should be in a narrative format and easy to follow and there should be pictures. People need to know what to do with their hazardous waste material so there needs to be instruction in the labeling how to dispose of that legally and responsibly. When I talk about hygienic maintenance, whether it is cleaning, disinfecting, or sterilizing, that has to be in there and well explained.Finally, post marketing considerations. We ask that the manufacturer put in a customer service number. That's the best way. We also ask that somebody be there 24/7 and not just an answering machine or somebody saying we will get back to you on Monday. That is not acceptable. We have a medical device reporting number -- go in there and look for the reporting section and they have a volunteer reporting section. If you have problems with your device and you want to let FDA know about it, go there and report it and you can be anonymous or you can be confidential. We also asked manufacturers about the selling and purchasing of used prescription devices. Sometimes, people put it on the web and try to sell it. These are prescribed devices for one person. That doesn't mean that they can go and be safely used on someone else. So, we are acting -- asking manufacturers to consider this in their design and how they communicate this to the customer. This is another slide that I find important. Home use devices should be useful. If not, they are going to be like a piece of exercise equipment that you have in your house that is never used. I think they also need to be usable. If they are not usable, they will not be used. I had an incident where an older lady was given a patient lift. It came in a box unassembled. She was taking care of her husband. This thing came in the box and she did not know how to assemble a. -- Assemble it. The patient lift is sitting under that, never been used. She continues to move her husband by herself. Devices need to be iterative. They need to follow a certain path. When you follow the instructions for use, it needs to give you a definite way to follow them. They also need to be intentional. So, when you are doing a device -- making the device [indiscernible]. They should be intuitive. People say -- what does this mean? A lot of people go down the smart phone route -- they say it is pretty intuitive. They can follow it -- if they press the wrong icon, nothing bad will happen. I use the word integrate herbal.. If you want to have a functioning device and live your life, you don't want to have something that cannot be integrated into your lifestyle. Teenagers with insulin pumps -- they don't want a big pop that is obtrusive. They want something they can walk around with that will not be seen. It has to integrate into your lifestyle. It should be informative. I don't think any of these devices need to give you any or information than you need to manage your disease entity or your chronic illness. If you get too much information, sometimes you don't know what to do with it. It should also address the risks unique to the home. Those are the things we talked about earlier. For me, having safe devices following this guidance can make them more safe, reliable, and I believe that that will lead to anyone living well outside of a clinical environment with one morbidity or comorbidities for any type of condition that they might have to live as independently as possible in as healthy a way as possible. These are some resources. The first one is the home use device website. I encourage you to go there. It is informative and talks about the workshop we are having in the guidance. It also has key studies and things that a been reported. It is interesting. We have a case study every month. The others are archived and you can take a look at those as well. We have a link to the draft guidance. If you haven't seen it, take a look. There is also a place for comments. We encourage this. We want to know that we are going down the right path. Again, the update for the consumer update -- you can go there. The bottom is the site for the registration for the workshop. When you register, if you can't make it here physically, you can register virtually. It is a two-day conference -- workshop. With that, I will open it up for questions. *1 At this time, if you would like to ask a question, please press. To withdraw your question, please press *2. One moment please. There is a question from peg board -- your line is open. Thank you. Great presentation. A couple of things -- when I got a new computer, one of the first things I did was take a deep breath and said how do I put this together? They included a visual step by step guide. It used the visual as well as simple words. I found it was a great tool to use. Also included was access to a more detailed information, but it also referred you to the website. I find that most people have a tendency to try to put something together without looking at the guy because it is too overwhelming. Another word for home -- the only other word I can come up with is residential. Thank you for the great presentation. Thank you. I received a garment for Christmas that came with a quick guide. -- A Garmin. I had to go to the website and register to get the information. It had pictures -- I found it to be helpful to have that as a guide as well. Thank you. Thank you for your comment. I appreciate it. Here is a question from Elizabeth [last name indiscernible] Thank you, that was a wonderful presentation. The word I like the best is community. I feel like I am a part of this. A couple of things -- 20 years ago I was involved with a device company -- one of the first ambulatory pumps. One thing that was interesting -- you could make it to everything except wash her dishes and make your breakfast. As a consumer, the thing that was most important to me is that it needs to be simple. It has to be simple. For me, the things that are the most important with what I use are -- that they are simple and secondly friability -- reliability. It is absolutely number one. It is what I depend on to live. So, those are the things from my perspective that are the most important. So, getting back to -- home use devices should be informative -- giving you the information you need and being reliable -- getting the proper feedback so that you know it is operating reliably. Yes, and I have had some pumps -- I have had them for 26 years. Some have lasted for five years. I have not had any problems at all. Yet, I talked to people at conferences that are constantly having problems. They are constantly alarming for small business. Those kind of things. From my perspective, one of the reasons I live a normal life is because most of the time I don't have to deal with any of those things. The pump I use has been incredibly reliable and this is very important to me. I am writing a couple of notes here. The person that I was showing you -- she is my sister. She has been remarkable living with her comorbidities for a long time. I was grateful to find that there were devices out there that could help her stay independent. Yes. And I could count on not having to have 911 calls on a regular basis. It was amazing to me that with all the intellect that these companies have that they want to make into more and more kinds of things. But, from a consumer perspective, it doesn't need to do all those things. I think of all the people in the country with DVD players that first came out -- everything was flashing because nobody knew how to set them. It is a combination of the fact that they didn't have good simple instructions and also that well-meaning people in designing them wanted it to be able to do everything and there were identical devices. I don't needed to do everything -- just one thing really well. Good point. Thank you. There is a question from Diane Llelock. I am guessing that your sister is doing so well because she has educated herself. Yes, we can't just rely on somebody to take care of this. My children are both diabetic. They are a young age. The idea of not wanting to do machines to do too much -- that is a generational thing. The younger generation -- the older folks what pictures and want to be told what to do. We wanted simple. I do believe that that is part of the older generation. I believe that with the manufacturers -- pictures are great and the instruction should be simple. Another example -- I had a 62-year-old sister diagnosed with diabetes. She put the strip in backwards. Everyone wants simple instructions. A lot of times, for the manufacturers, if they had training -- physicians that could train -- or over the phone instructions. I don't think they want to rely on them to do everything. All of us need to be educated. The older generation needs to learn that you can rely on people to explain it and show them once and then they can go on. We are asking manufacturers for a lot if we expect them to take care of the liability and also make it simple. Those are good points. If it is somebody with a chronic illness, do you say -- okay, let's put together a DVD so that there is a video available when you need to go back to it. Yes, something that we can look at my pictures or demonstration. None of us want to read. The younger generation wants to push a button and not worry. That is the way they look at technology. We look at it a little differently. Yes. That's a good point. It will be interesting to see when you get the pediatric devices for outside the clinical environment and they start to usability testing, the type of feedback. This will be an interesting area to follow. As right -- they want more information. They want to call their friends or text them. My daughter has an insulin pump. She is 27. It does so much. It gives her her grounds -- grass -- graphs. The older people don't want that information. Yes, and I am picking up my parents. My dad is 90. They want a cell phone just for dialing numbers. That's all they need. Do you make it available so it is something as simple and if somebody wants bells and whistles, that is also available? Yes, or if they give them the whole package -- then make the big quick reference instrument and if you want to get into depth, it is another click away. Yes. For whatever device you have. Okay. What to name it -- I don't know. A quick reference guide. We all like the word "quick". Thank you. Here's a question from Kathy P. Your line is open. Your presentation was excellent. I'm wondering if there is a way to get screenshots of this. I couldn't get them all written down. So I can go back and check them out. Is there a way to get something like that? This is Andrea. I have the slides and I can send them to everyone. I missed them. That would be a big help. I am interested in the one, especially, on power outages. I work for an electrical cooperative. I would like to see about that information. If you would like hard copies, we can send those to you. I will just go to entry on that. That would be great. That is all I had. When you look at the power outage booklet and you get the feedback, that would be wonderful. Yes, I need to see what that is. It is a problem we have. We are in ever will area. Anytime there is a power outage, it is hard to get to them because of the situation. We always try to tell people to be prepared for something like that. It is not always easy. Exactly. Next question -- your line is open. Good afternoon. Excellent presentation. I am grateful that I don't have any of these extremely important devices. What I do use are hearing aids. I am wondering whether the FDA done anything with regard to policing hearing aid offers with regard to quality and standards of what they offer, especially with -- sometimes they are confusing. They are improperly representing their materials. My question is -- does FDA have any authority over that particular kind of device? Yes, hearing aids are considered medical devices. We have a special section for hearing aids. They can follow-up on some of those things it you want to give us some information where there are problems with advertising -- it can be reported to the MedWatch system. Thank you. I will take the next steps. I appreciate it. I am amazed about the things that are out there. Yes, it is amazing. There are probably 20,000 different devices out there. Thanks again. You're welcome. There is a question from Anna McAllister. Your line is open. Hello there. Thank you so much for this presentation. This is good stuff. I have a quick question and a couple of comments. First -- what is the format for providing formal comments to the guidance and what is the deadline? We have a link on the resource site. Let me see if I can go back -- I couldn't find it. The deadline. We are checking that very I think I can get that answered for you. Okay. I might have missed it. I will see if I can go into this. I should have known this off the top of my head. I apologize. We believe it is March 13. It is usually 90 days from the day it is published. Someone will check right now and we will get you that information. They're going to verify this. It is usually 90 days. We want to make sure that we have the webinar during the comment time in case anybody wanted to say anything. That's great. I appreciate it. There's a lot of good stuff that you're considering that is important. I use multiple medical devices to control my disease. A couple of things -- when you were talking -- I would be a little concerned -- I understand the need to streamline the label and things like that, but one of the issues that we face especially with type I devices -- pump and glucose meters and monitors is that the manufacturers are constantly saying they can be more innovative it weren't for FDA. I have challenged them on that. I am involved as an advocate. The more complex we make the regulations, the more likely it is that it will stifle innovation. Having said that, we need to have [indiscernible]. All medical devices are not created the same. I am sure that you are aware of that. For advices that have consumer technology as a component -- they need to be accurate and work well. The meters need to be accurate. One of the issues -- there is no interoperability because the FDA won't let them. Other helpful devices that would be complement three or additive such as other meters. There is a lot of stuff that is not happening because streamlined and finance and regulations. There probably needs to be different guidance for different type of devices. I know you have that to some extent, but if you streamlined labels and requirements and those things for devices -- whether it is a pump in the hospital or for anesthesia versus an infusion pump that I have on my hip, there are differences in what is most relevant and most helpful for patients and there are white variations in this. -- Wide variations. Requiring all manufacturers to do things to meet various specific criteria in terms of usability limits the possibility of the types of innovation. Within a specific market to meet specific needs. It is a strange area when these devices -- in some respects, it is unrealistic. In others it is very feasible and there's a lot of good reason that things are done by the manufacturers -- FDA restrictions. I would be concerned about streamlining all personal home use medical devices. Because of the wide variation. I hope the agency will consider that -- there is a wide variation of devices and wide variation of patients and sophistication. There need to be safety considerations and the devices need to work well, but we don't want to create unnecessary limitations to innovation. I agree. I don't believe that FDA is stifling innovation. I think we try to encourage it. Let me explain about the guidance. The guidance is not a regulation. Is primarily the way of thinking so that when you're intending to have your device taking outside of a clinical environment, you should think about these things. We ask that you ache about this. -- Think about this. Regarding testing -- we will not dictate the kind of usability testing is going to be done, just so they are making sure that it is operating safely for the person intending to use it. They will be allowed to do whatever they can that they can say it is a valid usability testing with the right population. The guidance is voluntary compliance. It is just a guidance, not a regulation.For the innovation area, I believe that manufacturers can still be innovative looking at the guidelines. This is what we can follow and this is what we would be looking for if we are designing the device and these are the things we need to consider in that area.The other thing -- I didn't have a date yet. I believe it is March. March 13 is the date. That is the last date for comment. Now I have lost my train of thought. Where was I? We were talking about guidance versus regulation. That is true and I agree with you, but [indiscernible] The area of interoperability is a huge area. Their are devices that come in that are interoperable. Thing we have to work on is to figure out where the device begins and where it ends and the transfer of information going on with interoperability. And is it accurate? There has to be testing done there, too, to make sure that what you put in is coming out on the other end. Can it took up to something -- there are quite a few devices that are interoperable and they are bringing those in. I was surprised by your comment. They are encouraged -- if they have an idea, they are welcome to bring it in. There's a lot of monitoring equipment that is interoperable. The basic stuff -- people can hook up their pacemakers to the telephone. This is to transfer their information. That has been around for a while. It doesn't make sense for us to go point by point on interoperability. I hear you. There are a lot of things that are not happening they need to be happening. I hope that the guidance is not prohibitive. That's the other point I wanted to make. Guidance is based on a standard -- 60601 one 11 -- in case you are interested -- it was worked on by industry and nonindustry people. This is what is necessary for home medical equipment. That standard is specific to home medical equipment with electronic spaces to them. So, anything electronic would follow this standard. A lot of information we gathered with the guidance was developed by industry and we had the workshop in May, 2010 to go over these things and ask manufacturers what they would want to have for a guidance. I hope that they are not saying this is limiting them, but rather giving them an idea of where to go. I don't want to dominate this -- I am speaking from the patient's perspective. Devices and interoperability. That's what I am told by the manufacturer. Yes. It is a combination of cost, FDA, what is allowable, etc. What you are doing is critical -- we have to have standards. Insulin can be a dangerous drug. It must be safe. In terms of streamlining things like labeling, it would be great if there was a way to do that while we obtained a degree of flexibility that would enable innovation. I have written this down -- as we go through the comments for the guidance -- I am noting that. I appreciate it. Thank you. Here's a question from Steve [last name indiscernible] -- your line is open. Thank you. I will be brief. First, I am impressed by this presentation. You were thorough and succinct. The Q&A is extremely interactive. You have been very accommodating to all the questions. I commend you for your knowledge and approach. My question goes to the fact that -- it is not really an age thing for me, it is about crisis management. You can do all the labeling that you want and you can give photographs and other instructions. At the time that the patient brings into their home a certain medical device, you can have training, but it has been my experience that when things go wrong with a medical device, it is usually in the middle of the night. Many of us with chronic disabilities -- when something goes wrong with my CPAP and other things I use during the night, I don't have time to grab a file that says read page 5. Is there any discussion with the manufacturers as to the type of information in availability to be provided by manufacturers and maintenance of crisis hotlines? I am talking about individual crises. Something like an electronic glitch. I will leave that for your comment. Thank you very much. PICU for the question. I don't know if you can ever it limited all of this, but you can try to lessen it. Thank you for the question. To have them trained for whatever their devices -- that training is useful for that device. If they note that there might be a crisis in the middle of the night with that device, whether is an alarm or something -- something loosening -- there is something available right away -- they need to figure out what that is. That is up to them. They have designed the device to going to the home and now they have to figure out what happens if there is an issue like that and there is no one around to come and answer the alarm from a healthcare professionals point of view. If there are things that can be training or certification and they are thinking about as well, I think the ideal is to design anything that is risky out of the device. That will not happen completely. There are minimal warnings. Warnings can be a part of the design. If there is a warning, maybe they should consider how the device is designed so that there doesn't have to be a warning. This is where the usability testing comes in. As they design the device, what happens when they have that kind of thing happened during the testing and how do they rectify it? I am probably giving you a circular answer because I do not know if there is one specific answer. We had an incident where a patient -- a patient lift. This lady was taking care of her husband. It stopped working when she caught him up into the left. She could not move it. It was nonpower. She couldn't turn into get him into his seat. What seemed like an innocuous procedure ended up being a critical situation for her. She called the number for help and they said it shouldn't happen. She said well, it has happened. That is an unacceptable answer. What do you do in those cases? You might need to call 911. There has to be something that the manufacturer is telling the user in these situations. We would have to leave that to the manufacturer to make that decision. I don't want to have FDA tell them what to do. Does that help? Absolutely. Thank you. This is Andrea. We can't stop now and take questions via e-mail. Or we can continue. Whatever is best for you. I have a few more minutes if there are more questions. There are further questions. This is from [indiscernible] O'Brien -- your line is open. Thank you. I have a CPAP and pacemaker. Did I hear you say that the guidance suggests 24/7 service -- do you think people will comply with that? We are suggesting customer service in a form that they feel is the best thing for their device. I would prefer 24 flash/7 because I think -- on the weekends and in the middle lanai, that is when the problems tend to occur. We will let the manufacturers do that. That is too prescriptive on they FDA. Telling them they should have customer service is the right thing, not telling them 24/7 for every product out there. That is a difficult balance. I don't know if you have voluntary guidance. Speaking of compliance, I like the five things you can identify -- for CPAP, for a couple -- any study shows noncompliance. This is clearly something that has a lot of human factors. Nonetheless, the product itself has not met the need in the home environment. These things have to be identified. This begs a question -- in the guidance -- the human factor -- if someone is noncompliant, then it is not meeting the need. The most important point -- the pacemaker as it relates to labeling and monitoring. The pacemaker is passive. It works quite well and it does what it needs to do. It is the monitoring -- it has been taking place for a long time. I stopped monitoring for two reasons -- one is because despite having the monitor, the cardiologist still wants to see you every three months for follow-up. The other thing is -- the device manufacturers -- whether it be research or [indiscernible] -- . Stated their -- there is data there -- you can gather an incredible amount of information in terms of ADLs based on different things. The companies are looking to labeling as being an opportunity to get information for their subsequent marketing and sales and development, etc. This crosses over a difficult line. I don't want them to use the data for the reasons other than my medical care. Now it is being discussed labeling [indiscernible]. They are looking at GPS and other things to be able to use that type of information. I think the guidance should be clear in terms of privacy to not be used for marketing purposes. I am making a note of that. Thank you. I will address that. I think there was one -- a radiofrequency identifier. If there is a problem, they can notify people. You are saying that could cross over into invasion of privacy. Yes. This goes beyond guidance. Technology is great when it is relevant. There needs to be a use for that purpose. That is where you cross over the line. Thank you. Thank you again for the presentation. This is a question from any Alice. -- Annie Alice. I have enjoyed this discussion. I had a thought about using a word to replace "home -- how about living location. It says that these devices help us live in the places that we go. Thank you. There's a question from Kenneth [last name indiscernible] Thank you very much for the presentation. It was very informative. We appreciate it. The cure for the cold -- I suggest [indiscernible] Well, it is Friday. Recently my family was requested to take in my sister-in-law. We did. The weekend before the hurricane I am sitting on the couch with me to the news and talking about how bad it's going to be -- I am in Pittsburgh, by the way. We are 300 miles from the coast. They could have gotten here easily. She was laying in her hospice bed with her machine -- oxygen machine -- I thought to myself -- what do I do if we lose power? My point is if you are going to accept someone into your home which is the humane thing to do, I think that all these people are humane people or they would not be listening, I think it is your responsibility to prepare your home for these kinds of emergencies. These are mostly electric. If you lose power, you can bet that the our department has lost it, too. As a result, my point is -- I bought a generator. It was $2100. You can run it on gasoline. You can head off a lot of these things by planning. It is easy to say sure, send them over, but are you really ready to care taking care of them? That's all I wanted to say -- except the anxiety. They bring in the equipment and show you how to run a. You don't want to appear dumb so you say you understand. Really, you don't. Make sure that there is one other person there that will be there and you can't be there 24 hours a day. I did not know this before having had this experience. Thank you very much. Very good point. I appreciate that. Your points are well taken. Just a caution with a generator -- if there is medical equipment in the tome, -- home -- make sure that the generator can work with those devices. The interoperability. That is a question to ask if you plan to have something using a generator as a backup device. Just make sure that it can handle it. I agree with what you said. You also have the responsibility to maintain some sort of heat. There is no generator that will produce enough energy to run an electric furnace. You have to have portable heaters to take care of these people. I would also suggest that you make sure you have cell phone numbers of your emergency contacts. In some cases, the phone lines can be gone, too. Yes, in the power outage brochure lists all of the different numbers you might need. Everybody progress them into a cell phone. -- Programs them. Having those handy a power outage -- that's a part of the booklet. How long to cell phone/without recharging? Yes. I am just being the devil's advocate. You are being an advocate. Those are two different things. These are all the things we need to consider because more and more people are going home. They are going home not just post surgery, they're going on with equipment. Many people are coming home into hospice care -- they are terminal. We have to understand what we are taking on when we say yes. I agree. Operator, how me questions are in the queue? One further question. Mary, can you take this? Yes. Stand [last name indiscernible], your line is open. I, too, liked your presentation a great deal. I was moved by the story of the lady with the device underneath the bed. I will tell a quick story. Maybe this is an idea for the manufacturers. I bought a coffee maker recently. My wife and I both -- both have PhD's that we not could figure it out. I went on YouTube and Google did the name of the coffee maker and there were all kinds of videos. They are free. It showed me how to do it. I also use this with cameras and everything else. Another example -- my wife had for to go and so she went to the ENT and he said you need to do this maneuver. He showed us how to do it. We came home and forgot. I went on YouTube and Google to the Epley maneuver and watched it three or four times and learned how to do it. YouTube is an idea for this. People that struggle with learning how to run at various devices. That is a good point. Make sure that the video you are watching is a reliable source. That would be the thing I would add. True. It worked. Good. Thank you. That was the last question. Thank you so much, Mary, for staying almost a half an hour overtime. No problem. We have all been enlightened by this. I didn't realize how many things need to be consider. Thank you so much. It was a wonderful presentation. [indiscernible] If people would like a copy of the power outage brochure, it is available. We can send you a hard copy. Thank you. I appreciate any input from people outside of FTA because we live here and we think we know what we are talking about, but we need to make sure of this by speaking with people like you that we are going to on the right track or if we are missing something. I appreciate the comments and all of you for participating. I sent the e-mail out that I sent in December. Where to find these things. Again, thank you, Mary, and everyone for participating. Have a wonderful weekend. Thank you. Goodbye. [Event concluded] Actions ................
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