Perspectives of Major Players

As the workshop discussions suggested, there are many complex issues and challenges involved in designing and delivering safe, comfortable, and easily usable home medical equipment. And as the workshop also illustrated, the issues are viewed differently by the various constituencies.

In this section, we attempt to capture some of these issues and diverse viewpoints by summarizing the perspectives of the five key groups represented at the workshop: (1) caregivers and a bioethicist, (2) manufacturers, (3) suppliers, (4) regulatory officials, and (5) human factors specialists. Each of the five summary perspectives is based on the workshop presentations and discussions. They are meant neither to represent the views of specific presenters nor to serve as verbatim transcriptions. They are intended to convey the major needs, concerns, challenges, and trade-offs facing each key group.

CAREGIVERS

Presenters:

Carol Smith, School of Nursing, niversity of Kansas

Suzanne Mintz, National Family Caregivers Association

Arthur Caplan, Center for Bioethics, University of Pennsylvania Medical Center

Family caregivers are a sizable group—about 10 percent of the adult population in this country. They provide two-thirds of all the home care in



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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices Perspectives of Major Players As the workshop discussions suggested, there are many complex issues and challenges involved in designing and delivering safe, comfortable, and easily usable home medical equipment. And as the workshop also illustrated, the issues are viewed differently by the various constituencies. In this section, we attempt to capture some of these issues and diverse viewpoints by summarizing the perspectives of the five key groups represented at the workshop: (1) caregivers and a bioethicist, (2) manufacturers, (3) suppliers, (4) regulatory officials, and (5) human factors specialists. Each of the five summary perspectives is based on the workshop presentations and discussions. They are meant neither to represent the views of specific presenters nor to serve as verbatim transcriptions. They are intended to convey the major needs, concerns, challenges, and trade-offs facing each key group. CAREGIVERS Presenters: Carol Smith, School of Nursing, niversity of Kansas Suzanne Mintz, National Family Caregivers Association Arthur Caplan, Center for Bioethics, University of Pennsylvania Medical Center Family caregivers are a sizable group—about 10 percent of the adult population in this country. They provide two-thirds of all the home care in

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices Box 1 Caregivers sometimes feel invisible—as if we don't have a very loud voice when it comes to influencing home medical equipment. We want the people who make decisions about home medical equipment to understand what it is like to be a caregiver, to comprehend what we confront on a daily basis. It is frustrating, watching your spouse cope with pain, juggling family responsibilities, wishing you had more help, worrying about money, fearing you might lose your job if you take off too much time or refuse a promotion. My husband Leonard had a bowel tumor removed and is on TPN—total parenteral nutrition. For the rest of his life he needs daily infusions that take eight consecutive hours or more. With my help, he connects himself to the line before he goes to bed at night. The infusion goes through what is called a central venous catheter, which goes all the way toward the heart. There's a great risk of contamination and infection, and we have to follow daily cleaning procedures meticulously. If we're not extremely careful, septicemia could set in. TPN patients have died that way—so that's a risk every day of our lives. Obtaining and using home medical equipment carries a great deal of emotional stress, and that affects how we learn about the equipment and how we use and maintain it. Before Leonard was discharged from the hospital, we had a training session. I tried to listen carefully, but it was overwhelming—so many procedures to remember, so much terminology. And as the hospital nurse was talking, I was very aware of Leonard 's feelings. I think it really sank in then that he was going to depend on a machine for the rest of his life and that much of the load would fall on me. When I got home, I realized I hadn't absorbed half of what I'd been told. Fortunately, we had two more training sessions at the hospital, then periodic visits from a TPN team nurse. At first, the nurse walked us through the procedures step by step. Now she comes less often to check the equipment, answer our questions, and help us with any problems. If something seems amiss—if Leonard is overly tired or has a fever or the fluid balance doesn 't look quite right—we have to decide whether it's something that can be taken care of by adjusting the technology or whether there's another cause. Twice we have gone to the hospital emergency room, only to discover that we could have taken care of the problem at home. But we're not doctors or nurses, and we can't always tell whether a problem is urgent. Caregivers are people who require special handling. We did not choose our roles; we were thrust into them. In many ways we are ill prepared for the work we must do and the equipment we must use. We may forget what you tell us. We may seem frazzled or overbearing. But remember that you are not designing or selling happy products. Your literature and your sales people must be attentive to our state of mind. Make products that are user-friendly and give us information in terms that we can understand. Whenever possible, lessen our frustration level.

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices this country—and for free. Even for patients with insurance, home care can get expensive. For some it may involve high electricity bills, for others the costs of remodeling to make the house more accessible, for still others the price of daily attendant care. Caregivers take on many important duties, such as providing physical care, organizing home services, operating medical equipment, administering medications, dealing with insurance and supply companies, working out schedules, and coping with a range of emotional stresses—sometimes doing all this while raising children, working outside the home, or both. Caregivers must make many judgments (see Box 1). Most make some modifications in procedures—for example, changing the recommended schedules to fit their daily lives, buying a different brand of surgical dressing. And they don 't always tell the hospital or the nurse. People working with high-tech equipment are liable to make mistakes. The shift toward home care is creating new ethical questions. On one hand, modern technology could probably build a machine that monitors home patients 24 hours a day, feeds them on time, and regulates their bodily functions. But on the other, with all that machinery, the patient might not care anymore about being at home. The autonomy people want to have to choose home care carries a price: it can enable them to make bad choices or take foolish risks with technology. Most caregivers are willing to take the risks and put up with the fears in order to have their loved ones close by. From the perspective of caregivers, better education is a primary need. They need training and information before they leave the hospital, and also afterward. And they need the information incrementally. It is easier to absorb things in small quantities, after they become more familiar with the technology. It would also be helpful for them to have access to a family advocate—a nurse or other professional who knows how to operate the equipment, who knows something about insurance and support services, and who could advise what to do in emergencies. Caregivers are the customers. Although it is their loved ones who benefit from the equipment, caregivers are often the ones who manipulate it and make decisions about buying it. Most of them—the people who have to lift and carry the equipment—are female. For them, lightweight is not a luxury: it is a necessity. Manufacturers should consider the length of women's reach, the span of their arms, and their strength in wrists and fingers. Whenever possible, they should deinstitutionalize the look of home medical devices, give them character. That doesn 't mean camouflaging their function, and it doesn't mean making them cute. It means using good design. Caregivers and patients— Want the autonomy to choose home care. Want products that are safe, comfortable, attractive, and easy to use.

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices Need access to good training and support in using them. Want better avenues for offering their input, complaints, and suggestions about home medical equipment. MANUFACTURERS Presenters: Marcia Nusgart, Health Industry Manufacturers Association Kathy Sullivan, Baxter Health Care Corporation Scott Remes, CAIRE Julie Zawisza, Health Industry Manufacturers Association Bernie Liebler, Health Industry Manufacturers Association Thousands of companies manufacture and distribute home medical equipment in the United States. There are large companies that make everything from gauze pads to left ventricular assist devices. And there are small, specialized companies that make just a few products. It is a very diverse and competitive environment. It is important to note that the manufacturers represented at the workshop are not typical of the industry. They were invited because they have a commitment to user input in the design of home medical devices and to human factors expertise as an element of good design. Many smaller companies do not have the resources to obtain systematic feedback from their potential users. From the manufacturer's perspective as sketched out at the workshop, the challenge is to balance patient needs with the needs of many others involved in the purchase of a product—the medical equipment companies who provide home services, the third-party payers who manage care, and the physicians who prescribe a treatment. They must satisfy these providers, or they won't be in a position to worry about serving patients. The challenge is to accommodate everyone's needs when an engineering team designs a new product. Patient input can be an important source of information about problems with devices, but it is difficult and sometimes timeconsuming to gather such information systematically (see Box 2). Sometimes changes are made as a result of unsolicited feedback. When customers write letters with complaints or suggestions, a good manufacturer will take them seriously, sometimes modifying the product. An example is a company that makes a disposable synthetic rubber device for infusion therapy. It looks like a little baby bottle with a balloonlike attachment that creates pressure, causing the product to be released into the patient's vein. The device has to be worn very close to the body to work properly, but patients complained that it wasn't comfortable. When the company adjusted the position of the flow regulator, patients were pleased with the change. Again, from the manufacturer's perspective, best practice means placing a high priority on usability, considering the user at every phase. In addition to patient input, best-practice companies consult references,

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices Box 2 Our company makes various oxygen products for home and institutional use, including home liquid oxygen systems, home oxygen concentrators, and some medical nebulizer devices. We have a vested interest in making home products that satisfy customers, and, because of our size, we have the resources to involve users in the design. We don't want complaints and product returns, and we certainly don't want accidents and lawsuits. We care about making a profit in a competitive market, so we can continue to bring out new and better products. We believe that a well-designed product can both satisfy patients and improve our market edge. In our approach to developing products for home use, the company has gone through a learning curve. Several years ago, we tried to fit hospital products into the home with few changes—like trying to push the proverbial square peg into a round hole. Then we realized that, by making certain modifications, we could make the hospital products easier to use at home. Now we are developing products specifically for home use. So, for example, our oxygen systems have gone from those big, green, hospital-type cylinders to small, light, portable devices. To make our devices more efficient and user-friendly, we actively solicit input from patients and providers at all stages of the development and testing process. Our development people go out on patient visits with home care nurses and respiratory therapists. There is no substitute for going into the home and watching how a patient uses equipment. Probably 80 percent of the feedback we gather comes directly from patients in their home. We also solicit feedback through trade shows, focus groups, and associations. Every city has an organized group of home oxygen patients, and we attend their meetings. We also talk to physicians, third-party payers, case managers, and hospital discharge planners. The sales people for the supply companies are another excellent source of feedback. So are the therapists and drivers who work with patients day in, day out. And of course we talk to people in the suppliers' service centers and our own repair shops. If a piece of equipment breaks down all the time—well, then you know you have a design problem. We generally spend 1 to 2 months studying needs before we launch into designing. As soon as we have a drawing, we ask our customers “What do you think of this?” Then, when we have the first mock-up model, we again ask customers and patients. Once we have a prototype, we test it in the field for 2 to 4 months with real users. It would be nice to do more. But our investors want a return, and we want to beat the competition.

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices manuals, and books on human factors research and may also confer with human factors experts. Other companies, particularly smaller ones, may not be able to afford to budget so much for consultants and field research. They may say that they don't need human factors specialists because they have good engineers. Or that they get very few complaints about their products. Another hallmark of best-practice firms is that their products for the home come with comprehensive patient and caregiver training materials. Devices that require activation often have step-by-step pictorial guides. Many devices also come with troubleshooting guides to help caregivers and patients diagnose and correct specific problems. Some come with audio and video training packages. An important problem that manufacturers face is that, once they set up the tools to manufacture a specific product, it is expensive to make changes. In a field in which the setup costs can be $1 million for each product, even the smallest change can cost $50,000—making it difficult to respond to suggestions for change. Other factors also make it difficult to improve products continuously, even with good suggestions in hand. From the manufacturer's point of view, one of the biggest challenges is the Food and Drug Administration 's approval process. The FDA has two different procedures for reviewing new products before they are marketed. One is called a 510(k) review and applies to devices that are substantially equivalent to products already on the market. At best this is a 6-month process, and can take a year or longer. The other is called a PMA—premarket approval —for a device that is truly a breakthrough—that can take years. When a product is submitted for a 510(k) review, one of the things the FDA wants to know about is the user interface: What are the alarms? What are the knobs? What are the lights? So these features have to be defined a year in advance of manufacture. In the process of collecting feedback, the manufacturer may hear suggestions from patients for different features or features that work differently. Then there is a problem: the product is in the FDA queue, with the user interface already defined. Another frustration is timing and supply. Customers may suggest a simple improvement, such as making a knob bigger. Even if the manufacturer could bring a new model quickly to market, the suppliers may have a two-year inventory of the older model, so patients would still have to wait a long time to benefit from the change. Despite these challenges, the industry has come a long way in making home medical equipment more comfortable and usable, providing products that help people on a fundamental level. Manufacturers— Want to develop products that will compete well in the marketplace and earn profits.

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices Want satisfied customers, few product returns, and no accidents or injuries. Are under time pressure to bring products to market. Perceive themselves to be delayed by a lengthy federal approval process. SUPPLIERS Presenters: Taney Hamill, National Association for Medical Equipment Services Tom French, Homedco Escalating health care costs have made home care a growing and very competitive business. Home health care services are less expensive than institutional care and, in given circumstances, the quality can be comparable. The suppliers of home medical equipment who attended the workshop represent the high end of home health care services, which is characterized by certification by one of the existing accrediting bodies, standards for quality control, and a commitment to their patients and providing them with good access to a range of services. As shown by the presentations by supplier representatives at the workshop, full-service companies strive to offer a wide range of home care services and equipment. They help clients select equipment for rental or purchase. They deliver the equipment and set it up, provide caregiver education, retrieve and disinfect equipment, do maintenance and repairs, and offer 24-hour emergency service in case something goes wrong. They also provide specialized nursing and therapeutic services. They bill insurance companies and other third-party payers and collect the physician certificates required for Medicare. They comply with the infectious control procedures mandated by the Occupational Health and Safety Administration. They are also monitored by the U.S. Department of Transportation for the transportation of hazardous materials such as oxygen. Companies like these see themselves in competition with other businesses that don't offer the same level of service but may undercut prices on some items. People can walk into a discount store and purchase a wheelchair or bedside commode. Physicians' offices sometimes provide equipment; hospitals may deliver equipment; even drug stores are getting involved. Some mom-and-pop home medical equipment suppliers deal in limited product categories, and people can purchase items through mail-order catalogues. People even get medical equipment at secondhand stores and from charitable organizations—or they go into the closet and dig out things that Aunt Mary used five years ago. In these situations, the instruction booklets may be lost, and there may be no one to provide training. A full-service company would caution consumers to select their supplier carefully. A physician's prescription is required to purchase or rent most home

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices medical devices. With that in hand, patients can obtain the equipment themselves, although more often they work with a hospital discharge planner, social worker, or medical organization case manager to identify their equipment needs and select a supplier. Once approached, a full-service supplier does an intake evaluation to figure out the products and services that will meet the patient's needs. Although we tend to think of many products as standardized, they come in all different shapes and sizes, just as people do. Wheelchairs are an example. The supplier helps the patient choose the right size and finds out whether he or she needs removable arm rests, for example, or a certain type of leg rests (see Box 3). When the technicians deliver the equipment, they instruct the patient on safety and use. If a patient needs high-tech equipment, the supplier may start the training prior to hospital discharge. Most home care companies have checklists that patients or caregivers must sign to document that they received training. Training in the use of most kinds of high-tech home medical equipment should be provided by a therapist, nurse, or other certified clinician, but not all companies adhere to voluntary industry standards for clinicians. Some companies don't have any clinicians on staff; some contract with clinicians. Of course, suppliers are not the only source of training; manufacturers provide manuals, as well as audio and videotapes, and the hospital staff or physician's office staff sometimes does the training. Training is one of the supplier's most important roles and one of its greatest challenges. For example, with a complex piece of equipment like an infant apnea monitor, which is used to help prevent sudden infant death syndrome, it is important to train all the family's caregivers—not only the parents, but also grandparents, foster parents, babysitters, and other people in the home. And they need to learn not only about the monitor, but also cardiopulmonary resuscitation (CPR) techniques. If the monitor starts beeping, it may mean that the child has stopped breathing, and if so CPR must be administered immediately. An added complication is for caregivers to learn how to determine whether the monitor is wrong, because monitors sometimes do sound false alarms when the infant is fine. Suppliers are facing several new challenges. Third-party payers—health maintenance organizations, preferred provider organizations, Medicare, and insurance companies—are becoming much more influential. Lower costs per patient are a driving force. More and more third-party payers are moving away from the traditional model of reimbursing suppliers for specific services provided to specific patients, toward a contract model, in which they pay a company a fixed amount per plan enrollee to provide services to any patients enrolled in the insurance plan; thus, the risk is shared between the supplier and the insurance company. For the consumer, this means that the home medical equipment supplier is chosen at the front end, when the patient or his or her employer selects an insurer.

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices Box 3 Home medical equipment suppliers have several ways of keeping attuned to patient and caregiver needs. Our clinicians and technicians learn a lot about why patients have problems with specific kinds of equipment. When patients are not complying with their treatment protocol—the specific steps to be carried out to achieve a particular outcome —then we need to know why. Are they having trouble understanding something? Is the technology too complex? Is it just inconvenient? Is it because the patient doesn't think the equipment is doing what he or she thought it would? Are there problems with the equipment design? Could the labeling be better? With new “smart” equipment, we can actually monitor compliance. New kinds of infant apnea monitors have a computer chip inside that records every time someone touches a button. So we can tell if the parent is using it. Tragically, we have had reports of infant deaths, and we found that the parents weren't using the equipment. New technology also allows us to conduct diagnostics through a modem. For example, we can connect a modem to a home sleep apnea reading system. A technician at a remote site can monitor the study's progress and adjust the continuous positive airway pressure device, which is used to treat sleep apnea in adults. That type of technology saves us the labor of driving back and forth to the house every time an adjustment is needed. If there is a serious incident or equipment failure, we document it and report it to the manufacturers and, in some cases, to the FDA. We conduct our own customer surveys and review our client records. And if we have problems with a particular device, we will stop buying it—that gets the manufacturer's attention. Not every bit of information we learn from patients finds its way back to the manufacturers, however. If a patient suggests a small improvement in comfort or a design enhancement that doesn't affect safety, outcomes, or equipment maintenance, then it may or may not get passed along. Successful manufacturers actively solicit feedback about products in the home.

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices It is also true that case managers for third-party payers are getting more involved in ordering equipment. Of course, like manufacturers, suppliers are for-profit businesses, and the pressure to keep costs down affects their decisions. For example, they may pass up a product at a trade show that represents the latest, most sophisticated design, if they know they can get the same outcome for the patient with a less expensive item—especially one that involves lower labor costs for set-up, maintenance, and training. As the need for home medical equipment continues to grow, the industry is trying to improve the quality and consistency of its services. For example, the Joint Commission on Accreditation of Health Care Organizations, the Community Health Accreditation Program, and the National Association of Medical Equipment Suppliers have defined performance measures and quality standards for home medical equipment services that they continue to monitor and refine. The best companies set benchmarks and document patient satisfaction using these benchmarks. The services provided by home medical equipment suppliers have come a long way as the industry has matured. Suppliers— Want an expanding base of satisfied home care clients. Want minimal service, maintenance, and repair costs. Want to move out equipment already in inventory. Need to contain costs per patient to fulfill demands of third-party payers. REGULATORY OFFICIALS Presenters: Sue Bogner,Center for Devices and Radiological Health, Food and Drug Administration Pete Carstensen, Center for Devices and Radiological Health, Food and Drug Administration Dick Sawyer, Center for Devices and Radiological Health, Food and Drug Administration The Food and Drug Administration is the main federal regulatory agency that oversees the safety of home medical equipment. In its view, user error is a factor in a substantial number of patient deaths and injuries caused by home medical equipment. So a primary goal of its work is to reduce the likelihood of human errors. One way the FDA does this is to work with manufacturers to develop voluntary standards and guidelines for home medical equipment. It has about 180 staff—the equivalent of about 26 person-years—involved in 300 different standards-writing efforts. Although these standards are volun-

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices tary, it is in the manufacturers' interest to comply, because this assures the consumer that a product has met a basic level of safe and good design. And the industry is well aware that, when voluntary standards fail to meet the need, the FDA has a responsibility to issue regulatory standards. Guidelines are different from standards. Guidelines are options or recommendations for features that manufacturers may consider when designing a particular kind of product. Not every feature in a set of guidelines will be appropriate for every product. In a sense, guidelines are to product designers what a dictionary and thesaurus are to a writer. They are important aids, but they do not ensure good human factors design any more than reference books ensure good writing. The competitive marketplace, civil liability, and the FDA premarket approval process (discussed below) all encourage product designers to heed standards and guidelines. No one benefits from equipment that injures people, least of all the manufacturer—they are the ones who end up paying the big settlements. Most manufacturers are responsible and want to turn out better products. When standards and guidelines are available, engineers will use them. The FDA often fields calls from industry representatives asking if there is a standard for this or that device feature. So what is needed may not be additional standards so much as increased awareness of the standards that are already available. The major way the FDA influences home medical equipment design is through the approval process, which every new medical device must clear before it can be marketed in this country. FDA staff examine each device, trying to anticipate and weed out the opportunities for errors. The process may take longer than manufacturers would like, but the FDA has a responsibility to consumers to be thorough. Several aspects are involved in the product approval process. Often people think of human factors as being all about knobs and dials, and of course that's part of it. But there are other, less tangible things to consider, such as the cognitive abilities of the user. Does a design bombard the user with an overload of information? Does it follow a logical progression? For example, a product with a vertical scale on which the low reading is at the top and the high reading at the bottom is the reverse of our normal expectations—that kind of thing is very hard to unlearn, so mistakes could be made with it. The FDA examines the instructions and manuals that go along with the product, to see how clearly they convey information. It has published a document called Write it Right, which contains recommendations for developing instruction manuals for home medical equipment—and encourages manufacturers to use it. The FDA also tries to consider social and cultural factors—language, customs, family structure—that influence how people interact with devices. For example, in some cultures the extended family lives in the same house and shares the burden of the primary caregiver. What implications

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices does this have for training and use? Does the patient or caregiver speak English? In one instance, a certain glucose meter with pictorial directions, though good, had no instructions in Spanish. When asked about this, the company responded that Spanish speakers should call the toll-free number at the back of the manual to order Spanish-language instructions. But how many people are going to do that, especially if they do not read English in the first place? How can designers anticipate all these things? They start by getting to know the user. If a product is simple to operate, there is little risk of harm. The FDA looks for the worst cases, keeping in mind the likely users. An example is a certain blood glucose monitor with small strips that users have to insert into a small, credit card size meter. It presents problems for people with diabetes, who sometimes have circulatory problems and whose hands lack manipulability. And its instructions are in very small type, although people with advanced diabetes may have vision problems. The approval phase tries to catch bugs like these. But there are other, unforeseen problems that do not emerge until people actually use a product for a while. So the FDA uses several methods to monitor the safety of medical devices after they are marketed. They include regular reporting requirements that involve manufacturers, distributors, and users; error and accident reporting systems; device tracking; and other kinds of postmarket surveillance. The FDA gets thousands of reports each year about incidents involving home medical equipment. Many problems stem from poor design, combined with other things. These incidents underscore the importance of its monitoring work and how critical it is for manufacturersto consider human factors in the design phase (see Box 4). Incident reports vary in terms of quality. Some have lots of information, and some very little; some are meaningful, and some aren't. Some incidents are never reported at all. To determine the significance of an incident report, FDA staff look at several reports for the same model and sometimes collect corroborative data. If they find there is a real problem, they will contact the manufacturer, send out safety alerts, and recall the product if necessary. Some problems are outside the FDA's jurisdiction. A vexing one is the amount of suboptimal equipment still in inventory that manufacturers feel they must sell to recover their investments—even when the equipment is not state of the art. The FDA realizes how challenging it is for the designer of complex devices to put everything together in a coherent form—mechanics, software, and microprocessing. The best-designed products are those that make intuitive sense to the people who use them, without the need for complicated instructions or training. You might say that the ideal is to design a piece of equipment that a person can operate without referring to a manual. That may not often be achievable, but it is a worthy goal.

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices Box 4 Why is federal regulation important? There have been some tragic incidents involving home medical equipment. One involved a certain kind of infant apnea monitor. This device had wires at one end that attached to a patch on the child's chest, and small pins at the other end that plugged into a special 10- or 12-volt power source. In a few cases, the pins were plugged into a regular 110 AC wall outlet, probably by another child in the house, and the infant died instantly. This product now uses special safety connectors that cannot be plugged into anything else. This example shows what can happen when technology designed for hospital settings is put into the home without enough forethought. In fact, connectors are a frequent source of design problems in home medical equipment. Another kind of design flaw relates to visibility. We came across a certain infusion pump ‘with a setting of 722 milliliters per minute that looked like 122 milliliters per hour when viewed from an angle. Acting on that assumption could result in a deadly overinfusion. Another infusion pump looks wonderfully simple at first glance. It has an up/down switch, a select/activate button, and a display. So what's the problem? These simple controls mask some complex technology inside. By using just these two controls, you can set seven different infusion modes, but there is only one display. So if someone wants to program a continuous dosage, instead of an intermittent dosage, she has to press “select” seven times, then the “activate” button twice, then the select button once, then the activate button three times, then the select button once. Then she adjusts the interval with the up-down arrows. Confusing, to say the least.

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices Government regulatory agencies— Must enforce federal requirements for product safety and consumer protection. Conduct extensive product review to identify potential problems and hazards and screen out inferior products. Want to influence manufacturersto follow standards and guidelines for product safety and usability. HUMAN FACTORS SPECIALISTS Presenters: Michael Wiklund, American Institutes for Research Jonathan Gaev, Health Devices Group, Emergency Care Research Institute Human factors specialists can help manufacturers approach usability issues in a systematic and objective way. Human factors is a scientific discipline, with a body of knowledge, methodology, theory, and principles. There are 70 different academic programs that train people in human factors. Human factors scientists draw from an extensive archive of knowledge and empirical data about how the human mind and body work and how people interact with devices and environments. For example, human factors researchers have developed models that describe how much and what kinds of information a person can recall and use effectively and how information should be organized and presented to make it usable. Researchers have also collected data on how the human senses of sight, hearing, and touch operate in different environments and how the human body works mechanically—for example, how much weight can be lifted safely from different positions by men and women of different heights, weights, ages, and muscle strengths. Human factors researchers translate these data into principles that can be applied at all stages of the manufacturing and marketing processes. For example, a design consultant to several home medical equipment manufacturers has conducted postmarket testing for nonprofit organizations and done accident investigations for hospitals. People in this field can advise on concept development, look at sketches of new designs, and examine and test prototypes of new products. They also study equipment already on the market to identify usability problems. This kind of information can help manufacturers improve their products in the next go-round. Human factors is a systematic design process for making products more usable. Usability is the cumulative result of many different characteristics. A product may have 2,000 large and small features, any one of which could create problems. It could be a tiny label, or the placement of a button or the shape of a handle. How the weight centers when you carry it, or

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices whether it has a strap. It could be the amount and sequence of information that the user is required to process. There is a trade-off between complexity and usability. As a product becomes more complex, its usability tends to decrease. Human factors research seeks to overcome complexity, which is particularly important to home medical equipment because these devices are often complex and must absolutely be usable. Human factors specialists can develop usability goals—such as how long it should take someone to perform a certain task —and measure them. They have proven techniques for diagnosing what can go wrong with a device and analyzing what can be improved. At present, human factors science is not well integrated in the design of home medical equipment. Many manufacturers can produce a home medical device that looks good, and many can make one with a good user interface, but medical products still have a long way to go in terms of usability. Some products tend to be driven by technology rather than by user needs. Others are designed more for clinicians than for home users. Very few companies are exemplary in terms of investing in human factors research. Some may not even be aware that there is a discipline that can help them. Or they lack good examples of how human factors can be applied to particular devices. Or they think they cannot afford human factors expertise. One approach to product evaluation is to take measurements on a product in the laboratory. Testing the input and output is not that difficult; the challenge is to measure meaningful things, for which the result will make a difference. An equally important approach is to gather new data on how people use particular kinds of equipment in particular environments (see Box 5). So the equipment is tested in real settings, by having typical users interact with products. Users talk aloud as they go along, enabling the tester to see what confuses them. A person's facial expression can change from high confidence to bewilderment to irritation as they attempt to use a device. And people can become embarrassed and a little defensive when they can't get something to work properly. It is essential to understand how the user thinks about the equipment. Misunderstanding how a product works or being overtaxed by its complexity can be critically important causes of misuse or outright product failure. Sometimes, by examining a product in light of what is known about people's perception, memory, and thinking processes, inherent problems emerge—it is more complex than people's memory can handle, or its displays are likely to be misread or misinterpreted. Manufacturers may pay a high price for failing to consider human factors. They may lose consumers' good will. Consumers can become frustrated, make a mistake, or misadminister their therapy. If patient complaints reach the suppliers, sales will drop. People may return products. Complicated products usually require complicated instructions to explain

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices Box 5 Human factors engineers spend a lot of time asking “What if”? What if someone did this or did that? Let me give some real “What ifs” from an investigation I did involving an oxygen concentrator device used by respiratory patients. There were reports of these devices catching on fire and of people catching on fire. The problem turned out to be something we wouldn 't have imagined just by looking at the device—namely, that many of the people who used the concentrator had been lifelong smokers. Some of them found it so hard to quit that they kept right on smoking, even while they were on the machine. If you do that, you will catch on fire. We found other instances of people changing the flow setting on the same device. Their logic was that if 2 liters a minute made them feel good, then 3 liters might make them feel even better—but it doesn't work that way. From reading the data on this concentrator, we also saw that compliance was a big problem: people weren't using it when they should. Our investigation showed that people didn't like the noise it made: it was too loud. It was like having a little refrigerator running nonstop beside you.

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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices them, so the costs of documentation will be higher. If a product is really complicated, a lot of training time will be required. And eventually, if someone has a serious accident or injury, there will be negative publicity and perhaps a product liability suit. By the same token, an up-front investment in human factors research can be a wise and affordable choice for a manufacturer, whether a large company with billions of dollars in sales or a small company with one product line. With a systematic approach, a human factors specialist may wipe out the majority of a product's large usability problems and take care of a lot of the small ones, too. And if the equipment can be better fit to the user, then instructions can be shortened and the training time can be reduced, which may in turn expedite the FDA approval process. The manufacturer can achieve savings and gain potential market advantage. There are clear differences between companies that make human factors a priority and those that don't. One major distinguishing factor is the presence of an in-house champion—preferably a top executive who believes that the usability of products is as important as their durability, who will set the tone for good design work and invest in it. The companies that do the best job in terms of usability often have in-house human factors staff. Manufacturers take risks to bring new products to market. Human factors specialists can help reduce the uncertainties. If they can do a better job of getting information about usability out to the manufacturers, then perhaps they can influence them to get better products into the field. Human factors specialists— Want to apply their knowledge to make home medical equipment devices more usable. Want manufacturers to invest in human factors expertise. Want to contribute to the knowledge and research base in their field.