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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices Committee Observations As the perspectives in the preceding sections illustrate, the groups represented at the workshop have both common and divergent goals. Their overriding common goal is to provide the best possible home medical equipment to patients who need it. They want products that not only function effectively but are also safe, comfortable, and easy to use and maintain. Each group, however, is guided by somewhat distinct forces that motivate them to make different kinds of trade-offs. This final section presents the committee's observations about the issues raised during the workshop and their implications for improving human factors involvement in home medical equipment. SYNTHESIS OF ISSUES Caregivers and patients want products with high usability, comfort, and good design. They want products that are not too complicated and have clear instructions. They would like to have effective, ongoing training and access to customer support to help them use home technology effectively. They would like manufacturers and suppliers to listen to their complaints and suggestions. Patients and caregivers also want the autonomy to choose home care, which means, in essence, that some people will make poor or irresponsible decisions in using home medical equipment (e.g., emphysema patients who smoke while taking oxygen).
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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices Manufacturers of home medical equipment want to develop and sell products that will compete well in the market and earn profits. It is in their interest to get out new products as early as possible, but not so soon that quality is compromised. A poor product will result in dissatisfied customers and lost sales, perhaps even in accidents. An exceptionally well-designed device or breakthrough product could bring new customers and an enhanced market position. So there are some forces that work in favor of manufacturers spending time and effort on human factors in the design process. And there are others, such as a perception that products must be moved quickly into a lengthy queue for federal approval, that work against it. Suppliers of home medical equipment want to attract, keep, and expand a base of home care clients, so patient satisfaction is very much in their interest. But it is also in their interest to minimize service costs by supplying equipment that is low in maintenance and easy to use. They also need to move out equipment already in their inventories. And at the same time, suppliers need to satisfy third-party payers, a powerful force in the home care field, which means they must try to keep down their costs per patient. FDA regulators are charged with carrying out government requirements for product safety. Their goal is to protect consumers and ensure that only safe products get to market. The FDA reviews thousands and thousands of devices, looking for the worst-case scenarios, and this process usually takes longer than manufacturers would like. FDA regulators also try to influence home medical equipment manufacturers in the design phase by getting involved in industry efforts to set voluntary standards and guidelines. The upcoming revision of the FDA's “Current Good Manufacturing Practice (CGMP) Regulations” contains a section on human factors design guidelines. Maintaining a strong federal role in product safety is in the interest of FDA regulators, who would lose their jobs if their agency's mission was diminished. Human factors specialists have the knowledge to improve the usability, safety, and comfort of home medical equipment. User needs are their main focus. They also want to generate recognition for their field as well as business for themselves by encouraging manufacturers to invest in human factors expertise. Many also want to contribute to the knowledge base in their discipline. But there are industry forces —cost constraints, time pressures, lack of understanding—that work against sustained attention to human factors issues. How do these various motives play out in the home health care arena? The players with the least leverage in the field seem to be the patients and caregivers, who have the most direct benefits to gain, and the human factors researchers and practitioners, who have the most expertise to offer. The strongest players are the manufacturers and suppliers —both of whom are influenced heavily by third-party payers—and the regulators. Patients and caregivers have limited means to leverage the system,
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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices influence products, and impose their criteria for usability. The degree to which companies solicit their views and involve them in product testing varies by manufacturer. If patients or caregivers are mildly dissatisfied with a product or have an idea for a small improvement, their input may not reach manufacturers at all, unless the already overburdened caregiver takes the initiative to communicate it. There is no formal system for channeling to manufacturers the enormous amount of everyday information that employees of supply companies glean from patients and caregivers. And if patients are enrolled in an insurance plan that has a large contract with a particular supplier, their power to “vote with their feet” is severely diminished. Although the health care market rewards user satisfaction to a point, there are limits built into the system. Even if a customer has a good idea, there are negative incentives for manufacturers to make improvements once a product is in the regulatory pipeline, so the company waits until the next iteration. Moreover, there is little incentive for suppliers to purchase a new product that is slightly more comfortable or more elegant in design but gets the same results as the version already in inventory. So some improvements may fall by the wayside or take a long time to work their way through the system. Incident reporting is another area in which the channels from patient to manufacturer or regulator are unclear. If something goes wrong with a product, caregivers or patients may not know whom to notify. Human factors specialists also have limited leverage in the home health care system. Many companies view their involvement as something that slows down the development process. Some companies perceive human factors expertise as costing too much. Finally, the major constituencies have not addressed directly some of the fundamental ethical issues that underlie decisions about human factors and home medical equipment. How much autonomy should patients and caregivers have to make choices? How far should manufacturers or regulators go in correcting for everything that could possibly go wrong—in protecting people from their own foolishness and irresponsibility? How much risk should be allowed for the completely unexpected to occur? Should there be different usability requirements for different populations; for example, should a user with lower risks for making errors receive a different treatment protocol or device than a user with a higher risk? What is the balance between marketing for home use very complex, high-technology devices with potentially high error rates, and making available for home use only those devices that are easy for people to understand and operate? CONCLUSION Given the different forces and constraints that influence the key groups involved, it is likely that no one party will be entirely satisfied. But there
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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices may be steps that can be taken to increase the satisfaction of some parties without undue costs to others. One such step is to improve channels of communication. Because patients and caregivers, the ultimate users of home medical equipment, may not be the front line consumers (who are often insurance companies and suppliers), the usual market forces do not apply. Dissatisfied users cannot readily send a message to manufacturers by choosing something else. Current avenues of communication seem to be ad hoc, depending, for example, on whether suppliers and manufacturers make the effort to contact users to determine problems. There appears to be a need for more direct feedback channels, such as hot lines and formal incident reporting mechanisms. Even when communication channels do exist, some kinds of problems may escape the notice of patients and caregivers, such as adverse biomechanical loads that present opportunities for strain, design deficiencies that promote human error, and inconspicuous sources of discomfort. Human factors specialists can inform designers and manufacturers about these kinds of problems at the front end of product development. Training for the use of home medical equipment is another area in which there is clear room for improvement. Caregivers need training prior to patient discharge, along with additional opportunities for refresher instruction, continuing support, and on-line troubleshooting. These training experiences should be sensitive to both the nature of the device and the emotional state of users at the time of instruction. The times when patients and caregivers need training and support are often times of high stress, such as the day of hospital discharge or the moment of equipment failure. Human factors specialists understand the critical aspects of training, including the cognitive load imposed by the apparatus and the effects of stress on learning and retention. The unique demands that home medical equipment places on home care patients and caregivers have not been extensively studied and present an important set of new issues for human factors research. Patients and caregivers are a substantially different population from the groups for which existing cognitive, perceptual-motor, and biomechanical standards have been devised. Additional research is needed on how to extend existing standards and norms to the population of caregivers and patients who are not as strong and may suffer from degraded capabilities when compared with those populations on which current equipment design standards are based. The use of medical equipment in the home will continue to increase. The workshop reported here is intended to be a step toward opening further lines of communication among those affected by home medical equipment and to indicate ways in which human factors specialists can make positive contributions.
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Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices
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