As the formal health care system has become increasingly stressed, patients are being released from hospitals and other health care facilities still needing care. As a consequence, both laypeople and professional caregivers are making use of a wide variety of technologies, some of them quite complex, in noninstitutional settings to manage their own health, assist others with health care, or receive assistance with health management. These technologies provide support not only for care related to acute and chronic medical conditions but also for disease prevention and lifestyle choices.

The range of medical technologies used in nonclinical environments runs the gamut in complexity from simple materials used for administering first aid to sophisticated devices used for delivering advanced medical treatment, and in size from tiny wireless devices to massive machines. Some medical devices have been used in the home for many years; other devices are just beginning to migrate there; and emergent technologies present new opportunities for health care management in the home. While some of these devices were explicitly designed for use outside formal health care settings by professional home health caregivers as well as the general public, many devices were not. Consequently, many human factors challenges must be addressed to render these technologies, devices, and systems safe, usable, and effective for use in environments beyond the institution and for use by the much more varied population of users in these environments. This chapter discusses standalone medical devices used in home health care.

The Center for Devices and Radiological Health of the U.S. Food and Drug Administration (FDA) defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is … intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease” (Federal Food, Drug, and Cosmetic Act, 2005, Sec. 201 (h), 21 U.S.C. 321). The center’s Home Health Care Committee defines a home medical device as “a device intended for use in a nonclinical or transitory environment, [that] is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a health care professional in order to be used safely and effectively” (U.S. Food and Drug Administration, 2009b).

Medical devices used in home health care need to be appropriate for the people who use them and for the environments in which they are used. The people who use medical devices may be professional or lay caregivers or the care recipients themselves. As a group, these users have diverse physical, sensory, cognitive, and emotional characteristics. The environment of use may be the home, but it may also be the workplace or another destination in the community or across the globe. Environments vary in the quality and accessibility of utilities, the amount of space available, light and noise levels, temperature and humidity levels, and occupants, who may include children, pets, or vermin. All of these use factors must be considered in order to ensure that medical devices are safe and effective for people receiving home health care.