BACKGROUND

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.

Historical Use of Medical Devices in the Home

The most common types of medical devices, found in nearly every home, are used for delivering medications or first aid. Common medication administration equipment includes dosing cups for measuring medications in liquid form, such as cough medicine, and splitting devices for reducing the size and dosage of pills. First aid equipment includes thermometers (including oral, rectal, in-ear, and forehead), bandages, ace bandages, heating pads, and snakebite kits. Other types of medical devices commonly used in the home are assistive technologies and durable medical equipment. Assistive technologies are most often either mobility aids (e.g., wheelchairs, walkers, canes, crutches) or sensory aids (e.g., glasses, hearing aids). Other common assistive technologies are prosthetic devices (e.g., artificial arms or legs) or orthotic devices (e.g., leg braces, shoe inserts). Durable medical equipment includes environmental devices, such as specialized beds, person-lifting and transferring equipment, and toileting aids.



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