Climbing costs of health care services and hospital stays and shortages of health care facilities and of nurses and other skilled personnel have put pressure on the medical system to provide more care on an outpatient basis. Consequently, the range and complexity of medical devices being used outside formal health care institutions by diverse user populations are increasing. Even complex devices, such as ventilators, infusion pumps, and dialysis machines, are being used outside the hospital or clinic, often by lay users, even though many of those devices were not designed for and were not specifically labeled for this type of use. There are few regulations that limit the practice of using these devices in the home.

One of the problems associated with medical devices used in the home is that they often are not the same models as the ones used in formal health care settings. The devices may be older or of lower quality, and professionals who encounter the devices, either in the home or when patients bring them to the clinic or hospital, may not be familiar with them. Speaking on behalf of AdvaMed, Susan Morris, vice president for government affairs for Kinetic Concepts (a wound care technology firm), said, “One of the biggest concerns [of manufacturers] … is that legacy devices, old products that were used in the institution that may have been replaced by newer versions, are now migrating into the home because they’re available … but they aren’t products that we originally designed for use in the home” (Taft, 2007). Health care professionals sometimes send people home with medical devices, but consumers sometimes give the devices to other people or resell them, for example, through the Internet on Craigslist or eBay. Devices acquired in this manner are much less likely to be appropriate for the end-user, to be properly operated or maintained, or even to come with complete instructions.

Another challenge for medical device manufacturers is that the device user often is not the person who selected or purchased it. The device provider

may be a health care professional, or it may be a distributor or supplier. In the latter cases, the device may not be the optimal choice for the end-users, and the users may not receive the education, training, or ongoing customer support they need. In turn, the device manufacturer may not understand its end-users well because it may not recognize these populations as users of its products, and its designers may never come into direct contact with them.

The Centers for Medicare & Medicaid Services reported that approximately 8.3 million Americans received Medicaid home care in 2004, which represents a dramatic increase over the 1.64 million who received services in 1995 (National Association for Home Care and Hospice, 2008) . The growth trend is likely to continue.

Users of medical devices in the home are a diverse population. Some users are professional caregivers, such as physicians, nurses, nurse practitioners, physical and occupational therapists, social workers, and home care aides. These professionals are typically associated with home care organizations (e.g., home health agencies, hospices, homemaker and home care aide agencies, staffing and private-duty agencies, companies specializing in medical equipment and supplies) or they may be from registries or operate as independent providers. Other device users are lay caregivers, usually family members or friends of the person receiving care. Some care recipients operate devices themselves (while providing self-care). Lay caregivers may be of any age and may have developmental or acquired disabilities, a temporary or intermittent condition, a chronic disease, or a terminal illness.

Medical devices are used in nonclinical environments that include homes, workplaces (which may or may not be in office buildings), schools, hotels, stores, places of worship, entertainment venues, and transportation systems (cars, buses, trains, airplanes, ships, etc.). Depending on the device and the procedure, people may use medical devices in a private space, such as a bedroom, office, or restroom, or in a public space, such as an airplane, theater, or park. The variety of use environments presents significant challenges for device and user safety.