challenges to both caregivers and care recipients. This is because the equipment generally was not designed with their capabilities and limitations in mind, and because the home environment differs in significant ways from the controlled environment of the hospital or clinic. These developments also pose a challenge to the medical device industry, which must take into account these factors when designing medical technology which may be used in the home.
Technology relevant to health care can be separated into two major categories: medical devices and health information technologies (HIT). The dividing line between these two categories is becoming less clear as technology evolves (similar to the case of voice and data in telecommunications; see Federal Telemedicine News, 2010, April 25). This chapter describes issues, challenges, and relevant research related to these technologies.
Medical devices in the United States are regulated by the U.S. Food and Drug Administration (FDA). The Center for Devices and Radiological Health (CDRH) of the 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” (21 U.S.C. 321, Federal Food, Drug, and Cosmetic Act, 2005, Section 201(h)). The FDA’s Home Health Care Committee, recognizing the need for a definition of home medical device, drafted a definition that takes into account device use in a nonclinical environment under the direction of nonprofessional users. As of this writing, however, this definition is still under review, and the FDA solicited industry input on its wording at a May 2010 public meeting.
The FDA divides medical devices into three classes based on a number of factors, including the degree of risk a device presents to the patient. Only devices that pose a significant degree of risk require that developers/manufacturers complete a 510(k) premarket notification submission that documents, in great detail, an assessment of the risks associated with the device and describes the actions taken by the developer to address each risk identified. Although the determination of the class to which a particular device is assigned is not always simple, in general, the device classes are as follows: