Approximately 7.6 million individuals are receiving home healthcare, according to the National Association for Home Care & Hospice. These home care patients often need medical devices and equipment such as hemodialysis equipment to treat kidney failure, wound therapy care, intravenous therapy devices, and ventilators.

Recognizing that more patients of all ages are being discharged from hospitals to continue their medical treatment at home, the U.S. Food and Drug Administration announced an initiative to ensure that caregivers and patients safely use complex medical devices in the home. The initiative will develop guidance for manufacturers that intend to market such devices for home use, provide for post-market surveillance, and put in place other measures to encourage safe use of these products. The FDA also is developing education materials on home use of medical devices.

“Using complex medical devices at home carries unique challenges,” says Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health. “Caregivers may lack sufficient training, product instructions may be inadequate or overly technical, and the home environment itself may pose environmental or safety hazards that can affect the product’s functioning.

FDA currently does not have a clear regulatory pathway for devices intended for home use that describes the unique factors manufacturers should take into consideration when designing, testing, and labeling of such products. The home use guidance document that FDA intends to develop will:

• Make recommendations for actions manufacturers should take to support premarket approval or clearance of these devices, including device testing with at-home caregivers and patients in a nonclinical setting.

• Define circumstances under which the FDA may exercise its authority to require certain devices cleared for marketing to carry a statement in the labeling that the device has not been cleared for use in home.

• Recommend post-market surveillance through HomeNet, a subnetwork of the FDA’s Medical Device Surveillance Network, an adverse event reporting program that includes more than 350 healthcare facilities nationwide.

FDA also will launch a 10-month pilot program this summer, in which maker of home use devices may voluntarily submit their labeling to the agency for posting on a central website repository. Posting medical device labeling in the repository will help home care patients and caregivers to quickly and conveniently access important information about the safe use of their devices.