title: The Food and Drug Administration's initiative for safe design and effective use of home medical equipment.
abstract: Although home-use medical devices provide significant benefits, including improved quality of life and cost savings, they are associated with unique risks. These risks result from interactions among the user, the use environment, and the device, and they can greatly impact user and patient safety. This article describes measures being taken by the Food and Drug Administration to address safe use of medical equipment by trained and untrained people outside of clinical facilities.
authors.affiliation: Mary Weick-Brady, MSN, RN, is a Senior Policy Advisor, Office of the Center Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland. Simran Singh, MSN, RN, is a Health Science Intern, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Mary
authors.initials: M
authors.lastname: Weick-Brady
authors.forename: Simran
authors.initials: S
authors.lastname: Singh
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017028:Caregivers; D003430:Cross-Sectional Studies; D004867:Equipment Design / Q000379:methods; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005260:Female; D006699:Home Care Services; D064650:Home Health Nursing / Q000379:methods*; D006801:Humans; D008297:Male; D061214:Patient Safety; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*