The Food and Drug Administration's initiative for safe design and effective use of home medical equipment.

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.

A roundtable discussion: home healthcare-not a hospital in the home.

Home healthcare is vital for a large percentage of the population. According to data from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), 7 million people in the United States receive home healthcare annually. The use of medical devices in the home and other nonclinical environments is increasing dramatically. By the year 2050, an estimated 27 million people will need continuing care in the home or in the community and not in a controlled clinical environment. 1 The FDA recently announced its Home Use Devices Initiative and issued the document, "Draft Guidance for Industry and FDA Staff-Design Considerations for Devices Intended for Home Use" on Dec. 12, 2012. 2 The Center for Devices and Radiological Health (CDRH) regulates medical devices, but that regulatory authority alone is not enough to ensure safe and effective use of devices in the home. To address these and other issues, AAMI and FDA will co-host a summit on healthcare technology in nonclinical settings Oct. 9-10, 2013.

Medical devices in the home: a unique challenge for the FDA.

OBJECTIVE: With the rising numbers of elderly populations and those with chronic diseases, the Home Healthcare field has inevitable expanded within the United States. Patients, more specifically home-bound patients, are becoming increasingly dependent on medical technology to help sustain and improve their quality if life. Often times, home care patients, or care recipients, depend on a properly functioning medical device for recovery. As efficient as this method may be, home healthcare also comes along with many challenges involving use and management of medical devices. Difficulties regarding device function, use, the environment, and human factors can all serve as factors to jeopardize patient safety. FDA recognizes that devices need to be safe and capable of meeting needs in an uncontrolled home environment. PARTICIPANTS: Major stakeholders such as manufacturers, distributors, human factor specialists, professional health organizations, healthcare professionals, patient/caregivers, and other government agencies. RESULT: FDA would assure that manufacturers are designing and testing devices for the home, that proper training and education to use the device are available and completed, and the public knows how to report problems with their devices. METHODS: FDA launched the Medical Device Home Use Initiative in April 2010 which proposed different methods that can support safety and safe use of medical devices in the home environment. CONCLUSION: FDA faces many challenges in assuring safe usage of medical devices in the home. FDA hopes that stakeholders can also become actively involved in working with us to address a total life cycle approach on device safety.

Medical devices: promoting a safe migration into the home.

Medical device use in the home environment has grown in volume and complexity. Because of this, the Food and Drug Administration (FDA) needs to ensure that these products are safe and effective for use in this environment. The FDA must develop a partnership with home healthcare providers in areas of patient education, monitoring device adverse events that occur in the home environment, and communicating problems to the manufacturer.