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Policies and Pathways of Home-Use Medical Devices Through Hospitals

Tanno, Eleanor BS Biomed Eng

doi: 10.1097/JCE.0b013e3181f6b798
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Because of the demand to have at-home treatment, a significant number of medical devices are migrating into the home from the hospital setting. The Food and Drug Administration defines a home-use medical device as a device intended for users in a nonclinical or transitory environment, which is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a healthcare professional to be used safely and effectively (Food and Drug Administration [FDA], 2010). Examples of these home-use medical devices include, but are by no means limited to, continuous positive airway pressure devices, glucose meters, ventilators, wound care therapies, and infusion pumps.

Because of the demand to have at-home treatment, a significant number of medical devices are migrating into the home from the hospital setting. The Food and Drug Administration defines a home-use medical device as a device intended for users in a nonclinical or transitory environment, which is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a healthcare professional to be used safely and effectively (Food and Drug Administration [FDA], 2010). Examples of these home-use medical devices include, but are by no means limited to, continuous positive airway pressure devices, glucose meters, ventilators, wound care therapies, and infusion pumps.

From Food and Drug Administration, Silver Spring, Maryland.

Corresponding author: Eleanor Tanno, BS Biomed Eng, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20903 (Eleanor.Tanno@fda.hhs.gov).

Eleanor Tanno, BS Biomed Eng, is a biomedical engineer working at the Food and Drug Administration in Silver Spring, Maryland.

© 2010 Lippincott Williams & Wilkins, Inc.