FDA Emphasizes Safe Operation of Home-Use Medical Devices, Offers Tips for Consumers

December 19, 2012 | Strategic Insights for Health System


Healthcare risk managers may be interested in an article posted on the U.S. Food and Drug Administration (FDA) website that is intended to provide consumers with information on how to safely operate home-use medical devices, such as blood glucose monitors, infusion pumps, and respirators. FDA explains that, due to reports of serious, and even fatal, problems associated with medical devices used at home, the agency is working on ways to help consumers safely operate and maintain home-use devices, including the development of a draft guidance document for manufacturers on the design and testing of devices intended for home use and the creation of clearer instructions for users. In the article, FDA emphasizes the importance of understanding a device’s instructions.

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