The Food and Drug Administration's initiative for safe design and effective use of home medical equipment.
Approach to Improving Safety
Setting of Care
Medical devices are increasingly being used outside clinical facilities, and this can present unique safety challenges for both untrained and skilled personnel. This commentary describes FDA efforts intended to enhance safety of medical equipment use at home, including a guidance which focuses on factors relating to the user, environment, and labeling along with a campaign to increase public awareness of the risks associated with inappropriate device use.