Authors

  1. Weick-Brady, Mary D. MSN, RN
  2. Lazerow, Robert N.

Abstract

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.