The collaboration of hospitals, medical device manufacturers, and the US Food and Drug Administration serves to promote patient safety and device performance in the clinical setting. Each entity brings its own set of expertise, perspective, and resources that can be used to perform in-depth investigations into medical device–related safety concerns with the common goal of patient safety and device performance. This article describes the ways in which healthcare technology management professionals, medical device manufacturers, and Food and Drug Administration’s MedSun program work together to resolve medical device–related safety concerns, with a focus on case reports of exemplary communication and resolution of such concerns.
Corresponding author: Cedric W. Brown, Jr, MBA, is a biomedical engineer in the Office of Surveillance and Biometrics at the US Food and Drug Administration at 10903 New Hampshire Avenue, Silver Spring, MD 20993. He can be reached at email@example.com.
Julie Morabito, PhD, is a supervisory biomedical engineer in the Office of Surveillance and Biometrics at the US Food and Drug Administration at Silver Spring, Maryland.
The authors declare no conflicts of interest.