What is MedSun?
A. MedSun-which stands for the Medical Product Safety Network-is a project under the direction of the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA). It is designed to collect data on adverse events and situations indicating the potential for harm involving medical devices. Representatives from participating hospitals,nursing homes, and other healthcare facilities are specially trained in reporting deaths, serious injuries, and close calls involving medical devices. The Web-based MedSun data entry system resembles FDA’s MedWatch Form 3500A, which is currently used for reporting under the Safe Medical Devices Act (SMDA). The objective of the MedSun pilot program is to determine if the MedSun system proves useful in helping CDRH obtain better data on problems with medical devices from the clinical community.
