MedSun: Shining a Light on Medical Product Safety
What is MedSun?
The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002 by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). The primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.
A Partnership between Clinical Sites and FDA
MedSun fosters an important partnership between clinical sites and FDA. MedSun also serves as a powerful two-way channel of communication between CDRH and the clinical community. Once a problem is identified, MedSun researchers work with each facility’s representatives to clarify and understand the problem. Reports and lessons learned are shared with the clinical community and the public, without facility and patient identification, so that clinicians nationwide may take necessary preventive actions.
Identifying Potential Problems before Serious Injuries Occur
The Safe Medical Devices Act (SMDA) defines ‘user facilities’ as hospitals, nursing homes, and outpatient treatment and diagnostic centers. They are required to report medical device problems that result in serious illness, injury, or death. MedSun participants are also highly encouraged to voluntarily report problems with devices, such as ‘close-calls,’ potential for harm, and other safety concerns. By monitoring reports about problems and concerns before a more serious event occurs, FDA, manufacturers, and clinicians work together proactively to prevent serious injuries and death.
How MedSun Works
Participants use an Internet-based system that is designed to be an easy and secure way to report adverse medical device events. Each facility has online access to the reports they submit to MedSun so that they can be tracked and reviewed at any time.
The MedSun Subnetworks
These Subnetworks are designed to collect and share information about actual and potential adverse events from specific clinical areas of MedSun facilities using high-risk products.
HeartNet: Focuses on identifying, understanding, and solving problems with medical devices used in electrophysiology laboratories.
KidNet: Focuses on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric intensive care units.
CDRH-Medical Product Safety Network (MedSun Project)
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993