About MedSun
Overview
The U.S. Food and Drug Administration's (FDA's) Medical Product Safety Network (MedSun) is a program designed to identify problems with medical devices used in the clinical setting and help FDA work with manufacturers to produce safer products. Launched in 2002 by the FDA’s Center for Devices and Radiological Health (CDRH), MedSun comprises a network of 350 hospitals, nursing homes, and other health care institutions.
MedSun representatives from these sites are specially trained to collect and submit information about problems and potential problems with medical devices and human cells, tissues, and related products that may warrant action by FDA or manufacturers. This network of health care facilities also affords FDA the ability to communicate quickly with clinical specialists in order to better understand and evaluate particular medical device issues.
How MedSun Works
Hospitals, nursing homes, and other health care facilities are required to report serious medical device problems (those that result in serious injury or death) to CDRH and/or manufacturers under the Safe Medical Devices Act (SMDA). In addition to these required reports, participants in MedSun are encouraged to submit “voluntary” reports about issues that represent a potential for harm. The important data from both types of reports help FDA and manufacturers detect, understand and solve medical device problems to ensure patient safety. MedSun provides a secure, Internet-based data entry system that automates the process of submitting these reports.
"I would highly recommend being a part of this network. MedSun is like having a nationwide partner in safety!”
- Benja Morgan, Infection Control Manager, East Alabama Medical Center, Opelika, Alabama