About MedSun

How MedSun Works

Hospitals, nursing homes, and other healthcare facilities are currently required to report serious medical device problems (those that result in serious illness, injury, or death) to CDRH and/or manufacturers under the Safe Medical Devices Act (SMDA). MedSun is an Internet-based system that is designed to be an easy and secure way to report these events. The data entry screens are based on items on the MedWatch Form 3500A, which is currently used for SMDA reporting. MedSun also provides options to capture additional voluntary information that can help improve the safe and effective design and use of medical devices.

CDRH has contracted Social & Scientific Systems, Inc. (SSS) to manage the pilot program. SSS provides reporting assistance, processes reports submitted by participating healthcare facilities, and subsequently releases the reports to FDA and manufacturers. SSS also supplies MedSun participants with feedback concerning the reports and FDA's use of the data. Each facility will have online access to the reports that they have submitted to MedSun for internal tracking and review.

Click here to take a look at a sample MedSun screen.

Creating a Partnership Between Clinical Sites and FDA

MedSun is designed to foster an important partnership between clinical sites and FDA. The MedSun system is used to identify problems and work with the manufacturer to produce a safer product.

MedSun also serves as a powerful two-way channel of communications between CDRH and the clinical community. Once a problem is identified, MedSun researchers work with each facility's representatives to clarify the situation and fully understand the problem. Reports are later shared without facility identification so that clinicians can take necessary preventative actions.

"I am greatly impressed by MedSun, and the positive impact it has had on patient safety in those MedSun facilities like Northeastern Vermont Regional Hospital where it has been embraced."

Raymond D. Forsell, EI, Clinical Engineer, Technical Services Program, University of Vermont, Burlington, VT

Proactive Prevention Through Voluntary Reporting

"We enjoy being a part of MedSun for many reasons. It is great to learn about a problem before it becomes a problem in our hospital. We do not have to wait for a company to tell us about a concern or even a possible problem regarding a product. We are alerted through MedSun - what to look for and the outcome. When I scan the incidents that are reported, I try to remember those for future problems/concerns that we might encounter. I would highly recommend being part of this network - MedSun is like having a 'nationwide partner in safety'!"

Benja Morgan, RN, MPA CIC, Infection Control Manager, East Alabama Medical Center, Opelika, AL

Under SMDA, hospitals and nursing homes have a mandatory requirement to report medical device problems that result in serious illness, injury, or death. MedSun is expanding this program to include the reporting - on a voluntary basis - of problems like close calls or the rejection of a device over safety concerns. By getting data on problems and concerns before a more serious event occurs, FDA, manufacturers, and clinicians can work together proactively to prevent serious injuries and death.

Confidentiality

"There is serious attention to confidentiality, to protection. For instance, when we give feedback in the MedSun newsletter, the facilities are not identified."

Patricia Kingsley, U.S. Food and Drug Administration/CDRH

FDA will protect the identity of both the persons submitting the reports and the reporting institutions to the full extent allowed by statute and regulation, as is done in the current SMDA reporting system. FDA is also committed to maintaining the confidentiality and security of all MedSun data. A summary of the FDA security plan for this project is available upon request.

For more information about MedSun confidentiality, see FAQ: How is the information kept confidential?