Benefits to Your Organization

In the 2005 survey of MedSun Representatives, 97% of those responding indicated that they would recommend participation in MedSun to other organizations. In addition to helping ensure the safety of medical devices, participating in MedSun can deliver a host of other benefits to your organization. These benefits include:

Educational Programs

As requested by several MedSun sites, SSS and FDA have developed programs designed to encourage staff to report device problems using their internal reporting procedures. Slide presentations for various audiences (OR, pediatrics, lab, general nursing) are available.

MedSun Monthly Newsletter

"I had actually read in the MedSun newsletter that another hospital had been having the same problem that I had.....MedSun newsletters and websites give us the information that we need to further investigate a problem and see when there's a bigger picture."

Art Bartosch, Biomedical Engineer, Westchester Medical Center

MedSun facilities report that the greatest benefit of the program is the feedback they receive. This includes personal follow-up from MedSun staff members after filing a report, as well as information sharing among participating healthcare organizations through the MedSun newsletter.

The monthly newsletter keeps MedSun facilities up to date on program activity and includes:

• Descriptions (without identifiers) of reports received by MedSun
• Articles by FDA analysts concerning device problems
• Information from other MedSun participants concerning their involvement in the MedSun project

Special Database Analyses

MedSun participants can request special analyses of the MedSun database, as well as the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. The MedSun staff will assist in research to help ensure quick, quality information retrieval.

MedSun members receive CDRH alerts, advisories, and recall notices.

Assistance with Reporting Process

MedSun on-line reporting fulfills the requirement to report adverse medical device events to FDA. Participants can also use MedSun to submit reports to manufacturers as required under SMDA. In addition, SSS staff assist with compiling your annual report to FDA as required under SMDA.

Help Shape MedSun Network

Healthcare organizations that participate in MedSun will be on the forefront of a new system designed to produce important information about medical device safety. As an early participant in the project, your input will make an important contribution to the design of this critical system.

Clinical Engineering Topic Discussion Series

All MedSun Representatives are invited to take part in these conference call discussions, though the discussions focus on patient safety and adverse event topics of particular interest to clinical and biomedical engineers. The goals are to allow participants to share adverse event concerns and solutions with each other, to raise participant awareness of issues that are currently under study at FDA's Center for Devices and Radiological Health (CDRH) and to improve two-way communication between CDRH and the MedSun biomedical engineers. Topics have included: Clinical Alarm Systems, Electromagnetic Compatibility, and Human Factors in Medical Device Use Error.