Working closely with the Food and Drug Administration (FDA), Social & Scientific Systems establishes patient safety reporting systems to effectively communicate with and educate health care providers on current and potential safety issues with medical devices. This work helps FDA ensure the safety and effectiveness of medical products used in hospitals, nursing homes, and other settings.
Since 1996, we have worked with FDA's Center for Devices and Radiological Health (CDRH) on the Medical Product Safety Network (MedSun) to evaluate the feasibility and effectiveness of an active sentinel reporting system. MedSun was designed to provide CDRH with timely, high quality information about the problems with medical devices on the market and to provide a channel of communication between FDA and the clinical world. The initial period of development marked the beginning of electronic reporting of adverse medical device events by means of a secure FDA Web site. MedSun's data entry system automates this process and helps gather additional information that can help FDA, device manufacturers, and clinical facilities address safety concerns before they become widespread problems.
This system involves a sample of health care facilities that have been recruited and trained to report on medical device-related adverse events. MedSun has an important role in FDA's post-market surveillance effort as project staff identify and share information about problems with medical device usage.
Project activities in MedSun include sample design and selection, recruitment of hospitals and other health care facilities, orientation for participating facilities, data analysis, ongoing communication with participating sites, special surveys about particular device issues, educational programs, and systems development assistance.
Recognizing that communication with participating sites is a crucial part of the project, we provide feedback to MedSun facilities about medical device safety issues through safety tips, monthly newsletters, recalls and safety alerts, and regional conferences. MedSun facilities can electronically search the MAUDE database or request that our staff perform a search for them.
For more information on the project, visit http://www.medsun.net.
Click here to access additional information on our patient safety reporting systems (PDF).