159717 Medical Product Safety Network (MEDSUN) and interactive surveillance system, eliminating barriers to reporting and creating two way communication with FDA

Wednesday, November 7, 2007: 12:30 PM

Kristine Powell , Survey and Epidemiology Services, Social & Scientific Systems, Silver Spring, MD
Clarice Brown, MS , Survey and Epidemiology Services, Social & Scientific Systems, Silver Spring, MD
Doris Northrup , Survey and Epidemiology Services, Social & Scientific Systems, Silver Spring, MD
The Medical Product Safety Network (MedSun) is a pilot program launched in 2002 by the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) in response to the known underreporting of serious medical device problems to FDA. Hospitals, nursing homes, and other healthcare facilities are 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. MedSun also provides options to capture additional voluntary information that can help improve the safe and effective design and use of medical devices. The purpose of this presentation is to describe the Medical Product Safety Network, (MedSun), a voluntary surveillance system that places an emphasis on creating an interactive relationship between FDA and the clinical community to learn about, understand, solve and prevent medical device problems and to provide timely feedback to health professionals to improve patient safety. The Medical Product Safety Network is a Phase II Pilot Study sponsored by FDA's Center for Device and Radiological Health and currently involves representatives of 350 participating acute care nonfederal hospitals throughout the U.S. that are trained to recognize medical device adverse events and report to FDA using a web-based reporting tool. Since 2002 there have been more than 6000 reports made to MedSun, some of which have more than one type of event. These have included report of 138 deaths, 615 serious injuries and 809 minor injuries associated with medical devices. There were over 4802 cases with potential for harm, close calls, or manufacturer complaints. Reporting rates vary by hospital but have increased over the years. In the most recent years, MedSun facilities contributed more reports to FDA on medical device problems than from all other hospitals and other user facilities. The keys to MedSun's success include the design of a non-burdensome web-based reporting tool, selection of MedSun representatives in each hospital that have access to device adverse event reports and can be motivated to report to FDA and provide timely, useful feedback to MedSun sites (newsletters, audio conferences, database searches, safety tips and annual conference). MedSun reports have generated important signals of emerging problems and information in MedSun reports have allowed FDA and manufacturers to take regulatory and non-regulatory action that contribute to patient safety.

Learning Objectives:
1. To show how quality and quantity of medical device problem reporting is improved by eliminating reporting barriers, e.g. liability concerns, paperwork burden, and lack of problem recognition and by developing an interactive relationship between FDA/MedSun and the clinical community.

Keywords: Safety, Health Care Quality

Presenting author's disclosure statement:

Any relevant financial relationships? No
Any institutionally-contracted trials related to this submission?

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.