FDA Medical Product Safety Network (MedSun): Implementation of a conceptual framework to improve patient safety through voluntary reporting

PART OF PANEL: FDA Medical Product Safety Network (MedSun): Hospitals in the Program Providing Benefits for Patient Safety Nationwide. In the late 1990s, FDA developed a system to obtain medical device information about adverse events – the Medical Product Safety Network (MedSun). This enhanced system established a reporting network of US hospitals to supplement required reporting on medical device-related adverse events. MedSun was designed to assist FDA staff to detect, understand, and share information about medical device events earlier and more completely than otherwise possible through information enhancing that provided through mandatory user facility reporting under the Safe Medical Devices Act. The MedSun network of user facilities (hospitals, nursing homes, home health agencies, and outpatient treatment and diagnostic facilities) submits voluntary reports. These device-related reports primarily concern potential for harm (PFH) events such as close calls, which key since PFH isn't required reporting so PFH information is generally not available to FDA from its standard reporting sources. MedSun reports provide FDA with alerts and early signals about device problems (including use error) to take preventive actions before device issues result in serious events or death. Social & Scientific Systems (SSS) worked with FDA to design MedSun and then implement it since beginning data collection in 2002. Central to the conceptual framework is implementation of a two-way channel between FDA and user facilities. The network has a sample of 350 hospitals in the active reporting network along with a variety of associated healthcare facilities. The sample design uses the American Hospital Association database as the sampling frame for hospitals 100 beds or larger and involves roughly mirroring the same distribution as in US Census Divisions. Ongoing and proactive network management, based on community of practice (COP) literature, has been an essential aspect, with recruitment of and orientation for new reporters and motivation and engagement of reporters (by electronic newsletters, progress reports, educational webinars, print materials, and in-person network meetings) to ensure timely and comprehensive reporting. This has ensured 2-way information-sharing between FDA and network members and collateral communications with manufacturers and the public. The feasibility of the program was demonstrated early, especially for obtaining PFH reports. The successes described in the next presentation have come from the actively-contributing COP focused on improving patient safety. In return, MedSun hospitals devote staff time to provide reports that are critical to FDA's efforts to ensure the safety and effectiveness of medical devices.