sive surveillance system, and, Gardner noted, some initiatives for improving surveillance efforts are under way.

FDA surveillance systems include mandatory reporting though the Medical Device Reporting (MDR) system, voluntary reporting (primarily by health-care professionals or consumers) through the MedWatch system, hospital-based reporting through the Medical Product Safety Network (MedSun), and an international vigilance program in which reports are exchanged with global regulatory authorities.

Voluntary reporting was initiated in 1973 and now accounts for about 3% of the adverse-event reports that FDA receives, Gardner said. Mandatory reporting was initiated in 1984 for manufacturers and importers (accounting for 93% and 1% of reports, respectively) and in 1990, under the Safe Medical Device Act, for user facilities, including hospitals, nursing homes, surgical ambulatory centers, and so on (accounting for 3% of the reports). All together, FDA receives about 200,000 case reports a year and has a database of about 2.5 million reports.

Mandatory Reporting

For all device classes, FDA regulations require manufacturers to report deaths, serious injuries, and malfunctions to FDA within 30 working days of their becoming aware that a device may have caused or contributed to those events. User facilities are required to report deaths to FDA within 10 working days of recognition of an event and deaths and serious injuries to the manufacturer within 10 working days.

In addition to individual reports, FDA initiated in the late 1990s a program called summary reporting, which provides an abbreviated method for reporting device adverse events. The program relies on established codes (rather than text) for device events that are well known and allows the agency to assess the data for trends. Summary-reporting exemptions are granted only for a specific well-known product and a specific well-known adverse event. Whenever there is an incident related to a product that is outside those boundaries, the manufacturer must file a full individual report.

MedSun is a national network of 350 user facilities. Each facility has two liaisons to the program—an engineer and a risk manager—who are trained to recognize and report adverse events. The system uses electronic reporting to reduce the burden on staff. The emphasis of the program is on device use issues. In addition to the mandatory reporting requirements, FDA encourages user facilities to voluntarily report near-misses and close calls, which now account for bulk of the reports. The program has given the agency an additional connection to the clinical community beyond the reporting relationship, Gardner noted.

About 14 people are dedicated to reviewing postmarket surveillance



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