Breakout Session B (02/14): Postmarket Surveillance - Beyond Passive Surveillance

Susan N. Gardner, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850

The Safe Medical Device Act of 1990 and 1992 mandated universal reporting of device related adverse events by user facilities. The FDA Modernization Act of 1997 has legislated that the system be changed to reporting by a representative subset of users. FDA has proposed a newly designed device surveillance network that not only meets the legislative criteria, but incorporates lessons learned from a pilot study that looked at barriers to reporting, and advice from experts in the fields of surveillance and medical error reporting. Goals of the proposed system include collecting high quality data about adverse device related events, analysis of data to quickly identify emerging problems and changes in device use, and timely dissemination of information to health care professionals and the public. The knowledge gained from this reporting system will be applied to the device approval process and shared with industry to aid improving device performance.