TABLE C–1b Selected Examples of Federal Patient Safety/Health Care Reporting and Surveillance Systems

Federal Agency


Name of System


Type of system


History of reporting/ surveillance system

The FDA has had a postmarketing surveillance program in place since 1961. The FDA’s system evolved into five separate reporting forms for different products. Then, in 1993, the FDA developed MedWatch to consolidate the forms and eliminate confusion. Three FDA centers are currently responsible for handling reports: The Center for Devices and Radiological Health (CDRH) handles medical device events, the Center for Biologics Evaluation and Research (CBER) handles biologic and blood product events, and the Center for Drug Evaluation and Research (CDER) handles drug product events. In addition to these centers, the Office of Special Nutritionals handles reports of events or product problems associated with special nutritionals, such as dietary supplements, infant formulas, and medical foods. Most recently, in 2002, the CDRH launched a pilot program called MedSun (Medical Product Surveillance Network), which provides a secure, Internet-based data entry system that automates the MedWatch form for reporting medical device problems. MedSun is managed by CODA, a professional research organization.

aInformation on MedWatch has been obtained from the following sources: Henkel (1998), Food and Drug Administration (1996, 2001a, 2002).

bInformation on MPSMS has been obtained from the following sources: personal communication, S. Jencks and S. Kellie, 2002; personal communication, S. Kellie, March 27, 2002.

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