DHHS/PHS/FDA/Office of Facilities, Acquisition and Central Services, Contracts Operations Branch, HFA-512, 5600 Fishers Lane, Park Building, Room 3-32, Rockville, MD 20857

B -- SENTINEL SYSTEM SOL 223-96-6052 DUE 062596 POC Susan Pearlman, Contract Specialist, (301) 443-4420, M. Deborah Smith-Castle, Contracting Officer, (301) 443-0424, FAX (301) 443-3651 The Center for Devices and Radiological Health (CDRH), The Food and Drug Administration (FDA) has a requirement to evaluate the feasibility and effectiveness of a sentinel reporting system for adverse event reporting of medical device use in user facilities. The evaluation of a sentinel surveillance system shall be done by designing and carrying out a pilot study of about 10 to 20 user facilities. These facilities shall be purposefully selected to meet the objectives of the pilot. Designated facility staff shall be trained on reportability of adverse events related to medical devices and on the use of the reporting forms; study facilities shall be monitored throughout the pilot. A two year period of performance is anticipated. See numbered Note 1. (0129)

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