DHHS/PHS/FDA/Office Of Facilities, Acquisition, And Central Services, Division of Contracts and Program Management, HFA-512(COB), 5600 Fishers Lane, Rockville, MD 20857

B -- PILOT STUDY OF THE USE OF POPULATION BASED MEDICAL CARE DATA FOR THE STUDY OF PATTERNS OF USE AND ADVERSE EVENTS ASSOCIATED WITH SELECTED MEDICAL DEVICE IMPLANTS SOL 108276-00-98 DUE 072898 POC Trudy Dartouzos, Contract Specialist, ph: 301/827-7165, fax: 301/827-7101 The Food and Drug Administration [FDA], intends to award a purchase order to the Univeristy of Dundee, Dundee Scotland, for data related to the use of medical devices in the population of Tayside, Scotland. The data is in support of a pilot study on the use of joint implants in the population of Tayside in order to determine the suitability of the University of Dundee Medicines Monitoring Unit [MEMO] data system for obtaining the following types of information: 1] Demographic and medical history data pertaining to the recipients of the implants of interest, with comparison to an appropriately selected cohort of age and sex matched subjects, 2] Rates of implantation of selected medical devices, 3] Brand specific information on device use and, 4] Incidence of selected events known or thought to be associated with the devices of interest an extended period [up to ten [10] years, and, where appropriate in the comparison group. Data set procurement is to be based on a detailed data request to yield a series of summary data tables as well as an analysis data set for more detailed on site analysis by FDA staff. The necessary attributes of the data source include: 1] A wide range of medical care data, including inpatient hospitalization, physician services, pharmacy, surgical procedures; 2] Coverage of the entire population of a defined geographic area; 3] Sufficient numbers of subject under surveillance to obtain statistically valid medical device use data for more commonly used products such as cardiac pacemakers and joint implants; 4] Electronic access to medical encounter data [including physician visits, hospitalizations, surgical procedures] in order to allow rapid estimation of rates of events of interest in the population; 5] Availability of medical record data to verify information obtained from electronic databases; 6] Availability of independently collected medical device adverse event reports for the population under study through regulatory surveillance system or other source; 7] Access to brand-specific device usage data; 8] Access to supplementary data, including mortality, social services, death certification, road/traffic accidents to extend available outcome information; 9] Access to usage and adverse events data on device brands not currently in use in the U.S., and; 10] Linkage of medical, demographic, mortality and other data available on subjects through the use of a unique patient identification number in order to allow creation of anlaysis data sets with extensive detail on case mix and outcomes. See note #1. Written quotes required at 2:00 p.m. 7/28/98. Posted 07/01/98. (0182)

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