Abstract E13

Development of a Database of Information on the Effects of Reprocessing on Hemodialyzer Performance
Miriam Provost, Gema Gonzalez, Carolyn Y. Neuland, Ph.D., Barbara I. McCool CDRH/Office of Device Evaluation/Gastroenterology and Renal Devices Branch

Although most hemodialyzers were labled "single use only" reprocessing and reuse of a hemodialyzer on the same patient has become standard practice in the U.S. Recently, FDA has required hemodialyzer manufacturers to submit 510(k)s to relabel their hemodialyzers for multiple use. As part of this effort, the manufacturers were required to collect data on the effects of each recommended reprocessing method on key hemodialyzer performance characteristics, such as ultrafiltration coefficient and clearance of standard small and large molecules. Since all of this information was under review by the CDRH/Office of Device Evaluation/Gastroenterology and Renal Devices Branch, we decided to capture the information in a Microsoft Access database. The database allows us to investigate important parameters, such as (1) the effect of different reprocessing methods on a single membrane type (2) a comparison of the effect of a single reprocessing method on different membrane types and (3) the effect of reprocessing on the performance of high and low flux membranes within a single hemodialyzer family. The database will serve as a useful tool for the FDA to better understand the effects of reprocessing and reuse on these critical medical devices.