title: Effect of chemical germicides on the integrity of hemodialyzer membranes.
abstract: Epidemiologic investigations of bacteremia in dialysis patients by the Centers for Disease Control (CDC) identified an association with the use of dialyzers disinfected with a specific chemical germicide. A collaborative study by the CDC and the Food and Drug Administration (FDA) was conducted to determine the effect of dialyzer disinfectants on five types of dialyzer membranes: three cellulosic (Cuprophan, cellulose acetate, cuprammonium rayon); and two synthetic (polysulfone, polyacrylonitrile). The disinfectants tested were: 4% formaldehyde; Renalin; Cidex Dialyzer; Sporicidin HO; Warexin; and RenNew-D. Water was the control. Dialyzers were reprocessed up to 15 times. Each reprocessing consisted of rinsing, air-leak testing, filling with fresh disinfectant, and storing for 2 to 4 days. After 15 reprocessings or air-leak failure, each dialyzer was microbiologically challenged for membrane integrity. Membranes exposed to Renalin, Cidex Dialyzer, and water passed all tests. Cellulosic membranes exposed to Warexin failed all tests after 2 to 9 reprocessings. Cellulose acetate membranes exposed to Sporicidin HD failed microbiologic testing. One polysulfone dialyzer exposed to RenNew-D and one exposed to 4% formaldehyde failed microbiologic testing. These results and those obtained from epidemiologic studies suggest that membrane integrity testing (e.g. an air-leak test) should be an integral part of dialyzer reprocessing.
authors.affiliation: Nosocomial Infections Laboratory Branch, Centers for Disease Control, Atlanta, GA 30333.
authors.forename: L A
authors.initials: LA
authors.lastname: Bland
authors.forename: M S
authors.initials: MS
authors.lastname: Favero
authors.forename: G S
authors.initials: GS
authors.lastname: Oxborrow
authors.forename: S M
authors.initials: SM
authors.lastname: Aguero
authors.forename: B P
authors.initials: BP
authors.lastname: Searcy
authors.forename: J W
authors.initials: JW
authors.lastname: Danielson
mesh_terms: D001672:Biocompatible Materials; D002482:Cellulose / Q000031:analogs & derivatives; D004202:Disinfectants / Q000494:pharmacology*; D004869:Equipment Safety; D006801:Humans; D008567:Membranes, Artificial; D008828:Microbiological Techniques; D011549:Pseudomonas; D006435:Renal Dialysis / Q000295:instrumentation*
chemical_list: D001672:Biocompatible Materials; D004202:Disinfectants; D008567:Membranes, Artificial; D002482:Cellulose