title: Evaluation of one-way valves used in medical devices for prevention of cross-contamination.
abstract: BACKGROUND
  One-way valves used in day use devices (used on multiple patients throughout a day without reprocessing between patients) are intended to reduce the potential for cross-contamination between patients resulting from the backflow of patient fluids. One-way valves are typically designed to withstand high levels of back pressure before failure; however, they may not be explicitly designed as a means of infection control as used in medical device applications.
  
  
  METHODS
  Five different medical grade one-way valves were placed in low pressure configurations. After flushing in the intended direction of flow, bacteriophage, bacteria, or dye was placed patient side for 24 hours. The upstream device side of the valve was then evaluated for microbial growth or presence of visible dye.
  
  
  RESULTS
  Leakage (ie, backflow) of the microorganisms occurred with a variety of one-way valve designs across a range of fluid properties tested.
  
  
  CONCLUSIONS
  This study describes testing of the one-way valves (component-level testing) for the potential of cross-contamination. Although day use medical device systems may use numerous other factors to prevent patient cross-contamination, this work demonstrates that one-way valves themselves may not prevent leakage of contaminated fluid if the fluid is able to reach the upstream side of the one-way valve.
authors.affiliation: U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation or Office of Science and Engineering Laboratories, Silver Spring, MD.
authors.forename: Poulomi
authors.initials: P
authors.lastname: Nandy
authors.affiliation: U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation or Office of Science and Engineering Laboratories, Silver Spring, MD.
authors.forename: Megan
authors.initials: M
authors.lastname: Young
authors.affiliation: U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation or Office of Science and Engineering Laboratories, Silver Spring, MD.
authors.forename: Shanil P
authors.initials: SP
authors.lastname: Haugen
authors.affiliation: U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation or Office of Science and Engineering Laboratories, Silver Spring, MD.
authors.forename: Kristy
authors.initials: K
authors.lastname: Katzenmeyer-Pleuss
authors.affiliation: U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation or Office of Science and Engineering Laboratories, Silver Spring, MD.
authors.forename: Edward A
authors.initials: EA
authors.lastname: Gordon
authors.affiliation: U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation or Office of Science and Engineering Laboratories, Silver Spring, MD.
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Retta
authors.affiliation: U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation or Office of Science and Engineering Laboratories, Silver Spring, MD.
authors.forename: Steven C
authors.initials: SC
authors.lastname: Wood
authors.affiliation: U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation or Office of Science and Engineering Laboratories, Silver Spring, MD. Electronic address: anne.lucas@fda.hhs.gov.
authors.forename: Anne D
authors.initials: AD
authors.lastname: Lucas
mesh_terms: D003428:Cross Infection / Q000517:prevention & control*; D004864:Equipment and Supplies; D006801:Humans; D017053:Infection Control / Q000295:instrumentation*
keywords: Backflow; Day use devices; Health care–associated infection; Nonreturn valves; One-way valves