title: Challenges to validation of a complex nonsterile medical device tray.
abstract: Validation by steam sterilization of reusable medical devices requires careful attention to many parameters that directly influence whether or not complete sterilization occurs. Complex implant/instrument tray systems have a variety of configurations and components. Geobacillus stearothermophilus biological indicators (BIs) are used in overkill cycles to to simulate worst case conditions and are intended to provide substantial sterilization assurance. Survival of G. stearothermophilus spores was linked to steam access and size of load in the chamber. By a small and reproducible margin, it was determined that placement of the trays in a rigid container into minimally loaded chambers were more difficult to completely sterilize than maximally loaded chambers.
authors.forename: Daniel
authors.initials: D
authors.lastname: Prince
authors.forename: Jozef
authors.initials: J
authors.lastname: Mastej
authors.forename: Isabel
authors.initials: I
authors.lastname: Hoverman
authors.forename: Raja
authors.initials: R
authors.lastname: Chatterjee
authors.forename: Diana
authors.initials: D
authors.lastname: Easton
authors.forename: Daniela
authors.initials: D
authors.lastname: Behzad
mesh_terms: D001681:Biological Assay / Q000295:instrumentation / Q000592:standards*; D004866:Equipment Contamination / Q000517:prevention & control*; D019544:Equipment Failure Analysis / Q000295:instrumentation* / Q000592:standards*; D017408:Guidelines as Topic; D011785:Quality Assurance, Health Care / Q000379:methods*; D013242:Sterilization / Q000295:instrumentation* / Q000592:standards*; D014481:United States