title: False negative interpretation of biologic indicators or the importance of using two biologic indicator test strips.
abstract: The use of at least two biologic indicators to monitor a sterilization process greatly enhances failure detection. A retrospective study of a sterilization monitoring service's database revealed that 48.7% of tests using two test strips were single-strip positive. This indicates that there is a nonuniformity in the sterilization conditions within the sterilizer chamber and that there is a need for at least two test strips to detect this nonuniformity.
authors.affiliation: Regulatory Affairs and Quality Assurance, Englewood, Colorado, USA.
authors.forename: J R
authors.initials: JR
authors.lastname: Scoville
mesh_terms: D004784:Environmental Monitoring / Q000379:methods* / Q000592:standards; D004868:Equipment Failure; D005027:Ethylene Oxide; D006358:Hot Temperature; D015203:Reproducibility of Results; D012189:Retrospective Studies; D013171:Spores, Bacterial; D013227:Steam; D013242:Sterilization / Q000295:instrumentation* / Q000379:methods / Q000592:standards*
chemical_list: D013227:Steam; D005027:Ethylene Oxide