Elizabeth Gillespie BN, MPH, Stephen Blamey MBBS, FRACS, FACS
{"title":"Unexplained failure of biological indicators","authors":"Elizabeth Gillespie BN, MPH, Stephen Blamey MBBS, FRACS, FACS","doi":"10.1071/HI05131","DOIUrl":null,"url":null,"abstract":"<div><p>This report concerns a pattern of unexplained biological indicator system failure with low temperature hydrogen peroxide plasma sterilisation technology. This technology is a safe alternative to ethylene oxide (EtO) sterilisation and has its own specific biological indicator system. After establishing that our practices were in accordance with the manufacturers’ recommendations, the manufacturer re-engineered both the manufacturing process and the quality controls used during biological indicator manufacture. As a result, the biological indicator failure rate returned to a level consistent with the rest of the world.</p><p>The aim of the report is to identify the value of monitoring to ensure that the process outcomes predicted by a manufacturer are accurate. This in turn, assists in avoiding additional costs of a failed monitoring process.</p></div>","PeriodicalId":92877,"journal":{"name":"Australian infection control : official journal of the Australian Infection Control Association Inc","volume":"10 4","pages":"Pages 131-135"},"PeriodicalIF":0.0000,"publicationDate":"2005-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1071/HI05131","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Australian infection control : official journal of the Australian Infection Control Association Inc","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S132993601630061X","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
This report concerns a pattern of unexplained biological indicator system failure with low temperature hydrogen peroxide plasma sterilisation technology. This technology is a safe alternative to ethylene oxide (EtO) sterilisation and has its own specific biological indicator system. After establishing that our practices were in accordance with the manufacturers’ recommendations, the manufacturer re-engineered both the manufacturing process and the quality controls used during biological indicator manufacture. As a result, the biological indicator failure rate returned to a level consistent with the rest of the world.
The aim of the report is to identify the value of monitoring to ensure that the process outcomes predicted by a manufacturer are accurate. This in turn, assists in avoiding additional costs of a failed monitoring process.
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