
%0 Journal Article
%A Gillespie, Elizabeth 
%A Blamey, Stephen 
%T Unexplained failure of biological indicators
%J Healthcare Infection
%D 2005/12/01
%V 10
%N 4
%P 131-135
%K 
%R https://doi.org/10.1071/HI05131
%U https://www.publish.csiro.au/paper/HI05131 
%X 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. 
