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.