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BCR - Model 30-Min BI - Biological Indicators
Biological indicators (BIs) are test systems containing spores of heat-resistant bacteria, e.g. Geobacillus stearothermophilus. BIs are used to monitor sterilization processes in health care facilities. Government guidelines require that a spore test should be used on each sterilizer at least weekly. A spore test should also be used for every load with an implantable device. It has become common practice to test sterilizer daily, but there is a trend to use BIs with each load. In this respect, an inexpensive BI like the BCR-30 min BI affords testing with each load.
Despite many technological advances, present-day self-contained biological indicators (SCBIs) still have limitations: (1) relatively high cost compared to traditional spore strips; (2) occurrence of “false negatives” caused by air trapped in the indicator? false negatives are particularly significant because they may conceal contaminated surgical supplies in use; and (3) exclusion of extensive sterilization cycles that can damage either the growth medium or the fluorogenic substrate.
The unprecedented features of the BCR-30-min BI derive from a novel technology (patent pending) centered on phenotypically engineered spores (termed F-spores) that function as self-reporters of germination. F-spores have the unique property of being fluorogenic, i.e., they are non-fluorescent when dormant, but produce intense fluorescence a few minutes after the onset of germination (PLoS ONE 5, e9283, 2010). Measuring spore germination (instead of conventional spore outgrowth) enables extremely short readouts without sacrificing sterility assurance.
Features of the BCR-30-min BI
The figures below show the BCR-30-min BI together with a diagram of a self-contained BI (SCBI), currently the most used BI.
The outstanding features of the BCR-30-min BI are:
- Low cost
- 30-minute readout
- Simplicity
These features permit every load monitoring, considered the best practice for improving patient safety and preventing costly recalls due to sterilization malfunction.
Also, an attribute unique to the BCR-30-min BI is that it contains only spores (in contrast, SCBIs contain medium and fluorogenic substrate), which allows for extended sterilization, a significant advantage over existing self-contained indicators.”