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FDA Okays Quicker Method for Checking Effectiveness of Medical-Device Steam Sterilization

Results are obtained within 2 hours (July 12)

The FDA has allowed marketing of the Verify Cronos Self-Contained Biological Indicator (SCBI, Steris Corporation), a new test that can help speed the determination of whether steam sterilization of reusable medical devices is effective.

The first biological indicator test that gives results in 2 hours, the SCBI is used in reprocessing, a multistep process to clean and disinfect or sterilize reusable medical devices. Properly reprocessed reusable medical devices can be used safely for more than one patient.

Steam sterilization is one method for sterilizing reusable medical devices, such as surgical instruments and endoscopes. It involves loading medical devices into a chamber that is sealed and filled with steam. Specific conditions, such as temperature, exposure time, and chamber pressure, must be maintained throughout to kill microorganisms that may be present on the reusable medical devices.

Like other biological indicator tests, the Verify Cronos SCBI consists of a vial containing dried spores from the heat-resistant bacterium Geobacillus stearothermophilus. Before the start of a sterilization cycle, the reprocessing technician places the vial inside the sterilization chamber along with the sterilization load.

After the sterilization cycle is complete, the spores are incubated in “recovery medium,” a liquid that provides an ideal environment for the growth of any surviving bacteria, and are monitored for spore growth. The growth of bacteria indicates that a sterilization load failed.

The new test uses a genetically engineered strain of G. stearothermophilus that produces an enzyme that fluoresces in reaction with the recovery medium if test microorganisms are present after the sterilization process.

Source: FDA; July 12, 2013.

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