A process for improving flash sterilization - Statistical Data Included

AORN Journal,  Jan, 2002  by Karen A. Huggins,  Robert Mood,  Fran Koch

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Testing was broadened to use chemical integrators as these would examine the parameters in another context. Again, the purpose was to find air-removal gaps causing the inconsistency in the biological readouts. Six integrators were placed in the container, and the sterilizer was run at 135 [degrees] C (270 [degrees] F) for four minutes as recommended by the manufacturer. The integrators showed that all the parameters for sterilization had been met.

In addition, tests were conducted using six biological indicators (ie, spore strips) placed throughout the container in a similar manner to the integrators. These indicators were sent to the microbiology laboratory for incubation. The results were negative for biological growth at 48 hours and seven days; therefore, the parameters of sterilization appeared to have been met.

In light of the aforementioned factors and because containers are used, a decision was made to increase the sterilization time of all flash sterilization cycles. The decision was based on keeping the process consistent and simple for staff members by decreasing the alternative choices.

A summary of the department sterilization biological test results for May and June continued to show a few positive biological indicators with negative results when repeated. The occasional duplicate positive result usually indicated a mechanical failure or human error that was repaired or corrected.

Throughout the time period the sterilization process was being examined, the following factors appeared prominent.

* The conditioning time of some sterilizers was less than 1.5 minutes.

* The container may have trapped air or steam flow restrictions that impeded air removal.

* The overall sterilization time may not be sufficient to kill all spores in the specific test vial.

CONCLUSION

Changes were made in the biological monitoring of flash sterilization practices at Presbyterian Hospital of Dallas. The investigation did not indicate that there was a problem with the sterilization process; however, it raised questions and made staff members examine policies and procedures.

Department policies and procedures should mandate flash sterilization cycle times that support the requirements of the biological indicator being used. Staff members should ensure that the biological indicator and chemical integrator being used inside a test pack correlate to a standard load. When using a container system for flash sterilization, validate the use of the container to determine the appropriate sterilization time needed. Place multiple biological indicators and chemical integrators in the containers in a normal loading pattern in separate loads and run the cycle. If the biological indicators are positive, change the parameters of the cycle and retest. Do not use containers until all biological indicators are negative and the chemical integrators show acceptable results. This initial testing will assist in establishing policies and procedures that will lead to effective sterilization processes in health care facilities.