Amsco Evolution Series - Control Measure for Verifying Sterilization Process; Biological Monitors; Testing for Prevacuum Efficiency; Dart (Bowie-Dick) Test

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4-2

129390199 Operator Manual Techniques of Sterilization

4.2 Control Measure

for Verifying

Sterilization Process

As part of the operator’s verification of the sterilization process,

biological indicators may be used to demonstrate that sterilization

conditions have been met.

4.2.1 Biological Monitors A live spore test utilizing G. stearothermophilus is the most reliable

form of biological monitoring. This type of product utilizes controlled

populations of a controlled resistance, so that survival time and kill

time can be demonstrated.

To verify the process, insert the biological indicator in a test pack

and place pack on the bottom shelf. Run test pack through a typical

cycle. On completion, forward test pack and monitor to appropriate

personnel for evaluation. Refer to AAMI guidelines to conduct routine

biological monitoring.

4.2.2 Testing for Prevacuum

Efficiency

Tests such as the Dart

(Bowie-Dick) are designed to document the

removal of residual air from a sample challenge load.

Run a Dart (Bowie-Dick) test cycle daily before processing any loads

in a sterilizer equipped with prevacuum cycles. The first prevacuum

cycle of each day should be used to test the adequacy of air removal

from the chamber and load, so that steam can penetrate the load. It

is not a test for adequate exposure to heat in terms of time-at-

temperature.

4.2.3 Dart (Bowie-Dick) Test

A steam penetration test should be carried out at the beginning of

each day the sterilizer is to be used. Refer to instructions for running

the Dart (Bowie-Dick) test cycle in S

ECTION 6.14.1, DART (BOWIE-

ICK) TEST ON PAGE 6-31. Dart (Bowie-Dick) test packs are designed

to expose the pattern and document the removal of residual air from

the sample load. Any test package must be constructed in

accordance with instructions given in the ANSI/AAMI ST-79

standard.

In the case of this test, following exposure in a prevacuum test cycle,

the pack is opened, the indicator examined and conclusions are

drawn as to the pattern of residual air, if any, that remained in the

pack during the sterilizing cycle. Any indication of a malfunction

must be reported to the supervisor. Sterilizer must not be used to run

prevacuum cycles until approved by supervisor. The cause of the

malfunction must be determined and resolved prior to operating the

sterilizer.

1. In this context and elsewhere, where implied (such as on screen buttons), DART is an acronym for Daily Air Removal Test. However, note

that the term is also registered as a testing apparatus, i.e., Dart

Testing Apparatus to Determine the Effectiveness of Removing Air from a

Chamber.

WARNING – STERILITY

ASSURANCE HAZARD: Load

sterility may be compromised

if the biological indicator or

vacuum leak test indicates a

potential problem. If these

indicators show a potential

problem, refer the situation to

a qualified service technician

before using the sterilizer

further.