Archive December 2015

New standard draft for biological indicators

New standard draft for biological indicators

During the last ISO meeting gke has offered a standard draft where biological indicators are characterized to check sterilization processes with hydrogen peroxide.

In this draft a test method is presented to determine the resistance of biological indicators for hydrogen peroxide sterilization processes. It will allow to compare biological indicators of different manufacturers for the first time. Using this test method the innactivation kinetics can be determined. This is a very important step to validate and monitor hydrogen peroxide sterilization and disinfection processes.

The test results will be soon published in the “Central Service” magazine.

New gke test system

New gke test system

Type tests described in sterilizer standards EN 285 or EN 13060 are used to test the standard conformity of sterilizers and they are used like the Bowie-Dick Test to check the sterilizer after start-up working correctly.

Sometimes paper packages and helix systems are used for routine monitoring to check the sterility of the load. This procedure is quite often batch monitoring. These tests have no relation to the load. Therefore, it cannot automatically be concluded that loads of complex MIS instruments can be sterilized successfully.

Since the load configuration in hospitals is changing according to the different type of operations carried out routine monitoring to check sterility has to be adapted to the load and cannot assure if the sterilizers are working according to the sterilizer standard requirements only.

This adaption can be achieved in two ways:

  1. Process Monitoring System (PMS): The sterility of the load is assured if the sterilization process has been validated with a worst-case load. The continuous monitoring of the load shall be carried out with a test system which monitors the maximum performance of the sterilizer. Modern sterilizers provide much better performance than the required type tested mentioned above. For this purpose gke offers a variety of different PCDs (process challenge devices) with increasing sensitivities to monitor the process at highest level. These test devices are called process monitoring systems (PMS).

  2. Batch Monitoring System (BMS): If the characteristics of the load to be sterilized are known, a PCD can be designed and validated to be more difficult to sterilize than the defined load using the method according to DIN 58921 (medical device simulator). gke has already tested several typical loads with the method according to DIN 58921 and offers special PCDs for tattoo, dental and ophthalmic loads. For these test systems separate data sheets with detailed information are available.

gke has extended its product range with different test systems having even higher requirements than the hollow load test described in EN 867-5 and which shall be used as a batch monitoring system with every sterilization cycle selected according to one of the procedures described above.

The test system gke VHDH-PMS (very high demand hollow process monitoring system) with Compact-PCD, brown is now available and represents extreme complex instrument loads. More information about this test system and other gke PMS and BMS can be found using the links. The product data sheet is available for download following this link or under Downloads/Product Catalogues and Data sheets.