Bioindicators for self-monitoring of sterilizers / autoclaves

The topic of sterile goods reprocessing in facilities for medical devices in clinics, hospitals, and medical care centers (MVZ) is extremely sensitive. Steam sterilization is crucial for ensuring the sterility of medical devices.

The inspection and validation of autoclaves in healthcare facilities are regulated by various standards:

• EN ISO 17665 – 1: 2006 – 11: This standard addresses the development, validation, and control of sterilization processes for medical devices using moist heat.
• DIN EN 554: This standard specifies the validation and routine monitoring of moist heat sterilization.
• DIN 58946-7: 2014 – 01: This standard sets out the structural requirements and requirements for equipment and operation of steam sterilizers in healthcare.
• DIN EN 285: 2016 – 05: This standard defines the performance requirements and test methods for steam sterilizers.
• EN ISO 15883: This series of standards relates to cleaning and disinfection devices and the validation of reprocessing processes.

As part of a process analysis in a clinic in the administrative district of Düsseldorf, we used the Sterilization HyMo-Box from Hohenstein Laboratories GmbH & Co. KG to validate the sterilization process in the medical device reprocessing unit (AEMP).

Using bioindicators added to the autoclave, proof of the successful killing of the test germ “Geobacillus stearothermophilus” is provided. The HyMo-Box enables a biological verification of the sterilization process.

The bioindicators are removed after sterilization, sent to Hohenstein’s accredited laboratory, and evaluated. Growth of the test germ in the laboratory indicates a faulty sterilization.

In this case, further investigations of the sterilization process with the operator are necessary to check the settings and functionality of the sterilizer.

Successful proof of germ elimination in the laboratory indicates a safe sterilization process.

The test result is sent to the operator as a report with an assessment by the Hohenstein Laboratory and serves as self-monitoring for a successful sterilization process.

The use of bioindicators is intended to ensure the biological safety of the devices and can be applied in various medical facilities.

The HyMo-Box is used as an analytical tool in the context of our process analysis in AEMPs to make reliable statements about process safety in AEMP / sterilization.

The verification of biological safety in the autoclave should be carried out at least semi-annually. The responsible staff can independently and regularly perform the bioindicator test using the HyMo-Box. This is a cost-effective tool for checking the sterilization process and helps to minimize patient risk.

With the additional contact plates in the HyMo-Box, the cleanliness of work surfaces can be checked. The results can be used to adjust cleaning and disinfection plans and to optimize workflows to ensure sterilization.