Development of a simple and quick process for routine evaluation of cleaning and disinfecting performance when reprocessing thermolabile medical devices
IGF 16932 N
A steadily increasing number of medical devices is manufactured using polymers, that can be treated at temperatures of 60 °C at maximum. Subsequently these devices are defined as thermolabile. Moreover instruments like e.g. flexible endoscopes and other minimally invasive instruments feature complex geometries with e.g. long internal canal systems and therefore need special efforts for reprocessing. Due to the thermolabile characteristics these devices cannot be reprocessed using the common and safe thermal reprocessing procedures but have to be disinfected and sterilized using chemo-thermal or chemical procedures. The disinfection performance is classically checked using bioindicators employing Enterococcus faecium. The analysis of the biomonitors lasts several days and is highly expensive. A simple to use method for routine control was not available up to date.
Within the project a simple and fast monitoring method was developed that allows the rapid control and documentation of chemo-thermal cleaning and disinfection procedures. The developed monitor system is based on non-cellular preparations of “extremophile” enzymes that have a defined resistance towards the chemo-thermal reprocessing procedures to be controlled.
The IGF-project 16932 N of the research association Europäische Forschungsgemeinschaft Reinigungs- und Hygienetechnologie e.V., Campus Fichtenhain 11, D-47807 Krefeld, was supported via the AiF within the funding programme „Industrielle Gemeinschaftsforschung und –entwicklung (IGF)“ by the Federal Ministry of Economic Affairs and Energy (BMWi) due to a decision of the German Parliament.
The research report is available on request from FRT.