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Test of MDS according to DIN 58921

After use reusable medical devices (MD) are cleaned, disinfected and then sterilized. Depending on the individual design of the MP, the reprocessing requirements are very different. In order to fully evaluate whether the individual requirements are met by a remanufacturer, a microbiological examination of the complex hollow instruments may be necessary for process validation. This procedure is very costly and time-consuming, since a microbiological laboratory is necessary for the evaluation. The valid standards and guidelines therefore offer the option of testing simulators instead of the actual medical device.

A medical device simulator (MDS) is a process challenge device (PCD) that simulates a medical device in terms of steam sterilization requirements and eliminates the need for microbiological testing of the actual MD during process validation. The MDS is designed so that a chemical indicator or sensor can be easily placed inside at the relevant position . This greatly facilitates the evaluation of the reprocessing process in relation to the MP. The user saves time and costs during process validation, since the MD does not have to be handed over to a microbiological laboratory.

We, as an independent test laboratory, use very complex, freely programmable sterilizers and resistometers and have a microbiological laboratory. We can offer a professional test for compliance of the sterilization requirements of the MDS with those of the MD and thus the conformity with DIN 58921.

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