Multiple Reprocessing in RDG and Autoklave

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What is the goal of a multiple reprocessing in RDG & autoclave?

According to ISO 17664-1, limiting the reprocessing of your medical product can be a relevant factor in the risk analysis.

The aim of multiple reprocessing is to sterilize medical or other items and make them free from bacteria and other potentially harmful microorganisms.

Multiple reprocessing of a medical device entails the risk of wear and tear during use. Changes to the material and surface as well as an influence on the function can impair the safety of patients and users. Manufacturers take this effect into account and may define a maximum number of reprocessing cycles. These must be carried out in advance to be able to check the function and material of the maximum reprocessed product.

The autoclave exposes the items to heat and high pressure, which kills most microorganisms. Multiple reprocessing makes it possible to sterilize the items several times, thus ensuring their safety and usability over a longer period. This is particularly important in medical facilities to prevent infections and contamination.

What happens during a multiple reprocessing in RDG & autoclave?

The medical products for multiple reprocessing are cleaned, disinfected and autoclaved in the required number of cycles in accordance with the manufacturer's instructions. Tolerances and worst-case scenarios can be defined. The reprocessing processes can be carried out alternately or cumulatively. The products should then be checked for function and biocompatibility.

This procedure complies with ISO 10993-1. For sterilization containers, aging and function are checked in accordance with EN 868-8.

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In which areas are multiple reprocessing in RDG & autoclave used?

The specification of a maximum number of reprocessing cycles can be relevant for both instruments and sterilization containers in hospitals and medical practices. Proof that a medical product still meets the requirements of ISO 10993 for biocompatibility and is fully functional after a specified number of reprocessing cycles also serves to demonstrate compliance with the requirements of the essential safety and performance requirements of Regulation (EU) 2017/745.

Standards:  ISO 10993-1, EN 868-8

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