Multiple Reprocessing in RDG and Autoklave

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

According to ISO 17664-1, limiting the number of reuses of your medical device can be a relevant point in the risk analysis.

The goal of multiple reprocessing is to sterilize medical or other items, making them free of bacteria and other potentially harmful microorganisms.

The repeated 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 in order to be able to check the function and material of the maximum reprocessed product.

The autoclave exposes items to heat and high pressure, which kills most microorganisms. Multiple reprocessing allows items to be sterilized repeatedly, 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?

Medical devices for multiple reprocessing are cleaned, disinfected, and autoclaved according to the manufacturer's instructions for use in the desired number of cycles. Tolerances and worst-case scenarios can be defined. The reprocessing processes can be carried out alternately or cumulatively. Subsequently, the products should 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.

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

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

Standards: ISO 10993-1, EN 868-8