Method for determining the effectiveness of a sterilization method for a medical product in a sterilizer, data processing system, computer program product, and medical product

Abstract

A process is presented for determining the effectiveness of sterilization processes for medical devices, with the steps of: providing a data structure, wherein the data structure represents a grid formed of a plurality of three-dimensional cells, recreating the medical device arranged in the sterilizer in the data structure in such a way that a first plurality of cells of the grid represent a body of the medical device and that a second plurality of cells represent an interior of the sterilizer which is not occupied by the body of the medical device, recreating an initial state in the data structure in such a way that each cell of the second plurality of cells is assigned data with respect to the temperature prevailing at the location of the cell, the quantity of a first medium located in the area of the cell and the quantity of a second medium located in the area of the cell, recreating, step by step, changes in the temperature, the quantity of the first medium and the quantity of the second medium occurring in each cell of the second plurality of cells during the sterilization process, and calculating a reduction of a germ load achieved in each cell of the second plurality of cells during the sterilization process taking into account the prevailing temperature, quantity of the first medium and quantity of the second medium in the respective cell in each step. Furthermore, a data processing system as well as a computer program product for carrying out the process are presented.

1 . A process for determining the effectiveness of a sterilization process for a medical device in a sterilizer, with the steps of
 providing a data structure, wherein the data structure represents a grid formed of a plurality of three-dimensional cells,   recreating the medical device arranged in the sterilizer in the data structure in such a way that a first plurality of cells of the grid represent a body of the medical device and that a second plurality of cells represent an interior of the sterilizer which is not occupied by the body of the medical device,   recreating an initial state in the data structure in such a way that each cell of the second plurality of cells is assigned data with respect to the temperature prevailing at the location of the cell, the quantity of a first medium located in the area of the cell and the quantity of a second medium located in the area of the cell, recreating, step by step, changes in the temperature, the quantity of the first medium and the quantity of the second medium occurring in each cell of the second plurality of cells during the sterilization process,   calculating a reduction of a germ load achieved in each cell of the second plurality of cells during the sterilization process taking into account the prevailing temperature, quantity of the first medium and quantity of the second medium in the respective cell in each step.   
     
     
         2 . The process according to  claim 1 , wherein a quantity of a third medium present in each cell (Z) of the second plurality of cells is additionally taken into account. 
     
     
         3 . The process according to  claim 1 , wherein a phase transition of the first, second and/or third medium is taken into account for the recreation of the sterilization process. 
     
     
         4 . The process according to  claim 1 , wherein a shape change of the medical device is taken into account for the recreation of the sterilization process. 
     
     
         5 . The process according to  claim 1 , wherein a diffusion of the first, second and/or third medium through the material of the medical device is taken into account for the recreation of the sterilization process. 
     
     
         6 . The process according to  claim 1 , wherein the first medium is air. 
     
     
         7 . The process according to  claim 1 , wherein the second medium is water. 
     
     
         8 . The process according to  claim 1 , wherein the second or the third medium is ethylene oxide. 
     
     
         9 . A process for validating a sterilization process for a medical device, with the steps of:
 defining a reduction of a germ load to be achieved by the sterilization process;   carrying out the process according to  claim 1 ,   comparing the reduction of the germ load determined in each cell of the second plurality of cells; and   grading the sterilization process as effective if the necessary reduction of the germ load has been achieved for each of the cells, or   grading the sterilization process as not effective if the necessary reduction of the germ load has not been achieved for at least one of the cells.   
     
     
         10 . The process according to  claim 9 , wherein a checking process is additionally carried out, with the steps of:
 introducing a sample provided with a known germ load at a predefined point of a medical device to be sterilized,   carrying out the sterilization process to be validated on the medical device, determining the reduction of the germ load of the sample achieved by the sterilization process, and   grading the sterilization process as effective only when the reduction of the germ load of the sample actually achieved corresponds sufficiently precisely to the reduction of the germ load calculated for the corresponding point.   
     
     
         11 . A data processing system, comprising
 at least one processor,   a memory,   input means and   output means,   
       wherein program code information which, when executed by the processor, is able to prompt the latter to execute the process according to  claim 1  is stored in the memory. 
     
     
         12 . A computer program product, comprising a data carrier and program code information stored on the data carrier which, when executed by a processor, is able to prompt the latter to execute the process according to  claim 1 . 
     
     
         13 . A sterilized medical device, wherein the medical device has been subjected to a sterilization process, the effectivity of which has been determined by the process of  claim 1 . 
     
     
         14 . A sterilized medical device, wherein the medical device has been subjected to a sterilization process, which has been validated by the process of  claim 9 . 
     
     
         15 . A sterilized medical device, wherein the medical device has been produced in a sterilizer, wherein the effectivity of a sterilization method used in the sterilizer has been determined in the process of  claim 1 . 
     
     
         16 . A sterilized medical device, wherein the medical device has been produced in a sterilizer, wherein the effectivity of a sterilization method used in the sterilizer has been validated by the process of  claim 9 .