Automatic endoscope reprocessor

 
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 Soluscope 3

      Validated Process
      Compliant System
      Complete System
      Channel Control
      Microbiological Efficacy
      Chemistry



 

 

 

 

 

 

 

 

 

 

 

 

 


In use tests for evaluations of Washer disinfectors

 		 

After the in vitro validation of a disinfectant product, the whole process machine + products has to be validated for its antimicrobial efficacy following two different steps :
     
   Simulated use tests  
 

try to simulate an endoscope contamination in experimentally controlled conditions.
Methodologies may be slightly different depending on the country requirements. All of them use quantified contaminations, representative either of usual germs or of germs chosen for their known lack of sensitivity to disinfectants.
Tested bacterial strains : Pseudomonas aeruginosa, the most frequently recovered germ associated to gastroscopy and coloscopy, is of course used by the French methodology (Biotech-Germande laboratory), but also Aspergillus niger and Mycobacterium terrae to widen the evaluation towards interesting microorganisms for bronchoscopy. Two bacterial spores (Bacillus subtilis and Bacillus cereus ) are also tested regarding their different resistance to disinfectants.

Tested endoscopes : 3 endoscopes used for the process evaluation are also chosen to be representative of different kind of medical examinations on non sterile cavities.

Methodology : All channels are artificially contaminated with a quantified bacterial suspension including interfering matter. After drying, the endoscope is submitted to the recommended procedure (manual pretreatment with tap water only + machine standard cycle n°1), then sampled using a validated recovering solution.
 

Each assay is performed 6 times for each microbial strain. The efficiency of the automatic process is evaluated by comparing the contamination level of the endoscopes before and after the tested procedure.

Acceptance criteria are stated according to published scientific data :
Bacteria :                   7 log red
Fungi :                        6 log red
Mycobacteria :           5 log red
For a standard, non sporicidal, disinfection level :
Bacterial Spores :    4 log red
For a reinforced, sporicidal, disinfection level :
Bacterial Spores :     6 log red


  Clinical use tests  
 
are performed in hospital sites with "wild type" strains in realistic conditions.

The interesting purpose here is to test the whole process efficacy on typical flexible endoscopes routinely used in an actual clinical environment, without extra-ordinary procedures.

Methodology : A 1 st batch of 9 endoscopes (3 endoscopes of 3 different types) is sampled to measure contamination levels after patient examinations. A 2 nd equivalent batch of 9 endoscopes is submitted to the normal procedure within the machine and sampled after reprocessing.

Acceptance criteria are no surviving bacteria on endoscopes after exposure to the system.