7037 Quality control on biopsy forceps reprocessing.

Questions and fears have been raised concerning the efficacy of endoscopic accessories reprocessing: "Just how clean are cleaned instrument really ?''. The aim of this study was to confirm the sterility of reusable colonoscopic biopsy forceps after cleaning and sterilization. Material: 75 biopsy forceps (FB 24U-1 Olympus) were cleaned and sterilized according to ESGE (autoclaving 134°C for 18 min) or Japanese (autoclaving 134°C for 5 min) protocols. 15 new biopsy forceps were used as controls. Method: sterility studies were divided in 5 different evaluations: 15 reprocessed forceps and 3 controls for each campaign of sterility test. Tests were performed in a clean room in sterile conditions by an independent evaluation center, governmentally registered for quality control of sterility of medical devices. Biopsy forceps were introduced in a glass container filled with sterile Tryptone Soy Broth. Closed containers were submitted to an ultrasonic treatment during 10 min outside of a clean room, then incubated for 14 days at 37°C. Environmental controls and quality control of culture medium were carried on before, during and after the culture. Results: 73 of 75 biopsy forceps used in clinical investigation were sterile after cleaning and steam sterilization. Two samples of the first sterility test were contaminated by Aspergillus flavus, an environmental mold. At the same time, one other mold (Alternaria sp.) was isolated from an airborn control of the incubator. One control forceps of the fifth sterility test was contaminated by Staphylococcus epidermidis, bacterial strain of the environment. The efficacy of European and Japanese protocols was similar. Comments: this study underlines the technical difficulty of sterility test carried on endoscopic accessories as the handling of long and flexible forceps is very difficult, even in well-trained hands. As strains were found in few samples both from clinically used and controlled forceps, these two contaminants were most probably due to a culture operative failure. Conclusions: 1/ evaluation of quality control should be performed in a registered laboratory for evaluation of medical devices – 2/ even in these conditions, cross contamination, during evaluation procedure, could occur – 3/ whatever are the "debris'' found in forceps, they are microbiologically harmless for our patients – 4/ all single-use or reusable accessories carried on the same level of safety.