Importance of cleaning for reprocessing endoscopes and thermolabile sterile medical devices: French use and regulations.

In France, endoscope maintenance regulations present some particularities in terms of the definitions and texts referring to the disinfection and sterilization of medical devices, with respect to the prion risk. The main measures specified are a double cleaning prior to disinfection, with some stipulations concerning the procedure itself, such as time limits, duration and rinsing. The use of aldehydes in cleaning products is prohibited and it is recommended that peracetic acid, or any chlorinated product, be used at the disinfection phase. For machines, the recycling of detergents or disinfectants is prohibited, and traceability procedures are mandatory. The French Agency for Safety of Health Products (AFSSAPS) is committed to providing standards that prevent any undesirable consequences for the patient, the operator or the equipment. All these measures will be described in a 'user's guide' intended for medical care units, to be released by the National Technical Committee on Nosocomial Infections (CTIN).