Endoscope reprocessing devices are Class II devices cleared through the premarket notification by the United States Food and Drug Administration (FDA), [510(k)] pathway. Sterilization procedures are usually done by the manufacturer or supplier who made the flexible endoscopes. Since the instrument is sterile when it is manufactured, it must be also sterile when it is disassembled for reprocessing. Once the device is sterilized, the user will have complete control over the level of sterilization that needs to be applied. This is especially true when dealing with sensitive materials and tissues such as those found in endoscopes.
Automated endoscopy reprocessor helps remove toxic HLD solution residues and prevent the growth of waterborne pathogenic microorganisms during storage. Thus, there is an increasing demand for automated endoscopy reprocessors worldwide.
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