Reprocessing endoscopes: United States perspective

Abstract

Endoscopes are used frequently for the diagnosis and therapy of medical disorders. For example, greater than 10,000,000 gastrointestinal endoscopic procedures are performed each year in the United States. Failure to employ appropriate cleaning and disinfection/sterilization of endoscopes has been responsible for multiple nosocomial outbreaks and serious, sometimes life-threatening, infections. Flexible endoscopes, by virtue of the site of use, have a high bioburden of microorganisms after use. The bioburden found on flexible gastrointestinal endoscopes following use has ranged from 10 5 to 10 10 CFU/ml, with the highest levels being found in the suction channels. Cleaning dramatically reduces the bioburden on endoscopes. Several investigators have shown a mean log 10 reduction factor of 4 (99.99%) in the microbial contaminants with cleaning alone. Cleaning should be done promptly following each use of an endoscope to prevent drying of secretions, allow removal of organic material, and decrease the number of microbial pathogens. Because the endoscope comes into intimate contact with mucous membranes, high-level disinfection is the reprocessing standard after each patient use. High-level disinfection refers to the use of a disinfectant (e.g., FDA-cleared chemical sterilant or high-level disinfectant) that inactivates all microorganisms (i.e., bacteria, viruses, fungi, mycobacteria) but not high levels of bacterial spores. The disinfection process requires immersion of the endoscope in the high-level disinfectant and ensuring all channels are perfused for the approved contact time (e.g., for ortho-phthaladehyde this is 12 min in the US). Following disinfection, the endoscope and channels are rinsed with sterile water, filtered water, or tapwater. The channels are then flushed with alcohol and dried using forced air. The endoscope should be stored in a manner that prevents recontamination. A protocol that describes the meticulous manual cleaning process, the appropriate training and evaluation of the reprocessing personnel, and a quality assurance program for endoscopes should be adopted and enforced by each unit performing endoscopic reprocessing.