Assessment of a Novel Approach to Evaluate the Outcome of Endoscope Reprocessing

Abstract

OBJECTIVE: To investigate and evaluate the use of a portable luminometer system for detecting contamination following the reprocessing and high-level disinfection of flexible endoscopes., DESIGN: Random sampling of endoscopes spaced at 1- to 2-week intervals following normal use in patients., METHODS: Portable luminometer system testing of 31 endoscopes undergoing reprocessing, 63 stored endoscopes, and 15 reprocessed endoscopes that underwent in-depth microbiological analysis. For testing with the portable luminometer system, samples were collected by swabbing a 100-cm2 shank surface area and the internal tip end orifice. Standardization of portable luminometer system results was performed in vitro by comparison of serial dilutions of known quantities of microorganisms and blood, tested before and after sterilization by autoclave. Microbiological analysis included Gram stain, culture for aerobic bacteria, and gene probes for Mycobacterium tuberculosis, herpes simplex viruses 1 and 2, and Cytomegalovirus. Trichrome and calcofluor white stains were used to detect parasites and fungi. Legionella was detected by stain with fluorescent-labeled monoclonal antibody., SETTING: The gastroendoscopy unit of a Veterans Affairs hospital., RESULTS: The portable luminometer system was capable of detecting microbial and cellular contamination of flexible endoscopes following high-level disinfection and reprocessing. The sensitivity of the assay was sufficient for detecting low-level contamination., CONCLUSIONS: The system provided a rapid microbiological outcome monitor for the cleaning and disinfection process. The system was easy to use and relatively accurate.