SpyGlass application for duodenoscope working channel inspection: Impact on the microbiological surveillance.

ABSTRACT

BACKGROUND: Patient-ready duodenoscopes were designed with an assumed contamination rate of less than 0.4%; however, it has been reported that 5.4% of clinically used duodenoscopes remain contaminated with viable high-concern organisms despite following the manufacturer's instructions. Visual inspection of working channels has been proposed as a quality control measure for endoscope reprocessing. There are few studies related to this issue. AIM: To investigate the types, severity rate, and locations of abnormal visual inspection findings inside patient-ready duodenoscopes and their microbiological significance. METHODS: Visual inspections of channels were performed in 19 patient-ready duodenoscopes using the SpyGlass visualization system in two endoscopy units of tertiary care teaching hospitals (Tri-Service General Hospital and National Taiwan University Hospital) in Taiwan. Inspections were recorded and reviewed to evaluate the presence of channel scratches, buckling, stains, debris, and fluids. These findings were used to analyze the relevance of microbiological surveillance. RESULTS: Seventy-two abnormal visual inspection findings in the 19 duodenoscopes were found, including scratches (n = 10, 52.6%), buckling (n = 15, 78.9%), stains (n = 14, 73.7%), debris (n = 14, 73.7%), and fluids (n = 6, 31.6%). Duodenoscopes > 12 mo old had a significantly higher number of abnormal visual inspection findings than those ≤ 12 mo old (46 findings vs 26 findings, P < 0.001). Multivariable regression analyses demonstrated that the bending section had a significantly higher risk of being scratched, buckled, and stained, and accumulating debris than the insertion tube. Debris and fluids showed a significant positive correlation with microbiological contamination (P < 0.05). There was no significant positive Spearman's correlation coefficient between negative bacterial cultures and debris, between that and fluids, and the concomitance of debris and fluids. This result demonstrated that the presence of fluid and debris was associated with positive cultures, but not negative cultures. Further multivariate analysis demonstrated that fluids, but not debris, is an independent factor for bacterial culture positivity. CONCLUSION: In patient-ready duodenoscopes, scratches, buckling, stains, debris, and fluids inside the working channel are common, which increase the microbiological contamination susceptibility. The SpyGlass visualization system may be recommended to identify suboptimal reprocessing.