Prospective microbiologic evaluation of the forceps elevator in closed-channel duodenoscopes after reprocessing

Abstract

Background: Endoscopes are well-known sources of bacterial transmission in health care facilities offering endoscopy services. The association between multidrug-resistant bacterial infections in patients who had undergone an endoscopic retrograde cholangiopancreatography procedure with reprocessed duodenoscopes has been much discussed. Bacterial contamination of duodenoscopes has been attributed to difficulties with reprocessing these devices, specifically the distal end of the scope, which features a movable forceps elevator. In light of a recent Food and Drug Administration warning letter to Olympus regarding their closed-channel duodenoscope model TJF-Q180V, the aim of our study was to prospectively evaluate the efficacy and safety of our current reprocessing procedures with regard to the TJF-Q180V duodenoscope models used in our hospital.

Methods: From August 2015-March 2016, we prospectively collected microbiologic surveillance samples from 6 TJF-Q180V model duodenoscopes in routine use at the Division of Gastroenterology and Hepatology using the ESwab collection system (COPAN Diagnostics Inc, Murrieta, CA).

Results: A total of 237 microbiologic samples from the forceps elevator were obtained during the survey period. None of the samples yielded microorganism growth.

Conclusion: These findings suggest that when following a diligent and validated reprocessing standard in accordance with manufacturer's recommendations, closed-channel endoscope models can still be used. Nevertheless, validated adaptions of current closed-channel duodenoscope models are needed to allow for simple and safe reprocessing. Furthermore, comprehensive postmarket surveillance needs to be established.

Keywords: Infection control; Medical device safety; Microbiologic surveillance.