Duodenoscope Disinfect Study

Study Design

This study is designed to evaluate the effect of supplementing standard high-level disinfection with additional high level-disinfection or sterilization procedures on the frequency of duodenoscopes contamination. Duodenoscopes will be randomly assigned to one of three arms:

Standard high-level disinfection currently performed at BIDMC (standard HLD)

Standard high-level disinfection with an additional exposure time to disinfectant (double HLD)

Standard high-level disinfection followed by ethylene oxide (HLD/ETO)

The study will be conducted with the following elements:

All duodenoscopes will be randomly assigned to a study arm before the duodenoscope is used for an Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedure included in the study, including duodenoscopes introduced during the study.

All duodenoscopes used for ERCP will have the following cultures obtained in a sterile fashion

Patient study consent for obtaining patient rectal surveillance and clinical cultures will be obtained at the time of ERCP procedure consent among all patients undergoing ERCP. Patients will be blinded to duodenoscope disinfection/sterilization assignment.

The ERCP procedure will be performed according to standard clinical practice. Among patients consenting to specimen collection, a duodenal aspirate will be obtained during the procedure.

Among consenting patients, a rectal surveillance swab will be collected post-procedurally by ERCP staff.

After ERCP completion, current BIDMC-employed trained technicians will perform the assigned disinfection/sterilization procedure.