Discussion
infection
INFECTION

In this largest global study of a single-use duodenoscope, endoscopists with varying levels of experience had high procedural success in ERCPs, one-third of which were high complexity cases. The median performance ratings were high for this device. SAEs were in the expected range, based on the published safety data for reusable duodenoscopes. Consistent with two previously published clinical studies

In an effort to eliminate the potential for contamination or infection associated with ineffective reprocessing of reusable duodenoscopes, the FDA have cleared duodenoscopes with disposable components

Ecological sustainability is an important issue for both single-use and reusable devices. For example, a 2023 publication focused on manufacturing-associated carbon dioxide emissions reported that performing ERCP with single-use duodenoscopes releases a carbon dioxide equivalent that is 24–47 times greater than with a reusable duodenoscope or a reusable duodenoscope with disposable endcaps

The results from the current study are consistent with those from previous studies of the single-use duodenoscope

All ERCP-associated SAEs are concerning and continual efforts must be made to minimize them. We compared the safety results in the current study with the published safety data for procedures performed with reusable duodenoscopes. The largest analysis of ERCP safety available is from Andriulli et al.
These findings suggest that, when used by a group of endoscopists with a predominantly expert level of experience, the single-use duodenoscope has a comparable safety profile to reusable duodenoscopes. The comparable rate of infection also shows that endogenous infection can still occur with when using a single-use duodenoscope, so the procedure-associated infection rate is not guaranteed to be lower than the rate for reusable duodenoscopes.
Our study has several strengths, limitations, and considerations for study interpretation. This was a multinational observational study including a large number of scheduled ERCP cases with a range of complexity performed by endoscopists at varying levels of experience, including 30-day safety follow-up. Limitations include the lack of randomization and the absence of a control group. Although patients were consecutively screened, the 68 % who were eligible to participate in this study may not be typical of patients at all endoscopy centers. Specific reasons why 10 screened patients were excluded for “concern over safety of subject if study duodenoscope was used for procedure’’ were not documented. Of note, several investigators participated in the development of the single-use duodenoscope
In conclusion, academic endoscopists used the first marketed single-use duodenoscope to successfully complete a large number of scheduled ERCP procedures with a range of complexity in a diverse patient population. Consistent with past studies, the device showed good performance and an SAE rate comparable with the published estimates for reusable duodenoscopes.