Single-use duodenoscopes: is performance enough? Time to include sustainability as a prerequisite in clinical practice

Overall, the risk of infection after endoscopic procedures is clinically negligible if proper adherence to disinfection guidelines is ensured [1]. Recently, duodenoscope-associated infections (DAIs) have been referred as a major concern, especially those due to multidrug-resistant organisms (MDROs) [2]. Although duodenoscope-associated MDRO infections are associated with an increased morbimortality, most of them are also avoidable events. In fact, the complex design of duodenoscopes increases bacterial and biofilm harboring, resulting in higher post-procedural infection rates compared with other endoscopes [3]. As a result, this has led to the development of multiple strategies to reduce DAIs, including the improvement of reprocessing and maintenance techniques. However, these measures are far from being perfect and have been demonstrated to be somewhat insufficient [4]. Subsequently, disposable distal end cap attachments and single-use duodenoscopes have emerged as alternative strategies.

In particular, there has been a lot of debate around single-use duodenoscopes, as the “coup de grace” to eradicate duodenoscope-associated MDRO infections. Since then, multiple studies have demonstrated that, in patients with a regular biliopancreatic anatomy, single-use and reusable duodenoscopes are equally effective and safe [3] [4] [5] [6].

“The implementation of sustainability as a prerequisite in clinical practice will help to further outline the strategic positioning of not only reusable and single-use duodenoscopes, but also general endoscopic and other healthcare devices.”

While single-use duodenoscopes have emerged as potential mitigators of DAI, important questions have been raised regarding their environmental impact. In fact, endoscopy is among the top-three medical waste producers within a hospital [7], which can be easily understood given the large number of single-use devices used in the daily practice of an endoscopy department. In particular, the transition to single-use duodenoscopes is thought to generate 24 to 47 times more kgCO₂ equivalents than reusable duodenoscopes [8]. Although these single-use devices have been claimed to be potentially recyclable, the repurposing programs for the materials from duodenoscopes still lack complete transparency and we as a community must demand full disclosure from manufacturing companies to guarantee that recycling strategies are feasible.

With that in mind, is performance enough? Herewith, the questions are whether healthcare metrics should keep focusing solely on the most common effectiveness and cost outcomes and completely neglect sustainability as a healthcare critical domain and, if so, whether zero-contamination goals should be pursued, regardless of the price for planet earth.

In this issue of Endoscopy, Bruno et al. [9] present the results of the largest multicentric international case series on the use of single-use duodenoscopes for endoscopic retrograde cholangiopancreatography (ERCP) procedures. The study was conducted between 2019 and 2022 and included a total of 551 procedures, performed by 61 endoscopists at 22 academic centers from 11 different countries. The authors assessed the ability of both “expert” and “less expert” endoscopists to complete ERCP procedures for the designated indication, using the EXALT Model D single-use duodenoscope. The authors should also be acknowledged because this was the first study on single-use duodenoscopes to include patients with a modified biliopancreatic anatomy.

Bruno et al. clearly demonstrated that single-use duodenoscopes are effective and safe alternatives, when ERCP is performed by endoscopists with differing levels of competence. These disposable devices allowed the completion of procedures with varying levels of complexity, with rates of serious adverse events similar to those of reusable duodenoscopes. Surprisingly, the results of the present study indicate that the rates of endogenous infections were similar between single-use and reusable duodenoscopes, therefore hindering the potential of these disposable devices to eliminate all procedure-associated infections.

The employment of single-use duodenoscopes across endoscopy departments should be looked upon very carefully. Although the present study is reassuring that single-use duodenoscopes comply with major prerequisites, such as performance and safety, the exact positioning of disposable duodenoscopes remains somewhat unclear, mainly owing to financial and environmental concerns.

Although on one hand, there are “special” indications where single-use duodenoscopes are of great value, for example in known carriers of an MDRO and potentially when emergent offsite procedures are performed, single-use duodenoscopes also have disadvantages and the authors should be commended for highlighting the potential environmental issues related to the widespread implementation of single-use duodenoscopes. The authors did not however include an analysis of the environmental impact of single-use duodenoscopes. They further discuss that alternatives such as duodenoscope disposable elevator caps should be reconsidered following recent adverse events [10]. Nevertheless, it has been demonstrated that reusable duodenoscopes with a protective cap have the lowest overall health burden [8]. This raises the question as to whether improvement strategies to avoid distal cover technical issues will not be more sustainable than single-use duodenoscopes.

Moreover, the procedures in this study were predominantly performed by “expert” endoscopists, which may not be representative of the reality of all ERCP performing centers. Also, multiple authors were involved in the development of the single-use duodenoscope, which may have introduced potential selection bias. Finally, a higher number of patients included in a randomized controlled trial, with a comparative analysis of single-use versus reusable duodenoscopes, would have provided major insights in a less biased fashion.

In conclusion, this well-conducted study showed that, regardless of the levels of complexity and endoscopist expertise in ERCP, good performance with single-use duodenoscopes is achievable. However, the authors have failed to demonstrate that the infection rate of single-use duodenoscopes is dissimilar to reusable duodenoscopes, showing that, regardless of the source of infection, the perceived asset of single-use duodenoscopes to lower all procedure-associated infections might be less than initially anticipated. Importantly, this study should also bring awareness to the fact that healthcare metrics need to be revisited. The implementation of sustainability as a prerequisite in clinical practice will help to further outline the strategic positioning of not only reusable and single-use duodenoscopes, but also general endoscopic and other healthcare devices. Rather than focusing solely on direct patient outcomes and the nontrivial monetary issues, it is time that sustainability emerges as a critical healthcare domain.

Publication History

Article published online:
18 October 2023

• References

• 1 Beilenhoff U, Biering H, Blum R. et al. Reprocessing of flexible endoscopes and endoscopic accessories used in gastrointestinal endoscopy: Position Statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology Nurses and Associates (ESGENA) – Update 2018. Endoscopy 2018; 50: 1205-1234
• 2 Kwakman JA, Erler NS, Vos MC. et al. Risk evaluation of duodenoscope-associated infections in the Netherlands calls for a heightened awareness of device-related infections: a systematic review. Endoscopy 2022; 54: 148-155
• 3 Muthusamy VR, Bruno MJ, Kozarek RA. et al. Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol 2020; 18: 2108-2117.e3
• 4 Slivka A, Ross AS, Sejpal DV. et al. Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity. Gastrointest Endosc 2021; 94: 1046-1055
• 5 Bang JY, Hawes R, Varadarajulu S. Equivalent performance of single-use and reusable duodenoscopes in a randomised trial. Gut 2021; 70: 838-844
• 6 Napoléon B, Gonzalez JM, Grandval P. et al. Evaluation of the performances of a single-use duodenoscope: Prospective multi-center national study. Dig Endosc 2022; 34: 215-221
• 7 Siau K, Hayee BH, Gayam S. Endoscopy's current carbon footprint. Tech Innov Gastrointest Endosc 2021; 23: 344-352
• 8 Le NNT, Hernandez LV, Vakil N. et al. Environmental and health outcomes of single-use versus reusable duodenoscopes. Gastrointest Endosc 2022; 96: 1002-1008
• 9 Bruno MJ, Beyna T, Carr-Locke DL. et al. Global prospective case series of ERCP using a single-use duodenoscope. Endoscopy 2023; 55: 1103-1114 DOI: 10.1055/a-2131-7180.
• 10 US Food and Drug Administration. Center for Devices and Radiological Health United States: Inspections, compliance, enforcement, and criminal investigations; compliance actions and activities; warning letters. Warning letter, Olympus Medical Systems Corp. MARCS-CMS 654013 (March 15, 2023). Available at (Accessed 5 September 2023): www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/olympus-medical-systems-corp-654013-03152023