Article

Switching to Disposable Duodenoscopes: Risks and Rewards

Publish date: November 8, 2022

In 2013, the CDC warned the FDA that patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) were being infected with multidrug-resistant bacteria, and that the bacteria were likely coming from the duodenoscopes.¹ Subsequent changes to the instrument’s cleaning protocols did not significantly improve infection rates.² Thus in 2019, the FDA urged endoscopists to abandon use of reusable, hard-to-clean duodenoscopes when performing ERCP.³ The FDA wanted surgeons to adopt either single-use models or reusable tools redesigned with disposable tips.

The FDA’s request has created a lively debate among endoscopists.⁴ While single-use instruments would, by definition, eliminate risk of infection and save time related to endoscope cleanings, the constant replacement costs and the environmental impact of their disposal have prompted much discussion.^2,4 The estimated amount of greenhouse gas emissions, for example, from manufacturing the single-use instruments is remarkably higher than for other instruments.⁵

Alternatively, a “hybrid” duodenoscope, a reusable instrument equipped with a one-time-use tip, has been available for a few years; its use has been shown to significantly reduce bacterial contamination.⁶ However, that use has not entirely eliminated risk of microbial contamination despite adherence to high-level disinfection and reprocessing.⁷

Although the primary driver for disposable duodenoscopes has been reduction of infection risk from ERCP, other improvements are anticipated changes in ergonomic design for instrument operators with smaller hands, for example. A small case study has shown that expert endoscopists can finish ERCPs of different levels of complexity using disposable duodenoscopes.⁸

There is a need for technique modifications and training to improve ergonomics and comfort in the endoscopic space. A survey of 107 gastroenterologists highlighted differences in techniques, primarily due to physical differences.
Data from the Nationwide Inpatient Sample showed a small increase in ERCP utilization (from 0.38% to 0.44%), along with an increase in related adverse events such as pancreatitis and perforation.¹⁰
Estimated costs of single-use duodenoscopes, based on hospitals performing high and low volumes of ERCP.

References

US Food and Drug Administration. Infections associated with reprocessed duodenoscopes. Updated June 30, 2022. Accessed July 28, 2022. https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes
Heuvelmans M, Wunderink HF, van der Mei HC, Monkelbaan JF. A narrative review on current duodenoscope reprocessing techniques and novel developments. Antimicrob Resist Infect Control. 2021;10(1):171. doi:10.1186/s13756-021-01037-z
US Food and Drug Administration. Use duodenoscopes with innovative designs to enhance safety: FDA safety communication. Updated June 30, 2022. Accessed July 28, 2022. https://www.fda.gov/medical-devices/safety-communications/use-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication
Pass W. Weighing the pros and cons of disposable duodenoscopes. MDedge News. Published May 19, 2021. Accessed July 28, 2022. https://www.mdedge.com/gihepnews/article/240339/endoscopy
Le NNT, Hernandez L, Vakil N, Guda N, Patnode C, Jolliet O. Environmental and health outcomes of single-use versus reusable duodenoscopes. Gastrointest Endosc. 2022;S0016-5107(22)01765-5. doi:10.1016/j.gie.2022.06.014
Ridtitid W, Thummongkol T, Chatsuwan T, et al. Bacterial contamination and organic residue after reprocessing in duodenoscopes with disposable distal caps compared to duodenoscopes with fixed distal caps: a randomized trial. Gastrointest Endosc. 2022;S0016-5107(22)01766-7. doi:10.1016/j.gie.2022.06.015
Naryzhny I, Silas D, Chi K. Impact of ethylene oxide gas sterilization of duodenoscopes after a carbapenem-resistant Enterobacteriaceae outbreak. Gastrointest Endosc. 2016;84(2):259-262. doi:10.1016/j.gie.2016.01.055
Muthusamy VR, Bruno MJ, Kozarek RA, et al. Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2020;18(9):2108-2117.e3. doi:10.1016/j.cgh.2019.10.052
Bang JY, Hawes R, Varadarajulu S. Equivalent performance of single-use and reusable duodenoscopes in a randomised trial. Gut. 2021;70(5):838-844. doi:10.1136/gutjnl-2020-321836
Bhatt A, Thosani N, Patil P. ID: 3527241. Ergonomic study analyzing differences in endoscopy styles between female and male gastroenterologists [abstract]. Gastrointest Endosc. 2021;93(6 Suppl):AB42-AB43. doi:10.1016/j.gie.2021.03.148
Trindade AJ, Copland A, Bhatt A, et al. Single-use duodenoscopes and duodenoscopes with disposable end caps. Gastrointest Endosc. 2021;93(5):997-1005. doi:10.1016/j.gie.2020.12.033
Namburar S, von Renteln D, Damianos J, et al. Estimating the environmental impact of disposable endoscopic equipment and endoscopes. Gut. 2022;71(7):1326-1331. doi:10.1136/gutjnl-2021-324729
Kröner PT, Bilal M, Samuel R, et al. Use of ERCP in the United States over the past decade. Endosc Int Open. 2020;8(6):E761-E769. doi:10.1055/a-1134-4873
Patel K, Lad M, Siddiqui E, Ahlawat S. National trends in reimbursement and utilization of advanced endoscopic procedures in the Medicare population [abstract S0904]. Am J Gastroenterol. 2020;115:S465-S466. doi:10.14309/01.ajg.0000705664.35696.6e
Bang JY, Sutton B, Hawes R, Varadarajulu S. Concept of disposable duodenoscope: at what cost? Gut. 2019;68(11):1915-1917. doi:10.1136/gutjnl-2019-318227

References

US Food and Drug Administration. Infections associated with reprocessed duodenoscopes. Updated June 30, 2022. Accessed July 28, 2022. https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes
Heuvelmans M, Wunderink HF, van der Mei HC, Monkelbaan JF. A narrative review on current duodenoscope reprocessing techniques and novel developments. Antimicrob Resist Infect Control. 2021;10(1):171. doi:10.1186/s13756-021-01037-z
US Food and Drug Administration. Use duodenoscopes with innovative designs to enhance safety: FDA safety communication. Updated June 30, 2022. Accessed July 28, 2022. https://www.fda.gov/medical-devices/safety-communications/use-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication
Pass W. Weighing the pros and cons of disposable duodenoscopes. MDedge News. Published May 19, 2021. Accessed July 28, 2022. https://www.mdedge.com/gihepnews/article/240339/endoscopy
Le NNT, Hernandez L, Vakil N, Guda N, Patnode C, Jolliet O. Environmental and health outcomes of single-use versus reusable duodenoscopes. Gastrointest Endosc. 2022;S0016-5107(22)01765-5. doi:10.1016/j.gie.2022.06.014
Ridtitid W, Thummongkol T, Chatsuwan T, et al. Bacterial contamination and organic residue after reprocessing in duodenoscopes with disposable distal caps compared to duodenoscopes with fixed distal caps: a randomized trial. Gastrointest Endosc. 2022;S0016-5107(22)01766-7. doi:10.1016/j.gie.2022.06.015
Naryzhny I, Silas D, Chi K. Impact of ethylene oxide gas sterilization of duodenoscopes after a carbapenem-resistant Enterobacteriaceae outbreak. Gastrointest Endosc. 2016;84(2):259-262. doi:10.1016/j.gie.2016.01.055
Muthusamy VR, Bruno MJ, Kozarek RA, et al. Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2020;18(9):2108-2117.e3. doi:10.1016/j.cgh.2019.10.052
Bang JY, Hawes R, Varadarajulu S. Equivalent performance of single-use and reusable duodenoscopes in a randomised trial. Gut. 2021;70(5):838-844. doi:10.1136/gutjnl-2020-321836
Bhatt A, Thosani N, Patil P. ID: 3527241. Ergonomic study analyzing differences in endoscopy styles between female and male gastroenterologists [abstract]. Gastrointest Endosc. 2021;93(6 Suppl):AB42-AB43. doi:10.1016/j.gie.2021.03.148
Trindade AJ, Copland A, Bhatt A, et al. Single-use duodenoscopes and duodenoscopes with disposable end caps. Gastrointest Endosc. 2021;93(5):997-1005. doi:10.1016/j.gie.2020.12.033
Namburar S, von Renteln D, Damianos J, et al. Estimating the environmental impact of disposable endoscopic equipment and endoscopes. Gut. 2022;71(7):1326-1331. doi:10.1136/gutjnl-2021-324729
Kröner PT, Bilal M, Samuel R, et al. Use of ERCP in the United States over the past decade. Endosc Int Open. 2020;8(6):E761-E769. doi:10.1055/a-1134-4873
Patel K, Lad M, Siddiqui E, Ahlawat S. National trends in reimbursement and utilization of advanced endoscopic procedures in the Medicare population [abstract S0904]. Am J Gastroenterol. 2020;115:S465-S466. doi:10.14309/01.ajg.0000705664.35696.6e
Bang JY, Sutton B, Hawes R, Varadarajulu S. Concept of disposable duodenoscope: at what cost? Gut. 2019;68(11):1915-1917. doi:10.1136/gutjnl-2019-318227

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Switching to Disposable Duodenoscopes: Risks and Rewards

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