Background: Single use duodenoscopes and duodenoscopes with disposable/detachable caps emerged in the market to mitigate endoscopic retrograde cholangiopancreatography- related risk of infections. We aim to investigate post Food and Drug Administration (FDA) approval adverse events associated with these devices. Methods: We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from July 2018 to June 2021. Results: One hundred and ninety-five reports comprised 206 device issues and 118 patient complications were identified from July 2018 through June 2021. Most device issues related to the single use duodenoscope were due to optical problems (7 reports). Other reported device issues included difficulty in advancing the scope (2 reports), fluid leak (2 reports), and use of device problems (2 reports). Among the duodenoscopes with detachable endcaps, most device issues related to bacterial contamination (52 reports), followed by issues with device use (31 reports), detachment /separation of the device (25 reports), and crack/dent in device material (16 reports). Overall, the most reported patient adverse events were tissue injury (63 reports), perforation (8 reports), and bleeding (7 reports). Ninety reports of microbial contamination of duodenoscopes were identified of which Pseudomonas Aeruginosa was most common. Conclusion: Findings from the MAUDE database highlight patient and device complications that endoscopists should be aware of in using single-use duodenoscopes and duodenoscopes with detachable caps. While these devices mitigate infection transmission risk, they are associated with additional device-associated adverse events.

Analysis of Reported Adverse Events Related to Single Use Duodenoscopes and Duodenoscopes with Detachable Endcaps

Facciorusso, Antonio;
2022

Abstract

Background: Single use duodenoscopes and duodenoscopes with disposable/detachable caps emerged in the market to mitigate endoscopic retrograde cholangiopancreatography- related risk of infections. We aim to investigate post Food and Drug Administration (FDA) approval adverse events associated with these devices. Methods: We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from July 2018 to June 2021. Results: One hundred and ninety-five reports comprised 206 device issues and 118 patient complications were identified from July 2018 through June 2021. Most device issues related to the single use duodenoscope were due to optical problems (7 reports). Other reported device issues included difficulty in advancing the scope (2 reports), fluid leak (2 reports), and use of device problems (2 reports). Among the duodenoscopes with detachable endcaps, most device issues related to bacterial contamination (52 reports), followed by issues with device use (31 reports), detachment /separation of the device (25 reports), and crack/dent in device material (16 reports). Overall, the most reported patient adverse events were tissue injury (63 reports), perforation (8 reports), and bleeding (7 reports). Ninety reports of microbial contamination of duodenoscopes were identified of which Pseudomonas Aeruginosa was most common. Conclusion: Findings from the MAUDE database highlight patient and device complications that endoscopists should be aware of in using single-use duodenoscopes and duodenoscopes with detachable caps. While these devices mitigate infection transmission risk, they are associated with additional device-associated adverse events.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11369/414260
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