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Wang XL, Li BJ, Ye HW, Wang BZ, Yu CH, Zhang SH, Jin DD, Yu JL, Wang XY. Performance of a disposable colonoscope for routine examination: Pilot randomized controlled noninferiority trial (with video). Dig Endosc 2025. [PMID: 40289343 DOI: 10.1111/den.15040] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/03/2024] [Accepted: 04/07/2025] [Indexed: 04/30/2025]
Abstract
OBJECTIVES Reusable colonoscopes pose a risk of iatrogenic infections due to improper disinfection and maintenance, prompting the development of disposable colonoscopes. However, direct comparisons between disposable and reusable colonoscopes remain limited. This pilot study aimed to evaluate the technical performance of disposable colonoscopes compared to reusable ones for routine colon examinations. METHODS This randomized controlled, noninferiority study was conducted at two endoscopy centers. Patients requiring colonoscopy were randomly assigned to either the disposable or reusable colonoscope group. The primary outcome was the successful completion rate of colonoscopy between the groups, with a noninferior margin of -10%. Secondary outcomes included image characteristics, technical maneuverability, colonoscopy performance measures, and adverse events. RESULTS A total of 116 patients underwent colonoscopy (58 in each group). The successful completion rate of colonoscopy was 100% in both groups (difference: 0% [95% confidence interval -6.21% to 6.21%]), confirming noninferiority. Although the disposable colonoscope group had lower performance scorings in imaging characteristics, technical maneuverability, and longer operating time compared to the reusable colonoscope group, no significant differences were observed in cecal intubation rate, polyp detection rate, polyp characteristics, or adverse event rate. Additionally, experienced endoscopists achieved proficiency with disposable colonoscopes after approximately 10 cases, requiring minimal training. CONCLUSION With further technical advancements, disposable colonoscopes may serve as a safe and viable alternative to reusable colonoscopes for routine colon examinations in certain clinical scenarios.
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Affiliation(s)
- Xiao-Ling Wang
- Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China
| | - Bin-Jia Li
- Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China
| | - Huo-Wang Ye
- Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China
| | - Bing-Zhou Wang
- Department of Gastroenterology, Second Affiliated Hospital of Shantou University Medical College, Shantou, China
| | - Chang-Hui Yu
- Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China
| | - Shao-Heng Zhang
- Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China
| | - Dan-Dan Jin
- Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China
| | - Jian-Lin Yu
- Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China
| | - Xin-Ying Wang
- Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China
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Udine M, Huff ML, Tsay K, Diab ARF, Sujka J, DuCoin C, Docimo S. Disposable Gastrointestinal Scopes: A Systematic Review. Surg Laparosc Endosc Percutan Tech 2024; 34:321-329. [PMID: 38767593 DOI: 10.1097/sle.0000000000001278] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/12/2023] [Accepted: 02/26/2024] [Indexed: 05/22/2024]
Abstract
OBJECTIVE Endoscopes are an essential tool in the diagnosis, screening, and treatment of gastrointestinal diseases. In 2019, the Food and Drug Administration issued a news release, recommending that duodenoscope manufacturers and health care facilities phase out fully reusable duodenoscopes with fixed endcaps in lieu of duodenoscopes that are either fully disposable or those that contain disposable endcaps. With this study, we systematically reviewed the published literature on single-use disposable gastrointestinal scopes to describe the current state of the literature and provide summary recommendations on the role of disposable gastrointestinal endoscopes. MATERIALS AND METHODS For our inclusion criteria, we searched for studies that were published in the year 2015 and afterward. We performed a literature search in PubMed using the keywords, "disposable," "reusable," "choledochoscope," "colonoscope," "duodenoscope," "esophagoscope," "gastroscope," and "sigmoidoscope." After our review, we identified our final article set, including 13 articles relating to disposable scopes, published from 2015 to 2023. RESULTS In this review, we show 13 articles discussing the infection rate, functionality, safety, and affordability of disposable gastrointestinal scopes in comparison to reusable gastrointestinal scopes. Of the 3 articles that discussed infection rates (by Forbes and colleagues, Ridtitid and colleagues, and Ofosu and colleagues), each demonstrated a decreased risk of infection in disposable gastrointestinal scopes. Functionality was another common theme among these articles. Six articles (by Muthusamy and colleagues, Bang and colleagues, Lisotti and colleagues, Ross and colleagues, Kang and colleagues, and Forbes and colleagues) demonstrated comparable functionality of disposable scopes to reusable scopes. The most reported functionality issue in disposable scopes was decreased camera resolution. Disposable scopes also showed comparable safety profiles compared with reusable scopes. Six articles (by Kalipershad and colleagues, Muthusamy and colleagues, Bang and colleagues, Lisotti and colleagues, Luo and colleagues, and Huynh and colleagues) showed comparable rates of AEs, whereas 1 article (by Ofosu and colleagues) demonstrated increased rates of AEs with disposable scopes. Lastly, a cost analysis was looked at in 3 of the articles. Two articles (by Larsen et al and Ross and colleagues) remarked that further research is needed to understand the cost of disposable scopes, whereas 1 article (by Kang and colleagues) showed a favorable cost analysis. CONCLUSIONS After a review of the literature published since the 2015 Food and Drug Administration safety communication, disposable scopes have been shown to be effective in decreasing infection risks while maintaining similar safety profiles to conventional reusable scopes. However, more research is required to compare disposable and reusable scopes in terms of functionality and cost-effectiveness.
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Affiliation(s)
| | | | | | - Abdul-Rahman F Diab
- Department of Surgery, Division of Bariatric and Metabolic Surgery, University of South Florida, Tampa, FL
| | - Joseph Sujka
- Department of Surgery, Division of Bariatric and Metabolic Surgery, University of South Florida, Tampa, FL
| | - Christopher DuCoin
- Department of Surgery, Division of Bariatric and Metabolic Surgery, University of South Florida, Tampa, FL
| | - Salvatore Docimo
- Department of Surgery, Division of Bariatric and Metabolic Surgery, University of South Florida, Tampa, FL
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Barakat MT. In the era of duodenoscopes with single-use endcaps, what is the role for single-use duodenoscopes? Gastrointest Endosc 2023; 98:119-121. [PMID: 37004813 DOI: 10.1016/j.gie.2023.03.025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/07/2023] [Revised: 03/18/2023] [Accepted: 03/20/2023] [Indexed: 04/04/2023]
Affiliation(s)
- Monique T Barakat
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Stanford University School of Medicine, Division of Pediatric Gastroenterology, Hepatology & Nutrition, Department of Pediatrics, Lucile Packard Children's Hospital at Stanford, Stanford, California, USA
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A prospective, multicenter, clinical study of duodenoscope contamination after reprocessing. Infect Control Hosp Epidemiol 2022; 43:1901-1909. [PMID: 35300743 PMCID: PMC9753065 DOI: 10.1017/ice.2021.525] [Citation(s) in RCA: 10] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/14/2023]
Abstract
OBJECTIVE Several clinical procedures utilize duodenoscopes, which are processed for reuse after the procedures are completed. However, infection outbreaks due to improper duodenoscope processing occur frequently. To address this, we aimed to assess the contamination rates of duodenoscopes after reprocessing in nonoutbreak settings. DESIGN AND SETTING Prospective study in 16 clinical sites in the United States. METHODS We sampled and cultured reprocessed duodenoscopes following the FDA/CDC/ASM guideline; "Duodenoscope Surveillance Sampling and Culturing - Reducing the Risks of Infection." High-concern (HC) organisms were those highly associated with disease, including gram-negative rods, Staphylococcus aureus, Staphylococcus lugdunensis, β-hemolytic Streptococcus, Enterococcus spp, and yeasts. We evaluated duodenoscopes with ≥1 CFU of organisms after reprocessing. The reprocessing environments were also sampled and cultured. RESULTS We assessed 859 newer-model (NM) duodenoscopes (TJF-Q180V) and 850 older-model (OM) duodenoscopes (TJF-160F/VF); of these, 35 NM samples (4.1%) and 56 OM samples (6.6%) were contaminated with HC organisms. We detected and classified the HC organisms as gastrointestinal (45.4%), human origin (16.7%), environmental (24.1%), waterborne (13.0%), and unidentified (0.9%). CONCLUSIONS We detected an overall HC contamination rate of 5.3% in nonoutbreak settings. Although the relationship between endoscopic contamination and the occurrence of infections remains unclear, attempts should continue to be made to further reduce contamination rates. Additional improvements to the manufacturer's instructions for use, human factors during the reprocessing procedure, ongoing training programs, cleanliness of reprocessing environments, and the design of the distal end of the duodenoscope should be considered.
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Sanders DJ, Bomman S, Krishnamoorthi R, Kozarek RA. Endoscopic retrograde cholangiopancreatography: Current practice and future research. World J Gastrointest Endosc 2021; 13:260-274. [PMID: 34512875 PMCID: PMC8394185 DOI: 10.4253/wjge.v13.i8.260] [Citation(s) in RCA: 23] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/19/2021] [Revised: 05/18/2021] [Accepted: 07/09/2021] [Indexed: 02/06/2023] Open
Abstract
Endoscopic retrograde cholangiopancreatography (ERCP) has evolved from a primarily diagnostic to therapeutic procedure in hepatobiliary and pancreatic disease. Most commonly, ERCPs are performed for choledocholithiasis with or without cholangitis, but improvements in technology and technique have allowed for management of pancreatic duct stones, benign and malignant strictures, and bile and pancreatic leaks. As an example of necessity driving innovation, the new disposable duodenoscopes have been introduced into practice. With the advantage of eliminating transmissible infections, they represent a paradigm shift in quality improvement within ERCP. With procedures becoming more complicated, the necessity for anesthesia involvement and safety of propofol use and general anesthesia has become better defined. The improvements in endoscopic ultrasound (EUS) have allowed for direct bile duct access and EUS facilitated bile duct access for ERCP. In patients with surgically altered anatomy, selective cannulation can be performed with overtube-assisted enteroscopy, laparoscopic surgery assistance, or the EUS-directed transgastric ERCP. Cholangioscopy and pancreatoscopy use has become ubiquitous with defined indications for large bile duct stones, indeterminate strictures, and hepatobiliary and pancreatic neoplasia. This review summarizes the recent advances in infection prevention, quality improvement, pancreaticobiliary access, and management of hepatobiliary and pancreatic diseases. Where appropriate, future research directions are included in each section.
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Affiliation(s)
- David J Sanders
- Digestive Disease Institute, Virginia Mason Medical Center, Seattle, WA 98101, United States
| | - Shivanand Bomman
- Digestive Disease Institute, Virginia Mason Medical Center, Seattle, WA 98101, United States
| | - Rajesh Krishnamoorthi
- Digestive Disease Institute, Virginia Mason Medical Center, Seattle, WA 98101, United States
| | - Richard A Kozarek
- Digestive Disease Institute, Virginia Mason Medical Center, Seattle, WA 98101, United States
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Trindade AJ, Copland A, Bhatt A, Bucobo JC, Chandrasekhara V, Krishnan K, Parsi MA, Kumta N, Law R, Pannala R, Rahimi EF, Saumoy M, Trikudanathan G, Yang J, Lichtenstein DR. Single-use duodenoscopes and duodenoscopes with disposable end caps. Gastrointest Endosc 2021; 93:997-1005. [PMID: 33712228 DOI: 10.1016/j.gie.2020.12.033] [Citation(s) in RCA: 32] [Impact Index Per Article: 8.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/14/2020] [Accepted: 12/14/2020] [Indexed: 12/11/2022]
Abstract
BACKGROUND AND AIMS Multidrug-resistant infectious outbreaks associated with duodenoscopes have been documented internationally. Single-use duodenoscopes, disposable distal ends, or distal end cap sealants could eliminate or reduce exogenous patient-to-patient infection associated with ERCP. METHODS This document reviews technologies that have been developed to help reduce or eliminate exogenous infections because of duodenoscopes. RESULTS Four duodenoscopes with disposable end caps, 1 end sheath, and 2 disposable duodenoscopes are reviewed in this document. The evidence regarding their efficacy in procedural success rates, reduction of duodenoscope bacterial contamination, clinical outcomes associated with these devices, safety, and the financial considerations are discussed. CONCLUSIONS Several technologies discussed in this document are anticipated to eliminate or reduce exogenous infections during endoscopy requiring a duodenoscope. Although disposable duodenoscopes can eliminate exogenous ERCP-related risk of infection, data regarding effectiveness are needed outside of expert centers. Additionally, with more widespread adoption of these new technologies, more data regarding functionality, medical economics, and environmental impact will accrue. Disposable distal end caps facilitate duodenoscope reprocessing; postmarketing surveillance culture studies and real-life patient infection analyses are important areas of future research.
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Affiliation(s)
- Arvind J Trindade
- Zucker School of Medicine at Hofstra/Northwell, Long Island Jewish Medical Center, New Hyde Park, New York, USA
| | - Andrew Copland
- Division of Gastroenterology and Hepatology, Department of Medicine, University of Virginia, Charlottesville, Virginia, USA
| | - Amit Bhatt
- Department of Gastroenterology, Hepatology & Nutrition, Cleveland Clinic, Cleveland, Ohio, USA
| | - Juan Carlos Bucobo
- Department of Gastroenterology, Stony Brook Medicine, Stony Brook, New York, USA
| | - Vinay Chandrasekhara
- Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Kumar Krishnan
- Division of Gastroenterology, Department of Internal Medicine, Harvard Medical School and Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Mansour A Parsi
- Section for Gastroenterology and Hepatology, Tulane University Health Sciences Center, New Orleans, Louisiana, USA
| | - Nikhil Kumta
- Division of Gastroenterology, Mount Sinai Hospital, New York, New York, USA
| | - Ryan Law
- Department of Gastroenterology, University of Michigan, Ann Arbor, Michigan, USA
| | - Rahul Pannala
- Department of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, Arizona, USA
| | - Erik F Rahimi
- Department of Gastroenterology, Baylor Scott & White Health, Lakeway, Texas, USA
| | - Monica Saumoy
- Division of Gastroenterology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Guru Trikudanathan
- Department of Gastroenterology, Hepatology and Nutrition, University of Minnesota, Minneapolis, Minnesota, USA
| | - Julie Yang
- Division of Gastroenterology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA
| | - David R Lichtenstein
- Division of Gastroenterology, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts, USA
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Siddhi S, Dhar A, Sebastian S. Best Practices in Environmental Advocacy and Research in Endoscopy. TECHNIQUES AND INNOVATIONS IN GASTROINTESTINAL ENDOSCOPY 2021; 23:376-384. [DOI: 10.1016/j.tige.2021.06.002] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/17/2025]
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Pasricha PJ, Miller S, Carter F, Humphries R. Novel and effective disposable device that provides 2-way protection to the duodenoscope from microbial contamination. Gastrointest Endosc 2020; 92:199-208. [PMID: 32151661 DOI: 10.1016/j.gie.2020.03.001] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/12/2019] [Accepted: 03/02/2020] [Indexed: 12/11/2022]
Abstract
BACKGROUND AND AIMS Duodenoscope contamination is associated with notable patient morbidity and mortality and can occur despite high-level disinfection protocols, requiring a solution that protects against contamination of the endoscope in the first place. METHODS We assessed a newly cleared, single-use device to seal the distal end of duodenoscopes while preserving optics and other endoscope functionality and tested its ability to protect against contamination using dye immersion tests and microbial inoculation. RESULTS Dye immersion tests revealed a complete seal with no leakage. Rigorous microbial challenge tests showed the device can both protect against contamination of the endoscope by external microbes ("outside-in" protection) and shield instruments from contact with pre-existing microbial biofilm on or around the elevator that may have survived reprocessing ("inside-out" protection). Optical and mechanical performance of the endoscope was not compromised by the addition of the device. CONCLUSIONS The results show that this disposable device provides 2-way protection to the duodenoscope from microbial contamination, without the potential for disrupting current equipment, technique, and workflow.
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Affiliation(s)
- Pankaj J Pasricha
- Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
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Elta GH, Law RL. What are the needed criteria for the adoption of new technology aimed at preventing duodenoscope-transmitted infections? Gastrointest Endosc 2020; 92:209-210. [PMID: 32586543 DOI: 10.1016/j.gie.2020.03.3859] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/18/2020] [Accepted: 03/28/2020] [Indexed: 12/11/2022]
Affiliation(s)
- Grace H Elta
- Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA
| | - Ryan L Law
- Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA
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