Mesh : Disposable Equipment / economics Humans Equipment Reuse / economics Endoscopes, Gastrointestinal Equipment Design Gastrointestinal Diseases / diagnosis Endoscopy, Gastrointestinal / instrumentation economics Duodenoscopes / microbiology

来  源:   DOI:10.1097/SLE.0000000000001278

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.
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.
摘要:
目的:内窥镜是诊断的重要工具,筛选,和治疗胃肠道疾病。2019年,食品药品监督管理局发布了新闻稿,建议十二指肠镜制造商和医疗保健机构逐步淘汰具有固定端帽的完全可重复使用的十二指肠镜,以代替完全一次性或包含一次性端帽的十二指肠镜。通过这项研究,我们系统回顾了已发表的关于一次性使用一次性胃肠镜的文献,以描述文献的现状,并就一次性胃肠镜的作用提供总结建议.
方法:对于我们的纳入标准,我们搜索了2015年及之后发表的研究.我们在PubMed中使用关键字进行了文献检索,“一次性的,\"\"可重复使用,\"\"胆道镜,\"\"结肠镜,\"\"十二指肠镜,\"\"食管镜,“\”胃镜,\"和\"乙状结肠镜。“经过我们的审查,我们确定了我们的最终文章集,包括与一次性示波器有关的13篇文章,2015年至2023年出版。
结果:在这篇综述中,我们展示了13篇文章讨论感染率,功能,安全,与可重复使用的胃肠镜相比,一次性胃肠镜的可负担性。在讨论感染率的3篇文章中(福布斯及其同事,Ridtitid和他的同事们,和Ofosu及其同事),在一次性胃肠镜中,每种方法均显示感染风险降低.功能是这些文章中的另一个共同主题。六篇文章(由Muthusamy及其同事,Bang和同事们,Lisotti和他的同事们,罗斯和同事们,Kang和同事们,和福布斯及其同事)展示了一次性示波器与可重复使用示波器的可比功能。一次性示波器中报告最多的功能问题是相机分辨率降低。与可重复使用的范围相比,一次性范围也显示出可比的安全性。六篇文章(由Kalipershad及其同事,Muthusamy和他的同事们,Bang和同事们,Lisotti和他的同事们,罗和同事们,和Huynh及其同事)显示出相当的AE率,而一篇文章(由Ofosu及其同事撰写)显示一次性内窥镜的不良事件发生率增加。最后,在其中的3篇文章中进行了成本分析。两篇文章(由Larsen等人和Ross及其同事)指出,需要进一步的研究来了解一次性内窥镜的成本,而一篇文章(Kang及其同事)显示出有利的成本分析。
结论:在回顾了自2015年食品药品监督管理局安全沟通以来发表的文献后,已证明一次性镜可有效降低感染风险,同时保持与传统可重复使用镜相似的安全特征。然而,在功能和成本效益方面,需要更多的研究来比较一次性和可重复使用的范围。
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