USF Morsani College of Medicine.
Department of Surgery, Division of Bariatric and Metabolic Surgery, University of South Florida, Tampa, FL.
Surg Laparosc Endosc Percutan Tech. 2024 Jun 1;34(3):321-329. doi: 10.1097/SLE.0000000000001278.
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.
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.
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.
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.
内窥镜是诊断、筛查和治疗胃肠道疾病的重要工具。2019 年，美国食品和药物管理局发布新闻稿，建议内窥镜制造商和医疗机构逐步淘汰带有固定端盖的全复用十二指肠镜，转而使用全一次性或带有一次性端盖的十二指肠镜。本研究通过系统回顾一次性使用的胃肠道内窥镜的文献，描述了文献现状，并就一次性使用胃肠道内窥镜的作用提出了总结性建议。
纳入标准为 2015 年及以后发表的研究。我们在 PubMed 中使用“disposable”、“reusable”、“choledochoscope”、“colonoscope”、“duodenoscope”、“esophagoscope”、“gastroscope”和“sigmoidoscope”等关键词进行文献检索。检索后，我们确定了最终的文章集，包括 2015 年至 2023 年期间发表的 13 篇关于一次性内窥镜的文章。
在本综述中，我们展示了 13 篇文章，讨论了一次性胃肠道内窥镜在感染率、功能、安全性和成本效益方面与可重复使用的胃肠道内窥镜相比的情况。在讨论感染率的 3 篇文章（Forbes 等人、Ridtitid 等人和 Ofosu 等人）中，每篇文章都表明一次性胃肠道内窥镜感染风险降低。功能是这些文章的另一个常见主题。6 篇文章（Muthusamy 等人、Bang 等人、Lisotti 等人、Ross 等人、Kang 等人和 Forbes 等人）表明一次性内窥镜的功能与可重复使用的内窥镜相当。在一次性内窥镜中最常报告的功能问题是相机分辨率降低。一次性内窥镜的安全性与可重复使用的内窥镜相当。6 篇文章（Kalipershad 等人、Muthusamy 等人、Bang 等人、Lisotti 等人、Luo 等人和 Huynh 等人）显示不良事件发生率相当，而 1 篇文章（Ofosu 等人）显示一次性内窥镜不良事件发生率增加。最后，有 3 篇文章对成本分析进行了研究。2 篇文章（Larsen 等人和 Ross 等人）指出，需要进一步研究来了解一次性内窥镜的成本，而 1 篇文章（Kang 等人）则显示了有利的成本分析。
自 2015 年美国食品和药物管理局发布安全通讯以来，对文献的回顾表明，一次性内窥镜在降低感染风险的同时，保持了与传统可重复使用内窥镜相似的安全性。然而，在功能和成本效益方面，还需要更多的研究来比较一次性和可重复使用的内窥镜。
