Disposable Gastrointestinal Scopes: A Systematic Review.
Journal
Surgical laparoscopy, endoscopy & percutaneous techniques
ISSN: 1534-4908
Titre abrégé: Surg Laparosc Endosc Percutan Tech
Pays: United States
ID NLM: 100888751
Informations de publication
Date de publication:
17 May 2024
17 May 2024
Historique:
received:
12
06
2023
accepted:
26
02
2024
medline:
20
5
2024
pubmed:
20
5
2024
entrez:
20
5
2024
Statut:
aheadofprint
Résumé
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.
Identifiants
pubmed: 38767593
doi: 10.1097/SLE.0000000000001278
pii: 00129689-990000000-00236
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
The authors declare no conflicts of interest.
Références
Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication. U.S. Food and Drug Administration; 2015. https://wayback.archive-it.org/7993/20170722150658/; https:/www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454766.htm
Information for Health Care Facilities: Reprocessing of Reusable Medical Devices. U.S. Food and Drug Administration; 2023. https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/information-health-care-facilities-reprocessing-reusable-medical-devices
FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection. U.S. Food and Drug Administration; 2019. https://www.fda.gov/news-events/press-announcements/fda-recommends-health-care-facilities-and-manufacturers-begin-transitioning-duodenoscopes-disposable
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