Recent Actions by the US Food and Drug Administration

Haugen, Shanil P.; Ferriter, Ann; Connell, Jian; Min, Lauren J.; Wiyor, Hanniebey D.; Cole, Stephanie

doi:10.1016/j.giec.2020.06.010

Cited by 5 publications

(1 citation statement)

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“…Even prior to the COVID pandemic, efforts were made to optimize endoscopic efficiency and reduce risk of infection from reprocessed duodenoscopes ( 10 ). To remedy this, multiple manufacturers have been working on the development of single-use bronchoscopes, gastroscopes and duodenoscopes.…”

Section: Equipmentmentioning

confidence: 99%

A guide on transnasal endoscopy: setting up a pediatric unsedated endoscopy program

Friedlander,

Leinwand,

Bhardwaj

et al. 2024

Front. Pediatr.

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BackgroundUnsedated transnasal endoscopy is becoming an increasingly popular option for the evaluation of upper gastrointestinal tract disorders in adults and children worldwide. This innovative technology has transformative potential as it provides for a more efficient, safe, and cost-effective method for endoscopy and reduces the risks associated with anesthesia, which is particularly relevant in pediatrics as endoscopy is commonly done under general anesthesia or conscious sedation. The aim is to address knowledge gaps amongst pediatric gastroenterologists who may be considering the development of a TNE program, detailing how to implement sedation-free TNE into practice for pediatric patients and current and forthcoming technologies.MethodsWe conducted a comprehensive review of current literature and collection of data from experts and clinicians in the field on how sedation-free programs were started and being conducted. We aimed to collate the data to provide a guide to address knowledge gaps with a focus on setting up and starting a sedation-free endoscopy program.ResultsHere in, we provide a detailed guide for implementing a sedation-free endoscopy program in pediatrics including design and layout of a TNE unit, special staffing needs, equipment, current and forthcoming technologies, financial considerations and training considerations. We highlight special considerations that are relevant in pediatrics incorporating distraction or dissociation techniques such as Virtual Reality Systems, developmentally appropriate preparation for children, and topical analgesia.ConclusionSedation-free endoscopy is a rapidly growing option for pediatric patients. Development of an unsedated pediatric endoscopy program will improve patient care, decrease the need for anesthesia, provide a lower cost and safe alternative to traditional sedated endoscopy, and is a viable component to a pediatric gastroenterology practice.

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Section: Equipmentmentioning

confidence: 99%

A guide on transnasal endoscopy: setting up a pediatric unsedated endoscopy program

Friedlander,

Leinwand,

Bhardwaj

et al. 2024

Front. Pediatr.

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Rate and impact of duodenoscope contamination: A systematic review and meta-analysis

et al. 2020

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Background Multiple infection outbreaks have been linked to contaminated duodenoscopes worldwide. However, the contamination rate of patient-ready duodenoscopes varies highly amongst published studies testing this subject. We aimed to estimate the contamination rate of reprocessed patient-ready duodenoscopes for endoscopic retrograde cholangio-pancreatography (ERCP) based on currently available data. Methods We searched the PubMed and Embase databases from January 1, 2010 until March 10, 2020, for citations investigating contamination rates of reprocessed patient-ready duodenoscopes. Studies not assessing other types of endoscopes than duodenoscopes were excluded from the analysis. Study eligibility and data extraction was evaluated by three reviewers independently. A random-effects model (REM) based on the proportion distribution was used to calculate the pooled total contamination rate of reprocessed patient-ready duodenoscopes. Subgroup analyses were carried out to assess contamination rates when using different reprocessing methods by comparing single high-level disinfection (HLD) with double HLD and ethylene oxide (EtO) gas sterilization. Additionally, we investigated the contamination rate between studies conducted following an outbreak compared to non-outbreak-initiated studies. Findings We identified 15 studies that fulfilled the inclusion, which included 925 contaminated duodenoscopes from 13,112 samples. The calculated total weighted contamination rate was 15.25% ± 0.018 (95% confidence interval [Cl]: 11.74% - 18.75%). The contamination rate after only using HLD was 16.14% ± 0.019 (95% Cl: 12.43% - 19.85%) and after using either dHLD or EtO the contamination rate decreased to 9.20% ± 0.025 (95% Cl: 4.30% - 14.10%). Studies conducted following an outbreak (n=4) showed a 5.72% ± 0.034 (95% Cl: 0.00% - 12.43%) contamination rate, and non-outbreak-initiated studies (n=11) revealed a contamination rate of 21.50% ± 0.031 (95% Cl: 15.35% - 27.64%). Interpretation This is the first meta-analysis to estimate the contamination rate of patient-ready duodenoscopes used for ERCP. Based on the available literature, our analysis demonstrates that there is a 15.25% contamination rate of reprocessed patient-ready duodenoscopes. Additionally, the analysis indicates that dHLD and EtO reprocessing methods are superior to single HLD but still not efficient in regards to cleaning the duodenoscopes properly. Furthermore, studies conducted following an outbreak did not entail a higher contamination rate compared to non-outbreak-initiated studies. Funding The authors received no financial support for the research, authorship, and/or publication of this article.

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Collective bacterial disinfection by opto-chemical treatment on mature biofilm in clinical endoscope

Tran

Park

Khan

et al. 2022

Journal of Photochemistry and Photobiology B: Biology

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Recent Actions by the US Food and Drug Administration

Cited by 5 publications

References 0 publications

A guide on transnasal endoscopy: setting up a pediatric unsedated endoscopy program

A guide on transnasal endoscopy: setting up a pediatric unsedated endoscopy program

Rate and impact of duodenoscope contamination: A systematic review and meta-analysis

Collective bacterial disinfection by opto-chemical treatment on mature biofilm in clinical endoscope

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