The following is a summary of anFDA安全通信。要查看原始帖子，请单击here。
Given the cleaning concerns and contamination data with fixed endcap duodenoscopes and the increasing availability of duodenoscope models that facilitate or eliminate the need for reprocessing, the FDA states hospitals and endoscopy facilities should complete transition to innovative duodenoscope designs that include disposable components, such as disposable endcaps, or fully disposable duodenoscopes.
The use of a removable component to facilitate cleaning leads to significantly less contamination; interim results from one duodenoscope model with a removable component show a contamination rate of just 0.5%, as compared to older duodenoscope models, which had contamination rates as high as 6%. Duodenoscope manufacturers no longer market fixed endcap duodenoscopes in the U.S., and fixed endcap duodenoscopes still in use at healthcare facilities should be replaced with newer duodenoscope models.
Emerging data suggests the best solution to reducing the risk of disease transmission by duodenoscopes is through innovative device designs that make reprocessing easier, more effective, or unnecessary. Duodenoscopes that incorporate disposable components can facilitate cleaning, reduce contamination, and reduce disease transmission following reprocessing. Disposable designs may reduce between-patient duodenoscope contamination by half or more as compared to reusable or fixed endcaps.
To date, the FDA has cleared seven duodenoscopes with disposable components that facilitate reprocessing or are fully disposable:
完全一次性：
- AMBU创新GmbH，十二指肠镜模型Ascope Duodeno（完全一次性的十二指肠镜清除了Underk201098）
- Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope (fully disposable duodenoscope cleared under K193202)
一次性组件：
- Fujifilm Corporation, Duodenoscope model ED-580XT (disposable endcap duodenoscope cleared under K181745)
- Olympus医疗系统，Evis Exera III DuodeNovidesoscope Olympus tjf-Q190V（可端端端Duodododenoscope清除了Inderk193182）
- Pentax Medical, Duodenoscope model ED34-i10T2 (disposable elevator duodenoscope cleared under K192245 and K210710)
- Pentax Medical, Duodenoscope model ED32-i10 (disposable elevator duodenoscope cleared under K202365)
Studies are in progress for duodenoscopes with removable components. As of August 12, 2021, the Fujifilm ED-580XT duodenoscope with a removable cap has collected 57% of the required number of samples. Interim results for this newer model of duodenoscope indicate that 0% of samples tested positive for enough low-concern organisms to indicate a reprocessing failure and only 0.5% tested positive with high-concern organisms.
如果您认为设备有问题，FDA会鼓励您通过MedWatch自愿报告表报告问题。
受FDA用户设施报告要求的设施雇用的医疗保健人员应遵循其设施确定的报告程序。
