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Outbreak column 19: needleless connectors (NCs) tales from nine outbreaks

机译:爆发专栏19:九次爆发的无针连接器(NC)故事

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摘要

A critical review of historical outbreak reports that are still influencing practice today is presented.  These outbreak reports were used as evidence in support of guideline recommendations and of the US Food and Drug Administration’s (FDA) advisory notice requiring post-product surveillance for needleless connectors (NC) which have a positive displacement. Guideline recommendations were subsequently changed but not before other authorities had issued recommendations based on the original.  All the above led some purchasers to look for different NC designs.  The conclusions are that the evidence, as reported, does not support there being an increased risk from positive displacement NCs. Identified in this review were unsubstantiated claims, incompleteness in reporting of specifics, opinions considered as evidence and unexplored outbreak-provoking explanations.
机译:本文对目前仍在影响实践的历史性爆发报告进行了严格审查。这些爆发报告被用作支持指南建议和美国食品和药物管理局(FDA)咨询通知的证据,该通知要求对正位移的无针连接器(NC)进行产品后监视。指南的建议随后进行了更改,但在其他机构根据原始建议发布之前未作更改。以上所有这些导致一些购买者寻找不同的NC设计。结论是,如所报道的证据不支持正位移NCs的风险增加。这次审查中确定的是没有根据的主张,不完整的报告细节,被视为证据的观点以及未经探究的爆发原因的解释。

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