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Learning from incidents in medically assisted reproduction: the Notify Library as a learning tool
Reproductive BioMedicine Online ( IF 4 ) Pub Date : 2021-07-28 , DOI: 10.1016/j.rbmo.2021.07.015
Alessandra Alteri 1 , Evangelia Petrisli 2 , Paula Nolan 3 , Valerio Pisaturo 4 , Deirdre Fehily 5 , Aurora Navarro 6 , D Michael Strong 7 , Massimo Cardillo 8 , Mauro Costa 9
Affiliation  

Biovigilance is the systematic monitoring of serious adverse reactions and events (SARE) that ensures the quality and safety of tissues and cells for human application in medically assisted reproduction (MAR). The Notify Library is an open access database launched by the World Health Organization and supported by the Italian National Transplant Centre (CNT) that has collected information on documented adverse occurrences in transplantation, transfusion and MAR. It is not a SARE register, but rather a collection of SARE types identified primarily by review of published articles and case reports from national or regional vigilance programmes. The Notify Library includes many well-documented records of adverse occurrences in MAR treatment, representing a useful tool for MAR operators in the evaluation of the risks associated with the clinical application of reproductive tissues and cells. It is updated with new records when a new type of incident is reported for the first time. All incident types described might have teaching value during the risk management carried out by a MAR centre. Sharing lessons learned from these incidents represents an important didactic opportunity that can help MAR centres to improve their processes and to achieve higher standards of quality and safety.



中文翻译:

从医学辅助生殖事件中学习:通知库作为学习工具

生物警戒是对严重不良反应和事件 (SARE) 的系统监测,以确保用于人类医学辅助生殖 (MAR) 的组织和细胞的质量和安全。Notify Library 是一个由世界卫生组织发起并得到意大利国家移植中心 (CNT) 支持的开放访问数据库,该数据库收集了有关移植、输血和 MAR 中记录的不良事件的信息。它不是 SARE 登记册,而是主要通过审查国家或地区警戒计划的已发表文章和病例报告确定的 SARE 类型的集合。Notify Library 包括许多有据可查的 MAR 治疗中不良事件的记录,代表 MAR 操作员评估与生殖组织和细胞临床应用相关的风险的有用工具。当第一次报告新类型的事件时,它会使用新记录进行更新。在 MAR 中心进行风险管理期间,所有描述的事件类型都可能具有教学价值。分享从这些事件中吸取的经验教训是一个重要的教学机会,可以帮助 MAR 中心改进其流程并实现更高的质量和安全标准。

更新日期:2021-07-28
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