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首页> 外文期刊>Revista Brasileira de Hematologia e Hemoterapia >Adverse events and technical complaints related to central venous catheters marketed in Brazil
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Adverse events and technical complaints related to central venous catheters marketed in Brazil

机译:在巴西销售的与中央静脉导管有关的不良事件和技术投诉

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Aim: The objective of this study was to critically analyze data of the National Notification System for Adverse Events and Technical Complaints (Notivisa) related to central venous catheters, through an evaluation of the description of notifications recorded between 2006 and 2009. Methods: Notifications were categorized and evaluated to: (i) determine the number of adverse events and technical complaints, (ii) verify compliance with the classification criteria defined by the legislation, (iii) reclassify notifications, when necessary, in order for them to fit in with the legal definitions, (iv) verify registered companies in Brazil, (v) quantify the notifications according to the registered company and product lot, and (vi) identify the country of original of the notified product. Microsoft Excel® 2010 was used to categorize and systematize the data. Results: Some conceptual errors and incomplete records were found. Altogether, 228 notifications of technical complaints and 119 of adverse events were identified. Some notifications on guidewires and broken catheters were reported which led to the necessity of duplicating some medical procedures and to the occurrence of lesions/lacerations of vessels and tissue injury. Forty-seven percent of companies presented at least one notification in Notivisa and in all, 38 product lots had more than one notification. Conclusion: These data support a necessity for cooperation between all entities of the National Health Surveillance System to check compliance of this type of product and to properly report adverse events and technical complaints. It is also important to incorporate minimum standards for the management of technologies in health services, including in the acquisition of products and training of staff.
机译:目的:本研究的目的是通过对2006年至2009年间记录的通知的描述进行评估,以批判性地分析与中央静脉导管有关的国家不良事件和技术投诉通知系统(Notivisa)的数据。进行分类和评估,以:(i)确定不良事件和技术投诉的数量,(ii)验证是否符合法律定义的分类标准,(iii)必要时对通知进行重新分类,以使其符合法规要求。法律定义,(iv)验证在巴西的注册公司,(v)根据注册公司和产品批次对通知进行量化,以及(vi)标识所通知产品的原产国。使用MicrosoftExcel®2010对数据进行分类和系统化。结果:发现了一些概念上的错误和不完整的记录。总共确定了228项技术投诉通知和119项不良事件通知。据报导丝和导管破裂的一些通知导致重复某些医疗程序的必要性,并导致血管病变/裂伤和组织损伤的发生。 47%的公司在Notivisa中至少发出了一个通知,总共38个产品批次中有一个以上的通知。结论:这些数据支持国家健康监测系统所有实体之间进行合作的必要性,以检查此类产品的合规性并正确报告不良事件和技术投诉。同样重要的是,将卫生服务技术管理的最低标准纳入进来,包括在产品采购和员工培训中。

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