江苏省开展医疗器械不良事件监测工作的设想

医疗器械不良事件监测是发现医疗器械安全性隐患和采取风险管理措施的重要前提。江苏省开展医疗器械不良事件监测工作刚处于起步阶段,从分析江苏省开展医疗器械不良事件监测工作的重要性与必要性入手,提出了江苏省开展医疗器械不良事件监测工作的主要目标和相应的政策措施,旨在推进江苏省医疗器械不良事件监测工作的发展。     

浅谈医疗卫生机构医疗器械不良事件监测与管理

本文对医疗器械不良事件涵义、医疗器械不良事件监测的意义,及医疗器械不良事件监测工作中的问题进行了分析。对医疗卫生机构加强医疗器械不良事件监测与管理提出了建议。     

国家食品药品监督管理总局发布2013年医疗器械不良事件监测年度报告

近日,国家食品药品监管总局发布了2013年医疗器械不良事件监测年度报告,报告内容包括医疗器械不良事件报告概况、医疗器械不良事件报告统计分析、对部分医疗器械安全性问题采取的措施、医疗器械不良事件监测大事记等几部分内容。比较全面的反映了2013年我国医疗器械不良事件监测工作情况。     

地市级监测机构医疗器械不良事件风险管理工作实践与探索

通过梳理总结临沂市药物警戒中心开展医疗器械不良事件风险管理的工作措施,分析当前地市级医疗器械不良事件监测工作的形势要求,探索基于风险管理理念开展地市级医疗器械不良事件监测的方法路径,以期为地市级监测机构医疗器械不良事件监测工作深入发展提供经验参考。     

医疗器械不良事件监测网络建设初探

医疗器械不良事件监测工作包括对可疑不良事件的发现、报告、评价和控制的过程。如何建立合理的监测网络,搭建畅通的信息传递平台,充分发挥监测网络的功效,对医疗器械不良事件监测工作显得尤为重要。本文目的旨在实现医疗器械不良事件监测网络建设的远景目标,建立一个具备监测新问题、预测发展趋势、干预不良事件、评价干预措施和政策效果能力的医疗器械不良事件监测系统。     

医务工作者报告医疗器械不良事件的影响因素

目的了解不同医疗机构医务工作者对医疗器械不良事件及相关知识的认知程度,以及对医疗器械不良事件监测的评价,探讨影响报告医疗器械不良事件的因素及监管策略。方法采取分层整群随机抽样相结合的方法,对1897名医务工作者进行问卷调查。结果医务工作者对医疗器械不良事件及监测知识的了解程度较低,对医疗器械不良事件监测益处的评价持正向态度。报告医疗器械不良事件的意向较为强烈,但存在阻碍因素。结论应加强医务工作者的医疗器械不良事件培训,促使医疗机构建立和完善医疗器械不良事件监测体系,以增强医务工作者的认识,提高对不良事件的发现能力和报告能力。     

1572例医疗器械不良事件报告的分析与评价

目的完善医疗器械不良事件监测管理制度,提高医疗器械不良事件监测和管理水平。方法本研究采用回顾性分析法,对2014年1月至2019年3月医院上报的1572例医疗器械不良事件报表进行统计分析。结果通过对医疗器械不良事件的分析,从中发现存在对医疗器械不良事件发生的监督力度不够、管理体系中管理制度执行差、使用人员的重视程度不够等问题。结论本研究提出持续改进措施,以便引起医院对医疗器械不良事件监测工作的重视,并着力提高医疗器械不良事件监测水平,加强医疗器械管理制度建设,提高使用人员的业务素质,以发挥医疗器械效能,使其更好地服务于患者。     

浅议ADE报告的范围及豁免原则

近年来,医疗器械不良事件正在逐渐引起各国的关注,我国对此也给予很高的重视,相继颁布了《医疗器械监督管理条例》、《医疗器械不良事件监测和再评价管理办法（试行）》等规范性文件,医疗器械不良事件监测体系已初具雏形。由于相关工作还处于起步阶段,对医疗器械不良事件的认识尚不完善,因此,明确医疗器械不良事件报告的范围对我国医疗器械不良事件监测的发展有着及其重要的意义。本文试图通过对医疗器械不良事件的概念理解及对发达国家相关规定的比较分析,来阐述医疗器械不良事件的报告范围及豁免原则。     

桂林市启动医疗器械不良事件监测体系

日前，广西桂林市药监局启动桂林市医疗器械不良事件监测体系，全市56家医疗器械生产企业，116家医疗器械经营企业，以及全市33家二级以上医疗机构被纳入该监测体系。据介绍，医疗器械不良事件监测体系实行报告制度，桂林市所有纳入监测体系的单位一旦发现医疗器械可疑不良事件，要立即向市药监局相关主管部门报告，再由主管部门上报自治区一级不良事件监测机构。医疗器械不良事件是指获准上市的，     

浅谈医疗器械不良事件

本文剖析了医疗器械不良事件的定义及其产生原因,正视了我国医疗器械不良事件监测工作的现状及存在的问题,具体阐述了医疗机构如何处理医疗器械不良事件,提出医疗器械不良事件监测工作的意义和远景展望。     

建立检验检疫系统免疫接种副反应监测系统的探讨

[目的]保证免疫接种实施的安全性。提高接种质量,减少免疫接种副反应事件的发生。[方法]分析建立免疫接种副反应监测系统的重要意义,介绍国外的现状,提出建立检验检疫系统免疫接种副反应监测系统的模式。[结果]世界卫生组织已于1968年建立了免疫接种副反应监测项目,全球已有60多个国家参加了该项目。我国检验检疫机构所属的各国际旅行卫生保健中心,每年要承担大量的免疫接种工作,发生免疫接种副反应的概率较高,因而,亟需建立免疫接种副反应监测系统。该系统应包括：数据库的建立；信息的收集、整理、发布；建立专家咨询委员会；建立回诊制度；施种人员的专业培训等。[结论]疫苗的安全性问题和免疫接种副反应问题,越来越受到关注,因此,建立检验检疫系统免疫接种副反应监测系统势在必行。     

Field evaluation of vaccine safety

Surveillance of adverse events in the field represents an essential part of vaccination strategies. Safety studies conducted before vaccine licensure have often not enough power to detect rare or long-term adverse events. Furthermore, adverse events may be caused by incorrect procedures of storage or administration. Conducting surveillance of adverse events in the field is necessary for detecting unexpected increases in incidence of adverse events, for continuing education of health personnel involved in vaccine programs, for providing appropriate information to the public, and for supporting interventions to prevent further adverse events. Signals generated by surveillance systems may stimulate to conduct formal studies to assess causality.     

Surveillance of adverse effects following vaccination and safety of immunization programs

The aim of the review was to analyze conceptual and operational aspects of systems for surveillance of adverse events following immunization. Articles available in electronic format were included, published between 1985 and 2009, selected from the PubMed/Medline databases using the key words "adverse events following vaccine surveillance", "post-marketing surveillance", "safety vaccine" and "Phase IV clinical trials". Articles focusing on specific adverse events were excluded. The major aspects underlying the Public Health importance of adverse events following vaccination, the instruments aimed at ensuring vaccine safety, and the purpose, attributes, types, data interpretation issues, limitations, and further challenges in adverse events following immunization were describe, as well as strategies to improve sensitivity. The review was concluded by discussing the challenges to be faced in coming years with respect to ensuring the safety and reliability of vaccination programs.     

30 例T型含铜宫内节育器断裂不良事件报告分析

目的：了解T型含铜宫内节育器（IUD）断裂不良事件的情况。方法：收集国家人口计生委计划生育药具不良反应监测中心自2005年10月—2010年11月全国105个试点上报的T型含铜IUD（TCu380A/TCu220C）断裂不良事件报告共计30例,对事件进行因果关系分析和关联性评价,探索其相关影响因素,为其防治提供依据。结果：30例断裂事件中涉及TCu380A 4例,TCu220C 26例。其中28例断裂部位发生在横臂,2例发生在纵臂。B企业生产的TCu220C发生断裂事件的比例高于A企业（信息成分IC=0.40, 95%CI下限=0.02）。结论：建议加强对B企业的TCu220C上市后安全性监测。计划生育技术服务人员应重视IUD断裂事件,加强置器后随访服务,发现问题及时处理,并报告IUD严重伤害事件,减少其对育龄妇女健康的危害。     

Smallpox vaccine adverse events among civilians--United States,February 18-24, 2003

During the civilian smallpox vaccination program, CDC and state health departments are conducting surveillance for vaccine-associated adverse events. In the first stage of the program, active surveillance is being conducted for potentially life-threatening, moderate-to-severe, and other serious adverse events and for vaccinia transmission to contacts of vaccinees (Table). Nonserious events are reported through passive surveillance and are expected to be underreported. This report summarizes smallpox vaccine adverse events reported among civilians vaccinated as of February 21, 2003, and received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of February 24.     

Smallpox vaccine adverse events among civilians--United States,March 4-10, 2003

During the civilian smallpox vaccination program, CDC, the Food and Drug Administration, and state health departments are conducting surveillance for vaccine-associated adverse events. In the first stage of the program, active surveillance is being conducted for potentially life-threatening, moderate-to-severe, and other serious adverse events and for vaccinia transmission to contacts of vaccinees (Table). Nonserious events are reported through passive surveillance and are expected to be underreported. This report summarizes smallpox vaccine adverse events reported among civilians vaccinated as of March 7, 2003, and among contacts of vaccinees, received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of March 10.     

Smallpox vaccine adverse events among civilians--United States,February 25-March 3, 2003

During the civilian smallpox vaccination program, CDC, the Food and Drug Administration, and state health departments are conducting surveillance for vaccine-associated adverse events. In the first stage of the program, active surveillance is being conducted for potentially life-threatening, moderate-to-severe, and other serious adverse events and for vaccinia transmission to contacts of vaccinees (Table). Nonserious events are reported through passive surveillance and are expected to be underreported. This report summarizes smallpox vaccine adverse events reported among civilians vaccinated as of February 28, 2003, and among contacts of vaccinees, received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of March 3.     

The establishment of the Korean medical device safety information monitoring center: Reviewing ten years of experience

Medical devices may revolutionize healthcare delivery but can lead to serious adverse events for treated patients and users. While reporting of adverse events related to medical devices is an essential starting point for post-market surveillance, underreporting of medical device adverse events is a global problem. Korea introduced a voluntary medical device adverse event reporting system in 2010, called the Medical Device Safety Information Monitoring Center, which has led to an increase in adverse event reports. For 10 years, the Medical Device Safety Information Monitoring Center has analyzed medical device adverse events systematically and has provided active feedback to the manufacturers and education on safe use. Recently, the Medical Device Safety Information Monitoring Center contributed to harmonization of international medical device vigilance through the sharing of adverse events. This experience of Korea might contribute to improvements in medical device vigilance, which is a critical prerequisite for improving medical device policies and regulations.     

Smallpox vaccine adverse events among civilians--United States,January 24-February 18, 2003

During the civilian smallpox vaccination program, CDC and state health departments are conducting surveillance for vaccine-associated adverse events. In the first stage of the program, active surveillance is being conducted for potentially life-threatening, moderate-to-severe, and other serious adverse events and for vaccinia transmission to contacts of vaccinees (Table). Nonserious events are reported via passive surveillance and are expected to be underreported. This report summarizes smallpox vaccine adverse events reported among civilians vaccinated as of February 14, 2003, and received by CDC from the Vaccine Adverse Event Reporting System (VAERS) as of February 18.