开展医疗器械不良事件监测和报告工作是十分重要的。
It is important to carry out the work of monitoring and reporting the adverse events of medical instruments.
目的：初步探讨医疗器械不良事件监测和风险管理的概念和方法。
OBJECTIVE: To discuss the concepts and methods of medical device adverse event monitoring and risk man-agernent .
医疗器械不良事件监测是确保上市医疗器械安全有效的重要手段之一。
Medical device adverse event monitoring is one of the most important methods to guarantee the safety of post-marketing products.
结果医疗器械不良事件监测工作为安全有效使用医疗器械起到了预警作用。
Results The adverse medical device event monitoring work offered an early warning function on how to use medical device safely and effectively.
结论加强医疗器械不良事件监测工作是确保安全使用医疗器械的有力手段。
Conclusion Strengthening the adverse medical device event monitoring work is a powerful instrument to insure public can use medical device safely.
目的结合安徽省医疗器械不良事件监测工作，为开展医疗器械不良事件监测提供技术参考。
Objective Based on adverse events monitoring situation of medical devices in Anhui province, to provide the technique supports to develop adverse events monitoring of medical treatment.
通过对辖区内医疗机构使用植入医疗器械情况的调研统计，了解目前医疗器械不良事件监测工作的现状。
The investigation and calculation method on the use of embeded medical device in medical institution in the area shows the actual status of the monitoring work on the adverse event of medical device.
本文综述了加拿大医疗器械不良事件监测系统，旨在为我国医疗器械不良事件监测和再评价体系的建设提供参考。
Medical device adverse event monitoring system in Canada were reviewed in this article, aim to provide some reference to China's system construction.
目的通过对收集到的医疗器械不良事件信息的汇总分析，发挥医疗器械不良事件监测工作的指导作用，以保障公众用械安全。
Aim By analyzing adverse medical device event reports received in Anhui province, to promote instructional function of adverse medical device event monitoring to ensure safe use of medicine in public.
这又怎样来监测不良事件呢？
目前建议采用的二线治疗方案程序复杂、疗程过长，并需要密切监测不良事件和治疗结果。
The current recommended second-line treatment regimens are complex, of long duration, and require intensive monitoring of adverse events and treatment outcomes.
虽然早期结果令人鼓舞，但应继续监测不良事件。
Although early results are reassuring, monitoring for adverse events should continue.
还有一批合作伙伴将开展监测以发现不良事件。
And yet another group of partners will monitor for adverse events.
委员会进一步指出，如果疫苗用于群体免疫，特别重要的是要有不良反应事件监测系统来支持天花免疫规划。
The Committee further noted that if the vaccine is being used in mass campaigns, it would be especially important for smallpox immunization programmes to be supported by adverse event monitoring.
例如，所有国家应当建立国家和区域监测系统以便发现儿童中的严重药物不良反应事件和医疗错误。
For instance, all countries should establish national and regional monitoring systems for the detection of serious adverse medicine reactions and medical errors in children.
监测和管理免疫接种后不良事件是保持公众对免疫规划信任的基本内容。
The monitoring and management of AEFIs are essential elements in maintaining public confidence in immunization programmes.
2004年，有68%的国家报告存在监测免疫接种后不良事件的国家系统，而2001年为53%。
In 2004, 68% of countries reported the existence of a national system for the surveillance of AEFI, compared with 53% in 2001.
研究人员有责任向委员会提供监测资讯，特别是任何严重不良事件。
The researcher must provide monitoring information to the committee, especially information about any serious adverse events.
CDC的疫苗不良反应事件监测中心(VAERS)没有发现加德西与医生和疫苗接种者报告的不良反应事件之间存在联系。
The CDC's vaccine adverse event Reporting System (VAERS) finds no link between Gardasil and adverse events reported by doctors and vaccine recipients.
针对辖区内医疗器械不良事件报告率低的现象，结合现行的监测管理模式，查找并分析原因。
Focusing on the phenomena that the reported adverse event of medical device is quite low, we use the method to analyze the cause on the base of actual monitoring management.
目的通过对广东省2007年接收的可疑医疗器械不良事件报告表进行统计分析，为进一步开展监测工作提供参考。
Objective By analyzing the Medical Device Administration Events (MDAE) reports of Guangdong Province in 2007, to provide references for monitoring work.
本文介绍了医疗器械不良事件产生的原因、监测的意义，并对我院在该领域开展的相关工作具体方法措施等进行了探讨。
This article explains the reasons that medical adverse events occurred and the meaning of monitoring, and explores the concrete measures of the related field in author's hospital.
结果处方事件监测是发现不良反应的主要方法，是自发报告的重要补充。
Results and Conclusion Prescription- event monitoring is one of the most important methods of post-marketing drug surveillance and vital resource for providing ADR information.
处方事件监测用非干预性、观察性药品不良反应监测方法，1981年在英国最早开展。
Prescription Event monitoring (PEM) is a non-interventional observational method of adverse drug reaction monitoring, which was established first in England in 1981.
一旦试验启动，保证按试验目的准确招募研究中心及患者、监测数据质量、记录治疗过程中的突发不良事件，是非常重要的。
Once the trial has begun it is important to keep patient recruitment on target, monitor of the data quality, and document treatment emergent adverse events.
一旦试验启动，保证按试验目的准确招募研究中心及患者、监测数据质量、记录治疗过程中的突发不良事件，是非常重要的。
Once the trial has begun it is important to keep patient recruitment on target, monitor of the data quality, and document treatment emergent adverse events.
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