美国、欧盟与我国医疗器械不良事件监测体系比较研究

医疗器械不良事件监测是医疗器械安全监管的重要组成部分,也是确保医疗器械安全的重要手段。各国医疗器械不良事件监测体系均不相同,就美国、欧盟与我国的医疗器械不良事件的报告来源、报告时间、 不良事件数据库以及不良事件的反馈及控制等方面进行梳理和比较,探索我国医疗器械不良事件监测体系的改进策略,包括信息系统、上报机构、召回监管等。     

构建我国医疗器械安全警戒系统的探讨

引入医疗器械警戒系统的概念．建立我国医疗器械警戒制度是当前加强医疗器械监管的一项紧迫的工作。我国的制度建设应定位于国际接轨高度，尽可能直接采用国际市场中成熟的经验。根据国内的具体情况，讨论了不良事件的报告范围和各责任主体的关系．强调了这一制度的核心应围绕如何发现不良事件，将不良事件纳入属地化监管的体系并与现有其他法规的挂钩，在建立医疗器械不良事件报告制度的同时，应充分重视不良事件的处理。对植入器械的追踪在我国应尽快推广条形码技术。     

论医疗器械不良事件报告与医院医学伦理的关系

论证医疗器械不良事件报告是医院医学伦理的有机组成部分。从医疗器械不良事件报告和医院医学伦理二者在医院的共存、精神内涵、目的和具体实施比较分析,应从思想理念上把加强医疗器械不良事件报告与＂以患者为中心＂医学伦理学理念有效地结合起来,把高尚的医德医风与良好的医疗器械管理有机而高效地结合起来,才能更好地实现医院发展与医疗事业的进步。     

中国医疗不良事件报告与质量改进的分析研究

文章分析了来自国家卫生健康委员会医政医管局收集的82万例不良事件报告中最常见的三项错误，该三项错误占82万例不良事件的53％；还介绍了抽样医院主动报告的五类不良事件，以及国家药品不良事件反应网络监测中心的药品与器械不良事件报告。介绍了北京中卫云医疗数据分析与应用研究院100万例误诊报告的简要内容，简要列举了6个典型误诊病例。介绍了中国政府主要的质量政策以及通过医院评审工作落实政策，改善医院管理的做法，引用《柳叶刀》杂志对中国医疗状况的评价，说明质量政策与医院评审对提升医疗服务安全质量是有效的。同时指出要警惕新发疾病，减少误诊，关注新技术、新材料、新药品应用时可能出现新的不安全事件，以实现高质量发展的目标。     

医疗不良事件报告系统的设计与应用

目的设计科学合理的医疗不良事件报告系统,建立全面的、统一的医疗不良事件标准分类系统和患者安全术语,使不良事件上报管理更加标准化和科学化。方法通过借鉴国内外医疗不良事件报告系统的先进经验,本系统对医疗不良事件从类型、原因、对患者的影响、事后处理、原因分析等项目均设置了大量统一、规范的预设项,报告输入时采用选择题式和简单的描述性语言即可完成不良事件的上报。结论应用医疗不良事件报告系统后,不仅简化了医务人员工作量,提高了不良事件上报率,而且便于管理者对不良事件进行不同角度和纬度的统计分析,采取改进措施,避免类似事件的再次发生。     

医疗设备检测管理系统关键技术研究

为适应全国医疗器械检验机构日渐复杂的工作流程,为使医疗器械检验工作更加科学化、规范化,同时做到可查、可追,我们设计了此软件。目前,在国家食品药品监督管理局沈阳医疗器械质量监督检验中心实施执行此软件,它改变了检验工作档案记录没有数字化图像的历史,对于现场检验,避免漏检、错检起到了决定性的改变,实现了实时资料审查,及时修正错误。     

新型冠状病毒肺炎疫情下医疗器械不良事件的监测

目的:分析评价新型冠状病毒肺炎(COVID-19)疫情期间医疗器械的不良事件,提高医护人员对医疗器械不良事件的识别能力,确保疫情下医疗器械安全使用。方法:收集医院参与抗击疫情期间相关医疗器械使用情况资料,综合分析医疗器械使用中的不良事件。结果:医疗器械不良事件主要发生在中老年患者诊治中,Ⅲ类医疗器械不良事件构成比为62.07%,监护仪的不良事件占Ⅲ类医疗器械的41.37%。结论:加强老年患者使用医疗器械和疫情期间抢救器械的安全性监测至关重要。     

我国医疗安全不良事件报告系统现状分析与对策探讨

医疗不良事件报告是提高医疗质量的重要措施.指出我国医疗不良事件报告系统分为强制报告系统、自愿报告系统、内部报告系统等.从宏观和微观两方面分析了报告系统存在的问题.指出：应科学界定医疗不良事件,应提高系统上报安全性和保密性,应科学改进上报系统,应建立和完善报告激励机制,应实现信息共享,应落实人员培训等.     

对比ADR监测分析《医疗器械不良事件监测和再评价管理办法（试行）》的实施障碍

本文阐述药品与医疗器械的相关性和相似性,详细介绍我国药品不良反应监测的发展情况和成功做法,重点分析《医疗器械不良事件监测和再评价管理办法（试行）》宏观上的实施障碍及细节方面的影响因素,并提出相关改善建议,以期完善《医疗器械不良事件监测和再评价管理办法（试行）》的实施环节,确保其实施效果。     

Facilities strive to comply with new Act. The long-term effects of the Safe Medical Devices Act are still unknown

Unlike previous medical device laws, the Safe Medical Devices Act of 1990 (SMDA), which became effective November 28, 1991 applies to "device-user facilities" such as hospitals and long-term care facilities. Final regulations are scheduled for release later this spring. The SMDA's primary goals are to: Ensure all devices currently in or entering the marketplace are safe and effective Enable the U.S. Food and Drug Administration (FDA) to learn quickly about serious problems with medical devices Remove defective devices (old and new) from the market To achieve these goals, Congress has given the FDA new review and enforcement powers, including the authority to impose fines on those in violation of the law. Incidents in which a medical device caused or contributed to the death, serious illness, or serious injury of a patient are referred to as medical device-reportable (MDR) events. A user must report MDR deaths to the FDA and to the manufacturer (if known). Serious illnesses and serious injuries caused by or attributed to the use of a device must be reported to the device manufacturer or, if the manufacturer is unknown, to the FDA. Facilities must report MDR events to the FDA semiannually and maintain incident files for two years after reporting the MDR event. The FDA may assess civil penalties against parties that do not comply with the SMDA's reporting provisions. Healthcare facilities must develop and implement employee training and education programs to help physicians, nurses, and other allied health employees identify and report MDR events.     

'Global trigger tool' shows that adverse events in hospitals may be ten times greater than previously measured

Identification and measurement of adverse medical events is central to patient safety, forming a foundation for accountability, prioritizing problems to work on, generating ideas for safer care, and testing which interventions work. We compared three methods to detect adverse events in hospitalized patients, using the same patient sample set from three leading hospitals. We found that the adverse event detection methods commonly used to track patient safety in the United States today-voluntary reporting and the Agency for Healthcare Research and Quality's Patient Safety Indicators-fared very poorly compared to other methods and missed 90 percent of the adverse events. The Institute for Healthcare Improvement's Global Trigger Tool found at least ten times more confirmed, serious events than these other methods. Overall, adverse events occurred in one-third of hospital admissions. Reliance on voluntary reporting and the Patient Safety Indicators could produce misleading conclusions about the current safety of care in the US health care system and misdirect efforts to improve patient safety.     

不良事件报告系统医务人员使用影响因素分析

目的了解本院医务人员主动使用不良事件报告系统的现状,为完善不良事件报告系统提供依据。方法采用自行设计的问卷,对本院747名医务人员进行无记名调查。结果医务人员对主动上报不良事件和对不良事件报告系统的使用均不够满意;64.41%的人员认为本院不良事件上报率<50%;不愿意上报不良事件中19.93%的因为工作繁忙,65.30%的担心处罚或责备。仅19.74%的人员登陆过不良事件上报系统;39.49%的人员认为系统应改为匿名上报;42.56%的人员认为系统操作繁琐。结论医务人员工作繁忙和担心处罚或责备,是影响不良事件上报率的主要因素;加大宣传培训和改进不良事件上报系统,是提高不良事件上报系统使用率的关键因素。     

我国医疗不良事件报告系统研究与应用现状述评

医疗不良事件报告是防范医疗不良事件重复发生、提高医疗质量的一个重要措施.从我国医疗不良事件报告系统的政策和制度入手,对我国现有医疗不良事件报告系统进行概述和分析,总结其特点与缺陷,并对完善我国医疗不良事件报告系统提出了展望.     

太仓市医疗安全不良事件报告障碍影响因素分析

目的 分析影响医护人员报告医疗安全不良事件的障碍因素,为改进医疗安全不良事件报告系统提供参考.方法 于2019年9月11—12日,向江苏省太仓市123名医护人员发放电子调查问卷,调查问卷分为四个部分,分别为一般性资料、医疗安全不良事件上报情况、遇到医疗安全不良事件后的行动以及影响医疗安全不良事件上报的因素.使用主成分因...     

我国医疗器械GMP实施的法律思考

我国拟于明年1月起实施《医疗器械生产质量管理规范》,这是有监管法规以来医疗器械监管法律体系的明显进步,将对医疗器械行业产生巨大影响。文章从我国医疗器械GMP实施的法律定性、法律依据、法律意义等方面,对医疗器械GMP实施从法律的角度进行了全景思考。     

完善我国医疗器械不良事件监测工作机制的思考

医疗器械不良事件监测是保障群众用械安全的重要举措,作者结合工作实践,指出宣传培训、健全机构、创新机制、修订法规是加强医疗器械不良事件监测工作的努力方向.     

Data sources: use in the epidemiologic study of medical devices

Medical device epidemiology is the study of the prevalence and incidence of use, effectiveness, and adverse events associated with medical devices in a population. The identification of large data sources with medical device data provides a large population for epidemiologic studies. Two challenges in medical device epidemiology are the ability to find data on the specific device and the exposure of a patient to that device. This paper identifies data sources both from the govenment and from the private sector that can be used for epidemiologic studies of medical devices and, to a limited degree, studies of medical devices in women. Each source provides data for different types of devices and in differing specificity. The paper also discusses briefly the strengths and weaknesses of each data source. More data sources are needed to enhance the study of medical device epidemiology. Additional efforts and focus are needed to enhance the ability to study medical devices in women.     

医疗不良事件报告体系研究

医疗不良事件是指因诊疗活动而非疾病本身造成的损害。建立医疗不良事件报告制度是医院医疗安全体系建设的重要措施之一。医疗不良事件报告应实行非惩罚性报告和奖励措施,要做到“早发现、早报告、早处置、早控制”,目的是及时发现医院安全系统存在的不足,分析整个医疗服务系统中存在的不安全因素,防范医疗事故,保护患者利益。     

Improving global monitoring of vaccine safety: a quantitative analysis of adverse event reports in the WHO Adverse Reactions Database

The World Health Organization (WHO) Programme for International Drug Monitoring (PIDM) was initially developed for chemical rather than biological products. The PIDM made considerable achievements in analysing drug-related adverse event reports, progress was more limited for vaccine-related reports. In 2005, the Global Advisory Committee on Vaccine Safety, called for a global consultation to address the need for improved monitoring and analysis of vaccine-related adverse event reports on an international level. In preparation for this consultation, the WHO Adverse Reactions Database was quantitatively assessed and results of this analysis are presented in this paper. Three countries contributed 82% of vaccine-related reports in the database. The mean difference between onset date and report date was 2.4 years. Several issues of concern were identified, such as the fact that many member countries do not forward any or all reports of adverse events following immunization to the PIDM, and the poor timeliness and regularity of reporting, which could prevent timely generation of safety signals.     

医疗器械检测机构测量设备管理的几点思考

医疗器械检测机构测量设备存在着专业性强、种类繁多的特点,其管理存在着特殊性,并且许多设备目前无国家计量检定规程或校准规范。本文针对医疗器械检测机构测量设备的特点,提出了设备管理的几点新思路。