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.     

1028fly医疗器械不良事件报告的回顾性分析

目的对1028例医疗器械不良事件发生的特点及规律进行统计分析．为医疗器械不良事件监测工作提供建议。方法采用回顾性分析方法．对贵阳市2012年收集的1028例医疗器械不良事件报告进行综合分析。结果宫内节育器引起的严重不良事件所占比例较高。基层用户上报意识有待提高。医疗器械不良事件报告质量有待提高。结论加强宫内节育器的监测。从开展有针对性的宣传培训、建立健全医疗器械不良事件监测网络两方面提高不良事件监测工作水平。     

1900例可疑医疗器械不良事件报告分析

目的对1900例医疗器械不良事件报告进行分析,为加强医疗器械不良事件监测工作提供建议。方法采用回顾性分析方法．对河南省2008年收集的医疗器械不良事件报告及其质量进行综合分析。结果宫内节育器和骨科植入物引起的不良事件所占比例较高。医疗器械不良事件报告质量有待提高。结论应进一步加强宫内节育器和骨科植入器械的重点监测。建议开展宣传培训．进一步推动医疗器械不良事件监测工作．维护公众用械安全。     

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。     

做好医疗器械不良事件监测及监测制度的建立

本文通过正确认识和理解对医疗器械不良事件监测工作的重要意义,分析和评价了我国医疗器械不良事件监测工作的现状和不足,从加强法规体系、构建技术规范及完善监测网络等环节,对建立我国医疗器械不良事件监测制度进行探索和研讨,并对实践经验展开交流。     

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。     

基于麦肯锡7S管理模型的医疗器械不良事件监测管理的研究

目的:力求更好地开展公立医院医疗器械不良事件监测工作,提高患者就医安全。方法:运用麦肯锡7S管理模型相关理论,围绕构建以患者安全为中心的医疗器械不良事件监测管理体系进行探讨研究。结果:切实加强医疗器械不良事件监测工作,促进医疗器械不良事件报告数量和质量的提高,最大限度地控制医疗器械潜在风险,保证医疗器械安全有效地使用,使患者得到安全、有效的治疗。结论:创新地借鉴麦肯锡7S管理理论,结合三级甲等医院创建工作,研究医疗器械不良事件监测与管理工作的硬框架和软环境,可有效进行医疗器械不良事件的监测。     

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。     

接骨板医疗器械不良事件的回顾性分析与探讨

目的：对接骨板医疗器械不良事件报告的特点及规律进行统计分析,探索有利于预防接骨板医疗器械不良事件发生的方法。方法：采用回顾性分析方法,对贵阳市2019年～2020年收集的17例接骨板医疗器械不良事件报告进行综合分析。结果：医疗机构监测意识有待提高。患者术后非合理活动是接骨板类医疗器械不良事件主要原因。结论：对医疗机构开展有针对性的培训。患者术后科学运动有利于预防接骨板医疗器械不良事件发生。     

对医疗器械不良事件监测工作的探讨

本文首先阐明了何谓医疗器械不良事件，并简单介绍了我国开展医疗器械不良事件监测工作的情况，最后对如何正确认识医疗器械不良事件以及如何有效地做好医疗器械不良事件的监测工作，提出了本人的观点。     

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.     

Participant centred safety surveillance of health care workers receiving influenza vaccination

Following the introduction of mandatory influenza vaccination for staff working in high risk clinical areas in 2018, we conducted active surveillance for adverse events following immunisation utilising an automated online survey to vaccine recipients at three and 42?days post immunisation. Most participants 2285 (92%) agreed to participate; 515 (32%) staff reported any symptom and eight (1.6%) sought medical attention. The odds of having a reaction decreased with age by approximately 2% per year. The system was acceptable to staff, and the data demonstrated rates of reported symptoms within expected rates for influenza vaccines from clinical trials. Rates of medical attendance were similar to previous surveillance. Participant centred real-time safety surveillance proved useful in this staff influenza vaccination context, providing reassurance with expected rates and profile of common adverse events following staff influenza vaccination.     

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...     

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...     

国外医疗不良事件报告系统研究概述及启示

基于3篇国外有关医疗不良事件报告系统的文献研究成果,介绍了不良事件报告制度在提高安全性方面的有效性,影响不良事件报告频率的组织因素以及安全网络建设在提高不良事件报告准确性方面的应用情况。探讨了对于我国的启示:关注影响不良事件报告的主要因素,了解临床工作人员与管理人员看法的差异,推行在线事故报告系统,采取多级战略等。     

临床实习阶段负性事件对医学生职业意向的影响

目的:基于CMSS2019数据,探究临床实习阶段负性事件生对医学生从医意向的影响.方法:采用描述统计分析各类负性事件的发生范围和频率;使用logistic回归分析各类负性事件对不同医学生群体从医意向的影响.结果:87.3％的医学生表示临床实习期间经历过负性事件,各类负性事件的发生范围以及对不同医学生群体从医意向的影响不...     

Estimates of medical device--associated adverse events from emergency departments

BACKGROUND: The true public health burden of adverse events associated with medical devices is unknown. The purpose of this study, therefore, was to produce the first-ever national estimates of medical device-associated adverse events resulting in emergency department (ED) visits. METHODS: From July 1999 through June 2000, reports of 10,395 medical device-associated adverse events were accumulated using the National Electronic Injury Surveillance System (NEISS), which collects information on product-related injuries from the ED records of a national stratified probability sample of hospitals. The reports were used to estimate annual total number of medical device-associated adverse events as well as number of adverse events associated with specific devices, injury diagnoses, demographic characteristics, and patient disposition status. RESULTS: The total estimated number of adverse events was 454,383 (95% confidence interval [CI]=371,156-537,610), involving a broad range of devices from 15 medical specialty groups. Unintentional traumatic events associated with a particular device appeared to be the most common mechanism of injury. The most prevalent types of injuries included contusions/abrasions, punctures, and lacerations; 13% of total estimated cases resulted in patient hospitalization. Adverse events occurred within healthcare facilities, and some were occupationally related, although they occurred at home more frequently than any other location (about 42%). CONCLUSIONS: The magnitude of the total estimate, which is over four times greater than the annual number of adverse event reports received by medical device-regulating surveillance systems, emphasizes medical device-associated adverse events as an under-recognized public health problem. Planned collection of more detailed NEISS data will allow for appropriate public health interventions.     

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。     

Medizinprodukte und Patientensicherheit aus der Perspektive des Klinikers

In daily routine, clinically orientated physicians are confronted with various, often highly sophisticated medical devices. To ensure safe handling and usage, licensees and operators of those devices have to follow regulations and laws given by the German medical device legislation. For the clinician as an active user of the technology, basic knowledge of these regulations is essential. Quality-based health care focuses on the important issue of patient safety. Medical devices have made their way into virtually every sector of patient care. However, despite usage of these devices bearing substantial risk of adverse events, the problem of safe handling of sophisticated technology plays only a minor part in medical academic studies, medical specialist training, and manda¬tory continuing education of physicians. The option of further education is needed to ensure patient safety and protect operators of medical devices.