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。     

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。     

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。     

我国医疗器械不良事件监测体系建设之德尔菲法

目的和方法：采用德尔菲法(DELPHI法),针对我国医疗器械不良事件监测体系建设中涉及的一些关键问题听取专家意见,在统计分析专家意见的基础上,为进一步完善我国医疗器械不良事件监测和管理体系提出建议。结果：DELPHI法共进行两轮,两轮的积极系数分别为87．5%和92．9%,专家配合程度高；权威程度均为0．78,权威程度较高。通过两轮调查,76．9%的专家认为在我国应收集造成死亡或者严重伤害的医疗器械不良事件；61．5%的专家认为应遵循报告单位-省级监测机构-国家级监测机构三级报告程序；53．8%的专家认为“对生产企业、经营企业和使用单位均应实行强制性报告”；当发生与医疗器械有关的死亡事件时,分别由46．2%的专家认为应该“立即报告”和“经初步分析后于72小时内报告”；69．2%的专家认为在我国应设计2张医疗器械不良事件报告表；78．6%的专家认为在我国医疗器械不良事件报告表的报送可采用邮寄、传真、网上报送等多种方式。结论：根据德尔菲法调查结果,有些与我国现行医疗器械不良事件监测体系建设的要求和正在制定中的《医疗器械不良事件和再评价管理办法》的规定一致,例如对生产企业、经营企业和使用单位均采用强制性报告；有些方面不尽相同,例如对死亡事件的报告时限,几乎所有的专家都选择了“立即报告”或者“经初步分析后填写报告表于72小时内报告”,短于10个工作日,提示考虑到死亡或者严重伤害事件可能造成的严重后果,应缩短现在规定的报告时限。有些调查内容是现行监测体系建设中未涉及到的,例如,虽然正在制定的《办法》当中,明确规定在我国实行医疗器械不良事件的逐级报告制度,但是在办法当中只规定了报告单位(生产企业、经营企业和使用单位)、省级医疗器械不良事件监测机构和国家级医疗器械不良事件监测机构的职责,未涉及到省级以下监测机构的设置问题,虽然本次调查专家基本认可报告单位-省级监测机构-国家级监测机构,但具体的工作当中,为了调动下一级部门的积极性,便于工作的开展,有的省份已经成立了地市级监测机构,提示从国家的角度可提供一种工作模式,各省可在不违反《办法》规定的前提下,制定具体的实施办法。另其他诸如信息的发布渠道以及引起死亡或者严重伤害的补偿问题,也需要在现有法规或者将来的实施规范当中加以体现,提示可作为监督管理部门的参考。     

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。     

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。     

医疗器械不良事件监测计算机辅助系统设计

目的：与省里乃至全国的医疗器械不良事件报告中心接轨，建立医疗器械不良事件监测预警查询计算机辅助系统．以便及时发现医疗器械不良事件的发生，促进医疗器械上市后的再评价制度的建立。方法：设计软件，建立数据库．与报告中心联网利用医院医疗器械不良事件监测计算机辅助系统，对医疗器械不良事件自发呈报、预警监测和报告．对其中的关键技术作详细分析。结果：通过计算机网络等现代化手段对医疗器械不良事件进行自发呈报、收集、整理和管理．能快速准确提供医疗器械不良事件的信息和咨询。结论：该辅助系统为有关管理部门提供医疗器械管理、生产、应用的现代化监管手段．为新医疗器械的研发和教学提供一定的理论依据。     

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...     

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。     

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。     

Calcium intake in the elderly: validation of a dietary questionnaire

Epidemiological studies of calcium and osteoporosis have been hampered by the lack of a suitable tool for assessing calcium intake. This report describes a new frequency and amount questionnaire for measuring present and past calcium intake in the elderly. The validity of the questionnaire was tested against two commonly used standards of dietary assessment, five-day duplicate diets and seven-day weighed dietary inventories. The resulting correlation coefficients were, respectively, r = 0.76 and r = 0.69, while that for repeatability was r = 0.84. Furthermore, the questionnaire categorized subjects into thirds of the distribution of intake with almost no gross misclassification. It is suggested that the present findings may be extended to the majority of normal, healthy elderly subjects, implying wide application for the questionnaire in the assessment of calcium intake in the elderly.     

Self-reported health problems among Swedish miners one year after unemployment

Unemployment is considered to be a public health concern sincedeterioration in the health of the unemployed is often anticipated.However, for some groups, such as miners, unemployment mightimprove health due to a cessation of potentially harmful occupationalexposures. This study evaluates the health of 79 miners in oneSwedish iron-ore mine, and 226 age-matched controls from thegeneral population, during one year after the closure of themine. The participants received a questionnaire regarding medicalhistory and subjective symptoms at the beginning of the studyperiod, and after one year. Statistically significant negativeeffects on self-reported health attributable to unemploymentwere not found, although neuropsychiatric symptoms were morecommon among the unemployed miners. The miners reported a statisticallysignificant improvement in grip force (p=0.031). They had asignificantly higher prevalence of symptoms associated withmining related exposures when compared with the population controls;pain in the upper extremities [relative risk (RR)=2.27, 95%confidence interval (Cl)=1.44–3.59), back pain (RR=1.84;Cl=1.237–2.75), vasospastic disease of the fingers (RR=2.05;Cl=1.18–3.57) and obstructive respiratory symptoms (attacksof dyspnea and wheezing: RR=3.67; Cl=1.167–11.6).     

Excès de cas humains et animaux de tularémie en France au cours de l’hiver 2007–2008 : émergence ou phénomène isolé ?

Context

Tularemia is a zoonosis affecting humans and hares in France. We describe the results of surveillance in both species, in 2007 and 2008.

Methods

Human tularemia cases are mandatorily notifiable in France since 2003. In hares, surveillance relies on volunteer hunter associations in all districts of the country. Data from mandatory reports and volunteer surveillance in 2007/2008 were analyzed and compared with previous results.

Results

In 2007/2008, 144 cases were reported in humans and 117 cases in hares. This was a 100% increase compared to previous years. Human cases differed from those of previous years only by the frequency of contact with breeding animals. Human cases without any documented risk exposure were also more frequent.

Conclusion

An increase of tularemia cases occurred in 2007/2008 in both species. Complementary studies are needed to identify the species reservoir in France to understand the causes of this peak of cases.     

Occupational health hazards in mining: an overview

This review article outlines the physical, chemical, biological, ergonomic and psychosocial occupational health hazards of mining and associated metallurgical processes. Mining remains an important industrial sector in many parts of the world and although substantial progress has been made in the control of occupational health hazards, there remains room for further risk reduction. This applies particularly to traumatic injury hazards, ergonomic hazards and noise. Vigilance is also required to ensure exposures to coal dust and crystalline silica remain effectively controlled.     

Manufacture and use of nanomaterials: current status in the UK and global trends

This paper provides an overview of the production and use of nanomaterials (NMs), particularly in the UK. Currently, relatively few companies in the UK are identifiable as NM manufacturers, the main emphasis being the bulk markets in metals and metal oxides, and some niche markets such as carbon nanotubes and quantum dots. NM manufacturing in the UK does not reflect the global emphasis on fullerenes, nanotubes and fibres. Some assumptions have been made about the types of NM that are likely to be imported into the UK, which currently include fullerenes, modified fullerenes and other carbon-based NMs including nanotubes. Many university departments, spin-offs and private companies have developed processes for the manufacture of NMs but may only be producing small quantities for research and development (R&D) purposes. However, some have the potential to scale up to produce large quantities. The nanotechnology industry in the UK has strong R&D backup from universities and related institutions. This review has covered R&D trends at such institutions, and appropriate information has been added to a searchable database. While several companies are including NMs in their products, only a few (e.g. manufacturers of paints, coatings, cosmetics, catalysts, polymer composites) are using nanoparticles (NPs) in any significant quantities. However, this situation is likely to change rapidly. There is a need to collect more information about exposure to NPs in both manufacturing and user scenarios. As the market grows, and as manufacturers switch from the micro- to the nanoscale, the potential for exposure will increase. More research is required to quantify any risks to workers and consumers.     

深圳公立医院管理体制改革制度设计

深圳公立医院管理体制改革实行政事分开、管办分开,在理事会架构下按法定机构模式组建市医管中心,落实公立医院运营管理自主权.作者从当前公立医院管理体制的弊端入手,介绍了深圳市进行公立医院管理体制改革的基本思路及改革方案设计的主要举措,深入剖析了的改革方案的特点,并对改革效果进行了预测.     

Effects of nitrogen dioxide on red blood cells of rats: Changes in components of red cell membranes during in vivo exposure to NO2

Red cell membranes, prepared from red blood cells of rats exposed to 4, 10, or 20 ppm nitrogen dioxide (NO₂) for 1 to 10 days, were examined for evidence of changes in membrane components. Appreciable changes were not found in contents of phospholipid and cholesterol during exposure to 10 ppm NO₂. By contrast, protein content altered with the time of exposure. Moreover, changes in protein composition were observed by employing sodium dodecyl sulfate — polyacrylamide gel electrophoresis. Twenty-four-hour exposure to NO₂ at the concentration above 10 ppm resulted in a marked increase in the percentage of lysophosphatidylethanolamine (LysoPE) to the total phospholipids. The prolonged exposure to 10 ppm NO₂ gave rise to a further increase in LysoPE, whereas the percentage of phosphatidylethanolamine (PE) showed a gradual decrease. A 1-day exposure to 4.0 ppm NO₂ also caused an increase in sialic acid content and decreases in those of PE and hexose. In addition to contents of these components the percentage of LysoPE increased 5 days after exposure and the elevated values were maintained up to the end of exposure period. These results demonstrate that red blood cells in circulation exhibit different membrane properties in terms of lipid and carbohydrate composition during 10 days of exposure to 4.0 ppm NO₂.     

Investigating clusters in the workplace and beyond

Clusters of disease are common and occur in the workplace and in the general community. They often arouse considerable concern among the population. Investigations have sometimes lead to exciting new knowledge, but in general the investigation of clusters is difficult and often unrewarding, especially for community clusters. In the workplace, investigations are more likely to find associations and even new causes, but still many clusters remain enigmatic. Despite this, there are many reasons for investigating clusters, including allaying community concern and identifying uncontrolled exposures. A structure for investigating clusters in the workplace is suggested.