植入性医疗器械追溯管理系统的设计

目的：设计一种植入性医疗器械追溯管理系统,对植入性医疗器械进行信息化管理。方法：采用条形码技术录入植入性医疗器械产品数据,建立数据库,实现数据管理和信息监管。结果：系统以其产品编码化、数据标准化、管理信息化、监管全程化和信息透明化的特点,建立了可追溯的长效监管机制。结论：该系统的应用确保了植入性医疗器械使用的安全性和可溯性,不仅提高了医院管理水平,而且为患者提供了更佳的服务保障。     

高速摄像技术在弹道碎石器探头运动参数测量中的应用

简要介绍微创技术治疗肾结石中的气压弹道碎石技术,并利用高速摄像技术测量了弹道碎石器探头的运动参数,为气压弹道碎石器的研制提供了详细的技术数据.高速摄像技术的采用对于医疗器械的研制和生产会起到良好的促进作用.     

EWMA控制图系统在医疗器械生产管理中的应用

本论文研究了基于VB语言的EWMA控制图系统在医疗器械生产管理中的应用。该系统采用数据库对工序质量统计分析数据进行存储,可实现工序质量数据的共享。通过试验验证了算法以及应用在医疗器械生产管理中的可靠性。     

基于Web的医疗器械信息管理系统的研究

医疗器械信息管理在医院的信息化管理中具有重要的地位。本文介绍了一个基于Web浏览器的医疗器械信息管理系统,详细介绍了系统的设计思想、各功能模块和系统特点。系统的设计研究实现了医疗器械信息的网络化管理,极大地提高了管理效率。     

基于文本相似度的医疗器械分类推荐系统

目的 基于最新修订的2017版《医疗器械分类目录》,设计一种可实时交互的医疗器械分类推荐系统,实现医疗器械分类界定数据的高效匹配和搜索。方法 提取2017版《医疗器械分类目录》中的结构化数据,制作关联数据库表。采用基于TF-IDF的文本相似度匹配算法,将用户输入与举例产品名称逐一进行相似度计算,筛选出最匹配的内容。同时,结合数据库表的关联关系,借助Flask框架搭建的交互式网站,向用户展示医疗器械分类推荐结果。结果 分类推荐系统可根据用户输入的产品名称自动采用TF-IDF模型计算文本相似度,并根据数据库表的关联关系,通过网页返回匹配度最高的三级分类推荐编码、子目录（主序号、主名称）、一级产品类别（一级序号、一级名称）、二级产品类别（二级序号、二级名称）、产品描述、预期用途和管理类别等关键分类信息。结论 基于文本相似度的医疗器械分类推荐系统可为医疗器械分类编码工作提供便捷、精确和高效的指导,减少因缺乏专业知识和经验而造成的分类混淆、分类失效问题,具有较好的实际应用价值。     

设计类医疗器械软件分类管理探讨

当前设计类医疗器械软件主要用于辅助制定手术计划、设计医疗器械等，有多种重要用途，是一种比较特殊的软件，在监管工作中需要首先依据当前的相关法规明确此类产品管理属性。文章分析了设计类医疗器械软件产品的特点、目前产品的发展现状，结合我国和美国、欧盟的监管政策情况，根据《医疗器械分类目录》等法规并结合产品的使用风险，详细分析了对该类软件产品按照术前规划和生产加工两个不同的应用领域进行属性界定和管理类别划分的技术要求，并对应用新技术的该类软件的分类界定进行了探讨，从而为此类产品的监管工作提供技术参考。     

医疗器械不良事件统计分析系统开发的探讨

目的:医疗器械不良事件监测是医院在医疗器械质控管理中的重要环节.因此,需要设计出针对医院不良事件进行统计分析的系统,用来更好的对医疗器械不良事件进行监管,提高医疗器械质控管理水平.方法:通过Powerbuilder软件和Access数据库进行软件设计,完成整个系统的搭建工作.结果:使用医疗器械不良事件统计分析系统对医院21例医疗器械不良事件数据进行测试,能够准确的完成相应的统计分析工作.结论:医疗器械不良事件统计分析系统为医院的医疗器械不良事件监测工作带来了不少便利,有较好的应用前景     

医疗器械生产洁净区送排风系统及其检查要点

文章介绍了医疗器械生产洁净区的送排风系统,包括其构成、设计要素以及在监管过程中的检查要点,旨在指导医疗器械生产企业更好的运行其洁净区送排风系统,提高生产质量。     

医疗器械成本效益分析在HIS上的研发与应用

目的：研制医疗器械成本效益分析软件,实现医疗器械使用数据网上实时采集、运行成本录入与成本效益分析评价。方法：挂接并利用“军卫一号”HIS系统,与HIS系统价表、收费、报告等子系统互联互通。结果：该系统能够实时查询统计大型医疗设备及一次性医用耗材的收入、运行成本、成本效益率、使用评价,并以此为基础,建立医疗器械管理考核评价体系。结论：通过加强对现代医疗器械的信息化管理,促进其科学规范管理。     

基于医疗器械唯一标识的医用耗材主数据治理研究

为推动医疗器械唯一标识在院内实施,更好地促进医疗机构医用耗材的精细化管理,进行院内医用耗材主数据治理。对院内医用耗材数据进行清洗和规范,通过院内数据编码和国家医疗器械唯一标识、医保数据库进行三码映射,建立基于医疗器械唯一标识的医用耗材主数据,实现院内医用耗材主数据在各系统间的一致性和可分析性,为医用耗材院内精细化管理打下坚实的数据基础。     

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.     

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.     

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.     

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.