浅谈医疗器械的信息收集与开发利用

医疗器械管理涉及面很广，医疗器械信息管理是一项系统工程。本文介绍了医疗器械信息的种类以及获取的渠道，在信息收集的基础上，进行二次开发，从而指导医院进行装备规划的制定，以及医疗器械的采购、管理、使用和维修工作，并对现在工作进行评估，对未来工作进行预测，进一步提高管理层的决策能力。     

RFID信息管理技术在消毒供应室应用

目的对再生医疗器械处理进行完整、灵活和实时的过程追溯管理。方法采用无线射频识别技术（RFID）信息管理技术，结合无线网络、中间件等技术进行管理。结果在消毒供应室运用RFID信息管理技术，不仅使工作更加高效、准确、便捷，也更有效地控制再生器械的质量。结论消毒供应室实施RFID信息管理技术，对再生医疗器械处理的全过程实行了有效的质量追溯控制，达到了法理证据和人性化管理。     

构建思路在当前医疗设备管理数字化中的探索

所谓的数字化管理便是在进行设备管理工作的时候将网络或者信息技术添加进去，利用其进行信息的收集、存储、传输以及整合，在进行设备选购和管理以及保养的时候更加的科学，确保在医疗器械使用的过程中能够运行的更加合理和安全，确保其处于最好的状态，提高其使用的效率，将其作用更好的发挥出来，确保数字化管理的实现。     

甘肃加强和规范医疗器械注册管理

为加强医疗器械监督管理工作，规范医疗器械注册秩序，近日，甘肃省食品药品监督管理局发出通知，要求完善调整医疗器械注册检验，技术审评、注册审批的相关工作程序和内容，加强医疗器械注册管理，进一步提高医疗器械注册工作水平。通知规定，医疗器械生产企业在提交注册申报资料（包括首次注册、重新注册、涉及标准变化的变更申请以及说明书备案）时，     

写在前面的话

本刊在热心的读者和医疗器械领域的领导、专家的帮助与支持下，即将完成第四卷的编辑出版工作，并荣幸地在全国秋季医疗器械博览会开幕之际，增出一期赠刊。编辑部的初衷是扩大信息量，以读者最欢迎的热点、焦点话题为核心，请业内知名度较高的专家撰写论文。本刊是中国医疗器械行业协会主办的综合类科技期刊，有义务对我国医疗器械工业的发展现状、现行产品管理法规、政策、管理体系、市场特点、发展趋势等诸方面进行综合报道。尽管目前行业内信息体系不健全以及按市场机制运作还不成熟，但是经过多方努力，根据历年行业统计、分析，海关、…     

导读

01专题注册管理《新旧医疗器械监督管理条例的差异性解析》一文主要对新旧医疗器械监督管理条例进行理解分析，在此基础之上着重分析二者在医疗器械的定义、分类、注册管理和质量管理等方面的差异与联系，从而帮助读者进一步理解医疗器械监管工作的趋势和方向。     

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。     

口腔医疗器械临床管理的重要性及维护保养对策分析

口腔科是医学学科中比较重要的分类，口腔科和口腔健康具有密切联系。口腔医疗器械在口腔疾病患者的治疗中，意义重大，口腔医疗器械的性能优良与否，均能够直接影响口腔疾病的治疗效果，临床中需重视口腔医疗器械的维修以及保养工作。本篇文章，作者从口腔医疗器械的维护保养现状、管理措施分析，说明设备安全使用重要性，有效管理医疗器械。     

医院医疗器械数据资源的利用

医院信息化管理需要医疗器械的信息化管理,而医疗器械信息化管理迫切需要医疗器械的数据资源的充分利用。医疗器械数据资源包括临床科室在用的医疗设备及材料等固定资产的信息数据;医疗器械管理部门人、财、物的信息数据;医疗器械动态采购信息及维修保养信息等。医院医疗器械数据资源管理首先需要广泛采集、其次需要及时发布、最后需要充分合理利用。     

小议植入性医疗器械在使用管理中存在的问题

目的：探讨植入性医疗器械在使用管理中存在的问题;方法：通过工作实践、同事之间交流探讨及网上信息了解,资料收集等;结果：医疗机构对植入性医疗器械的使用管理普遍存在问题;结论：落实规范植入性医疗器械使用管理制度迫在眉睫。     

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.     

The occurrence of antimicrobial substances in toilet,sink and shower drainpipes of clinical units: A neglected source of antibiotic residues

Antibiotics represent one of the most important drug groups used in the management of bacterial infections in humans and animals. Due to the increasing problem of antibiotic resistance, assurance of the antibacterial effectiveness of these substances has moved into the focus of public health. The reduction in antibiotic residues in wastewater and the environment may play a decisive role in the development of increasing rates of antibiotic resistance. The present study examines the wastewater of 31 patient rooms of various German clinics for possible residues of antibiotics, as well as the wastewater of five private households as a reference.To the best of our knowledge, this study shows for the first time that in hospitals with high antibiotic consumption rates, residues of these drugs can be regularly detected in toilets, sink siphons and shower drains at concentrations ranging from 0.02?μg·L^?1 to a maximum of 79?mg·L^?1. After complete flushing of the wastewater siphons, antibiotics are no longer detectable, but after temporal stagnation, the concentration of the active substances in the water phases of respective siphons increases again, suggesting that antibiotics persist through the washing process in biofilms. This study demonstrates that clinical wastewater systems offer further possibilities for the optimization of antibiotic resistance surveillance.     

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.     

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.     

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.     

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.