医院医疗器械不良事件监测存在的问题和对策

为了确保用械安全,提高医疗质量．更好地服务于患者,我院针对医疗器械不良事件监测工作中存在的问题制定了相关管理措施,通过建章立制、强化培训、规范管理和落实责任制．保证了医疗器械不良事件监测与报告工作的有效实施,取得了良好效果。     

浅谈医疗卫生机构医疗器械不良事件监测与管理

本文对医疗器械不良事件涵义、医疗器械不良事件监测的意义,及医疗器械不良事件监测工作中的问题进行了分析。对医疗卫生机构加强医疗器械不良事件监测与管理提出了建议。     

生产企业开展医疗器械不良事件监测存在的问题及对策研究

通过对我国医疗器械不良事件监测工作开展的现状进行回顾性分析,提出存在的问题及对策,旨在探讨我国生产企业开展医疗器械不良事件监测工作的机制和方法,保证公众用械安全。     

对我国医疗器械不良事件监测系统的思考和建议

医疗器械不良事件的上报数量逐年增加,但上报系统还存在不足之处,导致对不良事件的评价和判定产生困惑。该文根据我国上报的医疗器械不良事件的特点,对上报系统的评价流程提出修订建议,以期实现对不同类型的不良事件以监管目标为导向及时进行有效管理。     

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。     

医疗机构医疗器械不良事件监管体系研究

本文探讨了我国医疗器械不良事件监管工作存在的问题,并从医院的视角出发,提出我国医疗器械不良事件监管的对策建议。以医疗器械不良事件监管理论作为分析方法,结合目前医院医疗器械不良事件监管的实际情况,提出我国医疗器械不良事件监管工作的管理流程和管理体系。     

医院医疗器械不良事件管理机制的建立

通过采用医疗器械不良事件的管理中,对科室、医疗器械不良事件监测员、医疗器械不良事件管理委员会三者之间建立闭环管理模式,可以有效的对闭环中各个环节进行风险控制,从而可以保证在用医疗设备使用安全管理。     

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。     

浅谈医疗器械不良事件

本文剖析了医疗器械不良事件的定义及其产生原因,正视了我国医疗器械不良事件监测工作的现状及存在的问题,具体阐述了医疗机构如何处理医疗器械不良事件,提出医疗器械不良事件监测工作的意义和远景展望。     

浅谈医院医疗器械不良事件监测与管理体制建立

本文提出了对医院医疗器械不良事件发生后如何进行监测与管理的看法。就医院医疗器械不良事件报告、评价模式、分类和时间性，以及监测管理机构、技术人员队伍、制度法规建立进行了探索性叙述。医院医疗器械不良事件监测将为我国医疗市场的健康发展，保证医疗器械的更安全、有效、可靠奠定基础。     

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.     

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.