医疗器械安全质量管理问题探讨

目的分析医疗器械上市前临床试用或验证中的缺陷,探讨医疗器械上市后的安全质量管理评价。方法采取定性分析与定量分析相结合的方法,分析医疗器械上市前临床试用中的缺陷以及医疗器械安全质量管理的途径。结果医疗器械安全质量通过医疗器械不良事件报告、医疗器械召回和医疗器械追踪得以实现。结论医疗器械进入市场后的不良事件报告、召回制度和追踪制度,是医疗器械进入市场后对其安全性、有效性和质量管理的重要环节。     

医疗器械监管座谈会在沪召开

受国家食品药品监管局医疗器械监管司委托,中国医疗器械行业协会于8月28日在上海召开了医疗器械监管座谈会。国家食品药品监管局医疗器械监管司司长王宝亭、医疗器械技术审评中心副主任曹国芳以及医疗器械监管司注册处负责人出席了座谈会,就医疗器械注册以及审评方面工作与参会企业代表进行了面对面的交流,并重点听取了企业的意见和建议。座谈会由医疗器械产业技术创新战略联盟理事长、医疗器械行业协会副会长姜峰主持,近百     

关于医疗器械风险管理标准的几点认识

医疗器械风险是指医疗器械损害的发生概率与医疗器械损害严重程度的结合。医疗器械的风险将可能引发对人体的伤害甚至死亡的损害,或对社会财产和环境造成损坏。因此必须对医疗器械实施风险管理,将医疗器械风险控制在可接受水平,以确保医疗器械安全有效。     

物联网在植入性医疗器械管理中的应用

目的：探讨物联网在植入性医疗器械管理中的优势.方法：分析目前植入性医疗器械管理存在的问题,提出运用物联网对植入性医疗器械进行管理,论证了物联网应用于植入性医疗器械管理的优势.结果：将物联网应用于植入性医疗器械管理,实现了从植入性医疗器械审核、入库、出库、使用、计费、付款的全程追踪管理.结论：物联网应用于植入性医疗器械管理,规范了医院植入性医疗器械管理流程,建立了植入性医疗器械使用信息库.     

中国医疗器械行业协会领导调研陕西医疗器械行业发展

受陕西省医疗器械协会邀请,科技部国家医疗器械产业技术创新战略联盟理事长、中国医疗器械行业协会副会长姜峰一行四人,于近日来陕召开医疗器械生产企业座谈会,深入部分医疗器械生产企业调研并举办医疗器械企业发展高峰论坛,了解陕西医疗器械生产企业产品和市场发展状况,分析存在的具体问题,寻求医疗     

医疗器械质量控制的工作方法分析

医疗器械质量直接影响着医疗工作水平,在临床医学中医疗器械质量对治疗效果产生一定的影响,与人的身体健康具有一定的相关性。因此,要重视医疗器械的质量控制,做好医疗器械质量控制工作。本文对医疗器械质量控制工作方法进行了分析,旨在通过医疗器械质量控制提高医疗器械质量。     

正确区分医疗器械编码与UDI间的不同概念

阐述了医疗器械唯一性标识与医疗器械编码间的不同概念.回顾了医疗器械编码的历史.提出了建立医疗器械编码的作用、原则和方法,及其与医疗器械命名、分类、分类目录、唯一性标识的关系.对如何建立我国医疗器械编码制度提出了建议.     

我国医疗器械标准质量评价初探

该文通过分析研究我国目前医疗器械标准质量状况,结合近十多年医疗器械发展趋势,对医疗器械标准质量评价系统提出意见和建议．旨在提高我国医疗器械标准管理水平以及医疗器械标准质量水平。     

中国医疗器械检验机构现状与发展

该文介绍了我国医疗器械检验机构现状,全国有医疗器械检验机构53家,其中国家级医疗器械检验机构10家。医疗器械检验机构服务于政府对医疗器械的监管,在医疗器械上市前注册和上市后监督过程中发挥着技术支持作用。同时,其也是我国的医疗器械标准化工作重要的践行者。最后,提出了检验机构目前存在的问题与解决对策,以利于我国医疗器械的持续发展。     

第三届中国医疗器械国际化论坛

本届论坛旨在帮助中国医疗器械企业了解其它主要国家和地区的医疗器械法规,促进中国医疗器械出口,并通过直接参与国际竞争,提高中国医疗器械的技术水平、产品质量和市场竞争能力,从而振兴中国医疗器械工业。     

Utilisation des lipides : oxydation ou stockage ?

The stability of body weight and composition requires an equilibrium between the intakes and outputs of energy and macronutrients. Fat mass depends on the equilibrium between the input and output of lipid but also on the metabolic fate of lipids (oxidation or storage). Examination of metabolic pathways and of their regulation shows that cells have efficient biochemical and molecular mechanisms to stimulate acutely and on the long term carbohydrate oxidation, lipogenesis and lipid storage and to inhibit lipid oxidation. On the contrary, the ability of cells to acutely stimulate lipid oxidation is limited. These differences in regulation of lipid and carbohydrate metabolism are also present at the whole body level. The ability to increase lipid oxidation in response to an increased lipid intake is still more reduced in obese subjects. Despite numerous attempts to develop pharmacological approaches, modifications of dietary intakes and physical exercise remain the best ways to reduce lipid storage and to increase fat oxidation.     

Food classifications: Levels and categories

People classify foods into multiple categories to construct order in complex food environments. This investigation in the U.S. used depth interviews and secondary analysis of existing qualitative data sets to examine how the public constructs and uses food classifications. Within sets of culturally recognized food classifications, smaller sets of socially significant classifications are found, and within these socially significant classifications are sets of personally operational classifications used most often in making everyday food choices. Food classifications become salient and are used within specific contexts. Food classifications are multidimensional, and include many organizing themes such as liked/disliked, healthy/ unhealthy, seasonal/out of season, and others. These classification dimensions and categories vary in salience and use within and between individuals and settings. Understanding food classifications may help improve communication between food and health professionals and the public.     

The health promotion implications of the knowledge and attitude of employees in relation to health and safety leaflets

Selected aspects of the efficacy of printed leaflets produced by a government health and safety agency and widely distributed by the enforcement bodies and other organisations to promote workplace health and safety are examined. It is based on a study of 30 small or medium-sized enterprises and examines the views of 120 employers and employees regarding the availability, attractiveness, relevance and usefulness of the leaflets and estimates the reader comprehension and readability of the selected leaflets. The results indicate that the selected leaflets are considered acceptable and comprehensible by the majority of respondents. As these are typical of the leaflets available in the health and safety field this is a positive outcome. The discussion focuses around the ability of the leaflets to engage and to inform and suggestions are made to encourage a wider debate on the criteria which contribute to these two aspects of leaflet use. It is contended that leaflets will continue to be important in the attempts of those involved in workplace health and safety to facilitate learning and to contribute to the overall process of behaviour change. This study raises a number of key issues regarding the future design and use of such leaflets.     

The Varieties of Dignity

As a part of a research project on Dignity and Older Europeans (Fifth Framework (Quality of Life) Programme3) I explore in this paper a set of notions of human dignity. The general concept of dignity is introduced and characterized as a position on a value scale and it is further specified through its relations to the notions of right, respect and self-respect. I present four kinds of dignity and spell out their differences: the dignity of merit, the dignity of moral or existential stature, the dignity of identity and the universal human dignity (Menschenwürde). Menschenwürde pertains to all human beings to the same extent and cannot be lost as long as the persons exist. The dignity of merit depends on social rank and position. There are many species of this kind of dignity and it is very unevenly distributed among human beings. The dignity of merit exists in degrees and it can come and go. The dignity of moral stature is the result of the moral deeds of the subject; likewise it can be reduced or lost through his or her immoral deeds. This kind of dignity is tied to the idea of a dignified character and of dignity as a virtue. The dignity of moral stature is a dignity of degree and it is also unevenly distributed. The dignity of identity is tied to the integrity of the subject's body and mind, and in many instances, although not always, also dependent on the subject's self-image. This dignity can come and go as a result of the deeds of fellow human beings and also as a result of changes in the subject's body and mind.     

Surveillance on self-report: a trial of health and safety monitoring in occupational settings

A method for monitoring health and safety in the workplace, referred to as 'surveillance on self-report', is presented. This occupational health and safety monitoring method consists of a collection of data on certain aspects of health and safety obtained by dispensing self-administered questionnaires to employees or managers and supervisors in workplaces, and administering regular feedback on the responses. Based on the responses, a continual monitoring and improvement on certain aspects of health and safety were possible in two workplaces in New Zealand. This study has shown a methodology for the surveillance of hazard control and monitoring, injuries and illnesses, and organizational policies in occupational settings.     

Researching children,intersectionality, and diversity in the digital age

Abstract

Research on children’s and adolescents’ experiences with media and technology over the past century has largely echoed the concerns of the middle-class and majority culture. We discuss scholars’ corrective efforts, particularly in recent years, in moving beyond these narrow foci to investigate how young people situated across social classes, racial and ethnic boundaries, and forms of disability engage with new media. In particular, we examine how scholars have conceptualized similarities and differences among children and families in relation to interconnected systems of oppression and privilege. We discuss how their work has challenged deficit-based approaches to cultural and social difference to understand how diverse families and young people actively negotiate media and technologies in everyday life. We argue that an intersectional, asset-oriented approach to studying the lived experiences of youth and families opens exciting new avenues for research that prioritizes the rights of children and adolescents in the digital age.     

The social consequences of occupational injuries and illnesses

BACKGROUND: Most outcome studies of occupational injuries and illnesses have tended to focus on direct economic costs and duration of work disability. Rarely have the broader social consequences of work-related disorders or their impacts on injured workers' families, coworkers, and community been investigated. This paper examines a wide range of social consequences including workers' psychological and behavioral responses, vocational function, and family and community relationships. METHODS: Literature review and development of conceptual framework. RESULTS: Complex and multifactorial relationships are described whereby occupational injuries and illnesses produce a variety of social consequences involving filing and administration of workers' compensation insurance claims, medical care experiences, domestic function and activities of daily living, psychological and behavioral responses, stress, vocational function, rehabilitation and return to work, and equity and social justice. CONCLUSION: A research agenda is proposed for guiding future investigations in this field.     

The human drama of genetics: 'hard' and 'soft' media representations of inherited breast cancer

This paper examines media coverage of 'breast cancer genetics', and explores its implications for public understanding. We present a content analysis of coverage in British newspapers and look at a variety of popular forms, including women's magazines, television soap opera and radio drama. Genetic/inherited risk receives a great deal of coverage across a wide range of media formats and outlets. Much of this attention has focused on individuals from 'high risk families' and dilemmas around prophylactic mastectomies. Through examining media coverage, combined with interviews with media personnel and their sources, we show why this story proved so attractive to the media and highlight the different production values which influence coverage. Finally, we introduce preliminary findings from focus group discussions to demonstrate how such 'human interest' framing has engaged audience attention and influenced public understandings. The paper concludes by highlighting the implications for analysing, predicting, and engaging with, media representations of science.     

Incidence and suspected cause of work-related musculoskeletal disorders, United Kingdom, 1996-2001

BACKGROUND: Musculoskeletal conditions are the most common self-reported work-related disease, with high costs incurred from long-term disability. In the United Kingdom, occupational physicians and rheumatologists have been reporting new cases of work-related musculoskeletal disorders to voluntary surveillance schemes since 1996. AIMS: To estimate population incidence rates for work-related musculoskeletal disorders reported by rheumatologists and occupational physicians by occupation and industry, in relation to tasks and movements suspected as causal. METHODS: Estimated average annual incidence rates were calculated for nine main job categories and eight industrial groups; Labour Force Survey figures were used as the denominator for rheumatologists, and a special survey for the occupational physicians. These were then related to tasks and movements reported as causal. RESULTS: Between October 1997 and the end of 2001, an estimated 2,599 new cases/year were reported by rheumatologists, and from January 1996, 5,278 cases/year by occupational physicians. Average annual rates overall were 94 per million for rheumatologists and 1,643 per million for occupational physicians (a 17-fold difference). Jobs at highest risk for the upper limb were primarily clerical, craft-related and machine work. Tasks associated with upper limb disorders and with neck and back problems were predominantly keyboard work and heavy lifting, and in craft-related occupations with gripping or holding tools. CONCLUSIONS: Jobs at risk and the associate tasks were identified which should assist prevention, but the extent to which these factors were causal or aggravating previous injury requires further study. The much higher rates reported by occupational physicians reflect, in part, the type of industries they served.     

重视新生儿临床用药研究

新生儿是特殊的儿童群体,其药代动力学和药效学与年长儿和成年人有显著差异,既往将年长儿或成年人用药经验用于新生儿群体疾病治疗,曾造成严重后果。由于新生儿药物临床试验存在费用高、风险大、伦理学问题及受试者招募困难等问题,新生儿临床用药研究仍亟待加强。目前各国已制定相应的法律、法规推动和规范儿童药物试验,新的研究技术和方法也不断应用于新生儿临床药物研究,新生儿科医师、临床药师及其他科研工作者有必要通力合作加大新生儿用药研究,确保新生儿用药的安全性和有效性。