Medical devices; immunology and microbiology devices; classification of the West Nile Virus IgM capture Elisa assay. Final rule

The Food and Drug Administration (FDA) is classifying the West Nile Virus IgM Capture Elisa assay into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.     

Hydrocephalus: a fatal late consequence of mumps encephalitis

Common and usually self-limited diseases may occasionally have fatal consequences. Hydrocephalus is a very rare complication of mumps, with just a few cases reported in the literature. Here we report a fatal case of hydrocephalus presenting 19 years after mumps encephalitis. The long latency period between encephalitis and hydrocephalus-associated symptoms makes this case particularly interesting.     

Fatal meningitis and encephalitis due to Bartonella henselae bacteria

Bacterial infection due to Bartonella henselae commonly develops in children and young adults following cat/dog contacts and/or cat/dog scratches. Regional lymphadenopathy is its most common clinical expression. However, encephalitis and Parinaud's syndrome (oculoglandular syndrome) have also been reported as has systemic illness. A review of the international literature in all languages revealed no fatal complications in immunocompetent hosts. A four-year-old white child with no underlying illness began to have seizure-like activity. She was taken to a local hospital and subsequently transferred to a medical center. The child was treated aggressively for seizures and fever of unknown origin. However, her condition rapidly declined and she died without a specific diagnosis. At autopsy there was marked cerebral edema with no gross evidence of acute meningitis. Microscopic exams revealed multiple granulomatous lesions as well as a meningitis and encephalitis. A variety of cultures and stains were negative for acid fast and fungal organisms. Warthin-Starry stains of involved tissue including brain and liver revealed pleomorphic rod shaped bacilli consistent with Barronella henselae. Analysis of brain tissue with polymerase chain reaction (PCR) and Southern blot for the deoxyribonucleic acid (DNA) was definitive for DNA of Bartonella henselae bacteria.     

西部开发与地方立法

西部开发中 ,地方多层次立法体制 ,应突出省级地方立法的领衔地位和作用 ;地方立法的体系构架 ,要经济立法、民主政治立法和社会保障立法三位一体 ;立法理念和思维须适应法治和市场经济进程的需求 ;根据西部的实际情况 ,地方立法要体现普遍性与弱势群体利益的特殊保护相结合。     

The Future of the West

From the editors of Kommunist: The editors publish Academician T. Zaslavskaia's article with the request that the readers participate in the discussion of little-investigated, debatable problems examined by the author and that they send in their articles, letters, and ideas, which we will publish in a new section of the journal: "Debates and Discussions."     

尼罗红显现潮湿纸张上油脂手印方法初探

目的探索显现潮湿纸张表面油脂手印的显现方法。方法取250枚纸张载体的油脂指印,分为AB-CDE 5组,分别用自来水浸泡不同时间后,用尼罗红工作液显现,并在465nm多波段光源下进行观察。结果 5组的显现率从56%～94%,表明显出率比较高。结论该方法简单实用,可用于案件检验。     

成人非典型急性流脑猝死1例

随着抗生素的广泛使用 ,流行性脑膜炎的发病死亡率已经很低 ,而成人患此病死亡则更罕见 ,[1] 现报道一例 :某男 ,2 6岁。某日被人发现死亡 ,死亡前一天因头痛、头昏、发烧、咽痛到某医院门诊就诊。家属怀疑死亡与临床用药有关 ,要求尸检确定死亡原因。尸检发现 :死者发育正常 ,营养中等 ,颜面部及躯干、四肢皮肤点状或片状出血 ,大小为针头大至 1.5ｃｍ× 1.5ｃｍ ,双眼睑结膜下出血点。左肺 5 5 0 ｇ ,右肺 6 2 0 ｇ ,双肺表面可见出血斑 ,切面未见结节及空洞。心包腔见少量液体 ,心 330ｇ ,心包膜可见出血点 ,冠状动脉及心瓣膜未见明显异…     

美国西部"世界花园"神话与美国文学中的西部意识

美国开发西部,最初是为了开辟亚洲市场和南美洲市场。随着人们的不断开拓,西部渐渐成了"世界花园"和远离东部现代文明的宁静的田园乐土,这一观念深入到了美国人的意识深处。尽管开发西部的结果是把西部变成了与东部一样的现代化地区,"世界花园"神话被现实击破,但人们的西部意识并未消失。一旦他们对现代文明有所不适,便想到要回归"西部",在下意识中寻找自由的"乐土"。     

成人非典型急性流脑猝死1例

随着抗生素的广泛使用,流行性脑膜炎的发病死亡率已经很低,而成人患此病死亡则更罕见 ,[1]现报道一例: 某男,26岁.某日被人发现死亡,死亡前一天因头痛、头昏、发烧、咽痛到某医院门诊就诊 .家属怀疑死亡与临床用药有关,要求尸检确定死亡原因.     

西方法官解释的历史与学派之争

法官解释是在法律适用过程中,法官对法律规定的理解、分析与说明。西方人认为没有法官解释就没有法律适用。然而,对法官解释的认可有一个历史发展的过程,而且,在肯定法官解释存在的基础上,如何解释亦存在派别之争。当今的派别主要有德沃金的无需造法的法官解释、波斯纳的超越成文法的解释以及哈特的调和式法官解释。这三种有代表性的观点从不同角度对法官解释进行了有价值的探讨,对我国法制建设具有参考意义。     

论罗宾·韦斯特的文化女性主义法学观

文化女性主义法学的核心人物罗宾·韦斯特拿捏起文化女性主义的关键词——关联、移情、亲密、责任,以之对抗主流法学对分离、个体、自治和权利的垂重,以之抨击主流法学视之为理所当然的男性气质,以之锤炼和重构关注女性独特经历的文化女性主义法学。整体观之,韦斯特的理论少了自由主义女性主义法学保守改良之弊,少了激进女性主义法学极端激进之失,于犀利深刻中层层缔造和推进出自身的文化女性主义法学观。