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中国医用气体工程质量控制建议

林硕*, Hélène van den Brink, Eric Fouassier, Alejandro Berardi   

  1. 1. 法国第十一大学 药学院, 药品法律与经济管理研究室, 法国
    2. 法国液化空气公司 国际医疗业务部, 法国
  • 收稿日期:2010-03-09 修回日期:2010-04-15 出版日期:2010-05-15 发布日期:2010-05-15
  • 通讯作者: 林硕*

Solutions to improve the quality management of medical gas pipeline systems in China

Shuo Lin*, Hélène van den Brink, Eric Fouassier, Alejandro Berardi   

  1. 1. Pharmaceutical Law and Economics Laboratory, Paris-Sud 11 University, 5, rue J.B. Clément, 92296 Châtenay-Malabry Cedex, France
    2. Air Liquide Santé International, 28, rue d'Arcueil, 94250 Gentilly, France
  • Received:2010-03-09 Revised:2010-04-15 Online:2010-05-15 Published:2010-05-15
  • Contact: Shuo Lin*

摘要:

气体长期应用于世界各地的医疗领域。其中, 医用氧是最重要的医用气体, 在医院和家庭中广泛使用。医用氧被定义为药品, 它的医用运输系统属于医疗器械范畴, 其质量和管理应符合相关标准的要求。在中国, 医疗机构医用氧的运输和使用中存在较多的问题。这些问题可导致例如气管爆炸等致命事故的发生和假冒药品的使用。究其原因, 这是由于缺乏相关的标准, 管理和实践经验造成的。因此作者建议通过学习国, 如法国的先进经验和规章制度, 来解决这些问题。

关键词: 医用气体工程, 医用氧, 标准, 质量, 中国

Abstract: Gases have long been used for medical applications across the world. Medical oxygen, one of the most important medical gases, has been widely applied both in hospitals and at home. It is defined as a drug and its pipeline distribution systems are medical devices whose quality and management should conform to specific standards. In China, several deficiencies relating to the distribution and use of medical oxygen, which may lead to a number of fatal accidents like gas pipeline explosion and cause illicit product use, have been revealed in health facilities. They are the result of a lack of the relevant standards, management and practical experiences. To overcome these failures, it might be interesting to refer to the experience and regulations of other countries, for example, those of France.

Key words: Medical gas pipeline systems, Oxygen, Standardisation, Quality, China

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*Correspondent author. Tel.: (+)33-609079202; fax: (+)33-145843984