眼内手术中使用医疗器械的安全性

J. Pastor
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引用次数: 0

摘要

本文综述了西班牙巴利亚多利德大学应用眼生物学研究所视网膜组的经验。讨论了眼内手术中使用的不同全氟碳液体,因为自2013年以来,它们在许多国家造成了数百例不可逆失明。审查了可能的原因,并考虑到目前的状况和应采取的措施,以防止这些情况在未来发生。其中包括:提高眼科医生的意识,以便他们向各自的卫生机构(医疗器械办公室)报告疑似病例,而不必担心政府机构或患者的法律报复;临床专家和制造商在国际标准化组织委员会中进行更密切的合作,以便单独管理每种产品;并进行适当的化学和生物试验,以保证产品的安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Safety of Medical Devices Used During Intraocular Surgery
This review article summarizes the experience of the Retina Group at the Institute for Applied Ophthalmobiology, University of Valladolid, Spain. Different perfluorocarbon liquids used in intraocular surgery are discussed, as they have caused hundreds of cases of irreversible blindness in many countries since 2013. The possible causes are examined, and consideration is given to the current status and the measures that should be taken to prevent these situations from occurring in the future. Among these are: a greater awareness among ophthalmologists so they report suspected cases to their respective health agencies (medical devices office), without fear of legal reprisals by either government agencies or patients; a closer collaboration between expert clinicians and manufacturers on committees for the International Organization for Standardization in order to regulate each product individually; and the conducting of appropriate chemical and biological tests to guarantee the safety of the products.
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