Ethylene oxide plant reopening won’t halt FDA plans to seek alternatives

环氧乙烷装置重新开放不会阻止 FDA 寻找替代品的计划

2019-07-19 01:17:29 Mass Device


The FDA will continue its efforts to find alternative medical device sterilization methods to ethylene oxide , even though a major EO plant is slated to reopen. Yesterday, medtech sterilization company Sterigenics and the state of Illinois announced they had reached a proposed consent agreement to reopen a plant in Willowbrook, Ill., which the state shut down in February, citing excessive emissions of EO, a carcinogenic gas. The plant had sterilized millions of devices annually — 594 types of devices, according to the FDA, including sutures, clamps, knives, stents and needles. Get the full story on our sister site, Medical Design & Outsourcing.
FDA 将继续努力寻找替代医疗器械的环氧乙烷灭菌方法,尽管一个主要的 EO 工厂将重新开放。 昨天,医疗技术消毒公司 Stereigics 和伊利诺斯州宣布,他们已经达成了重新开放伊利诺伊州 Willowbrook 工厂的协议。因为过量排放的 EO (一种致癌性气体)而于2月份关闭。据 FDA 称,该工厂每年对数百万台设备进行灭菌——594种设备,包括缝合、夹钳、刀具、支架和针头。 了解我们姐妹网站医疗设计和外包的全部情况。