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The device reprocessing debate in the EU: can reprocessing help

机译：欧盟对设备后处理的争论：可以进行后处理帮助

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摘要

The European Commission recently submitted to the European Parliament its report on the reprocessing of medical devices, in accordance with Article 12a of Directive 93/42/EEC (COM(20IO) 443)'-5.The report concluded that, while not all SUDs are suited for reprocessing, the use of reprocessing in the EU "needs to be evaluated and validated" so as to "reduce the potential hazards associated with reprocessing of a specific single-use medical device".The commission is assessing what measures would be appropriate to regulate reprocessing at an EU-wide level.The measures will be considered within the framework of the proposed recast of the EU medical device directives - proposals that are likely to be finalised by the start of 2012.
机译：根据第93/42 / EEC号指令（COM（20IO）443）'-5第12a条，欧洲委员会最近向欧洲议会提交了有关医疗器械再处理的报告。适用于后处理，在欧盟“需要评估和确认”后处理的使用，以便“减少与特定一次性医疗器械的后处理相关的潜在危害”。委员会正在评估哪些措施是合适的在欧盟范围内规范后处理。将在拟议的欧盟医疗器械指令重塑框架内考虑这些措施，这些提议很可能在2012年初完成。

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