植入性医疗器械是使用过程中风险最高的一类器械,至今在GHTF法规体系中各国尚没有建立统一的追溯方法。本文讨论了此类医疗器械上市后销售的模式、植入性医疗器械的追溯模式,以及在医疗机构中对患者和植入性医疗器械身份准确记录的重要性。对于在追溯系统中如何采用信息化手段,使用国际统一编码标准(GS1)建立医疗器械产品唯一标识(UDI);医疗器械最低追溯信息的范围;以及采用自动识别技术释读追溯信息所需要的产品数据库、追溯信息监督等问题本文提出了解决的途径。
<<The implantable medical device is the medical device with the highest potential risk during use,and so far a harmonized product traceability system has not been established in the countries and regions within GHTF. This article is to discuss the distributing model and tracing model of such devices in post market surveillance,as well as the importance of correct identity recording of patients and implantable medical devices in medical institutions;and provide the solutions for how to use the information means in the traceability system,establish a unique device identification (UDI) for implantable device based on the GS1 product coding standard,define the minimum information in tracing process,and establish a central database to support automatic reading of the tracing information,as well as the supervision of tracing information,etc.
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