统计发现,在产品抽查中发现的标识标签及说明书不合格的产品主要是有源类医疗器械,极少数一次性使用无菌产品也有类似问题,植入类医疗器械没有此类问题。在产品召回中发现的医疗器械标记不合规产品中,有源类医疗器械不合规问题尤为集中。2017~2019年,有源类医疗器械因标记不符合产品要求导致的产品召回数占该类召回总数的比例分别为100%、98。59%和78。26%。在细致分析导致上述合规性问题的原因的基础上,本文提出三条建议:①全面推行医疗器械唯一标识(UDI)系统;②提高有关医疗器械标记标准的通用性;③加强医疗器械设计开发和生产过程控制。
<<Statistics show that the products which are found to be not qualified in the label and instruction in the sample inspection mainly occur in the active medical devices,few of which are used aseptically at once,and no medical devices are implanted. Among the non-compliance products found in the product recall,the problem of non-compliance of active medical devices is especially concentrated. From 2017 to 2019,the total number of recalls of active medical devices due to non-compliance with the product requirements was 100%,98.59% and 78.26% respectively. On the basis of careful analysis of the reasons leading to the above-mentioned compliance problems,this paper puts forward three pieces of suggestion:(1)UDI system for medical equipment;(2)improving the universality of the standard of medical device marking;and (3)strengthening the design,development and production process control of medical equipment.
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