中国质量新闻网讯 黑龙江省牡丹江市市场监督管理局聚焦冷链关键环节，以冷藏库、检验科为重点场所，在全市医疗机构开展体外诊断试剂等冷藏冷冻类医疗器械风险排查，严守使用环节质量安全底线。
在排查中，执法人员认真核查冷藏冷冻设施设备的实际运转情况，重点检测温湿度监测系统的准确性并核对历史记录数据的完整性，确保冷链设备运行稳定、温控全程不断链。随机选取诊断试剂产品，现场追溯其采购资质审核、供货方票据留存及入库验收等环节的执行情况，严格核对票、账、货是否一致，确保产品全程温度可控。现场进行规范指导，强调有效期内、开封后产品的分区存放及使用时限要求，进一步规范操作细节。同时，执法人员深入了解了医疗器械唯一标识（UDI）在医疗机构诊疗环节的实际应用情况，督促相关单位严格落实主体责任。
此次共排查医疗机构34家，发现温湿度记录不完整、开封后产品未标注开封日期等问题，均已责令整改，并立案1起。
下一步，牡丹江市市场监管局将进一步加强医疗器械经营使用环节安全监管力度，强化产品追溯体系核查，加大高风险产品监督抽检力度，切实守护公众用械安全。（来源：黑龙江省牡丹江市市场监管局）
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