转自:中国质量报
本报讯 (记者秦海峰)近日,山西省朔州市市场监管局联合朔州市市场监管综合执法队,对医疗机构检验科室冷链管理和经营冷链供应的企业开展专项检查,规范冷链医疗器械使用行为,排查化解安全风险。
此次检查覆盖市、县两级二级以上公立医疗机构9家,重点围绕资质审核、进货查验、在途运输、贮存使用四大环节从严监管。比如,在进货环节,核查上游供货企业资质、发票,随货同行、运输过程中的温湿度记录等,确保试剂等器械质量安全;在医院贮存使用环节,检查专用冷藏及电子温湿度设备运行试剂保质期等情况,确保贮存条件符合标准。
对于此次专项检查中发现的过期试剂问题,执法人员已移交当地市场监管局立案查处,以刚性执法压实主体责任。对于市区4家经营冷链业务的企业,执法人员除检查上游供货方和公司储存方式外,还就远程温湿度计、冷藏室、保温箱是否按规定检验验证,是否配备应急发电设备、断电时能否第一时间接收到信息、能否正常发电,应急预案是否周密、是否符合本企业实际情况等进行了核查。执法人员对1家备用电设备存在故障的企业责令暂停冷链相关业务,要求整改完成验收合格后再行经营,对发现的其他轻微问题现场要求立即改正。
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