近日,广西壮族自治区食品药品监督管理局、卫生厅联合制定《广西壮族自治区医疗机构医疗器械专项检查方案》并下发通知,要求全区各地食品药品监管和卫生部门深入开展医疗机构医疗器械专项检查,重点检查医疗、美容机构在用第三类医疗器械(植入人体,用于支持、维持生命、对人体具有潜在危险,对其安全性、有效性必须严格控制)购进渠道的合法性、产品合法性、医疗器械可追溯性和不良事件监测的情况,及时消除监管风险隐患和产品质量安全隐患,不断提高医疗器械质量安全水平。
此次专项检查的对象包括全区二级(含二级)以上公立医疗机构、各级民营医疗机构、各级开展医疗美容业务的医疗机构、各级使用医疗器械的美容机构。主要检查三个方面:一是医疗、美容机构是否留存在用第三类医疗器械生产、经营企业的合法证明及产品资质证明,包括购进记录是否完整,《医疗器械生产企业许可证》、《医疗器械经营企业许可证》、《企业法人营业执照》及《医疗器械产品注册证》是否合法有效;二是医疗、美容机构是否安排专人对在用第三类医疗器械进行日常维护保养及维修,并留存保养记录和维修记录;由厂家保修的在用第三类医疗器械是否留存厂家的保养记录和维修记录;三是医疗、美容机构是否安排专人负责开展在用医疗器械不良事件监测工作。
通知要求突出重点,严格执法,做到问题不解决不放过,风险未排除不放过,整改不到位不放过。对违法违规行为,要立即立案查处,涉及刑事犯罪的及时移送公安机关。同时,要针对辖区内各级医疗、美容机构开展专项检查自查、检查情况、工作成效、存在的薄弱环节、整改措施和结果进行全面总结,对工作中发现的问题及时纠正或查处,对涉及系统性风险的问题认真梳理排查,采取有效措施加以防范,确保全区各级医疗、美容机构在用医疗器械安全有效。
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