{"errCode":0,"errMsg":"success","timeStamp":"1780913847","data":{"trueId":"4899916394581073278","title":"国家医疗器械不良事件监测年报发布","author":[],"tags":[],"detail":"\u003cp\u003e□ 闫若瑜\u003c/p\u003e\u003cp\u003e4月7日，国家药品不良反应监测中心发布《国家医疗器械不良事件监测年度报告（2022年）》（以下简称《年报》）。《年报》显示，2022年，国家医疗器械不良事件监测信息系统接收到医疗器械不良事件报告69万余份，28个省（区、市）的医疗器械不良事件报告县级覆盖率达到100%。\u003c/p\u003e\u003cp\u003e《年报》指出，2022年，我国医疗器械不良事件监测工作坚持“科学评价为基础，风险管理为主线，服务患者为中心”，持续加强制度体系建设，探索医疗器械警戒制度研究，不断拓展宣传培训方式，深入研究监测评价新工具、新标准、新方法，全面提升风险预警和处置能力，医疗器械不良事件监测工作取得了新进展。\u003c/p\u003e\u003cp\u003e报告收集工作稳步推进\u003c/p\u003e\u003cp\u003e2022年，全国医疗器械不良事件报告数量和每百万人口平均报告数量稳步提升。《年报》显示，国家医疗器械不良事件监测信息系统接收到医疗器械不良事件报告694866份，比2021年增加6.79%；每百万人口平均报告数为493份，比2021年增加6.94%。\u003c/p\u003e\u003cp\u003e根据《年报》，医疗器械不良事件监测信息系统基层注册用户［包括注册人和备案人（以下简称注册人）］数量持续提升。截至2022年12月31日，在国家医疗器械不良事件监测信息系统中注册的基层用户达到39万余家，比上年增长5.43%。其中，医疗器械注册人达3万余家，比上年增长7.51%。\u003c/p\u003e\u003cp\u003e从报告来源看，使用单位上报60.8万份，占报告总数的87.43%；注册人上报1.6万份，占报告总数的2.32%；经营企业上报7万余份，占报告总数的10.20%。\u003c/p\u003e\u003cp\u003e从医疗器械管理类别看，涉及第三类医疗器械的报告24.4万份，占报告总数的35.14%；涉及第二类医疗器械的报告33万份，占报告总数的47.45%；涉及第一类类医疗器械的报告5.8万份，占报告总数的8.36%。\u003c/p\u003e\u003cp\u003e《年报》显示，医疗器械不良事件报告涉及医疗器械分类目录中的所有类别。不良事件报告数量排名前五位的类别为：注输、护理和防护器械，医用诊察和监护器械，物理治疗器械，临床检验器械，呼吸、麻醉和急救器械。\u003c/p\u003e\u003cp\u003e监测评价能力持续提升\u003c/p\u003e\u003cp\u003e《年报》显示，2022年，全国医疗器械不良事件评价处置工作持续开展，系统运用日常监测、预警分析及季度汇总等手段，确保及时发现、评价并处置风险。国家药品不良反应监测中心密切跟踪全球医疗器械监管情况，全年发布12期《医疗器械警戒快讯》，汇总美国、英国、澳大利亚、加拿大发布的包括呼吸机、吻合器、覆膜支架、除颤仪、新冠病毒检测试剂等医疗器械在内的共86条安全性信息，为我国开展相关医疗器械的安全性评价和风险控制提供参考借鉴。\u003c/p\u003e\u003cp\u003e《年报》介绍了重点监测工作推进情况，包括按工作方案要求全面推进重点监测工作，审核37个医疗器械品种不良事件重点监测实施方案，认定105家第一批国家医疗器械不良事件监测哨点，组织召开重点监测专家研讨及工作推进会等。\u003c/p\u003e\u003cp\u003e同时，专项检查也在持续开展。《年报》显示，2022年，国家药品不良反应监测中心组织对18家企业开展了医疗器械不良事件监测专项检查，并督促注册人对检查发现的缺陷完成整改。\u003c/p\u003e\u003cp\u003e《年报》指出，2022年，我国深入探索医疗器械警戒制度研究，积极参与国际交流合作。国家药品不良反应监测中心承担中国药品监管科学行动计划第二批重点项目医疗器械警戒技术和方法研究，聚焦医疗器械警戒制度研究和高风险、植入类医疗器械主动监测中的关键技术，持续提高警戒智能化和现代化监测评价能力。同时，积极参加国际医疗器械监管机构论坛（IMDRF）相关会议，有序开展国家监管机构报告（NCAR）信息交换工作，持续跟踪不良事件术语和编码（AET）项目组工作进展，促进医疗器械不良事件监测工作国际交流与合作。\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003ch4\u003e\u003c/h4\u003e","createdAt":1681787959,"updatedAt":1681787960,"source":0,"reprintedUrl":"http://bk.cnpharm.com/zgyyb/2023/04/18/318887.html","type":0,"vShowStyle":0,"transCodingObjKey":"https://img.hubpd.com/hubpd/643e0c387969990001cdaa32","transCodingObjKeyMp4":"https://img.hubpd.com/hubpd/","mpIcon":"https://img.hubpd.com/hubpd/ad28ec10-c530-11ec-be45-ce7461699b21.png","mpName":"中国医药报","mpIsVerified":true,"mpId":"60209","covers":[],"coversType":0,"blurImage":"","publishedAt":1681747200,"classificationName":"社会","tap":983,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"4899916394581073278|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":[],"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},"hisHots":{"hotData":null,"mpName":"中国医药报","mpIcon":"https://img.hubpd.com/hubpd/ad28ec10-c530-11ec-be45-ce7461699b21.png","mpIntro":"国家药品监督管理局直属行业报纸","mpId":"60209","mpIsVerified":true},"similar":[{"trueId":"864691128460240230","title":"医疗器械警戒质量管理规范发布，17省份试行","author":null,"tags":null,"source":0,"reprintedUrl":"https://www.cnpharm.com/c/2026-04-14/1094918.shtml","type":0,"vShowStyle":0,"mpIcon":"https://img.hubpd.com/hubpd/ad28ec10-c530-11ec-be45-ce7461699b21.png","mpName":"中国医药报","mpIsVerified":false,"mpId":"60209","covers":null,"coversType":0,"blurImage":"","publishedAt":1776145260,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"864691128460240230|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":null,"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},{"trueId":"8935141660708171635","title":"多项医疗器械警戒技术文件发布","author":null,"tags":null,"source":0,"reprintedUrl":"http://bk.cnpharm.com/zgyyb/2026/04/18/324451.html","type":0,"vShowStyle":0,"mpIcon":"https://img.hubpd.com/hubpd/ad28ec10-c530-11ec-be45-ce7461699b21.png","mpName":"中国医药报","mpIsVerified":false,"mpId":"60209","covers":null,"coversType":0,"blurImage":"","publishedAt":1776441600,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"8935141660708171635|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":null,"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},{"trueId":"2594073385370311576","title":"医疗器械警戒质量管理规范发布","author":null,"tags":null,"source":0,"reprintedUrl":"http://bk.cnpharm.com/zgyyb/2026/04/16/324430.html","type":0,"vShowStyle":0,"mpIcon":"https://img.hubpd.com/hubpd/ad28ec10-c530-11ec-be45-ce7461699b21.png","mpName":"中国医药报","mpIsVerified":false,"mpId":"60209","covers":null,"coversType":0,"blurImage":"","publishedAt":1776268800,"tap":0,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"2594073385370311576|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":null,"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},{"trueId":"8070450532253179909","title":"国家药品不良反应监测年度报告（2025年）（摘登）","author":null,"tags":null,"source":0,"reprintedUrl":"http://bk.cnpharm.com/zgyyb/2026/05/14/324685.html","type":0,"vShowStyle":0,"mpIcon":"https://img.hubpd.com/hubpd/ad28ec10-c530-11ec-be45-ce7461699b21.pn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