【网络辟谣】一台手术用破四个球囊？啥情况？国家医保局调查回应
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今年8月，有媒体发布题为《一台手术用破四个球囊！业内呼吁“低价中标”理念应客观评价》的报道，其中提到某心内科专家说：“集采招标后，球囊质量怎么样也仍需评价。最近我做了一个病人，连用了四个球囊都破裂了，造成血管穿孔，这在以前是不存在的”。为回应社会关切，国家医保局有关司负责人就相关情况回答了记者提问。
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<strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">针对媒体报道“一台手术用破四个球囊”的情况，有关部门开展了哪些调查工作？具体情况是怎样的？</strong>
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看到媒体报道后，有关部门迅速对报道提及的问题进行了调查核实。<strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 20px;box-sizing: border-box !important;overflow-wrap: break-word !important;">一是</span></strong>医保部门核实了媒体报道病例的有关情况，并向所在医疗机构调阅相关病案，了解破裂球囊产品的品牌、型号、批次等基本情况。<span style="outline: 0px;max-width: 100%;font-size: 20px;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">二是</strong></span>由首都医科大学国家医疗保障研究院组织全国范围内10名心血管领域专家，就该病例背对背开展了独立的“双盲”评议，从术中医疗器械使用方面调查球囊破裂原因。<span style="outline: 0px;max-width: 100%;font-size: 20px;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">三是</strong></span>国家药监局按照医疗器械质量抽查检验有关规定，委托上海市药监局、广东省药监局分别对相关产品开展质量抽查检验。
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经核实，媒体报道提到的发生多个球囊破裂的手术，为2021年8月3日复旦大学附属中山医院开展的一台冠脉支架植入手术，术者为心内科负责人。该例手术共使用14个冠脉球囊，破裂5个，其中1个为美敦力（上海）管理有限公司代理进口的产品，4个为广东博迈医疗科技有限公司生产的产品。上海市冠脉球囊类医用耗材集中带量采购于2021年6月9日公布中选结果，7月30日落地实施。<span style="outline: 0px;max-width: 100%;color: rgb(171, 25, 66);box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">上述两家企业为上海市冠脉球囊集采中选企业，但破裂的5个球囊生产日期均为2021年5月，在集采开展之前。</strong></span>
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产品质量调查结果显示，<strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(171, 25, 66);box-sizing: border-box !important;overflow-wrap: break-word !important;">相关批次冠脉球囊抽检符合质量标准，未发现相关企业在生产记录、供应商审核、来料检验等质量管理方面存在问题。</span></strong>此外，经查询医疗器械不良事件监测相关记录，未接到相关医疗器械不良事件的反馈信息。
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从病案评议情况看，专家认为，由于患者血管重度弥漫性钙化，冠脉球囊扩张时易被钙化部位扎破，<strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(171, 25, 66);box-sizing: border-box !important;overflow-wrap: break-word !important;">球囊连续破裂与球囊质量无关，而与病变及手术操作有关</span></strong>；专家排除了球囊破裂导致血管穿孔的可能性，普遍认为血管损伤与术中操作有一定关系。同时，该例手术还存在术前评估不充分、病案记录不完善等问题。
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<strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">02</strong>
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<strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">调查过程中，病例所在医院在事件处理和规范诊疗等方面做了哪些工作？</strong>
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在媒体报道事件调查过程中，复旦大学附属中山医院积极配合，提供了涉及病例的完整病案，并组织对相关医务人员临床诊疗规范等有关情况开展了自查。近日，上海市医保局等有关部门履行医药采购和医疗器械监管职责，对该院进行了约谈，通报了关于冠脉球囊质量的调查结果。
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该院表示，<strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(171, 25, 66);box-sizing: border-box !important;overflow-wrap: break-word !important;">认可有关部门和专家组的调查结论，针对个别医务人员对外发表不准确评论等问题，将加强内部管理，规范临床诊疗行为，提高医疗质量。</span></strong>该院将认真落实党中央、国务院关于集中带量采购改革的部署要求，维护医疗器械监管秩序，加强医务人员思想政治工作，主动消除不良影响。
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<strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">03</strong>
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<strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">集采降低药品耗材虚高价格后，广大群众对中选产品的质量非常关注。能否介绍一下有关部门在质量保障方面作了哪些工作，下一步还有什么考虑？</strong>
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在集中带量采购工作中，我们对质量问题始终坚持“零容忍”态度，以严格的规则和制度设计确保中选产品质量安全。目前，国家层面已组织开展6批药品集采、2批高值医用耗材集采。药监部门将所有中选产品列入监管重点，按照“四个最严”要求开展全周期、全覆盖监管，压实企业主体责任，严守质量安全底线，确保“降价不降质”。<strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(171, 25, 66);box-sizing: border-box !important;overflow-wrap: break-word !important;">截至目前，药监部门对中选药品和冠脉支架的全覆盖监督检查和质量抽检，未发现违法违规情况。</span></strong>近期，国内20家知名三甲医院针对第一批国家组织药品集采部分中选仿制药开展的大规模真实世界研究评价显示，<strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(171, 25, 66);box-sizing: border-box !important;overflow-wrap: break-word !important;">中选仿制药与原研药相比临床疗效和安全性一致</span></strong>。下一步，有关部门将进一步加强政策协同和工作配合，并支持医疗机构持续开展中选产品临床疗效和安全性评价，确保集采中选产品质量安全，保障人民群众获得高质量、有效率、能负担的医药卫生服务。
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最后，我们欢迎社会各界秉承客观、严谨、务实的工作态度和职业操守，对我们的工作进行监督，共同维护医药集中采购和医疗器械监管秩序。同时，我们也呼吁包括医疗机构、医务人员、医药企业在内的各方正确看待集中带量采购改革，共同营造风清气正的医药购销和行医环境，真正造福广大群众。
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<span style="outline: 0px;max-width: 100%;font-size: 14px;color: rgb(136, 136, 136);box-sizing: border-box !important;overflow-wrap: break-word !important;"></span><span style="outline: 0px;max-width: 100%;letter-spacing: 0.544px;font-size: 14px;color: rgb(136, 136, 136);box-sizing: border-box !important;overflow-wrap: break-word !important;">来源</span><span style="outline: 0px;max-width: 100%;letter-spacing: 0.544px;font-size: 14px;color: rgb(136, 136, 136);box-sizing: border-box !important;overflow-wrap: break-word !important;">：互联网联合辟谣平台</span>
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<span style="max-width: 100%;letter-spacing: 0.544px;font-size: 18px;font-family: 宋体;box-sizing: border-box !important;overflow-wrap: break-word !important;">编辑：</span><span style="letter-spacing: 0.544px;max-width: 100%;font-family: 宋体;font-size: 18px;box-sizing: border-box !important;overflow-wrap: break-word !important;">杨</span><span style="letter-spacing: 0.544px;max-width: 100%;font-size: 18px;font-family: 宋体;box-sizing: border-box !important;overflow-wrap: break-word !important;"> 扬</span>
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<span style="letter-spacing: 0.544px;max-width: 100%;font-size: 18px;font-family: 宋体;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="letter-spacing: 0.544px;"><span style="letter-spacing: 0.544px;">主编：</span>陈友海</span> </span>
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