医疗器械编码，开始验证了...

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data-id="13006"><section><section><section><section><section><p><strong><span>医械监管工作进入新阶段</span></strong></p></section><section><p><br  /></p></section></section></section><section></section></section></section></section><section><span><span>据国家药监局、卫健委公布的文件显示，</span><span><span>从</span>8<span>月开始，将开始验证</span>“<span>医疗器械唯一</span></span><span>标识的创建和赋予</span><span>”<span>。</span></span><span>医疗器械身份证的新一轮工作启动在即，进入验证新阶段。</span><br  /></span></section><section><span></span></section><section><span>&nbsp;</span></section><section><span><span>目前，受到广泛关注的医疗器械唯一标识系统，已经确定试点品种和参与单位。</span><span>唯一标识系统试点工作部门协作工作小组已经成立，试点工作方案已经印发。</span></span></section><section><span>&nbsp;</span></section><section><span>经过组织开展试点的培训，启动试点工作在即。试点单位制定了实施方案，具体任务和措施也已经细化。</span></section><section data-style-type="1" data-tools="新媒体排版" data-id="13006"><section><section><section><section><section><p><strong><span>与医保结算和临床挂钩</span></strong></p></section><section><p><br  /></p></section></section></section><section></section></section></section></section><section><span><span>根据国家药监局发布《医疗器械唯一标识系统试点工作方案》可以看到，该标识将不仅涉及生产流通的全过程，在经销商十分关注的医保结算也将</span><span>“</span><span>登场</span><span>”</span><span>。</span><br  /></span></section><section><span></span></section><section><span>&nbsp;</span></section><section><span>将建立医疗器械唯一标识系统框架。实现医疗器械唯一标识的创建、赋予以及数据上传下载和共享功能，形成试点品种的医疗器械唯一标识数据库，建立唯一标识数据平台。</span></section><section><span>&nbsp;</span></section><section><span>在试用上环节上，将在医疗器械生产、经营、流通和使用等各环节的开始应用。</span></section><section><span>&nbsp;</span></section><section><span>众所周知，医疗器械经常不可避免的出现一些不良事件、产品召回等问题，唯一识别系统将开始试用其追踪追溯功能。</span></section><section><span>&nbsp;</span></section><section><span>需要指出的是，其在卫生、医保等领域唯一识别系统也将衔接与应用，将实现注册审批、临床应用、医保结算等信息平台的数据共享。</span></section><section><span>&nbsp;</span></section><section><span><span>由此可见，以后耗材招标、采购和支付环节将开始愈来愈透明化，这种透明也意味着监管更加细化和深化，有机可乘的环节将逐步减少。</span></span></section><section data-style-type="1" data-tools="新媒体排版" data-id="13006"><section><section><section><section><section><p><strong><span>高风险植入类医疗器械</span></strong><strong><span>先试点</span></strong></p></section><section><p><br  /></p></section></section></section><section></section></section></section></section><section><span>从最近公布的安排上可以看出，在试点品种上高风险的医疗器械将最先关注。方案里明确提及以心脏、颅脑植入物、假体类等高风险植（介）入类医疗器械为重点品种，同时覆盖不同种类的典型产品。<br  /></span></section><section><span>&nbsp;</span></section><section><span>对于医疗器械注册人，要按照唯一标识系统规则和标准，对其产品创建和赋予唯一标识，完成唯一标识数据库数据上传工作，向下游企业或者使用单位提供唯一标识信息，并建立唯一标识在产品追溯中的应用。</span></section><section><span>&nbsp;</span></section><section><span>同时，经营流通企业在经营流通业务中要应用唯一标识验证多码并行的操作性，与业务系统的对接操作流程。</span></section><section><span>&nbsp;</span></section><section><span>文件指出，此次编码是为了实现唯一标识在生产、经营、流通和使用中的示范应用，形成从源头生产到最终临床使用全链条联动。</span></section><section data-style-type="1" data-tools="新媒体排版" data-id="13006"><section><section><section><section><section><p><strong><span>医用耗材编码规则和方法</span></strong></p></section><section><p><br  /></p></section></section></section><section></section></section></section></section><section><span>编码标准如何规定的呢？国家医保局在《医保疾病诊断和手术操作、药品、医疗服务项目、医用耗材四项信息业务编码规则和方法》，对医保医用耗材编码做了展示：</span><br  /></section><section><span>&nbsp;</span></section><section><p><img src="image/20200927/964332bcc83fa9c48c8e057c638f735f_2.png" /></p></section><p><br  /></p><section><span><span><span>医保医用耗材编码分</span>5<span>个部分共</span>20<span>位，通过大写英文字母和阿拉伯数字按特定顺序排列表示。</span></span><span>其中第</span><span>1<span>部分是耗材标识码，第</span>2<span>部分是分类码，第</span>3<span>部分是通用名码，第</span>4<span>部分是产品特征码，第</span>5<span>部分是生产企业码。</span></span><span></span></span></section><section><span>&nbsp;</span></section><section><span><span><span>第</span>1<span>部分：</span></span><span>耗材标识码，用</span><span>1<span>位大写英文字母</span>“C”<span>表示。</span></span><span></span></span></section><section><span><span><span>第</span>2<span>部分：</span></span><span>分类码，根据医用耗材学科、用途、部位、功能划分，用</span><span>6<span>位阿拉伯数字表示。</span></span><span></span></span></section><section><span><span><span>第</span>3<span>部分：</span></span><span>通用名码，创建全国统一的医保医用耗材通用名码，用</span><span>3<span>位阿拉伯数字表示。</span></span><span></span></span></section><section><span><span><span>第</span>4<span>部分：</span></span><span>产品特征码，根据耗材材质、规格等特征赋予的代码，用</span><span>5<span>位阿拉伯数字表示。</span></span><span></span></span></section><section><span><span><span>第</span>5<span>部分：</span></span><span>生产企业码，依据医疗器械注册证或备案凭证为耗材生产企业赋予的唯一代码，用</span></span><span>5<span>位阿拉伯数字表示。</span></span></section><section data-style-type="1" data-tools="新媒体排版" data-id="13006"><section><section><section><section><section><section><strong><span>终结</span></strong></section><strong><span>乱序，重构行业</span></strong></section></section></section><section></section></section><p><br  /></p></section></section><section><span>以前，医院对很多环节的检验普遍依赖于人工方式，长期存在产品注册备案编号、集中采购编码、医疗机构信息系统编码、医保收费编码等多码共存的情况，各环节编码自成体系。造成了严重的信息不对称、行迹不透明等问题，对医疗器械的监管治理很不利。<br  /></span></section><section><span>&nbsp;</span></section><section><span>此次全国正式统一实施唯一器械标识，意味着将打通这最后一层限制，实现全国，乃至与全球范围内医疗器械监管统一。一械一码，以唯一器械标识为手段，就相当于任何一个医疗器械都有了唯一一张“身份证”。</span><span></span></section><section><span>&nbsp;</span><span></span></section><section data-style-type="7" data-tools="新媒体排版" data-id="9067"><section powered-by="gulangu"><section><section><p><img src="image/20200927/c7659f7b519a2301d75b97e695e65186_3.gif" /></p></section></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><section><span>来源：</span><span>赛柏蓝器械</span></section><section><span>免责声明：本文著作权属原创者所有，不代表本微信号立场。我们转载此文出于传播更多资讯之目的，如涉著作权事宜请联系删除。</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br  /></p>