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<section class="" data-tools="gulangu" data-id="87810" data-color="rgb(30, 155, 232)" style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><section class="" style="margin-top: 10px; margin-right: auto; margin-left: auto; max-width: 100%; box-sizing: border-box; border: 1px solid rgb(204, 204, 204); border-top-right-radius: 10px; border-bottom-left-radius: 10px; word-wrap: break-word !important;"><p style="padding-bottom: 3px; max-width: 100%; box-sizing: border-box; width: 634.909px; border-bottom-width: 1px; border-bottom-style: solid; border-bottom-color: rgb(30, 155, 232); line-height: 2em; word-wrap: break-word !important;"><span data-width="16px" style="max-width: 100%; display: inline-block; width: 16px; height: 32px; vertical-align: middle; color: rgb(255, 255, 255); box-sizing: border-box !important; word-wrap: break-word !important; background: rgb(30, 155, 232);"></span><span class="" data-brushtype="text" style="max-width: 100%; font-size: 18px; color: rgb(30, 155, 232); box-sizing: border-box !important; word-wrap: break-word !important;"> 导读</span></p><section class="" style="margin-top: 10px; padding-right: 20px; padding-bottom: 25px; padding-left: 20px; max-width: 100%; box-sizing: border-box; font-size: 14px; color: rgb(66, 66, 66); word-wrap: break-word !important;"><p style="max-width: 100%; min-height: 1em; white-space: normal; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;"> 我国目前有不少二手医疗器械进入市场，仅仅靠《医疗器械监督管理条例》第四十一条规定还不能解决目前二手医疗器械回收、翻新、维修、转让和销售等问题，应及时出台相关法律法规来规范。</span></p></section></section></section><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p><br /></p><section class="" data-color="rgb(30, 155, 232)" style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"> 笔者在日常检查中发现，辖区一家社区服务中心使用的生化分析仪是该市某大型医院无偿提供给其使用的。经调查，这台生化分析仪是该大型医院原来使用的设备，由于业务发展需要，医院购进了一台新的生化分析仪，便将淘汰更换下来的生化分析仪无偿提供给与其有合作关系的社区服务中心使用。转手过程中的拆卸和安装费用由社区服务中心承担。此后,这台生化分析仪未经任何检验就投入使用。</span></p><section class="" data-tools="gulangu" data-id="8" data-color="rgb(30, 155, 232)" style="max-width: 100%; box-sizing: border-box; color: rgb(62, 62, 62); line-height: 21.3333px; white-space: normal; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><p style="margin-top: 10px; margin-bottom: 10px; padding-bottom: 5px; max-width: 100%; min-height: 1em; white-space: normal; color: rgb(30, 155, 232); font-weight: bolder; font-size: 24px; border-bottom-width: 1px; border-bottom-style: dotted; border-color: rgb(30, 155, 232); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important;">淘汰定义之争</p></section><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"> 社区服务中心使用医院淘汰下来的老旧医疗器械，这样的器械能否保证安全有效？有稽查人员认为应将社区服务中心的行为定性为使用淘汰医疗器械，理由是：《医疗器械监督管理条例》(国务院令<span style="max-width: 100%; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">650</span>号<span style="max-width: 100%; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">)</span>第六十六条规定，“有下列情形之一的，由县级以上人民政府食品药品监督管理部门责令改正，没收违法生产、经营或者使用的医疗器械……<span style="max-width: 100%; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">(</span>三<span style="max-width: 100%; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">)</span>经营、使用无合格证明文件、过期、失效、淘汰的医疗器械，或者使用未依法注册的医疗器械的。”</span></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"> 还有执法人员认为，社区服务中心使用大型医院淘汰下来的医疗器械行为合法。此处的“淘汰”，与法律法规中所指的“淘汰医疗器械”不能等同，本案中的生化分析仪是有证合法的医疗器械，社区服务中心使用这样的医疗器械合法合理。</span></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"> 第三种意见认为，社区服务中心的行为应该定性为使用无合格证明的医疗器械。本案中“淘汰”的生化分析仪已经使用多年，该器械所附的原合格证明已经不能证明其是否符合医疗器械相关标准，也就是说，原合格证明已经无效，所以该器械应该定性为无合格证明的医疗器械。</span></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><br /></span></p><p style="text-align:center"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhvc5y2cAfeY3M8ap1xBlKRL355jlAsJ7QS8RSYz9StnrDQSzVs82ajaicHvdcnyWIRfrCXFkFLw1Yqw/0?wx_fmt=jpeg" data-ratio="0.5200945626477541" data-w="423" /><br /></span></p><p style="text-align:center"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><br /></span></p><section class="" data-tools="gulangu" data-id="8" data-color="rgb(30, 155, 232)" style="max-width: 100%; box-sizing: border-box; color: rgb(62, 62, 62); line-height: 21.3333px; white-space: normal; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><p style="margin-top: 10px; margin-bottom: 10px; padding-bottom: 5px; max-width: 100%; min-height: 1em; white-space: normal; color: rgb(30, 155, 232); font-weight: bolder; font-size: 24px; border-bottom-width: 1px; border-bottom-style: dotted; border-color: rgb(30, 155, 232); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important;">此“淘汰”非彼“淘汰”</p></section><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; line-height: inherit; box-sizing: border-box !important; word-wrap: break-word !important;"> </span><span style="max-width: 100%; font-family: 宋体; font-size: 14px; line-height: inherit; box-sizing: border-box !important; word-wrap: break-word !important;"> 无论是修订前的《医疗器械监督管理条例》</span><span style="max-width: 100%; font-family: 宋体; font-size: 14px; line-height: inherit; box-sizing: border-box !important; word-wrap: break-word !important;">(</span><span style="max-width: 100%; font-family: 宋体; font-size: 14px; line-height: inherit; box-sizing: border-box !important; word-wrap: break-word !important;">国务院令</span><span style="max-width: 100%; font-size: 14px; line-height: inherit; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">276</span><span style="max-width: 100%; font-family: 宋体; font-size: 14px; line-height: inherit; box-sizing: border-box !important; word-wrap: break-word !important;">号</span><span style="max-width: 100%; font-size: 14px; line-height: inherit; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">)</span><span style="max-width: 100%; font-family: 宋体; font-size: 14px; line-height: inherit; box-sizing: border-box !important; word-wrap: break-word !important;">还是修订后的《医疗器械监督管理条例》</span><span style="max-width: 100%; font-size: 14px; line-height: inherit; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">(</span><span style="max-width: 100%; font-family: 宋体; font-size: 14px; line-height: inherit; box-sizing: border-box !important; word-wrap: break-word !important;">国务院令</span><span style="max-width: 100%; font-size: 14px; line-height: inherit; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">650</span><span style="max-width: 100%; font-family: 宋体; font-size: 14px; line-height: inherit; box-sizing: border-box !important; word-wrap: break-word !important;">号</span><span style="max-width: 100%; font-size: 14px; line-height: inherit; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">)</span><span style="max-width: 100%; font-family: 宋体; font-size: 14px; line-height: inherit; box-sizing: border-box !important; word-wrap: break-word !important;">，都对经营使用淘汰医疗器械这一违法行为设立了罚责，却没有明确给出淘汰医疗器械的定义。</span></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"> 我们习惯于将医疗机构由于发展需要而被新设备替换下来的老设备称之为淘汰医疗器械。那么，《医疗器械监督管理条例》中所表述的“淘汰”与我们日常生活中所说的“淘汰”含义是否相同呢？</span></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"> 《医疗器械监督管理条例》(国务院令<span style="max-width: 100%; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">650</span>号<span style="max-width: 100%; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">)</span>第六十六条规定中的“淘汰”，是指由于落后的产能或与现代医学不配套而不再适宜用于临床或者是不良事件频发而被禁止使用的医疗器械，“淘汰”这一动作的指令发出者是国家机关或行业协会，具有全国性、统一性。我们平常所说的医疗机构“淘汰”下来的医疗器械，是指医疗机构为了提高自身硬件条件的需要，用更先进的医疗器械替换原来的医疗器械，这个“淘汰”的动作指令发出者是医疗机构，具有单一性和针对性。</span></p><section class="" data-tools="gulangu" data-id="8" data-color="rgb(30, 155, 232)" style="max-width: 100%; box-sizing: border-box; color: rgb(62, 62, 62); line-height: 21.3333px; white-space: normal; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><p style="margin-top: 10px; margin-bottom: 10px; padding-bottom: 5px; max-width: 100%; min-height: 1em; white-space: normal; color: rgb(30, 155, 232); font-weight: bolder; font-size: 24px; border-bottom-width: 1px; border-bottom-style: dotted; border-color: rgb(30, 155, 232); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important;">上述两个“淘汰”的区别在于</p></section><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"> 1.动作发出者不同，法条所指的淘汰动作发出者是国家机关或行业协会，平常所说的淘汰动作发出者是医疗器械使用单位；</span></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"> 2.淘汰原因不同，前者是为了安全有效，后者是为了发展；</span></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"> 3.结果不同，前者在全国范围内都不得再使用，而后者还具有一定的使用价值，依然能为医疗机构提供服务。</span></p><section class="" data-tools="gulangu" data-id="8" data-color="rgb(30, 155, 232)" style="max-width: 100%; box-sizing: border-box; color: rgb(62, 62, 62); line-height: 21.3333px; white-space: normal; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><p style="margin-top: 10px; margin-bottom: 10px; padding-bottom: 5px; max-width: 100%; min-height: 1em; white-space: normal; color: rgb(30, 155, 232); font-weight: bolder; font-size: 24px; border-bottom-width: 1px; border-bottom-style: dotted; border-color: rgb(30, 155, 232); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important;">不允许翻新上市</p></section><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;"> 虽然本案中的医疗器械不属于法律法规禁止经营和使用的淘汰医疗器械，但这样的器械在法律法规框架下是不允许翻新组装重新上市的。</span></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"> 国家食品药品监管局在《关于上海成田医疗设备有限公司翻新组装医疗器械处理问题的批复》(国食药监市<span style="max-width: 100%; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">[2005]79</span>号<span style="max-width: 100%; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">)</span>中明确规定：“……利用回收旧医疗器械的可用零部件及新采购的管路等零部件，翻新组装医疗器械的活动，无论是作为维修备用机还是用于销售，客观上都形成了将旧部件组装成新机的事实，属于生产行为。持有《医疗器械经营企业许可证》的企业，应在许可范围内从事经营活动。若从事医疗器械生产活动，必须取得《医疗器械生产企业许可证》。取得《医疗器械生产企业许可证》的企业生产的医疗器械，还必须依据规定办理注册，没有注册的医疗器械不得在中国销售使用。”可见，当时国家层面对这一问题的态度非常明确：翻新组装医疗器械行为不被允许，如果需要翻新组装医疗器械，必须取得生产许可和产品注册。但国内至今并无翻新组装的产品获得过产品注册证书，所以目前翻新组装医疗器械的行为并不合法。</span></p><section class="" data-tools="gulangu" data-id="8" data-color="rgb(30, 155, 232)" style="max-width: 100%; box-sizing: border-box; color: rgb(62, 62, 62); line-height: 21.3333px; white-space: normal; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><p style="margin-top: 10px; margin-bottom: 10px; padding-bottom: 5px; max-width: 100%; min-height: 1em; white-space: normal; color: rgb(30, 155, 232); font-weight: bolder; font-size: 24px; border-bottom-width: 1px; border-bottom-style: dotted; border-color: rgb(30, 155, 232); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important;">允许转让在用医械</p></section><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"> 近年，我国的医疗条件得到了极大改善，大型设备的更新频率加大，有不少被大型医疗机构更新下来的尚可使用的医疗器械重新进入市场，但这些更换下来的大型设备并没有法律法规来规范它们的回收、翻新、维修、转让和销售行为。在《医疗器械监督管理条例》修订时考虑到了规范这类医疗器械的流转问题。《医疗器械监督管理条例》(国务院令<span style="max-width: 100%; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">650</span>号<span style="max-width: 100%; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">)</span>第四十一条规定：“医疗器械使用单位之间转让在用医疗器械，转让方应当确保所转让的医疗器械安全、有效，不得转让过期、失效、淘汰以及检验不合格的医疗器械。”</span></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"> 本案中的情形属于使用单位之间转让在用医疗器械，按照《医疗器械监督管理条例》的规定，某大型医院应当确保所转让的医疗器械安全、有效。上述第三种意见所认为的“原合格证明已无效，所以应定性为无合格证明医疗器械”不完全正确。从《医疗器械监督管理条例》<span style="max-width: 100%; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">(</span>国务院令<span style="max-width: 100%; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">650</span>号<span style="max-width: 100%; font-family: 'Times New Roman'; box-sizing: border-box !important; word-wrap: break-word !important;">)</span>第四十一条规定可以看出，转让在用医疗器械的行为是被允许的，也并没有要求重新出具合格证明，但必须保证转让的医疗器械安全、有效。如果转让的医疗器械过期、失效、淘汰或者经检验不合格，可以适用《医疗器械监督管理条例》第六十七条进行处罚。</span></p><p style="max-width: 100%; min-height: 1em; white-space: normal; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;"> 目前，我国有不少被更换下来的医疗器械进入市场，仅仅靠《医疗器械监督管理条例》第四十一条规定进行约束，还不能解决目前二手医疗器械回收、翻新、维修、转让和销售问题。笔者建议，国家应及时出台相关法律法规来规范二手医疗器械。</span></p><p style="line-height: 2em;"><span style="max-width: 100%; font-size: 14px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;"><br /></span></p></section><p><br /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: Arial, Verdana, sans-serif; font-size: 14px; line-height: 24px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(249, 249, 249);">广州市设备维修有限公司</span></p><p style="max-width: 100%; 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发表于 2020-10-19 23:45:12