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<p><span style="font-family: 微软雅黑; font-size: 14px; line-height: 30px;"><img src="http://mmbiz.qpic.cn/mmbiz/A1DicCH9Vl6NUXQmXic84hmOAHRbLG9r89sNItMiavFpp7gM4PQZFx1Rd4koXyxicbibkyFUWuob0Ut261JMNVFH4Qw/0" style="font-family: 微软雅黑; line-height: 28px; text-indent: 32px; white-space: normal;" data-ratio="0.25" data-w="400" /></span></p><p><span style="font-family: 微软雅黑; font-size: 14px; line-height: 30px;">宜兴市药监局近日在对医疗机构的专项检查中发现，宜兴一家医院使用的西门子X射线诊断系统，是无注册证医疗器械，且是大医院淘汰的旧设备。据了解，由于二手医疗设备的市场需求大，目前类似的私下交易并不少见。</span><br style="margin: 0px; padding: 0px; border: 0px; font-family: 微软雅黑; font-size: 14px; line-height: 30px; white-space: normal;" /><span style="font-family: 微软雅黑; font-size: 14px; line-height: 30px;"> 租用的设备是无注册证医疗器械</span><br style="margin: 0px; padding: 0px; border: 0px; font-family: 微软雅黑; font-size: 14px; line-height: 30px; white-space: normal;" /><span style="font-family: 微软雅黑; font-size: 14px; line-height: 30px;"> 宜兴这家乡镇医院使用的西门子X射线诊断系统，是上海某医疗器械公司提供的，并收取安装调试费及6年的设备使用费。经调查，设备的部分部件是该医疗器械公司从上海某医院回收取得，其他部件是该医疗器械公司向安徽某医院通过拍卖形式购得的报废品。2012年6月，该医疗器械公司将这些废旧设备的零部件运至宜兴某医院，在未取得《医疗器械生产企业许可证》及西门子X射线诊断系统《医疗器械注册证》的情况下，进行组装并调试，2012年10月，医院将该设备正式投入临床使用。</span><br style="margin: 0px; padding: 0px; border: 0px; font-family: 微软雅黑; font-size: 14px; line-height: 30px; white-space: normal;" /><span style="font-family: 微软雅黑; font-size: 14px; line-height: 30px;"> 根据规定，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，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。对此，宜兴药监局确认上述西门子X射线诊断系统为无注册证医疗器械。目前，该案正在进一步调查处理中。</span><br style="margin: 0px; padding: 0px; border: 0px; font-family: 微软雅黑; font-size: 14px; line-height: 30px; white-space: normal;" /><span style="font-family: 微软雅黑; font-size: 14px; line-height: 30px;"> 期待开放二手医疗设备市场交易</span><br style="margin: 0px; padding: 0px; border: 0px; font-family: 微软雅黑; font-size: 14px; line-height: 30px; white-space: normal;" /><span style="font-family: 微软雅黑; font-size: 14px; line-height: 30px;"> 记者在采访中了解到，这套西门子X射线诊断系统系原装进口，主要部件是上海一家大医院更新换代后淘汰下来的。“大医院一套设备用个3-5年就会升级换代，十分常见。原来使用的设备仍有使用价值，但大医院需要功能更强大的新设备，旧设备不能直接卖给其他医疗机构，只能当废品处理。但实际上，这些设备仍可以使用，而且比一些国产的新设备更好用。”</span><br style="margin: 0px; padding: 0px; border: 0px; font-family: 微软雅黑; font-size: 14px; line-height: 30px; white-space: normal;" /><span style="font-family: 微软雅黑; font-size: 14px; line-height: 30px;"> 据医疗界业内人士透露，关于二手医疗设备的处理，一直让各家医疗机构头疼。“公立大医院淘汰下来的二手设备当白菜贱卖，这也是国有和集体资产的一种流失，而小医院急需购买使用却不能办理合法手续买卖。”该业内人士称，二手医疗设备的市场巨大，却苦于目前国家没有相应法律法规进行规范。由于基层呼声不断，数年前相关部门曾计划制订二手医疗设备交易的征求意见稿，但由于种种原因至今被搁置。</span><br style="margin: 0px; padding: 0px; border: 0px; font-family: 微软雅黑; font-size: 14px; line-height: 30px; white-space: normal;" /><span style="font-family: 微软雅黑; font-size: 14px; line-height: 30px;"> 对此，不少医疗界人士呼吁，尽早出台相关法律法规，开放二手医疗设备市场交易，由专业鉴定机构对二手设备根据使用年限和频率等进行价格评估，通过规范的手段来制约目前的“潜规则”交易。</span></p><p style=""><span style="max-width: 100%; color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; line-height: 24px; background-color: rgb(231, 240, 247); word-wrap: break-word !important; box-sizing: border-box !important;"><span style="max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><span style="max-width: 100%; font-size: 15px; line-height: 26px; text-align: -webkit-center; background-color: rgb(255, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;"><img src="http://mmbiz.qpic.cn/mmbiz/rz7R73cuHRrv6jdOCoJeZmYwvEAIoHpY0a7yJL2egiaEokLTpwkIsIRTzTFUic09aEThKHS4hrEcSqU0lAS3tu5g/0" data-ratio="0.14784394250513347" data-w="487" width="auto" width="auto" src="http://mmbiz.qpic.cn/mmbiz/rz7R73cuHRrv6jdOCoJeZmYwvEAIoHpY0a7yJL2egiaEokLTpwkIsIRTzTFUic09aEThKHS4hrEcSqU0lAS3tu5g/0" style="word-wrap: break-word !important; box-sizing: border-box !important; width: auto !important; visibility: visible !important;" /></span></span></span></p><p style=""><legend style="padding: 0px; max-width: 100%; white-space: normal; color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; line-height: 24px; orphans: 2; widows: 2; margin: 0px; word-wrap: break-word !important; box-sizing: border-box !important;"><span style="max-width: 100%; margin: 0px; padding: 0px; font-family: arial, helvetica, sans-serif; word-wrap: break-word !important; box-sizing: border-box !important;"><strong style="max-width: 100%; color: rgb(102, 102, 102); word-wrap: break-word !important; box-sizing: border-box !important;"><span class="bkcolor" style="max-width: 100%; margin: 0px 8px 0px 0px; padding: 4px 10px; color: rgb(255, 255, 255); background-color: rgb(191, 0, 0); word-wrap: break-word !important; box-sizing: border-box !important; border-top-left-radius: 5px !important; border-top-right-radius: 5px !important; border-bottom-right-radius: 5px !important; border-bottom-left-radius: 5px !important;"></span></strong><strong style="max-width: 100%; color: rgb(60, 117, 45); word-wrap: break-word !important; box-sizing: border-box !important;"><span style="max-width: 100%; margin: 0px; padding: 0px; color: rgb(192, 0, 0); word-wrap: break-word !important; box-sizing: border-box !important;">ID: </span></strong></span></legend></p><p style=""><legend style="padding: 0px; max-width: 100%; color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; line-height: 24px; orphans: 2; widows: 2; margin: 0px; word-wrap: break-word !important; box-sizing: border-box !important;"><span style="max-width: 100%; margin: 0px; padding: 0px; font-family: arial, helvetica, sans-serif; word-wrap: break-word !important; box-sizing: border-box !important;"><strong style="max-width: 100%; color: rgb(60, 117, 45); word-wrap: break-word !important; box-sizing: border-box !important;"><span style="max-width: 100%; margin: 0px; padding: 0px; color: rgb(192, 0, 0); word-wrap: break-word !important; box-sizing: border-box !important;"></span></strong></span></legend></p><p style="margin-top: 0px; margin-bottom: 0px; max-width: 100%; word-wrap: normal; min-height: 1em; white-space: pre-wrap; background-color: rgb(255, 255, 255); color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; line-height: 24px; orphans: 2; widows: 2; box-sizing: border-box !important;"><span style="max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;">平台的理念：分享维修经验，工程师交流学习，传递医疗器械有价值信息。</span></p><p style="margin-top: 0px; margin-bottom: 0px; max-width: 100%; word-wrap: normal; min-height: 1em; white-space: pre-wrap; background-color: rgb(255, 255, 255); color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; line-height: 24px; orphans: 2; widows: 2; box-sizing: border-box !important;"><span style="font-family: 仿宋; font-size: 19px;">微信公众号:</span></p><p style="margin-top: 0px; margin-bottom: 0px; max-width: 100%; word-wrap: normal; min-height: 1em; white-space: pre-wrap; background-color: rgb(255, 255, 255); color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; line-height: 24px; orphans: 2; widows: 2; box-sizing: border-box !important;"><span style="font-family: 仿宋; font-size: 19px;"> </span><strong><span style="color: rgb(255, 0, 0); font-size: 20px;"><span style="max-width: 100%; margin: 0px; padding: 0px; word-wrap: break-word !important; box-sizing: border-box !important;"></span></span></strong><br /></p><p style="margin-top: 0px; margin-bottom: 0px; max-width: 100%; word-wrap: normal; min-height: 1em; white-space: pre-wrap; background-color: rgb(255, 255, 255); color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; line-height: 24px; orphans: 2; widows: 2; box-sizing: border-box !important;"><span style="font-family: 仿宋; font-size: 19px;">群主微信号：</span><span style="font-family: sans-serif; font-size: 16px;"> </span></p><p style="margin-top: 0px; margin-bottom: 0px; max-width: 100%; word-wrap: normal; min-height: 1em; white-space: pre-wrap; background-color: rgb(255, 255, 255); color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; line-height: 24px; orphans: 2; widows: 2; box-sizing: border-box !important;"><strong><span style="font-size: 20px; color: rgb(255, 0, 0);"> shanying916</span></strong></p><fieldset class="brcolor" style="white-space: normal; margin: 0px; padding: 5px; border: 1px solid rgb(0, 187, 236); max-width: 100%; color: rgb(62, 62, 62); font-family: 微软雅黑; line-height: 24px; font-size: 12px; background-color: rgb(248, 247, 245); word-wrap: break-word !important; box-sizing: border-box !important;"><legend style="padding: 0px; max-width: 100%; color: rgb(51, 51, 51); margin: 0px 10px; border-width: 0px; word-wrap: break-word !important; box-sizing: border-box !important;"><span class="bkcolor" style="max-width: 100%; margin: 0px; padding: 5px 10px; border: 0px; color: rgb(255, 255, 255); font-weight: bold; font-size: 14px; border-top-left-radius: 5px; border-top-right-radius: 5px; border-bottom-right-radius: 5px; border-bottom-left-radius: 5px; background-color: rgb(0, 187, 236); word-wrap: break-word !important; box-sizing: border-box !important;"><span style="max-width: 100%; margin: 0px; padding: 0px; border: 0px; word-wrap: break-word !important; box-sizing: border-box !important;">复制上面微信号</span><img data-s="300,640" data-ratio="1.35" data-w="20" src="http://mmbiz.qpic.cn/mmbiz/A1DicCH9Vl6NE8iaIXiblrE1WKyXQz6qbATAS0VZxTKlGupjMMNvicoNs9vhvYGBr83wmsdO1ouTw7kVDibk9w6VoMg/0" class="" id="c6" width="auto" width="auto" src="http://mmbiz.qpic.cn/mmbiz/A1DicCH9Vl6NE8iaIXiblrE1WKyXQz6qbATAS0VZxTKlGupjMMNvicoNs9vhvYGBr83wmsdO1ouTw7kVDibk9w6VoMg/640?tp=webp" style="margin: 0px; padding: 0px; border: 0px; word-wrap: break-word !important; box-sizing: border-box !important; visibility: visible !important; width: auto !important;" /><span style="max-width: 100%; margin: 0px; padding: 0px; border: 0px; word-wrap: break-word !important; box-sizing: border-box !important;">联系我哟</span></span></legend><blockquote style="padding: 0px; border: 0px; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="margin-top: 0px; margin-bottom: 0px; max-width: 100%; word-wrap: normal; min-height: 1em; white-space: pre-wrap; padding: 0px; border: 0px; box-sizing: border-box !important;"><span style="max-width: 100%; margin: 0px; padding: 0px; border: 0px; color: rgb(255, 192, 0); font-size: 14px; word-wrap: break-word !important; box-sizing: border-box !important;"></span><span style="max-width: 100%; color: rgb(255, 192, 0); margin: 0px; padding: 0px; border: 0px; font-size: 14px; word-wrap: break-word !important; box-sizing: border-box !important;">? </span><span style="max-width: 100%; color: rgb(127, 127, 127); margin: 0px; padding: 0px; border: 0px; line-height: 28px; word-wrap: break-word !important; box-sizing: border-box !important;">定期推送</span><span style="max-width: 100%; color: rgb(255, 192, 0); margin: 0px; padding: 0px; border: 0px; line-height: 28px; word-wrap: break-word !important; box-sizing: border-box !important;">医械资讯</span><span style="max-width: 100%; margin: 0px; padding: 0px; border: 0px; line-height: 28px; word-wrap: break-word !important; box-sizing: border-box !important;"><span style="max-width: 100%; margin: 0px; padding: 0px; border: 0px; word-wrap: break-word !important; box-sizing: border-box !important;"><span style="max-width: 100%; color: rgb(127, 127, 127); word-wrap: break-word !important; box-sizing: border-box !important;">，</span><span style="max-width: 100%; color: rgb(0, 176, 80); word-wrap: break-word !important; box-sizing: border-box !important;">厂家推介</span><span style="max-width: 100%; color: rgb(127, 127, 127); margin: 0px; padding: 0px; border: 0px; word-wrap: break-word !important; box-sizing: border-box !important;">，</span><span style="max-width: 100%; margin: 0px; padding: 0px; border: 0px; word-wrap: break-word !important; box-sizing: border-box !important;"><span style="max-width: 100%; color: rgb(112, 48, 160); word-wrap: break-word !important; box-sizing: border-box !important;">维修知识</span><span style="max-width: 100%; color: rgb(127, 127, 127); word-wrap: break-word !important; box-sizing: border-box !important;">，</span><span style="max-width: 100%; color: rgb(0, 176, 240); word-wrap: break-word !important; box-sizing: border-box !important;">产品知识</span><span style="max-width: 100%; color: rgb(127, 127, 127); word-wrap: break-word !important; box-sizing: border-box !important;">，</span><span style="max-width: 100%; color: rgb(146, 208, 80); word-wrap: break-word !important; box-sizing: border-box !important;">医疗器械相关</span></span></span><span style="max-width: 100%; color: rgb(127, 127, 127); word-wrap: break-word !important; box-sizing: border-box !important;">等诸多优质内容，</span><span style="max-width: 100%; color: rgb(127, 127, 127); margin: 0px; padding: 0px; border: 0px; word-wrap: break-word !important; box-sizing: border-box !important;">最接地气</span><span style="max-width: 100%; color: rgb(127, 127, 127); word-wrap: break-word !important; box-sizing: border-box !important;">、</span><span style="max-width: 100%; color: rgb(127, 127, 127); margin: 0px; padding: 0px; border: 0px; word-wrap: break-word !important; box-sizing: border-box !important;">重价值</span><span style="max-width: 100%; color: rgb(127, 127, 127); word-wrap: break-word !important; box-sizing: border-box !important;">的医疗器械微信平台！关注我们妥妥没错，<span style="max-width: 100%; margin: 0px; padding: 0px; word-wrap: break-word !important;">推广合作联系我呦</span>！</span></span></p></blockquote></fieldset><p style=""><img data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz/A1DicCH9Vl6MYAEPWTib8tjxcvx0icbN5kq6PvfS6PHyKaMRwicKyXRpyaPRoHgn3OOr1vBKYm6b9vtYp87hJM8nXw/0" data-ratio="0.7835365853658537" data-w="328" src="http://mmbiz.qpic.cn/mmbiz/A1DicCH9Vl6MYAEPWTib8tjxcvx0icbN5kq6PvfS6PHyKaMRwicKyXRpyaPRoHgn3OOr1vBKYm6b9vtYp87hJM8nXw/640?tp=webp" style="word-wrap: break-word !important; box-sizing: border-box !important; width: auto !important; visibility: visible !important;" /></p>
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发表于 2020-10-21 13:50:22