食药总局发布国家医疗器械不良事件监测年度报告（2014年度）

admin · 发表于 2020-10-21 13:14:42

2014年全国医疗器械不良事件监测工作继续稳步发展，全年报告数已达26万份，平均百万人口报告数达198份，较2013年分别增长了11.1%和10.6%，保持着较好的发展态势；在报告数量持续增长的同时，不良事件报告质量也明显提升。 　　（一）可疑不良事件报告数量 2014年，国家药品不良反应监测中心共收到《可疑医疗器械不良事件报告表》265,246份，企业后续提交的《医疗器械不良事件补充报告表》1,295份；《医疗器械不良事件年度汇总报告表》2,509份（表1-1）。<table cellspacing="0" cellpadding="0" width="522"><tbody style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 24px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="24" rowspan="2" width="278" style="margin: 0px; padding: 1px; word-break: break-all; border-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">报告类型</td><td height="24" width="132" colspan="2" style="margin: 0px; padding: 1px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(253, 209, 206); word-wrap: break-word !important; box-sizing: border-box !important;">报告数量</td><td height="24" rowspan="2" width="117" style="margin: 0px; padding: 1px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(211, 248, 212); word-wrap: break-word !important; box-sizing: border-box !important;">年度增长率(%)</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 24px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="24" width="56" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(253, 209, 206); word-wrap: break-word !important; box-sizing: border-box !important;">2013年</td><td height="24" width="73" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(253, 209, 206); word-wrap: break-word !important; box-sizing: border-box !important;">2014年</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 24px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="24" width="278" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">《可疑医疗器械不良事件报告表》（《医疗器械不良事件补充报告表》）</td><td height="24" width="56" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(253, 209, 206); word-wrap: break-word !important; box-sizing: border-box !important;">238650（705）</td><td height="24" width="73" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(253, 209, 206); word-wrap: break-word !important; box-sizing: border-box !important;">265246（1295）</td><td height="24" width="117" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(211, 248, 212); word-wrap: break-word !important; box-sizing: border-box !important;">11.1（83.7）</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 24px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="24" width="278" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">《医疗器械不良事件年度汇总报告表》</td><td height="24" width="56" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(253, 209, 206); word-wrap: break-word !important; box-sizing: border-box !important;">1805</td><td height="24" width="73" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(253, 209, 206); word-wrap: break-word !important; box-sizing: border-box !important;">2509</td><td height="24" width="117" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(211, 248, 212); word-wrap: break-word !important; box-sizing: border-box !important;">39.0</td></tr></tbody></table>　表1-1 2014年可疑不良事件报告数量与2013年比较情况　 （二）死亡及严重伤害事件报告数量 2014年，国家药品不良反应监测中心共收到死亡不良事件报告98份，严重伤害事件报告40,920份，共计41,018份，占可疑不良事件报告总数的15.5%，比2013年的34,599份增长了18.6%（图1-1）。 <img title="1.jpg" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIM8Lro4Vfjlo2ib3FgBTg0Nib2S8nzVDWm5PA5hXg5s9Ba7kaFFrBmX6g/0?wx_fmt=jpeg" orgsrc="/directory/web/WS01/images/76871437376144546.jpg" class="" data-type="jpeg" data-ratio="0.646" data-w="500" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIM8Lro4Vfjlo2ib3FgBTg0Nib2S8nzVDWm5PA5hXg5s9Ba7kaFFrBmX6g/640?wx_fmt=jpeg&tp=webp&wxfrom=5" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" />图1-1 2013-2014年全国死亡及严重伤害事件报告数比较 （三）补充报告数量 2014年，国家药品不良反应监测中心共收到医疗器械不良事件补充报告1295份，年度增长率有了83.7%的显著提高，这表明生产企业的报告主体意识明显增强；对于器械安全性监测而言，这些来自生产企业的补充报告则提供了更为全面和准确的不良事件涉及器械的相关信息（图1-2）。 <img title="2.jpg" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAICZbVUTwHJGZWPNyzudslIn4psVSia3tu8FAuUIYuWFZqiatPGT2DeOqQ/0?wx_fmt=jpeg" orgsrc="/directory/web/WS01/images/22391437376205117.jpg" class="" data-type="jpeg" data-ratio="0.646" data-w="500" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAICZbVUTwHJGZWPNyzudslIn4psVSia3tu8FAuUIYuWFZqiatPGT2DeOqQ/640?wx_fmt=jpeg&tp=webp&wxfrom=5" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" />图1-2 2010-2014年全国医疗器械不良事件补充报告数量 （四）年度汇总报告数量 按照《医疗器械不良事件监测和再评价管理办法（试行）》的要求，第二、三类医疗器械生产企业应当在每年1月底前对上一年度医疗器械不良事件监测情况进行汇总分析，并填写《医疗器械不良事件年度汇总报告表》，报所在地省、自治区、直辖市医疗器械不良事件监测技术机构。 　　2014年，国家药品不良反应监测中心共收到医疗器械不良事件年度汇总报告2,509份，较2013年增长了39.0%；但与我国近万家的二、三类医疗器械生产企业数量而言，企业年度汇总报告率仅约为1/4，各级监测机构还需加强对生产企业的监督和指导。 　　（五）每百万人口平均报告数量 2014年，我国百万人口平均可疑医疗器械不良事件报告数为198份，与2013年相比增长19份，但各省间发展不平衡，报告数量差距较大。较之报告总数的增长，百万人口报告数可更好地反映报告数量的增长情况（图1-3）。 <img title="3.jpg" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIvshq2HibCopYstFwcke0CGkq6sDUKic17CspUKBC3p52xDxfz06lD33A/0?wx_fmt=jpeg" orgsrc="/directory/web/WS01/images/66111437376248006.jpg" class="" data-type="jpeg" data-ratio="0.646" data-w="500" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIvshq2HibCopYstFwcke0CGkq6sDUKic17CspUKBC3p52xDxfz06lD33A/640?wx_fmt=jpeg&tp=webp&wxfrom=5" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" />图1-3 2010-2014年全国百万人口报告数量比较 （六）注册基层用户数量 截止2014年12月31日，在全国医疗器械不良事件监测系统中，注册基层用户（包括生产企业、经营企业和使用单位）共174,372家。其中，医疗器械生产企业9,255家，占注册基层用户总数的5.3%；经营企业75,002家，占注册基层用户的43.0%；使用单位90,115家，占注册基层用户的51.7%（图1-4）。<img title="4.jpg" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIwSf5tEvIgXpxFvtSldxAibicOGPF0nRjewE9OOGNImZicoarJBBLWDictg/0?wx_fmt=jpeg" orgsrc="/directory/web/WS01/images/52571437376279512.jpg" class="" data-type="jpeg" data-ratio="0.646" data-w="500" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIwSf5tEvIgXpxFvtSldxAibicOGPF0nRjewE9OOGNImZicoarJBBLWDictg/640?wx_fmt=jpeg&tp=webp&wxfrom=5" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /> 图1-4
2014年全国医疗器械不良事件监测系统基层用户注册情况 2014年度，在174,372家注册基层用户中，提交过报告的单位数量为60,080，占34.5%，较2013年提高了13.3%。基层用户上报情况详见表1-2。 <table cellspacing="0" cellpadding="0"><tbody style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 27px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="27" rowspan="2" width="74" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">基层用户</td><td height="27" rowspan="2" width="61" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">注册数</td><td height="27" width="311" colspan="4" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">上报报告的单位数量</td><td height="27" rowspan="2" width="55" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">百分比（%）</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 58px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="58" width="50" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">总数</td><td height="58" width="99" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">可疑医疗器械不良事件报告</td><td height="58" width="110" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">医疗器械不良事件补充报告</td><td height="58" width="106" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">医疗器械不良事件年度汇总报告</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 36px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="36" width="74" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">使用单位</td><td height="36" width="61" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">90115</td><td height="36" width="50" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">35827</td><td height="36" width="99" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">35827</td><td height="36" width="110" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">0</td><td height="36" width="74" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">0</td><td height="36" width="55" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">39.8</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 36px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="36" width="74" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">生产企业</td><td height="36" width="61" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">9255</td><td height="36" width="50" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">3328</td><td height="36" width="99" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">1933</td><td height="36" width="110" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">183</td><td height="36" width="74" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">2509</td><td height="36" width="55" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">36.0</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 36px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="36" width="74" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">经营企业</td><td height="36" width="61" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">75002</td><td height="36" width="50" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">20925</td><td height="36" width="99" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">20925</td><td height="36" width="110" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">0</td><td height="36" width="74" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">0</td><td height="36" width="55" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">27.9</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 36px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="36" width="74" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">合计</td><td height="36" width="61" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">174372</td><td height="36" width="50" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">60080</td><td height="36" width="99" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">58685</td><td height="36" width="110" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">183</td><td height="36" width="74" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">2509</td><td height="36" width="55" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">34.5</td></tr></tbody></table>　　表1-2 基层用户上报报告情况 （七）2002年至2014年全国可疑不良事件报告数量 2002年1月1日至2014年12月31日，国家药品不良反应监测中心累计收到《可疑医疗器械不良事件》1000,805份（图1-5）。 <img title="5.jpg" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIkrq8vdN4Td50y5EENS8YJYdpnpMib5WrIUx7JBGXX77G2c8hLibClkiaA/0?wx_fmt=jpeg" orgsrc="/directory/web/WS01/images/60101437376436487.jpg" class="" data-type="jpeg" data-ratio="0.51" data-w="500" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIkrq8vdN4Td50y5EENS8YJYdpnpMib5WrIUx7JBGXX77G2c8hLibClkiaA/640?wx_fmt=jpeg&tp=webp&wxfrom=5" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /> 图1-5 2002-2014年全国可疑医疗器械不良事件报告数量 （一）按报告来源统计分析 2014年医疗器械不良事件报告中，使用单位上报208,107份，占报告总数的78.5%；生产企业上报6,122份，占报告总数的2.3%；经营企业上报50,348份，占报告总数的19.0%；还有666份报告来自于个人，占报告总数的0.3%；此外还有3份报告来源不详（图2-1）。 <img title="6.jpg" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIBQLib2oY1ECJeT6vjSTvfYwGGRic9YtooupwKNsPoyltAKF6t9iaSibLIg/0?wx_fmt=jpeg" orgsrc="/directory/web/WS01/images/33951437376491924.jpg" class="" data-type="jpeg" data-ratio="0.51" data-w="500" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIBQLib2oY1ECJeT6vjSTvfYwGGRic9YtooupwKNsPoyltAKF6t9iaSibLIg/640?wx_fmt=jpeg&tp=webp&wxfrom=5" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /> 图2-1 2014年医疗器械不良事件报告来源 总体来看，器械不良事件报告仍主要来源于器械的使用单位。相比2013年，生产企业提交报告所占比例有所下降，与其器械使用安全第一责任人的地位不符，其履行职责的自觉性有待提高。此外，经营企业报告所占百分比也下降了3.1个百分点。 　　2014年，注册基层用户数量达到174,372，比2013年增长了17.4%。在所有注册基层用户中34.5%的用户提交过不良事件报告。在系统注册的9,255家生产企业用户中有3,328家提交了报告，占36.0%，比2013年提高了5.5%；注册的75,002家经营企业用户中有20,925家提交了报告，占27.9%，比2013年提高了12.3%；注册的90,115家使用单位中有35,827家提交了报告，占39.8%，比2013年提高了15.2%（图2-2，图2-3）。 <img title="7.jpg" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAI48fDMjiciaS7Z0gB1DWicAAbmvEeadToFsdV2ib2ibicIoFgokEpnMicu8xIg/0?wx_fmt=jpeg" orgsrc="/directory/web/WS01/images/92341437376539235.jpg" class="" data-type="jpeg" data-ratio="0.4782608695652174" data-w="" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAI48fDMjiciaS7Z0gB1DWicAAbmvEeadToFsdV2ib2ibicIoFgokEpnMicu8xIg/640?wx_fmt=jpeg&tp=webp&wxfrom=5" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /> 图2-2 2014年注册基层用户提交报告情况 <img title="8.jpg" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIqCblsicvMHoJPicdzaWIQJaJOoMQv40cyLoZQqcdBvaCwia8oSicZ7TkQw/0?wx_fmt=jpeg" orgsrc="/directory/web/WS01/images/73481437376590972.jpg" class="" data-type="jpeg" data-ratio="0.4782608695652174" data-w="" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIqCblsicvMHoJPicdzaWIQJaJOoMQv40cyLoZQqcdBvaCwia8oSicZ7TkQw/640?wx_fmt=jpeg&tp=webp&wxfrom=5" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /> 图2-3 2013、2014年注册基层用户提交报告比例情况 （二）按事件伤害程度统计分析 2014年可疑医疗器械不良事件报告中，事件伤害为死亡的报告共98份，占总报告数的0.04%；事件为严重伤害的报告共40,920份，占总报告数的15.4%；事件伤害为其他的报告共224,228份，占总报告数的84.5%（图2-4）。 <img title="9.jpg" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIbR7KOVMGB4aoYo1NCp1Y5UjxkmFUg4otQqWPLZDibRKLhEjvAWDUqZQ/0?wx_fmt=jpeg" orgsrc="/directory/web/WS01/images/74041437376709955.jpg" class="" data-type="jpeg" data-ratio="0.4782608695652174" data-w="" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIbR7KOVMGB4aoYo1NCp1Y5UjxkmFUg4otQqWPLZDibRKLhEjvAWDUqZQ/640?wx_fmt=jpeg&tp=webp&wxfrom=5" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" />图2-4
2014年医疗器械不良事件报告事件伤害程度情况 　　2014年，各类伤害程度报告的绝对数量都继续增加，其所占比例与2013年相似。总体来看，可疑医疗器械不良事件的报告数量延续了近几年的增长趋势，报告的质量及信息的可利用程度都有了较大提升（图2-5）。 <img title="10.jpg" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIlY4y7iaiaGJJdiaMCDjJTEDHVGXaHTkBQW0d1xyyGEEp3hMlJGJzlgwEA/0?wx_fmt=jpeg" orgsrc="/directory/web/WS01/images/21571437376750950.jpg" class="" data-type="jpeg" data-ratio="0.4782608695652174" data-w="" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIlY4y7iaiaGJJdiaMCDjJTEDHVGXaHTkBQW0d1xyyGEEp3hMlJGJzlgwEA/640?wx_fmt=jpeg&tp=webp&wxfrom=5" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /> 图2-5 2009-2014年全国报告数量与死亡及严重伤害报告数量比较 （三）按医疗器械管理类别统计分析 　2014年医疗器械不良事件报告中，涉及Ⅲ类医疗器械的报告最多，共113,220份（其中死亡及严重伤害事件报告25,398份），占总报告数量的42.7%；涉及Ⅱ类医疗器械的报告次之，共97,337份（其中死亡及严重伤害事件报告11,722份），占总报告的36.7%；涉及Ⅰ类医疗器械的报告最少，共48,152份（其中死亡及严重伤害事件报告3,381份），占总报告数的18.2%；部分报告涉及的器械管理类别不详，共6,537份（其中死亡及严重伤害事件报告517份），占报告总数的2.5%。数据显示，Ⅱ类、Ⅲ类医疗器械的报告是构成主体，这与医疗器械风险程度高低相吻合（图2-6，图2-7）。 <img title="11.jpg" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIHIPWmuIwFwdBaG7cHD45FDnGcdicFxjvgwXVs6jaqgwG7ZgVsGRNpFw/0?wx_fmt=jpeg" orgsrc="/directory/web/WS01/images/59061437376782535.jpg" class="" data-type="jpeg" data-ratio="0.4782608695652174" data-w="" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIHIPWmuIwFwdBaG7cHD45FDnGcdicFxjvgwXVs6jaqgwG7ZgVsGRNpFw/640?wx_fmt=jpeg&tp=webp&wxfrom=5" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" />图2-6 2014年医疗器械不良事件报告涉及产品管理类别情况 <img title="12.jpg" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIWleELDj2SHfocPxgytCcfeqWYtK3Q3Fs2Z9gzvWAfaJUJ50zH6ucIA/0?wx_fmt=jpeg" orgsrc="/directory/web/WS01/images/28281437376811129.jpg" class="" data-type="jpeg" data-ratio="0.4782608695652174" data-w="" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIWleELDj2SHfocPxgytCcfeqWYtK3Q3Fs2Z9gzvWAfaJUJ50zH6ucIA/640?wx_fmt=jpeg&tp=webp&wxfrom=5" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" />图2-7 2014年死亡及严重伤害医疗器械不良事件报告涉及产品管理类别情况 （四）按医疗器械分类产品目录统计分析 按照现行的《医疗器械分类目录》，2014年可疑医疗器械不良事件报告共涉及43类产品（除产品分类不详或未填写等其他外），涵盖了《医疗器械分类目录》中的所有医疗器械类别。其中，报告数量位列前十位的产品类别依次为医用高分子材料及制品，注射穿刺器械，医用卫生材料及敷料，物理治疗设备，植入材料和人工器官，医用光学器具、仪器及内窥镜设备，普通诊察器械，医用电子仪器设备，手术室、急救室、诊疗室设备及器具和临床检验分析仪器。与2013年相比，临床检验分析仪器取代了医用缝合材料及粘合剂成为排名第十位的产品类别，其他产品类别相同仅排名略有变化。 　　<table cellspacing="0" cellpadding="0" width="670" style="width: 522px;"><tbody style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 22px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="22" width="39" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">排名</td><td height="22" width="289" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(250, 228, 205); word-wrap: break-word !important; box-sizing: border-box !important;">产品分类</td><td height="22" width="83" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 205, 201); word-wrap: break-word !important; box-sizing: border-box !important;">报告数</td><td height="22" width="92" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(202, 252, 213); word-wrap: break-word !important; box-sizing: border-box !important;">构成比（%）</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 22px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="22" width="39" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">1</td><td height="22" width="289" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(250, 228, 205); word-wrap: break-word !important; box-sizing: border-box !important;">6866医用高分子材料及制品</td><td height="22" width="83" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 205, 201); word-wrap: break-word !important; box-sizing: border-box !important;">52097</td><td height="22" width="92" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(202, 252, 213); word-wrap: break-word !important; box-sizing: border-box !important;">19.6</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 22px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="22" width="39" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">2</td><td height="22" width="289" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(250, 228, 205); word-wrap: break-word !important; box-sizing: border-box !important;">6815注射穿刺器械</td><td height="22" width="83" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 205, 201); word-wrap: break-word !important; box-sizing: border-box !important;">36266</td><td height="22" width="92" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(202, 252, 213); word-wrap: break-word !important; box-sizing: border-box !important;">13.7</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 22px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="22" width="39" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">3</td><td height="22" width="289" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(250, 228, 205); word-wrap: break-word !important; box-sizing: border-box !important;">6864医用卫生材料及敷料</td><td height="22" width="83" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 205, 201); word-wrap: break-word !important; box-sizing: border-box !important;">34008</td><td height="22" width="92" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(202, 252, 213); word-wrap: break-word !important; box-sizing: border-box !important;">12.8</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 22px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="22" width="39" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">4</td><td height="22" width="289" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(250, 228, 205); word-wrap: break-word !important; box-sizing: border-box !important;">6826物理治疗设备</td><td height="22" width="83" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 205, 201); word-wrap: break-word !important; box-sizing: border-box !important;">24401</td><td height="22" width="92" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(202, 252, 213); word-wrap: break-word !important; box-sizing: border-box !important;">9.2</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 22px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="22" width="39" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">5</td><td height="22" width="289" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(250, 228, 205); word-wrap: break-word !important; box-sizing: border-box !important;">6846植入材料和人工器官</td><td height="22" width="83" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 205, 201); word-wrap: break-word !important; box-sizing: border-box !important;">20684</td><td height="22" width="92" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(202, 252, 213); word-wrap: break-word !important; box-sizing: border-box !important;">7.8</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 22px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="22" width="39" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">6</td><td height="22" width="289" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(250, 228, 205); word-wrap: break-word !important; box-sizing: border-box !important;">6822医用光学器具、仪器及内窥镜设备</td><td height="22" width="83" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 205, 201); word-wrap: break-word !important; box-sizing: border-box !important;">13105</td><td height="22" width="92" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(202, 252, 213); word-wrap: break-word !important; box-sizing: border-box !important;">4.9</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 22px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="22" width="39" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">7</td><td height="22" width="289" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(250, 228, 205); word-wrap: break-word !important; box-sizing: border-box !important;">6820普通诊察器械</td><td height="22" width="83" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 205, 201); word-wrap: break-word !important; box-sizing: border-box !important;">11064</td><td height="22" width="92" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(202, 252, 213); word-wrap: break-word !important; box-sizing: border-box !important;">4.2</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 22px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="22" width="39" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">8</td><td height="22" width="289" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(250, 228, 205); word-wrap: break-word !important; box-sizing: border-box !important;">6821医用电子仪器设备</td><td height="22" width="83" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 205, 201); word-wrap: break-word !important; box-sizing: border-box !important;">10116</td><td height="22" width="92" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(202, 252, 213); word-wrap: break-word !important; box-sizing: border-box !important;">3.8</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 22px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="22" width="39" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">9</td><td height="22" width="289" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(250, 228, 205); word-wrap: break-word !important; box-sizing: border-box !important;">6854手术室、急救室、诊疗室设备及器具</td><td height="22" width="83" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 205, 201); word-wrap: break-word !important; box-sizing: border-box !important;">9097</td><td height="22" width="92" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(202, 252, 213); word-wrap: break-word !important; box-sizing: border-box !important;">3.4</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 22px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="22" width="39" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">10</td><td height="22" width="289" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(250, 228, 205); word-wrap: break-word !important; box-sizing: border-box !important;">6840临床检验分析仪器</td><td height="22" width="83" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 205, 201); word-wrap: break-word !important; box-sizing: border-box !important;">5424</td><td height="22" width="92" style="margin: 0px; padding: 1px 1px 0px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(202, 252, 213); word-wrap: break-word !important; box-sizing: border-box !important;">2.0</td></tr></tbody></table>　　表2-1 2014年医疗器械不良事件报告涉及产品分类目录情况 （五）按可疑医疗器械不良事件报告数量排名前五位产品统计分析 　2014年可疑医疗器械不良事件报告中，报告数量排名前五位的无源医疗器械分别为一次性使用输液器、一次性使用无菌注射器、宫内节育器、角膜接触镜和静脉留置针，占总报告的32.1%，详见表2-2。报告数量排名前五位的有源医疗器械分别为病人监护仪、输液泵和注射泵、电子血压计、心电图机和呼吸机，占报告总数的4.5%，详见表2-3。　<table cellspacing="0" cellpadding="0" width="670" style="width: 522px;"><tbody style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="19" width="39" style="margin: 0px; padding: 1px; word-break: break-all; border-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">排名</td><td height="19" width="156" style="margin: 0px; padding: 1px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(249, 225, 200); word-wrap: break-word !important; box-sizing: border-box !important;">产品名称</td><td height="19" width="60" style="margin: 0px; padding: 1px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">报告数</td><td height="19" width="96" style="margin: 0px; padding: 1px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">占报告总数的百分比（%）</td><td height="19" width="78" style="margin: 0px; padding: 1px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">严重伤害报告数</td><td height="19" width="109" style="margin: 0px; padding: 1px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">占本类产品报告数百分比（%）</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="19" width="39" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">1</td><td height="19" width="156" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(249, 225, 200); word-wrap: break-word !important; box-sizing: border-box !important;">一次性使用输液器</td><td height="19" width="60" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">30965</td><td height="19" width="96" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">11.7</td><td height="19" width="78" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">2613</td><td height="19" width="109" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">8.4 </td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="19" width="39" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">2</td><td height="19" width="156" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(249, 225, 200); word-wrap: break-word !important; box-sizing: border-box !important;">一次性使用无菌注射器</td><td height="19" width="60" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">18876</td><td height="19" width="96" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">7.1</td><td height="19" width="78" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">758</td><td height="19" width="109" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">4.0 </td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="19" width="39" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">3</td><td height="19" width="156" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(249, 225, 200); word-wrap: break-word !important; box-sizing: border-box !important;">宫内节育器</td><td height="19" width="60" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">16169</td><td height="19" width="96" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">6.1</td><td height="19" width="78" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">9270</td><td height="19" width="109" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">57.3
</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="19" width="39" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">4</td><td height="19" width="156" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(249, 225, 200); word-wrap: break-word !important; box-sizing: border-box !important;">角膜接触镜</td><td height="19" width="60" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">9686</td><td height="19" width="96" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">3.7</td><td height="19" width="78" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">2067</td><td height="19" width="109" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">21.3
</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="19" width="39" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">5</td><td height="19" width="156" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(249, 225, 200); word-wrap: break-word !important; box-sizing: border-box !important;">静脉留置针</td><td height="19" width="60" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">9377</td><td height="19" width="96" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">3.5</td><td height="19" width="78" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">1718</td><td height="19" width="109" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">18.3
</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="19" width="39" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">合计</td><td height="19" width="156" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(249, 225, 200); word-wrap: break-word !important; box-sizing: border-box !important;"> </td><td height="19" width="60" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">85073</td><td height="19" width="96" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">32.1</td><td height="19" width="78" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">16426</td><td height="19" width="109" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">-</td></tr></tbody></table>　 表2-2 报告数量排名前五位的无源医疗器械 <table cellspacing="0" cellpadding="0" width="670" style="width: 522px;"><tbody style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 42px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="42" width="41" style="margin: 0px; padding: 1px; word-break: break-all; border-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">编号</td><td height="42" width="150" style="margin: 0px; padding: 1px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(251, 215, 180); word-wrap: break-word !important; box-sizing: border-box !important;">产品名称</td><td height="42" width="61" style="margin: 0px; padding: 1px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">报告数</td><td height="42" width="102" style="margin: 0px; padding: 1px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">占报告总数的百分比（%）</td><td height="42" width="76" style="margin: 0px; padding: 1px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">严重伤害报告数</td><td height="42" width="107" style="margin: 0px; padding: 1px; word-break: break-all; border-left-width: medium; border-left-style: none; border-top-color: white; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">占本类产品报告数百分比（%）</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="19" width="41" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">1</td><td height="19" width="150" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(251, 215, 180); word-wrap: break-word !important; box-sizing: border-box !important;">病人监护仪</td><td height="19" width="61" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">5251</td><td height="19" width="102" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">2.0</td><td height="19" valign="top" width="76" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">657</td><td height="19" width="107" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">12.5
</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="19" width="41" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">2</td><td height="19" width="150" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(251, 215, 180); word-wrap: break-word !important; box-sizing: border-box !important;">输液泵和注射泵</td><td height="19" width="61" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">2697</td><td height="19" width="102" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">1.0</td><td height="19" valign="top" width="76" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">482</td><td height="19" width="107" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">17.9
</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="19" width="41" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">3</td><td height="19" width="150" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(251, 215, 180); word-wrap: break-word !important; box-sizing: border-box !important;">电子血压计</td><td height="19" width="61" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">1809</td><td height="19" width="102" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">0.7</td><td height="19" width="76" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">70</td><td height="19" width="107" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">3.9 </td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="19" width="41" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">4</td><td height="19" width="150" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(251, 215, 180); word-wrap: break-word !important; box-sizing: border-box !important;">心电图机</td><td height="19" width="61" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">1271</td><td height="19" width="102" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">0.5</td><td height="19" width="76" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">113</td><td height="19" width="107" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">8.9 </td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="19" width="41" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">5</td><td height="19" width="150" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(251, 215, 180); word-wrap: break-word !important; box-sizing: border-box !important;">呼吸机</td><td height="19" width="61" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">909</td><td height="19" width="102" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">0.3</td><td height="19" valign="top" width="76" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">316</td><td height="19" width="107" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">34.8
</td></tr><tr style="margin: 0px; padding: 0px; max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td height="19" width="41" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-top-style: none; border-right-color: white; border-bottom-color: white; border-left-color: white; max-width: 100%; background-color: rgb(204, 255, 255); word-wrap: break-word !important; box-sizing: border-box !important;">合计</td><td height="19" width="150" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(251, 215, 180); word-wrap: break-word !important; box-sizing: border-box !important;"> </td><td height="19" width="61" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">11937</td><td height="19" width="102" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">4.5</td><td height="19" width="76" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(204, 255, 204); word-wrap: break-word !important; box-sizing: border-box !important;">1638</td><td height="19" width="107" style="margin: 0px; padding: 1px; word-break: break-all; border-top-width: medium; border-left-width: medium; border-top-style: none; border-left-style: none; border-right-color: white; border-bottom-color: white; max-width: 100%; background-color: rgb(254, 211, 211); word-wrap: break-word !important; box-sizing: border-box !important;">-</td></tr></tbody></table>　　表2-3 报告数量排名前五位的有源医疗器械 （六）按涉及使用人员统计分析 　　2014年可疑医疗器械不良事件报告中，71.9%的报告所涉及的医疗器械是由专业人员操作的；1.7%的报告所涉及的医疗器械是由非本人的非专业人员操作的；8.8%的报告所涉及的医疗器械是由患者自己操作的，17.6%的报告操作人不详。其中由专业人员操作的报告所占比例与2013年的70.1%基本持平。现有信息提示，操作人员是分析事件发生原因时要考量的重要因素之一，而报告操作人不详所占比例偏大，提示报告质量仍有待提高（图2-8）。 <img title="13.jpg" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIZ2BAbzqe7jW8wng1zOLB6Dr0muSzQ0Udr20ich5ibTdoUXSkvMpy0tpA/0?wx_fmt=jpeg" orgsrc="/directory/web/WS01/images/89361437377002421.jpg" class="" data-type="jpeg" data-ratio="0.4782608695652174" data-w="" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAIZ2BAbzqe7jW8wng1zOLB6Dr0muSzQ0Udr20ich5ibTdoUXSkvMpy0tpA/640?wx_fmt=jpeg&tp=webp&wxfrom=5" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /> 图2-8 2014年医疗器械不良事件报告涉及使用人员情况（七）按涉及实际使用场所统计分析2014年可疑医疗器械不良事件报告中，使用场所为“医疗机构”的报告187,766份，占70.8%；使用场所为“家庭”的报告共34,439份，占13.0%；使用场所为“不详”的报告共33,975份，占12.8%（图2-9）。医疗器械的使用场所呈现多元化的趋势，使用场所的复杂性是分析不良事件发生原因时需要考量的因素之一。 <img title="14.jpg" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAI6OXbjdLh9QRPkLGKBFSzOdoe28rsBiaYZd1gibFhx3IxUEEFgxibiaZstA/0?wx_fmt=jpeg" orgsrc="/directory/web/WS01/images/15361437377076302.jpg" class="" data-type="jpeg" data-ratio="0.4782608695652174" data-w="" src="http://mmbiz.qpic.cn/mmbiz/cZcu8wCxhdFllpRyFvzKomU9WWY9YKAI6OXbjdLh9QRPkLGKBFSzOdoe28rsBiaYZd1gibFhx3IxUEEFgxibiaZstA/640?wx_fmt=jpeg&tp=webp&wxfrom=5" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" />图2-9 2014年医疗器械不良事件报告涉及实际使用场所情况 <hr style="white-space: normal; color: rgb(131, 104, 28); font-family: Avenir, sans-serif; line-height: 25px;" /> ID: 最具人气的医疗器械维修新媒体平台分享医疗器械前沿动态、医疗器械维修经验 加群主微信 shanying916 与更多行业从业人员互动交流<img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/A1DicCH9Vl6MoypciaNOibiaxmVLk8eA6ibKL14uWjKsZwrWboQYKTfXqPicXycwL1icfia1pAG0VzlTX3MRR4FPV0ZtZA/0?wx_fmt=jpeg" data-ratio="1.0136054421768708" data-w="147" style="float: none;" />

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