[转帖]关于心导管重复使用的讨论

石桥wshh1975

<p class="MsoBodyTextIndent" style="MARGIN: 0cm 0cm 0pt;"><span style="FONT-FAMILY: 楷体_GB2312; mso-ascii-font-family: &quot;Times New Roman&quot;;"><strong>近年来我国临床界的学术活动异彩纷呈，极为活跃，专家、学者及各级医生围绕着临床中一些难点、热点开展了很多实质性的探讨，这是一种良好的职业与学术氛围。从本期开始，“同行切磋”栏目将刊登各学科领域医生们感兴趣的临床学术观点与难点话题，让医生朋友们在“同行切磋”中沟通互动，交流各自的临床看法与做法，百家争鸣，取长补短，希望医生朋友们通过“同行切磋”有所收获。——本版主持人</strong></span></p><p class="MsoNormal" align="center" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 28.1pt; TEXT-ALIGN: center; mso-char-indent-count: 2.0;"><span><strong><font size="6">关于心导管重复使用的讨论<p></p></font></strong></span></p><p class="MsoNormal" align="center" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 21.1pt; TEXT-ALIGN: center; mso-char-indent-count: 2.0;"><b><span style="FONT-FAMILY: 楷体_GB2312; mso-ascii-font-family: &quot;Times New Roman&quot;;">胡大一</span></b><b><span lang="EN-US" style="mso-fareast-font-family: 楷体_GB2312;"><p></p></span></b></p><p class="MsoNormal" align="center" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 21.1pt; TEXT-ALIGN: center; mso-char-indent-count: 2.0;"><b><span lang="EN-US" style="mso-fareast-font-family: 楷体_GB2312;"><font face="Times New Roman">2004.11.03<span style="mso-spacerun: yes;">&nbsp; </span>7</font></span></b><b><span style="FONT-FAMILY: 楷体_GB2312; mso-ascii-font-family: &quot;Times New Roman&quot;;">版</span></b><b><span lang="EN-US" style="mso-fareast-font-family: 楷体_GB2312;"><span style="mso-spacerun: yes;"><font face="Times New Roman">&nbsp; </font></span></span></b><b><span style="FONT-FAMILY: 楷体_GB2312; mso-ascii-font-family: &quot;Times New Roman&quot;;">医生论坛·探求</span></b><b><span lang="EN-US" style="FONT-SIZE: 14pt; mso-bidi-font-size: 12.0pt;"><p></p></span></b></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">目前，心脏电生理导管（简称心导管）广泛用于临床诊断和消融治疗一些心律失常，已有</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">20</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">多年临床经验证实是安全、有效和经济的。近年来，关于重复使用心导管还有许多争论，多数与事实不相符合。</span><chsdate wst="on" isrocdate="False" islunardate="False" day="27" month="6" year="2000"><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">2000</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">年</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">6</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">月</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">27</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">日</span></chsdate><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">北美起搏与电生理学会（</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">NASPE</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">）和美国心脏病学院（</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">ACC</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">）致美国卫生、教育、劳工和社会保障部门（</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">HELP</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">）一份关于重复使用经过加工消毒处理过的导管安全性和经济性的报告，引发了一场讨论。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">NASPE</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">和</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">ACC</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">为这一问题提供了相关依据，已经开始与美国食品和药品管理委员会（</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">FDA</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">）一道就此问题开始研究，也为此提供了健康保护指南。这两组织讨论的出发点是基于患者的安全，并没有从中直接或间接获得任何经济利益。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><p></p></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">一、重复使用心导管的可行性</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman"><span style="mso-spacerun: yes;">&nbsp;&nbsp;&nbsp; </span><p></p></font></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">在心脏电生理检查中通常要用</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">3</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">到</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">6</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">根导管，每根导管又有</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">4</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">到</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">20</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">个电极来记录电信号或起搏心脏。标准的电生理导管是光滑、没有中空的实心设计，一些导管还有特殊结构。有些导管容易放置到靶点位置，还有一些就需要重复多次移动和操作才能到达靶点。这就要求导管在制作上坚韧耐用，使再加工消毒处理重复使用成为可能。对一些疑难病例，射频消融过程通常需要数个小时完成，有时导管不管新旧都难以到达心脏特殊的靶点，就常常需要更换导管，试用数根才能找到最理想的靶点。如果这些导管均为一次性，就会大大增加手术成本。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><p></p></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">导管的价格是参考电生理检查所使用的电极、质量和材料来决定。用于诊断的导管价格在</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">100</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">到</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">1000</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">美元之间。用于消融可调节顶端弯曲的一般导管价格在</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">400</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">到</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">800</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">美元之间，一些设计比较先进可提供定位的导管在</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">2000</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">到</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">3000</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">美元之间。从</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">30</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: &quot;Times New Roman&quot;; mso-hansi-font-family: &quot;Times New Roman&quot;;">年前第一例电生理检查用于临床，电生理导管坚韧耐用并可消毒重复使用的特点已被临床广泛接受。在不损害患者安全的前提下，重复使用导管主要是为了减少手术费用避免导管的浪费。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><p></p></span></p>

石桥wshh1975

<p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">二、重复使用心导管存在的问题</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman"><span style="mso-spacerun: yes;">&nbsp;&nbsp;&nbsp; </span><p></p></font></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">1.</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">安全问题</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman"><span style="mso-spacerun: yes;">&nbsp;&nbsp;&nbsp; </span><p></p></font></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">电生理导管没有较长的中空管道，容易清洗、消毒和检查。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">FDA</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">对早期心导管的反馈调查发现，没有明显的证据表明，重复使用一次性心电导管会得到不同结果。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">GAO</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">最近报告显示，一次性心导管经过再次加工消毒处理后重复使用，不会对患者的健康造成危害。过去</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">10</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">年院内感染监测系统也没有监测到此类感染事件的发生。再加工的过程如果能安全顺利完成，患者的治疗也不会受重复使用导管的影响。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">GAO</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">给美国国会的报告称“除了人为疏忽外，没有证据表明重复使用导管是有害的。”单单把危险性归于导管的重复使用是很不合理的，实际上，这种危险性是很低的，可以忽略不计。如果禁止或限制重复使用心导管，反而增加了手术费用。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">1988</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">年在《起搏与临床电生理杂志》发表的一篇综合</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">12</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">个医学中心的文章结果显示，重复使用导管是安全的，感染并发症发生率极低。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">1987</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">年美国《心脏病学杂志》报道，</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">178</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">根导管在</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">847</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">次电生理检查中使用</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">1576</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">次，经过</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">5</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">年的评估，结果显示没有并发症发生。稍后的一项研究，</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">69</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">根导管用于</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">336</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">项电生理检查，得出结果某种型号的导管因为一次性心导管坚韧耐用，可重复使用超过</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">5</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">次，而对患者健康无损害。相关的临床电生理试验和</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">GAO</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">的报告表明是安全的。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">NASPE</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">和</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">ACC</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">赞同</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">GAO</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">的报告并继续支持。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><p></p></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">尽管临床上使用了成千上万根导管，但只有一份重复使用出现危害的报告递交给</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">FDA</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><p></p></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">案例</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">1</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">，一个新的消融导管放置在右房，操作中导管顶端脱落并楔入冠状静脉窦。患者经过一天观察并无并发症出现。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><p></p></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">案例</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">2</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">，一个新的导管靠近电极端在操作中有小部分脱落，脱落部分没有被找到。没有进一步的相关资料。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><p></p></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">案例</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">3</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">，一个旧的重复使用的大头导管在撤出心脏时，操作医师感觉到阻力，随后的</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">X</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">线显示是电极的一小部分嵌在右房壁中。据分析认为是导管上一个铂电极在再加工消毒过程中受到损坏。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><p></p></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">这三个案例可见，不管导管的新旧同样都会出现器械问题。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">FDA</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">发布了一项政策来增加有效的监控，同时制定了导管再次加工消毒处理操作规范，主要通过第三方的质量检测系统来监督检测。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><p></p></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">2.</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">标注问题</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman"><span style="mso-spacerun: yes;">&nbsp;&nbsp;&nbsp; </span><p></p></font></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">美国</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">FDA</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">并未要求对心导管进行一次性使用标注。而生产厂商却广泛采用一次性使用标注，因而不再考虑重复使用这些导管对患者的危害。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">NASPE</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">和</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">ACC</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">已经建议</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">FDA</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">审核这一问题，重新进行产品标注。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><p></p></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">3.</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">知情报告问题</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman"><span style="mso-spacerun: yes;">&nbsp;&nbsp;&nbsp; </span><p></p></font></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">这是一个被广泛争论的话题。在使用导管之前不让患者知情，这已被</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">FDA</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">警告，必须要有知情报告，而且医师不能建议患者不需要考虑导管问题。患者需在没有思想<personname wst="on" productid="束缚和">束缚和</personname>医师强迫的情况下作出决定。患者必须被告知检查的性质和目的，可选择的治疗方法及器械优劣和对器械的选择。患者有提出问题以及获得明白答复的权利。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><p></p></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">在心脏电生理诊疗中，出现生命危险或并发症的几率是</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">1</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">：</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">1000</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">。重复使用心导管出现的危险性是很小的以至于可以忽略，重复使用电生理导管是相对最安全的。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">NASPE</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">和</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">ACC</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">因此认为重复使用导管并没有增加危险性，也不存在伦理道德问题，因此给患者的知情报告是没必要的。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><p></p></span></p>

石桥wshh1975

<p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">三、</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">FDA</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">目前的政策</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman"><span style="mso-spacerun: yes;">&nbsp;&nbsp;&nbsp; </span><p></p></font></span></p><p class="MsoNormal" style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; mso-char-indent-count: 2.0;"><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">FDA</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">已经制定了一项政策，要求提供导管的功能、安全性、特点以及再次加工消毒中可能受到的损坏。其中有一点是，经再加工重复使用的一次性导管，要优先考虑重新划分发生高、中、低危险性的程度。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">FDA</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">还发布一项试行草案“一次性使用器械在第三方生产商和医院加工处理过程中的施行规则”指出，所有的诊断和消融导管都属于高危险器械，因此要实行较严格的标准来对导管再加工消毒处理。因为研究显示电生理导管感染的危险性以及再次消毒的困难性都不高，</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">NASPE</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">和</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">ACC</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">也提议</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><font face="Times New Roman">FDA</font></span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman';">对导管的一次性设计和选择不同类型导管进行监测和评估。</span><span lang="EN-US" style="FONT-SIZE: 12pt;"><p></p></span></p><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 1.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">总之，</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman'; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">NASPE</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 1.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">和</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman'; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">ACC</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 1.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">赞赏</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman'; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">GAO</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 1.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">的统计结果很出色。</span><span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman'; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">GAO</span><span style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-font-kerning: 1.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">的报告清楚地表明，心导管在重新加工消毒后重复使用是安全的，不会危及患者的健康，同样也提示导管的再加工处理给医院为控制费用提供了一个经济、负责任的办法。</span>

xxxxxx666666

<p>这个话题比较敏感，实际上心导管复用单纯从感染管理角度我认为可以复用。但是从材料学角度就不知道了。</p><p>这需要统计数据，即复用是否会导致感染增加。</p><p>实际上大规模的复用与感染发生的关系搞院感的都很清楚——很低，只是谁也不敢写这样一篇论文“心导管复用ＸＸＸ例与医院感染发病率相关分析研究”。</p><p>实际工作中极少看到复用导管导致感染的病例，是不报还是其他？</p>

safihu

<div class="quote"><b>以下是引用<i>xxxxxx666666</i>在2007-4-27 14:44:00的发言：</b><br/><p>这个话题比较敏感，实际上心导管复用单纯从感染管理角度我认为可以复用。但是从材料学角度就不知道了。</p><p>这需要统计数据，即复用是否会导致感染增加。</p><p>实际上大规模的复用与感染发生的关系搞院感的都很清楚——很低，只是谁也不敢写这样一篇论文“心导管复用ＸＸＸ例与医院感染发病率相关分析研究”。</p><p>实际工作中极少看到复用导管导致感染的病例，是不报还是其他？</p></div><p>赞同,确实很低今天刚问过导管室护士长,多少年来还没有因为使用一些重复灭菌的电极什么的导致感染的,而且还是那个情况,几千上万的费用不能收费怎么不重复使用啊!!!</p>

shencuihua

为了减少浪费，降低病人医疗费用。请专家建议国家尽快出台相应的管理规范。

2008guoli

我工作在一所心血管疾病医院，我院的心导管手术也比较多，如今正在申请心导管介入培训基地。通过十多年的介入工作，我认为，心导管还是应当一次性使用。我想问版主一个不太礼貌的问题，如果是你本人或者是你的家人需要做介入手术，你愿意用别人使用过的导管吗？我们可以想象一下，几十厘米长、几毫米宽的导管，全部到要在病人的血液中停留一段时间，什么样的清洗手段能够将如此细的导管清晰干净呢？这些物品可都是属于高度危险品。国家对于内镜的清洗消毒都有严格的规范，包括清洗、消毒、检测、登记等一系列的工作。而对于心导管，目前未见到有关的东西，而且，对于中空的导管，在清洗和灭菌过程中，确实难以达到要求。