济闻闻 发表于 2023-12-19 18:20:07

济源XX口腔门诊使用已过期的医疗器械

<p style="margin: 0px;padding: 0px;clear: both;min-height: 1em;color: rgb(51, 51, 51);font-size: 17px;font-style: normal;font-variant-ligatures: normal;font-variant-caps: normal;font-weight: 400;orphans: 2;text-indent: 0px;text-transform: none;white-space: normal;widows: 2;word-spacing: 0px;-webkit-text-stroke-width: 0px;text-decoration-thickness: initial;text-decoration-style: initial;text-decoration-color: initial;outline: 0px;max-width: 100%;font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;text-align: center;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="letter-spacing: 0.544px;white-space: normal;color: rgb(255, 41, 65);font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, 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style="margin-bottom: 8px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;text-wrap: wrap;background-color: rgb(255, 255, 255);line-height: 1.75em;text-indent: 2em;"><span style="outline: 0px;font-size: 16px;font-family: 仿宋_GB2312;"></span></p><p></p><section data-role="paragraph" style="margin-bottom: 0px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;text-wrap: wrap;background-color: rgb(255, 255, 255);"><section style="outline: 0px;text-align: center;line-height: 2em;"><span style="outline: 0px;letter-spacing: 2px;"></span></section></section><p></p><p style="margin-bottom: 0px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;text-wrap: wrap;background-color: rgb(255, 255, 255);"><span style="outline: 0px;font-size: 18px;"><strong style="outline: 0px;"><span style="outline: 0px;color: rgb(0, 122, 170);"></span></strong></span></p><p></p><section data-support="96编辑器" data-style-id="38866" style="margin-bottom: unset;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;text-wrap: wrap;background-color: rgb(255, 255, 255);"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="outline: 0px;text-indent: 2em;">济源市市场监督管理局聚焦民生领域群众反映强烈、社会舆论关注的突出问题,重拳出击,严厉打击食品安全违法违规、声称减肥壮阳等食品非法添加、油品质量违法和加油站计量作弊、“神医”“神药”等虚假违法广告、医疗美容领域虚假宣传、翻新“黑气瓶”、超期未检电梯、面向未成年人开展“无底线营销”违法违规行为,查办了一批与群众生活紧密相关的违法案件。&nbsp;</section><section style="outline: 0px;text-indent: 2em;">本期“铁拳行动曝光台”曝光的是济源市市场监督管理局查处的济源市XX口腔门诊使用已过期的医疗器械案。</section></section></section></section></section></section><section data-support="96编辑器" data-style-id="25945" style="margin-bottom: unset;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;text-wrap: wrap;background-color: rgb(255, 255, 255);"><section style="margin-bottom: unset;outline: 0px;"><section data-support="96编辑器" data-style-id="30852" style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section data-support="96编辑器" data-style-id="20822" style="margin-bottom: unset;outline: 0px;"><section data-align="title" style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section data-support="96编辑器" data-style-id="30852" style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section data-support="96编辑器" data-style-id="30852" style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section data-support="96编辑器" data-style-id="30852" style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section data-support="96编辑器" data-style-id="30852" style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section data-support="96编辑器" data-style-id="28043" style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><p style="outline: 0px;"><br style="outline: 0px;"/></p></section></section></section></section><p style="outline: 0px;text-align: center;">济源市XX口腔门诊使用已过期的医疗器械案</p></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-support="96编辑器" data-style-id="38865" style="margin-bottom: unset;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;text-wrap: wrap;background-color: rgb(255, 255, 255);"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><p style="outline: 0px;"><br style="outline: 0px;"/></p></section></section><section style="margin-bottom: unset;outline: 0px;"><p style="outline: 0px;">案情回放</p></section></section><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="outline: 0px;text-indent: 2em;">2023年7月20日,济源市市场监督管理局执法人员对济源市XX口腔门诊进行现场检查,在其经营场所发现的两包医用棉签、5支一次性使用无菌注射器带针、1包医用检查手套、一套牙釉质粘合剂树脂(光固化型)均已过有效期,执法人员依法实施扣押行政强制措施。经查,当事人没有及时清理过期的医疗器械,将其与正常待用的医疗器械共同存放在经营场所内,故应认定当事人的行为是使用过期医疗器械的违法行为。当事人未建立并执行完善的进货查验登记记录制度,无法提供被扣押过期医疗器械的供货商资质、随货同行单等资料。</section></section></section></section></section></section><section style="margin-bottom: unset;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;text-wrap: wrap;background-color: rgb(255, 255, 255);"><section data-support="96编辑器" data-style-id="38865" style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"></section></section><section style="margin-bottom: unset;outline: 0px;"><p style="outline: 0px;">以案说法</p></section></section><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="outline: 0px;text-indent: 2em;">当事人未按规定建立并执行医疗器械进货查验记录制度的行为违反了《医疗器械监督管理条例》第四十五条第一款“医疗器械经营企业、使用单位应当从具备合法资质的医疗器械注册人、备案人、生产经营企业购进医疗器械。购进医疗器械时,应当查验供货者的资质和医疗器械的合格证明文件,建立进货查验记录制度。从事第二类、第三类医疗器械批发业务以及第三类医疗器械零售业务的经营企业,还应当建立销售记录制度。”的规定;使用已过期医疗器械的行为违反了《医疗器械监督管理条例》第五十五条“医疗器械经营企业、使用单位不得经营、使用未依法注册、无合格证明文件以及过期、失效、淘汰的医疗器械。”的规定,已构成违法。</section><section style="outline: 0px;text-indent: 2em;">依据《医疗器械监督管理条例》第八十九条第三项“有下列情形之一的,由负责药品监督管理的部门和卫生主管部门依据各自职责责令改正,给予警告;拒不改正的,处1万元以上10万元以下罚款;情节严重的,责令停产停业,直至由原发证部门吊销医疗器械注册证、医疗器械生产许可证、医疗器械经营许可证,对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员处1万元以上3万元以下罚款:</section><section style="outline: 0px;text-align: left;text-indent: 0em;">(三)医疗器械经营企业、使用单位未依照本条例规定建立并执行医疗器械进货查验记录制度”的规定,以及第八十六条第(三)项“有下列情形之一的,由负责药品监督管理的部门责令改正,没收违法生产经营使用的医疗器械;违法生产经营使用的医疗器械货值金额不足1万元的,并处2万元以上5万元以下罚款;货值金额1万元以上的,并处货值金额5倍以上20倍以下罚款;情节严重的,责令停产停业,直至由原发证部门吊销医疗器械注册证、医疗器械生产许可证、医疗器械经营许可证,对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员,没收违法行为发生期间自本单位所获收入,并处所获收入30%以上3倍以下罚款,10年内禁止其从事医疗器械生产经营活动:(三)经营、使用无合格证明文件、过期、失效、淘汰的医疗器械,或者使用未依法注册的医疗器械的”的规定,济源市市场监督管理局对当事人作出警告、没收扣押的过期医疗器械和罚款2万元的行政处罚。</section></section></section></section></section></section></section></section><section data-support="96编辑器" data-style-id="30852" style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><p style="outline: 0px;"><br style="outline: 0px;"/></p></section></section><section data-support="96编辑器" data-style-id="38865" style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><p style="outline: 0px;">案件警示&nbsp;&nbsp;</p></section></section><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="margin-bottom: unset;outline: 0px;"><section style="outline: 0px;text-indent: 2em;">患者在接受医疗治疗时没有自主选择权,一般都是医生直接使用医疗器械对患者进行检查治疗,患者无法验证使用的医疗器械是否过期,这就要求医疗器械使用单位应该切实履行职责,建立健全医疗器械进货查验和有效期预警制度。</section><section style="outline: 0px;text-indent: 2em;">市场监管部门将持续加强对医疗器械经营和使用单位的监督检查力度,规范医疗机构医疗器械的使用和管理,打造消费者安心、社会放心的消费环境。</section></section></section></section></section></section></section></section></section></section><section style="margin-bottom: 0em;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;text-indent: 0em;text-wrap: wrap;background-color: rgb(255, 255, 255);color: rgb(34, 34, 34);caret-color: rgb(34, 34, 34);text-align: left;font-size: 14px;visibility: visible;"><span style="outline: 0px;color: rgb(61, 170, 214);font-family: 微软雅黑;letter-spacing: 0.544px;visibility: visible;">来源&nbsp;| 济源市场监管</span></section><p></p><p style="margin-bottom: 0px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;text-wrap: wrap;background-color: 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