涉及驼人！河南41家医院因医疗器械问题被通报

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                    <section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.jpg" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-tools="gulangu" data-id="97917"><section><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><section><br  /></section></section></section></section></section></section></section></section></section></section><section><span>7月13日，记者从河南省药品监督管理局(以下简称河南省药监局)获悉，该局近日公布了关于2019年下半年关于医疗器械检查整改情况的通告，涉及医疗器械经营企业、生产企业和使用单位。</span></section><section><span><br  /></span></section><section><span><strong><span>41家医院被整治，彩超仪、呼吸机等是检查重点</span></strong></span></section><section><span><strong><span><br  /></span></strong></span></section><section><span>2019年下半年，依据《药品医疗器械飞行检查办法》，河南省药品监督管理局共组织对41家医疗器械使用单位开展了飞行检查。</span></section><section><span><br  /></span></section><section><span>针对高值医用耗材、无菌和植入类、体外诊断试剂、注射用透明质酸钠、定制式义齿、彩色超生诊断仪、全氟丙烷气体、婴儿培养箱、呼吸机等重点产品，制定检查方案，按照医疗器械使用质量监督管理办法等要求，重点检查。</span></section><section><span><br  /></span></section><section><span>对检查中发现的问题和线索，检查组已移交医疗器械使用单位所在地监管部门根据《医疗器械监督管理条例》《医疗器械不良事件监测和再评价管理办法》《医疗器械使用质量监督管理办法》等有关规定进行依法调查、处理。</span></section><p><p><img src="image/20201014/a5963f87631404fec9c68853071d3ebb_2.jpg" /></p></p><p><p><img src="image/20201014/957869c8a1551a4ed2f6a60b4395244b_3.jpg" /></p></p><p><p><img src="image/20201014/7859d812406e55b394b6c9326e94b219_4.jpg" /></p></p><section><span><strong><span>羚锐制药、驼人医疗等医疗器械企业被查</span></strong></span></section><section><span><strong><span><br  /></span></strong></span></section><section><span>河南省药监局指出，2019年下半年，依据《药品医疗器械飞行检查办法》，检查主要涉及无菌、体外诊断试剂、医用电气、齿科材料、贴敷类共86个产品。</span></section><p><p><img src="image/20201014/a35c065044dd42fe3a1de76eb97586b0_5.jpg" /></p></p><p><p><img src="image/20201014/22aca53d49576007016e84ff07905fc6_6.jpg" /></p></p><p><p><img src="image/20201014/737160a811b9c41d5087d4a63702f596_7.jpg" /></p></p><p><p><img src="image/20201014/c6a81203f41ba2dca1d1383fd1a17bd3_8.jpg" /></p></p><section><br  /></section><section><span>该局针对不同产品特点和风险类型企业，制定检查方案，按照医疗器械生产质量管理规范及配套法规文件要求，重点检查企业落实质量安全主体责任落实情况、产品质量安全管理情况，对采购、生产过程、产品检验和产品可追溯性等重点环节进行了全面检查。</span></section><section><span><br  /></span></section><section><span>检查发现，部分企业对医疗器械法律法规掌握不熟练，风险管理意识有待进一步提高;企业不同程度的存在原材料采购控制不严格、产品放行控制不到位、文件记录不规范等问题。</span></section><section><br  /></section><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><section><br  /></section></section></section><section data-width="100%"><section><section><section><section data-width="100%"><section><section><p><img src="image/20201014/2aac877ff9233ba5a66e7a5ff3a4febf_9.gif" /></p></section><section data-brushtype="text">戳一下，更有料！</section></section><section><br  /></section><section><a target="_blank" 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