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怕交叉感染?一次性胃肠镜真的来了!

2021-08-03 胃肠病 胃肠病

最近,深圳岱川医疗出品了一次性使用的电子胃镜和电子结肠镜,图像清晰,具有电子染色功能,操作部分灵活可靠,已经获得美国药品监督局(FDA)和欧盟(CE)的批准。

全球约50%的消化道肿瘤发生在中国,胃肠镜检查是消化道肿瘤早期诊断和治疗的首要手段。

目前,越来越多的人接受了胃肠镜检查,但还是有很人担心:一根管子,从那么多人胃肠里插来插去,会交叉感染吗?能消毒彻底吗?

图片

待洗消的胃镜

实际上,内镜医生也有类似的担心。

虽然洗消有着一套非常严格的程序,并且国家有相关的质控标准,每一个环节护士都会严格操作,但是,医学从来都不是100%完美的科学,难以确保每一条内窥镜都是干净、无菌的。

传统内窥镜包括多种器具,当它们被伸入病人的喉咙、肠腔以及其他腔体时,会沾染黏液、血液以及非常多的病菌,标准的消毒流程是将它们在消毒液中刷洗和浸泡。

但是,由于高温会毁坏核心部件,使得它们不像手术刀那样可以高温高压下彻底地消毒,仍然可能有病菌残留,产生医疗感染的隐患。

图片

美国Medscape的报道:图A: B医院胃镜,管腔中脱落的内衬

图B:C医院胃镜,远端破损,金属线露出

图C: C医院胃镜,远端水流射出口出现的白色碎片

据相关研究显示,内窥镜在医疗器械交叉感染风险排行榜中位列第一,70%以上的内窥镜(主要是难以洗消的十二指肠镜、柔性支气管镜和膀胱镜)存在清洗不干净的问题,接近四分之三的医用内窥镜被细菌污染。由此内窥镜使用安全成为不可回避的问题。

图片

 

Medscape的报道标题:接近四分之三的常用内镜被细菌污染。


2018年12月,内窥镜巨头奥林巴斯因为十二指肠内窥镜感染问题,被美国罚款6.48亿美元。据悉,在频发的感染事件中,奥林巴斯没有确保内窥镜充分清洗的范围,导致院方清洗、消毒不彻底。在2012年~2015年间,美国共导致了190多人感染细菌。

于是,人们迫切希望有一款一次性使用的胃肠镜问世。

最近,深圳岱川医疗出品了一次性使用的电子胃镜和电子结肠镜,图像清晰,具有电子染色功能,操作部分灵活可靠,据了解,这种EndoFresh(安士)的一次性胃肠镜,已经获得美国药品监督局(FDA)和欧盟(CE)的批准;

在国内的临床试验也已经完成,正在上报国家NMPA审批中,相信不久的将来就能上市。

图片

EndoFresh安士内窥镜

EndoFresh的最大好处,就是解决了胃肠镜存在老大难问题(无法清洗干净)。

EndoFresh性能参数已经很接近传统的名牌产品。例如:

 

高清图像:拥有1920*1080像素;电子染色功能,

 

多功能:自带清洗功能,确保整个诊疗过程中内窥镜视野清晰;

 

允许内窥镜附件以任何弯曲角度通过;

 

四个方向调弯210°。

当然如果想让EndoFresh达到奥林巴斯的胃肠镜一样的功能和性能,估计还需要一段时间。

一次性内窥镜的出现,不仅解决了交叉感染的问题,在疫情期间,一次性内窥镜的使用,为避免行业交叉感染,加快基层医院诊疗速度与效率,稳定疫情防控成效都将做出重要贡献。对患者来说,相较于传统内窥镜,目前一次性内窥镜所需费用会更高。

参考资料:

[1] 郑业欣.行业研究|一“窥”中国内窥镜产业发展趋势. 北拓资本. 2020-11-03.

[2] 顿雨婷.一次性内窥镜蓄势待发,瀚湄医疗获1500万元Pre-A轮融资. 36氪. 2020-03-06.

[3] 介凡社.医用内窥镜“耗材化”趋势已现,国产厂商弯道超车. 点石资本DAS Capital . 2021-01-15.

[4] 内窥镜:国产替代浪潮下砥砺前行. 国元证券. 2020-12-15.

[5] MedTF.EndoFresh:FDA批准国产一次性胃肠镜,2021-05-24

[6] 李兆申,许国铭消化内镜清洗消毒历史、现状及展望

[7] https://khn.org/news/olympus-faces-new-trial-over-medical-scopes-tied-to-superbug-deaths/

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  2. [GetPortalCommentsPageByObjectIdResponse(id=1705615, encodeId=81af1e0561580, content=<a href='/topic/show?id=f2cc8336074' target=_blank style='color:#2F92EE;'>#胃肠镜#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83360, encryptionId=f2cc8336074, topicName=胃肠镜)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=638f31003880, createdName=fengting13, createdTime=Sun Nov 14 13:54:29 CST 2021, time=2021-11-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1014329, encodeId=2f3410143295a, content=应该会贵一些🤔🤔, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4dcb5439452, createdName=DECTE, createdTime=Fri Sep 03 17:22:57 CST 2021, time=2021-09-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1011475, encodeId=8fec10114e5c2, content=感觉价格不菲, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=74095396205, createdName=ms8000000902354994, createdTime=Wed Aug 25 20:28:09 CST 2021, time=2021-08-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1434529, encodeId=e7d91434529b4, content=<a href='/topic/show?id=95de81e4889' target=_blank style='color:#2F92EE;'>#肠镜#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81748, encryptionId=95de81e4889, topicName=肠镜)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Thu Aug 05 02:54:29 CST 2021, time=2021-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1502435, encodeId=843b150243582, content=<a href='/topic/show?id=d03a2433420' target=_blank style='color:#2F92EE;'>#交叉感染#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=24334, encryptionId=d03a2433420, topicName=交叉感染)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bbf89540714, createdName=zhangyxzsh, createdTime=Thu Aug 05 02:54:29 CST 2021, time=2021-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1004866, encodeId=68b81004866d9, content=文章很棒, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210803/18a80d2367814f61bbe4c923e65f1d98/16479f926d194fa8a9ea5e1f2e022e9b.jpg, createdBy=e1981971406, createdName=1e1606abm78(暂无匿称), createdTime=Tue Aug 03 12:31:49 CST 2021, time=2021-08-03, status=1, ipAttribution=)]
    2021-09-03 DECTE

    应该会贵一些🤔🤔

    0

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    2021-08-25 ms8000000902354994

    感觉价格不菲

    0

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    2021-08-05 zhouqu_8
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    2021-08-03 1e1606abm78(暂无匿称)

    文章很棒

    0

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