医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)标(biao)准(zhun)(zhun)(zhun)是医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)研制、生产(chan)(chan)、经营、使用(yong)以及监(jian)(jian)(jian)督(du)管(guan)(guan)理所(suo)共(gong)同遵循的(de)(de)技(ji)术(shu)(shu)规(gui)范，是医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)监(jian)(jian)(jian)管(guan)(guan)和(he)产(chan)(chan)业发展(zhan)(zhan)的(de)(de)重(zhong)要(yao)技(ji)术(shu)(shu)支撑。药监(jian)(jian)(jian)局(ju)(ju)高度重(zhong)视医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)标(biao)准(zhun)(zhun)(zhun)工作(zuo)(zuo)(zuo)，按照“四(si)个严”的(de)(de)要(yao)求，结合(he)医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)产(chan)(chan)业发展(zhan)(zhan)和(he)监(jian)(jian)(jian)管(guan)(guan)工作(zuo)(zuo)(zuo)实(shi)(shi)际，不断完善(shan)医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)标(biao)准(zhun)(zhun)(zhun)管(guan)(guan)理制度体(ti)系(xi)(xi)、持(chi)续(xu)开展(zhan)(zhan)医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)标(biao)准(zhun)(zhun)(zhun)制修(xiu)(xiu)订工作(zuo)(zuo)(zuo)，我(wo)(wo)国(guo)医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)标(biao)准(zhun)(zhun)(zhun)体(ti)系(xi)(xi)不断完善(shan)，医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)标(biao)准(zhun)(zhun)(zhun)对监(jian)(jian)(jian)管(guan)(guan)和(he)产(chan)(chan)业发展(zhan)(zhan)的(de)(de)技(ji)术(shu)(shu)支撑能力持(chi)续(xu)提升。一(yi)、加强医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)标(biao)准(zhun)(zhun)(zhun)制度建设。为贯彻落(luo)实(shi)(shi)国(guo)务院深(shen)化(hua)(hua)标(biao)准(zhun)(zhun)(zhun)化(hua)(hua)改革重(zhong)大决(jue)策部署(shu)，依(yi)据《中华(hua)人民共(gong)和(he)国(guo)标(biao)准(zhun)(zhun)(zhun)化(hua)(hua)法》，立足(zu)我(wo)(wo)国(guo)医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)产(chan)(chan)业发展(zhan)(zhan)和(he)监(jian)(jian)(jian)管(guan)(guan)工作(zuo)(zuo)(zuo)实(shi)(shi)际，2017年4月，原食(shi)品药品监(jian)(jian)(jian)管(guan)(guan)总局(ju)(ju)修(xiu)(xiu)订印(yin)发《医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)标(biao)准(zhun)(zhun)(zhun)管(guan)(guan)理办法》，该办法的(de)(de)出台(tai)对指导我(wo)(wo)国(guo)医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)标(biao)准(zhun)(zhun)(zhun)管(guan)(guan)理、规(gui)范标(biao)准(zhun)(zhun)(zhun)制修(xiu)(xiu)订、促进标(biao)准(zhun)(zhun)(zhun)实(shi)(shi)施(shi)、提升医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)质量(liang)等起(qi)到(dao)了积(ji)极作(zuo)(zuo)(zuo)用(yong)。为贯彻落(luo)实(shi)(shi)《医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)标(biao)准(zhun)(zhun)(zhun)管(guan)(guan)理办法》，原食(shi)品药品监(jian)(jian)(jian)管(guan)(guan)总局(ju)(ju)先后印(yin)发《医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)标(biao)准(zhun)(zhun)(zhun)制修(xiu)(xiu)订工作(zuo)(zuo)(zuo)管(guan)(guan)理规(gui)范》和(he)《医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)标(biao)准(zhun)(zhun)(zhun)报批发布工作(zuo)(zuo)(zuo)细则》等文(wen)件(jian)，进一(yi)步(bu)规(gui)范了医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)标(biao)准(zhun)(zhun)(zhun)工作(zuo)(zuo)(zuo)程(cheng)序，强化(hua)(hua)了标(biao)准(zhun)(zhun)(zhun)精细化(hua)(hua)过程(cheng)管(guan)(guan)理，为提升医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)标(biao)准(zhun)(zhun)(zhun)质量(liang)奠(dian)定了坚(jian)实(shi)(shi)的(de)(de)制度基础(chu)。

导(dao)(dao)尿(niao)(niao)(niao)包，主(zhu)要(yao)适用于导(dao)(dao)尿(niao)(niao)(niao)术，导(dao)(dao)尿(niao)(niao)(niao)术是(shi)一种在无菌操(cao)(cao)作(zuo)条(tiao)件下，将(jiang)导(dao)(dao)尿(niao)(niao)(niao)管经(jing)过(guo)(guo)尿(niao)(niao)(niao)道(dao)插入膀(bang)胱(guang)，进(jin)行引流尿(niao)(niao)(niao)液的方法。一次性使用导(dao)(dao)尿(niao)(niao)(niao)包步骤：1、提前准备(bei)导(dao)(dao)尿(niao)(niao)(niao)包产品(pin)，可以是(shi)无菌导(dao)(dao)尿(niao)(niao)(niao)包或者是(shi)一次性导(dao)(dao)尿(niao)(niao)(niao)包；操(cao)(cao)作(zuo)者要(yao)进(jin)行洗手(shou)，佩戴口罩(zhao)，佩戴手(shou)套(tao)；3、拆开(kai)导(dao)(dao)尿(niao)(niao)(niao)包，将(jiang)物品(pin)放(fang)在专门(men)的器械盘上(shang)，将(jiang)物品(pin)拿到床边；4、核对病(bing)(bing)人(ren)的身(shen)(shen)份，并向病(bing)(bing)人(ren)解释接下来的操(cao)(cao)作(zuo)，让病(bing)(bing)人(ren)能够(gou)放(fang)松(song)心情(qing)；5、将(jiang)门(men)窗关闭，用病(bing)(bing)房内独有的屏风遮挡(dang)病(bing)(bing)床；6、将(jiang)床旁的椅子(zi)放(fang)在合适的位置(zhi)，将(jiang)便盆放(fang)在椅子(zi)上(shang)；7、掀(xian)开(kai)被子(zi)；8、病(bing)(bing)人(ren)无法起身(shen)(shen)的情(qing)况(kuang)下，可以让家属或操(cao)(cao)作(zuo)者帮助病(bing)(bing)人(ren)褪去裤子(zi)，对侧的腿部(bu)盖上(shang)被子(zi)，近(jin)处(chu)盖上(shang)毛(mao)巾，可以避免病(bing)(bing)人(ren)太过(guo)(guo)羞耻，影响操(cao)(cao)作(zuo)；

2月5日，药(yao)监(jian)(jian)局(ju)接(jie)到卫(wei)生(sheng)(sheng)健康(kang)委通(tong)报(bao)，上(shang)(shang)海新兴(xing)医药(yao)股(gu)份有限公司（以下(xia)(xia)简称“上(shang)(shang)海新兴(xing)”）生(sheng)(sheng)产的(de)一批(pi)(pi)次(ci)静(jing)注人免疫球(qiu)蛋白（批(pi)(pi)号：20180610Z）艾(ai)(ai)滋(zi)病(bing)(bing)(bing)病(bing)(bing)(bing)毒抗体检(jian)(jian)测(ce)为(wei)阳性。药(yao)监(jian)(jian)局(ju)立即要求上(shang)(shang)海市药(yao)监(jian)(jian)局(ju)对(dui)(dui)上(shang)(shang)海新兴(xing)开展(zhan)现场(chang)(chang)检(jian)(jian)查(cha)，组(zu)织对(dui)(dui)同批(pi)(pi)原(yuan)料血浆生(sheng)(sheng)产的(de)产品和(he)相邻批(pi)(pi)次(ci)产品进(jin)行检(jian)(jian)验，并(bing)派出督(du)导(dao)检(jian)(jian)查(cha)组(zu)抵达上(shang)(shang)海、江西，督(du)促指导(dao)地方(fang)药(yao)监(jian)(jian)部门开展(zhan)调(diao)查(cha)处置工作(zuo)(zuo)。药(yao)监(jian)(jian)局(ju)、卫(wei)生(sheng)(sheng)健康(kang)委联(lian)合下(xia)(xia)发通(tong)知，要求立即暂停使用该(gai)企(qi)业生(sheng)(sheng)产的(de)相关(guan)产品，并(bing)及时采取封存(cun)等控制(zhi)措施。上(shang)(shang)海方(fang)面(mian)对(dui)(dui)涉(she)事批(pi)(pi)次(ci)静(jing)注人免疫球(qiu)蛋白进(jin)行的(de)艾(ai)(ai)滋(zi)病(bing)(bing)(bing)、乙肝、丙肝三种(zhong)病(bing)(bing)(bing)毒核酸检(jian)(jian)测(ce)，结果均(jun)为(wei)阴(yin)性；江西方(fang)面(mian)对(dui)(dui)患(huan)者的(de)艾(ai)(ai)滋(zi)病(bing)(bing)(bing)病(bing)(bing)(bing)毒核酸检(jian)(jian)测(ce)，结果为(wei)阴(yin)性。对(dui)(dui)企(qi)业现场(chang)(chang)核查(cha)等有关(guan)工作(zuo)(zuo)正(zheng)在进(jin)一步进(jin)行中。

一次性使用导尿包相关问答问：有什么区别次性使用导尿包+18？答：导尿包咨询热线 :0512-66615979答：导尿管的外直径,一般男性临床用12~16比较多见,问： 一次性使用引尿包的注意事项有哪些？答：1、本品经环氧乙环灭菌，使用前请注意内袋包装上灭菌指示标志。2、本品灭菌后，在包装完好时，推荐医用无菌塑柄手术刀包内所有器件均为无毒、无菌。3、包装破损，禁止使用。4、本产品灭菌有效期两年，生产日期见封口处。5、本产品仅限于一次性使用，医用无菌塑柄手术刀批发用(yong)后(hou)销(xiao)毁。问： 一次性(xing)使用(yong)引尿(niao)包(bao)的(de)使用(yong)方法(fa)是(shi)怎(zen)样的(de)？答：1、取出(chu)本(ben)品(pin)(pin)，从启(qi)口(kou)处(chu)撕(si)开，取出(chu)无菌内(nei)包(bao)，放置工作(zuo)(zuo)台(tai)中央。2、打开内(nei)包(bao)，戴上(shang)无菌医用(yong)手套(tao)，按(an)操(cao)作(zuo)(zuo)规程(cheng)进行操(cao)作(zuo)(zuo)。3、使用(yong)时注意正确使用(yong)引流袋(dai)等各种配(pei)件(jian)。4、本(ben)产(chan)品(pin)(pin)使用(yong)结束后(hou)，丢弃(qi)所有组件(jian)，不(bu)可重复(fu)使用(yong)。

一次(ci)性使(shi)(shi)(shi)用(yong)导(dao)尿(niao)(niao)(niao)(niao)包(bao)(bao)的(de)(de)(de)使(shi)(shi)(shi)用(yong)方(fang)法1、导(dao)尿(niao)(niao)(niao)(niao)包(bao)(bao)的(de)(de)(de)配置和包(bao)(bao)装设计是根据《中华护(hu)理大全》中关于(yu)(yu)导(dao)尿(niao)(niao)(niao)(niao)部(bu)分的(de)(de)(de)操(cao)作程(cheng)序和各医院(yuan)实际导(dao)尿(niao)(niao)(niao)(niao)操(cao)作过(guo)程(cheng)中的(de)(de)(de)要求设计制定。2 导(dao)尿(niao)(niao)(niao)(niao)包(bao)(bao)的(de)(de)(de)使(shi)(shi)(shi)用(yong)方(fang)法可按各医院(yuan)规定的(de)(de)(de)导(dao)尿(niao)(niao)(niao)(niao)操(cao)作规程(cheng)进(jin)(jin)(jin)行(xing)操(cao)作。3如在(zai)(zai)使(shi)(shi)(shi)用(yong)过(guo)程(cheng)中导(dao)尿(niao)(niao)(niao)(niao)包(bao)(bao)内(nei)的(de)(de)(de)配置和包(bao)(bao)装顺序与贵医院(yuan)的(de)(de)(de)导(dao)尿(niao)(niao)(niao)(niao)操(cao)作规程(cheng)有不(bu)相符的(de)(de)(de)情况(kuang)请(qing)向供应(ying)商提出改进(jin)(jin)(jin)建议。4在(zai)(zai)使(shi)(shi)(shi)用(yong)导(dao)尿(niao)(niao)(niao)(niao)包(bao)(bao)前(qian)请(qing)确认(ren)您(nin)(nin)所(suo)使(shi)(shi)(shi)用(yong)的(de)(de)(de)导(dao)尿(niao)(niao)(niao)(niao)包(bao)(bao)是否是您(nin)(nin)选用(yong)的(de)(de)(de)型号(hao)，并确认(ren)导(dao)尿(niao)(niao)(niao)(niao)包(bao)(bao)包(bao)(bao)装完(wan)好(hao)(hao)无破损(sun)。5 在(zai)(zai)操(cao)作前(qian)请(qing)做好(hao)(hao)准备工作，安(an)排患(huan)者(zhe)正确体位铺好(hao)(hao)洞巾。并对患(huan)者(zhe)进(jin)(jin)(jin)行(xing)安(an)慰。6、请(qing)按医院(yuan)的(de)(de)(de)导(dao)尿(niao)(niao)(niao)(niao)操(cao)作规程(cheng)进(jin)(jin)(jin)行(xing)外消(xiao)(xiao)毒(du)(du)(du)和内(nei)消(xiao)(xiao)毒(du)(du)(du)两(liang)次(ci)消(xiao)(xiao)毒(du)(du)(du)。消(xiao)(xiao)毒(du)(du)(du)时不(bu)能选择(ze)对皮肤有较(jiao)强刺(ci)激的(de)(de)(de)消(xiao)(xiao)毒(du)(du)(du)剂(ji)，建议使(shi)(shi)(shi)用(yong)0.5％的(de)(de)(de)碘伏的(de)(de)(de)消(xiao)(xiao)毒(du)(du)(du)剂(ji)或(huo)其他低刺(ci)激的(de)(de)(de)消(xiao)(xiao)毒(du)(du)(du)剂(ji)。7、使(shi)(shi)(shi)用(yong)前(qian)请(qing)将导(dao)尿(niao)(niao)(niao)(niao)管球(qiu)囊(nang)(nang)进(jin)(jin)(jin)行(xing)充水试验，确认(ren)导(dao)尿(niao)(niao)(niao)(niao)管球(qiu)囊(nang)(nang)是否正常(chang)。充水后(hou)的(de)(de)(de)球(qiu)囊(nang)(nang)应(ying)在(zai)(zai)球(qiu)囊(nang)(nang)中留(liu)2－3ml蒸馏水，用(yong)于(yu)(yu)保障球(qiu)囊(nang)(nang)外表光滑(hua)。

一(yi)(yi)次(ci)(ci)性(xing)使(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)无(wu)(wu)菌(jun)(jun)导尿(niao)包(bao)是(shi)一(yi)(yi)款身(shen)体(ti)行动不方(fang)便或(huo)者(zhe)(zhe)手术后(hou)没有办法自(zi) 由行动患者(zhe)(zhe)设计而(er)(er)成的(de)(de)一(yi)(yi)次(ci)(ci)性(xing)使(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)产(chan)品(pin)。本产(chan)品(pin)是(shi)由注(zhu)(zhu)射器、导尿(niao)管(guan)、 导管(guan)夹(jia)、塑(su)料镊.塑(su)料试管(guan)、孔巾、展(zhan)巾、纱布块、止水(shui)(shui)(shui)(shui)器、润(run)(run)(run)滑(hua)(hua)剂(ji)、引流袋托盘、消毒棉球(qiu)手套组(zu)成的(de)(de)-套产(chan)品(pin)。那么，本产(chan)品(pin)如(ru)何(he)使(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)?有哪(na)些(xie)注(zhu)(zhu)意(yi)事(shi)项?在使(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)本产(chan)品(pin)的(de)(de)时候首先要(yao)润(run)(run)(run)滑(hua)(hua),就是(shi)胶(jiao)乳导尿(niao)管(guan)插入(ru)前,需用(yong)(yong)(yong)(yong)(yong)(yong)医(yi)用(yong)(yong)(yong)(yong)(yong)(yong)润(run)(run)(run)滑(hua)(hua)剂(ji)润(run)(run)(run)滑(hua)(hua)。超滑(hua)(hua)胶(jiao)乳导尿(niao)管(guan)插入(ru)前先用(yong)(yong)(yong)(yong)(yong)(yong)无(wu)(wu)菌(jun)(jun)水(shui)(shui)(shui)(shui)充分湿(shi)润(run)(run)(run),即达到(dao)超滑(hua)(hua)效果(guo),无(wu)(wu)需使(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)润(run)(run)(run)滑(hua)(hua)剂(ji)。然(ran)后(hou)就是(shi)插入(ru)和(he)注(zhu)(zhu)水(shui)(shui)(shui)(shui)等的(de)(de)步骤(zhou)了。就是(shi)将润(run)(run)(run)滑(hua)(hua)后(hou)的(de)(de)导管(guan)小心插入(ru)膀(bang)胱(guang)(guang),用(yong)(yong)(yong)(yong)(yong)(yong)不带(dai)针的(de)(de)注(zhu)(zhu)射器注(zhu)(zhu)入(ru)定量无(wu)(wu)菌(jun)(jun)水(shui)(shui)(shui)(shui),使(shi)(shi)膨胀了的(de)(de)水(shui)(shui)(shui)(shui)妻卡信膀(bang)胱(guang)(guang)即可。后(hou)取出排水(shui)(shui)(shui)(shui)管(guan)。还需要(yao)医(yi)护(hu)(hu)人(ren)员(yuan)留置(zhi)观察以及护(hu)(hu)理。在使(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)时也要(yao)注(zhu)(zhu)意(yi),不要(yao)使(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)含石油(you)基质的(de)(de)润(run)(run)(run)滑(hua)(hua)剂(ji);而(er)(er)且,本产(chan)品(pin)经环氧乙烷灭莹,供(gong)一(yi)(yi)次(ci)(ci)性(xing)使(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong),如(ru)包(bao)装破损,不能使(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong);本产(chan)品(pin)仅供(gong)医(yi)护(hu)(hu)人(ren)员(yuan)操作(zuo)使(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong),储藏要(yao)避光防(fang)热(re)。