医疗器械标准是医疗器械研制、生产、经营、使用以及监督管理所共同遵循的技术规范，是医疗器械监管和产业发展的重要技术支撑。医用一次性使用医用无菌阴道扩张器药监局高度重视医疗器械标准工作，按照“四个严”的要求，结合医疗器械产业发展和监管工作实际，不断完善医疗器械标准管理制度体系、持续开展医疗器械标准制修订工作，我国医疗器械标准体系不断完善，医疗器械标准对监管和产业发展的技术支撑能力持续提升。一、加强医疗器械标准制度建设。一次性使用医用无菌阴道扩张器批发为贯彻落(luo)实(shi)(shi)(shi)国务院深化(hua)标(biao)(biao)准(zhun)(zhun)化(hua)改革(ge)重大决策部(bu)署，依据(ju)《中华人民共和国标(biao)(biao)准(zhun)(zhun)化(hua)法》，立足我国医(yi)疗器(qi)械(xie)(xie)产业(ye)发(fa)(fa)展和监管(guan)工(gong)(gong)作实(shi)(shi)(shi)际(ji)，2017年4月，原食品(pin)药品(pin)监管(guan)总(zong)(zong)局修订(ding)(ding)印(yin)发(fa)(fa)《医(yi)疗器(qi)械(xie)(xie)标(biao)(biao)准(zhun)(zhun)管(guan)理办法》，该办法的出台对指(zhi)导我国医(yi)疗器(qi)械(xie)(xie)标(biao)(biao)准(zhun)(zhun)管(guan)理、规(gui)范(fan)标(biao)(biao)准(zhun)(zhun)制修订(ding)(ding)、促进(jin)标(biao)(biao)准(zhun)(zhun)实(shi)(shi)(shi)施、提(ti)升(sheng)医(yi)疗器(qi)械(xie)(xie)质量等起(qi)到了(le)积极作用。为贯彻落(luo)实(shi)(shi)(shi)《医(yi)疗器(qi)械(xie)(xie)标(biao)(biao)准(zhun)(zhun)管(guan)理办法》，原食品(pin)药品(pin)监管(guan)总(zong)(zong)局先后印(yin)发(fa)(fa)《医(yi)疗器(qi)械(xie)(xie)标(biao)(biao)准(zhun)(zhun)制修订(ding)(ding)工(gong)(gong)作管(guan)理规(gui)范(fan)》和《医(yi)疗器(qi)械(xie)(xie)标(biao)(biao)准(zhun)(zhun)报(bao)批发(fa)(fa)布工(gong)(gong)作细则(ze)》等文(wen)件，进(jin)一步规(gui)范(fan)了(le)医(yi)疗器(qi)械(xie)(xie)标(biao)(biao)准(zhun)(zhun)工(gong)(gong)作程(cheng)序，强化(hua)了(le)标(biao)(biao)准(zhun)(zhun)精细化(hua)过(guo)程(cheng)管(guan)理，为提(ti)升(sheng)医(yi)疗器(qi)械(xie)(xie)标(biao)(biao)准(zhun)(zhun)质量奠定了(le)坚实(shi)(shi)(shi)的制度基础。

2月13日(ri)，联(lian)合(he)整治“保(bao)健”市(shi)(shi)(shi)场(chang)乱象(xiang)(xiang)百(bai)日(ri)行(xing)(xing)动联(lian)合(he)工(gong)(gong)作组在市(shi)(shi)(shi)场(chang)监(jian)(jian)管(guan)(guan)(guan)总局(ju)(ju)(ju)召开工(gong)(gong)作组会(hui)议。市(shi)(shi)(shi)场(chang)监(jian)(jian)管(guan)(guan)(guan)总局(ju)(ju)(ju)副局(ju)(ju)(ju)长(zhang)甘霖同志(zhi)出席会(hui)议并(bing)讲话(hua)，市(shi)(shi)(shi)场(chang)监(jian)(jian)管(guan)(guan)(guan)总局(ju)(ju)(ju)、工(gong)(gong)业和信(xin)息化(hua)部(bu)(bu)(bu)、公安部(bu)(bu)(bu)、民(min)政部(bu)(bu)(bu)、住房和城乡(xiang)建设部(bu)(bu)(bu)、农(nong)业农(nong)村部(bu)(bu)(bu)、商务(wu)部(bu)(bu)(bu)、文(wen)化(hua)和旅游(you)部(bu)(bu)(bu)、卫生(sheng)健康(kang)委员(yuan)(yuan)(yuan)会(hui)、广播(bo)电视(shi)总局(ju)(ju)(ju)、中医药管(guan)(guan)(guan)理(li)局(ju)(ju)(ju)、药品监(jian)(jian)督管(guan)(guan)(guan)理(li)局(ju)(ju)(ju)、网信(xin)办等13部(bu)(bu)(bu)门(men)(men)成(cheng)员(yuan)(yuan)(yuan)单(dan)位(wei)负责同志(zhi)及(ji)联(lian)络员(yuan)(yuan)(yuan)和市(shi)(shi)(shi)场(chang)监(jian)(jian)管(guan)(guan)(guan)总局(ju)(ju)(ju)“百(bai)日(ri)行(xing)(xing)动”工(gong)(gong)作组成(cheng)员(yuan)(yuan)(yuan)单(dan)位(wei)负责同志(zhi)及(ji)联(lian)络员(yuan)(yuan)(yuan)参加会(hui)议。“百(bai)日(ri)行(xing)(xing)动”开展以来，各(ge)部(bu)(bu)(bu)门(men)(men)积极落实《关于开展联(lian)合(he)整治“保(bao)健”市(shi)(shi)(shi)场(chang)乱象(xiang)(xiang)百(bai)日(ri)行(xing)(xing)动的通(tong)知(zhi)》要求(qiu)，立足自身职能，迅速部(bu)(bu)(bu)署落实，在相关领域(yu)和行(xing)(xing)业内开展行(xing)(xing)动。市(shi)(shi)(shi)场(chang)监(jian)(jian)管(guan)(guan)(guan)总局(ju)(ju)(ju)切实履行(xing)(xing)监(jian)(jian)管(guan)(guan)(guan)执法、联(lian)络调度、汇集信(xin)息、服务(wu)保(bao)障(zhang)等职责，通(tong)过建立工(gong)(gong)作协调机制、建立工(gong)(gong)作台账、召开调度会(hui)议、加强新(xin)闻宣(xuan)传等方(fang)式，组织(zhi)各(ge)部(bu)(bu)(bu)门(men)(men)、市(shi)(shi)(shi)场(chang)监(jian)(jian)管(guan)(guan)(guan)系统迅速深入开展“百(bai)日(ri)行(xing)(xing)动”。

一(yi)(yi)次(ci)(ci)性(xing)使(shi)(shi)用(yong)(yong)导(dao)(dao)尿(niao)(niao)(niao)包(bao)(bao)相关(guan)问(wen)答(da)(da)问(wen)：有(you)(you)(you)(you)什么区别次(ci)(ci)性(xing)使(shi)(shi)用(yong)(yong)导(dao)(dao)尿(niao)(niao)(niao)包(bao)(bao)+18？答(da)(da)：导(dao)(dao)尿(niao)(niao)(niao)包(bao)(bao)咨询热(re)线 :0512-66615979答(da)(da)：导(dao)(dao)尿(niao)(niao)(niao)管的外直径,一(yi)(yi)般男性(xing)临床用(yong)(yong)12~16比(bi)较多见,问(wen)： 一(yi)(yi)次(ci)(ci)性(xing)使(shi)(shi)用(yong)(yong)引(yin)尿(niao)(niao)(niao)包(bao)(bao)的注意事(shi)项有(you)(you)(you)(you)哪些？答(da)(da)：1、本品(pin)经环氧乙环灭菌(jun)(jun)，使(shi)(shi)用(yong)(yong)前请注意内袋包(bao)(bao)装上灭菌(jun)(jun)指示(shi)标志。2、本品(pin)灭菌(jun)(jun)后(hou)，在包(bao)(bao)装完好时，包(bao)(bao)内所(suo)有(you)(you)(you)(you)器件均为(wei)无(wu)毒、无(wu)菌(jun)(jun)。3、包(bao)(bao)装破损，禁止使(shi)(shi)用(yong)(yong)。4、本产(chan)(chan)品(pin)灭菌(jun)(jun)有(you)(you)(you)(you)效期两(liang)年(nian)，生产(chan)(chan)日(ri)期见封(feng)口(kou)处。5、本产(chan)(chan)品(pin)仅(jin)限于一(yi)(yi)次(ci)(ci)性(xing)使(shi)(shi)用(yong)(yong)，用(yong)(yong)后(hou)销(xiao)毁(hui)。问(wen)： 一(yi)(yi)次(ci)(ci)性(xing)使(shi)(shi)用(yong)(yong)引(yin)尿(niao)(niao)(niao)包(bao)(bao)的使(shi)(shi)用(yong)(yong)方法是怎样的？答(da)(da)：1、取(qu)出本品(pin)，从启(qi)口(kou)处撕开，取(qu)出无(wu)菌(jun)(jun)内包(bao)(bao)，放置工作(zuo)(zuo)台中央。2、打开内包(bao)(bao)，戴(dai)上无(wu)菌(jun)(jun)医用(yong)(yong)手套，按操(cao)作(zuo)(zuo)规程进行操(cao)作(zuo)(zuo)。3、使(shi)(shi)用(yong)(yong)时注意正确使(shi)(shi)用(yong)(yong)引(yin)流(liu)袋等各(ge)种(zhong)配件。4、本产(chan)(chan)品(pin)使(shi)(shi)用(yong)(yong)结(jie)束后(hou)，丢弃所(suo)有(you)(you)(you)(you)组(zu)件，不可重复(fu)使(shi)(shi)用(yong)(yong)。

一(yi)次(ci)性使(shi)(shi)用(yong)(yong)吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)的(de)使(shi)(shi)用(yong)(yong)。导读：如何使(shi)(shi)用(yong)(yong)一(yi)次(ci)性吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)？小编为(wei)大家准(zhun)备(bei)(bei)了使(shi)(shi)用(yong)(yong)吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)的(de)方(fang)法(fa)和使(shi)(shi)用(yong)(yong)吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)需要注意的(de)三点，这(zhei)可(ke)能对你有(you)(you)帮助。使(shi)(shi)用(yong)(yong)吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)的(de)方(fang)法(fa)：1.检(jian)查吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)，检(jian)查吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)装置功能，检(jian)查吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)导管(guan)(guan)(guan)(guan)是(shi)否通畅，是(shi)否影响正常吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)手术(shu)。2.准(zhun)备(bei)(bei)所有(you)(you)吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)项(xiang)目(mu)，将(jiang)这(zhei)些物品放在床头(tou)柜上，向(xiang)病(bing)人(ren)(ren)(ren)解释下一(yi)次(ci)手术(shu)，说明某些项(xiang)目(mu)的(de)使(shi)(shi)用(yong)(yong)情况，并为(wei)病(bing)人(ren)(ren)(ren)做(zuo)好准(zhun)备(bei)(bei)。3.让病(bing)人(ren)(ren)(ren)侧头(tou)，稍向(xiang)后，如果(guo)病(bing)人(ren)(ren)(ren)本(ben)身(shen)处(chu)于昏迷(mi)状态，需要用(yong)(yong)舌板打开病(bing)人(ren)(ren)(ren)的(de)嘴，然(ran)后将(jiang)痰(tan)(tan)(tan)(tan)(tan)(tan)吸(xi)(xi)管(guan)(guan)(guan)(guan)侧到(dao)咽喉等，当(dang)(dang)病(bing)人(ren)(ren)(ren)吸(xi)(xi)气(qi)时(shi)，将(jiang)吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)插(cha)入(ru)(ru)气(qi)管(guan)(guan)(guan)(guan)。如果(guo)病(bing)人(ren)(ren)(ren)很难从(cong)嘴里吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)，就可(ke)以从(cong)鼻腔插(cha)入(ru)(ru)痰(tan)(tan)(tan)(tan)(tan)(tan)。当(dang)(dang)然(ran)，禁止(zhi)使(shi)(shi)用(yong)(yong)颅底(di)骨(gu)折患者。对于气(qi)管(guan)(guan)(guan)(guan)内插(cha)管(guan)(guan)(guan)(guan)或(huo)气(qi)管(guan)(guan)(guan)(guan)切开术(shu)的(de)病(bing)人(ren)(ren)(ren)，可(ke)以从(cong)插(cha)管(guan)(guan)(guan)(guan)或(huo)插(cha)管(guan)(guan)(guan)(guan)中插(cha)入(ru)(ru)吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)。4.插(cha)入(ru)(ru)吸(xi)(xi)入(ru)(ru)管(guan)(guan)(guan)(guan)前，打开吸(xi)(xi)入(ru)(ru)开关(guan)。然(ran)而，T管(guan)(guan)(guan)(guan)的(de)侧孔(kong)应该放松，当(dang)(dang)痰(tan)(tan)(tan)(tan)(tan)(tan)吸(xi)(xi)管(guan)(guan)(guan)(guan)在一(yi)定(ding)深度插(cha)入(ru)(ru)气(qi)管(guan)(guan)(guan)(guan)时(shi)，可(ke)根据闭合侧孔(kong)立即吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)。吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)时(shi)，吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)应从(cong)底(di)部慢慢抬(tai)起，左(zuo)右旋转，以便(bian)吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)。防止(zhi)粘(zhan)膜被(bei)破坏，通过固定(ding)一(yi)个地方(fang)，或(huo)向(xiang)上和向(xiang)下，以吸(xi)(xi)引它(ta)。吸(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)取出后，吸(xi)(xi)收水分(fen)，冲洗管(guan)(guan)(guan)(guan)内痰(tan)(tan)(tan)(tan)(tan)(tan)，以免(mian)堵塞痰(tan)(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)。关(guan)掉(diao)吸(xi)(xi)管(guan)(guan)(guan)(guan)开关(guan)。