2月5日，药(yao)监(jian)(jian)(jian)局接到卫(wei)生(sheng)(sheng)健康(kang)委(wei)通报，上海(hai)新兴医(yi)药(yao)股份(fen)有(you)限(xian)公司（以下简称“上海(hai)新兴”）生(sheng)(sheng)产(chan)(chan)的(de)一批次静注人(ren)免疫球(qiu)蛋白（批号：20180610Z）艾(ai)滋病病毒(du)抗体检(jian)(jian)(jian)(jian)测(ce)(ce)为阳性(xing)(xing)。药(yao)监(jian)(jian)(jian)局立即要(yao)求上海(hai)市药(yao)监(jian)(jian)(jian)局对(dui)上海(hai)新兴开展(zhan)(zhan)现场检(jian)(jian)(jian)(jian)查(cha)，组织对(dui)同批原料血(xue)浆(jiang)生(sheng)(sheng)产(chan)(chan)的(de)产(chan)(chan)品(pin)和(he)相(xiang)邻(lin)批次产(chan)(chan)品(pin)进(jin)行(xing)检(jian)(jian)(jian)(jian)验，并派出督(du)导检(jian)(jian)(jian)(jian)查(cha)组抵达(da)上海(hai)、江西(xi)，督(du)促指导地方(fang)药(yao)监(jian)(jian)(jian)部(bu)门开展(zhan)(zhan)调查(cha)处置工(gong)作(zuo)。药(yao)监(jian)(jian)(jian)局、卫(wei)生(sheng)(sheng)健康(kang)委(wei)联合下发(fa)通知，要(yao)求立即暂(zan)停使(shi)用该企(qi)业(ye)生(sheng)(sheng)产(chan)(chan)的(de)相(xiang)关(guan)产(chan)(chan)品(pin)，并及时采取(qu)封(feng)存等(deng)控(kong)制措(cuo)施。上海(hai)方(fang)面对(dui)涉事(shi)批次静注人(ren)免疫球(qiu)蛋白进(jin)行(xing)的(de)艾(ai)滋病、乙(yi)肝、丙(bing)肝三种(zhong)病毒(du)核酸(suan)检(jian)(jian)(jian)(jian)测(ce)(ce)，结果(guo)均为阴性(xing)(xing)；江西(xi)方(fang)面对(dui)患者的(de)艾(ai)滋病病毒(du)核酸(suan)检(jian)(jian)(jian)(jian)测(ce)(ce)，结果(guo)为阴性(xing)(xing)。对(dui)企(qi)业(ye)现场核查(cha)等(deng)有(you)关(guan)工(gong)作(zuo)正在进(jin)一步(bu)进(jin)行(xing)中(zhong)。

医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)准(zhun)是医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)研(yan)制(zhi)(zhi)、生产(chan)、经营、使用(yong)以及监督管(guan)(guan)(guan)理所共(gong)同遵循的(de)技术(shu)规(gui)范(fan)，是医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)监管(guan)(guan)(guan)和(he)产(chan)业(ye)发(fa)展(zhan)的(de)重(zhong)要技术(shu)支撑。药(yao)监局(ju)高度重(zhong)视医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)准(zhun)工(gong)(gong)作(zuo)(zuo)，按照(zhao)“四个严”的(de)要求，结合医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)产(chan)业(ye)发(fa)展(zhan)和(he)监管(guan)(guan)(guan)工(gong)(gong)作(zuo)(zuo)实(shi)(shi)际，不断完(wan)善医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)准(zhun)管(guan)(guan)(guan)理制(zhi)(zhi)度体(ti)系(xi)、持续(xu)开展(zhan)医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)准(zhun)制(zhi)(zhi)修订工(gong)(gong)作(zuo)(zuo)，我国医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)准(zhun)体(ti)系(xi)不断完(wan)善，医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)准(zhun)对(dui)监管(guan)(guan)(guan)和(he)产(chan)业(ye)发(fa)展(zhan)的(de)技术(shu)支撑能力持续(xu)提升。一、加强(qiang)医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)准(zhun)制(zhi)(zhi)度建设。为(wei)贯彻落实(shi)(shi)国务院深化(hua)标(biao)(biao)准(zhun)化(hua)改(gai)革重(zhong)大决策部(bu)署(shu)，依(yi)据《中华人民共(gong)和(he)国标(biao)(biao)准(zhun)化(hua)法(fa)》，立足我国医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)产(chan)业(ye)发(fa)展(zhan)和(he)监管(guan)(guan)(guan)工(gong)(gong)作(zuo)(zuo)实(shi)(shi)际，2017年(nian)4月，原食(shi)品药(yao)品监管(guan)(guan)(guan)总(zong)局(ju)修订印发(fa)《医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)准(zhun)管(guan)(guan)(guan)理办法(fa)》，该(gai)办法(fa)的(de)出(chu)台对(dui)指导我国医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)准(zhun)管(guan)(guan)(guan)理、规(gui)范(fan)标(biao)(biao)准(zhun)制(zhi)(zhi)修订、促进(jin)标(biao)(biao)准(zhun)实(shi)(shi)施、提升医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)质量等(deng)起到了(le)积(ji)极作(zuo)(zuo)用(yong)。为(wei)贯彻落实(shi)(shi)《医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)准(zhun)管(guan)(guan)(guan)理办法(fa)》，原食(shi)品药(yao)品监管(guan)(guan)(guan)总(zong)局(ju)先后印发(fa)《医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)准(zhun)制(zhi)(zhi)修订工(gong)(gong)作(zuo)(zuo)管(guan)(guan)(guan)理规(gui)范(fan)》和(he)《医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)准(zhun)报批发(fa)布工(gong)(gong)作(zuo)(zuo)细(xi)则》等(deng)文(wen)件，进(jin)一步规(gui)范(fan)了(le)医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)准(zhun)工(gong)(gong)作(zuo)(zuo)程序，强(qiang)化(hua)了(le)标(biao)(biao)准(zhun)精细(xi)化(hua)过程管(guan)(guan)(guan)理，为(wei)提升医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)准(zhun)质量奠定了(le)坚实(shi)(shi)的(de)制(zhi)(zhi)度基础。

疫(yi)(yi)苗(miao)(miao)(miao)(miao)管(guan)(guan)理(li)(li)(li)法(fa)草案(an)23日(ri)首次(ci)提(ti)请十三届人大常委会第七次(ci)会议(yi)(yi)审(shen)议(yi)(yi)。草案(an)就疫(yi)(yi)苗(miao)(miao)(miao)(miao)管(guan)(guan)理(li)(li)(li)单(dan)独立法(fa)，突出(chu)疫(yi)(yi)苗(miao)(miao)(miao)(miao)管(guan)(guan)理(li)(li)(li)特点，强化疫(yi)(yi)苗(miao)(miao)(miao)(miao)的(de)风险管(guan)(guan)理(li)(li)(li)、全程控制(zhi)、严格监管(guan)(guan)和社(she)会共治，切实疫(yi)(yi)苗(miao)(miao)(miao)(miao)安全、有(you)效和规范接种(zhong)。党中央、国务(wu)院高度重视(shi)疫(yi)(yi)苗(miao)(miao)(miao)(miao)监管(guan)(guan)工作，要求(qiu)加快(kuai)完善疫(yi)(yi)苗(miao)(miao)(miao)(miao)药品监管(guan)(guan)长效机(ji)制(zhi)。疫(yi)(yi)苗(miao)(miao)(miao)(miao)管(guan)(guan)理(li)(li)(li)单(dan)独立法(fa)，有(you)利(li)于(yu)进一(yi)步提(ti)高疫(yi)(yi)苗(miao)(miao)(miao)(miao)管(guan)(guan)理(li)(li)(li)措施的(de)稳定性。药监局政策法(fa)规司有(you)关负责人介绍，2005年国务(wu)院出(chu)台了《疫(yi)(yi)苗(miao)(miao)(miao)(miao)流通和预防(fang)接种(zhong)管(guan)(guan)理(li)(li)(li)条(tiao)例》，并于(yu)2016年进行(xing)了修(xiu)订。此次(ci)提(ti)交(jiao)审(shen)议(yi)(yi)的(de)疫(yi)(yi)苗(miao)(miao)(miao)(miao)管(guan)(guan)理(li)(li)(li)法(fa)草案(an)，对疫(yi)(yi)苗(miao)(miao)(miao)(miao)研制(zhi)、生(sheng)产、流通、预防(fang)接种(zhong)、补(bu)偿、赔偿等以法(fa)律形式(shi)进行(xing)明确规定，有(you)利(li)于(yu)建(jian)立系统的(de)、全链条(tiao)的(de)疫(yi)(yi)苗(miao)(miao)(miao)(miao)管(guan)(guan)理(li)(li)(li)制(zhi)度。

指导要点1.告知患者胸腔引流的目的及配合方法。2.鼓励患者咳嗽，深呼吸及变换体位，并告知正确咳嗽、深呼吸、变换体位的方法。（四）注意事项。1.出血量多于100ml／h，呈鲜红色，优质一次性使用灌肠包有血凝块，同时伴有脉搏增快，提示有活动性出血的可能，及时通知医生。2.水封瓶打破或接头滑脱时，要立即夹闭或反折近胸端胸引管。3.引流管自胸壁伤口脱出，立即用手顺皮肤纹理方向捏紧引流口周围皮肤（注意不要直接接触伤口），一次性使用灌肠包批发并立即(ji)通(tong)知医生(sheng)处理。4.患(huan)者(zhe)下床活(huo)动时(shi)(shi)，引流(liu)(liu)瓶(ping)的位(wei)置(zhi)应低于膝(xi)盖(gai)且保持平(ping)稳，保障长管(guan)(guan)没入液面下；外出检(jian)查(cha)前(qian)须将引流(liu)(liu)管(guan)(guan)夹闭，漏气(qi)(qi)明显(xian)的患(huan)者(zhe)不(bu)可夹闭胸引管(guan)(guan)。5.拔管(guan)(guan)后注意观察患(huan)者(zhe)有(you)无胸闷(men)、憋(bie)气(qi)(qi)，皮下气(qi)(qi)肿，伤口渗液及(ji)出血等症状，有(you)异常及(ji)时(shi)(shi)通(tong)知医生(sheng)。一次性使用导(dao)尿包（三）指导(dao)要点。1.告(gao)知患(huan)者(zhe)心包、纵膈(ge)引流(liu)(liu)的目的、配合方法(fa)。2.告(gao)知患(huan)者(zhe)更换体位(wei)时(shi)(shi)防止引流(liu)(liu)管(guan)(guan)意外脱出或(huo)打折、受压等措施。

使(shi)用一(yi)(yi)次(ci)(ci)性(xing)换(huan)药(yao)包(bao)(bao)时(shi),换(huan)药(yao)拆(chai)线前需(xu)要(yao)做哪些准(zhun)(zhun)备(bei)(bei)工(gong)作?首(shou)先换(huan)药(yao)室清洁消(xiao)毒(du)，再(zai)通知病(bing)人准(zhun)(zhun)时(shi)去换(huan)药(yao)室拆(chai)线，然后操作者准(zhun)(zhun)备(bei)(bei)用物。具(ju)体准(zhun)(zhun)备(bei)(bei)的用物放(fang)治疗(liao)车上，有一(yi)(yi)次(ci)(ci)性(xing)无菌(jun)换(huan)药(yao)包(bao)(bao)、碘(dian)(dian)伏(fu)(fu)包(bao)(bao)或碘(dian)(dian)伏(fu)(fu)、无菌(jun)刀片、无菌(jun)敷料，医用垃(la)圾袋，锐器盒，最好带(dai)一(yi)(yi)个助(zhu)手，要(yao)帮忙(mang)倒碘(dian)(dian)伏(fu)(fu)。操作者和(he)助(zhu)手洗手，戴(dai)口(kou)罩(zhao)和(he)帽子。准(zhun)(zhun)备(bei)(bei)工(gong)作大(da)概就是这些，因为现在规定换(huan)药(yao)包(bao)(bao)内不(bu)能(neng)放(fang)碘(dian)(dian)伏(fu)(fu)包(bao)(bao)，所以只能(neng)拿碘(dian)(dian)伏(fu)(fu)瓶倒在棉(mian)球上或者一(yi)(yi)次(ci)(ci)性(xing)碘(dian)(dian)伏(fu)(fu)包(bao)(bao)。

一(yi)次(ci)性使(shi)用(yong)(yong)(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)的(de)(de)(de)(de)(de)使(shi)用(yong)(yong)(yong)(yong)。导读：如何使(shi)用(yong)(yong)(yong)(yong)一(yi)次(ci)性吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)？小编为大(da)家准备了使(shi)用(yong)(yong)(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)的(de)(de)(de)(de)(de)方(fang)法(fa)和(he)(he)使(shi)用(yong)(yong)(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)需要注(zhu)意的(de)(de)(de)(de)(de)三点(dian)，这(zhei)可能(neng)(neng)对你(ni)有帮(bang)助。使(shi)用(yong)(yong)(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)的(de)(de)(de)(de)(de)方(fang)法(fa)：1.检(jian)查吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)，检(jian)查吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)装置功能(neng)(neng)，检(jian)查吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)导管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)是(shi)否通(tong)畅，是(shi)否影响正常吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)手(shou)术(shu)。2.准备所有吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)项目(mu)，将(jiang)这(zhei)些物品放在床头(tou)柜上，向(xiang)病(bing)人(ren)(ren)解(jie)释下(xia)一(yi)次(ci)手(shou)术(shu)，说明(ming)某些项目(mu)的(de)(de)(de)(de)(de)使(shi)用(yong)(yong)(yong)(yong)情况，并(bing)为病(bing)人(ren)(ren)做好准备。3.让病(bing)人(ren)(ren)侧头(tou)，稍向(xiang)后(hou)(hou)(hou)，如果(guo)病(bing)人(ren)(ren)本身(shen)处于昏迷状态，需要用(yong)(yong)(yong)(yong)舌板打开(kai)病(bing)人(ren)(ren)的(de)(de)(de)(de)(de)嘴，然后(hou)(hou)(hou)将(jiang)痰(tan)(tan)(tan)(tan)(tan)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)侧到咽喉等(deng)，当病(bing)人(ren)(ren)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)气(qi)时，将(jiang)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)插(cha)入(ru)(ru)(ru)气(qi)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)。如果(guo)病(bing)人(ren)(ren)很难从嘴里(li)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)，就可以从鼻腔插(cha)入(ru)(ru)(ru)痰(tan)(tan)(tan)(tan)(tan)。当然，禁止使(shi)用(yong)(yong)(yong)(yong)颅底骨折患者。对于气(qi)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)内(nei)插(cha)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)或(huo)气(qi)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)切(qie)开(kai)术(shu)的(de)(de)(de)(de)(de)病(bing)人(ren)(ren)，可以从插(cha)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)或(huo)插(cha)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)中插(cha)入(ru)(ru)(ru)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)。4.插(cha)入(ru)(ru)(ru)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)入(ru)(ru)(ru)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)前，打开(kai)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)入(ru)(ru)(ru)开(kai)关。然而，T管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)的(de)(de)(de)(de)(de)侧孔(kong)应(ying)该放松，当痰(tan)(tan)(tan)(tan)(tan)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)在一(yi)定深度插(cha)入(ru)(ru)(ru)气(qi)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)时，可根据(ju)闭合侧孔(kong)立(li)即(ji)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)。吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)时，吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)应(ying)从底部(bu)慢慢抬起，左(zuo)右旋转，以便吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)。防止粘膜被破(po)坏(huai)，通(tong)过(guo)固定一(yi)个地方(fang)，或(huo)向(xiang)上和(he)(he)向(xiang)下(xia)，以吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)引它。吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)取出后(hou)(hou)(hou)，吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)收水分，冲洗管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)内(nei)痰(tan)(tan)(tan)(tan)(tan)，以免堵塞痰(tan)(tan)(tan)(tan)(tan)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)。关掉吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)管(guan)(guan)(guan)(guan)(guan)(guan)(guan)(guan)开(kai)关。