2月5日，药(yao)监局接到卫(wei)生(sheng)健(jian)康委通(tong)(tong)报(bao)，上(shang)海新兴医(yi)药(yao)股份有限公司（以下(xia)简称“上(shang)海新兴”）生(sheng)产的(de)一(yi)批(pi)次(ci)静注人免(mian)疫球(qiu)蛋(dan)白（批(pi)号：20180610Z）艾(ai)滋(zi)病病毒抗体检(jian)(jian)(jian)测(ce)(ce)为阳性(xing)。药(yao)监局立即要(yao)求上(shang)海市药(yao)监局对(dui)上(shang)海新兴开展现场检(jian)(jian)(jian)查，组织(zhi)对(dui)同批(pi)原料(liao)血浆生(sheng)产的(de)产品(pin)和相邻批(pi)次(ci)产品(pin)进行(xing)(xing)检(jian)(jian)(jian)验，并派出督(du)导检(jian)(jian)(jian)查组抵(di)达上(shang)海、江(jiang)(jiang)西，督(du)促指导地方(fang)药(yao)监部门(men)开展调查处置工(gong)作。药(yao)监局、卫(wei)生(sheng)健(jian)康委联合(he)下(xia)发通(tong)(tong)知，要(yao)求立即暂(zan)停使用该企业生(sheng)产的(de)相关(guan)产品(pin)，并及时采取(qu)封存(cun)等控制措施。上(shang)海方(fang)面(mian)对(dui)涉事批(pi)次(ci)静注人免(mian)疫球(qiu)蛋(dan)白进行(xing)(xing)的(de)艾(ai)滋(zi)病、乙肝、丙肝三种(zhong)病毒核(he)酸检(jian)(jian)(jian)测(ce)(ce)，结果均(jun)为阴性(xing)；江(jiang)(jiang)西方(fang)面(mian)对(dui)患者的(de)艾(ai)滋(zi)病病毒核(he)酸检(jian)(jian)(jian)测(ce)(ce)，结果为阴性(xing)。对(dui)企业现场核(he)查等有关(guan)工(gong)作正在(zai)进一(yi)步进行(xing)(xing)中。

导尿设备在医疗当中也是经常使用的一种产品,在泌尿肛肠等医疗科室经常用到导尿设备一般都是一次性使用的。下面介绍的这种-次性的无莹导尿产品就是同类产品中性能非常优越的一种。医用医用导尿包产品的用途和性能,这种-次性的无菌导尿包主要是给临床上的患者导尿之用，这种产品是经过了环氧乙烷灭莹,非常的卫生和安全，使用起来也非常方便。该产品是由洞巾,布和一次性使用的导尿管、橡胶医用手套、海绵刷、纱布块、石蜡棉球物品盒和一次性的引流袋等几部分组成。这种- -次性产品使用起来也非常方便。医用导尿包价格这种产(chan)(chan)品(pin)使(shi)(shi)用起来也比(bi)较简(jian)单,首先(xian),在使(shi)(shi)用前要检查单包(bao)装是(shi)(shi)不是(shi)(shi)没(mei)有(you)(you)损坏,灭菌的有(you)(you)效期是(shi)(shi)不是(shi)(shi)正常;其次,在使(shi)(shi)用的时(shi)候(hou),先(xian)打(da)(da)开包(bao)装,在将包(bao)布打(da)(da)开,再戴上手套,然(ran)后(hou);按照常规的方法(fa)来使(shi)(shi)用导尿包(bao)里的组件;其三(san),-般的产(chan)(chan)品(pin)的有(you)(you)效期是(shi)(shi)两年 ,如(ru)果(guo)(guo)产(chan)(chan)品(pin)已经过了(le)(le)有(you)(you)效期,绝对不能使(shi)(shi)用;四,如(ru)果(guo)(guo)包(bao)装破损了(le)(le)也不能使(shi)(shi)用;五,这是(shi)(shi)-次性(xing)的使(shi)(shi)用产(chan)(chan)品(pin)，禁止重复使(shi)(shi)用,在使(shi)(shi)用完(wan)后(hou)要销(xiao)毁,生产(chan)(chan)日期般在包(bao)装封口处。

一(yi)次性(xing)使(shi)用(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)痰管(guan)(guan)操作方法(1)检查(cha)吸(xi)(xi)(xi)(xi)(xi)引(yin)器各部连接(jie)是否完善，有(you)无漏气(qi)。接(jie)通(tong)电源，打开(kai)(kai)开(kai)(kai)关，检查(cha)吸(xi)(xi)(xi)(xi)(xi)引(yin)器性(xing)能，调节负压(ya)。一(yi)般成人(ren)吸(xi)(xi)(xi)(xi)(xi)痰负压(ya)约40-50 kPa，小儿吸(xi)(xi)(xi)(xi)(xi)痰约13-30kPa，将(jiang)一(yi)次性(xing)使(shi)用(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)痰管(guan)(guan)置于(yu)(yu)水中(zhong)，试验(yan)吸(xi)(xi)(xi)(xi)(xi)引(yin)力，并冲洗皮管(guan)(guan)。(2)将(jiang)病(bing)人(ren)头部转向护士，铺治(zhi)疗(liao)巾于(yu)(yu)颌(he)下。(3)插入一(yi)次性(xing)使(shi)用(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)痰管(guan)(guan)，其(qi)顺序是由(you)(you)口(kou)腔(qiang)(qiang)前庭→颊部→咽部，将(jiang)各部吸(xi)(xi)(xi)(xi)(xi)尽(jin)。如口(kou)腔(qiang)(qiang)吸(xi)(xi)(xi)(xi)(xi)痰有(you)困难(nan)时，可由(you)(you)鼻(bi)腔(qiang)(qiang)插入(颅底(di)骨折患(huan)者禁用(yong)(yong))，其(qi)顺序由(you)(you)鼻(bi)腔(qiang)(qiang)前庭→下鼻(bi)道→鼻(bi)后孔→咽部→气(qi)管(guan)(guan)(约20-25cm)，将(jiang)分(fen)泌物逐段吸(xi)(xi)(xi)(xi)(xi)尽(jin)。若有(you)气(qi)管(guan)(guan)插管(guan)(guan)或气(qi)管(guan)(guan)切开(kai)(kai)时，可由(you)(you)插管(guan)(guan)或套管(guan)(guan)内(nei)插入，将(jiang)痰液吸(xi)(xi)(xi)(xi)(xi)出。昏迷病(bing)人(ren)可用(yong)(yong)压(ya)舌板或开(kai)(kai)口(kou)器先将(jiang)口(kou)启开(kai)(kai)，再行吸(xi)(xi)(xi)(xi)(xi)引(yin)。

局(ju)(ju)(ju)机关(guan)各(ge)司(si)局(ju)(ju)(ju)、各(ge)直属单位(wei)：为加强对药品(pin)监(jian)管政务(wu)(wu)公(gong)(gong)开(kai)(kai)工(gong)(gong)作(zuo)(zuo)的(de)领(ling)导，局(ju)(ju)(ju)党组(zu)(zu)会议研(yan)究(jiu)决(jue)定(ding)成立(li)药品(pin)监(jian)督(du)(du)管理局(ju)(ju)(ju)政务(wu)(wu)公(gong)(gong)开(kai)(kai)领(ling)导小组(zu)(zu)，下设办(ban)公(gong)(gong)室（以下简称政务(wu)(wu)公(gong)(gong)开(kai)(kai)办(ban)）。现将有关(guan)事项通知如(ru)下：一(yi)、政务(wu)(wu)公(gong)(gong)开(kai)(kai)领(ling)导小组(zu)(zu)组(zu)(zu)成及职责(ze)（一(yi)）组(zu)(zu)成组(zu)(zu)长：李利焦红副组(zu)(zu)长：徐景和(he)陈时飞颜江瑛(ying)成员：各(ge)司(si)局(ju)(ju)(ju)、各(ge)直属单位(wei)主要负(fu)责(ze)同志颜江瑛(ying)同志负(fu)责(ze)领(ling)导小组(zu)(zu)日常工(gong)(gong)作(zuo)(zuo)。（二(er)）主要职责(ze)。在局(ju)(ju)(ju)党组(zu)(zu)领(ling)导下，负(fu)责(ze)贯彻(che)落(luo)(luo)实(shi)党中央(yang)、国务(wu)(wu)院关(guan)于政务(wu)(wu)公(gong)(gong)开(kai)(kai)工(gong)(gong)作(zuo)(zuo)的(de)方针政策，研(yan)究(jiu)制(zhi)(zhi)定(ding)落(luo)(luo)实(shi)措施；研(yan)究(jiu)制(zhi)(zhi)定(ding)药品(pin)监(jian)管政务(wu)(wu)公(gong)(gong)开(kai)(kai)工(gong)(gong)作(zuo)(zuo)的(de)发(fa)展规(gui)划和(he)政策措施；审(shen)定(ding)局(ju)(ju)(ju)政务(wu)(wu)公(gong)(gong)开(kai)(kai)工(gong)(gong)作(zuo)(zuo)制(zhi)(zhi)度，研(yan)究(jiu)局(ju)(ju)(ju)政务(wu)(wu)公(gong)(gong)开(kai)(kai)工(gong)(gong)作(zuo)(zuo)和(he)实(shi)施方案(an)，研(yan)究(jiu)解(jie)决(jue)政务(wu)(wu)公(gong)(gong)开(kai)(kai)工(gong)(gong)作(zuo)(zuo)中遇(yu)到的(de)重大(da)问题；协调各(ge)司(si)局(ju)(ju)(ju)、各(ge)单位(wei)抓好政务(wu)(wu)公(gong)(gong)开(kai)(kai)工(gong)(gong)作(zuo)(zuo)任务(wu)(wu)落(luo)(luo)实(shi)，并(bing)加强督(du)(du)促检查。

医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)是(shi)医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)研(yan)制(zhi)(zhi)、生产、经营、使用以及监(jian)(jian)(jian)(jian)(jian)督管(guan)(guan)(guan)(guan)(guan)理(li)所共同遵循(xun)的技术(shu)规范(fan)，是(shi)医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)监(jian)(jian)(jian)(jian)(jian)管(guan)(guan)(guan)(guan)(guan)和(he)(he)(he)产业发(fa)展(zhan)(zhan)的重(zhong)(zhong)要技术(shu)支撑。药监(jian)(jian)(jian)(jian)(jian)局高度重(zhong)(zhong)视医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)工(gong)(gong)作，按照“四个严”的要求，结合(he)医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)产业发(fa)展(zhan)(zhan)和(he)(he)(he)监(jian)(jian)(jian)(jian)(jian)管(guan)(guan)(guan)(guan)(guan)工(gong)(gong)作实际，不(bu)(bu)断完善医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)管(guan)(guan)(guan)(guan)(guan)理(li)制(zhi)(zhi)度体系、持续开展(zhan)(zhan)医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)制(zhi)(zhi)修订(ding)工(gong)(gong)作，我国(guo)(guo)(guo)医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)体系不(bu)(bu)断完善，医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)对监(jian)(jian)(jian)(jian)(jian)管(guan)(guan)(guan)(guan)(guan)和(he)(he)(he)产业发(fa)展(zhan)(zhan)的技术(shu)支撑能力持续提(ti)升。一、加强医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)制(zhi)(zhi)度建设。为贯彻(che)落(luo)(luo)实国(guo)(guo)(guo)务院深化(hua)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)化(hua)改革重(zhong)(zhong)大决(jue)策部署，依据《中华人民共和(he)(he)(he)国(guo)(guo)(guo)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)化(hua)法(fa)》，立(li)足我国(guo)(guo)(guo)医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)产业发(fa)展(zhan)(zhan)和(he)(he)(he)监(jian)(jian)(jian)(jian)(jian)管(guan)(guan)(guan)(guan)(guan)工(gong)(gong)作实际，2017年4月，原食品药品监(jian)(jian)(jian)(jian)(jian)管(guan)(guan)(guan)(guan)(guan)总(zong)局修订(ding)印发(fa)《医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)管(guan)(guan)(guan)(guan)(guan)理(li)办(ban)法(fa)》，该办(ban)法(fa)的出台对指导我国(guo)(guo)(guo)医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)管(guan)(guan)(guan)(guan)(guan)理(li)、规范(fan)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)制(zhi)(zhi)修订(ding)、促进(jin)(jin)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)实施、提(ti)升医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)质量等(deng)起到(dao)了(le)(le)(le)积极(ji)作用。为贯彻(che)落(luo)(luo)实《医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)管(guan)(guan)(guan)(guan)(guan)理(li)办(ban)法(fa)》，原食品药品监(jian)(jian)(jian)(jian)(jian)管(guan)(guan)(guan)(guan)(guan)总(zong)局先后印发(fa)《医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)制(zhi)(zhi)修订(ding)工(gong)(gong)作管(guan)(guan)(guan)(guan)(guan)理(li)规范(fan)》和(he)(he)(he)《医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)报批发(fa)布工(gong)(gong)作细(xi)(xi)则(ze)》等(deng)文(wen)件，进(jin)(jin)一步规范(fan)了(le)(le)(le)医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)工(gong)(gong)作程(cheng)序(xu)，强化(hua)了(le)(le)(le)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)精细(xi)(xi)化(hua)过程(cheng)管(guan)(guan)(guan)(guan)(guan)理(li)，为提(ti)升医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)标(biao)准(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)质量奠定(ding)了(le)(le)(le)坚实的制(zhi)(zhi)度基础。