本产品主要采血前后对献血者进行护理使用，消毒棉棒采用液棒，使用方便；产品无菌，一次性使用，方便护理人员操作，防止交叉感染。优质一次性使用会阴护理包具体特点如下：1、无菌垫单：防水无纺布2、止血带：进口高弹非乳胶材料，弹力好，防止皮肤过敏。3、消毒棉签：超长碘伏棒设计，确保面积消毒充分，碘伏棒易折，免得头设计合理，不滴不漏；两端面头采用不同颜色区分，使用方便；内装医用碘伏液体，其有效碘含量为0.45-0.55%，消毒效果好。4、采血贴：主要用于采血针眼等小创口的止血与保护，产品止血迅速、创口愈合快，可有效降低针眼感染及皮下淤血的几率，从根本上解决了棉球及普通创可贴无法克服的止血愈合效果差的难题，减轻了献血者的心里负担。一次性使用会阴护理包厂家改良肤色材料，强(qiang)调人性化设计(ji)，粘性强(qiang)，易剥落。

局(ju)(ju)机关各司(si)局(ju)(ju)、各直属单(dan)位：为加强(qiang)对药品监(jian)管政(zheng)(zheng)(zheng)务(wu)(wu)(wu)(wu)公(gong)(gong)(gong)(gong)开(kai)工(gong)(gong)作(zuo)(zuo)的(de)领导(dao)，局(ju)(ju)党(dang)组会议研究决定(ding)成立药品监(jian)督(du)管理(li)局(ju)(ju)政(zheng)(zheng)(zheng)务(wu)(wu)(wu)(wu)公(gong)(gong)(gong)(gong)开(kai)领导(dao)小(xiao)组，下(xia)(xia)设办公(gong)(gong)(gong)(gong)室(shi)（以下(xia)(xia)简称政(zheng)(zheng)(zheng)务(wu)(wu)(wu)(wu)公(gong)(gong)(gong)(gong)开(kai)办）。现(xian)将有关事项通知如下(xia)(xia)：一、政(zheng)(zheng)(zheng)务(wu)(wu)(wu)(wu)公(gong)(gong)(gong)(gong)开(kai)领导(dao)小(xiao)组组成及职责(ze)（一）组成组长：李(li)利(li)焦红(hong)副组长：徐景和(he)陈时(shi)飞颜江瑛(ying)成员：各司(si)局(ju)(ju)、各直属单(dan)位主(zhu)要(yao)负(fu)责(ze)同(tong)志(zhi)(zhi)颜江瑛(ying)同(tong)志(zhi)(zhi)负(fu)责(ze)领导(dao)小(xiao)组日常工(gong)(gong)作(zuo)(zuo)。（二）主(zhu)要(yao)职责(ze)。在局(ju)(ju)党(dang)组领导(dao)下(xia)(xia)，负(fu)责(ze)贯彻落实(shi)党(dang)中央(yang)、国(guo)务(wu)(wu)(wu)(wu)院关于(yu)政(zheng)(zheng)(zheng)务(wu)(wu)(wu)(wu)公(gong)(gong)(gong)(gong)开(kai)工(gong)(gong)作(zuo)(zuo)的(de)方(fang)针政(zheng)(zheng)(zheng)策，研究制定(ding)落实(shi)措施；研究制定(ding)药品监(jian)管政(zheng)(zheng)(zheng)务(wu)(wu)(wu)(wu)公(gong)(gong)(gong)(gong)开(kai)工(gong)(gong)作(zuo)(zuo)的(de)发展规划(hua)和(he)政(zheng)(zheng)(zheng)策措施；审定(ding)局(ju)(ju)政(zheng)(zheng)(zheng)务(wu)(wu)(wu)(wu)公(gong)(gong)(gong)(gong)开(kai)工(gong)(gong)作(zuo)(zuo)制度(du)，研究局(ju)(ju)政(zheng)(zheng)(zheng)务(wu)(wu)(wu)(wu)公(gong)(gong)(gong)(gong)开(kai)工(gong)(gong)作(zuo)(zuo)和(he)实(shi)施方(fang)案，研究解(jie)决政(zheng)(zheng)(zheng)务(wu)(wu)(wu)(wu)公(gong)(gong)(gong)(gong)开(kai)工(gong)(gong)作(zuo)(zuo)中遇(yu)到的(de)重大问题；协调各司(si)局(ju)(ju)、各单(dan)位抓好政(zheng)(zheng)(zheng)务(wu)(wu)(wu)(wu)公(gong)(gong)(gong)(gong)开(kai)工(gong)(gong)作(zuo)(zuo)任务(wu)(wu)(wu)(wu)落实(shi)，并(bing)加强(qiang)督(du)促检查(cha)。

如何(he)预(yu)(yu)防插(cha)(cha)导(dao)(dao)尿(niao)(niao)包(bao)时出现感(gan)(gan)染(ran)(ran)现象?全(quan)(quan)科(ke)(ke)医(yi)生(sheng)(sheng)是经(jing)过(guo)全(quan)(quan)科(ke)(ke)医(yi)学专业培训(xun)，临床技能(neng)(neng)全(quan)(quan)面、医(yi)德高(gao)尚的(de)(de)高(gao)素质(zhi)基层(ceng)医(yi)疗(liao)保(bao)健人(ren)才,富有(you)独立(li)工(gong)作(zuo)(zuo)能(neng)(neng)力(li),对个人(ren)家(jia)庭及(ji)社区提供便捷、廉(lian)价的(de)(de)防、 治保(bao)康全(quan)(quan)方(fang)位的(de)(de)优质(zhi)服(fu)务(wu)(wu)(wu)。开展全(quan)(quan)科(ke)(ke)医(yi)疗(liao)服(fu)务(wu)(wu)(wu), 如果没有(you)具有(you)活(huo)力(li)的(de)(de)全(quan)(quan)科(ke)(ke)医(yi)生(sheng)(sheng)做坚实的(de)(de)基础,工(gong)作(zuo)(zuo)将缺乏生(sheng)(sheng)气和动力(li),那(nei)种以单(dan)纯的(de)(de)专科(ke)(ke)医(yi)疗(liao)的(de)(de)服(fu)务(wu)(wu)(wu)体系,势必(bi)造(zao)成(cheng)医(yi)疗(liao)秩(zhi)序的(de)(de)混乱,也没有(you)任(ren)何(he)国家(jia)的(de)(de)经(jing)济能(neng)(neng)够负担(dan)得起。那(nei)么,插(cha)(cha)导(dao)(dao)尿(niao)(niao)管(guan)如何(he)预(yu)(yu)防感(gan)(gan)染(ran)(ran)呢?导(dao)(dao)尿(niao)(niao)包(bao)相关尿(niao)(niao)路(lu)感(gan)(gan)染(ran)(ran)预(yu)(yu)防SOP尿(niao)(niao)路(lu)感(gan)(gan)染(ran)(ran)(UTI)是二位常(chang)见医(yi)院感(gan)(gan)染(ran)(ran)类(lei)型, 75% ~ 80%与留置导(dao)(dao)尿(niao)(niao)管(guan)相关。为有(you)效预(yu)(yu)防导(dao)(dao)尿(niao)(niao)管(guan)相关尿(niao)(niao)路(lu)感(gan)(gan)染(ran)(ran),特制定以下(xia)控制措(cuo)施(shi):插(cha)(cha)管(guan)前准备(bei)与插(cha)(cha)管(guan)时的(de)(de)措(cuo)施(shi)1.尽量避免不必(bi)要的(de)(de)留置导(dao)(dao)尿(niao)(niao);2.仔细检查无(wu)菌(jun)导(dao)(dao)尿(niao)(niao)包(bao)，如过(guo)期、外(wai)包(bao)装破损(sun)潮湿,不得使用;3.根(gen)据年龄、性(xing)(xing)别、尿(niao)(niao)道(dao)情况选(xuan)择合适的(de)(de)导(dao)(dao)尿(niao)(niao)管(guan)口(kou)(kou)(kou)径、类(lei)型。通常(chang)成(cheng)年男性(xing)(xing)选(xuan)16F ,女(nv)性(xing)(xing)选(xuan)14F ;4.规范手卫生(sheng)(sheng)和载手套的(de)(de)程序;5.常(chang)规的(de)(de)消毒方(fang)法:用0.1%的(de)(de)新洁(jie)尔灭(mie)消毒尿(niao)(niao)道(dao)口(kou)(kou)(kou)及(ji)其周围皮肤粘(zhan)膜,程序如下(xia):男性(xing)(xing):自尿(niao)(niao)道(dao)口(kou)(kou)(kou)、龟(gui)头(tou)向外(wai)旋(xuan)转擦拭消毒,注意洗(xi)净(jing)包(bao)皮及(ji)冠(guan)状沟。女(nv)性(xing)(xing):先清(qing)洗(xi)外(wai)阴(yin),其原(yuan)则由上至下(xia),由内向外(wai),然后(hou)清(qing)洗(xi)尿(niao)(niao)道(dao)口(kou)(kou)(kou)、前庭、两侧大小阴(yin)唇,后(hou)会阴(yin)、肛门,每(mei)一(yi)个棉球(qiu)不能(neng)(neng)重复使用;6.插(cha)(cha)管(guan)过(guo)程严(yan)格执行无(wu)菌(jun)操(cao)作(zuo)(zuo),动作(zuo)(zuo)要轻(qing)柔,避免尿(niao)(niao)道(dao)粘(zhan)膜损(sun)伤;7.对留置导(dao)(dao)尿(niao)(niao)患者(zhe),应采用密闭式引流系统。

一次(ci)性吸(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)包(bao)的使(shi)用(yong)方法一次(ci)性使(shi)用(yong)吸(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)管(guan)(guan)(guan)用(yong)于临床患者抽取气(qi)管(guan)(guan)(guan)内痰(tan)(tan)(tan)(tan)液(ye)或分(fen)泌(mi)液(ye)用(yong)。一次(ci)性使(shi)用(yong)吸(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)管(guan)(guan)(guan)吸(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)动作要(yao)轻、稳。一次(ci)吸(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)时(shi)间不应超过(guo)15秒，吸(xi)(xi)(xi)引(yin)器(qi)连续使(shi)用(yong)时(shi)间不超过(guo)3分(fen)钟。1检查(cha)吸(xi)(xi)(xi)引(yin)器(qi)各部(bu)连接(jie)是否完善，有(you)无(wu)漏气(qi)。接(jie)通电源，打开(kai)开(kai)关(guan)，检查(cha)吸(xi)(xi)(xi)引(yin)器(qi)性能，调节负压。一般(ban)成人(ren)(ren)(ren)吸(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)负压约(yue)40-50 kPa，小儿(er)吸(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)约(yue)13-30kPa，将(jiang)(jiang)一次(ci)性使(shi)用(yong)吸(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)管(guan)(guan)(guan)置于水中，试验吸(xi)(xi)(xi)引(yin)力，并(bing)冲洗(xi)皮管(guan)(guan)(guan)。2将(jiang)(jiang)病人(ren)(ren)(ren)头(tou)部(bu)转向护士(shi)，铺治疗(liao)巾于颌下(xia)。插入(ru)一次(ci)性使(shi)用(yong)吸(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)管(guan)(guan)(guan)，其(qi)顺序是由(you)口(kou)(kou)腔前(qian)庭(ting)→颊(jia)部(bu)→咽部(bu)，将(jiang)(jiang)各部(bu)吸(xi)(xi)(xi)尽。如(ru)(ru)口(kou)(kou)腔吸(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)有(you)困难时(shi)，可由(you)鼻(bi)腔插入(ru)(颅底骨折(zhe)患者禁用(yong))，其(qi)顺序由(you)鼻(bi)腔前(qian)庭(ting)→下(xia)鼻(bi)道(dao)→鼻(bi)后孔→咽部(bu)→气(qi)管(guan)(guan)(guan)(约(yue)20-25cm)，将(jiang)(jiang)分(fen)泌(mi)物逐段吸(xi)(xi)(xi)尽。3气(qi)管(guan)(guan)(guan)内吸(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)，待病人(ren)(ren)(ren)吸(xi)(xi)(xi)气(qi)时(shi)，快速将(jiang)(jiang)导管(guan)(guan)(guan)插入(ru)，自下(xia)而上(shang)边(bian)退(tui)边(bian)左右旋转导管(guan)(guan)(guan)，消(xiao)(xiao)除气(qi)道(dao)分(fen)泌(mi)物，并(bing)注意观察病人(ren)(ren)(ren)的呼吸(xi)(xi)(xi)。在吸(xi)(xi)(xi)引(yin)过(guo)程中，如(ru)(ru)病人(ren)(ren)(ren)咳嗽厉(li)害，应稍等片(pian)刻后再行吸(xi)(xi)(xi)出(chu)。并(bing)随时(shi)冲洗(xi)吸(xi)(xi)(xi)引(yin)管(guan)(guan)(guan)，以免痰(tan)(tan)(tan)(tan)液(ye)堵塞。4吸(xi)(xi)(xi)毕，关(guan)闭吸(xi)(xi)(xi)引(yin)器(qi)开(kai)关(guan)，弃吸(xi)(xi)(xi)痰(tan)(tan)(tan)(tan)导管(guan)(guan)(guan)于小桶(tong)内，吸(xi)(xi)(xi)引(yin)胶管(guan)(guan)(guan)玻璃接(jie)头(tou)插入(ru)床栏上(shang)盛有(you)消(xiao)(xiao)毒液(ye)瓶(ping)内备用(yong)，将(jiang)(jiang)病人(ren)(ren)(ren)口(kou)(kou)腔周围(wei)擦净。观察吸(xi)(xi)(xi)出(chu)液(ye)的量、颜色及(ji)性质(zhi)，必要(yao)时(shi)做(zuo)好记(ji)录(lu)。

2月5日(ri)，药(yao)(yao)监(jian)局接到卫生(sheng)健康委(wei)通报，上(shang)(shang)(shang)海(hai)新(xin)兴医药(yao)(yao)股(gu)份有(you)限公(gong)司(si)（以(yi)下简(jian)称(cheng)“上(shang)(shang)(shang)海(hai)新(xin)兴”）生(sheng)产(chan)的一(yi)批次(ci)静注(zhu)人免疫球蛋(dan)白（批号：20180610Z）艾(ai)滋病病毒抗体检(jian)(jian)(jian)测(ce)为阳性(xing)。药(yao)(yao)监(jian)局立(li)即(ji)要求上(shang)(shang)(shang)海(hai)市(shi)药(yao)(yao)监(jian)局对(dui)上(shang)(shang)(shang)海(hai)新(xin)兴开展(zhan)现场检(jian)(jian)(jian)查(cha)(cha)，组(zu)织对(dui)同(tong)批原(yuan)料血浆生(sheng)产(chan)的产(chan)品(pin)和(he)相(xiang)邻(lin)批次(ci)产(chan)品(pin)进行(xing)检(jian)(jian)(jian)验，并(bing)派(pai)出督导(dao)检(jian)(jian)(jian)查(cha)(cha)组(zu)抵达(da)上(shang)(shang)(shang)海(hai)、江(jiang)西，督促(cu)指(zhi)导(dao)地(di)方药(yao)(yao)监(jian)部(bu)门开展(zhan)调查(cha)(cha)处置工作。药(yao)(yao)监(jian)局、卫生(sheng)健康委(wei)联合(he)下发通知，要求立(li)即(ji)暂停使用该企(qi)业(ye)生(sheng)产(chan)的相(xiang)关产(chan)品(pin)，并(bing)及时(shi)采取(qu)封存等控制措(cuo)施。上(shang)(shang)(shang)海(hai)方面对(dui)涉事批次(ci)静注(zhu)人免疫球蛋(dan)白进行(xing)的艾(ai)滋病、乙肝(gan)、丙肝(gan)三种病毒核酸检(jian)(jian)(jian)测(ce)，结果均为阴性(xing)；江(jiang)西方面对(dui)患者(zhe)的艾(ai)滋病病毒核酸检(jian)(jian)(jian)测(ce)，结果为阴性(xing)。对(dui)企(qi)业(ye)现场核查(cha)(cha)等有(you)关工作正在(zai)进一(yi)步进行(xing)中。

医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)是医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)研制(zhi)、生产、经营、使(shi)用(yong)(yong)以及(ji)监(jian)(jian)督管(guan)(guan)(guan)理(li)(li)(li)(li)所共(gong)同遵循的技术(shu)(shu)规(gui)(gui)(gui)范(fan)，是医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)监(jian)(jian)管(guan)(guan)(guan)和(he)产业(ye)发(fa)(fa)展的重(zhong)要(yao)技术(shu)(shu)支撑(cheng)。药监(jian)(jian)局高度(du)(du)重(zhong)视(shi)医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)工(gong)(gong)作(zuo)，按照“四(si)个严”的要(yao)求，结(jie)合医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)产业(ye)发(fa)(fa)展和(he)监(jian)(jian)管(guan)(guan)(guan)工(gong)(gong)作(zuo)实(shi)(shi)(shi)际，不(bu)断完善(shan)医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)管(guan)(guan)(guan)理(li)(li)(li)(li)制(zhi)度(du)(du)体系、持续开展医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)制(zhi)修订(ding)工(gong)(gong)作(zuo)，我(wo)(wo)(wo)国(guo)医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)体系不(bu)断完善(shan)，医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)对(dui)监(jian)(jian)管(guan)(guan)(guan)和(he)产业(ye)发(fa)(fa)展的技术(shu)(shu)支撑(cheng)能力持续提(ti)(ti)升。一、加(jia)强医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)制(zhi)度(du)(du)建设(she)。为贯彻落实(shi)(shi)(shi)国(guo)务院深化标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)化改革重(zhong)大(da)决(jue)策部署，依据《中华人民共(gong)和(he)国(guo)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)化法(fa)》，立足我(wo)(wo)(wo)国(guo)医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)产业(ye)发(fa)(fa)展和(he)监(jian)(jian)管(guan)(guan)(guan)工(gong)(gong)作(zuo)实(shi)(shi)(shi)际，2017年4月，原(yuan)食品(pin)药品(pin)监(jian)(jian)管(guan)(guan)(guan)总局修订(ding)印发(fa)(fa)《医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)管(guan)(guan)(guan)理(li)(li)(li)(li)办(ban)法(fa)》，该办(ban)法(fa)的出台对(dui)指(zhi)导我(wo)(wo)(wo)国(guo)医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)管(guan)(guan)(guan)理(li)(li)(li)(li)、规(gui)(gui)(gui)范(fan)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)制(zhi)修订(ding)、促进(jin)(jin)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)实(shi)(shi)(shi)施(shi)、提(ti)(ti)升医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)质(zhi)量等起到了积极作(zuo)用(yong)(yong)。为贯彻落实(shi)(shi)(shi)《医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)管(guan)(guan)(guan)理(li)(li)(li)(li)办(ban)法(fa)》，原(yuan)食品(pin)药品(pin)监(jian)(jian)管(guan)(guan)(guan)总局先后印发(fa)(fa)《医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)制(zhi)修订(ding)工(gong)(gong)作(zuo)管(guan)(guan)(guan)理(li)(li)(li)(li)规(gui)(gui)(gui)范(fan)》和(he)《医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)报批发(fa)(fa)布工(gong)(gong)作(zuo)细则(ze)》等文件(jian)，进(jin)(jin)一步规(gui)(gui)(gui)范(fan)了医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)工(gong)(gong)作(zuo)程序，强化了标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)精细化过程管(guan)(guan)(guan)理(li)(li)(li)(li)，为提(ti)(ti)升医(yi)(yi)疗(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)(xie)(xie)(xie)标(biao)(biao)(biao)(biao)准(zhun)(zhun)(zhun)质(zhi)量奠定(ding)了坚实(shi)(shi)(shi)的制(zhi)度(du)(du)基础。