2月(yue)5日(ri),药(yao)(yao)监局(ju)接到卫生(sheng)健康(kang)委通报,上(shang)(shang)海(hai)新(xin)兴(xing)医药(yao)(yao)股份有限公司(以下简称(cheng)“上(shang)(shang)海(hai)新(xin)兴(xing)”)生(sheng)产(chan)(chan)的一批(pi)次静注人免疫(yi)球蛋白(批(pi)号:20180610Z)艾滋病病毒(du)抗体(ti)检(jian)测(ce)为(wei)阳性。药(yao)(yao)监局(ju)立即要求(qiu)上(shang)(shang)海(hai)市药(yao)(yao)监局(ju)对(dui)上(shang)(shang)海(hai)新(xin)兴(xing)开展(zhan)现场检(jian)查(cha),组(zu)织(zhi)对(dui)同批(pi)原料血(xue)浆生(sheng)产(chan)(chan)的产(chan)(chan)品和(he)相邻批(pi)次产(chan)(chan)品进(jin)行检(jian)验,并派出督导(dao)检(jian)查(cha)组(zu)抵达(da)上(shang)(shang)海(hai)、江(jiang)西,督促指(zhi)导(dao)地方(fang)药(yao)(yao)监部门开展(zhan)调查(cha)处置工作(zuo)(zuo)。药(yao)(yao)监局(ju)、卫生(sheng)健康(kang)委联合下发通知(zhi),要求(qiu)立即暂(zan)停使用该企业生(sheng)产(chan)(chan)的相关产(chan)(chan)品,并及(ji)时采取(qu)封存等(deng)控制措施。上(shang)(shang)海(hai)方(fang)面对(dui)涉事(shi)批(pi)次静注人免疫(yi)球蛋白进(jin)行的艾滋病、乙肝(gan)、丙(bing)肝(gan)三种病毒(du)核酸检(jian)测(ce),结果(guo)(guo)均(jun)为(wei)阴性;江(jiang)西方(fang)面对(dui)患(huan)者的艾滋病病毒(du)核酸检(jian)测(ce),结果(guo)(guo)为(wei)阴性。对(dui)企业现场核查(cha)等(deng)有关工作(zuo)(zuo)正(zheng)在进(jin)一步进(jin)行中。
一(yi)次(ci)性(xing)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰包(bao)的使用(yong)(yong)(yong)(yong)(yong)方(fang)法一(yi)次(ci)性(xing)使用(yong)(yong)(yong)(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰管(guan)(guan)(guan)用(yong)(yong)(yong)(yong)(yong)于(yu)(yu)临床(chuang)患者(zhe)抽取气(qi)管(guan)(guan)(guan)内(nei)痰液(ye)或分(fen)泌液(ye)用(yong)(yong)(yong)(yong)(yong)。一(yi)次(ci)性(xing)使用(yong)(yong)(yong)(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰管(guan)(guan)(guan)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰动作要轻、稳。一(yi)次(ci)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰时(shi)间不(bu)(bu)应超过(guo)15秒,吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)(yin)器(qi)连(lian)续使用(yong)(yong)(yong)(yong)(yong)时(shi)间不(bu)(bu)超过(guo)3分(fen)钟。1检查(cha)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)(yin)器(qi)各(ge)部(bu)(bu)连(lian)接(jie)(jie)是否完善,有无漏(lou)气(qi)。接(jie)(jie)通电(dian)源,打开开关(guan)(guan),检查(cha)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)(yin)器(qi)性(xing)能,调节负压(ya)。一(yi)般(ban)成人(ren)(ren)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰负压(ya)约(yue)40-50 kPa,小儿吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰约(yue)13-30kPa,将(jiang)(jiang)一(yi)次(ci)性(xing)使用(yong)(yong)(yong)(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰管(guan)(guan)(guan)置(zhi)于(yu)(yu)水中,试(shi)验吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)(yin)力,并(bing)冲洗皮管(guan)(guan)(guan)。2将(jiang)(jiang)病人(ren)(ren)头(tou)部(bu)(bu)转向护(hu)士,铺治疗巾于(yu)(yu)颌下。插入一(yi)次(ci)性(xing)使用(yong)(yong)(yong)(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰管(guan)(guan)(guan),其顺序是由(you)口腔前庭(ting)→颊部(bu)(bu)→咽部(bu)(bu),将(jiang)(jiang)各(ge)部(bu)(bu)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)尽。如口腔吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰有困难时(shi),可由(you)鼻(bi)腔插入(颅(lu)底骨折(zhe)患者(zhe)禁用(yong)(yong)(yong)(yong)(yong)),其顺序由(you)鼻(bi)腔前庭(ting)→下鼻(bi)道→鼻(bi)后(hou)孔→咽部(bu)(bu)→气(qi)管(guan)(guan)(guan)(约(yue)20-25cm),将(jiang)(jiang)分(fen)泌物逐(zhu)段(duan)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)尽。3气(qi)管(guan)(guan)(guan)内(nei)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰,待病人(ren)(ren)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)气(qi)时(shi),快速将(jiang)(jiang)导管(guan)(guan)(guan)插入,自(zi)下而上边(bian)退边(bian)左右旋转导管(guan)(guan)(guan),消(xiao)除气(qi)道分(fen)泌物,并(bing)注意(yi)观(guan)察病人(ren)(ren)的呼吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)。在(zai)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)(yin)过(guo)程中,如病人(ren)(ren)咳嗽厉害,应稍等片刻(ke)后(hou)再行吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)出(chu)。并(bing)随时(shi)冲洗吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)(yin)管(guan)(guan)(guan),以免痰液(ye)堵塞。4吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)毕,关(guan)(guan)闭(bi)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)(yin)器(qi)开关(guan)(guan),弃吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰导管(guan)(guan)(guan)于(yu)(yu)小桶内(nei),吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)(yin)胶管(guan)(guan)(guan)玻璃接(jie)(jie)头(tou)插入床(chuang)栏上盛有消(xiao)毒液(ye)瓶内(nei)备用(yong)(yong)(yong)(yong)(yong),将(jiang)(jiang)病人(ren)(ren)口腔周围(wei)擦(ca)净(jing)。观(guan)察吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)出(chu)液(ye)的量、颜(yan)色(se)及性(xing)质,必要时(shi)做好记录。
2月13日,联合整治“保健”市场乱象百日行动联合工作组在市场监管总局召开工作组会议。优质一次性使用医用导尿包市场监管总局副局长甘霖同志出席会议并讲话,市场监管总局、工业和信息化部、公安部、民政部、住房和城乡建设部、农业农村部、商务部、文化和旅游部、一次性使用医用导尿包批发卫生健康委员(yuan)会、广播电视总局、中医药管(guan)理局、药品监(jian)督管(guan)理局、网信(xin)(xin)办(ban)等(deng)13部(bu)(bu)门成(cheng)员(yuan)单位负责(ze)同志及联络员(yuan)和市(shi)(shi)场(chang)监(jian)管(guan)总局“百(bai)日行(xing)(xing)(xing)动(dong)(dong)(dong)(dong)”工(gong)作(zuo)组成(cheng)员(yuan)单位负责(ze)同志及联络员(yuan)参加(jia)会议(yi)(yi)。“百(bai)日行(xing)(xing)(xing)动(dong)(dong)(dong)(dong)”开(kai)展(zhan)以来(lai),各部(bu)(bu)门积极落实《关于开(kai)展(zhan)联合整治“保健”市(shi)(shi)场(chang)乱象百(bai)日行(xing)(xing)(xing)动(dong)(dong)(dong)(dong)的通(tong)(tong)知》要(yao)求,立足自身职能,迅(xun)速(su)部(bu)(bu)署落实,在相关领(ling)域和行(xing)(xing)(xing)业(ye)内开(kai)展(zhan)行(xing)(xing)(xing)动(dong)(dong)(dong)(dong)。市(shi)(shi)场(chang)监(jian)管(guan)总局切实履(lv)行(xing)(xing)(xing)监(jian)管(guan)执法、联络调(diao)(diao)(diao)度、汇集信(xin)(xin)息(xi)、服务保障等(deng)职责(ze),通(tong)(tong)过建(jian)立工(gong)作(zuo)协调(diao)(diao)(diao)机制(zhi)、建(jian)立工(gong)作(zuo)台账、召(zhao)开(kai)调(diao)(diao)(diao)度会议(yi)(yi)、加(jia)强新闻(wen)宣传等(deng)方式(shi),组织各部(bu)(bu)门、市(shi)(shi)场(chang)监(jian)管(guan)系统迅(xun)速(su)深入开(kai)展(zhan)“百(bai)日行(xing)(xing)(xing)动(dong)(dong)(dong)(dong)”。
导(dao)尿设(she)备在(zai)(zai)(zai)医疗(liao)(liao)当中(zhong)也(ye)(ye)是(shi)(shi)经(jing)常(chang)(chang)使(shi)(shi)用(yong)(yong)(yong)的(de)(de)(de)(de)(de)一(yi)(yi)(yi)种(zhong)(zhong)产(chan)品(pin)(pin)(pin)(pin),在(zai)(zai)(zai)泌尿肛肠等医疗(liao)(liao)科(ke)室经(jing)常(chang)(chang)用(yong)(yong)(yong)到(dao)导(dao)尿设(she)备一(yi)(yi)(yi)般(ban)都是(shi)(shi)一(yi)(yi)(yi)次性(xing)使(shi)(shi)用(yong)(yong)(yong)的(de)(de)(de)(de)(de)。下面(mian)介绍的(de)(de)(de)(de)(de)这种(zhong)(zhong)-次性(xing)的(de)(de)(de)(de)(de)无(wu)莹(ying)导(dao)尿产(chan)品(pin)(pin)(pin)(pin)就(jiu)是(shi)(shi)同(tong)类产(chan)品(pin)(pin)(pin)(pin)中(zhong)性(xing)能非(fei)(fei)常(chang)(chang)优(you)越的(de)(de)(de)(de)(de)一(yi)(yi)(yi)种(zhong)(zhong)。产(chan)品(pin)(pin)(pin)(pin)的(de)(de)(de)(de)(de)用(yong)(yong)(yong)途和性(xing)能,这种(zhong)(zhong)-次性(xing)的(de)(de)(de)(de)(de)无(wu)菌(jun)导(dao)尿包(bao)(bao)(bao)主要(yao)是(shi)(shi)给临床上的(de)(de)(de)(de)(de)患者导(dao)尿之用(yong)(yong)(yong),这种(zhong)(zhong)产(chan)品(pin)(pin)(pin)(pin)是(shi)(shi)经(jing)过(guo)了(le)环氧乙烷灭莹(ying),非(fei)(fei)常(chang)(chang)的(de)(de)(de)(de)(de)卫(wei)生和安全(quan),使(shi)(shi)用(yong)(yong)(yong)起来也(ye)(ye)非(fei)(fei)常(chang)(chang)方便。该产(chan)品(pin)(pin)(pin)(pin)是(shi)(shi)由洞巾,布(bu)和一(yi)(yi)(yi)次性(xing)使(shi)(shi)用(yong)(yong)(yong)的(de)(de)(de)(de)(de)导(dao)尿管(guan)、橡胶(jiao)医用(yong)(yong)(yong)手(shou)套(tao)、海绵刷、纱(sha)布(bu)块、石蜡棉球物品(pin)(pin)(pin)(pin)盒和一(yi)(yi)(yi)次性(xing)的(de)(de)(de)(de)(de)引流袋等几部(bu)分组成。这种(zhong)(zhong)- -次性(xing)产(chan)品(pin)(pin)(pin)(pin)使(shi)(shi)用(yong)(yong)(yong)起来也(ye)(ye)非(fei)(fei)常(chang)(chang)方便。这种(zhong)(zhong)产(chan)品(pin)(pin)(pin)(pin)使(shi)(shi)用(yong)(yong)(yong)起来也(ye)(ye)比较简(jian)单(dan),首(shou)先,在(zai)(zai)(zai)使(shi)(shi)用(yong)(yong)(yong)前要(yao)检查(cha)单(dan)包(bao)(bao)(bao)装(zhuang)是(shi)(shi)不(bu)是(shi)(shi)没(mei)有(you)损坏(huai),灭菌(jun)的(de)(de)(de)(de)(de)有(you)效(xiao)期是(shi)(shi)不(bu)是(shi)(shi)正常(chang)(chang);其次,在(zai)(zai)(zai)使(shi)(shi)用(yong)(yong)(yong)的(de)(de)(de)(de)(de)时候,先打开(kai)(kai)包(bao)(bao)(bao)装(zhuang),在(zai)(zai)(zai)将(jiang)包(bao)(bao)(bao)布(bu)打开(kai)(kai),再戴上手(shou)套(tao),然(ran)后(hou);按照(zhao)常(chang)(chang)规的(de)(de)(de)(de)(de)方法(fa)来使(shi)(shi)用(yong)(yong)(yong)导(dao)尿包(bao)(bao)(bao)里的(de)(de)(de)(de)(de)组件;其三,-般(ban)的(de)(de)(de)(de)(de)产(chan)品(pin)(pin)(pin)(pin)的(de)(de)(de)(de)(de)有(you)效(xiao)期是(shi)(shi)两年 ,如(ru)果产(chan)品(pin)(pin)(pin)(pin)已经(jing)过(guo)了(le)有(you)效(xiao)期,绝对不(bu)能使(shi)(shi)用(yong)(yong)(yong);四,如(ru)果包(bao)(bao)(bao)装(zhuang)破损了(le)也(ye)(ye)不(bu)能使(shi)(shi)用(yong)(yong)(yong);五,这是(shi)(shi)-次性(xing)的(de)(de)(de)(de)(de)使(shi)(shi)用(yong)(yong)(yong)产(chan)品(pin)(pin)(pin)(pin),禁止重复使(shi)(shi)用(yong)(yong)(yong),在(zai)(zai)(zai)使(shi)(shi)用(yong)(yong)(yong)完后(hou)要(yao)销毁,生产(chan)日期般(ban)在(zai)(zai)(zai)包(bao)(bao)(bao)装(zhuang)封口(kou)处。
一(yi)次性使用吸(xi)(xi)(xi)痰(tan)(tan)(tan)管(guan)操作方法(1)检(jian)查(cha)吸(xi)(xi)(xi)引(yin)器各(ge)部连接(jie)是否(fou)完善,有(you)无漏气。接(jie)通电源(yuan),打开(kai)开(kai)关,检(jian)查(cha)吸(xi)(xi)(xi)引(yin)器性能,调节负压(ya)。一(yi)般(ban)成人吸(xi)(xi)(xi)痰(tan)(tan)(tan)负压(ya)约(yue)40-50 kPa,小(xiao)儿吸(xi)(xi)(xi)痰(tan)(tan)(tan)约(yue)13-30kPa,将(jiang)一(yi)次性使用吸(xi)(xi)(xi)痰(tan)(tan)(tan)管(guan)置于(yu)水中,试验(yan)吸(xi)(xi)(xi)引(yin)力,并冲洗皮管(guan)。(2)将(jiang)病人头部转向(xiang)护士,铺(pu)治(zhi)疗(liao)巾于(yu)颌下。(3)插入(ru)一(yi)次性使用吸(xi)(xi)(xi)痰(tan)(tan)(tan)管(guan),其顺序(xu)是由(you)(you)口腔(qiang)前庭→颊部→咽部,将(jiang)各(ge)部吸(xi)(xi)(xi)尽。如口腔(qiang)吸(xi)(xi)(xi)痰(tan)(tan)(tan)有(you)困难时,可由(you)(you)鼻(bi)(bi)腔(qiang)插入(ru)(颅(lu)底骨(gu)折患(huan)者禁用),其顺序(xu)由(you)(you)鼻(bi)(bi)腔(qiang)前庭→下鼻(bi)(bi)道→鼻(bi)(bi)后孔(kong)→咽部→气管(guan)(约(yue)20-25cm),将(jiang)分泌物逐段吸(xi)(xi)(xi)尽。若有(you)气管(guan)插管(guan)或气管(guan)切(qie)开(kai)时,可由(you)(you)插管(guan)或套管(guan)内插入(ru),将(jiang)痰(tan)(tan)(tan)液吸(xi)(xi)(xi)出(chu)。昏迷病人可用压(ya)舌(she)板(ban)或开(kai)口器先将(jiang)口启开(kai),再行(xing)吸(xi)(xi)(xi)引(yin)。