2月5日，药(yao)(yao)监局(ju)接到卫(wei)生(sheng)健康委通报，上(shang)海(hai)(hai)新兴医药(yao)(yao)股份有(you)限公司(si)（以下(xia)简(jian)称(cheng)“上(shang)海(hai)(hai)新兴”）生(sheng)产的(de)(de)(de)一批(pi)次(ci)(ci)静注人免疫球(qiu)蛋白（批(pi)号：20180610Z）艾滋病病毒抗体检(jian)测(ce)为(wei)阳性(xing)(xing)。药(yao)(yao)监局(ju)立即要求(qiu)上(shang)海(hai)(hai)市(shi)药(yao)(yao)监局(ju)对(dui)上(shang)海(hai)(hai)新兴开(kai)展(zhan)现场(chang)(chang)检(jian)查，组织对(dui)同批(pi)原料血浆(jiang)生(sheng)产的(de)(de)(de)产品和相(xiang)邻批(pi)次(ci)(ci)产品进(jin)(jin)行检(jian)验，并派出(chu)督(du)导检(jian)查组抵达上(shang)海(hai)(hai)、江西，督(du)促指导地方药(yao)(yao)监部门(men)开(kai)展(zhan)调查处置(zhi)工作。药(yao)(yao)监局(ju)、卫(wei)生(sheng)健康委联合下(xia)发通知，要求(qiu)立即暂(zan)停使用该(gai)企业生(sheng)产的(de)(de)(de)相(xiang)关产品，并及(ji)时采取封存(cun)等(deng)控(kong)制(zhi)措施(shi)。上(shang)海(hai)(hai)方面对(dui)涉事批(pi)次(ci)(ci)静注人免疫球(qiu)蛋白进(jin)(jin)行的(de)(de)(de)艾滋病、乙肝、丙(bing)肝三种病毒核(he)(he)酸检(jian)测(ce)，结(jie)果均为(wei)阴性(xing)(xing)；江西方面对(dui)患者的(de)(de)(de)艾滋病病毒核(he)(he)酸检(jian)测(ce)，结(jie)果为(wei)阴性(xing)(xing)。对(dui)企业现场(chang)(chang)核(he)(he)查等(deng)有(you)关工作正在进(jin)(jin)一步进(jin)(jin)行中(zhong)。

对业内(nei)企(qi)(qi)业来说(shuo)，焦点核心的(de)(de)(de)(de)(de)还有(you)(you)(you)(you)：几十种医疗器(qi)(qi)械(xie)的(de)(de)(de)(de)(de)管(guan)(guan)理(li)类(lei)(lei)(lei)别降了，有(you)(you)(you)(you)从三类(lei)(lei)(lei)降为(wei)(wei)(wei)(wei)二(er)(er)类(lei)(lei)(lei)的(de)(de)(de)(de)(de)，也有(you)(you)(you)(you)从二(er)(er)类(lei)(lei)(lei)降为(wei)(wei)(wei)(wei)一类(lei)(lei)(lei)的(de)(de)(de)(de)(de)。也有(you)(you)(you)(you)部分产(chan)(chan)品(pin)(pin)是(shi)(shi)升类(lei)(lei)(lei)了的(de)(de)(de)(de)(de)。还有(you)(you)(you)(you)的(de)(de)(de)(de)(de)产(chan)(chan)品(pin)(pin)将(jiang)不再作为(wei)(wei)(wei)(wei)医疗器(qi)(qi)械(xie)管(guan)(guan)理(li)。产(chan)(chan)品(pin)(pin)类(lei)(lei)(lei)别上的(de)(de)(de)(de)(de)变化(hua)是(shi)(shi)要直接影响医疗器(qi)(qi)械(xie)生(sheng)产(chan)(chan)经营企(qi)(qi)业的(de)(de)(de)(de)(de)，比如生(sheng)产(chan)(chan)企(qi)(qi)业，原本自家产(chan)(chan)品(pin)(pin)是(shi)(shi)三类(lei)(lei)(lei)，降为(wei)(wei)(wei)(wei)二(er)(er)类(lei)(lei)(lei)管(guan)(guan)理(li)之后(hou)，企(qi)(qi)业将(jiang)无需再跑到北京、到药监(jian)(jian)总局(ju)来进行产(chan)(chan)品(pin)(pin)注(zhu)册(ce)(ce)(ce)，只(zhi)(zhi)需在本省(sheng)药监(jian)(jian)局(ju)注(zhu)册(ce)(ce)(ce)即可(ke)。从二(er)(er)类(lei)(lei)(lei)降为(wei)(wei)(wei)(wei)一类(lei)(lei)(lei)管(guan)(guan)理(li)的(de)(de)(de)(de)(de)，生(sheng)产(chan)(chan)企(qi)(qi)业则更(geng)省(sheng)事，产(chan)(chan)品(pin)(pin)无需注(zhu)册(ce)(ce)(ce)，只(zhi)(zhi)需备案即可(ke)。降类(lei)(lei)(lei)之后(hou)，在注(zhu)册(ce)(ce)(ce)更(geng)省(sheng)事之外，节省(sheng)的(de)(de)(de)(de)(de)还有(you)(you)(you)(you)注(zhu)册(ce)(ce)(ce)费(fei)用。以三类(lei)(lei)(lei)降为(wei)(wei)(wei)(wei)二(er)(er)类(lei)(lei)(lei)为(wei)(wei)(wei)(wei)例，原有(you)(you)(you)(you)境内(nei)三类(lei)(lei)(lei)产(chan)(chan)品(pin)(pin)首次注(zhu)册(ce)(ce)(ce)要收(shou)费(fei)15.36万(wan)元，而(er)(er)转到地方注(zhu)册(ce)(ce)(ce)后(hou)，目前收(shou)费(fei)最便宜的(de)(de)(de)(de)(de)宁夏仅有(you)(you)(you)(you)3.13万(wan)元，还有(you)(you)(you)(you)十多个省(sheng)份则还没开始收(shou)费(fei)呢。当然，反过来，对升类(lei)(lei)(lei)产(chan)(chan)品(pin)(pin)而(er)(er)言，注(zhu)册(ce)(ce)(ce)要比现在麻烦(fan)一些了，由二(er)(er)类(lei)(lei)(lei)升为(wei)(wei)(wei)(wei)三类(lei)(lei)(lei)的(de)(de)(de)(de)(de)，风险级别大增，也将(jiang)面临(lin)药监(jian)(jian)更(geng)为(wei)(wei)(wei)(wei)严格和密集的(de)(de)(de)(de)(de)监(jian)(jian)管(guan)(guan)举措(cuo)。

一(yi)次性使用导(dao)尿(niao)包(bao)常用指南操作(zuo)要点1.定(ding)时(shi)(shi)挤(ji)压(ya)引(yin)(yin)(yin)流管(guan)，引(yin)(yin)(yin)流液多(duo)或(huo)有血(xue)块则按需(xu)正(zheng)确挤(ji)压(ya)，捏(nie)(nie)紧引(yin)(yin)(yin)流管(guan)的远端，向(xiang)胸腔的方(fang)向(xiang)挤(ji)压(ya)，再缓(huan)慢松开(kai)捏(nie)(nie)紧的引(yin)(yin)(yin)流管(guan)，防止引(yin)(yin)(yin)流瓶中液体(ti)倒吸。如(ru)接有负压(ya)装置，吸引(yin)(yin)(yin)压(ya)力适宜，过大的负压(ya)引(yin)(yin)(yin)起胸腔内出血(xue)及(ji)患者疼痛。一(yi)次性使用导(dao)尿(niao)包(bao)2.根(gen)据病情尽可能采取半卧位。3.引(yin)(yin)(yin)流装置应保(bao)持(chi)密闭(bi)和无菌(jun)，保(bao)持(chi)胸壁引(yin)(yin)(yin)流口处的敷料清洁干燥(zao)，敷料渗出液较多(duo)应及(ji)时(shi)(shi)通知医(yi)生更换(huan)(huan)。4.根(gen)据病情需(xu)要定(ding)时(shi)(shi)准确记录引(yin)(yin)(yin)流量。5引(yin)(yin)(yin)流瓶内无菌(jun)生理盐(yan)水每(mei)天更换(huan)(huan)，引(yin)(yin)(yin)流瓶每(mei)周更换(huan)(huan)，床旁备血(xue)管(guan)钳，更换(huan)(huan)时(shi)(shi)必须夹闭(bi)引(yin)(yin)(yin)流管(guan)，防止空气进入(ru)胸膜腔引(yin)(yin)(yin)起气qi胸。

导尿(niao)(niao)设备(bei)在(zai)医(yi)疗当中(zhong)也(ye)是(shi)(shi)(shi)经(jing)常(chang)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)的(de)一种(zhong)(zhong)产(chan)(chan)(chan)品(pin)(pin)(pin)(pin)(pin),在(zai)泌尿(niao)(niao)肛肠(chang)等医(yi)疗科室经(jing)常(chang)用(yong)(yong)(yong)(yong)(yong)(yong)到导尿(niao)(niao)设备(bei)一般(ban)(ban)都是(shi)(shi)(shi)一次性(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)的(de)。下(xia)面(mian)介绍的(de)这(zhei)(zhei)种(zhong)(zhong)-次性(xing)(xing)(xing)的(de)无莹导尿(niao)(niao)产(chan)(chan)(chan)品(pin)(pin)(pin)(pin)(pin)就是(shi)(shi)(shi)同类产(chan)(chan)(chan)品(pin)(pin)(pin)(pin)(pin)中(zhong)性(xing)(xing)(xing)能(neng)(neng)非常(chang)优越(yue)的(de)一种(zhong)(zhong)。产(chan)(chan)(chan)品(pin)(pin)(pin)(pin)(pin)的(de)用(yong)(yong)(yong)(yong)(yong)(yong)途和性(xing)(xing)(xing)能(neng)(neng),这(zhei)(zhei)种(zhong)(zhong)-次性(xing)(xing)(xing)的(de)无菌导尿(niao)(niao)包主要是(shi)(shi)(shi)给(ji)临床上的(de)患者导尿(niao)(niao)之用(yong)(yong)(yong)(yong)(yong)(yong)，这(zhei)(zhei)种(zhong)(zhong)产(chan)(chan)(chan)品(pin)(pin)(pin)(pin)(pin)是(shi)(shi)(shi)经(jing)过了环氧乙烷灭莹,非常(chang)的(de)卫生(sheng)和安全，使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)起来(lai)也(ye)非常(chang)方便。该产(chan)(chan)(chan)品(pin)(pin)(pin)(pin)(pin)是(shi)(shi)(shi)由(you)洞巾,布和一次性(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)的(de)导尿(niao)(niao)管(guan)、橡胶医(yi)用(yong)(yong)(yong)(yong)(yong)(yong)手(shou)套、海绵刷、纱布块(kuai)、石蜡棉球物品(pin)(pin)(pin)(pin)(pin)盒和一次性(xing)(xing)(xing)的(de)引流袋等几部(bu)分组(zu)成。这(zhei)(zhei)种(zhong)(zhong)- -次性(xing)(xing)(xing)产(chan)(chan)(chan)品(pin)(pin)(pin)(pin)(pin)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)起来(lai)也(ye)非常(chang)方便。这(zhei)(zhei)种(zhong)(zhong)产(chan)(chan)(chan)品(pin)(pin)(pin)(pin)(pin)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)起来(lai)也(ye)比较简单,首(shou)先,在(zai)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)前要检查单包装是(shi)(shi)(shi)不(bu)是(shi)(shi)(shi)没有损(sun)坏,灭菌的(de)有效(xiao)期(qi)是(shi)(shi)(shi)不(bu)是(shi)(shi)(shi)正常(chang);其次,在(zai)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)的(de)时候(hou),先打开(kai)包装,在(zai)将包布打开(kai),再(zai)戴上手(shou)套,然后(hou);按照常(chang)规(gui)的(de)方法来(lai)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)导尿(niao)(niao)包里的(de)组(zu)件;其三(san),-般(ban)(ban)的(de)产(chan)(chan)(chan)品(pin)(pin)(pin)(pin)(pin)的(de)有效(xiao)期(qi)是(shi)(shi)(shi)两年 ,如果(guo)产(chan)(chan)(chan)品(pin)(pin)(pin)(pin)(pin)已经(jing)过了有效(xiao)期(qi),绝对不(bu)能(neng)(neng)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong);四,如果(guo)包装破(po)损(sun)了也(ye)不(bu)能(neng)(neng)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong);五,这(zhei)(zhei)是(shi)(shi)(shi)-次性(xing)(xing)(xing)的(de)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)产(chan)(chan)(chan)品(pin)(pin)(pin)(pin)(pin)，禁(jin)止(zhi)重(zhong)复使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong),在(zai)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)完(wan)后(hou)要销毁,生(sheng)产(chan)(chan)(chan)日期(qi)般(ban)(ban)在(zai)包装封口处。

接近医生，与医生的第一次接触对于医疗器械销售员来说，是一个很高的门槛。最容易被医生拒绝的时候也在这个时候，没有一定的接近方法，新的医疗器械销售员很难获得与医生交谈的机会。 因为陌生人相识，压力极大。医用一次性使用导尿包再说销售工作被很多人误解，也被一些不良的医接近医生，与医生的第一次接触对于医疗器械销售员来说，是一个很高的门槛。一次性使用导尿包批发最(zui)容易被(bei)(bei)医(yi)生(sheng)拒(ju)绝的(de)(de)(de)(de)时(shi)候也在这个时(shi)候，没有一定(ding)的(de)(de)(de)(de)接近方法(fa)，新(xin)的(de)(de)(de)(de)医(yi)疗(liao)(liao)器(qi)(qi)械(xie)销(xiao)售(shou)员很难获(huo)(huo)得与医(yi)生(sheng)交(jiao)谈(tan)的(de)(de)(de)(de)机会。因为陌生(sheng)人(ren)相(xiang)识，压力极大。再说销(xiao)售(shou)工作(zuo)被(bei)(bei)很多人(ren)误解，也被(bei)(bei)一些不良的(de)(de)(de)(de)医(yi)疗(liao)(liao)器(qi)(qi)械(xie)销(xiao)售(shou)员做坏了(le)名声，医(yi)生(sheng)一般对医(yi)疗(liao)(liao)器(qi)(qi)械(xie)销(xiao)售(shou)员都有拒(ju)绝心(xin)态。医(yi)疗(liao)(liao)器(qi)(qi)械(xie)销(xiao)售(shou)员除了(le)需要(yao)在接近医(yi)生(sheng)前(qian)，做好医(yi)生(sheng)资料分析、选择拜访路线、熟练(lian)产品知(zhi)识外，还要(yao)决定(ding)使用什么接近医(yi)生(sheng)的(de)(de)(de)(de)方法(fa)。给予医(yi)生(sheng)一个见面的(de)(de)(de)(de)理由(you)，是(shi)获(huo)(huo)得交(jiao)谈(tan)机会的(de)(de)(de)(de)敲门砖。