据悉，70%世界医疗器械oem产品是中国企业制造的，但未必是中国企业的牌子，可能是通过OEM方式进入的（OEM指的是定牌或者贴牌生产）。”据了解，我国高端医疗器械主要靠进口，检验设备出口占85%，心电图出口占90%，医用一次性使用灌肠包中高端监护占到80%，高档生理记录占到90%。 “一带一路”有助于产生中国品牌。 “我国产品的特点是知识产权少，自有品牌少。”蔡天智表示。提倡的“一带一路”战略，为中国发展自主品牌的医疗器械提供了环境和条件。“一带一路”覆盖了44亿人口，这些和地区的国民生产总值为21万亿美元。一次性使用灌肠包厂家我(wo)国(guo)(guo)出(chu)口到(dao)亚洲(zhou)的医(yi)疗器械占整个出(chu)口市场(chang)的33.12%，而(er)我(wo)国(guo)(guo)需要(yao)从(cong)中亚进口大量(liang)的医(yi)疗器械原料，与其(qi)这样，不如把高分子类产品直接输(shu)入到(dao)中亚，在那(nei)里进行组装，在当地进行销售。

医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)是医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)研制(zhi)、生产、经(jing)营、使用(yong)以及监(jian)(jian)(jian)(jian)督管(guan)(guan)(guan)理所共同遵循的技(ji)术(shu)规范(fan)，是医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)监(jian)(jian)(jian)(jian)管(guan)(guan)(guan)和产业发(fa)(fa)展(zhan)(zhan)的重要技(ji)术(shu)支撑。药(yao)监(jian)(jian)(jian)(jian)局(ju)高度重视医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)工(gong)作(zuo)，按照“四个严”的要求，结合(he)医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)产业发(fa)(fa)展(zhan)(zhan)和监(jian)(jian)(jian)(jian)管(guan)(guan)(guan)工(gong)作(zuo)实(shi)际(ji)，不断完善医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)管(guan)(guan)(guan)理制(zhi)度体系(xi)、持续(xu)开展(zhan)(zhan)医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)制(zhi)修(xiu)(xiu)订(ding)工(gong)作(zuo)，我(wo)国(guo)医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)体系(xi)不断完善，医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)对(dui)监(jian)(jian)(jian)(jian)管(guan)(guan)(guan)和产业发(fa)(fa)展(zhan)(zhan)的技(ji)术(shu)支撑能力(li)持续(xu)提(ti)升。一、加(jia)强(qiang)医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)制(zhi)度建设。为贯彻落(luo)实(shi)国(guo)务院深化(hua)(hua)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)化(hua)(hua)改革重大决(jue)策部署，依(yi)据《中(zhong)华人民共和国(guo)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)化(hua)(hua)法(fa)(fa)》，立足我(wo)国(guo)医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)产业发(fa)(fa)展(zhan)(zhan)和监(jian)(jian)(jian)(jian)管(guan)(guan)(guan)工(gong)作(zuo)实(shi)际(ji)，2017年4月，原食品药(yao)品监(jian)(jian)(jian)(jian)管(guan)(guan)(guan)总局(ju)修(xiu)(xiu)订(ding)印(yin)发(fa)(fa)《医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)管(guan)(guan)(guan)理办(ban)法(fa)(fa)》，该办(ban)法(fa)(fa)的出台对(dui)指导我(wo)国(guo)医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)管(guan)(guan)(guan)理、规范(fan)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)制(zhi)修(xiu)(xiu)订(ding)、促进(jin)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)实(shi)施、提(ti)升医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)质量等起到(dao)了(le)积极(ji)作(zuo)用(yong)。为贯彻落(luo)实(shi)《医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)管(guan)(guan)(guan)理办(ban)法(fa)(fa)》，原食品药(yao)品监(jian)(jian)(jian)(jian)管(guan)(guan)(guan)总局(ju)先(xian)后印(yin)发(fa)(fa)《医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)制(zhi)修(xiu)(xiu)订(ding)工(gong)作(zuo)管(guan)(guan)(guan)理规范(fan)》和《医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)报批发(fa)(fa)布工(gong)作(zuo)细则》等文(wen)件，进(jin)一步规范(fan)了(le)医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)工(gong)作(zuo)程序，强(qiang)化(hua)(hua)了(le)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)精细化(hua)(hua)过程管(guan)(guan)(guan)理，为提(ti)升医(yi)(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)(biao)(biao)(biao)准(zhun)质量奠定了(le)坚实(shi)的制(zhi)度基(ji)础。

2月5日，药(yao)(yao)(yao)监(jian)局接到卫生(sheng)健(jian)康委通(tong)报，上(shang)(shang)海(hai)(hai)新(xin)兴医(yi)药(yao)(yao)(yao)股份有限公(gong)司（以下简称“上(shang)(shang)海(hai)(hai)新(xin)兴”）生(sheng)产(chan)的(de)一(yi)批次静(jing)注人(ren)免(mian)疫球蛋(dan)(dan)白（批号：20180610Z）艾滋(zi)病(bing)(bing)病(bing)(bing)毒(du)抗体检(jian)(jian)测为阳性。药(yao)(yao)(yao)监(jian)局立(li)即(ji)要(yao)求上(shang)(shang)海(hai)(hai)市药(yao)(yao)(yao)监(jian)局对上(shang)(shang)海(hai)(hai)新(xin)兴开展(zhan)现(xian)场(chang)检(jian)(jian)查，组(zu)织对同批原料血浆(jiang)生(sheng)产(chan)的(de)产(chan)品和(he)相邻批次产(chan)品进(jin)行(xing)检(jian)(jian)验，并派出(chu)督导检(jian)(jian)查组(zu)抵达上(shang)(shang)海(hai)(hai)、江西(xi)，督促指导地方药(yao)(yao)(yao)监(jian)部门开展(zhan)调查处置工作(zuo)。药(yao)(yao)(yao)监(jian)局、卫生(sheng)健(jian)康委联合下发通(tong)知，要(yao)求立(li)即(ji)暂停使用该企业(ye)生(sheng)产(chan)的(de)相关产(chan)品，并及(ji)时(shi)采取封存等控制措施。上(shang)(shang)海(hai)(hai)方面(mian)对涉事批次静(jing)注人(ren)免(mian)疫球蛋(dan)(dan)白进(jin)行(xing)的(de)艾滋(zi)病(bing)(bing)、乙肝、丙(bing)肝三(san)种病(bing)(bing)毒(du)核(he)酸检(jian)(jian)测，结(jie)果均(jun)为阴(yin)(yin)性；江西(xi)方面(mian)对患者的(de)艾滋(zi)病(bing)(bing)病(bing)(bing)毒(du)核(he)酸检(jian)(jian)测，结(jie)果为阴(yin)(yin)性。对企业(ye)现(xian)场(chang)核(he)查等有关工作(zuo)正在进(jin)一(yi)步进(jin)行(xing)中。

一(yi)次(ci)性(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)无菌(jun)导(dao)(dao)尿包是一(yi)款身体行动(dong)不(bu)方便或者手术后(hou)(hou)没有办法(fa)自 由行动(dong)患者设计而(er)成(cheng)的一(yi)次(ci)性(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)产品(pin)(pin)。本产品(pin)(pin)是由注(zhu)(zhu)射器、导(dao)(dao)尿管(guan)(guan)、 导(dao)(dao)管(guan)(guan)夹、塑(su)料镊.塑(su)料试管(guan)(guan)、孔巾(jin)(jin)、展(zhan)巾(jin)(jin)、纱布(bu)块(kuai)、止(zhi)水(shui)(shui)(shui)(shui)器、润(run)滑(hua)(hua)剂(ji)、引流袋托盘、消毒棉球(qiu)手套组成(cheng)的-套产品(pin)(pin)。那么(me)，本产品(pin)(pin)如何使(shi)(shi)(shi)用(yong)(yong)(yong)?有哪些注(zhu)(zhu)意事(shi)项?在(zai)使(shi)(shi)(shi)用(yong)(yong)(yong)本产品(pin)(pin)的时候首先要(yao)润(run)滑(hua)(hua),就是胶乳(ru)导(dao)(dao)尿管(guan)(guan)插入(ru)前(qian),需(xu)(xu)用(yong)(yong)(yong)医(yi)用(yong)(yong)(yong)润(run)滑(hua)(hua)剂(ji)润(run)滑(hua)(hua)。超滑(hua)(hua)胶乳(ru)导(dao)(dao)尿管(guan)(guan)插入(ru)前(qian)先用(yong)(yong)(yong)无菌(jun)水(shui)(shui)(shui)(shui)充(chong)分湿(shi)润(run),即达到(dao)超滑(hua)(hua)效果(guo),无需(xu)(xu)使(shi)(shi)(shi)用(yong)(yong)(yong)润(run)滑(hua)(hua)剂(ji)。然后(hou)(hou)就是插入(ru)和注(zhu)(zhu)水(shui)(shui)(shui)(shui)等的步(bu)骤了。就是将润(run)滑(hua)(hua)后(hou)(hou)的导(dao)(dao)管(guan)(guan)小心插入(ru)膀胱(guang),用(yong)(yong)(yong)不(bu)带(dai)针的注(zhu)(zhu)射器注(zhu)(zhu)入(ru)定量无菌(jun)水(shui)(shui)(shui)(shui),使(shi)(shi)(shi)膨胀了的水(shui)(shui)(shui)(shui)妻卡信膀胱(guang)即可。后(hou)(hou)取(qu)出排水(shui)(shui)(shui)(shui)管(guan)(guan)。还需(xu)(xu)要(yao)医(yi)护(hu)人员留(liu)置观察(cha)以及(ji)护(hu)理。在(zai)使(shi)(shi)(shi)用(yong)(yong)(yong)时也要(yao)注(zhu)(zhu)意,不(bu)要(yao)使(shi)(shi)(shi)用(yong)(yong)(yong)含石油基质的润(run)滑(hua)(hua)剂(ji);而(er)且,本产品(pin)(pin)经环氧乙(yi)烷灭莹,供一(yi)次(ci)性(xing)使(shi)(shi)(shi)用(yong)(yong)(yong),如包装破损,不(bu)能使(shi)(shi)(shi)用(yong)(yong)(yong);本产品(pin)(pin)仅供医(yi)护(hu)人员操作使(shi)(shi)(shi)用(yong)(yong)(yong),储藏(zang)要(yao)避(bi)光防(fang)热。