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医疗器械标准是医疗器械研制、生产、经营、使用以及监督管理所共同遵循的技术规范,是医疗器械监管和产业发展的重要技术支撑。医用一次性使用医用吸痰包药监局高度重视医疗器械标准工作,按照“四个严”的要求,结合医疗器械产业发展和监管工作实际,不断完善医疗器械标准管理制度体系、持续开展医疗器械标准制修订工作,我国医疗器械标准体系不断完善,医疗器械标准对监管和产业发展的技术支撑能力持续提升。一、加强医疗器械标准制度建设。一次性使用医用吸痰包批发为(wei)贯彻落(luo)实国(guo)务院深化(hua)标(biao)(biao)(biao)准(zhun)(zhun)化(hua)改革(ge)重(zhong)大决(jue)策部署,依据《中华人民共和国(guo)标(biao)(biao)(biao)准(zhun)(zhun)化(hua)法(fa)》,立足我国(guo)医(yi)疗(liao)器(qi)械(xie)产(chan)业(ye)发(fa)展和监管(guan)(guan)工(gong)作实际,2017年4月,原(yuan)食(shi)品(pin)(pin)(pin)药(yao)品(pin)(pin)(pin)监管(guan)(guan)总(zong)局修(xiu)订(ding)印(yin)发(fa)《医(yi)疗(liao)器(qi)械(xie)标(biao)(biao)(biao)准(zhun)(zhun)管(guan)(guan)理(li)办(ban)法(fa)》,该办(ban)法(fa)的(de)出台对指导我国(guo)医(yi)疗(liao)器(qi)械(xie)标(biao)(biao)(biao)准(zhun)(zhun)管(guan)(guan)理(li)、规范(fan)标(biao)(biao)(biao)准(zhun)(zhun)制(zhi)(zhi)修(xiu)订(ding)、促进(jin)标(biao)(biao)(biao)准(zhun)(zhun)实施、提(ti)升医(yi)疗(liao)器(qi)械(xie)质(zhi)量(liang)等起(qi)到(dao)了积(ji)极作用。为(wei)贯彻落(luo)实《医(yi)疗(liao)器(qi)械(xie)标(biao)(biao)(biao)准(zhun)(zhun)管(guan)(guan)理(li)办(ban)法(fa)》,原(yuan)食(shi)品(pin)(pin)(pin)药(yao)品(pin)(pin)(pin)监管(guan)(guan)总(zong)局先后印(yin)发(fa)《医(yi)疗(liao)器(qi)械(xie)标(biao)(biao)(biao)准(zhun)(zhun)制(zhi)(zhi)修(xiu)订(ding)工(gong)作管(guan)(guan)理(li)规范(fan)》和《医(yi)疗(liao)器(qi)械(xie)标(biao)(biao)(biao)准(zhun)(zhun)报批(pi)发(fa)布(bu)工(gong)作细(xi)则》等文件,进(jin)一步规范(fan)了医(yi)疗(liao)器(qi)械(xie)标(biao)(biao)(biao)准(zhun)(zhun)工(gong)作程序,强(qiang)化(hua)了标(biao)(biao)(biao)准(zhun)(zhun)精(jing)细(xi)化(hua)过程管(guan)(guan)理(li),为(wei)提(ti)升医(yi)疗(liao)器(qi)械(xie)标(biao)(biao)(biao)准(zhun)(zhun)质(zhi)量(liang)奠定了坚实的(de)制(zhi)(zhi)度基础。
导尿(niao)设(she)备在(zai)医(yi)疗当中(zhong)也(ye)(ye)是经常(chang)(chang)(chang)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)的(de)(de)(de)(de)(de)(de)(de)一(yi)(yi)种(zhong)产品(pin)(pin)(pin)(pin)(pin)(pin),在(zai)泌尿(niao)肛肠等(deng)医(yi)疗科(ke)室经常(chang)(chang)(chang)用(yong)(yong)(yong)到(dao)导尿(niao)设(she)备一(yi)(yi)般(ban)都(dou)是一(yi)(yi)次(ci)性(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)的(de)(de)(de)(de)(de)(de)(de)。下面介绍的(de)(de)(de)(de)(de)(de)(de)这(zhei)种(zhong)-次(ci)性(xing)的(de)(de)(de)(de)(de)(de)(de)无莹导尿(niao)产品(pin)(pin)(pin)(pin)(pin)(pin)就是同类产品(pin)(pin)(pin)(pin)(pin)(pin)中(zhong)性(xing)能(neng)非常(chang)(chang)(chang)优(you)越的(de)(de)(de)(de)(de)(de)(de)一(yi)(yi)种(zhong)。产品(pin)(pin)(pin)(pin)(pin)(pin)的(de)(de)(de)(de)(de)(de)(de)用(yong)(yong)(yong)途和(he)性(xing)能(neng),这(zhei)种(zhong)-次(ci)性(xing)的(de)(de)(de)(de)(de)(de)(de)无菌导尿(niao)包(bao)主要是给(ji)临床(chuang)上的(de)(de)(de)(de)(de)(de)(de)患者导尿(niao)之(zhi)用(yong)(yong)(yong),这(zhei)种(zhong)产品(pin)(pin)(pin)(pin)(pin)(pin)是经过了环(huan)氧乙烷灭莹,非常(chang)(chang)(chang)的(de)(de)(de)(de)(de)(de)(de)卫生和(he)安全,使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)起来(lai)(lai)也(ye)(ye)非常(chang)(chang)(chang)方便(bian)。该产品(pin)(pin)(pin)(pin)(pin)(pin)是由洞巾,布(bu)和(he)一(yi)(yi)次(ci)性(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)的(de)(de)(de)(de)(de)(de)(de)导尿(niao)管、橡胶医(yi)用(yong)(yong)(yong)手套(tao)、海绵(mian)刷(shua)、纱布(bu)块、石蜡(la)棉球(qiu)物品(pin)(pin)(pin)(pin)(pin)(pin)盒和(he)一(yi)(yi)次(ci)性(xing)的(de)(de)(de)(de)(de)(de)(de)引流袋等(deng)几(ji)部分组成。这(zhei)种(zhong)- -次(ci)性(xing)产品(pin)(pin)(pin)(pin)(pin)(pin)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)起来(lai)(lai)也(ye)(ye)非常(chang)(chang)(chang)方便(bian)。这(zhei)种(zhong)产品(pin)(pin)(pin)(pin)(pin)(pin)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)起来(lai)(lai)也(ye)(ye)比较简单,首先,在(zai)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)前要检(jian)查单包(bao)装(zhuang)是不(bu)是没(mei)有(you)损(sun)坏(huai),灭菌的(de)(de)(de)(de)(de)(de)(de)有(you)效(xiao)(xiao)期是不(bu)是正常(chang)(chang)(chang);其(qi)次(ci),在(zai)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)的(de)(de)(de)(de)(de)(de)(de)时(shi)候,先打开包(bao)装(zhuang),在(zai)将包(bao)布(bu)打开,再戴上手套(tao),然后;按照常(chang)(chang)(chang)规的(de)(de)(de)(de)(de)(de)(de)方法来(lai)(lai)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)导尿(niao)包(bao)里的(de)(de)(de)(de)(de)(de)(de)组件(jian);其(qi)三,-般(ban)的(de)(de)(de)(de)(de)(de)(de)产品(pin)(pin)(pin)(pin)(pin)(pin)的(de)(de)(de)(de)(de)(de)(de)有(you)效(xiao)(xiao)期是两年 ,如(ru)果(guo)产品(pin)(pin)(pin)(pin)(pin)(pin)已经过了有(you)效(xiao)(xiao)期,绝对不(bu)能(neng)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong);四(si),如(ru)果(guo)包(bao)装(zhuang)破损(sun)了也(ye)(ye)不(bu)能(neng)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong);五,这(zhei)是-次(ci)性(xing)的(de)(de)(de)(de)(de)(de)(de)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)产品(pin)(pin)(pin)(pin)(pin)(pin),禁止重复使(shi)(shi)(shi)(shi)用(yong)(yong)(yong),在(zai)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)完后要销毁,生产日期般(ban)在(zai)包(bao)装(zhuang)封口处。
一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)用(yong)(yong)(yong)(yong)胃(wei)(wei)(wei)镜检(jian)查(cha)包(bao)(bao)相(xiang)关问(wen)答(da)(da)问(wen): 一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)腔包(bao)(bao)为何是(shi)(shi)(shi)一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing)?答(da)(da):因为该(gai)口(kou)(kou)腔包(bao)(bao)里的(de)东(dong)西(xi)没有(you)办法(fa)进行高(gao)温高(gao)压消(xiao)毒,会变形融化,所以是(shi)(shi)(shi)一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing)的(de),污(wu)染(ran)后就不(bu)(bu)能(neng)(neng)用(yong)(yong)(yong)(yong)了口(kou)(kou)腔科(ke) 1个(ge)(ge)(ge)(ge)回(hui)(hui)答(da)(da) 问(wen): 胃(wei)(wei)(wei)镜检(jian)查(cha)的(de)器(qi)材是(shi)(shi)(shi)一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing)的(de)吗比如(ru)咬口(kou)(kou)大(da)夫手(shou)(shou)套?答(da)(da):病情分析: 你好(hao)!胃(wei)(wei)(wei)镜检(jian)查(cha)为侵入性(xing)(xing)操作,如(ru)果不(bu)(bu)注意(yi)会引起交叉感染(ran)。 指导(dao)意(yi)见: 正(zheng)规(gui)(gui)医(yi)院的(de)胃(wei)(wei)(wei)镜耗材均为一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing),胃(wei)(wei)(wei)镜不(bu)(bu)可(ke)能(neng)(neng)为一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing),但是(shi)(shi)(shi)都经过严格消(xiao)毒的(de)。内(nei)科(ke) 1个(ge)(ge)(ge)(ge)回(hui)(hui)答(da)(da) 问(wen): 一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)腔包(bao)(bao)的(de)材料是(shi)(shi)(shi)什(shen)么?答(da)(da):应该(gai)是(shi)(shi)(shi)托(tuo)盘还(hai)有(you)开(kai)口(kou)(kou)器(qi)之(zhi)类的(de)。 希望对你有(you)帮助。 麻烦好(hao)评(ping),谢(xie)谢(xie)商业 1个(ge)(ge)(ge)(ge)回(hui)(hui)答(da)(da) 问(wen): 什(shen)么情况下应该(gai)使(shi)(shi)用(yong)(yong)(yong)(yong)胃(wei)(wei)(wei)镜做检(jian)查(cha)?答(da)(da):对于(yu)钝形物体在胃(wei)(wei)(wei)内(nei)已存(cun)留2周(zhou),或在十(shi)二指肠内(nei)存(cun)留1周(zhou)时(shi),都应用(yong)(yong)(yong)(yong)内(nei)镜取出消(xiao)化内(nei)科(ke) 1个(ge)(ge)(ge)(ge)回(hui)(hui)答(da)(da) 问(wen): 一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)用(yong)(yong)(yong)(yong)手(shou)(shou)术(shu)(shu)材料包(bao)(bao)包(bao)(bao)括那些?答(da)(da):一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)用(yong)(yong)(yong)(yong)手(shou)(shou)术(shu)(shu)材料包(bao)(bao)(手(shou)(shou)术(shu)(shu)包(bao)(bao)、参与包(bao)(bao)、产包(bao)(bao)、流产包(bao)(bao))产科(ke) 1个(ge)(ge)(ge)(ge)回(hui)(hui)答(da)(da)问(wen): 一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)用(yong)(yong)(yong)(yong)无(wu)菌(jun)敷料包(bao)(bao)适用(yong)(yong)(yong)(yong)于(yu)什(shen)么?答(da)(da):适用(yong)(yong)(yong)(yong)于(yu)医(yi)疗(liao)单位手(shou)(shou)术(shu)(shu)后、创伤的(de)换药。医(yi)疗(liao)健康(kang) 1个(ge)(ge)(ge)(ge)回(hui)(hui)答(da)(da)问(wen): 一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)用(yong)(yong)(yong)(yong)手(shou)(shou)术(shu)(shu)包(bao)(bao)标配和(he)常规(gui)(gui)的(de)区别(bie)?答(da)(da):这(zhei)个(ge)(ge)(ge)(ge)各个(ge)(ge)(ge)(ge)医(yi)院有(you)自己的(de)常规(gui)(gui)和(he)标配,具(ju)体看规(gui)(gui)定答(da)(da):这(zhei)个(ge)(ge)(ge)(ge)区别(bie)也不(bu)(bu)是(shi)(shi)(shi)很大(da) 具(ju)体相(xiang)同的(de)很多的(de)。 点(dian)(dian)击好(hao)评(ping),祝(zhu)你事(shi)事(shi)顺(shun)利。眼部整形 2个(ge)(ge)(ge)(ge)回(hui)(hui)答(da)(da)问(wen): 一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing)使(shi)(shi)用(yong)(yong)(yong)(yong)口(kou)(kou)腔包(bao)(bao)为何是(shi)(shi)(shi)一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing)?答(da)(da):因为该(gai)腔包(bao)(bao)里的(de)东(dong)西(xi)没有(you)办法(fa)进行高(gao)温高(gao)压消(xiao)毒,会变形融化,所以是(shi)(shi)(shi)一(yi)次(ci)(ci)(ci)(ci)(ci)性(xing)(xing)的(de),污(wu)染(ran)后就不(bu)(bu)能(neng)(neng)用(yong)(yong)(yong)(yong)了口(kou)(kou)腔科(ke) 1个(ge)(ge)(ge)(ge)回(hui)(hui)答(da)(da)问(wen): 胃(wei)(wei)(wei)镜检(jian)查(cha)有(you)点(dian)(dian)包(bao)(bao)块要紧?答(da)(da):出现这(zhei)样的(de)情况考虑(lv)是(shi)(shi)(shi)由(you)于(yu)明显的(de)乳腺(xian)增(zeng)生(sheng)疾(ji)病有(you)很大(da)关系的(de),需要去乳腺(xian)科(ke)做个(ge)(ge)(ge)(ge)检(jian)查(cha)消(xiao)化内(nei)科(ke) 1个(ge)(ge)(ge)(ge)回(hui)(hui)答(da)(da)问(wen): 胃(wei)(wei)(wei)镜检(jian)查(cha)包(bao)(bao)和(he)胃(wei)(wei)(wei)管包(bao)(bao)是(shi)(shi)(shi)一(yi)个(ge)(ge)(ge)(ge)东(dong)西(xi)吗答(da)(da):不(bu)(bu)是(shi)(shi)(shi)一(yi)个(ge)(ge)(ge)(ge)东(dong)西(xi)
一(yi)次性吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)包的使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)方法一(yi)次性使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)管(guan)(guan)(guan)用(yong)(yong)(yong)(yong)于临床患者(zhe)抽取气管(guan)(guan)(guan)内(nei)痰(tan)(tan)(tan)液(ye)或(huo)分泌液(ye)用(yong)(yong)(yong)(yong)。一(yi)次性使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)管(guan)(guan)(guan)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)动作要轻(qing)、稳(wen)。一(yi)次吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)时(shi)间不应超过(guo)15秒,吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)器(qi)(qi)连(lian)续使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)时(shi)间不超过(guo)3分钟。1检(jian)查吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)器(qi)(qi)各(ge)部连(lian)接是(shi)否(fou)完善,有无漏(lou)气。接通电源,打开开关(guan)(guan),检(jian)查吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)器(qi)(qi)性能,调节(jie)负(fu)压。一(yi)般成人吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)负(fu)压约40-50 kPa,小儿吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)约13-30kPa,将(jiang)一(yi)次性使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)管(guan)(guan)(guan)置于水中,试验吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)力,并冲(chong)洗皮管(guan)(guan)(guan)。2将(jiang)病人头部转向护士(shi),铺治疗(liao)巾于颌下。插(cha)入(ru)一(yi)次性使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)管(guan)(guan)(guan),其(qi)顺序是(shi)由(you)口腔前(qian)庭→颊部→咽部,将(jiang)各(ge)部吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)尽。如(ru)口腔吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)有困难时(shi),可由(you)鼻(bi)(bi)(bi)腔插(cha)入(ru)(颅底骨折(zhe)患者(zhe)禁用(yong)(yong)(yong)(yong)),其(qi)顺序由(you)鼻(bi)(bi)(bi)腔前(qian)庭→下鼻(bi)(bi)(bi)道(dao)→鼻(bi)(bi)(bi)后孔→咽部→气管(guan)(guan)(guan)(约20-25cm),将(jiang)分泌物(wu)逐段吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)尽。3气管(guan)(guan)(guan)内(nei)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan),待病人吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)气时(shi),快速将(jiang)导(dao)管(guan)(guan)(guan)插(cha)入(ru),自下而上(shang)边退边左右旋(xuan)转导(dao)管(guan)(guan)(guan),消除气道(dao)分泌物(wu),并注意观(guan)察病人的呼吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)。在吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)过(guo)程中,如(ru)病人咳(ke)嗽厉害,应稍等(deng)片刻后再行吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)出。并随时(shi)冲(chong)洗吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)管(guan)(guan)(guan),以免(mian)痰(tan)(tan)(tan)液(ye)堵塞。4吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)毕,关(guan)(guan)闭吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)器(qi)(qi)开关(guan)(guan),弃(qi)吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)痰(tan)(tan)(tan)导(dao)管(guan)(guan)(guan)于小桶内(nei),吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)引(yin)胶(jiao)管(guan)(guan)(guan)玻璃接头插(cha)入(ru)床栏上(shang)盛(sheng)有消毒液(ye)瓶内(nei)备(bei)用(yong)(yong)(yong)(yong),将(jiang)病人口腔周围(wei)擦净。观(guan)察吸(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)(xi)出液(ye)的量、颜色(se)及性质,必要时(shi)做好记(ji)录。