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　　2015年(nian)10月21日,國家(jia)食品藥品監督管理(li)(li)總局(ju)發布《醫療器(qi)械使用質量監督管理(li)(li)辦法》（以下簡稱《辦法》）。《辦法》共(gong)六(liu)章35條(tiao)，將(jiang)于(yu)2016年(nian)2月1日起(qi)施行。

　　使(shi)用(yong)環(huan)節的醫(yi)療(liao)器械(xie)(xie)質量(liang)對確(que)保用(yong)械(xie)(xie)安全有效至關(guan)重要。《辦法》針對當前(qian)醫(yi)療(liao)器械(xie)(xie)使(shi)用(yong)單位采(cai)購渠道不規(gui)(gui)范、進(jin)貨查驗不落實、維護(hu)保養不嚴格、質量(liang)管理不完(wan)善等問題，對《醫(yi)療(liao)器械(xie)(xie)監督管理條例(li)》規(gui)(gui)定的進(jin)貨查驗、信(xin)息記錄、貯存(cun)運輸、質量(liang)檢查、維護(hu)保養等使(shi)用(yong)環(huan)節質量(liang)管理義務作(zuo)了細化和補充(chong)完(wan)善。

　　《辦(ban)法》明確(que)了醫(yi)(yi)療器(qi)械(xie)(xie)采購、驗(yan)收、貯存、使(shi)(shi)用(yong)(yong)、維(wei)(wei)(wei)(wei)(wei)(wei)護(hu)、轉讓(rang)等(deng)(deng)與使(shi)(shi)用(yong)(yong)質(zhi)(zhi)量(liang)密切(qie)相(xiang)關(guan)的(de)各(ge)個環節(jie)的(de)管(guan)(guan)(guan)理(li)(li)(li)(li)規(gui)定(ding)(ding)(ding)，要(yao)求(qiu)(qiu)醫(yi)(yi)療器(qi)械(xie)(xie)使(shi)(shi)用(yong)(yong)單(dan)位(wei)(wei)建立覆蓋質(zhi)(zhi)量(liang)管(guan)(guan)(guan)理(li)(li)(li)(li)全過程的(de)醫(yi)(yi)療器(qi)械(xie)(xie)使(shi)(shi)用(yong)(yong)管(guan)(guan)(guan)理(li)(li)(li)(li)制(zhi)度，并每年對(dui)質(zhi)(zhi)量(liang)管(guan)(guan)(guan)理(li)(li)(li)(li)工作(zuo)進(jin)行全面(mian)自查(cha)。一是(shi)(shi)嚴(yan)格(ge)質(zhi)(zhi)量(liang)查(cha)驗(yan)管(guan)(guan)(guan)理(li)(li)(li)(li)要(yao)求(qiu)(qiu)。規(gui)定(ding)(ding)(ding)使(shi)(shi)用(yong)(yong)單(dan)位(wei)(wei)要(yao)對(dui)醫(yi)(yi)療器(qi)械(xie)(xie)采購實(shi)行統一管(guan)(guan)(guan)理(li)(li)(li)(li)，嚴(yan)格(ge)查(cha)驗(yan)供貨(huo)商資質(zhi)(zhi)和(he)產品證明文(wen)件，妥善(shan)保存相(xiang)關(guan)記錄和(he)資料，并建立醫(yi)(yi)療器(qi)械(xie)(xie)使(shi)(shi)用(yong)(yong)前質(zhi)(zhi)量(liang)檢查(cha)制(zhi)度。二是(shi)(shi)加強(qiang)維(wei)(wei)(wei)(wei)(wei)(wei)護(hu)維(wei)(wei)(wei)(wei)(wei)(wei)修(xiu)(xiu)(xiu)(xiu)管(guan)(guan)(guan)理(li)(li)(li)(li)。針(zhen)對(dui)實(shi)踐中存在的(de)突出(chu)(chu)問題，詳(xiang)細規(gui)定(ding)(ding)(ding)了使(shi)(shi)用(yong)(yong)單(dan)位(wei)(wei)自行維(wei)(wei)(wei)(wei)(wei)(wei)護(hu)維(wei)(wei)(wei)(wei)(wei)(wei)修(xiu)(xiu)(xiu)(xiu)、委托維(wei)(wei)(wei)(wei)(wei)(wei)修(xiu)(xiu)(xiu)(xiu)服務(wu)機構維(wei)(wei)(wei)(wei)(wei)(wei)護(hu)維(wei)(wei)(wei)(wei)(wei)(wei)修(xiu)(xiu)(xiu)(xiu)、約定(ding)(ding)(ding)生(sheng)產經營(ying)企(qi)業維(wei)(wei)(wei)(wei)(wei)(wei)護(hu)維(wei)(wei)(wei)(wei)(wei)(wei)修(xiu)(xiu)(xiu)(xiu)等(deng)(deng)不(bu)同情形(xing)的(de)管(guan)(guan)(guan)理(li)(li)(li)(li)要(yao)求(qiu)(qiu)，明確(que)規(gui)定(ding)(ding)(ding)在使(shi)(shi)用(yong)(yong)單(dan)位(wei)(wei)自行維(wei)(wei)(wei)(wei)(wei)(wei)護(hu)維(wei)(wei)(wei)(wei)(wei)(wei)修(xiu)(xiu)(xiu)(xiu)或者委托維(wei)(wei)(wei)(wei)(wei)(wei)修(xiu)(xiu)(xiu)(xiu)服務(wu)機構維(wei)(wei)(wei)(wei)(wei)(wei)護(hu)維(wei)(wei)(wei)(wei)(wei)(wei)修(xiu)(xiu)(xiu)(xiu)時(shi)，生(sheng)產經營(ying)企(qi)業應(ying)當(dang)嚴(yan)格(ge)按(an)照(zhao)合(he)同約定(ding)(ding)(ding)，提供維(wei)(wei)(wei)(wei)(wei)(wei)護(hu)手(shou)冊、故障代碼表、維(wei)(wei)(wei)(wei)(wei)(wei)修(xiu)(xiu)(xiu)(xiu)密碼等(deng)(deng)維(wei)(wei)(wei)(wei)(wei)(wei)護(hu)維(wei)(wei)(wei)(wei)(wei)(wei)修(xiu)(xiu)(xiu)(xiu)必需的(de)材料和(he)信息。三是(shi)(shi)完善(shan)在用(yong)(yong)醫(yi)(yi)療器(qi)械(xie)(xie)轉讓(rang)和(he)捐(juan)贈(zeng)管(guan)(guan)(guan)理(li)(li)(li)(li)。規(gui)定(ding)(ding)(ding)使(shi)(shi)用(yong)(yong)單(dan)位(wei)(wei)轉讓(rang)醫(yi)(yi)療器(qi)械(xie)(xie)應(ying)當(dang)確(que)保所轉讓(rang)的(de)醫(yi)(yi)療器(qi)械(xie)(xie)安全、有效(xiao)，及時(shi)移(yi)交說明書(shu)、維(wei)(wei)(wei)(wei)(wei)(wei)修(xiu)(xiu)(xiu)(xiu)記錄等(deng)(deng)資料，受(shou)讓(rang)方(fang)應(ying)當(dang)參(can)照(zhao)相(xiang)關(guan)要(yao)求(qiu)(qiu)進(jin)行進(jin)貨(huo)查(cha)驗(yan)。針(zhen)對(dui)越來(lai)越多的(de)醫(yi)(yi)療器(qi)械(xie)(xie)捐(juan)贈(zeng)行為，《辦(ban)法》對(dui)捐(juan)贈(zeng)方(fang)和(he)受(shou)贈(zeng)方(fang)均提出(chu)(chu)了要(yao)求(qiu)(qiu)，并規(gui)定(ding)(ding)(ding)使(shi)(shi)用(yong)(yong)單(dan)位(wei)(wei)之(zhi)間(jian)的(de)捐(juan)贈(zeng)參(can)照(zhao)轉讓(rang)管(guan)(guan)(guan)理(li)(li)(li)(li)。四是(shi)(shi)強(qiang)化分類監(jian)管(guan)(guan)(guan)和(he)信用(yong)(yong)監(jian)管(guan)(guan)(guan)。強(qiang)調依風險實(shi)施監(jian)管(guan)(guan)(guan)的(de)原則，對(dui)較高(gao)風險或者有特(te)殊儲(chu)運(yun)要(yao)求(qiu)(qiu)的(de)醫(yi)(yi)療器(qi)械(xie)(xie)，以及有不(bu)良信用(yong)(yong)記錄的(de)醫(yi)(yi)療器(qi)械(xie)(xie)使(shi)(shi)用(yong)(yong)單(dan)位(wei)(wei)等(deng)(deng)實(shi)施重點監(jian)管(guan)(guan)(guan)。

　　《辦法》的出臺進一步豐富了《醫療器械監督管理條例》配套規章體系，對加強醫療器械監督管理，保障用械安全具有重要意義。