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醫療器械(xie)質(zhi)量安全備受社(she)會關注。近年來，山東省泰(tai)(tai)安市泰(tai)(tai)山區市場監(jian)(jian)管局始(shi)終(zhong)堅持落實“四個(ge)最嚴”，聚焦醫療器械(xie)質(zhi)量安全，積(ji)極(ji)探索醫療器械(xie)經(jing)營(ying)使用監(jian)(jian)管新方式，三級聯(lian)動，多方治理，深入開展醫療器械(xie)專項整(zheng)治，盡心竭力保障(zhang)市民群眾用械(xie)安全。

強(qiang)化統籌(chou)，搭建(jian)“三(san)級(ji)聯動(dong)”機制。一(yi)是(shi)強(qiang)化組織領(ling)導(dao)(dao)，制定藥(yao)化械科(ke)(ke)(ke)隊(dui)(dui)所“三(san)級(ji)聯動(dong)”實(shi)施意見，成(cheng)立藥(yao)化械監(jian)(jian)(jian)(jian)管(guan)(guan)“三(san)級(ji)聯動(dong)”機制建(jian)設領(ling)導(dao)(dao)小組，形成(cheng)“主要領(ling)導(dao)(dao)牽頭(tou)抓總、分管(guan)(guan)領(ling)導(dao)(dao)統籌(chou)協(xie)調、業(ye)務科(ke)(ke)(ke)室(shi)具體推進”的(de)(de)(de)工作格局。二(er)是(shi)優化運行(xing)機制，對于上級(ji)轉辦(ban)的(de)(de)(de)網絡監(jian)(jian)(jian)(jian)測、投訴(su)舉報、輿(yu)情(qing)信息等(deng)案(an)(an)(an)件(jian)(jian)線(xian)索(suo)(suo)(suo)，科(ke)(ke)(ke)室(shi)及時移交執(zhi)法大(da)隊(dui)(dui)或(huo)監(jian)(jian)(jian)(jian)管(guan)(guan)所，科(ke)(ke)(ke)室(shi)參(can)與現場核查、調查取證(zheng)、案(an)(an)(an)件(jian)(jian)會商(shang)等(deng)工作環(huan)節；案(an)(an)(an)件(jian)(jian)查辦(ban)要堅持上溯源頭(tou)、下查流向，局、隊(dui)(dui)、所依職責(ze)分工，深化縱向執(zhi)法聯動(dong)。案(an)(an)(an)件(jian)(jian)辦(ban)結后，在(zai)向上級(ji)報告的(de)(de)(de)同(tong)時，及時將查處情(qing)況(kuang)通報給相關科(ke)(ke)(ke)室(shi)。三(san)是(shi)理清工作職責(ze)，推進跨區(qu)域(yu)(yu)協(xie)同(tong)執(zhi)法，基層(ceng)監(jian)(jian)(jian)(jian)管(guan)(guan)所在(zai)監(jian)(jian)(jian)(jian)管(guan)(guan)過程中發(fa)現的(de)(de)(de)跨區(qu)域(yu)(yu)案(an)(an)(an)件(jian)(jian)線(xian)索(suo)(suo)(suo)，在(zai)通報給其他監(jian)(jian)(jian)(jian)管(guan)(guan)所的(de)(de)(de)同(tong)時，及時向監(jian)(jian)(jian)(jian)管(guan)(guan)科(ke)(ke)(ke)室(shi)和執(zhi)法大(da)隊(dui)(dui)報告。監(jian)(jian)(jian)(jian)管(guan)(guan)科(ke)(ke)(ke)室(shi)在(zai)監(jian)(jian)(jian)(jian)管(guan)(guan)過程中發(fa)現的(de)(de)(de)案(an)(an)(an)件(jian)(jian)線(xian)索(suo)(suo)(suo)應及時移交給執(zhi)法大(da)隊(dui)(dui)。執(zhi)法大(da)隊(dui)(dui)牽頭(tou)組織查處，案(an)(an)(an)件(jian)(jian)辦(ban)結后，及時將查處情(qing)況(kuang)通報給監(jian)(jian)(jian)(jian)管(guan)(guan)科(ke)(ke)(ke)室(shi)和監(jian)(jian)(jian)(jian)管(guan)(guan)所。對發(fa)現的(de)(de)(de)案(an)(an)(an)件(jian)(jian)線(xian)索(suo)(suo)(suo)要一(yi)案(an)(an)(an)多查、一(yi)查到底，全鏈條打擊違法犯罪行(xing)為。

提(ti)質(zhi)(zhi)強(qiang)能(neng)，夯(hang)實(shi)“三級聯動”基石。創新性將“以檢代訓(xun)(xun)”納入醫(yi)療(liao)(liao)(liao)(liao)器械(xie)監(jian)(jian)(jian)管能(neng)力建設核心任務(wu)(wu)(wu)，與人(ren)(ren)才(cai)隊伍體系(xi)構(gou)(gou)建同步推(tui)進(jin)，通(tong)(tong)過(guo)實(shi)地檢查(cha)(cha)、現場(chang)指導、專(zhuan)題(ti)培(pei)訓(xun)(xun)等多(duo)種(zhong)形式，將監(jian)(jian)(jian)管與服務(wu)(wu)(wu)深度融合。一(yi)是(shi)加(jia)(jia)強(qiang)業(ye)務(wu)(wu)(wu)培(pei)訓(xun)(xun)。通(tong)(tong)過(guo)集中(zhong)培(pei)訓(xun)(xun)、交叉(cha)互(hu)查(cha)(cha)、以查(cha)(cha)代訓(xun)(xun)等方式，堅持“走出去”“引進(jin)來”相結合，多(duo)次(ci)組(zu)(zu)織(zhi)監(jian)(jian)(jian)管人(ren)(ren)員(yuan)開展(zhan)相關培(pei)訓(xun)(xun)，提(ti)升執法(fa)(fa)人(ren)(ren)員(yuan)業(ye)務(wu)(wu)(wu)素質(zhi)(zhi)和監(jian)(jian)(jian)管能(neng)力。2024年共(gong)舉辦3期，涉及(ji)人(ren)(ren)員(yuan)達120余人(ren)(ren)次(ci)；通(tong)(tong)過(guo)培(pei)訓(xun)(xun)進(jin)一(yi)步加(jia)(jia)強(qiang)基層醫(yi)療(liao)(liao)(liao)(liao)器械(xie)安(an)全監(jian)(jian)(jian)管能(neng)力建設，推(tui)動構(gou)(gou)建覆蓋(gai)城鄉的社會(hui)共(gong)治(zhi)體系(xi)。二是(shi)加(jia)(jia)強(qiang)哨點建設。組(zu)(zu)織(zhi)轄區醫(yi)療(liao)(liao)(liao)(liao)機構(gou)(gou)和監(jian)(jian)(jian)測哨點開展(zhan)2次(ci)醫(yi)療(liao)(liao)(liao)(liao)器械(xie)安(an)全性檢測業(ye)務(wu)(wu)(wu)培(pei)訓(xun)(xun)。通(tong)(tong)過(guo)培(pei)訓(xun)(xun)，有效推(tui)進(jin)全區醫(yi)療(liao)(liao)(liao)(liao)器械(xie)不良(liang)反應（事(shi)(shi)件(jian)(jian)）監(jian)(jian)(jian)測工作(zuo)質(zhi)(zhi)量。2024年上報(bao)醫(yi)療(liao)(liao)(liao)(liao)器械(xie)不良(liang)事(shi)(shi)件(jian)(jian)報(bao)告707例，其(qi)中(zhong)嚴重報(bao)告107例。三是(shi)加(jia)(jia)強(qiang)執法(fa)(fa)辦案。以網絡違(wei)法(fa)(fa)違(wei)規銷售、無證(zheng)生(sheng)產(chan)(chan)經營、生(sheng)產(chan)(chan)經營無證(zheng)產(chan)(chan)品(pin)為重點，持續(xu)加(jia)(jia)大案件(jian)(jian)查(cha)(cha)辦力度，確保線(xian)索查(cha)(cha)處(chu)(chu)到位，嚴格落(luo)實(shi)“處(chu)(chu)罰到人(ren)(ren)”，實(shi)施沒收(shou)違(wei)法(fa)(fa)所得、限制從業(ye)、列入嚴重違(wei)法(fa)(fa)失信名單、聯合懲戒(jie)等措施。依法(fa)(fa)公開處(chu)(chu)罰信息，加(jia)(jia)大案件(jian)(jian)曝光力度，公布(bu)典型案例。

綜合(he)施策，提升“三(san)級(ji)聯動(dong)”質(zhi)(zhi)效。秉持(chi)(chi)以(yi)人(ren)民健康為核心的理(li)念，全(quan)力(li)開(kai)(kai)展(zhan)(zhan)全(quan)鏈條、全(quan)生命周期的醫療(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)監管(guan)工(gong)(gong)作。持(chi)(chi)續深入開(kai)(kai)展(zhan)(zhan)醫療(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)監管(guan)領域專項(xiang)整(zheng)治(zhi)行(xing)動(dong)，2024年共檢查(cha)醫療(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)生產、經(jing)營企業(ye)和(he)使用單位(wei)681家(jia)(jia)，責令整(zheng)改88家(jia)(jia)，立案29家(jia)(jia)。一是(shi)狠抓風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)會(hui)商(shang)。局、隊、所共同收(shou)(shou)集風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)信(xin)(xin)息，聯合(he)開(kai)(kai)展(zhan)(zhan)風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)會(hui)商(shang)，合(he)力(li)化解風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)隱(yin)(yin)患(huan)。針(zhen)對(dui)轄區內(nei)一類醫療(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)標(biao)(biao)簽(qian)問(wen)題的投訴舉報(bao)(bao)，收(shou)(shou)集風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)信(xin)(xin)息，進(jin)行(xing)風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)分析(xi)研判(pan)，評(ping)(ping)估(gu)風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)等級(ji)和(he)影響范圍，發(fa)布風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)預(yu)警(jing)通報(bao)(bao)，通報(bao)(bao)相關(guan)單位(wei)，根據風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)研判(pan)結果，制(zhi)(zhi)定了風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)防(fang)控措施處(chu)(chu)置(zhi)落實(shi)。風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)處(chu)(chu)置(zhi)過程(cheng)中，加強(qiang)案件查(cha)辦，依法(fa)打擊(ji)違法(fa)違規行(xing)為，組織開(kai)(kai)展(zhan)(zhan)了專項(xiang)一類醫療(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)標(biao)(biao)簽(qian)問(wen)題專項(xiang)檢查(cha)，形成有力(li)震懾(she)。對(dui)已處(chu)(chu)置(zhi)的風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)隱(yin)(yin)患(huan)進(jin)行(xing)跟蹤評(ping)(ping)估(gu)總結，形成風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)防(fang)控閉(bi)環管(guan)理(li)。二是(shi)狠抓隱(yin)(yin)患(huan)排查(cha)。聚焦(jiao)風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)、聚焦(jiao)企業(ye)、聚焦(jiao)產品、聚焦(jiao)處(chu)(chu)置(zhi)，緊(jin)(jin)緊(jin)(jin)圍繞醫療(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)監管(guan)工(gong)(gong)作中發(fa)現(xian)的質(zhi)(zhi)量安全(quan)風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)隱(yin)(yin)患(huan)開(kai)(kai)展(zhan)(zhan)風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)會(hui)商(shang)。實(shi)施風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)清(qing)單責任(ren)制(zhi)(zhi)和(he)風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)銷號制(zhi)(zhi)，對(dui)發(fa)現(xian)的風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)信(xin)(xin)息及(ji)時(shi)調查(cha)和(he)處(chu)(chu)置(zhi)。完善風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)清(qing)單銷號管(guan)理(li)制(zhi)(zhi)度，及(ji)時(shi)將(jiang)各(ge)(ge)類風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)信(xin)(xin)號納入清(qing)單實(shi)行(xing)動(dong)態管(guan)理(li)，及(ji)時(shi)督(du)辦整(zheng)治(zhi)，及(ji)時(shi)處(chu)(chu)置(zhi)輿情(qing)風(feng)(feng)(feng)(feng)險(xian)(xian)(xian)(xian)。三(san)是(shi)狠抓社會(hui)共治(zhi)。變“被動(dong)整(zheng)治(zhi)”為“主(zhu)動(dong)防(fang)控”，通過宣傳引導，構(gou)建社會(hui)共治(zhi)局面(mian)。2024年開(kai)(kai)展(zhan)(zhan)現(xian)場宣傳1場次，現(xian)場接受群眾咨(zi)詢70余(yu)人(ren)次，發(fa)放各(ge)(ge)種宣傳資料200余(yu)份。

本文(wen)由廣州(zhou)佳譽(yu)醫(yi)療(liao)器(qi)械有(you)限(xian)公(gong)司/佛(fo)山(shan)浩揚醫(yi)療(liao)器(qi)械有(you)限(xian)公(gong)司聯(lian)合編(bian)輯