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今(jin)年(nian)以來(lai)，山(shan)東省(sheng)棗莊市市場監(jian)管局緊(jin)緊(jin)圍繞全(quan)市醫療器械(xie)風險防(fang)控(kong)工作，深入推進醫療器械(xie)質量(liang)安全(quan)鞏固(gu)提升行動，強化質量(liang)管理，提升監(jian)管效能，壓實企業責(ze)任，規范市場秩(zhi)序，堅決做到嚴(yan)管嚴(yan)防(fang)嚴(yan)控(kong)各類風險隱患，全(quan)市醫療器械(xie)全(quan)周期質量(liang)安全(quan)防(fang)線(xian)更加鞏固(gu)。

　　深(shen)化(hua)風險(xian)(xian)(xian)(xian)(xian)會(hui)商閉環管理，把(ba)穩(wen)安(an)全風險(xian)(xian)(xian)(xian)(xian)“方向盤(pan)”。棗莊市場監(jian)管局(ju)(ju)嚴格按(an)照《山東省醫(yi)療(liao)(liao)器(qi)(qi)(qi)(qi)械風險(xian)(xian)(xian)(xian)(xian)會(hui)商工(gong)作規范(fan)》要(yao)求，打(da)破部(bu)(bu)門壁(bi)壘，將(jiang)參會(hui)范(fan)圍由局(ju)(ju)相關單位(wei)(wei)擴展至二級以上醫(yi)療(liao)(liao)機構器(qi)(qi)(qi)(qi)械科負(fu)責(ze)(ze)人(ren)、重點經營企(qi)業質量負(fu)責(ze)(ze)人(ren)和行(xing)(xing)政審批部(bu)(bu)門等(deng)，并邀(yao)請山東省局(ju)(ju)器(qi)(qi)(qi)(qi)械處(chu)(chu)領導通過網絡視頻的(de)方式(shi)，全程觀摩指導風險(xian)(xian)(xian)(xian)(xian)會(hui)商會(hui)議，對(dui)(dui)省局(ju)(ju)領導反饋的(de)意(yi)見(jian)，及(ji)時(shi)采取整改措施(shi)，使風險(xian)(xian)(xian)(xian)(xian)會(hui)商的(de)實(shi)用性(xing)、有(you)效(xiao)性(xing)進一(yi)(yi)步增強。同時(shi)，棗莊市場監(jian)管局(ju)(ju)深(shen)挖行(xing)(xing)業風險(xian)(xian)(xian)(xian)(xian)隱(yin)患，重點對(dui)(dui)醫(yi)療(liao)(liao)器(qi)(qi)(qi)(qi)械風險(xian)(xian)(xian)(xian)(xian)評估、監(jian)測、評價(jia)、處(chu)(chu)置(zhi)和醫(yi)療(liao)(liao)器(qi)(qi)(qi)(qi)械審批、經營、使用過程中發現(xian)的(de)風險(xian)(xian)(xian)(xian)(xian)隱(yin)患進行(xing)(xing)全方位(wei)(wei)的(de)深(shen)入交流探(tan)討，溯(su)源分析成(cheng)因，共商解決方案(an)，從更深(shen)層次保(bao)障醫(yi)療(liao)(liao)器(qi)(qi)(qi)(qi)械產品(pin)安(an)全。同時(shi)，還對(dui)(dui)會(hui)商梳理的(de)問題(ti)及(ji)上級指導意(yi)見(jian)實(shi)施(shi)“清(qing)單式(shi)銷(xiao)號管理”，確保(bao)風險(xian)(xian)(xian)(xian)(xian)信(xin)號調查處(chu)(chu)置(zhi)到位(wei)(wei)。對(dui)(dui)普遍性(xing)問題(ti)深(shen)挖源頭，發現(xian)一(yi)(yi)條，整改一(yi)(yi)條；對(dui)(dui)問題(ti)企(qi)業堅持檢查一(yi)(yi)家、規范(fan)一(yi)(yi)家、提(ti)升(sheng)一(yi)(yi)家，形成(cheng)“研(yan)判-處(chu)(chu)置(zhi)-銷(xiao)號-提(ti)升(sheng)”的(de)閉環管理模式(shi)，實(shi)現(xian)風險(xian)(xian)(xian)(xian)(xian)隱(yin)患動態清(qing)零。

　　強化(hua)監(jian)管(guan)能力(li)(li)立(li)體(ti)支(zhi)撐，鍛造風(feng)(feng)險(xian)(xian)防控“硬實(shi)力(li)(li)”。該局注重加強全市醫療(liao)器械監(jian)管(guan)人員培(pei)訓，著力(li)(li)解(jie)決監(jian)管(guan)人員本(ben)領(ling)恐慌、能力(li)(li)不足等問(wen)題，著力(li)(li)提(ti)高(gao)其在(zai)監(jian)督檢查(cha)中發(fa)現(xian)、排查(cha)、解(jie)決安(an)全隱(yin)患的核心(xin)能力(li)(li)；同時，堅持(chi)引導行業規范自(zi)律。面(mian)向企(qi)(qi)業、醫療(liao)機(ji)構(gou)質量負(fu)責人及不良事件(jian)上(shang)報人員開展(zhan)精準(zhun)培(pei)訓，重點(dian)解(jie)讀(du)企(qi)(qi)業主體(ti)責任規定、經營(ying)質量管(guan)理規范、說(shuo)明書標簽規定等法規及不良事件(jian)監(jian)測要(yao)求，推動監(jian)管(guan)聯動、企(qi)(qi)業自(zi)律、公眾參與(yu)相結合(he)的多(duo)元(yuan)化(hua)綜合(he)監(jian)管(guan)體(ti)系，壓實(shi)企(qi)(qi)業質量安(an)全主體(ti)責任與(yu)風(feng)(feng)險(xian)(xian)管(guan)理第(di)一責任。

　　構建多元協同(tong)共(gong)(gong)(gong)治(zhi)格局(ju)，織密風險防(fang)控“防(fang)護(hu)(hu)網”。今年(nian)以來，該(gai)局(ju)先后(hou)出(chu)臺(tai)了《棗莊(zhuang)市(shi)加強醫療監督(du)跨(kua)(kua)部門(men)執法聯動(dong)工(gong)作(zuo)(zuo)(zuo)的(de)(de)實施方案(an)》《棗莊(zhuang)市(shi)藥品經營(ying)使用(yong)部門(men)綜合監管(guan)實施方案(an)》等(deng)一系列文件，建立健全聯席會議、行刑(xing)銜接(jie)、案(an)件研討、信息共(gong)(gong)(gong)享、交(jiao)流合作(zuo)(zuo)(zuo)齊抓共(gong)(gong)(gong)管(guan)的(de)(de)工(gong)作(zuo)(zuo)(zuo)機制，形成跨(kua)(kua)部門(men)信息互(hu)通(tong)共(gong)(gong)(gong)享、檢查通(tong)力協作(zuo)(zuo)(zuo)工(gong)作(zuo)(zuo)(zuo)格局(ju)。同(tong)時(shi)，為(wei)營(ying)造(zao)社(she)會共(gong)(gong)(gong)治(zhi)氛圍，依托電視、報(bao)紙、網絡、微(wei)信等(deng)平(ping)臺(tai)，大(da)力開(kai)展(zhan)安(an)全用(yong)藥用(yong)械用(yong)妝活動(dong)，深(shen)入(ru)開(kai)展(zhan)科普宣(xuan)傳(chuan)“五(wu)進”（進商場、校園、社(she)區、企(qi)業、農村）活動(dong)，共(gong)(gong)(gong)累計(ji)開(kai)展(zhan)活動(dong) 9余場次，發放宣(xuan)傳(chuan)資料 1000 余份，大(da)大(da)提高了公眾對(dui)醫療器(qi)械的(de)(de)安(an)全防(fang)護(hu)(hu)意識和社(she)會監督(du)效能，鞏固了社(she)會共(gong)(gong)(gong)治(zhi)格局(ju)。

本文由廣州佳譽醫療器械有限公司/佛山浩揚醫療器械有限公司聯合編輯