面对突如其来的新冠肺炎疫情,湖北省各级政府、全体民众和企业单位在习近平总书记提出的“坚定信心、同舟共济、科学防治、精准施策”的战略方针指引下,团结一心、努力奋斗,实现了省内医疗防护物资供应由严重短缺到紧平衡、由紧平衡到有结余、由有结余到可对外出口的“三个阶段的跨越”。湖北省药监局通过实施应急审批与注册、出口产品对标评价和快速检验等手段,快速提高了湖北省的医用防护服等防疫物资供应保障能力。相关企业在政府引领下积极扩充产能,全省实现医用防护服月产量由7。5万套增至630万套,医用防护口罩月产量由108万只增至1260万只,医用外科口罩月产量由1140万只增至1。38亿只,为打赢抗疫攻坚战提供了充足的“弹药”。本文从保障供应、严格监管、重整飞跃这三个方面探讨医疗器械应急监管模式如何在重大公共卫生突发事件中实现“保供、保质、保安全”。
<<Hubei province was the place where the COVID-19 epidemic outbroke,and it became the hardest hit area of COVID-19 at the early stage of fighting against coronavirus. In the meantime,there was a severe imbalance between medical supply and demand,which affected the society to prevent and control epidemic effectively. Facing the sudden difficulties,President Xi Jinping proposed strategic policy that “firm confidence,tight together,scientific prevention and precise implementation”. Meanwhile,by the guidance of this policy,provincial governments at all levels,all of relevant enterprises and people in the society have put their endeavor into taking actions positively and striving assiduously with unity. Eventually,the predicament of shortage and imbalance between supply and demand on medical material by the Three-Stage of Leap. It has been changed from severe shortage to tight balance at the first stage. Then supply and demand relation has been moved from tight balance to have surplus afterwards. And finally it makes that relevant local enterprises are capable to export medical supply at the third stage. Drug Administration of Hubei province has played an important role in improving and maintaining the ability of supply medical materials. It implied several efficient actions,such as urgent approval and registration procedure,benchmarking evaluation system of import & export products and fast checking procedures,etc. Relative enterprises actively expanded production capability by the guidance of provincial government at all levels;it achieved the goal of personal protection gown daily production capability from 2480 to 210000. Also the medical mask daily productivity was increased sharply in a short term from 36000 to 420000. Especially the output of medical surgical mask daily capability reached to 4600000 from 380000. These achieved goals showed that determinations at all levels of provincial governments and enterprises with unity to maintain sufficient medical supply,which can support the society to fight against epidemic of Covid-19. This essay would discuss the new operational model about emergency supervision of medical supply and demand from three parts:how to guarantee supply,strict supervision and optimization. We will further illustrate that how this new model to achieve “guarantee,quality and security” on relation between supply and demand in public health emergency.
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