1、Good Refurbishment Practicesfor Medical Devices医疗器械优良再制造规范,Andrew NorthupDirector, Global AffairsMITA美国医学影像与技术联盟全球事务主任,Introduction to MITAMITA介绍,Section 1,MITA, the Medical Imaging & Technology Alliance a division of NEMA, founded in 1926医学影像与技术联盟-北美电器制造商协会的一个分会，成立于1962年,MITA is the leading organiz
2、ation and collective voice of medical imaging equipment, radiation therapy and radiopharmaceutical manufacturers, innovators and product developers. 作为领导组织，代表医学影像设备、放射治疗及放射药物制造商、研究开发者共同的声音。It represents companies whose sales comprise more than 90 percent of the global market for medical imaging tech
3、nology. 所代表的企业占医学影像技术90%以上的全球市场。These technologies include: 包括：medical X-Ray equipment 医学x-射线设备 computed tomography (CT) scanners CT扫描Ultrasound 医用超声诊断设备nuclear imaging 核医学成像设备Radiopharmaceuticals 放射诊断药物radiation therapy equipment 放射治疗设备magnetic resonance imaging (MRI), 核磁共振imaging information syste
4、ms 影像信息系统,Refurbished equipment has many benefits/翻新再造有许多利好,Upgraded/升级:Image quality/影像质量Functionalities/功能Access to care/可用性Safety/安全 For less than the cost of new equipment/较新设备价格低Good for hospitals/利于医院Good for patients/利于病患Good for health systems/利于医保系统Good for the environment and circular econ
5、omy/利于环保和循环经济,however, sale of refurbished equipment is banned or tightly restricted/然而，翻新再造设备禁止进口或严限销售使用,Many countries ban or restrict sale of refurbished equipment, or the practice of refurbishing equipmentChina is one of 5 countries that bans import and sale of refurbished equipmentRestrictions
6、have been put in place to protect the public from unsafe equipmentUnintended consequence: patients are denied access to safe, high-quality equipment as wellApproximately 3.4 billion people live in countries where refurbished equipment is not an option, in a time of limited health system budgets,Obje
7、ctive: safe and high-quality imaging equipment目的：安全而高质量影像设备,MITA leads efforts on creating standards for Good Refurbishment Practices for Medical Electrical EquipmentMITA is an accredited standards developing organization (SDO)Standards widely used for regulation of medical devicesInternational, nat
8、ional, and industry standardsRegulators reference standards in their jurisdictions regulationsISO 13485 Quality Management Systems IEC 60601 Safety and effectiveness of medical devicesISO 14971 Risk assessment,Good Refurbishment Practices (GRP)优良再造规范,MITAs GRP Standard mandates the minimum steps tha
9、t must be taken to ensure equipment is refurbished to guarantee safety and effectiveness /MITA的翻新再造标准规定了最少步骤，保障翻新再造设备实现其安全有效,Step 1/步骤1,Andrew,Selection,De-installation,Refurbishment,Installation,Warranty,Age / condition/年限和状态 Service history/使用历史 Performance/性能表现 Upgradeability of software and hard
10、ware status /软硬件可升级否,Step 2/步骤2,Andrew,Installation,Warranty,Inspection/检测 Shipping in original packing material/ 原包装材料包装运输,De-installation,Selection,Remanufacture,Step 3,Selection,Installation,Warranty,Cleaning, disinfection and painting (partial or full painting)清洁、消毒和喷漆 (部分或全部喷漆)Replacement of wo
11、rn parts更换磨损部件Checking of components and subsystems检查组件和子系统Installation of latest applicable software updates安装最新的软件更新Replacement of existing tube / coils etc. based on customer orders根据客户订单替换现有的管/线圈等Complete system check to manufacturers specification根据制造商的要求进行完整的系统检查Application of a Quality seal加贴
12、质量合格封条或标签,De-installation,Refurbishment,Step 4,Andrew,Warranty,Transportation and installation by qualified service providers 使用合格的服务提供商运输和安装 Start-up and system performance check 启动和系统性能检查 Optional application training 使用培训可供选择,Installation,Selection,De-installation,Refurbishment,Step 5,Andrew,Sele
13、ction,Warranty typically equivalent to a new system 提供与一个全新的系统一样的质量担保 Spare parts availability for a minimum of 5 years 备件可至少5年中可以提供,Warranty,De-installation,Installation,Refurbishment,Benefits of regulating and standardizing refurbishment规范翻新再造的好处,Helps small and medium healthcare institutions prov
14、ide advanced treatment at lower rates for patients帮助中小医院提供先进但低价治疗手段Reduced healthcare costs and improved patient health降低医保费用，改善健康 Accelerates the upgrading of the infrastructure of medical institutions to more modern technologies at lower costs加速提升医疗机构设备现代化水平 Inhibits the spread of unregulated pre-
15、owned medical equipment and reduces safety and market risks; medical staff from small hospitals may be under-trained to distinguish good remanufactured devices from inferior pre-owned devices 禁止二手设备非发转售，降低安全风险，小医院无法鉴别二手设备是否符合优良再造规范。,Regulatory changes are needed需要法规变革,China has committed to expandin
16、g access to high-quality healthcare to all citizens 中国承诺向国民提供高质医疗服务National, provincial, and local authorities must deliver healthcare while being mindful of budgets各级政府需提供医保但需考虑费用预算MITA encourages Chinese regulators and standards agencies to review their policies on refurbished equipment MITA鼓励立法者和
17、标准机构重新考虑其再造政策China, Brazil, and other rapidly developing countries see value in safe and high-quality refurbished medical equipment中国、巴西及其他快速发展中国家认识到翻新再造医疗设备安全和高质量的价值MITA offers experience and assistance to Chinese regulators and standards bodies。 MITA愿意给中国政府和标准机构提供经验和帮助。,With your help:需要您的帮助：,Patients benefit 为了患者的利益Hospitals benefit 为了医院的利益National, provincial, and local health systems benefit 国家和地方医保系统的利益The environment benefits环境保护利益The circular economy benefits循环经济利益With regulation and standardization of Good Refurbishment Practices, everyone benefits!有了优良再造规范标准，大家均收益,
