1、Good Refurbishment Practicesfor Medical Devices医疗器械优良再制造规范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 org
2、anization 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 tec
3、hnology.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 systems 影像
4、信息系统Refurbished equipment has many benefits/翻新再造有许多利好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 ec
5、onomy/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 equi
6、pmentRestrictions 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 syst
7、em budgetsObjective:safe and high-quality imaging equipment目的：安全而高质量影像设备目的：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 d
8、evicesInternational,national,and industry standardsRegulators reference standards in their jurisdictions regulationsISO 13485 Quality Management Systems IEC 60601 Safety and effectiveness of medical devicesISO 14971 Risk assessmentGood Refurbishment Practices(GRP)优良再造规范优良再造规范 MITAs GRP Standard mand
9、ates the minimum steps that 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Selection De-installation Refurbishment InstallationWarrantyStep 1/步骤步骤1AndrewSelection De-installation Refurbishment InstallationWarranty Age/conditio
10、n/年限和状态 Service history/使用历史 Performance/性能表现 Upgradeability of software and hardware status/软硬件可升级否 Step 2/步骤步骤2Andrew InstallationWarranty Inspection/检测 Shipping in original packing material/原包装材料包装运输 De-installationSelection RemanufactureStep 3Selection InstallationWarranty Cleaning,disinfection
11、and painting(partial or full painting)清洁、消毒和喷漆(部分或全部喷漆)Replacement of worn 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 ma
12、nufacturers specification根据制造商的要求进行完整的系统检查 Application of a Quality seal加贴质量合格封条或标签 De-installation RefurbishmentStep 4AndrewWarranty 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
13、InstallationSelection De-installationRefurbishmentStep 5 AndrewSelection 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 RefurbishmentBenefits of regulating and standardizing refurbish
14、ment规范翻新再造的好处规范翻新再造的好处Helps small and medium healthcare institutions provide 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 technolog
15、ies at lower costs加速提升医疗机构设备现代化水平 Inhibits the spread of unregulated pre-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
16、造规范。Regulatory changes are needed需要法规变革需要法规变革China has committed to expanding 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 stand
17、ards agencies to review their policies on refurbished equipment MITA鼓励立法者和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 an
18、d standards bodies。MITA愿意给中国政府和标准机构提供经验和帮助。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：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，大家均收益有了优良再造规范标准，大家均收益
