Good Refurbishment Practices for Medical Devices 医疗器械优良再制造规范 Andrew

Good Refurbishment Practices for Medical Devices 医疗器械优良再制造规范 Andrew Northup Director, Global Affairs MITA 美国医学影像与技术联盟全球事务主任

Section 1 Introduction to MITA MITA 介绍

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 organization 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 technology. 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 economy/ 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 equipment China is one of 5 countries that bans import and sale of refurbished equipment Restrictions have been put in place to protect the public from unsafe equipment Unintended consequence: patients are denied access to safe, high-quality equipment as well Approximately 3.4 billion people live in countries where refurbished equipment is not an option, in a time of limited health system budgets

Objective: 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 Equipment MITA is an accredited standards developing organization (SDO) Standards widely used for regulation of medical devices International, national, and industry standards Regulators reference standards in their jurisdictions’ regulations ISO 13485 – Quality Management Systems IEC 60601 – Safety and effectiveness of medical devices ISO 14971 – Risk assessment

Good Refurbishment Practices (GRP) 优良再造规范 MITA’s GRP Standard mandates 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 Installation Warranty

Step 1/ 步骤 1 Andrew Selection De-installation Refurbishment Installation Age / condition/ 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 Warranty

Step 2/ 步骤 2 Andrew Selection De-installation Remanufacture Installation Warranty Inspection/ 检测 Shipping in original packing material/ 原包装 材料包装运输

Step 3 Selection De-installation Refurbishment 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 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 manufacturer’s 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

Step 4 Andrew Selection De-installation Refurbishment Installation 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 Warranty

Step 5 Andrew Selection De-installation Refurbishment Installation Warranty 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

Benefits of regulating and standardizing refurbishment 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 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-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 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 standards 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 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