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.ppt

Good Refurbishment Practicesfor 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 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 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 Electrica