摘要
磁共振在中国医院使用已经很普遍，一些大型医院的磁共振使用已经超过二十
年，开始寻求更新换代，很多中小医院也以配置磁共振设备为医院竞争力的核心代
表。而磁共振价格昂贵，生产厂商也日益增多，竞争日趋激烈。磁共振生产厂商开
始将目光瞄准二手磁共振的再制造业务。然而不同于传统行业的回收再制造，磁共
振属于医疗设备，医疗设备从研发、生产、销售、售后全过程都受到药监局严格的
法律法规监管。药监局的多项法规要求医疗设备生产商对产品的全流程进行风险管
控。目前厂商对磁共振的风险管理主要集中在新产品设计开发阶段，磁共振回收再
制造过程由于有二手部件，可能引入的风险更高，厂商再制造产品投入市场是否对
用户造成新的风险，这一系列风险控制问题都还缺乏一套规范流程和系统的监督管
理。
本文首先对再制造和再制造医疗设备风险管理的相关理论和文献进行综述，并
介绍了医疗设备风险管理主要理论方法。然后以磁共振厂商M公司为研究对象，
对公司再制造的风险管理进行了现状分析，指出回收再制造过程风险识别、风险评
估和投入市场后的信息收集都存在缺乏系统管控，或没有有效手段来实施的问题。
文章采用问题清单法，FMEA，鱼骨图分析法对磁共振再制造的风险进行识别分析，
使用定量、半定量方法计算伤害发生的可能性，并用风险矩阵进行风险估计和评估，
同时给出了风险控制的优先策略，以及进行剩余风险评估后给出完整的风险控制表。
最后针对产品投入市场后的后市场数据进行收集反馈的闭环风险管理系统。可以帮
助医疗器械生产企业建立再制造流程的风险控制，从而降低风险和伤害的发生概率，
保障医务人员，患者和操作者的安全。文章最后提出一些未尽事宜，为公司后续改
善指方向。
关键词：磁共振，再制造，风险管理，FMEA，风险矩阵
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ABSTRACT
Using of Magnetic Resonance Imaging (MRI) in China hospital is very common.
Some large hospitals have been using MRI for over 20 years and are looking for new
models. At the meantime, many smallor medium hospitals consider MRI as great
competitiveness. While the price of MRI is prettyexpensive, at the same time the
manufactures of MRI are increasing quickly, so is the competition. MRI manufactures start
to look at thebusiness of remanufacturing. However, different withthe traditional
industries, remanufacturing MRI which belongs to medical device, is strictly supervised by
regulatory from design, manufacturing, sales, and service. Regulationspublished by
regulatory request medical device manufacture perform risk management in the whole life
cycle of medical device. Currently the risk management in MRI manufacture only focus
on design phase. Used parts are recycled and reused for MRI's remanufacturing, which
potential risk could be higher. And not sure if some new risk is delivered to market along
with the remanufacturing products, the overall risk control still lacks standard process and
systematic management.
This thesissummarizes thetheory and literatureof remanufacturing andrisk
management in remanufacturing medical device. It also introduces the methodology of risk
management in medical device. Analysis of current risk management status in company M
which is research subject is performed. The issues are identified during remanufacturing.
There is no effective method or systemic control during risk identification, evaluation,
information collection and feedback in post market. Question list, FMEA and fish bones
are used for risk identification and analysis for MRI remanufacturing. Quantitative, semi-
quantitative examinations measure the probability of harm. Risk acceptability matrix is
used for risk estimation and evaluation, and finally determined if risk is acceptable or not.
Meanwhile the priorities of risk control methods are provided, as well as residual risk's
evaluation and entire cause mitigation table. Finally, the data collection and feedback of
remanufacture product in post market, serve as part of the closed loop of risk management.
They can be used to help medical device manufactures set up risk management control
process especially in remanufacturing activities, also can help reduce the probability of risk
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and harm, protect the safety of doctors, patients, and operators. In the end, unaccomplished
matter is listed, can be used as the continuous improvement in the future.
KEY WORDS: MRI, Remanufacturing, Risk Management, FMEA, Risk Acceptability
Matrix
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