前 言 医用耗材作为医疗器械的重要组成部分，技术发展十分迅速。大量新型医用耗材投入临床使用，在手术、护理、诊疗各个方面已经成为不可缺少的器械，尤其在植入、介入诊疗等领域高值耗材广泛使用，促进了医疗技术的发展和医疗质量的提高。同时，医用耗材使用管理问题也引起广泛的关注。目前，医院在医用耗材使用管理主要集中在经济管理方面，包括成本控制、绩效管理、物流供应链管理及遏制医用耗材费用的不合理增长等方面。在临床使用中“患者安全”相关的使用安全风险的观念相对薄弱，是管理的“短板”。如何规范医用耗材的使用安全风险管理成为医用耗材管理的重要议题。2019年国家卫生健康委员会发布的《医疗机构医用耗材管理办法（试行）》明确要求对医用耗材的遴选、采购、验收、存储、发放、临床使用、监测、评价等工作进行全流程管理。在临床使用环节，为加强医疗器械临床使用管理，保障医疗器械临床使用安全、有效，2021年1月国家卫生健康委员会发布《医疗器械临床使用管理办法》，2021年3月国务院发布修订的《医疗器械监督管理办法》2021版（国务院令第739号），在2021年6月1日施行。这些法律、法规明确了医用耗材使用安全管理的职责与内容，成为医用耗材使用安全风险管理的准则。 医用耗材管理与医疗设备管理方式、方法明显不同。不同类别耗材的管理也不一样，在临床使用管理方面具有极强的专业性，已经成为医院医疗质量安全管理的新内容。近年来，国内外医院发生与医用耗材应用相关的不良事件、使用安全事件及引发的医疗纠纷、事故也呈明显增加的趋势。医用耗材使用安全问题已经成为医疗安全重要隐患之一。 医用耗材使用安全风险管理方面缺少经验和技术，这些问题已经引起各方面重视和共识。为了让医院医用耗材管理人员、医护人员、临床工程技术人员系统地了解医用耗材临床使用安全风险的因素以及医用耗材使用安全风险管理的理论和模式；掌握不同耗材使用安全风险管理特点、方法和技术，以及如何应用信息化、智能化管理方法实现医用耗材安全风险管理，我们根据广大医院医用耗材管理人员、医护人员和临床医学工程人员的实际需求，结合国内外医用耗材管理方面的最新进展、管理经验，编写了《医用耗材使用安全风险管理》一书，希望能够为各级医院医用耗材管理人员、医护人员和临床工程人员开展 VIII 医用耗材使用安全风险管理 医用耗材安全管理工作，达到保障患者安全，促进医疗质量提高的目标。 本书在编写过程中得到河南驼人控股集团、史赛克（北京）医疗、深圳迈瑞；碧迪医 疗；四川素问天码等单位提供资料和支持，特此致谢。 马丽平 谢松城 2021 年5 月 Clinical care and diagnosis procedure continuously improve with the advancement of medical devices and supplies. A large number of medical supplies are being used clinically, and have become an indispensable part of patient care particularly in surgery, nursing, diagnosis, and treatment. High-value supplies are widely used in the field of implantation, and interventional diagnosis and treatment. The enormous reliant of medical supplies in patient care have prompted many developments in technological advancement for such products, so-much-so the development and availability trajectory is comparable to medical devices, hence it warrants greater effort and attention in managing it’s associated safety and risk. Presently, it is noted that hospitals are focusing their management of medical supplies only in areas of cost (product, transaction, logistics), economic benefits such as increase productivity or profitability, and managing unreasonable yearly increase of its cost. The ideology and believes towards managing medical supplies require a new management culture where managing associated safety and risk should be given the priority over cost and commercial benefit. The Administrative Measures for Management of Medical Supplies in Medical Institutions (Trial Version) issued by the National Health Commission in 2019 clearly requires the full-process management of the selection, procurement, acceptance, storage, distribution, clinical use, monitoring and evaluation of medical supplies. In January 2021, The National Health Commission issued the Administrative Measures in the Clinical Use of Medical Device, requiring hospitals to strengthen their management of medical supplies for clinical use. In March 2021, the State Council issued the revised Regulations for the Supervision and Administration of Medical Device (State Council Decree 739, 2021)，which will be implemented on June 1, 2021. These laws and regulations clarify the responsibilities and contents on safety management of medical supplies, and become the guidelines for the safe use and risk management of medical supplies and consumables. The management of medical supplies and consumables is obviously different from the management of medical equipment. The management of different types of consumables is also Preface X 医用耗材使用安全风险管理 different. Hospitals are currently challenging with the lack of professional expertise to manage safety and risk associated to medical supplies, which is an important component. In recent years, adverse events and safety incidents of medical devices have caused many medical disputes and litigation, in which the number of events related to the application of medical supplies in hospitals both domestically and internationally indicates a significant increase in trend. There is seemingly a lack of experience, knowledge, and tools to manage medical supplies safety and risk, and such requirements are gaining greater attention with the prevalence of new guidelines and regulations. A concerted effort was initiated to produce a book titled “Application of Safety and Risk Management for Medical Supplies”. The book describes findings from our research on domestic and international best practices, various factors and requirements of medical supply management personnel, medical staff and clinical engineers of hospitals in relation to managing medical supply’s safety and risk management. We hope this book provide insight, and support medical supply management personnel, medical staff and clinical engineers in managing safety risk associated to medical supplies and consumables, enhancing patient safety outcomes, and promote the improvement of medical care standard and quality. The book provides a systematically structured understanding on the clinical safety and risk associated, and theories and models of safety and risk management in the use of medical supplies. Stakeholders’adoption of principles, guidelines and methods, and adopting technological tools and management system would improve the overall management of medical supplies safety and risk. Thanks to Henan Tuoren Holding Group, Stryker (Beijing) Medical Equipment Co., Ltd., Shenzhen Mindray, BD Medical, Sichuan Suwen Tianma, etc for providing informative materials and support in the compilation of this book. Ma liping Xie Songcheng May, 2021

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