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Measures of the National Health Commission and the State Administration of Traditional Chinese Medicine for the Management of Medical Supplies in Medical Institutions (For Trial Implementation) [Not Yet Effective]
国家卫生健康委、国家中医药局关于印发医疗机构医用耗材管理办法(试行)的通知 [尚未生效]
【法宝引证码】

Measures of the National Health Commission and the State Administration of Traditional Chinese Medicine for the Management of Medical Supplies in Medical Institutions (For Trial Implementation) 

国家卫生健康委、国家中医药局关于印发医疗机构医用耗材管理办法(试行)的通知

(No. 43 [2019] of the National Health Commission) (国卫医发〔2019〕43号)

The health commissions and traditional Chinese medicine administrations of all provinces, autonomous regions, municipalities directly under the Central Government, and Xinjiang Production and Construction Corps: 各省、自治区、直辖市及新疆生产建设兵团卫生健康委、中医药管理局:
For purposes of regulating the management of medical supplies in medical institutions, promoting the use of medical supplies in a reasonable and effective way, ensuring the quality and safety of medical services, the National Health Commission (“NHC”) and the State Administration of Traditional Chinese Medicine (“SATCM”) have organized the formulation of the Measures for the Management of Medical Supplies in Medical Institutions (For Trial Implementation), which can be downloaded from the Medical Administration column of the NHC's portal website. The Measures are hereby issued to you for your implementation. 为规范医疗机构医用耗材管理,促进医用耗材合理规范使用,保障医疗质量与安全,国家卫生健康委、国家中医药局组织制定了《医疗机构医用耗材管理办法(试行)》(可在国家卫生健康委网站医政医管栏目下载)。现印发给你们,请遵照执行。
Annex: Measures for the Management of Medical Supplies in Medical Institutions (For Trial Implementation) 附件:医疗机构医用耗材管理办法(试行)
National Health Commission 国家卫生健康委
State Administration of Traditional Chinese Medicine 国家中医药局
June 6, 2019 2019年6月6日
Measures for the Management of Medical Supplies in Medical Institutions (For Trial Implementation) 医疗机构医用耗材管理办法(试行)
Chapter I General provisions 

第一章 总则

 
Article 1 The Measures are developed to strengthen the management of medical supplies in medical institutions, promote the use of medical devices and equipment in a reasonable manner, and protect the public's health in accordance with the Law on Medical Practitioners, the Regulation on the Administration of Medical Institutions, the Regulation on the Supervision and Administration of Medical Devices, and other laws and regulations.   第一条 为加强医疗机构医用耗材管理,促进医用耗材合理使用,保障公众身体健康,根据《执业医师法》《医疗机构管理条例》《医疗器械监督管理条例》等有关法律法规规定,制定本办法。
Article 2 For the purpose of the Measures, “medical supplies” mean the consumable medical devices (including disposable and reusable medical supplies), which can be used for a limited number of times upon the approval of the drug administration departments.   第二条 本办法所称医用耗材,是指经药品监督管理部门批准的使用次数有限的消耗性医疗器械,包括一次性及可重复使用医用耗材。
For the purpose of the Measures, “management of medical supplies” means the effective organization, implementation and management of the complete process concerning medical supplies in medical institutions (including procurement, storage, use, tracing, monitoring, evaluation, and supervision) centered on patients and based on medical science, so as to promote the special technical services in using medical supplies for clinical purposes in a scientific and reasonable way as well as the management of medical supplies; and it is an essential part of medical service management. 本办法所称医用耗材管理,是指医疗机构以病人为中心,以医学科学为基础,对医用耗材的采购、储存、使用、追溯、监测、评价、监督等全过程进行有效组织实施与管理,以促进临床科学、合理使用医用耗材的专业技术服务和相关的医用耗材管理工作,是医疗管理工作的重要组成部分。
Article 3 The NHC and the SATCM shall be responsible for supervising and administering the management of medical supplies in medical institutions across China.   第三条 国家卫生健康委、国家中医药局负责全国医疗机构医用耗材管理工作的监督管理。
The local health administrative departments and the competent authorities of traditional Chinese medicine at the county level or above shall be responsible for supervising and administering the management of medical supplies in medical institutions within their respective administrative areas. 县级以上地方卫生健康行政部门、中医药主管部门负责本行政区域内医疗机构医用耗材管理工作的监督管理。
Article 4 The Measures shall apply to the management of medical supplies in Grade-II or above hospitals, and may apply, mutatis mutandis, to other medical institutions. In particular, the Measures may be referred to by non-public medical institutions in the selection and purchase of their medical supplies.   第四条 本办法适用于二级以上医院医用耗材管理,其他医疗机构可参照执行。其中,非公立医疗机构的医用耗材遴选、采购工作可参照本办法进行。
Article 5 A medical institution shall designate a department as the medical supplies management department responsible for the regular management of the selection, purchase, examination and acceptance, storage, and distribution of medical supplies; and designate a department as the medical service management department responsible for the regular management of special technical services (including clinical use, monitoring, and evaluation) related to medical supplies.   第五条 医疗机构应当指定具体部门作为医用耗材管理部门,负责医用耗材的遴选、采购、验收、存储、发放等日常管理工作;指定医务管理部门,负责医用耗材的临床使用、监测、评价等专业技术服务日常管理工作。
Article 6 The personnel of medical institutions who engage in the management of medical supplies shall have the professional qualifications or technical titles corresponding to the management work, or receive the specific technical trainings.   第六条 医疗机构从事医用耗材管理相关工作的人员,应当具备与管理工作相适应的专业学历、技术职称或者经过相关技术培训。
The personnel of medical institutions who directly contact medical supplies shall take a physical check every year. Victims of epidemic diseases, suspects of such diseases, and pathogen carriers shall, before being cured or cleared of suspicion, be barred from the work that requires them to directly contact medical supplies. 医疗机构直接接触医用耗材的人员,应当每年进行健康检查。传染病病人、病原携带者和疑似传染病病人,在治愈前或者在排除传染病嫌疑前,不得从事直接接触医用耗材的工作。
Chapter II Administration of medical institutions 

第二章 机构管理

 
Article 7 Grade-II or above hospitals shall each set up a medical supplies management commission; and other medical institutions shall set up a medical supplies management organization. In a village health office (center or station), outpatient department, clinic, and dispensary that may not require a medical supplies management organization, the person in charge shall designate personnel to manage its medical supplies.   第七条 二级以上医院应当设立医用耗材管理委员会;其他医疗机构应当成立医用耗材管理组织。村卫生室(所、站)、门诊部、诊所、医务室等其他医疗机构可不设医用耗材管理组织,由机构负责人指定人员负责医用耗材管理工作。
The medical supplies management commission shall be composed of the personnel with professional technical qualifications from such divisions as clinics, pharmacy, medical engineering, nursing, and medical technology, as well as the responsible persons of such departments as hospital infection management, medical supplies management, medical service management, financial management, medical insurance management, information management, discipline inspection and supervision, and auditing. 医用耗材管理委员会由具有高级技术职务任职资格的相关临床科室、药学、医学工程、护理、医技科室人员以及医院感染管理、医用耗材管理、医务管理、财务管理、医保管理、信息管理、纪检监察、审计等部门负责人组成。
The responsible person of a medical institution shall serve as the director of the medical supplies management commission; and the responsible persons of the medical supplies management department and the medical service management department shall serve as the deputy directors of the medical supplies management commission. 医疗机构负责人任医用耗材管理委员会主任委员,医用耗材管理部门和医务管理部门负责人任医用耗材管理委员会副主任委员。
Article 8 The daily work of the medical supplies management commission shall be undertaken by the designated medical supplies management department and the medical service management department based on the division of functions.   第八条 医用耗材管理委员会的日常工作由指定的医用耗材管理部门和医务管理部门分工负责。
Article 9 The main functions of the medical supplies management commission include:   第九条 医用耗材管理委员会的主要职责:
1. implementing the laws, regulations, and rules related to health care and the management of medical supplies, reviewing the development of rules and systems regarding the management of medical supplies in a medical institution, and supervising the implementation of rules and systems; (一)贯彻执行医疗卫生及医用耗材管理等有关法律、法规、规章,审核制定本机构医用耗材管理工作规章制度,并监督实施;
2. establishing a system of selecting medical supplies, reviewing the applications submitted by the divisions or departments of a medical institution for purchasing medical supplies, or adjusting the types of medical supplies or suppliers, and developing a catalogue of medical supplies in the medical institution (hereinafter referred to as the “Catalogue of Medical Supplies”); (二)建立医用耗材遴选制度,审核本机构科室或部门提出的新购入医用耗材、调整医用耗材品种或者供应企业等申请,制订本机构的医用耗材供应目录(以下简称供应目录);
3. promoting the development and implementation of guiding principles for the clinical use of medical supplies, monitoring and assessing the use of medical supplies in a medical institution, proposing the measures for intervention and improvement, and guiding the reasonable use of medical supplies for clinical purposes; (三)推动医用耗材临床应用指导原则的制订与实施,监测、评估本机构医用耗材使用情况,提出干预和改进措施,指导临床合理使用医用耗材;
4. analyzing and assessing the adverse reactions in using medical supplies, and the quality and safety incidents of medical supplies, and providing consultancy and guidance; (四)分析、评估医用耗材使用的不良反应、医用耗材质量安全事件,并提供咨询与指导;
5. supervising and guiding the clinical use and standard management of medical supplies; (五)监督、指导医用耗材的临床使用与规范化管理;
6. monitoring the use of medical supplies in clinical practices, and monitoring the key medical supplies; (六)负责对医用耗材的临床使用进行监测,对重点医用耗材进行监控;
7. educating and training medical staff on laws, regulations, rules and systems regarding the management of medical supplies as well as the knowledge of how to properly use medical supplies, and spreading the knowledge to patients; and (七)对医务人员进行有关医用耗材管理法律法规、规章制度和合理使用医用耗材知识教育培训,向患者宣传合理使用医用耗材知识;
8. other important matters related to the management of medical supplies. (八)与医用耗材管理相关的其他重要事项。
Article 10 A medical institution shall provide its medical supplies management department and medical service management department with necessary sites, devices and facilities, and personnel.   第十条 医疗机构应当为医用耗材管理部门、医务管理部门配备和提供必要的场所、设备设施和人员。
Article 11 A medical institution shall establish and improve the work system, operation procedures and performance records regarding the management of medical supplies, and organize the implementation accordingly.   第十一条 医疗机构应当建立健全医用耗材管理相应的工作制度、操作规程和工作记录,并组织实施。
Chapter III Selection and procurement 

第三章 遴选与采购

 
Article 12 A medical institution shall select a list of medical supplies and establish a catalogue, and manage the medical supplies in a dynamic way.   第十二条 医疗机构应当遴选建立本机构的医用耗材供应目录,并进行动态管理。
The medical supplies management department shall, according to the principles of legality, safety, effectiveness, appropriateness, and cost-efficiency, select a list of necessary medical supplies and their producers and business operators, report it to the medical supplies management commission for approval, and create a catalogue of medical supplies. 医用耗材管理部门按照合法、安全、有效、适宜、经济的原则,遴选出本机构需要的医用耗材及其生产、经营企业名单,报医用耗材管理委员会批准,形成供应目录。
The catalogue of medical supplies shall be adjusted regularly and the adjustment periods shall be determined by the medical supplies management department. 供应目录应当定期调整,调整周期由医用耗材管理委员会规定。
The medical supplies in the catalogue shall fall into three levels: Level I, Level II and Level III according to the Catalogue of Medical Devices issued by the National Medical Products Administration. 纳入供应目录的医用耗材应当根据国家药监局印发的《医疗器械分类目录》明确管理级别,为Ⅰ级、Ⅱ级和Ⅲ级。
Article 13 A medical institution shall select a list of medical supplies from the catalogue of centralized procurement at the national, provincial or municipal level. The medical supplies outside the catalogue of centralized procurement shall be selected according to the relevant provisions.   第十三条 医疗机构应当从已纳入国家或省市医用耗材集中采购目录中遴选本机构供应目录。确需从集中采购目录之外进行遴选的,应当按照有关规定执行。
Article 14 A medical institution shall strengthen the management of the number of suppliers in the catalogue of medical supplies, and limit the number of suppliers of medical supplies with identical or similar functions in the catalogue.   第十四条 医疗机构应当加强供应目录涉及供应企业数量管理,统一限定纳入供应目录的相同或相似功能医用耗材供应企业数量。
Article 15 The procurement of medical supplies shall be managed by the medical supplies management department in a unified manner. Other divisions or departments shall neither engage in the procurement of medical supplies nor use the medical supplies purchased by a non-medical supplies management department.   第十五条 医用耗材的采购相关事务由医用耗材管理部门实行统一管理。其他科室或者部门不得从事医用耗材的采购活动,不得使用非医用耗材管理部门采购供应的医用耗材。
Article 16 Any division or department that requires medical supplies shall submit a procurement application to the medical supplies management department according to actual needs.   第十六条 医用耗材使用科室或部门应当根据实际需求向医用耗材管理部门提出采购申请。
Article 17 The medical supplies management department shall, according to the procurement application submitted by a division or department requiring medical supplies, determine the products to be purchased, suppliers, number of products, and purchasing price, and sign a written procurement agreement according to laws, administrative regulations, and relevant provisions of the State Council.   第十七条 医用耗材管理部门应当根据医用耗材使用科室或部门提出的采购申请,按照相关法律、行政法规和国务院有关规定,采用适当的采购方式,确定需要采购的产品、供应商及采购数量、采购价格等,并签订书面采购协议。
Article 18 The procurement of medical supplies shall be carried out by at least two staff members under the supervision of the relevant departments.   第十八条 医用耗材采购工作应当在有关部门有效监督下进行,由至少2名工作人员实施。
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