FDA 月度新闻盘点-医疗器械篇

21 CFR Parts 210 and 211 - Current

Good Manufacturing Practice In

Manufacturing, Processing, Packing

or Holding of Drugs; General and

Current Good Manufacturing

Practice For Finished

Pharmaceuticals

Revisions as of 2 May 2006 Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

Sec. 210.1 Status of current good manufacturing practice regulations. 210.2 Applicability of current good manufacturing practice regulations. 210.3 Definitions. Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart A - General Provisions

Sec. 211.1 Scope. 211.3 Definitions. Subpart B - Organization and Personnel 211.22 Responsibilities of quality control unit. 211.25 Personnel qualifications. 211.28 Personnel responsibilities. 211.34 Consultants. Subpart C - Buildings and Facilities 211.42 Design and construction features. 211.44 Lighting. 211.46 Ventilation, air filtration, air heating and cooling. 211.48 Plumbing. 211.50 Sewage and refuse. 211.52 Washing and toilet facilities. 211.56 Sanitation. 211.58 Maintenance. Subpart D - Equipment 211.63 Equipment design, size, and location. 211.65 Equipment construction. 211.67 Equipment cleaning and maintenance. 211.68 Automatic, mechanical, and electronic equipment. 211.72 Filters. Subpart E - Control of Components and Drug Product Containers and Closures 211.80 General requirements. 211.82 Receipt and storage of untested components, drug product containers, and closures. 211.84 Testing and approval or rejection of components, drug product containers, and closures. 211.86 Use of approved components, drug product containers, and closures. 211.87 Retesting of approved components, drug product containers and closures. 211.89 Rejected components, drug product containers, and closures. 211.94 Drug product containers and closures. Subpart F - Production and Process Controls 211.100 Written procedures; deviations. 211.101 Charge-in of components. 211.103 Calculation of yield. 211.105 Equipment identification. 211.110 Sampling and testing of in-process materials and drug products. 211.111 Time limitations on production. 211.113 Control of microbiological contamination. 211.115 Reprocessing. Subpart G - Packaging and Labeling Control 211.122 Materials examination and usage criteria. 211.125 Labeling issuance. 211.130 Packaging and labeling operations. 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 211.134 Drug product inspection. 211.137 Expiration dating. Subpart H - Holding and Distribution 211.142 Warehousing procedures. 211.150 Distribution procedures. Subpart I - Laboratory Controls 211.160 General requirements. 211.165 Testing and release for distribution. 211.166 Stability testing. 211.167 Special testing requirements. 211.170 Reserve samples. 211.173 Laboratory animals. 211.176 Penicillin contamination. Subpart J - Records and Reports 211.180 General requirements. 211.182 Equipment cleaning and use log. 211.184 Component, drug product container, closure, and labeling records. 211.186 Master production and control records. 211.188 Batch production and control records. 211.192 Production record review. 211.194 Laboratory records. 211.196 Distribution records. 211.198 Complaint files. Subpart K - Returned and Salvaged Drug Products 211.204 Returned drug products. 211.208 Drug product salvaging.

学术论著中国医学装备2024年2月第21卷第2期 China Medical Equipment 2024 February Vol.21 No.2

Discussion on hot topics and promotion paths for post-market surveillance and supervise of medical consumables based on non-active medical devices/Dong Fang1, Yang Jianlong2, Li Jiayue3, Ning Peng4, Chen Fangfang2, Shi Shengnan2, Qiu Xiaolan2, Xie Zigui2, Cui Zeshi5 1Center for Drug Reevaluation, NMPA, Beijing 100076, China; 2China Association of Medical Equipment, Beijing 100086, China; 3Beijing Haijia School, Beijing 101300, China; 4Editorial Board of China Medical Equipment, Beijing 100050; 5China; School of Pharmacy, China Medical University, Shenyang 110122, ChinaCorresponding author: [Abstract] Objective: To explore the research hotspots and effective promotion paths of post market surveillance and supervise of medical consumables with non-active medical devices. Methods: Data mining methods were used to collect related journal literatures and documents from the websites of China regulatory institutions and the China National Knowledge Infrastructure (CNKI), order sub item data of medical device adverse event reports, extract the MeSH element words of literatures and documents, perform bibliometric analysis and visual display. Results: The number of medical devices adverse event reports in China has been increasing year by year, reaching 694 866 in 2022, in the four statistical years from 2019 to 2022, the number of reports on non-active medical devices and IVD reagents also showed a parallel increasing trend, accounting for about 65.00% of the total number of adverse event reports on medical devices in the year. The bibliometric analysis of journal literature shows that research in this field has received varying degrees of participation from regulatory institutions, universities, medical institutions, and enterprises. Regulatory institutions have contributed 46 articles, accounting for 56.79% of the total number of articles, followed by 28 articles from universities. The co-occurrence analysis shows that hot topic is focused in 5 clusters: quality management, risk management, international experiences discussion and adverse event surveillance and re-evaluation and real-world research. China regulatory institutions attach great importance to post market surveillance and supervise, and have issued more than 20 relevant documents since 2006, focusing on specific topics and gradually deepening around safety and effectiveness. Conclusion: The post market surveillance and supervise of medical devices, especially medical consumables based on non-active medical devices, need to be promoted synchronously in three dimensions: regulatory institutions, medical institutions, and enterprises. Universities, research institutes, and industry organizations should work in coordinating to strengthen the collection, identification, and active surveillance of risk signals based on adverse event surveillance, safety evaluation based on risk management, and conducting real-world research, research and develop risk control and corrective and preventive measures. [Key words] Post-market surveillance; Non-active medical device; Medical consumables; Risk management; Active surveillance; Real world research; Adverse event Fund programs: National Key R & D Program (2022YFC2407604, 2021YFC2701302)[摘要] 目的：探讨基于无源医疗器械类医用耗材上市后监测监管的研究热点与推进路径。方法：采用数据挖掘方法对我国医疗器械监管相关机构网站和中国知网中国国家知识基础设施(CNKI)进行相关文献、文件采集；梳理医疗器械不良事件报告分项数据，提取期刊文献和文件主题要素词，进行文献计量分析与可视化显示。结果：我国医疗器械不良事件报告数量逐年增加，2022年为694 866份；在2019年至2022年4个统计年度数据中，无源医疗器械及体外诊断(IVD)试剂的报告数也呈并行增加趋势，占年度医疗器械不良事件报告总数的65.00%左右。期刊文献的常规文献计量表明该领域研究得到监管机构、高校院所、医疗机构及生产企业不同程度参与，监管机构贡献了46篇，占文献总数的56.79%，其次是高校28篇；词篇共现分析显示，研究热点聚集在质量管理、风险管理、国际经验解析、再评价、真实世界研究5类；我国监管机构高度重视上市后监测监管，2006年以来发布相关文件20余份，围绕安全有效愈渐深入。结论：研究热点从基于不良事件报告的质量管理、风险管理、国际经验讨论逐步向主动监测、真实世界研究等方面深入。进一步加强医疗器械尤其是无源医疗器械类医用耗材上市后监测监管需要在政府监管、医疗机构与消费者用户和生产经营企业3个维度同步推进，高校院所、行业组织协同助力，加强监测技术和方法学研究，建立真实世界研究数据资源库与数据标准，拓展不良事件监测序贯活动，研究制定风险控制和纠正预防措施，服务于我国医疗健康和产业发展。 [关键词] 上市后监测监管；无源医疗器械；医用耗材；风险管理；主动监测；真实世界研究；不良事件基金项目：国家重点研发计划(2022YFC2407604，2021YFC2701302)引用本文：董放,杨建龙,李嘉悦,等.无源医疗器械类医用耗材上市后监测监管研究热点与推进路径[J].中国医学装备,2024,21(2):166-173.DOI:10.3969/J.ISSN.1672-8270.2024.02.032董 放1 杨建龙2 李嘉悦3 宁 鹏4 陈芳芳2 时胜楠2 邱晓岚2 谢子归2 崔泽实51国家药品监督管理局药品评价中心 北京 100076；2中国医学装备协会 北京 100086；3北京市海嘉学校 北京 101300；4《中国医学装备》杂志社 北京 100050；5中国医科大学药学院 沈阳 110122通信作者：崔泽实，Email：DOI: 10.3969/j.issn.1672-8270.2024.02.032中图分类号：R816.8 文献标识码：A无源医疗器械类医用耗材上市后监测监管研究热点与推进路径探讨学术论著

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医疗器械消毒管理制度

篇一：一次性医疗用品、消毒器械与消毒剂的使用管理制度

一次性医疗用品、消毒器械与消毒剂的使用管理制度

（一）一次性使用医疗用品的使用管理制度

一次性使用医疗用品,是指无菌、无热源、经检验合格，在有效期的一次性直接使用的医疗器械。如无菌注射器、无菌注射针、无菌输液器、无菌输血器和无菌输液袋等.

1、根据规范化管理要求,采购渠道原则为指定的部门,禁止从非法渠道采购医疗器械.

2、直接从生产或经营企业采购无菌器械,应索取生产或经营企业的必要证件(卫生许可证、产品批准文号、营业执照、该批产品的检验报告单、产品合格证)、销售人员的合法身份.

3、建立无菌器械采购的索证验收制度,严格执行并做好记录.索证验收记录至少应包括:购进产品的企业名称、产品名称、型号规格、产品数量、生产批号、灭菌批号、产品有效期等.按照记录应追查到每批无菌器械的进货来源.

4、器械到货后应在24小时内验收,验收人员应在记录上签名.

5、验收或使用过程中若发现小包装已破损、表示不清的无菌器械,应立即停止使用、封存，并及时与生产厂家联系，予以更换；若发现不合格无菌器械，应立即停止使用封存，并及时报告药品监督局予以处竭诚为您提供优质文档/双击可除

理。

6.储存一次性无菌器械的场所应阴凉干燥、通风良好，并每月打扫，保持清洁卫生。

7、应定期检查在库的无菌器械的有效期和质量情况发现疑问及时处理并有记录。

8、凡使用的进入人体组织或无菌器官的医疗用品必须达到灭菌要求，一次性注射器具应当一人一用一灭菌，凡接触皮肤黏膜的器械和用品必须达到消毒要求。

9、建立无菌器械使用后的销毁制度。凡使用的一次性医疗用品，应当消毒并做毁形处理，能够焚烧的，应当及时焚烧。并做好记录。

10、一次性医疗废物的暂时储存，应当远离医疗区、食品加工区和人员活动区以及生活垃圾存放场所，并设置明显的警示标识和防渗漏、防鼠、防蚊蝇、防蟑螂、防盗及预防儿童基础的安全措施。

1

瑞蓝凝胶BDDE致癌风险评估

P020023

瑞蓝（Restylane）凝胶包含1,4-丁二醇二缩水甘油醚（BDDE），该化合物在几种不同的检测系统中

均出现了突变。在其中一项研究中，对小鼠局部使用BDDE后，认为可能与肿瘤的形成有关。因此，应谨

慎地评估接受瑞蓝凝胶注射的患者所面临的潜在BDDE致癌风险。下面列举两种测定人体过量摄入BDDE

致癌风险的方法：1）采用简单的线性外推法，以小鼠研究中导致肿瘤发生率增加的BDDE最低剂量为基

础，外推10-6

风险度相关的剂量，并将该剂量转换为人体等效剂量；2）采用剂量反应曲线模型假定肿瘤

发生率为10%，使用不确定性系数估算人体10-6

肿瘤发生率对应的剂量。最后用以上两种方法推导出的过

量摄入BDDE导致癌症风险10-6

对应的人体等效剂量与接受瑞蓝注射患者摄入的BDDE剂量估算值进行

比较。

线性外推方法

BDDE在污染物致突变性检测试验（Ames试验）和其它基因毒性试验中均出现了突变；但在

Giba-Geigy小鼠致癌性试验得到的所有肿瘤剂量反应曲线模型数据不适合做定量风险评估。对小鼠局部使

用阴性对照溶剂丙酮，其发生肿瘤的概率，远大于使用以下两种不同浓度BDDE后肿瘤的发生率。故无法

因此外推出与风险最低或风险可接受度相关的用药剂量。

相反， Giba-Geigy试验揭示雌性小鼠得淋巴恶性肿瘤的概率有明显的增加。利用这些数据进行BDDE

定量风险评估，用吸收途径外推法（route-to-route extrapolation）估算BDDE摄入量，用种间外推法

（interspecies extrapolation）估算BDDE人类等效剂量，用低剂量外推法（low dose extrapolation）估

算与风险可接受度相关的BDDE剂量，或反之估算患者能接受的BDDE上限剂量相关的癌症风险。

局部给药剂量 丙酮对照 0.05% BDDE 0.2% BDDE

肿瘤发生率 2/100（2%） 3/49（6.1%） 5/50（10%）