新材料骨植入医疗器械审评方法研究及相关思考

随着新材料在骨植入医疗器械的应用，国家药品监督管理局启动医疗器械新材料监管科学研究，寻求管理方法的突破，以期促进新材料成果转化。通过总结可降解镁金属和增材制造用聚醚醚酮等新材料骨植入医疗器械注册申报资料存在的问题，分析目前技术审评方法的局限性，为提升审评人员在新材料研究方面的专业技术水平，帮助加强申请人对医疗器械安全有效性评价的理解，提出审评方法改进建议，以期调整审评思路，提高审评效率，促进监管服务质量的提升。     

体外诊断试剂稳定性评价要求及常见问题

稳定性评价是体外诊断试剂产品性能验证的重要组成部分,一般包括实时稳定性、使用稳定性、运输稳定性等,是贯穿于整个试剂研发、上市前评价及上市后监测的重要内容,是产品有效期设计的依据。本文旨在参照我国现行注册申报相关法规及文件要求基础上,结合相关审评经验,阐述体外诊断试剂稳定性评价研究及常见问题,为从事该类产品注册申报前性能研究的从业人员提供参考。     

国家食品药品监督管理局药品审评中心网站开通“审评案例”栏目

 为进一步加大药品技术审评工作信息公开力度,为我国药品研发提供参考,同时接受社会监督,日前,国家食品药品监督管理局药品审评中心网站开设了“审评案例”专栏,这是药品技术审评信息公开由程序公开扩大到实质内容公开的重大突破。审评案例将通过对具体品种的评价分析讨论,使药物研究的技术要求更易于理解和准确把握,为药品注册申请人在药品研究时进行风险与效益评估提供借鉴,同时也为审评人员提供参考。详情可登陆国家食品药品监督管理局网站查阅（http://www.sda.gov.cn/WS01/CL0050/36537.html）。     

可降解镁金属骨科植入器械简介及注册审评考量

可降解镁金属骨科植入器械在骨修复重建功能过程中,能够逐渐被机体代谢吸收,具有广阔的应用前景。本文对可降解镁金属骨科植入器械进行简要介绍,针对该类器械应用的风险点,整理注册审评过程中的关注点,并对该类产品注册审评中医疗器械补正资料通知的具体内容进行讨论和提出解决方案,为产品研发转化提供支持。     

中国有源医疗器械行业可靠性及其审评现状研究EI北大核心CSCD

有源医疗器械是使用范围比较广泛的医疗器械产品,产品具备高可靠性水平是国产有源医疗器械产业实现高质量发展目标的必要要求。本文通过文献研究、资料收集、实地调研、材料综合梳理分析等方式,从产业政策、企业开展情况和审评方法等维度对我国有源医疗器械行业可靠性及其审评现状和存在的问题进行了系统的分析研究,并结合可靠性工作的技术特点,从标准和指导原则两个方向给出具体的问题解决建议,为后续行业制定科学、客观、符合我国行业现状和监管特点的有源医疗器械可靠性技术标准体系和指导原则提供参考。     

个体化解剖匹配骨植入假体的上市前临床评价及上市后研究要求

目的探索个体化解剖匹配(广义定制)骨植入假体的上市前注册资料技术审评关注点,以区别于型号规格参数定型的骨植入物。同时,对"定制"概念进行细分梳理,探索与审评结论相适应的、对定制产品上市后研究的要求。方法在专家咨询会及初步补充资料的基础上,审评员对申请注册的"个性化定制型颅颌面骨外科修复重建植入物"进行技术审评,并提出补充研究的要求;在与审评员的密切沟通下,生产企业研发者及临床试验研究者针对产品设计规范,补充进行了设计开发的临床确认工作。针对开放的、单组的、非随机的、自身对照病例系列研究的固有缺陷,补充相同病患群体接受传统重建接骨板治疗的回顾性研究数据,形成历史性的病例对照研究;基于对比结果的临床显著性,审评员评价产品上市风险,并与生产企业共同分析,细化了对产品上市后研究的要求。结果有别于型号规格参数定型的骨植入物产品的注册产品标准,审评员促使企业形成定性的、具有设计边界的产品设计规范;基于上市前设计开发验证与确认所形成的先验信息,审评结论提出了进一步的临床和非临床两方面的上市后研究要求,包括产品设计参数与性能数据累积,及临床随访数据的汇总统计要求。这些内容与企业制定的上市后研究方案相互补。结论有别于型号规格参数设计定型的骨科医疗器械,个体化解剖匹配骨植入假体的风险控制,必须整合上市前后两部分的临床研究信息,以对综合风险趋势做出判定。审评机构应促进个体化定制到批量化标准产品的转化,加速精准医疗产品的研发,助力国产医疗器械原创研发实现换道超车。     

药审中心发布《化学仿制药注册批生产规模的一般性要求(试行)》

正为进一步贯彻中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字[2017]42号)精神,推动药品注册技术标准国际接轨,促进仿制药研发和生产水平的提升,提高药品注册及审评审批技术要求,药审中心起草制定了《化学仿制药注册批生产规模的一般性技术要求(试行)》,供申请人参考。详情请登录国家食品药品监督管理总局药品审评中心网站http://www.cde.org.cn/news.do?method=view Info Common     

国内外定制式增材制造医疗器械监管法规概述及对行业发展的思考

目的 概述国内外定制式增材制造医疗器械监管法规,分析医疗器械监管科学研究对增材制造医疗器械行业发展的意义,以期能够为生产企业及监管机构未来的工作提供参考。方法 该文通过对国内外关于定制式增材制造医疗器械监管法规及注册体系进行分析,剖析定制式增材制造医疗器械监管法规及注册体系的创新发展对于我国医疗器械行业发展的拉动效应。结果 美国、欧盟、澳大利亚、加拿大、中国均已建立定制式增材制造医疗器械监管法规及注册体系,给出了定制式医疗器械的定义,明确了定制式医疗器械临床使用和上市后监管的要求,但各国间还存在一定的差异,使得各国对于定制式医疗器械的监管模式也稍有差异,建立医疗器械科学监管模式将推动增材制造医疗器械行业发展。结论 构建基于精准风险控制的评价监管体系,加强监管人员、审评人员与科研、医疗人员间的相互协同作用将有助于定制式增材制造医疗器械科学监管模式的构建。     

布鲁氏菌IgM/IgG抗体检测试剂临床试验设计解析

布鲁氏菌IgM/IgG抗体检测试剂属于体外诊断试剂,该类试剂需向国家药品监督管理局提交相关技术资料进行注册申报,获得医疗器械注册证后方可在医疗机构使用。按照法规要求,该类试剂应通过临床试验路径开展临床评价,以证明其安全性和有效性。如何科学合理地开展临床试验对于该类试剂的注册申报至关重要。为了指导申请人能够科学地设计和开展临床试验,基于笔者对于该类试剂的技术审评经验,本文对该类试剂注册临床试验时应关注的重点问题,包括临床试验机构选择、对比方法的选择、样本量和统计分析等要点进行了解析。     

个性化骨植入医疗器械质量控制及技术评价研究

目的 对个性化骨植入医疗器械质量控制及技术评价提出相关建议,以期为监管机构和生产企业等相关人员提供指导和参考。方法 立足于个性化骨植入医疗器械的特点,依照医疗器械安全和性能的基本原则,汲取风险管理意识经验,为促进质量控制和技术评价的科学性,从法规体系建设、上市前研究和上市后监管等角度出发,对个性化骨植入医疗器械的质量控制和技术评价的关注点进行充分探讨。结果 个性化骨植入医疗器械的质量控制应重点关注机构和人员、设备、文件管理、设计开发等方面,技术评价应重点关注个性化骨植入医疗器械的基本特征和实际应用产品的技术评价。结论 建议完善个性化骨植入医疗器械指导文件的建设,深入个性化骨植入医疗器械上市前研究,加强个性化骨植入医疗器械上市后的监管。     

Food and Drug Administration's perspectives on pediatric cardiac assist devices

Dual missions of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) are 1) promoting public health by promptly reviewing and taking appropriate, timely action regarding the marketing of regulated medical devices while at the same time, and 2) protecting public health by ensuring a reasonable assurance of the safety and effectiveness of medical devices deemed appropriate for human use. In the past, clinicians have used cardiac assist devices intended for adults to treat pediatric heart failure patients. However, because of the larger size of the approved devices, many pediatric patients are underserved by this approach. Currently, several cardiac assist devices intended for use in pediatric patients are being developed. FDA believes that clinical data used to support such safety and probable benefit may be derived from a small focused clinical trial in this target population, and developers may want to consider this approach for approval of the humanitarian device exemption application. Pediatric device development is challenging and early communication with FDA to develop an appropriate regulatory and scientific pathway for device submission is advised and warranted. This early interaction can facilitate the development of a small but necessary trial for these life-sustaining pediatric cardiac assist devices.     

基于Reason模型的医疗器械不良事件的影响因素研究

目的探讨在用医疗器械不良事件的影响因素。方法基于文献分析法,在CNKI、万方等数据库检索相关文献273篇,并采用其中74篇作为证据文献;应用Reason模型,从组织影响、不安全监督、不安全的行为前提和不安全的行为方面分析不良事件成因。结果结合证据文献的案例分析,对学者分析的导致医疗器械不良事件的原因进行归纳,并构建了医疗器械不良事件影响因素的Reason致因模型。结论医疗器械不良事件的影响因素映射为产品在组织管理、临床试验监管、产品设计、物流管理和临床使用环节中出现的"漏洞"中的隐形失效,应该加强医疗器械上市前可靠性要求和临床使用风险管控。     

Designing the design phase of critical care devices: a cognitive approach

In this study, we show how medical devices used for patient care can be made safer if various cognitive factors involved in patient management are taken into consideration during the design phase. The objective of this paper is to describe a methodology for obtaining insights into patient safety features--derived from investigations of institutional decision making--that could be incorporated into medical devices by their designers. The design cycle of a product, be it a medical device, software, or any kind of equipment, is similar in concept, and course. Through a series of steps we obtained information related to medical errors and patient safety. These were then utilized to customize the generic device design cycle in ways that would improve the production of critical care devices. First, we provided individuals with different levels of expertise in the clinical, administrative, and engineering domains of a large hospital setting with hypothetical clinical scenarios, each of which described a medical error event involving health professionals and medical devices. Then, we asked our subjects to "think-aloud" as they read through each scenario. Using a set of questions as probes, we then asked our subjects to identify key errors and attribute them to various players. We recorded and transcribed the responses and conducted a cognitive task analysis of each scenario to identify different entities as "constant," "partially modifiable," or "modifiable." We compared our subjects' responses to the results of the task analysis and then mapped them to the modifiable entities. Lastly, we coded the relationships of these entities to the errors in medical devices. We propose that the incorporation of these modifiable entities into the device design cycle could improve the device end product for better patient safety management.     

3D打印钛及钛合金医疗器械的优势及临床应用现状*

3D打印作为一种新型快速成型制造技术,在个性化、复杂三维结构及难加工医疗器械的制造中,无论在成本还是交付时间上,都体现出传统技术无可比拟的优势。本文概述了3D打印医疗器械的主要应用特点和优势,重点论述了3D打印钛及钛合金医疗器械的研究动态、临床应用及病例,对其大规模广泛应用和推广前景进行了展望。     

提高创新医疗器械研发质量有效途径的探索

随着新技术的发展,越来越多的创新医疗器械上市,临床疗效已经成为医疗器械高质量发展中人们关注的焦点。 医疗器械的临床疗效主要是由其研发质量决定的,切实提高医疗器械研发质量已经成为医疗器械产业高质量发展的抓手。该 文围绕创新医疗器械的研发过程,结合《医疗器械注册质量管理体系核查指南》和创新医疗器械特别审批要求,提出制造商 要将法规要求融入研发技术路线制定、设计验证和临床评价等环节,以提高创新医疗器械研发质量。     

Why compliance is not good enough

Although reducing risks for medical devices is an element of product liability risk management, reducing risks for medical device manufacturers is the ultimate objective. With so much riding on the product development pipeline, what can manufacturers do to ensure a successful launch and healthy return on their investment? We argue in this editorial that the operating environment for the medical device industry is so dynamic that compliance is not enough. Instead, we suggest that risk abatement must become a part of a medical device manufacturer's operating strategy. We outline a robust risk abatement strategy involving corporate cultural changes, scenario modeling tools, and implementation systems.     

北京市医用高分子材料在医疗器械产业发展中的现状调研

目的深入调研北京市医疗器械用高分子材料的开发及产业化情况,探寻本领域发展所面临的机遇与挑战。方法 2014~2016年,北京理工大学材料学院师生结合专业学习,与中关村医疗器械产业联盟合作,对北京市与医用材料产业化相关的企业、科研院所、专家学者及行业协会,通过问卷调查、参观、生产实习、座谈等形式进行调研,并对调研结果进行深入的分析。结果梳理了北京市医疗器械用高分子材料的开发及产业化过程中,在新型高分子材料的研发及应用、技术开发及创新、人才培养等方面所存在的问题及解决的措施,为加速实现医用高分子材料的产业化提出了有针对性的意见和建议。结论本研究对促进北京市医疗器械用高分子材料的开发及产业化具有一定的指导意义。     

Design for risk control: the role of usability engineering in the management of use-related risks

The majority of medical device incident reports can primarily be attributed to use error. Greater attention to human factors and usability during development of a medical device could improve this situation. However, recent studies have shown that companies do not find the application of a sound usability engineering process according to international standards a simple task. The purpose of this collaborative research project between a medical device company, two universities and a university hospital was to study the practical application of the International Standard for Application of Usability Engineering to Medical Devices, IEC 62366, by means of a case study in industrial practice. This paper describes the user studies in the case and reveals the factors important to success. Also, the paper demonstrates how to apply an iterative usability engineering process within a linear product development process in industry. Management support and careful planning of resources and activities proved essential. To control use-related risks, the usability engineer should 'design for risk control' in a structured manner, while the risk manager should remain responsible for acceptable levels of residual risk. The paper concludes with recommendations for the improvement of IEC 62366 and ISO 14971, the standard for the risk management of medical devices.