United States regulatory approval of medical devices and software applications enhanced by artificial intelligence

In the United States, regulatory oversight of medical devices has evolved with the changing technology. With the introduction into routine clinical practice software applications and computer-based devices, the U.S. Food and Drug Administration (FDA) has further defined categories of risk and intended use to better uphold patient safety, while encouraging innovation in medical technology. However, as new software technologies such as artificial intelligence (AI) are developed, refined, and introduced into the healthcare sector, there will be a need for regulatory bodies to rapidly respond. In the current review, we discuss the evolution of US FDA oversight of medical devices, initially of hardware, and the present stance on medical software applications, including devices augmented with artificial intelligence.     

从美国FDA2010年度医疗器械相关企业单位抽查警告信看cGMP 违规行为

公开警告信是美国FDA(食品和药品管理局)的一种监管手段.截至2011年3月7日,FDA发布在其公众网站上的2010年度检查警告信共有597件,其中涉及医疗器械行业的有168件.在这168件警告信中,cGMP、上市前审批和医疗器械不良事件通报(MDR)方面的违规行为分别占所有违规行为的前三名.本文就cGMP违规行为中最常见的三种,即纠正和预防措施(CAPA)、投诉处理以及设计控制,作了一些初步的分析.     

A multidisciplinary approach to online support for device research translation: regulatory change and clinical engagement

ObjectivesTo promote an appreciation of the EU medical device regulatory framework in the biomedical research community and encourage greater levels of clinical engagement to further medical device research innovation, translation and effective clinical trials.MethodsAn interdisciplinary, iterative, needs-based design approach was used to develop medical device regulatory training, information and clinical expertise resources.ResultsA multimedia based self-paced e-Learning course focusing on the ‘Fundamentals of Medical Device Design and Regulation’ was produced in tandem with an interactive online web portal: Medtech Translate.ConclusionsHealth research translation relies on both clinical input and regulation to drive progress and to ensure quality and safety standards from concept development to clinical investigation. A lack of regulatory awareness and access to clinical expertise has the potential to significantly impact on health research translation and ambition for market. Our interdisciplinary academic-regulator-clinical-industry led approach meets the need for a coordinated stakeholder response to support innovation and promote growth in the medical technology sector.     

对在用医疗器械实施风险管理的思考

风险管理贯穿于医疗器械监管的全过程,对在用医疗器械也十分必要。文在分析在用医疗器械风险管理的现状基础上,对医疗器械使用环节风险管理的主体、参与者及切入点等重要内容进行了思考。     

中美医疗器械说明书和标签法规管理的比较研究

目的为我国完善和发展医疗器械标签和说明书的管理提供借鉴。方法采用内容分析方法,资料是从美国食品药品管理局网站上收集的有关美国管理医疗器械标签和说明书的10个法律文件,并以联邦法规为主进行对比分析。结果中美医疗器械标签和说明书法规的主要差异体现在体系结构、管理范围、管理对象、管理特征和实际使用5个方面。结论美国已建立了一套完整的法律体系管理医疗器械标签和说明书,我国应从中得到启示,分类管理处方器械和非处方器械,建立相关指导原则,以确保医疗器械安全、有效地使用。     

Accountability,organisational learning and risks to patient safety in England: Conflict or compromise?

This article examines the current risk regulation regime, within the English National Health Service (NHS), by investigating the two, sometimes conflicting, approaches to risk embodied within the field of policies towards patient safety. The first approach focuses on promoting accountability and is built on legal principles surrounding negligence and competence. The second approach focuses on promoting learning from previous mistakes and near-misses, and is built on the development of a ‘safety culture’. Previous work has drawn attention to problems associated with risk-based regulation when faced with the dual imperatives of accountability and organisational learning. The article develops this by considering whether the NHS patient safety regime demonstrates the coexistence of two different risk regulation regimes, or merely one regime with contradictory elements. It uses the heuristic device of ‘institutional logics’ to examine the coexistence of and interrelationship between ‘organisational learning’ and ‘accountability’ logics driving risk regulation in health care.     

急救医学设备的安全及风险管理

分析了急救设医学装备风险类型,提出了风险管理的模式、风险分析方法．风险评估（包括风险分值计算）．风险控制的要点。急救医学设备风险分值高,直接关系到病人的生命安全,必须加以重视。     

Adverse Event Reports Associated with Vaginal Mesh: An Interrupted Time Series Analysis

BackgroundSurgery with vaginal mesh is often used to treat female urinary incontinence. Questions have emerged over the past decade about the safety and efficacy of vaginal mesh devices.ObjectiveThis study examines trends in adverse event reports associated with vaginal mesh devices, testing the hypothesis that Food and Drug Administration (FDA) announcements will result in increased adverse event reports to the FDA.MethodsUsing interrupted time series regression models, we analyzed adverse event report data collected from the FDA's Manufacturer and User Facility Device Experience reporting system in 1998 through 2015.ResultsFDA announcements had limited effects on the number of adverse event reports, whereas an announcement from a mesh manufacturer that it was withdrawing devices from the market resulted in a large spike in reports.ConclusionsThese findings raise concerns about the dispersion of risk communications, the FDA's reliance on adverse event reports for postmarket surveillance, and the FDA's clearance of vaginal mesh without safety or efficacy testing.     

医疗器械生物学评价国际标准新动向

本文介绍了国际标准化组织医疗器械生物学评价标委会(ISO/TC194)第22届年会中,关于医疗器械生物安全性评价、化学表征、风险评估管理策略及纳米材料安全性评价等方面提出的新要求,关注了医疗器械生物学评价国际标准ISO10993的最新动向。     

医疗设备风险评估与安全管理

目的：改变对医疗器械传统的＂资产和物质管理＂理念,对医疗器械实施＂技术和风险管理＂。方法：建立起涵盖医疗器械采购、验收、评价、检测、考核、维护等使用全过程的一系列管理制度,推行美国的国际联合委员会（JCI）管理标准的实施,建立设备风险评估体系,实现对医疗器械使用风险的全程控制,确保采购的医疗器械符合临床需求等。结果：最大限度降低风险发生率,避免设备安全问题的发生。结论：通过JCI标准中的风险评估模式使得医疗设备安全使用有了进一步的保障,减少了医疗机构的风险,提升了病患的医疗安全,减少了临床的医疗风险。     

医学装备风险管理文献的计量研究

目的:计量我国近10年的中文期刊医学装备风险管理研究文献,分析医学装备风险管理现状及热点领域。方法:检索万方、中国知网(CNKI)及维普数据库(2003-2012年)及追溯参考文献采集文献,运用文献计量学和文献评阅分析研究医学装备风险管理现状及热点领域。结果:检索出中文期刊文献331篇,刊登在114种期刊,其中中国科技论文与引文数据库(CSTPCD)收录期刊169篇,中国科技期刊要目总览(PKU)收录期刊34篇,中国科学引文数据库(CSCD)收录期刊16篇,Medline收录期刊17篇;发文量≥5篇的作者有8位;综述类文献203篇,研究论著文献128篇,基本呈逐年上升趋势。结论:我国医学装备风险管理研究的热点领域主要集中在对在用医学装备的风险评估、风险控制、安全管理以及监管部门对医疗器械不良事件的分析研究。     

美国FDA医疗器械说明书和标签指导原则介绍

目的:为我国完善和发展医疗器械标签和说明书的管理提供借鉴。方法:采用内容翻译和分析方法,主要资料是美国食品药品管理局网站发布的《医疗器械标签和说明书指导原则》。结果:分章介绍了美国医疗器械标签和说明书的指导原则,包括定义、安全有效性考虑、预期用途、禁忌症、警告说明、注意事项、特殊适用群体、不良事件、处方器械等12项内容。结论:我国应从FDA管理经验中得到启示,分类管理处方器械和非处方器械,建立相关指导原则,以确保医疗器械安全、有效地使用。     

The Economic Evaluation of Medical Devices

The economic evaluation of medical technology has evolved as a key element in supporting health budget allocation decisions. Among suppliers of innovation, the medical device industry is one of the most dynamic fields of medical progress with thousands of new products marketed every year. Accordingly, the broad variety of technologies covered by the umbrella term ‘medical devices’ have come under increasing scrutiny regarding their cost effectiveness. In the process, a number of device-specific factors have become apparent, each of which can complicate a thorough economic evaluation and limit its informative value. Some of these factors relate to specific characteristics of device functioning. Examples of such factors include the fact that most technologies require, or form part of, a procedure and that many devices have multiple indications or purposes. Others in turn reflect external conditions and are more general in character, such as the regulatory framework that a medical device manufacturer faces prior to market approval and the structure of the medical device industry. Drawing on the available literature, these complicating factors and their practical implications are discussed and used as a basis to elaborate on the emerging challenges for the economic evaluation of medical devices.     

Improving Medical Device Regulation: The United States and Europe in Perspective

Context: Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients.Methods: We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed literature and legislative documents.Findings: The two regulatory systems differ in their mandate and orientation, organization, pre-and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real-world use, and exchanging pertinent information on devices with key users such as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered.Conclusions: Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring high-quality evidence of benefit for medium-and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating links between device identifier systems and existing data collection tools, such as electronic health records; and fostering increased and more effective use of registries to ensure safe postmarket use of new and existing devices.     

FDA人工智能医疗器械软件变更的监管思路分析

人工智能技术为医疗器械创新带来新的契机,人工智能医疗器械软件与传统医疗器械软件相比较呈现出一些新的特点.文章对美国国家食品药品监督管理局(FDA)提出的一项旨在促进人工智能医疗器械自我学习、迭代更新的变更监管框架提议进行介绍.该提议允许企业在软件全生命周期管理条件下,在注册时提交一系列规范文件,为预期变更提前制定计划.     

关于医疗器械软件产品管理工作的思考

本文结合医疗器械软件产品的特点,从医疗器械软件产品分类目录动态管理机制的建立、安全性评价方法的探索、监管队伍的专业化建设和专家队伍的管理等几个方面,对医疗器械软件产品的管理工作提出了建议。     

FDA医疗器械指南开发程序介绍

目的：通过对FDA医疗器械指南开发程序的研究,为建立我国医疗器械指南管理提供借鉴。方法：采用指南文件翻译和分析方法,主要资料来源于美国食品药品管理局网站上已发布的医疗器械相关指南及相关法规文件。结果与结论：FDA对医疗器械指南进行分类管理,在21C F R中明确了良好指南管理规范的要求,并有专门的“规范的指南开发程序”。我国应以此为借鉴,制定符合我国国情的医疗器械指南开发程序,完善我国医疗器械指南编写和管理工作,为提升我国医疗器械行业技术要求和管理水平提供保障。     

浅谈医院医疗器械不良事件的监测管理

在医疗水平高速发展阶段,医疗安全依然是关注热点,由医院医疗器械诱发的医疗纠纷不在少数,因此加强医院医疗器械安全管理成为重中之重。建设医院监测管理体系,实现对医疗器械质量的监测与管理,减少医院医疗器械不良事件的发生率,对保障患者生命安全有重要意义。文章在明晰监测管理工作意义的基础上,就现阶段医院医疗器械监测管理中存在的不良事件予以总结,制定可完善问题的策略,保障患者生命安全,提升医院安全管理工作水平。     

从生产企业的角度浅析医疗器械上市后风险管理

本文在分析了与医疗器械上市后风险管理有关的法律后,在借鉴美国医疗器械上市后安全性监测和GHTF(医疗器械国际协调会议)中关于生产企业不良事件报告决策程序的基础上,从生产企业的角度对医疗器械上市后的风险的评价、风险管理的过程、采取的措施等方面进行了解析。     

医疗设备临床使用风险分析和评估体系的研究

目的:通过建立医疗设备临床使用风险分析和评估体系,实现对医疗设备的周期维护,确保设备的安全使用。方法:利用医疗设备风险值(RiskLevel,RL)评估,划分出临床医疗设备等级,制定不同的巡检及维护周期。结果:通过评估体系的建立,合理安排了巡检、设备预防性维护,确保了临床设备的安全使用。结论:医疗设备临床使用风险分析和评估体系的建立,对医疗设备的安全使用和患者的生命安全有着重要的意义。