美国、欧盟与我国医疗器械不良事件监测体系比较研究

医疗器械不良事件监测是医疗器械安全监管的重要组成部分,也是确保医疗器械安全的重要手段。各国医疗器械不良事件监测体系均不相同,就美国、欧盟与我国的医疗器械不良事件的报告来源、报告时间、 不良事件数据库以及不良事件的反馈及控制等方面进行梳理和比较,探索我国医疗器械不良事件监测体系的改进策略,包括信息系统、上报机构、召回监管等。     

Assessing risk by analogy: a case study of us medical device risk management policy

Medical devices occupy an increasingly important place in global medical care, and yet the risk management systems that govern them are largely overlooked in academic literatures. In the US, home to the largest medical devices market, Food and Drug Administration (FDA) regulation allows most medical devices to enter the market based on analogy, or substantial equivalence, with previously marketed devices. Thus, risk assessment is administered without premarket clinical trials for safety and efficacy. This system represents a permissive regulatory regime based in neoliberal tenets, where risk, in the form of adverse events, is inherently tolerated within governance structures, evidencing risk colonisation. This paper employs a case study approach, examining market clearances of vaginal mesh surgical devices, which have been the subject of US multi-district litigation. We identified 266 devices cleared before 31 December 2017 and analysed the complicated web of device ‘ancestry’ whereby devices as disparate as cardiac patches and hernia mesh allowed clearance of surgical devices for urogynecology. Perhaps of greatest concern, 10 recalled or withdrawn devices influenced new device clearances for up to 17 years after their market-removal. While the FDA must balance its dual mandate to safeguard patients and promote innovation, we find that medical device regulation structurally favours innovation over safety. ‘Light touch’ risk assessment is not counterbalanced with postmarket mechanisms to safeguard against residual and developmental risks that are associated with medical devices, particularly permanent implants. The proportionality principle associated with a precautionary approach should inform medical device risk management.     

医疗器械行业标准YY0505-2012及电磁发射测试解读

有源医疗器械在临床应用的各个领域都扮演着举足轻重的角色,现代临床医学离不开有源医疗器械.近年来我国非常重视国产医疗器械产品的自主研发,而对于医疗器械标准的实施也是紧跟欧美日等发达国家步伐,医用电气设备和系统YY 0505-2012《医用电气设备第1-2部分:安全通用要求并列标准:电磁兼容要求和试验》自2014年1月1日发布实施以来,对我国有源医疗器械行业产生巨大影响,之前已经发布实施的专用标准中有关电磁兼容的内容也随即开始执行.文章主要是对医疗器械行业标准Y Y0505-2012及有源医疗器械电磁兼容测试的一些关键点进行解读.     

欧美医疗器械管理经验及对中国医疗器械法规体系改革的启示

飞速发展的医疗器械提高了无数人的生活质量或挽救了他们的生命，但同时医疗器械不良事件日益增多，各国政府对此都十分重视。我国于2000年颁布了“医疗器械监督管理条例”，开始实行医疗器械市场准入制度．这在很大程度上提高了产品的安全性和有效性．但由于缺乏对上市后和使用中的医疗器械的有效监管．大量的假冒伪劣产品仍然存在。因此．改进现行的医疗器械管理体系．成了当务这急。一些发达国家，如美国和欧盟，有数十年对安全、风险变化的研究，已经建立了一个相对完善的医疗器械管理体系。分析了欧盟、美国和中国的医疗器械法规体系，包括医疗器械监督管理法规的实质性要求及其实际执行．介绍了欧美的管理经验．目的是希望对我国的医疗器械管理体系改革有所启示。     

From sandbox to pandemic: Agile reform of Canadian drug regulation

Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Omnibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, however, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. In addition, Bill C-97 informed Canada's COVID-19 response in important ways, particularly in relation to clinical trials. The measures adopted by the drug regulatory authority, Health Canada (HC) during COVID-19 may become the new norm in Canadian regulatory practice insofar as they help achieve the amendments introduced by Bill C-97. Finally, despite government rhetoric of transparency, the agenda-setting, formulation, and implementation of the amendments have occurred with little opportunity for scrutiny or public engagement.     

Divergent evidence requirements for authorization and reimbursement of high-risk medical devices – The European situation

BackgroundUnsafe and dangerous medical devices have entered the European market during the last decade, raising public awareness. Consequently, regulatory processes and their requirements for evidence are under discussion.ObjectiveThis research aims to explore the authorization and reimbursement processes and associated evidence requirements for high-risk medical devices in four regions: Europe, the United States, Australia and Canada.MethodsA literature search in PubMed about the authorization and reimbursement processes in the four regions was performed. Seven high-risk medical devices were selected as examples, and their authorization and reimbursement status were analyzed. Information was extracted from publicly available summaries of the authorization agencies of the regions, from the Controlled Clinical Trial Database, supplemented by information from HTA and reimbursement organizations.ResultsThe evidence required for the authorization and reimbursement processes differs strongly in the four regions regarding the levels of methodology and scrutiny. All seven devices have been authorized in Europe, three in Australia, one in the USA, and one in Canada. Currently none of the devices is recommended for reimbursement in the regions except one, in the USA. Devices that have been authorized in more than one region show that authorization has been two to three years earlier in Europe.ConclusionHuge differences and gaps in the evidence required for market authorization and for reimbursement were observed, especially between the two processes (authorization and reimbursement) in Europe. To ensure the high quality and safe provision of medical devices, harmonization of requirements and transparency in processes are needed.     

医疗器械的监管对策与建议

本文通过研究和比较分析美国和我国医疗器械行业发展状况和监管体制,积极探索医疗器械监管的新模式,提出既可以促进医疗器械行业持续健康快速发展,又能保证产品质量安全的监管对策。     

Regulatory regimes and procedural values for health-related motion data in the United States and Canada

ObjectivesDigital health technologies often have minimal regulatory oversight if the perceived risk to users is low. This is especially relevant to motion data captured from wearable devices, which are increasingly used across sectors and in clinical settings. The aim of this research is to identify gaps in procedural values embedded in two policy regimes for the governance of health-related motion data.MethodsThis paper examines the policy regimes of the state of California in the United States and the province of Ontario in Canada with respect to digital health applications and the use of motion data, and demonstrates how three example technologies would be regulated under these regimes. This is followed by a gap analysis of procedural values within the two policy regimes.ResultsApplications that are categorized as health and wellness or are not classified as medical devices under these regimes are not typically required to adhere to the strict guidelines of data usage, application standards and accountability reserved for health care, despite collecting and distributing data that may be used to infer information about a user's health. The values-based gaps in these policy regimes illustrate three crucial issues for research and policy on this topic: Inconsistent regulatory implications for different entities, a lack of trustworthy practices, and challenges over the definition of “reasonableness”.ConclusionGreater consideration of procedural values embedded in policies could better advance the goal of ameliorating the risks of motion data collected by wearable devices and applications.Public Interest SummaryDigital applications that use movement data from wearable devices are appearing more frequently throughout society. They are even used in many health care settings. Movement data and applications are usually considered relatively low risk to users, and as such often bypass health data and medical device regulatory protections. However, these data can be used to generate information about a person's health, and may in some cases influence treatment decisions. This paper provides an overview of the regulatory environments for digital health applications and motion data for the state of California in the United States and the province of Ontario in Canada. We demonstrate how three example digital health applications would be regulated in these jurisdictions, and use them to highlight the need for policies that better protect the public from the potential risks of health-related motion data collected by wearable devices.     

Regulatory and HTA early dialogues in medical devices

Introduction: Specific guidance and examples for health technology assessment (HTA) of medical devices are scarce in medical device development. A more intense dialogue of competent authorities, HTA agencies, and manufactures may improve evidence base on clinical and cost-effectiveness. Especially as the new Medical Device Regulation requires more clinical evidence.Methods: We explore the perceptions of manufacturers, competent authorities, and HTA agencies towards such dialogues and investigate how they should be designed to accelerate the translational process from development to patient access using semi-structured interviews. We synthesized the evidence from manufacturers, competent authorities, and HTA agencies from 14 different jurisdictions across Europe.Results: Eleven HTA agencies, four competent authorities, and eight manufacturers of high-risk devices expressed perceptions on the current situation and the expected development of three types of early dialogues.Discussion: The MDR has to be taken into account when designing the early dialogue processes. Transferring insights from medicinal product regulation is limited as the regulatory pathways differ substantially.Conclusion: Early dialogues promise to accelerate the translational process and to provide faster access to innovative medical devices. However, health policy-makers should promote and fully establish regulatory and HTA early dialogues before introducing parallel early dialogues of regulatory, HTA agencies, and manufacturers. For initiating change, the legislator must create the legal basis and set the appropriate incentives for manufacturers.     

Epidata软件在医疗器械不良事件监测中应用的可行性研究

目的探讨Epidata软件在我国医疗器械不良事件监测中应用的可行性。方法采用定性定量相结合的方法，对全国医疗器械不良事件报告应用Epidata软件接收处理情况进行了分析总结。结果Epidata软件有效承担了报告接收管理工作，积极发挥了报告管理功能，为监测人员、企业、医院提供了有效工具。结论Epidata报告软件通过1年的实践，表现出良好的数据录入能力和数据管理能力，为医疗器械不良事件监测的报告管理工作提供了有效的技术支持。     

关于推进医疗器械上市后安全性监测工作的探讨

在回顾我国医疗器械不良事件监测工作现状的基础上,分析了当前存在的主要问题和面临的挑战,并就全面推进我国医疗器械上市后安全性监测工作提出了相关建议。     

国内外医学教育标准比较研究

文章简要介绍了全球医学教育标准的概况,对比了中国医学教育标准与美、日欧及全球医学教育标准的差异,并对如何借鉴发达国家先进经验改革我国医学教育提出了建议。     

医疗器械安全管理规范及应用要求

本文结合我国和欧美等国家对医疗器械安全管理的法规和技术要求,从医疗器械的注册审批、生产质量管理体系和临床使用管理等方面进行阐述,探讨医疗器械安全管理法规在临床使用管理中的应用。     

对医疗器械不良事件监测机构建设的思考

目的:探讨在原有药品不良反应监测系统的基础上建立医疗器械不良事件监测系统的模式方法,并提供建议;方法:采用定性与定量研究相结合的方法,提出医疗器械不良事件监测机构建设的基本概念、框架;结果:医疗器械不良事件监测机构建设的远景目标是建立一个具备检测新出现问题能力、测量危险因素变化和趋势能力、干预能力、评价干预措施和政策效果能力的医疗器械不良事件监测系统;监测机构内部设置应包括政策研究部、综合干预部、规范实施部、监测评价部、宣传培训部等部门来共同协调工作;需要合理的人力资源和必要的经费支持;机构建设在硬件设施配置的基础上,更需要相应规章制度的软件建设;结论:目前需要在框架建设阶段充分论证监测模式,制定客观科学的监测机构建设策略,统一思想、统一认识,在监测机构建设早期树立科学的监测理念,制定有效的、可行的具体措施.     

中国和美国UDI法规框架与实施分析

分析了中国和美国在医疗器械唯一标识(unique device identification,UDI)法规框架、发码机构、数据库、实施方式等方面的差异,指出了我国在发码机构退出机制以及初期实施UDI过程中部分企业存在对《医疗器械唯一标识系统规则》认识不足等问题并给出建议,为后续更深入开展UDI工作提供了建设性意见.     

Prevention and control of viral hepatitis through adolescent health programmes in Europe

The Viral Hepatitis Prevention Board jointly organized with the European Union for School and University Health and Medicine a meeting on the prevention and control of viral hepatitis through adolescent health programmes in Europe, held in Ljubljana, Slovenia, 15–16 March 2007. Participants from some 16 countries in Europe as well as the United States of America emphasized the importance of reaching adolescents mainly through school health programmes, provided an overview of currently existing youth health systems and reviewed their experiences with childhood and adolescent immunization programmes. The meeting concluded with a discussion of issues, lessons learnt, opportunities and action points for the future.     

Regulating human implant technologies in Europe--understanding the new era in medical device regulation

It has been suggested that we are entering a new era in medical device regulation in Europe. This paper discusses the implementation of the European Medical Devices Directive (EMDD) in EU member states with a particular focus on the UK. Case studies are then presented of two models of implant technologies--Trilucent breast implants and the 3M Capital hip prosthesis. Both have been withdrawn from the marketplace recently in controversial circumstances. Different aspects of regulatory activity are outlined with a bearing upon benefits and safety from national health services' and consumers' perspectives, and a number of issues concerned with the ability of regulatory mechanisms and practices to serve public health and safety are identified. Our analysis of the case studies draws parallels with studies of drug regulation, and explores the construction of risk and public participation in policy making. We argue that there are weaknesses in the regulation of medical devices and that commercial interests have dominated regulatory policy. Our case studies, however, suggest a shift towards a more user-oriented shaping of regulation.     

我国医学计量的现状与挑战

述评了我国医学计量的现状、面临的医学变革挑战以及应对策略。     

Validation of Electronic Systems to Collect Patient-Reported Outcome (PRO) Data—Recommendations for Clinical Trial Teams: Report of the ISPOR ePRO Systems Validation Good Research Practices Task Force

Outcomes research literature has many examples of high-quality, reliable patient-reported outcome (PRO) data entered directly by electronic means, ePRO, compared to data entered from original results on paper. Clinical trial managers are increasingly using ePRO data collection for PRO-based end points. Regulatory review dictates the rules to follow with ePRO data collection for medical label claims. A critical component for regulatory compliance is evidence of the validation of these electronic data collection systems. Validation of electronic systems is a process versus a focused activity that finishes at a single point in time. Eight steps need to be described and undertaken to qualify the validation of the data collection software in its target environment: requirements definition, design, coding, testing, tracing, user acceptance testing, installation and configuration, and decommissioning. These elements are consistent with recent regulatory guidance for systems validation. This report was written to explain how the validation process works for sponsors, trial teams, and other users of electronic data collection devices responsible for verifying the quality of the data entered into relational databases from such devices. It is a guide on the requirements and documentation needed from a data collection systems provider to demonstrate systems validation. It is a practical source of information for study teams to ensure that ePRO providers are using system validation and implementation processes that will ensure the systems and services: operate reliably when in practical use; produce accurate and complete data and data files; support management control and comply with any existing regulations. Furthermore, this short report will increase user understanding of the requirements for a technology review leading to more informed and balanced recommendations or decisions on electronic data collection methods.