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0 引言
工欲善其事,必先利其器,精良的医疗器械是临床医生的得力助手,在心脏病学领域也不例外.从古老的听诊器到近代的心电图,一直到今天的心脏直视手术、导管介入等高科技手段,一代代医疗器械造福于成千上万的患者,与心脏病学同步成长,见证了人类对心脏认识的不断深入.心脏病学作为近30余年来医学各部门中进展最快的学科之一,也是器械研发和创新最为活跃的领域.据美国食品与药品监督管理局(FDA)统计,通过其上市前批准(PMA)的医疗器械中一半以上都来自于心血管领域.心血管器械的研发不仅有赖于工业界的投入与创新,临床医生也在其中起到重要作用. 相似文献
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目的 为我国治疗罕见病的医疗器械的发展提供建议.方法 采用文献调研法,结合政策制定及修订背景和动因,分析了美国人道主义器械豁免(HDE)审批途径的主要内容及实施成效,并提出对我国的启示.结果 HDE政策的实施有力推动了罕见病医疗器械的创新和发展.结论 与美国相比,我国的医疗器械监管仍待完善,我国应从制定罕见病医疗器械特殊审批政策、加强监管部门和医疗器械生产企业的沟通、建立上市后监管体系以及引导医疗器械生产企业承担社会责任等方面作出改进. 相似文献
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医疗器械法规的目标是通过关注医疗器械的安全性和有效性来促进和保护公众健康.医疗器械在设计和功能方面具有多样性,因此需要依据其复杂性和风险特征采取不同的监管方法.以FDA医疗器械风险管理的过程模式为指南,CDRH通过上市前审批计划,确保新的、高风险的、复杂的医疗器械安全有效;通过上市后监测计划、科学研究、法律约束和教育计划等,最大限度地确保上市后医疗器械的安全有效.正是由于CDRH这些计划的相互作用,使医疗器械从设计、上市使用,到更新换代,组成了一个维护公众健康安全的统一体. 相似文献
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《医院领导决策参考》2008,(15)
中国初步建立起医疗器械监管体系确保安全 国务院新闻办公室近日发表的《中国的药品安全监管状况》白皮书说,2000年中国发布实施《医疗器械监督管理条例》,初步建立了以产品上市前审批、上市后监督和警戒以及对生产企业监管为核心的医疗器械监管体系。白皮书说,警戒主要包括不良事件监测、再评价和预警召回等制度;对生产企业监管的主要手段包括质量监督抽验、 相似文献
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医疗器械的研发、批准上市和监管与处方药在某些方面有相似之处,同时更具有挑战性。然而,器械管理的传统和药品大不相同,存在问题更多。例如,Lenzer和Brownlee(doi:10.1136/bmj.c4753)报道了一种治疗癫痫的交感神经刺激器,这种 相似文献
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1990年美国食品与药物管理局(FDA)批准了23种新分子本体(NME),19种用于治疗,4种用于诊断(见表1)。除上述NME外,FDA还批准了11种治疗用药,但它们在1990年底前不会上市(见表2)。 相似文献
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医疗器械技术的发展对于现代医疗行业的转型具有极其重要的作用与意义。国产医疗器械技术水平随着我国经济实力的增强及国家政策的大力支持,已取得了显著的进步,但在应用推广方面还存在着一定的挑战。本文通过介绍国家对医疗器械行业的政策扶持情况、“十二五”与“十三五”部署要点、浙江省对国产医疗器械的推广经验及进一步措施等,点明了国产医疗器械的应用推广方向及应用示范措施。基于国家前期的部署与经验,国产医疗设备的应用示范将进一步助推我国医疗器械行业的发展,并为提升我国基层医疗水平、解决基层医疗服务不到位不可及的问题带来变革性的推动作用。 相似文献
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The Food & Drug Administration (FDA) is considering the permanent exemption of premarket notification requirements for several Class I and II medical device products, including several artificial Intelligence (AI)–driven devices. The exemption is based on the need to rapidly more quickly disseminate devices to the public, estimated cost-savings, a lack of documented adverse events reported to the FDA’s database. However, this ignores emerging issues related to AI-based devices, including utility, reproducibility and bias that may not only affect an individual but entire populations. We urge the FDA to reinforce the messaging on safety and effectiveness regulations of AI-based Software as a Medical Device products to better promote fair AI-driven clinical decision tools and for preventing harm to the patients we serve. 相似文献
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目的基于医疗器械唯一标识(Unique Device Identification,UDI)构建流通企业全流程信息化管理体系。方法通过升级优化企业现有ERP系统、WMS系统增加UDI条码识别功能,同时与国家药品监督管理局UDI数据库对接,实现医疗器械从供应商到流通企业到下游客户UDI的全流程可追溯。结果实现了对于生产企业已经赋UDI码的医疗器械扫码出入库,并以UDI唯一标识为线索实现ERP、WMS、SPD多个信息系统协同。结论基于UDI的医疗器械信息化管理体系提高医疗器械出入库及库房管理效率和精细度,降低了流通企业物流管理成本,为实现医疗器械全生命周期闭环管理和全流程追溯打下良好的数据基础,为医疗器械经营企业的UDI推进提供实践参考。 相似文献
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Kadija Ferryman 《J Am Med Inform Assoc》2020,27(12):2016
The exponential growth of health data from devices, health applications, and electronic health records coupled with the development of data analysis tools such as machine learning offer opportunities to leverage these data to mitigate health disparities. However, these tools have also been shown to exacerbate inequities faced by marginalized groups. Focusing on health disparities should be part of good machine learning practice and regulatory oversight of software as medical devices. Using the Food and Drug Administration (FDA)''s proposed framework for regulating machine learning tools in medicine, I show that addressing health disparities during the premarket and postmarket stages of review can help anticipate and mitigate group harms. 相似文献
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Nilanjan Dey Amira S. Ashour Fuqian Shi Simon James Fong João Manuel R. S. Tavares 《Journal of medical systems》2018,42(4):74
Medical cyber-physical systems (MCPS) are healthcare critical integration of a network of medical devices. These systems are progressively used in hospitals to achieve a continuous high-quality healthcare. The MCPS design faces numerous challenges, including inoperability, security/privacy, and high assurance in the system software. In the current work, the infrastructure of the cyber-physical systems (CPS) are reviewed and discussed. This article enriched the researches of the networked Medical Device (MD) systems to increase the efficiency and safety of the healthcare. It also can assist the specialists of medical device to overcome crucial issues related to medical devices, and the challenges facing the design of the medical device’s network. The concept of the social networking and its security along with the concept of the wireless sensor networks (WSNs) are addressed. Afterward, the CPS systems and platforms have been established, where more focus was directed toward CPS-based healthcare. The big data framework of CPSs is also included. 相似文献
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Jeffrey S Brown Aaron B Mendelsohn Young Hee Nam Judith C Maro Noelle M Cocoros Carla Rodriguez-Watson Catherine M Lockhart Richard Platt Robert Ball Gerald J Dal Pan Sengwee Toh 《J Am Med Inform Assoc》2022,29(12):2191
The US Food and Drug Administration (FDA) created the Sentinel System in response to a requirement in the FDA Amendments Act of 2007 that the agency establish a system for monitoring risks associated with drug and biologic products using data from disparate sources. The Sentinel System has completed hundreds of analyses, including many that have directly informed regulatory decisions. The Sentinel System also was designed to support a national infrastructure for a learning health system. Sentinel governance and guiding principles were designed to facilitate Sentinel’s role as a national resource. The Sentinel System infrastructure now supports multiple non-FDA projects for stakeholders ranging from regulated industry to other federal agencies, international regulators, and academics. The Sentinel System is a working example of a learning health system that is expanding with the potential to create a global learning health system that can support medical product safety assessments and other research. 相似文献
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目的推进医疗器械唯一标识(Unique Device Identification,UDI)在医疗机构或企业的落地应用,助力医用耗材的精细化管理。方法利用国家UDI数据库的DI数据资源和国药集团中国医疗器械有限公司标准化医疗器械大数据库,通过建立"UDI公共服务平台"的计算机系统,对医疗机构或企业的数据进行DI的对码及不规范数据的规范化转换。同时,增加或改造医疗机构或企业数据字典的字段内容。结果实现医疗机构或企业数据字典的DI数据对应,确保医用耗材数据唯一性,并规范医疗机构或企业现有数据字典内容,为医用耗材的供应链精细化合规管理打下数据基础。结论UDI公共服务平台的模型探索,有助于推进UDI在医疗机构的导入与深度应用,为我国各类型医疗机构导入UDI提供有效助力,也为监管机构更好地服务医疗机构,提供示范和借鉴经验。 相似文献
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医疗器械是一个多学科交叉的高技术行业,本研究采用定量与定性相结合的分析方法识别中国医疗器械的重点子领域。通过对Derwent Innovation数据库中医疗器械领域的专利进行检索,根据国家药品监督管理局组织修订的《医疗器械分类目录》,并结合医药器械的专利分类特点,将医疗器械领域专利分为17个子领域,采用统计学分析方法对中国医疗器械17个子领域技术开发特点进行分析,并对重点子领域进行识别。中国在医疗器械的消毒灭菌设备,注输、护理和防护器械,医院设备,呼吸麻醉和急救器械,患者承载器械五个子领域占据创新优势。 相似文献