基于FDA MAUDE数据库的手术机器人不良事件数据的智能化分析

检索了美国食品药品监督管理局(Food and Drug Administration,FDA)制造商和用户设施设备体验(Manufa-cturer and User Facility Device Experience,MAUDE)数据库中2000—2021年的达芬奇机器人手术系统不良事件数据,利用Python对所有不良事件进行了智能化处理与分析,重点阐述了达芬奇机器人手术系统的不良事件变化趋势、应用科室分布和各类不良事件占比、主要设备故障类型、2013—2019年的手术量及分布科室,为达芬奇机器人手术系统安全性评价提供了临床证据。

美国FDA MAUDE数据库气管插管不良事件相关数据的分析

目的:分析呼吸机用气管插管不良事件相关数据,探讨影响气管插管安全性相关因素,为临床合理及安全使用气管插管提出建议。方法:检索美国FDA MAUDE数据库,对2019-2021年间3777例气管插管不良事件报告进行统计分析。结果:气管插管不良事件器械故障方面主要表现为气囊问题、连接问题、导管问题和标签问题等;患者伤害方面主要表现为非计划性拔管、缺氧/低血氧饱和度和呼吸功能问题等。结论:通过分析美国FDA MAUDE数据库中2019-2021年气管插管不良事件发生原因,建议我国气管插管生产企业应积极主动开展不良事件监测工作,加强对气管插管的质量管控,落实企业主体责任;使用单位应严格执行气管插管术操作规范,熟练掌握插管技术,特别警惕呼吸机与气管插管配合使用进行机械通气所产生的风险;监管部门应加强监督检查和开展医疗器械不良事件培训工作。

美国FDA MAUDE数据库呼吸机致死不良事件分析

检索了美国食品药品监督管理局(Food and Drug Administration,FDA)医疗器械制造商和用户设施设备体验(Manufacturer and User Facility Device Experience,MAUDE)数据库中2022年1月1日至2022年12月31日呼吸机不良事件的报告数据,利用Python提取了呼吸机不良事件中致人死亡的数据并进行了统计分析,指出了消音泡沫降解、使用不当、呼吸机故障等为呼吸机致人死亡的主要原因,从用料、生产商、使用方、设备维护维修方、监管部门等5个方面提出了相关建议,为其他医疗设备的使用管理和不良事件控制提供了参考。

基于美国MAUDE数据库的机械通气设备患者安全影响因素研究

目的通过对机械通气设备的患者安全影响因素进行分析,预防和减少医疗过程中机械通气设备给患者造成的风险、错误和伤害。方法本文采用回顾性分析的方法,对美国MAUDE数据库中的机械通气设备进行检索和分析,从而找出影响患者安全的几种关键因素。结果报警疲劳、操作不当、未正确连接管路等人为因素对患者安全的影响较大,占比为63.84%;包括可预防故障和不可预防故障的设备因素占比为24.79%;火灾、停电等其他因素占11.38%。结论保障机械通气设备的患者安全,需要加强患者安全文化建设,完善呼吸治疗师培养体系,同时,可以结合人因工程学,优化报警阈值及使用环境,完善设备的实时监测,加强设备的预防性维护、质量控制。

Formalization of P Systems by Maude

Rewriting logic is a unified model of concurrency, which provides a formal commo n framework of well-known models of concurrent systems. A new formal method of t he specification and execution of P systems using rewriting logic was proposed. The powerful tool Ma ude 2.0 is used to implement this specification. In order to present the general ideas in a concr ete case study, a simple and classical example from the literature is adopted to present how to formally spe cify and execute a P system.

FDA MAUDE database analysis of titanium middle ear prosthesis

Purpose:Partial ossicular replacement(PORP)and total ossicular replacement prostheses(TORP)are used to restore ossicular chain function.Despite favorable auditory outcomes,these interventions have associated risks and complications.This study examines the FDA MAUDE database for ossicular chain prosthesis adverse events to highlight complications,interventions,and root cause analysis(RCA)findings.Materials and methods:The MAUDE database was searched for Medical Device Reports(MDRs)relating to PORPs and TORPs from 2010 to 2020.MDR event descriptions were reviewed,and adverse events were identified as a device issue,patient issue,and/or packaging issue that occurred intraoperatively or postoperatively.Results:Our search identified 70 MDRs which included 110 reported adverse events.Events consisted of 63 device issues,often due to device breaks and displacements,39 patient issues,including common complaints of hearing loss and erosion,and 8 packaging issues.When comparing PORPs and TORPs,TORPs had more reported device issues whereas PORPs had more packaging issues.Intraoperative device issues were commonly resolved by completing the procedure with a backup device and most postoperative device issues required additional surgery.For devices returned to the manufacturer,RCA determined that most breaks were caused by modification and/or mishandling or that the product met specifications with an undetermined cause for the break.Conclusion:Device issues were the most common adverse events and frequently required subsequent intervention.Displacement occurred more often with TORPs and was associated with changes in hearing or erosion.The findings of this study are purely descriptive and may not have direct clinical relevance.

FDA MAUDE数据库中血透机不良事件相关数据分析

目的为血透机相关的不良事件监测工作提供参考。方法对美国FDA MAUDE数据库2016年6月1日至2019年3月31日收集到的212份费森尤斯医疗(Fresenius Medical Care)公司生产的血透机不良事件报告情况进行统计分析,进而探讨血透机使用安全性影响因素。结果不良事件主要是机器故障,其中设备内的回流是主要问题,再者就是液体泄漏问题。不良事件造成的结果主要是导致患者受伤,导致患者死亡的事件较少。结论相关部门要重视开展血透机不良事件的监测工作,为公众使用医疗器械的安全提供保障。

Formal Modeling and Analysis of AADL Threads in Real Time Maude

This paper presents, without altering the AADL meta-model, a formal description of static and behavioral aspects of the AADL thread component. This active and concurrent applicative component of AADL poses many challenges to its formalization and analysis including instantaneous and/or delayed communications, concurrent tasks and time-dependent features, and the need to analyze correctness. This formalization, based on real-time object-oriented theories, allows not only a precise description of the semantics of threads composition with respect to their timing requirements but also makes possible the formal verification of behavioral properties.

美国FDA MAUDE数据库中口腔科器械与设备类产品不良事件报告汇总分析

通过对美国FDA MAUDE数据库中口腔科器械与设备类产品不良事件报告进行统计分析,总结其不良事件特点,初步探讨其安全性影响因素,为公众用械安全提供保障。

Web服务组合事务处理及基于细胞膜演算的正确性分析

事务处理是Web服务及其组合服务能否得到广泛应用的关键技术之一。本文分析总结了现有的事务处理模型,针对Web服务组合环境下的异构性、自治性和动态性,提出了一个基于组合Web服务的事务处理模型WS-CTM,并基于细胞膜演算对模型的正确性进行了验证。

Petri网的重写逻辑模型及其属性验证

为了对大规模或复杂结构的系统进行规格,人们在经典的库所/迁移Petri网基础上加入层次、时间等来扩展它。为此,提出使用重写逻辑表达Petri网的新方法来探索对Petri网的替代。通过把异步并发系统的Petri网图形表达转化为重写逻辑理论,可以更容易和更直接地验证原系统的安全性、活性和可达性等行为属性,而不需要建立标识图或搜索网络不变量。以银行家问题为例,展示模型转化过程,并检测了该模型的无死锁性。结果表明,库所/变迁Petri网可以等效转化为重写规则代数组合的重写逻辑,并能在重写逻辑软件Maude中验证保留的基本属性。

基于项重写系统的联锁系统模型检测方法研究

模型检测方法对安全苛求系统建模的完整性需要一套严谨的方法论与技术,对于验证系统的正确性,具有传统方法无法比拟的优势。提出利用项重写系统建立安全苛求系统模型与验证方法,采用基于项重写系统原理的Maude工具语言,对铁路联锁系统的站场进行形式化建模,通过其语法和语义定义各类约束和离散事件,构架联锁系统属性和行为。在模型建立的基础上,对联锁站场的静态属性和安全属性进行形式化模型验证。结果表明,基于项重写系统的模型检测方法可以较好地应用于实际联锁系统软件的开发,对开发安全苛求系统和模型检测方法的实际应用提供借鉴。

麻醉机不良事件相关数据分析

目的:分析麻醉机不良事件相关数据,探讨影响麻醉机安全性的相关因素,为临床合理及安全使用麻醉机提供有效信息。方法:检索美国食品药品监督管理局(FDA)医疗器械制造商和用户设施设备体验(MAUDE)数据库,从MAUDE数据库中2018年8-12月麻醉机225例不良事件报告中整理归纳出221例有效报告数据,对不良事件报告来源、不良事件类型以及不良事件主要表现和原因进行统计分析。结果:麻醉机不良事件主要表现为患者死亡、患者受伤和仅设备故障未对患者造成伤害3类,其中患者死亡3例,占1.36%;患者受伤(包含轻伤及重伤)9例,占4.07%;设备故障209例,占94.57%,设备故障为不良事件多发区。结论:麻醉机生产单位应提高生产技术,加强故障检测及自动报警功能;使用单位应严格按照诊疗规范操作,提高临床医务人员和维修人员的风险意识,加强设备日常维护和保养,为医疗器械安全有效使用提供保障。

基于重写逻辑的PKMv3协议形式化建模与验证

IEEE802.16m标准在MAC安全子层定义了密钥管理PKMv3协议,用于认证和授权信息的传输以及密钥的交换。由于宽带无线网络具有易遭受攻击的特性,引入入侵者模型分析密钥管理协议的安全机制。利用一种基于重写逻辑的形式化建模语言Maude,实现对PKMv3网络环境中的通信主体以及系统状态的建模,并利用其自带的模型检测工具验证协议的安全特性。验证结果表明,PKMv3协议能保证密钥的机密性以及认证的可靠性,但仍有可能遭遇到中间人攻击破坏消息传输的完整性。

审计人才能力需求与MAud教学改革问题研究

以审计人才能力需求的视角作为切入点,结合现实问题与北京国家会计学院在审计专业硕士学位教育中积累的经验,从培养目标、课程设置、教学方法三个方面探索并提出了我国审计专业硕士学位教育中的一些改革建议。

Stenian A-type granitoids in the Namaqua-Natal Belt,southern Africa,Maud Belt,Antarctica and Nampula Terrane,Mozambique:Rodinia and Gondwana amalgamation implications

We carried out SHRIMP zircon U-Pb dating on A-type granitic intrusions from the Namaqua-Natal Province,South Africa,Sverdrupfjella,western Dronning Maud Land,Antarctica and the Nampula Province of northern Mozambique.Zircon grains in these granitic rocks are typically elongated and oscillatory zoned,suggesting magmatic origins.Zircons from the granitoid intrusions analyzed in this study suggest^1025-1100 Ma ages,which confirm widespread Mesoproterozoic A-type granitic magmatism in the Namaqua-Natal(South Africa),Maud(Antarctica)and Mozambique metamorphic terrains.No older inherited(e.g.,~2500 Ma Achean basement or^1200 Ma island are magmatism in northern Natal)zircon grains were seen.Four plutons from the Natal Belt(Mvoti Pluton,Glendale Pluton,Kwalembe Pluton,Ntimbankulu Pluton)display 1050-1040 Ma ages,whereas the Nthlimbitwa Pluton in northern Natal indicates older 1090-1080 Ma ages.A sample from Sverdrupfjella,Antarctica has^1091 Ma old zircons along with^530 Ma metamorphic rims.Similarly,four samples analysed from the Nampula Province of Mozambique suggest crystallization ages of^1060-1090 Ma but also show significant discordance with two samples showing younger^550 Ma overgrowths.None of the Natal samples show any younger overgrowths.A single sample from southwestern Namaqualand yielded an age of^1033 Ma.Currently available chronological data suggest magmatism took place in the Namaqua-Natal-MaudMozambique(NNMM)belt between^1025 Ma and^1100 Ma with two broad phases between^1060-1020 Ma and 1100-1070 Ma respectively,with peaks at between^1030-1040 Ma and^1070-1090 Ma.The age data from the granitic intrusions from Namaqualand.combined with those from Natal,Antarctica and Mozambique suggest a crude spatial-age relationship with the older>1070 Ma ages being largely restricted close to the eastern and western margins of the Kalahari Craton in northern Natal,Mozambique.Namaqualand and WDML Antarctica whereas the younger<1060 Ma ages dominate in southern Natal and western Namaqualand and are largely restricted to the southern and possibly the western margins of the Kalahari Craton.The older ages of magmatism partially overlap with or are marginally younger than the intracratonic Mkondo Large lgneous Provinee intruded into or extruded onto the Kalahari Craton,suggesting a tectonic relationship with the Maud Belt.Similar ages from granitic augen gneisses in Sri Lanka suggest a continuous belt stretching from Namaqualand to Sri Lanka in a reconstituted Gondwana,formed during the terminal stages of amalgamation of Rodinia and predating the East African Orogen.This contiguity contributes to defining the extent of Rodinia-age crustal blocks,subsequently fragmented by the dispersal of Rodinia and Gondwana.

人工智能环境下MAud“二元三能力”人才培养模式研究

随着人工智能的兴起,人机协同作业将成为未来审计方式的常态,给审计行业产生巨大冲击。作为高层次审计专业人才输送基地的高校,其教学培养模式对MAud环境适应能力起着关键性作用。本文首先分析了人工智能给审计带来的影响,以此为基础探讨了人工智能环境对审计人员专业胜任能力要求;其次分析了我国MAud教育存在的问题,进而构建了理论课程与实践课程并重,培养良好的沟通技能与表达能力、数据采集处理与分析能力以及独立思考与批判性思维能力的"二元三能力"的MAud人才培养模式,为当前高校MAud人才培养提供新的思路。

基于实务导向的MAud课程体系创新研究

对于审计专业硕士(MAud)这种新型人才的培养,其课程教学的目标、模式和方法与审计学硕士、MPAcc存在较大差异。文章首先提出了以审计实务应用为导向、以满足审计职业需求为目标、以综合素养和应用知识能力的提高为核心的MAud课程体系的构建理念,然后对目前高校MAud课程体系现存问题进行剖析,最后基于实务导向给出MAud课程体系的改进建议。

Beyond Sorrow,Being Eternal——The Textual Analysis of Yeats' When You Are Old

When You Are Old is a famous poem written by Yeats to his infatuation Maud Gonne. The paper analyzes the poem in the following aspects: the conflicting elements, rhythm, the opposition and unity of form and content in the text to reveal the theme thoroughly: to be beyond sorrow, then to be eternal in love and life.

A Comparative Study of When You Are Old and The Song of Wandering Aengus

William Butler Yeats is well known for his skills in poetry as symbolism and mysticism which bring blocks for readers to get the intensions of his poems while which offer more larger space for students to interpret or read them. This paper, by means of a comparative reading of Yeats' two lyrics, When you are old and The Song of Wandering Aengus, and in the perspective of archetype and image of Maud Gonne, poet's apple-like lover, aims to rediscover the two poems and to get a better understanding of them in order to catch the poet's thinking on love.