目的/意义 针对医疗器械制造商与用户设施不良事件报告(manufacturer and user facility device experience, MAUDE)数据库分析中存在的技术复杂度高与效率低等问题,设计并实现自动化分析框架,降低数据库分析难度并加速研究产出。方法/...目的/意义 针对医疗器械制造商与用户设施不良事件报告(manufacturer and user facility device experience, MAUDE)数据库分析中存在的技术复杂度高与效率低等问题,设计并实现自动化分析框架,降低数据库分析难度并加速研究产出。方法/过程 基于双链式结构设计AutoQUEST框架,其具备研究问题自动生成、结构化SQL查询构建及数据分析能力。通过5组案例评估框架查询成功率、执行时间及报告质量。结果/结论 在最优案例中,该框架查询成功率达100%,执行时间158秒,综合质量评分4.74分(满分5分),既能实现MAUDE数据库高效自动化分析,又能保持高质量的分析结果,可为医疗机构、医疗器械制造商及监管机构提供便捷可靠的数据分析支持。展开更多
回顾性分析了美国食品药品监督管理局制造商和用户设施设备体验(Manufacturer and User Facility Device Experience,MAUDE)数据库2021年1月至2024年6月的弹簧圈不良事件,结合山东省内医院调研和专家论证情况指出了弹簧圈在临床使用过...回顾性分析了美国食品药品监督管理局制造商和用户设施设备体验(Manufacturer and User Facility Device Experience,MAUDE)数据库2021年1月至2024年6月的弹簧圈不良事件,结合山东省内医院调研和专家论证情况指出了弹簧圈在临床使用过程中存在的风险点并进行了原因分析,提出了落实注册人的主体责任、提高使用单位的专业技能、强化监管部门的监管力度等改进措施,为弹簧圈的安全使用提供了参考。展开更多
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...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。展开更多
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Py...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。展开更多
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 rewri...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.展开更多
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...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。展开更多
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....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.展开更多
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...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.展开更多
制造商和用户设备体验数据库(manufacturer and user facility device experience database,MAUDE)是美国FDA管理医疗器械不良事件的国家数据库,乳房假体作为医用器械材料在MAUDE数据库中存在大量不良事件的报道,检索并下载自2020年11月...制造商和用户设备体验数据库(manufacturer and user facility device experience database,MAUDE)是美国FDA管理医疗器械不良事件的国家数据库,乳房假体作为医用器械材料在MAUDE数据库中存在大量不良事件的报道,检索并下载自2020年11月1日至2023年10月31日所有不良事件,其中主要包括临床常见的局部并发症和非特异性的乳房置入疾病(breast implant illness,BII)。目前在学术界对BII的发生与乳房假体之间的因果关系尚无定论,而对BII的更好理解可能会让患者进一步思考乳房置入的益处是否大于风险。笔者现就乳房假体置入的风险和不良反应作一综述。展开更多
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 challe...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.展开更多
Many of W.B. Yeats' s poems are inspired and influenced by Maud Gonne, as his love of the life, whose images have been changing from hi"sRose"with beauty and untouchability to"Helen"with destru...Many of W.B. Yeats' s poems are inspired and influenced by Maud Gonne, as his love of the life, whose images have been changing from hi"sRose"with beauty and untouchability to"Helen"with destructive power and"Phoenix"with spiritual eternity during different Irish historical and social backgrounds. By analyzing three selected poems, this paper reveals that Yeats' s creating of the images of Maud Gonne is not single but multiple, which are not only concerned with the eulogy of her beauty but also her powerful mind and faithful dedication towards Irish national independence and liberation.展开更多
文摘目的/意义 针对医疗器械制造商与用户设施不良事件报告(manufacturer and user facility device experience, MAUDE)数据库分析中存在的技术复杂度高与效率低等问题,设计并实现自动化分析框架,降低数据库分析难度并加速研究产出。方法/过程 基于双链式结构设计AutoQUEST框架,其具备研究问题自动生成、结构化SQL查询构建及数据分析能力。通过5组案例评估框架查询成功率、执行时间及报告质量。结果/结论 在最优案例中,该框架查询成功率达100%,执行时间158秒,综合质量评分4.74分(满分5分),既能实现MAUDE数据库高效自动化分析,又能保持高质量的分析结果,可为医疗机构、医疗器械制造商及监管机构提供便捷可靠的数据分析支持。
文摘回顾性分析了美国食品药品监督管理局制造商和用户设施设备体验(Manufacturer and User Facility Device Experience,MAUDE)数据库2021年1月至2024年6月的弹簧圈不良事件,结合山东省内医院调研和专家论证情况指出了弹簧圈在临床使用过程中存在的风险点并进行了原因分析,提出了落实注册人的主体责任、提高使用单位的专业技能、强化监管部门的监管力度等改进措施,为弹簧圈的安全使用提供了参考。
文摘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。
文摘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。
基金National Natural Science Foundation ofChina (No. 60173033) and 973 Project( No. 2002CB312002 ) of China, andGrand Project of the Science and Tech-nology Commission of Shanghai Munici-pality ( No. 03dz15027 and No.03dz15028)
文摘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.
文摘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。
基金supported by a Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science to K.S.(Nos.09041116and 13440151)a Grant-in-Aid for the Young Scientists from JSPS to T.H.Antarctic Research funding to GHG from the NRF,SouthAfrica,Grant ID.110739
文摘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.
文摘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.
文摘制造商和用户设备体验数据库(manufacturer and user facility device experience database,MAUDE)是美国FDA管理医疗器械不良事件的国家数据库,乳房假体作为医用器械材料在MAUDE数据库中存在大量不良事件的报道,检索并下载自2020年11月1日至2023年10月31日所有不良事件,其中主要包括临床常见的局部并发症和非特异性的乳房置入疾病(breast implant illness,BII)。目前在学术界对BII的发生与乳房假体之间的因果关系尚无定论,而对BII的更好理解可能会让患者进一步思考乳房置入的益处是否大于风险。笔者现就乳房假体置入的风险和不良反应作一综述。
文摘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.
文摘Many of W.B. Yeats' s poems are inspired and influenced by Maud Gonne, as his love of the life, whose images have been changing from hi"sRose"with beauty and untouchability to"Helen"with destructive power and"Phoenix"with spiritual eternity during different Irish historical and social backgrounds. By analyzing three selected poems, this paper reveals that Yeats' s creating of the images of Maud Gonne is not single but multiple, which are not only concerned with the eulogy of her beauty but also her powerful mind and faithful dedication towards Irish national independence and liberation.
