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
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
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
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
This paper proposes an approach to making livehess model checking problems under fairness feasible.The proposed method divides such a problem into smaller ones that can be conquered.It is not superior to existing tool...This paper proposes an approach to making livehess model checking problems under fairness feasible.The proposed method divides such a problem into smaller ones that can be conquered.It is not superior to existing tools dedicated to model checking liveness properties under fairness assumptions in terms of model checking performance but has the following positive aspects:1)the approach can be used to model check liveness properties under anti-fairness assumptions as well as fairness assumptions,2)the approach can help humans better understand the reason why they need to use fairness and/or anti-fairness assumptions,and 3)the approach makes it possible to use existing linear temporal logic model checkers to model check liveness properties under fairness and/or anti-fairness assumptions.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
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。
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This paper proposes an approach to making livehess model checking problems under fairness feasible.The proposed method divides such a problem into smaller ones that can be conquered.It is not superior to existing tools dedicated to model checking liveness properties under fairness assumptions in terms of model checking performance but has the following positive aspects:1)the approach can be used to model check liveness properties under anti-fairness assumptions as well as fairness assumptions,2)the approach can help humans better understand the reason why they need to use fairness and/or anti-fairness assumptions,and 3)the approach makes it possible to use existing linear temporal logic model checkers to model check liveness properties under fairness and/or anti-fairness assumptions.
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。
