医疗设备使用风险分析方法的对比改进与应用

归纳了当前医疗设备生产行业的主要风险分析方法,评价了这些方法对医疗机构的适用性.在此基础上提出了面向医疗机构的设备使用风险分析模型,并结合模糊数学和灰色关联理论对定量评估方法进行了改进,形成了以FMEA为核心的设备使用风险预测和控制的流程体系.最后给出了方法的实际应用案例.     

基于FMEA的污水排放设备维护策略

以污水排放系统的设备为研究对象,采用系统失效模式及后果分析方法(系统FMEA)区分设备的关键等级,综合运用设备失效模式及后果分析方法(设备FMEA)确定各设备的主导故障,定制不同设备的维护策略.通过一具体实例说明运用FMEA定制维护策略的全过程.     

故障树分析法在医疗设备维修中的运用分析

为了满足医疗设备高效利用的需求,目前故障树分析法被大范围应用。故障树分析法是较完备的设备检修方法,采用故障树,可提高设备检修的质量,保证医疗设备资源不浪费。该文通过文献研究法、调查法,剖析了故障树分析法的应用价值。研究内容包括了故障树运用原理、实施程序、故障树应用创新要点等。研究结果表明,故障树分析法的应用,可从源头快速、有效地维护医疗设备,为使用安全性提供了较为全面的技术保障。     

FMEA在烟草设备管控和设计中的应用

为积极响应《制造强国2025》“创新驱动、质量优先、绿色发展、结构优化、人才为本”的基本方针,采用一种风险评估技术——FMEA(Failure Mode and Effects Analysis),通过失效模式和影响分析,实现对设备的精确管控,促进企业提升产品和服务质量。介绍了FMEA在济南卷烟厂设备管控和设计中的两个应用案例,包括FMEA因子的导入、表格制作及FMEA结果的应用三个方面。结果表明,探索建立的标准化失效模式和影响分析流程,在降低设备故障率、研发新型检测系统、提高设备工艺水平方面成效显著。这种标准化的流程为实现对设备的精确管控奠定了基础。     

基于FMEA的临床路径医疗风险成本估计

为了解决目前医疗风险成本研究主要关注医疗风险结果成本,忽视临床路径医疗风险成本估计的问题,提出了一种基于可靠性理论的临床路径医疗风险成本估计的方法。为了验证该方法的性能,以北京市某三级甲等医院食道癌手术临床路径为例,运用事故树分析（FTA）、失效模式与影响分析（FMEA）明确临床路径关键风险因素,并结合临床路径风险频率及严重度评分表与平均风险消除成本,对临床路径医疗风险成本进行量化。计算结果表明：该医院食道癌手术术中加权平均风险消除成本为14 710元,全年食道癌手术术中加权平均医疗风险消除成本为397 290元。所提出方法可以有效地估计临床路径医疗风险成本,并为实际应用提供指导。     

基于FMEA的军队第三方物流供应商选择

目的 针对军队第三方物流供应商的选择问题,从风险视角对供应商完成军事保障任务过程中可能存在的风险进行识别和评估,以降低军事物流外包风险,为军队第三方物流供应商决策提供方法和思路。方法 提出可将FMEA技术运用于军队第三方供应商选择中的操作性框架,按照框架流程确定评价标准、识别潜在失效模式、决策分析,可更加全面、科学地对军队第三方供应商做出选择。结果 在不考虑风险的情况下,5家候选供应商中E的原始评分最高,D排名居中,但经过FMEA分析后,由于E在单项评价指标上的风险比例太大,而D的各项指标风险比原始排名靠前的供应商小很多,因此D成为军队最终选择的供应商。结论 利用FMEA分析军队第三方物流供应商选择问题,可以起到事先识别可能出现的失效模式,分析产生原因和可能导致的后果以及现有措施的可控程度,从而评估每位候选供应商在确定的评价标准中的风险大小,最后综合原始评分得出了供应商选择的结果。该方法操作简单、计算方便,能比较全面衡量军队第三方物流供应商的综合水平,有助于提高军队物资保障效率,降低物资保障风险。     

温度载荷条件下的新装备故障模式影响及危害性分析

针对由于新装备历史数据缺乏、依赖人工分析导致测试性试验样本存在主观性和盲目性等问题,在现有方法的基础上提出温度载荷下的的故障模式影响及危害性分析方法。首先,分别建立元器件和焊点在温度载荷下的失效模型;然后,提出基于元器件、焊点融合失效模型的典型故障模式的失效概率计算方法;最后,将元器件和焊点加速退化试验数据带入融合失效模型进行计算实现最终分析。试验结果表明:该方法可对现有故障模式影响及危害性分析方法提供有效补充和修正,充分暴露产品测试性设计缺陷并为测试性设计改进工作提供支持。     

计算机技术在医疗设备维护中的应用

文章主要介绍了计算机技术在医疗仪器设备维护过程中的运用情况,并结合相关实例,阐述了我国常见医疗设备维修中所用到的计算机技术,希望有助于促进计算机技术在医疗设备维护中的进一步发展与运用。     

浅谈目标管理在医疗设备中的应用

目标管理在医疗设备管理中具有政策性强、有计划、有组织,并能对管理过程各个环节进行调节,避免浪费,使科室能充分利用现代化的仪器设备,获得最佳使用效果,大大提高设备的使用率。本文结合医疗设备的目标管理进行了探讨。     

医疗设备档案管理在医患服务中的作用初探

建立有利于医院发展和患者需求的医疗设备档案管理体系,通过管理体系定期和不定期地检查设备质量、运行状况和检测维修情况;通过已建立的医疗设备档案,确定医疗设备购置与否,最终避免重复购置,降低成本,减少浪费;完善设备维修档案,并付诸实施,实行建档和管理相结合,有利于进行医疗设备使用效益分析;通过互联网建立统一的医疗设备档案库,实现资源整合和共享,有效应对突发事和紧急事。     

塔里木油田氮气钻井内防喷器组的可靠性分析

综合应用故障模式影响及危害度分析（FMECA）与故障树分析(FTA)对氮气钻井内防喷器组进行可靠性分析。首先对氮气钻井内防喷器组进行系统级和设备级的故障模式影响及危害度分析,找出各个设备的常见故障模式,提出对应的改进措施,并定量计算出故障模式的危害度和系统内各个内防喷工具的危害度,为故障树分析确定顶事件。故障树分析,求出导致氮气钻井内防喷器组主要故障的所有底事件和最小割集,进而确定底事件的结构重要度的大小和底事件的组合方式对系统故障的影响力,对结构重要度大的底事件和底事件的组合方式对系统故障的影响力高的故障形式优先采取改进措施,并对薄弱零部件进行可靠度计算,更有针对性地对薄弱零部件进行设计改进和故障监测。鉴于对氮气钻井内防喷器组的可靠性研究,得出箭型止回阀锥面密封故障、翻板浮阀的复位弹簧失效、投入式止回阀的投球被压溃、旁通阀的扣断裂和旋塞阀的旋球被“抱死”是导致系统失效的主要故障模式,分析5种故障模式的所有可能的原因并提出了相应的改进方案。     

基于灰色关联分析的故障模式危害性决策方法

 通过考虑产品设计者的设计意图及偏好,计算了各危害性故障模式对危害性理想故障模式的灰关联度,依此对各故障模式危害性进行了排序,克服了传统风险优先数法当RPN值相等或相近时各故障模式危害程度难以比较以及各个风险优先数因子无相对权重的问题.最后以某产品的工艺FMECA分析为例,进行了验证.     

Test sample allocation method for testability verification test

An extended failure mode effect and criticality analysis (FMECA)-based sample allocation method for testability verification is presented in this study to deal with the poor representativeness of test sample sets and the randomness of the testability evaluation results caused by unreasonable selection of failure samples. First, the fault propagation intensity is introduced as part of the extended information of FMECA, and the sample allocation impact factors of component units and failure modes are determined under this framework. Then, the failure mode similarity and impact factor support are defined, and the game decision method for weighing the relationship between similarity and support is proposed to obtain the weight of failure mode impact factor. Finally, a two-step allocation framework of test samples is formulated to realize the sample allocation of component units and failure modes. This method is applied to the testability verification test of a launch control system. Results show that this method can obtain more representative test samples compared with the traditional sample allocation method while effectively reducing randomness of single testability evaluation result.     

Reliability analysis techniques for mechanical systems

This paper discusses the application of known system reliability analysis techniques and identifies problems encountered in the practical implementation of these methods, revealing that no single technique is sufficient or even feasible in the case of complex mechanical systems. A new functional analysis method as well as a (new) criticality quantitative approach and failure mechanism analysis are presented and used to analyse an aircraft fuel system. A rigorous and detailed FMECA is still required. Besides its main function it will supply much of the valuable information for many other techniques.     

基于电子器件失效分析流程对失效LED分析方法的研究

结合一般电子器件失效分析方法,系统地设计了针对已失效LED器件的分析流程,并从封装结构和光、热特性几个方面比较了LED与一般器件失效分析方法的不同之处。通过分析发现了一般分析难以检测到的表面污染物污染、内部芯片断层等失效模式。实验证明,此方法对判断LED失效模式、推测失效机理更加准确,并可以有效地避免一般分析方法中过早的破坏性分析引入的损伤,以及将光电检测中电流和温度应力导致的损伤误判为器件原有失效因素。     

A new risk prioritization model for failure mode and effects analysis

Failure modes and effects analysis is a framework that has been widely used to improve reliability by prioritizing failures modes using the so‐called risk priority number. However, the risk priority number has some problems frequently pointed out in literature, namely its non‐injectivity, non‐surjectivity, and the impossibility to give weights to risk variables. Despite these disadvantages, the risk priority number continues to be widely used due to its higher simplicity when compared with other alternatives found in literature. In this paper, we propose a novel risk prioritization model to overcome the major drawbacks of the risk priority number. The model contains 2 functions, the risk isosurface function that prioritizes 3 risk variables considering their order of importance in a given risk scenario, and the risk prioritization index function which prioritizes 3 risk variables considering their weights. The novelty of the proposed model is its injectivity, surjectivity, and ease of use in failure modes prioritization. The performance of the proposed model was analyzed using some examples typically used to discuss the conventional risk priority number shortcomings. The model was applied to a case study and its performance correlated with other risk prioritization models. Results show that the failure modes prioritization reached with the proposed model agrees with the expectations made for the risk scenario.     

New Failure Mode and Effects Analysis: An Evidential Downscaling Method

Failure mode and effects analysis (FMEA) is an engineering and management technique, which is widely used to define, identify, and eliminate known or potential failures, problems, errors, and risk from the design, process, service, and so on. In a typical FMEA, the risk evaluation is determined by using the risk priority number (RPN), which is obtained by multiplying the scores of the occurrence, severity, and detection. However, because of the uncertainty in FMEA, the traditional RPN has been criticized because of several shortcomings. In this paper, an evidential downscaling method for risk evaluation in FMEA is proposed. In FMEA model, we utilize evidential reasoning approach to express the assessment from different experts. Multi‐expert assessments are transformed to a crisp value with weighted average method. Then, Euclidean distance from multi‐scale is applied to construct the basic belief assignments in Dempster–Shafer evidence theory application. According to the proposed method, the number of ratings is decreased from 10 to 3, and the frame of discernment is decreased from 2¹⁰ to 2³, which greatly decreases the computational complexity. Dempster's combination rule is utilized to aggregate the assessment of risk factors. We illustrate a numerical example and use the proposed method to deal with the risk priority evaluation in FMEA. The results and comparison show that the proposed method is more flexible and reasonable for real applications. Copyright © 2014 John Wiley & Sons, Ltd.     

A Method for Forecasting Credit Risk of Global Device Purchasing

With the development of the Internet and E-commerce, enterprises can achieve global device purchasing with a good cost performance. But the credit risk is the key factor in selecting a device provider. Credit risk involves many qualitative and quantitative factors. We construct a multi-agent credit rating model system based on CSCW, which organically combines the people‘s aptitude and the capability of machines. Enterprises can use this credit rating system for forecasting and defeating the credit risk of global device purchasing.     

浅谈医疗器械标准制修订需注意的问题

本文根据标准制修订的相关法规和规定,结合在医疗器械行业标准审查过程中发现的一些问题,对医疗器械标准制修订需注意的要点进行了初步探讨。     

一种综合赋权的改进FMEA风险评估方法

针对传统故障模式和影响分析(failure mode and effects analysis, FMEA)方法中的未考虑风险因子权重以及风险因子权重难确定这一问题,提出一种综合赋权的改进FMEA风险评估方法。该方法首先通过FMEA团队明确评估对象和FMEA范围,然后列出所有潜在故障模式,对故障模式进行打分,得到所有的专家打分评估表,再通过语言变量转化为直觉模糊数。由层次分析法确定主观权重,由数据本身确定客观权重,使用直觉模糊混合加权算子(intuitionistic fuzzy hybrid weighted, IFHW)算子集结评价信息,得到所有的故障模式的得分函数,最后基于风险最大化选取每个故障模式的最大分数,进行排名,得到最终的故障模式风险顺序。通过对静电纺丝设备进行FMEA分析,并与其他方法进行比较,验证了所提方法的可行性。