血液透析机的维护与管理

血液透析机是肾病患者安全有效的治疗设备,因此,加强其在临床使用中的全面维护与管理,对提高血液透析机的安全性和使用率,提高临床救治的成功率,减少临床风险具有十分重要意义。本文主要论述了血液透析机的维护与管理方法。     

血液透析设备的安全管理

目的：探讨血液透析设备的安全管理，使血液透析患者得到安全有效的治疗。方法：总结了血液透析设备的安装、使用、保养等方面的管理方法。结果：通过严格的管理和规范的制度，血液透析患者可得到安全有效的治疗。结论：通过规范化管理，可以减少设备故障，延长设备寿命，提高设备使用率，使患者得到更好、更安全、更满意的治疗。     

费森尤斯4008B型血液透析机的常见故障维修与维护

血液透析机是肾脏替代疗法中最为重要的体外循环设备[1]。血液透析机由于需长期运作,加之受部分精密元件老化、设备磨损等因素影响,因此普遍存在高损耗现象,易发生故障。医工人员及时、熟练地排除故障并定期进行日常维护可降低血液透析机的故障发生风险,保障患者的生命安全。我院血液透析室拥有35台费森尤斯4008B型血液透析机,其中21台使用超过7年,7台已使用6年,7台已使用5年。     

柯达DV8900激光相机开机故障分析与排除

医用激光相机是医院常用数字医学诊断系统的主要输出设备,由于使用频率高而致故障经常发生,因此维修和维护非常重要。激光相机开机失效也是一个日常使用中常见的故障,通过对故障检修过程的分析,引起对仪器设备在日常使用过程中维护和保养的重视,确保设备在临床使用中的有效性和安全性。     

不可忽视散热风扇在医疗设备使用过程中的作用

医疗设备在正常的使用过程中 ,由于电流的作用 ,使医疗设备的内部 (控制箱 )有不同程度的温升。所以 ,厂家在产品设计时已考虑到这些因素 ,如果在正常使用 (或长时间使用 )情况下 ,温升超出安全范围的 ,安装散热风扇或降温装置 (一台甚至多台 ) ,以保证设备在使用过程中的正常运行 ,提高设备使用的安全性。因此 ,在医疗设备维护保养、维修时要注意对设备散热情况 (温升 )的检查 ,以避免因散热风扇工作不正常而导致电路元器件过热而发生故障 ,影响医疗设备的正常使用及造成不必要的经济损失。就我院的两台设备的故障情况分析与同行们共同探讨…     

失效模式与影响分析在血液透析类设备风险管理中的应用研究

目的:运用失效模式与影响分析(FMEA)风险管理方法,对血液透析类设备进行风险管控,评估保障患者透析安全的作用。方法:根据FMEA风险管理方法构建流程图,结合临床实际选定血液透析机型及参与人员,剖析血液透析机主要系统中关键要素结构和功能,通过失效分析建立失效链,评估其风险等级,针对高中风险值事件采取有效持续改进措施并引入再评价机制实现闭环管理,形成规范化的管理制度文件。结果:项目实施1年后血液透析机整体风险事件发生频度较实施前3年降低46%,可探测度提升65%,高风险事件100%下降至中风险;选定机型血液透析机整体故障率下降43%,维修周期降低35%,患者满意度上升5%。结论:FMEA风险管理方法能有效指引血液透析类设备关键要素的预防性维护保养,降低设备使用风险,保障设备使用安全,提升医疗服务满意度。     

血液透析设备的保养与维护研究

为解决血液透析设备在保养与维护中的短板,此次研究以提高血液透析设备保养水平,完善维护方案,保障医疗安全为目的,对血液透析设备进行深层次研究。根据血液透析设备故障维修实例分析,以对比分析法对血液透析设备保养方案调整优化实践效果整合,积累血液透析设备保养与维护经验,提高血液透析设备管理水平,并解决保养与维护中的问题,以期为相关人员提供参考。     

基于并口的浅表组织聚焦超声治疗系统安全监控方法研究

目的：探讨高强度聚焦超声（HIFU）治疗设备的安全监控方法,消除在使用时对人体产生的潜在危险,提高其安全性和有效性。方法：通过分析HIFU设备“浅表组织高强度聚焦超声治疗系统”的系统特征和失效危险,设计基于增强型并行端口（EPP）模式的并口监控模块,使得数据能够在PC机和下位机间双向流动,并设计上位机看门狗和实时功率监测模块。结果：监控模块能够及时处理各种异常状况,保持系统的安全稳定运行。防止由于上位机故障或线缆故障导致的控制失效,并且上位机程序能够实时监控功率源实时输出功率。结论：通过分析HIFU设备的系统特征和失效危险,针对性地设计了基于EPP模式的监控模块,有效的提高了超声治疗系统的可靠性和安全性。     

血液透析用水处理设备预处理部分的改良

本文通过分析透析用水处理设备的现状、各个预处理组件的功能及“跳过”该组件可能的影响,结合血液透析临床工作的需要,将水处理设备的预处理设备进行重新设计改造.改良后的预处理部分可在确保患者治疗安全的前提下,保证任一组件发生故障时均可正常供应透析用水,提高血液透析用水处理设备整体的稳定性.     

HD—secura血液透析机的维护与保养

德国Ｂ、ＢＲＡＵＮ公司血液透析机以其优异的性能进入中国市场 ,赢得了众多医院的信赖 ,该机是一种具有高灵敏度、高可靠性的精密设备 ,为肾病患者提供安全有效的治疗手段。由于该机在正常使用时 ,所用透析液为各种酸、盐等腐蚀性液体 ,所以做好日常维护与保养及定期检查工作 ,对机器的安全稳定、正常运行是非常重要的。同时该机为保证其灵敏度与可靠性 ,采用多种检测手段 ,以保证设备工作安全可靠 ,因此也增加了设备故障发生的概率 ,只有清楚了解机器故障发生的原因 ,熟练掌握故障排除方法 ,才能提高设备使用效率。几年来 ,我们在日常维护…     

针对费森尤斯4008系列血液透析机常见故障与维修

血液透析机是治疗肾衰竭许多方案中最为有效的方式之一,在目前科技飞速发展的今天,血液透析机已经逐渐被大众所熟知,在市场上一定的推广和应用,占据了治疗肾功能衰竭病症的一定地位。血液透析机的主要功能是模仿人工肾的功能,对人体内的体液进行调节。虽然血液透析机技术已经较为成熟,但仍存在一定的故障,需要及时维修,保证透析机的正常运行。本文针对费森尤斯4008系列的血液透析机进行故障分析,并对其故障的维修方式作出了阐述。     

Infective tricuspid valve endocarditis due to abscess of an endogenous arteriovenous fistula in a chronic hemodialysis patient

Patients on chronic hemodialysis are at high risk for endocarditis due to prosthetic access devices. Right-sided endocarditis without any predisposing factors is rare in dialysis patients. A 76-year-old female, who had chronic renal failure had been treated by hemodialysis and had a permanent pacemaker implanted, was admitted to our hospital with a high fever and lumbago after abscess formation at an autogenous arteriovenous fistula for hemodialysis. Methicillin Resistant Staphylococcus Aureus was identified by blood culture examination. Echocardiography revealed vegetation attached to the tricuspid valve. Chest X-ray and perfusion lung scintigraphy showed pulmonary infarction, perhaps due to vegetation-derived emboli. Computed tomography also showed pyogenic spondylitis in L4 and L5. Repeated vascular punctures even of autogenous grafts expose dialysis patients to bacteremia and imply a higher risk of infectious endocarditis.     

Clinical Application of PES Membrane Dialyzer

Objective The dialysate membrane can be classified into acetate membrane and synthetic membrane,while the latter can be further divided into polysulfone,polyacrylonitrile,etc.Polyethersulfone membrane is high molecular membrane material with excellent biocompatibility,stable mechanical properties,high temperature and pressure resistance,and good cleaning performance,which has been applied for more than 10 years.This trial is to assess the safety and efficacy of hollow polysulfone membrane fiber dialyzer with pattern number Enttex~(TM)-16LF (E60) for hemodialysis in patients with acute or chronic renal failure due to multiple factors.Methods Totally 76 patients receiving maintenance hemodialysis were included in a two-site,random,open label,two-stage,positive crossover and non inferiority validation study.The clinical efficacy and safety of the test device were observed,which was a hollow fiber dialyzer produced by Guangzhou Enttex Medical Products Co.,Ltd.,with polyethersulfone membrane imported from Germany.It was a low flux dialyzer with the pattern number of EnttexTM-16LF (E60).Inclusion criteria:①patients with acute or chronic renal failure due to various reasons who needed hemodialysis;②18 to 80 years old,gender unlimited;③patients who received stable dialysis for more than 3 months,regular hemodialysis 3 times a week,4 h at each time,blood flow rate of 200～350ml/min;④using bicarbonate dialysate at a flow rate of 500ml/min;⑤patients with arteriovenous fistula or who received artificial blood vessel puncture dialysis;received anticoagulation by heparin or low molecular weight heparin.Exclusion criteria:①patients needing heparin free dialysis for severe anemia,tumor and active bleeding;②patients with severe cardiac (gradeⅢcardiac function),hepatic (severe hepatitis and cirrhosis) and pulmonary diseases (severe respiratory failure).Results Comparison of parameters,including the changes of Kt/V,general creatinine and urea clearance rates and URR (urea reduction rate) shows no statistical significance in differences between the two devices,indicating that the test and control devices can equally and effectively eliminate toxins including creatinine and urea,etc.PPP and MITTP results are consistent.Comparison of ultrafiltration rates between two groups of patients shows no statistical difference.PPP and MITTP results are consistent,indicating that both the test device and control device can effectively eliminate water.In MITTP,electrolytes including K~+,Na~+,Cl~-,Ca~(2+),HCO_3~-,etc.show no statistical significance in difference between the test and control devices before and after dialysis (P>0.05).After treating by using test and control devices,body weight,serum potassium and phos-phorus all significantly decrease (P<0.001);serum Ca~(2+),PO_2,PCO_2and HCO_3~-all significantly increase (P <0.001).These results indicate that both the test and control devices can effectively eliminate serum potassium and phosphorus,and eliminate excess water in body,maintain the balance between liquid and electrolytes in patients.PPP and MITTP results are consistent.Conclusion This clinical trial confirms that hollow polyethersulfone membrane fiber dialyzer can be safely and effectively used in hemodialysis therapy.     

血液透析设备专业化 安全化管理的研究

目的:探讨如何运用有效的管理方法,保证血液透析设备的使用安全。方法:血液透析室采用专业化、安全化的管理模式。结果:血液透析设备的维修率降低,使用寿命延长。结论:树立血液透析设备的安全管理意识,运用专业化的管理方法,有效的保证血液透析设备的良好,提高血液透析患者的生存质量。     

不同血液净化方法对慢性肾衰竭维持性血液透析患者血清β2-微球蛋白的影响

目的探讨不同血液净化方法对慢性肾衰竭维持性血液透析（MHD）患者血清β2微球蛋白（BrMG）的清除效果。方法将40例慢性肾衰竭MHD患者随机分为四组：血液透析（HD）组,高通量血液透析（HFD）组,血液透析滤过（HDF）组,HD＋血液吸附（AP）组,每组各10例。记录患者治疗前后血清β2-MG测得值并进行组内和组间统计学比较。结果HD组第1次血液净化后β2-MG测得值[（53．49±1．15）mg／L]较第1次血液净化前（基线值）[（49．10±2．31）mg／L]上升但差异无统计学意义（P〉0．05）,6个月血液净化后β2-MG测得值[（55．63±1．30）mg／L]较基线值上升且差异有统计学意义（P〈0．05）。HFD组、HDF组和HD＋AP组第1次血液净化后及6个月血液净化后β2-MG测得值较基线值均有明显下降趋势（P〈0．05）。并且HD＋AP组6个月血液净化后β2-MG测得值较HFD组和HDF组下降趋势更为明显（P〈0．05）。结论HD对β2-MG无清除效果,HFD、HDF和HD＋AP能有效清除β2-MG,并且6个月后HD＋AP清除β2-MG效果更佳。     

不同血液净化方法对慢性肾衰竭维持性血液透析患者血清β2-微球蛋白的影响

目的 探讨不同血液净化方法对慢性肾衰竭维持性血液透析(MHD)患者血清β2-微球蛋白(β2-MG)的清除效果.方法 将40例慢性肾衰竭MHD患者随机分为四组:血液透析(HD)组,高通量血液透析(HFD)组,血液透析滤过(HDF)组,HD+血液吸附(AP)组,每组各10例.记录患者治疗前后血清β2-MG测得值并进行组内和组间统计学比较.结果 HD组第1次血液净化后β2-MG测得值[(53.49±1.15)mg/L]较第1次血液净化前(基线值)[(49.10±2.31)ms/L]上升但差异无统计学意义(P>0.05),6个月血液净化后β2-MG测得值[(55.63±1.30)mg/L]较基线值上升且差异有统计学意义(P<0.05).HFD组、HDF组和HD+AP组第1次血液净化后及6个月血液净化后β2-MG测得值较基线值均有明显下降趋势(P<0.05).并且HD+AP组6个月血液净化后β2-MG测得值较HFD组和HDF组下降趋势更为明显(P<0.05).结论 HD对β2-MG无清除效果,HFD、HDF和HD+AP能有效清除β2-MG,并且6个月后HD+AP清除β2-MG效果更佳.     

Delayed nephrologist referral and inadequate vascular access in patients with advanced chronic kidney failure

We sought to determine whether late referral to a nephrologist in patients with chronic renal failure influences the adequacy of vascular access for hemodialysis. We analyzed data describing all health care encounters for all Medicare and Medicaid patients with end-stage renal failure in New Jersey between January 1991 and June 1996. Patients were required to have been diagnosed with renal disease at least 1 year prior to onset of hemodialysis. In the resulting cohort of 2,398 incident hemodialysis patients, 35% had their first nephrologist consultation < or =90 days prior to initiation of dialysis. After controlling for demographic characteristics, socio-economic status and underlying renal disease, we found that patients who were referred to a nephrologist >90 days prior to onset of hemodialysis were 38% more likely to have undergone predialysis vascular access surgery than those who were referred to a nephrologist < or =90 days before dialysis [OR: 1.38; 95% CI (1.15; 1.64)]. Similarly, patients referred late were 42% more likely to require central venous access for hemodialysis compared to those seen by a nephrologist early [OR: 1.42; 95% CI (1.17; 1.71)]. Inadequate development of vascular access for renal replacement therapy in patients with late nephrologist referral unnecessarily contributes to the burden of disease experienced by this vulnerable patient population.     

Hepatic assist devices

Acute liver failure (ALF) is associated with significant morbidity and mortality. Better understanding of the pathophysiology of the disease and improvements in patient management have resulted in increased survival. Liver transplantation remains the only proven therapeutic modality. Primarily because of organ donor shortage, a number of strategies have been developed in an attempt to support patients with severe ALF until either an organ becomes available for transplantation or until they recover. Liver support strategies include use of either non-biological or biological systems. Non-biological systems include plasma exchange, hemodialysis, hemofiltration, charcoal and resin hemoperfusion. These systems are able to remove toxins, but their utility is limited by their inability to provide missing liver synthetic function. Biological liver support systems include ex vivo liver perfusion and use of hepatocyte-based extracorporeal devices. Like non-biological systems, biological ones provide a means of detoxification and in addition biotransformation and biosynthetic functions. The major limitation of these systems is the lack of availability of an effective highly differentiated human hepatocyte line for clinical use. Currently clinically tested liver support systems use either porcine hepatocytes or human hepatoma cell lines. As liver support therapy evolves, there will be a role for both biological and non-biological liver support systems to treat specific forms of liver failure.     

血液透析类产品临床试验设计要点

血液净化疗法是指应用物理、化学或免疫学等方法清除体内过多的水分及血中代谢废物、毒物、自身抗体、免疫复合物等致病物质,以维持体内水、电解质和酸碱平衡的治疗方法。血液透析作为血液净化疗法的一种,是针对慢性肾衰竭的主要治疗手段之一。近年来随着透析治疗技术的发展,国产透析机、透析器等器械的注册申报数量也越来越多,文章拟对血液透析治疗中几类主要医疗器械的临床试验设计展开探讨,以供同行参考交流。     

故障树分析法在血液透析机水路系统风险分析中的应用

目的：通过理论与实践相给合,探讨故障树分析（FTA）法应用于血液透析机水路系统的风险分析,从而为血液透析机的维护维修提供指导与参考。方法：在收集上海市3家三级甲等医院血液透析室2008年血液透析机维护维修数据的基础上,通过建立故障树、定性分析和定量分析,对血液透析机进行风险分析。结果：通过分析与计算,找出了造成血液透析机因故障而带来风险的主要原因为：除气泵故障和电磁阀故障。结论：应用FTA能为开展血液透析机的预防性维护和降低风险提供参考依据,增进医院临床工程师对血液透析机进行风险管理的意识,促进风险管理活动的展开。