透析器复用经验交流

透析器复用经验交流,Dialyser reuse,提要Contents, 透析器复用Reason, disputes, methods of reuse 复用的原因和争议及现状 复用的方法部分B.Braun客户使用、复用Diacap Polysulfone的经验experience of our customer复用中的可能问题Potential problems,透析器复用,1 复用的原因和争议及现状Reason, disputes a.复用的支持和反对意见Pros and cons b.复用现状Whats on 2 复用的方法Methods a.自动复用Automatic b.手工复用Manual c.两者的比较Comparison,1.复用的原因和争议及现状 Reason, disputes,a 复用的支持意见pros降低使用成本，减轻病人经济负担economical consideration CTS, 1991改善生物相容性，减少相应的免疫反应increase biocompatibility Daugirdas and Ing,1988; Hakim and Lowrie, 1980 减少透析器首次使用综合症reduce 1st use syndrome Bok et al, 1980有利于环保environmental friendly,透析器的性能受到的可能影响possible influence of the dialyser Gotch , 1986; Cheung, 1999; Pizziconi, 1990消毒不严格带来的可能后果malpractice of disinfection残余消毒剂带来的不利影响adverse reaction of disinfectant血液交叉感染/对滤器处理人员的危险cross infection,a 可能的不利因素cons,National Kidney Foundation report on dialyzer reuse. Task Force on Reuse of Dialyzers, Council on Dialysis, National Kidney Foundation. Am J Kidney Dis. 1997 美国肾病基金会报告,The National Kidney Foundation takes no position for or against dialyzer reuse. The principal reason for the practice of reuse is economical. 经济原因决定复用In view of the uncertainties related to the safety and biological impact of reuse procedures, the task force recommends that a full discussion of the issue of reuse and its potential beneficial and detrimental effects be undertaken with each patient. 复用的考虑应个体化Dialyzers should not be reprocessed from patients who have tested positive for hepatitis B surface antigen. HBV阳性不应复用Given the significant fall in dialyzer efficiency for urea removal that can occur after repeated uses of a dialyzer, dialysis prescriptions in units practicing reuse should be designed to deliver a Kt/V or URR value that exceeds the dose used for patients treated with single-use dialyzers to make allowance for any possible reuse-induced reduction in dialyzer efficiency. 治疗剂量的调整The effects of reprocessing high-flux dialyzers on beta2-microglobulin clearance are dependent on the reprocessing technique, the number of reuses, and the nature of the dialyzer membrane used.复用技术对后续使用有很大影响,The effect of dialyzer reuse on dialysis delivery.Sherman RA,Cody RP,Rogers ME,Solanchick JC Sherman Department of Medicine, UMDNJ-Robert Wood Johnson Medical School, New Brunswick Am J Kidney Dis. 1994 Dec;24(6):924-6.滤器复用对治疗的效应,Prospective 436-patient, 34-center study. All patients underwent formal urea kinetic modeling monthly, usually for 3 sequential months. Dialyzers were reprocessed and reused in the usual manner for each unit. Kt/V urea for the treatment using the dialyzer with the most reuses (mean, 13.8) was compared with that with the treatment using the dialyzer with the fewest reuses (mean, 3.8). The mean Kt/V delivered for high reuse treatments was significantly lower than that for low reuse treatments (1.05 v 1.10, P = 0.002). 复用对清除产生明显负面的影响Of the 23 centers using formalin-based reprocessing, an average difference of or = 0.12 (mean, 0.17) in Kt/V between high and low reuse treatments was seen in 10 centers. Dialyzer reprocessing significantly impairs dialysis delivery, an effect that may be related to the methods and procedures in individual dialysis centers.复用过程对治疗效果有极大影响,b.复用现状whats on,US Reuse of dialyzers and clinical outcomes: fact or fiction. Agodoa L, Wolfe RA, Port FK Am J Kidney Dis 6:S88-S92, 1998 Since its introduction in the United States more than two decades ago, the practice of dialyzer reuse has continued to grow. In recent years, it appears to have been based mainly on economic, rather than medical, considerations. demographic, comorbidity, laboratory, treatment, socioeconomic, and insurance data on a large random sample of approximately 20,000 of the US dialysis patient population over a 3-year period, using the dialysis records. Data were collected 20,000 个病人纳入研究The results show that there has been a significant increase in the practice of dialyzer reuse in the United States. 滤器复用在增加Large regional differences exist, and reuse is greatest in freestanding for-profit (FSFP) units (87%) and freestanding nonprofit (FSNP) units (77%) and least in hospital units (49%).复用的分布情况与医疗机构性质有关,b.复用现状whats on,HEMODIALYZER REUSE: CONSIDERATIONS OF SAFETY AND COSTS. Montreal: CTS, 1991. 65 复用的使用及经济学分析Since dialyser reuse was first described in 1969, it has been employed with increasing frequency in the United States of America where the percentage of patients who reuse their hemodialysers has increased from 18% in 1976 to 72% in 1988. In Europe, the general level of reuse is lower average 10% in 1988. Differences between European countries are however, considerable, for example; Belgium 19%, United Kingdom 16%, Denmark 12%, France 8%, Sweden, Norway, Holland and Ireland all below 1%. In Canada, in 1987, 13% of dialysis centres practised reutilization. 欧洲的情况Economic consequences of reutilisation in QuebecTo gain some idea of the possible savings which might be achieved in Quebec, a study was made of the difference in direct cost between single use and multiple reuse 6 to 11 times of hemodialysers. It was estimated that 5 reuses might generate economies of approximately $3,245 dollars per patient per year $2,700 to $3,800. The saving associated with 10 reutilisations would be of the order of $3,500 per year.十次复用可达的每年经济效应Further estimations can be made on the assumption that only in units in excess of 30 patients would it be economically feasible to purchase automated reconditioning equipment. If all such units practised 10 reutilisations for each patient in whom there were no contraindications, the total saving would be between 2 and 2.7 million dollars per year.复用规模效应 In the U.S.A., companies are available to collect, recondition and re-distribute hemodialysers at a cost of approximately of $6 per use. 专业化经营,BACKGROUND AND AIM: Dialyser reuse treatments in Korea were first practised at a facility in 1985. Until 1999, there was only one facility practising dialyser reuse treatments, but the reuse practice has gradually increased since 1999. The purpose of this study was to gather and analyse the current (April 2002) dialyser reuse treatment data in Korea. METHOD AND RESULTS: Data was collected via a questionnaire sent to the each hospital that reuses the dialyser, and we received a response from 26 out of 29 facilities (89.7%). Twenty-nine facilities comprised 7.7% (29 of 376) of the total nationwide haemodialysis facilities in Korea. The percentage of patients on dialyser reuse treatments was 6.2% (1234 of 20,010). All facilities used an automated reuse processing technique for dialyser reuse and 22 facilities used a peracetic acid mixture (PAM) without hypochlorite. There was one facility that used the heated citric acid method. Eighty per cent of facilities used only high flux membranes (Kuf or = 20 mL/h per mmHg) and 12% of the facilities used both high and low flux membranes. The average number of the reuse treatments was 15-fold (range 10-22) and the average of the maximum number of reuse treatments was 20-fold (range 10-50). CONCLUSION: Although dialyser reuse treatments are not a common practice in Korea, the reuse programs are steadily increasing. Strict quality control and further regulations regarding the reuse program should be promptly enacted to provide a better quality of haemodialysis treatment for patients in Korea.复用率不高；复用次数大于中国；尚无严格法规,Status of dialyser reuse in Korea.Cho HKCho HK,Shin GT,Kim H Nephrology (Carlton). 2004 Aug;9(4):212-6. Department of Nephrology, Ajou University School of Medicine, Suwon, Korea.韩国的复用,中国China,中国大陆范围约七成为复用市场70% reuse经济原因对复用有直接关系，有一些地方有强制非复用规定economical reason is the motivation自动，手工复用同时存在，以后者为主；复用质量有待提高both manual and automatic,2.复用方法methods,a.自动复用automatic reuse标记labeling自动冲洗rinse自动安全测试safety test自动消毒液灌注disinfection科学化管理（条码识别）management,b.手工复用过程概述manual method,标记 labeling 下机后冲洗 cleaning after use安全检测 safety check消毒和保存 disinfection and store 使用前冲洗 rinsing 目的是为冲去残余消毒剂，避免不良反应的发生。预充及循环管路 rinsing, circulation 循环管路是为了最大限度降低滤器中消毒剂浓度，防止透析中不良反应的发生，也有观点认为循环管路时加做超滤会有益于抗凝。,c.两者的比较comparison,自动复用automatic对冲洗水压，水流控制更好，更稳定；避免了不良反应的发生stable control, less complication避免了处理时的个体差异universal in practice节约了人力和时间用于病员护理saving of manpower保证复用质量better QC手工复用manual 节约成本，机动灵活cost effective for small scale practice, flexible,B.Braun客户使用Polysulfone的经验,1 上海华山医院血透中心2 上海浦东新区人民医院肾脏科3 上海南汇区人民医院肾脏科4 四川大学华西医院血透中心5 中山大学附属一院6 深圳红会医院血透中心7 马来西亚用户经验,上海华山医院血透中心,目前有血透机40台贝朗机器12 台，其中Advance6台，HDF online机4台，Dialog+2台固定透析病员数约150人,1.下机后冲洗rinsing,使用反渗水冲洗, 水压一般介于0.1-0.2Mpa/cm2间。在气温较低时，用温水冲洗，低温水会促使血液凝结，使凝块更难冲洗。冲洗时逆血流方向进行，即滤器内由静脉端向动脉端冲，还应包括正向（超滤）及反向（反超滤）冲洗。如血凝块存在，使用0.2%过氧乙酸浸泡，直至目测洗出液变清。将过氧乙酸注入透析液室及血室，依靠弥散来发生作用。（低浓度溶液使血块溶解，高浓度溶液使血块凝结。）应对所用消毒剂的浓度进行检查，明确是否使用了适当的浓度。再次冲洗直至洗出液清亮,2.安全检测safety test,血室容积试验，血室容积不小于原值80%(TCV test) 血室容积下降反映透析室内有可能的微小血块或蛋白残留，将对下次的透析产生影响破膜试验(Membrane Rupture Test) 将血路一端堵死，使用250-270mmHg的压力在另一端进行检测，没有泄漏为准不能通过两项试验者应弃去。(Discard for those can not pass the test),3.消毒和保存disinfection and storage,灌入消毒剂之前应确定水分已完全排除，避免消毒剂被水份稀释，无法达成消毒效果。灌入相当三倍血室容积的消毒剂使用0.4%过氧乙酸溶液进行封管消毒，持续至少12小时后备用，有效7天。将血室及透析液室均灌满消毒剂后，封口，置于冷藏室中,4.使用前冲洗rinsing,首先将透析器内消毒剂放空使用至少1000ml0.9%生理盐水冲洗，将此水放空而不应同时用于循环管路。,5.预充及循环管路priming and circulation,预充血泵速度为150ml/min。过快的预充速度会在管路中导致湍流，产生小气泡，对以后的凝血起重要的促进作用。预充时仔细检查，确认管路中没有气泡的残留。0.9%NS500ml循环管路,血泵速 300ml/min，循环20min, 循环末期回路中加入20mg左右的肝素循环，使管路及滤器上可以吸附部分肝素。,6.抗凝剂的使用anticoagulation,首剂0.4mg/kg, 维持量0.080.16mg/kg/h; 使用单次追加法的时候首剂量较持续推注维持法时可能要大。首剂肝素510min后开始引血， 低分子肝素使用，常规情况在开始前使用一剂可满足治疗需要。现常用以下种类，于血透开始前动脉端注入： 速避凝 (Fraxiparine)0.4ml吉派林 5000法安明 (Fragmin) 5000,上海浦东新区人民医院肾脏科Peoples Hospital,Pu Dong New Area, Shanghai,血透机20台Dialog advance 单泵 6台，双泵2台，plus 4 台，Secura 2台透析病员数约85人,反渗水冲洗，正向反向共10min，水压0.1Mpa，直至洗出液清晰3.5%Renalin灌注消毒一晚备用二次使用前，管路连接完毕后用500ml盐水冲洗管路；500ml循环管路加用超滤900ml/h，其中并加入肝素30mg；首剂肝素量30mg,引血前710min加入，追加5mg/h,低分子肝素一剂给完（复用血路管，同样用Renalin消毒）复用至三次为止,下机后反渗水冲洗，正向反向，水压0.1Mpa，直至洗出液清晰除蛋白：2%次氯酸钠 浸泡一晚（已废除）消毒处理： 3.5% Renalin 灌注， 可放置21天上机前先冲去消毒剂；血泵速 300ml/min, 循环15min加入 20mg Heparin 肝素：首剂2025mg, 追加 810mg/h，按公斤体重调整复用五次,上海南汇区人民医院肾脏科 Peoples Hospital, Nan Hui District, Shanghai,38台透析机28台B.Braun机器90个病人,四川大学华西医院血透中心Western China Hospital, Sichuan University,四川大学华西医院血透中心Western China Hospital, Sichuan University,反渗水冲洗至目测洗出液清晰1%次氯酸钠透析器膜内短时灌注两次，除蛋白，去除沉积物 过氧乙酸浸泡消毒，浓度至少0.5%以上,0.8%两小时可复用,四川大学华西医院血透中心 Western China Hospital, Sichuan University,0.9%NS1000ml冲洗残余消毒液肝素20mg加入盐水500ml循环管路，约1020min首剂肝素2530mg,810mg/h追加高低通复用方法一致，复用八次,中山大学附属一院No.1 Affiliated Hospital,Zhong Shan University,60余血透机器固定透析病人200余人透析器复用35次,两袋盐水(每袋1000ml)预冲管路,在预冲第二袋开始循管,循管量为500ml在循管加肝素,剂量为18-22mg,加用超滤病人治疗前体内肝素化,剂量为18mg左右,治疗中维持量为6-10mg/h,中山大学附属一院No.1 Affiliated Hospital,Zhong Shan University,深圳红会医院血透中心Hong Hui Hospital, Shengzhen,血透机12台贝朗机器9台透析病员数约60人,深圳红会医院血透中心 Hong Hui Hospital, Shengzhen,反渗水冲洗,直至洗出液清晰1%次氯酸钠浸泡 ，膜内膜外保持15min34%甲醛封管消毒四瓶盐水(每瓶500ml)预冲,在预冲完1000ml(两瓶)后,第三瓶循管,并开始加肝素,一般剂量为16-22mg，在此阶段将机器设置到循管超滤模式 病人在治疗前体内肝素化,加入剂量为12-16mg。治疗开绐后,肝素维持剂量为6-8mg/h。,马来西亚用户使用方法Malaysian Experience,40% 人工复用, 60% 自动复用 反渗水(RO)冲洗，水压2大气压,直至洗出液清晰人工复用用2%过氧乙酸/3.54.5%福尔马林消毒 ； 自动复用用3.5%Renalin消毒1L 盐水用于使用前冲洗冲洗完成后使用试纸检测残余Renalin浓度肝素: 2000 IU 首剂, 1000 IU 追加 /3 hrs 可随病人体重调整,复用中的可能问题potential problems,1 复用次数不够fewer reuse times2 复用后破膜membrane rupture3 残余消毒液反应disinfectant reaction4 感染反应infection,不适当的使用消毒剂会导致透析膜的损伤，在膜上形成毛糙面，有利于蛋白及血细胞的沉积，并进而导致凝血。Improper use of disinfectants推荐使用3.5%Renalin，在美国被50%以上的透析中心使用，证明了它的有效和安全性；次氯酸钠及双氧水的强大氧化作用对膜可能产生巨大的伤害。The effect of bleach,Dialyzer-dependent changes in solute and water permeability with bleach reprocessing.Scott MK,Mueller BA,Sowinski KM, Clark WR Am J Kidney Dis. 1999 Jan;33(1):87-96.（漂白剂对复用滤器清除率影响）,We compared the effects of automated bleach/formaldehyde reprocessing on solute and hydraulic permeability for cellulose triacetate (CT190) and polysulfo