| Abstract|| |
Since the introduction of dialyzer reuse more than three decades ago, several studies have reported its safety, efficacy and cost effectiveness. Reuse of hemodialyzer was prospectively studied in ten chronic hemodialysis (HD) patients recruited from the renal unit, the King Khalid University Hospital, Riyadh, Saudi Arabia, for three months. During the study period, 66 dialyzers were used for 408 sessions of HD, with a mean reuse of 6.2 ± 5.3 episodes per dialyser, the mean of maximum reuse episodes being 13.7 ± 8.0. The urea reduction ratio was maintained between 73 ± 5% at baseline to 71.2 ± 9.03% (p=0.53) at the maximum reuse. Similarly phosphate reduction with each HD session was maintained; mean decrease in phosphate levels was 0.67 mmol/L. Significant increase in heparin requirement was noted; however, the risk of bleeding was not increased. Hematocrit levels increased from 30.4 ± 4.1% to 33.2 ± 3.6% at the end of the study (p=0.6). Albumin leak in dialysate decreased with each reuse; baseline 8.27 ± 7.93 mg/L to 2.8 ± 0.4 mg/L at maximum reuse (p=0.04). Serum albumin levels remained stable. No short-term adverse effects on patients' morbidity and mortality were noted. Total cost savings of 53% was achieved with the reuse of dialyzers, excluding capital equipment used for preparation for reuse. In conclusion, dialyzer reuse seems to be safe and may provide an economical and efficient dialysis. Studies involving larger number of patients is required to validate this observation.
Keywords: Hemodialysis, Reuse, Saudi Arabia, Cost, Morbidity, Mortality.
|How to cite this article:|
Mitwalli AH, Abed J, Tarif N, Alam A, Al-Wakeel J S, Abu-Aisha H, Memon N, Sulaimani F, Ternate B, Mensah M O. Dialyzer Reuse Impact on Dialyzer Efficiency, Patient Morbidity and Mortality and Cost Effectiveness. Saudi J Kidney Dis Transpl 2001;12:305-11
|How to cite this URL:|
Mitwalli AH, Abed J, Tarif N, Alam A, Al-Wakeel J S, Abu-Aisha H, Memon N, Sulaimani F, Ternate B, Mensah M O. Dialyzer Reuse Impact on Dialyzer Efficiency, Patient Morbidity and Mortality and Cost Effectiveness. Saudi J Kidney Dis Transpl [serial online] 2001 [cited 2013 Dec 12];12:305-11. Available from: http://www.sjkdt.org/text.asp?2001/12/3/305/33554
| Introduction|| |
Development of dialyzer reuse more than 37 years  ago was followed by controversial reports about it's efficiency for clearance of solute as well as safety and economics. ,, However, later studies suggested that reused dialyzer was safe and more beneficial than single use dialyzer due to less risk of hemolysis and first-use phenomena. ,, Firstuse phenomena associated with leucopoenia, complement activation and sometimes anaphylactoid reactions was much less with reused dialyzer. Effect of dialyzer reuse on patient's morbidity and mortality is still of major concern to nephrologists.
Different trends of morbidity and mortality have been reported with use of different germicides and reuse practices and, recently, other factors have been implicated suggesting the need of more randomized controlled trials. ,,,,
Even in the presence of all these persisting concerns, the practice of reuse is increasing due to its economic benefits. Recently Agodoa et al reported their preliminary evaluation of 20,000 patients from the USRDS data showing an increase in the percentage of units practicing reuse from 68% to 81% during the period 1989-1996.  They also noticed prescription of a higher dialysis dose, greater use of high-flux dialyzers and higher serum albumin levels in units practicing reuse. Though reuse has been in practice for the last two decades in the Middle East (personal communication), no study has been reported from Saudi Arabia.
Taking all these into consideration we conducted a study on 10 chronic hemodialysis patients to prospectively evaluate the effect of dialyzer reuse on solute clearance, shortterm patient morbidity, dialysate leak of albumin and cost effectiveness of the procedure.
| Material and Methods|| |
Ten patients on regular hemodialysis for more than six months at the King Khalid University Hospital's Renal Dialysis Unit, Riyadh, Saudi Arabia were randomly selected to participate in the study. Informed consent was signed by all patients (5 males and 5 females) aged between 17 to 70 years. Patients who tested positive to HBsAg, anti-hepatitis C and HIV were excluded from the study. Patients having acute medical and vascular access problems noticed within two weeks prior to start of study were also excluded.
Each patient underwent hemodialysis with minimum blood flow of 350 ml/min and bicarbonate dialysate flow of 500 ml/min. High-flux polysulfone dialyzer (Minntech BV, Heerlen, Netherlands) was used during the study period. Renatron Automated Dialyzer Reprocessing System with Renalin® cold sterilant (Minntech BV, Heerlen, Netherlands) was used for sterilization of dialyzers. The whole process of preparation of a dialyser for reuse took thirty minutes and included: initial high-pressure check for any fiber break followed by measurement of fiber volume. If fiber volume was more than 80 ml, the dialyzer would be passed by the computer for reuse processing. Cold sterilization by Renalin® was then done and the dialyzer labeled and stored for more than 36 hours before the next session.
Each dialyzer was crosschecked by the nurse for correct labeling before initiation of hemodialysis. Rinsing of the dialyzers was as usual before connecting to patients. Residual Renalin® levels were checked using reagent strip before initiation of dialysis. Levels > 3 PPM warranted repeat rinsing of the blood circuit.
All patients were followed for a total of three months. Data such as urea reduction rate (URR), phosphate reduction and albumin loss to dialysate was collected at reuse.
Hemoglobin, hematocrit and serum albumin levels were measured monthly for three months and at the end of the study. Dialysate and water culture were done monthly. Any adverse events related to the patients such as infection, allergic reactions, access problems, or other medical illnesses were recorded during the study period.
| Statistics|| |
All data were reported as mean + SD. Paired "t" test was used to analyze and compare all variables in the study. Statistical significance was set at p value of less than < 0.05.
| Results|| |
During the three months of study, 66 dialyzers were used for 408 sessions of hemodialysis, with a mean reuse episodes of 6.2 ± 5.3 per dialyser and the mean of maximum reuse being 13.7 ± 8.0. Three patients frequently clotted their dialyzers and consumed maximum number of dialyzers. Excluding these patients, the mean dialyzer reuse increased to 9.9 ± 6.0 and the mean of the maximum reuse to 16.9 ± 7.5 episodes per dialyser. The dialysate albumin leak at first use was 8.3 mg/L ± 8.0, which significantly decreased by maximum reuse session to 2.8 ± 0.4 mg/L (p=0.04) [Figure - 1]. Dialyzer volume at first use and at session before failure or end of study were 103 ml ± 13.9 and 89 ± 11.0 respectively (p<0.001).
Heparin dose per patient at baseline was 4,500 ± 1200 IU with maximum dose of 6,500 IU. During the study period, the heparin dose increased to mean 6,650 ± 2000 IU with maximum dose of 10,000 IU/session. However, no episodes of bleeding or prolonged post-hemodialysis hemostasis were noted.
The mean urea reduction ratio (URR) was 74 ± 6.0% and the mean at the maximum reuse was 71.0% ± 9.0 (p=0.527) [Figure - 2]. Phosphorus removal during each reuse session remained the same from the first to the last session of dialysis. Mean reduction of phosphorus was 0.67 + 0.3 mmol/l. Baseline hematocrit of 30.4 + 4.1% increased to 33.2 + 3.6% at the end of three months study period [Figure - 2]. Baseline serum albumin value was 34.0 ± 3.5 gm/L, and was 33.0 gm/L ± 3.6 after three months, a change that was statistically insignificant [Figure - 2]. Monthly water culture did not show any bacterial growth.
One patient developed cellulitis of the lip easily treated with a short course of oral antibiotics. No other episodes of infection, allergic reactions or access problems were noted. No labeling error happened and reuse processing was easily learnt by the staff in one week.
Cost of dialyzer and other consumables including Renalin® solution needed for sterilization and testing and excluding reuse machine, computer system and personnel was 15,107 Saudi riyals (approximately $4,000) for 10 patients over three months period. If we used the same high-flux dialyzer without reuse the total cost would have been 32,640 Saudi Riyals ($ 8,700), thus yielding a saving of 52.8%.
| Discussion|| |
The results of this study show that dialyzer reuse does not affect its clearance capacity of low molecular weight solutes.
The URR was maintained all through the reuse study period [Figure - 3].
Studies evaluating the dialyzer clearance of small solutes have mentioned a decrease in small solute clearance with decreasing total cell volume of the dialyzer after reuse. ,, In our study, we used the recommended cell volume of more than 80% to achieve the optimum solute clearances , [Figure - 4]. Clearance of small solutes i.e. urea, creatinine and phosphate was well maintained all through the study period.
The reuse process itself does not remove the protein adsorbed to the fiber completely and has been cited as beneficial in preventing complement activation and first use effect. ,, This, however, may reduce the removal of larger solutes such as β2 microglobulin and other proteins such as albumin.
Recently, Leypoldt et al showed the differential solute removal characteristics of the small and large solutes.  Urea, creatinine and phosphate clearances were monitored all through the 15 reuse sessions whereas the clearance of β2 microglobulin and total protein concentration decreased progressively with each dialyzer reuse. We did not check the β2 microglobulin levels; however, we measured the albumin levels in the dialysate, which progressively decreased with each hemodialysis session [Figure - 1].
The reuse process itself was not an extra burden on our staff. Nurses assigned to the reuse processing learnt the procedure in one week and were able to perform the processing between shifts. There were no episodes of mislabeling or wrong dialyzer connection and the computer processing and immediate labeling were almost fool proof.
In general, patients felt better during the three months study period, though we did not interview or collect data concerning the general well being of the patients.
Concerns about the safety of reuse in terms of patient morbidity and mortality have appeared repeatedly. These concerns have been associated with the type of germicide, infection outbreak, type of facility (hospital based or for profit) and type of dialyzer (low-flux or high-flux). ,,,,, Our study did not show any short-term adverse effects on patients morbidity with dialyzer reuse. Infection has been reported in higher frequency in centers practicing reuse. This has been attributed to microbial contamination of water and/or when dialyzer were reused more than 20 times. ,
Monthly water cultures in our unit were negative and no febrile episodes or serious infections were noted in the patients. Furthermore, in two of our patients where reuse was 19 and 35 times respectively, no febrile episodes were noted.
Loss of cell volume, resulting in failure of dialyzers, usually results from clotting in the fibers.  Heparin requirement increased in our patients. Most of this increase was noticed in three patients with frequent failure of dialyzers. Despite this increase, we did not notice any episode of bleeding and the mean hematocrit improved from baseline.
Serum albumin levels have a direct effect on the patients' mortality and any loss of albumin in the dialysate with reuse will have an adverse effect. We found a minimal loss of albumin in the dialysate, which decreased with the progressive reuse of the dialyzer. Similar results have been shown by other authors. ,
The current trend of steady increase in reuse practice, especially in the USA, has been motivated by its economical advantage. This resulted from the trend for better dialysis using high-flux dialyzers and cost containment practices at the same time. 
In the three-month study period, we saved 52% of our expenditure on dialysis. This saving, although does not consider the cost of the reuse machine, was significant enough that the overall saving may override its expense. Our unit being small (43 patients), we could handle the reuse of dialyzers without need for extra nursing staff. In a larger unit, the cost of increased nursing requirement may counter balance the cost saving obtained from the increased volume of reuse. This, however, needs further objective evaluation.
We conclude that dialyzer reuse in our patients did not affect the efficiency of the dialyzer in the clearance of small solute such as urea, creatinine and phosphate. The reuse decreased the amount of albumin leak. No short-term adverse events and effects on morbidity were noted. Considerable costs were also saved with the reuse of dialyzers. However, there is a need for a large or multi-center study to address the safety and efficiency of reuse in Saudi Arabia.
| Acknowledgement|| |
Special thanks to all the nursing staff and to Mr. J. Ali of our hemodialysis unit for making this study a success. We are also indebted to Dr. Arthur Isnani and Miss Miriam Culanding Tampos in helping to prepare this manuscript.
The study was made possible by fund provided by Minntech BV, Herleen, The Netherlands.
| References|| |
|1.||Shaldon SH, Silva H, Rosen SM. The technique of refrigerated coil reservation haemodialysis with femoral venous catheterization. Br Med J 1964;2:72-4. |
|2.||Kant KS, Pallack VE, Cathey M, Goetz D, Berlin R. Multiple use of dialyzers: safety and efficacy. Kidney Int 11981;19:728-38. |
|3.||Pollak VE, Kant KS, Parnell SL, Levin NW, Repeated use of dialyzers is safe: long-term observations on morbidity and mortality in patients with end-stage renal disease. Nephron 1986;42:217-23. |
|4.||Kant KS, Pollak VE, Goetz D, Cathey M. Dialyzer reuse: a long-term study of safety and efficacy at one center. Proc Clin Dial Transplant Forum 1980;10:35-8. [PUBMED] |
|5.||Orringer EP, Mattern WD. Formaldehydeinduced hemolysis during chronic hemodialysis. N Engl J Med 1976;294:1416-20. [PUBMED] |
|6.||Hakim RM, Lowrie EG. Effect of dialyzer reuse on leukopenia hypoxemia and total hemolytic complement system. Trans Am Soc Artif Intern Organs 1980;26:159-64. [PUBMED] |
|7.||Charoenpanich R, Pollak VE, Kant KS, Robson MD, Cathey M. Effect of first and subsequent use of hemodialyzers on patient well-being: the rise and fall of a syndrome associated with new dialyzer use. Artif Organs 1987;11:123-7. [PUBMED] |
|8.||Held PJ, Pouly MV, Diamond L. Survival analysis of patients undergoing dialysis. JAMA 1987;257:645-50. |
|9.||Feldman HI, Kinosian M, Bilker WB, et al. Effect of dialyzer reuse on survival of patients treated with hemodialysis. JAMA 1996;276:620-5. [PUBMED] |
|10.||Collins AJ, Ma JZ, Constantini EG, Everson SE. Dialysis unit and patient characteristics associated with reuse practices and mortality. 1989-1993. J Am Soc Nephrol 1998;9:2108-17. |
|11.||Agodoa LY, Wolfe RA, Port FK. Reuse of dialyzers and clinical outcomes: fact or fiction: Am J Kidney Dis 1998;32(6)Suppl 4:S88-92. |
|12.||Deane N, Benies JA. Multiple use of hemodialysis final report to National Institute of Arthritis, diabetes and digestive and kidney diseases. Contract No. N01AM-9-2214, Manhattan Kidney Center, National Nephrology Foundation 1981. |
|13.||Kaye M, Gagnon R, Mulheaeu B, Spergel D. Prolonged dialyzer reuse. Trans Am Soc Artif Inter Organs 1984;30:491-3. |
|14.||Garred LT, Canard B, Flavier JL, Pouse C, Polito-Boulour C, Milon C. Effect of reuse on dialyzer efficacy. Artif Organs 1990; 14:80-4. |
|15.||Leypoldt JK. Fouling of ultrafiltration and hemodialysis membranes by plasma proteins. Blood Purif 1994;12:285-91. [PUBMED] |
|16.||Leypoldt JK, Cheung AK, Deeter RB. Effect of hemodialyzer reuse: dissociation between clearance of small and large solutes. Am J Kidney Dis 1998;32(2):295-301. |
|17.||Tokars JI, Alter MJ, Favero MS, Moyer LA, Miller E, Bland LA. National surveillance of dialysis associated diseases in the United States 1993. ASAIO J 1996;42:21029. |
|18.||Favero MS, Alter MJ, Bland LA. Dialysisassociated infection and their control, in Benett JV, Brachman PS (eds): Hospital infections (3 rd ed), Chap Boston MA Little Brown 1992;375-403. |
|19.||Ouseph R, Brier MF, Ward RA. Improved dialyzer reuse after use of a population pharmacodynamic model to determine heparin doses. Am J Kidney Dis 2000; 35(1):89-94. |
|20.||Matos JP, Andre MB, Rembold SM, Caldeira FE, Lugon JR. Effects of dialyzer reuse on the permeability of Low-flux membranes. Am J Kidney Dis 2000; 35(5):839-44. |
Ahmed H Mitwalli
Department of Medicine (38), King Khalid University Hospital, P.O. Box 2925, Riyadh 11461
[Figure - 1], [Figure - 2], [Figure - 3], [Figure - 4]