| Abstract|| |
Reuse of dialysers has been an integral part of hemodialysis since its inception. Over the past decade, reuse has increased significantly in many countries, most notably in the United States, while vanishing entirely in some other countries, such as Portugal and France. In the United States, which is most widely used as an example because of the large amount of data available, the mortality of dialysis patients has steadily decreased even as reuse has increased. This improvement is probably the result of a complex of factors including understanding the role of comorbidity, treatment unit characteristics, barriers to adequate dialysis, nutrition, anemia, high flux dialysis and dialyser membrane improvements and the desired dialysis dose. Reuse provides a significant economic benefit that allows the use of more efficient and expensive larger biocompatible synthetic membranes to provide high-quality dialysis in the face of cost inflation, limited medical resources and fixed reimbursement. Rather than being legitimized by clinical practice alone, reprocessing, supported by clinical studies, allows the provision of superior treatment to more patients safely and economically. Recent reports concerning dialyser reprocessing have centered not only on morbidity and mortality, but also on questions of the specific effects of different germicides on various types of dialyser membranes (e.g., cellulosic, synthetic, high-flux, etc.) and on the possible role of dialyser reprocessing in the transmission of hepatitis C.
Keywords: Hemodialysis, Dialyser reprocessing, Mortality, Review, Reuse, Hepatitis.
|How to cite this article:|
Brown C. Current Opinion and Controversies of Dialyser Reuse. Saudi J Kidney Dis Transpl 2001;12:352-63
| Introduction|| |
Since the beginning of chronic hemodialysis therapy, dialyser reuse, or reproce-ssing, has been practised. ,,, Dialyser reprocessing can be defined as the disinfection of a dialyser for multiple uses for the same patient.  Although the practice of reuse is firmly joined to the practice of dialysis, controversy has surrounded the practice of reprocessing throughout the past 30 years. ,,,, This controversy stems from several sources.
Occasional reports have suggested that dialyser reuse is less safe than dialyser single use. These papers have suggested higher mortality and morbidity with dialyser reuse. , In addition, safety concerns about increased rates of infection have been suggested at centers that practice reuse. ,, Manufacturers of dialysers, of course, have a vested interest in dialyser sales for single use, which has led to a marketing strategy promoting single use and disparaging dialyser reprocessing.
Despite the controversial issues, reuse has increased throughout the world. For example, in 1997, reuse was practiced in 82% of the centers in the United States.  Several factors have favored the advance in dialyser reuse. Increases in quality control through standardization and monitoring of dialyser reprocessing, ,,,,,,,,,,, economic factors balancing the increased costs of high flux dialysers/ synthetic membranes with reduced reimbursement ,,,,,, and the need for higher dialysis doses for a greater number of patients with limited facility resources ,, have all led to an increase in the practice of dialyser reuse.
This review will focus on the primary controversies between single dialyser use and dialyser reuse. Differences in mortality, pyrogen reactions and infections between single use and reuse remain the major issues. Further, the factors that have favored the increased practice of dialyser reuse such as increased quality control and standardization of reprocessing and economic issues of providing the best possible dialysis treatment within the constraints of reimbursement and limited medical resources will be considered.
| Prevalence of Reuse|| |
Over the past decade, the mortality of dialysis patients has steadily decreased in the United States. ,,,,, This improvement is probably the result of a complex of factors based on the better understanding of the role of comor-bidity ,, treatment unit characteristics, , barriers to adequate dialysis, , nutri-tion, , anemia, ,,, increased high flux dialysis/synthetic membrane use and higher dialysis dose. , Data on reuse is collected by the Health Care Financing Administration (HCFA) and reported to the Centers for Disease Control (CDC).  [Figure - 1] shows the reuse situation in the United States from 1976 through 1997. As shown, reuse had increased steadily during this time course and in 1997, over 80% of dialysis centers have a reuse program. Looking at the specific sterilants used [Figure - 2] during the latter part of this time period, it is clear that formaldehyde use has fallen off during the 1990s.  Although the greatest amount of information exists for reuse in the United States, it is important to note that reuse is practiced in many other countries of the world [Figure - 3]. Although the percentage of dialyser reuse varies according to country, most practice dialyser reuse to some degree. [Figure - 4]a shows that a number of countries practice dialyser reuse at a greater than 95% rate. In other countries, reuse is practiced to a lesser degree [Figure - 4]b. Japan, most of the Middle East and a few scattered countries in Europe and South America do not practice any dialyser reuse. The European countries not practicing reuse are primarily those with high reimbursement rates (The Netherlands, Scandinavia) and/or legal restrictions (Portugal, France). It should be noted that France practices no reuse, even though reuse is allowed if the dialyser is labeled for multiple use. This is due to past blood bank scandals and the resulting concern in the general public with regard to blood and infections, so that even dialysers labeled for multiple use are not reused. It is noteworthy that most dialysers are now labeled for multiple use in the United States in accordance with FDA regulations, but as was earlier the case in the United States, the same dialysers are generally labeled for single use in other countries. Currently, only one manufacturer actively markets its multiple-use labeled dialysers outside of the United States.
Automated reprocessing has also increased steadily over the years, becoming favored over manual reprocessing in the United States. Over 60% of centers practicing reuse use automated methods.  The Renatron® (Minntech Corporation, Minneapolis, MN) is the dominant automated dialyser reuse system employed world-wide, and is used in over 60% of the dialysis centers practicing automated reuse in the United States. Dialyser reuse varies according to facility type in the United States. Reuse is the highest in freestanding and for-profit facilities reflecting the economic factor in these operations. Reuse is also higher in large versus smaller facilities. The frequency of reuse varies with facility but averaged 17 reuses per dialyser in 1997. 
As shown in [Figure - 4], automated reprocessing is also increasingly practiced in other countries. Interestingly, in countries with lower reuse rates (30%), the rate of automated processing is higher (>95%, [Figure - 4]B compared to countries with higher reuse rates (>95%, [Figure - 4]A), where manual reuse is still common. A notable exception to this trend is Singapore, with a high reuse rate (>95%) and a high degree of automation (>95%). However, automated reprocessing also seems to be on the rise in countries previously practicing manual reuse, as these countries begin to implement qualityimprovement programs for dialysis. Automated reuse is also clearly the method of choice in countries that have only recently begun implementing dialyser reuse, such as South Korea and Saudi Arabia.
| Controversies of Dialyser Reuse|| |
For most medical practices, economic considerations are weighed against safety and effectiveness for patients and staff. Dialyser reuse is such a medical practice. It is of some importance to consider the realistic balance that must be reached between these two factors. While the welldocumented clinical benefits of dialyser reuse with cellulosic membranes (elimination of first-use syndrome, improved biocompatibility) ,,,,, have become of secondary importance in countries where steamsterilized, synthetic membranes are widely used, there is little argument about the cost savings possible through the practice of dialyser reuse (see below). Since cost savings are possible through the practice of dialyser reuse, then the safety factors and effectiveness must be as good as with single-use dialysers within the range of product variation for new products. Further, if adequate safety and effectiveness can be ensured in the institution with practices, procedures and policies of dialyser reprocessing with a cost factor less than single dialyser use, then dialyser reuse is the desirable route. No country is so rich that it can afford to squander its health-care resources unnecessarily.
| Quality Control in Reuse|| |
The safety of reuse has been greatly supported by the development of recommended practice guidelines for dialyser reprocessing by members of the dialysis community. ,,,, These recomme-ndations were formalized and published by the Association for the Advancement of Medical Instrumentation (AAMI) in 1986. In 1987, the Health Care Financing Administration (HCFA) mandated compliance with the AAMI standards as a condition of coverage. These guidelines are general in nature and serve as a basis for developing institutional guidelines for reprocessing dialysers. The recent DOQI (Dialysis Outcomes Quality Initiative) guidelines for hemodialysis prepared by the National Kidney Foundation also embody many of the key AAMI guidelines for dialyser reprocessing, including the requirement to measure total cell volume (TCV) after every reuse, and to "preprocess" dialysers in order to obtain an accurate TCV baseline value prior to the first use.  There is now substantial acceptance of reuse by the dialysis community as a safe and effective procedure if guidelines are followed. In fact, problems encountered in dialyser reuse can often be traced to inadequate adherence to the recommended guidelines for reprocessing. The acceptance and success of dialyser reprocessing by clinical practice suggests that adherence to these guidelines is reasonable and costeffective for hemodialysis centers.
It has been suggested that reuse has been primarily legitimized by clinical practice, as all dialysers presently marketed were originally labeled for single use by their manufacturers. Ironically, some of the world's largest dialyser manufacturers are also the world's largest reprocessors of dialysers (their own and those of their competitors) in their own dialysis centers. These contrasts in practice are seldom stated and in no way detract from any legitimate concern that reprocessing dialysers may impair their effectiveness. It is necessary, however, to recognize that manufacturers have an underlying interest in seeing dialysers used in a single-use, disposable manner to increase dialyser sales, while individual centers of practice must maintain the most efficient and economic care balance while maintaining patient health and safety. Since the introduction of the FDA's guidelines for multiple-use labeling of dialysers in 1995, dialyser manufacturers have been required to validate the suitability of their dialysers for multiple use with in-vitro and clinical test data. [Figure - 5] shows a list of dialysers validated for reuse by their manufacturers and approved by the FDA for multiple uses.
| Economic Issues|| |
In the 1980's, manufacturers began to provide dialysers with high-flux capabilities. These filters are more expensive but have become preferred by clinicians because of the more biocompatible, and higher dialysis delivery available with these units. Given the high cost of these newer dialysers, reuse appears to be necessary rather than optional for cost-effective care. , It is evident that no reuse or low percentage reuse is typically accompanied by high reimbursement rates. The introduction of the automated systems for reprocessing has also increased the attractiveness of reuse, by allowing dialysers to be used more often, while ensuring a minimal loss in treatment efficiency during the life of the dialyser.
Several studies have shown substantial savings with reuse. Wittich  reported that reprocessing of high flux dialysers saved roughly 95% of the dialyser costs annually when each dialyser is reused 20 times. Francouer et al,  reported that Renalin® reprocessing in the Toronto Western Hospital saved Can $309,000 annually. Sesso et al,  also reported cost savings with dialyser reuse in Brazil. Drozdz et al,  reported that a reprocessed highflux synthetic dialyser costs less than half as much as the cheapest low-flux, cellulosic, single-use dialyser in Poland. At the Sheffield Kidney Institute and its associated satellite dialysis centers, we have demonstrated significant savings approaching £250,000 annually while being able to make the more costly, high-flux synthetic membrane available to all our nearly 400 patients. ,,
| Pyrogen Reactions and Infections|| |
Pyrogenic reactions (i.e. fever, rigors, possible hypotension) events are more likely to occur in centers practicing dialyser reuse and centers using high flux rather than cellulose dialysers, according to the CDC. ,,, However, in a prospective study of three centers using reprocessed conventional cellulose, high-efficiency and high-flux dialysers, there was no difference between the overall rate of pyrogenic reactions between the centres.  The incidence rate of 0.3 per 1000 treatments did not vary by treatment shift, week or centre. The rate was also similar for first use versus reused dialysers. Several pyrogen reactions have been reported in reuse facilities utilizing formaldehyde. In each case, the outbreaks were attributed to the use of water supplies or dialysates that were contaminated and did not meet the AAMI standards. As the use of high-flux dialysers and hemodiafiltration increases, greater attention is being paid to the quality of water used for dialysis, and to the microinflammatory effects caused by endotoxins in the water treatment and distribution systems.
Gram-negative bacterial infections have been reported in patients exposed to reprocessed dialysers. ,,,, In one report, it was determined that these infections were due to inadequate exposure of the dialyser to sterilant from improper dilution and mixing of the sterilant solutions. In the other report, it was determined that the infections were due to the failure of a technician to change gloves after working with a patient with a known arteriovenous fistula infection. A report of six episodes of gram-negative infections and seven pyrogenic reactions was determined to be due to the use of a water supply that did not meet AAMI standards and failure to disinfect.
The rise of hepatitis C infections among dialysis patients and staff is of increasing concern in many countries, and the role of dialyser reprocessing in this process has been questioned. Jadoul et al, , reported that ,during a 54 month study period in Belgium, application of the CDC Universal Precautions in dialysis centers practicing reuse completely prevented the transmission of hepatitis C. In 1994, dos Santos et al,  found no difference in hepatitis C incidence among units that reprocessed and those that did not reprocess dialysers in Portugal. However, among the centers that reprocessed, the incidence was lower in units that used Renalin® instead of formaldehyde. Murthy and Pereira recently discussed hepatitis C and HIV related to dialysis. 54 The incidence and the prevalence of hepatitis C infection among patients is steadily declining. Conventional cleansing and sterilization procedures for reprocessing the dialysers appear to be adequate to inactivate the virus. Separate machines, patient isolation or cessation of reuse are not recommended by the CDC for hepatitis C patients, as it is very unlikely that transmission will occur in dialysis units that conform to the standard practice guidelines.
| Increased Mortality|| |
Perhaps the most important question in comparing single use and reuse of dialysers, as well as in comparing the germicides used for reprocessing, is a difference in mortality rates for dialysis patients. The higher mortality rates in the United States dialysis patients and the higher prevalence of dialyser reuse in this country led workers to ask whether reuse was a contributing factor. ,,,,
A national study evaluating the relationship between reuse and mortality evaluating patients through a one year follow-up of patients between 1989 and 1990 in freestanding centers utilizing either reused, low flux dialysers or single use low flux dialysers.  Patients in centers using Renalin® were reported to have a higher mortality rate than centers that did not reuse dialysers. Patients in centers reusing dialysers reprocessed with formaldehyde, on the other hand, had a mortality rate comparable to centers that did not reuse dialysers. Despite the fact that this study was prospective in nature and adjusted statistically for a number of factors, it was not a randomized, controlled trial. Unmeasured differences in study populations could well have influenced the results and no cause-effect relationship was established. Importantly, the authors did not address confounding areas of concern such as comorbidity and dialysis unit profit status.
Using the same methods and considering the same time period, Luehmann and Consentino reported on mortality rates in hospital-based dialysis units and found no effect on mortality associated with reuse germicides. 
Another study, using the same data base but a different analytical method, also suggested that patients treated with Renalin® reused low flux dialysers had a higher mortality risk in freestanding units but no difference in hospital-based units.  In this study, incident rather than prevalent ESRD patients were followed for four to five years. This study was also not randomized and suffered from the same shortcomings of the previous study in drawing conclusions.
The inadequacy of the study and analytical techniques of these earlier studies has been made clear by a more recent report. Collins et al,  reanalyzed the same data for 19891990 as well as the data for 1991-1993. In addition, these investigators also expanded the analysis to include both free-standing and hospital-based dialysis facilities, controlling for potential heterogeneity in the patient population by adjusting for patient specific comorbid conditions, characteristics specific to individual dialysis units, unit profit status and in analyzing noreuse unit data separately. The investigators found that although there was an isolated higher mortality risk with Renalin® reuse in 1989-1990, it was only with manual reuse in for profit only, freestanding dialysis units. No differences between Renalin® reprocessed conventional dialysers in any type of dialysis unit and dialyser noreuse was identified in 1991-1993. However, differences with other sterilants were identified during this time period. This more complete and detailed analysis showed that from 1991-1993 there were differences between dialysis units based on profit status for centers not practicing reuse. These results make it clear that neither reuse nor the choice of sterilant appear to affect mortality. It appears mortality is more likely to be affected by the dialysis therapy, nutrition and anemia correction and not reuse or sterilant selection.
A more recent report of the USRDS DMMS has further verified that there is no difference in mortality for reuse and singleuse dialysis.  However, the authors went further to suggest that there were trends that there was a survival advantage when reused dialysers were treated with bleach. Bleach, while having little effect on urea clearance, actually increases the beta-2-microglobulin clearance with certain polysulfone dialysers. It has been suggested that bleach alters the membrane structure of these polysulfone dialysers, allowing beta-2-microglobulin to pass through the membrane more readily than with new membranes. ,,, Without bleach, beta-2-microglobulin clearance is severely decreased when formaldehyde is used as the germicide. It should be pointed out that the biocompatibility of membranes is decreased by the use of bleach. In addition, using bleach to open up the membrane pores also results in the potential for increased albumin loss.  Parallel to earlier works, more complete analysis shows that bleach use does not appear to offer any advantage in terms of mortality. , Interestingly enough, the original article showed a higher relative risk of mortality for single use than for any form of reuse.
| Conclusion|| |
Reuse of hemodialysers is the predominant practice world-wide. While clinical use may have legitimized the reuse of dialysers, the analysis above shows that the validity of the practice of reuse is supported by the studies in the literature. It is clear that reuse can and does produce substantial cost savings without compromising the safety or effectiveness of the treatment. Reuse has also been shown to be environmentally friendly.
The pyrogen reactions and infections reported with reuse are typically traced back to inadequate water supplies, poor sterilant mixing and technician errors. It has been suggested that strict adherence to AAMI guidelines for dialysate preparation and dialysate filtration can reduce the bacterial and endotoxin load by 99.9%.
All studies to date on the risk of mortality due to reuse are limited in design because they are not prospective, randomized and controlled trials. The reports by Collins et al, which suggest that the chemical sterilant is not a factor in mortality, are probably the most complete studies to date in eliminating confounding variables. It has been suggested that the variable that should receive attention is the quantity of dialysis delivered. The current Dialysis and Morbidity Study (DMMS) has this factor under consideration and preliminary reports from this study suggest that centers practicing reuse actually provide a greater quantity of dialysis to patients than centers which practice single dialyser use (Kt/V 1.22 versus 1.19).  Moreover, it is generally agreed that higher dialysis dose is positively correlated with improved mortality.
While hepatitis C among dialysis patients is a growing concern in many countries, studies have shown that reuse, when properly performed, is not a cause of hepatitis C transmission. Current CDC guidelines therefore do not require the use of separate dialysis machines or reuse equipment for hepatitis C patients.
As reimbursement rates for dialysis are lowered in many European countries, while high-flux dialysis and hemodiafiltration with synthetic membranes are being more widely used, and as the use of automated reuse equipment and standardized guidelines replaces manual formaldehyde reuse, it is to be expected that high-quality dialyser reuse will continue to grow. While certain large chains of clinics may be able to afford single use using dialysers from their own manufacturing division, this certainly will not be feasible for the majority of other centers around the world. In fact, it is to be feared that higher prices charged to outside centers will fund the single use within these chains, at the expense of dialysis patients and health-care systems around the world.
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Consultant Renal Physician, Sheffield Kidney Institute, Sheffield
[Figure - 1], [Figure - 2], [Figure - 3], [Figure - 4], [Figure - 5]