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      Dialyzer reuse: is it safe and worth it?

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      Jornal Brasileiro de Nefrologia

      Sociedade Brasileira de Nefrologia

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          Abstract

          Dialyzer reuse, the practice of using the same dialyzer for multiple hemodialysis treatments, has been in place since 1960s.1 , 2 While there has been a steady decline of dialyzer reuse in the United States and Europe since late 1990s, it continues to be mainstream across most of the developing world.3 - 6 Dialyzer reuse involves a complicated multistep process that includes rinsing, cleaning, performance testing, and disinfection of dialyzers prior to reuse. The process requires the use of cleaning and germicidal agents that are potentially toxic, and accidental contact with these agents may expose both patients and dialysis staff to health hazards.1 , 7 - 9 There are also reports of Gram-negative bacteremia outbreaks from the break-down in infection-control systems,10 - 12 and even a low-level exposure to toxins and microbiological contamination may contribute to chronic inflammation. Despite these potential risks, there are no randomized-controlled trials comparing single-use and reuse practices, and the evidence from observational studies are inconsistent.6 , 13 There is also a concern for conflicts of interest as studies sponsored by disinfectant manufacturers tend to show single-use and reuse practices having similar health outcomes while those sponsored by dialyzer manufacturers are more prone to show reduced risk with single-use.13 , 14 Notwithstanding the available evidence, given the 50 years of clinical experience with dialyzer reuse, there is a general agreement that the reuse process is likely safe when there is a strict adherence to the standards set by the Association for the Advancement of Medical Instrumentation (AAMI).15 Traditionally, dialyzer reuse was employed to improve dialyzer membrane biocompatibility, particularly of cellulose membranes, and lower the risk of first-use syndromes observed in ethylene oxide-sterilized dialyzers. These advantages of reuse are now moot due to the widespread availability of biocompatible dialyzer membranes and favorable sterilization techniques.6 Economic considerations, on the other hand, continue to make dialyzer reuse appealing for many dialysis service providers. Economic considerations, however, are not uniform around the world or, in many places, even within the same country. There is an argument that the cost-benefit with reuse may be negligible in areas of the world where the costs related to reuse-related personnel and safe storage space are high.6 The relative cost savings, however, is expected to be higher in areas where the personnel and space costs are low.3 , 5 , 16 Even a marginal cost-saving would be important in financially strained health systems, or in instances when patients share the cost of their dialysis care. In this backdrop, Dr. Ribeiro and colleagues report the findings of their small cross-over study examining the differences in clinical and microbiological parameters with single-use and reuse practices.17 Ten patients were selected to undergo one hemodialysis treatment using the single-use practice and twelve hemodialysis treatments using the reuse-practice. Clinical, laboratory, and microbiological parameters were collected during the single-use treatment (N = 10 sessions) and during the 1st, 6th, and 12th reuse treatments (N = 30 sessions). High-flux polysulfone dialyzers that were steam-sterilized were used, and the reprocessing was done manually using the institutional protocol that was based on the AAMI’s standards. Dialyzers were cleaned using the solution composed of peracetic acid, hydrogen peroxide, acetic acid, and active oxygen (Peroxide P50, Bell Type Industries, Brazil). Inflammatory biomarkers, C-reactive protein (CRP), and ferritin were noted to be high at baseline and increase after hemodialysis in both single-use and reuse treatments. Endotoxin levels were similar before and after both single-use and reuse treatments. Median serum levels of CRP and endotoxins, pre- and post- hemodialysis treatments, were not significantly different between single-use and reuse sessions. Blood and protein residues were found in most dialyzers after the reuse sessions, but samples from the sanitizing liquid stored in the dialyzer blood chamber were free of bacterial and endotoxin contamination. While the findings from this study provide reassurances about the safety of dialyzer reuse, there are important caveats. First, there was no wash-out phase in the study, and patients were using reused dialyzers prior to their first and only single-use treatment. So, if there is any benefit to single-use dialyzer, one treatment alone may not be adequate to observe a change in clinical and laboratory parameters. Second, the adverse consequences from reuse tend to occur when there are human errors in the implementation of the AAMI’s standards. Therefore, a reassuring finding in a study of ten patients still leaves open the question of whether the reuse practice is safe in large health systems where any lapse in the execution of reprocessing standards may lead to adverse patient outcomes. Third, the findings from this study are only valid for the type of dialyzers and cleaning agents used in the study, namely steam-sterilized high-flux polysulfone dialyzers and the peracetic acid-based cleaning system. It would thus not be advisable to extrapolate these findings to modified-cellulose dialyzers, dialyzers that use sterilization practices other than steam, or to reuse systems that do not use peracetic acid-based cleaning agents. In conclusion, the study by Dr. Ribeiro and colleagues reinforces the notion that the dialyzer reuse practice is likely safe when performed according to the standards set by the AAMI. The medical reasoning for dialyzer reuse, however, is obsolete in the current era of biocompatible dialyzers, and the potential for cost-saving is the only rationale for its continued practice. It is now imperative to conduct a systematic cost-benefit analysis of reuse practices in developing countries where any cost-saving can have an important impact in the availability of hemodialysis treatments.

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          Most cited references 15

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          Hemodialysis in Asia

           Narayan Prasad,  Vivekanand Jha (corresponding) (2015)
          Background: Asia is the largest, most populous and most heterogeneous continent in the world. The number of patients with end-stage renal disease is growing rapidly in Asia. Summary: A fully informed report on the status of dialysis therapies including hemodialysis (HD) is limited by the lack of systematic registries. Available data suggest remarkable heterogeneities, with some countries like Taiwan, Japan and Korea exhibiting well-established HD systems, high prevalence and universal access to all patients, while low- and low-middle income countries are unable to provide HD to eligible patients because of high cost and poor healthcare systems. Many Asian countries have unregulated dialysis units, with poor standards of delivery, quality control and outcome reporting. This leads to high mortality due to preventable complications like infections. Modeling data suggest that at least 2.9 million people need dialysis in Asia, which represents a gap in availability of dialysis to the tune of -66%. The population is projected to grow rapidly in the coming years. Several countries are expanding access to HD. Innovative modifications in dialysis practice are being made to optimize outcomes. It is important to develop robust systems of documentation and outcome reporting to evaluate the effects of such changes. HD needs to develop in conjunction with effective preventive programs and improvement of health systems. Key Messages: The practice of HD in Asia is growing and evolving. Rapid expansion will improve the currently dismal access to care for large sections of the population. Quality issues need to be addressed if the full benefit of this therapy is to reach the population. Developed countries of Asia can provide substantial messages to developing economies. HD programs must develop in conjunction with prevention efforts. Facts from East and West: (1) While developed Western and Asian countries provide end-stage renal disease patients full access to HD, healthcare systems from South and South-East Asia can offer access to HD only to a limited fraction of the patients in need. Even though the annual costs of HD are much lower in less developed countries (for instance 30 times lower in India compared to the US), patients often cannot afford costs not covered by health insurance. (2) The recommended dialysis pattern in the West is at least three sessions weekly with high-flux dialyzers. Studies from Shanghai and Taiwan might however indicate a benefit of twice versus thrice weekly sessions. In less developed Asian countries, a twice weekly pattern is common, sometimes with dialyzer reuse and inadequate water treatment. A majority of patients decrease session frequency or discontinue the program due to financial constraint. (3) As convective therapies are gaining popularity in Europe, penetration in Asia is low and limited by costs. (4) In Asian countries, in particular in the South and South-East, hepatitis and tuberculosis infections in HD patients are higher than in the West and substantially increase mortality. (5) Progress has recently been made in countries like Thailand and Brunei to provide universal HD access to all patients in need. Nevertheless, well-trained personnel, reliable registries and better patient follow-up would improve outcomes in low-income Asian countries.
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            Single-use versus reusable dialyzers: the known unknowns.

            The practice of reusing dialyzers has been widespread in the United States for decades, with single use showing signs of resurgence in recent years. Reprocessing of dialyzers has traditionally been acknowledged to improve blood-membrane biocompatibility and prevent first-use syndromes. These proposed advantages of reuse have been offset by the introduction of more biocompatible membranes and favorable sterilization techniques. Moreover, reuse is associated with increased health hazard from germicide exposure and disposal. Some observational studies have also pointed to an increased mortality risk with dialyzer reuse, and the potential for legal liability is another concern. The desire to save cost is the major driving force behind the continued practice of dialyzer reuse in the United States. It is imperative that future research focus on the environmental consequences of dialysis, including the need for more optimal management of disinfectant-related waste with reuse, and solid waste with single use. The dialysis community has a responsibility to explore ways to mitigate environmental consequences before single-use and a more frequent dialysis regimen becomes a standard practice in the United States.
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              Dialyzer best practice: single use or reuse?

              Outcome studies have shown either no additional risk or a small additional risk for hospitalization and mortality associated with reprocessing dialyzers. Although the risks from reprocessing dialyzers have yet to be fully elucidated, reuse can be done safely if it is performed in full compliance with the standards of Association for the Advancement of Medical Instrumentation (AAMI). Like most industrial processes, however, complete control of the reuse process in a clinical environment and full compliance with regulations at all times is difficult. Potential errors and breakdowns in the reuse process are continuing concerns. The quality controls for reprocessing of dialyzers are not equal to the rigor of the manufacturing process under the purview of the U.S. Food and Drug Administration (FDA). Therefore, if one were to determine "best practice," single use is preferable to reuse of dialyzers based on medical criteria and risk assessment. The long-term and cumulative effects of exposure to reuse reagents are unknown and there is no compelling medical indication for reprocessing of dialyzers. The major impediment when deciding to convert from reuse to single use of dialyzers is economic. The experience in Fresenius Medical Care-North America (FMCNA) facilities demonstrates that converting from a practice of reuse to single use is achievable. However, the overall economic impact of conversion to single use is provider specific. The dominance of reuse has been negated of late by a major shift in practice toward single use. Physicians and patients should be well informed in making decisions regarding the practice of single use versus reuse of dialyzers.
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                Author and article information

                Journal
                J Bras Nefrol
                J Bras Nefrol
                jbn
                Jornal Brasileiro de Nefrologia
                Sociedade Brasileira de Nefrologia
                0101-2800
                2175-8239
                02 September 2019
                Jul-Sep 2019
                : 41
                : 3
                : 312-314
                Affiliations
                [1 ] orgnameBoston University School of Medicine orgdiv1Section of Nephrology Boston, MA United States of America originalBoston University School of Medicine, Section of Nephrology, Boston, MA, United States of America.
                Author notes
                Correspondence to: Ashish Upadhyay. E-mail: ashishu@ 123456bu.edu

                AUTHOR’S CONTRIBUTION

                Ashish Upadhyay contributed substantially to the conception or design of the study; collection, analysis, or interpretation of data; writing or critical review of the manuscript; and final approval of the version to be published.

                CONFLICT OF INTEREST

                No financial conflict of interest. The author is a voting member of the Renal Disease and Detoxification Committee, Association for the Advancement of Medical Instrumentation (AAMI).

                Article
                10.1590/2175-8239-JBN-2019-0134
                6788837
                31508668

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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