Reuse Of Hemodialyzers Research Articles

Renal Support for Acute Kidney Injury in the Developing World

There is wide variation in the management of acute kidney injury (AKI) and the practice of renal replacement therapy (RRT) around the world. Clinicians in developing countries face additional challenges due to limited resources, reduced availability of trained staff and equipment, cultural and socioeconomic aspects, and administrative and governmental barriers. In this article, we report the consensus recommendations from the 18th Acute Dialysis Quality Initiative conference in Hyderabad, India. We provide the minimal requirements for provision of acute RRT in developing countries, including patient selection, choice of RRT modality and monitoring, transition, and termination of acute RRT. We also discuss areas of uncertainty and propose themes for future research. These recommendations can serve as a foundation for clinicians to implement renal support for AKI in low resource settings.

Effects of dialyzer reuse on dialysis adequacy, anemia control, erythropoieting-stimulating agents use and phosphate level.

Almost 50 years have passed since the first time the concept of dialyzer reuse in hemodialyzed patients was introduced for primarily economic reasons [1]. Hemodialyzers are labeled by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) as single use only. In recognition of the widespread practice of reuse in the United States, in 1996 the FDA required manufacturers to label dialyzers for multiple use and to back up this claim with data showing that the performance of the dialyzer is sustained over multiple uses [2]. In Poland there is also a tendency to stop the reuse of dialyzers. There are three major concerns with reuse: the risk of infection; biochemical and immunologic effects; and loss of performance with impairment in clearance and/or ultrafiltration [3].

CMS Finalizes Revisions to Conditions to Participation

CMS Finalizes Revisions to Conditions to Participation

Association of Dialyzer Reuse and Hospitalization Rates among Hemodialysis Patients in the US

Objectives: To determine if reuse of hemodialyzers is associated with higher rates of hospitalization and their resulting costs among end-stage renal disease (ESRD) patients. Methods: Noncurrent cohort study of hospitalization rates among 27,264 ESRD patients beginning hemodialysis in the United States in 1986 and 1987. Results: Dialysis in free-standing facilities reprocessing dialyzers was associated with a greater rate of hospitalization than in facilities not reprocessing (relative rate (RR) = 1.08, 95% confidence interval (CI), 1.02–1.14). This higher rate of hospitalization was observed with dialyzer reuse using peracetic/acetic acids (RR = 1.11, CI 1.04–1.18) and formaldehyde (RR = 1.07, CI 1.00–1.14), but not glutaraldehyde (p = 0.97). There was no difference among hospitalization rates in hospital-based facilities reprocessing dialyzers with any sterilant and those not reprocessing. Hospitalization for causes other than vascular access morbidity in free-standing facilities reusing dialyzers with formaldehyde was not different from hospitalization in facilities not reusing. However, reuse with peracetic/acetic acids was associated with higher rates of hospitalization than formaldehyde (RR = 1.08, CI 1.03–1.15). Conclusions: Dialysis in free-standing facilities reprocessing dialyzers with peracetic/acetic acids or formaldehyde was associated with greater hospitalization than dialysis without dialyzer reprocessing. This greater hospitalization accounts for a large increment in inpatient stays in the USA. These findings raise important concerns about potentially avoidable morbidity among hemodialysis patients.

Reuse of angioplasty catheters and risk of Creutzfeldt-Jakob disease

Background In 1996, the Quebec Ministry of Health and Social Services, concerned that reuse of devices contaminated with blood or blood products could cause the transmission of Creutzfeldt-Jakob disease (CJD), discontinued its practice of reusing angioplasty catheters despite the significant cost savings reuse had afforded the health care system for several years. The objective of this study was to establish whether the medical literature provides documentation of any cases in which CJD was transmitted by reused percutaneous transluminal coronary angioplasty (PTCA) equipment. Methods and Results A Medline search was performed to identify previous studies that examined this issue. Key words for the search included PTCA, CJD, and material and equipment reuse. A substantial amount of effort has been spent on the study of PTCA catheter reuse in relation to the risk of infection, toxicity, and catheter breakage as well as cost. In Québec, studies by the Conseil d’Évaluation des Technologies de la Santé investigated the effectiveness of cleaning and sterilizing PTCA equipment and considered the possibility that reuse of single-use catheters, hemodialyzers, and cardiac pacemakers could spread CJD. A number of other studies found evidence that iatrogenic transmission was responsible for several cases of CJD by direct implantation in or adjacent to the central nervous system during neurosurgery. CJD was also transmitted to human beings by injection of pituitary growth hormone and to mice through cerebral inoculation of contaminated blood and urine. However, there were no documented cases of CJD occurring as a complication of PTCA equipment reuse. Conclusions The current literature indicates that there are no known cases of CJD attributable to the reuse of PTCA devices contaminated by blood or to the transfusion of blood or blood products. This practice is associated with a very low risk of CJD transmission. With the considerable cost savings made possible by reuse of PTCA equipment, reimplementation of this practice should be considered by health delivery systems, provided that stringent methods of cleaning and sterilization are observed. (Am Heart J 1999;137:1173-8.)

Association of Dialyzer Reuse with Hospitalization and Survival Rates Among U.S. Hemodialysis Patients: Do Comorbidities Matter?

The objective of this study was to determine whether the associations between reuse of hemodialyzers and higher rates of death and hospitalization persist after adjustment for comorbidity. This was a nonconcurrent cohort study of survival and hospitalization rates among 1491 U.S. chronic hemodialysis patients beginning treatment in 1986 and 1987. The impact of dialyzer reuse was compared across three survival models: an unadjusted model, a “base” model adjusted only for demographics and renal diagnosis, and an “augmented” model additionally adjusted for comorbidities. We found that reuse of dialyzers was associated with a similarly higher rate of death in analyses unadjusted for confounders (relative risk [RR] 1.25, 95% confidence interval [CI] 0.97–1.61), adjusted for demographics and renal diagnosis (RR 1.16, 95% CI 0.96–1.41), and analyses additionally adjusted for comorbidities (RR = 1.25, CI, 1.03, 1.52). Reusing dialyzers was also associated with a greater rate of hospitalization that was stable regardless of adjustment procedures. We conclude that higher rates of death and hospitalization associated with dialyzer reuse persist regardless of adjustment for demographic characteristics or baseline comorbidities. These findings amplify concerns that there exists elevated morbidity among hemodialysis patients treated in facilities that reuse hemodialyzers. Although the association we observed was not confounded by comorbidity, a cause-and-effect relationship between dialyzer reuse and morbidity could not be proved because of the inability to control for aspects of care other than dialyzer reuse.

Update on Reuse of Hemodialyzers

Update on Reuse of Hemodialyzers

National kidney foundation report on dialyzer reuse

The Council on Dialysis of the National Kidney Foundation convened an expert panel to evaluate the current practice and literature related to the reuse of hemodialyzers. The panel reviewed and evaluated literature related to reuse since the last report of the National Kidney Foundation recommendations on reuse was published in 1988. The group sought to develop a consensus concerning the effect of reuse of hemodialyzers on mortality; the efficiency of delivered hemodialysis when reused hemodialyzers are used in the clinical setting; the clinical effects of reused dialyzers as compared with dialyzers not reused on intradialytic symptoms; infections in patients using reused dialyzers; and the effect of reused dialyzers on complement activation, cytokine production, and β 2-microglobulin metabolism and clearance. In addition, the panel reviewed the literature on the potential toxicity of germicides used in the processing of dialyzers for reuse as well as recent changes in federally mandated regulations concerning labeling of dialyzers for reuse, the monitoring of the reuse process, and the effectiveness of reused dialyzers to achieve a prescribed delivered clearance as estimated by urea kinetic modeling or by percent urea reduction. The National Kidney Foundation takes no position for or against dialyzer reuse. The principal reason for the practice of reuse is economical. 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. There is no conclusive evidence to substantiate the notion that either morbidity or mortality associated with single use or reuse is different. Microbial contamination of the water used for dialyzer reprocessing increases patient morbidity. The chemical quality of water used for dialyzer reprocessing should, at least, fall within the same standards as those recommended for product water intended for hemodialysis. Dialyzers should not be reprocessed from patients who have tested positive for hepatitis B surface antigen. The effects of reprocessing high-flux dialyzers on β 2-microglobulin clearance are dependent on the reprocessing technique, the number of reuses, and the nature of the dialyzer membrane used. There are insufficient data on the effects of reuse on β 2-microglobulin behavior to make uniform recommendations. Untoward effects of reused dialyzers may still occur in spite of rigorous adherence to the AAMI guidelines. For example, use of the total cell volume method for assessing changes in small molecule clearances will not show the loss of performance attributable to dialysate shunting. For this reason, the measurement of Kt/V for urea as recommended by the AAMI or the determination of the urea reduction ratio (URR) is strongly recommended at least monthly to gauge the adequacy of the dialysis procedure. 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. Technicians and other personnel responsible for the reprocessing of dialyzers should receive proper training. These health care providers should be certified in reprocessing by an examining body so that professional competency can be assured.

Microbiological and Endotoxin Assays of Hemodialysis Fluids

The potential for exposure of dialysis patients to greater levels of microbial and endotoxin contamination has increased dramatically during the last decade with the increase in reuse of hemodialyzers, and the use of bicarbonate dialysate and high flux dialysis. To help prevent pyrogenic reactions and bacteremia in hemodialysis patients caused by microbial and endotoxin contamination of hemodialysis fluids, the Association for the Advancement of Medical Instrumentation (AAMI) has promulgated standards for maximum allowable concentrations of bacteria and endotoxin in these fluids. Each dialysis center should develop microbiological and endotoxin surveillance policies and procedures for the types of hemodialysis fluids to assay, frequency and manner of sample collection, assay techniques, and methods for recording and interpreting results to ensure compliance with the AAMI standards. These necessary components of a comprehensive surveillance program are discussed in depth in this article. A safer environment will be provided for each dialysis patient if appropriate microbiological assay procedures are followed and the results are consistently within the AAMI microbiological and endotoxin standards.

Anaphylactoid reactions associated with reuse of hollow-fiber hemodialyzers and ACE inhibitors

From July 18 through November 27, 1989, 12 anaphylactoid reactions (ARs) occurred in 10 patients at a hemodialysis center in Virginia. One patient required hospitalization; no patients died. ARs occurred within minutes of initiating dialysis and were characterized by peripheral numbness and tingling, laryngeal edema or angioedema, facial or generalized sensation of warmth, and/or nausea or vomiting. All 12 ARs occurred with dialyzers that had been reprocessed with an automated reprocessing system. A cohort study, including all patients undergoing dialysis sessions on the six days when an AR occurred, showed that the patients who experienced ARs were significantly more likely than patients who did not to be treated with angiotensin-converting enzyme (ACE) inhibitors (7/10 vs. 3/33; relative risk = 7.9; 95% confidence interval = 2.5 to 25.2) and to have been exposed to reused dialyzers rather than to new dialyzers (12/70 sessions vs. 0/31; P = 0.016). In those sessions using a reused dialyzer, the mean number of dialyzer uses in case-sessions was significantly higher than for noncase-sessions (10.3 vs. 6.2; P = 0.016). After reuse of dialyzers was discontinued at the center, no further ARs occurred, despite the continued administration of ACE inhibitors. This is the first report of an outbreak of ARs associated exclusively with reused dialyzers. We hypothesize that interactions between a dialyzer that has been repeatedly reprocessed and reused, blood, and additional factors, such as ACE inhibitors, increased the risk of developing ARs.

A Prospective Study on Intradialytic Symptoms Associated with Reuse of Hemodialyzers

The benefits and disadvantages of hemodialyzer reuse is controversial. While biochemical data have suggested potential benefits from reuse, there is dispute over the clinical impact on the patient. Limited data show that reuse is associated with less intradialytic symptoms compared to first use. We conducted a prospective study of acute symptoms during clinical dialysis using new and reused cellulose acetate membrane hollow-fiber dialyzers. A total of 106 sessions using new dialyzers and 871 sessions employing reused dialyzers were monitored. Dialyzers were processed with an automated machine using hydrogen peroxide and peroxyacetic acid as sterilants. We found that, compared to new ones, reused dialyzers were associated with a similar frequency of overall and specific symptoms. In addition, there was no difference in the magnitude of changes in blood pressure during and after the treatments between the two groups. We conclude that maintenance hemodialysis with reused cellulose acetate membrane dialyzers processed with hydrogen peroxide and peroxyacetic acid was not associated with more or fewer subjective symptoms than dialysis with new dialyzers.

Cost-Effectiveness Analysis of the Treatment of End-Stage Renal Disease in Brazil

Cost-effectiveness analysis compared four treatments of end-stage renal disease in Brazil: continuous ambulatory peritoneal dialysis (CAPD), in-center hemodialysis (HD), cadaver donor transplantation (CD-Tx), and living related donor transplantation (LR-Tx). After 2 years, the costs per year of survival were CAPD, $12,134; HD, $10,065; CD-Tx, $6,978; and LR-Tx, $3,022. The HD cost was lower than CAPD partially because of the reuse of hemodialyzers in Brazil. Although less cost-effective, both dialysis treatments yielded more years of survival after 2 years. This analysis reveals a trade-off between cost per year of survival and years of survival.

Reuse of hemodialyzers. Results of nationwide surveillance for adverse effects.

In 1986, the Centers for Disease Control, in collaboration with the Health Care Financing Administration, surveyed 1350 chronic hemodialysis centers in the United States to ascertain practices associated with the reuse of disposable hemodialyzers and the frequency of pyrogenic reactions and septicemia among patients. Reuse of hemodialyzers was reported by 63% of the centers. Centers that used RenNew-D (n = 5) for reprocessing hemodialyzers, compared with centers that did not reuse (n = 495), were more likely to report pyrogenic reactions (60% vs 13%) and episodes of septicemia (100% vs 55%) among their patients. Reusing hemodialyzers more than 20 times and, in some instances, also using manual reprocessing systems was significantly associated with clustering of pyrogenic reactions regardless of the type of germicide used. To detect membrane leaks developing after multiple reuses, air-pressure-leak tests should be performed on all reprocessed hemodialyzers.

Regulatory and legal issues in the reprocessing and reuse of hemodialyzers. A critical overview.

Regulatory and legal issues in the reprocessing and reuse of hemodialyzers. A critical overview.

Development of Anti-N-Like Antibodies During Formaldehyde Reuse in Spite of Adequate Predialysis Rinsing

The development of anti-N-like antibodies has been demonstrated with formaldehyde reuse of hemodialyzers. It has been recommended to pursue a postrinsing venous effluent formaldehyde concentration in the range of or below 2 to 10 ppm, in order to prevent the development of these anti-N-like antibodies. In the present study, we evaluated formaldehyde reuse in a population of 50 patients and whether the strict control of predialysis effluent formaldehyde concentration below 2 to 3 ppm could prevent the development of anti-N-like antibodies. Five of 50 patients (10%) became positive 6 to 14 months after the start of formaldehyde reuse, indicating that even a careful control of effluent formaldehyde concentration cannot prevent the occurrence of this abnormality.

Automated Reuse of Capillary Hemodialyzers

Automated Reuse of Capillary Hemodialyzers

National Kidney Foundation revised standards for reuse of hemodialyzers.

The National Kidney Foundation, Inc convened a group with expertise and experience in dialysis, including one or more physicians, nurses, consumers (patients), industry representatives, and microbiologists to formulate these standards, which were subsequently approved by the Executive Committee of the National Kidney Foundation at its December 2, 1983 meeting. The Executive Committee of the National Kidney Foundation has decided to issue these Standards for Reuse of Hemodialyzers in the interest of better patient care. These standards will be reviewed periodically as the science of dialyzer reuse develops. Accordingly, the Foundation requests comments and suggestions from all interested parties.

Industry concerns regarding the practice of remanufacture and reuse of single-use hemodialyzers.

Artificial OrgansVolume 6, Issue 2 p. 225-226 Industry Concerns Regarding the Practice of Remanufacture and Reuse of Single-Use Hemodialyzers G. Briggs Phillips Ph. D., G. Briggs Phillips Ph. D. Senior Vice President Scientific Affairs Health Industry Manufacturers AssociationSearch for more papers by this author G. Briggs Phillips Ph. D., G. Briggs Phillips Ph. D. Senior Vice President Scientific Affairs Health Industry Manufacturers AssociationSearch for more papers by this author First published: May 1982 https://doi.org/10.1111/j.1525-1594.1982.tb04090.xAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume6, Issue2May 1982Pages 225-226 RelatedInformation

Reuse of single-use hemodialyzers. Technical, legal, medical and economic implications.

Artificial OrgansVolume 3, Issue 3 p. 281-281 Reuse of Single-Use Hemodialyzers Technical, Legal, Medical and Economic Implications George T. Willingmyre, George T. Willingmyre The Health Industry Manufacturers Association 1030 Fifteenth Street, N.W. Washington, D.C., 20005, USA.Search for more papers by this authorP.E. Director, P.E. Director The Health Industry Manufacturers Association 1030 Fifteenth Street, N.W. Washington, D.C., 20005, USA.Search for more papers by this authorTechnical Services, Technical Services The Health Industry Manufacturers Association 1030 Fifteenth Street, N.W. Washington, D.C., 20005, USA.Search for more papers by this author George T. Willingmyre, George T. Willingmyre The Health Industry Manufacturers Association 1030 Fifteenth Street, N.W. Washington, D.C., 20005, USA.Search for more papers by this authorP.E. Director, P.E. Director The Health Industry Manufacturers Association 1030 Fifteenth Street, N.W. Washington, D.C., 20005, USA.Search for more papers by this authorTechnical Services, Technical Services The Health Industry Manufacturers Association 1030 Fifteenth Street, N.W. Washington, D.C., 20005, USA.Search for more papers by this author First published: August 1979 https://doi.org/10.1111/j.1525-1594.1979.tb01065.xAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume3, Issue3August 1979Pages 281-281 RelatedInformation