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.
Lacson
Eduardo
E
Fresenius Medical Care-North America, Lexington, Massachusetts 02421, USA. elacson@fmc-na.com
Lazarus
J Michael
JM
D004203:Disinfection / Q000592:standards; D017743:Equipment Reuse / Q000191:economics; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy; D017063:Outcome Assessment, Health Care; D006435:Renal Dialysis / Q000295:instrumentation*