What you should know about dialyzer reuse national kidney. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Guidance for hemodialyzer reuse labeling, and guidance for the content of premarket notifications for. For a complete copy of this aami document, contact aami at 17724226 or visit.
The clinical studies described in this guidance are intended solely to collect data to support hemodialyzer reuse labeling. For earlier literature the reader is referred to other sources 1, 2. Fda releases final guidance on the reprocessing and reuse. The iec 62304 medical device software standard medical device software software life cycle processes is comprised of five processes in five chapters 59. Fda software guidances and the iec 62304 software standard. Guidance for hemodialyzer reuse labeling, and guidance for the. Dialyzer reuse appears to be a safe and costeffective procedure for highflux and highurea removal dialyzers.
Media destruction guidance national security agency. Dialyzer reuse techniques and controversy springerlink. Inclusion on a list does not constitute an endorsement by nsa or the u. Environmental impact of dialyzer reuse and singleuse practices. A guide for hemodialysis patients and their families. National kidney foundation revised standards for reuse of hemodialyzers. Recommendations for hemodialyzers may be found in these separate guidance documents. Hemodialyzer reuse refers to the practice of using the dialyzer multiple times for a single patient. Guidance for hemodialyzer reuse labeling october 6, 1995. A quality and costbenefit analysis of dialyzer reuse in hemodialysis patients article in renal failure 305. Reuse of a hemodialyzer means that the same hemodialyzer filter is used more than once for the same patient.
The products on the list meet specific nsa performance requirements for sanitizing, destroying, or disposing of media containing sensitive or classified information. If a hemodialyzer is intended for multiple use, the submission should also include all information described in the guidance for hemodialyzer reuse labeling october 6, 1995 which can be. Premarket notification 510k guidance for contact lens care products. Guidance for the content of premarket notifications for. Pdf effects of hemodialyzer reuse on clearances of urea. National kidney foundation report on dialyzer reuse sciencedirect.
The requirements for softwarecontrolled medical devices and for the use of. Hemodialyzer reuse refers to the processing of a used dialyzer cartridge with or. Dialyzer, insert sheet, optifluxhemoflow, multiple use fresenius. A quality and costbenefit analysis of dialyzer reuse in.
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