Inclusion on a list does not constitute an endorsement by nsa or the u. 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. Guidance for hemodialyzer reuse labeling, and 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. National kidney foundation revised standards for reuse of hemodialyzers. What you should know about dialyzer reuse a guide for hemodialysis patients and their families. A quality and costbenefit analysis of dialyzer reuse in. For a complete copy of this aami document, contact aami at 17724226 or visit. Dialyzer reuse techniques and controversy springerlink.
Fda releases final guidance on the reprocessing and reuse. Recommendations for hemodialyzers may be found in these separate guidance documents. Premarket notification 510k guidance for contact lens care products. The products on the list meet specific nsa performance requirements for sanitizing, destroying, or disposing of media containing sensitive or classified information. Dialyzer, insert sheet, optifluxhemoflow, multiple use fresenius. Guidance for hemodialyzer reuse labeling, and guidance for the. Media destruction guidance national security agency. The requirements for softwarecontrolled medical devices and for the use of. Fda software guidances and the iec 62304 software standard. 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. What you should know about dialyzer reuse national kidney. Environmental impact of dialyzer reuse and singleuse practices.
The iec 62304 medical device software standard medical device software software life cycle processes is comprised of five processes in five chapters 59. Dialyzer reuse appears to be a safe and costeffective procedure for highflux and highurea removal dialyzers. Guidance for the content of premarket notifications for. The clinical studies described in this guidance are intended solely to collect data to support hemodialyzer reuse labeling. Hemodialyzer reuse refers to the practice of using the dialyzer multiple times for a single patient. A guide for hemodialysis patients and their families. A quality and costbenefit analysis of dialyzer reuse in hemodialysis patients article in renal failure 305. Guidance for hemodialyzer reuse labeling october 6, 1995.
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