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PubMed · 3680196

Multiple use of plasmafilters.

Abstract

The practice of multiple use of membrane plasmafilters was examined in six patients receiving intermittent or regular plasmapheresis treatment. The plasmafilters were cleaned by flushing and ultrafiltration using positive pressure in the blood and filtrate compartments of the plasmafilter. Twenty-six plasmafilters were studied and the membrane permeability characteristics were examined during 56 plasmapheresis treatments with reused plasmafilters. The clearances of nitrogen urea and creatinine, and the sieving coefficients of albumin and immunoglobulins remained unchanged with the reuse of plasmafilters. The practice is safe, efficient, and can contribute to cost containment in plasmapheresis treatment.

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BibTeXRIS

K N Lai, F M Lai, C W Lam. 1987. Multiple use of plasmafilters.. https://doi.org/10.1002/jca.2920030409

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The Food and Drug Administration (FDA or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA.

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