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Cellulose acetate dialyzer expiration dating may be required; FDA issues alert following patient injuries.

This article was originally published in The Gray Sheet

Executive Summary

CELLULOSE ACETATE DIALYZER EXPIRATION DATING REQUIREMENT likely will be developed by FDA in response to recent adverse events with the devices. The events, all occurring in September at a Huntsville, Alabama hospital, are thought to be related to use of 10-year-old cellulose acetate dialyzers to treat seven patients who developed conjunctivitis, visual loss, and/or hearing loss within 24 hours of hemodialysis.
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