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"O" ring urinary ostomy appliance.

Abstract

A non-adhesive urostomy system represents a major departure from ostomy appliances that have been used to date. Experience of 123 ostomates who have lived with the traditional as well as the new appliance indicates a high degree of patient acceptance and satisfaction. The "O" ring appliance promises to simplify and improve the quality of life for patients who are committed to this form of urinary disposition.

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BibTeXRIS

J J Kaufman, K F Jeter. 1984. "O" ring urinary ostomy appliance.. https://doi.org/10.1016/0090-4295(84)90017-7

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Medical devices; reprocessed single-use devices; requirement for submission of validation data. Direct final rule.

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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