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PubMed · 8322402

Types of endoscopic instruments.

Abstract

1. Rigid endoscopes provide excellent optics and are durable, but are not as versatile as flexible scopes. Flexible endoscopes provide accessibility to otherwise inaccessible areas, but have poorer optics. 2. There are several issues to consider when making the decision to use disposable or reusable items. This decision must be made jointly by the OR manager and the surgeon. The most important issue is patient outcome. 3. It is certain that the trend towards noninvasive procedures will continue as surgeons from additional surgical specialties adopt endoscopic techniques. The perioperative nurse must be ready to expand practice to facilitate the growing technology of endoscopic procedures.

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C L Nelson-Conley. Types of endoscopic instruments.. https://pubmed.ncbi.nlm.nih.gov/8322402/

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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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