Posted on June 3, 2016 by Cogentix Medical

ANSI and AAMI Guideline for Sterile Endoscopes

Nurse holding "safety first." signIt is no secret that cross-contamination in endoscopes is a rising issue. The movement to make reprocessing of endoscopes safer is ongoing and driven by the recommendations of opinion leaders in Infection Prevention and Epidemiology about the sterility of patient-ready endoscopes. The EndoSheath® protective barrier is helping pave the path to sterile, patient ready instruments with simplicity, practicality, and a cost-effective approach.

ANSI/AAMI Guideline

The American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) recently released a new guideline for national standards for endoscope reprocessing. In this guideline, the organizations have established accepted and recommended practices for flexible and semi-rigid endoscope reprocessing in health care facilities. The national standards are intended to assist for healthcare professionals to develop and implement the safest and most sterile practices that are available. All AAMI standards and recommended practices are strictly voluntary, unless they are adopted by government regulatory or procurement authorities. Each standard, or recommended practice, reflects the collective experience of a committee of health care professionals, and industrial representatives, whose work has been reviewed nationally, and sometimes internationally.

Section 7 of ANSI/AAMI

In section 7 of the ANSI/AAMI guideline, there is recognition for, “sheaths that are intended to prevent endoscope soiling and thus serve as microbial barriers.” The new national standard recognizes the intended use of some sheaths, such as the EndoSheath, as microbial barriers. Microbial barriers allow the reprocessing of endoscopes to be simplified, creating more efficient, less complex reprocessing routines. The standards require following the manufacturer's Instructions for Use for reprocessing an endoscope that utilizes the microbial barrier, which includes cleaning with an enzymatic detergent wipe down, a rinse cycle, and a wipe down with a towelette saturated with a 70%–ethyl/isopropyl alcohol disinfectant. To be covered by the standard, the microbial barrier technology must, like EndoSheath, have FDA clearance for the streamlined reprocessing instructions for use.

EndoSheath Meets the National Standard

The EndoSheath protective barrier is a unique, sterile, single-use product consistent with the ANSI/AAMI standards. Not only does the EndoSheath protective barrier cover the endoscope from end to end, isolating the endoscope from patient contact and protecting the endoscope controls from contamination during the procedure, each EndoSheath model includes a sterile, single-use working/irrigation/suction channel. The protective barrier is designed to maintain integrity through use and, to prevent tearing or leaking that could cause possible breaches to the barrier.

In addition to providing a sterile solution for every patient, the EndoSheath protective barrier significantly reduces processing time between cases.  Because scope turnover takes mere minutes, endoscopy needs are met with fewer endoscopes. This equates to less expense on capital inventory. 

The inclusion of microbial barriers in the ANSI/AAMI guideline reinforces the relevance of disposable microbial barriers in endoscopy. The added benefits of efficiency and reduced costs make EndoSheath a practical choice for any endoscopy department.

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