Posted on June 26, 2017 by Cogentix Medical

Guidelines for Microbial Barriers in Flexible Endoscopy

Regulations and Guidelines

For over a decade, sterile, single-use microbial barriers have been recognized in national guidelines as an option for flexible endoscopy which may eliminate the need for high level disinfection (HLD) between procedures. And now, the new 2017 Guidelines for Perioperative Practice from the Association of periOperative Registered Nurses (AORN) provides key information, including an overview of the clinical data and other factors, that multidisciplinary teams should consider in evaluating “single-use endoscope sheaths.”  One of the criteria they identified is that, “The manufacturer has validated the sheath to be impermeable to penetration by microorganisms and has validated that sheath application and removal can be accomplished without contamination of the endoscope. The barrier properties of the sheath have been validated, and a minimum of ILD [intermediate level disinfection] is required before application of a new sheath.” This means that they recommend that the proposed product be cleared as a microbial barrier by the FDA before it is approved for use within a clinic or hospital.

This new stance from AORN on the use of microbial barriers echoes the position of section 7 of the ANSI-AAMI ST91 National Standard on Flexible and Semi-Rigid Endoscope Reprocessing in Health Care Facilities, as well as the 2014 Joint AUA/SUNA White Paper on the Reprocessing of Flexible Cystoscopes, both of which recognize the intended use of some sheaths, such as the EndoSheath protective barrier from Cogentix Medical, as microbial barriers. The use of EndoSheath is also supported in the 2016 VHA Directive 116 from the Department of Veterans Affairs. The inclusion of single-use, microbial barriers in national guidelines can help any account looking for a more efficient and cost effective way to remain compliant to the increasingly stringent standards for flexible endoscope reprocessing and sterilization. 

EndoSheath as a Microbial Barrier

EndoSheath meets high standards that were set forth in the FDA Guidance for achieving clearance as a microbial barrier. These standards include the ability to be applied and removed using aseptic technique to ensure sterility as well as being impermeable to microorganisms as small as 27 nanometers. This testing threshold was established and evaluated through an FDA lead study, and confirmed EndoSheath as a true microbial barrier. To date, EndoSheath is the only FDA-cleared microbial barrier for flexible endoscopy and has been validated for use with PrimeSight endoscopes in bronchoscopy, cystoscopy, esophagoscopy and laryngoscopy.

Because the EndoSheath acts as a barrier between patient and the scope, there is no need for HLD between procedures. After the scope is removed from the EndoSheath and the EndoSheath is discarded, the scope is cleaned with an enzymatic wipe, rinsed, and wiped with 70% isopropyl alcohol. This process means that the scope will be ready for the next procedure in less than 10 minutes, and the physician can feel confident that they are introducing a sterile product into their next patient. Every sheath is 100% leak tested, with a 0% acceptable failure rate; and in over 25 years of use and more than 5 million sold, there have been ZERO reports of patient-to-patient cross contamination. EndoSheath is also backed by more than 30 different clinical studies and research papers supporting the safety, efficacy, and cost efficiency of using PrimeSight™ with EndoSheath for flexible endoscopy.

Now Available - CE Program on Microbial Barriers

With the continued evolution of recommendations and guidelines surrounding reprocessing, most organizations agree that it is vital for anyone involved in infection control to remain up to date through continuing education programs. Cogentix Medical has recently partnered with Pfiedler Enterprises to create an online continuing education course, which educates professionals on the current issues in conventional flexible endoscope reprocessing and the benefits of utilizing a microbial barrier sheath. Several of the aforementioned industry guidelines and extensive clinical research studies are included to bring to light the many changes in flexible endoscope reprocessing that have occurred over the last several years; and how microbial barrier sheaths are being more widely recognized as an important tool in the infection control space.

The course is titled Connecting Innovation to Need: Microbial Barrier Sheaths for Endoscopes. This course offers 2.0 contact hours and carries credit for nursing, sterile processing personnel, and surgical technologists (NCCT, not AST). This course is accredited for nursing through the California Board of Registered Nursing and for infection control professionals by the  International Association of Healthcare Central Service Materiel Management (IAHCSMM), and  Certification Board for Sterile Reprocessing and Distribution (CBSPD). Follow the link below to access the course and continue learning about how EndoSheath, a microbial barrier sheath, can impact infection control in your practice.

CE Program on Microbial Barriers

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