Animation Demonstrates the Role and Safety of the EndoSheath® Protective Barrirer
Flexible endoscopy is one of the most commonly performed procedures in healthcare. Unfortunately, there are persisting concerns about dirty endoscopes and questions as to whether conventional reprocessing methods are enough.
But what if the endoscope never really got dirty?
The EndoSheath protective barrier is a sterile, single-use product that acts as a microbial barrier between the endoscope and patient. Prior to each procedure, a specially-designed PrimeSight™ endoscope is inserted into the sterile EndoSheath barrier. EndoSheath is validated with the endoscope it is being used with, as indicated. The D-shaped endoscope does not contain a working channel. Instead the working channel and accessory port are included in the single-use EndoSheath barrier.
Due to this innovative design, the Endosheath barrier completely isolates the PrimeSight endoscope from the patient during the procedure. EndoSheath is proven effective as a microbial barrier against organisms as small as 27 nanometers per FDA guidance and testing. FDA clearance for microbial barriers requires testing by an independent lab; and EndoSheath also underwent a 12 month review by the CDC on technology design, safety record, and performance.
Each EndoSheath is 100% leak tested, with a 0% acceptable failure rate, before leaving the facility to ensure consistent performance and protection. Every lot is randomly sampled to be functionally tested, or put through simulated use; then tested for barrier integrity.
There is no contact between the endoscope and the patient at any time. So, when the PrimeSight endoscope is removed from the EndoSheath at the end of the procedure, the organic patient material is left on the single-use barrier which is thrown away. There is no need for high level disinfection between cases. Instead the PrimeSight endoscope is reprocessed in a few steps which take less than 10 minutes. Simply clean the endoscope using an enzymatic wipe, rinse with water, and wipe with alcohol. Then, the PrimeSight endoscope is ready for a new EndoSheath barrier and another patient.
In other words, instead of cleaning, flushing and disinfecting the hard-to-clean channel, seals and ports, you simply replace them. This eliminates the concern about improper or inadequate cleaning. What’s more, the use of EndoSheath, along with abbreviated reprocessing, is recognized in key reprocessing guidelines as a viable alternative to conventional measures.
This simplified approach to reprocessing has allowed facilities of all sizes to easily and efficiently become compliant with national reprocessing standards. In 25 years of clinical use, there has never been a reported case of patient-to-patient cross contamination. The use of PrimeSight and EndoSheath is backed by more than 30 clinical studies, supporting the safety, efficacy, and cost effectiveness, including 4 peer reviewed studies that evaluated post-clinical use of EndoSheath technology without any failures of the barrier.
EndoSheath protective barrier is available for bronchoscopy, cystoscopy, esophagoscopy, and laryngoscopy.
Sterile Endoscopy Webinar Series
Cogentix Medical has sponsored a webinar series about the role microbial barriers play in the quest for sterile endoscopy. To learn more, view past webinars or sign-up for an upcoming webinar.