EndoSheath Systems advantageous over germicidal immersion in preventing flexible ENT scope contamination

MedtronicFeb 6 2010

Results of a clinical study presented Thursday, Feb. 4 at the annual Triological Society meetings in Orlando, Fla., suggest a sterile barrier sheath system has distinct advantages over germicidal immersion processes used to prevent contamination of fiberoptic nasopharyngolaryngoscopes (flexible ENT scopes). Flexible ENT scopes are used by otolaryngologists to examine the nose and throat area for various disorders such as dysphagia, reflux disease, snoring, and chronic sinusitis.

“The EndoSheath System is designed to allow physicians to cover the insertion tube of the flexible ENT scope with a sterile microbial barrier when performing endoscopy procedures in the clinic and office environments”

Microbial study results show that sterile disposable sheaths, when used with endoscopes, are as effective as using a liquid germicidal system for disinfecting scopes between patient procedures and provide protection against cross-contamination equivalent to immersion in germicidal solutions.

Study authors Alphi Elackattu, MD; Mary Zoccoli, MD; Jeffrey H. Spiegel, MD, FACS; and Kenneth M. Grundfast, MD, FACS, all from Boston University School of Medicine, note in their conclusion that through the use of sterile disposable sheaths, physicians will be able to prevent cross-contamination. Using the individually packaged disposable sterile sheaths has been cleared by the U.S. Food and Drug Administration as an acceptable alternative to high level disinfection following endoscope use.

The Medtronic Slide-On™ EndoSheath® System is a sterile, disposable cover for flexible endoscopes that provides a latex-free barrier between the scope and the patient. The system is designed to reduce patient contact with organic debris and staff exposure to hazardous chemicals. The study authors noted that the system is an alternative to time-intensive chemical reprocessing, allows for quick scope turnaround and helps physicians maximize time treating patients.

“The EndoSheath System is designed to allow physicians to cover the insertion tube of the flexible ENT scope with a sterile microbial barrier when performing endoscopy procedures in the clinic and office environments,” said Janis Saunier, marketing director for the ENT division at Medtronic. “We believe the use of a sterile sheath on a nasopharyngoscope, combined with enzymatic detergent cleaning and disinfection with 70 percent alcohol, can provide a reliably decontaminated, patient-ready instrument, providing an acceptable alternative to high-level disinfection of endoscopes.”