Slide-On® EndoSheath® System Provides Sterile, Efficient Alternative to High-Level Disinfection of Flexible Endoscopes

SAN JOSE, Calif. -- Results of a clinical study presented today at the annual meeting of the Association for Professionals in Infection Control and Epidemiology (APIC) suggest a sterile barrier sheath system may eliminate the need for nasendoscope high-level disinfection.

One hundred flexible endoscopes using the Slide-On® EndoSheath® sterile barrier system distributed by Medtronic, Inc. were evaluated for sheath integrity and bacterial contamination after use in patients. The study was conducted at an ambulatory ENT clinic using standard 30 cm flexible nasopharyngoscopes.

Each patient-ready scope was cultured:

-- Prior to its use for a baseline contamination of insertion tube and control head

-- After use and removal of the sheath

-- Post reprocessing

Immediately after use the barrier sheaths were removed and leak-tested to confirm that there were no tears or holes created during use. An additional 20 unused sterile barrier sheaths were also leak-tested to assess the possibility of pre-use leaks. All leak testing results showed no failures.

The study showed that following use of the sterile EndoSheath® and an enzymatic detergent cleaning and ethanol disinfection procedure, the scopes were negative for any bacterial presence.

In our study results, the nasendoscopes fitted with the sterile EndoSheath® system in combination with thorough post-use enzymatic detergent cleaning followed by a 70 percent ethanol wipe, provided a patient ready instrument equivalent to high-level disinfection, stated Carla J. Alvarado, PhD, a research scientist in human factors engineering at the Center for Quality and Productivity Improvement at the University of Wisconsin-Madison, and lead researcher on the study. In this particular use environment, it provides an alternative to chemicals requiring more time and labor intensive processes.

On Monday Alvarado received the APIC-sponsored 2007 William A. Rutala Award for her abstract. The award is given to an APIC member whose abstract most closely reflects the excellence demonstrated by William A. Rutala, a world-renowned expert in disinfection, sterilization and antisepsis.

Located in Jacksonville, Fla., the ENT business at Medtronic develops and manufactures products designed to treat ear, nose and throat (ENT) diseases.

Source: Medtronic, Inc.