Disposable, sheathed, flexible sigmoidoscopy: A prospective, multicenter, randomized trial☆,☆☆,★,★★,♢,♢♢,♦
Section snippets
METHODS
The protocol for this study was devised and executed by the authors at the request of the manufacturer. The manufacturer did not take part in the design of the study or the analysis of the data. The authors have no financial interest in Vision Sciences, Inc., and costs of the study were borne by the manufacturer. The Institutional Review Board at each site approved the protocol.
The 15 facilities chosen by the authors represent diverse geographic areas and practice settings at university
RESULTS
One hundred forty-three flexible sigmoidoscopies were performed at 15 study sites. A total of 24 endoscopists and 30 reprocessing personnel (nurses and assistants) participated in the study and rated up to 10 procedures each. Seventy-three sigmoidoscopies were done with the disposable sheathed system, and 70 were done with standard endoscopes. The results are presented in Table 1. The differences in age, sex, height, and indication for endoscopy were not significant between study groups. The
DISCUSSION
In a comprehensive review of the literature, contributing causes of endoscope-transmitted infection were improper cleaning and disinfection, contamination of automated reprocessing machines, and the complex arrangement of channels and valves in the instrument.19 Studies of the interior surfaces of endoscope channels have documented debris, damage, and structural design that may prevent adequate cleaning and disinfection.20, 21
In addition to the potential for infective complications, current
Acknowledgements
The Disposable Endoscope Study Group includes the following individuals and institutions (Principal Investigators are listed first):
University of Colorado, Denver VAMC, Denver, Colorado: Dennis Ahnen, MD; Susie Fredrick, RN.
Tufts Medical School, Baystate Medical Center, Springfield, Massachusetts: Canan Avunduk, MD, PhD; Mark A. Hirschkorn, MD; Mary Ann Huse, RN; Virginia Shute, LPN.
Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts: David Carr-Locke, MD; David
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Cited by (34)
Cleaning and Disinfecting Gastrointestinal Endoscopic Equipment
2011, Clinical Gastrointestinal Endoscopy, Second EditionMicrobiologic assessment of disposable sterile endoscopic sheaths to replace high-level disinfection in reprocessing: A prospective clinical trial with nasopharygoscopes
2009, American Journal of Infection ControlCitation Excerpt :Peracetic acid can cause severe burns from direct skin contact; irreversible blindness from direct contact to the eyes; and irritation of the nose, throat, and lungs from inhalation of vapor or mist.18 Hydrogen peroxide has caused acute colitis when introduced into the colon during colonoscopy.2 To avoid toxic effects, all of these agents must be handled and disposed of in strict accordance with specific protocols and guidelines, but this can be difficult to achieve consistently, especially in busy ambulatory, office-based practices.
Sterile disposable sheath system for flexible cystoscopes
2005, UrologyCitation Excerpt :Although optics and light sources have improved, relatively few advances in the sterilization and handling of instruments have occurred. Prospective randomized trials comparing standard endoscopes and those with a disposable sheath for a variety of purposes have yielded no major differences from an assistant, patient, or surgeon perspective.1–3,8 In particular, no breaches with infection control were recorded.
Novel flexible bronchoscope and single-use disposable-sheath endoscope system: A preliminary technology evaluation
2000, ChestCitation Excerpt :The results of this preliminary evaluation demonstrate the acceptable optics and handling profile of this novel system. We believe this justifies consideration for its introduction into general bronchoscopic practice, particularly since the system has been approved by the US Food and Drug Administration, and similar systems are already being used for flexible sigmoidoscopy10 and nasopharyngeal laryngoscopy.11 Current technology does not allow incorporation of a distal charge-coupled device into the D-shaped flexible bronchoscope.
APIC guideline for infection prevention and control in flexible endoscopy
2000, American Journal of Infection ControlCitation Excerpt :The latter has been systematically evaluated in a randomized controlled trial and found to be clinically equivalent to standard models, with a significant decrease in reprocessing work and turnaround time. No infection or contamination has been associated with this new technology.75 To prevent toxic effects of residual chemicals after disinfection, the equipment must be adequately rinsed.
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From the Section of Gastroenterology and the Technology Assessment Program, Department of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
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Dr. Littenberg is an American College of Physicians George Morris Piersol Teaching and Research Scholar.
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This work was supported by Vision Sciences, Inc.
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Reprint requests: Richard I. Rothstein, MD, Section of Gastroenterology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756.
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GASTROINTESTINAL ENDOSCOPY