Carla J Alvarado1, Ashley G Anderson2, Dennis G Maki3. 1. Center for Quality and Productivity Improvement, Systems Engineering Initiative for Patient Safety (SEIPS),University of Wisconsin School of Medicine and Public Health, Madison, WI. 2. Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI. 3. Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI. Electronic address: dgmaki@medicine.wisc.edu.
Abstract
BACKGROUND: Conventional reprocessing of endoscopes with high-level disinfection is labor intensive, expensive, delays the turnover of instruments, and involves potential exposure of personnel to toxic chemicals. We report a prospective clinical trial with rigorous microbiologic assessment of a novel disposable, sterile, polyurethane sheath, which can be easily and snugly applied over a nasopharyngoscope before performing the endoscopic procedure, with enzymatic cleansing and disinfection of the instrument with 70% ethanol following the procedure to determine whether the use of the novel sheath can provide reliable protection against bacterial contamination and obviate the need for routine high-level disinfection in reprocessing. METHODS: Baseline cultures were obtained at 3 time periods from the control heads and insertion shafts of nasopharyngoscopes used in 100 clinical examinations: before application of the protective sheath and execution of the procedure; immediately after the procedure and removal of the sheath; and after enzymatic cleaning, disinfection with 70% ethanol, and drying. All 100 used sheaths and 20 unused sheaths were subjected to high-pressure leak testing to assess barrier integrity. RESULTS: Bacteria were detected on 16 control heads and 6 shafts prior to the procedure; from 13 heads and 1 shaft immediately following the nasopharyngoscopic procedure and sterile sheath removal; and none of the instruments following cleaning, ethanol disinfection, and drying. No sheath showed loss of barrier integrity on leak testing. CONCLUSION: Use of a high-quality, snugly fitting, sterile, disposable polyurethane sheath on a nasopharyngoscope during a clinical examination, combined with enzymatic detergent cleaning and disinfection with 70% ethanol, can provide a reliably decontaminated, patient-ready instrument, eliminating the need for high-level disinfection of endoscopes.
BACKGROUND: Conventional reprocessing of endoscopes with high-level disinfection is labor intensive, expensive, delays the turnover of instruments, and involves potential exposure of personnel to toxic chemicals. We report a prospective clinical trial with rigorous microbiologic assessment of a novel disposable, sterile, polyurethane sheath, which can be easily and snugly applied over a nasopharyngoscope before performing the endoscopic procedure, with enzymatic cleansing and disinfection of the instrument with 70% ethanol following the procedure to determine whether the use of the novel sheath can provide reliable protection against bacterial contamination and obviate the need for routine high-level disinfection in reprocessing. METHODS: Baseline cultures were obtained at 3 time periods from the control heads and insertion shafts of nasopharyngoscopes used in 100 clinical examinations: before application of the protective sheath and execution of the procedure; immediately after the procedure and removal of the sheath; and after enzymatic cleaning, disinfection with 70% ethanol, and drying. All 100 used sheaths and 20 unused sheaths were subjected to high-pressure leak testing to assess barrier integrity. RESULTS: Bacteria were detected on 16 control heads and 6 shafts prior to the procedure; from 13 heads and 1 shaft immediately following the nasopharyngoscopic procedure and sterile sheath removal; and none of the instruments following cleaning, ethanol disinfection, and drying. No sheath showed loss of barrier integrity on leak testing. CONCLUSION: Use of a high-quality, snugly fitting, sterile, disposable polyurethane sheath on a nasopharyngoscope during a clinical examination, combined with enzymatic detergent cleaning and disinfection with 70% ethanol, can provide a reliably decontaminated, patient-ready instrument, eliminating the need for high-level disinfection of endoscopes.