title: Microbiologic assessment of disposable sterile endoscopic sheaths to replace high-level disinfection in reprocessing: a prospective clinical trial with nasopharygoscopes.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Center for Quality and Productivity Improvement, Systems Engineering Initiative for Patient Safety (SEIPS),University of Wisconsin School of Medicine and Public Health, Madison, WI.
authors.forename: Carla J
authors.initials: CJ
authors.lastname: Alvarado
authors.affiliation: Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI.
authors.forename: Ashley G
authors.initials: AG
authors.lastname: Anderson
authors.affiliation: Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI. Electronic address: dgmaki@medicine.wisc.edu.
authors.forename: Dennis G
authors.initials: DG
authors.lastname: Maki
mesh_terms: D003428:Cross Infection / Q000382:microbiology / Q000517:prevention & control*; D004203:Disinfection / Q000379:methods*; D004209:Disposable Equipment / Q000382:microbiology*; D019723:Endoscopes / Q000382:microbiology*; D004866:Equipment Contamination / Q000517:prevention & control; D017743:Equipment Reuse; D000431:Ethanol; D006801:Humans; D017053:Infection Control / Q000379:methods; D009305:Nasopharynx; D010036:Otolaryngology / Q000295:instrumentation; D011446:Prospective Studies
chemical_list: D000431:Ethanol