Objective: This in vitro model was designed to determine whether using a no-touch method for catheter preparation and insertion would affect the degree of contamination transmitted to intermittent urinary catheters.
Setting: Northview Laboratories, Northbrook, IL 60062, USA.
Methods: This was a parallel experimental study conducted in vitro at an independent testing laboratory under Good Manufacturing Practices. Six different models of intermittent urinary catheter were tested in triplicate, in accordance with the manufacturer's Instructions For Use (IFU). Gloved hands were contaminated with a known amount of Staphylococcus aureus or Escherichia coli, preparation for insertion was mimicked according to the manufacturer's IFU. The number of bacteria transferred to the catheter was then quantified using a validated technique. The null hypothesis tested was that the bacterial contamination resulting from handling would be the same for all of the catheters. The primary outcome measure was the amount of bacteria, expressed as colony forming units (CFU), recovered from the catheters. The catheter wrappers were sampled to confirm that active transfer of microorganisms had taken place and nonhandled samples served as the negative controls.
Results: For both test organisms, the number of bacteria recovered from the catheters was significantly lower (P < 0.05) for the catheters featuring the no-touch design (approximately 5 CFU/plate versus 2.1 x 10(2) to 4.4 x 10(2) for the traditional hydrophilic catheters). The bacterial recovery from those catheters with the no-touch design often fell below the nominal detection limit.
Conclusion: The results of this study allow the null hypothesis to be rejected; it can be concluded that the no-touch method provides a significant benefit in reducing the potential for external contamination of an intermittent urinary catheter. This result supports the recent recommendations for aseptic intermittent catheterization promoted within the guidelines issued by the European Association of Urologists (EAU).