title: Quantification of User and Manufacturer Variabilities in Urinary Catheter Anchoring Balloon Inflation and Mitigation of Variability by Flow Resistance.
abstract: OBJECTIVE
  To quantify user variability and manufacturer variability in urinary catheter anchoring balloon inflation pressure and to mitigate any significant variance by incorporating flow resistance into the anchoring balloon inflation process.
  
  
  METHODS
  Inflation of a urinary catheter anchoring balloon was performed at atmospheric pressure by different users (n = 8) to investigate user variability. A calibrated pressure transducer measured inflation pressures, and a video extensometer measured balloon inflation profiles. Manufacturer variability was investigated by applying constant forces to the plunger of conventional syringes to mimic "heavy-," "intermediate-," and "light"-handed users for 3 brands of catheter. Flow restrictors of variable reduced cross-sectional areas were introduced to the outflow of the inflation syringes to investigate the effect of flow resistance on anchoring balloon inflation profiles.
  
  
  RESULTS
  Variations in maximum inflation pressures (range: 75-355 kPa) were observed among the different users. There were no significant differences in maximum inflation pressure between brands at any of the 3 simulated hand forces (P = .97). Increasing the flow resistance significantly reduces the applicable inflation pressure of all hand forces (P < .001). Specifically, the difference in inflation pressure between heavy- and light-handed forces is reduced from over 405 kPa to under 65 kPa. Introducing flow resistance does not result in a significant difference in inflation pressure between brands (P = .254).
  
  
  CONCLUSIONS
  There is significant user variability in urinary catheter balloon inflation pressure. This variation can be significantly reduced by introducing flow resistance to the inflation technique.
authors.affiliation: Department of Urology, Tallaght Hospital, Dublin, Ireland; Centre for Applied Biomedical Engineering and Research, School of Engineering, Bernal Institute and the Health Research Institute, University of Limerick, Castletroy, Limerick, Ireland. Electronic address: michael.walsh@ul.ie.
authors.forename: Niall F
authors.initials: NF
authors.lastname: Davis
authors.affiliation: Centre for Applied Biomedical Engineering and Research, School of Engineering, Bernal Institute and the Health Research Institute, University of Limerick, Castletroy, Limerick, Ireland.
authors.forename: Eoghan M
authors.initials: EM
authors.lastname: Cunnane
authors.affiliation: Centre for Applied Biomedical Engineering and Research, School of Engineering, Bernal Institute and the Health Research Institute, University of Limerick, Castletroy, Limerick, Ireland.
authors.forename: Rory C
authors.initials: RC
authors.lastname: Mooney
authors.affiliation: Department of Urology, Tallaght Hospital, Dublin, Ireland.
authors.forename: Rustom P
authors.initials: RP
authors.lastname: Manecksha
authors.affiliation: Department of Urology, Tallaght Hospital, Dublin, Ireland.
authors.forename: John A
authors.initials: JA
authors.lastname: Thornhill
authors.affiliation: Centre for Applied Biomedical Engineering and Research, School of Engineering, Bernal Institute and the Health Research Institute, University of Limerick, Castletroy, Limerick, Ireland.
authors.forename: Michael T
authors.initials: MT
authors.lastname: Walsh
mesh_terms: D002408:Catheters, Indwelling / Q000009:adverse effects*; D004867:Equipment Design / Q000379:methods*; D006801:Humans; D007049:Iatrogenic Disease / Q000517:prevention & control*; D066192:Manufacturing Industry / Q000592:standards; D011312:Pressure / Q000009:adverse effects; D012308:Risk Management / Q000379:methods; D014521:Urethra / Q000293:injuries*; D062885:Urinary Catheters / Q000009:adverse effects / Q000592:standards