Contamination Risk During Fecal Management Device Removal: An In vitro, Simulated Clinical Use Study

Abstract

This in vitro study was conducted to compare device removal factors and subsequent splash of simulated fecal matter of 3 different designs of FMDs using a simulated rectum. A Universal Test Machine was used to automatically measure removal forces (in newtons [N]) and tube extensions as the FMDs were pulled from the simulated rectum by the machine. Splash distance and quantity were measured using a splash-capture cylinder and image analysis software. Each device was tested 3 times. Two-sample t tests were conducted to examine statistical differences in removal forces, removal extensions, and splash areas. The forces required to remove the FMDs from the simulated rectum were significantly lower for the device with a collapsible, donut-shaped retention balloon compared with the devices with a green, foldable, trumpet-shaped retention cuff and a foldable, spherical-shaped retention balloon (12.0 ± 0.3 N vs. 32.6 ± 4.3 N and 34.8 ± 3.1 N, respectively; P <.05). The extensions of the catheter tubing were significantly lower for the device with a collapsible, donut-shaped retention balloon compared with the devices with a green, foldable, trumpet-shaped retention cuff and a foldable, spherical-shaped retention balloon (32.0 ± 7.5 mm vs. 81.3 ± 9.1 mm and 105.2 ± 10.6 mm, respectively; P <.05). Simulated fecal matter was splashed over mean areas of 25.5 ± 16.1 cm2 and 27.3 ± 13.5 cm2 for the devices with a green, foldable, trumpet-shaped retention cuff and a foldable, spherical-shaped retention balloon, respectively; no splash was observed for the device with a collapsible, donut-shaped retention balloon. In vitro observations suggest contamination and potential infection risk during FMD removal from the patient are influenced by FMD design. Future in vitro and clinical studies assessing the infectious nature of effluent and methods for containment are warranted.