Irradiance simulation data for probe surfaces.

Medical devices that contact non-intact skin or mucous membranes are considered semi-critical devices and must undergo high-level disinfection (HLD) before use. Studies have identified several potential limitations of UV-C for HLD of semi-critical medical devices, including a lack of data demonstrating that UV-C irradiance can be uniformly applied to complex surfaces that contain grooves, notches and imperfections. This study focused on ultrasound probes as commonly used medical devices to show the distribution of irradiance on these surfaces. An endocavity bi-plane probe and curved array surface probe with typical surface topology were 3D scanned and modelled and an array of UV-C light-emitting diodes (LEDs) irradiating the probe surfaces was simulated (simulated wavelength: 275nm [peak], power output: 50mW). The simulated chamber wall material was equivalent to highly reflective polished aluminum with a defined reflectance of 79% at 275nm. To calculate the cycle time required to achieve HLD on probe surfaces, a minimum effective dosage of 1500mJ/cm2 based on published research was used. The simulated irradiance distribution showed a large difference between the points of highest and lowest irradiance (maximum/minimum ratio: 14.70 for the surface probe and 12.74 for the endocavity probe). In addition, the presence of shadowing effects adjacent to notches or grooves was evident. By applying an effective UV-C dose from the literature, cycle times of up to 25 minutes would be required to achieve HLD in the minimally irradiated areas of the probes used in the simulation. These findings highlight the need to demonstrate the efficacy of UV-C radiation against worst case organisms in the areas of lowest irradiance on medical devices to provide assurance these devices are reliably high level disinfected.