Effects of biomedical sterilization processes on performance characteristics of MEMS pressure sensors.

The effects of steam and gamma sterilization on the performance of bulk-micromachined pressure sensors were investigated using a variable pressure setup. Commercially available piezoresistive MEMS (microelectromechanical systems) pressure sensor die were characterized prior and subsequent to sterilization over a 0-500 Torr pressure range. The effects of sterilization were examined as changes in sensor output voltage (DeltaV) at various applied pressures. For steam sterilization, DeltaV decreased with applied pressure ranging from +0.27 mV at 100 Torr to -0.14 mV at 500 Torr. In contrast, the corresponding values for gamma-sterilized sensors were lower, decreasing from +0.01 mV 100 Torr to -0.06 mV at 500 Torr. The increased variation in DeltaV for the steam-sterilized sensors was attributed to the formation of an oxide film, which was confirmed using energy dispersive X-ray (EDX) spectroscopy. Statistical analysis revealed that the effect of both sterilization procedures on sensor performance was insignificant.