PNNL

Abstract

Gamma ionizing energy used for sterilization of medical devices is challenged by cobalt-60 supply and processor capacity. To maintain a robust ionizing energy sterilization marketplace for the rapidly growing single-use medical device industry, investigation of potential alternatives to gamma technology, such as electron beam (eBeam) and X-ray technology, is critical. In this work, we directly compare the effects of ionizing energy source (gamma, eBeam, and X-ray) and dose levels (15, 25, 50, and 70 kGy) on the polymeric materials and function of a commercial pulsed lavage device used for wound care. Product functionality, polymer mechanical, and polymer optical properties were evaluated based on ASTM standards and input from the manufacturer. Statistical results show that functionality of the product was not inhibited by ionizing energy although the X-ray processed device battery exhibited greater voltage loss compared to batteries in the gamma and eBeam processed products. Statistically significant differences between gamma and eBeam processing and between gamma and X-ray processing were also observed for appearance in terms of yellowness index of several polymers considered. The results of this study support the viability of eBeam and X-ray ionizing energy technologies as alternatives to cobalt-60 gamma technology for sterilization of the single-use pulsed lavage medical device investigated.