Replacement of cobalt in medical device sterilization: current trends, opportunities and barriers to adoption of x-ray and e-beam within the medical device sterilization market

Abstract EN

Radioactive sources, specifically Co-60, are crucially important to the medical device sterilization industry; however, their benefits must be balanced against the need to ensure that the materials are secure.

Accelerator-based sterilization methods, including X-ray and E-Beam, can in many cases sufficiently replace Co-60 and ethylene oxide, the dominant modalities currently in use; however, a lack of hands-on experience with accelerators, regulations, and a lack of capacity have hampered faster adoption of these technologies.

The market is likely to change, however, given public pressures against ethylene oxide and concerns over the cost and long-term supply chain robustness of Co-60.

This may provide an opportunity for growth for accelerator capabilities.

Current research at Sandia National Laboratories and Argonne National Laboratory, on behalf of the Department of Energy's National Nuclear Security Administration Office of Radiological Security, is focused on developing an understanding of the medical device sterilization marketplace, the different modalities that are used to sterilize goods, and the drivers that affect the actors within it.

Research at Pacific Northwest National Laboratory, in conjunction with the medical device sterilization industry, has focused on expanding the industry's understanding of the capabilities of X-ray sterilization and developing data that can inform the industry's consideration of a transition towards accelerator-based devices.