On Sept. 17, IARC at Fermilab hosted a workshop on medical device sterilization that focused on accelerator-sourced radiation. The workshop, titled Medical Device Sterilization: Continuing the Conversation, served as a virtual bridge between last year’s successful in-person event, the Midwest Medical Device Sterilization Workshop, and a future in-person workshop (stay tuned!). One-hundred-thirty people registered, almost double last year’s 70 registrants. More than two-thirds of this year’s registrants did not attend the previous workshop. Among these new attendees were individuals from the bioprocessing industry, which makes products for the manufacture of pharmaceuticals and vaccines.
The Q&A section of the webinar resulted in vivid discussion among the panelists, which included Byron Lambert of Abbott Laboratories, the keynote speaker for the 2019 workshop.
One outcome from last year’s workshop was the understanding that manufacturers are hungry for guidance on how to choose a sterilization modality. In response, this year’s program consisted of a reprise on the physics involved with device sterilization; updates on a project led by Pacific Northwest National Laboratory on the performance of materials that have been exposed to gamma rays, electron beams, or X-rays; and a report on the efforts of various standards groups to provide guidance for device manufacturers who might be interested in choosing new sterilization modalities.
The workshop culminated in a round-table discussion on behalf of Sandia National Laboratories. Sandia is conducting a study to compare the economics of gamma, e-beam and X-ray sterilization. The workshop committee assisted Sandia in distributing a survey of all stakeholders in device sterilization, and the preliminary results were discussed by leading members of the field. The members of the round-table discussion were Byron Lambert of Abbott Vascular, Suresh Pillai of Texas A&M University and the National Center for Electron Beam Research, Paul Wynne of the International Irradiation Association, and Rod Parker of Stryker Instruments. Jodi Lieberman of Sandia and Joe Adduci of Argonne National laboratory led the discussion.
Security and environmental concerns with the two major sterilization modalities — gamma rays from cobalt-60 and ethylene oxide gas — have led to new interest in accelerator-based radiation sources, both electron beams and X-rays, for sterilizing medical devices. A “we’ve always done it this way” mentality and a limited number of accelerator-based facilities have slowed the adoption of new technologies. However, things are changing. The desire to learn more about these alternative technologies is growing, and there have been recent announcements of new facilities offering accelerator-based radiation for sterilization.
Fermilab has been working with the National Nuclear Security Administration to facilitate and promote accelerator-based radiation sources in order to reduce the dependence on radioactive isotopes, such as cobalt-60, in order to reduce the security risks that those materials pose. These workshops are organized in partnership with Baxter International. The proximity of their international headquarters and their interest in investigating in e-beam and X-ray for sterilization has led to a fruitful collaboration in providing guidance and support to the sterilization industry. In addition to supporting the NNSA’s mission for reducing our reliance on radioactive sources, this collaboration also helps develop a market for compact superconducting accelerators, one of IARC’s major development activities.
Direct communication with industry about their needs means IARC can focus on developing an accelerator that will provide more efficient and reliable source of electron beams and X-rays for the medical device sterilization of the future.
Thomas Kroc is a physicist at IARC at Fermilab.