IARC’s third medical device sterilization workshop exceeds the possibilities

On Sept. 22-24, IARC at Fermilab hosted its third annual workshop on medical device sterilization that focused on accelerator-sourced radiation. The workshop, titled “Medical Device Sterilization: Understanding the Possibilities,” remained virtual again this year. Even so, 300 people registered, double last year’s registration, which itself doubled the first year. Seventy-five percent of this year’s registrants did not attend either of the previous workshops, representing an expansion in our outreach. This year’s speakers included the returned participation from the U.S. Food and Drug Administration. Participants represented the whole supply chain for sterilization of medical devices, from medical device manufacturers, service providers, accelerator manufacturers, regulatory agencies, standard setting organizations, software companies, etc.

Betty Howard from Steris presented on the “Future of X-ray Services.”

Sterilization capacity for medical devices is getting very tight, due to tightness in cobalt-60 supply and concerns about ethylene oxide, the two most common methods for sterilizing medical devices. This makes the expansion into accelerator-sourced radiation more urgent, along with safety and security concerns regarding cobalt-60. This series of workshops strives to help facilitate that expansion.

After a warm welcome by the DOE’s Fermi Site Office manager Rick Verhaagen, the sessions on the first day looked at medical device sterilization tools, including new horizons for dosimetry and modeling and simulation to predict the required dose to assure sterilization. Tools like them are needed to shorten the time it takes to validate the sterilization of new products or production methods. While high-energy physics extensively uses simulation to design shielding and detector components, and the medical community uses it to plan radiation treatments for cancer patients, it has not been used much for medical device sterilization. As practitioners probably know, the present simulation software requires highly specialized subject matter experts to use the codes.

One point of discussion during the workshop was how to simplify the codes and make them more user-friendly.

The second day focused on future outlooks for the use of electron and X-ray beams. In my opinion, the highlight this day was a presentation by ZimmerBiomet on the success it had in transitioning one of their products from gamma irradiation to X-ray. Examples like it are important to guide the industry in considering alternative technologies for existing products.

Day three featured our keynote speaker Joyce Hansen of Johnson & Johnson who gave her view of the future of medical device sterilization. Her keynote was followed by a presentation regarding the regulatory landscape in Europe, as well as a presentation by three members of the FDA. The day concluded with a panel discussion among all of the day’s speakers, which focused on how device manufacturers can effectively communicate with regulators regarding approval of their devices.

Fermilab has been working with the National Nuclear Security Administration to facilitate and promote accelerator-based radiation sources to reduce the dependence on radioactive isotopes, such as cobalt-60, and reduce the security risks that those materials pose. These workshops are organized in partnership with individuals from Baxter International, Medtronic and Abbott. 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.