Fermilab continues its support of expanding capacity for sterilizing medical devices

On Sept. 21-23, IARC at Fermilab hosted its fourth workshop on medical device sterilization that focused on accelerator-sourced radiation. The workshop, titled “Medical Device Sterilization: From Possibilities to Practice,” remained virtual. Registration this year was 345, of which 252 attended from 22 countries. Representing a continued expansion of our outreach, 60% were first-time attendees. The highlight of this year’s workshop was a mock meeting with the U.S. Food and Drug Administration. Participants represented the entire supply chain for sterilization of medical devices: from medical device manufacturers, service providers, accelerator manufacturers, regulatory agencies, standard setting organizations, software companies, etc.

Sterilization capacity for medical devices continues to be very tight, due to limitations in cobalt-60 supply and concerns about ethylene oxide, the two most common methods for sterilizing medical devices. Restricted capacity 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 by increasing the communication between the players and facilitating the transfer of knowledge.

After a warm welcome by the U.S. Department of Energy’s Fermi Site Office Manager Roger Snyder, the keynote address was given by Aftin Ross, senior special advisor for emerging initiatives with the FDA. Her talk focused on ways the FDA can work with industry to ease the regulatory burden of changing sterilization methods.

Three different types of case studies followed, showing how various companies and industry groups are transitioning to accelerator-based forms of radiation. One study was from the bio-process industry, which makes single-use systems to produce pharmaceuticals and vaccines. Their sterilization needs presently require the use of gamma rays from cobalt-60. Accelerator sourced X-rays are directly interchangeable with gamma rays. The bio-process industry is working closely with the FDA to make the transition as smooth as possible.

The mock Q-sub meeting showed both productive and unproductive ways of asking questions so that the fictional company could get the most from the meeting. Image: IARC

The highlight of day two was another interaction with U.S. regulators. The FDA makes available certain meetings, called Q-subs, that allow industry to ask questions on regulatory issues before formal submission for approval. However, much of the industry is unfamiliar with these meetings. The workshop hosted a mock version of one of these meetings where a fictional company engaged in a pre-submission meeting with the FDA regarding a fictional product. The mock meeting showed both productive and unproductive ways of asking questions so that the company could get the most from the meeting.

Day three highlighted advancements in modeling and simulation software that has been made since last year’s workshop. The medical community uses simulation to plan radiation treatments for cancer patients; however, it has not been used much for medical device sterilization. The workshop concluded with a panel discussion with contract sterilizers and industrial accelerator manufacturers. Not only is sterilization capacity very tight, but the supply of new industrial accelerators is also very restricted. The conversation helped others in the industry understand when new supply might be available.

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.