April 15, 2016

ACR Participates in Radioactive Sources Security Workshop

The American College of Radiology (ACR) participated in the White House Office of Science and Technology Policy (OSTP) Group on Alternatives to High-Activity Radioactive Sources (GARS) workshop on April 7, 2016.

The GARS is a multi-agency group under the National Science and Technology Council charged with developing a report of recommendations for federal health care providers seeking alternatives to high risk radiological sources. The materials of primary concern are Category 1 and 2 sources, notably Cobalt-60 (Co-60), Cesium-137 (Cs-137), and Iridium-192 (Ir-192), used in radiation therapy, blood irradiation, research and device sterilization.

The target audience for a future GARS report would be federal agencies that provide health care services, such as the Veterans Administration and Department of Defense, though concern was expressed at the workshop that the report could also influence government agencies involved with regulation, payment and research.

Representatives from radiation therapy, blood irradiation, medical device sterilization, and research professional and industry stakeholder groups were invited to participate in the interactive workshop. They were asked to provide input on the preconditions, requirements and barriers to replacement.

The ACR (represented by James Welsh, MD, FACR , American Society for Radiation Oncology, and other participants expressed serious concerns about assumptions underlying the GARS charge — namely that the physical security of these high-risk sources is a temporary fix and that the only permanent solution from a counterterrorism perspective would be their replacement with alternative technologies wherever and whenever feasible.

Participants emphasized that several other considerations beyond anti-terrorism — e.g., clinical efficacy/patient outcomes, accuracy, user familiarity, studies/R&D maturity of alternatives, costs (up front and maintenance), redundancy, reimbursement, and more — must be essential components of any decision-making process used by federal health care providers seeking replacement technologies.

Participants were ardent in their position that many medical technologies, particularly in the radiation therapy and research domains, are clearly not replaceable with existing alternatives and that the use of future alternatives in humans requires the highest degree of scrutiny about effectiveness, safety, accuracy, and reliability.

GARS will draft a report of recommendations for federal agencies in June.. Pertinent federal agencies will go through a formal concurrence process in July and implementation/finalization of the recommendations will occur in December.

At this time, GARS does not have explicit plans to invite further public input or to release the future report for inspection at the end of the process, although these options are available to the group. The report is not technically subject to public transparency requirements that apply to many other federal agency activities, such as rulemakings or federal advisory committee meetings. However, the ACR recommended that GARS release the future draft report for public review and comment prior to finalization.