Radiation Safety Aspects of Iodine-131 metaiodobenzylguanidine (131I mIBG) Therapy Program Startup

Abstract

As a medical center without a pre-existing radiopharmaceutical therapy program, it was a daunting endeavor to implement a 131I metaiodobenzylguanidine (mIBG) high-dose treatment regimen. It took several years of planning with hospital administration, vendors, and Texas Department of Health Radiological Control regulators to establish a viable program. Effective communication between physicians, nursing, nuclear medicine, environmental services, maintenance, and other support staff is essential and paramount for the successful execution and continued sustainability of the mIBG therapy program. Besides providing an effective treatment for patients, an additional goal for the program is to keep radiation exposure As Low As Reasonably Achievable (ALARA) for staff and patient caregivers. As such, start-up presented many training, logistical, and radiation safety challenges. The location of the isolation room and shielding specifications were designed to keep radiation exposure to public access areas to less than 2 microsieverts per hour. Before the first patient was treated the policies and procedures for training, radiation safety, product quality control, and infusion process needed to be developed, tested, and approved by various committees. Furthermore, a similar process was required for developing room set-up, post therapy cleanup, and waste storage procedures. Throughout the maturation process of the program, the departments involved have found that our safety culture has continually improved by the re-enforcement of knowledge and lessons learned, as both the ancillary and treatment staff grew more confident in each other’s ability during more patient treatments are performed. This article describes the process and lessons learned during the time leading up to the startup and early years of the mIBG therapy program.

Failure modes and effects analysis of pediatric I‐131 MIBG therapy: Program design and potential pitfalls

“…Several reports have provided detailed guidance on implementing I-131 MIBG programs, with strong emphasis on radiation exposure and contamination control of patients, staff, caregivers, and the general public. [8][9][10][11][12][13] However, there are currently no reports that quantitatively assess the robustness of these programs' detailed processes and potential safety risks.…”

“…In this work, we have outlined how we built and established our own pediatric I-131 MIBG program, following the recommendations of others [8][9][10][11]13 and as a close collaboration between pediatric oncology, radiation oncology, and our radiation safety team. We have also performed an FMEA to identify and quantitatively assess potential pitfalls in all process steps, from initial room design and construction to patient release at the completion of treatment.…”

“…FMEA scoring criteria adapted from American Association of Physicists in Medicine (AAPM) TG-10013 for application to radiopharmaceutical therapies…”