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MIRDOSE 3, the radiation internal dose calculation software widely used in nuclear medicine, is no longer being distributed by the Radiation Internal Dose Information Center (RIDIC; Oak Ridge, TN), according to director Richard E. Toohey, PhD. The decision to pull the software from active distribution was made by RIDIC staff after a February phone call from the Food and Drug Administration (FDA). In this call, Stuart Crumpler, PhD, software expert in the Office of Compliance at the Center for Devices and Radiological Health (CDRH; Bethesda, MD) reported to Toohey that the FDA is looking at whether such software should be classified as treatment planning devices that would require cleared premarket notification 501 (k). After consultation with legal staff, Toohey moved to pull MIRDOSE 3 from active circulation until the matter can be resolved. The FDA's position on such softwareand the future of MIRDOSE and other software for clinical and research applications-is of vital interest to the practice of nuclear medicine both now and in the future.
Background
The main purpose of the MIRDOSE software is to perform calculations needed to obtain dose estimates for the various organs of the body once both the kinetics of a radiopharmaceutical agent and the resident times or areas under the timeactivity curve for the various source organs are established. The code's other purpose is to help the user apply standardized recognized models and techniques for dosimetry into the calculations. Michael Stabin, PhD, RIDIC scientist and original author of MIRDOSE, reports that the first program, written in the mid 1980s, was a response to the tedium of dose calculations: "I originally wrote the code for myself, as I got tired of the many repetitive calculations using lookup tables. Later, I decided to share it with others, both to make their lives easier and provide some standardization of the way that dose calculations are done."
With MIRDOSE, basic dose calculations could now be made in seconds instead of hours. MIRDOSE 1 was used only in-house at RIDIC. The program was limited in its applications and could be run on only one type of computer.
MIRDOSE 2 was released in 1987 for IBMcompatible computers and included about 60 radionuclides and 6 anthropomorphic phantoms representing both children and adults (the Cristy-Eckerman series). MIRDOSE...