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Abstract:
The use of radioactive materials in medicine is one of the most highly regulated areas the physician has to deal with. There are three basic types of licenses for use of radioactive material defined in the Code of Federal Regulations (CFR), chapter 10, part 35. These are the general license, which is mainly applicable to small volume in vitro work; the specific license, which is used in most medical facilities; and the broad license, which is suited for larger research-oriented practices. Licensing requires proof of competence of the user and of adequate provision for protection of public health. Materials used in medicine are grouped for convenience into three diagnostic categories and two therapeutic categories. A sixth group, for sealed implants, is not generally applicable in nuclear medicine. Training and experience of users may be documented in a number of ways, including board certification in nuclear medicine. Therapeutic applications require additional proof of direct personal experience. The radiation safety officer is a pivotal individual in the licensing procedure, being directly responsible for carrying out the highly detailed requirements for protection of personnel and patients. A radiation safety program based on the "as low as reasonably achievable" (ALARA) concept requires personal monitoring, inventory control, detection and control of contamination, and strict adherence to licensing rules. Training of personnel and proper maintenance of equipment and facilities are also vital parts of the licensing process. The requirements of licensing and for renewal are clearly spelled out by the various regulatory agencies and require meticulous record keeping with documentation that all prescribed procedures have been followed and duly recorded.