Diagnostic and Therapeutic Nuclear Medicine
Medical use advice offered and provided is intended to emulate the most up-to-date U.S. Nuclear Regulatory Commission (NRC) diagnostic and therapeutic nuclear medicine regulatory standards. The assistance provides an understanding of basic radiobiology; the facilities and equipment used in nuclear medicine departments; clinical diagnostic and therapeutic procedures and protocols involving the administration of radiopharmaceuticals to patients for diagnostic imaging; safe handling of patients and the protection of staff and visitors; area radiation surveys; responsibilities of key personnel; function of the Radiation Safety Committee; licensee’s ALARA program; and authorized user and authorized medical physicist training standards. Discussions cover topics such as transportation of diagnostic and therapeutic radioactive materials in sealed and unsealed form, emergency response procedures including all associated record keeping requirements, quality assurance (for both radiopharmaceuticals and imaging devices), instrument calibrations, radioactive waste storage, and disposal of radioactive material are also covered.
Brachytherapy, Gamma Knife, and Emerging Medical Uses for Radiotherapy
This aspect of the consultancies provides a focus to determine if the country’s regulatory staff has a basic understanding of medical radiation therapy, focusing on Manual Brachytherapy, High Dose Rate Afterloaders and Stereotactic Radiosurgery using sealed sources and machine produced therapeutic equipment. Topics covered include: Principles of Radiobiology, Radiation Therapy Terminology, Brachytherapy, Gamma Knife, Linear Accelerators and Other Medical Modality Uses Licensed in accordance with Title 10 CFR 35.1000 (Emerging Technologies), Quality Control Concepts, Patient Dosimetry, Safety and Emergency Procedures, Devices and Instruments. Licensing and inspection tools will be discussed if practicable. Discussions also cover the safety evaluation of license application review and the inspection process.
Cyclotron Technology and Cyclotron Pharmaceutical Production
Where this technology is employed or about to be employed in a partner country, an introduction and understanding of the basic operation of cyclotrons used in research and medical facilities including self-shielded and non-shielded cyclotrons with energies ranging from 8 MeV to 18 Mev used for the production of fluorine-18 for the use in positron emission tomography for medical diagnostic procedures are discussed. Various aspects of the regulator’s oversite responsibilities and include all safety and security regulatory requirements; safety systems; audits and self-inspection items; equipment; control room security and operation; cyclotron maintenance; radiation safety officer, operator, and radiopharmacist responsibilities; swipe tests for leakage and pertinent radiation surveys of activated products; emergency procedures; commercial applications and distribution through consortiums; dosimetry; regulations; the licensing review process; and safety inspections. Also, discussion topics cover the safety evaluation of license application review and the inspection process.
The AdSTM expert(s) will provide expertise in the evaluation of the F-18 production and pharmaceutical grade synthesis operations. Assistance provides the oversite by the technical expert, of the country’s regulatory body’s assessment of the licensee’s radiation protection program (RPP) and the conduct of a safety and security inspection if practicable.
Assistance for non-shielded cyclotrons relative to the site location determination by the applicant is also available. Site visits and observance of the operational and construction specifications in use can be very beneficial for purposes of checking, among other aspects, records of F18/FDG activity produced, personnel dosimetry, target material and other F-18 waste disposal to include F-18 radioactive material transportation.