RADIOISOTOPES

Online ISSN: 1884-4111 Print ISSN: 0033-8303
RADIOISOTOPESは日本アイソトープ協会が発行する学術論文誌です
Radioisotopes 75(3): 195-202 (2026)
doi:10.3769/radioisotopes.750305

資料Materials (Data)

病院設置型サイクロトロン施設の安定運用に向けた実務的課題—院内18F-FDG製造開始後2年間の経験—Practical Considerations for Sustainable Operation of a Hospital-Based Cyclotron Facility—Lessons Learned During the First Two Years Following Implementation of In-House 18F-FDG Production—

藤田医科大学病院 放射線部セラノスティクスセンターDepartment of Radiology, Theranostics Center, Fujita Health University Hospital

受付日:2026年7月7日Received: July 7, 2026
受理日:2026年8月20日Accepted: August 20, 2026
発行日:2026年11月15日Published: November 15, 2026
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病院設置型サイクロトロン施設における院内18F-FDG製造の安定運用には,標準操作手順書の整備と変更管理,設備・環境管理,品質保証,人員教育と代替性,物品・廃棄物管理,放射線安全管理,臨床部門との情報共有を一体として整備する必要がある。本資料では,院内18F-FDG製造開始後2年間に経験した実務課題と対応を横断的に整理した。個別の被ばく線量,廃棄物管理,照射条件,品質試験上の疑義,保守後確認,在庫管理等の詳細は,既報または個別研究に委ねる。さらに,従来の時間,距離,遮へいによる物理的防護を補完する運用的放射線防護として,需要を超える不要な放射能を製造しないこと,および特定作業者への被ばくと業務負担の集中を回避することを提示する。

Hospital-based cyclotron facilities require an integrated operational system after implementation of in-house fluorine-18 fluorodeoxyglucose production. This article summarizes practical issues encountered during the first two years of routine operation, including standard operating procedures and change control, equipment and environmental management, quality assurance, personnel training and backup capacity, inventory and radioactive waste management, radiation safety management, and coordination with clinical departments. Detailed analyses of individual topics, including occupational exposure, waste management, irradiation conditions, questionable quality test results, post-maintenance changes, and inventory management, are outside the scope of this article and are treated as separate topics. The experience indicates that sustainable operation depends on an integrated quality assurance system that links responsibilities, communication pathways, documentation, education, and continuous improvement. In addition to the conventional principles of time, distance, and shielding, two complementary operational radiation protection principles are proposed: avoiding production of unnecessary radioactivity beyond clinical demand and preventing concentration of occupational exposure and workload in particular workers. Radiation protection in hospital-based radiopharmacy therefore begins at the stages of production planning and workforce organization.

Key words: hospital-based cyclotron; fluorine-18 fluorodeoxyglucose (FDG); positron emission tomography (PET); quality assurance; operational radiation protection

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This page was last modified on 2026-10-06T13:43:46.000+09:00


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