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Ever since the National Cancer Registration and Statistics in Korea was conducted in 1999, the incidence rate of cancer has increased g radually until now. In accordance with its increase, the use of radiotherapy equipment has also increased. On the ground that most of radiation t herapy is carried out by external beam radiotherapy equipments, this study is concerned with the safe, efficient use and management of external radiotherapy equipments from the perspective of health technology or medical device. Based on a study of the related systems and guidelines abroad, this study purports that the safe, efficient use and management of radiotherapy equipments are as follows. In the pre-marketing phase, the prod uct approval procedures need to be further integrated and improved. Manufacturers or distributors of radiotherapy equipments are required to obtain a approval from the Nuclear Safety and Security Commission and a medical device approval from the Ministry of Food & Drug Safety in consecutive order to attain authorization for marketing. This procedur e needs to be improved because dossiers submitted are partially repetitive. In postmarketing phase, safety measures focusing on the patient safety are re-quired. Presently, the Nuclear Safety Act centers exclusively o n radiation utilization facilities and radiation workers. Supplementary revisions of regulations and current systems are required for the safe management of patients.
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