在血液中心采购马辐射室和操作许可证的文件
Rakesh Kumar Luhar1, Kishore Maheshwari1, Ripal J Shah1
1Department of Transfusion Medicine, Prathama Blood Centre, Advanced Transfusion Medicine Research Foundation, Ahmedabad, Gujarat, India.
Asian journal of transfusion science
|August 21, 2025
概括
玛辐射室 (GIC) 通过非活化淋巴细胞来预防移植对宿主疾病至关重要. 这一审查旨在解决印度GIC运营和许可的监管挑战,旨在简化流程.
科学领域:
- 医学物理和辐射瘤学
- 输血医学
- 监管科学
背景情况:
- 移植对宿主疾病 (GvHD) 是一个严重的移植后并发症,特别是在免疫受损的患者中.
- 使用-137或-60的玛辐射室 (GIC) 对于预防GvHD的血液产品中的淋巴细胞失活至关重要.
- GIC的运营涉及到复杂的法律和监管框架,特别是在印度.
研究的目的:
- 审查印度GIC运营的法律,监管和政策环境.
- 确定与GIC许可和采购相关的挑战和机遇.
- 制定标准化指导文件,以促进原子能监管委员会 (AERB) 的许可程序.
主要方法:
- 对印度GIC运营的现有法律,监管和政策文件进行全面审查.
- 对GIC在AERB许可申请过程中获得的实践经验进行分析.
- 编制GIC许可和采购所需的文件和程序步骤.
主要成果:
- 印度目前的GIC许可程序很长,从采购到运营许可都需要大量的文件和时间.
- 有限的用户机构和缺乏经验丰富的人员在监管途径上带来了挑战.
- 通过明确的指导方针和培训来简化流程,可以减少行政负担并加快GIC的部署.
结论:
- 标准化指导和改善血液中心工作人员和放射安全官员的培训对于高效的GIC实施至关重要.
- 解决监管障碍和知识差距将有助于在印度更广泛地采用和有效使用GIC.
- 优化GIC许可程序支持关键的输血医学实践和患者安全.
相关概念视频
Radiological Investigation I: X-ray and CT
1.8K
Radiological investigations, including X-rays and computed tomography (CT) scans, are critical for diagnosing and evaluating various medical conditions. These imaging techniques provide valuable insights into the body's internal structures, aiding in the detection of abnormalities, assessment of disease progression, and development of treatment strategies. This article delves into two primary radiological investigations, chest X-rays and CT scans, outlining their purpose, procedures, and...
1.8K
Radiological Investigation II: MRI and Ventilation Perfusion Scan
1.0K
Description
Magnetic Resonance Imaging (MRI) and Ventilation Perfusion Scans are two radiological investigations that offer detailed diagnostic images of the body, particularly lung structures.
MRI
MRI uses magnetic fields and radiofrequency signals to distinguish between normal and abnormal tissues. This technology provides a more detailed diagnostic image than CT scans, enabling it to characterize pulmonary nodules, stage bronchogenic carcinoma, and evaluate inflammatory activity in...
Magnetic Resonance Imaging (MRI) and Ventilation Perfusion Scans are two radiological investigations that offer detailed diagnostic images of the body, particularly lung structures.
MRI
MRI uses magnetic fields and radiofrequency signals to distinguish between normal and abnormal tissues. This technology provides a more detailed diagnostic image than CT scans, enabling it to characterize pulmonary nodules, stage bronchogenic carcinoma, and evaluate inflammatory activity in...
1.0K
Radiological Investigation III: Pulmonary Angiogram and PET Scan
732
Radiological investigations are paramount in the diagnosis and management of various pulmonary diseases. Two essential investigations are the Pulmonary Angiogram and the Positron Emission Tomography (PET) Scan.
Pulmonary Angiogram
A Pulmonary Angiogram is an invasive procedure involving injecting a contrast medium through a catheter threaded into the pulmonary artery or the right side of the heart to visualize the pulmonary vasculature. Computed Tomography (CT) scans have mainly replaced this...
Pulmonary Angiogram
A Pulmonary Angiogram is an invasive procedure involving injecting a contrast medium through a catheter threaded into the pulmonary artery or the right side of the heart to visualize the pulmonary vasculature. Computed Tomography (CT) scans have mainly replaced this...
732
Imaging Studies II: Positron Emission Tomography and Scintigraphy
861
Positron Emission Tomography (PET) is a medical imaging technique that provides crucial insights into the body's physiological functions at a molecular level. It is an indispensable resource for diagnosing, staging, and monitoring various illnesses, notably cancer, neurological disorders, and cardiovascular conditions.
Fundamental Principles of PET
Fundamental Principles of PET
861
Imaging Studies for Cardiovascular System IV: CMRI
542
Cardiovascular magnetic resonance imaging, or CMRI, is a non-invasive diagnostic test that employs a magnetic field and radiofrequency waves to create precise images of the heart and arteries. It provides comprehensive information about cardiac anatomy, function, perfusion, and tissue characterization without ionizing radiation.IndicationsCMRI diagnoses various heart conditions, including tissue damage from heart attacks, ischemic heart disease, myocarditis, aortic issues (tears, aneurysms,...
542
Imaging Studies for Cardiovascular System V: CT
673
Cardiac computed tomography (CT) scanning is an advanced cardiac imaging technique that utilizes CT technology, with or without intravenous (IV) contrast, to produce accurate cross-sectional virtual slices of specific areas of the heart, coronary circulation, and major blood vessels such as the aorta, pulmonary veins, and arteries. The computer processes these slices to generate three-dimensional images. Multidetector CT (MDCT) is a rapid form of CT scanning that captures multiple slices...
673


