Society and Nuclear Energy: What Is the Role for Radiological Protection?

ABSTRACT: The harm that society expects from ionizing radiation does not match experience. Evidently there is some basic error in this assumption. A reconsideration based on scientific principles shows how simple misunderstandings have exaggerated dangers. The consequences for society are far-reaching. The immediate impact of ionizing radiation on living tissue is destructive. However, this oxidative damage is similar to that produced during normal metabolic activity where the subsequent biological reaction is not only protective but also stimulates enhanced protection. This adaptation means that the response to oxidative damage depends on past experience. Similarly, social reaction to a radiological accident depends on the regulations and attitudes generated by the perception of previous instances. These shape whether nuclear technology and ionizing radiation are viewed as beneficial or as matters to avoid. Evidence of the spurious damage to society caused by such persistent fear in the second half of the 20 th century suggests that these laws and attitudes should be rebased on evidence. The three stages of radiological impact-the initial physical damage, the subsequent biological response, and the personal and social reaction-call on quite different logic and understanding. When these are confused, they lead to regulations and public policy decisions that are often inept, dangerous, and expensive. One example is when the mathematical rigor of physics, appropriate to the immediate impact, is misapplied to the adaptive behavior of biology. Another, the tortured historical reputation of nuclear technology, is misinterpreted as justifying a radiological protection policy of extreme caution.Specialized education and closed groups of experts tend to lock in interdisciplinary misperceptions. In the case of nuclear technology, the resulting lack of independent political confidence endangers the adoption of nuclear power as the replacement for fossil fuels. In the long term, nuclear energy is the only viable source of large-scale primary energy, but this requires a re-working of public understanding.

Replace the Linear No-threshold Model with a Risk-informed Targeted Approach to Radiation Protection.

ABSTRACT: The linear no-threshold (LNT) model may be useful as a simple basis for developing radiation protection regulations and standards, but it bears little resemblance to scientific reality and is probably overly conservative at low doses and low dose rates. This paper is an appeal for a broader view of radiation protection that involves more than just optimization of radiation dose. It is suggested that the LNT model should be replaced with a risk-informed, targeted approach to limitation of overall risks, which include radiation and other types of risks and accidents/incidents. The focus should be on protection of the individual. Limitation of overall risk does not necessarily always equate to minimization of individual or collective doses, but in some cases it might. Instead, risk assessment (hazards analysis) should be performed for each facility/and or specific job or operation (straightforward for specialized work such as radiography), and this should guide how limited resources are used to protect workers and the public. A graded approach could be used to prioritize the most significant risks and identify exposure scenarios that are unlikely or non-existent. The dose limits would then represent an acceptable level of risk, below which no further reduction in dose would be needed. Less resources should be spent on ALARA and tracking small individual and collective doses. Present dose limits are thought to be conservative and should suffice in general. Two exceptions are possibly the need for a lower (lifetime) dose limit for lens of the eye for astronauts and raising the public limit to 5 mSv y -1 from 1 mSv y -1 . This would harmonize the public limit with the current limit for the embryo fetus of the declared pregnant worker. Eight case studies are presented that emphasize how diverse and complex radiation risks can be, and in some cases, chemical and industrial risks outweigh radiation risks. More focus is needed on prevention of accidents and incidents involving a variety of types of risks. A targeted approach is needed, and commitments should be complied with until they are changed or exemptions are granted. No criticism of regulators or nuclear industry personnel is intended here. Protection of workers and the public is everyone's goal. The question is how best to accomplish that.

Science-informed Policy Making for Protecting People and the Environment from Radiation.

ABSTRACT: The process to arrive at the radiation protection practices of today to protect workers, patients, and the public, including sensitive populations, has been a long and deliberative one. This paper presents an overview of the US Environmental Protection Agency's (US EPA) responsibility in protecting human health and the environment from unnecessary exposure to radiation. The origins of this responsibility can be traced back to early efforts, a century ago, to protect workers from x rays and radium. The system of radiation protection we employ today is robust and informed by the latest scientific consensus. It has helped reduce or eliminate unnecessary exposures to workers, patients, and the public while enabling the safe and beneficial uses of radiation and radioactive material in diverse areas such as energy, medicine, research, and space exploration. Periodic reviews and analyses of research on health effects of radiation by scientific bodies such as the National Academy of Sciences, National Council on Radiation Protection and Measurements, United Nations Scientific Committee on the Effects of Atomic Radiation, and the International Commission on Radiological Protection continue to inform radiation protection practices while new scientific information is gathered. As a public health agency, US EPA is keenly interested in research findings that can better elucidate the effects of exposure to low doses and low dose rates of radiation as applicable to protection of diverse populations from various sources of exposure. Professional organizations such as the Health Physics Society can provide radiation protection practitioners with continuing education programs on the state of the science and describe the key underpinnings of the system of radiological protection. Such efforts will help equip and prepare radiation protection professionals to more effectively communicate radiation health information with their stakeholders.

The Impact of the Linear No-threshold Hypothesis on Litigation.

ABSTRACT: As the basis of radiation safety practice and regulations worldwide, the linear no-threshold (LNT) hypothesis exerts enormous influence throughout society. This includes our judicial system, where frivolous lawsuits are filed alleging radiation-induced health effects caused by negligent companies who subject unwitting victims to enormous financial and physical harm. Typically, despite the lack of any supporting scientific basis, these cases result in enormous costs to organizations, insurance companies, and consumers.

A Revised System of Radiological Protection Is Needed.

ABSTRACT: The system of radiological protection has been based on linear no-threshold theory and related dose-response models for health detriment (in part related to cancer induction) by ionizing radiation exposure for almost 70 y. The indicated system unintentionally promotes radiation phobia, which has harmed many in relationship to the Fukushima nuclear accident evacuations and led to some abortions following the Chernobyl nuclear accident. Linear no-threshold model users (mainly epidemiologists) imply that they can reliably assess the cancer excess relative risk (likely none) associated with tens or hundreds of nanogray (nGy) radiation doses to an organ (e.g., bone marrow); for 1,000 nGy, the excess relative risk is 1,000 times larger than that for 1 nGy. They are currently permitted this unscientific view (ignoring evolution-related natural defenses) because of the misinforming procedures used in data analyses of which many radiation experts are not aware. One such procedure is the intentional and unscientific vanishing of the excess relative risk uncertainty as radiation dose decreases toward assigned dose zero (for natural background radiation exposure). The main focus of this forum article is on correcting the serious error of discarding risk uncertainty and the impact of the correction. The result is that the last defense of the current system of radiological protection relying on linear no-threshold theory (i.e., epidemiologic studies implied findings of harm from very low doses) goes away. A revised system is therefore needed.

A Review of Recent Low-dose Research and Recommendations for Moving Forward.

ABSTRACT: The linear no-threshold (LNT) model has been the regulatory "law of the land" for decades. Despite the long-standing use of LNT, there is significant ongoing scientific disagreement on the applicability of LNT to low-dose radiation risk. A review of the low-dose risk literature of the last 10 y does not provide a clear answer, but rather the body of literature seems to be split between LNT, non-linear risk functions (e.g., supra- or sub-linear), and hormetic models. Furthermore, recent studies have started to explore whether radiation can play a role in the development of several non-cancer effects, such as heart disease, Parkinson's disease, and diabetes, the mechanisms of which are still being explored. Based on this review, there is insufficient evidence to replace LNT as the regulatory model despite the fact that it contributes to public radiophobia, unpreparedness in radiation emergency response, and extreme cleanup costs both following radiological or nuclear incidents and for routine decommissioning of nuclear power plants. Rather, additional research is needed to further understand the implications of low doses of radiation. The authors present an approach to meaningfully contribute to the science of low-dose research that incorporates machine learning and Edisonian approaches to data analysis.

Potential risk assessment: a model for quality evaluation in fluoroscopy-guided interventional procedures.

This study presented a model applied for potential risk assessment in an interventional radiology setting. The model of potential risk assessment (MARP) consisted of the creation of a scale of indicators ranging from 0 to 5. The radiation levels were categorized according to gender, kind of procedure, value of kerma air product (Pka), and accumulated radiation dose (mGy). The MARP model was applied in 121 institutions over 8 y. A total of 201 656 patient radiation doses (Dose-area product and accumulated kerma) data were launched into the system over time, with an average of 22 406 doses per year. In the context of the workers (cardiologists, radiographers, and nurses) monitored during the MARP application, 8007 cases (with an average of 890 per year) of occupational radiation doses were recorded. This study showed a strategy for quality evaluation in fluoroscopy using a model with a compulsory information system for monitoring safety.

Prospective dose monitoring using a manual dose management system: experience in brain computed tomography from a tertiary hospital in Nigeria.

A manual radiation dose management system was developed to track the radiation dose and scan parameters of patients for brain computed tomography (CT). Radiation dose in volume computed tomography dose index (CTDIvol) and dose length product (DLP) were monitored to identify procedures that may require optimisation using notification values. The data were analysed and compared with national and international diagnostic reference levels (DRLs). A total of 596 brain CTs were monitored and grouped as <1: 36, 1-<5: 38, 5-<10: 25, 10-<15: 31 and adult: 466. The CTDIvol notification value identified the following number of examinations having high CTDIvol in <1 y: 1, 1-<5: 1, 5-<10: 0, 10-<15: 0 and adult (>15): 11. Furthermore, the DLP notification values identified the following examinations with high DLP in <1 y: 1, 1-<5:1, 5-<10:1, 10-<15: 1 and adults (>15): 18. The established local paediatric DLP DRLs were 2-3 times higher than the international paediatric DLP DRLs. This calls for a total protocol review and optimisation considering the local CT practices for paediatric imaging.

Updating national diagnostic reference levels for computed tomography in Greece: Challenges on patient protection optimisation.

The escalating use of Computed Tomography (CT) imaging necessitates establishment and periodic revision of Diagnostic Reference Levels (DRLs) to ensure patient protection optimization. This paper presents the outcomes of a national survey conducted from 2019 to 2022, focusing on revising DRLs for adult CT examinations. Dosimetric data from 127 scanners in 120 medical facilities, representing 25% of the country's CT scanners, were collected, emphasizing geographic distribution and technology representation. Τhe parameters used for DRLs were the CTDIvol and the DLP of a typical acquisition of the region of interest (scan DLP). In addition to the 7 CT examination for which the DRL values were revised, establishment of DRLs for neck, cervical spine, pelvic bones-hips, coronary artery calcium (Ca) score and cardiac computed tomography angiography (CCTA) examinations was performed. Revised DRLs exhibited a 15 % average decrease in CTDIvol and a 7 % average decrease in scan DLP from the initial DRLs. This reduction of dosimetric values is relatively low compared to other national studies. The findings revealed wide variations in dosimetric values and scan lengths among scanners, emphasizing the need for standardization and optimization. Incorporation of advanced technologies like Iterative Reconstruction (IR) showcased potential for further dose reduction, yet challenges in uniform implementation persist. The study underscores the importance of ongoing optimisation efforts, particularly in the context of increased CT utilization and evolving technology. The revised DRLs have been officially adopted in Greece, emphasizing the commitment to safe and effective CT practices.

Radioprotection issues in uraniferous minerals collections with reference to an actual case.

Our work investigated the radioprotection implications associated with the possession of a collection of uraniferous minerals. Considering different scenarios, we developed (and applied to an actual collection) specific formulas for radiation doses evaluation. We discussed the shielding necessary to reduce the gamma irradiation down to the required values. A mathematical model was developed to estimate the minimum air flow rate to reduce the radon air concentration below the reference values. The radiation risks associated to the handling of single specimens was also addressed, including hand skin irradiation and shielding capabilities of surgical lead gloves. Finally, we discussed the radiation risks associated to the exhibition of a single specimen. The results, compared to the safety standards of the EU Directive 13/59, show that the exhibition of uraniferous samples with activity of a few MBq do not need specific radioprotection requirements nor for the involved personnel nor for visitors.

Guardians of precision: advancing radiation protection, safety, and quality systems in nuclear medicine.

BACKGROUND: In the rapidly evolving field of nuclear medicine, the paramount importance of radiation protection, safety, and quality systems cannot be overstated. This document provides a comprehensive analysis of the intricate regulatory frameworks and guidelines, meticulously crafted and updated by national and international regulatory bodies to ensure the utmost safety and efficiency in the practice of nuclear medicine. METHODS: We explore the dynamic nature of these regulations, emphasizing their adaptability in accommodating technological advancements and the integration of nuclear medicine with other medical and scientific disciplines. RESULTS: Audits, both internal and external, are spotlighted for their pivotal role in assessing and ensuring compliance with established standards, promoting a culture of continuous improvement and excellence. We delve into the significant contributions of entities like the International Atomic Energy Agency (IAEA) and relevant professional societies in offering universally applicable guidelines that amalgamate the latest in scientific research, ethical considerations, and practical applicability. CONCLUSIONS: The document underscores the essence of international collaborations in pooling expertise, resources, and insights, fostering a global community of practice where knowledge and innovations are shared. Readers will gain an in-depth understanding of the practical applications, challenges, and opportunities presented by these regulatory frameworks and audit processes. The ultimate goal is to inspire and inform ongoing efforts to enhance safety, quality, and effectiveness in nuclear medicine globally.

Dosis efectivas asociadas a estudios híbridos SPECT-CT en pacientes adultos / Effective dose associated to hybrid SPECT-CT imaging in adult patients / Doses eficazes associadas a estudos de SPECT-CT híbridos em pacientes adultos

Introducción: la técnica de imagen híbrida de SPECT-CT combina la imagen de la tomografía por emisión de fotón único (SPECT) con el estudio de tomografía computada (TC), obteniendo información funcional y anatómica en un mismo estudio. La dosis efectiva total de radiación ionizante recibida en los estudios SPECT-CT puede ser estimada a partir de la dosis efectiva atribuible a la actividad administrada del radiofármaco y la dosis efectiva del componente de tomografía computada (TC). Objetivos: estimar la dosis efectiva total en los protocolos SPECT-CT utilizados en población adulta y determinar el aporte adicional del estudio TC sobre la dosis efectiva total. Método: se evaluaron 258 estudios SPECT-CT para estimar la dosis efectiva total aportada por la administración de los radiofármacos y los estudios de TC de baja dosis. Para estimar el aporte de ambos componentes se utilizaron factores de conversión específicos de cada radiofármaco y región explorada mediante TC. Resultados: la dosis efectiva total (media ± DS) en los estudios SPECT-CT fueron: 12,4 ± 1,44 mSv en el estudio de perfusión miocárdica, 1,14 ± 0,25 mSv en ganglio centinela de mama, 8,6 ± 0,6 mSv paratiroides, 1,48 ± 1,02 mSv tiroides y los estudios óseos de las regiones de cuello 4,5 ± 0,3, tórax 6,07 ± 0,3 mSv, abdomen y pelvis 6,1 ± 0,3 mSv. La dosis de radiación aportada por el estudio TC se encuentra entre 0,46 mSv para la región del tórax en el estudio de ganglio centinela de mama y 2,3 mSv para el SPECT-CT óseo en la región de abdomen y pelvis. Conclusión: se logró estimar la dosis efectiva en los protocolos SPECT-CT de uso clínico más frecuente en población adulta y el aporte de los estudios TC a la dosis efectiva total siendo relativamente baja comparado con la dosis aportada por los radiofármacos administrados con la excepción del estudio de ganglio centinela donde la contribución del componente TC es aproximadamente la mitad de la dosis efectiva total.

Introduction: SPECT-CT Hybrid image technique combines the SPECT (single-photon emission computed tomography) image with the CT (computerized tomography) image to obtain both functional and anatomical images in the same study. The total effective ionizing radiation dose received in SPECT-CT studies may be estimated based on the effective dose from the radiopharmaceutical administered and the effective dose from the CT (computerized tomography) component. Objectives: the study aims to estimate the total effective dose in SPECT-CT protocols applied for the adult population, and to determine the additional contribution from the CT component to the total effective dose. Method: 258 SPECT-CT studies were evaluated to estimate the total effective dose from the administration of radiopharmaceuticals and low dose CT studies. Specific conversion factors for each radiopharmaceutical and area of the body explored with the CT were used to estimate radiation doses from both components. Results: total effective dose (average ± SD) in the SPECT-CT studies was: 12.4 ± 1.44 mSv in the myocardial perfusion study, 1.14 ± 0.25 mSv in the breast sentinel lymph node study, 8.6 ± 0.6 mSv in the parathyroid study, 1.48 ± 1.02 mSv in the thyroid study. As to bone studies, doses found were: 4.5 ± 0.3, in neck studies, 6.07 ± 0.3 mSv in thoracic studies and 6.1 ± 0.3 mSv in abdominal and pelvic studies. The radiation dose from the CT study ranges from 0.46 mSv for the thoracic region on the breast sentinel lymph node study to 2.3 mSv for the bone SPECT-CT study of the abdominal and pelvic region. Conclusions: we managed to estimate the effective dose in the the most frequently used SPECT-CT protocols for the adult population and the contribution of CT studies to the total effective dose. It was found to be relatively low when compared to the dose contributed by the radiopharmaceuticals administered, with the exception of the sentinel lymph node study for which the contribution from the CT study is approximately half the total effective dose.

Introdução: a técnica de imagem híbrida SPECT-CT combina a imagem de tomografia por emissão de fóton único (SPECT) com o estudo de tomografia computadorizada (TC), obtendo informações funcionais e anatômicas no mesmo estudo. A dose efetiva total de radiação ionizante recebida em estudos SPECT-CT pode ser estimada a partir da dose efetiva atribuível à atividade administrada do radiofármaco e da dose efetiva do componente de tomografia computadorizada (TC). Objetivos: estimar a dose efetiva total nos protocolos SPECT-CT utilizados na população adulta e determinar a contribuição adicional do estudo de TC na dose efetiva total. Método : 258 estudos SPECT-CT foram avaliados para estimar a dose efetiva total fornecida pela administração de radiofármacos e estudos de TC de baixa dose. Para estimar a contribuição de ambos os componentes, foram utilizados fatores de conversão específicos para cada radiofármaco e região explorada pela TC. ⁠ Resultados: a dose efetiva total (média ± DP) nos estudos SPECT-CT foi: 12,4 ± 1,44 mSv no estudo de perfusão miocárdica, 1,14 ± 0,25 mSv no linfonodo sentinela mamário, 8,6 ± 0,6 mSv paratireoide, 1,48 ± 1,02 mSv estudos de tireoide e ossos das regiões do pescoço 4,5 ± 0,3, tórax 6,07 ± 0,3 mSv, abdômen e pelve 6,1 ±0,3mSv. A dose de radiação fornecida pelo estudo de TC está entre 0,46 mSv para a região do tórax no estudo do linfonodo sentinela da mama e 2,3 mSv para o SPECT-CT ósseo na região do abdome e pelve. Conclusão: foi possível estimar a dose efetiva nos protocolos de SPECT-CT mais utilizados clinicamente na população adulta e a contribuição dos estudos de TC para a dose efetiva total, sendo relativamente baixa em relação à dose fornecida pelos radiofármacos administrados com a exceção do estudo do linfonodo sentinela onde a contribuição do componente TC é aproximadamente metade da dose efetiva total.

Occupational exposure in the work process of radiology technologists with 68Ga-labeled radiopharmaceuticals.

The study identified occupational exposure in the work of radiology technologists with 68Ga radiopharmaceuticals, in a Nuclear Medicine service in southern Brazil, by means of observation and document analysis. The occupational exposure related the factors, distance, time and shielding. Thus, it was observed high times during handling of the material, small distances between sources and radiosensitive structures, such as the eye lens and the thyroid gland. It is recommended to reassess and standardize the work, once that critical moments should not be restricted only to dosimetric reading.

Copaifera langsdorffii Desf. bark extract: optimisation of dyeing conditions to wool and colour fastness properties.

The ability to add value to waste materials from industrial operations has come to the attention of the wood processing industry, with reports, for example, of extracts from the bark tree conveying colour and UV protection to textile fibres. The objective of the present work was to expand our developments in this arena by using Copaifera langsdorffii Desf. bark extract as a natural dye for textile dyeing. A complete 2³-statistical experimental design and the central point was elaborated. The results showed that the optimal dyeing conditions were 98 °C, for 60 min, using undiluted bark extract. The dyed fabric was analysed by a spectrophotometer using the CIELAB system for evaluation of the colour strength. The results showed a K/S value of 5.78, and the dyed fabric had good colour fastness to rubbing and washing.

Optimización de la protección en radiología y cardiología intervencionista pediatrica en América Latina y el Caribe (OPRIPALC) / Optimization of protection in pediatric interventional cardiology and radiology in Latin America and the Caribbean (OPRIPALC)

El objetivo del presente artículo ha sido describir el programa "Optimización de la Protección en Radiología Intervencionista Pediátrica en América Latina y el Caribe" (OPRIPALC) que nace el año 2018 como respuesta conjunta de la Organización Panamericana de la Salud y la Organización Mundial de la Salud, en cooperación con el Organismo Internacional de Energía Atómica, para colaborar con sus Estados miembros en asegurar que las exposiciones a la radiación de los pacientes pediátricos sean las mínimas necesarias durante los procedimientos intervencionistas. Actualmente, hay 18 centros de los siguientes 10 países que participan: Argentina, Brasil, Chile, Colombia, Costa Rica, Cuba, Ecuador, México, Perú y Uruguay. Para el desarrollo del programa se plantean una serie de objetivos, productos, actividades y resultados esperados. La puesta en marcha de la WEB de OPRIPALC ha significado un instrumento muy válido para seguir la información actualizada del programa. Un programa actualizado de formación en radioprotección para los profesionales implicados en el programa, se está realizando por medio de "webinars". Se deberá seguir actuando en la aplicación del programa de control de calidad básico para los equipos de rayos X participantes y validar los valores de los Niveles de Referencia para Diagnóstico (NRDs). Se propone formar un equipo de trabajo entre los Físicos Médicos y Tecnólogos Médicos participantes de OPRIPALC para implicarse en las pruebas de control básicas que todos los centros debieran realizar. Se han presentado algunos resultados iniciales de OPRIPALC en eventos científicos internacionales. Se está avanzando en proponer unos primeros valores sobre NRDs en procedimientos de intervencionismo cardiológico pediátrico por bandas de edad y peso. OPRIPALC es una de las pocas iniciativas de carácter regional para obtener valores de NRDs en procedimientos intervencionistas pediátricos. Se espera que tanto los valores de referencia como la metodología empleada en OPRIPALC, puedan ser utilizados en otras regiones del mundo.

The objective of this article has been to describe the program "Optimization of Protection in Pediatric Interventional Radiology in Latin America and the Caribbean" (OPRIPALC) that was born in 2018 as a joint response of the Pan American Health Organization and the World Organization of the Health, in cooperation with the International Atomic Energy Agency, to collaborate with its member states in ensuring that radiation exposures of pediatric patients are the minimum necessary during interventional procedures. Currently, there are 18 centers from the following 10 countries participating: Argentina, Brazil, Chile, Colombia, Costa Rica, Cuba, Ecuador, Mexico, Peru and Uruguay. For the development of the program, a series of objectives, products, activities and expected results are proposed. The launch of the OPRIPALC WEBSITE has been a very valid instrument for following up-to-date information on the program. An updated training program in radiation protection for the professionals involved in the program is being carried out through webinars. It should continue acting in the application of the basic quality control program for the participating X-ray equipment and validate the values of the Diagnostic Reference Levels (DRLs). It is proposed to form a work team among the OPRIPALC participating medical physicists to get involved in the basic control tests that all centers should carry out. Some initial results of OPRIPALC have been presented at international scientific events. Progress is being made in proposing first values on DRLs in pediatric cardiac intervention procedures by age and weight bands. OPRIPALC is one of the few regional initiatives to obtain DRLs values in pediatric interventional procedures. It is expected that both the reference values and the methodology used in OPRIPALC can be used in other regions of the world.

The internal dosimetry user group position statement on molecular radiotherapy.

The Internal Dosimetry User Group (IDUG) is an independent, non-profit group of medical professionals dedicated to the promotion of dosimetry in molecular radiotherapy (www.IDUG.org.uk). The Ionising Radiation (Medical Exposure) Regulations 2017, IR(ME)R, stipulate a requirement for optimisation and verification of molecular radiotherapy treatments, ensuring doses to non-target organs are as low as reasonably practicable. For many molecular radiotherapy treatments currently undertaken within the UK, this requirement is not being fully met. The growth of this field is such that we risk digressing further from IR(ME)R compliance potentially delivering suboptimal therapies that are not in the best interest of our patients. For this purpose, IDUG proposes ten points of action to aid in the successful implementation of this legislation. We urge stakeholders to support these proposals and ensure national provision is sufficient to meet the criteria necessary for compliance, and for the future advancement of molecular radiotherapy within the UK.

Effect of focused protocol on reducing radiation dose for children who require computed tomography for suspected appendicitis.

BACKGROUND: Despite efforts to incorporate ultrasound into the evaluation of children for appendicitis, computed tomography (CT) is often used to aid in its diagnosis. CT scans, however, expose children to a considerable amount of radiation. In 2017, our institution began using a height-based Focused CT protocol for children with suspected appendicitis in need of CT. OBJECTIVE: To compare the radiation dose received by children with suspected appendicitis who underwent a Standard CT of the abdomen and pelvis (CTAP) with that of a Focused CT. METHODS: We conducted a retrospective study of children <18 years who underwent a CT scan for suspected appendicitis (2014-2020). We included all patients whose indication for CT was "appendicitis" or "right lower quadrant pain" and excluded those whose CT scan record lacked a radiation dose report. The effective radiation dose delivered was calculated using the dose-length product from the dose report. We compared the effective dose of those who received a Standard CTAP to those who received a Focused CT. To account for differences in radiation dose over time and by CT scanner, analyses were adjusted for CT dose index volume (CTDIvol) and size-specific dose estimate (SSDE) using quantile regression. RESULTS: A total of 474 patients who underwent CT were included. Prior to CT, 362(76%) had received an ultrasound. In total, 309(65%) patients underwent a Standard CTAP and 165(35%) underwent a Focused CT. The appendix was identified in 259(84%) Standard CTAPs compared to 151(92%) Focused CTs (p = 0.02). Compared to the Standard CTAP, children who received a Focused CT were exposed to a significantly lower effective dose (relative difference: CTDI-adjusted -13%[95% CI:-21,-5]; SSDE-adjusted -14%[95% CI:-24,-3]). CONCLUSIONS: Our height-based Focused CT protocol reduces radiation for children undergoing CT evaluation for suspected appendicitis without sacrificing diagnostic accuracy. Further study is needed to validate these findings at other institutions.

The U.S. Food and Drug Administration's role in improving radiation dose management for medical X-ray imaging devices.

The U.S. Food and Drug Administration (FDA) has been concerned with minimizing the unnecessary radiation exposure of people for half a century. Manufacturers of medical X-ray imaging devices are important partners in this effort. Medical X-ray imaging devices are regulated by FDA under both its electronic product regulations andits medical device regulations. FDA also publishes guidance documents that represent FDA's current thinking on a topic and provide a suggested or recommended approach to meet the requirements of a regulation or statute. FDA encourages manufacturers to develop medical devices that conform to voluntary consensus standards. Use of these standards is a central element of FDA's system to ensure that all medical devices marketed in the U.S. meet safety and effectiveness requirements. FDA staff participate actively in the development and maintenance of these standards, often advancing or introducing new safety and dose management requirements. Use of voluntary consensus standards reduces the amount of time necessary to evaluate a premarket submission and reduces the burden on manufacturers. FDA interacts with industry and other stakeholders through meetings with industry groups, public meetings, public communications, and through the development of voluntary consensus standards. In these interactions, FDA staff introduce new concepts for improving the safety of these devices and provide support for similar initiatives from professional organizations. FDA works with all stakeholders to achieve its mission of protecting and promoting the public health.