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At least 379 records · Page 21

Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015

Purpose: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non–radiation oncology devices. Methods and Materials: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact). Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001). Conclusions: Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance, improved software design, and manufacturer–user training may help mitigate these events.

07 ISOTOPE AND RADIATION SOURCES↗

Evaluation of the NSUF Reactor Activation and Damage (RAD) Calculator damage component

The Nuclear Science User Facilities (NSUF) provide researchers access to nuclear research facilities and expertise all over the United States and at the Belgian Center for Nuclear Research (SCK/CEN). One special capability of the NSUF is providing access to nuclear research and test reactors often used for conducting material testing experiments. These services are provided at no cost to the researcher through a competitive, peer-reviewed process. With so many proposals being submitted simultaneously, an NSUF information management resource called the Combined Materials Experiment Toolkit (CoMET) was implemented to speed up the review process and give users access to the information and tools necessary for designing meaningful experiments and writing the best proposals possible. One of CoMET’s tools is the Reactor Activation and Damage (RAD) Calculator. For those with little or no background in it, neutron irradiation in research and test reactors can be a challenging subject to include in a proposal. That is why the RAD Calculator was created to assist users with providing estimates of irradiation and post-irradiation conditions, enabling them to select the best neutron irradiation and post-irradiation examination facilities for reaching their experiment goals. The RAD Calculator is a general scoping tool that estimates radiation damage in terms of DPA, in addition to the resulting radioactivity of the material post-irradiation. This report evaluates the neutron damage component of the RAD Calculator. The evaluation of the activation component of the calculator is covered in report INL/EXT-20-58080.

22 GENERAL STUDIES OF NUCLEAR REACTORS↗

BASD: SIRTF Telescope Instrument Changeout and Cryogen Replenishment (STICCR) study

The Space Infrared Telescope Facility (SIRTF) is a long-life cryogenically cooled space-based telescope for infrared astronomy from 2 micrometer to 700 miocrometers currently under study by NASA-ARC, and planned for launch in approximately the mid 90's. SIRTF will operate as a multi-user facility, initially carrying 3 instruments at the focal plane. It will be cooled to below 2 K by superfluid liquid helium to achieve radiometric sensitivity limited only by the statistical fluctuations in the natural infrared background radiation over most of its spectral range. The lifetime of the mission will be limited by the lifetime of the liquid helium supply, and is currently baselined to be 2 years. The telescope changes required to allow in-space replenishment of the 2,000 liter superfluid helium tank are investigated. A preliminary design for the space services equipment is also developed. The impacts of basing the equipment and servicing on the space station are investigated. Space replenishment and changeout of instruments requires changes to the telescope design and preliminary concepts are presented.

Mord, A. J.↗

Assembly of MiniFuel Targets for Irradiation of TRISO Fuel Compacts in the High Flux Isotope Reactor

To support the development of Kairos Power’s fluoride-salt-cooled high-temperature reactor, irradiation testing of tristructural isotropic (TRISO) fuel compacts was performed at the Oak Ridge National Laboratory (ORNL) High Flux Isotope Reactor (HFIR) to collect experimental data on TRISO fuel during high particle-power operation and validate fuel performance models. Fuel compacts containing enriched uranium oxycarbide (UCO), natural UCO (NUCO), or uranium dioxide (UO 2 ) TRISO particles were fabricated at ORNL and inserted into MiniFuel targets for HFIR irradiation. Five MiniFuel targets were successfully assembled, welded, tested, and delivered to HFIR, along with their quality assurance documentation. The targets were inserted into HFIR’s inner vertical experiment facility within the permanent beryllium reflector. Each target contains six fuel compacts and will be irradiated in HFIR for four cycles, with target temperatures of 500, 700, and 900°C. This report summarizes the experiment design, test matrix, and fabrication. This work was performed under the Nuclear Science User Facility program.

11 NUCLEAR FUEL CYCLE AND FUEL MATERIALS↗

Nuclear & Materials Science Research at LANSCE [Slides]

The nuclear and materials science research capabilities at LANSCE are operated as a DOE-designated user facility in service to the nation. We provide neutron and proton beams as well as instrumentation and sample environments for basic, applied, industry, and defense-related research in nuclear physics and materials science. A yearly call invites proposals for beam time for experiments from other national laboratories, academia, and industry users. Proprietary and nonproprietary industry projects are considered for beam time.

36 MATERIALS SCIENCE↗

Overview of the Microgravity Science Glovebox (MSG)

MSG is a third generation glovebox for Microgravity Science investigations: SpaceLab Glovebox (GBX); Middeck/MIR Gloveboxes (M/MGBX); and GBX and M/MGBX developed by Bradford Engineering (NL). Previous flights have demonstrated utility of glovebox facilities: Contained environment enables broader range of science experiments; Affords better control of video and photographic imaging (a prime data source); Provides better environmental control than cabin atmosphere; and Useful for contingency operations. MSG developed in response to demands for increased work volume, increased capabilities and additional resources. MSG is multi-user facility to support a wide range of small science and technology investigations: Fluid physics; Combustion science; Material science; Biotechnology (cell culturing and protein crystal growth); Space processing; Fundamental physics; and Technology demonstrations. Topics included in this viewgraph are: MSG capabilities; MSG hardware items; MSG, GSE, and OSE items; MSG development approach; and Science utilization.

Wright, Mary Etta↗

X-rays put molecules into a spin

The past decade has witnessed the emergence of a new X-ray light source technology that has been under development for some decades: the so-called self-amplified spontaneous emission-based free-electron laser (FEL). Furthermore, such lasers provide pulses with durations from just below 1 fs (10 –15 s) to over 100 fs and with energies from a few microjoules to a few millijoules, permitting the study of, for example, nonlinear optical effects (1), ultrafast processes (2), coherent diffractive imaging of biological systems such as protein crystals (3, 4), and mimivirus (5). After the opening of the first extreme-UV to soft X-ray user facility, namely FLASH in the Deutsches Elektronen-Synchrotron at Hamburg, Germany (6), a number of other machines covering the extreme-UV (FERMI FEL-1, DALIAN), soft X-ray (FERMI FEL-2, FLASH1/FLASH2), and hard X-ray spectral ranges (LCLS, PAL-XFEL, SACLA, and XFEL) have been opened to users from a wide range of scientific and engineering disciplines.

74 ATOMIC AND MOLECULAR PHYSICS↗

ARM Aerosol Measurement Science Group 2019 Strategic Planning Workshop Report

This report summarizes the results of a U.S. Department of Energy Atmospheric Radiation Measurement (ARM) user facility workshop held in November 2019 to advance a science-based strategy for ARM’s aerosol measurement program. This was the second such workshop since the Aerosol Measurement Science Group (AMSG) was chartered in 2015 to enhance coordination of ARM observations of aerosols and atmospheric trace gases with the needs of ARM users. The results presented here reflect the AMSG’s focus in recent years on science-based strategies that will contribute to the increased use of ARM data to fulfill its mission of improving process representations and predictability in climate models. Sessions held during the workshop range from interfacing with models through aerosol sampling strategies to calibration protocols and data products. The strategies set forth here were also developed to be directly relevant to ARM’s updated Decadal Vision. The AMSG workshops have been designed to recommend actions that will enable ARM to evolve and continue to meet its mission. To that end, the AMSG will develop an actionable plan from the recommendations outlined here. Some are well defined and can reasonably be accomplished in the short term. Others are less definite or of a larger scope that calls for a longer-term implementation. Further discussion will be required to develop and prioritize actionable items related to such areas. Task teams comprising the appropriate expertise and perspective from the AMSG and other members of the community will be formed to achieve this outcome. Some particular topics are recognized as high priority, so plans are underway to develop task teams and to hold follow-on discussions to address them. Four areas currently being considered for short, focused discussion are 1) aerosol measurements on the North Slope of Alaska, 2) improving data usability for modeling, 3) strategies for advancing remote sensing, vertical profiling, and distributed measurements of aerosols, and 4) aerosol sampling strategies at existing ARM sites to provide intensive modes of operation to promote data usage for process and modeling studies.

54 ENVIRONMENTAL SCIENCES↗

ARM Aerosol Measurement Science Group 2019 Strategic Planning Workshop Report

This report summarizes the results of a U.S. Department of Energy Atmospheric Radiation Measurement (ARM) user facility workshop held in November 2019 to advance a science-based strategy for ARM’s aerosol measurement program. This was the second such workshop since the Aerosol Measurement Science Group (AMSG) was chartered in 2015 to enhance coordination of ARM observations of aerosols and atmospheric trace gases with the needs of ARM users. The results presented here reflect the AMSG’s focus in recent years on science-based strategies that will contribute to the increased use of ARM data to fulfill its mission of improving process representations and predictability in climate models. Sessions held during the workshop range from interfacing with models through aerosol sampling strategies to calibration protocols and data products. The AMSG workshops have been designed to recommend actions that will enable ARM to evolve and continue to meet its mission. To that end, the AMSG will develop an actionable plan from the recommendations outlined here. Some are well defined and can reasonably be accomplished in the short term. Others are less definite or of a larger scope that calls for a longer-term implementation. Further discussion will be required to develop and prioritize actionable items related to such areas. Task teams comprising the appropriate expertise and perspective from the AMSG and other members of the community will be formed to achieve this outcome. Some particular topics are recognized as high priority, so plans are underway to develop task teams and to hold follow-on discussions to address them. Four areas currently being considered for short, focused discussion are 1) aerosol measurements on the North Slope of Alaska, 2) improving data usability for modeling, 3) strategies for advancing remote sensing, vertical profiling, and distributed measurements of aerosols, and 4) aerosol sampling strategies at existing ARM sites to provide intensive modes of operation to promote data usage for process and modeling studies.

54 ENVIRONMENTAL SCIENCES↗

2023 Atmospheric Radiation Measurement (ARM) (Annual Report)

For more than 30 years, the Atmospheric Radiation Measurement (ARM) user facility, which is managed by the U.S. Department of Energy (DOE) Office of Science, has provided freely available data and resources to scientists worldwide. Providing these services effectively requires getting out in the field and engaging with the science community. With COVID travel restrictions behind us, we are focused on connecting in person with ARM users, establishing new partnerships, and supporting fieldwork that might have waited during the pandemic.

54 ENVIRONMENTAL SCIENCES↗

How Data Becomes Physics: Inside the RACF

The RHIC & ATLAS Computing Facility (RACF) at the U.S. Department of Energy’s (DOE) Brookhaven National Laboratory sits at the center of a global computing network. It connects more than 2,500 researchers around the world with the data generated by millions of particle collisions taking place each second at Brookhaven Lab's Relativistic Heavy Ion Collider (RHIC, a DOE Office of Science User Facility for nuclear physics research), and the ATLAS experiment at the Large Hadron Collider in Europe. Watch this video to learn how the people and computing resources of the RACF serve these scientists to turn petabytes of raw data into physics discoveries.

71 CLASSICAL AND QUANTUM MECHANICS, GENERAL PHYSIC↗

Development of a Tender-Energy Microprobe for Geosciences at NSLS and NSLS-II

This funding is to develop a new Synchrotron user facility for microbeam X-ray absorption spectroscopy (XAS) and quantitative X-ray fluorescence (XRF) imaging, at the National Synchrotron Light Source (NSLS) and NSLS-II. It includes design, purchase of components, and construction of the microprobe endstation and controls. Initial development, commissioning, and application is ongoing at NSLS Beamline X15B, with planned transition in 2014-15 to the NSLS-II TES (Tender-Energy Spatially Resolved X-ray Absorption Spectroscopy) beamline. It is optimized for the “tender” energy range of 1-5 keV, reaching up to 8 keV. Thus it uniquely covers the K absorption edges of critical elements Mg, Al, Si, P, S, Cl, and Ca, and can reach up to Co. A stable, high-flux microbeam focus, user-tunable from ~50 to ~5 microns, has been achieved using two-stage achromatic focusing. Existing beamline optics collimate, monochromate, and macro-focus the X-ray beam to ~1 mm at a secondary source aperture (SSA). Beam from the SSA is then re-focused by a pair of mirrors in KB geometry to the microbeam scale. Size of the microbeam is tunable, at the expense of flux, by adjusting the size of the SSA as a virtual source. The new experimental endstation consists of 1) a sample chamber operable as a radiation enclosure with helium atmosphere to facilitate measurements in this energy range, 2) the KB microfocusing optics, 3) a sample-positioning stage for raster-scanning and positioning the sample, 4) X-ray fluorescence detectors, an existing Ge detector for low-signal sensitivity and a new Si detector for high count rates, 5) an optical camera for viewing samples and locating target locations, 6) beam intensity monitors and diagnostics, and 7) controls and data acquisition system. An important aspect of this project is the added capability for fast, on-the-fly scanning of the monochromator (energy), required for fast XAS and advanced XAS imaging. This instrument will be available for initial PI and Co-I measurements, and for General Users to apply for beamtime to use, at NSLS X15B for the remaining operation of NSLS, to September 30, 2014. Phase two of this project will transition this facility, both the primary optics and the endstation, to NSLS-II after NSLS ceases operation. While this transition itself is beyond the scope of the current grant, preparation and planning for it is included.

58 GEOSCIENCES↗

Eastern North Atlantic (ENA) Aerosol Supplementary Site (S1) Data Analysis Report

We present strategies to identify time periods when local aerosol sources impact the data collected at the U.S. Department of Energy (DOE) Atmospheric Radiation Measurement (ARM) user facility in the Eastern North Atlantic (ENA). Data from the aerosol observing system (AOS) at the Central Facility and a temporary aerosol Supplementary Site (S1) were evaluated. S1 instrumentation was deployed within 0.75 km of the ENA Central Facility (C1) for approximately one year. Two time periods, one during the summer and one during the winter, were examined in support of the Aerosol and Cloud Experiments in the Eastern North Atlantic (ACE-ENA) intensive operating periods (IOPs) in 2017 and 2018. As the criteria for identifying regionally representative data varies based on the specific needs of the user, we present and discuss different strategies using measured aerosol properties and their associated meteorological parameters to isolate periods in AOS data that were impacted by local aerosol at ENA. We identify high-concentration aerosol events at ENA using submicron number concentrations, size distributions, high-time-resolution measurements, and diurnal profiles. An improved understanding of local aerosol to select the optimal aerosol mask was obtained with an understanding of local meteorology during the different seasons. We developed a mathematical algorithm that employs AOS data to mask high-concentration aerosol events at ENA. We validated the ENA Aerosol Mask with aerosol data from C1 and S1 and associated meteorological data. The Supplementary Site was ideal to understand and constrain local aerosol sources within the region. In its absence, collocated data from the ENA AOS could be used to select appropriate parameters to develop an aerosol mask that would limit over- or underestimating the regional baseline aerosol data. When available, associated metadata, such as airport flight logs and visual identification with AOS cameras should also be used to validate the application of an aerosol mask at a new site. Our results confirm the importance of optimizing an aerosol mask prior its application. In the future, the application of an aerosol mask at ARM observatories and during mobile deployments could be used to increase the data quality of continuous AOS data and to reduce uncertainties when parameterizing regional aerosol processes and impacts on clouds for incorporation in models.

54 ENVIRONMENTAL SCIENCES↗

D-Side: A Facility and Workforce Planning Group Multi-criteria Decision Support System for Johnson Space Center

"To understand and protect our home planet, to explore the universe and search for life, and to inspire the next generation of explorers" is NASA's mission. The Systems Management Office at Johnson Space Center (JSC) is searching for methods to effectively manage the Center's resources to meet NASA's mission. D-Side is a group multi-criteria decision support system (GMDSS) developed to support facility decisions at JSC. D-Side uses a series of sequential and structured processes to plot facilities in a three-dimensional (3-D) graph on the basis of each facility alignment with NASA's mission and goals, the extent to which other facilities are dependent on the facility, and the dollar value of capital investments that have been postponed at the facility relative to the facility replacement value. A similarity factor rank orders facilities based on their Euclidean distance from Ideal and Nadir points. These similarity factors are then used to allocate capital improvement resources across facilities. We also present a parallel model that can be used to support decisions concerning allocation of human resources investments across workforce units. Finally, we present results from a pilot study where 12 experienced facility managers from NASA used D-Side and the organization's current approach to rank order and allocate funds for capital improvement across 20 facilities. Users evaluated D-Side favorably in terms of ease of use, the quality of the decision-making process, decision quality, and overall value-added. Their evaluations of D-Side were significantly more favorable than their evaluations of the current approach. Keywords: NASA, Multi-Criteria Decision Making, Decision Support System, AHP, Euclidean Distance, 3-D Modeling, Facility Planning, Workforce Planning.

Tavana, Madjid↗

The FRIB Decay Station: New Horizons with Rare Isotopes

In May 2022, the Facility for Rare Isotope Beams (FRIB), located on the campus of Michigan State University (MSU), began delivering exotic isotopes to an international community of scientists. New discoveries are now being reported from radioactive decay of neutron-rich nuclei near N = 20 and N = 28.FRIB is expected to produce roughly 80% of the unstable or radioactive isotopes predicted to exist up to uranium (Z = 92). The new user facility is supported by the U.S. Department of Energy, and it is operated by MSU. A high-power superconducting linear accelerator, shaped like a paper-clip, drives the production of these rare isotopes by colliding stable nuclei moving at half the speed of light with a rotating, water-cooled graphite tar-get. These collisions cause the primary stable beam to fragment into a wide variety of unstable nuclei, which can be subsequently filtered through a multistage magnetic separator, the Advanced Rare Isotope Separator, and transported to one of several experimental stations. The FRIB Decay Station initiator (FDSi) (see Figure 1) was developed to enable comprehensive radio-active decay studies of the exotic nuclei produced by FRIB and it was used in the first two experiments in 2022. Further, the FDSi is a highly reconfigurable multidetector system with two focal planes (FP1 for discrete spectroscopy and FP2 for total absorption spectroscopy) that can be optimized for the specific science goals of each experiment. It is designed, built, and operated by a community of users with the sup-port of U.S. funding agencies, including the Department of Energy and National Science Foundation.

07 ISOTOPE AND RADIATION SOURCES↗

2021 Annual Report: Atmospheric Radiation Measurement

In fiscal year 2021 (FY2021), the COVID-19 pandemic continued to have an impact on activities within the Atmospheric Radiation Measurement (ARM) user facility. Travel was limited, which affected field activities and forced the continuation of virtual meetings. However, the ability to travel expanded significantly through the year, bringing some return to normalcy, and throughout the year, there was a great deal of activity dedicated to advancing the facility. Because of COVID, ARM twice delayed the TRacking Aerosol Convection interactions ExpeRiment (TRACER) in the Houston, Texas, area. Originally planned to launch in the spring, TRACER started October 1, 2021, one month after the Surface Atmosphere Integrated Field Laboratory (SAIL) campaign began near Crested Butte, Colorado. ARM teams worked onsite and remotely to make sure both campaigns could launch on this new schedule that was set early in the year. Data from SAIL and TRACER will be critical to improving earth system models, each contributing to different sets of issues. SAIL measurements will provide insights into how precipitation forms and water travels through the Upper Colorado River Basin. TRACER scientists want to know whether tiny atmospheric particles can influence the severity of thunderstorms. In October 2020, the Multidisciplinary Drifting Observatory for the Study of Arctic Climate (MOSAiC) expedition ended after 13 months. MOSAiC data from ARM and other organizations are already helping scientists better understand how ice, atmosphere, and ocean systems are connected in the central Arctic. This report discusses some early investigations from MOSAiC, along with other ARM campaigns and activities generating prolific research. In this report, you will also learn how research activities moved forward during the pandemic at ARM’s fixed-location atmospheric observatories. There were important science applications from measurements across the facility. ARM spent a significant amount of FY2021 looking back—and ahead. In November 2020, ARM had its Triennial Review. This review is held every three years to evaluate ARM’s effectiveness in science, operations, and management. Overall, the reviewers had positive feedback regarding the breadth and impact of science activities using ARM data and the way ARM strives to meet changing user needs. The reviewers also provided some recommendations for strengthening ARM going forward. Incorporating feedback from the review, we finalized an updated Decadal Vision document that will help guide ARM priorities in the coming years. This report describes the four themes driving ARM’s Decadal Vision.

54 ENVIRONMENTAL SCIENCES↗

Data Management at the Advanced Photon Source

Data are crucial to the scientific discoveries enabled by experiments performed at the APS. Presently the APS generates approximately 10 PB of raw experimental data per year from its sixty-six operating beamlines that house over 100 unique instruments. This data is generated as a part of over 6,000 annual experiments performed by over 5,500 facility users each year. Similar to other synchrotrons, the amount of data generated at the APS continues to quickly increase due to beamline advances, such as new measurement techniques, technological advances in detectors, high-throughput instrumentation, multi-modal instruments that can acquire several measurements in a single experiment, and advanced data processing algorithms. This trend is expected to continue in the future. The revolutionized high-energy synchrotron facility proposed in the APS-U project will increase brightness and coherence, leading to further increases in data rates. Successful management of data is of vital importance to the current and future scientific productivity of the APS.

96 KNOWLEDGE MANAGEMENT AND PRESERVATION↗

The genome portal of the Department of Energy Joint Genome Institute: 2014 updates

The U.S. Department of Energy (DOE) Joint Genome Institute (JGI), a national user facility, serves the diverse scientific community by providing integrated high-throughput sequencing and computational analysis to enable system-based scientific approaches in support of DOE missions related to clean energy generation and environmental characterization. The JGI Genome Portal (http://genome.jgi.doe.gov) provides unified access to all JGI genomic databases and analytical tools. The JGI maintains extensive data management systems and specialized analytical capabilities to manage and interpret complex genomic data. A user can search, download and explore multiple data sets available for all DOE JGI sequencing projects including their status, assemblies and annotations of sequenced genomes. In this paper, we describe major updates of the Genome Portal in the past 2 years with a specific emphasis on efficient handling of the rapidly growing amount of diverse genomic data accumulated in JGI.

59 BASIC BIOLOGICAL SCIENCES↗