Results for “device” — Page 14

NASA NTRS2004

Novel Biomedical Device Utilizing Light-Emitting Nanostructures Developed

Sketches and chemical diagrams of state-of-the-art device and novel proposed device are presented. Current device uses a diode laser that emits into a fluorescent fluid only one wavelength and a photodetector diode that detects only one wavelength. Only one type of bacteria can be detected. The proposed device uses a quantum dot array that emits into a fluorescent fluid multiple wavelengths and an NIR 512 spectrometer that scans 0.8- to 1.7-mm wavelengths. Hundreds of different bacteria and viruses can be detected. A novel biomedical device is being developed at the NASA Glenn Research Center in cooperation with the University of Michigan. This device uses nano-structured quantum dots that emit light in the near-infrared (IR) region. The nanostructured quantum dots are used as a source and excite fluorochrome polymers coupled with antibodies that seek out and attach to specific bacteria and viruses. The fluorochrome polymers/antibodies fluoresce at specific wavelengths in the near-IR spectrum, but these wavelengths are offset from the excitation wavelength and can be detected with a tunable spectrometer. The device will be used to detect the presence of viruses and bacteria in simple fluids and eventually in more complex fluids, such as blood. Current state-of-the-art devices are limited to single bacteria or virus detection and a considerable amount of time and effort is required to prepare samples for analysis. Most importantly, the devices are quite large and cumbersome, which prohibits them from being used on the International Space Station and the space shuttles. This novel device uses nanostructured quantum dots which, through molecular beam epitaxy and highly selective annealing processes, can be developed into an illumination source that could potentially generate hundreds of specific wavelengths. As a result, this device will be able to excite hundreds of antibody/fluorochrome polymer combinations, which in turn could be used to detect hundreds of bacteria and viruses in fluids. A novel sample preparation technique that exploits micromembrane filtration and centrifugation methods has been developed for this device. The technique greatly reduces the time required to prepare the sample and the amount of sample needed to perform an accurate and comprehensive analysis. Last, and probably most important, because of the nano-light-emitting source and the novel sample preparation technique, the overall size of the device could be reduced dramatically. This device will serve as a nanoscale lab-on-a-chip for in situ microorganism detection and will enable tests to be performed on a time scale of minutes rather than days. Thus, it is ideally suited for monitoring the environmental conditions onboard the International Space Station and the space shuttles, thereby enhancing the safety of the astronauts. In addition, the device has important commercial applications, such as detecting the presence of bacteria and viruses in water at food- and beverage-processing centers, water treatment plants, and restaurants. Also, this technology has the potential to be used to detect bacteria and viruses in more complex fluids, such as blood--which in all likelihood would revolutionize blood analysis as it is performed today. This project was made possible through the Director's Discretionary Fund and is ongoing. In addition, this project provides funding to Dr. Rachel Goldman of the University of Michigan for the research and development of nanostructured quantum dots.

Scardelletti, Maximilian C.↗

NASA NTRS2022

Turning Limitations into Opportunities in the Development of the Orion Medical System: Incorporation of mHealth Devices

INTRODUCTION: Selection of medical devices for the Orion medical system is a complex task which is dependent on the current state of terrestrial technology. In this work we review the interplay between NASA requirements, constraints, and opportunities for synergy during the development of the Orion medical system. METHODS: The “plan to treat” list of conditions, and subsequently the medical resource list for the Orion Artemis II lunar flyby mission was completed using semi-quantitative methods. During this process, some medical resources were excluded to comply with mass and volume limits, while other resources applicable to multiple medical requirements were prioritized for inclusion. Choices were also examined considering NASA level of care standards for the Artemis design reference missions. As a means to optimize capabilities in spite of mass and volume constraints, ideas for integration of multiple devices into a single platform were explored, including a ‘hackathon’ challenge which was conducted to generate and evaluate concepts for combining medical devices into a single app-based mobile device (ultrasound, ECG, etc.). RESULTS: The Orion team identified 128 medical conditions that we “plan to treat”, with 139 unique medical resources to address these conditions, including 5 digital diagnostic devices (ECG, otoscope, stethoscope, pulse oximeter, and blood pressure monitor). During selection of these digital devices the team noted that miniaturized medical devices often use mobile device platforms (mHealth), some displaying and transmitting data exclusively via mobile device. Of the 5 initially selected devices, all are capable of mobile connection, one which cannot function without a mobile device (ECG). Furthermore, only one of these devices connects natively to a Windows platform, which is currently the only operating system available on Orion. DISCUSSION: Significant savings in mass and volume as well as training and usability improvements can be achieved by leveraging mHealth technologies. However, the platform presents significant challenges for deployment within the Artemis Program including lack of internet connectivity, incompatible operating systems, and radiation concerns. Each of these drawbacks are surmountable with investment in the supporting vehicle architecture, which may become necessary to support the technology trends seen in commercially available medical devices today. Objective: Learn about the opportunities and challenges of leveraging mHealth devices in the development of medical capabilities for austere environments. Learn about the constraints of the NASA spaceflight environment with regards to digital medical device integration.

Douglas Ebert↗

DOE OSTI2017

Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015

Purpose: To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non–radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Methods and Materials: Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), 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 Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001). Conclusions: Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

NASA NTRS2004

Buffer Layer Effects on Tandem InGaAs TPV Devices

Single junction indium gallium arsenide (InGaAs) based TPV devices have demonstrated efficiencies in excess of 20% at radiator temperatures of 1058 C. Modeling suggests that efficiency improvements in single bandgap devices should continue although they will eventually plateau. One approach for extending efficiencies beyond the single bandgap limit is to follow the technique taken in the solar cell field, namely tandem TPV cells. Tandem photovoltaic devices are traditionally composed of cells of decreasing bandgap, connected electrically and optically in series. The incident light impinges upon the highest bandgap first. This device acts as a sieve, absorbing the high-energy photons, while allowing the remainder to pass through to the underlying cell(s), and so on. Tandem devices reduce the energy lost to overexcitation as well as reducing the current density (Jsc). Reduced Jsc results in lower resistive losses and enables the use of thinner and lower doped lateral current conducting layers as well as a higher pitch grid design. Fabricating TPV tandem devices utilizing InGaAs for all of the component cells in a two cell tandem necessitates the inclusion of a buffer layer in-between the high bandgap device (In0.53 Ga0.47As - 0.74eV) and the low bandgap device (In0.66Ga0.34As - 0.63eV) to accommodate the approximately 1% lattice strain generated due to the change in InGaAs composition. To incorporate only a single buffer layer structure, we have investigated the use of the indium phosphide (InP) substrate as a superstrate. Thus the high-bandgap, lattice- matched device is deposited first, followed by the buffer structure and the low-bandgap cell. The near perfect transparency of the high bandgap (1.35eV) iron-doped InP permits the device to be oriented such that the light enters through the substrate. In this paper we examine the impact of the buffer layer on the underlying lattice-matched InGaAs device. 0.74eV InGaAs devices were produced in a variety of configurations both with and without buffer layers. All structures were characterized by reciprocal space x-ray diffraction to determine epilayer composition and residual strain. Electrical characterization of the devices was performed to examine the effect of the buffer on the device performance. The effect of the buffer structure depends upon where it is positioned. When near the emitter region, a 2.6x increase in dark current was measured, whereas no change in dark current was observed when it was near the base region.

Wilt, David M.↗

DOE OSTI2016

Radiation dermatitis caused by a bolus effect from an abdominal compression device

American Association of Physicists in Medicine (AAPM) Task Group 176 evaluated the dosimetric effects caused by couch tops and immobilization devices. The report analyzed the extensive physics-based literature on couch tops, stereotactic body radiation therapy (SBRT) frames, and body immobilization bags, while noting the scarcity of clinical reports of skin toxicity because of external devices. Here, we present a clinical case report of grade 1 abdominal skin toxicity owing to an abdominal compression device. We discuss the dosimetric implications of the utilized treatment plan as well as post hoc alternative plans and quantify differences in attenuation and skin dose/build-up between the device, a lower-density alternative device, and an open field. The description of the case includes a 66-year-old male with HER2 amplified poorly differentiated distal esophageal adenocarcinoma treated with neoadjuvant chemo-radiation and the use of an abdominal compression device. Radiation was delivered using volumetric modulated arc therapy (VMAT) with 2 arcs using abdominal compression and image guidance. The total dose was 50.4 Gy delivered over 40 elapsed days. With 2 fractions remaining, the patient developed dermatitis in the area of the compression device. The original treatment plan did not include a contour of the device. Alternative post hoc treatment plans were generated, one to contour the device and a second with anterior avoidance. In conclusion, replanning with the device contoured revealed the bolus effect. The skin dose increased from 27 to 36 Gy. planned target volume (PTV) coverage at 45 Gy was reduced to 76.5% from 95.8%. The second VMAT treatment plan with an anterior avoidance sector and more oblique beam angles maintained PTV coverage and spared the anterior wall, however at the expense of substantially increased dose to lung. This case report provides an important reminder of the bolus effect from external devices such as abdominal compression. Special consideration must be given to contour and/or avoiding beam entrance to the device, and to the use of such devices in patients who may have heightened radiosensitivity, such as those who are human immunodeficiency virus (HIV)–positive.

61 RADIATION PROTECTION AND DOSIMETRY↗

NASA NTRS2007

Determining Desirable Cursor Control Device Characteristics for NASA Exploration Missions

The Crew Exploration Vehicle (CEV) that will travel to the moon and Mars, and all future Exploration vehicles and habitats will be highly computerized, necessitating an accurate method of interaction with the computers. The design of a cursor control device will have to take into consideration g-forces, vibration, gloved operations, and the specific types of tasks to be performed. The study described here is being undertaken to begin identifying characteristics of cursor control devices that will work well for the unique Exploration mission environments. The objective of the study is not to identify a particular device, but to begin identifying design characteristics that are usable and desirable for space missions. Most cursor control devices have strengths and weaknesses; they are more appropriate for some tasks and less suitable for others. The purpose of this study is to collect some initial usability data on a large number of commercially available and proprietary cursor control devices. A software test battery was developed for this purpose. Once data has been collected using these low-level, basic point/click/drag tasks, higher fidelity, scenario-driven evaluations will be conducted with a reduced set of devices. The standard tasks used for testing cursor control devices are based on a model of human movement known as Fitts law. Fitts law predicts that the time to acquire a target is logarithmically related to the distance over the target size. To gather data for analysis with this law, fundamental, low-level tasks are used such as dragging or pointing at various targets of different sizes from various distances. The first four core tasks for the study were based on the ISO 9241-9:(2000) document from the International Organization for Standardization that contains the requirements for non-keyboard input devices. These include two pointing tasks, one dragging and one tracking task. The fifth task from ISO 9241-9, the circular tracking task was not used because it is a movement that is not applicable to most of the applications used on aviation displays. Additionally, we opted to add a multi-size and multi-distance pointing task, and two ecologically more valid tasks which included text selection, and interaction with drop down menus, sliders, and checkboxes. The Visual Basic test battery tracks the task and trial numbers, measures the pointing, tracking or dragging time, as well as the number and types of errors. The testing session includes a practice set for each input device, then the randomized 7 tasks, and finally a questionnaire about the device. This is repeated for all the devices tested within a session. The experiment is a within-subjects design, with participants returning for multiple sessions to test additional devices. The input devices will be compared based on objective performance data from the tasks, as well as subjective feedback and ratings on the questionnaire.

Aniko Sandor↗

NASA NTRS2005

Thermoelectric Air/Soil Energy-Harvesting Device

A proposed thermoelectric device would exploit natural temperature differences between air and soil to harvest small amounts of electric energy. Because the air/soil temperature difference fluctuates between nighttime and daytime, it is almost never zero, and so there is almost always some energy available for harvesting. Unlike photovoltaic cells, the proposed device could operate in the absence of sunlight. Unlike a Stirling engine, which could be designed to extract energy from the air/soil temperature difference, the proposed device would contain no moving parts. The main attractive feature of the proposed device would be high reliability. In a typical application, this device would be used for low-power charging of a battery that would, in turn, supply high power at brief, infrequent intervals for operating an instrumentation package containing sensors and communication circuits. The device (see figure) would include a heat exchanger buried in soil and connected to a heat pipe extending up to a short distance above the ground surface. A thermoelectric microgenerator (TEMG) would be mounted on top of the heat pipe. The TEMG could be of an advanced type, now under development, that could maintain high (relative to prior thermoelectric generators) power densities at small temperature differentials. A heat exchanger exposed to the air would be mounted on top of the TEMG. It would not matter whether the air was warmer than the soil or the soil warmer than the air: as long as there was a nonzero temperature difference, heat would flow through the device and electricity would be generated. A study of factors that could affect the design and operation of the device has been performed. These factors include the thermal conductances of the soil, the components of the device, the contacts between the components of the device, and the interfaces between the heat exchangers and their environments. The study included experiments that were performed on a model of the device to demonstrate feasibility. Because a TEMG suitable for this device was not available, a brass dummy component having a known thermal conductance of 1.68 W/K was substituted for the TEMG in the models to enable measurement of heat flows. The model included a water-based heat pipe 30 in. (76.2 cm) long and 1 in. (2.54 cm) in diameter, wrapped with polyethylene insulation to reduce radial heat flow. Several different side heat exchangers were tested. On the basis of the measurements, it was predicted that if a prototype of the device were equipped with a TEMG, daily temperature fluctuations would cause its output power to fluctuate between 0 and about 0.1 mW, peaking to 0.35 mW during early afternoon.

Snyder, Jeffrey↗

DOE OSTI2015

Processes for multi-layer devices utilizing layer transfer

A method includes forming a release layer over a donor substrate. A plurality of devices made of a first semiconductor material are formed over the release layer. A first dielectric layer is formed over the plurality of devices such that all exposed surfaces of the plurality of devices are covered by the first dielectric layer. The plurality of devices are chemically attached to a receiving device made of a second semiconductor material different than the first semiconductor material, the receiving device having a receiving substrate attached to a surface of the receiving device opposite the plurality of devices. The release layer is etched to release the donor substrate from the plurality of devices. A second dielectric layer is applied over the plurality of devices and the receiving device to mechanically attach the plurality of devices to the receiving device.

42 ENGINEERING↗

DOE OSTI2016

Estimating the probability of fish encountering a marine hydrokinetic device

We report strong tidal currents in eastern Maine, USA, make that region attractive for tidal power development. We know very little about the effects of marine hydrokinetic (MHK) devices on fish, yet many fish species use tidal currents for movements. We used empirical data from stationary and mobile hydroacoustic surveys to examine the probability that fish would be at the depth of an MHK device and may therefore encounter it. The probability was estimated using three components: 1) probability of fish being at device-depth when the device was absent; 2) probability of fish behavior changing to avoid the device in the far-field; and 3) probability of fish being at device-depth in the near-field when the device was present. Furthermore, there were differences in probabilities of fish encountering the MHK device based on month, diel condition and tidal stage. The maximum probability of fish encountering the whole device was 0.432 (95% CI: [0.305, 0.553]), and the probability of fish encountering only device foils was 0.058 (95% CI: [0.043, 0.073]). Mobile hydroacoustics indicated that fish likely avoided the device with horizontal movement beginning 140 m away. Finally, we estimated the encounter probability for one device, but results can be applied to arrays, which may have bay-wide implications.

16 TIDAL AND WAVE POWER↗

DOE OSTI2019

Comparison of Radiation Effects in Custom-and Commercially-Fabricated Resistive Memory Devices

The radiation response of TaO x -based RRAM devices fabricated in academic (Set A) and industrial (Set B) settings was compared. Ionization damage from a 60 Co gamma source did not cause any changes in device resistance for either device type, up to 45 Mrad(Si). Displacement damage from a heavy ion beam caused the Set B in the high resistance state to decrease in resistance at 1 x 10 21 oxygen displacements per cm 3 ; meanwhile, the Set A devices did not exhibit any decrease in resistance due to displacement damage. Both types of devices exhibited an increase in resistance around 3 x 10 22 oxygen displacements per cm 3 , possibly due to damage at the oxide/metal interfaces. These extremely high levels of damage represent near-total atomic disruption, and if this level of damage were ever reached, other circuit elements would likely fail before the RRAM devices in this study. Overall, both sets of devices were much more resistant to radiation effects than other devices reported in the literature. Displacement damage effects were only observed in the Set A devices once the displacement-induced oxygen vacancies surpassed the intrinsic vacancy concentration in the devices, suggesting that high oxygen vacancy concentration played a role in the devices’ high tolerance to displacement damage.

46 INSTRUMENTATION RELATED TO NUCLEAR SCIENCE AND ↗

DOE OSTI2017

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↗

DOE OSTI2014

Semiconductor-based, large-area, flexible, electronic devices on {110}<100> oriented substrates

Novel articles and methods to fabricate the same resulting in flexible, oriented, semiconductor-based, electronic devices on {110}<100> textured substrates are disclosed. Potential applications of resulting articles are in areas of photovoltaic devices, flat-panel displays, thermophotovoltaic devices, ferroelectric devices, light emitting diode devices, computer hard disc drive devices, magnetoresistance based devices, photoluminescence based devices, non-volatile memory devices, dielectric devices, thermoelectric devices and quantum dot laser devices.

36 MATERIALS SCIENCE↗

DOE OSTI2015

[100] or [110] aligned, semiconductor-based, large-area, flexible, electronic devices

Novel articles and methods to fabricate the same resulting in flexible, large-area, [100] or [110] textured, semiconductor-based, electronic devices are disclosed. Potential applications of resulting articles are in areas of photovoltaic devices, flat-panel displays, thermophotovoltaic devices, ferroelectric devices, light emitting diode devices, computer hard disc drive devices, magnetoresistance based devices, photoluminescence based devices, non-volatile memory devices, dielectric devices, thermoelectric devices and quantum dot laser devices.

46 INSTRUMENTATION RELATED TO NUCLEAR SCIENCE AND ↗

DOE OSTI2016

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.

60 APPLIED LIFE SCIENCES↗

DOE OSTI2016

TU-AB-204-01: Device Approval Process

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.

60 APPLIED LIFE SCIENCES↗

DOE OSTI2016

TU-AB-204-02: Device Adverse Events and Compliance

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.

60 APPLIED LIFE SCIENCES↗

DOE OSTI2022

Software Development for Data Visualization and Analysis of PN-Diodes & MOSFET Devices

The U.S. Department of Energy has a broad mission to ensure the nation’s security by addressing ongoing environmental challenges, developing novel energy production technologies, and mitigating nuclear security concerns. These efforts benefit from developing more effective semiconductor materials and devices. The research discussed in this report aims to further the development of these new electronics by improving implementations of vertical device structures, which offer theoretically better performance compared to lateral structures. Specifically, it reviews the background and development of a new and easy-to-use program for data processing and analysis from experiments run on vertical gallium nitride power devices. Current vertical structures fall short in critical performance metrics, such as On-Resistance and Breakdown Voltage, due to poor management of the device’s electric field. Junction termination extensions, or JTEs, are a field management technique that increases a device’s resilience to expected failure modes by controlling its surface electric fields. Each JTE design requires significant experimental validation, consisting of hundreds of tested devices, each outputting an enormous set of data points. The new software includes multiple methods of filtering large sets of device testing data to identify and remove flawed devices, automate device analyses, and provide statistical breakdowns for four metrics used to define the effectiveness of the JTE and the current carrying capacity of the device. These results can then be related back to fabrication techniques and device design, and in the future, be combined with processing simulations to further improve our understanding of the JTE mechanisms.

97 MATHEMATICS AND COMPUTING↗

DOE OSTI2022

Countering Weapons of Mass Destruction (CWMD) Device Cybersecurity Characterization Process and Profile

Countering Weapons of Mass Destruction (CWMD) recognizes that threats in the cyberspace domain continue to grow, which requires CWMD devices and supporting systems to be both cybersecure (ability to protect or defend from cyber-attacks) and resilient (ability to maintain required capability in the face of adversity) to cyber threats. The CWMD cybersecurity characterization approach in this document supports existing cyber resilience activities within the Acquisition Lifecycle Framework. Similarly, this process supports existing Department of Homeland Security Cyber Resilience Test and Evaluation activities, which consist of iterative processes, starting at the initiation of system acquisition and continuing throughout the entire device and system life cycle. Cyber resilience is the ability of an information system to continue to operate while under attack, even if in a degraded or debilitated state, and to rapidly recover operational capabilities for essential functions after a successful attack. The goal of the security characterization task for CWMD is to support the development of a CBRN device-dependent profile that aligns with device network capabilities and maps to recommended security controls to create a characterization security profile impact levels. The impact levels for CWMD devices should be characterized as Low (L), Moderate (M), High (H) to align with the low, moderate, high control baselines. To estimate the impact levels, the device’s security-related attributes are translated into the security objectives: Confidentiality (C), Integrity (I), and Availability (A), known as the CIA triad. The potential impact for each device can be L, M, H, for devices that connect and transmit different types of data and may have different impact levels. National Institute of Standards and Technology Federal Information Processing Standards Publication 199 states, “the potential impact values assigned to the respective security objectives shall be the highest value from among those security categories that have been determined for each type of information resident on the information system.” As CWMD is determining the cybersecurity impact levels of CBRN devices based on network connections and data transfers, the impact levels are aligned with the associated attributes of network connections and communications. For example, if the device system is connected to a wireless network and transmits different data types based on the confidentiality of the data, the highest impact value for each security objective should represent the device’s CIA impact level. This document is intended to be used by test managers, test team, and program managers.

45 MILITARY TECHNOLOGY, WEAPONRY, AND NATIONAL DEF↗