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Hardware Development Process for Human Research Facility Applications

The simple goal of the Human Research Facility (HRF) is to conduct human research experiments on the International Space Station (ISS) astronauts during long-duration missions. This is accomplished by providing integration and operation of the necessary hardware and software capabilities. A typical hardware development flow consists of five stages: functional inputs and requirements definition, market research, design life cycle through hardware delivery, crew training, and mission support. The purpose of this presentation is to guide the audience through the early hardware development process: requirement definition through selecting a development path. Specific HRF equipment is used to illustrate the hardware development paths. The source of hardware requirements is the science community and HRF program. The HRF Science Working Group, consisting of SCientists from various medical disciplines, defined a basic set of equipment with functional requirements. This established the performance requirements of the hardware. HRF program requirements focus on making the hardware safe and operational in a space environment. This includes structural, thermal, human factors, and material requirements. Science and HRF program requirements are defined in a hardware requirements document which includes verification methods. Once the hardware is fabricated, requirements are verified by inspection, test, analysis, or demonstration. All data is compiled and reviewed to certify the hardware for flight. Obviously, the basis for all hardware development activities is requirement definition. Full and complete requirement definition is ideal prior to initiating the hardware development. However, this is generally not the case, but the hardware team typically has functional inputs as a guide. The first step is for engineers to conduct market research based on the functional inputs provided by scientists. CommerCially available products are evaluated against the science requirements as well as modifications needed to meet program requirements. Options are consolidated and the hardware development team reaches a hardware development decision point. Within budget and schedule constraints, the team must decide whether or not to complete the hardware as an in-house, subcontract with vendor, or commercial-off-the-shelf (COTS) development. An in-house development indicates NASA personnel or a contractor builds the hardware at a NASA site. A subcontract development is completed off-site by a commercial company. A COTS item is a vendor product available by ordering a specific part number. The team evaluates the pros and cons of each development path. For example, in-bouse developments utilize existing corporate knowledge regarding bow to build equipment for use in space. However, technical expertise would be required to fully understand the medical equipment capabilities, such as for an ultrasound system. It may require additional time and funding to gain the expertise that commercially exists. The major benefit of subcontracting a hardware development is the product is delivered as an end-item and commercial expertise is utilized. On the other hand, NASA has limited control over schedule delays. The final option of COTS or modified COTS equipment is a compromise between in-house and subcontracts. A vendor product may exist that meets all functional requirements but req uires in-house modifications for successful operation in a space environment. The HRF utilizes equipment developed using all of the paths described: inhouse, subcontract, and modified COTS.

Bauer, Liz↗

Long Duration Medical System Foundation for Lunar Orbital and Lunar Surface Exploration Missions

For long-duration lunar orbital and lunar surface (LDLOS) exploration missions, the NASA Human Research Program (HRP) Exploration Medical Capability (ExMC) Element has developed a medical system foundation through which clinical considerations may be represented via a systems engineering-based model. Components of the Long Duration Medical System Foundation model include a concept of operations (ConOps), functional decomposition, medical conditions to be addressed, clinical capabilities and resources, technical requirements, and traces of requirements to NASA standards documents and parent-level (Program- and Vehicle habitat system-level) requirements. The Foundation model offers the means to present information in a readily accessible format that is understandable across all clinical, engineering, scientific, and managerial disciplines. Collectively, these components constitute a foundation that serves future programs with similar long duration mission profiles as a starting point for medical system design. The Foundation was developed by a multidisciplinary team of systems engineers, scientists, and clinicians across NASA. The process started with ConOps development, subsequently decomposed into the functionalities needed to diagnose, treat, and prevent medical conditions. The clinical team identified medical conditions most likely needed to be diagnosed and treated during a long-duration lunar exploration mission. Through these approaches, requirements were codified for the LDLOS medical system. These requirements were then traced to NASA standards, medical conditions, medical capabilities, and medical resources, facilitating stakeholders’ use of the Foundation model to analyze traces and to identify medical system interfaces with other vehicle systems or subsystems. In addition, the Foundation may be used as a basis for performing risk trades on medical system mass and volume allocation. This discussion will focus on the processes through which the LDLOS Medical System Foundation was developed, how the Foundation builds a bridge between the medical and engineering domains, and how these processes may be applied more broadly to a crew health and performance system and other system domains.

Jay Lemery↗

Developing Mars-Based Clinical Scenarios for an Earth Independent Medical Operations (EIMO) – Based Decision Support Service

As crewed missions move beyond Low-Earth Orbit, pre-mission planning cannot fully buy down the medical risks of exploration-class missions. Martian missions, where increased hazards exist, (such as long-duration spaceflight, surface-level EVA operations, and communications delays) will require a paradigm shift in the structure of a medical system. An Earth-Independent Medical Operations-based Medical System (EIMO-MS) will need to optimize four critical domains to help provide medical care: utilization of Pre-Mission Planning, augmentation of Acute and Prolonged Medical Decision Making, automated tracking of Resource Management, and assistance in Task Load Balance. The ideal EIMO-MS will be able to accomplish this goal by having an interactive, adaptable interface that will be able to provide real-time medical services. It must respond based on the level of crewmember training, medical situation, and available medical and non-medical resources. To showcase the capabilities and requirements of such a sophisticated automated MS, a series of clinical scenarios of escalating complexity were developed with clinical and systems engineering input. These scenarios describe in clinical detail what a theoretical future medical system, enhanced with multiple information streams (such as a medical database, an AI-based Decision Support System, real-time monitoring, enhanced in-situ laboratory imaging, etc.) can achieve in conjunction with a trained and experienced crew. Scenarios are comprised of: a context section including objectives and applicable spaceflight environment, a highlighted assumptions section, a clinical narrative section, and a systems engineering activity diagram demonstrating the integrated Medical System (MS). The “swim lanes” of the activity diagram act as the logistical core of each scenario and show how the MS will interact with the crew, ground support, and other in-flight systems. The Design Reference Mission that is used for the scenarios is based on existing reference mission profiles [1] with a projected 30-sol stay on the Martian surface. Scenarios span the spectrum from planned evaluations, minor medical care, urgent care, surgical guidance, critical and expectant management, and behavioral health care. Mission complexity will exponentially increase during deep space and Mars exploration-class missions, and medical support for these missions will likewise need to increase in autonomy and adaptability. The integrated system that will support these missions will need to provide assistance in a variety of anticipated and unforeseen scenarios. These medical scenarios, guided by clinician input, are initial steps in crafting the requirements for an EIMO-based medical system. By working in a systems engineering framework, requirements and capabilities can be extracted and mapped while maintaining a clinical core.

Prashant Parmar↗

Some approaches to medical support for Martian expedition

Medical support in a Martian expedition will be within the scope of crew responsibilities and maximally autonomous. Requirements to the system of diagnostics in this mission include considerable use of means and methods of visualization of the main physiological parameters, telemedicine, broad usage of biochemical analyses (including "dry" chemistry), computerized collection, measurement, analysis and storage of medical information. The countermeasure system will be based on objective methods of crew fitness and working ability evaluation, individual selection of training regimens, and intensive use of computer controlled training. Implementation of the above principles implies modernization and refinement of the countermeasures currently used by space crews of long-term missions (LTM), and increases of the assortment of active and passive training devices, among them a short-arm centrifuge. The system of medical care with the functions of prevention, clinical diagnostics and timely treatment will be autonomous, too. The general requirements to medical care during the future mission are the following: availability of conditions and means for autonomous urgent and special medical aid and treatment of the most possible states and diseases, "a hospital", and assignment to the crew of one or two doctors. To ensure independence of medical support and medical care in an expedition to Mars an automated expert system needs to be designed and constructed to control the medical situation as a whole. c2003 Published by Elsevier Science Ltd.

Mars↗

Filtering Water by Use of Ultrasonically Vibrated Nanotubes

Devices that could be characterized as acoustically driven molecular sieves have been proposed for filtering water to remove all biological contaminants and all molecules larger than water molecules. Originally intended for purifying wastewater for reuse aboard spacecraft, these devices could also be attractive for use on Earth in numerous settings in which there are requirements to obtain potable, medical-grade, or otherwise pure water from contaminated water supplies. These devices could also serve as efficient means of removing some or all water from chemical products . for example, they might be useful as adjuncts or substitutes for stills in the removal of water from alcohols and alcoholic beverages. These devices may be constructed using various materials, such as ceramics, metallics, or polymers, depending on end-use requirements. A representative device of this type (see figure) would include a polymeric disk, about 1 mm in diameter and between 1 and 40 microns thick, within which would be embedded single-wall carbon nanotubes aligned along the thickness axis. The polymeric disk would be part of a unitary polymeric ring assembly. An acoustic transducer in the form of a piezoelectric-film-and-electrode subassembly - typically 9 microns thick and made of poly(vinylidene fluoride) coated with copper 150 nm thick -. would be affixed to the outside of the outer polymeric ring by means of an electrically nonconductive epoxy. The nanotubes would be chosen to have diameters between about 8 and about 13.5 A because water molecules could fit into the nanotubes, but larger molecules could not. Water to be purified would be placed in contact with one face (typically, the upper face) of the filter disk. The surface tension of water is low enough that water molecules should enter and travel along the nanotubes, and computational simulations of molecular dynamics and experimental measurements have shown that the water molecules inside the nanotubes in this size range can be expected to become aligned into helical columns that exhibit properties of both hexagonal ice crystals and liquid water

Gavalas, Lillian Susan↗

Medical Data Architecture Prototype Development - Summary of Recent Work and Proposed Ideas for Upcoming Work

The Medical Data Architecture (MDA) project supports the Exploration Medical Capability (ExMC) risk to minimize or reduce the risk of adverse health outcomes and decrements in performance due to in-flight medical capabilities on human exploration missions. To mitigate this risk, the ExMC MDA project addresses the technical limitations identified in ExMC Gap Med 07: We do not have the capability to comprehensively process medically-relevant information to support medical operations during exploration missions, and in ExMC Gap Med 10: We do not have the capability to provide computed medical decision support during exploration missions. These gaps recognize the need for a comprehensive medical data management system and the accompanying computational support to provide autonomous medical care during long duration exploration missions. As the MDA matures—including the capability to comprehensively process and discover medically-relevant information to support medical operations during exploration missions—project focus will shift to maturing and extending the MDA platform to enable clinical decision support and real-time guidance. To date, the MDA foundational architecture has recommended exploration medical system Level of Care IV requirements through a series of test bed prototype developments and analog demonstrations. The next stage in the development will focus on more autonomous clinical decision making necessary to address challenges in executing a self-contained medical system that enables health care both with and without assistance from ground support. A thorough understanding of current state of medical decision support systems, advanced machine learning algorithms and vast and varied data sources is required. The development of a clinical decision support for exploration missions (Level of Care V) roadmap is needed: one that assesses of current state of the art of clinical decision support systems (CDSS), interoperability issues, identification of challenges in health and performance monitoring, obtaining and processing information from biosensors, knowledge and data management, data integration and fusion, and advanced algorithm development. This roadmap must also include rapid prototype development in the areas of data processing, advanced analysis and prediction of medical events, and treatment based on medically relevant information processing and evidence-based best practices. In this presentation, an overview of the relevant issues and the beginning framework of a Level of Care V CDSS development roadmap will be provided.

Krihak, M.↗

Interplanetary Transit Simulations Using the International Space Station

It has been suggested that the International Space Station (ISS) be utilized to simulate the transit portion of long-duration missions to Mars and near-Earth asteroids (NEA). The ISS offers a unique environment for such simulations, providing researchers with a high-fidelity platform to study, enhance, and validate technologies and countermeasures for these long-duration missions. From a space life sciences perspective, two major categories of human research activities have been identified that will harness the various capabilities of the ISS during the proposed simulations. The first category includes studies that require the use of the ISS, typically because of the need for prolonged weightlessness. The ISS is currently the only available platform capable of providing researchers with access to a weightless environment over an extended duration. In addition, the ISS offers high fidelity for other fundamental space environmental factors, such as isolation, distance, and accessibility. The second category includes studies that do not require use of the ISS in the strictest sense, but can exploit its use to maximize their scientific return more efficiently and productively than in ground-based simulations. In addition to conducting Mars and NEA simulations on the ISS, increasing the current increment duration on the ISS from 6 months to a longer duration will provide opportunities for enhanced and focused research relevant to long-duration Mars and NEA missions. Although it is currently believed that increasing the ISS crew increment duration to 9 or even 12 months will pose little additional risk to crewmembers, additional medical monitoring capabilities may be required beyond those currently used for the ISS operations. The use of the ISS to simulate aspects of Mars and NEA missions seems practical, and it is recommended that planning begin soon, in close consultation with all international partners.

Charles, J. B.↗

Task Load Management in Earth Independent Medical Operations

BACKGROUND: Medical care in spaceflight carries a high task load and can easily overwhelm a small crew. Present day operations in low Earth orbit (LEO) offload most medical tasks to ground teams in mission control. This team includes dozens of flight surgeons, specialists, and engineers and supports the on-orbit crew in monitoring environmental systems, tracking medications, guiding procedures, providing expert advice, and many other tasks. However, the physical limitations of the speed of light and technical limitations of bandwidth, channel capacity, and signal processing mean that missions beyond LEO cannot rely on this level of telemedical support. The further we travel from Earth the more these tasks will fall on the shoulders of the crew and the greater the risk of task saturation to the wellbeing of the crew and the success of the mission. Exploration class space crews will need progressively more robust systems for managing task load as they progress further out in space. OVERVIEW: Medical task management systems will need to assist with two broad categories of tasks; cognitively intensive tasks and procedure execution tasks. In both cases the goal is for the systems to operate in the background with minimal human-in-the-loop intervention. To accomplish this such systems will need to be designed with careful consideration for human factors and human systems integration to maximize efficiency, minimize alarm fatigue, and avoid inadvertently increasing task loads. Finally, the key domains of space medicine tasking can be used to map present day and near future technologies to the areas where they are best suited to support and identify gaps which can be targeted for research and development. DISCUSSION: Task load is a major challenge for Earth Independent Medical Operations to overcome. It will require careful coordination between experts in a variety of fields paying attention to human factors and human systems integration as well as technical and medical expertise. If done well medical task management systems can handle many of the tasks currently run by humans in mission control and enable human crews to maintain terrestrial standards of care in the extraterrestrial environment.

Dana Levin↗

Space Medicine: A Surgeon's Perspective

For the first four decades of human space flight NASA's priorities in life sciences and medical programs have been preventative medicine (astronaut selection and training); assessment of the physiologic effects of microgravity and other unique aspects of space flight, implementation of countermeasures to protect against adverse effects, and amelioration of these adverse effects. Because most of the U.S. space flight experience has been on short duration missions, the need for medical and diagnostic treatment capabilities have been limited.The first long-term crews will arrive on the International Space Station (ISS) in early 2000. This will usher in a new era, an era of sustained human presence in Low Earth Orbit. One of the principal purposes of the ISS program is to increase the knowledge of the effects of long duration space flight on humans, a pre-requisite to future exploration class missions beyond Low Earth Orbit (e.g., a return to the Moon or an exploration of Mars). Areas of particular interest include protection from radiation, muscle atrophy, bone loss, cardiovascular alterations, immune dysfunction, adverse psychological response to hazards and confinement, and neurovestibular alterations. In addition, long duration space flight requires the development of autonomous medical care capabilities, as the distances involved eliminate the possibility of real-time telemedicine or robotic intervention, and prevent a mission abort and a rapid return to Earth. The objectives of this presentation include: 1. A description of the International Space Station project, including its research facilities and on-orbit medical capabilities; 2. An overview of the physiological and medical problems associated with microgravity in space flight; 3. A review of NASA's biomedical research priorities and ongoing work to develop clinical care capabilities for space flight crews (including surgical interventions) and; 4. An overview of current and proposed research priorities for NASA Research Announcements, NASA Space Biomedical Research Institute, Small Business Innovation Research Grant, and other funding sources.

Dawson, David L.↗

Interplanetary Transit Simulations Using the International Space Station

We evaluated the space life sciences utility of the International Space Station (ISS) to simulate the outbound transit portion of missions to Mars and Near Earth Asteroids (NEA) to investigate biomedical and psychological aspects of such transits, to develop and test space operation procedures compatible with communication delays and outages, and to demonstrate and validate technologies and countermeasures. Two major categories of space life sciences activities can capitalize on ISS capabilities. The first includes studies that require ISS (or a comparable facility), typically for access to prolonged weightlessness. The second includes studies that do not strictly require ISS but can exploit it to maximize their scientific return more efficiently and productively than in ground-based simulations. For these studies, ISS offers a high fidelity analog for fundamental factors on future missions, such as crew composition, mission control personnel, operational tasks and workload, real-world risk, and isolation, and can mimic the effects of distance and limited accessibility. In addition to conducting Mars- and NEA-transit simulations on 6-month ISS increments, extending the current ISS increment duration from 6 months to 9 or even 12 months will provide opportunities for enhanced and focused research relevant to long duration Mars and NEA missions. Increasing the crew duration may pose little additional risk to crewmembers beyond that currently accepted on 6-month increments, but additional medical monitoring capabilities will be required beyond those currently used for ISS operations. Finally, while presenting major logistical challenges, such a simulation followed by a post-landing simulation of Mars exploration could provide quantitative evidence of capabilities in an actual mission. Thus, the use of ISS to simulate aspects of Mars and NEA missions seems practical. If it were to be implemented without major disruption of on-going ISS activities, then planning should begin soon, in close consultation with all international partners.

Charles, John B.↗

Apparel for Cleaner Clean Rooms

In the 1960s NASA pioneered contamination control technology, providing a base from which aerospace contractors could develop control measures. NASA conducted special courses for clean room technicians and supervisors, and published a series of handbooks with input from various NASA field centers. These handbooks extended aerospace experience to the medical, pharmaceutical, electronics, and other industries where extreme cleanliness is important. American Hospital Supply Company (AHSC) felt that high technology products with increasingly stringent operating requirements in aerospace, electronics, pharmaceuticals and medical equipment manufacturing demanded improvement in contamination control techniques. After studying the NASA handbooks and visiting NASA facilities, the wealth of information gathered resulted in Micro-clean non-woven garments and testing equipment and procedures for evaluating effectiveness.

Source record↗

The Integrated Medical Model - Optimizing In-flight Space Medical Systems to Reduce Crew Health Risk and Mission Impacts

The Integrated Medical Model (IMM) is a decision support tool used by medical system planners and designers as they prepare for exploration planning activities of the Constellation program (CxP). IMM provides an evidence-based approach to help optimize the allocation of in-flight medical resources for a specified level of risk within spacecraft operational constraints. Eighty medical conditions and associated resources are represented in IMM. Nine conditions are due to Space Adaptation Syndrome. The IMM helps answer fundamental medical mission planning questions such as What medical conditions can be expected? What type and quantity of medical resources are most likely to be used?", and "What is the probability of crew death or evacuation due to medical events?" For a specified mission and crew profile, the IMM effectively characterizes the sequence of events that could potentially occur should a medical condition happen. The mathematical relationships among mission and crew attributes, medical conditions and incidence data, in-flight medical resources, potential clinical and crew health end states are established to generate end state probabilities. A Monte Carlo computational method is used to determine the probable outcomes and requires up to 25,000 mission trials to reach convergence. For each mission trial, the pharmaceuticals and supplies required to diagnose and treat prevalent medical conditions are tracked and decremented. The uncertainty of patient response to treatment is bounded via a best-case, worst-case, untreated case algorithm. A Crew Health Index (CHI) metric, developed to account for functional impairment due to a medical condition, provides a quantified measure of risk and enables risk comparisons across mission scenarios. The use of historical in-flight medical data, terrestrial surrogate data as appropriate, and space medicine subject matter expertise has enabled the development of a probabilistic, stochastic decision support tool capable of optimizing in-flight medical systems based on crew and mission parameters. This presentation will illustrate how to apply quantitative risk assessment methods to optimize the mass and volume of space-based medical systems for a space flight mission given the level of crew health and mission risk.

Kerstman, Eric↗

Exploration Medical Capability Science and Research Overview and Update

The mission of the Exploration Medical Capability (ExMC) Element is to advance medical system design and risk-informed decision making for exploration beyond low Earth orbit to promote human health and performance in space. In order to accomplish this mission, the Element takes a progressively Earth-independent approach to three main areas: - Answering key clinical and science research questions that will help to address the challenges of providing medical care in the extreme environment of space - Applying systems engineering processes to medical system design with the goal of developing robust requirements that can be fully integrated into future space exploration vehicle designs - Developing and demonstrating novel medical technologies that will improve future medical capabilities in space This presentation will focus on selected scientific and technical conceptual drivers for the Element, the current and future research risks and gaps, and provide an overview of the Element’s progress in 2022. In particular, it will address the ongoing effort for the IMPACT trade space analysis tool suite, the closeout work on a clinical decision support prototype, potential requirements for a long-duration lunar orbit and lunar surface medical system, and an International Space Station technology demonstration of a point-of-care laboratory analysis capability.

Kris Lehnhardt↗

Space Station Freedom CHeCS overview

The current status, progress, and future plans for development of the Crew Health Care System (CHeCS) for the International Space Station Freedom are presented. Essential operational biomedical support requirements for the astronauts, including medical care, environmental habitat monitoring, and countermeasures for the potentially maladaptive physiological effects of space flight will be provided by the CHeCS. Three integral parts will make up the system: a health maintenance facility, an environmental health system, and the exercise countermeasures facility. Details of each of the major systems and their subsystems are presented.

Boyce, Joey B.↗

Communications infrastructure requirements for telemedicine/telehealth in the context of planning for and responding to natural disasters: Considering the need for shared regional networks

During the course of recent years the frequency and magnitude of major disasters - of natural, technological, or ecological origin - have made the world community dramatically aware of the immense losses of human life and economic resources that are caused regularly by such calamities. Particularly hard hit are developing countries, for whom the magnitude of disasters frequently outstrips the ability of the society to cope with them. In many cases this situation can be prevented, and the recent trend in disaster management has been to emphasize the importance of preparedness and mitigation as a means of prevention. In cases of disaster, a system is needed to respond to relief requirements, particularly the delivery of medical care. There is no generic telecommunications infrastructure appropriate for the variety of applications in medical care and disaster management. The need to integrate telemedicine/telehealth into shared regional disaster management telecommunications networks is discussed. Focus is on the development of infrastructure designed to serve the needs of disaster prone regions of the developing world.

Scott, John Carver↗

Crucial factor: human. Safely extending the human presence in space

The concept of advanced manned space missions has captured the interest and imagination of spacefaring nations. However, the physiological and psychological effects of space flight increase in magnitude and significance in the 'extended time-in-space' context. The unencumbered weightless condition enjoyed during short flights might compromise crew productivity upon return to a gravity field and extremely effective countermeasures may be essential. Missions remote from Earth require careful consideration of the medical facilities, psychological support and life support needed. The author discusses pressing issues that must be resolved before the visions of bolder human missions can be realistically fulfilled.

NASA Discipline General Space Life Sciences↗

Exploration Medical Capability (ExMC) Program

This document reviews NASA's Exploration Medical Capability (ExMC) program. The new space exploration program, outlined by the President will present new challenges to the crew's health. The project goals are to develop and validate requirements for reliable, efficient, and robust medical systems and treatments for space exploration to maximize crew performance for mission objectives.

Kalla, Elizabeth↗

Planetary Protection Policy and Technology Developments for the Crewed Exploration of Mars

As part of planning for potential future crewed exploration of Mars, NASA is developing its planetary protection policy for crewed missions, building on concepts developed within the international space exploration community. COSPAR (The Committee on Space Research), together with participating space agencies, has over the last several years organized and held interdisciplinary meetings to consider next steps in addressing knowledge gaps for planetary protection for the first human missions to Mars. Beginning with these workshop discussions as a base, NASA has held follow-on planning activities to identify the necessary steps to be accomplished to close those knowledge gaps. Significant overlap was identified between the planetary protection needs, including; microbial monitoring requirements for crew health and medical systems; studies of the microbiome of the built environment; environmental control and life support system (ECLSS) venting and disinfection strategies; waste management, and; planetary surface operations. In many cases, efforts to mature exploration systems for Mars that are occurring in other technology domains can be leveraged with minor changes to address planetary protection gaps as well. In other cases, work planned for testing on ISS as an analog for Mars transit, or on the lunar surface as an analog for Mars surface operations, can be used to close gaps in current planetary protection capabilities. This presentation provides a status update on the findings of the COSPAR Meetings on this topic to date, together with NASA’s responses in terms of agency-level plans and activities.

James N Benardini↗