Medical requirements in support of long duration manned space flight
Medical support program for crew health and performance requirements in manned space flights of long duration
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Medical support program for crew health and performance requirements in manned space flights of long duration
This paper presents how the Exploration Medical Capability Element of the National Aeronautics and Space Administration’sHuman Research Program usingModel-Based System Engineering is defining Level 4 Foundational Requirements to provide Medical Level-of-Care IV in a space Habitat during exploration missions.
The major health hazards of spaceflight include higher levels of damaging radiation, altered gravity, extended periods of isolation and confinement, a closed and potentially hostile living environment, and the stress associated with being a long distance from Earth. As we increase the duration of lunar stays with foreseeable communication latencies and disruptions, there will be a progressive need for crew to maintain their own health and independently respond to critical medical events. The Exploration Medical Capability element of the NASA Human Research Program is developing a set of Medical System requirements for lunar transit and surface operations. These requirements specify the capabilities, processes and procedures of a habitat Medical System needed for a range of conditions known to occur during spaceflight. Requirement text is written so as not to constrain innovative design solutions necessary for a resilient system. The requirement set includes attributes and functions the Medical System imposes on eight additional habitat systems. A key property of the Medical System is the provision of medical knowledge that will be stored, updated, analyzed, and secured within a Habitat Data System. A Task Performance Support System will aid in medical data acquisition and interpretation, crew training, medical condition prevention, diagnosis and treatment, provide interactive procedures, and track medical inventory. A Wellness System will focus on the provision of countermeasures to prevent, mitigate or treat adverse physical and behavioral health effects while the Medical System recommends adjustments to these countermeasures to maintain crew health. An Environmental Monitoring System will share out-of-bounds readings of air and water quality, acoustics, and radiation exposure levels with the Medical System to help identify issues before they affect crew health and performance. A Communications System will provide secured and private consultations between crew and the ground medical team and their loved ones on Earth. The Medical System also imposes requirements on a Research & Testbed System, fostering advanced medical science such as human research. A Waste Management System provides biohazard waste containment and waste disposal options (recycle and reuse). An Extravehicular Activity System supports crew health during lunar surface activities. And finally, a Maintenance Support System ensures that medical equipment is performing as expected. These requirements are being specifically developed for lunar surface operations but could help to identify Medical System requirements for any space habitat (e.g., I-Hab, commercial endeavors, etc.).
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. This gap identifies that the current in-flight medical data management includes a combination of data collection and distribution methods that are minimally integrated with on-board medical devices and systems. Furthermore, there are a variety of data sources and methods of data collection. For an exploration mission, the seamless management of such data will enable a more medically autonomous crew than the current paradigm of medical data management on the International Space Station. ExMC has recognized that in order to make informed decisions about a medical data architecture framework, current methods for medical data management must not only be understood, but an architecture must also be identified that provides the crew with actionable insight to medical conditions. This medical data architecture will provide the necessary functionality to address the challenges of executing a self-contained medical system that approaches crew health care delivery without assistance from ground support. Hence, the products derived from the third MDA prototype development will directly inform exploration medical system requirements for Level of Care IV in Gateway missions.In fiscal year 2019, the MDA project developed Test Bed 3, the third iteration in a series of prototypes, that featured integrations with cognition tool data, ultrasound image analytics and core Flight Software (cFS). Maintaining a layered architecture design, the framework implemented a plug-in, modular approach in the integration of these external data sources. An early version of MDA Test Bed 3 software was deployed and operated in a simulated analog environment that was part of the Next Space Technologies for Exploration Partnerships (NextSTEP) Gateway tests of multiple habitat prototypes. In addition, the MDA team participated in the Gateway Test and Verification Demonstration, where the MDA cFS applications was integrated with Gateway-in-a-Box software to send and receive medically relevant data over a simulated vehicle network. This software demonstration was given to ExMC and Gateway Program stakeholders at the NASA Johnson Space Center Integrated Power, Avionics and Software (iPAS) facility. Also, the integrated prototypes served as a vehicle to provide Level 5 requirements for the Crew Health and Performance Habitat Data System for Gateway Missions (Medical Level of Care IV). In the upcoming fiscal year, the MDA project will continue to provide systems engineering and vertical prototypes to refine requirements for medical Level of Care IV and inform requirements for Level of Care V.
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. This gap identifies that the current in-flight medical data management includes a combination of data collection and distribution methods that are minimally integrated with on-board medical devices and systems. Furthermore, there are a variety of data sources and methods of data collection. For an exploration mission, the seamless management of such data will enable a more medically autonomous crew than the current paradigm of medical data management on the International Space Station. ExMC has recognized that in order to make informed decisions about a medical data architecture framework, current methods for medical data management must not only be understood, but an architecture must also be identified that provides the crew with actionable insight to medical conditions. This medical data architecture will provide the necessary functionality to address the challenges of executing a self-contained medical system that approaches crew health care delivery without assistance from ground support. Hence, the products derived from the third MDA prototype development will directly inform exploration medical system requirements for Level of Care IV in Gateway missions. In fiscal year 2019, the MDA project developed Test Bed 3, the third iteration in a series of prototypes, that featured integrations with cognition tool data, ultrasound image analytics and core Flight Software (cFS). Maintaining a layered architecture design, the framework implemented a plug-in, modular approach in the integration of these external data sources. An early version of MDA Test Bed 3 software was deployed and operated in a simulated analog environment that was part of the Next Space Technologies for Exploration Partnerships (NextSTEP) Gateway tests of multiple habitat prototypes. In addition, the MDA team participated in the Gateway Test and Verification Demonstration, where the MDA cFS applications was integrated with Gateway-in-a-Box software to send and receive medically relevant data over a simulated vehicle network. This software demonstration was given to ExMC and Gateway Program stakeholders at the NASA Johnson Space Center Integrated Power, Avionics and Software (iPAS) facility. Also, the integrated prototypes served as a vehicle to provide Level 5 requirements for the Crew Health and Performance Habitat Data System for Gateway Missions (Medical Level of Care IV). In the upcoming fiscal year, the MDA project will continue to provide systems engineering and vertical prototypes to refine requirements for medical Level of Care IV and inform requirements for Level of Care V.
The number one cause of death in the U.S. is coronary heart disease (CHD). It is probably a major cause of death and disability in the lives of employees at Kennedy Space Center (KSC) as well. The KSC Biomedical Office used a multifactorial mathematical formula from the Framingham Heart Study to calculate CHD risk probabilities for individuals in a segment of the KSC population that required medical evaluation for job certification. Those assessed to be high-risk probabilities will be targeted for intervention. Every year, several thousand KSC employees require medical evaluations for job related certifications. Most medical information for these evaluations is gathered on-site at one of the KSC or Cape Canaveral Air Station (CCAS) medical clinics. The formula used in the Framingham Heart Study allows calculation of a person's probability of acquiring CHD within 10 years. The formula contains the following variables: Age, Diabetes, Smoking, Left Ventricular Hypertrophy, Blood Pressure (Systolic or Diastolic), Cholesterol, and HDL cholesterol. The formula is also gender specific. It was used to calculate the 10-year probabilities of CHD in KSC employees who required medical evaluations for job certifications during a one-year time frame. This KSC population was profiled and CHD risk reduction interventions could be targeted to those at high risk. Population risk could also be periodically reevaluated to determine the effectiveness of intervention. A 10-year CHD risk probability can be calculated for an individual quite easily while gathering routine medical information. An employee population's CHD risk probability can be profiled graphically revealing high risk segments of the population which can be targeted for risk reduction intervention. The small audience of NASA/contractor physicians, nurses and exercise/fitness professionals at the breakout session received the lecture very well. Approximately one third indicated by a show of hands that they would be interested in implementing a similar program at their NASA Center. Questions were asked pertaining to standardization for age, the validity of using the idealized male values also for the female population, and indications of the screening test's sensitivity and specificity.
The Exploration Medical Capabilities (ExMC) Element of NASA's Human Research Program is charged with identifying medical capabilities that can address the challenges of prevention, diagnosis, and treatment of disease and injuries that could occur during exploration missions beyond Earth's orbit. Faced with the obstacle of access to in-flight medical care, and limitations of vehicle space, time, and communications; it is necessary to prioritize what medical consumables are manifested for the flight, and which medical conditions are addressed. Studies of astronaut health establish the incidence of common and high risk medical conditions that require medical intervention during long-duration exploration missions. In 2000, the Institute of Medicine (IOM) convened a committee of experts, Committee on Creating a Vision for Space Medicine during Travel beyond Earth Orbit, to examine the issues surrounding astronaut health and safety for long duration space missions. Two themes run throughout the committee's final report: (1) that not enough is known about the risks to human health during long-duration missions beyond Earth's orbit or about what can effectively mitigate those risks to enable humans to travel and work safely in the environment of deep space and (2) that everything reasonable should be done to gain the necessary information before humans are sent on missions of space exploration (IOM, 2001). Although several spaceflight focused pharmaceutical research studies have been conducted, few have provided sufficient data regarding medication usage or potency changes during spaceflight. The Du pharmaceutical stability study assessed medications flown on space shuttles to and from the International Space Station (ISS) from 2006 until 2008; of which some medications were still viable beyond their expiration dates (Du et al, 2011). However, as with many spaceflight studies, the small 'n' associated with this study limits the ability to draw strong conclusions from it. Dr. Wotring and others have recently published articles containing information regarding medication usage, indications, and efficacy gleaned from spaceflight records (Wotring et al, 2015, 2016; Barger et al, 2014; Basner and Dinges, 2014). Although some conclusions can be drawn from these studies, the inability to fully quantify medication usage, indications, side effects, and effectiveness, limits insight as to which medications should be prioritized for further research.
In 2016, the Integrated Medical Model (IMM) v4.0 underwent an extensive external review in preparation for transition to an operational status. In order to insure impartiality of the review process, the Exploration Medical Capabilities Element of NASA's Human Research Program convened the review through the Systems Review Office at NASA Goddard Space Flight Center (GSFC). The review board convened by GSFC consisted of persons from both NASA and academia with expertise in the fields of statistics, epidemiology, modeling, software development, aerospace medicine, and project management (see Figure 1). The board reviewed software and code standards, as well as evidence pedigree associated with both the input and outcomes information. The board also assesses the models verification, validation, sensitivity to parameters and ability to answer operational questions. This talk will discuss the processes for designing the review, how the review progressed and the findings from the board, as well as summarize the IMM project responses to those findings. Overall, the board found that the IMM is scientifically sound, represents a necessary, comprehensive approach to identifying medical and environmental risks facing astronauts in long duration missions and is an excellent tool for communication between engineers and physicians. The board also found IMM and its customer(s) should convene an additional review of the IMM data sources and to develop a sustainable approach to augment, peer review, and maintain the information utilized in the IMM. The board found this is critically important because medical knowledge continues to evolve. Delivery of IMM v4.0 to the Crew Health and Safety (CHS) Program will occur in the 2017. Once delivered for operational decision support, IMM v4.0 will provide CHS with additional quantitative capability in to assess astronaut medical risks and required medical capabilities to help drive down overall mission risks.
1.HMTA responsibilities: a) Assure program/project compliance with Agency health and medical requirements at identified key decision points. b) Certify that programs/projects comply with Agency health and medical requirements prior to spaceflight missions. c) Assure technical excellence. 2. Designation of applicable NASA Centers for HMTA implementation and Chief Medical Officer (CMO) appointment. 3. Center CMO responsible for HMTA implementation for programs and projects at the center. JSC HMTA captured in "JSC HMTA Implementation Plan". 4. Establishes specifics of dissenting opinion process consistent with NASA procedural requirements.
This NASA Technical Standard provides medical requirements and clinical procedures designed to ensure crew health and safety and occupational longevity of NASA career astronauts. This NASA Technical Standard used for selection and annual recertification of astronauts reflects the medical requirements to successfully complete specific mission tasks and the multifaceted training and performance required of a NASA astronaut. These include, but are not limited to, flying in high performance aircraft, exposure to hypobaric and hyperbaric conditions, exposure to unique environments (e.g., microgravity), and conducting specialized operations (e.g., extra-vehicular activities, robotic arm operations). NASA policy for establishing standards to protect the health and safety of crew and for providing health and medical programs for astronauts during all phases of space flight is authorized by NPD 1000.3 - The NASA Organization, and by NPD 8900.5B - NASA Health and Medical Policy for Human Space Exploration. This document includes medical evaluations for private astronauts and NASA Suborbital Research Specialist (NSRS). Private astronauts are defined as a crew member who is not a NASA career (U.S. government) astronaut or international partner astronaut. NASA Suborbital Research Specialist is an individual who is employed by NASA or funded by NASA to conduct research, technology testing, training, or other activities onboard a sub-orbital vehicle. This excludes those individuals who are the commercially employed crew of the suborbital vehicle. This NASA Technical Standard also provides mission specific medical evaluations which include both clinical and occupational requirements that may be tailored for future missions.
Introduction: A study was requested in December, 2005 by the Space Medicine Division at the NASA-Johnson Space Center (JSC) to identify Apollo mission issues relevant to medical operations that had impact to crew health and/or performance. The objective was to use this new information to develop medical requirements for the future Crew Exploration Vehicle (CEV), Lunar Surface Access Module (LSAM), Lunar Habitat, and Advanced Extravehicular Activity (EVA) suits that are currently being developed within the exploration architecture. Methods: Available resources pertaining to medical operations on the Apollo 7 through 17 missions were reviewed. Ten categories of hardware, systems, or crew factors were identified in the background research, generating 655 data records in a database. A review of the records resulted in 280 questions that were then posed to surviving Apollo crewmembers by mail, face-to-face meetings, or online interaction. Response analysis to these questions formed the basis of recommendations to items in each of the categories. Results: Thirteen of 22 surviving Apollo astronauts (59%) participated in the project. Approximately 236 pages of responses to the questions were captured, resulting in 107 recommendations offered for medical consideration in the design of future vehicles and EVA suits based on the Apollo experience. Discussion: The goals of this project included: 1) Develop or modify medical requirements for new vehicles; 2) create a centralized database for future access; and 3) take this new knowledge and educate the various directorates at NASA-JSC who are participating in the exploration effort. To date, the Apollo Medical Operations recommendations are being incorporated into the exploration mission architecture at various levels and a centralized database has been developed. The Apollo crewmembers input has proved to be an invaluable resource, prompting ongoing collaboration as the requirements for the future exploration missions continue to evolve and be refined.
This report summarizes the initial work accomplished by the ACCESS 5 Human System Integration (HSI) team to identify Unmanned Aircraft System (UAS) Pilot Knowledge, Skill and Ability (KSA), Training and Medical requirements. To derive this information the following tasks were accomplished: a) Mission and Function analyses were performed; b) Applicable FARs and FAA Advisory Circulars (ACs) were reviewed; c) Meetings were conducted with NASA and FAA Human Factors personnel; d) Surveys were completed by ACCESS 5 HSI Working group UA Pilots; e) Coordination meetings were conducted with the ACCESS 5 Policy IPT. The results of these efforts were used to develop a summary of the current qualifications. for an individual to function as a Pilot In Command (PIC) for UAs currently flown by UNITE companies, to develop preliminary Pilot KSAs for each phase of flight, and to delineate preliminary Pilot Training and Medical requirements. These results are to be provided to the Policy IPT to support their development of recommendations for UA Pilot Rating Criteria, training and medical qualifications. It is expected that the initially an instrument rated pilot will be required to serve as the PIC. However, as operational experience is gained, and automation is applied to accomplish various system functions, it is expected that pilot rating criteria could be lessened.
The space radiation environment consists of ionizing radiation that poses healthrisks to crew members who embark on a mission to Mars. NASA requiresthat astronaut career radiation limits for the Risk of Exposure Induced Death(REID) should not exceed 3% at the upper 95% confidence level for cancermortality. However, the lifetime career limit is likely to be exceeded for eventhe shortest round-trip mission scenario to Mars. As such, approaches fordirectly reducing the radiation risk, despite the large uncertainties, are beinginvestigated. A recent study showed that medical countermeasures (MCM)which reduced background cancer mortality rates may be effective in mitigatingthe REID, where the data employed in the sensitivity analysis were limited tocohort studies of aspirin and warfarin. The present work addresses the generalMCM requirements that are needed to meet the lifetime career exposure limitsby examining modifications to the background cancer mortality rates, radiationquality factor, and low-LET radiation risk models for a Mars mission scenario.These results may be used to help inform decision-makers about potentialexperimental measurements that facilitate the greatest propensity for MCM risk reduction.
Medical requirements are currently being developed for NASA's space exploration program. Lunar surface operations for crews returning to the moon will be performed on a daily basis to conduct scientific research and construct a lunar habitat. Inherent to aggressive surface activities is the potential risk of injury to crew members. To develop an evidence-base for handling medical contingencies on the lunar surface, a simulation project was conducted using the moon-Mars analog environment at Devon Island, Nunavut, high Canadian Arctic. A review of the Apollo lunar surface activities and personal communications with Apollo lunar crew members provided a knowledge base of plausible scenarios that could potentially injure an astronaut during a lunar extravehicular activity. Objectives were established to 1) demonstrate stabilization, field extraction and transfer an injured crew member to the habitat and 2) evaluate audio, visual and biomedical communication capabilities with ground controllers at multiple mission control centers. The simulation project s objectives were achieved. Among these objectives were 1) extracting a crew member from a sloped terrain by a two-member team in a 1-g analog environment, 2) establishing real-time communication to multiple space centers, 3) providing biomedical data to flight controllers and crew members, and 4) establishing a medical diagnosis and treatment plan from a remote site. The simulation project provided evidence for the types of equipment and methods needed for planetary space exploration. During the project, the crew members were confronted with a number of unexpected scenarios including environmental, communications, EVA suit, and navigation challenges. These trials provided insight into the challenges of carrying out a medical contingency in an austere environment. The knowledge gained from completing the objectives of this project will be incorporated into the exploration medical requirements involving an incapacited astronaut on the lunar surface.
Since 2006 there have been 6 reported cases of altered visual acuity and intracranial pressure (ICP) in long duration astronauts. In order to document this risk and develop an integrated approach to its mitigation, the NASA Space Life Sciences Directorate (SLSD) and Human Research Program (HRP) have chosen to use the Human System Risk Board (HSRB) and the risk management analysis tool (RMAT). The HSRB is the venue in which the stakeholders and customers discuss and vet the evidence and the RMAT is the tool that facilitates documentation and comparison of the evidence across mission profiles as well as identification of risk factors, and documentation of mitigation strategies. This process allows for information to be brought forward and dispositioned so that it may be properly incorporated into the RMAT and contribute to the design of the research and mitigation plans. The evidence thus far has resulted in the identification of a visual impairment/intracranial pressure (VIIP) project team, updating of both short and long duration medical requirements designed to assess visual acuity, and a research plan to characterize this issue further. In order to understand this issue more completely, a plan to develop an Accelerated Research Collaboration (ARC) has been approved by the HSRB. The ARC is a novel research model pioneered by the Myelin Repair Foundation. It is a patient centered research model that brings together researchers and clinicians, under the guidance of a scientific advisory panel, to collaborate and produce results much quickly than accomplished through traditional research models. The data and evidence from the updated medical requirements and the VIIP ARC will be reviewed at the HSRB on a regular basis. Each review package presented to the HSRB will include an assessment and recommendation with respect to continuation of research, countermeasure development, occupational surveillance modalities, selection criteria, etc. This process will determine the course of the VIIP project and ultimately how SLSD and HRP mitigate this emerging human health and performance risk.
Medical requirements for the future Crew Exploration Vehicle (CEV), Lunar Surface Access Module (LSAM), advanced Extravehicular Activity (EVA) suits and Lunar habitat are currently being developed. Crews returning to the lunar surface will construct the lunar habitat and conduct scientific research. Inherent in aggressive surface activities is the potential risk of injury to crewmembers. Physiological responses and the operational environment for short forays during the Apollo lunar missions were studied and documented. Little is known about the operational environment in which crews will live and work and the hardware will be used for long-duration lunar surface operations. Additional information is needed regarding productivity and the events that affect crew function such as a compressed timeline. The Space Medicine Division at the NASA Johnson Space Center (JSC) requested a study in December 2005 to identify Apollo mission issues relevant to medical operations that had impact to crew health and/or performance. The operationally oriented goals of this project were to develop or modify medical requirements for new exploration vehicles and habitats, create a centralized database for future access, and share relevant Apollo information with the multiple entities at NASA and abroad participating in the exploration effort.
Medical requirements for the future Crew Exploration Vehicle (CEV), Lunar Surface Access Module (LSAM), advanced Extravehicular Activity (EVA) suits and Lunar habitat are currently being developed. Crews returning to the lunar surface will construct the lunar habitat and conduct scientific research. Inherent in aggressive surface activities is the potential risk of injury to crewmembers. Physiological responses to and the operational environment of short forays during the Apollo lunar missions were studied and documented. Little is known about the operational environment in which crews will live and work and the hardware that will be used for long-duration lunar surface operations.Additional information is needed regarding productivity and the events that affect crew function such as a compressed timeline. The Space Medicine Division at the NASA Johnson Space Center (JSC) requested a study in December 2005 to identify Apollo mission issues relevant to medical operations that had impact to crew health and/or performance. The operationally oriented goals of this project were to develop or modify medical requirements for new exploration vehicles and habitats, create a centralized database for future access, and share relevant Apollo information with the multiple entities at NASA and abroad participating in the exploration effort.
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