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Recommendations for Exploration Space Medicine from the Apollo Medical Operations Project

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.

Scheuring, R. a.↗

Human Factors and ISS Medical Systems: Highlights of Procedures and Equipment Findings

As part of the Space Human Factors Engineering Critical Questions Roadmap, a three year Technology Development Project (TDP) was funded by NASA Headquarters to examine emergency medical procedures on ISS. The overall aim of the emergency medical procedures project was to determine the human factors issues in the procedures, training, communications and equipment, and to recommend solutions that will improve the survival rate of crewmembers in the event of a medical emergency. Currently, each ISS crew remains on orbit for six month intervals. As there is not standing requirement for a physician crewmember, during such time, the maintenance of crew health is dependant on individual crewmembers. Further, in the event of an emergency, crew will need to provide prolonged maintenance care, as well as emergency treatment, to an injured crewmember while awaiting transport to Earth. In addition to the isolation of the crew, medical procedures must be carried out within the further limitations imposed by the physical environment of the space station. For example, in order to administer care on ISS without the benefit of gravity, the Crew Medical Officers (CMOs) must restrain the equipment required to perform the task, restrain the injured crewmember, and finally, restrain themselves. Both the physical environment and the physical space available further limit the technology that can be used onboard. Equipment must be compact, yet able to withstand high levels of radiation and function without gravity. The focus here is to highlight the human factors impacts from our three year project involving the procedures and equipment areas that have been investigated and provided valuable to ISS and provide groundwork for human factors requirements for medical applications for exploration missions.

Byrne, V. E.↗

Assessment of Evidence Base from Medical Debriefs Data on Space Motion Sickness Incidence and Treatment

An objective of this data compilation and analysis project is to examine incidence and treatment efficacy of common patho-physiological disturbances during spaceflight. Analysis of medical debriefs data indicated that astronauts used medications to alleviate symptoms of four major ailments for which astronauts received treatment for sleep disturbances, space motion sickness (SMS), pain (headache, back pain) and sinus congestion. In the present data compilation and analysis project on SMS treatment during space missions, subject demographics (gender, age, first-time or repeat flyer), incidence and severity of SMS symptoms and subjective treatment efficacy from 317 crewmember debrief records were examined from STS-1 through STS-89. Preliminary analysis of data revealed that 50% of crew members reported SMS symptoms on at least one flight and 22% never experienced it. In addition, there were 387 medication dosing episodes reported, and promethazine was the most commonly used medication. Results of analysis of symptom check lists, medication use/efficacy and gender and flight record differences in incidence and treatment efficacy will be presented. Evidence gaps for treatment efficacy along with medication use trend analysis will be identified.

Younker, D.R.↗

Concept of Operations Evaluation for Mitigating Space Flight-Relevant Medical Issues in a Planetary Habitat

Introduction: Analogue environments assist the NASA Human Research Program (HRP) in developing capabilities to mitigate high risk issues to crew health and performance for space exploration. The Habitat Demonstration Unit (HDU) is an analogue habitat used to assess space-related products for planetary missions. The Exploration Medical Capability (ExMC) element at the NASA Johnson Space Center (JSC) was tasked with developing planetary-relevant medical scenarios to evaluate the concept of operations for mitigating medical issues in such an environment. Methods: Two medical scenarios were conducted within the simulated planetary habitat with the crew executing two space flight-relevant procedures: Eye Examination with a corneal injury and Skin Laceration. Remote guidance for the crew was provided by a flight surgeon (FS) stationed at a console outside of the habitat. Audio and video data were collected to capture the communication between the crew and the FS, as well as the movements of the crew executing the procedures. Questionnaire data regarding procedure content and remote guidance performance also were collected from the crew immediately after the sessions. Results: Preliminary review of the audio, video, and questionnaire data from the two scenarios conducted within the HDU indicate that remote guidance techniques from an FS on console can help crew members within a planetary habitat mitigate planetary-relevant medical issues. The content and format of the procedures were considered concise and intuitive, respectively. Discussion: Overall, the preliminary data from the evaluation suggest that use of remote guidance techniques by a FS can help HDU crew execute space exploration-relevant medical procedures within a habitat relevant to planetary missions, however further evaluations will be needed to implement this strategy into the complete concept of operations for conducting general space medicine within similar environments

Barsten, Kristina↗

Preliminary Evaluation of Commercial Off the Shelf (COTS) Packing Materials for Flight Medication Dispenser (FMD) Technology Development

With the advent of longer duration space missions, pharmaceutical use in space has increased. During the first 33 space shuttle missions, crew members took more than 500 individual doses of 31 different medications . Anecdotal reports from crew members described medications as generally "well tolerated" and "effective". However, reported use of increased medication doses and discrepancies in ground vs. flight efficacy may result from reduced potency or altered bioavailability due to changes in chemical and/or physical parameters of pharmaceutical stability. Based on preliminary results from a ground-based irradiation and an inflight study on pharmaceutical stability, three susceptible medications, Amoxicillin/Clavulanate and Sulfamethoxazole/trimethoprim antibiotics tablets and promethazine (PMZ), an antihistamine were selected for testing using two types of Oliver-Tolas bags, TPC-1475(Clear) and TPF-0599B (Foil) for radiation Shielding effectiveness. The material composition of the bags included aluminum coated Mylar sheathing coated with multifunctional nanocomposities based on polyethylene with dispersed boron-rich nanophases. Two bags of each medication were irradiated for different time intervals with 14.6 rad/min to achieve 0.1 Gy, 1 Gy and 10 Gy of cumulative radiation dose. Active pharmaceutical content (API) in each medication was determined and results analyzed. No significant difference in API content was observed between control and irradiated samples for both antibiotic tablets suggesting both types of bags may offer protection against gamma radiation; results with PMZ were inconclusive. These preliminary results suggest that Oliver-Tolas TPL-1475 and TPF-0599B materials may possess characteristics suitable for protection against ionizing radiation and can be considered for designing and further testing of FMD technology.

Du, Brian↗

The Space Medicine Exploration Medical Condition List

Exploration Medical Capability (ExMC) is an element of NASA s Human Research Program (HRP). ExMC's goal is to address the risk of the "Inability to Adequately Recognize or Treat an Ill or Injured Crewmember." This poster highlights the approach ExMC has taken to address this risk. The Space Medicine Exploration Medical Condition List (SMEMCL) was created to define the set of medical conditions that are most likely to occur during exploration space flight missions. The list was derived from the International Space Station Medical Checklist, the Shuttle Medical Checklist, in-flight occurrence data from the Lifetime Surveillance of Astronaut Health, and NASA subject matter experts. The list of conditions was further prioritized for eight specific design reference missions with the assistance of the ExMC Advisory Group. The purpose of the SMEMCL is to serve as an evidence-based foundation for the conditions that could affect a crewmember during flight. This information is used to ensure that the appropriate medical capabilities are available for exploration missions.

Watkins, Sharmi↗

Assessing the Likelihood of Rare Medical Events in Astronauts

Despite over half a century of manned space flight, the space flight community is only now coming to fully assess the short and long term medical dangers of exposure to reduced gravity environments. Further, as new manned spacecraft are designed and with the advent of commercial flight capabilities to the general public, a full understanding of medical risk becomes even more critical for maintaining and understanding mission safety and crew health. To address these critical issues, the National Aeronautics and Space Administration (NASA) Human Research Program (HRP) has begun to address the medical hazards with a formalized risk management approach by effectively identifying and attempting to mitigate acute and chronic medical risks to manned space flight. This paper describes NASA Glenn Research Center?s (GRC) efforts to develop a systematic methodology to assess the likelihood of in-flight medical conditions. Using a probabilistic approach, medical risks are assessed using well established and accepted biomedical and human performance models in combination with fundamentally observed data that defines the astronauts? physical conditions, environment and activity levels. Two different examples of space flight risk are used to show the versatility of our approach and how it successfully integrates disparate information to provide HRP decision makers with a valuable source of information which is otherwise lacking.

Myers, Jerry G., Jr.↗

Microbiology and Crew Medical Events on the International Space Station

The closed environment of the International Space Station (ISS) creates an ideal environment for microbial growth. Previous studies have identified the ubiquitous nature of microorganisms throughout the space station environment. To ensure safety of the crew, microbial monitoring of air and surface within ISS began in December 2000 and continues to be monitored on a quarterly basis. Water monitoring began in 2009 when the potable water dispenser was installed on ISS. However, it is unknown if high microbial counts are associated with inflight medical events. The microbial counts are determined for the air, surface, and water samples collected during flight operations and samples are returned to the Microbiology laboratory at the Johnson Space Center for identification. Instances of microbial counts above the established microbial limit requirements were noted and compared inflight medical events (any non-injury event such as illness, rashes, etc.) that were reported during the same calendar-quarter. Data were analyzed using repeated measures logistic regression for the forty-one US astronauts flew on ISS between 2000 and 2012. In that time frame, instances of microbial counts being above established limits were found for 10 times for air samples, 22 times for surface samples and twice for water. Seventy-eight inflight medical events were reported among the astronauts. A three times greater risk of a medical event was found when microbial samples were found to be high (OR = 3.01; p =.007). Engineering controls, crew training, and strict microbial limits have been established to mitigate the crew medical events and environmental risks. Due to the timing issues of sampling and the samples return to earth, identification of particular microorganisms causing a particular inflight medical event is difficult. Further analyses are underway.

Oubre, Cherie↗

Microbiology and Crew Medical Events on the International Space Station

The closed environment of the International Space Station (ISS) creates an ideal environment for microbial growth. Previous studies have identified the ubiquitous nature of microorganisms throughout the space station environment. To ensure safety of the crew, microbial monitoring of air and surface within ISS began in December 2000 and continues to be monitored on a quarterly basis. Water monitoring began in 2009 when the potable water dispenser was installed on ISS. However, it is unknown if high microbial counts are associated with inflight medical events. The microbial counts are determined for the air, surface, and water samples collected during flight operations and samples are returned to the Microbiology laboratory at the Johnson Space Center for identification. Instances of microbial counts above the established microbial limit requirements were noted and compared inflight medical events (any non-injury event such as illness, rashes, etc.) that were reported during the same calendar-quarter. Data were analyzed using repeated measures logistic regression for the forty-one US astronauts flew on ISS between 2000 and 2012. In that time frame, instances of microbial counts being above established limits were found for 10 times for air samples, 22 times for surface samples and twice for water. Seventy-eight inflight medical events were reported among the astronauts. A three times greater risk of a medical event was found when microbial samples were found to be high (OR = 3.01; p =.007). Engineering controls, crew training, and strict microbial limits have been established to mitigate the crew medical events and environmental risks. Due to the timing issues of sampling and the samples return to earth, identification of particular microorganisms causing a particular inflight medical event is difficult. Further analyses are underway.

Oubre, Cherie M.↗

Medication Use by U.S. Crewmembers on the International Space Station

This study examined medication use during long-duration. Medication records from 24 crewmembers on 20 missions (greater than 30 days duration) were examined for trends in usage rates, efficacy, indication, as well as adverse event qualities, frequencies and severities. No controls were possible in this observational, retrospective analysis of available data; comparisons are made to similar studies of individuals on shortduration spaceflights and submarine deployments. The most frequently used medications were for sleep problems, pain, congestion or allergy. Medication use during spaceflight missions was similar to what is seen in adult ambulatory medicine; one notable exception is that usage of sleep aids was about 10 times higher in spaceflight. There were also two apparent treatment failures in cases of skin rash, raising questions about the efficacy or suitability of the treatments used. Many spaceflight-related medication uses were linked to extravehicular-activities and operationally-driven schedule changes. The data suggest that sleep and skin rash merit additional study prior to longer space exploration missions. It also seems likely that alterations in schedule-shifting or extravehicular activity suits would reduce the need for many medication uses, preserving resources as well as improving crew quality of life.

Wotring, V. E.↗

Inflight Pharmacokinetic and Pharmacodynamic Responses to Medications Commonly Used in Spaceflight

Researchers do not know if medications act the same in the spaceflight environment as they do on Earth. Aspects of the spaceflight environment (low gravity, radiation exposure, closed environment, stress) have been shown to alter human physiology. Some of these physiological changes could be expected to alter either pharmacokinetics (PK, how the body absorbs, distributes, metabolizes and excretes administered medications) or pharmacodynamics (PD, receptors or signaling systems that are the targets of medication action). Anecdotal data has suggested that, at least for certain medications or indications, inflight medication efficacy is poor. In order to prepare for exploration missions where speedy evacuation to Earth may not be a possibility, the likelihood of unexpected medication action must be determined.

Wotring, V. E.↗

Exploration Medical Capability System Engineering Introduction and Vision

Human exploration missions to beyond low Earth orbit destinations such as Mars will require more autonomous capability compared to current low Earth orbit operations. For the medical system, lack of consumable resupply, evacuation opportunities, and real-time ground support are key drivers toward greater autonomy. Recognition of the limited mission and vehicle resources available to carry out exploration missions motivates the Exploration Medical Capability (ExMC) Element's approach to enabling the necessary autonomy. The Element's work must integrate with the overall exploration mission and vehicle design efforts to successfully provide exploration medical capabilities. ExMC is applying systems engineering principles and practices to accomplish its integrative goals. This talk will briefly introduce the discipline of systems engineering and key points in its application to exploration medical capability development. It will elucidate technical medical system needs to be met by the systems engineering work, and the structured and integrative science and engineering approach to satisfying those needs, including the development of shared mental and qualitative models within and external to the human health and performance community. These efforts are underway to ensure relevancy to exploration system maturation and to establish medical system development that is collaborative with vehicle and mission design and engineering efforts.

Mindock, J.↗

Risk of Adverse Health Outcomes and Decrements in Performance Due to In-flight Medical Conditions

The drive to undertake long-duration space exploration missions at greater distances from Earth gives rise to many challenges concerning human performance under extreme conditions. At NASA, the Human Research Program (HRP) has been established to investigate the specific risks to astronaut health and performance presented by space exploration, in addition to developing necessary countermeasures and technology to reduce risk and facilitate safer, more productive missions in space (NASA Human Research Program 2009). The HRP is divided into five subsections, covering behavioral health, space radiation, habitability, and other areas of interest. Within this structure is the ExMC Element, whose research contributes to the overall development of new technologies to overcome the challenges of expanding human exploration and habitation of space. The risk statement provided by the HRP to the ExMC Element states: "Given that medical conditions/events will occur during human spaceflight missions, there is a possibility of adverse health outcomes and decrements in performance in mission and for long term health" (NASA Human Research Program 2016). Within this risk context, the Exploration Medical Capabilities (ExMC) Element is specifically concerned with establishing evidenced-based methods of monitoring and maintaining astronaut health. Essential to completing this task is the advancement in techniques that identify, prevent, and treat any health threats that may occur during space missions. The ultimate goal of the ExMC Element is to develop and demonstrate a pathway for medical system integration into vehicle and mission design to mitigate the risk of medical issues. Integral to this effort is inclusion of an evidence-based medical and data handling system appropriate for long-duration, exploration-class missions. This requires a clear Concept of Operations, quantitative risk metrics or other tools to address changing risk throughout a mission, and system scoping and system engineering. Because of the novel nature of the risks involved in exploration missions, new and complex ethical challenges are likely to be encountered. This document describes the relevant background and evidence that informs the development of an exploration medical system.

Antonsen,Erik↗

Medical Simulations for Exploration Medicine

Medical simulation is a useful tool that can be used to train personnel, develop medical processes, and assist cross-disciplinary communication. Medical simulations have been used in the past at NASA for these purposes, however they are usually created ad hoc. A stepwise approach to scenario development has not previously been used. The NASA Exploration Medical Capability (ExMC) created a medical scenario development tool to test medical procedures, technologies, concepts of operation and for use in systems engineering (SE) processes.

Reyes, David↗

The Pathway to a Safe and Effective Spaceflight Medication Formulary: Expert Review Panel Recommendations

Exploration spaceflight poses several challenges to the provision of a comprehensive medication formulary. This formulary must accommodate the size and space limitations of the spacecraft, while addressing individual medication needs and preferences of the crew, consequences of a degrading inventory over time, the inability to resupply used or expired medications, and the need to forecast the best possible medication candidates to treat conditions that may occur. The Exploration Medical Capability (ExMC) Element's Pharmacy Project Team has developed a research plan (RP) that is focused on evidence-based models and theories as well as new diagnostic tools, treatments, or preventive measures aimed to ensure an available, safe, and effective pharmacy sufficient to manage potential medical threats during exploration spaceflight. Here, we will discuss the ways in which the ExMC Pharmacy Project Team pursued expert evaluation and guidance, and incorporated acquired insight into an achievable research pathway, reflected in the revised RP.

Daniels, V. R.↗

Introduction to Medical Extensible Dynamic Probabilistic Risk Assessment Tool (MEDPRAT)

A key component in the development of NASA Human Research Programs (HRP) next generation risk model, the Medical Extensible Dynamic Probabilistic Risk Assessment Tool (MEDPRAT) intends to deliver a means to quantify how HRP products impact astronaut medical and health risks. MEDPRAT is extensible to the majority of exploration missions. Similar to other risk models, the tool utilizes the available space and terrestrial medical data. MEDPRAT is designed to be extended with additional human health research information, medical equipment, space and terrestrial standards and practices to assess space flight medical risk in a manner consistent with other risk measures used in spacecraft and mission design. This tool provides risk-based medical system design information necessary to evaluate new technologies, procedures, research insights and mission plans.

physiological response↗

Exploration Medical Capability Systems Engineering Overview and Update

Long duration Lunar and Martian missions will change the way NASA currently practices medicine. The missions will require more autonomous capability compared to current low Earth orbit operations. For the medical system, lack of consumable resupply, evacuation opportunities, and real-time ground support are key drivers toward greater autonomy. Recognition of the limited mission and vehicle resources available to carry out exploration missions motivates the Exploration Medical Capability (ExMC) Element’s approach to enabling the necessary autonomy. The ExMC Systems Engineering (SE) team’s mission is to “Define, develop, validate, and manage the technical system design needed to implement exploration medical capabilities for Mars and test the design in a progression of proving grounds.” The Element’s work must integrate with the overall exploration mission and vehicle design efforts to successfully provide exploration medical capabilities. ExMC is using Model-Based System Engineering (MBSE) to accomplish its integrative goals. The MBSE approach to medical system design offers a paradigm shift toward greater integration between the vehicle and the medical system, and directly supports the transition of Earth-reliant ISS operations to the Earth-independent operations envisioned for Mars. This talk will provide a high-level overview of what the ExMC SE team has accomplished since the last IWS and what they are focusing on for the upcoming year.

Kerry McGuire↗

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: 1)answering key clinical and science research questions that will help to address the challenges of providing medical care in the extreme environment of space, 2)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, and 3)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 2020.

Kris Lehnhardt↗