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At least 127 records · Page 7

Bisphosphonate Treatment: Risk Management in Long Duration Spaceflight

Bisphosphonates are a class of pharmaceuticals used to treat diverse bone disorders such as osteoporosis, Paget's disease, and multiple myeloma. They constitute a class of drugs which adhere to bony surfaces and interfere with the resorptive activity of osteoclasts. They also represent a potential countermeasure towards the loss of bone mass experienced by astronauts during spaceflight. Recently, the medical literature has revealed cases of osteonecrosis of the jaw in individuals receiving intravenous bisphosphonate therapy with a smaller number of cases occurring in individuals receiving the oral form of the medication. Risk management for long duration missions requires consideration of mission success and lifetime health care of astronauts. We performed MEDLINE and PubMed searches (1966 December 2006) using the following keywords: osteonecrosis, jaw, bisphosphonates. Additional references were obtained from the citations of the retrieved articles. Injectable bisphosphonates such as pamidronate and zoledronic acid have been highlighted recently in the literature due to a possible link with osteonecrosis of the jaw. The mechanism of action remains unclear but may be linked to physiologic microdamage in the jawbones resulting from suppression of bone metabolism. The most predisposing factors appear to be the type and dose of bisphosphonate used, a history of dental surgery, trauma, and/or dental infection. In addition, patients diagnosed with a malignancy such as breast cancer or multiple myeloma, who have been on intravenous bisphosphonate therapy for several months seem to be at increased risk. The use of oral bisphosphonates appears to place patients more at risk from acute events such as gastrointestinal tract injury or perforation. Although some studies report little to no increase in GI events compared to placebo, we must remember that in microgravity, astronauts may be unable to comply with medication instructions. They may have difficulty remaining upright for the required 30-45 minutes post-ingestion. We are currently unaware if this inability to comply with instructions on the package insert may lead to an increased risk for GI events. There is a potential long-term complication that resides with both forms of bisphosphonate therapy. In order to repair normally occurring physiologic microdamage to bone, both osteoclastic resorption and osteoblastic bone deposition must be functional. Controversy exists in the literature regarding whether prolonged use of bisphosphonates may lead to the suppression of bone turnover and accumulation of microdamage. Bisphosphonates are a powerful class of drugs that suppress bone turnover, but may cause serious adverse clinical events such as gastrointestinal tract injury or osteonecrosis of the jaw. Unfortunately, little to no data exists currently which may help us provide answers regarding the risks of their use in a healthy astronaut cohort. While controversy exists in the literature regarding their mechanism and long-term consequences, the potential mission impact or lifetime health care impact of an adverse clinical event resulting from bisphosphonate therapy must be considered.

Fogarty, Jennifer A.↗

Radiation Effects on Emerging Technologies: Implications of Space Weather Risk Management

As NASA and its space partners endeavor to develop a network of satellites capable of supporting humankind's needs for advanced space weather prediction and understanding, one of the key challenges is to design a space system to operate in the natural space radiation environment In this paper, we present a description of the natural space radiation environment, the effects of interest to electronic or photonic systems, and a sample of emerging technologies and their specific issues. We conclude with a discussion of operations in the space radiation hazard and considerations for risk management.

LaBel, Kenneth A.↗

Managing Risk in Safety Critical Operations - Lessons Learned from Space Operations

The Mission Control Center (MCC) at Johnson Space Center (JSC) has a rich legacy of supporting Human Space Flight operations throughout the Apollo, Shuttle and International Space Station eras. Through the evolution of ground operations and the Mission Control Center facility, NASA has gained a wealth of experience of what it takes to manage the risk in Safety Critical Operations, especially when human life is at risk. The focus of the presentation will be on the processes (training, operational rigor, team dynamics) that enable the JSC/MCC team to be so successful. The presentation will also share the evolution of the Mission Control Center architecture and how the evolution was introduced while managing the risk to the programs supported by the team. The details of the MCC architecture (e.g., the specific software, hardware or tools used in the facility) will not be shared at the conference since it would not give any additional insight as to how risk is managed in Space Operations.

Gonzalez, Steven A.↗

Risk management and expert system development methodology

A risk-based expert-system development methodology has been developed to provide guidance to managers and technical personnel and to serve as a standard for developing expert systems. Expert-system development differs from conventional software development in that the information needed to prepare system requirements for expert systems is not known at the outset of a project and is obtained by knowledge engineering methods. The paper describes the expert-system life cycle, development methodology, and the approach taken in this methodology to manage and reduce the risks in expert system development. Also examined are the risks of using and of not using a methodology, the studies undertaken to validate the provisions of the expert system development methodology, and the results of these validation studies.

Hull, Larry↗

Human System Risk Management - Tools of our Trade

The risk of infectious disease to select individuals has historically been difficult to predict in either spaceflight or on Earth with health care efforts relying on broad-based prevention and post-infection treatment. Over the past 10 years, quantitative microbial risk assessment evaluations have evolved to formalize the assessment process and quantify the risk. This process of hazard identification, exposure assessment, dose-response assessment, and risk characterization has been applied by the water and food safety industries to address the public health impacts associated with the occurrence of and human exposure to pathogens in water and food for the development of preventive strategies for microbial disease. NASA is currently investigating the feasibility of using these techniques to better understand the risks to astronauts and refine their microbiological requirements. To assess these techniques, NASA began an evaluation of the potable water system on the International Space Station to determine how the microbial risk from water consumption during flight differed from terrestrial sources, such as municipal water systems. The ultimate goal of this work is to optimize microbial requirements which would minimize unnecessary cargo and use of crew time, while still protecting the health of the crew. Successful demonstration of this risk assessment framework with the water system holds the potential to maximize the use of available resources during spaceflight missions and facilitate investigations into the evaluation of other routes of infection, such as through the spaceflight foods system.

Ott, C. Mark↗

A systematic risk management approach employed on the CloudSat project

The CloudSat Project has developed a simplified approach for fault tree analysis and probabilistic risk assessment. A system-level fault tree has been constructed to identify credible fault scenarios and failure modes leading up to a potential failure to meet the nominal mission success criteria.

risk management fault tree analysis probabilistic ↗

The Current State and Future of the Former Central Nervous System Risk Managed by Space Radiation Element Part of NASA’s Human Research Program

Historically, the Space Radiation Element, as part of the NASA Human Research Program, was responsible for the scientific strategy and funding of research focused on characterizing and mitigating the effects of space radiation exposure on the central nervous system (CNS). During the past few of years, there have been two major changes that have affected the management of the science associated with the CNS risk. The first major change was the integration of several related risks: CNS (C), Behavioral medicine (B), and sensorimotor (S) to be managed as an integrated effort called CBS. CBS was formed to accelerate research on combined spaceflight stressors, specifically space radiation, microgravity, isolation, and confinement. CBS was managed by Human Factors and Behavioral Performance (HFBP) with support and inputs from Space Radiation as well as Human Health Countermeasures. Secondly, and more recently, the CNS risk was absorbed by the behavioral medicine risk currently also held by HFPB. As a result, the gaps associated with CNS were removed and aspects of them are represented in the BMED gaps (link). However, due to recent changes in element leadership, budget, and timeline, extensive restructuring of CBS is in progress. In addition, in an effort to harmonize datasets to be used in modelling efforts, an Animal Standardization TIM was held in June 2021 to standardize the type of behavioral and cognitive tasks as well as experimental set-ups. This presentation is an effort to communicate with the radiation research community concerning the strategy, management, and future of the former central nervous system risk and the role of the Space Radiation Element.

central nervous system↗

The Current State and Future of the Former Central Nervous System Risk Managed by Space Radiation Element Part of NASA’s Human Research Program

Historically, the Space Radiation Element, as part of the NASA Human Research Program, was responsible for the scientific strategy and funding of research focused on characterizing and mitigating the effects of space radiation exposure on the central nervous system (CNS). During the past few years, there have been two major changes that have affected the management of the science associated with the CNS risk. The first major change was the integration of several related risks: CNS (C), behavioral medicine (B), and sensorimotor (S) to be managed as an integrated effort called CBS. CBS was formed to accelerate research on combined spaceflight stressors, specifically space radiation, microgravity, isolation, and confinement. CBS was managed by Human Factors and Behavioral Performance (HFBP) with support and inputs from Space Radiation as well as Human Health Countermeasures. Secondly, and more recently, the CNS risk was absorbed by the behavioral medicine risk currently also held by HFPB. As a result, the gaps associated with CNS were removed and aspects of them are represented in the BMED gaps (link). However, due to recent changes in element leadership, budget, and timeline, extensive restructuring of CBS is in progress. In addition, in an effort to harmonize datasets to be used in modeling efforts, an Animal Standardization TIM was held in June 2021 to standardize the type of behavioral and cognitive tasks as well as experimental set-ups used in animal models of future funded research. This presentation is an effort to communicate with the radiation research community concerning the strategy, management, and future of the former central nervous system risk and the role of the Space Radiation Element.

Janice A Zawaski↗

An Investigation of Risk Management Approaches for NASA Piloted X-Plane Projects

NASA is resuming X-plane research. It plans to build a low-boom supersonic flight demonstrator (LBFD), an all-electric general aviation aircraft (X-57), and possibly an ultra-efficient subsonic transport (UEST) demonstrator. In an attempt to define what levels of risk are appropriate in piloted X-plane research, the NASA Office of the Chief Engineer (OCE) evaluated numerous NASA, Department of Defense (DoD), and industry project management and risk assessment tools. Provided are the results of the evaluations of NASA Procedural Requirements (NPR) 7120.5, 7120.8, and 8705.4; Langley Research Center (LaRC) Procedural Requirement (LPR) 7120.5; Dryden (Armstrong) Center Procedures S-002 and X-009; and Military Handbook 516C. Some of these were applied to the LBFD and X-57 aircraft. The impacts on risk of budgeting decisions and specialized flight conditions were also considered. None of the evaluated processes were found to be fully appropriate for governing experimental aircraft projects, but many useful elements were found in some of them.

X-59↗