Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation.

Leachables leached from a medical device during its clinical use are important due to the patient health-related effects they may have. Thus, medical devices are profiled for leachables (and/or extractables as probable leachables) by screening extracts or leachates of the medical device for released organic substances via non-targeted analysis (NTA) employing chromatographic methods coupled with mass spectrometric detection. Chromatographic mass spectral response factors for extractables and leachables vary significantly from compound to compound, complicating the application of assessment strategies such as the Analytical Evaluation Threshold (AET), which is the concentration threshold at or above which an extractable or leachable must be reported for quantitative toxicological risk assessment.

Unveiling adipose populations linked to metabolic health in obesity.

Precision medicine is still not considered as a standard of care in obesity treatment, despite a large heterogeneity in the metabolic phenotype of individuals with obesity. One of the strongest factors influencing the variability in metabolic disease risk is adipose tissue (AT) dysfunction; however, there is little understanding of the link between distinct cell populations, cell-type-specific transcriptional programs, and disease severity. Here, we generated a comprehensive cellular map of subcutaneous and visceral AT of individuals with metabolically healthy and unhealthy obesity.

Dependence of Europe's most threatened mammals on movement to adapt to climate change.

Current rates of climate change and gloomy climate projections confront managers and conservation planners with the need to integrate climate change into already complex decision-making processes. Predicting and prioritizing climatically stable areas and the areas likely to facilitate adaptive species' range adjustments are important stages in maximizing conservation outcomes and rationalizing future land management. I determined, for the most threatened European terrestrial mammal species, the spatial adaptive trajectories (SATs) of highest expected persistence up to 2080.

Online and Offline Prioritization of Chemicals of Interest in Suspect Screening and Non-targeted Screening with High-Resolution Mass Spectrometry.

Recent advances in high-resolution mass spectrometry (HRMS) have enabled the detection of thousands of chemicals from a single sample, while computational methods have improved the identification and quantification of these chemicals in the absence of reference standards typically required in targeted analysis. However, to determine the presence of chemicals of interest that may pose an overall impact on ecological and human health, prioritization strategies must be used to effectively and efficiently highlight chemicals for further investigation. Prioritization can be based on a chemical's physicochemical properties, structure, exposure, and toxicity, in addition to its regulatory status.

Temperate species underfill their tropical thermal potentials on land.

Understanding how temperature determines the distribution of life is necessary to assess species' sensitivities to contemporary climate change. Here, we test the importance of temperature in limiting the geographic ranges of ectotherms by comparing the temperatures and areas that species occupy to the temperatures and areas species could potentially occupy on the basis of their physiological thermal tolerances. We find that marine species across all latitudes and terrestrial species from the tropics occupy temperatures that closely match their thermal tolerances.

Computational modeling of the thermal effects of flow on radio frequency-induced heating of peripheral vascular stents during MRI.

. The goal of this study was to develop and validate a computational model that can accurately predict the influence of flow on the temperature rise near a peripheral vascular stent during magnetic resonance imaging (MRI)..

Magnetic Resonance Safety Evaluation of a Novel Alumina Matrix Composite Ceramic Knee and Image Artifact Comparison to a Metal Knee Implant of Analogous Design.

Background: Image artifacts caused by metal knee implants in 1.5T and 3T magnetic resonance imaging (MRI) systems complicate imaging-based diagnosis of the peri-implant region after total knee arthroplasty. Alternatively, metal-free knee prostheses could effectively minimize MRI safety hazards and offer the potential for higher quality diagnostic images.

Drivers of mangrove vulnerability and resilience to tropical cyclones in the North Atlantic Basin.

The North Atlantic Basin (NAB) has seen an increase in the frequency and intensity of tropical cyclones since the 1980s, with record-breaking seasons in 2017 and 2020. However, little is known about how coastal ecosystems, particularly mangroves in the Gulf of Mexico and the Caribbean, respond to these new "climate normals" at regional and subregional scales. Wind speed, rainfall, pre-cyclone forest height, and hydro-geomorphology are known to influence mangrove damage and recovery following cyclones in the NAB.

Data error propagation in stacked bioclimatic envelope models.

Stacking is the process of overlaying inferred species potential distributions for multiple species based on outputs of bioclimatic envelope models (BEMs). The approach can be used to investigate patterns and processes of species richness. If data limitations on individual species distributions are inevitable, but how do they affect inferences of patterns and processes of species richness? We investigate the influence of different data sources on estimated species richness gradients in China.

A quixotic view of spatial bias in modelling the distribution of species and their diversity.

Ecological processes are often spatially and temporally structured, potentially leading to autocorrelation either in environmental variables or species distribution data. Because of that, spatially-biased in-situ samples or predictors might affect the outcomes of ecological models used to infer the geographic distribution of species and diversity. There is a vast heterogeneity of methods and approaches to assess and measure spatial bias; this paper aims at addressing the spatial component of data-driven biases in species distribution modelling, and to propose potential solutions to explicitly test and account for them.

Exploratory study of the provision of academic and health-related accommodations to transition-age adolescents and emerging adults with spina bifida.

Purpose: The purpose of this exploratory study was to investigate the types of academic and health-related accommodations provided to adolescents and emerging adults with spina bifida aged 9-20 years.

Methods: Data were extracted from the paper and electronic records of transition-age youth enrolled in the study. Four open ended items involved content analysis.

Humid tropical vertebrates are at lower risk of extinction and population decline in forests with higher structural integrity.

Reducing deforestation underpins global biodiversity conservation efforts. However, this focus on retaining forest cover overlooks the multitude of anthropogenic pressures that can degrade forest quality and imperil biodiversity. We use remotely sensed indices of tropical rainforest structural condition and associated human pressures to quantify the relative importance of forest cover, structural condition and integrity (the cumulative effect of condition and pressures) on vertebrate species extinction risk and population trends across the global humid tropics.

Tropical forests are home to over half of the world's vertebrate species.

Tropical forests are renowned for their astonishing diversity of life, but the fundamental question of how many species occur in tropical forests remains unanswered. Using geographic range maps and data on species habitat associations, we determined that tropical forests harbor 62% of global terrestrial vertebrate species, more than twice the number found in any other terrestrial biome on Earth. Up to 29% of global vertebrate species are endemic to tropical forests, with more than 20% of these species at risk of extinction.

Potential for invasion of traded birds under climate and land-cover change.

Humans have moved species away from their native ranges since the Neolithic, but globalization accelerated the rate at which species are being moved. We fitted more than half million distribution models for 610 traded bird species on the CITES list to examine the separate and joint effects of global climate and land-cover change on their potential end-of-century distributions. We found that climate-induced suitability for modelled invasive species increases with latitude, because traded birds are mainly of tropical origin and much of the temperate region is 'tropicalizing.

Dispersal abilities favor commensalism in animal-plant interactions under climate change.

Scientists still poorly understand how biotic interactions and dispersal limitation jointly interact and affect the ability of species to track suitable habitats under climate change. Here, we examine how animal-plant interactions and dispersal limitations might affect the responses of Brazil nut-dependent frogs facing projected climate change. Using ecological niche modelling and dispersal simulations, we forecast the future distributions of the Brazil nut tree and three commensalist frog species over time (2030, 2050, 2070, and 2090) in the regional rivalry (SSP370) scenario that includes great challenges to mitigation and adaptation.

Report on investigation of ISO 10993-12 extraction conditions.

The international standard ISO 10993-12 describes extraction conditions for generating extracts of medical devices to be used in testing of biological safety. Questions about the adequacy of the extraction conditions (and their variations) for hazard identification drove the development and execution of a round robin study. Four relevant device materials were each evaluated by four laboratories following an established protocol that specified multiple options of extraction solvent, temperature, duration, and ratio of solvent volume to quantity of test article.

Impacts of the SARS-CoV-2 pandemic on the global demand for exotic pets: An expert elicitation approach.

The SARS-CoV-2 pandemic has caused immense social and economic costs worldwide. Most experts endorse the view that the virus has a zoonotic origin with the final spillover being associated with wildlife trade. Besides human consumption, wild animals are also extensively traded as pets.

Improvements in reports of species redistribution under climate change are required.

Studies have documented climate change-induced shifts in species distributions but uncertainties associated with data and methods are typically unexplored. We reviewed 240 reports of climate-related species-range shifts and classified them based on three criteria. We ask whether observed distributional shifts are compared against random expectations, whether multicausal factors are examined on equal footing, and whether studies provide sufficient documentation to enable replication.

The evolution of critical thermal limits of life on Earth.

Understanding how species' thermal limits have evolved across the tree of life is central to predicting species' responses to climate change. Here, using experimentally-derived estimates of thermal tolerance limits for over 2000 terrestrial and aquatic species, we show that most of the variation in thermal tolerance can be attributed to a combination of adaptation to current climatic extremes, and the existence of evolutionary 'attractors' that reflect either boundaries or optima in thermal tolerance limits. Our results also reveal deep-time climate legacies in ectotherms, whereby orders that originated in cold paleoclimates have presently lower cold tolerance limits than those with warm thermal ancestry.

Discriminating climate, land-cover and random effects on species range dynamics.

Species are reportedly shifting their distributions poleward and upward in several parts of the world in response to climate change. The extent to which other factors might play a role driving these changes is still unclear. Land-cover change is a major cause of distributional changes, but it cannot be discarded that distributional dynamics might be at times caused by other mechanisms (e.

An Analytical Strategy Based on Multiple Complementary and Orthogonal Chromatographic and Detection Methods (Multidetector Approach) to Effectively Manage the Analytical Evaluation Threshold (AET).

To address patient safety, a drug product is chromatographically screened for organic leachables. Similarly, medical device and packaging system extracts are chromatographically screened for organic extractables as probable leachables. To protect patient health, the screening methods must respond to all potentially unsafe substances.

The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation.

A drug product is chromatographically screened for organic leachables, derived from the product's packaging system, as leachables might adversely impact the health of a patient to whom the drug product is administered. Similarly, medical device and packaging system extracts are chromatographically screened for organic extractables as probable leachables. To be protective of patient health, the screening methods must produce recognizable responses for all potentially unsafe substances.

Clinical Features and Temporal Changes of RT-PCR and Chest CT in COVID-19 Pediatric Patients.

This work aims to investigate the clinical features and the temporal changes of RT-PCR and CT in COVID-19 pediatric patients. The clinical, RT-PCR, and CT features of 114 COVID-19 pediatric in-patients were retrospectively reviewed from January 21 to March 14, 2020. All patients had chest CT on admission and were identified as positive by pharyngeal swab nucleic acid test.