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The purpose of this study is to collect baseline internal and external pressure data for the three most commonly used pelvic circumferential compression devices (PCCD). Unstable pelvic fractures as a result of automobile accidents, falls, and other traumatic injuries mortality rate [3]. Early use of pelvic circumferential compression devices can mitigate fatal outcomes [4]-[5]. Prolonged eternal pressure above 9.3kPa can result in long-term soft tissue damage and pressure ulcers [7]. This study hypothesizes that the application of the three most commonly used PCCDs would result in the same mean maximum point pressure exertion. To study this, internal and external, both analog and digital, pressure apparati were used to collect data. The results of this data collection demonstrate a discrepancy in the pressure distribution between right and left greater trochanters within each PCCD. Additionally, the results suggest there is an effect of internal packing on the pressure exertion externally at the two greater trochanters within each PCCD. Lastly, the differences in pressure exertion between each PCCD, internally and externally, were inconclusive as some compared metrics resulted in statistically significant results while others did not. The methodologies employed in this study can be improved through fixation of pressure collection instruments, utilization of digital pressure mats, and removal of confounding factors. The results of this study indicate that digitized, discrete data over a fixed time interval may be clinically useful, suggesting that a digital data collection would yield more reliable data. Additionally, internally mounted pressure sensor data will provide more precise results than the analog method employed herein, as well as provide insight towards bone reduction and displacement following the application of PCCDs. Finally, the information gathered from this study can be utilized to improve upon existing technologies to create a more innovative solution.
The purpose of this study is to collect baseline internal and external pressure data for the three most commonly used pelvic circumferential compression devices (PCCD). Unstable pelvic fractures as a result of automobile accidents, falls, and other traumatic injuries mortality rate [3]. Early use of pelvic circumferential compression devices can mitigate fatal outcomes [4]-[5]. Prolonged eternal pressure above 9.3kPa can result in long-term soft tissue damage and pressure ulcers [7]. This study hypothesizes that the application of the three most commonly used PCCDs would result in the same mean maximum point pressure exertion. To study this, internal and external, both analog and digital, pressure apparati were used to collect data. The results of this data collection demonstrate a discrepancy in the pressure distribution between right and left greater trochanters within each PCCD. Additionally, the results suggest there is an effect of internal packing on the pressure exertion externally at the two greater trochanters within each PCCD. Lastly, the differences in pressure exertion between each PCCD, internally and externally, were inconclusive as some compared metrics resulted in statistically significant results while others did not. The methodologies employed in this study can be improved through fixation of pressure collection instruments, utilization of digital pressure mats, and removal of confounding factors. The results of this study indicate that digitized, discrete data over a fixed time interval may be clinically useful, suggesting that a digital data collection would yield more reliable data. Additionally, internally mounted pressure sensor data will provide more precise results than the analog method employed herein, as well as provide insight towards bone reduction and displacement following the application of PCCDs. Finally, the information gathered from this study can be utilized to improve upon existing technologies to create a more innovative solution.
Lab-grown food products of animal cell origin, now becoming popularly coined as, ‘Cellular Agriculture’ is a revolutionary breakthrough technology that has the potential to penetrate the lives of every American or citizen of the world. It is important to recognize that the impetus for developing this technology is fueled by environmental concerns with climate change, rising geopolitical instability, and population growth projections, where farm-grown food has now become a growing national security issue. Notwithstanding its potential, in addition to the necessary technological innovation and economic scalability, the market success of cellular agriculture will depend greatly on regulatory oversight by multiple government agencies without which it can cause undue harm to individuals, populations, and the environment. Thus, it is critical for those appropriate United States governing bodies to ensure that the technology being developed is both safe and of an acceptable quality for human consumption and has no adverse environmental impact. As such, animal foods, derived from farms, previously regulated almost exclusively by the United States Department of Agriculture (USDA) are now being regulated under a joint formal agreement between the US Food and Drug Administration (US FDA) and the USDA if derived from the lab, i.e., lab-grown animal foods. The main reason for joint oversight between the FDA and the USDA is that the FDA has developed the in-house expertise to oversee primary cell harvesting and cell storage, as well as, cell growth and differentiation for the development of 3D-engineered tissues intended for tissue and organ replacement for the emerging field of regenerative medicine. As such, the FDA has been given the authority to oversee the ‘front end’ of lab-grown food processes which relies on the very same processes utilized in engineered human tissues to produce food-grade engineered tissues. Oversight then transitions to the USDA-FSIS (Food Safety and Inspection Service) during the harvesting stage of the cell culture process. The USDA-FSIS then oversees the further production and labeling of these products. Included in the agreement is the understanding that both bodies are responsible for communicating necessary information to each other and collaboratively developing new regulatory actions as needed. However, there currently lacks clarity on some topics regarding certain legal, ethical, and scientific issues. Lab-grown meat products require more extensive regulation than farm-grown animal food products to ensure that they are safe and nutritious for consumption. To do this, CFSAN can create new classes of lab-grown foods, such as ‘lab-grown USDA foods,’ ‘lab-grown non-USDA foods,’ ‘lab-grown extinct foods,’ ‘lab-grown human food tissues,’ and ‘medically activated lab-grown foods.’
In 2015, the FDA began a process to reevaluate and update the regulations surrounding homeopathic products to better fit their present risk-based model. Past regulations were set in 1938; and as the world evolved, these have been found to set inadequate standards. By reviewing the agency’s guidance drafts and core regulatory documents, we come to understand that these changes are motivated by a desire for homeopathic remedies to follow high standards that apply to other products for the benefit of the U.S. consumers. FDA has made significant advances by proposing new Guidances on homeopathic products, listening to homeopathic community and consumers, and withdrawing the Compliance Policy Guide 400.400 issued in 1988.
We recommend for homeopathic manufacturers and practitioners to see the FDA as an ally and cooperate fully with the proposed changes for the regulation the agency gives out. Doing so will give the homeopathic community the best chance at continuing to sell their products and reach their consumers in the United States. In the same token, the FDA should do their best to involve homeopathic professionals in some way in this regulatory process, to encourage participation and compliance by the broader homeopathic community. Doing so ensures a climate of teamwork among different facets of the medical community in the United States.