A Risk-based Approach towards Assessment of Potential Safety Deficiencies

2011 ◽  
pp. 209-223
Author(s):  
Jens Braband
Keyword(s):  
2020 ◽  
Vol 32 (2) ◽  
pp. 229-234
Author(s):  
Benjamin Kolb ◽  
John Large ◽  
Stuart Watson ◽  
Glyn Smurthwaite

The authors present a technical note for a prone positioning system developed to facilitate cervical extension osteotomy for ankylosing spondylitis in the presence of severe deformity and frailty. Chin-on-chest deformity represents one of the most debilitating changes of ankylosing spondylitis. Where the chin-brow angle approaches or exceeds 90°, prone positioning becomes problematic due to the fixed position of the head. Furthermore, the challenge is compounded where physiological deconditioning leads to frailty, and the side effects of medical therapies decrease muscle mass and skin quality. Conventional prone positioning equipment is not able to cater to all patients. A versatile system was developed using a 3D reconstruction to enable a positioning simulation and verification tool. The tool was used to comprehensively plan the perioperative episode, including spatial orientation and associated equipment. Three-dimensional printing was used to manufacture a bespoke positioning device that precisely matched the contours of the patient, reducing contact pressure and risk of skin injury. The authors were able to safely facilitate surgery for a patient whose deformity and frailty may otherwise have precluded this possibility. The system has potential safety and economic implications that may be of significant utility to other institutions engaging in complex spinal surgery.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Suxing Liu ◽  
Dong Liu ◽  
Ru Shen ◽  
Di Li ◽  
Qiyue Hu ◽  
...  

AbstractClinical success of IL-17/IL-23 pathway biologics for the treatment of moderate to severe psoriasis suggests that targeting RORγt, a master regulator for the proliferation and function of Th17 cells, could be an effective alternative. However, oral RORγ antagonists (VTP43742, TAK828) with high systemic exposure showed toxicity in phase I/II clinical trials and terminated development. To alleviate the potential safety concerns, identifying compounds with skin-restricted exposure amenable for topical use is of great interest. Systematic structure activity relationship study and multi-parameter optimization led to the discovery of a novel RORγ antagonist (SHR168442) with desired properties for a topical drug. It suppressed the transcription of IL-17 gene, leading to reduction of IL-17 cytokine secretion. It showed high exposure in skin, but low in plasma. Topical application of SHR168442 in Vaseline exhibited excellent efficacy in the imiquimod-induced and IL-23-induced psoriasis-like skin inflammation mouse models and correlated with the reduction of Th17 pathway cytokines, IL-6, TNFα and IL-17A. This work demonstrated restricted skin exposure of RORγ antagonist may provide a new topical treatment option as targeted therapeutics for mild to moderate psoriasis patients and may be suitable for the treatment of any other inflammatory disorders that are accessible locally.


Molecules ◽  
2018 ◽  
Vol 23 (11) ◽  
pp. 3044 ◽  
Author(s):  
Junfeng Shi ◽  
Yifan Ma ◽  
Jing Zhu ◽  
Yuanxin Chen ◽  
Yating Sun ◽  
...  

Intracellular delivery is a critical step in biological discoveries and has been widely utilized in biomedical research. A variety of molecular tools have been developed for cell-based gene therapies, including FDA approved CAR-T immunotherapy, iPSC, cell reprogramming and gene editing. Despite the inspiring results of these applications, intracellular delivery of foreign molecules including nucleic acids and proteins remains challenging. Efficient yet non-invasive delivery of biomolecules in a high-throughput manner has thus long fascinates the scientific community. As one of the most popular non-viral technologies for cell transfection, electroporation has gone through enormous development with the assist of nanotechnology and microfabrication. Emergence of miniatured electroporation system brought up many merits over the weakness of traditional electroporation system, including precise dose control and high cell viability. These new generation of electroporation systems are of considerable importance to expand the biological applications of intracellular delivery, bypassing the potential safety issue of viral vectors. In this review, we will go over the recent progresses in the electroporation-based intracellular delivery and several potential applications of cutting-edge research on the miniatured electroporation, including gene therapy, cellular reprogramming and intracellular probe.


Author(s):  
Mostafa Namian ◽  
Mohammad Khalid ◽  
George Wang ◽  
Yelda Turkan

Unmanned aerial vehicles (UAVs) have gained their prevalent recognition in construction because of their exceptional advantages. Despite the increasing use of UAVs in the industry and their remarkable benefits, there are serious potential safety risks associated that have been overlooked. Construction is one of the most hazardous industries in the United States. In addition to the ordinary hazards normally present in dynamic construction workplaces, UAVs can expose workers to a wider range of never-before-seen safety risks that must be recognized and controlled. The industry is not equipped with safety measures to prevent potential accidents, because of scarce research on drone-associated hazards and risks. The aim of this research was to (1) identify the UAV-associated hazards in construction that may expose personnel and property to potential harms, and (2) study the relative impact of each hazard and the associated safety risks. In Phase I, the researchers conducted an extensive literature review and consulted with a construction UAV expert. In Phase II, the researchers obtained data from 54 construction experts validating and evaluating the identified hazards and risks. The results revealed that adopting UAVs can expose construction projects to a variety of hazards that the industry is not familiar with. “Collision with properties,”“collision with humans,” and “distraction” were identified as the top three safety risks. Moreover, the study introduces effective strategies, such as having qualified crew members, proper drone model selection, and drone maintenance, to mitigate the safety risks. Finally, a post-hoc case study was investigated and presented in this article.


2011 ◽  
Vol 255-260 ◽  
pp. 752-756 ◽  
Author(s):  
Jiang Miao Zhu ◽  
Zhi Xin Li ◽  
Ying Wang ◽  
Ran Li

The water seepage of underground structure is the serious problem in the construction engineering, and becomes one of the most harm in current infrastructure with the huge potential safety hazard and economic loss. The electro-osmosis technology is once widely used in the fields of soft ground stabilization of rock engineering, the biological pharmacy and the oil production engineering in China. This paper referred experiences of overseas, combined electric pulse signal and the electro-osmosis technology to reduce seepage of the underground structure, and solved underground structure water seepage problems. The paper comprehensively analyzed the research status of the technology at home and abroad and its feasibility in theory, also introduced the general implementation methods of projects, and carried on the comparison of the pulse electro-osmosis technology and the traditional moisture-proof technology in application.


2002 ◽  
Vol 713 ◽  
Author(s):  
Allan Hedin ◽  
Ulrik Kautsky ◽  
Lena Morén ◽  
Patrik Sellin ◽  
Jan-Olof Selroos

ABSTRACTIn preparation for coming site investigations for siting of a deep repository for spent nuclear fuel, the Swedish Nuclear Fuel and Waste Management Company, SKB has carried out the longterm safety assessment SR 97, requested by the Swedish Government. The repository is of the KBS-3 type, where the fuel is placed in isolating copper canisters with a high-strength cast iron insert. The canisters are surrounded by bentonite clay in individual deposition holes at a depth of 500 m in granitic bedrock. Geological data are taken from three sites in Sweden to shed light on different conditions in Swedish granitic bedrock.The future evolution of the repository system is analysed in the form of five scenarios. The first is a base scenario where the repository is postulated to be built entirely according to specifications and where present-day conditions in the surroundings, including climate, persist. The four other scenarios show the evolution if the repository contains a few initially defective canisters, in the event of climate change, in the event of earthquakes, and in the event of future inadvertent human intrusion.The principal conclusion of the assessment is that the prospects of building a safe deep repository for spent nuclear fuel in Swedish granitic bedrock are very good. The results of the assessment also serve as a basis for formulating requirements and preferences regarding the bedrock in site investigations, for designing a programme for site investigations, for formulating functional requirements on the repository's barriers, and for prioritisation of research.SR 97 has been reviewed both by an international group of OECD/NEA experts and by Swedish authorities. The NEA reviewers concluded that “SR 97 provides a sensible illustration of the potential safety of the KBS-3 concept”, and no issues were identified that need to be resolved prior to proceeding to the investigation of potential sites. The authorities' conclusions were in principal consistent with those of the NEA.Uncertainties and lack of knowledge in different areas identified in SR 97 have strongly influenced the contents and structure of SKBs most recent research programme, RD&DProgramme 2001.Since SR 97, the methodology for probabilistic consequence analyses have been further developed. Analytic approximations to the numerical transport models used in SR 97 have been developed. The new models have been used to extend the probabilistic calculations in SR 97.


2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Zhengyu Xie ◽  
Limin Jia ◽  
Yong Qin ◽  
Li Wang

With the rapid development of high-speed railway in China, high-speed railway transport hub (HRTH) has become the high-density distribution center of passenger flow. In order to accurately detect potential safety hazard hidden in passenger flow, it is necessary to forecast the status of passenger flow. In this paper, we proposed a hybrid temporal-spatio forecasting approach to obtain the passenger flow status in HRTH. The approach combined temporal forecasting based on radial basis function neural network (RBF NN) and spatio forecasting based on spatial correlation degree. Computational experiments on actual passenger flow status from a specific bottleneck position and its correlation points in HRTH showed that the proposed approach is effective to forecast the passenger flow status with high precision.


2012 ◽  
Vol 550-553 ◽  
pp. 1915-1918
Author(s):  
Lin Lin Shang ◽  
Wei Feng

Safe food packaging is of great significance in solving food safety problem, which can ensure the quality of the food. At the same time protecting the environment should be taken into consideration, and therefore sound food packaging is not only safe to human health but also green to the environment. In this paper potential safety hazards in food packaging materials and how to develop green food packaging are discussed at length.


2018 ◽  
Vol 1 (1) ◽  
pp. 27-36
Author(s):  
Patriciu Constantin Popovici ◽  
Viorel Robert Ancuceanu ◽  
Tudorel Octavian Olaru ◽  
Cristina-Silvia Stoicescu ◽  
Mihaela Dinu

Abstract The fern Nephrolepis exaltata (L.) Schott, fam. Nephrolepidaceae, has little traditional medicinal use. In order to estimate its potential safety, in the present study we have investigated the phytotoxicity (on Triticum aestivum L.) and toxicity on brine shrimp of extracts from plants grown hydroponically. The species identity was confirmed by macroscopic and microscopic examinations on rhizomes, rachises, pinnae and runners, using bright field and fluorescent microscopy. Biological assays were performed on aqueous and ethanol solutions of the fronds. The brine shrimp lethality assay was performed on Artemia franciscana Kellog and a phytobiological bioassay on Triticum aestivum L. Lethality, root elongation and karyokinetic film modifications were evaluated, and LC50 and IC50 values were calculated. The microscopic analysis revealed the main histo-anatomic elements: polystelic structure and hypodermis (rhizome, rachis, runners), trichomes (rachis), homogenous structure, trichomes and diacytic/anisocytic stomata (leaves). The ethanol and aqueous extracts showed low cytotoxic effects on both Triticum aestivum roots and Artemia franciscana nauplii.


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