Safety Of End Users Research Articles

TEMPORARY REMOVAL: Exploring the potential of reconstructed human epithelial tissue models for safety assessment of intraoral medical devices

Medical devices are integral to a wide array of medical interventions and are increasingly utilized in both clinical and home settings. Within the oral cavity, intraoral medical devices are employed for various applications, to improve quality of life and maintain oral health and hygiene. However, the dynamic and complex environment of the oral cavity, characterized by the influence of factors, such as saliva composition, fluctuating pH, and microbial flora presents a challenge to ensure the safety of end-users. In this paper, we investigate the feasibility of utilization of 3D reconstructed human tissue models for the assessment of biocompatibility of intraoral medical devices. Building upon experiences drawn from the development and validation of ISO 10993-23 and from the development of a protocol for ocular irritation and photo-irritation, we suggest a new protocol for buccal mucosa irritation testing. The methodology is based on the viability assessment and analysis of cytokine release into media. By addressing intraoral medical devices biocompatibility testing, we aim to contribute to the advancement of biocompatibility assessment methodologies and increase the applicability of ISO 10993-23.

Technology management: innovated water welding machine for entrepreneurship

The study aimed to determine the effectiveness and acceptability of an innovative water welding machine for entrepreneurship during the 2019-2020 academic year, as the basis for technology management. The innovative water welding machine for entrepreneurship for campus maintenance was evaluated on the acceptability of its effectiveness and sustainability, awareness, safety, and health. The quasi-experiment method, particularly survey research, was employed in this study. Questionnaires were given to 10 professors/instructors, 45 Second Year BIT Welding and Fabrication Technology students, 45 Third Year BIT Welding and Fabrication Technology students, and 5 Experts from Small Scale Industries, Pinamungajan, Cebu for evaluation. The study found that the technology management of innovative water welding machines for entrepreneurship on school campuses is highly acceptable for effectiveness, awareness, safety, and health. It is recommended to adopt this innovative technology Water Machine for maintenance and safety of end users. Keywords: Acceptability; awareness; effectiveness; innovation; technology management; water welding machine.

Entomopathogenic nematodes and their symbiotic bacteria: from genes to field uses.

The term "microbial control" has been used to describe the use of microbial pathogens (bacteria, viruses, or fungi) or entomopathogenic nematodes (EPNs) to control various insect pest populations. EPNs are among the best biocontrol agents, and major developments in their use have occurred in recent decades, with many surveys having been conducted all over the world to identify EPNs that may have potential in the management of insect pests. For nematodes, the term "entomopathogenic" means "causing disease to insects" and is mainly used in reference to the bacterial symbionts of Steinernema and Heterorhabditis (Xenorhabdus and Photorhabdus, respectively), which cause EPN infectivity. A compendium of our multiannual experiences on EPN surveys and on their collection, identification, characterization, and use in agro-forestry ecosystems is presented here to testify and demonstrate once again that biological control with EPNs is possible and offers many advantages over chemicals, such as end-user safety, minimal damage to natural enemies, and lack of environmental pollution, which are essential conditions for an advanced IPM strategy.

Artificial intelligence governance: Ethical considerations and implications for social responsibility

AbstractA number of articles are increasingly raising awareness on the different uses of artificial intelligence (AI) technologies for customers and businesses. Many authors discuss about their benefits and possible challenges. However, for the time being, there is still limited research focused on AI principles and regulatory guidelines for the developers of expert systems like machine learning (ML) and/or deep learning (DL) technologies. This research addresses this knowledge gap in the academic literature. The objectives of this contribution are threefold: (i) It describes AI governance frameworks that were put forward by technology conglomerates, policy makers and by intergovernmental organizations, (ii) It sheds light on the extant literature on ‘AI governance’ as well as on the intersection of ‘AI’ and ‘corporate social responsibility’ (CSR), (iii) It identifies key dimensions of AI governance, and elaborates about the promotion of accountability and transparency; explainability, interpretability and reproducibility; fairness and inclusiveness; privacy and safety of end users, as well as on the prevention of risks and of cyber security issues from AI systems. This research implies that all those who are involved in the research, development and maintenance of AI systems, have social and ethical responsibilities to bear toward their consumers as well as to other stakeholders in society.

Flood Vulnerability Study of a Roadway Bridge Subjected to Hydrodynamic Actions, Local Scour and Wood Debris Accumulation

The increased occurrence and intensity of flooding events have represented a real threat to bridge reliability and end-user safety. As flood vulnerability assessment is a valuable tool for enhancing the resilience of bridges to climate change, it is of interest to push the development of such methods. To this end, a computationally efficient methodology to assess the flood vulnerability of a bridge was developed and implemented in a case study. A particular focus was devoted to modelling wood debris loads on the bridge pier, for which two different approaches were implemented. The first is a standards-based approach, whereas the second is based on up-to-date research data. The results indicate that the second approach is less conservative as it leads up to a 40% higher exceedance probability for the considered limit states. The interaction between wood debris loads and local scour was also examined and proved to have a relevant impact on the vulnerability of the bridge. These results highlight the shortcomings of the existing standards in providing accurate results. It is perceived that not only will the new quantitative tool be valuable in ensuring optimal bridge design, but it will also be beneficial for assessing bridge risk mitigation measures.

A novel transdermal ketoprofen formulation for analgesia in cattle.

Ketoprofen is registered in many countries for injectable administration in cattle. Because it is soluble in a wide range of excipients, development of a novel transdermal (TD) ketoprofen formulation was pursued to provide a convenient and pain-free route of administration in cattle. One hundred and six excipient combinations were screened using in vitro techniques (Franz diffusion cells), with a 20%(w/v) ketoprofen formulation dissolved in a combination of 45%:45%(v/v) ethanol and isopropyl myristate (IPM) and 10%(v/v) eucalyptus oil achieving maximal penetration of ketoprofen through bovine skin. A bioavailability study was then conducted using a randomized cross-over design (n=12), including IV, IM (both 3mg/kg) and TD (10mg/kg) ketoprofen formulations administered with a one-week washout period between administrations. The IV and IM formulation pharmacokinetic results were as expected. The CMAX , Tmax and AUC0-Last were significantly higher (arithmetic mean ± SD) after TD administration (20.0 ± 6.5μg/ml, 115 ± 17 min and 3940 ± 1324 μg*min/ml, respectively), compared to IM (11.0 ± 4.0μg/ml, 74 ± 43 min and 2376 ± 738 μg*min/ml, respectively), although there were no significant differences for T½β . However, dose corrected values CMAX and AUCinf were significantly higher for IM compared to TD. The arithmetic mean bioavailability (F) of the transdermal formulation was 50%. The plasma concentration of the TD formulation at a dose of 10mg/kg was similar to the IM formulation at 3mg/kg by 30 min post-dosing with an arithmetic mean ± SD of 7.97 ± 4.38 vs. 8.02 ± 3.55 μg/ml, respectively. The TD formulation was generally well tolerated by cattle, although some local irritation along the site of application was noted after 12 h of exposure during the bioavailability study. Results indicate that this novel TD formulation provides a substantial improvement in administration convenience, may improve animal welfare and end-user safety through needle-free administration, and achieves similar plasma pharmacokinetics to the IM product when administered at 10mg/kg.

Study of Augmented Reality Based Manufacturing for Further Integration of Quality Control 4.0: A Systematic Literature Review

Augmented Reality (AR) has gradually become a mainstream technology enabling Industry 4.0 and its maturity has also grown over time. AR has been applied to support different processes on the shop-floor level, such as assembly, maintenance, etc. As various processes in manufacturing require high quality and near-zero error rates to ensure the demands and safety of end-users, AR can also equip operators with immersive interfaces to enhance productivity, accuracy and autonomy in the quality sector. However, there is currently no systematic review paper about AR technology enhancing the quality sector. The purpose of this paper is to conduct a systematic literature review (SLR) to conclude about the emerging interest in using AR as an assisting technology for the quality sector in an industry 4.0 context. Five research questions (RQs), with a set of selection criteria, are predefined to support the objectives of this SLR. In addition, different research databases are used for the paper identification phase following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) methodology to find the answers for the predefined RQs. It is found that, in spite of staying behind the assembly and maintenance sector in terms of AR-based solutions, there is a tendency towards interest in developing and implementing AR-assisted quality applications. There are three main categories of current AR-based solutions for quality sector, which are AR-based apps as a virtual Lean tool, AR-assisted metrology and AR-based solutions for in-line quality control. In this SLR, an AR architecture layer framework has been improved to classify articles into different layers which are finally integrated into a systematic design and development methodology for the development of long-term AR-based solutions for the quality sector in the future.

Studies on the Impact of Hydrogen on the Results of THT Measurement Devices

An essential prerequisite for safe transport and use of natural gas is their appropriate odorization. This enables the detection of uncontrolled gas leaks. Proper and systematic odorization inspection ensures both safe use of gas and continuity of the process itself. In practice, it is conducted through, among others, measuring odorant concentrations in gas. Control devices for rapid gas odorization measurements that are currently used on a large scale in the gas industry are equipped with electrochemical detectors selective for sulfur compounds like tetrahydrothiophene (THT). Because the selectivity of electrochemical detector response to one compound (e.g., THT), the available declarations of manufacturers show that detector sensitivity (indirectly also the quality of the measurement result) is influenced by the presence of increased e.g., sulfur or hydrogen compound content in the gas. Because of the lack of sufficient source literature data in this field, it was necessary to experimentally verify this impact. The results of studies on experimental verification of suspected influence of increased amounts of hydrogen in gas on the response of electrochemical detector was carried out at the Oil and Gas Institute—National Research Institute (INiG—PIB). They are presented in this article. The data gathered in the course of researching the dependence between THT concentration measurement result quality and hydrogen content in gas composition enabled a preliminary assessment of the threat to the safety of end users of gaseous fuels caused by the introduction of this gas into the distribution network. Noticing the scope of necessary changes in the area of odorization is necessary to guarantee this safety.

Portable System for Home Use Enables Closed-Loop, Continuous Control of Multi-Degree-of-Freedom Bionic Arm.

Commercial prosthetic hands are frequently abandoned due to unintuitive control methods and a lack of sensory feedback from the prosthesis. Advanced neuromyoelectric prostheses can restore intuitive control and sensory feedback to prosthesis users and potentially reduce abandonment. However, not all advanced prosthetic systems are deployable for home use on portable systems with limited computational power. In this work, we use a commercially available portable neural interface processor (the Ripple Neuro Nomad), and a multi-degree-of-freedom bionic arm (the DEKA LUKE Arm) to create a closed-loop neuromyoelectric prosthesis. The system restores intuitive, independent, continuous control over the arm's six-degrees-of-freedom and provides sensory feedback for up to 288 neural and six vibrotactile channels. Additionally, the large storage capacity of the system enables high-resolution logging of EMG, hand positions, prosthesis sensors, and stimulation parameters. We developed two GUIs enabling wireless, real-time adjustments to motor control and feedback parameters: one with nearly full control over motor control and feedback parameters for investigators, and one with restricted capabilities enabling end-user safety. We verified the system's closed-loop function through a fragile egg task with vibrotactile sensory feedback. We tested the neural stimulation with an amplifier capable of eliciting transcutaneous percepts. This neuromyoelectric prosthetic system will be used for an extended take-home trial that could provide strong clinical justification for advanced, closed-loop prostheses.Clinical Relevance- This work establishes an advanced, intuitive, sensorized prosthesis that can be used in home and clinical settings.

Preliminary study of Augmented Reality based manufacturing for further integration of Quality Control 4.0 supported by metrology

Augmented Reality (AR) is a key technology enabling Industry 4.0, which enriches human perspectives by overlaying digital information onto the real world. The maturity of AR technology has grown recently. As processes in the automotive and aeronautic sectors require high quality and near-zero error rates to ensure the safety of end-users, AR can be implemented to facilitate workers with immersive interfaces to enhance productivity, accuracy and autonomy in the quality sector. In order to analyse whether there is a real and growing interest in the use of AR as assisting technology for manufacturing sector in general and quality control in particular, two specific research questions are defined. In addition, two well-known research databases (Scopus, Web of Science) are used for the paper selection phase in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology to conduct a preliminary study and evaluate the current development of AR applications in manufacturing sector in order to answer the defined questions. It is found that while the development of AR technology has widely implemented to assign real-time information to several systems and processes in assembly and maintenance sectors, this tendency has only emerged in the quality sector over the last few years. However, AR-based quality control has proved its advantages in improving productivity, accuracy and precision of operators as well as benefits to manufacturing in terms of product and process quality control across different manufacturing phases.

Phytochemicals with nanoparticles and their potential applications in medicine – A review

Phytochemicals having multiple properties which are used to cure various diseases such as cancer, diabetes, neurodegeneration, angiogenesis, aging, inflammatory, cardiovascular and arthritic disease, etc., Extensive use of phytochemicals and their derivatives leads to unavailability or scarcity of products in nature. Despite this episode, the nanotechnology resolves the setback of handling phytochemicals by increasing their bioavailability, long-lost acting, target-specific and less or no toxicity. Here, we focused on the 24 known phytochemicals and preparation of NPs without discriminating the polymers and metals in NPs. All the phytochemicals did not fully satisfy the toxicological hazards, physical-pharmaceutical challenges, bioethical and health issues research. Hence these NPs and their NP incorporated phytochemicals need to be characterized in a way to give direct usage to the common man. Commercialization of NP formulations in pharmaceuticals needs statutory regulation norms for complete satisfaction and safety for end-users. As of now, many NP mediated pharmaceutical products are available in the market with full-fledged but still many unrevealed about their fate in the environment. In this review, the characterization of nanoparticles, the transparent benefit of nanoparticles (NPs), and their current application in various fields has been discussed.

Prevention through Design: Architecture Student Cognizance

Prevention through Design (PtD) is a process to prevent and control any potential injury occurrences, illnesses, and fatalities by “designing out” or minimizing hazards and risks early in the designing building. It is a process that incorporates related safety-design strategies during the design phase. Due to an overwhelming number of construction industry accidents in recent years, early attention to safety precautions in the design process has been of very deep concern. The lack of PtD knowledge among designers could be a barrier to implement the PtD concept, from improving the life-cycle of the project to considering safety matters that start from the design stage. Especially in Malaysia, architecture-based programs are generally focused on their design goals at the institutional level, and they aim towards accomodating end-user safety. However, there is no space for a new PtD-centric course to be introduced. Although there have been previous studies on the introduction of PtD, specific studies on the presence of PtD education in architecture programs are still lacking. This paper, therefore, seeks to obtain constructive feedback on prevention through design and its awareness among architecture students. The ideal period of PtD exposure is by scholastic interference to further express the importance of safety concerns in an early design process. Thus, a total of 60 respondents were selected among third-year to fourth-year architecture students in Universiti Teknologi MARA Seri Iskandar Campus in Perak. The findings showed that educational engagement strengthened students’ views on the causality of accidents and promoted safe design thought at the initial design process. However, in the design course, insufficient emphasis on PtD proves to be a challenge for students to consider in the design project application. Further studies are therefore deemed necessary to identify the method of incorporating PtD sentience through scholastic intervention as an initiative to promote PtD in university degree programs to enhance awareness of safety issues.

Copolymerization of butyl acrylate with methyl methacrylate in a bubble column reactor and the use of copolymer in corrosion protection

In this paper, copolymerization of methyl methacrylate (MMA) with n-butyl acrylate (BA) in a bubble column reactor using benzoyl peroxide as free radical initiator, at a temperature over 85 °C, is presented. This mode of copolymerization keeps an inert atmosphere throughout the entire reaction and contributes to proper mixing of the monomers. Higher pressure of the bubbling ensures the faster contact of the species, and a higher conversion was obtained in a shorter reaction time. The conversion of monomer at 124 Pa after 210 min is total, which is particularly noteworthy due to the absence of residual monomer that represents hazardous compounds, with negative impact upon employees and end-user safety. Higher conversions are obtained at 96 °C, 124 Pa nitrogen bubble pressure, 60/40% moles monomer ratio BA/MMA and 2% POB. The molar mass Mw, Mn and PDI decrease with the increase in temperature quite linearly. In the absence of nitrogen bubbling, the copolymer composition is approximately the same as in the feeding mixture. The corrosion protection efficiency of steel painted with these acrylic coatings was carried out by means of OCP and potentiodynamic polarization testing and electrochemical impedance spectroscopy (EIS).

A comparison of motor vehicle recalls between Brazil and Germany: different approaches and results

Failures during the product development process can lead to problems in product quality and reliability, which in turn can cause serious harm to its end-users. When such failures are discovered after a vehicle is already in usage, a safety recall is required, which can incur in potential damage and losses to brand image. Recall rates of multinational companies can be affected by regional law enforcement and quality requirements of local governments. Despite its importance for the safety of end-users, the automotive vehicle recall process in Brazil is little studied by the academy. The main objective of this project was to collect data and clarify how the automotive vehicle recall process is carried out in Brazil and how it could be improved by comparing it with Germany, a country with very advanced regulations in this sector and with a fleet of vehicles similar to that of Brazil. To achieve this goal, the work provided an overview of the available data in both countries, developed a scalable method for comparing recall rates and an analysis of recall rates of the main OEMs in operation. The work concludes using this data to draw insights on how these processes can be improved.

Current Challenges in Labelling for Generic Medicinal Products: Company Core Data Sheet (CCDS) Development and Maintenance.

Labelling of pharmaceutical products plays a vital role in the safe and effective use of approved medicinal products. This information may be provided to end-users including patients and/or prescribers, and it needs to be made available in multiple formats including printed forms (patient information leaflets, pack inserts, etc.) or web portals of the product, based on national authority guidelines. The Company Core Data Sheet (CCDS) serves as a key document representing the pharmaceutical company’s position on the product and is used as a reference document for national labels. Content from national labels may differ from the CCDS for different reasons including implementation of national authority requirements in the serving market and findings from local markets. In the current article, we discuss the process, challenges and key concepts in creating and maintaining CCDS documents for generic products. We highlight key parameters that are worthy of process improvement in generic products’ CCDS updates. In addition, we argue that labelling harmonisation across multiple regions, especially safety section-related information, plays a key role in promoting end-user safety and would help communicate risks. We also strongly believe that the topic is worthy of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) consideration, and propose that this is the key area that requires standardisation and harmonisation.

Safety assessment of homeopathic medicines: The Adonis vernalis paradox and the 'analysis trap' of using different pharmacopeias.

Regulatory agencies have to ensure the end-user safety of botanically derived homeopathic medicines prepared with diluted starting materials derived even from toxic plants. In the case of plant-derived homeopathic products, assessment must consider the particular characteristics of an extract and its component molecules, even if diluted. The identification and quantification of these molecules have a crucial role in risk assessment, as it allows complete toxicological evaluation in a regulatory perspective. Different results can be achieved using different approaches and references supported by the same regulatory framework, as different methods of preparation used, assays and test analysis performed in compliance with different referent pharmacopoeias. All these facts can introduce a bias in the safety assessment and the paradoxical outcome for homeopathic Adonis vernalis underlines the need for caution. The case also demonstrates the relevance of considering the analytical method for assessment of all herbal medicinal products or herbal supplements, with the purpose of finding the total amount of toxicants as a good approach.

Complex Motor Learning and Police Training: Applied, Cognitive, and Clinical Perspectives.

The practices surrounding police training of complex motor skills, including the use of force, varies greatly around the world, and even over the course of an officer’s career. As the nature of policing changes with society and the advancement of science and technology, so should the training practices that officers undertake at both central (i.e., police academy basic recruit training) and local (i.e., individual agency or precinct) levels. The following review is intended to bridge the gap between scientific knowledge and applied practice to inform best practices for training complex motor skills that are unique and critical to law enforcement, including the use of lethal force. We begin by providing a basic understanding of the fundamental cognitive processes underlying motor learning, from novel skill acquisition to complex behaviors including situational awareness, and decision-making that precede and inform action. Motor learning, memory, and perception are then discussed within the context of occupationally relevant stress, with a review of evidence-based training practices that promote officer performance and physiological responses to stress during high-stakes encounters. A lack of applied research identifying the neurophysiological mechanisms underlying motor learning in police is inferred from a review of evidence from various clinical populations suffering from disorders of cognitive and motor systems, including Alzheimer’s and Parkinson’s disease and stroke. We conclude this review by identifying practical, organizational, and systemic challenges to implementing evidence-based practices in policing and provide recommendations for best practices that will promote training effectiveness and occupational safety of end-users (i.e., police trainers and officers).

Analysis of spring operated pressure relief valve proof test data: Findings and implications

Ten years of research into spring operated pressure relief valve (SOPRV) proof test data are reviewed. Previously unpublished results are also presented. The principle findings are: proof test data alone are insufficient to properly analyze SOPRV safety behavior; root cause analysis (RCA) of all failed SOPRV is also required; probability of initial failure is a real and concerning phenomenon in both new (not previously installed) as well as used (previously installed) SOPRV but does not affect all SOPRV equally; SOPRV failure rates and safety performances depend on many variables including set pressure, SOPRV design and manufacturing specifics, and end user safety and maintenance practices; certain SOPRV require shorter proof test intervals (2–3 years) to maintain desired safety ratings but others can endure much longer proof test intervals with only small additional safety risks. Understanding all of the parameters which impact SOPRV safety performance and collecting safety performance data (including RCA of failed SOPRV) at the individual facility level are the keys to optimizing commissioning and pre‐installation proof testing and proof test intervals, and potentially to extending turnaround times. © 2018 American Institute of Chemical Engineers Process Saf Prog 37: 467–477, 2018

Performance Evaluation of Design AD System Biogas Purification Filter

Biogas purification which is the removal of impurities so as to improve the efficiency of gas produced, ensure the safety of end users and prolong the life of the equipment cannot be neglected. This paper is focused on the design and performance evaluation of AD system biogas purification filter. Three different conceptual designs were generated from possible design consideration, feasibility study and preliminary test and with the help of decision matrix; the best conceptual design was selected from which the purification filter was fabricated. The selected concept for detail design was a transparent polyethene cylindrical purification filter fitted with local iron sponge containing activated charcoal and local potash. The reagents were arranged in this order; local potash for the removal of water vapour and carbon dioxide followed by activated charcoal which serves as a purifying agent for hydrogen sulphide. The results obtained showed reduction in percentage composition of hydrogen sulphide (H2S), carbon dioxide, and water vapour. On the other hand, there was an increase in percentage composition of methane (CH4) which is an indication of improvement in methane production after purification. The outcomes of the results obtained were satisfactory and the combination of local potash and activated charcoal was adequate for biogas purification.

Assessment of commercial micro-machined hydrogen sensors performance metrics for safety sensing applications

Hydrogen sensors are increasingly recognized as safety enhancing components in applications where hydrogen is used as a clean energy carrier. The availability of low-cost, reliable, high performance hydrogen sensors is critical for facilitating the widespread and safe deployment of hydrogen systems. Accordingly, new sensing element designs based on advanced manufacturing techniques are being developed. Using micro-machining techniques, miniaturized versions of conventional hydrogen gas sensing elements have already been introduced in the market, with the promise of low-cost and high performance sensing metrics. An assessment of commercial micro-machined sensing elements relative to their conventional counterpart is presented in this paper. The results show that although some performance improvements were observed for commercial micro-machined sensors relative to their conventional counterparts, some models of micro-machined sensors were plagued with significant performance degradation. Furthermore, actual sensor performance, as determined by laboratory assessment often did not meet the manufacturer's published specifications. This work verifies the sensing metrics improvements brought by the micro-technology as well as its shortcomings for guiding the end-user safety applications.