Functional Safety Research Articles

Cybersecurity Requirements for Industrial Machine Control Systems

The first part of this paper discusses the research context, taking a closer look at the development of Industry 4.0 and the growing importance of the IIoT, which entails new cybersecurity challenges. The issue of cyber threats and the need to increase the level of protection in machine control systems, which are particularly vulnerable to attacks due to their connection to the network, is also presented. The Introduction concludes with a presentation of the article’s objective, which is to analyze the requirements of security levels (SLs) and the implementation of relevant international standards. The next section reviews the current research on cybersecurity in machine control systems. This section also points out the research gaps that the article aims to fill. The next section presents the risk assessment used to ensure safety during machine operations based on ISO 12100. The article describes safety functions implemented in machine control systems, including the SIL (safety integrity level) and PL (performance level) specifications. An important part of the article is the creation of a relationship between PL and SL, showing how the safety functions of systems are related to protection against cyber threats. The last part of the article gives a case study in the form of examples of machines and their control systems performing safety functions, which require various SLs depending on the PLs.

Efficacy and Safety of Altibrain® as an Adjunctive Therapy for Autism Spectrum Disorder: An Open Label Trial Targeting Core Symptoms.

This study aimed to evaluate the effectiveness and safety of Altibrain® in combination with standard Autism Spectrum Disorder (ASD) treatment compared to standard ASD treatment alone in individuals diagnosed with ASD. A randomized, open-label trial was conducted involving 120 participants aged 3 to 17 years, randomly assigned to either the Standard ASD Treatment group or the Altibrain® + Standard ASD Treatment group. Sixty patients were randomly allocated to each Standard ASD Treatment group or the Altibrain® + Standard ASD Treatment group. participant allocation was done by computer-generated randomization. Participants had confirmed ASD diagnoses based on DSM-IV or ICD-11 criteria and demonstrated moderate to severe core ASD symptoms. Informed consent was obtained from caregivers. A total number of 120 subjects were included, consisting of 71 male and 49 female patients. Participants received either standard ASD treatment alone or Altibrain® in addition to standard ASD treatment orally once daily for 24 weeks. A total of 7 study visits/24 weeks to analyze the intervention efficacy of the Standard ASD Treatment group or the Altibrain ® + Standard ASD Treatment group. Primary outcomes included changes in core ASD symptoms measured by the Autism Diagnostic Observation Schedule (ADOS) and safety assessments. Secondary outcomes included alterations in social communication skills, reduction in repetitive behaviors, overall functional improvements, and safety and tolerability of Altibrain®. Altibrain® significantly improved qualitative deficits in social interaction and repetitive behaviors compared to standard ASD treatment alone (p < 0.0001). The Altibrain® + Standard ASD Treatment group demonstrated significant improvements in social functioning, social awareness, cognition, communication, and motivation compared to the Standard ASD Treatment group (p < 0.0001). Additionally, Altibrain® showed superior efficacy in reducing hyperactivity/noncompliance, inappropriate speech, irritability, lethargy/ social withdrawal, stereotypic behavior, and aberrant behavior compared to standard treatment alone (p < 0.0001). Additionally, Altibrain® exhibited a favorable safety profile as per the 4-week post-treatment safety follow-up. Further research is warranted to confirm and expand upon these results, including longer-term studies with larger cohorts and investigations into underlying mechanisms. Overall, Altibrain® holds promise as a valuable therapeutic option for individuals with ASD and their families. Limitations of the study include neuroimaging and biomarkers analysis.

Elevated CO2-mediated climate warming favors protozoan's top-down effect on controlling toxic Microcystis.

Under temperature and CO2 level rising, the dominance of toxic cyanobacteria in primary producers is continuously increasing the risks of water safety and hindering functions of aquatic ecosystems. Thus, it is necessary to evaluate the efficiency of algal control measures under climate warming. Based on highly efficient control of cyanobacteria by protozoan reported in previous studies, this study aimed to investigate top-down effect of protozoan Paramecium on toxic Microcystis under CO2-mediated climate warming. Results showed that Microcystis removal by Paramecium was mainly affected by Microcystis growth under climate warming based on path analysis. Growth rate and ingestion rate of Paramecium increased with Microcystis density, especially Paramecium growth was further promoted by >20% under high-density Microcystis at elevated CO2 and high temperature, however, Microcystis exhibited the contrary response, which indicated that there was a stronger sensitivity of Paramecium growth to increasing Microcystis relative to Microcystis itself under simulated conditions of "climate warming" such as elevated CO2 and high temperature, thereby helping Paramecium control Microcystis. Furthermore, reduction ratio of Microcystis and degradation ratio of microcystins were about 100% by Paramecium at the end of experiment. The time to Microcystis extinction and the time to microcystins degradation by Paramecium were reduced by about 10% at high CO2 and high temperature, and decrease rate of the ratio of Microcystis and Paramecium was enhanced by at least 25% relative to that under current temperature, which further demonstrated that enhanced top-down effect of Paramecium on Microcystis. Consequently, these findings demonstrated that climate warming and enhanced cyanobacterial growth by elevated CO2 and high temperature did not exacerbate the challenge for protozoans removing algae but promoted their top-down effect. Overall, this study provides new insights in protozoan-cyanobacteria interactions and strongly supports a practical application using protozoan in cyanobacteria-contaminated lake management under actual-future global warming.

Understanding factors influencing safety and team functionality at operative vaginal birth through multidisciplinary perspectives: a mixed methods study

BackgroundOperative vaginal birth (OVB) relies on effective teamwork to optimise outcomes. This study aims to explore providers’ perspectives of factors influencing safety and team functionality at OVB.MethodsThis mixed methods study involved four maternity sites at Monash Health, Australia. Surveys sent to healthcare providers invited quantitative and qualitative appraisal of safety and team functionality at OVB. Semi-structured interviews further explored themes emerging from survey responses. Categorical survey data were compared between staff roles using Pearson’s chi-squared tests. Thematic analysis of free-text survey responses and interviews identified themes influencing safety and team functionality at OVB.FindingsWe received 100 survey responses from obstetric (n = 41), midwifery (n = 52) and paediatric (n = 7) staff, including senior (n = 49) and junior (n = 51) roles. Overall, 99% thought team communication should improve and 82% had witnessed practices outside protocol. Obstetric versus midwifery or paediatric staff were less likely to rate communication as low or very low quality (5% vs. 29%, p = 0.010). Reporting being extremely or very confident to escalate concerns was more likely in obstetric versus midwifery or paediatric staff (49% vs.12%, p = 0.003) and senior versus junior staff (44% vs. 10%, p = 0.008). Five overarching themes impacted on team functionality at OVB; (1) Quality of communication, (2) Preparation and risk assessment, (3) Leadership and interpersonal dynamics, (4) Transfer from Birth Unit to Operating Theatre, (5) Variation in clinical practice.DiscussionSome care providers perspectives of team functionality at OVB differed, with midwifery and paediatric staff more likely to report challenges with communication and were less empowered to escalate concerns. Training in factors impacting team functionality at OVB should be considered.

Post-hoc analysis of the tofogliflozin post-marketing surveillance study (J-STEP/LT): Tofogliflozin improves liver function in type 2 diabetes patients regardless of BMI.

Patients with type 2 diabetes are at high risk of developing steatotic liver disease (SLD). Weight loss has proven effective in treating metabolic dysfunction-associated steatotic liver disease (MASLD) in obese patients with type 2 diabetes, with sodium-glucose cotransporter 2 (SGLT2) inhibitors showing promising results. However, lean MASLD is more prevalent in Japan, necessitating alternative approaches to body weight reduction. We used the J-STEP/LT dataset including up to 3-year treatment data to analyze the effects of the SGLT2 inhibitor tofogliflozin on liver function and treatment safety and conducted a subgroup analysis based on body mass index (BMI; kg/m2, <20, 20-<23, 23-<25, 25-<30, and ≥30). This study included 4,208 participants. Tofogliflozin significantly reduced alanine aminotransferase (ALT) levels in participants with baseline ALT levels >30 U/L across all BMI groups, with median changes of -12, -16, -13, -15, and -15 U/L, respectively (P = 0.9291 for trends). However, median changes in body weight with tofogliflozin were -2.00, -2.75, -2.00, -3.00, and -3.80 kg, respectively (P < 0.0001 for trends), with no significant weight loss observed in the BMI <20 group. ALT levels were also significantly decreased in participants who did not lose weight. Safety assessments according to BMI and age categories revealed no clear differences in the frequency of adverse events. Tofogliflozin reduced ALT levels without substantial body weight reduction among lean participants. These findings suggest that SGLT2 inhibitors may be a viable treatment option for non-obese patients with type 2 diabetes and SLD.

Developing a cost-effective and efficient safety case management solution for data coordinating center projects.

A centralized safety function can support multiple clinical trials and provide efficient, standardized processes for the management of serious adverse events. From 2017 to 2022, the centralized safety desk used pharmacovigilance software compliant with FDA regulations, including 21 CFR Part 11. This software assisted with processing safety cases for regulated clinical trials, including allowing capture of event data, and provided process flow management, documentation storage, and transmission of safety reports to FDA. During the software's tenure, we experienced incompatibilities with other clinical research software resulting in unanticipated inefficiencies. Furthermore, the small number of periodic and suspected unexpected serious adverse reaction (SUSAR) cases rendered the annual license fee not cost-effective. An internal analysis of our workflow, systems, and processes revealed that developing a cost-effective and efficient customized solution for our existing data coordinating center (DCC) projects was feasible. The customized solution mimics the key functionality and workflow of the prior software. It utilizes existing electronic data capture systems and document management solutions, ensuring 21 CFR Part 11 compliance without incurring additional expenses. The proposed process received internal approval and launched in December 2022. The process outlined in this paper is particularly advantageous for DCCs or academic clinical research sites that must meet regulatory reporting requirements without depending on specialized pharmacovigilance software. Additionally, it is a cost-effective option for organizations with a low volume of SUSAR events. In this paper, we present the process of developing and implementing a customized safety case management solution and the lessons learned pre and post implementation.

Enhancing the function of the aids to navigation by practical usage of the deep learning algorithm

Abstract Information is provided to navigators through advanced onboard navigation equipment, such as the electronic chart display and information system (ECDIS), radar and the automatic identification system (AIS). However, maritime accidents still occur, especially in coastal and inland water where many navigational dangers exist. The recent artificial intelligence (AI) technology is actively applied in navigation fields, such as collision avoidance and ship detection. However, utilising the aids to navigation (AtoN) system requires more engagement and further exploration. The AtoN system provides critical navigation information by marking the navigation hazards, such as shallow water areas and wrecks, and visually marking narrow passageways. The prime function of the AtoN can be enhanced by applying AI technology, particularly deep learning technology. With the help of this technology, an algorithm could be constructed to detect AtoN in coastal and inland waters and utilise the detected AtoN to create a safety function to supplement watchkeepers using recent navigation equipment.

Multicomponent telerehabilitation program for veterans with multimorbidity: A randomized controlled feasibility study.

Older veterans with multimorbidity experience physical and social vulnerabilities that complicate receipt of and adherence to physical rehabilitation services. Thus, traditional physical rehabilitation programs are insufficient to address this population's heterogenous clinical presentation. To evaluate the feasibility and acceptability of a MultiComponent TeleRehabilitation (MCTR) program for older veterans with multimorbidity. Randomized controlled cross-over feasibility study. Telehealth from Veterans Affairs Medical Center to participants' homes. Fifty U.S. military veterans, age ≥60 years (mean ± SD; 69.2 ± 6.7) with ≥3 comorbidities (6.0 ± 1.9), and impaired physical function were randomized and allocated equally to two groups. The MCTR program consisted of high-intensity rehabilitation, coaching, social support, and technologies. Physical therapists delivered 12 individual and 20 group telerehabilitation sessions/participant. Participants in the education group started the MCTR program after 12 weeks. The primary outcome was combined adherence (>75% of participants attending ≥80% sessions). Acceptability was measured by the Acceptability of Intervention Measure. Secondary outcomes included safety, participant surveys, and physical function. Patient-level outcomes were collected at baseline, 12 (primary time point), and 24 weeks. Of 50 participants, 39 adhered to total session attendance (0.78 [95% confidence interval: 0.64-0.88], p = .76), 45 adhered to individual sessions (0.90 [95% confidence interval: 0.78-0.97], p = .01), and 48 rated the program as acceptable (0.96 [95% confidence interval: 0.85-0.99], p < .001). Thirty-five participants reported 78 safety events, and 12 (15%) had some degree of relatedness to the protocol. Most patient-level outcomes were similar between groups at 12-weeks. The MCTR program was feasible based on high adherence to individual sessions and high acceptability. Adherence results were consistent with previous exercise studies in older adults. Most in-session safety events were related to underlying medical conditions and consistent with in-person physical rehabilitation safety events. These results can inform use of telerehabilitation for similar populations.

Induced polarization of clay-rich materials — Part 4: Water content and temperature effects in bentonites

Deep geological disposals (DGDs) are widely seen to be the best solution to contain high-level radioactive wastes safely. Compacted bentonite and bentonite-sand mixtures are considered the most appropriate buffers or sealing materials for access drifts, ramps, and shafts due to their favorable physicochemical and hydromechanical properties. Bentonite-sand mixtures are expected to swell and seal all voids when in contact with water, forming an impermeable barrier to radioactive elements. The parameters that will most affect the hydraulic performance of these seals are their water content, dry density, water salinity, and temperature. Monitoring and assessing these parameters are, therefore, crucial to confirm that the seals’ safety functions are fulfilled during the life of a DGD. Induced polarization (IP) is a nonintrusive geophysical method able to perform this task. However, the underlying physics of bentonite-sand mixtures has not been checked. The complex conductivity spectra of 42 compacted bentonite-sand mixtures are measured in the frequency range of 1 Hz–45 kHz in order to develop workable relationships between in-phase and quadrature conductivities versus water content and saturation, pore water conductivity, bentonite-sand ratio (10% to 100%), temperature (10°C–60°C), and dry density (0.97 to 1.64 [Formula: see text]). We observe that conductivity is mostly dominated by surface conductivity associated with the Stern layer coating the surface of smectite, the main component of bentonite. At a given salinity and temperature, the in-phase and quadrature conductivities obey power law relationships with water content and saturation. The in-phase and quadrature conductivities depend on temperature according to a classical linear relationship with the same temperature coefficient. A Stern layer-based model is used to explain the dependence of the complex conductivity with water content, dry density, water salinity, and temperature. It could be used to interpret IP field data to monitor the efficiency of the seal of DGD facilities.

Functional safety-oriented hazard analysis and risk assessment for vehicular fuel cell systems.

Functional safety is an emerging trend for safety design in the automobile industry. This study is an innovative exploration of a hazard analysis and quantitative risk assessment (QRA) methodology based on the functional safety of vehicular fuel cell systems. In this study, the potential hazards that fuel cell vehicles may encounter during operation were identified using the automobile generic hazard list. The failure modes and influences of the main components of the fuel cell system were determined via hazard and operability studies. Furthermore, the risks and consequences of the fuel cell system were explored using the QRA method. The failure frequency and unavailability of the fuel-cell system were calculated, and the architecture was optimized using a redundant design with a focus on hydrogen safety. The results showed that the optimized system architecture could effectively reduce the hazard of hydrogen leakage, and the unavailability and failure frequency of hydrogen leakage risk were reduced by 94.4% and 36.8%, respectively. Thus, this study provides powerful insights for future research and improvement of vehicular fuel cell systems.

Dual antiplatelet therapy after minor strokes or high-risk TIA: Evidence from the Austrian stroke registry.

Three large, randomized trials demonstrated the benefit of short-term dual antiplatelet therapy (DAPT) versus monotherapy after non-cardioembolic minor stroke or high-risk transient ischemic attack (TIA). The aim of this study was to evaluate effects of DAPT versus monotherapy on functional outcomes and safety in a real-life setting. Patients with minor stroke (NIHSS <4) or high-risk TIA (ABCD2 score ≥4) of non-cardioembolic origin without major vessel occlusion or revascularization therapy (thrombolysis or thrombectomy) treated between 2018 and 2023 were analyzed based on a prospective nationwide stroke unit registry. Data on risk factors, stroke etiology, admission stroke severity (NIHSS), functional status at 3 months (mRS), and mortality were extracted. Excellent functional outcome (mRS 0-1) at 3 months, early neurological deterioration (END), symptomatic intracranial hemorrhage (SICH) and major extracranial bleeds were defined as study endpoints and adjusted for covariates using inverse probability of treatment weighted regression models. Two Thousand Two Hundred Fifty-four of 8546 patients with non-cardioembolic minor stroke or high-risk TIA received DAPT. Patients treated with DAPT had significantly more risk factors and comorbidities compared to those treated with monotherapy. After robust statistical adjustment, DAPT was significantly associated with lower occurrence of END (OR 0.50 95% CI 0.35-0.72), increased odds of excellent outcome at 3 months (aOR 1.59; 95% CI 1.20-2.09) and equivalent frequencies of SICH (aOR 1.19, 95% CI 0.30-4.73) or major extracranial bleeding (aOR 0.84; 95% CI 0.16-4.56). DAPT in non-cardioembolic minor stroke or high-risk TIA in a real-life setting appears to be safe and associated with improved functional outcome.

Advancements of astaxanthin production in Haematococcus pluvialis: Update insight and way forward.

The global market demand for natural astaxanthin (AXT) is growing rapidly owing to its potential human health benefits and diverse industry applications, driven by its safety, unique structure, and special function. Currently, the alga Haematococcus pluvialis (alternative name H. lacustris) has been considered as one of the best large-scale producers of natural AXT. However, the industry's further development faces two main challenges: the limited cultivation areas due to light-dependent AXT accumulation and the low AXT yield coupled with high production costs resulting from complex, time-consuming upstream biomass culture and downstream AXT extraction processes. Therefore, it is urgently to develop novel strategies to improve the AXT production in H. pluvialis to meet industrial demands, which makes its commercialization cost-effective. Although several strategies related to screening excellent target strains, optimizing culture condition for high biomass yield, elucidating the AXT biosynthetic pathway, and exploiting effective inducers for high AXT content have been applied to enhance the AXT production in H. pluvialis, there are still some unsolved and easily ignored perspectives. In this review, firstly, we summarize the structure and function of natural AXT focus on those from the algal H. pluvialis. Secondly, the latest findings regarding the AXT biosynthetic pathway including spatiotemporal specificity, transport, esterification, and storage are updated. Thirdly, we systematically assess enhancement strategies on AXT yield. Fourthly, the regulation mechanisms of AXT accumulation under various stresses are discussed. Finally, the integrated and systematic solutions for improving AXT production are proposed. This review not only fills the existing gap about the AXT accumulation, but also points the way forward for AXT production in H. pluvialis.

Automotive Functional Safety: Scope, Standards, and Perspectives on Practice

Automotive Functional Safety: Scope, Standards, and Perspectives on Practice

Identification Tests of Modern Vehicles’ Electromagnetic Environment as Part of the Assessment of Their Functional Safety

Are the regulations relating to electromagnetic compatibility (EMC) sufficient to ensure the safety of all autonomy systems? EMC is one of the critical factors influencing the proper functioning of a vehicle and its safety. However, the safety of autonomous vehicles from the perspective of EMC has not been comprehensively researched to date. The purpose of this article is to evaluate whether the currently imposed requirements are adequate. To assess research methods and requirements, it is necessary to determine the electromagnetic environment of vehicles. For this purpose, identification tests of the vehicle’s operating environment were conducted. The article presents the results of research on both the internal and external electromagnetic environments of vehicles. These studies were carried out using normative methods. Despite the significant importance of EMC and the existence of defined normative requirements, the results of the conducted research indicate that some devices available on the market, including those unrelated to vehicle autonomy, fail to meet these standards. Consequently, devices responsible for vehicle safety must be resistant to such electromagnetic exposures. In extreme cases, the malfunction of a single vehicle component due to inadequate electromagnetic compatibility could lead to the disruption of vehicle functions or driver disorientation. Such occurrences pose a direct threat to road traffic safety and the well-being of passengers.

Tranexamic Acid Within 4.5 Hours of Intracerebral Hemorrhage With the CTA Spot Sign: Systematic Review and Individual Patient Meta-analysis.

The antifibrinolytic agent tranexamic acid has been tested in intracerebral hemorrhage trials with overall neutral results. Ongoing contrast extravasation on CT angiography (spot sign) can identify individuals with ongoing bleeding who may benefit from anti-fibrinolytic therapy. We aimed to investigate the effect of tranexamic acid on hematoma growth in patients with spot signs treated within 4.5 hours of onset. We conducted a systematic review and individual patient meta-analysis, which we report according to the Preferred Reporting Items for Systematic Review and Meta-analyses of Individual Participant Data guidelines. PubMed and Embase were searched from inception to May 29, 2023, using the terms ((stroke) AND (randomised OR randomized) AND (tranexamic acid) AND (haemorrhage OR hemorrhage)). We included randomized trials comparing tranexamic acid with placebo in participants with primary intracerebral hemorrhage who had a spot sign and who had follow-up imaging within the required timeframe. Individual patient data were provided by each study and were integrated by the coordinating center. Data were pooled using a random-effects model. The primary endpoint was hematoma growth within 24 hours, defined as ≥33% relative or ≥6 mL absolute hematoma expansion compared with baseline, analyzed using mixed-effects-modified Poisson regression with robust standard errors, adjusted for baseline hematoma volume. Safety outcomes were mortality and major thromboembolic events within 90 days. Of 197 studies identified, 3 were eligible, contributing 162 participants for the primary analysis (60 female and 102 male). Hematoma growth occurred in 36 of 74 (49%) participants treated with tranexamic acid, compared with 48 of 88 (55%) participants treated with placebo (adjusted risk ratio 0.86, 95% CI 0.84-0.89, p < 0.001). Adjusted median absolute hematoma growth was 1.60 mL (95% CI 0.77-2.43) lower with tranexamic acid vs placebo. No differences in functional outcome or safety were observed. Tranexamic acid modestly reduced hematoma growth in patients with CT angiography spot signs treated within 4.5 hours of onset. Given the trials in the meta-analysis were individually neutral, these results require further validation before clinical application.

Riverbed Adjustments in Gravel–Sand Reaches Immediately Downstream of Large Reservoirs

The operation of large reservoirs significantly modifies flow–sediment regimes, and the reaches immediately downstream of the dams are the first to undergo responsive channel adjustments. Considering that the geomorphological responses are directly related to the flood control safety, channel stability and other sustainable functions of rivers, this paper explores the similarities and dissimilarities of the channel adjustments in the two reaches with gravel–sand beds immediately downstream of the Xiangjiaba reservoir and the Three Gorges Dam, respectively. The results show that major erosion primarily occurred during the initial years of reservoir impoundment. And then with the prominent reduction in washable sediment on the riverbed, the erosion intensity further weakened. It takes 6 to 13 years for the two reaches to reach a new state of relative equilibrium. In comparison, after the equilibrium state has been achieved, the reach with significant tributary sediment inflows exhibits alternating erosion and deposition dynamics, while the other remains relatively stable. The tributaries that transport a large amount of sediment during floods are the main sources of sediment deposition in the downstream reaches of the Xiangjiaba reservoir. However, the tributary inflow of the Qing River with low sediment concentrations has little impact on the riverbed evolution of the reaches from Yichang to Zhicheng immediately downstream of the Three Gorges Dam. These findings contribute to a deeper understanding of geomorphic adjustments near dams in response to upstream damming.

Partnerships for improved food safety: MESPT's engagements in effective pesticides governance and management in selected counties in Kenya

Pesticides continue to receive criticism due to their adverse impacts on the environment and human health, a food safety concern emanating from pesticide residues in food and the occupational pesticide exposure risks on farms. This usage has elicited increased attention from policymakers, consumer organizations, and the private and public sectors, pushing the authorities to strengthen pesticide governance and compliance. For instance, the East Africa Community (EAC) has borrowed heavily from the United States and European Union in revising its pesticide standards, which are currently under adoption among the six member states. The Pest Control Products Board (PCPB) in Kenya is at the frontline in the domestication and adoption of the EAC standards by developing new bills and reviewing regulations guiding pesticide usage. Furthermore, with agriculture being a devolved function, counties have woken up and are exploring avenues for promoting the wise use of pesticides. Counties are leveraging partnerships and multi-stakeholder collaboration to efficiently strengthen the pesticide policy-practice nexus. Micro Enterprises Support Program Trust (MESPT), a development organization in Kenya, is closely partnering with and building the capacity of 21 county governments to improve food safety and increase sustainable agricultural productivity through good agricultural practices (GAP) initiatives. This paper reviews the deliberate programmatic interventions by MESPT in facilitating investments within food safety control systems by key sector players. Furthermore, the paper highlights institutional efforts to strengthen farmer organizations to comply with and adapt sustainable agricultural practices that promote the reduced and safe use of pesticides in production. Through MESPT interventions, County Governments have established a functional food safety coordination mechanism and surveillance system backed by legal infrastructure. Additionally, the private sector has been capacitated on food safety compliance, thus influencing smallholder farmers to meet market standards, especially for formal markets. Across the counties, multi-stakeholder collaborations have been strengthened, fueling timely discussions on pesticide compliance toward improved food safety.

TRISO Fuel’s Safety Functions, Contributions to Reactor Safety, and Necessary Safety Limits

Safety functions are the actions, passive or active, that structures, systems, and components of a nuclear facility contribute to the safety of the workers, the public, or the environment. Well-defined safety functions are the foundation of a solid safety case for a reactor. For reactors that use tri-structural isotropic (TRISO)-coated particles, the TRISO fuel plays an important part in the safety case because of its ability to contain radionuclides in the fuel itself. This ability enables the use of a functional containment strategy for the reactor where radionuclide retention is the primary safety function supported by the safety functions of controlling reactivity control and controlling heat rejection. This paper establishes at a deeper level the role that TRISO fuel plays in each of these safety functions and the associated quality assurance and testing requirements for TRISO particle manufacturing to ensure these safety functions. Safety limits necessary to protect these safety functions include manufacturing specifications, operational limits, time-at-temperature limits, and fission gas release activity limits. This approach demonstrates the role that specific aspects of TRISO fuel play in protecting the safety of workers, the public, and the environment.

A Standardized Boswellia serrata Extract Improves Knee Joint Function and Cartilage Morphology in Human Volunteers with Mild to Moderate Osteoarthritis in a Randomized Placebo-Controlled Study

Background and objective Boswellia serrata Roxb. ex Colebr. (Family: Burseraceae; Genus: Boswellia) gum resin (Salai guggul) has profound therapeutic value in Ayurvedic and Unani medicines in alleviating several chronic inflammatory illnesses, including arthritis, asthma, skin and blood diseases, fever, etc. SN13108F (Aflapin®) is a proprietary, standardized Boswellia serrata gum resin extract. This 180-day randomized, placebo-controlled clinical study aimed to evaluate cartilage morphology using magnetic resonance imaging (MRI), pain and joint function and long-term safety in the SN13108F-supplemented volunteers with knee osteoarthritis (KOA). Materials and methods Eighty adult male and female subjects with the Kellgren-Lawrence grade II - III KOA were supplemented with SN13108F (100 mg/day) or a matched placebo for 180 consecutive days. Results SN13108F reduced (p < 0.001; vs. baseline and placebo) Western Ontario and McMaster Universities Osteoarthritis Index, Visual Analogue Scale, Lequesne’s Functional Index scores, improved six-minute walk test, and stair climb test. Post-trial MRI assessments of the tibiofemoral joints revealed that the cartilage volume, thickness, and joint space width were increased (p < 0.001; vs. placebo), and levels of high-sensitivity C-reactive protein, matrix metalloproteinase-3, Fibulin-3, type II collagen degradation peptide in serum, and cross-linked C-terminal telopeptide of type II collagen in urine were significantly reduced (p < 0.001; vs. baseline and placebo) in the SN13108F-supplemented subjects. Hematology, complete serum biochemistry, urine analysis, and the participants’ vital signs did not alter between the groups. Conclusion SN13108F supplementation is safe, and it mitigates joint pain and improves musculoskeletal function and cartilage morphology in KOA.

A Conceptual Framework for Sustainable Evidence-Based Design for Aligning Therapeutic and Sustainability Outcomes in Healthcare Facilities: A Systematic Literature Review.

Objective: The aim of this systematic review was to identify which aspects of evidence-based design (EBD) and sustainable design principles overlap based on evidence in the peer reviewed academic literature. By doing so, the study enables hospital infrastructure design decisions that prioritize both sustainability outcomes (sustainable hospital infrastructure design) and therapeutic (EBD) outcomes. Background: Healthcare facilities need to adapt to the future demands from a changing climate, demographic shifts, and economic restraints. Facilities need to be designed in ways that better support patients, staff, and the environment to ensure their long-term success. Methods: A systematic literature search was conducted through searches in SCOPUS and Web of Science. All studies in acute care settings were included in the review except those investigating EBD in the context of specific health conditions, which were excluded. Themes that overlap were identified to form a conceptual framework for sustainable EBD. Results: Sixty-five articles were included in the final analysis. Identified sustainability features were related to: Sociocultural and functional, Indoor environmental quality and wellbeing, Energy and atmosphere, Water, Materials and resources, Waste, Sustainable sites, and Facility design. EBD thematic analyses were categorized into Indoor environmental quality, Design, Sociocultural, and Functional performance and safety. Conclusions: Key areas of synergy include Indoor environmental quality and wellbeing and Energy and atmosphere. The development of the conceptual framework enables scholars and practitioners to identify design features that align both priorities and through future research, refine the framework.