Safety Objectives Research Articles

Study on screening and evaluation methods of cosmetics for people with facial sensitive skin.

Objective:The purpose of this study is to screen and evaluate cosmetic products for sensitive skin on the face.Methods:Thirty-five subjects with positive lactic acid sting test (LAST) were recruited from the staff of our hospital from November 2019 to February 2020. First, the human skin enclosed patch test of cosmetic gel (abbreviated as gel) was performed, and then the tested products were continuously applied for 4 weeks to complete the long-term efficacy test. Subjects’ sensation of application, pruritus, tingling and burning were assessed on a 0 to 9 scale prior to, 14, and 28 days after topical application. Moreover, the transepidermal water loss rate (TEWL), stratum corneum (SC) hydration, melanin index (MI), erythema index (EI) and dendritic cells and inflammatory cell infiltration were noninvasively detected by the tester. LAST were performed before applying, 14 and 28 days after application, and then the test results were compared.Results:In this study, a total of 34 people participated in the test. The results of human skin enclosed patch test indicated that only 1 case of grade 1 reaction occurred among the tested subjects. The subjects felt good after applying the products, and the gel showed high degree of skin comfortable, no irritation and good tolerability. Subjective safety evaluation illustrated that the scores of pruritus, tingling and burning of the subjects decreased in D14 and D28 patient revisit, showing statistically significant differences (P < .05). When the gel was applied for 4 weeks, TEWL (8.42 ± 1.12) and EI (201.35 ± 13.51) were lower than the results before application (P < .05), and the SC hydration (65.36 ± 2.56) was higher than that before application (P < .05). There was no correlation between the SC hydration and TEWL (R = 0.092, P = .416). The results of skin CT indicated that the number of facial dendritic cells decreased in 17 subjects (accounting for 50%) in D28 patient revisit, and the degree of inflammatory cell infiltration decreased in 27 subjects (accounting for 80%). Compared with the baseline value, the LAST score and total sensory score decreased after application the product for 4 weeks, and the difference was statistically significant (the mean value of P < .05).Conclusion:The subjective feeling of application and efficacy of cosmetics in people with sensitive skin could be successfully evaluated by the comprehensive application of human skin enclosed patch test, long-term trial test, subjective safety evaluation and objective efficacy evaluation. And it provides the basis to judge whether the cosmetic is consistent with the efficacy claim of sensitive skin.

Economic shipping policies for assuring safety integrity level of E/E/PE safety-related software

Electrical/electronic/programmable electronic (E/E/PE) safety-related systems are widely applied in several industrial fields due to noticeable technical growth of information processing technologies. In the design and development for the E/E/PE safety-related software, safety assessment is required by following IEC 61508, which is the international basic standard for the E/E/PE safety-related systems. And, quantitative safety assessment technologies is useful for enhancing and validating their safety for the hardware as well as for the software of the E/E/PE safety-related systems. Especially for the E/E/PE safety-related software, the manager pays a lot of attention for quantitative software safety assessment technologies, which have not provided by IEC 61508, and for realizing economic software development with their safety objective. This article discusses mathematical approaches for conducting quantitative safety assessment for the E/E/PE safety-related software and mathematical software release problem for supporting decision making on when to release the E/E/PE safety-related software economically with assuring a certain safety objective.

IMPLEMENTATION OF CONSTRUCTION SAFETY MANAGEMENT SYSTEM ON CONSTRUCTION PROJECTS IN INDONESIA (CASE STUDY: BRIDGE REPLACEMENT IN BANGKA REGENCY, BANGKA BELITUNG PROVINCE)

The Construction Safety Management System is part of the construction work implementation management system to ensure the realization of construction safety, security, safety, health and sustainability standards which are technical guidelines for security, safety, construction workplace health and labor social protection and local environment and environmental management in the implementation of construction services. Safety targets or objects consist of the work environment, the project affected environment, the natural environment and the built environment. The analysis of the Construction Work Plan for Service Providers on Bridge Replacement Works in Bangka Regency, Bangka Belitung Province which is reviewed in this discussion is that the identification of the level of risk that has been stated in the Construction Work Plan Document for Bridge Replacement Works has been detailed and can be used as a reference in the implementation in the field. so that the fulfillment of security, safety, health and sustainability standards that ensure the safety of construction engineering, labor safety and health, public safety and environmental safety can be maintained. An assessment of the implementation of Construction Safety on Bridge Replacement Works by Service Users has been carried out, from the results of the assessment there are still things that need to be improved continuously. Implementation of Construction Safety on Bridge Replacement Work has been carried out in accordance with the mandate of the legislation, but it still needs to be continuously improved so as to get maximum results.

Ensuring the objectives of environmental safety when using agricultural land

The article examines the state of legal regulation of relations related to ensuring national security. The importance of ensuring environmental safety as an integral part of the national security of the Russian Federation is noted. The author refers to the documents of strategic planning — Strategies on national security, on environmental security. Based on the analysis of the current state of protection of the individual, society, state from internal and external threats, using the approaches to ensuring the types of security specified in the strategy, the conclusion is made about the importance of implementing a set of measures aimed at ensuring security, among which the author highlights state supervision (control). Among a large number of bodies of such supervision, the author singles out and analyzes the activities of a specially authorized body for the implementation of state supervision over the state and use of agricultural land — the Federal Service for Veterinary and Phytosanitary Supervision. The author refers to the documents that regulate the implementation of supervisory functions, to documents reflecting the results of the work of this body, analyzes the results of such activities, draws conclusions about the presence of difficulties, problems in the implementation of such supervision in an effective way, suggests options for solving such problems.

Evaluasi Indikator Kinerja Keselamatan Reaktor Non Daya

Safety performance indicators (SPI) are observable actions/efforts that provide safety insights directly aimed at measuring how adequately the controls prevent accidents or unwanted incidents. In addition, the SPI is used to identify trends in performance relative to safety objectives, allowing actions to be taken to address unintended changes. Currently, the IAEA has the format for SPI non-power reactors, and BAPETEN has issued Regulation Number 1 of 2017 on Implementation of Inspections in Regulatory of Nuclear Energy Utilization; therefore, it is necessary to evaluate the harmony format of the SPI for non-day reactors. The purpose of this paper is to harmonize the contents of the IAEA version of the SPI with the BAPETEN regulations so that the contents of the IAEA version of the SPI are more detailed. Therefore, all aspects of the IAEA version of the SPI are accommodated in the SPI evaluation result format, and the evaluation version of the SPI format accommodates BAPETEN Regulation Number 1 of 2017. Keywords: safety performance indicator, research reactor.

Quality Analysis of Railroad Train Shunting Operation Plan Using the Intelligent Body Model

Shunting work is an important component part of railway transport production and is an important link in realizing the train marshalling plan and the train operation map, accelerating the rotation of vehicles, and completing the task of transport production. With the present, the gradual construction of passenger dedicated lines and high-speed train operation bring a new dawn to railroad transportation on the one hand, but on the other hand, high-speed train operation makes the process of train operation more complicated, and the safety hazards and uncontrollable factors of trains are higher than before. Compared with existing lines, passenger dedicated lines put forward higher requirements on the performance of train operation and dispatching system, requiring better real-time, intelligence, and interactive response characteristics of the train operation and dispatching system. The construction of passenger dedicated lines and the increase in train operation speed have put forward higher requirements for safe, on-time, and high-efficiency train operation. The train operation scheduling system is one of the cores of intelligent railroad transportation system, which is the guarantee of safe and on-time train operation. This requires the search for new control strategies to meet the requirements of high-speed train operation and multiple objectives of safety, punctuality, and comfort. Train operation scheduling is a typical distributed system. At present, there are still problems in the safety of railway shunting operations, such as disconnection in management and implementation, failure to revise some rules and regulations, frequent occurrence of obstacles in equipment and facilities, and substandard quality of operators. Therefore, it is necessary to make a systematic analysis of the current situation of railway shunting safety and propose countermeasures and measures. By studying the structure of intelligent body and multi-intelligent body theory, it decomposes the influencing factors of railroad shunting operation, designs the intelligent body model of each element, and applies it in train shunting operation to improve the quality of railroad shunting operation.

Smart streetlight framework for collision prediction of vehicles

Road accidents cause a large number of public fatalities in developing countries affecting them economically. It has been more than a decade since automobile industries are into developing intelligent vehicles with a major objective of road safety. In order to warn or assist the drivers, various automobile manufacturers have been focusing on developing autonomous or semi-autonomous vehicles, but not much effort has been drawn towards developing the smart infrastructure to supplement the development of intelligent vehicles. This paper proposes a framework for a smart vehicle monitoring system to provide smooth mobility of vehicles using roadside units such as streetlights. Such a system aims to eliminate the necessity of equipping each vehicle with smart sensors, which is typically an expensive scheme in most of the developing and underdeveloped countries around the world. This paper attempts to approach the problem of vehicle collision prediction by designing the system based on the concepts from science and engineering such as relative motion and vectors and implementing it using a machine learning-based model. These concepts led to the generation of datasets over which the prediction model was trained. The performance of the proposed model has been simulated using the software - Virtual Crash.

Fire performance and regulatory considerations with modern methods of construction

Modern methods of construction (MMC) are becoming increasingly popular for a broad range of reasons. They are portrayed as providing significant economic and sustainability benefits over ‘traditional’ construction methods, <em>e.g</em>. efficiencies gained by integrating the processes and technologies of design, manufacturing, and construction to result in higher quality buildings. It may also include a reduction in delivery times, more predictable costs, and fewer environmental impacts. However, MMC introduces increased complexity and can present challenges for traditional building regulatory approaches, especially those which focus on inspecting and verifying construction at many points in the construction process. With prefabricated components and modules this requires different approaches. Performance concerns arise for meeting the fire safety objectives of the final building. One particular fire challenge is the presence of void spaces, often needed to facilitate the connection of modules, which can potentially serve as avenues for the spread of fire, smoke, and hot gases. These fabrication issues, performance concerns, and regulatory challenges are explained. Fire performance issues are then explored for different regulatory typologies (prescriptive, performance based, market based), the verification of subsystem performance, and the compliance of installed components/whole building. Recommendations for regulatory frameworks are provided to provide increased confidence and reduced risks. <em><strong>Policy relevance</strong></em> While every country needs to work within their regulatory framework and implement systems that work for them, it seems that with the growing use of MMC, additional regulatory guidance and oversight may be warranted to help increase confidence in the performance of modular buildings, in particular from a fire performance perspective. This might include the development of design and installation guidance, as well as regulatory review, inspection, and approval guidance. It may also mean the development of new test methods or standards, especially if materials or connection conditions (<em>e.g</em>. void spaces) warrant. As many countries have already mandated, it seems that the requirement for some form of quality assurance/quality control (QA/QC) procedures to help assure manufactured/fabricated components comply with regulatory requirements is an essential component.

O-306 LINZAGOLIX FOR ENDOMETRIOSIS-ASSOCIATED PAIN: SAFETY RESULTS FROM EDELWEISS 3, A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Abstract Study question Is once-daily linzagolix treatment for women with moderate to severe endometriosis-associated pain (EAP) safe for use for up to 6 months of treatment? Summary answer Both doses of linzagolix were well-tolerated with minimal BMD decrease and few TEAEs &amp;gt;5% in either linzagolix arm. What is known already Linzagolix (LGX) is an investigational once-daily oral GnRH receptor antagonist that reduces serum estradiol in a dose-dependent manner and is being developed in two dosages for the treatment of endometriosis-associated pain (EAP): 75 mg, and 200 mg dose with hormonal add-back therapy (ABT). Study design, size, duration EDELWEISS 3 is a randomized, double-blind, placebo-controlled, multicenter Phase 3 trial of linzagolix in women with moderate to severe EAP. The trial includes 3 treatment arms: 75 mg LGX, 200 mg LGX with ABT (E2 1 mg/ NETA 0.5 mg), or placebo. Here we present safety results up to 6 months (24 weeks) of treatment. Participants/materials, setting, methods Eligible reproductive-aged women with moderate-to-severe EAP were randomized and treated (n = 484) for 6 months with 75 mg LGX, 200 mg LGX with ABT (E2 1 mg/ NETA 0.5 mg), or placebo. Safety and tolerability objectives reported here include 6-month results for treatment emergent adverse events (TEAEs), assessment of mean percent change from baseline (CfB) in lumbar spine (LS) bone mineral density (BMD) and Z-scores. The safety analysis set included 484 subjects across the 3 treatment groups. Main results and the role of chance The overall incidence of TEAEs was similar between the placebo and LGX 75 mg group (46.9%) and slightly higher (56.8%) in the LGX 200 mg + ABT group. There were few (3) serious TEAEs, and none were related to LGX. TEAEs that occurred in over 5% of patients in either active treatment arm included headache (10.5%, 8.1%, and 8.0%), hot flush (6.8%, 7.5%, and 2.5%), and fatigue (6.8%, 3.8%, and 2.5%) for the 200 mg LGX with ABT, 75 mg LGX, and placebo groups, respectively. Mean percent CfB (95% CI) in LS BMD was -0.79% (-1.15, -0.43%), -0.89% (-1.31, -0.47%), and +0.78% (0.41, 1.15%) for the 200 mg LGX with ABT, 75 mg LGX, and placebo groups, respectively. Z-scores at 6 months remained within the same range as baseline in all groups. Limitations, reasons for caution Additional efficacy and safety results from the trial's 24 weeks (6 mo) extension phase are pending. (Edelweiss 6 protocol: NCT04335591) Wider implications of the findings These results support further development of ABT and non-ABT doses of linzagolix that have potential to provide flexibility and choice for women seeking treatment for EAP. A non-ABT option is important for women who have a contraindication to, are at increased risk for complications, or prefer not to use ABT. Trial registration number ClinicalTrials.gov: NCT02778399

Automated Synthesis of Generalized Invariant Strategies via Counterexample-Guided Strategy Refinement

Strategy synthesis for multi-agent systems has proved to be a hard task, even when limited to two-player games with safety objectives. Generalized strategy synthesis, an extension of generalized planning which aims to produce a single solution for multiple (possibly infinitely many) planning instances, is a promising direction to deal with the state-space explosion problem. In this paper, we formalize the problem of generalized strategy synthesis in the situation calculus. The synthesis task involves second-order theorem proving generally. Thus we consider strategies aiming to maintain invariants; such strategies can be verified with first-order theorem proving. We propose a sound but incomplete approach to synthesize invariant strategies by adapting the framework of counterexample-guided refinement. The key idea for refinement is to generate a strategy using a model checker for a game constructed from the counterexample, and use it to refine the candidate general strategy. We implemented our method and did experiments with a number of game problems. Our system can successfully synthesize solutions for most of the domains within a reasonable amount of time.

Application of Quantitative Microbiology and Challenge Tests to Reach a Suggested Food Safety Objective in a Middle Eastern-Style Ready-to-Cook Chicken Product.

The contamination of ready-to-eat (RTE) and ready-to-cook (RTC) food products is a major global issue raising worry to consumers. Therefore, the behavior of Listeria monocytogenes and Salmonella spp., inoculated on a traditional Middle Eastern (M.E.) ready-to-cook (RTC) chicken product (“Taouk”-style), using the Risk Ranger® tool and the necessary management options (to accomplish the hypothetical food safety objectives (FSO)), when unsuspecting consumers may taste such a product were the primary subjects of our study. The behavior of the aforementioned pathogens was studied in the presence and absence of a selected natural antimicrobial combination (chitosan [CH] and thyme oil [T]), and were added as a combined treatment (M-CH-T) to the RTs chicken samples, stored at 4 or 8 °C for a period of 8 d. In the product, wherein no antimicrobials were added (control treatment, M), the initial counts of L. monocytogenes increased by ca. 1.5 (4 °C) and 3.0 (8 °C) log colony-forming units (CFU)/g during an 8-d storage. Salmonella spp. numbers did not increase during storage at 4 °C in the non-treated product, but at 8 °C, an increase of ca. 2.5 log CFU/g occurred. Addition of CH in combination with T to the RTC product (M-CH-T) inhibited the growth of L. monocytogenes and produced lower counts of Salmonella at 4 °C. However, M-CH-T treatment was less effective against both pathogens compared to the control after the 6th day of storage (8 °C). Predictive models based on quantitative microbiology, combined with hazard identification applied in the present study, may be potential means of assessing the safety of the RTC chicken products. It must be noted that for warranting the food safety of especially perishable items (e.g., chicken products), an efficient food safety management system must be applied, in addition to testing of the finished product, (e.g., based on the HACCP principles).

P1576: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, COMPARATOR-CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF V114 PNEUMOCOCCAL VACCINE IN HEMATOPOIETIC CELL TRANSPLANT RECIPIENTS (PNEU-STEM)

Background: Allogeneic hematopoietic cell transplant (allo-HCT) represents a definitive therapy for a variety of hematological diseases. Immunosuppressive therapy following allo-HCT and graft-vs-host disease (GVHD) render the patient susceptible to infectious complications, including invasive pneumococcal disease. Post-allo-HCT pneumococcal vaccination is recommended 3-6 months after transplant in a multi-dose series to help prevent pneumococcal disease. Aims: V114 is a 15-valent pneumococcal conjugate vaccine (PCV) approved in adults, containing all 13 serotypes in Prevnar 13™ (PCV13; contains serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) as well as epidemiologically important serotypes 22F and 33F. This study evaluated safety and immunogenicity of V114 when given to allo-HCT recipients. Methods: Individuals ≥3 years of age were randomized 1:1 to receive 3 doses of V114 or PCV13 in one-month intervals starting 3-6 months after allo-HCT. At 12 months after HCT, participants received either PNEUMOVAXTM 23 or a fourth dose of PCV if they experienced chronic GVHD. All participants or their legal representatives provided informed consent at enrollment. Primary safety objective was to evaluate the proportion of participants with adverse events (AEs) within each vaccination group for 3 to <18 years old and ≥18 years old age groups. Primary immunogenicity objective was to evaluate serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) for all 15 V114 serotypes at 30 days following the third PCV dose (Day 90) in each vaccination group. A key secondary objective was to evaluate opsonophagocytic activity (OPA) geometric mean titers (GMTs) for all V114 serotypes at Day 90. Results: A total of 274 subjects (14 children [3 to <18 years of age] and 260 adults ≥18 years old) were enrolled and vaccinated in the study. The proportion of participants with systemic AEs and serious AEs after any dose of study vaccine were generally comparable between intervention groups in the pediatric and adult cohorts. V114 recipients reported a higher proportion of injection-site AEs and vaccine-related systemic AEs compared to PCV13 in the adult cohort. Of all vaccinated participants, 32.4% experienced serious AEs during the study (28.8% in V114 group, 36.3% in PCV13 group). Seventeen participants (5.8% in V114 group, 6.7% in PCV13 group) died during the study. None of the deaths were determined by the investigator to be related to study vaccines. For both IgG GMCs (Table 1) and OPA GMTs, V114 was generally comparable to PCV13 for the 13 shared serotypes, and higher for serotypes 22F and 33F at Day 90. Image:Summary/Conclusion: V114 was well tolerated in allo-HCT recipients with a generally comparable safety profile to PCV13 for both pediatric and adult participants. Despite the immunocompromised status of the participants, the study vaccines induced serotype-specific immunogenicity and V114 induced generally comparable responses to PCV13 by IgG GMCs and OPA for the 13 shared serotypes at Day 90. In addition, V114 induced higher antibody responses than PCV13 for serotypes unique to V114 (22F and 33F). Study results support the use of V114 in allo-HCT recipients.

Seismic performance assessment of conventional construction concrete moment-resisting frame buildings in Canada using the FEMA P695 methodology

National Building Code of Canada (NBC) specifies 45 Seismic Force Resisting Systems to ensure the safety of building structures. Conventional construction concrete moment-resisting frame (CC-CMF) is one of these systems whose seismic response has not been systematically studied in Canada. This paper is an attempt to study the seismic performance of this system using the FEMA P695 methodology. In this regard, different archetype configurations were developed and analyzed through nonlinear static and dynamic analyses. Performance assessment results show that the CSA and NBC requirements for CC-CMF system represent the lower bound of values for seismic force modification factors, and conservatively meet life safety objectives presented in the NBC. Furthermore, different scenarios were considered for identifying ductility-related seismic force modification factor from pushover curves. The effect of height and gravity load levels on seismic force modification factors and collapse margin ratios are also presented by comparing archetypes having different configurations.

Study of solid municipal waste accumulation rates in penitentiary facilities in Perm Krai during the pandemic of 2020

Preventing the release of hazardous substances from waste into the environment is the most important environmental safety objective of municipal waste management. Uncontrolled dumping in landfills has a negative impact on the environment, being a source of harmful chemical and biological substances in the ground and surface waters, atmospheric air and soil, creating a certain threat to the health and life of the population. At present, the environmental problem associated with the collection and disposal of solid municipal waste (MSW) and is relevant not only for civil organisations, but also for institutions of the penitentiary system. The volume of MSW flows needs to be constantly updated, and therefore an average annual waste generation rate needs to be determined. The research described in the article was carried out during four seasons of 2020 at the facilities of the penal and correctional system of Perm Krai, on the example of remand prisons. The methodology for performing calculations based on the current regulatory documents is presented: methodological recommendations on issues related to the determination of MSW accumulation standards, approved by Order No. 524 of the Ministry of Construction and Housing and Communal Services of the Russian Federation dated July 28, 2016 and the Russian Government Decree No. 269 dated April 4, 2016 "On determining the accumulation standards for solid municipal waste". As a result of the work, the average daily and average annual volumes and masses of waste generated per person were determined. Fluctuations in waste generation during the four seasons were insignificant.

Prevention and practical strategies to control mycotoxins in the wheat and maize chain

Within this study, food safety management systems for wheat and maize, and derived white wheat flour and maize flour, have been evaluated, considering different prevention and practical intervention measures to be applied during storage and processing. For this purpose, through an operational flow chart, authors have performed mycotoxin-hazard analysis in the pre- and post-harvest phases and applied Food Safety Objective (FSO) and Performance Objective (PO) concept. Mycotoxin-hazard and analysis of control measures in the pre-harvest operations indicated that the most important practices at pre-harvest level for the control of mycotoxins in wheat/maize chain may include: (i) land preparation, such as tillage, cover crop and crop rotation, (ii) planting and antifungal mulch treatment, application of botanical extracts and intercropping, (iii) application of fungal biocontrol agents to reduce aflatoxins and (iv) application of fungal and bacterial biocontrol agents. For the post-harvest operations one Critical Control Point (CCP) and five Control Points (CPs) have been determined. The CCP includes an intervention measure that can be applied during storage, such as the application of treatments with volatile bioactive compounds, cold plasma, ozonisation or UV treatment. The results of FSO/PO analysis applied to wheat/maize chain revealed that FSO (the maximum level of mycotoxins in final food products given in European legislation) could be reached by combining conventional production steps such as cleaning and milling with different intervention strategies. For all strategies presented here, application on actual food production site must take into account local specificities and its interaction with climatic conditions. • Mycotoxin-hazard analysis for pre- and post-harvest operations for wheat and maize. • Intervention measure during grain storage as potential critical control point. • Combination of cleaning and milling with intervention measures to reach food safety objectives.

Single incision laparoscopic surgery (SILS) versus conventional laparoscopic technique for ileostomy: a retrospective cohort study.

Minimal-invasive surgery has gained wide acceptance in colorectal surgery. Single incision laparoscopic surgery (SILS) was designed to minimize surgical trauma and improve postoperative outcome. However, the role of SILS in ileostomy formation is unclear. In this retrospective cohort study 26 patients were included. Six patients were operated with SILS and 20 with conventional laparoscopic technique for ileostomy. We retrospectively evaluated patient charts for baseline characteristics including prior abdominal surgeries and combination of surgeries. Our primary efficacy objectives were operation time and postoperative hospitalization days. Our safety objectives included the prevalence of postoperative pain, parastomal hernia, incisional hernia, perforation, wound infection, ileus, and infections in general. Baseline characteristics including previous abdominal surgery and concomitant surgeries were comparable in both groups. Total operation time using SILS (37.5 ± 6.2 min [mean ± SD]), compared to laparoscopic surgery (82.2 ± 54.8 min [mean ± SD]) was significantly shorter (p = 0.0002). In a sensitivity analysis excluding patients with combined surgery, ileostomy formation by SILS was shorter (36.5 ± 6.2 min [mean ± SD]), compared to laparoscopy (59.7 ± 28.7 min [mean ± SD]; p = 0.024). Length of postoperative stay was not statistically different between the groups (SILS: 5.5 ± 2.4 days [mean ± SD]; laparoscopic: 13.8 ± 17.3 days [mean ± SD], p = 0.193). Postoperative complication rates were low and comparable in both groups. Placement of a loop ileostomy using SILS technique not only reduces surgical trauma but also operation time without affecting postoperative hospital stay or postoperative complication rates. Single-incision laparoscopic surgery for ileostomy is an appealing approach for ileostomy in selected patients.

Fragility-based framework for optimal damper placement in low-rise moment-frame buildings using machine learning and genetic algorithm

Commonly, seismic fragility is used as an assessment tool rather than a design constraint for existing building structures. In addition, the degree of seismic fragility safety margin after retrofitting existing structures is usually unknown during the early retrofit design stage. The current study proposes a framework that allows the designer to assign the preferred seismic fragility margin as a design variable before retrofit of a structure using soft computing techniques. In addition, it provides the design damping ratio to achieve the optimal damper capacity distribution required for retrofit. To this end, a machine learning model (MLM) is used to construct safety margin curve (SMC) graphs for the structural system considering different limit states to obtain the design damping ratio. This MLM is trained with a wide range of structural systems subjected to various levels of ground motion intensities for predicting seismic responses of the system. The main role of the MLM and SMC is to provide a reasonable approximate range for damper capacity in each story to reduce the computational time required for the optimization process. After that, a genetic algorithm (GA) optimization process is implemented to obtain the optimum capacities of the energy dissipation devices (EDDs) required for retrofitting the structure using the design damping ratio obtained from the SMC. Displacement-dependent EDDs are used in the current study because of their effectiveness in dissipating seismic energy. The EDDs are arranged such that the seismic demands are controlled to achieve the required basic seismic safety objective maintaining the optimal EDD capacity for each story. The reliability and robustness of the framework are investigated using various case-study examples and validated by comparing the results with those obtained from nonlinear time history (NLTH) and nonlinear static methods. The proposed framework is validated for low-rise moment-resisting frame buildings that can be represented using a single degree of freedom (SDOF) system. The framework is expected to enable researchers and engineers to effectively implement the required level of seismic safety in retrofitted structures with less computational cost and allows the designer to select the most suitable retrofit scheme considering multiple limit state criteria checks.

Efficacy of cleaning and sanitation methods against Listeria innocua on apple packing equipment surfaces

Previous foodborne listeriosis outbreaks and recalls of fresh produce have been linked to cross-contamination with food contact surfaces (FCS) of packing equipment. Thus, effective cleaning and sanitation practices should be implemented in the short-term to contribute to the overall food safety objective for FCS which have a suboptimal hygienic design. This research aimed to evaluate the efficacy of seven cleaning and sanitation treatment combinations against Listeria innocua populations on FCS common to produce packinghouses that have been found to have a higher prevalence of Listeria spp. harborage. Polishing brushes made of two different materials (100% nylon and nylon/horsehair mix), 100% polyethylene wash brushes, stainless steel rollers and polytetrafluorethylene (Teflon®) wrapped rollers, and interlocking conveyor belts were evaluated (n = 6 per treatment). These FCS were inoculated with L. innocua (9 log CFU/mL) and fouled with food-grade wax, with the exception of brush rollers that are encountered before waxing. Treatments included the use chlorine (200 ppm), peroxyacetic acid (PAA) (500 ppm) for 15 min, alone or in combination with an alkaline detergent (1.6%) or a degreaser, and the use of steam at 95 °C for 15 s. L. innocua was enumerated and the log reduction was calculated and compared to untreated controls. Horsehair mix polishing brushes were the surface with the lowest log reduction regardless of treatment applied (p < 0.05). Compared to 100% nylon polishing brushes, where a >3 log reduction was reached, horsehair mix brushes only reached this level of reduction when degreaser + PAA was applied. For both types of rollers and interlocking conveyor belt, an effective wax removal using a degreaser or detergent followed by sanitizer application caused the greatest L. innocua reduction (>5 log reduction). The application of steam did not show a significant log reduction on any surface (p > 0.05). This study highlights that cleaning and sanitation strategies must focus on effective wax removal if applied postharvest. In addition, 100% nylon polishing brushes could potentially offer a better hygienic design in produce packinghouses compared to the horsehair mix.

A system-based operational assessment of external beam radiotherapy.

Advanced technologies have led to improvements in modern radiotherapy over the years. However, adoption of advanced technologies can present challenges to existing clinical operations and negatively impact safety. The purpose of this work is to perform an assessment of modern radiotherapy for the operational objectives of safety, efficiency, and financial viability. This work focuses on external beam radiotherapy (EBRT). The operational assessment included department management, treatment planning, treatment delivery, and associated workflows for three equipment configurations of Ethos, Halcyon, and TrueBeam with the ARIA information system, Eclipse treatment planning, and IDENTIFY surface guidance. Systems-theoretic process analysis (STPA) was used to analyze the related workflows. Control actions, unsafe contexts of those control actions, and associated causal scenarios that can lead to unsafe radiation and non-radiation physical injury (safety objective), reduced treatment capacity (efficiency objective), and costs that exceed budget (financial viability objective) were identified. The number of control actions (and causal scenarios) were 18 (254), 18 (267), and 20 (267) for the equipment configurations of Halcyon, TrueBeam, and Ethos, respectively. The extent that safety, efficiency, and financial viability were impacted is similar across the different equipment configurations, but there were some noteworthy differences related to information transfer and workflow bottlenecks potentially impacting access to care. Seventy-five percent of the scenarios across all three configurations were related to safety. Overall, 29% of the scenarios impacted more than one operational objective and 48% were related to human decisions during the process of care. Planned or unplanned process changes were responsible for 8% of the causal scenarios. Broad-based clinical improvements may be realized by addressing causal scenarios that impact multiple objectives. Redesigning the roles and responsibilities of the clinical team and some aspects of the radiotherapy workflow may be helpful to fully realize the benefits of advanced technologies. Radiotherapy may benefit from additional tools to improve the consistency between decisions and actions when system or process changes occur.

Practical application of international recommendations and safety standards in the systematic planning and implementation of remediation of sites or areas with residual radioactive material

The IAEA fundamental safety objective is ‘to protect people and the environment from harmful effects of ionizing radiation’ and this must be done ‘without unduly limiting the operation of facilities or the conduct of activities that give rise to radiation risks’, while ensuring that people and the environment, present and future are protected against radiation risks (IAEA 2006 Fundamental Safety Principles, Safety Fundamentals No. SF-1). In addition, ‘protective actions to reduce existing or unregulated radiation risks must be justified and optimized’ (IAEA 2006 Fundamental Safety Principles, Safety Fundamentals No. SF-1). An international system of radiological protection can be applied such that processes, such as remediation, can be systematically undertaken to address the wide range of ‘existing exposure situations’ present globally. In doing so, decisions made regarding actions undertaken can be demonstrated to be ‘justified’ and ‘optimized’ (i.e. balanced), such that the amount of effort should be commensurate with the risk (applying a ’graded approach’). In addition, protection of people and the environment can be demonstrated by comparing the actual exposure to appropriate criteria over the lifetime of remediation. This paper provides an overview of the current IAEA safety standards on remediation of sites or areas contaminated with residual radioactive material within the international system of radiological protection and provides practical examples of their application through case studies considered in IAEA international model validation programs.