International Organization For Standardization Research Articles

Hearing Screening of Infant and Children Suspected of Congenital Hearing Loss at Dustira Cimahi Hospital

Hearing problems in children impact development, especially speech and language. Some risk factors are known to influence the occurrence of congenital deafness. For the last five years, screening with Otoacoustic Emissions (OAE) and Brainstem Evoked Response Audiometry (BERA) examinations has been used at Dustira Hospital to make a diagnosis and intervene as early as possible. This study aims to obtain the prevalence, risk factors, and OAE and BERA examination results at Dustira Cimahi Hospital. A retrospective descriptive study was conducted on children who underwent the OAE and BERA examination by collecting subject data for the period of January 2020– December 2022. The OAE examination uses distortion product otoacoustic emissions, while the BERA examination is based on the International Standard Organization (ISO). Of the 42 patients who were screened for hearing loss, the 3–5-year-old group was the most dominant (40.4%). Most of the patients were male (66%). While the prenatal risk factor was a history of TORCH infection (12%), the perinatal risk factor was low birth weight (14.2%) and the postnatal risk factor was hyperbilirubinemia (19%). The majority of the OAE examination results were refers found at 32 people (76.1%). The results of the BERA click examination were the presence of wave V found in 38 people (90.4%)). Patients with suspected congenital deafness who underwent hearing screening were in the age range of 3–5 years and were all male. The risk factors found were a history of TORCH infection, low birth weight, and hyperbilirubinemia. The majority of the results of the OAE examination was refer and that of the BERA was wave V. Keywords: BERA, children, congenital deafness, OAE

A realistic approach for evaluating antimicrobial surfaces for dry surface exposure scenarios.

The severe acute respiratory syndrome coronavirus 2 pandemic has raised public awareness about the importance of hygiene, leading to an increased demand for antimicrobial surfaces to minimize microbial contamination on high-touch surfaces. This is particularly relevant in public and private transportation settings, where surfaces frequently touched by individuals pose a significant, yet preventable, risk of infection transmission. Typically, the antimicrobial activity of surfaces is tested using test methods of the International Standards Organization, American Society for Testing and Materials, or Japanese Industrial Standards, which involve complete submersion in liquid, elevated temperature (37°C), and prolonged (24 h) contact periods. However, these conditions do not accurately represent real-world scenarios where surfaces are exposed to air. In this study, we propose a modified test method designed to better reflect real-life conditions in the intended end-use setting. The modifications included using deionized water instead of nutrient broth while preparing bacterial inoculum, applying a small test inoculum to the surface and allowing it to dry, maintaining ambient temperature and relative humidity throughout the contact period, and reducing the contact period to 4 h. With this modified approach, the antimicrobial activity of 20 samples was reassessed. This screening revealed that out of 20 samples, only 2 samples were effective against all species, while 8 samples demonstrated partial effectiveness against selected species, and 10 samples showed no significant effect. These findings highlight the inadequacy of the current test standard and emphasize the urgent necessity for revised and adapted testing method to ensure a reliable and accurate evaluation.IMPORTANCEThe recent severe acute respiratory syndrome coronavirus 2 pandemic has sparked increased demand for antimicrobial surfaces to mitigate the risk of fomites-transmitted infection in both indoors and confined spaces. Commonly, the antimicrobial activity of these surfaces is assessed using test standards established by national standards bodies, which do not distinguish between different application scenarios. While these test standards are suitable for surfaces intended for submerged application, they are inappropriate for antimicrobial surfaces designed for dry surface exposure. The usage of these standards can lead to an overestimation of antimicrobial efficacy. Thus, this study introduces a modified dry exposure test method aimed at better reflecting real-life conditions in the intended end-use setting. Our results revealed the subpar antimicrobial performance of numerous samples, highlighting the necessity to revise and tailor the universal test standard to real-world scenarios in order to ensure a reliable and accurate evaluation.

ProtectingSmall and Medium Enterprises: A Specialized Cybersecurity Risk Assessment Framework and Tool

As the number of Small and Medium Enterprises (SMEs) rises in the world, the amount of sensitive data used also increases, making them targets for cyberattacks. SMEs face a host of issues such as a lack of resources and poor cybersecurity talent, resulting in multiple vulnerabilities that increase overall risk. Cybersecurity risk assessment frameworks have been developed by multiple organizations such as the National Institute of Science and Technology (NIST) and the International Organization for Standardization (ISO), but they are complicated to understand and challenging to implement. This research aimed to create an effective cybersecurity risk assessment framework specifically for SMEs while considering their limitations. This was achieved by first identifying common threats and vulnerabilities and categorizing them according to their importance and risk. Secondly, popular frameworks like the NIST CSF and ISO 27001/2 were analyzed for their proficiencies and deficiencies while identifying relevant areas for SMEs. Finally, novel techniques catered to SMEs were explored and incorporated to create an effective framework for SMEs. This framework was also developed in the form of a tool, providing an interactive and dynamic environment. The tool was effective, and the framework is a promising start but requires more quantitative analysis.

Bankruptcy Prediction and Performance: the Influence of Quality Certification on Portuguese SMEs

Objective: To observe the existence of a relationship between quality certification and performance and bankruptcy prediction for Portuguese SMEs. Theoretical Reference: The search for quality and its certification, via the International Standard Organization (ISO), theoretically, is related to the going concern assumption, making it possible to enhance the company's economic and financial sustainability. Method: Multisectoral Multivariate Discriminant Analysis (ADM) models, considered the most efficient, were selected for application, as well as the commonly used Univariate Analysis indicators. In Bureau Van Dijk's SABI Database, we collected Portuguese SMEs, with financial information from 2014 to 2018, certified in the scope of quality, ISO 9000 or 9001, on 12/31/2018, of these, we focused on those with main activity in NACE D - Electricity, Gas, Steam, Hot and Cold Water and Cold Air or G - Wholesale and Retail Trade, Repair of Motor Vehicles and Motorcycles as they are the most important. The Sector Average Company was also collected for the same NACE via Banco de Portugal Sector Tables. Then, having applied the models and indicators under study, we compared the results obtained between them, in order to observe the possible effect of quality certification on financial performance. Results and Discussion: No implication of quality certification in improving or optimizing the performance or economic-financial position of entities is identified. Implications of the Research: Uncover the influence of quality certification on the economic-financial position of companies, allowing for deeper investigation into bankruptcy, sustainability and value creation. Originality/Value: The specificities of the sectors and business size, crises and increasing closures make it vital to identify what will influence performance and sustainability, as no studies have been identified on this topic, focusing on Portuguese SMEs, certified via ISO 9000 or 9001.

Impact of speed sintering on the mechanical and optical properties of multilayered zirconia

Speed sintering techniques have been introduced to shorten the sintering time of zirconia ceramics, yet their impact on multilayered zirconia properties remains understudied. The purpose of this in vitro study was to assess the effect of speed sintering on the optical properties and the mechanical flexural strength of multilayered zirconia materials. A total of 360 disks (Ø14 ±2 mm ×1.2 ±0.02 mm) were fabricated by following the International Organization for Standardization (ISO) 6872:2015 standard using 2 types of Vita A2 shade multilayered zirconia materials: IPS e.max ZirCAD Prime (ZP) and IPS e.max ZirCAD Prime Esthetic (ZPE). Each material comprised translucent (Tr), gradient l (Gr), and dentin (De) layers, with 60 disks per layer. Half were sintered using a standard sintering protocol and half using a speed sintering protocol. Biaxial flexural strength was accessed using a universal testing machine equipped with the Blue Hill Universal software program by following the ISO 6872:2015 standard, with 20 disks per subgroup. The spectrophotometric analysis of optical properties (contrast ratio [CR], translucency parameter [TP], and total transmittance [Tt%]) was performed using a dual-beam spectrophotometer (Ultrascan VIS) in accordance with the ISO 7491:2000 standard, with 10 disks per subgroup. The comparison of the optical properties and the mechanical flexural strength between the speed and standard protocol was analyzed using an unpaired t test (α=.05). Speed sintering reduced biaxial flexural strength in all ZP layers (P<.05) and in ZPE-Gr (P<.05). A statistically significant difference in the CR was observed in the ZP-Tr, ZP-Gr, and ZPE-Gr layers (P<.05). The TP of the ZP-Gr, ZP-De, and ZPE-Gr layers was significantly lower when using the speed sintering protocol. Tt% was significantly lower with speed sintering for both materials (P<.05). Speed sintering statistically changed both the optical (CR, TP, Tt%) and mechanical (flexural strength) properties of multilayered zirconia materials, but the differences may not be clinically relevant.

Evaluation of Commercially Available Plant-based Food Serving Disposable Crockery for Quality Standards

Biomass-based disposable crockery products are in high demand as an alternative to the plastic-based products considering negative effects of plastic-based products on environment. Biomass-based cutleries are being made from locally available different sources such as leaves, sheaths, straws and other plant fibres. A study was conducted to assess the quality of the biomass-based utensil product and provide the standard technical requirements of selected biomass-based disposable products. The plant-based utensils made from corn starch, sugarcane bagasse, areca, paper and Sal (Shorea robusta) leaves were selected for this study. The available standard methods such as International Organization for Standardization (ISO), Technical Association of the Pulp and Paper Industry (TAPPI), National Standard of the People’s Republic of China, and Bureau of Indian Standards (BIS) were adapted, with suitable modifications wherever required, for conducting the experiment. The test included measurement of dimensional specifications, grammage, moisture content, temperature resistance test, load bearing test, high heat performance test, drop test, tensile test and three point bending rig test. The plant-based utensils were classified as very strong, strong and weak based on the strength characteristics test. The utensils made from sugarcane bagasse fall in all three categories (very strong, strong and weak), whereas areca-based lies between very strong and strong while corn starch- based fall between strong and weak category. Overall, the results showed a lot of variation in strength characteristics of biomass-based disposable crockery products. The data of this study can serve as a valuable information for manufacturers and suppliers of plant-based utensils to ensure and improve product quality while maintaining the technical standards.

Experimental investigation on sustainable machining of monel using vegetable oils as cutting fluids and machine learning-based surface roughness prediction

Abstract The material processing industry is anticipated to mitigate environmental degradation. The protocols established by the International Organisation for Standardisation were adhered to. As a result, it would be prudent to investigate the feasibility of minimizing the use of synthetic cutting fluids from the machining process. This study discusses an environmentally-friendly machining technique for turning nickel-based alloy Monel-500, which evaluates four different cooling conditions: dry machining, flood machining, Co-MQL (coconut oil), and Rb-MQL (Rice Bran Oil). These conditions were tested by experimenting with various machining parameters to investigate four aspects of the turning process: surface finish,cutting temperature, tool wear and chip morphology. Rice bran oil is considered eco-friendly compared to synthetic cutting fluids, and employing it in minimum quantity is economical and helps improve the machined workpiece’s surface finish. The investigation has been further extended by applying machine learning algorithms to predict surface roughness, utilising two logical regressions implemented in Python. Among the two machine learning approaches, the random forest regression technique has demonstrated superior results, achieving a prediction accuracy of 99.8%. Consequently, a decision tree has been developed using this regression model to predict the surface roughness. The structured analysis of the decision tree provides more accurate conclusions, offering flexibility in adjusting parameters and expanding options for operation. As a result, the decision tree approach enables the efficient utilisation of production resources and enhances production capacity by making informed choices about cooling methods during the turning process. Rb-MQL has performed better in all aspects than the other three cooling conditions. When comparing machining under dry conditions, flood cooling, Co-MQL, and Rb-MQL (rice bran oil) reduce the tooltip temperature by 39.5%,25.45 and 24.11%, respectively. Rb-MQL reduced surface roughness by 28.23%,43.59 and 60.49% in contrast with machining under dry, flood, and Co-MQL.

Numerical study on effects of leading-edge manufacturing defects on cavitation performance of a full-scale propeller. II. Simulation for the full-scale propeller with defects

Paper II of this two-part paper investigated the effects of leading-edge (LE) manufacturing defects on the open-water cavitation performance of a full-scale propeller based on the geometry of David Taylor Model Basin propeller by using the three-dimensional (3D) steady Reynolds-Averaged Navier–Stokes solver. Various simulation parameters, including domain size, grid size, stretch ratio, first-grid spacing, y+, and turbulence model, were carefully examined for their effects on the solutions, leading to the development of the best modeling practices for the full-scale propeller with LE defects. Employing these recommended best-practice settings, simulations were conducted on the full-scale propellers with 0.10, 0.25, and 0.50 mm LE defects. Compared to the predictions from Paper I [Jin et al., “Numerical study on effects of leading-edge manufacturing defects on cavitation performance of a full-scale propeller—Paper I: Simulation for the model- and full-scale propellers without defect,” Phys. Fluids 36, 105179 (2024).], which did not account for LE defects, the results showed that the LE defects within International Standards Organization (ISO) 484 Class S tolerances narrow the cavitation buckets. As a consequence, such LE defects can result in more than 40% reduction in cavitation inception speed, which is similar to the conclusions drawn from earlier two-dimensional (2D) studies [Jin et al., “2D CFD studies on effects of leading-edge propeller manufacturing defects on cavitation performance,” in SNAME Maritime Convention (The Society of Naval Architects and Marine Engineers, 2020).]. Note that Paper I [Jin et al., “Numerical study on effects of leading-edge manufacturing defects on cavitation performance of a full-scale propeller—Paper I: Simulation for the model- and full-scale propellers without defect,” Phys. Fluids 36, 105179 (2024).] presents the simulations for the model- and full-scale propellers without LE defects.

Polymyxin B Peptide Hydrogel Coating: A Novel Approach to Prevent Ventilator-Associated Pneumonia.

Ventilator-associated pneumonia (VAP) remains one of the most common hospital-acquired infections (HAI). Considering the complicated diagnosis and the lack of effective treatment, prophylactic measures are suggested as the new standard to prevent the disease. Although VAP often manifests a polymicrobial nature, Pseudomonas aeruginosa remains one of the pathogens associated with the highest morbidity and mortality rates within these mechanically ventilated patients. In this paper, we report on the development of an antibacterial hydrogel coating using the polymyxin B (PMB) peptide to prevent bacterial adhesion to the polymeric substrate. We fully characterized the properties of the coating using atomic force microscopy (AFM), scanning electron microscopy (SEM), wettability analyses and Fourier-transform infrared (FTIR) and Raman spectroscopy. Furthermore, several biological assays confirmed the antibacterial and anti-biofilm effect of the tubing for at least 8 days against P. aeruginosa. On top of that, the produced coating is compliant with the requirements regarding cytocompatibility stated in the ISO (International Organization for Standardization) 10993 guidelines and an extended release of PMB over a period of at least 42 days was detected. In conclusion, this study serves as a foundation for peptide-releasing hydrogel formulas in the prevention of VAP.

Discussing the Terms Biomimetic and Bioinspired within Bioinorganic Chemistry.

The terms biomimetic and bioinspired are very relevant in the field of bioinorganic chemistry and have been widely applied. Although they were defined by the International Organization for Standardization in 2015, these terms have at times been used rather ambiguously in the literature. This may be due to the inherent complexity of bioinorganic systems where, for example, a structural model of an enzyme active site may not replicate its function. Conversely, the function of an enzyme may be reproduced in a system where the structure does not resemble the enzyme's active site. To address this, we suggest definitions for the terms biomimetic and bioinspired wherein structure and function have been decoupled. With the help of some representative case studies we have outlined the challenges that may arise and make suggestions on how to apply terminology with careful intention.

Analysis of rebaudioside A in probiotic-fermented milk via quantitative nuclear magnetic resonance spectroscopy

Rebaudioside A is used in the food and beverage industries owing to its sweetness, even in extremely small amounts, as well as its natural origin. Liquid chromatography is commonly used to quantify rebaudioside A; however, it suffers from complicated sample pretreatment and time consumption. External-calibration quantitative nuclear magnetic resonance (qNMR) analysis of probiotic-fermented milk has thus far not been reported. Moreover, it involves more factors contributing to errors than internal standard approaches used in the official methods, such as those recommended by the International Organization for Standardization. In this study, we developed a method for quantifying rebaudioside A in probiotic-fermented milk using internal-calibration qNMR. This method entails a simple pretreatment step with dilution and solid-phase extraction, enabling rebaudioside A determination in five types of beverages including probiotic-fermented milk. The results revealed a recovery rate and relative standard deviation of 85.4–104 % and 1.57–4.09 %, respectively, satisfying the international guidelines. The working range of qNMR was 0.80–26.7 mg/100 g of product, and the analysis time was 10–20 min. Therefore, the proposed internal-calibration qNMR method facilitates easy, rapid, and accurate quantification of rebaudioside A in probiotic-fermented milk and is applicable for analyzing various other beverages and foods.

Mechanical Properties of Newly Developed Flowable Composite Derived from Rice Husk at Different Monomer Ratios

An ideal flowable composite (FC) requires good mechanical properties to fulfill its role as a dental restorative material and ensure durability and clinical efficacy, with these properties being influenced by different monomer ratios. The study aimed to evaluate the mechanical properties of the newly developed FC on Vickers hardness, flexural strength, and flexural modulus at different monomer ratios. The newly developed FC employed nanohybrid silica from rice husk and zirconia as fillers, and the ratio of urethane dimethacrylate to triethylene glycol dimethacrylate (UDMA:TEGDMA) at 20:80, 30:70, 50:50, 60:40, 80:20 and 90:10 as monomers. Filtek Supreme Ultra Flowable Restorative, Revolution Formula 2, and G-aenial Universal Flo served as control groups. The data were statistically analyzed using one-way ANOVA with post-hoc Bonferroni test. Generally, the higher UDMA ratio in the newly developed FCs exhibited higher mechanical properties. All newly developed FCs demonstrated a significant decrease in Vickers hardness than control groups. The flexural strength values at ratios of 50:50, 60:40, 80:20, and 90:10 were comparable with control groups and passed the International Organization for Standardization 4049 requirement. Meanwhile, the flexuralmodulus of the newly developed FC at the ratio of 90:10 was comparable to Revolution Formula 2. In summary, the differences in monomer ratios affect the mechanical properties of the newly developed FCs. The improved mechanical properties at ratios of 80:20 and 90:10 could potentially substitute sustainable dental restorative materials, subjected to further investigations.

Prevalence of hearing loss in pseudohypoparathyroidism

BackgroundThe main clinical features of pseudohypoparathyroidism (PHP)/inactivating parathyroid hormone/parathyroid hormone-related protein signaling disorders (iPPSD), including parathyroid hormone (PTH) resistance, brachydactyly and short stature, develop during middle and late childhood. Very few studies have addressed hearing loss in PHP/iPPSD patients, and these studies have yielded widely divergent conclusions. The aim of our study was to assess hearing and determine the predictive factors of hearing loss in patients with PHP/iPPSD.MethodsOur retrospective cohort study was conducted between March 2019 and May 2020 in the Otolaryngology Department and the calcium phosphate reference center for rare diseases in Bicêtre Paris-Saclay Hospital, France. We retrospectively collected data from patients with PHP/iPPSDs (age, sex, genetic mutations, height, body mass index (BMI), PTH resistance, presence or absence of ectopic ossifications and brachydactyly). All patients underwent auditory investigations, including tonal and vocal audiometry. The primary outcome was the pure tone average (PTA). The PTA was compared with the norm according to the International Organization for Standardization. Hearing loss was defined as a PTA ≥ 20 db.ResultsThe median age of the patients was 15.6 years [9.5, 28.5]. Thirty-six patients were diagnosed with iPPSD2, and eight were diagnosed with iPPSD3. Twenty-six of them (59%) were female. Hearing impairment was confirmed in 17 patients (39%). The mean PTA and the mean SRT of the deaf ears were 40 ± 26 db and 31 ± 14 db. The mean difference in the PTA between the patients and the normal controls was 11.4 db (p = 0.00002). Short stature and the presence of ectopic ossifications were two significant predictive factors of hearing loss (p = 0.009 and p = 0.03, respectively). Sex, BMI, PTH resistance, mutation category and brachydactyly were not associated with an increased risk of hearing loss (p = 0.19, p = 0.41, p = 0.13, p = 0.50, p = 0.19, respectively).ConclusionOur study confirmed the frequency of hearing loss in patients with PHP/iPPSD disease (prevalence = 39%). A diagnosis of PHP/iPPSD should trigger auditory investigations and follow-up, especially when short stature and/or ectopic ossifications are present.

A Comprehensive Review on Studying and Developing Guidelines to Standardize the Inspection of Properties and Production Methods for Mycelium-Bound Composites in Bio-Based Building Material Applications.

Mycelium-bound composites (MBCs) represent a promising advancement in bio-based building materials, offering sustainable alternatives for engineering and construction applications. This review provides a comprehensive overview of the current research landscape, production methodologies, and standardization ideas related to MBCs. A basic search on Scopus revealed over 250 publications on MBCs between 2020 and 2024, with more than 30% focusing on engineering and materials science. Key studies have investigated the physical and mechanical properties of MBCs, optimizing parameters such as substrate type, fungal species, incubation time, and post-processing to enhance material performance. Standardizing the inspection of MBC properties is crucial for ensuring quality and reliability. Various testing standards, including those from the American Society for Testing and Materials (ASTM), the International Organization for Standardization (ISO), the Japanese Industrial Standard (JIS), European Standards (EN), Deutsches Institut für Normung (DIN), and the Thai Industrial Standards Institute (TIS), are utilized to evaluate density, water absorption, compression strength, tensile strength, insulation, and other critical properties. This review highlights the distinction between lab-scale and apply-scale testing methodologies, emphasizing the need for comprehensive evaluation protocols. Additionally, the production process of MBCs involves critical steps like substrate preparation, fungal species selection, and mycelium growth, necessitating the implementation of good manufacturing practices (GMPs) to ensure consistency and quality. The internal and external structures of MBCs significantly influence their performance, necessitating standardized inspection methods using advanced techniques such as scanning electron microscopy (SEM), X-ray computed tomography (CT) scanning, and surface profilometry. By establishing robust inspection protocols and production standards, the industry can enhance the reliability and adoption of MBCs, contributing to innovations in materials science and promoting environmental sustainability. This review underscores the importance of interdisciplinary collaboration, advanced characterization tools, and regulatory frameworks to address challenges and advance the field of MBCs.

ISO Standards in Healthcare Organizations: Research Evolution and Trends from a Bibliometric Analysis

This study provides an overview of trends and evolution in International Organization for Standardization (ISO) implementation in healthcare over the past three decades, useful for researchers, practitioners, and policymakers in the sector. As an additional contribution, we propose the NU-index, which allows the evaluation of authors’ scientific output in a comprehensive way that will be valuable for researchers, institutions, and funding agencies seeking to assess researcher performance more accurately and understandably. A bibliometric analysis of 476 scientific articles from the Scopus Database was conducted, examining the scientific output, key authors, high-impact journals, and frequent keywords using VOSviewer, Bibliometrix library, and statistical analysis. Results reveal a significant increase in publications on ISO standards in healthcare since 2009, particularly in areas such as telemedicine, artificial intelligence, and information security. The emergence of ISO 11073 (health informatics) and ISO 13606 (electronic health records) highlights a growing trend towards information and communication technologies. Despite reported implementation barriers, such as lack of top management commitment and associated costs, adoption of these standards is increasing due to the demand for high-quality healthcare services and the need to comply with regulatory requirements.

Strengthening the Application of the DAIDS GCLP Guidelines: The Implementation of an Integrated Laboratory Oversight Framework.

The Division of AIDS (DAIDS) Good Clinical Laboratory Practice (GCLP) Guidelines establish a framework to guide the oversight of laboratories supporting DAIDS-sponsored clinical research or trials. Compliance with these guidelines promotes data reliability, validity, and safety of the clinical research or trial participants and laboratory staff and ensures adherence to regulatory requirements. Acknowledgment and adoption of the DAIDS GCLP Guidelines are critical in building laboratory capacity and preparedness for conducting clinical trials. In collaboration with DAIDS, laboratory experts support the implementation of the DAIDS Integrated Laboratory Oversight Framework (Framework) activities. This article describes the implementation of the GCLP Guidelines, the Framework activities, and the coordinated efforts to strengthen laboratory performance. The Framework activities include four components: Quality Assurance Oversight, GCLP Audits, GCLP Training, and Laboratory Quality Improvement. Comparison of GCLP Guidelines with other regulations or standards, including U.S. Clinical Laboratory Improvement Amendments regulation 42 CFR 493, College of American Pathologists, World Health Organization GCLP, and International Organization for Standardization, ISO 15189:2012 standards, highlighted the differences and similarities to guide integration and harmonization efforts. Processes related to the Framework activities are outlined in detail, including key data derived from the managed activities of over 175 laboratories worldwide. Via the evolution of the DAIDS GCLP Guidelines and laboratory oversight workflows, the laboratories participating in DAIDS-sponsored clinical research and trials have successfully participated in internal and external regulatory audits. The collaborative and integrated oversight approach promotes knowledge-sharing and accountability to support the implementation of the DAIDS GCLP Guidelines and compliance monitoring. Lessons learned have helped with the implementation of the DAIDS integrated laboratory oversight approach and quality oversight programs at multiple laboratories worldwide.

Efficacy of Teleconsultation Versus Usual Care in Improving Quality of Life Among Geriatric Patients Aged 60 and Above: A Randomized Controlled Trial.

Introduction The geriatric population, aged 60 years and older, is rapidly growing worldwide. This demographic shift has led to a higher prevalence of chronic diseases, comorbidities, and functional impairments, placing immense pressure on healthcare systems. Teleconsultation, which uses telecommunication technologies to deliver healthcare services remotely, offers a potential solution. This study aimed to assess the efficacy of teleconsultation versus usual care in improving the quality of life among the geriatric population aged 60 years and older. Methods A parallel, randomized controlled trial with a 1:1 allocation ratio was conducted. Eligible participants, aged 60 and above, were recruited at the triage emergency department (ED) following a baseline eligibility assessment. Inclusion criteria included the ability to communicate in English or Hindi, possession of International Organization for Standardization (ISO-certified) instruments for self-monitoring, and willingness to comply with study procedures and provide written consent. Participants were randomly assigned to experimental and control arms using a computer-generated sequence, with allocation concealment achieved through sequentially numbered opaque sealed envelopes (SNOSEs), which were opened in front of participants after obtaining baseline data. A total of 2,000 participants (1,000 per arm) were enrolled and randomly assigned to either the teleconsultation or usual care group. Results In the teleconsultation group (n=1,000), 36.5% of participants (365) were female and 63.5% of participants (635) were male. Similarly, in the usual care group (n=1,000), 37.1% of participants (371) were female and 62.9% of participants (629) were male. The teleconsultation group significantly outperformed the usual care group in several domains pre-intervention, with higher mean scores in the physical health domain (11.16 vs. 10.96, P = 0.009), psychological domain (11.74 vs. 11.62, P = 0.020), and environment domain (12.44 vs. 12.26, P = 0.0001). No significant difference was observed in the social relationships domain (P = 0.452). The teleconsultation group significantly outperformed the usual care group in all domains post-intervention, with higher mean scores in the physical health domain (14.49 vs. 12.74), psychological domain (13.75 vs. 12.35), social relationships domain (14.05 vs. 12.90), and environment domain (13.91 vs. 12.94) (P < 0.001 for all). Conclusion These findings suggest that teleconsultation significantly improves the quality of life for elderly patients by providing a more accessible and convenient means of healthcare delivery and addressing the physical, emotional, and social challenges associated with chronic illnesses.

Enhancing Pharmaceutical Product Quality With a Comprehensive Corrective and Preventive Actions (CAPA) Framework: From Reactive to Proactive.

Corrective and preventive actions (CAPA) are crucial components of quality assurance (QA) within the pharmaceutical industry, essential for maintaining product quality, safety, and regulatory compliance. The review explores the multifaceted role of CAPA in pharmaceutical manufacturing, emphasizing its structured approach to detecting, addressing, and preventing quality issues. CAPA systems are integral to the broader quality management system (QMS), functioning as a dual-loop mechanism that is reactive and proactive approach aligned with continuous improvement principles outlined by the International Organization for Standardization (ISO) 9001:2000. It details the three distinct phases of CAPA: correction or remedial action, corrective action (CA), and preventive action (PA). It highlights the importance of root cause analysis and the necessity for immediate corrections and long-term preventive measures to avoid recurring issues. Regulatory expectations, such as those from the Food and Drug Administration (FDA) under the Code of Federal Regulations (CFR) title 21 part 820 and theInternational Council for Harmonisationof Technical Requirements for Pharmaceuticals for Human Use (ICH) Q10, are discussed, underscoring the need for a comprehensive CAPA plan that integrates data analysis and ongoing process enhancements. Additionally, the paper introduces the 8D methodology as a structured problem-solving approach to complement CAPA efforts. By providing an in-depth examination of CAPA procedures and their implementation, this article aims to contribute to the understanding and effectiveness of quality systems in pharmaceutical manufacturing.

Evaluation of a continuous glucose monitoring system in healthy dairy calves and adult goats.

To determine the accuracy of a continuous glucose monitoring system (CGMS) device by comparing glucose concentrations measured over time as determined by the CGMS to those of the chemistry analyzer (reference method). 7 healthy goats and 7 dairy calves. A randomized, crossover design with 3 treatments: control, hypoglycemia, and hyperglycemia. The CGMS device was applied to the neck. Hypoglycemia and hyperglycemia were induced by insulin and xylazine, respectively. Glucose concentrations were measured by the chemistry analyzer CGMS, point-of-care glucometer, and intensive care unit machine at 0 (before treatment), 2, 4, 6, 8, 10, and 12 hours. Agreement between the CGMS and the chemistry analyzer was determined by Bland-Altman plots. The analytical and clinical accuracy of the CGMS was determined using the International Organization for Standardization (ISO) 15197:2013 criteria and the Parkes error grid analysis. In goats, the CGMS overestimated glucose concentrations during the hypoglycemic, normoglycemia, and hyperglycemia treatments. In calves, the CGMS underestimated glucose concentrations during the hypoglycemic treatment but overestimated glucose concentrations in normoglycemia and hyperglycemic treatments. The CGMS met the ISO clinical accuracy criteria for goats and calves, with > 99% of the glucose measurements in zones A and B of the Parkes grid. However, the CGMS did not meet the ISO 15197:2013 criteria for analytical accuracy. The CGMS evaluated in our study only met the ISO 15197:2013 clinical accuracy criteria, not the analytical accuracy. Therefore, the device might be considered for clinical use.

Cyclic fatigue resistance of two pediatric rotary files manufactured with different heat treatments: an in-vitro study.

Nickel-titanium (NiTi) instruments offer many advantages during endodontic instrumentation; however, the fracture risk within the canal remains a concern. Manufacturers continuously develop and introduce instruments to the market with supposedly enhanced cyclic fatigue resistance and increased flexibility, achieved through different proprietary manufacturing processes, the details of which have not been made public. In recent years, two rotary systems specially designed for deciduous teeth have been commercially available, but information about their performance is lacking. This investigation aimed to identify which manufacturing process provides better cyclic fatigue resistance: the AF-H Wire technology used in the AF baby rotary files (AF-f) or the CM-Wire technology used in the i3 Gold deciduous teeth rotary files (i3G-f). Forty rotary International Organization for Standardization (ISO) 25/04 files were tested in artificial canals with a standard geometry of 60° angle and 2.5 mm radius until fracture. The number of cycles to fracture was calculated, and the length of the fragments was measured. A scanning electron microscope (SEM) was used to examine the fracture surfaces and fragments. Energy dispersive spectroscopy (EDS) was used to determine the percentage weight of NiTi in each file. The statistical analysis (Mann-Whitney test) showed that the cyclic fatigue resistance of the AF-f was significantly higher (p < 0.0001) than that of the i3G-f. Additionally, there was a significant difference (p = 0.0419) in the length of the fractured fragments. All instruments showed one or more types of manufacturing defects and presented similar NiTi percentages by weight. The manufacturing process is critical to cyclic fatigue resistance, and there seems to be responsible for the difference in cyclic fatigue resistance between these similar instruments.