Safety Authority Research Articles

INSAFEDARE Project: Innovative Applications of Assessment and Assurance of Data and Synthetic Data for Regulatory Decision Support.

Digital health solutions hold promise for enhancing healthcare delivery and patient outcomes, primarily driven by advancements such as machine learning, artificial intelligence, and data science, which enable the development of integrated care systems. Techniques for generating synthetic data from real datasets are highly advanced and continually evolving. This paper aims to present the INSAFEDARE project's ambition regarding medical devices' regulation and how real and synthetic data can be used to check if devices are safe and effective. The project will consist of three pillars: a) assurance of new state-of-the-art technologies and approaches (such as synthetic data), which will support the validation methods as part of regulatory decision-making; b) technical and scientific, focusing on data-based safety assurance, as well as discovery, integration and use of datasets, and use of machine learning approaches; and c) delivery to practice, through co-production involving relevant stakeholders, dissemination and sustainability of the project's outputs. Finally, INSAFEDARE will develop an open syllabus and training certification for health professionals focused on quality assurance.

Doing urban research on ‘hard-to-reach’ populations during the COVID-19 pandemic: advantages and ethical dilemmas using digital ethnography as a new alternative

This paper presents insights on conducting urban research amidst the COVID-19 pandemic, emphasizing the adoption of digital ethnography as an innovative and flexible approach. Drawing from an expanding body of literature on fieldwork among 'hard-to-reach' populations during crises such as the COVID-19 pandemic, we share our experiences from a study on the socio-economic impacts of mandatory lockdowns on poor urban residents in Harare, Zimbabwe. Our research highlighted several methodological benefits of digital ethnography, including its non-intrusive and non-intimidating nature, cost and time efficiency, ability to increase participant diversity, assurance of respondent safety, research flexibility, and the generation of impactful data. Unlike traditional immersive ethnography, digital ethnography proved adept at navigating the complexities of the 'global', 'local', and 'trans-local' dimensions of contemporary urban research subjects. However, this approach also presents several ethical challenges. These challenges include obtaining informed consent, ensuring confidentiality and anonymity, participants' potential misunderstanding of the research context, the risk of exacerbating stress during crises, and respecting privacy in digital spaces. Urban researchers must carefully consider these ethical issues before undertaking their studies. In conclusion, virtual environments have become integral to modern life and represent essential avenues for urban researchers, particularly during periods of limited physical interaction and when studying populations that are difficult to reach in person but more accessible online. Further, the adoption of digital ethnography, extends beyond the necessity imposed by the COVID-19 pandemic. It reflects an ongoing evolution in ethnographic practices, adapting to the realities of a digitally connected world. We suggest that urban researchers should think of digital ethnographic ethics from the point of view of reciprocal and mutual collaboration with participants. With this thinking, urban research subjects become co-participants and co-researchers rather than subjects of exploitation in the expanding and complex digital space.

Quantitative Analysis of Pb in Soil Using Laser-Induced Breakdown Spectroscopy Based on Signal Enhancement of Conductive Materials.

Studying efficient and accurate soil heavy-metal detection technology is of great significance to establishing a modern system for monitoring soil pollution, early warning and risk assessment, which contributes to the continuous improvement of soil quality and the assurance of food safety. Laser-induced breakdown spectroscopy (LIBS) is considered to be an emerging and effective tool for heavy-metal detection, compared with traditional detection technologies. Limited by the soil matrix effect, the LIBS signal of target elements for soil heavy-metal detection is prone to interference, thereby compromising the accuracy of quantitative detection. Thus, a series of signal-enhancement methods are investigated. This study aims to explore the effect of conductive materials of NaCl and graphite on the quantitative detection of lead (Pb) in soil using LIBS, seeking to find a reliable signal-enhancement method of LIBS for the determination of soil heavy-metal elements. The impact of the addition amount of NaCl and graphite on spectral intensity and parameters, including the signal-to-background ratio (SBR), signal-to-noise ratio (SNR), and relative standard deviation (RSD), were investigated, and the mechanism of signal enhancement by NaCl and graphite based on the analysis of the three-dimensional profile data of ablation craters and plasma parameters (plasmatemperature and electron density) were explored. Univariate and multivariate quantitative analysis models including partial least-squares regression (PLSR), least-squares support vector machine (LS-SVM), and extreme learning machine (ELM) were developed for the quantitative detection of Pb in soil with the optimal amount of NaCl and graphite, and the performance of the models was further compared. The PLSR model with the optimal amount of graphite obtained the best prediction performance, with an Rp that reached 0.994. In addition, among the three spectral lines of Pb, the univariate model of Pb I 405.78 nm showed the best prediction performance, with an Rp of 0.984 and the lowest LOD of 26.142 mg/kg. The overall results indicated that the LIBS signal-enhancement method based on conductive materials combined with appropriate chemometric methods could be a potential tool for the accurate quantitative detection of Pb in soil and could provide a reference for environmental monitoring.

Superconductive and flexible antenna based on a tri-nanocomposite of graphene nanoplatelets, silver, and copper for wearable electronic devices

Printed electronics, fueled by graphene's conductivity and flexibility, are revolutionizing wearable technology, surpassing copper's limitations in cost, signal quality, size, and environmental impact. Graphene-based inks are positioned to lead in this domain, offering cost-effective solutions directly applicable to materials such as textiles and paper. However, graphene encounters a primary drawback due to its lack of an energy band gap, constraining its potential applications in various electronic devices. In this study, we present a novel formulation of a superconductive, flexible leather graphene antenna utilizing a tri-nanocomposite structure of Graphene Nanoplatelet/Silver/Copper (GNP/Ag/Cu), covering a wideband bandwidth from 5.2 GHz to 8.5 GHz. The electrical conductivity of the GNP/Ag/Cu sample was assessed using the four-point probe method. With each additional layer, conductivity increased from 10.473 × 107 S/m to 40.218 × 107 S/m, demonstrating a direct correlation between conductivity and antenna gain. The study evaluates the efficacy of various thicknesses of conductive Graphene (GNP/Ag/Cu) ink on drill fabric. Safety assurance is provided through specific absorption rate (SAR) testing, indicating 0.84 W/kg per 10 g of tissue for an input power of 0.5 W, in compliance with ICNIRP standards for wearable device safety. Additionally, a morphological analysis of the antenna was conducted, showcasing its potential for efficient signal transmission in wearable electronic devices.

Safety assurance and nutritional quality enhancement of Phyllospora comosa biomass using hydrothermal treatment derived ensemble machine learning models

One of the major barriers to the mass industrial utilisation of brown seaweeds as food sources stem from the food safety risks associated with their iodine and arsenic concentrations, which typically exceed regulatory limits. Hydrothermal treatments might effectively reduce the high iodine and arsenic concentration of Phyllospora comosa below the Australian maximum residual limits (iodine = 1 mg/g and arsenic = 0.00667 mg/g; dry weight) set for brown seaweeds. The experimental hydrothermal treatments dictated that the 82 °C–250 s treatment reduced the iodine concentration from 2.76 mg/g to 0.88 mg/g (68% reduction) and arsenic concentration from 0.01693 mg/g to 0.00965 mg/g (43% reduction). Machine learning models predicted that blanching at 100 °C for ∼4 minutes will reduce the arsenic concentration below its maximum residual limit. Additive log-ratio transformations showed that around 50% (dw) of the hydrothermally treated Phyllospora comosa samples were leached out during the highest treatment intensity, 82 °C–250 s. Even though, a half of the biomass is lost, hydrothermally treated Phyllospora comosa products are safer for human consumption and thus may permit the expansion of seaweed production and consumption in Australia.

Rapid counting of coliforms and Escherichia coli by deep learning‐based classifier

AbstractTo ensure that food has been handled hygienically, manufacturers routinely examine the numbers of indicator bacteria, such as coliforms and Escherichia coli. Using the deep‐learning algorithm YOLO, we developed a classifier that automatically counts the number of coliforms (red colonies) and E. coli (blue colonies) on a chromogenic agar plate. Using Citrobacter freundii IAM 12471T and E. coli NBRC 3301, we trained our YOLO‐based classifier with images of Petri dishes grown with each strain alone (10 images) and/or with a mixture of both strains (5 images). When the performance of the classifier was evaluated using 83 images, the accuracy rates for coliforms and E. coli reached 99.4% and 99.5%, respectively. We then investigated whether this classifier could detect other, non‐trained coliform species (22 species) and E. coli strains (13 strains). The accuracy rates for coliforms and E. coli were 98.7% (90 Petri dishes) and 94.1% (46 Petri dishes), respectively. Furthermore, we verified the practical feasibility of the developed classifier using 38 meats (chicken, pork, and beef). The accuracy rates for coliforms and E. coli in meat isolates were 98.8% (80 Petri dishes) and 93.8% (35 Petri dishes), respectively. The time required to count coliforms/E. coli on a single plate was ~70 ms. This novel method should enable users to rapidly quantify coliforms/E. coli without relying on a human inspector's color vision, leading to improved assurance of food safety.

SAFER: Safety Assurances for Emergent Behavior

SAFER: Safety Assurances for Emergent Behavior

A review on development of enzymatic biosensors for industrial applications

Enzymatic biosensors are vital tools across various industries due to their high specificity, sensitivity, and rapid response times. They are extensively used in medical diagnostics for monitoring biomarkers like glucose and lactate, environmental monitoring to detect pollutants, food safety and quality assurance, bioprocess control in industrial fermentation, pharmaceutical drug development and quality control, soil health and agrochemical detection in agriculture, and for identifying biological warfare agents. However, several challenges limit their broader adoption and effectiveness in industrial settings. Key challenges include enzyme stability, as enzymes can denature under extreme environmental conditions, reducing sensor lifespan and performance. Variability in enzyme activity and immobilization techniques also leads to inconsistencies, affecting sensor reproducibility and reliability. Complex sample matrices, such as those in environmental and food samples, introduce interference that can affect sensor accuracy. Integrating biosensors into existing industrial processes is another significant challenge, requiring compatibility with automated systems and real-time data processing capabilities. Additionally, high production costs and scalability issues hinder widespread adoption. Regulatory and standardization barriers further complicate the development and deployment of enzymatic biosensors. Despite these limitations, advancements in materials science, nanotechnology, and bioengineering are paving the way for more robust and reliable biosensors. Innovations such as nanomaterial-based enzyme immobilization, synthetic biology for enzyme engineering, and advanced data analytics integration hold promise for overcoming current limitations. Collaborative efforts among researchers, industry stakeholders, and regulatory bodies are essential to accelerate the development and application of enzymatic biosensors in industrial settings. While enzymatic biosensors offer significant potential, addressing these challenges through ongoing research and technological advancements is crucial for their widespread implementation and optimization.

Composite electrolyte with self‐inserted structure and all‐trans F conformation provides fast Li+ transport for solid‐state Li metal batteries

AbstractSolid‐state Li metal battery has attracted increasing interests for its potentially high energy density and excellent safety assurance, which is a promising candidate for next generation battery system. However, the low ionic conductivity and Li+ transport number of solid‐state polymer electrolytes limit their practical application. Herein, a composite polymer electrolyte with self‐inserted structure is proposed using the layered double hydroxides (LDHs) as dopant to achieve a fast Li+ transport channel in poly(vinylidene‐co‐trifluoroethylene) [P(VDF‐TrFE)] based polymer electrolyte. In such a composite electrolyte, P(VDF‐TrFE) polymer has an all‐trans conformation, in which all fluorine atoms locate on one side of the polymer chain, providing fast Li+ transport highways. Meanwhile, the LDH can immobilize the anions of Li salts based on the electrostatic interactions, promoting the dissociation of Li salts, thereby enhancing the ionic conductivity (6.4 × 10−4 S cm−1) and Li+ transference number (0.76). The anion immobilization effect can realize uniform electric field distribution at the anode surface and suppress the dendritic Li growth. Moreover, the hydrogen bonding interaction between LDH and polymer chains also endows the composite electrolyte with strong mechanical properties. Thus, at room temperature, the Li || Li symmetric cells can be stably cycled over 1000 h at a current density of 0.2 mA cm−2, and the full cells with LiFePO4 cathode deliver a high capacity retention (>95%) after 200 cycles. This work offers a promising route to construct solid‐state polymer electrolytes with fast Li+ transport.image

Three-Dimensional Reconstruction and Visualization of Underwater Bridge Piers Using Sonar Imaging.

The quality of underwater bridge piers significantly impacts bridge safety and long-term usability. To address limitations in conventional inspection methods, this paper presents a sonar-based technique for the three-dimensional (3D) reconstruction and visualization of underwater bridge piers. Advanced MS1000 scanning sonar is employed to detect and image bridge piers. Automated image preprocessing, including filtering, denoising, binarization, filling, and morphological operations, introduces an enhanced wavelet denoising method to accurately extract the foundation contour coordinates of bridge piers from sonar images. Using these coordinates, along with undamaged pier dimensions and sonar distances, a model-driven approach for a 3D pier reconstruction algorithm is developed. This algorithm leverages multiple sonar data points to reconstruct damaged piers through multiplication. The Visualization Toolkit (VTK) and surface contour methodology are utilized for 3D visualization, enabling interactive manipulation for enhanced observation and analysis. Experimental results indicate a relative error of 13.56% for the hole volume and 10.65% for the spalling volume, demonstrating accurate replication of bridge pier defect volumes by the reconstructed models. Experimental validation confirms the method's accuracy and effectiveness in reconstructing underwater bridge piers in three dimensions, providing robust support for safety assessments and contributing significantly to bridge stability and long-term safety assurance.

Natural compounds-based nanomedicines for cancer treatment: Future directions and challenges.

Several efforts have been extensively accomplished for the amelioration of the cancer treatments using different types of new drugs and less invasives therapies in comparison with the traditional therapeutic modalities, which are widely associated with numerous drawbacks, such as drug resistance, non-selectivity and high costs, restraining their clinical response. The application of natural compounds for the prevention and treatment of different cancer cells has attracted significant attention from the pharmaceuticals and scientific communities over the past decades. Although the use of nanotechnology in cancer therapy is still in the preliminary stages, the application of nanotherapeutics has demonstrated to decrease the various limitations related to the use of natural compounds, such as physical/chemical instability, poor aqueous solubility, and low bioavailability. Despite the nanotechnology has emerged as a promise to improve the bioavailability of the natural compounds, there are still limited clinical trials performed for their application with various challenges required for the pre-clinical and clinical trials, such as production at an industrial level, assurance of nanotherapeutics long-term stability, physiological barriers and safety and regulatory issues. This review highlights the most recent advances in the nanocarriers for natural compounds secreted from plants, bacteria, fungi, and marine organisms, as well as their role on cell signaling pathways for anticancer treatments. Additionally, the clinical status and the main challenges regarding the natural compounds loaded in nanocarriers for clinical applications were also discussed.

Speciation-specific chromium bioaccumulation and detoxification in fish using hydrogel microencapsulated biogenic nanosilver and zeolite synergizing with biomarkers.

Grass carp intestinal waste-mediated biosynthesized nanosilver (AgNPs) was valorized using guaran and zeolite matrices, resulting in AgNPs-guaran, AgNPs-zeolite, and AgNPs-guaran -zeolite composites. The valorized products were examined using Environmental Scanning Electron Microscopy, Energy Dispersive X-ray analysis and X-ray Diffraction analysis to confirm uniform dispersion and entrapment of AgNPs within the matrixes. These valorized products were evaluated for their efficacy in detoxifying the ubiquitous and toxic hexavalent chromium (Cr6+) in aquatic environments, with Anabas testudineusexposed to 2mgl-1 of Cr6+ for 60days. Remarkable reduction of Cr6+ concentration to 0.86 ± 0.007mgl-1 was achieved with AgNPs-guaran-zeolite composite, indicating successful reclamation of contaminated water and food safety assurance. Consistency in results was further corroborated by minimal stress-related alterations in fish physiological parameters and integrated biomarker response within the experimental group treated with the AgNPs-guaran-zeolite composite. Despite observed chromium accumulation in fish tissues, evidence of physiological stability was apparent, potentially attributable to trivalent chromium accumulation, serving as an essential nutrient for the fish. Additionally, the challenge study involvingAnabas testudineus exposed to Aeromonas hydrophila exhibited the lowest cumulative mortality (11.11%) and highest survival rate (87.5%) within the same experimental group. The current study presents a novel approach encompassing the valorization of AgNPs for Cr6+ detoxification under neutral to alkaline pH conditions, offering a comprehensive framework for environmental remediation.

Classification of Composite Hazards of Gas and Coal Spontaneous Combustion in Gob

ABSTRACT To prevent the occurrence of gas and coal spontaneous combustion composite disasters in gob areas during coal mining, this study considers the gob area of the Longfeng Coal Mine as the experimental background. By analyzing the pressure values of the hydraulic props in the isolation wall, the composition of gases in the gob area, and the low-temperature oxidation characteristics of coal, it was found that the pressure values of the hydraulic props were correlated with the concentration of gases in the gob area, temperature, and the g-factor and free radical concentration of coal. The absolute values of the correlation coefficients were ranked as T > O2 > CH4 > CO2 > g-values > Ng > N2, and all correlation coefficients were greater than 0.85. When the isolation wall was located in the stress concentration area, the wall deformed and cracked, leading to frequent gas exchange between the gob-side entry retaining (GSER) and the gob area, which increased the risk of gas and coal spontaneous combustion composite disasters in the gob area. According to the safety risk level, the areas adjacent to the gob area were divided into high-risk areas (0 ~ 100 m, 300 ~ 600 m, 700 ~ 900 m, 1050 ~ 1200 m), moderate risk areas (200 ~ 300 m, 900 ~ 1050 m), general risk areas (600 ~ 700 m), and low-risk areas (100 ~ 200 m), the positions at 500 ~ 550 m and 700 ~ 750 m were located in the gas and coal spontaneous combustion composite disaster area. The study suggests that for high-risk areas, the injection amount of fire extinguishing materials should be increased to strengthen safety assurance, whereas for low-risk areas, the injection can be moderately adjusted and reduced to achieve the optimal balance between economic benefits and safety benefits.

Lifelong reinforcement learning tracking control of nonlinear strict-feedback systems using multilayer neural networks with constraints

This paper presents a novel safe integral reinforcement learning (IRL)-based optimal trajectory tracking scheme for nonlinear systems with uncertain dynamics that is subject to constraints. We leverage multilayer neural networks (MNNs) for actor-critic MNNs along with an NN identifier in the backstepping process for minimizing a discounted value function. A time-varying barrier Lyapunov function (TVBLF) is utilized for handling constraints and to provide safety assurances. Online weight update laws for the actor and critic MNNs are derived that are driven by Bellman error and control input error. We introduce an online lifelong learning (LL) method in the critic NN, utilizing the Bellman error in MNNs to address catastrophic forgetting. The method’s effectiveness is demonstrated through simulations on mobile robot multitask tracking. The paper concludes with a stability analysis of the closed-loop system.

Study on the hydrate growth characteristics and rheology of silica-containing sand water-in-oil emulsion system

Understanding the transportability of silica-sand-containing hydrate slurries is crucial for production safety of non-consolidated natural gas hydrate reservoirs, especially when solid-state fluidization technology is utilized. Despite some research on silica sand and marine sediments’ influence on hydrate formation kinetics, rheological studies are scarce for systems with silica sands. The formation process of cyclopentane hydrates under the coexistence of hydrophilic silica particles and surfactants were observed. The effects of the concentration and particle size of silica sands as well as the water cut and surfactant concentration of emulsion on the rheological properties of hydrate slurries were investigated using a rheometer. The results indicated: (1) Hydrophilic sand aggregates were entrapped in water droplets, indirectly affecting the oil–water contact area due to the increase in water droplet volume, which was conducive to the combination of alkanes and water molecules to form a hydrate shell; silica particles provided nucleation sites at the oil–water interface to promote the adsorption and aggregation of cyclopentane molecules. (2) The synergistic effect of silica sand and surfactants significantly shortened the induction time of hydrates and increased the viscosity of the slurry. As the concentration of silica sand (1 wt%, 5 wt%, 10 wt%) increased, the induction time of hydrate formation decreased by 44.8 min. Within the concentration range below 5 wt%, the viscosity of the slurry increased as the concentration increased, with an amplitude of 13830.7 mPa·s. The induction time of hydrate formation decreased with increasing silica sand particle size (2 μm, 6.5 μm, 12 μm), but the size of silica sand particles had no significant effect on the viscosity of the slurry. (3) Hydrate slurries in all systems exhibited shear-thinning behavior. There was no obvious relationship between the yield stress of slurry under different silica sand concentrations. However, the yield stress of the slurry was inversely proportional to the size of silica sand particles. The yield stress decreased by 141.13 Pa when the size of silica sand particles increased from 2 μm to 12 μm. Overall, this study highlighted the influence of silica sand presence on flow safety assurance in solid-state fluidization technology.

Analysis of a balanced safety performance indicator as a key element of operational controlling in the ATS organization

Controlling is considered as a versatile modern focus of management. It is widespread in various fields of human activity but has not found direct application in civil aviation yet. Meanwhile, any aviation organization is subject to the general laws of management, therefore, controlling can and should find its application in the management of an aviation organization. Due to the particular importance of safety management considerations, controlling, as a management concept that allows you to control processes rather than results, fits seamlessly into the procedures of safety management systems (SMS) of aviation service providers. In particular, the development and monitoring of safety performance indicators (SPI) can be considered as a key element of operational controlling. In the SMS, the procedure to deal with the SPI, in conjunction with the risks mitigation procedure for safety, is an essential component of the entire system. To ensure the effectiveness of this procedure in the Air Traffic Service (ATS) organization, it is necessary to develop a balanced overall SPI. As the analysis showed, the indicators applicable in ATS organizations are focused on considering only incidents of the same “weight” and do not objectively reflect a level of safety assurance at ATS and its dynamics. The article presents a variant of developing a revised balanced indicator, which considers less significant deviations from the proper ATS system operation, errors and violations of personnel. The indicator was developed on the basis of the expert survey of ATS specialists. Monitoring and predicting of indicators are also important tasks of operational controlling. These problems can be solved by various methods, the applicability and comparative effectiveness of some of them are discussed in this article. All calculations are based on real data of one of the major ATS organizations of the Russian Federation.

Advancements in integrated robotic sensing: A European perspective

Robotic Non-destructive Testing and Sensing stands at the forefront of technological innovation, offering capabilities in assessing structural integrity, safety, and material quality across diverse industries. This comprehensive review article provides a detailed exploration of the field, focusing on the substantial contributions of European researchers and institutions. The need for non-destructive testing has been a constant in industries that rely on structural integrity, including aerospace, manufacturing, energy, construction, and healthcare. Traditional testing methods, such as radiography, ultrasonic testing, magnetic particle testing, and dye penetrant testing, have been integral for quality control and safety assurance. However, the robotisation of such methods has marked a profound shift, enabling precise, fast, efficient, and repeatable testing while minimising human exposure to hazardous environments. European researchers and institutions have played an instrumental role in driving the evolution of integrated robotic sensing. The historical perspective of the field reveals the pioneering spirit of Europe, as collaborative initiatives led to the development of robotic platforms equipped with advanced sensors and testing techniques. A critical aspect of the European impact on robotic inspection applications lies in developing advanced sensors, innovative robotic platforms, novel robotic path-planning and control approaches and data collection and visualisation tools. These developments continue to influence the global landscape of robotic sensing. European researchers remain at the forefront of current trends and innovations as the field continues to evolve. This review article will delve into these recent advancements, highlighting Europe’s pivotal role in pushing the boundaries of technology and application. The implications and applications of robotic sensing reverberate across multiple sectors worldwide. From inspecting critical aerospace components to ensuring the quality of manufactured goods, these technologies underpin safety and quality standards.

Tailoring of NASA‐STD‐3001 to Lunar Gateway Program Requirements

AbstractThe Gateway Program must meet NASA's Agency‐level human rating requirements, which are intended to accommodate human capabilities and limitations while protecting the safety of the crew, and providing to the maximum extent practical, the capability to safely recover the crew from hazardous situations. Human systems integration represents a key human rating component of Moon to Mars systems to support the execution of Artemis missions, including compliance with mandatory standards for Health and Medical, Safety and Mission Assurance, and Engineering. The human system requirements, together with the human systems integration plan, medical operations requirements, and Gateway subsystem specifications, represent the flow‐down of NASA Health and Medical Standards (NASA‐STD‐3001, Volumes 1 and 2) into the Gateway system. This paper discusses how these documents and other human systems integration activities provide full consideration of human capabilities and limitations as part of the total system design trade space, serving as an example on how the human must be effectively integrated as part of the system in order to achieve mission success. At a bigger scale, the paper contributes to the application of systems engineering standards to cutting‐edge space exploration initiatives and to the dialogue on how systems engineering can continue to evolve to meet the needs of such ambitious projects.

Assessment of 19 Operation Room and Sterile Processing Units in Puerto Rico, 2023: Preliminary Findings using a new ICAR Tool

Background: Infection prevention and control assessments in healthcare settings serve as a primary resource for obtaining data and providing recommendations based on safety, compliance, and quality assurance guidelines. In Puerto Rico (PR), surgical site infections are underreported in the Epi Info platform used by the Puerto Rico Department of Health (PRDOH), mainly due to the complexity of their identification. By focusing on evaluating Operating Rooms/Sterile Processing and Distribution (OR/SPD) units in acute care facilities (ACFs), our goal is to generate new data within the Healthcare-Associated Infection/Antibiotic Resistance (HAI/AR) Program, specifically related to patient management throughout preoperative, intraoperative, and postoperative phases, as well as reprocessing practices. Methods: Nineteen evaluations of ACFs' OR/SPDs were conducted from May through December 2023. Direct observations, file reviews, and personnel assessments were performed using an infection control assessment and response (ICAR) tool developed collaboratively by a team from an acute facility in PR and the HAI/AR Program staff. This ICAR Tool was customized based on guidelines from the certified Board for Sterile Processing and Distribution (CBSPD), the Association of periOperative Registered Nurses (AORN), and the Association for the Advancement of Medical Instrumentation (AAMI), among other regulatory agencies. The Division of Health Quality Promotion (DHQP) reviewed and approved the tool for use in these evaluations. Results: Key findings indicate that 32% of Sterile Processing Department (SPD) units restrict access to dedicated personnel with available manufacturer’s instructions, yet only 36% of SPD personnel are certified in CBSPD and packaging practices. Only 10% of facilities had a water treatment system for sterilization and Immediate Use Steam Sterilization (IUSS) policies. Notably, 84% of endoscopy areas require additional equipment for cultivating endoscopes, and no facility possessed a borescope for visually inspecting endoscope lumens. Tray inspection occurred in 21%, and only 31% of staff knew the Spaulding Classification and Class V Indicators. Conclusion: These data underscore the necessity of evaluating OR/SPD units in ACFs to provide updated recommendations and mitigate the incidence of surgical site infections (SSI). They offer insight into the structural and functional status of OR/SPD units in Puerto Rico, aligning reporting with OR/SPD practices to enhance patient care and minimize infection risks.

Risk Analysis, Safety Assurance Requirements, and Safety Evaluation Test for Robotic Agricultural Machinery

Risk Analysis, Safety Assurance Requirements, and Safety Evaluation Test for Robotic Agricultural Machinery