Consumer Trends Reflected in the Contents of the Pediatric Esophagus: A 20-Year Review.

OBJECTIVES: To evaluate epidemiological trends of pediatric esophageal foreign body (EFB) ingestion over two decades. METHODS: A retrospective analysis was performed using data from the National Electronic Injury Surveillance System (NEISS) database for children <18 years who presented to a United States Emergency Department (ED) with EFB between 2003 and 2022. Number of cases and type of EFB were recorded. Rates of EFBs over time were analyzed via linear regression. RESULTS: A total of 52,315 EFB cases were identified over the 20-year period, with a national estimate of 1,589,325 cases. The most frequently ingested objects were coins (37.6%), toys (13.5%), and batteries (6.8%). Overall incidence of EFB ingestion increased from 7.3 to 14.2/10,000 children from 2003 to 2022 (R2 = 0.8, p < 0.0001). Incidence of coin ingestion increased from 3 to 4.5/10,000 children (R2 = 0.06, p = 0.335) but represented a smaller proportion of all EFB over time (66% in 2003 versus 43% in 2022). Incidence of magnet, battery, and toy ingestion have increased from 0.3 to 1.0/10,000 (R2 = 0.9, p < 0.0001), 0.3 to 1/10,000 (R2 = 0.7, p < 0.0001), and 0.6 to 2.3/10,000 (R2 = 0.8, p < 0.0001) children, respectively, between 2003 and 2022. The proportion of magnet, battery, and toy ingestion have increased over time (3.2%, 6.5%, and 11.8%, respectively, in 2003 to 11.4%, 11.7%, and 22.2%, respectively, in 2022). CONCLUSION: Magnet, battery, and toy ingestion have increased significantly in the past two decades, while the proportion of coin ingestion has decreased. This trend may reflect shifts within the consumer market and increased availability of electronics concurrent with the adoption of digital currency. LEVEL OF EVIDENCE: 4 Laryngoscope, 2024.

What do we know about dermal bioaccessibility of metals coated on antibacterial films?

Antibacterial films have gained attention since the outbreak of the COVID-19 pandemic; however, the impact of metals contained in antibacterial films on human safety have not been sufficiently investigated. This study reports on the important features that must be considered when assessing the bioaccessibility of Ag, Cu, and Zn in antibacterial films. Specifically, the effects of the artificial sweat component (i.e., amino acid and pH), surface weathering of antibacterial films, wipe sampling, and sebum were carefully examined. Our findings suggest that amino acids greatly affect bioaccessibility as amino acids act as ligands to facilitate metal ion leaching. In addition, constant exposure to ultraviolet C causes the film surface to oxidize, which significantly increases metal bioaccessibility due to the electrostatic repulsion between metal oxides and organic substrates. The presence of sebum in artificial sweat and physical damage to the film surface had no significant effects. Furthermore, the wipe sampling used to mimic the realistic dermal contact suggests the feasibility of applying this method for the assessment of bioaccessibility of metals in antibacterial films. The method offers significant advantages for evaluating the human safety aspects of skin contact with consumer products in future research.

Rare earths and other elements content in hen eggs sold in Italy: comparison among main types of farming methods and consumer's health risk assessment.

Recently, in Italy, consumers are choosing hen eggs from farming systems with higher ethical value, due to their perception of a related higher quality and safety. The purposes of this study were to evaluate the existence of differences in elemental content in Italian eggs from organic, barn, and caged hen farming methods and to determine the related potential consumer exposure risk to inorganic contaminants due to the consumption of eggs. One hundred seventy-six egg samples were collected and analyzed using Q-ICP-MS to investigate the content of 14 elements (Pb, As, Hg, Cd, Tl, Fe, Zn, Mn, Cu, Se, Co, Ni, V, and Cr) and 13 rare earth elements (La, Ce, Pr, Nd, Sm, Eu, Gd, Tb, Dy, Ho, Er, Tm, and Yb). The scenarios of exposure to rare earth and other elements from eggs were estimated for three age groups of consumers. The daily intake values were always lower than the respective safety reference values. In conclusion, Italian hen eggs contain low levels of rare earth and other elements, and therefore, their consumption does not represent a risk of exposure. Finally, no significant differences in contaminants between conventional and organic farming methods were found.

Virtual reality consumer product injuries: An analysis of national emergency department data.

INTRODUCTION: The growing popularity of virtual reality devices and increasingly widespread distribution of VR products into the home exposes users to risk of bodily harm. Safety features are integrated into the devices themselves, but the burden of cautious use rests upon the end user. The purpose of this study is to quantify and describe the array of injuries and demographics effected by the burgeoning VR industry to inform and encourage mitigation strategies. MATERIALS AND METHODS: The National Electronic Injury Surveillance System (NEISS) data was used to examine a nationwide sample of emergency department records from 2013 - 2021. Inverse probability sample weights for cases were applied to arrive at national estimates. NEISS data included consumer product injuries, patient age, sex, race and ethnicity, drug and alcohol involvement, diagnoses, injury descriptions, and emergency department disposition. RESULTS: The first VR-related injury was reported in the NEISS data in 2017, and injuries were estimated to number 125. Incidents of VR-related injuries amplified as increased VR units sold, and by 2021, there was a 352% increase in VR injuries totaling a weighted estimate of 1,336 ED visits. The most common VR-related injury diagnosis is fracture (30.3%), followed by laceration (18.6%), contusion (13.9%), other (11.8%), and strain / sprain (10.0%). VR-related injuries involve the hand (12.1%), face (11.5%), finger (10.6%), and knee (9.0%), head (7.0%) and upper trunk (7.0%). Patients age 0-5 most commonly experienced injuries to the face (62.3%). Injuries in patients 6-18 were mostly to the hand (22.3%) and face (12.8%). Patients 19-54 experienced primarily injuries to the knee (15.3%), finger (13.5%), and wrist (13.3%). Patients aged 55 and older disproportionately experienced injuries in the upper trunk (49.1%) and upper arm (25.2%). CONCLUSIONS: This is the first study to describe the incidence, demographics and characteristics of injuries from VR device use. Sales of home VR units continue to increase annually and the rapid increase in VR consumer injuries is being managed by emergency departments across the country. An understanding of these injuries will inform VR manufacturers, application developers, and users to promote safe product development and operation.

Safety and risks of CBD oils purchased online: unveiling uncertain quality and vague health claims.

Introduction: The unmet need for highly effective, naturally derived products with minimal side effects results in the over-popularity of ever-newer medicinal plants. In the middle of 2010, products containing cannabidiol (CBD), one of the special metabolites of Cannabis sativa, started to gain popularity. For consumers and healthcare providers alike, the legal context surrounding the marketing of CBD products is not entirely clear, and the safety of using some products is in doubt. Companies in the online medicinal product market profit from the confusion around CBD oils. Methods: In our study, we employed a complex method known as risk-based safety mapping of the online pharmaceutical market, which included health claim content analysis of online stores, test purchases, and labeling and quantitative analysis of the CBD content. Results: There were discovered 16 online retailers selling an average of 2-7 goods and CBD oils with a concentration of 3%-5% (30-50 mg/mL) CBD. The majority (n/N = 10/16, 62.5%) displayed potential health-related benefits indirectly on their website, and in the case of one web shop (n/N = 1/16, 6.3%), we detected COVID-19-related use. Altogether, 30 types of purported "indications" were collected. A total of 12 CBD oil products were test-purchased from online retailers in December 2020. Upon evaluating the packaging and product information, we noticed that three products (n/N = 3/12, 25%) lacked instructions on use, hence increasing the risk of inappropriate application and dosing. The cannabidiol content was quantified using UHPLC. The measured CBD concentrations of the products ranged from 19.58 mg/mL to 54.09 mg/mL (mean 35.51 mg/mL, median 30.63 mg/mL, and SD ± 12.57 mg/mL). One (8.33%) product was underlabeled, five (41.67%) were over-labeled, and only every second product (50%) was appropriately labeled based on the quantitative assessment of CBD concentration. Discussion: Further research and quality control are necessary to establish the regulatory context of the usage and classification of CBD and other cannabinoids in nonmedicinal products (e.g., food supplements), as authorities and policymakers worldwide struggle with the uncertainties surrounding CBD products.

Predicting emerging chemical content in consumer products using machine learning.

Chemical ingredients in consumer products are continually changing. To understand our exposure to chemicals and their consequent risk, we need to know their concentrations in products, or chemical weight fractions. Unfortunately, manufacturers rarely report comprehensive weight fraction data on product labels. The goal of this study was to evaluate the utility of machine learning strategies for predicting weight fractions when chemical constituent data are limited. A "data-poor" framework was developed and tested using a small dataset on consumer products containing engineered nanomaterials to represent emerging substances. A second, more traditional framework was applied to a "data-rich" product dataset comprised of bulk-scale organic chemicals for comparison purposes. Feature variables included chemical properties, functional use categories (e.g., antimicrobial), product categories (e.g., makeup), product matrix categories, and whether weight fractions were manufacturer-reported or experimentally obtained. Classification into three weight fraction bins was done using a random forest or nonlinear support vector classifier. An ablation study revealed that functional use data improved predictive performance when included alongside chemical property data, suggesting the utility of functional use categories in evaluating the safety and sustainability of emerging chemicals. Models could roughly stratify material-product observations into order of magnitude weight fractions with moderate success; the best of these achieved an average balanced accuracy of 73% on the nanomaterials product data. Framework comparisons also revealed a positive trend in sample size versus average balanced accuracy, suggesting great promise for machine learning approaches with continued investment in chemical data collection.

Risk assessment of consumer spray products using in vitro lung surfactant function inhibition, exposure modelling and chemical analysis.

Consumer spray products release aerosols that can potentially be inhaled and reach the deep parts of the lungs. A thin layer of liquid, containing a mixture of proteins and lipids known as lung surfactant, coats the alveoli. Inhibition of lung surfactant function can lead to acute loss of lung function. We focused on two groups of spray products; 8 cleaning and 13 impregnation products, and in the context of risk assessment, used an in vitro method for assessing inhibition of lung surfactant function. Original spray-cans were used to generate aerosols to measure aerodynamic particle size distribution. We recreated a real-life exposure scenario to estimate the alveolar deposited dose. Most impregnation products inhibited lung surfactant function at the lowest aerosolization rate, whereas only two cleaning products inhibited function at the highest rates. We used inhibitory dose and estimated alveolar deposition to calculate the margin of safety (MoS). The MoS for the inhibitory products was ≤1 for the impregnation products, while much larger for the cleaning products (>880). This risk assessment focused on the risk of lung surfactant function disruption and provides knowledge on an endpoint of lung toxicity that is not investigated by the currently available OECD test guidelines.

Avaliação das rotulagens de alimentos frente à legislação vigente e do uso de alegações não regulamentadas / Evaluation of food labeling before legislation and the use of non-regimented claims

Este estudo objetivou analisar a conformidade de 56 rótulos de produtos alimentícios divididos em 14 categorias em relação às legislações gerais e específicas de rotulagem de alimentos vigentes até o momento de sua publicação, bem como apresentar abordagens com relação à necessidade da constante melhoria e aperfeiçoamento da legislação. Constatou-se um total de 158 não conformidades e que 55,3% dos produtos avaliados apresentavam pelo menos uma não conformidade em sua rotulagem. Biscoitos e produtos artesanais foram as categorias que mais apresentaram rótulos com pelo menos uma não conformidade. Entre as informações obrigatórias, as referentes ao lote, à data de fabricação, ao prazo de validade e à conservação foram as mais recorrentes entre as não conformidades. Verificou-se também que algumas expressões como "produto caseiro", "vegano", "vegetariano", "base vegetal", entre outras, requerem melhor regulamentação ou legislação específica, portanto, não puderam ser avaliadas em relação à conformidade. Os motivos para tal cenário podem ser a aplicação incorreta da legislação e o uso de estratégias de marketing com o objetivo de atender a desejos e expectativas dos consumidores. Portanto, faz-se necessária uma intensificação da fiscalização, assim como maior celeridade na regulamentação de alegações específicas por parte dos órgãos responsáveis (AU).

This study aimed to evaluate the suitability of the labeling of 56 industrialized and packaged food products in the absence of the consumer, divided into 14 categories, before general and specific legislations on food labeling was in force at the time of its publication, as well as to present an approach regarding the need for constant improvement of legislation. It was found that 55.3% of the products presented at least one non-compliance in their labeling, and that there were a total of 159 non-compliances. Cookies and products with artisanal claims were the categories that most often presented products with at least one non-conformity. Among the mandatory information, batch, production date, expiration date, and conservation conditions were the ones that most presented non-conformities. It was also found that some claims, such as vegan, vegetarian, homemade, and plant-based, among others, lack of specific legislation, and therefore could not be assessed whether it was in compliance. This scenario shows misapplication of current legislation by food industry, as well as marketing strategies aiming to meet consumer''s seek. Thus, it is necessary to intensify inspection and also speed up the requirement for specific claims for the responsible agencies, mainly those related to health issues (AU).

I'm All Ears: A Population-Based Analysis of Consumer Product Foreign Bodies of the Ear.

OBJECTIVES: The purpose of this study was to assess the nationwide incidence of ear foreign body (FB) presentations to the emergency department (ED) and analyze the most common FB consumer products encountered. METHODS: The National Electronic Injury Surveillance System (NEISS) was evaluated for ED visits that included "ear foreign bodies" from 2010 through 2019. The most frequent foreign bodies were identified and organized by demographics. RESULTS: A total of 20,545 ear FB cases were found, with an estimated 608,860 ED visits nationwide. Female patients (56%) were more likely to have jewelry and first aid equipment FBs. Males between the ages of 5 and 15 years were significantly (P < 0.05) more likely to have paper products, pens/pencils, and desk supplies in their ears. CONCLUSION: Ear FBs represent a substantial proportion of healthcare expenditures. Although children are the most commonly affected individuals, all ages require further education and preventive measures.

A Short Critique on the Stance of the Netherlands Food and Consumer Product Safety Authority on Melamine Polymer Formaldehyde Exposures.

In February 2021, the Netherlands Food and Consumer Product Safety Authority came out with their risk assessment on formaldehyde exposure from melamine crockery with bamboo fiber to especially young children. In this short commentary, I will critique their assessment of this type of food-contact material (FCM). The main flaws are at least: (i) absence of a proper valuation of the available principal scientific literature yielding a biased risk assessment; (ii) discounting the endogenous formaldehyde formation that outweighs background exposure substantially; (iii) ad hoc positing of an unjustifiable and unfounded low background exposure levels to formaldehyde whereby risks of exposure to melamine formaldehyde is grossly exaggerated. This biased assessment has created societal unrest that is wholly uncalled for. Additionally, it has wide-ranging European consequences for the use of all melamine FCM.

[The regenerative medicine and stem cell business: confusion with legal implications]. / El negocio de la medicina regenerativa y las células madre: confusión con implicaciones legales.

The rise of regenerative medicine and the growth of the offer of autologous therapies, obtained from blood, cells or tissues of the patients, have been favoured by the current availability of an increasing number of commercial devices. Most of these devices are easy to use, allowing the elaboration of products and its application within the same procedure. Regardless of the questionable efficacy and safety of many of the treatments offered under the claim of stem cells or regenerative medicine, most of the centres and professionals offering these treatments are unaware of the legal requirements and implications of their use. A common confusion consists in not distinguishing between the authorization required by the equipment itself, considered a medical device, and the authorization for the use of the product obtained, usually considered a medicinal product (whether advanced therapy or not) or a transplant. Moreover, these treatments frequently have an experimental nature. In that case, in addition to requiring the corresponding ethical evaluation and the authorization of various regulatory bodies, their administration must be offered free of charge, obtaining the patient's informed consent and after contracting a specific insurance policy. In this article we present a brief summary of the main requirements for the application of these autologous biological products with the aim of serving as a guide both for the professionals who prescribe them and for those who inspect the centres where the products are administered. Finally, we include some recommendations for patients.

Poisonings due to storage in a secondary container reported to the National Poison Data System, 2007-2017.

BACKGROUND: Transfer of xenobiotics from their original container to an unlabeled or secondary container is a well-identified risk factor for poisoning. Nonetheless, recent large-scale data on the practice are unavailable. The objective of this study is to describe the incidence and features of poisonings in the United States due to xenobiotics stored in a secondary container. METHODS: This was a retrospective review of the National Poison Data System (NPDS) from 2007 to 2017. Non-suicidal exposures associated with the scenario "container transfer involved (product transferred from original container to unlabeled container, incorrectly labeled container, or food container for use or storage and patient accessed product from second container)" were included. RESULTS: Forty-five thousand five hundred and twelve cases were included. The median age of subjects was 30 years (interquartile range: 6-53); 52% were female. Cleaning products (38.2%), disinfectants (17.3%), and hydrocarbons (5.0%) were the most common xenobiotics reported. The annual incidence of cases increased over the study period. There were 9369 (20.6%) ED visits and 1856 (4.1%) hospital admissions. Most cases (72%) were deemed nontoxic or resulted in no effects; 4.4% resulted in serious outcomes (moderate effects, major effects, or death), including 23 deaths. Morbidity was highest for pesticides, prescription medications, and herbicides, with 10.3%, 9.8%, and 7.6% of cases resulting in serious outcomes, respectively. Hydrofluoric acid and herbicides were associated with the most deaths (13/23 [57%]). CONCLUSIONS: Transfer of xenobiotics to a secondary container is a scenario increasingly reported to U.S. poison centers. Although most exposures do not result in significant toxicity, ED visits are common and substantial morbidity can occur. This represents an opportunity for public health intervention to curb the practice.

A comprehensive study of nickel levels in everyday items in Brazil.

BACKGROUND: Nickel is a ubiquitous element used in many everyday items. In recent decades nickel has become a leading allergen, which has become a public health problem. OBJECTIVE: To evaluate frequently used nickel products in Brazil. We investigated if these objects release nickel that is capable of inducing sensitization or cause clinical manifestations in terms of allergic contact dermatitis (ACD). METHODS: Dimethylglyoxime (DMG) spot tests assessed nickel release from several common utensils used in everyday life in São Paulo and Rio de Janeiro, Brazil. RESULTS: We tested 46 coins (two denominations) and 90 common utensils. Approximately 91.1% produced nickel-positive results using the DMG spot test. CONCLUSIONS: The DMG limit of detection was 1.67 ppm of nickel. We observed that many objects in our test series released nickel above the DMG test limit. This observation suggests that nickel-sensitive individuals may be exposed to nickel, representing a public health issue.

Validação da limpeza de produtos para saúde no cotidiano do centro de material e esterilização / Validation of daily medical device cleaning in the sterile processing department / Validación de la limpieza de productos de salud en todos los días del centro de material y esterilización

Objetivo: Discutir os aspectos que devem ser considerados na validação concorrente da limpeza no Centro de Materiais e Esterilização (CME). Método: Revisão narrativa da literatura científica, legislação e normatização pertinentes. Resultados: A validação da limpeza na rotina deve considerar: o design dos produtos, a definição e a exequibilidade dos procedimentos operacionais padrão, além da estrutura do CME, dimensionamento, seleção e treinamento de pessoal, registro e interpretação dos resultados obtidos pelos testes químicos na rotina. Conclusão: A validação concorrente da limpeza dos produtos para saúde no CME imprime a cultura da valorização dessa etapa do processamento entre todos os colaboradores do setor, de tal forma que a limpeza passa a ser, de fato, o núcleo central do processamento

Objective: To discuss the aspects that should be considered in the concurrent cleaning validation at Sterile Processing Department (SPD). Method: Narrative review of scientific literature, legislation, and pertinent normalizations. Results: The routine cleaning validation should consider the product design, definition, and feasibility of standard operating procedures (SOP); SPD structure; staff sizing; selection and training; and the recording and interpretation of results obtained by routine chemical tests. Conclusion: The concurrent cleaning validation of health products at SPD points out the value of this stage to all employees in the sector such that cleaning becomes a core function of health service product processing.

Objetivo: Discutir los aspectos que deben considerarse en la validación concurrente de limpieza en el Centro de Materiales y Esterilización (CME). Método: revisión narrativa de la literatura científica relevante, legislación y normas. Resultados: La validación de la limpieza en la rutina debe considerar: el diseño de los productos, la definición y la viabilidad de los procedimientos operativos estándar, además de la estructura del CME, dimensionamiento, selección y capacitación del personal, registro e interpretación de los resultados obtenidos por las pruebas químicas en el rutina Conclusión: La validación concurrente de la limpieza de productos de salud en CME impresiona la cultura de valorar esta etapa de procesamiento entre todos los empleados del sector, de tal manera que la limpieza se convierta, de hecho, en el núcleo central del procesamiento

Korean Consumers' Recognition of Risks Depending on the Provision of Safety Information for Chemical Products.

After the 2011 "Oxy accident" involving deaths from humidifier disinfectants, Korean consumers' anxiety about chemical products has risen. To provide timely, appropriate information to consumers, we must understand their risk recognition and explore methods of safety information provision. We investigated Korean consumers' level of risk perception for chemical products depending on the provision of safety information and other factors. We conducted an online survey for 10 days with 600 adult Korean consumer participants and analyzed seven factors: catastrophic potential, controllability, familiarity, fear, scientific knowledge, and risk for future generations. Our results showed that married women over 30 perceived chemical products as higher risk, but when information was provided on how to use products safely, catastrophic potential, controllability, fear, scientific knowledge, as well as risk perception, increased significantly. When only risk diagnosis information was provided, catastrophic potential, fear, and risk for future generations remained static, but familiarity had a negative effect (R^2 = 0.586). Age and scientific knowledge affected the recognition of risk when safe risk management methods were provided (R^2 = 0.587). Risk controllability did not have any effect on risk perception. These results suggest that providing information about avoiding or dealing with risks has a positive effect on consumers' risk perception.

Cosmetovigilance: A New Concept for the Residency Curriculum.

Description Primary care physicians need to incorporate "cosmetovigilance" into their post-graduate curriculum to increase their residents' awareness of the adverse reactions induced by the use of cosmetic products, as well as promoting good reporting behavior.

Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015.

Policy Points Food and Drug Administration (FDA) advisory committee recommendations and the agency's final actions exhibit high rates of agreement, with cases of disagreement tending to reflect the proposed action type and degree of advisory committee consensus. In the case of disagreements, the FDA tended to be less likely than its advisory committees to approve new products, approve new supplemental indications, or enact new safety changes. These findings raise important issues regarding the factors that differentially shape decision making by advisory committees and the FDA as an agency, including institutional or reputational concerns. CONTEXT: The Food and Drug Administration (FDA) convenes advisory committees to provide external scientific counsel on potential agency actions and to inform regulatory decision making. The degree to which advisory committees and their respective agency divisions disagree on recommendations has not been well characterized across product and action types. METHODS: We examined public documents from FDA advisory committee meetings and medical product databases for all FDA advisory committee meetings from 2008 through 2015. We classified the 376 voting meetings in that period by medical product, regulatory, and advisory committee meeting characteristics. We used multivariable logistic regression to determine the associations between these characteristics and discordance between the advisory committee's recommendations and the FDA's final actions. FINDINGS: Twenty-two percent of the FDA's final actions were discordant with the advisory committee's recommendations. Of these, 75% resulted in the FDA making more restrictive decisions after favorable committee recommendations, and 25% resulted in the agency making less restrictive decisions after unfavorable committee recommendations. Discordance was associated with lower degrees of advisory committee consensus and was more likely for agency actions focused on medical product safety than for novel approvals or supplemental indications. Statements by public speakers, advisory committee conflicts of interest, and media coverage were not associated with discordance between the committee and the agency. CONCLUSIONS: The FDA disagrees with the recommendation of its advisory committees a minority of the time, and in these cases it tends to be less likely to approve new products or supplemental indications and take safety actions. Deviations from recommendations thus offer an opportunity to understand the factors influencing decisions made by both the agency and its expert advisory groups.