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.

Analysis of Traditional Chinese Medicine regulation in Canada / 国际中医中药杂志

This paper analyzes the laws, regulations and concre measures of Traditional Chinese Medicine (TCM) in Canada, so as to provide reference for TCM products to enter Canada, and for the establishment of TCM regulation system and the improvement of its detailed rules in China. The regulation of TCM in Canadian, on the one hand, supervision is to provide guidance for the protection of consumers' rights and interests, including the guidance of rational drug use and rational purchase for consumers; on the other hand, it is to supervise enterprises, including the safety, effectiveness and quality certification of TCM products, labeling and packaging requirements, as well as the site certification of product manufacturing, packaging, labeling and import. The Ministry of health of Canada takes evidence as the core of evaluation, and ensures the safe and effective use of TCM products in Canada through product and site licensing evaluation. In the supervision of TCM, relevant departments in China should further strengthen the protection of consumers' drug rights and interests, strengthen the construction of TCM registration evidence system, and pay attention to the risk management of drug production quality.

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

El auge de la medicina regenerativa y el crecimiento de la oferta de terapias autólogas obtenidas a partir de sangre, células o tejidos de los propios pacientes se ha visto favorecido por la actual disponibilidad de diversos dispositivos comerciales de fácil manejo que permiten la elaboración de los productos y su aplicación dentro de un mismo procedimiento. Independientemente de las dudosas eficacia y seguridad de muchos de los tratamientos que se ofrecen bajo el reclamo de las células madre o la medicina regenerativa, la mayor parte de los centros y de los profesionales que ofrecen estos tratamientos desconocen los requisitos y las implicaciones legales de su uso. Una confusión frecuente consiste en no distinguir entre la autorización que requiere el propio dispositivo, considerado producto sanitario, y la autorización para el uso del producto obtenido, que en general se trata de un medicamento, ya sea de terapia avanzada o no, o de un trasplante. Por otra parte, es frecuente que estos tratamientos tengan un carácter experimental, por lo que su administración en ese caso, además de requerir la evaluación ética correspondiente y la autorización de diversos organismos reguladores, debe ofrecerse de forma gratuita y tras recabar el consentimiento informado del paciente y contratar una póliza de seguros específica. En este artículo se presentan, de forma resumida, los principales requisitos para la aplicación de estos productos biológicos autólogos, con el objetivo de que puedan servir de guía tanto para los profesionales que los prescriben como para aquellos que inspeccionan los centros donde se administran. Por último, se ofrecen algunas recomendaciones para los pacientes. (AU)

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. (AU)

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.

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.

[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.

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.