Confined bioprinting and culture in inflatable bioreactor for the sterile bioproduction of tissues and organs.

The future of organ and tissue biofabrication strongly relies on 3D bioprinting technologies. However, maintaining sterility remains a critical issue regardless of the technology used. This challenge becomes even more pronounced when the volume of bioprinted objects approaches organ dimensions. Here, we introduce a novel device called the Flexible Unique Generator Unit (FUGU), which is a unique combination of flexible silicone membranes and solid components made of stainless steel. Alternatively, the solid components can also be made of 3D printed medical-grade polycarbonate. The FUGU is designed to support micro-extrusion needle insertion and removal, internal volume adjustment, and fluid management. The FUGU was assessed in various environments, ranging from custom-built basic cartesian to sophisticated 6-axis robotic arm bioprinters, demonstrating its compatibility, flexibility, and universality across different bioprinting platforms. Sterility assays conducted under various infection scenarios highlight the FUGU's ability to physically protect the internal volume against contaminations, thereby ensuring the integrity of the bioprinted constructs. The FUGU also enabled bioprinting and cultivation of a 14.5 cm3 human colorectal cancer tissue model within a completely confined and sterile environment, while allowing for the exchange of gases with the external environment. This FUGU system represents a significant advancement in 3D bioprinting and biofabrication, paving the path toward the sterile production of implantable tissues and organs.

A new protocol for renal collecting system sterilization with antibiotic irrigation during lithotripsy in retrograde intrarenal surgery: a prospective, comparative study.

PURPOSE: To present a new protocol using antibiotic irrigation during lithotripsy in retrograde intrarenal surgery (RIRS) to provide sterility of the renal collecting system. METHODS: This prospective study included 102 patients who underwent RIRS between January 2022 and August 2023. The patients were examined in two groups as those who received antibiotic irrigation (n:51) and standard irrigation (n:51). In the antibiotic irrigation group, 80 mg of gentamicin was dissolved in normal saline in a 3 L irrigation pouch to obtain a 26.7 mg/L concentration. In the standard irrigation group, normal saline was used. Preoperative information, including age, sex, body mass index (BMI), ASA score, stone side, volume, and density, and the Seoul National University Renal Stone Complexity (S-ReSC) score. The groups were compared with respect to postoperative fever (> 38 °C), urinary tract infection (UTI), systemic inflammatory response syndrome (SIRS), infectious complications such as sepsis, and stone-free rate. RESULTS: No statistically significant difference was determined between the groups with respect to age, sex, BMI, ASA score, stone side, volume and density, and S-ReSC score (p > 0.05 for all). Statistically significant differences were determined between the groups with respect to postoperative fever (p = 0.05), SIRS (p = 0.05), and hospital length of stay (p = 0.05). Sepsis was observed in one patient in the standard irrigation group and in none of the antibiotic irrigation group. CONCLUSION: The reliability, efficacy, and utility of antibiotic irrigation during lithotripsy in RIRS were presented in this study as a new protocol for sterilization of the renal collecting system which will be able to reduce infectious complications.

Dimensional accuracy and simulation-based optimization of polyolefins and biocopolyesters for extrusion-based additive manufacturing and steam sterilization.

Polyolefins exhibit robust mechanical and chemical properties and can be applied in the medical field, e.g. for the manufacturing of dentures. Despite their wide range of applications, they are rarely used in extrusion-based printing due to their warpage tendency. The aim of this study was to investigate and reduce the warpage of polyolefins compared to commonly used filaments after additive manufacturing (AM) and sterilization using finite element simulation. Three types of filaments were investigated: a medical-grade polypropylene (PP), a glass-fiber reinforced polypropylene (PP-GF), and a biocopolyester (BE) filament, and they were compared to an acrylic resin (AR) for material jetting. Square specimens, standardized samples prone to warpage, and denture bases (n = 10 of each group), as clinically relevant and anatomically shaped reference, were digitized after AM and steam sterilization (134 °C). To determine warpage, the volume underneath the square specimens was calculated, while the deviations of the denture bases from the printing file were measured using root mean square (RMS) values. To reduce the warpage of the PP denture base, a simulation of the printing file based on thermomechanical calculations was performed. Statistical analysis was conducted using the Kruskal-Wallis test, followed by Dunn's test for multiple comparisons. The results showed that PP exhibited the greatest warpage of the square specimens after AM, while PP-GF, BE, and AR showed minimal warpage before sterilization. However, warpage increased for PP-GF, BE and AR during sterilization, whereas PP remained more stable. After AM, denture bases made of PP showed the highest warpage. Through simulation-based optimization, warpage of the PP denture base was successfully reduced by 25%. In contrast to the reference materials, PP demonstrated greater dimensional stability during sterilization, making it a potential alternative for medical applications. Nevertheless, reducing warpage during the cooling process after AM remains necessary, and simulation-based optimization holds promise in addressing this issue.

Peracetic acid sterilized tendon and ligament allografts for knee reconstruction : For anterior cruciate ligament (ACL), posterior cruciate ligament (PCL) and complex knee surgery.

BACKGROUND: The use of allografts and autografts has been met with mixed views on whether allografts are a suitable alternative to autografts. QUESTION: We aimed to investigate if chemically sterilized allografts show similar rerupture rates to those reported in the literature for allografts and autografts in anterior (ACL) and posterior cruciate ligaments (PCL) and complex knee surgery. MATERIALS AND METHODS: Retrospective data on knee reconstructions performed between 2011 and 2015 with tendon/ligamnet allografts sterilized with peracetic acid were collected in the form of a questionnaire. The inclusion criteria of 2 years for each patient were met by 38 patients, representing 22 ACL reconstructions, 5 PCL reconstructions, 3 OTHER surgeries, including the Larson technique and medial patellofemoral ligament (MPFL) reconstruction and 8 COMPLEX surgeries. The main endpoints were rerupture and complication rate. Secondary endpoints included stability of the knee (Lachman test, Pivot shift test) and the range of motion. RESULTS: The rerupture rate was 7.9% (3 grafts). Reruptures only occurred in the ACL group. No reruptures were observed in the PCL, OTHER and COMPLEX surgery groups. Stability improved significantly after surgery and the range of motion returned to values similar to that of healthy knees. CONCLUSIONS: Tendon allografts sterilized with peracetic acid show promising low rerupture rates and good clinical scores and the results are comparable to the literature on autografts and other allografts.

Radiation processing of bacterial cellulose-monolaurin wound dressing: Physicochemical effects, functional analysis, and sterilization.

A commercial bacterial cellulose-monolaurin wound dressing was investigated for changes in the chemical structure, mechanical strength, thermal degradation, morphology, and functional swelling properties after exposure to gamma and electron beam radiations at doses 15-50 kGy. Radiation-induced oxidation occurred as seen in the FT-IR peaks at 1720-1750 cm-1. Degradation of the cellulosic network was observed in tensile strength reduction and shift in degradation temperature to lower values. The SEM cross-section images of the irradiated dressings revealed a less dense nanostructure network compared to the non-irradiated samples while the XRD diffractograms indicated a change in lattice direction/plane. Despite these changes, irradiation caused no significant effect on the functional properties especially at 15-25 kGy doses where most biomedical devices are sterilized. All irradiated wound dressings exhibited physical integrity, increased exudate absorption, and water vapor transmission rate - properties beneficial to wound-healing functionality. The pre-selected sterilization dose of 15 kGy for each ionizing radiation was successfully verified and substantiated following ISO 11137-2:2016, hence ionizing radiation is a suitable sterilization modality for the product.

Structure and properties of the acellular porcine cornea irradiated with 60Co-γ and electron beam and its histocompatibility.

Acellular porcine cornea (APC) has been used in corneal transplantation and treatment of the corneal diseases. Sterilization is a key step before the application of graft, and irradiation is one of the most commonly used methods. In this paper, APC was prepared by the physical freeze-thawing combined with biological enzymes, and the effects of the electron beam (E-beam) and cobalt 60 (60Co-γ) at the dose of 15 kGy on the physicochemical properties, structure, immunogenicity, and biocompatibility of the APC were investigated. After decellularization, the residual DNA was 20.86 ± 1.02 ng/mg, and the α-Gal clearance rate was more than 99%. Irradiation, especially the 60Co-γ, reduced the cornea's transmittance, elastic modulus, enzymatic hydrolysis rate, swelling ratio, and cross-linking degree. Meanwhile, the diameter and spacing of the collagen fibers increased. In the rat subcutaneous implantation, many inflammatory cells appeared in the unirradiated APC, while the irradiated had good histocompatibility, but the degradation was faster. The lamellar keratoplasty in rabbits indicated that compared to the E-beam, the 60Co-γ damaged the chemical bond of collagen to a larger extent, reduced the content of GAGs, and prolonged the complete epithelization of the grafts. The corneal edema was more serious within 1 month after the surgery. After 2 months, the thickness of the APC with the two irradiation methods tended to be stable, but that in the 60Co-γ group became thinner. The pathological results showed that the collagen structure was looser and the pores were larger, indicating the 60Co-γ had a more extensive effect on the APC than the E-beam at 15 kGy.

The Process of Sterilizing Tattoo Inks Releases Formaldehyde.

INTRODUCTION: Around 12% of Europeans and 20% of Americans have at least one tattoo. Tattoo inks, the substances used to create tattoos on the body, consist of chemicals that contain formaldehyde, which can be harmful to human health. The amount of formaldehyde present in commercially available tattoo inks and its causes are not well understood. METHODS: We investigated the levels of formaldehyde in tattoo ink products sold in different countries and identified the factors contributing to its production. We also explored methods to reduce formaldehyde generation in tattoo inks. Seven tattoo inks from various brands were tested. RESULTS: Formaldehyde release was predominantly associated with gamma radiation sterilization. Formaldehyde levels were observed to be higher in compositions containing organic components compared to those with inorganic components, irrespective of sterilization method and container type. Glycerin released over seven times more formaldehyde than other components during gamma-ray sterilization. CONCLUSION: The results suggest that the presence of hydroxyl groups in carbon organic compounds in tattoo ink leads to photodegradation during gamma-ray radiation sterilization, resulting in increased concentrations of formaldehyde. Further research is needed to examine the chemical reactions occurring during sterilization processes and identify alternative sterilization methods that minimize formaldehyde formation. Additionally, the development of tattoo inks with reduced formaldehyde content and the establishment of strict quality control measures can help ensure the safety of tattooing practices.

Research status and prospects of organic photocatalysts in algal inhibition and sterilization: a review.

An increasing amount of sewage has been discharged into water bodies in the progression of industrialization and urbanization, causing serious water pollution. Meanwhile, the increase of nutrients in the water induces water eutrophication and rapid growth of algae. Photocatalysis is a common technique for algal inhibition and sterilization. To improve the utilization of visible light and the conversion efficiency of solar energy, more organic photocatalytic materials have been gradually developed. In addition to ultraviolet light, partial infrared light and visible light could also be used by organic photocatalysts compared with inorganic photocatalysts. Simultaneously, organic photocatalysts also exhibit favorable stability. Most organic photocatalysts can maintain a high degradation rate for algae and bacteria after several cycles. There are various organic semiconductors, mainly including small organic molecules, such as perylene diimide (PDI), porphyrin (TCPP), and new carbon materials (fullerene (C60), graphene (GO), and carbon nanotubes (CNT)), and large organic polymers, such as graphite phase carbon nitride (g-C3N4), polypyrrole (PPy), polythiophene (PTH), polyaniline (PANI), and polyimide (PI). In this review, the classification and synthesis methods of organic photocatalytic materials were elucidated. It was demonstrated that the full visible spectral response (400-750 nm) could be stimulated by modifying organic photocatalysts. Moreover, some problems were summarized based on the research status related to algae and bacteria, and corresponding suggestions were also provided for the development of organic photocatalytic materials.

The effect of sterilization and storage on the viscoelastic properties of human tendon allografts - Continued: Storage for 0 to 4 months.

The role of donor-derived tendons, also known as allografts, in anterior cruciate ligament replacement surgeries is steadily increasing. Before surgery, temporary storage and, in most cases, sterilization are essential. It is, thus, crucial to determine how these procedures alter the grafts' biomechanical properties. The purpose of this research was to analyze the effect of different sterilization methods (native, frozen, frozen + 21 kGy gamma irradiation, frozen + 21 kGy electron beam irradiation) and storage durations (0 to 4 months) on the deformation and creep of two tendon types (tibialis anterior, peroneus longus). 80 tibialis anterior and 83 peroneus longus tendons from 51 human cadavers were included. The samples were removed, placed in a radio-cryoprotectant solution, then slowly cooled, sterilized and stored at -80 °C. All groups were subject to 60 s static creep test with 250 N load. Deformation during the loading phase, creep during static loading, and the ratio of these two were evaluated. Deformation at the end of the loading phase and creep consistently exhibited significantly smaller values in the tibialis anterior compared to the peroneus longus type, as well as in electron beam-sterilized grafts as opposed to gamma beam-sterilized ones. Prolonged storage periods (within 0 to 4 months) resulted in a notable increase in these values, particularly in deformation. Based on the experimental data, the tibialis anterior tendon type and sterilization by gamma beam irradiation are better choices for anterior cruciate ligament reconstruction than the peroneus longus and sterilization by electron beam. Increased storage time affects negatively the evaluated mechanical properties.

Modelo lógico-teórico como ferramenta de planejamento para melhoria da cobertura vacinal infantil no Rio Grande do Norte, Brasil / Theoretical-logic model as a planning tool to improve childhood vaccination coverage in Rio Grande do Norte, Brazil / Modelo teórico-lógico como herramienta de planificación para mejorar la cobertura de vacunación infantil en Rio Grande do Norte, Brasil

Introdução:A vacinação tem se apresentado como uma importante estratégia de proteção à saúde da população. A redução da cobertura vacinal é um alerta para o retorno de doenças imunopreveníveis que já haviam sido erradicadas.Objetivo:Mapear o cenário de cobertura vacinal de crianças menores de 2 anos no Rio Grande do Norte no período de 2012 a 2021, e propor um modelo teórico-lógico para o planejamento das ações. Metodologia:Trata-se de um estudo do tipo ecológico, acerca da cobertura vacinal no estado em questão. Os dados foram coletados a partir do Departamento de Informática do Sistema Único de Saúde (DATASUS), por meio das Informações em Saúde (TABNET). Para coleta dos dados, elegeu-se como variáveis o ano para compor a linha da tabela a ser gerada pelo sistema, o imunobiológico para compor a coluna e, como medida, foi selecionada a cobertura vacinal. O período analisado foi de 2012 a 2021. Resultados:Nacionalmente, os anos de 2020 e 2021 apresentaram queda com relação aos dois anos anteriores à pandemia do novo coronavírus (SARS-CoV-2). Foi identificada a mesma tendencia de queda na cobertura vacinal infantil no estado de interesse do estudo ao comparar a média de cobertura de 2018/2019 com a média de 2020/2021. O modelo lógico teórico apresentado neste estudocontribui para a otimizaçãodo planejamento e das ações do programa estadual de imunização. Conclusão:Este estudose mostrou relevante para direcionar as estratégias da Secretaria de Saúde Pública do Rio Grande do Norte,ao propor ummodelo teórico-lógicocomo ferramenta para melhoria dos indicadoresde cobertura vacinal infantil (AU).

Introduction:Vaccination has been presented as an important health protection strategy for the population. The reduction in vaccination coverage is an alert for the return of immune preventable diseases that had already been eradicated. Objective:To map the vaccination coverage scenario for children under 2 years old in Rio Grande do Norte from 2012 to 2021 and propose a theoretical-logical model for planning actions. Methodology:This is an ecological study on vaccination coveragein the state in question. Data were collected from the Department of Informatics of the Brazilian National Health System (DATASUS), through Health Information (TABNET). The variables chosen for data collection were the year, which formed the rows of the table generated by the system, the immunobiological vaccine, which formed the columns, and the vaccination coverage rate as the measure. The period analyzed was from 2012 to 2021. Results:Nationally, the years 2020 and 2021 showed a drop compared to the two years prior to thenew coronavirus pandemic (SARS-CoV-2). The same downward trend in childhood vaccination coverage was identified in the state of interest when comparing the average coverage of 2018/2019 with the average of 2020/2021. The theoretical logic model presented in this study contributes to optimizing the planning and actions of the state immunization program. Conclusion:This study proved to be relevant for directing the strategies of the Rio Grande do Norte Public Health Department, by proposing a theoretical-logical model as a tool for improving infant vaccination coverage indicators (AU).

Introducción:La vacunación se hapresentado como una importante estrategia para proteger la salud de la población. La reducción de la cobertura de vacunación es una alerta para el regreso de enfermedades inmunoprevenibles que ya habían sido erradicadas. Objetivo:Mapear el escenario de cobertura de vacunación para niños menores de 2 años en Rio Grande do Norte en el período de 2012 a 2021, y proponer un modelo lógico-teórico para la planificación de acciones. Metodología:Este es un estudio ecológico sobre la cobertura de vacunación enelEstado en cuestión. Los datos fueron recolectados del Departamento de Informática del Sistema Único de Salud (DATASUS), a través del Información en Salud (TABNET). Las variables seleccionadas para la recopilación de datos fueron el año, que conformó las filas de la tabla generada por el sistema, la vacuna inmunobiológica, que conformó las columnas, y la tasa de cobertura vacunal como medida. El período analizado fue de 2012 a 2021. Resultados:A nivel nacional, los años 2020 y 2021 mostraron un descenso encomparación con los dos años previos a la pandemia del nuevo coronavirus (SARS-CoV-2). La misma tendencia a la baja en la cobertura de vacunación infantil se identificó en el estado de interés al comparar la cobertura media de 2018/2019 con la media de 2020/2021. El modelo lógico teórico presentado en este estudio contribuye a optimizar la planificación y las acciones del programa estatal de inmunización. Conclusión:Este estudio demostró ser relevante para direccionar las estrategias de la Secretaría de Salud Pública de Rio Grande do Norte, al proponer un modelo teórico-lógico como herramienta para mejorar los indicadores de cobertura de vacunación infantil (AU).

Investigação sobre os métodos de assepsia e equipamentos de proteção individual utilizados por manicures e pedicures / Research on asepsy methods and personal protective equipment used by manicurs and pedicurers / Investigación sobre métodos de asepsia y equipos de protección individual utilizados por manicuras y pedicuras

Introdução: As atividades laborais de manicures e pedicures geram riscos de exposições acidentais aos patógenos vinculados ao sangue como vírus, fungos e bactérias, devido à falta de adesão às medidas de biossegurança, e procedimentos de esterilização acarretando riscos à saúde dos profissionais e clientes. Objetivo:Verificar os conhecimentos das manicures e pedicures sobre os métodos de limpeza e esterilização de materiais, o uso de equipamentos de proteção individual e doenças relacionadas à profissão. Metodologia:Estudo transversal de abordagem quantitativa, realizado entre Outubro de 2017 a Janeiro de 2018, com 22 participantes finais. Incluídos os maiores de 18 anos, ambos os sexos, experiência mínima de um ano e residir em Nova Floresta. A técnica para seleção da amostra foi snowball. Resultados: A limitação de conhecimento sobre os riscos laborais na exposição de agentes infectantes, a baixa adesão no uso de equipamentos de proteção individuale a falta de padronização no processo de descontaminação, limpeza, desinfecção e esterilização dos instrumentais estão associados ao potencial risco de contaminação por agentes infecciosos, e ao acometimento de doenças infectocontagiosas por manicures, pedicures e clientela. Conclusões:Existem fragilidades no conhecimento destes profissionais,a maioria expõe métodos de antissepsia precários, devido a falta de sistematização e padronização dos procedimentos de limpeza, descontaminação dos instrumentais e o uso de equipamentos de proteção individual, além do conhecimento da profissão ter sido adquirido informalmente (AU).

Introduction: The work activities of manicurists and pedicurists generate risks of accidental exposure to pathogens linked to the blood such as viruses, fungi and bacteria, due to the lack of adherence to biosafety measures, and sterilization procedures causing risks to the health of professionals and clients. Objective:To verify the knowledge of manicurists and pedicurists on methods of cleaning and sterilizing materials, the use of personal protective equipment and diseases related to the profession. Methodology: Cross-sectional study with a quantitative approach, carried out between October 2017 and January 2018, with 22 final participants. Included are those over 18 years of age, both sexes, with at least one year's experience and residing in Nova Floresta. The technique for sample selection was snowball.Results:Limited knowledge about occupational risks in the exposure of infectious agents, low adherence to the use of personal protective equipmentand the lack of standardization in the process of decontamination, cleaning, disinfection and sterilizationof instruments are associated with the potential risk of contamination by infectious agents, and the spread of infectious diseases by manicurists, pedicurists and clientele. Conclusions:There are weaknesses in the knowledge of these professionals, most expose precarious antisepsis methods, due to the lack of systematization and standardization of cleaning procedures, decontamination of instruments and the use of personal protective equipment, in addition to the knowledge of the profession having been acquired informally (AU).

Introducción: Las actividades laborales de manicuras y pedicuras generan riesgos de exposiciónaccidental a patógenos ligados a la sangre como virus, hongos y bacterias, debido al incumplimiento de medidas de bioseguridad y procedimientos de esterilización generando riesgos a la salud de profesionales y clientes. Objetivo:Verificar los conocimientos de manicuras y pedicuras sobre métodos de limpieza y esterilización de materiales, el uso de equipos de protección personal y enfermedades relacionadas con la profesión. Metodología:Estudio transversal de abordaje cuantitativo, realizado entre octubre de 2017 y enero de 2018, con 22 participantes finales. Se incluyen los mayores de 18 años, de ambos sexos, con experiencia mínima de un año y vivir en Nova Floresta. La técnica para la selección de la muestra fue la de bola de nieve. Resultados:El conocimiento limitado sobre los riesgos laborales en la exposición de agentes infecciosos, la baja adherencia al uso de equipo de protección personal y la falta de estandarización en el proceso de descontaminación, limpieza, desinfección y esterilización de instrumentos se asocian con el riesgo potencial de contaminación por agentes infecciosos, y la propagación de enfermedades infecciosas entre manicuras, pedicuras y clientela. Conclusiones:Existen debilidades en el conocimiento de estos profesionales, la mayoría expone métodos de antisepsia precarios, debido a la falta de sistematización y estandarización de los procedimientos de limpieza, descontaminación de los instrumentos y el uso de equipo de protección Personal,además de haber adquirido los conocimientos de la profesión informalmente (AU).

Reutilización de barrera de tela de algodón estéril en la práctica clínica: estudio observacional longitudinal / Reusing sterile cotton fabric barriers in the clinical practice: an observational and longitudinal study / Reuso de barreira estéril de tecido de algodão na prática clínica: estudo longitudinal observacional

Objetivo: analizar las características de barrera física y biológica de los campos de algodón utilizados como sistema de barrera estéril después de ser sometidos a múltiples usos y procesos en la práctica clínica. Método: estudio observacional longitudinal de seguimiento y evaluación de tela 100% algodón, utilizada como sistema de barrera estéril en un hospital de mediano porte. Se recolectaron muestras antes del uso (después de tres lavados) y después de tres, seis, nueve, 12 y 15 meses de uso y se evaluaron el número, grosor e integridad de los hilos, peso, absorción de agua y penetración húmeda de microorganismos. Resultados: después de 85 lavados, no cambió el número de hilos, aumentó el número de fibras deshilachadas y el volumen de agua absorbida. La prueba microbiológica mediante la metodología estándar alemana obtuvo un resultado negativo y la de penetración húmeda de microorganismos no mostró cambios significativos con el tiempo, a pesar de que una fracción de células microbianas pasó a través de las muestras de doble capa. Conclusión: las propiedades físicas de la tela 100% algodón utilizada como sistema de barrera estéril cambiaron con el uso/procesamiento; sin embargo, no interfirieron significativamente con los resultados obtenidos en las pruebas realizadas a la barrera microbiológica hasta los 85 lavados.

Objective: to analyze the physical and biological barrier characteristics of cotton fields used as a sterile barrier system after multiple use and processing cycles in the clinical practice. Method: an observational and longitudinal study to monitor and evaluate 100% cotton fabric used as a sterile barrier system in a medium-sized hospital. Samples were collected before use (after three washes) and at three, six, nine, 12 and 15 months of use and evaluated for the number, thickness and integrity of threads, weight, water absorption and wet penetration by microorganisms. Results: after 85 washes, the number of threads remained unchanged, and the shredded fibers and the water volume absorbed were increased. The microbiological test using the German standard methodology obtained a negative result and wet penetration by microorganisms did not show significant changes over time, although a percentage of the microbial cells passed through the double-layer samples. Conclusion: the physical properties of 100% cotton used as a sterile barrier system changed with use/processing cycles; however, these alterations did not significantly interfere with the results obtained by the tests performed on the microbiological barrier up to 85 washes.

Objetivo: analisar as características de barreira física e biológica de campos de algodão, que são utilizados como sistema de barreira estéril, após múltiplos usos e processamentos na prática clínica. Método: estudo longitudinal observacional de acompanhamento e de avaliação de tecido 100% algodão que foi utilizado como sistema de barreira estéril em um hospital de médio porte. Amostras foram coletadas antes do uso (após três lavagens) e com três, seis, nove, 12 e 15 meses de uso e avaliadas quanto ao número, à espessura e à integridade dos fios, peso, absorção de água e penetração úmida de micro-organismos. Resultados: após 85 lavagens, o número de fios permaneceu inalterado, porém aumentaram-se as fibras desfiadas e o volume de água absorvido. O teste microbiológico utilizando metodologia padrão alemão obteve resultado negativo; já o de penetração de úmida de micro-organismos não apresentou mudanças significativas ao longo do tempo, embora uma fração das células microbianas tenham passado pelas amostras de dupla camada. Conclusão: as propriedades físicas do tecido 100% algodão, utilizado como sistema de barreira estéril, alteraram com usos/processamentos; entretanto essas não interferiram significativamente nos resultados obtidos pelos testes realizados na barreira microbiológica até 85 lavagens.

Beyond Sterilization: A Comprehensive Review on the Safety and Efficacy of Opportunistic Salpingectomy as a Preventative Strategy for Ovarian Cancer.

Ovarian cancer (OC) is Canada's third most common gynecological cancer, with an estimated 3000 new cases and 1950 deaths projected in 2022. No effective screening has been found to identify OC, especially the most common subtype, high-grade serous carcinoma (HGSC), at an earlier, curable stage. In patients with hereditary predispositions such as BRCA mutations, the rates of HGSC are significantly elevated, leading to the use of risk-reducing salpingo-oophorectomy as the key preventative intervention. Although surgery has been shown to prevent HGSC in high-risk women, the associated premature menopause has adverse long-term sequelae and mortality due to non-cancer causes. The fact that 75% of HGSCs are sporadic means that most women diagnosed with HGSC will not have had the option to avail of either screening or prevention. Recent research suggests that the fimbrial distal fallopian tube is the most likely origin of HGSC. This has led to the development of a prevention plan for the general population: opportunistic salpingectomy, the removal of both fallopian tubes. This article aims to compile and review the studies evaluating the effect of opportunistic salpingectomy on surgical-related complications, ovarian reserve, cost, and OC incidence when performed along with hysterectomy or instead of tubal ligation in the general population.

A comparison of clinical outcomes of acellular dermal matrix with and without radiation sterilization process in immediate prepectoral direct-to-implant breast reconstruction.

BACKGROUND: Although there are many acellular dermal matrix (ADM) products, the sterilization process varies for each product. We compared the clinical outcomes of immediate prepectoral direct-to-implant (DTI) breast reconstruction with and without sterilization products. METHODS: This was a retrospective study of immediate prepectoral DTI breast reconstructions performed between 2018 and 2020. We classified patients depending on whether the used ADM products had undergone radiation sterilization and compared the patient demographics and surgical outcomes, including seroma, infection, mastectomy flap necrosis, capsular contracture, and implant failure. RESULTS: The study included 357 patients, 182 in the no-sterilization group and 179 in the sterilization group. The ADM size differed significantly between the no-sterilization and sterilization groups (122.7 cm2 vs. 145.4 cm2, respectively, P = 0.01). There were no significant differences in overall rates of complications between the two groups, including seroma (P = 0.28), infection (P = 0.63), mastectomy flap necrosis (P = 0.76), and capsular contracture (P = 0.76). However, implant failure from infection (0% vs. 3.4%, P = 0.01) and drainage amount (690.3 mL vs. 779.36 mL, P = 0.04) with similar removal days were significantly higher in the sterilization group. CONCLUSION: The authors demonstrated similar complication rates for seroma, infection, mastectomy flap necrosis, and capsular contracture. Whereas a bigger size of ADM was needed to cover a similar implant volume, and drain amount was higher in the sterilization group, the salvage rate from infection was higher in the no-sterilization group with a significant difference.

Sterilization of 20 billion medical devices by ethylene oxide (ETO): Consequences of ETO closures and alternative sterilization technologies/solutions.

BACKGROUND: To prevent healthcare-associated infections, it is essential that critical medical devices be sterilized before use. Although there are several sterilization technologies for medical devices, only ethylene oxide (ETO) sterilization has virtually universal material compatibility. METHODS: We searched the published English literature (Google, Google scholar and PubMed) for articles on the sterilization of medical devices by ethylene oxide, the consequences of ETO closures, and alternative sterilization technologies/solutions. RESULTS: ETO's compatibility and effectiveness with medical products allows for sterilization of many medical devices that would otherwise be rendered ineffective or unsafe if sterilized with an alternative method. CONCLUSIONS: At present, there are no alternatives to ETO that provide the same sterility assurance and result in the same device performance as ETO; therefore, it is likely irreplaceable for years.

Risk of disease transmission to patients from "contaminated" surgical instruments and immediate use steam sterilization.

BACKGROUND: There are several sources of pathogens that cause surgical site infections (SSI) to include the patients endogenous microflora and exogenous sources (e.g., air, surfaces, staff, surgical equipment). METHODS: We searched the published English literature (Google, Google Scholar, PubMed) for articles on reprocessing surgical instruments, effectiveness of sterilization methods, microbial load on surgical instruments, frequency of "contaminated" instruments, and the infection risk associated with "contaminated" surgical instruments and immediate use steam sterilization. RESULTS: There is substantial redundancy in instrument reprocessing to include: even if a patient was exposed to a "contaminated" instrument, the decontamination and sterilization process would have removed and/or inactivated the contaminating pathogens due to the exceptional effectiveness of the manual and mechanical cleaning (i.e., washer-disinfector) and the remarkable robustness of sterilization technology; and the low-level of microorganisms on surgical instruments after use and before cleaning. CONCLUSIONS: A critical review of the literature suggests that the risk of acquiring an SSI from instruments used in surgery is essentially zero if the sterilization cycle is validated.

Fractional order ATR-FTIR differential spectroscopy for detection of weak bands and assessing the radiation modifications in gamma sterilized UHMWPE.

This study presents a new method for identifying radiation modifications in UHMWPE polymer samples. The method involves using a mathematical technique called fractional order differential transformation on IR spectra obtained through ATR-FTIR spectroscopy. This new method was compared to existing techniques such as FTIR, XRD, and DSC, and it was found to be more sensitive and accurate in detecting radiation-induced changes in the polymer. The study focused on identifying changes in weak IR bands in the UHMWPE samples caused by gamma sterilization while simulating IR spectra using different orders of fractional derivatives and compared them to experimental spectra. It was found that applying a lower order of differentiation was more suitable for identifying radiation-induced changes in the UHMWPE samples. Using this method, they were able to identify specific changes in the gamma irradiated structure, such as the splitting of a single absorption peak into a doublet, which was only present in the 50 kGy irradiated sample. The study also used correlation index analysis, principal component analysis, and hierarchy cluster analysis to analyze the simulated and experimental spectra. These techniques allowed to confirm the effectiveness of the fractional order differential transformation method and to identify the specific regions of the IR spectra that were affected by radiation-induced changes in the UHMWPE samples. Overall, this study presents a new method for identifying radiation-induced changes in UHMWPE polymer samples that is more sensitive and accurate than existing techniques. By identifying these changes, researchers can better understand the effects of gamma sterilization on medical equipment and potentially develop new methods for sterilization that do not damage the equipment.

SALpingectomy for STERilisation (SALSTER): study protocol for a Swedish multicentre register-based randomised controlled trial.

INTRODUCTION: Salpingectomy is currently suggested as an alternative to tubal ligation for sterilisation. Precursor lesions of ovarian carcinoma can be found in the fallopian tubes; thus, salpingectomy could possibly reduce the incidence. Most of the existing trials on safety are small, on caesarean section and report on surrogate ovarian function measures. Randomised trials in laparoscopy are lacking. Well-designed trials are needed to evaluate safety of laparoscopic opportunistic salpingectomy. METHODS AND ANALYSIS: In SALSTER, a national register-based randomised controlled non-inferiority trial, 968 women <50 years, wishing laparoscopic sterilisation will be randomised to either salpingectomy or tubal ligation. The Swedish National Quality Register of Gynecological Surgery (GynOp) will be used for inclusion, randomisation and follow-up. Primary outcomes are any complication up to 8 weeks postoperatively, and age at menopause. Both outcomes are measured with questionnaires, complications are also assessed by a gynaecologist. In a nested trial, ovarian function will be evaluated comparing the mean difference of anti-Müllerian hormone (AMH), assessed preoperatively and 1 year after surgery. ETHICS AND DISSEMINATION: Performing salpingectomy for sterilisation has become increasingly common, despite the unclear risk-benefit balance. SALSTER studies the safety of salpingectomy compared with tubal ligation. Regardless of the result, SALSTER will provide gynaecologists with high quality evidence to inform women to decide on salpingectomy or not. The central ethical review board of Gothenburg, Sweden (Dnr. 316-18) approved the trial in 2018. Results will be presented at scientific congresses and published in peer-reviewed scientific journals. The results will be communicated through professional organisations and research networks. TRIAL REGISTRATION NUMBER: NCT03860805.