Risk management prioritization in medical device SMEs based on AHP analysis

Purpose - Risk management is crucial for the longevity of companies and it is also required by many standards and regulations, such as ISO 9001 and ISO 13485. Particularly for the medical device industry the standards are stricter, due to the level of risk that products can represent. However, each standard is particular on its requirements and establishing the risk management process can be challenging, namely for small and medium-sized enterprises (SMEs). This research aims to identify and prioritize the key features for the risk management of medical device SMEs. Design/methodology/approach - The Analytic Hierarchy Process (AHP) was applied as follows: from the literature review and the above-mentioned standards the authors defined the problem, objectives, alternatives and identified 5 evaluation criteria and 8 evaluation subcriteria, organized in the hierarchical structuring of four matrices, which were the basis for data collection and analysis. Five experts from Brazilian and Portuguese companies operating in the sector were interviewed and asked to evaluate each of the matrices, establishing the relative importance among the criteria, for the calculation of local priorities. Findings - The results led to the involvement of employees as the most important criterion for risk management, followed by employees training and qualification. Organizational culture was listed as the least important criterion, with four of the five evaluators considering training and qualification as a way to work towards a cultural change and encourage risk-based thinking. Originality/value - Recent researches highlight the need for methodological and scientific support on risk management for the companies. This paper provides discussion regarding whether the literature reflects the reality of organizations and how the process is considered by them.CAPES - Coordenação de Aperfeiçoamento de Pessoal de Nível Superior(undefined

ADUBAÇÃO POTÁSSICA NA PRODUTIVIDADE DA SOQUEIRA DE CANA-DE-AÇÚCAR COLHIDA SEM QUEIMA

An experiment was performed where the aim was to appraise the response of the potassium fertilization allotment in root reaped sugarcane. The experiment was installed on the Nova Aliança farm in Sales de Oliveira, São Paulo, Brazil, on the first root sugarcane (SP 80-1816). The experiment was appraised in delineation entirely casually witch 5 treatments and 4 repetitions. The treatments were constituted by rate of potassium as following: 1) 0 and 60 kg ha-1 K2O; 2) 0 and 90 kg ha-1 K2O; 3) 0 and 120 kg ha-1 K2O; 4) 60 and 60 kg ha-1 K2O; 5) 60 and 120 kg ha-1 K2O, applied to 30 and 60 days after the root sprout respectively. Technological parameters were appraised (pH, pol% sugarcane, purity, fiber, redactor sugar and recoverable total sugar) and the culms and sugar production. The potassium application in higher doses than 60 kg ha -1 K2O didn’t affect the technological quality of the root sugarcane, in the meantime the rate of 120 kg ha-1 K2O divided into two allotments made the culms production higher. It was concluded that the rate of potassium increment is more important in the culms production than for the root sugarcane technological quality.O objetivo desse trabalho foi de verificar o efeito da aplicação do potássio na produtividade da soqueira de cana-de-açúcar de primeiro corte colhida sem despalha à fogo. O experimento foi instalado na fazenda Nova Aliança em Sales de Oliveira-SP, Brasil, na primeira soqueira de cana-de-açúcar (SP 80-1816). O experimento foi avaliado em delineamento inteiramente casualizado com 5 tratamentos e 4 repetições. Os tratamentos foram constituídos por doses de potássio da seguinte forma: 1) 0 e 60 kg ha -1 K2O; 2) 0 e 90 kg ha -1 K2O; 3) 0 e 120 kg ha -1 K2O; 4) 60 e 60 kg ha -1 K2O; 5) 60 e 120 kg ha -1 K2O, aplicados aos 30 e 60 dias após a brotação da soqueira respectivamente. Avaliaram-se os parâmetros tecnológicos (pH, pol%cana, pureza, fibra, açúcares redutores e açúcares totais recuperáveis) e a produção de colmos e de açúcar. A aplicação do potássio em doses maiores que 60 kg ha -1 K2O não afetou a qualidade tecnológica da soqueira de cana-de-açúcar, entretanto a dose de 120 kg ha -1 K2O dividida em dois parcelamentos proporcionou maior produção de colmos. Concluiu-se que o incremento das doses de potássio é mais importante na produção de colmos do que para a qualidade tecnológica da soqueira de cana-de-açúcar

Gestão do processo de mudança nas organizações de saúde: revisão narrativa da literatura

Este artigo é um estudo de revisão narrativa acerca da gestão do processo de mudança nas organizações de saúde em contexto atual. As organizações de saúde são ambientes complexos, não estanques e em constante mudança. Com os rápidos avanços técnico-científicos e o processo de globalização é imprescindível que estas organizações adotem uma gestão de mudança, de modo que a organização se mantenha atualizada e consiga encontrar respostas para as suas necessidades quotidianas. Tendo como objetivo contribuir para um melhor conhecimento acerca do processo de mudança organizacional e identificar a forma como as mudanças organizacionais são percecionadas, foi definida a seguinte questão de partida: Quais os fatores que interferem no processo de mudança nas organizações de saúde? Para encontrar resposta para a questão foram efetuadas pesquisas de artigos nas bases de dados Business Source Complete e American Psychology Association PsycInfo, utilizando os descritores “organizacional change management” e “healthcare”, sendo identificados 195 artigos dos quais, após seleção e verificação de elegibilidade, foram incluídos 8 artigos relevantes e atuais na presente revisão narrativa. A análise dos artigos incluídos reforça a ideia que a resistência à mudança é um dos principais fatores para o fracasso. Pudemos concluir que um dos principais fatores de resistência à mudança é a falta de confiança entre os colaboradores e os seus superiores hierárquicos; o fracasso da gestão do processo de mudança prende-se com o facto do gestor não ter em consideração as opiniões, renitência e anseios dos seus colaboradores face a essa mesma mudança; a formação contínua, o desenvolvimento profissional e a comunicação influenciam a eficácia e desempenho dos profissionais.info:eu-repo/semantics/publishedVersio

BIOLOGIC THERAPY IN ATOPIC ECZEMA

O eczema atópico é uma dermatose inflamatória comum, que afecta até 20% das crianças e 3% dos adultos nos países industrializados. A maioria dos doentes apresenta doença ligeira a moderada que é eficazmente controlada com terapêutica tópica. Os casos graves ou persistentes podem requerer períodos de terapêutica sistémica, a qual pode ser agrupada em convencional e biológica. Os medicamentos sistémicos convencionais estão associados a toxicidade potencial que limita o seu uso continuado e frequentemente não fornecem respostas terapêuticas adequadas. Mais recentemente os biológicos foram propostos para o tratamento do eczema atópico grave, podendo constituir uma opção menos tóxica e mais dirigida ao mecanismo etiopatogénico. Contudo, até à data nenhum biológico foi aprovado para o tratamento do eczema atópico. A sua utilização off-label é recomendável apenas nas formas graves refractárias aos tratamentos convencionais. Apresenta-se uma revisão da literatura sobre a utilização da terapêutica biológica no eczema atópico grave.Atopic eczema is a common inflammatory skin disease, affecting up to 20% of children and 3% of adults in industrialized countries. Most cases of atopic eczema are mild to moderate and will be adequately managed with topical therapy. Persistent or severe cases may require periods of systemic treatment, which can be broadly grouped into conventional and biologic agents. Conventional systemic agents are associated with potential toxicities that limit the continued use and often do not provide adequate therapeutic responses. More recently, biologic agents have been proposed for the treatment of severe atopic eczema, holding promise for a more targeted and less toxic approach. However, none of the biologics have been approved for atopic eczema therapy yet. At present, its off-label use is advisable only in severe atopic eczema refractory to conventional treatments. In this report, the authors comprehensively review the literature regarding the use of biologic therapy in severe EA

A Novel Hyaluronidase from Brown Spider (Loxosceles intermedia) Venom (Dietrich's Hyaluronidase): From Cloning to Functional Characterization

Loxoscelism is the designation given to clinical symptoms evoked by Loxosceles spider's bites. Clinical manifestations include skin necrosis with gravitational spreading and systemic disturbs. the venom contains several enzymatic toxins. Herein, we describe the cloning, expression, refolding and biological evaluation of a novel brown spider protein characterized as a hyaluronidase. Employing a venom gland cDNA library, we cloned a hyaluronidase (1200 bp cDNA) that encodes for a signal peptide and a mature protein. Amino acid alignment revealed a structural relationship with members of hyaluronidase family, such as scorpion and snake species. Recombinant hyaluronidase was expressed as N-terminal His-tag fusion protein (similar to 45 kDa) in inclusion bodies and activity was achieved using refolding. Immunoblot analysis showed that antibodies that recognize the recombinant protein cross-reacted with hyaluronidase from whole venom as well as an anti-venom serum reacted with recombinant protein. Recombinant hyaluronidase was able to degrade purified hyaluronic acid (HA) and chondroitin sulfate (CS), while dermatan sulfate (DS) and heparan sulfate (HS) were not affected. Zymograph experiments resulted in similar to 45 kDa lytic zones in hyaluronic acid (HA) and chondroitin sulfate (CS) substrates. Through in vivo experiments of dermonecrosis using rabbit skin, the recombinant hyaluronidase was shown to increase the dermonecrotic effect produced by recombinant dermonecrotic toxin from L. intermedia venom (LiRecDT1). These data support the hypothesis that hyaluronidase is a spreading factor. Recombinant hyaluronidase provides a useful tool for biotechnological ends. We propose the name Dietrich's Hyaluronidase for this enzyme, in honor of Professor Carl Peter von Dietrich, who dedicated his life to studying proteoglycans and glycosaminoglycans.Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)Fundacao Araucaria-PR (FAP)Secretaria de Estado de Ciencia, Tecnologia e Ensino Superior do Parana (SETI)Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)Univ Fed Parana, Dept Cell Biol, BR-80060000 Curitiba, Parana, BrazilUniv Fed Parana, Clin Hosp, Dept Clin Pathol, BR-80060000 Curitiba, Parana, BrazilUniv Estadual Ponta Grossa, Dept Struct Mol Biol & Genet, Ponta Grossa, BrazilCatholic Univ Parana, Hlth & Biol Sci Inst, Curitiba, Parana, BrazilUniversidade Federal de São Paulo, Dept Biochem, São Paulo, BrazilUniversidade Federal de São Paulo, Dept Biochem, São Paulo, BrazilWeb of Scienc

Focal Peripheral Neuropathy Associated with Lymphoma in Dogs

Background: Peripheral neuropathies result in sensory, motor or autonomic dysfunctions due to impairment of peripheral spinal or cranial nerves. Neoplasms such as lymphoma are cited as one of the many aetiological causes and it may affect the nerve directly, by compression, or indirectly, or paraneoplastic, by remote action of the neoplasm located in an extra-neural site. This study aimed to report two cases of cranial nerve neuropathy (trigeminal and facial) associated with canine lymphoma, contributing to a better understanding of its paraneoplastic effects on the nervous system, as well as the diagnosis and treatment of these conditions.Cases: Two cases of canine lymphoma associated with possible signs of paraneoplastic peripheral neuropathy were attended at the Veterinary Hospital from the Universidade Federal de Minas Gerais (HV UFMG). Case 1. A spayed mixed breed bitch, with lethargy and unilateral exophthalmos. Brain computed tomography revealed a retrobulbar mass and cytology was diagnostic for extranodal lymphoma. Subsequent to computed tomography, the dog was presented with hypotrophy of the facial musculature and difficulty in grasping food, consistent with trigeminal nerve palsy, which resolved after institution of the 19-week chemotherapy protocol from the University of Wisconsin. Nevertheless, disease reccurred and a rescue protocol was initiated. Case 2. A female Dalmatian, spayed, was diagnosed with multicentric lymphoma, after cytology of the left mandibular lymph node. Chemotherapy was initiated with the same protocol of the previous case. However, the disease progressed and it was observed facial asymmetry with ptosis of the left eyelid, pina and lips, in addition to difficulty in grasping food, suggesting facial and trigeminal cranial nerve palsy. Clinical signs resolved after institution of a rescue chemotherapy protocol. However, in both cases, disease progression and poor clinical condition resulted in decision of euthanasia and necropsy was not authorized.Discussion: Canine lymphoma is often associated with paraneoplastic syndromes, with neuropathy being one of its possible clinical manifestations. In spite of that its pathogenesis remains unclear, with little information in the veterinary literature. Diagnosis is challenging and must be initially based on recognition of neurological clinical signs and lesion localization, as in the reported cases with lesions located on the fifth and seventh cranial nerves. In the patient from the first case, the absence of clinical signs and laboratory abnormalities suggestive of endocrinopathies, associated with neurological signs restricted to the trigeminal nerve, bilaterally, before starting chemotherapy and without the identification of brain lesions in computed tomography, suggested paraneoplastic involvement as the cause of neuropathy. In the second case described, the absence of clinical signs and laboratory abnormalitiess suggestive of endocrinopathies or nutritional deficiencies, associated with neurological signs restricted to the facial and trigeminal cranial nerves, suggested direct or indirect tumour involvement. Both cases showed improvement of neurological clinical signs after chemotherapy which favored the therapeutic diagnosis. Nevertheless, failure to authorize necropsy of patients made it impossible to confirm that peripheral neuropathy is secondary to the remote effect of lymphoma