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Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.
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Legislação de Dispositivos Médicos , Cuba , Política de Saúde , Humanos , Programas Nacionais de SaúdeRESUMO
Subglottic stenosis is characterized by the narrowing of the airway at the inferior edge of the cricoid cartilage level. It is either congenital or acquired, the latter being more commonly secondary to internal iatrogenic trauma. Airway management of these cases is challenging and requires multidisciplinary discussion. We present a case of a 17-year-old boy scheduled for tracheostomy in the context of subglottic stenosis probably caused by prolonged endotracheal intubation. On the day of surgery, it was decided to perform an asleep fiberoptic visualization of the lesion through a supraglottic device, which revealed a narrow circumferential fibrous membrane just below the vocal cords. Given the findings, a suspension laryngoscopy accompanied by supraglottic manual jet ventilation was performed. Balloon dilatation with the application of mitomycin C was the elected otorhinolaryngologic technique. At the end of the procedure, a fiberoptic exam was performed and only a minimal portion of the membrane remained. The patient was asymptomatic on follow-up visits. We aim to raise awareness of how the anesthetic management of patients with subglottic stenosis may prove challenging. Communication between anesthetic and surgical teams is essential for the achievement of the main goal, which is the acquisition of an adequate airway that allows normal patient activity associated with minimal postoperative morbidity.
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BACKGROUND: Regional anaesthesia can be an attractive alternative anaesthetic approach in clavicle surgery, but it requires the peripheral block of multiple cervical and brachial nerves that transmit nociceptive information. Deep cervical plexus blocks, as paravertebral nerve block, can lead to severe side effects, such as unilateral diaphragmatic paralysis. CASE REPORT: A 66-year-old male patient, American Society of Anesthesiologists physical status III, was scheduled for open reduction and internal fixation of the right clavicle with plates and screws after a high-energy trauma. Pre-anaesthetic evaluation revealed right hemopneumothorax and bilateral rib fractures. We decided to perform regional anaesthesia (superficial cervical plexus block and clavipectoral fascial plane block), combined with dexmedetomidine perfusion to avoid invasive mechanical ventilation and prevent additional pulmonary complications. The surgical procedure was successfully completed without any further anaesthesia requirements. The patient remained comfortable during the postoperative period. CONCLUSION: Regional anaesthesia for clavicle surgeries has the advantage of promoting non-opioid free anaesthesia. Effective pain control enhances patient satisfaction and reduces the length of stay in hospital. In our case report, a combined superficial cervical plexus block and clavipectoral fascial plane block was a safe and effective regional anaesthetic approach.
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Leishmania infantum, a zoonotic vector-born parasite, is endemic in the Mediterranean region, presenting mostly as visceral (VL), but also as cutaneous (CL) and mucosal leishmaniasis (ML). This study aimed to describe the epidemiological and clinical aspects of the CL and ML cases diagnosed in mainland Portugal between 2010 and 2020. Collaboration was requested from every hospital of the Portuguese National Health System. Cases were screened through a search of diagnostic discharge codes or positive laboratory results for Leishmania infection. Simultaneously, a comprehensive literature search was performed. Descriptive statistics and hypothesis testing were performed using IBM® SPSS® Statistics. A total of 43 CL and 7 ML cases were identified, with a predominance of autochthonous cases (86%). In CL, immunosuppressed individuals constituted a significant proportion of patients (48%), and in this group, disseminated CL (22%) and simultaneous VL (54%) were common. In autochthonous cases, lesions, mostly papules/nodules (62%), were frequently observed on the head (48%). The approach to treatment was very heterogeneous. ML cases were all autochthonous, were diagnosed primarily in older immunosuppressed individuals, and were generally treated with liposomal amphotericin B. The findings suggest a need for enhanced surveillance and reporting, clinical awareness, and diagnostic capacity of these forms of leishmaniasis to mitigate underdiagnosis and improve patient outcomes. A holistic One Health approach is advocated to address the multifaceted challenges posed by leishmaniases in Portugal and beyond.
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Meningoencephalocele is a rare congenital midline defect of cranial bone fusion characterized by herniation of the brain and meninges through the skull. In addition to the challenges of managing a major neurosurgical procedure in a pediatric patient, airway management in this group of patients requires advanced skills, and a difficult airway should be anticipated from the start. Since awake intubation is not an option in most pediatric cases with airway anatomy abnormalities and maintaining an adequate seal with a pediatric face mask is often impossible, airway management in patients with these lesions is highly challenging. We present the case of a 12-month-old girl with a postnatal diagnosis of frontoethmoidal meningoencephalocele who underwent craniotomy, followed by encephalocele resection, subsequent frontal cranioplasty, and reconstruction of the nasal bone defect. We discuss the timely adaptation of an adult face mask (size five) rotated 180º over the patient's entire face to perform adequate preoxygenation and spontaneous ventilation assistance with hand-bag ventilation after the inhalational induction of general anesthesia. After obtaining adequate depth of anesthesia, an initial video laryngoscopy with pediatric Medan® was performed. The epiglottis and vocal cords were identified, and rocuronium was administered. After complete muscle relaxation, another video laryngoscopy was performed and orotracheal intubation was successful on the first attempt. As an alternative airway, we planned orotracheal intubation using a pediatric fiberoptic bronchoscope with the aid of a laryngeal mask airway if required. As a rescue measure, we also ensured that an otolaryngologist was present in the operating room if a tracheostomy was deemed necessary. We aim to raise awareness of the importance of safe practices in anesthesia, reinforce preventive measures during careful airway examination, and plan approach strategies.
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BACKGROUND: Post-extubation negative pressure pulmonary oedema is a rare, potentially life-threatening complication associated with general anaesthesia. Chest radiography is used as a diagnostic tool, but it implies a non-negligible radiation exposure, a very important consideration, especially for the paediatric population. However, lung ultrasound can overcome this problem and can be used to detect postoperative pulmonary complications. CASE REPORT: A 16-year-old male was scheduled for tympanoplasty. General anaesthesia was conducted, and after extubation, the patient developed a laryngospasm. On arrival at the post-anaesthetic care unit, the patient started to cough, a pink frothy sputum and hypoxemia were noticed, and auscultation revealed crepitations. A bedside lung ultrasound showed more than three B-lines per intercostal window, suggesting an alveolar-interstitial syndrome. DISCUSSION: With this case report, we would like to raise awareness to this clinical entity and demonstrate bedside ultrasound has an important role in the diagnostic and therapeutic assessment during the perioperative period.
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OBJECTIVE: To evaluate the elderly persons' functionality, based on the International Classification of Functionality. METHODS: a cross-sectional, descriptive study; a stratified random sample of 903 elderly persons; a confidence level of 95%; and a margin of error of 2.5%. Questionnaire based on the International Classification of Functionality; data was collected based on structured interviews undertaken by health professionals in the health centers in the Alentejo region of Portugal. RESULTS: 30.7% of the elderly persons stated that they were illiterate, and 22.9% lived alone. Feeding/dietary (18.7%), housing (19.2%) and health needs (26.0%) were not met. Orientation functions were maintained in 83.4%; 58% of the elderly persons referred to pain so intense that it required care; 73.3% of the elderly persons did not have functional dentition. Levels of performance were superior to 80% in the participation activities: washing oneself (82.6%), toileting (92.2%), dressing, eating, and drinking (89%). CONCLUSION: although a progressive decline in functionality is observed as age advances, the majority of dimensions are preserved until around 75 years of age.
Assuntos
Atividades Cotidianas , Avaliação Geriátrica , Necessidades e Demandas de Serviços de Saúde , Serviços de Saúde para Idosos , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Feminino , Humanos , Masculino , Inquéritos e QuestionáriosRESUMO
RESUMEN La actividad reguladora relacionada con los equipos médicos en Cuba se ejerce mediante un sistema basado en el Programa Regulador de Equipos Médicos para garantizar la seguridad, eficacia y efectividad de estas tecnologías que se utilizan en el Sistema Nacional de Salud. Este programa comenzó a desarrollarse en 1992 con la aprobación del Reglamento para la Evaluación Estatal y el Registro de los Equipos Médicos. Las etapas por las que ha transitado y la fusión de las actividades reguladoras de medicamentos y equipos médicos han significado un avance a estrategias más sólidas, transparentes y de control hacia la industria y el Sistema Nacional de Salud. El programa cubano ha encontrado en su avance tanto desafíos como dificultades que ha enfrentado basado en su experiencia. En el nuevo período, los mayores retos se concentran en que los sistemas regulatorios incluyan la evaluación científica, los niveles de riesgos, el máximo rigor mediante la utilización de las normas técnicas y la implementación de recomendaciones internacionales, junto a la aplicación del esquema de certificación según ISO 13485, el perfeccionamiento del seguimiento en el mercado y la clasificación de los equipos médicos por su incidencia en el contexto de las políticas de salud establecidas en el país. Desde el punto de vista regional, el mayor reto está en trabajar hacia una convergencia reguladora. El Centro Colaborador para la Reglamentación de las Tecnologías de Salud apoyará la proyección estratégica reguladora y de las prioridades regionales establecidas, considerando el desarrollo de las acciones referidas a equipos médicos.
ABSTRACT Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country’s national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.
Assuntos
Gestão de Recursos Humanos , Mão de Obra em Saúde/organização & administração , CubaRESUMO
OBJECTIVE: To evaluate the elderly persons' functionality, based on the International Classification of Functionality. METHODS: a cross-sectional, descriptive study; a stratified random sample of 903 elderly persons; a confidence level of 95%; and a margin of error of 2.5%. Questionnaire based on the International Classification of Functionality; data was collected based on structured interviews undertaken by health professionals in the health centers in the Alentejo region of Portugal. RESULTS: 30.7% of the elderly persons stated that they were illiterate, and 22.9% lived alone. Feeding/dietary (18.7%), housing (19.2%) and health needs (26.0%) were not met. Orientation functions were maintained in 83.4%; 58% of the elderly persons referred to pain so intense that it required care; 73.3% of the elderly persons did not have functional dentition. Levels of performance were superior to 80% in the participation activities: washing oneself (82.6%), toileting (92.2%), dressing, eating, and drinking (89%). CONCLUSION: although a progressive decline in functionality is observed as age advances, the majority of dimensions are preserved until around 75 years of age.
OBJETIVO: avaliar a funcionalidade dos idosos com base na Classificação Internacional da Funcionalidade. MÉTODOS: estudo transversal, descritivo; amostra aleatória, estratificada, com 903 idosos; nível de confiança 95%; margem de erro 2,5%. Questionário desenvolvido com base na Classificação Internacional da Funcionalidade; dados coletados a partir de entrevista estruturada por profissionais de saúde nos centros de saúde do Alentejo. RESULTADOS: 30,7% dos idosos declaram-se analfabetos, 22,9% vivem sozinhos. As necessidades de alimentação (18,7%), habitação (19,2%) e saúde (26,0%) não estão satisfeitas. Funções de orientação preservadas em 83,4%; 58% dos idosos referem uma intensidade de dor que requer cuidados; 73,3% dos idosos não apresentam dentição funcional. Níveis de desempenho superior a 80% nas atividades de participação: lavar-se (82,6%), atividades relacionadas ao processo de excreção (92,2%), vestir, comer, beber (89%). CONCLUSÃO: decréscimo progressivo da funcionalidade à medida que a idade avança; todavia, está preservada em grande parte as dimensões até cerca dos 75 anos.
OBJETIVO: Evaluar la funcionalidad de los ancianos basado en la Clasificación Internacional del Funcionamiento. MÉTODOS: Estudio transversal, descriptivo; muestra aleatorizada, estratificada con 903 ancianos; nivel de confianza 95%; margen de error 2,5%. Cuestionario desarrollado basado en la Clasificación Internacional del Funcionamiento; datos recolectados a partir de entrevista estructurada por profesionales de salud en los Centros de Salud del Alentejo. RESULTADOS: el 30,7% de los ancianos se declara analfabeto, 22,9% vive solo. Las necesidades de alimentación (18,7%), habitación (19,2%) y salud (26,0%) no están atendidas. Funciones de orientación preservadas en el 83,4%; el 58% de los ancianos indica una intensidad de dolor que demanda cuidados; el 73,3% de los ancianos no demuestra dentición funcional. Niveles de desempeño superiores al 80% en las actividades de participación: lavarse (82,6%), actividades relacionadas al proceso de excreción (92,2%), vestir, comer, beber (89%). CONCLUSIÓN: Disminución progresivo del funcionamiento con el avance del edad, aunque sigue preservada grande parte de las dimensiones hasta acerca del edad de 75 años.
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Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Atividades Cotidianas , Avaliação Geriátrica , Serviços de Saúde para Idosos , Necessidades e Demandas de Serviços de Saúde , Estudos Transversais , Inquéritos e QuestionáriosRESUMO
O objetivo da pesquisa foi estudar os efeitos dos curativos hidrocolóides em queimaduras cutâneas profundas tratadas com curativos hidrocolóides. Foram utilizadas 80 cobaias divididas em dez grupos de dez cada, estudados com 7, 14, 21 e 28 dias de evoluçäo após a queimadura. O curativo hidrocolóide foi colocado em uma das duas queimaduras provocadas por placa de cobre aquecida por quinze segundos, atingindo a temperatura de 120ºC e mantida sobre a área dorsal do animal por quinze segundos. A outra área permaneceu exposta. A posiçäo do curativo foi alternada e metade da amostra recebeu o curativo hidrocolóide caudalmente, e a outra cefalicamente. A cada sete dias realizou-se a troca do curativo e observaram-se os aspectos macroscópicos cicatrizaçäo e desbridamento da escara, que foram mais precoces nas lesöes tratadas. O estudo microscópico revelou reaçöes inflamatórias agudas e crônica abreviadas e menos intensas, fibrose discreta e regeneraçäo epitelial mais representativa no grupo tratado em relaçäo ao grupo controle
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Animais , Feminino , Cobaias , Queimaduras/terapia , Cicatrização , Coloides/uso terapêutico , Curativos Oclusivos , Queimaduras/patologia , Fatores de TempoRESUMO
Apresenta os programas de atençäo à saúde do idoso para o município de Säo Paulo, aborda a legislaçäo sanitária e discute o envelhecimento da populaçäo (AMSB)