[Regulatory Program for Medical Devices in Cuba: experiences and current challenges]. / Experiencias y desafíos actuales para el Programa Regulador de Equipos Médicos en Cuba.

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.

Anesthetic Management of a Patient With Subglottic Stenosis: The Crucial Role of Communication Between Teams.

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.

Epidemiological and Clinical Aspects of Cutaneous and Mucosal Leishmaniases in Portugal: Retrospective Analysis of Cases Diagnosed in Public Hospitals and Reported in the Literature between 2010 and 2020.

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.

Airway Management of a Patient With a Giant Frontoethmoidal Encephalocele: A Pediatric Case Report.

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.

Bedside ultrasound in post-anaesthetic care unit for the diagnosis of post-extubation negative pressure pulmonary oedema: A paediatric case.

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.

Evaluation of elderly persons' functionality and care needs.

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.

Evaluation of elderly persons' functionality and care needs / Avaliação da funcionalidade e necessidades de cuidados dos idosos / Evaluación del funcionamiento y necesidades de cuidados de los ancianos

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.

Aspectos evolutivos da cicatrizaçäo em queimaduras cutâneas tratadas com curativos hidrocolóides: estudo experimental em cobaias / Evolutive aspects of healing in cutaneous burns treated with hydrocolloid dressings: experimental study in guinea pigs

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

Idoso: encargo ou patrimônio? O envelhecer em Säo Paulo / The aged: duty or patrimony? To age in Säo Paulo

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)