Uneven primary healthcare supply of rural doctors and medical equipment in remote China: community impact and the moderating effect of policy intervention.

BACKGROUND: Unequal access to primary healthcare (PHC) has become a critical issue in global health inequalities, requiring governments to implement policies tailored to communities' needs and abilities. However, the place-based facility dimension of PHCs is oversimplified in current healthcare literature, and formulating the equity-oriented PHC spatial planning remains challenging without understanding the multiple impacts of community socio-spatial dynamics, particularly in remote areas. This study aims to push the boundary of PHC studies one step further by presenting a nuanced and dynamic understanding of the impact of community environments on the uneven primary healthcare supply. METHODS: Focusing on Shuicheng, a remote rural area in southwestern China, multiple data are included in this village-based study, i.e., the facility-level healthcare statistics data (2016-2019), the statistical yearbooks, WorldPop, and Chinese GDP's spatial distribution data. We evaluate villages' PHC service capacity using the number of doctors and essential equipment per capita, which are the major components of China's PHC delivery. The indicators describing community environments are selected based on extant literature and China's planning paradigms, including town- and village-level factors. Gini coefficients and local spatial autocorrelation analysis are used to present the divergences of PHC capacity, and multilevel regression model and (heterogeneous) difference in difference model are used to examine the driving role of community environments and the dynamics under the policy intervention. RESULTS: Despite the general improvement, PHC inequalities remain significant in remote rural areas. The village's location, aging, topography, ethnic autonomy, and economic conditions significantly influence village-level PHC capacity, while demographic characteristics and healthcare delivery at the town level are also important. Although it may improve the hardware setting in village clinics (coef. = 0.350), the recent equity-oriented policy attempts may accelerate the loss of rural doctors (coef. = - 0.517). Notably, the associations between PHC and community environments are affected inconsistently by this round of policy intervention. The town healthcare centers with higher inpatient service capacity (coef. = - 0.514) and more licensed doctors (coef. = - 0.587) and nurses (coef. = - 0.344) may indicate more detrimental policy effects that reduced the number of rural doctors, while the centers with more professional equipment (coef. = 0.504) and nurses (coef. = 0.184) are beneficial for the improvement of hardware setting in clinics. CONCLUSIONS: The findings suggest that the PHC inequalities are increasingly a result of joint social, economic, and institutional forces in recent years, underlining the increased complexity of the PHC resource allocation mechanism. Therefore, we claim the necessity to incorporate a broader understanding of community orientation in PHC delivery, particularly the interdisciplinary knowledge of the spatial lens of community, to support its sustainable development. Our findings also provide timely policy insights for ongoing primary healthcare reform in China.

Health system lessons from the global fund-supported procurement and supply chain investments in Zimbabwe: a mixed methods study.

BACKGROUND: The Global Fund partnered with the Zimbabwean government to provide end-to-end support to strengthen the procurement and supply chain within the health system. This was accomplished through a series of strategic investments that included infrastructure and fleet improvement, training of personnel, modern equipment acquisition and warehouse optimisation. This assessment sought to determine the effects of the project on the health system. METHODS: This study employed a mixed methods design combining quantitative and qualitative research methods. The quantitative part entailed a descriptive analysis of procurement and supply chain data from the Zimbabwe healthcare system covering 2018 - 2021. The qualitative part comprised key informant interviews using a structured interview guide. Informants included health system stakeholders privy to the Global Fund-supported initiatives in Zimbabwe. The data collected through the interviews were transcribed in full and subjected to thematic content analysis. RESULTS: Approximately 90% of public health facilities were covered by the procurement and distribution system. Timeliness of order fulfillment (within 90 days) at the facility level improved from an average of 42% to over 90% within the 4-year implementation period. Stockout rates for HIV drugs and test kits declined by 14% and 49% respectively. Population coverage for HIV treatment for both adults and children remained consistently high despite the increasing prevalence of people living with HIV. The value of expired commodities was reduced by 93% over the 4-year period. Majority of the system stakeholders interviewed agreed that support from Global Fund was instrumental in improving the country's procurement and supply chain capacity. Key areas include improved infrastructure and equipment, data and information systems, health workforce and financing. Many of the participants also cited the Global Fund-supported warehouse optimization as critical to improving inventory management practices. CONCLUSION: It is imperative for governments and donors keen to strengthen health systems to pay close attention to the procurement and distribution of medicines and health commodities. There is need to collaborate through joint planning and implementation to optimize the available resources. Organizational autonomy and sharing of best practices in management while strengthening accountability systems are fundamentally important in the efforts to build institutional capacity.

Suitability of the Current Health Technology Assessment of Innovative Artificial Intelligence-Based Medical Devices: Scoping Literature Review.

BACKGROUND: Artificial intelligence (AI)-based medical devices have garnered attention due to their ability to revolutionize medicine. Their health technology assessment framework is lacking. OBJECTIVE: This study aims to analyze the suitability of each health technology assessment (HTA) domain for the assessment of AI-based medical devices. METHODS: We conducted a scoping literature review following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodology. We searched databases (PubMed, Embase, and Cochrane Library), gray literature, and HTA agency websites. RESULTS: A total of 10.1% (78/775) of the references were included. Data quality and integration are vital aspects to consider when describing and assessing the technical characteristics of AI-based medical devices during an HTA process. When it comes to implementing specialized HTA for AI-based medical devices, several practical challenges and potential barriers could be highlighted and should be taken into account (AI technological evolution timeline, data requirements, complexity and transparency, clinical validation and safety requirements, regulatory and ethical considerations, and economic evaluation). CONCLUSIONS: The adaptation of the HTA process through a methodological framework for AI-based medical devices enhances the comparability of results across different evaluations and jurisdictions. By defining the necessary expertise, the framework supports the development of a skilled workforce capable of conducting robust and reliable HTAs of AI-based medical devices. A comprehensive adapted HTA framework for AI-based medical devices can provide valuable insights into the effectiveness, cost-effectiveness, and societal impact of AI-based medical devices, guiding their responsible implementation and maximizing their benefits for patients and health care systems.

Assessing medical devices: a qualitative study from the validate perspective.

OBJECTIVES: Our objective was to explore procedures and methods used at health technology assessment (HTA) agencies for assessing medical devices and the underlying views of HTA practitioners about appropriate methodology to identify challenges in adopting new methodologies for assessing devices. We focused on the role of normative commitments of HTA practitioners in the adoption of new methods. METHODS: An online survey, including questions on procedures, scoping, and assessments of medical devices, was sent to members of the International Network of Agencies for Health Technology Assessment. Interviews were conducted with survey respondents and HTA practitioners involved in assessments of transcatheter aortic valve implantation to gain an in-depth understanding of choices made and views about assessing medical devices. Survey and interview questions were inspired by the "values in doing assessments of health technologies" approach towards HTA, which states that HTA addresses value-laden questions and information. RESULTS: The current practice of assessing medical devices at HTA agencies is predominantly based on procedures, methods, and epistemological principles developed for assessments of drugs. Both practical factors (available time, demands of decision-makers, existing legal frameworks, and HTA guidelines), as well as commitments of HTA practitioners to principles of evidence-based medicine, make the adoption of a new methodology difficult. CONCLUSIONS: There is a broad recognition that assessments of medical devices may need changes in HTA methodology. In order to realize this, the HTA community may require both a discussion on the role, responsibility, and goals of HTA, and resulting changes in institutional context to adopt new methodologies.

Implications of variability on medical device chemical equivalence assessment.

Chemical equivalence testing can be used to assess the biocompatibility implications of a materials or manufacturing change for a medical device. This testing can provide a relatively facile means to evaluate whether the change may result in additional or different toxicological concerns. However, one of the major challenges in the interpretation of chemical equivalence data is the lack established criteria for determining if two sets of extractables data are effectively equivalent. To address this gap, we propose a two-part approach based upon a relatively simple statistical model. First, the probability of a false positive conclusion, wherein there is an incorrectly perceived increase for a given analyte in the comparator relative to the baseline device, can be reduced to a prescribed level by establishing an appropriate acceptance criterion for the ratio of the observed means. Second, the probability of a false negative conclusion, where an actual increase in a given analyte cannot be discerned from the test results, can be minimized by specifying a limiting value of applicability based on the margin of safety (MoS) of the analyte. This approach provides a quantitative, statistically motivated method to interpret chemical equivalence data, despite the relatively high intrinsic variability and small number of replicates typically associated with a chemical characterization evaluation.

Is read-across for chemicals comparable to medical device equivalence and where to use it for conformity assessment?

Novel medical devices must conform to medical device regulation (MDR) for European market entry. Likewise, chemicals must comply with the Registration, Evaluation, Authorization and Restriction of Chemicals (REACh) regulation. Both pose regulatory challenges for manufacturers, but concordantly provide an approach for transferring data from an already registered device or compound to the one undergoing accreditation. This is called equivalence for medical devices and read-across for chemicals. Although read-across is not explicitly prohibited in the process of medical device accreditation, it is usually not performed due to a lack of guidance and acceptance criteria from the authorities. Nonetheless, a scientifically justified read-across of material-based endpoints, as well as toxicological assessment of chemical aspects, such as extractables and leachables, can prevent failure of MDR device equivalence if data is lacking. Further, read-across, if applied correctly can facilitate the standard MDR conformity assessment. The need for read-across within medical device registration should let authorities to reconsider device accreditation and the formulation of respective guidance documents. Acceptance criteria like in the European Chemicals Agency (ECHA) read-across assessment framework (RAAF) are needed. This can reduce the impact of the MDR and help with keeping high European innovation device rate, beneficial for medical device patients.

Industry Payments to US Physicians by Specialty and Product Type.

This study examines the distribution of payments within and across specialties and the medical products associated with the largest total payments.

[Exploration of Application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices: Take Artificial Joint Products as Example].

Through the effective application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (EP), to continuously improve the corresponding management tools to ensure the safety and effectiveness of medical device in the quality management system, risk management system, evaluation of safety and effectiveness for the supervision departments and manufacturers. The current status of the application of EP and the application issues are analyzed in the study. Take artificial joint products for example, the idea of using EP in quality management system, risk management system and evaluation of safety and effectiveness is investigated, and several thoughts are proposed. Supervision departments should strengthen the unified understanding of EP, develop requirements according to the classification of medical device，and refine specific execution requirements.

Lifecycle evaluation of medical devices: supporting or jeopardizing patient outcomes? A comparative analysis of evaluation models.

OBJECTIVES: Lack of evidence regarding safety and effectiveness at market entry is driving the need to consider adopting a lifecycle approach to evaluating medical devices, but it is unclear what lifecycle evaluation means. This research sought to explore the tacit meanings of "lifecycle" and "lifecycle evaluation" as embodied within evaluation models/frameworks used for medical devices. METHODS: Drawing on qualitative evidence synthesis methods and using an inductive approach, novel methods were developed to identify, appraise, analyze, and synthesize lifecycle evaluation models used for medical devices. Data was extracted (including purpose; audience; characterization; outputs; timing; and type of model) from key texts for coding, categorization, and comparison, exploring embodied meaning across four broad perspectives. RESULTS: Fifty-two models were included in the synthesis. They demonstrated significant heterogeneity of meaning, form, scope, timing, and purpose. The "lifecycle" may represent a single stage, a series of stages, a cycle of innovation, or a system. "Lifecycle evaluation" focuses on the overarching goal of the stakeholder group, and may use a single or repeated evaluation to inform decision-making regarding the adoption of health technologies (Healthcare), resource allocation (Policymaking), investment in new product development or marketing (Trade and Industry), or market regulation (Regulation). The adoption of a lifecycle approach by regulators has resulted in the deferral of evidence generation to the post-market phase. CONCLUSIONS: Using a "lifecycle evaluation" approach to inform reimbursement decision-making must not be allowed to further jeopardize evidence generation and patient safety by accepting inadequate evidence of safety and effectiveness for reimbursement decisions.

Mapping horizon scanning systems for medical devices: similarities, differences, and lessons learned.

OBJECTIVES: This article presents the mapping of horizons scanning systems (HSS) for medical devices, conducted by the Medical Devices Working Group of the International Horizon Scanning Initiative (IHSI MDWG). It provides an overview of the identified HSS, highlights similarities and differences between the systems, and lessons learned. METHODS: Potentially relevant HSS were identified through literature searches, scan of an overview of EuroScan members, and input from the IHSI MDWG members. Structured information was collected from organizations that confirmed having an HSS for medical devices. RESULTS: Sixteen initiatives could be identified, of which 11 are currently ongoing. The purposes of the HSS range from raising awareness of trends and new developments to managing informed decisions on innovative health services in hospitals. The time-horizon is most often 3 years up to a few months before market entry. Three models of identification of new technologies crystallized: a reactive (stakeholders outside HSS inform), a pro-active (actively searching multifold sources), and a hybrid model. Prioritization is often conducted by separate committees via scoring or debate. The outputs focus either on in-depth information of single technologies or on a class of technologies or on technologies in specific disease areas. CONCLUSIONS: The identified HSS share the common experience that horizon scanning (HS) for medical devices is a resource-intensive exercise that requires a dedicated and skilled team. Insights into the identified HSS and their experiences will be used in the continued work of the IHSI MDWG on its proposal for an IHSI HSS for medical devices.

Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices.

This study reviewed public comments for all Medicare National Coverage Determinations between June 2019 and 2022 on select pulmonary and cardiac devices to determine whether financial conflicts of interest were disclosed.

Which value aspects are relevant for the evaluation of medical devices? Exploring stakeholders' views through a Web-Delphi process.

BACKGROUND: Implementation and uptake of health technology assessment for evaluating medical devices require including aspects that different stakeholders consider relevant, beyond cost and effectiveness. However, the involvement of stakeholders in sharing their views still needs to be improved. OBJECTIVE: This article explores the relevance of distinct value aspects for evaluating different types of medical devices according to stakeholders' views. METHODS: Thirty-four value aspects collected through literature review and expert validation were the input for a 2-round Web-Delphi process. In the Web-Delphi, a panel of participants from five stakeholders' groups (healthcare professionals, buyers and policymakers, academics, industry, and patients and citizens) judged the relevance of each aspect, by assigning a relevance-level ('Critical', 'Fundamental', 'Complementary', or 'Irrelevant'), for two types of medical devices separately: 'Implantable' and 'In vitro tests based on biomarkers'. Opinions were analysed at the panel and group level, and similarities across devices were identified. RESULTS: One hundred thirty-four participants completed the process. No aspects were considered 'Irrelevant', neither for the panel nor for stakeholder groups, in both types of devices. The panel considered effectiveness and safety-related aspects 'Critical' (e.g., 'Adverse events for the patient'), and costs-related aspects 'Fundamental' (e.g., 'Cost of the medical device'). Several additional aspects not included in existing frameworks' literature, e.g., related to environmental impact and devices' usage by the healthcare professional, were deemed as relevant by the panel. A moderate to substantial agreement across and within groups was observed. CONCLUSION: Different stakeholders agree on the relevance of including multiple aspects in medical devices' evaluation. This study produces key information to inform the development of frameworks for valuing medical devices, and to guide evidence collection.

Eficacia y seguridad del espaciador intervertebral cervical con sistema de bloqueo de anclaje en pacientes adultos con enfermedad degenerativa del disco cervical con mielopatía y/o radiculopatía que no responden al tratamiento conservador / Efficacy and safety of the cervical intervertebral spacer with anchor locking system in adult patients with degenerative cervical disc disease with myelopathy and/or radiculopathy who do not respond to conservative treatment

ANTECEDENTES: En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias, aprobada mediante Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N° 111-IETSI-ESSALUD-2021 y ampliada mediante Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N° 97-IETSI-ESSALUD2022, se ha elaborado el presente dictamen preliminar sobre la evaluación de la eficacia y seguridad del espaciador intervertebral cervical con sistema de bloqueo de anclaje en pacientes adultos con enfermedad degenerativa del disco cervical con mielopatía y/o radiculopatía que no responden al tratamiento conservador. ASPECTOS GENERALES: La enfermedad degenerativa del disco cervical es una causa muy frecuente de dolor de cuello a nivel mundial (Kazeminasab et al., 2022). Su etiología es multifactorial, siendo el envejecimiento el factor más relevante, donde el proceso degenerativo puede ..comenzar desde la segunda década de vida pasando por fases conocidas como disfunción, inestabilidad y estabilización hasta llegar a la senectud (Fakhoury & Dowling, 2022). De esta forma, se han reportado prevalencias de casi 30 % en menores de 50 años y cerca de 90 % en mayores de 80 años (Teraguchi et al., 2014). La degeneración cervical puede resultar en mielopatía y/o radiculopatía cervical. La mielopatía se refiere a la compresión o afección de la médula espinal a nivel del canal espinal, mientras que la radiculopatía se traduce en la compresión o afección de una o varias de sus raíces cervicales. La compresión suele ser debido a una hernia discal, presencia de osteofitos, masas adyacentes, espondilosis o estenosis congénita del canal espinal (McCartney et al., 2018). La incidencia de ambas han sido previamente reportadas, con 4 casos de mielopatía cervical por 100 000 personas-año (Nouri et al., 2015), y 107.3 casos de radiculopatía cervical en varones y 63.5 en mujeres por 100 000 personas-año (Radhakrishnan et al., 1994). METODOLOGÍA: Se realizó una búsqueda bibliográfica exhaustiva con el objetivo de identificar la mejor evidencia sobre la eficacia y seguridad del espaciador intervertebral cervical con sistema de bloqueo de anclaje en pacientes adultos con enfermedad degenerativa del disco cervical con mielopatía y/o radiculopatía, que no responden al tratamiento conservador. La búsqueda bibliográfica se llevó a cabo en las bases de datos PubMed, The Cochrane Library, Web of Science y LILACS. Además, se realizó una búsqueda manual en Google y dentro de las páginas web pertenecientes a grupos que realizan evaluaciones de tecnologías sanitarias (ETS) y guías de práctica clínica (GPC), incluyendo el Centro Nacional de Excelencia Tecnológica en Salud (CENETEC), National Institute for Health and Care Excellence (NICE), la Agency for Healthcare Research and Quality's (AHRQ), Scottish Intercollegiate Guidelines Network (SIGN), The Guidelines International Network (GIN), National Health and Medical Research Council (NHMRC), Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA), Comissáo Nacional de Incorporacáo de Tecnologias no Sistema Único de Saúde (CONITEC), Instituto de Evaluación Tecnológica en Salud (IETS), Instituto de Efectividad Clínica y Sanitaria (IECS), Scottish Medicines Consortium (SMC), Canadian Agency for Drugs and Technologies in Health (CADTH), Instituto de Calidad y Eficiencia en la Atención de la Salud (IQWiG, por sus siglas en alemán), y Hauté Autorité de Santé (HAS). Asimismo, se realizó una búsqueda de GPC en las páginas web de las principales sociedades o instituciones especializadas el manejo de patologías de la médula espinal, tales como: Spine Intervention Society (SIS), Spine Society of Australia (SSA) y la Asia Pacific Spine Society (APOA). Finalmente, se realizó una búsqueda de estudios en curso aún no publicados en las páginas web de ClinicalTrials.govy la International Clinical Trials Registry Platform. RESULTADOS: La búsqueda bibliográfica se llevó a cabo el 18 de octubre de 2022. Se incluyeron dos GPC (Fehlings et al., 2017; Latka et al., 2016) que tuvieron recomendaciones relacionadas al procedimiento, pero no al dispositivo; una RS con metaanálisis en red (NMA, por sus siglas en inglés "Network meta-analysis") (Xu et al., 2020) que realizó comparaciones indirectas de la intervención y comparador de la pregunta PICO planteada con otros dispositivos que no formaron parte la presente ETS, motivo por el que se decidió identificar ECA. Es así que también se incluyó un ECA (Zhou et al., 2020) que no evaluó todos los desenlaces planteados en la pregunta PICO (tiempo quirúrgico y eventos adversos), por lo que se decidió incluir EO que contribuyan con estos desenlaces. De esta forma se incluyeron dos EO (Wang et al., 2015; Zhou et al., 2018) que tuvieron un diseño tipo cohorte retrospectiva. CONCLUSIÓN: Por lo expuesto, el Instituto de Evaluación de Tecnologías en Salud e InvestigaciónIETSI aprueba el uso del espaciador intervertebral cervical con sistema de bloqueo de anclaje como tratamiento para los pacientes adultos con enfermedad degenerativa del disco cervical con mielopatía y/o radiculopatía que no responden al tratamiento conservador.

Sensor pré-calibrado para monitorização de pressão intravascular e minimamente invasiva do débito cardíaco, Flotrac®, para cirurgias, maiores e de alto risco / Pre-calibrated sensor for intravascular and minimally invasive monitoring of cardiac output, Flotrac®, for major and high-risk surgeries

INTRODUÇÃO: O padrão ouro atual para monitorização hemodinâmica durante cirurgias é o cateter de artéria pulmonar, que exige punção venosa profunda. O FloTrac® é um sistema para monitorização hemodinâmica minimamente invasivo pois conecta-se à uma punção arterial distal, com potencial menor risco de complicações. TECNOLOGIA: Sensor pré-calibrado para monitorização hemodinâmica contínua do débito cardíaco e da pressão intravascular, sistema FloTrac. PERGUNTA: O uso do sistema FloTrac® em pacientes submetidos a procedimentos cirúrgicos de grande porte ou de alto risco é eficaz e seguro quando comparado ao uso do cateter de artéria pulmonar? EVIDÊNCIAS CIENTÍFICAS: As buscas identificaram apenas um ensaio clínico randomizado, cujo objetivo foi comparar o efeito da terapia guiada por metas realizada utilizando o cateter de artéria pulmonar versus o sistema FloTrac® após cirurgia de revascularização miocárdica. Os pacientes do grupo FloTrac® receberam mais volume e ficaram em média cinco horas a menos em suporte ventilatório, ambos desfechos estatisticamente significativos. Estudo com alto risco de viés e certeza da evidência avaliada como muito baixa. AVALIAÇÃO ECONÔMICA (AE): O demandante optou por descartar as diferenças observadas no ensaio clínico e considerar as tecnologias com igual eficácia, adotando um modelo econômico de custo-minimização. O preço do FloTrac® foi ofertado de forma a ser equivalente ao preço do cateter de artéria pulmonar em compras públicas recentes. A busca no Banco de Preços em Saúde foi atualizada pelo parecerista e observou-se que o preço proposto (R$ 1.200,00) está acima do valor SIGTAP (R$ 518,70) e da mediana de preços das compras públicas realizadas nos últimos 18 meses (R$ 358,50 a R$ 380,00 dependendo do tamanho do cateter). ANÁLISE DE IMPACTO ORÇAMENTÁRIO (AIO): A avaliação do impacto orçamentário foi realizada por demanda aferida e considerou apenas o custo de aquisição dos cateteres. O demandante considerou o mesmo preço para as tecnologias e consequentemente impacto orçamentário zero. O impacto foi recalculado com base na mediana e média ponderada dos preços atualizados no BPS em relação ao preço ofertado sendo constatado um impacto incremental em torno de 22,5 a 33,7 milhões de reais em cinco anos. RECOMENDAÇÕES DE AGÊNCIAS DE ATS: CONSIDERAÇÕES FINAIS: A monitorização minimamente invasiva é uma opção à monitorização invasiva com potencial, porém não comprovado, de redução de risco de complicações como infecção associada ao cateter e pneumotórax. Um único ensaio clínico, com muita baixa confiabilidade demonstrou superioridade do FloTrac® em relação ao cateter de artéria pulmonar com redução de cinco horas no tempo médio de ventilação assistida. O demandante optou por considerar eficácia semelhante e ofertar o FloTrac® com preço igual à mediana de preço de compras no BPS do cateter de artéria pulmonar, ou seja, sem custos incrementais ao SUS. Porém, os valores atualizados no BPS são inferiores aos valores apresentados. RECOMENDAÇÃO PRELIMINAR DA CONITEC: Pelo exposto, o Plenário da Conitec, em sua 114ª Reunião Ordinária, no dia 09 de novembro de 2022, deliberou por unanimidade que a matéria fosse disponibilizada em Consulta Pública com recomendação preliminar desfavorável à incorporação do FloTrac®, sistema para monitorização do débito cardíaco minimamente invasivo em cirurgias de grande porte e de alto risco. Os membros da Conitec consideraram que o preço da tecnologia é superior ao preço do cateter de artéria pulmonar hoje disponibilizado no SUS, o que é divergente da proposta apresentada pelo demandante de igualdade de preços e impacto orçamental nulo. Após revisão das compras realizadas nos últimos 18 meses, o preço proposto do FloTrac® (R$ 1.200,00), em relação ao preço do cateter de artéria pulmonar, encontra-se significativamente superior ao valor SIGTAP (R$ 518,70), média ponderada (R$ 380 a R$ 651,34 cateteres 7,0/7,5 french) ou mediana de preços (R$ 358,50 a R$ 380,00 cateteres 7,0/7,5 french) e que por isso causaria um impacto orçamentário incremental sem comprovação de benefícios clínicos ou de segurança que justificassem o investimento. CONSULTA PÚBLICA: Foram recebidas 7 contribuições, sendo todas de experiência e opinião. Diante das argumentações apresentadas, o plenário da Conitec entendeu que não houve argumentação suficiente para mudança de entendimento acerca de sua recomendação preliminar, com base em evidência científica frágil. Desse modo, a Comissão, diante das incertezas quanto ao real benefício do dispositivo, manteve a posição desfavorável à incorporação do sensor pré-calibrado para monitorização hemodinâmica contínua do débito cardíaco e da pressão intravascular, sistema FloTrac. RECOMENDAÇÃO FINAL DA CONITEC: Diante do exposto, os membros presentes do Comitê de Produtos e Procedimentos da Conitec, em sua 116ª Reunião Ordinária, realizada no dia 15 de março de 2023, deliberaram, por unanimidade, recomendar a não incorporação, no SUS, sensor pré-calibrado para monitorização de pressão intravascular e minimamente invasiva do débito cardíaco, FloTrac®, para cirurgias de grande porte e de alto risco. Para essa recomendação, a Conitec considerou que a consulta pública não trouxe elementos novos que alterassem a recomendação preliminar. Foi assinado o registro de deliberação nº 801/2023. DECISÃO: Não incorporar, no âmbito do Sistema Único de Saúde - SUS, o sensor pré-calibrado para monitorização de pressão intravascular e minimamente invasiva do débito cardíaco, FloTrac®, para cirurgias de grande porte e de alto risco, publicada no Diário Oficial da União nº 74, seção 1, página 195, em 18 de abril de 2023.

Functional quality assessment of whole-body vibration training devices based on instantaneous amplitude and frequency of photogrammetric vibration measurements.

The practical use of whole-body vibration training (WBVT) and such research may be negatively influenced by generated vibrations with amplitudes, frequencies, and/or patterns that deviate from preset adjustments on WBVT devices. This study examined whether prolonged regular use can generate respective deviations. Four WBVT devices, used for 19 months in a research project on the effects of WBVT, were analyzed using photogrammetry before start of the research project and after 19 months. Divergences between preset and measured amplitudes and frequencies were calculated for all measurements. To quantify how well the output of devices correlates with the target setting, the vibration characteristics were calculated. In particular, exact long-term measurements related to the vibration amplitude is conducted and analyzed for the first time, which has been found as an important measure of the device functional quality. One device had a significantly (p<0.01) larger machine run time than the other three. This one showed the most pronounced signs of functional impairments concerning instantaneous amplitudes, frequencies and the mode of vibration after prolonged use. These results based on photometric measurements underline again that prolonged use can result in divergences between preset and actual applied amplitudes, frequencies, mode of vibration and other accuracy measurement metrics.

Tecnologías para la Evaluación, Diagnóstico y Tratamiento del Trastorno por Déficit de Atención e Hiperactividad: Una Revisión Preliminar e Integradora / Technologies for the Evaluation, Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder: A Preliminary and Integrative Review

El trastorno por déficit de atención e hiperactividad (TDAH) es uno de los trastornos del neurodesarrollo con más alta prevalencia, estimada en 5%, en la población infantil. El objetivo de esta revisión fue sintetizar las tecnologías existentes que sirven para evaluar, diagnosticar y tratar síntomas de TDAH en población pediátrica. Esta es una revisión preliminar, de tipo integradora, que incluyó artículos publicados en 3 bases de datos especializadas, PsycINFO, Eric y Web of Science, entre los años 2005 y 2021. Se encontró que las pruebas diagnósticas clásicas se dividen en pruebas psicométricas, evaluación por biomarcadores y movimientos oculares. Por su parte, las pruebas que utilizan la tecnología son aquellas a evaluación y diagnóstico (DIDE, MOXO, AULA, AQUIARUM y BRAINGAZE) y aquellas que se utilizan en la terapéutica (SINCROLAB, PSIOUS, SISTEMA eTNS y varias basadas en neurofeedback). Las modernas tecnologías ofrecen cierto porcentaje de sensibilidad con baja inversión, tampoco requieren de equipos costosos y la preparación del profesional psicólogo o médico para su aplicación, es relativamente sencilla y accesible, ya que viene como complemento en la compra de la mayoría de los programas. Con el fin de continuar examinando su efectividad, se recomienda seguir evaluando estas herramientas con metodologías más robustas, en poblaciones clínicas grandes, debiendo ser esto una prioridad para futuras investigaciones.

Attention deficit hyperactivity disorder (ADHD) is one of the neurodevelopmental disorders with the highest prevalence, estimated at 5%, in the pediatric population. The objective of this review was to synthesize the existing technologies used to evaluate, diagnose, and treat ADHD symptoms in the pediatric population. This is a preliminary, integrative review, which included articles published in 3 specialized databases, PsycINFO, Eric and Web of Science, between 2005 and 2021. It was found that classical diagnostic tests are divided into psychometric tests, biomarker assessment and eye movements. On the other hand, the tests that use technology are those for evaluation and diagnosis (DIDE, MOXO, AULA, AQUIARUM and BRAINGAZE) and those used in therapy (SINCROLAB, PSIOUS, SISTEMA eTNS and several based-on neurofeedback). The modern technologies offer a certain percentage of sensitivity with low investment, they do not require expensive equipment and the preparation of the psychologist or medical professional for their application is relatively simple and accessible, since it comes as a complement in the purchase of most of the programs. To continue examining their effectiveness, it is recommended to continue assessing these tools with more robust methodologies, in large clinical populations, and this should be a priority for future research.

Guía para la gestión de riesgos de los dispositivos médicos para el diagnóstico / Risk management guidance for diagnostic medical devices

Introducción: Los fabricantes de los dispositivos médicos no siempre disponen de experiencia para realizar un proceso de gestión de riesgos que cumpla con la norma ISO 14971:2019 e incluya los requisitos metrológicos necesarios; por tanto, para un mejor uso de estos equipos, especialmente los de diagnóstico, se debe implementar y mantener un proceso de gestión de riesgos basado en las normativas establecidas. Objetivo: Proponer una guía para la gestión de los riesgos indirectos en pacientes con diagnósticos incorrectos o retrasados. Métodos: Se revisaron las normas internacionales aplicables y se analizaron expedientes de gestión del riesgo de dispositivos médicos, entre ellos reactivos para el diagnóstico in vitro. Resultados: La guía ofrece elementos orientadores para cada etapa del proceso de gestión de riesgos en los dispositivos médicos para el diagnóstico: plan de gestión del riesgo, análisis, valoración y control del riesgo, evaluación del riesgo residual global, revisión de la gestión de riesgo y retroalimentación a partir de la información de producción o posproducción. Conclusiones: Esta guía es una herramienta útil para diseñadores, fabricantes, evaluadores de dispositivos médicos para el diagnóstico, asesores en temas de gestión de riesgos y la calidad de los dispositivos y personal médico(AU)

Introduction: Manufacturers of medical devices do not always have the expertise to perform a risk management process that complies with ISO 14971:2019 and includes the necessary metrological requirements; therefore, for better use of these devices, especially diagnostic devices, a risk management process based on established regulations should be implemented and maintained. Objective: To provide guidance for the management of indirect risks in patients with incorrect or delayed diagnoses. Methods: Applicable international standards were reviewed and risk management dossiers for medical devices, including in-vitro diagnostic reagents, were analyzed. Results: The guidance provides guiding elements for each step of the risk management process for diagnostic medical devices: risk management plan, risk analysis, risk assessment, risk evaluation and control, overall residual risk assessment, risk management review, and feedback from production or post-production information. Conclusions: This guide is a useful tool for designers, manufacturers, evaluators of diagnostic medical devices, risk management and device quality assessors, and medical personnel(AU)