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.

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.

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.

[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.

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.

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.

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)

Health State Assessment of Industrial Equipment Driven by the Fusion of Digital Twin Model and Intelligent Algorithm.

Equipment health state assessment is of great significance to improve the efficiency of industrial equipment maintenance support and realize accurate support. Using the method driven by the fusion of digital twin model and intelligent algorithm can make the equipment health state assessment more suitable for the "accuracy" requirement of equipment support. Taking the neural network algorithm as an example, this paper studies the method of unit level health state assessment of equipment driven by the fusion of digital twin model and intelligent algorithm. The principle and opportunity of equipment health state assessment based on digital twin model are analyzed, the equipment health state grade is redefined from the data-driven perspective, the selection principles of assessment parameters are established, and the unit level health state assessment model of equipment based on digital twin model and neural network algorithm is established. The proposed method is implemented by programming with Python, and the effectiveness of the method is verified by a case study. It provides support for further research of equipment-level health state assessment and the decision-making of equipment maintenance and provides reference for the study of the combination of digital twin model and other intelligent algorithms for health state assessment.

Eficacia y seguridad del uso de colchoneta, cojinete y rodete de gel polímero viscoelástico para mesa de sala de operaciones en pacientes de cualquier edad con indicación de cirugía cardiaca de alta complejidad / Efficacy and safety of the use of viscoelastic polymer gel mattress, bearing and impeller for operating room table in patients of any age with indication for highly complex cardiac surgery

ANTECEDENTES: En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias, aprobada mediante Resolución del Instituto de Evaluación de Tecnologías en Salud e Investigación N° 111-IETSI-ESSALUD-2021, se ha elaborado el presente dictamen, el cual expone la evaluación de la eficacia y seguridad del uso de colchoneta, cojinete y rodete de gel polímero viscoelástico para mesa de sala de operaciones, en pacientes de cualquier edad, que presentan indicación de cirugía cardiaca de alta complejidad. A través de la Nota N°548-DIR-INCOR-ESSALUD-2020, los médicos especialistas del Servicio de Anestesiología, del Instituto Nacional Cardiovascular (INCOR), a través de la gerencia de su dirección, solicitan al Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) la evaluación para la posible incorporación de los dispositivos: 1) colchoneta de polímero para mesa de sala de operaciones, 2) cojinete para mesa de operaciones, y 3) rodete circular; los cuáles, según los especialistas, son tecnologías fabricadas con gel polímero viscoelástico. Asimismo, debido a que son tecnologías de uso concomitante, para efectos del presente dictamen preliminar se les denominará como: "Colchoneta, cojinete y rodete de gel polímero viscoelástico para mesa de sala de operaciones". ASPECTOS GENERALES: Las úlceras de presión son lesiones de la piel que ocurren debido a isquemia y necrosis en zonas de la piel que se encuentran sometidas a fricción o presión constante sobre una superficie. Por ello, son comunes en personas postradas debido a condiciones incapacitantes y que generan dificultades motrices (Zaidi S and Sharma S 2021). En el año 2019 se estimó que casi 850,000 personas a nivel mundial tenían al menos una úlcera de presión, lo que representa poco más del doble del número reportado en el año 1990 (420,000) (Zhang et al. 2021). Asimismo, la mayoría de los casos se identificaron en Norteamérica (221,138), Europa Occidental (168,939) y Centroamérica (61,804) (Zhang et al. 2021). Las personas con úlceras de presión suelen presentar desde molestias hasta dolor en la zona afectada, lo que puede afectar su calidad de vida. Del mismo modo, una úlcera de presión puede convertirse en la vía de ingreso para una infección, que eventualmente podría convertirse en una sepsis (Zaidi S and Sharma S 2021). Un grupo particularmente vulnerable a presentar esta complicación son los pacientes sometidos a cirugía cardiaca; pues se estima que casi un tercio de ellos presentará una úlcera de presión luego de la intervención (Feuchtinger, Halfens, and Dassen 2005). Esto se atribuye a la larga duración de este tipo de cirugías y, consecuentemente, al contacto prolongado de la piel del paciente sobre la mesa de operaciones, así como a las fuerzas de cizallamiento ocurridas durante el acto quirúrgico (Chen et al. 2017). METODOLOGÍA: Se realizó una búsqueda bibliográfica exhaustiva con el objetivo de identificar la mejor evidencia disponible sobre la eficacia y seguridad del uso de colchonetas, cojinetes y rodetes de gel polímero viscoelástico, en comparación con la colchoneta estándar de mesa de operaciones y campos de tela enrollados, en pacientes de todas las edades sometidos a cirugía cardiaca de alta complejidad. La búsqueda bibliográficasse realizó en las bases de datos de PubMed, Cochrane Library y LILACS. Asimismo, se realizó una búsqueda manual en Google y dentro de las páginas web pertenecientes a grupos que realizan GPC y ETS, incluyendo el Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI), Centro Nacional de Excelencia Tecnológica en Salud (CENETEC), National Institute for Health and Care Excellence (NICE), Agency for Healthcare Research and Quality (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 lncorporagáo de Tecnologías 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 Haute Autorité de Santé (HAS). Además, se realizó una búsqueda de GPC en las páginas web de las principales sociedades o instituciones especializadas en cirugía cardiaca o en la prevención y/o tratamiento de las úlceras de presión, como: National Pressure lnjury Advisory Panel (NPIAP), European Pressure Ulcer Advisory Panel (EPUAP), Pan Pacific Pressure Injury Alliance (PPPIA), Japanese Society of Pressure Ulcers (JSPU), la American College of Cardiology (ACC), y la European Society of Cardiology (ESC). Por último, se realizó una búsqueda de estudios clínicos en ejecución o aún no terminados en ClinicalTrials.gov e International Clinical Trial Registry Platform (ICTRP). RESULTADOS: Luego de la búsqueda bibliográfica con fecha 16 de diciembre de 2021, se incluyeron para evaluación 2 GPC: NICE, y JSPU (Japanese Society of Pressure Ulcers 2016, National Institute for Health and Care Excellence 2018), y una ETS elaborada por la Medical Advisory Secretariat (MAS) de Ontario, en Canadá (Medical Advisory Secretariat 2009). CONCLUSIÓN: Por lo expuesto, el Instituto de Evaluación de Tecnologías en Salud e Investigación no aprueba la incorporación de las tecnologías colchoneta, cojinete y rodete de gel polímero viscoelástico al petitorio de dispositivos de EsSalud, para su uso en pacientes de cualquier edad con indicación de cirugía cardiaca de alta complejidad. Asimismo, se sugiere a los especialistas, que, de existir otro tipo de superficies de redistribución de presión cuyo uso consideren podría ser de beneficio para la prevención de la incidencia de úlceras de presión o quemaduras por cizallamiento, en los pacientes con indicación de cirugía cardiaca de alta complejidad, envíen sus solicitudes debidamente justificadas para ser valorados en una nueva ETS.

An integrated benefit-risk assessment of cobalt-containing alloys used in medical devices: Implications for regulatory requirements in the European Union.

In 2017, the European Union (EU) Committee for Risk Assessment (RAC) recommended the classification of metallic cobalt (Co) as Category 1B with respect to its carcinogenic and reproductive hazard potential and Category 2 for mutagenicity but did not evaluate the relevance of these classifications for patients exposed to Co-containing alloys (CoCA) used in medical devices. CoCA are inherently different materials from Co metal from a toxicological perspective and thus require a separate assessment. CoCA are biocompatible materials with a unique combination of properties including strength, durability, and a long history of safe use that make them uniquely suited for use in a wide-range of medical devices. Assessments were performed on relevant preclinical and clinical carcinogenicity and reproductive toxicity data for Co and CoCA to meet the requirements under the EU Medical Device Regulation triggered by the ECHA re-classification (adopted in October 2019 under the 14th Adaptation to Technical Progress to CLP) and to address their relevance to patient safety. The objective of this review is to present an integrated overview of these assessments, a benefit-risk assessment and an examination of potential alternative materials. The data support the conclusion that the exposure to CoCA in medical devices via clinically relevant routes does not represent a hazard for carcinogenicity or reproductive toxicity. Additionally, the risk for the adverse effects that are known to occur with elevated Co concentrations (e.g., cardiomyopathy) are very low for CoCA implant devices (infrequent reports often reflecting a unique catastrophic failure event out of millions of patients) and negligible for CoCA non-implant devices (not measurable/no case reports). In conclusion, the favorable benefit-risk profile also in relation to possible alternatives presented herein strongly support continued use of CoCA in medical devices.

Incidence and risk factors of medical device-related pressure injuries among patients undergoing prone position spine surgery in the operating room.

AIM: We aimed to investigate the incidence rate and risk factors of medical device-related pressure injuries (MDRPIs) among patients undergoing prone position spine surgery. MATERIALS AND METHODS: This was a prospective observational study of 147 patients who underwent spine surgery in an orthopaedic hospital in Korea. The incidence of MDRPI according to intrinsic and extrinsic factors was assessed using the independent t-, χ2 -, or Fisher's exact tests. A logistic regression analysis was performed exclusively for MDRPI areas with an incidence rate >5%. RESULTS: The mean incidence rate of overall MDRPI was 27.4%, while that of MDRPI by Wilson frame, bi-spectral index, and endotracheal tube (ETT) was 56.5%, 52.4%, and 9.5%, respectively. The risk factors under Wilson frame were operation time and body mass index classification. Compared to their normal weight counterparts, those who were underweight, overweight, and obese had a 46.57(95% CI: 6.37-340.26), 3.96 (95% CI: 1.13-13.86), and 5.60 times (95% CI: 1.62-19.28) higher risk of developing MDRPI, respectively. The risk factors by bi-spectral index were sex, operation time, and the American Society of Anaesthesiologists classification. Compared to ETT intubation of <2 h, the risk of MDRPI increased by 7.16 times (95% CI: 1.35-38.00) and 7.93 times (95% CI: 1.45-43.27) for<3 and ≥3 h' duration, respectively. CONCLUSION: The difficulty of device repositioning can increase the incidence of MDRPI, and prolonged surgery was a significant risk factor. Thus, appropriate planning and correct equipment utilization is needed during prone position spine surgeries.

Accuracy assessment methods for physiological model selection toward evaluation of closed-loop controlled medical devices.

Physiological closed-loop controlled (PCLC) medical devices are complex systems integrating one or more medical devices with a patient's physiology through closed-loop control algorithms; introducing many failure modes and parameters that impact performance. These control algorithms should be tested through safety and efficacy trials to compare their performance to the standard of care and determine whether there is sufficient evidence of safety for their use in real care setting. With this aim, credible mathematical models have been constructed and used throughout the development and evaluation phases of a PCLC medical device to support the engineering design and improve safety aspects. Uncertainties about the fidelity of these models and ambiguities about the choice of measures for modeling performance need to be addressed before a reliable PCLC evaluation can be achieved. This research develops tools for evaluating the accuracy of physiological models and establishes fundamental measures for predictive capability assessment across different physiological models. As a case study, we built a refined physiological model of blood volume (BV) response by expanding an original model we developed in our prior work. Using experimental data collected from 16 sheep undergoing hemorrhage and fluid resuscitation, first, we compared the calibration performance of the two candidate physiological models, i.e., original and refined, using root-mean-squared error (RMSE), Akiake information criterion (AIC), and a new multi-dimensional approach utilizing normalized features extracted from the fitting error. Compared to the original model, the refined model demonstrated a significant improvement in calibration performance in terms of RMSE (9%, P = 0.03) and multi-dimensional measure (48%, P = 0.02), while a comparable AIC between the two models verified that the enhanced calibration performance in the refined model is not due to data over-fitting. Second, we compared the physiological predictive capability of the two models under three different scenarios: prediction of subject-specific steady-state BV response, subject-specific transient BV response to hemorrhage perturbation, and leave-one-out inter-subject BV response. Results indicated enhanced accuracy and predictive capability for the refined physiological model with significantly larger proportion of measurements that were within the prediction envelope in the transient and leave-one-out prediction scenarios (P < 0.02). All together, this study helps to identify and merge new methods for credibility assessment and physiological model selection, leading to a more efficient process for PCLC medical device evaluation.

Neither protective nor harmonized: the crossborder regulation of medical devices in the EU.

To what extent does inadequate market regulation contribute to poor health outcomes? A series of prominent scandals involving harmful medical devices has made improving the regulation of these devices an urgent problem for the European Union (EU). This is, however, a specific example of a general phenomenon. The EU remains first and foremost a large and integrated market within which the EU institutions have considerable regulatory authority. Even if there is little EU commitment to a health or social policy agenda, its use of that regulatory authority shapes health care cost and quality and should be understood as health policy. We use data from EU-level and national policy documents to analyse the EU's current regulatory framework for medical devices and assess its likely future efficacy. Despite revising the medical devices directive to require more stringent pre-authorization requirements for high-risk medical devices and improvements in post-market surveillance, the key underlying problems of market fragmentation and patient safety persist. Without strong and consistent support for the implementation of the new directive, the likely result is the status quo, with significant consequences for health in Europe.

Glycemic Status Assessment by the Latest Glucose Monitoring Technologies.

The advanced and performing technologies of glucose monitoring systems provide a large amount of glucose data that needs to be properly read and interpreted by the diabetology team in order to make therapeutic decisions as close as possible to the patient's metabolic needs. For this purpose, new parameters have been developed, to allow a more integrated reading and interpretation of data by clinical professionals. The new challenge for the diabetes community consists of promoting an integrated and homogeneous reading, as well as interpretation of glucose monitoring data also by the patient himself. The purpose of this review is to offer an overview of the glycemic status assessment, opened by the current data management provided by latest glucose monitoring technologies. Furthermore, the applicability and personalization of the different glycemic monitoring devices used in specific insulin-treated diabetes mellitus patient populations will be evaluated.

Hospital Pharmacy: Comprehensive management of medical devices during SARS-CoV-2.

Medical devices have become essential to the prevention and control of the  COVID-19 pandemic, being crucial for health professionals and patients in  particular, and the population in general. It is important to be aware of the laws  that regulate the management, distribution, and control of medical devices.  Article 82 of the Spanish Law 29/2006 on Guarantees and Rational Use of  Medicines and Medical Devices establishes that it is the responsibility of Hospital  Pharmacy Services "to participate in and coordinate the purchase of medicines and medical devices in the hospital to ensure an efficient acquisition  and rational use of medical devices". For this reason, working groups of the Spanish Society of Hospital Pharmacy and other scientific societies have issued technical guidelines and consensus statements to provide technical support and updated information on the use of masks, individual  protection equipments and other medical devices. In addition, the shortage of  medical devices caused by the high demand has resulted in the uncontrolled  production and distribution of medical devices. This phenomenon, added to the  fraudulent selling of medical devices, highlights the need for a closer surveillance of the market to guarantee the efficacy and safety of available medical devices. A rational use of medical devices is necessary to ensure the availability and safety of these products, which requires the involvement of  different stakeholders, including hospital pharmacists. Thus, it is essential that  hospital pharmacists receive specific training in technical aspects concerning the possession and use of medical devices. This will help guarantee an effective and safe use of medical products. The acquisition and use of medical  devices requires a keen understanding of the technical and legal aspects  concerning these products, which makes hospital pharmacists essential for the  integral management of medical devices.

Los productos sanitarios se han convertido en imprescindibles en la prevención y control de la pandemia actual generada por COVID-19, tanto para el personal  sanitario y pacientes, como para la ciudadanía en su totalidad. Los productos  sanitarios cuentan con una legislación propia que es preciso conocer para su  correcta gestión, distribución y control. El artículo 82 de la Ley 29/2006 de  garantías y uso racional de los medicamentos y productos sanitarios establece  que es responsabilidad de los servicios de farmacia hospitalaria "participar y  coordinar la gestión de las compras de los productos sanitarios del hospital a  efectos de asegurar la eficiencia de la misma y así contribuir al uso racional de  los mismos". Por este motivo, grupos de trabajo de expertos de la Sociedad Española de Farmacia Hospitalaria, junto a otras sociedades científicas, han desarrollado durante esta pandemia documentos técnicos y consensos para dar soporte técnico e informativo de forma actualizada en  relación con las mascarillas, los equipos de protección individual y otros  productos sanitarios. Por otro lado, los problemas de desabastecimiento  secundarios a la elevada demanda han llevado a una producción y  comercialización descontrolada de productos sanitarios. Este hecho, asociado a  la comercialización fraudulenta de productos sanitarios en el mercado, ha  generado la necesidad de una vigilancia exhaustiva, capaz de garantizar la  eficacia y seguridad de los productos sanitarios en circulación. El uso racional,  para asegurar la disponibilidad y seguridad de los productos sanitarios, es una  responsabilidad multidisciplinar compleja. Para ello, es fundamental una  formación específica como la del farmacéutico de hospital en aspectos técnicos  de tenencia y uso que permite salvaguardar las garantías de eficacia, seguridad  y calidad de los productos sanitarios. El conocimiento técnico y legal que  requieren los productos sanitarios hace imprescindible la implicación del  farmacéutico de hospital como uno de los profesionales sanitarios capacitado  para la gestión integral de estos productos.