Implementation of the classification of medical devices of Ukraine in international approaches.

OBJECTIVE: Aim: To study the level of compliance of the National Classifier of Ukraine ≪Classifier of Medical Devices of Ukraine NC 024: 2023≫ with international approaches to the classification and use of medical devices. PATIENTS AND METHODS: Materials and Methods: National Classifier of Ukraine ≪Classifier of Medical Devices of Ukraine NC 024: 2023≫ and the international nomenclature of medical devices Global Medical Device Nomenclature. Methods: bibliosemantic, of content analysis and of structural-and-logical analysis. CONCLUSION: Conclusions: In the course of the study, full compliance of the national classifier of medical devices of Ukraine NC 024: 2023 with the GMDN system was established.

Medical equipment effectiveness evaluation model based on cone-constrained DEA and attention-based bi-LSTM.

This study constructs a composite indicator system covering the core dimensions of medical equipment input and output. Based on this system, an innovative cone-constrained data envelopment analysis (DEA) model is designed. The model integrates the advantages of the analytic hierarchy process (AHP) with an improved criterion importance through intercriteria correlation (CRITIC) method to determine subjective and objective weights and employs game theory to obtain the final combined weights, which are further incorporated as constraints to form the cone-constrained DEA model. Finally, a bidirectional long short-term memory (Bi-LSTM) model with an attention mechanism is introduced for integration, aiming to provide a novel and practical model for evaluating the effectiveness of medical equipment. The proposed model has essential reference value for optimizing medical equipment management decision-making and investment strategies.

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.

Digital Avatars and Personalized Voices-How AI Is Helping to Restore Speech to Patients.

In this Medical News article, Edward Chang, MD, chair of the department of neurological surgery at the University of California, San Francisco Weill Institute for Neurosciences joins JAMA Editor in Chief Kirsten Bibbins-Domingo, PhD, MD, MAS, to discuss the potential for AI to revolutionize communication for those unable to speak due to aphasia.

Dispositivos médicos en pacientes diabéticos y dermatitis de contacto / Medical Devices in Patients With Diabetes and Contact Dermatitis

El desarrollo y comercialización de los sensores de glucosa y las bombas de insulina han supuesto una revolución en el control de los pacientes diabéticos. En los últimos años se han detectado múltiples casos de dermatitis de contacto relacionados con estos dispositivos médicos, con el creciente interés sobre los alérgenos responsables de la sensibilización. Isobornil acrilato fue sin duda el alérgeno principal del dispositivo FreeStyle, motivando al fabricante a modificar la composición eliminando este alérgeno. Curiosamente, este alérgeno está presente en casi todos los sensores comercializados. La colofonia y derivados del ácido abiético desempeñan un papel relevante en cuanto al adhesivo. Recientemente aparecen nuevos componentes identificados como alérgenos, no comercializadas, como el dipropilene glicol diacrilato, la N,N-dimetilacrilamida, o el metacrilato de trietilenglicol, que están siendo foco de estudio. El impacto positivo que tiene el uso de estos dispositivos puede verse mermado por la sensibilización a uno de sus ingredientes, obligando en ocasiones a abandonar el dispositivo, y por ende, restando calidad de vida. El dermatólogo debe posicionarse respecto al estudio dirigido de estos pacientes, dando soporte a los servicios de endocrinología, con la finalidad de orientar tanto el cuidado de la piel como las alternativas posibles, especialmente con la colaboración de los fabricantes.(AU)

The development and commercialization of glucose sensors and insulin pumps has revolutionized the management of diabetes. These devices have been linked to multiple cases of contact dermatitis in recent years, however, giving rise to a growing interest in identifying the sensitizing allergens. Isobornyl acrylate was clearly identified as one of the main allergens responsible for contact dermatitis among users of the FreeStyle glucose sensor and was subsequently removed from the product ingredients. Remarkably, however, it is still used in most other sensors on the market. The common adhesive ingredients colophony and abietic acid derivatives have also been shown to be sensitizing agents. New components under study, such as dipropylene glycol diacrylate, N,N-dimethylacrylamide, and triethylene glycol methacrylate have recently been identified as allergens, though they are not commercially available for clinical testing. The benefits offered by glucose sensors and insulin pumps may be offset by sensitization to product ingredients, in some cases forcing discontinuation and diminishing quality of life. Dermatologists should play a role in this clinical and research scenario, offering case-by-case guidance to endocrinologists on skin care and possible alternatives for patients with glucose sensors and insulin pumps who develop contact dermatitis. They should also collaborate with the manufacturers developing these devices.(AU)

[Translated article] Medical Devices in Patients With Diabetes and Contact Dermatitis / Dispositivos médicos en pacientes diabéticos y dermatitis de contacto

El desarrollo y comercialización de los sensores de glucosa y las bombas de insulina han supuesto una revolución en el control de los pacientes diabéticos. En los últimos años se han detectado múltiples casos de dermatitis de contacto relacionados con estos dispositivos médicos, con el creciente interés sobre los alérgenos responsables de la sensibilización. Isobornil acrilato fue sin duda el alérgeno principal del dispositivo FreeStyle, motivando al fabricante a modificar la composición eliminando este alérgeno. Curiosamente, este alérgeno está presente en casi todos los sensores comercializados. La colofonia y derivados del ácido abiético desempeñan un papel relevante en cuanto al adhesivo. Recientemente aparecen nuevos componentes identificados como alérgenos, no comercializadas, como el dipropilene glicol diacrilato, la N,N-dimetilacrilamida, o el metacrilato de trietilenglicol, que están siendo foco de estudio. El impacto positivo que tiene el uso de estos dispositivos puede verse mermado por la sensibilización a uno de sus ingredientes, obligando en ocasiones a abandonar el dispositivo, y por ende, restando calidad de vida. El dermatólogo debe posicionarse respecto al estudio dirigido de estos pacientes, dando soporte a los servicios de endocrinología, con la finalidad de orientar tanto el cuidado de la piel como las alternativas posibles, especialmente con la colaboración de los fabricantes.(AU)

The development and commercialization of glucose sensors and insulin pumps has revolutionized the management of diabetes. These devices have been linked to multiple cases of contact dermatitis in recent years, however, giving rise to a growing interest in identifying the sensitizing allergens. Isobornyl acrylate was clearly identified as one of the main allergens responsible for contact dermatitis among users of the FreeStyle glucose sensor and was subsequently removed from the product ingredients. Remarkably, however, it is still used in most other sensors on the market. The common adhesive ingredients colophony and abietic acid derivatives have also been shown to be sensitizing agents. New components under study, such as dipropylene glycol diacrylate, N,N-dimethylacrylamide, and triethylene glycol methacrylate have recently been identified as allergens, though they are not commercially available for clinical testing. The benefits offered by glucose sensors and insulin pumps may be offset by sensitization to product ingredients, in some cases forcing discontinuation and diminishing quality of life. Dermatologists should play a role in this clinical and research scenario, offering case-by-case guidance to endocrinologists on skin care and possible alternatives for patients with glucose sensors and insulin pumps who develop contact dermatitis. They should also collaborate with the manufacturers developing these devices.(AU)

Is it Time to Include Wearable Sleep Trackers in the Applied Psychologists’ Toolbox?

Wearable sleep trackers are increasingly used in applied psychology. Particularly, the recent boom in the fitness tracking industry has resulted in a number of relatively inexpensive consumer-oriented devices that further enlarge the potential applications of ambulatory sleep monitoring. While being largely positioned as wellness tools, wearable sleep trackers could be considered useful health devices supported by a growing number of independent peer-reviewed studies evaluating their accuracy. The inclusion of sensors that monitor cardiorespiratory physiology, diurnal activity data, and other environmental signals allows for a comprehensive and multidimensional approach to sleep health and its impact on psychological well-being. Moreover, the increasingly common combination of wearable trackers and experience sampling methods has the potential to uncover within-individual processes linking sleep to daily experiences, behaviors, and other psychosocial factors. Here, we provide a concise overview of the state-of-the-art, challenges, and opportunities of using wearable sleep-tracking technology in applied psychology. Specifically, we review key device profiles, capabilities, and limitations. By providing representative examples, we highlight how scholars and practitioners can fully exploit the potential of wearable sleep trackers while being aware of the most critical pitfalls characterizing these devices. Overall, consumer wearable sleep trackers are increasingly recognized as a valuable method to investigate, assess, and improve sleep health. Incorporating such devices in research and professional practice might significantly improve the quantity and quality of the collected information while opening the possibility of involving large samples over representative time periods. However, a rigorous and informed approach to their use is necessary. (AU)

[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.

Manual de organización y funciones de la Dirección de la Cadena de Suministro / Organization and functions manual of Supply Chain Management

Como parte de la modernización de la administración pública y con el propósito de contar con un documento que regule y oriente el accionar a desarrollar por la Dirección de la Cadena de Suministros, se establece el presente "manual de organización y funciones", como un instrumento que servirá de apoyo gerencial y operativo tanto para la Dirección, como para otras instancias que requieran conocer el funcionamiento de la Dirección y los elementos orgánicos que se vinculan para contribuir a la consecución de objetivos y resultados esperados en el ámbito de los suministros para la salud, describiendo sus unidades y oficinas que enmarcan el trabajo administrativo y operativo que desarrollan

As part of the modernization of public administration and with the purpose of having a document that regulates and guides the actions to be carried out by the Supply Chain Management, this "organization and functions manual" is established as an instrument that will serve as managerial and operational support both for the Directorate and for other entities that require knowledge of the functioning of the Directorate and the organic elements that are linked to contribute to the achievement of objectives and expected results in the field of health supplies. , describing its units and offices that frame the administrative and operational work they carry out

Lineamientos técnicos para el manejo seguro de dispositivos invasivos y del sitio quirúrgico en la prevención de infecciones / Technical Guidelines for the Safe Management of Invasive Devices and Surgical Sites in Infection Prevention

Las infecciones asociadas a la atención en salud (IAAS), son infecciones locales o sistémicas contraídas durante la hospitalización o durante la atención ambulatoria en los servicios de salud, que se constituyen en un problema de salud pública importante debido a la frecuencia con que se producen, la morbilidad y mortalidad que provocan y la carga que imponen a los pacientes, al personal de salud y a los sistemas de salud. Los presentes lineamientos técnicos establecen las disposiciones necesarias para el manejo seguro de dispositivos invasivos y del sitio quirúrgico, con la finalidad de fortalecer las intervenciones del personal de salud, en los establecimientos de salud del SNIS, evitar errores durante la atención, detectar oportunamente factores de riesgo relacionados con el uso y mantenimiento de los dispositivos e incidir inmediatamente en ellos, mejorando la calidad de atención y reduciendo las tasas de incidencia de morbimortalidad relacionada al uso y mantenimiento de los mismos

Infections associated with health care (IAAS) are local or systemic infections contracted during hospitalization or during outpatient health care, which constitute a major public health problem because of the frequency with which they occur, the morbidity and mortality they cause and the burden they impose on patients, health personnel and health systems. These technical guidelines establish the necessary provisions for the safe management of invasive devices and the surgical site, with the aim of strengthening the interventions of health personnel, in the health facilities of the SNIS, avoid errors during care, detect timely risk factors related to the use and maintenance of the devices and immediately affect them, improving the quality of care and reducing the incidence of morbidity and mortality related to their use and maintenance

[Common Problems and Improvement Suggestions for the Special Review Application of Shanghai's Class â ¡ Innovative Medical Device].

This study conducted statistics on the special review applications for Class Ⅱ innovative medical devices in Shanghai from April 2020 to April 2023. It summarized and analyzed common problems in the innovation review application stage, and gave suggestions for applicants and reviewers in order to further improve the quality of innovation application and improve the pass rate of innovation applications.

Flexible neural probes: a review of the current advantages, drawbacks, and future demands. / 柔性神经探针：当前的优点、缺点及未来需求.

Brain diseases affect millions of people and have a huge social and economic impact. The use of neural probes for studies in animals has been the main approach to increasing knowledge about neural network functioning. Ultimately, neuroscientists are trying to develop new and more effective therapeutic approaches to treating neurological disorders. The implementation of neural probes with multifunctionalities (electrical, optical, and fluidic interactions) has been increasing in the last few years, leading to the creation of devices with high temporal and spatial resolution. Increasing the applicability of, and elements integrated into, neural probes has also led to the necessity to create flexible interfaces, reducing neural tissue damage during probe implantation and increasing the quality of neural acquisition data. In this paper, we review the fabrication, characterization, and validation of several types of flexible neural probes, exploring the main advantages and drawbacks of these devices. Finally, future developments and applications are covered. Overall, this review aims to present the currently available flexible devices and future appropriate avenues for development as possible guidance for future engineered devices.

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.

Evidence from clinical trials on high-risk medical devices in children: a scoping review.

BACKGROUND: Meeting increased regulatory requirements for clinical evaluation of medical devices marketed in Europe in accordance with the Medical Device Regulation (EU 2017/745) is challenging, particularly for high-risk devices used in children. METHODS: Within the CORE-MD project, we performed a scoping review on evidence from clinical trials investigating high-risk paediatric medical devices used in paediatric cardiology, diabetology, orthopaedics and surgery, in patients aged 0-21 years. We searched Medline and Embase from 1st January 2017 to 9th November 2022. RESULTS: From 1692 records screened, 99 trials were included. Most were multicentre studies performed in North America and Europe that mainly had evaluated medical devices from the specialty of diabetology. Most had enrolled adolescents and 39% of trials included both children and adults. Randomized controlled trials accounted for 38% of the sample. Other frequently used designs were before-after studies (21%) and crossover trials (20%). Included trials were mainly small, with a sample size <100 participants in 64% of the studies. Most frequently assessed outcomes were efficacy and effectiveness as well as safety. CONCLUSION: Within the assessed sample, clinical trials on high-risk medical devices in children were of various designs, often lacked a concurrent control group, and recruited few infants and young children. IMPACT: In the assessed sample, clinical trials on high-risk medical devices in children were mainly small, with variable study designs (often without concurrent control), and they mostly enrolled adolescents. We provide a systematic summary of methodologies applied in clinical trials of medical devices in the paediatric population, reflecting obstacles in this research area that make it challenging to conduct adequately powered randomized controlled trials. In view of changing European regulations and related concerns about shortages of high-risk medical devices for children, our findings may assist competent authorities in setting realistic requirements for the evidence level to support device conformity certification.

Acceso vascular seguro y de calidad en el paciente geriátrico: valorando la satisfacción profesional / Safe and quality vascular access for the geriatric patient: giving value to professional satisfaction

Introducción: El Hospital Central de la Cruz Roja San José y Santa Adela (Madrid) promovió la mejora en calidad asistencial poniendo en práctica los avances en dispositivos intravenosos basados en evidencia científica, creando un equipo de terapia intravenosa que canaliza y forma al personal para mantener catéteres centrales de inserción periférica y líneas medias. Objetivos: Evaluar la satisfacción de las enfermeras ante los catéteres y la presencia de un equipo especializado en terapia y accesos vasculares. Metodología: Estudio observacional, descriptivo y transversal, basado en una encuesta de satisfacción anónima y voluntaria, creada ad hoc por los investigadores. Con una participación final de 45 enfermeras del área médica. Resultados: El 100% afirmó conocer la existencia de los dispositivos en el hospital. Se obtuvieron datos sobre la información recibida en el mantenimiento de los dispositivos. En función a su comodidad y confort los describen, en su mayoría, como óptimo para el paciente, evitando además las punciones múltiples y reiteradas, notando el 91% de los participantes reducción en su carga de trabajo. El estudio refleja que las complicaciones más asiduas son: obstrucción y salida accidental del catéter. El 97,7% refiere la necesidad de un equipo específico para la canalización y ayuda ante adversidades. Conclusiones: Los resultados obtenidos muestran un alto grado de satisfacción con el uso de estos catéteres, igualmente ponen en valor la necesidad de un equipo formado para la valoración e inserción de estos dispositivos y de apoyo en los cuidados.(AU)

Introduction: The Red Cross’s Central Hospital San José and Santa Adela (Madrid) promoted the improvement in care quality, putting into practice the advances in intravenous devices based on scientific evidence, building an intravenous therapy team that manages and trains staff to maintain central catheters of peripheral insertion and midlines. Objective: To evaluate the satisfaction of nurses with catheters and the presence of a specialized team in therapy and vascular access. Methodology: Observational, descriptive and cross-sectional study, based on an anonymous and voluntary satisfaction survey, created ad hoc by the researchers. With a final entry of 45 nurses from the medical area. Results: 100% stated that they were aware of the existence of the devices in the hospital. Data was obtained on the information received in the maintenance of the devices. Based on convenience and comfort, they are mostly described as optimal for the patient, avoiding multiple and repeated punctures as well, with 91% of the participants noting a reduction in their workload. The study reflects that the most frequent complications are obstruction and accidental exit of the catheter. 97.7% refer to the need for a specific team for managing and helping in the face of adversity. Conclusions: The results obtained show a high degree of satisfaction with the use of these catheters. They also highlight the need for a team trained to assess and insert these devices and supporting nursing.(AU)

Navigating the FDA regulatory landscape.

Recent research and technological developments have led to an expanding number of novel and rapidly acting therapeutics being developed across a variety of neuropsychiatric disorders. Novel medical devices range from implantable and non-invasive brain stimulating and recording technologies to digital therapeutics. This perspective provides an overview of FDA regulatory oversight for medical devices, including a discussion of regulatory pathways and the review of neuromodulation devices for psychiatric disorders. We highlight the importance of early engagement with FDA and special programs that may be useful to device developers participating in interactions with the FDA that are solution focused. We explore current novel and rapid treatments for psychiatric disorders and those on the horizon. Lastly, we provide considerations for developers in navigating the regulatory landscape for neuromodulation devices intended for psychiatric disorders, including approaches to incorporating patient perspectives.

Intestinal retentive systems - recent advances and emerging approaches.

Intestinal retentive devices (IRDs) are devices designed to anchor within the lumen of the intestines for long-term residence in the gastrointestinal tract. IRDs can enable impactful medical device technologies including sustained oral drug delivery systems, indwelling sensors, or real-time diagnostics. The design and testing of IRDs present a myriad of challenges, including precise deployment of the device at desired intestinal locations, secure anchoring within the gastrointestinal tract to allow for natural function, and safe removal of the IRD at user-defined times. Advancing the state-of-the-art of IRD is an interdisciplinary effort that requires innovations such as new materials, novel anchoring mechanisms, and medical device design with consistent input from clinical practitioners and end-users. This perspective briefly reviews the current state-of-the-art for IRDs and charts a path forward to inform the design of future concepts. Specifically, this article will highlight materials, retention mechanisms, and test beds to measure the efficacy of IRDs and their mechanisms. Finally, potential synergies between IRD and other medical device technologies are presented to identify future opportunities.

The attitude towards Medical Device-Related Pressure Injuries Questionnaire: a Turkish validity and reliability study.

BACKGROUND: The attitudes of nurses should be measured using valid and reliable tools to develop effective nursing care strategies for the prevention of medical device-related pressure injuries and to organize necessary training programs. PURPOSE: This study was planned to conduct the Turkish validity and reliability study of the Attitude towards Medical Device-Related Pressure Ulcers/Injuries Questionnaire (MDRPU/I Questionnaire (the English-language version)) in nurses. METHODS: This methodological study included 134 nurses working in hospitals of different sizes and characteristics (public hospitals, training and research hospitals, and university hospitals) in Turkey. The validity and reliability of the Attitude Towards Medical Device-Related Pressure Injuries (MDRPI Questionnaire (the Turkish-language version)) Questionnaire were tested using language validity, content validity, face validity, construct validity, and reliability analyses. RESULTS: The final version of the questionnaire had a content validity index of 98.03%, sufficient construct validity, and a Cronbach α value of 0.92 for the total questionnaire. CONCLUSIONS: The Turkish version of the MDRPI Questionnaire is valid, reliable, and suitable for measuring the attitudes of nurses in Turkey toward the prevention and care of medical device-related pressure injuries.

Las reservas de material sanitario estratégico. Reflexiones legales y económicas / [Reserves of strategic medical supplies. Legal and economic reflections]

En este trabajo se presenta un análisis de los principales problemas que plantean las reservas de material sanitario estratégico. Entre otras cuestiones se aborda las referidas a la identificación de la agencia responsable de crear tales reservas, qué se ha de reservar, cómo se han de gestionar las reservas, la trascendencia del enfoque conjunto, así como la necesidad de establecer estrategias adecuadas para emergencias y catástrofes que puedan tener impacto en la salud pública. (AU)

This paper presents an analysis of the key issues posed by strategic healthcare material reserves. Among other matters, it addresses those related to identifying the agency responsible for creating such reserves, what should be reserved, how reserves should be managed, the significance of a collaborative approach, as well as the necessity to establish appropriate strategies for emergencies and disasters that may impact public health. (AU)