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Evaluar la eficacia del dispositivo artesanal de asistencia respiratoria no invasivo de administración de presión positiva continua en las vías respiratorias (CPAP) Wayrachi en comparación con la cánula de alto flujo comercial (CAF) para el tratamiento de pacientes con SARS-CoV-2. Estudio realizado en el Hospital Honorio Delgado Espinoza de Arequipa (Hospital COVID-MINSA Arequipa). Se evaluó a las historias clínicas de pacientes con SARS-CoV-2, de severidad moderada o grave que requerían asistencia respiratoria no invasiva, hospitalizados en el servicio de medicina interna durante la segunda ola de COVID en el Perú. Se realizó un análisis de supervivencia considerando los días a la muerte comparando al Wayrachi con la CAF. Se exploró el efecto de las variables sobre la muerte mediante una regresión de Cox. Resultados: Se evaluaron 114 pacientes tratados con Wayrachi (56,44 %) y 88 con CAF (43,5 %), observándose una frecuencia de muerte de 34,2 % y 34,1 % respectivamente. Al comparar la frecuencia de muerte, o su sobrevida, en ambos manejos no se observó una diferencia significativa (p=0,986 y p=0,928), esto se mantuvo en el modelo multivariado. El CPAP Wayrachi tuvo resultados similares a los presentados por el equipo CAF comercial lo que lo indica como una opción eficaz para el manejo de pacientes COVID que requieran soporte respiratorio no invasivo.
To evaluate the efficacy of the Wayrachi continuous positive airway pressure (CPAP) non-invasive respiratory support device compared to the commercial high-flow cannula (CAF) for the treatment of patients with SARS-CoV-2. Study carried out at the Honorio Delgado Espinoza Hospital in Arequipa (Hospital COVID-MINSA Arequipa). The medical records of patients with SARS-CoV-2, of moderate or severe severity, who required non-invasive respiratory assistance, hospitalized in the internal medicine service during the 2nd wave of COVID in Peru, were evaluated. A survival analysis was performed considering days to death comparing Wayrachi with CAF. The effect of variables on death was explored using Cox regression. Results: 114 patients treated with Wayrachi (56.44%) and 88 with CAF (43.5%) were evaluated, observing a frequency of death of 34.2% and 34.1%, respectively. When comparing the frequency of death, or its survival, in both managements, no significant difference was observed (p=0.986 and p=0.928), this was maintained in the multivariate model. The Wayrachi CPAP had similar results to those presented by the commercial CAF equipment, which indicates it as an effective option for the management of COVID patients who require non-invasive respiratory support.
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OBJECTIVE@#To improve the electromagnetic compatibility (EMC) quality of medical devices, improve the efficiency of EMC testing, and promote the speed of market approval.@*METHODS@#The unqualified cases of EMC test items of medical devices in recent years were statistically analyzed, and the reasons of low EMC quality of medical devices were analyzed from the perspective of test.@*RESULTS@#Based on the analysis of the reasons, the suggestions were given from the perspectives of medical device manufacturers and testing organizations.@*CONCLUSIONS@#In order to ensure the quality of EMC of medical devices, medical device manufacturers, regulatory authorities and inspection and testing institutions should strengthen the monitoring and evaluation of medical device electromagnetic compatibility, to ensure the safety of products work together to promote the development of the medical device industry healthily and orderly.
Subject(s)
Electromagnetic Phenomena , Industry , Electromagnetic FieldsABSTRACT
Standard drafting is an important part in the process of standard formulation and revision. By analyzing the status of the medical device industry standards drafting, thoughts and suggestions were proposed to further promote all relevant parties to actively participate in the standard drafting, effectively improve the quality of the standards, strengthen the technical support and promote the high-quality development of the industry. The statistical data of the participation of social organizations in the drafting and as the first unit drafting medical devices standards from 2017 to 2021 was researched, and the problems in the drafting of standards at this stage were analyzed. Based on the research and analyses, some thoughts and suggestions were proposed to strengthen the management of standard drafting units and promote the participation of all relevant parties in standard drafting. It is necessary to expand and enhance social participation in standard drafting further by innovating incentives, refining and strengthening normative requirements, and creating a positive social atmosphere.
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Reference Standards , China , IndustryABSTRACT
Animal study plays a key role to evaluate the safety and effectivity of medical devices. This study aims to share evaluated consideration on the role, general principles, necessity, study design and quality management system of animal study, in order to improve the quality of animal study and reduce unnecessary study.
Subject(s)
Animals , Equipment and Supplies , Models, AnimalABSTRACT
This study overviewed equivalence demonstration, the principles for the selection of comparative devices, the difficulties in equivalence demonstration, and the equivalence demonstration of special medical devices. In addition, the concept of equivalence demonstration was adopted for the products exempted from clinical evaluation, and there were many confusion in actual use. The operation points and difficult points of equivalence demonstration for the products exempted from clinical evaluation were introduced in order to provide reference for medical device colleagues.
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On October 21, 2021, the National Medical Products Administration issued and implemented the Self-examination Management Regulations for Medical Device Registration. The regulations clarify the specific requirements of the registration applicants in the process of self-examination, and put forward detailed requirements from the aspects of self-examination ability, self-examination report, declaration materials and responsibility requirements, so as to ensure the orderly development of the self-examination of medical device registration. Based on the actual verification work of in vitro diagnostic reagent, this study briefly discussed the understanding of the relevant contents of the regulations, aiming to provide some reference for enterprises and related supervision departments that have the requirement of registered self-examination.
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Medical Device Legislation , Reagent Kits, Diagnostic/standardsABSTRACT
From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.
Subject(s)
Needles , Endoscopy , Injections , Risk Management , IndustryABSTRACT
This study briefly introduces the revised content of Guidance for Registration of Metallic Bone Plate Internal Fixation System (Revised in 2021) compared to the original guidance, mainly including the principles of dividing registration unit, main performance indicators of standard specification, physical and mechanical performance research, and clinical evaluation. At the same time, in order to provide some references for the registration of metallic bone plate internal fixation system, this study analyzes the main concerns in the review process of these products based on the accumulation of experience combining with the current review requirements.
Subject(s)
Bone Plates , Fracture Fixation, Internal , Biomechanical PhenomenaABSTRACT
Authenticity verification is a very important aspect of medical device registration quality management system verification of medical device. How to verify the authenticity of samples is a problem worth discussing. This study analyzes the methods of authenticity verification from the aspects of product retention sample, registration inspection report, traceability of records, hardware facilities and equipment. In order to provide reference for relevant supervisors and inspectors in the verification of registration quality management system.
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Blood compatibility is the main restriction of blood-contacting medical devices in clinical application, especially long-term blood-contacting medical devices will stimulate the immune defense mechanism of the host, resulting in thrombosis. Heparin anticoagulant coating links heparin molecules to the surface of medical device product materials, improves the compatibility between the material surface interface and the body, and reduces the host immune defense reactions. This study reviews the structure and biological properties of heparin, the market application status of heparin-coated medical products, the insufficiency and improvement of heparin coating, which can provide a reference for the application research of blood contact medical devices.
Subject(s)
Humans , Heparin/chemistry , Anticoagulants/chemistry , Thrombosis , Coated Materials, Biocompatible/chemistry , Surface PropertiesABSTRACT
This study briefly introduces the tongue diagnostic equipment of traditional Chinese medicine. It analyzes and discusses the key points of technical evaluation of tongue diagnostic equipment from the aspects of product name, performance parameters, image processing functions, product use methods, clinical evaluation, etc. It analyzes the safety risks and effectiveness indicators of tongue diagnostic equipment, hoping to bring some help to the gradual standardization of tongue diagnostic equipment and the registration of enterprises.
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Medicine, Chinese Traditional/methods , Tongue , Image Processing, Computer-Assisted , Diagnostic Equipment , Reference StandardsABSTRACT
Based on the current situation of approval and publicity of class II innovative medical devices in various provinces and cities, especially after analyzing the problems found in the review of class II innovative medical devices in Shanghai and the factors affecting the listing process of innovative medical devices, this study puts forward some thoughts on supervision for reference in establishing and perfecting systems and regulations, changing the review and approval thinking, extending services to the development of innovative medical devices and the formulation of clinical trial schemes.
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Device Approval , China , Equipment and SuppliesABSTRACT
Due to the rapid development of new medical devices and the national policy adjustment of medical device review and approval, the difficulty of clinical trial institution and ethics committee in the risk assessment of medical device clinical trials has greatly increased. By sorting out the legal norms, standards and safety evaluation materials of medical devices, this paper systematically summarized and suggested the existing risks in clinical trials of medical devices from seven aspects, including the collection and utilization of biological sample, site environment safety, information security, product production and inspection, use of device, clinical trial design, and technical capabilities, with a view to providing a reference basis for the sponsors, clinical trial institutions, and ethics committees to scientifically establish a risk assessment system for medical devices before clinical trials, thereby reducing potential risks of compliance and safety during the clinical trial process.
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Guaranteeing the rights and safety of subjects is an important responsibility of all participants in the medical devices clinical trial, including medical institutions, sponsors and researchers. The legal disputes caused by serious adverse events in the clinical trial of medical devices are characterized by complex legal relationships, great difficulty in handling, and many points of dispute. Based on a typical case of medical device clinical trials, this paper discussed the litigation subject qualification, the treatment of contract breach and tort in medical device clinical trial, analyzed the responsibility of different subjects, and provided constructive suggestions on the risk management of medical device clinical trial.
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By sorting out the research of new generation of artificial intelligence (AI) independent software reviewed by medical ethic committee of a grade A tertiary hospital in Beijing from January 2017 to November 2021, this paper analyzed and summarized the common problems involved in multiple dimensions, such as the integrity of the protocol design, protection of the rights and interests of the subjects, the data using and storing, and proposed that ethic committee should pay special attention to the protocol integrity, data security, risk assessment, track review, and other aspects different from conventional clinical research, thus providing a idea for ethical review of new generation AI independent software research.
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@#With the rapid development of the field of interventional therapy of cardiac valve, the innovative researches of interventional therapy of cardiac valve products have become the focus of global research. At present, there is a serious shortage of interventional valvular medical devices on the market in China, and large-scale interventional valve products are undergoing early human trials or confirmatory clinical trials. The effective quality control of clinical trials is of great significance to ensure that clinical trial data can be used to support the marketing of device products. By analyzing the problems in clinical trials quality control of interventional valvular medical devices in our hospital, and combining the characteristics of device products and diseases, we explore the key points of quality control and provide reference for the implementation and completion of high-quality clinical trials.
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Objective:To explore the factors affecting the management of medical devices in the COVID-19 pandemic, and to provide guidance for the management of medical devices in public health emergencies.Methods:A total of 184 hospitals caring COVID-19 patients in Jiangsu, Zhejiang, Shanghai, Anhui and Shandong were selected, and clinical engineers were randomly sampled. A self-compiled questionnaire was used to conduct an online survey on factors affecting medical device management during the COVID-19 pandemic from August to December 2021.The index system of influencing factors of medical device management during the COVID-19 pandemic was determined through an exploratory factor analysis, and then the structural equation model was used to verify the rationality and scientificity of the index system, while the relative weight method was used to calculate the weight of the index system.Results:277 valid questionnaires were recovered. Through the exploratory factor analysis, an index system of influencing factors of medical device management was established, which consisted of such level-indexes as the human factor, device factor, material factor, method factor, and environment factor, as well as 17 level-2 indexes. The fitness-indexes of the second-order structural equation model were finally fitted as follows: the chi-square to freedom ratio was 2.606, the approximate root mean square error was 0.076, and the value of value-added adaptation index, non-standard adaptation index and comparative adaptation index were 0.921, 0.903 and 0.920, respectively. The weights of the method factor, human factor, device factor, material factor and environment factor of the level-1 indexes were 0.216, 0.191, 0.175, 0.274 and 0.144, respectively. Such factors as manpower, regulations and institutional processes, and information technology ranked top three among the 17 level-2 indexes, which were 0.090, 0.082 and 0.080 respectively.Conclusions:The influencing factor model of medical device management during the COVID-19 pandemic in this study is ideal; human factors and method factors are the influencing factors deserving high priority in medical device management during the COVID-19 pandemic. Ensuring sufficient human resources, improving laws, regulations and processes, as well as enhancing information management level are breakthroughs expected in medical device management.
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Objective:To promote clinical innovation and patent transformation, Ningbo First Hospital built a medical device innovation and transformation management information platform to optimize the supply of clinical innovation and transformation resources and explore a new path of clinical innovation and transformation management.Methods:A series of processes of medical device innovation research, patent declaration, and transformation were managed by the cloud data platform based on Springboot micro-service architecture. The functions and practices of the medical device innovation and transformation management information platform were elaborated on in detail, and the problems in the platform construction were discussed.Results:The medical device innovation and transformation management information platform has been accepted and recognized by clinical care, enterprises, and third-party agents for shortening the research and development and transformation time of innovative projects.Conclusions:The medical device innovation and transformation management information platform can promote the output and achievement transformation of clinical innovative projects.
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Objetivo: Consolidar as informações de aspectos regulatórios, de desenvolvimento e implicações para avaliação dos dispositivos médicos personalizados. Métodos: Foram realizadas buscas nas agências internacionais de avaliação de tecnologias e consulta aos documentos de harmonização sanitária e estudos públicos de análise de impacto regulatório realizados por agências regulatórias de diversos países. Resultados: Ainda não há evidências científicas robustas sobre a eficácia e a segurança de dispositivos impressos em 3D; isso significa que o paciente deve ser suficientemente informado para poder dar consentimento válido. A quantidade e a qualidade atuais das evidências e as características exclusivas dessas tecnologias podem apresentar desafios na realização de avaliações de tecnologias abrangentes. Conclusão: O uso dos dispositivos médicos personalizados impressos em 3D tem grande potencial no setor de saúde, especialmente nos tratamentos de condições específicas de pacientes em que não há tecnologias comercialmente disponíveis, porém o estado da evidência pode ser uma barreira para sua adoção nos serviços de saúde. De forma a viabilizar o intercâmbio de informações e contribuir para a pesquisa colaborativa, a adoção de termo comum nos estudos é imprescindível. A falta de consenso sobre a terminologia pode apresentar desafios para a elaboração de estudos de avaliação de tecnologias que realizam buscas dependentes de estratégias de pesquisa e revisão da literatura, como avaliações econômicas e revisões sistemáticas.
Objective: Consolidate information on regulatory aspects, development and implications for the evaluation of personalized medical devices. Methods: Searches were carried out in international technology assessment agencies, consultation of health harmonization documents, public studies of regulatory impact analysis carried out by regulatory agencies from different countries. Results: There is still no robust scientific evidence on the efficacy and safety of 3D printed devices, which means that the patient must be sufficiently informed to be able to give valid consent. The current quantity and quality of evidence and the unique characteristics of these technologies can present challenges in conducting comprehensive technology assessments. Conclusion: The use of personalized 3D printed medical devices has great potential in the healthcare sector, especially in the treatment of specific patient conditions where there are no commercially available technologies, but the state of evidence can be a barrier to their adoption in healthcare services. In order to facilitate the exchange of information and contribute to collaborative research, the adoption of a common term in the studies is imperative. The lack of consensus on terminology can present challenges for the development of technology assessment studies that perform searches dependent on research strategies and literature review, such as economic evaluations and systematic reviews.
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Technology Assessment, Biomedical , Equipment and Supplies , Access to Essential Medicines and Health Technologies , Health Economic-Industrial ComplexABSTRACT
El desarrollo de vacunas contra la COVID-19 ha constituido una de las principales prioridades de la comunidad científica global. Hasta la fecha, múltiples vacunas han sido aprobadas para uso por numerosos países y la Organización Mundial de la Salud ha incluido algunas de estas en su programa de listado de uso de emergencia. El presente trabajo ofrece información sobre estos aspectos y analiza el reto colosal que ha representado para el sector regulatorio enfrentarse al creciente desarrollo de vacunas contra la COVID-19, asegurando su calidad, seguridad y eficacia. De igual forma, se abordan los nuevos enfoques en el desarrollo de los ensayos clínicos, o modificaciones en los procedimientos regulatorios existentes, que han sido cuidadosamente adaptados por las agencias reguladoras, sin perder su capacidad de escrutinio y la integridad de la evaluación científico-regulatoria(AU)
The development of anti-COVID-19 vaccines has been one of the main priorities of the global scientific community. To date, multiple vaccines have been approved for use by numerous countries, and the World Health Organization has already included some of these in its emergency use listing program. This paper offers information on these aspects and analyzes the colossal challenge that facing the growing development of vaccines against COVID-19 has represented for the regulatory sector, ensuring their quality, safety and efficacy. Similarly, new approaches in the development of clinical trials are addressed, or modifications in existing regulatory procedures that have been carefully adapted by regulatory agencies, without losing their scrutiny capacity and the integrity of the scientific-regulatory evaluation(AU)