Terapia de fotobiomodulação em lesões por pressão relacionada a dispositivos médicos: relato de caso em lábio de um paciente adulto / Photobiomodulation therapy for medical device-related pressure injuries: a case report of an adult with lip involvement

Lesão por pressão relacionada a dispositivos médicos é uma complicação bastante comum e geralmente oriunda da fixação do dispositivo utilizado na intubação endotraqueal para ventilação mecânica. Desta forma, o presente estudo reportou o caso de um paciente do sexo masculino, 65 anos, leucoderma, internado em uma unidade de terapia intensiva, e que desenvolveu lesão ulcerada na região de fixação do dispositivo utilizado para intubação orotraqueal. Após alívio da pressão local exercida, terapia de fotobiomodulação foi proposta como única estratégia para cicatrização da lesão e diminuição do edema. Após 3 sessões diárias foi possível observar excelente curso de reparação tecidual e remissão dos sinais flogísticos. De acordo com o presente caso, a terapia de fotobiomodulação parece ser bastante eficiente para o tratamento de lesões por pressão relacionada a dispositivos médicos(AU)

Medical device-related pressure injuries are very common complications and usually arise from the fixation of the device used in endotracheal intubation for mechanical ventilation. Thus, the present study reports a case of a Caucasian male patient, 65 years old, who was admitted to an intensive care unit and developed later an ulcerated lesion on the region of fixation of the device used for orotracheal intubation. After relieving the local pressure exerted, photobiomodulation therapy was proposed as the only strategy for wound healing and edema reduction. After 3 daily sessions, it was possible to note an excellent tissue repair course and remission of phlogistic signs. According to the present case, photobiomodulation therapy appears to be a quite efficient treatment strategy for medical device-related pressure injuries(AU)

Dispositivos médicos en tiempos de pandemia: Eficacia de un sistema artesanal de alto flujo en el manejo de pacientes hospitalizados por COVID-19

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.

Discussion on quality control in clinical trials of interventional valvular medical devices / 中国胸心血管外科临床杂志

@#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.

Factors affecting medical device management in COVID-19 pandemic / 中华医院管理杂志

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.

Design and application of an information management platform for medical device innovation and transformation / 中华医学科研管理杂志

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.

Discussion of Application Status and Key Attentions on Registration for Ossicular Replacement Prosthesis / 中国医疗器械杂志

The ossicular replacement prosthesis should have good biocompatibility, stability, easy to install, and excellent sound transmission capacity. In this study, the characteristics of ideal materials for the ossicular replacement prosthesis were analyzed by searching the types of materials used in clinical practice and comparing the advantages and disadvantages of various materials and structures. At the same time, in combination with the current evaluation requirements and evaluation experience, the focus of the performance research project of ossicular replacement prosthesis in the process of registration is discussed to clarify the performance evaluation requirements of these products, so as to provide reference for the future work of manufacturers and regulators. The performance evaluation of ossicular replacement prosthesis focuses on its mechanical properties, fixation stability, sound transmission characteristics, biological characteristics, and magnetic resonance compatibility.

Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation / 中国医疗器械杂志

Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.

Introduction and Reflection on Novel Medical Device Regulatory Science Tool MDDT / 中国医疗器械杂志

In recent years, emerging technology medical devices have developed rapidly. How to more scientifically and more efficiently regulate these novel medical devices so as to improve access to advanced medical technology while ensuring safety and effectiveness is a new challenge faced by regulatory authorities, and is also the core topic of regulatory science. New tools, new standards and new methods are important means to achieve regulatory science. "Medical Device Development Tool" proposed by the U.S. FDA is a novel medical device regulatory science tool, which can help medical device developers to predict and evaluate product performance more efficiently. It is also helpful for regulatory authorities to make regulatory decisions more efficiently. This study introduces the concept, qualification process, role of MDDT in medical device regulation and MDDT examples, and makes some discussion on the device evaluation from the perspective of reliability and validity. MDDT can facilitate the developing of novel medical device.

Introduction and Discussion of IMDRF Personalized Medical Device Regulatory Pathways / 中国医疗器械杂志

OBJECTIVE@#To interpret the key contents of the guidance of Personalized Medical Device Regulatory Pathways issued by the IMDRF, and provide reference for the improvement of China's medical device regulatory system.@*METHODS@#The regulatory requirements of personalized medical devices and point-of-care manufacture of medical device were described respectively, and the feasibility of implementing the regulation of point-of-care manufacture of medical device in China was analyzed.@*RESULTS@#The different regulatory pathways of medical devices produced at point-of-care are feasible and have different regulatory risks.@*CONCLUSIONS@#In combination with the recommendations provided by the IMDRF guidance and the clinical and regulatory realities in China, we should accelerate the improvement of the regulations and supporting documents for point-of-care manufacture of medical device in China.

Reflections on Research and Development Institutions Becoming Medical Device Registrants / 中国医疗器械杂志

As the special subject of the applicant for registration of medical device, the research and development institutions have insufficient conditions and abilities to become medical device registrants, and there are certain difficulties in the actual registration application process, such as not clearing the certification path for the research and development institutions to hold the certificate. In view of the existing problems, by comparing the path of medicine research and development institutions to become medical device registrants and combining with the actual medical device industry to give relevant suggestions, including improving quality management over the whole life cycle of medical devices, quality and safety responsibility ability of research and development institutions, establishing the registration and certification path of research and development institutions, supporting laws and regulations, etc., so as to ensure that the research and development institutions become medical device registrants successfully.

Risk Analysis and Study of Post-marketing Adverse Events for Absorbable Sutures / 中国医疗器械杂志

Objective To investigate, analyze, and evaluate the risk data associated with the clinical use of absorbable sutures by retrieving and summarizing information from the databases of the US FDA and CNKI, as well as the adverse event reports related to absorbable sutures from January 2019 to October 2022 within Zhejiang province. The adverse event reports are obtained from both incident locations and monitoring organizations affiliated with the registrant. The aim is to identify the main risk factors associated with the clinical use of absorbable sutures. The key risk factors are potential product quality defects, product design and material selection, clinical selection and application, and postoperative recovery care including patient's self-care. Risk control strategies are further proposed to reduce or minimize the risk of adverse events caused by this product.

Analysis of Key Points of Technical Review of Traditional Chinese Medicine Fumigation Treatment Device / 中国医疗器械杂志

Traditional Chinese medicine fumigation device is the carrier of traditional Chinese medicine fumigation treatment. In recent years, with the rapid development of new technology and new materials, the development of fumigation device changes with each passing day, and a variety of new products continue to emerge. However, at present, the lack of corresponding evaluation norms, resulting in some difficulties in the registration, marketing, quality control, evaluation scale and other aspects of the product. Some products have many disadvantages in clinical use. From the perspective of technical review, this paper elaborates and analyzes the main concerns in technical review, such as product structure, main risks, performance requirements, clinical evaluation, etc., in order to provide a basis for the design, development, production, registration, use and post-marketing supervision of the devices.

Risk Management Analysis of Medical Device Registration Self-inspection / 中国医疗器械杂志

Through the analysis of laws and policies related to registration self-inspection, visiting and researching enterprises, holding symposiums, and issuing nationwide questionnaires, the risks in the registration self-inspection process were summarized, analyzed, and evaluated. From the aspects of regulatory departments and manufacturing enterprises, we suggest to improve China's medical device registration regulations system and reduce the risks of all parties in the registration self-inspection work.

Development and Research Progress of 3D Printing Technology in Orthopedic Medical Devices / 中国医疗器械杂志

With the characteristics of fast prototyping and personalized manufacturing, 3D-printing (three-dimensional printing) is an emerging technology with promising applications for orthopedic medical devices. It can complete the process of medical devices with complex shape which can not be completed by conventional fabrication process. At present, a variety of orthopedic medical devices manufactured by 3D printing technology, has been approved for marketing, and their use has been proved to be beneficial. 3D bioprinting in this area has also made a few breakthroughs. However, many challenges still remain to be addressed as well. In this study, the research status, as well as the development of the 3D-printing technology in the field of orthopedic medical devices is elaborated.

Research on the Classification Management of Digital Therapeutics Software / 中国医疗器械杂志

According to the current domestic laws and regulations of the medical devices classification management, combined with the characteristics of digital therapeutics products and the existing status of classification management of medical software products in China, and drawing on international classification management experience, this study discusses and analyzes the attribute definition and classification of digital therapeutics software products, with a view to provide reference for the classification management of digital therapeutics software products.

Development Opportunities and Challenges of Digital Therapy in China / 中国医疗器械杂志

With the development of new technologies such as the Internet, big data, and AI, digital therapy has gradually developed into an emerging sector in digital diagnosis and treatment. Even 6 years after the global development of digital therapy, numerous problems that need to be solved have been identified through research and investigation. Through comparative analysis of the current development status of digital therapy both domestically and internationally, this study proposes opportunities for its development in China from both policy and technology perspectives, as well as corresponding challenges from the perspectives of cognition, classification, and quality. In response to these challenges, it proposes prospects and suggestions for the future development of digital therapy.

Research Status and Trend of Devices for Treating Advanced Heart Failure / 中国医学科学院学报

Heart failure (HF),a chronic progressive disease,is a global health problem and the leading cause of deaths in the global population.The pathophysiological abnormalities of HF mainly include abnormal cardiac structure (myocardium and valves),disturbance of electrophysiological activities,and weakened myocardial contractility.In addition to drug therapy and heart transplantation,interventional therapies can be employed for advanced-stage HF,including transcatheter interventions and mechanical circulatory assist devices.This article introduces the devices used for advanced HF that have been marketed or certified as innovative or breakthrough devices around the world and summarizes the research status and prospects the trend in this field.As diversified combinations of HF devices are used for the treatment of advanced HF,considerations regarding individualized HF therapy,risk-benefit evaluation on device design,medical insurance payment,post-market supervision system,and protection of intellectual property rights of high-end technology are needed,which will boost the development of the technology and industry and benefit the patients.

Risk Assessment before Conducting Clinical Trials of Medical Devices / 中国医学伦理学

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.

Analysis on Legal Relationship Based on a Typical Case of Medical Device Clinical Trial / 中国医学伦理学

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.

Focus of Ethical Review on the Research of New Generation Artificial Intelligence Independent Software Based on Deep Learning Algorithm / 中国医学伦理学

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.