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.

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.

Explored the Function of Electromagnetic Compatibility (EMC) of Medical Devices from the Perspective of Test / 中国医疗器械杂志

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.

Analysis and Reflection on Drafting Units of Medical Device Industry Standards in China / 中国医疗器械杂志

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.

Regulatory Consideration for Animal Study of Medical Device / 中国医疗器械杂志

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.

A Brief Analysis of Equivalence Demonstration Techniques for Clinical Evaluation of Medical Devices / 中国医疗器械杂志

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.

A Brief Discussion on the in Vitro Diagnostic Reagent Inspection Practice of Self-examination Management Regulations for Medical Device Registration / 中国医疗器械杂志

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.

Concerns of Technical Evaluation on Registration of Disposable Endoscopic Injection Needle / 中国医疗器械杂志

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.

Analysis of Revision Content and Evaluation Attentions on Guidance for Registration of Metallic Bone Plate Internal Fixation System (Revised in 2021) / 中国医疗器械杂志

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.

Discussion on the Authenticity Verification Method in the Verification of Medical Device Registration Quality Management System / 中国医疗器械杂志

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.

Progress in Application of Heparin Coating in Blood Contact Medical Devices / 中国医疗器械杂志

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.

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.