中国医疗器械杂志最新文献

Injectable fillers for plastic surgery are widely used in the field of aesthetic plastic surgery, and their safety and effectiveness are of vital importance. To ensure the safety and effectiveness of the products, it is indispensable to conduct scientific, rigorous, comprehensive and standardized preclinical physicochemical evaluations. According to the raw materials, injectable fillers for plastic surgery can be classified into sodium hyaluronate type, collagen type and polyester type, etc. The evaluation items and indicators for different materials vary. Preclinical physicochemical evaluations not only include general physicochemical project evaluation, such as the content of active ingredients, pH value, osmotic pressure, total heavy metal content, trace elements, etc., but also need to carry out corresponding evaluation items according to the particularity of different materials, such as the crosslinking degree of sodium hyaluronate gel, the collagen content of collagen products and the copolymerization rate of polyester products. This article not only briefly introduces the test methods of some general evaluation items, but also provides detailed introductions to some evaluation items that have no mature methods or have room for improvement in existing methods, aiming to provide references for the research and development and quality control of injectable fillers for plastic surgery, and help improve the safety and effectiveness of injectable fillers for plastic surgery.

Objective From the perspectives of algorithmic transparency and data security to establish a practical and feasible ethical review mechanism for medical artificial intelligence (AI) research, effectively safeguarding the life, health, personal dignity, and legitimate rights and interests of research participants. Methods To sort out the basis for ethical review of medical AI research at home and abroad, analyze the problems and difficulties in relevant ethical review practices, and explore the procedures and key points of ethical review of medical AI research based on practical work. Results It has been clarified that the ethical review of medical AI research needs to strengthen interdisciplinary cooperation, invite experts from multiple fields such as software engineering and computer science to participate in the review work, optimize the process of ethical application and acceptance, standardize the way of ethical review, and develop corresponding review points based on different types of medical AI research, focusing on the evaluation of research risk-benefit ratio and the standardization of informed consent procedures. Conclusion This study proposes a standardized and effective implementation path for ethical review of medical AI research, while adhering to the basic requirements of traditional ethical review and taking into account the particularity of AI technology. The path is highly practicable.

This paper introduces and analyzes the principles and structure inside the high-voltage generator, and for the first time proposes the viewpoint that using an inverter to increase the inverter frequency can enhance the imaging performance of the digital radiography (DR) system. The theoretical basis for using an inverter to increase the inverter frequency to eliminate ripple is analyzed. Considering the characteristics of ripple, a pulse width modulation (PWM) inverter circuit based on insulated gate bipolar transistor (IGBT) is designed to suppress the ripple generated inside the high-voltage generator. For the first time, detective quantum efficiency (DQE) is introduced to quantitatively analyze the DR imaging performance before and after the installation of the inverter, in order to verify whether the addition of the inverter frequency module has improved the imaging performance.

In order to support the demonstration application of domestic innovative medical device magnetocardiography (MCG) in China and promote the systematic display and promotion of clinical diagnosis solutions, this paper designs and constructs a networked, intelligent and standardized information service system of MCG diagnosis technology for coronary microvascular dysfunction. In response to the functional and performance requirements of the system, an efficient and scalable architecture is designed, which is based on the Node.js, supported by the React (frontend) and NestJS (backend) frameworks, and JSON Web Token (JWT) authentication. This architecture enables efficient and convenient data sharing and information exchange among multiple medical institutions. Currently, the system has provided demonstration, promotion, and resource integration of MCG clinical diagnostic solutions for 10 hospitals, with a cumulative collection of 845 case report forms (CRF). It provides technical support for the clinical diagnostic solution of homegrown innovative MCG in coronary microvascular dysfunction from the perspectives of information platform and service.

The digital surgical suction system integrates Intelligent digital technologies, features rapid iterations, and has complex components and high control accuracy requirements, which puts forward higher requirements for product quality control and medical device quality management system certification. This study puts forward the key points for quality management system certification in manufacturing of such products through the analysis of the technical characteristics and product life cycle risk of digital surgical suction system, combined with the requirements of ISO 13485:2016 medical device quality management system for regulations. It has certain reference significance for the quality management of enterprises and the medical device quality management system audit of certification bodies.

Aiming at the challenges of poor sampling accuracy, unstable reagent test results, and excessive carryover contamination in high-speed biochemical analyzers, this study systematically investigated the structural design methodology of sampling needles, using Company A's Project B as a case study. The design focused on precise adjustment of needle core dimensions, the application of variable-diameter structures, and strict control of the inner and outer wall roughness of the needle core. Reynolds number calculations and ANSYS simulations were employed to ensure optimal fluid dynamics and needle strength, resulting in the successful development of a sampling needle structure compatible with high-speed instruments. Roughness measurements were conducted on sampling needles from different manufacturers, followed by tests on small-volume quantification, reagent performance, and carryover contamination. The results were analyzed in depth based on varying roughness levels. The research demonstrates that needle core dimensions and variable-diameter structures significantly influence fluid dynamics during sampling and needle strength. The optimized needle structure notably improves sampling stability and precision, enhances cleaning efficiency, and reduces residual liquid adhesion. Furthermore, the scientific setting of parameters such as inner and outer wall roughness is identified as a critical factor determining the overall performance of biochemical analyzers, including quantification accuracy, reagent test reliability, and carryover contamination levels.

Recombinant collagen has emerged as a core material for medical device innovation due to its programmable molecular structure, excellent biocompatibility, and scalable production capabilities. This article reviews the application value of recombinant collagen in regenerative medicine, tissue engineering, drug delivery, and wound repair. By combining molecular design strategies with innovative preparation processes, the intrinsic relationship between material properties and clinical efficacy is elucidated. The review explores bottlenecks in clinical translation and highlights emerging trends, such as AI-driven design for predicting material performance via machine learning and 3D bioprinting technology for promoting the regeneration of complex organs. These advancements demonstrate the multi-dimensional application potential of recombinant collagen and drive its efficient translation from laboratory research to clinical applications.

Digital therapeutics, as a clinically evidence-based medical intervention driven by software programs, have shown immense potential in the early screening, diagnosis, management, and rehabilitation of cardiovascular diseases. This article firstly succinctly outlines the advantages of digital therapeutics in real-time monitoring, personalized and precise management, improving adherence, and optimizing healthcare resources. And then it systematically analyzes the relevant research findings and clinical application value of digital therapeutics in common cardiovascular diseases. Additionally, it delves into the challenges of evidence-based practices, regulation, and data security, and proposes strategies to address these issues, considering patient experience, medical practice, and ethical and legal concerns. The goal is to further promote the role of digital therapeutics in the treatment of cardiovascular diseases and provide new pathways for constructing an efficient, accessible, and secure digital diagnosis and treatment system.

Canaloplasty is a new and effective method for the treatment of glaucoma. During the procedure, a flexible microcatheter equipped with an optical fiber must be inserted and navigated within the Schlemm's canal. However, due to the difficulty in controlling the direction of the catheter during insertion, the success rate of the surgery depends on the experience and proficiency of the surgeon. This paper proposed a magnetic navigation system based on electromagnets to guide the direction of the catheter and assist the surgeon in smoothly performing the catheter insertion operation. The layout of the system was designed based on the requirements of the operation, and the current of the electromagnet was calculated by the optimization algorithm to achieve the control of the magnetic field. Simulations confirmed that the magnetic field variations during the navigation process were within the feasible solution domain, indicating that the system's solution space could meet the requirements for navigating the magnet along the target path. Finally, experiments were conducted for further validation, demonstrating that the system could achieve positional control of the catheter, guiding the magnet along a predetermined path.

With the widespread application of medical device software in clinical diagnosis and treatment, the accuracy and reliability of graphics measurement functions, which are core modules of medical device software, directly impact the quality of medical decision-making. However, the current lack of standardized testing methods both domestically and internationally has led to inconsistencies in verification approaches and testing protocols. Addressing the standardized testing requirements for graphics measurement functions in medical device software, this study systematically analyzes the common characteristics of these measurement functions. Based on the black-box testing methodology and a digital phantom-based standardized testing framework, it constructs a testing indicator system encompassing functional applicability and accuracy, while designing preparation methods for digital phantoms and traceability validation processes. The standardized testing method developed in this study fills a critical gap in the standardization of testing methods for this domain. It provides quantifiable technical criteria for the regulatory review and quality verification of graphics measurement functions in medical device software. This advancement contributes to enhancing the clinical safety of medical software and ensuring regulatory consistency.