中国医疗器械杂志最新文献

When applying for registration of an active medical device, it is necessary to submit research and verification data regarding the device's service life. This study primarily proposes how to verify and evaluate the preset service life of active medical devices through reliability testing. Initially, the definition of the product's service life is introduced. Subsequently, the determination of the test sample size, the type and magnitude of the test stress, the conventional test duration, the accelerated test duration, and the evaluation of the service life of the active medical device based on the test results are elucidated. Finally, an example of evaluating the service life of a non-invasive ventilator is provided for further illustration. This study offers a comprehensive closed-loop process for verifying and evaluating the preset service life of active medical devices using the test method, providing a scientific, reasonable, practical, and exhaustive test evaluation approach for enterprises and regulatory agencies. This has broad significance for universal dissemination and aids enterprises and testing institutions in conducting pertinent research and verification tasks.

Brain-computer interface (BCI) devices are crucial tools for neural stimulation and recording, offering broad prospects in the diagnosis and treatment of neurological disorders. Furthermore, magnetic resonance imaging (MRI) is an effective and non-invasive technique for capturing whole-brain signals, providing detailed information on brain structures and activation patterns. Integrating the neural stimulation/recording capabilities of BCI devices with the non-invasive detection function of MRI is considered highly significant for brain function analysis. However, this combination imposes specific requirements on the magnetic and electronic performance of neural interface devices. The interaction between BCI devices and MRI is initially explored. Subsequently, potential safety risks arising from their combination are summarized and organized. Starting from the source of these hazards, such as the metallic electrodes and wires of BCI devices, the issues are analyzed, and current research countermeasures are summarized. In conclusion, the regulatory oversight of BCI's magnetic resonance safety is briefly discussed, and suggestions for enhancing the magnetic resonance compatibility of related BCI devices are proposed.

Objective: To investigate the application of equivalent uniform dose (EUD) in intensity-modulated rotational radiotherapy and to explore optimization methods for improving the quality of modulated treatment plans.

Methods: The impact of the parameter a in the EUD formula on the characteristics of the EUD curve was analyzed using Python. Thirty cases of head and neck tumors, thoracic tumors, and pelvic tumors were randomly selected for treatment planning. Dose optimization for the target area and organs at risk were performed using a physics-based optimization approach or an optimization approach that combines physical constraints with the EUD function. The dose distribution and compliance with constraints of the two groups of plans were compared, while also observing the effect of different values of a on the planning outcomes.

Results: The impact of the value of a on the changes in EUD curve characteristics was consistent with its impact on the results of EUD plan optimization. When -15≤ a≤-5, the dose distribution in the target area was more uniform; when 1≤ a≤7, the effect on the uniform dose and low-dose regions in organs at risk was more noticeable; when 10≤ a≤30, the effect of constraining the high-dose regions in organs at risk was more pronounced, with the EUD for the target area and organs at risk exhibiting different expressions under different a values. The study also found that the target dose distribution and the protection of organs at risk in the EUD optimization group were better than those in the physical optimization group only.

Conclusion: The a-value has a significant impact on the, the dose distribution in the target area and the organ at risk, providing a reference for the setting of a-value while using EUD to optimize the intensity modulation plan. The using of EUD optimization method can not only achieve excellent dose distribution in the target area, but also significantly reduce the normal tissue dose and the probability of complications, which has certain clinical application value.

To improve the level of modern hospital management and establish a scientific and effective medical equipment maintenance guarantee system, this paper proposes the construction of a dynamic interactive fault repair knowledge base system for magnetic resonance imaging (MRI) equipment based on knowledge graph technology. This innovative application of intelligent management for large medical equipment involves collecting and organizing actual maintenance data. The paper constructs the medical equipment maintenance knowledge base, with MRI equipment as a case study, and initially implements functions such as fault information retrieval, technical guidance, and training and learning for MRI equipment. These functions aim to provide an objective decision-making basis for the maintenance and management of large medical equipment, enhance the efficiency of fault repair and maintenance, and elevate the construction level of intelligent hospitals.

The aim of this study is to evaluate the effectiveness of a smart non-invasive blood glucose monitor prototype during pregnancy through clinical validation. The monitor utilizes near-infrared spectroscopy combined with AI big data analysis of photoelectric volumetric pulse wave data to achieve non-invasive monitoring of blood glucose in women during pregnancy. The research team developed a monitor that employs a sensing chip, effectively overcoming the problems of weak signals and individual differences in non-invasive blood glucose monitoring. The user experience is enhanced by visualizing the test results on the accompanying cell phone APP (application) of the smart non-invasive pregnancy blood glucose monitor. Clinical validation revealed that the non-invasive monitoring data for pregnant women aged 20~30 years significantly differed from those obtained via traditional blood glucose measurement methods, whereas no significant difference ( P<0.05) was observed for pregnant women aged 31~42 years. The study concluded that further calibration of the monitor and an expansion of the sample size are necessary to enhance consistency with invasive glucose monitoring results.

Surgical robot is the national strategic diagnostic and therapeutic equipment research focus, get a number of scientific research institutes, colleges and universities and enterprises pay extensive attention to the design and development of a variety of surgical robots, and registration declaration. This article explores the critical technologies of surgical robots and key areas for optimizing their performance, including kinematic positioning errors, pose errors, feedback model errors, image recognition positioning errors, path planning, and safety aspects. The findings not only provide a scientific basis for future standardization research on surgical robots but also offer significant theoretical and practical references for the research, manufacturing, and registration processes in the medical robotics industry.

With the development of the economy and technological progress, more and more animal-derived mesh products are being utilized in the medical field for tissue and organ repair and replacement. Owing to the complexity of their structure and production process, these animal-derived meshes still face several challenges in practical applications, such as insufficient mechanical strength, rapid degradation rates, and the detection of harmful leachable substances. Among these challenges, the production process is a key factor affecting product quality. This paper reviews the key aspects of the production process and quality control for animal-derived meshes in China, offering new insights for the quality control and regulatory oversight of such products.

This study summarizes the clinical application, technical characteristics, and production process of intravascular shockwave catheters. It collects statistics on adverse events of related products from the MAUDE database, analyzes the causes of adverse events and failure modes of intravascular shockwave catheters, and identifies risk points. Based on the whole life cycle management method of medical devices, combined with product risks and the requirements of Good Manufacturing Practice for Medical Devices and related appendices, the critical control points of such products in the design and development, manufacturing, sales, and use stages are discussed.

This paper investigates the mechanism of radio-frequency (RF) heating that occurs when two adjacent orthopedic implants are present together under magnetic resonance imaging (MRI) at 1.5 Tesla and 3.0 Tesla. When a patient has multiple implants close to each other, interactions between the implants may increase RF heating. Typical generic interlocking plate and antibiotic nail implants are adopted as examples. To analyze the effect of adjacent implants, the amplitude and direction of incident and scattering vector electric fields at the hot spot position are calculated and extracted using numerical simulation based on Huygens principle. It is shown that a strong coupling effect occurs due to the existence of both the incident field and a strong scattering field. Huygens principle can be used to obtain the first and second order scattering fields generated between implants. If the first- and second-order electric field terms are summed within a certain region, the RF-induced heating of this dual-implant system increases.

High-voltage pulsed electric field (HV-PEF) ablation technology has demonstrated promising applications in the clinical treatment of chronic obstructive pulmonary disease (COPD). However, its use has been limited to exploratory applications in a small number of cases, and the underlying mechanisms remain largely undefined. To facilitate broader clinical implementation, comprehensive molecular mechanism studies via extensive animal experimentation are essential. Rats, due to their ease of modeling COPD and the availability of comprehensive molecular reagents, serve as an optimal model for such studies. Consequently, the development of electrodes specifically designed for HV-PEF respiratory ablation in SD rats is of significant importance. In this study, we meticulously examined the anatomical structure of rat airways and investigated various equipment parameters, including material composition, rigidity, diameter, electrode ring dimensions, spacing between positive and negative poles, insulation coating for the catheters, welding techniques between the guidewire and electrode ring, and the design of vent holes in the catheter. Based on these considerations, we fabricated PVC ablation electrode catheters with integrated ventilation functionality. Subsequently, we employed finite element simulation to estimate the field strengths that could be applied by these electrodes. The simulation results were then validated in normal rats to assess the electrical safety and efficacy of the electrodes. These findings laid the groundwork for further investigation into the mechanisms of HV-PEF treatment for COPD.