中国医疗器械杂志最新文献

With the continuous advancement of artificial intelligence in the field of prostate cancer research, numerous studies have shown that AI performance can rival that of physicians. This review examines the recent applications and developments of AI in the early, accurate, and non-invasive diagnosis of prostate cancer, subsequently elucidating its importance, benefits, and limitations. The review emphasizes the exploration of the potential integration of AI with multi-omics and other cutting-edge technologies. Considering the current status of AI in prostate cancer diagnosis, the review summarizes the challenges faced in the clinical adoption of AI technologies and looks forward to improved and enhanced AI-based prostate cancer diagnostic techniques. The goal is to offer a reference for the integration of artificial intelligence into clinical practice.

In order to achieve precise risk control of medical devices, it is necessary to establish a scientific evaluation system throughout the entire life cycle of medical devices that focuses on risk identification and risk control. This study summarizes the medical device adverse event monitoring system of the US on regulatory agencies and regulatory law, adverse events reporting forms and time limits, adverse event database, adverse event report analysis and evaluation, as well as adverse event feedback and control. Furthermore, some examples are provided to illustrate the application of the MAUDE database in risk analysis, physical and mechanical performance research, and clinical evaluation of medical device registration and application materials.

To comprehensively assess the true visual function of clinical dry eye patients and the comprehensive impact of blinking characteristics on functional vision of the human eye, an intelligent vision measurement system has been designed and developed to detect and analyze blinks from the side. The system employs deep learning keypoint recognition technology to analyze eyelid features from a lateral perspective. It presents the data of identified key points for the upper and lower eyelids in a line chart format and annotates the trough of each blink. By setting benchmark values, the system automatically calculates the proportion of complete and incomplete blinks in the tested individuals. The results indicate that the system is stable in performance and accurate in measurement, successfully achieving the anticipated design objectives. It thereby provides reliable technical support for future clinical applications.

As the direct microenvironment of assisted reproductive technology, the evaluation of culture medium for human assisted reproduction technology is particularly important. This paper discussed the classification management, technical review points, clinical evaluation and review thinking, focusing on the basic requirements, raw material control, biological evaluation, sterilization process of culture medium for human assisted reproduction technology, combined with some material limit, new added material and quality system control to thoroughly assess management risk of the whole life cycle of culture medium for human assisted reproduction technology.

This paper describes the design of an innovative linear accelerator image-guided radiosurgery (IGRS) device, which is based on a composite twofold rotary gantry structure. The paper discusses five aspects of the innovative device: its overall composition, the safety net space created by the accelerator radiation head as it rotates around the patient's longitudinal axis, the non-coplanar spherical coverage in the direction of the incidence angle for quasi-4π delivery, the structural features of the composite twofold rotary gantry, and the processes of treatment planning and implementation. It elaborates on the device's manufacturing feasibility, safety, effectiveness, accuracy, and efficiency. The conclusion is that this innovative device design holds significant development value and market promotion potential.

The proton therapy system has significant clinical advantages over traditional tumor radiation treatment equipment and is also far more complex in terms of system architecture. However, due to the large size and complexity of these devices, electromagnetic compatibility testing faces considerable challenges. To address these challenges, this paper studies the electromagnetic characteristics and working principles of various components in the proton therapy system, combines them with corresponding standard requirements, and delves into the difficulties and testing methods of electromagnetic compatibility immunity detection through actual repeated tests. Furthermore, the paper proposes testing key points for beam quality tests and provides references for the selection of emission sources and distance settings in radio frequency electromagnetic field radiation immunity testing. The paper also supplements and improves the descriptions of alternative methods in the standards and offers solutions and testing suggestions for issues such as the excessive thickness of cables in the proton therapy system and the lack of suitable fixtures in conducted anti-interference tests. The provision of these solutions offers more effective references for related staff during testing, helps address difficulties encountered in practical operations, and thus more effectively ensures the safety and effectiveness of proton therapy systems.

Depression's high recurrence rate and severe consequences pose significant challenges to public health. To address this issue effectively, this review explores the innovative application of wearable devices in monitoring and intervening in depression, surpassing the limitations of traditional subjective assessments and patient self-reports. The paper systematically analyzes recent studies utilizing wearable devices to monitor physiological and behavioral indicators of depression, categorizing them by different technological types and evaluating their practical effectiveness in early diagnosis and intervention. The findings indicate that wearable devices can continuously monitor physiological indicators and behavioral patterns related to depression, potentially enabling early detection of depressive episodes and supporting timely interventions. Despite challenges such as data privacy and user acceptance, wearable technology holds immense potential in enhancing clinical outcomes in depression treatment.

Integrated PET/MR is one of cutting-edge technologies in functional and molecular imaging. A review of the current development status of integrated PET/MR products can provide inspiration and promote the development of related fields. This study introduced the technical characteristics and research and development difficulties of integrated PET/MR products from both hardware and software aspects, summarized the publication of English and Chinese papers related to the clinical application of PET/MR products from 2008 to 2022, analysed the differences and current status of clinical application of integrated PET/MR products at home and abroad, and pointed out the development status and direction of integrated PET/MR products in China. Finally, the development of integrated PET/MR products was discussed in terms of technology, clinical application prospects, and market strategies.

Objective: To investigate the impact of different infusion media on the flow rate of infusion pumps.

Methods: Ten infusion pumps were randomly selected and tested for infusion rates using deionized water, saline solution, glucose solution, and parenteral nutrition solution. The infusion flow rate was set at 30 mL/h, and the testing methodology conformed to the standards for the calibration and quality control of syringe pumps and infusion pumps.

Results: For infusion set A, the infusion rate was unaffected by the infusion media, remaining within the acceptable quality control standards. For infusion set B, when infused with deionized water, saline solution, and glucose solution, the infusion errors were within the quality control standards. However, when using parenteral nutrition solution as the infusion medium, the infusion error exceeded the acceptable quality control standards.

Conclusion: Both the infusion set and the infusion medium can affect the flow rate of infusion pumps. It is crucial to calibrate the flow rate according to the specific infusion medium to reduce medical risks associated with infusion pumps during clinical use.

Objective: The purpose of this study is to compare the wear properties of UHMWPE acetabular liners after undergoing 3 million (3 Mc) and 5 million (5 Mc) cycles of in-vitro wear testing. The results will serve as a reference for the design of in-vitro testing for hip prostheses and as a control for clinical revision removals.

Methods: Wear tests were conducted on three different sizes of acetabular liners (28 mm, 32 mm, and 36 mm internal diameters) using a hip simulator to determine the amount of wear after 3 and 5 million cycles. The analysis included the number, size, and shape of abrasive particles.

Results: After 3 and 5 million cycles of wear, the amount of wear on the acetabular liner increased as the inner diameter increased. The abrasive particles had an average equivalent circular area diameter (ECD) of 0.27 μm and 0.29 μm, and 94.4% and 90.1% of the aspect ratio (AR) less than 4.

Conclusion: The amount of wear on the acetabular liner after 3 Mc wear can indicate the wear performance of the product. The number of particles increased and the percentage of fibrous particles was higher after 5 Mc wear compared to 3 Mc wear.