中国医疗器械杂志最新文献

The treatment of bone defects caused by fractures or bone tissue lesions has always been a difficult problem in the field of orthopedics. Implantation of high-performance titanium alloy prosthesis is an effective method to treat bone defects. 3D printing technology can produce low-modulus titanium alloy implants with porous structures, providing a better solution to the above problems. This technology is convenient to design and has a huge advantage in making orthopedic implants. The article used electron beam melting in 3D printing technology to create two samples of Ti-6Al-4V prosthesis, including solid structural pelvic prosthesis and porous structural pelvic prosthesis. The mechanical properties of the prosthesis showed that the yield and tensile strengths of the rod tensile specimen were 894 MPa and 956 MPa, respectively, and the compressive modulus and compressive strength of the porous pelvic prosthesis were 55 GPa and 65.2 MPa, respectively. The results of the L929 cytotoxicity assay and the MC3T3-E1 cell adhesion assay demonstrated good biocompatibility of the prosthetic samples. New Zealand white rabbits were used to prepare the femoral joint cavity defect models and two pelvic prostheses were implanted. A microscopic CT scan 4 weeks after implantation showed that the bone defect caused by the drill had healed and that the porous structure of the pelvic prosthesis formed a new trabecular structure within the hole. In conclusion, the 3D printed Ti-6Al-4V pelvic prosthesis has excellent mechanical properties, biocompatibility, and the ability to promote new bone growth.

Pulse rate and blood oxygen levels are crucial physiological parameters that reflect physiological and pathological information within the human body. The system designs a wireless pulse wave monitoring system utilizing a flexible reflective probe and the AFE4490, which is capable of monitoring pulse wave and blood oxygen levels on the human forehead. The system is predominantly based on a reflective flexible probe, the AFE4490, a power supply module, a control microcontroller unit (MCU), and a Wi-Fi module. Post-processing by a slave computer, the collected pulse wave data is wirelessly transmitted to a smartphone. The real-time pulse waveform, pulse rate, and blood oxygen levels are displayed on an application. Following relevant tests and verifications, the system can accurately detect pulse wave signals, meet the requirements for wearable technology, and possesses significant market application potential.

Polyetheretherketone (PEEK) has emerged as a thermoplastic material of choice in the realm of implantable medical devices, owing to its high biocompatibility and exceptional mechanical strength. Despite its promise for custom-made medical devices, 3D-printed PEEK in orthopedics, trauma, and spinal implants has not yet achieved widespread application. This study outlines the properties of PEEK, 3D-printed PEEK-based composites, and their utilization in implantable medical devices, thereby fostering the development and regulation of next-generation medical devices.

The pre-research of medical device standards is of great significance for the enactment and amendment of standards. This study discusses four aspects and explores how to promote more scientific and reasonable pre-research. Based on the pre-research practice of medical device standards project, this study puts forward relevant work ideas and suggestions.

As an important part of the Big Health Industry, in vitro diagnostic(IVD) reagents play a vital role in the prevention, diagnosis and treatment of diseases. In recent years, especially after the novel coronavirus infection, IVD industry has developed rapidly in China, but it still cannot meet the needs of clinical use. By conducting desk research, expert interview, manufacturer survey and hospital survey, this study analyzed the development status of IVD industry in Shanghai, summarized the problems encountered in the high-quality development from the aspects of raw materials, innovation ability, and clinical trials, etc., and proposed recommendations for promoting the high-quality innovation and development of IVD industry in Shanghai.

Objective: To design and test a device which is capable of accurately measuring and dynamically adjusting the axial pressure at the fracture end in real-time.

Methods: Upon completion of the design, the pressure measurement and adjustment device was implemented in a canine tibial fracture external fixation model. A pressure sensor was mounted at the fracture end, and the displayed values of the pressure sensor were used as the standard for comparison. The relationship between the displayed values of the measurement and adjustment device and the pressure sensor under identical conditions was examined.

Results: The device was utilized in external fixation models of tibial fractures in five beagles. A linear correlation was observed between the displayed values of the device and the pressure sensor at the fracture end. The measurement values from the device could be transformed into fracture end pressure through the application of coefficients, thereby facilitating accurate measurement and dynamic adjustment of the fracture end pressure.

Conclusion: The pressure measurement and adjustment device at the fracture end is easy to operate, enabling precise measurement and dynamic regulation of the pressure at the fracture end. It is well-suited for animal experiments aimed at investigating the impact of axial compression on fracture healing, demonstrating promising potential for experimental applications.

Objective: This study analyzes the risk points in the quality control of bioink and the main processes of bioprinting, clarifies and explores the quality control and supervision model for bioprinting medical devices, and provides theoretical and practical guidance to ensure the safety and effectiveness of bioprinting medical devices.

Methods: The quality control risk points throughout the bioprinting process were comprehensively analyzed, with a particular focus on bioprinting materials and key processes. The regulatory model and methods for bioprinting medical devices were examined. This research concentrated on critical technologies such as extrusion, laser-assisted, and in situ bioprinting, assessing their potential for clinical applications and regulatory challenges.

Results: Bioink from different sources should meet regulatory requirements. It is essential to ensure aseptic handling of raw materials and to validate sterilization under "worst-case" conditions.

Conclusion: As bioprinting technology advances rapidly, corresponding research into materials, processes, and quality risk control should be conducted to ensure the concurrent development of the regulatory system. This will continuously contribute to the orderly progression of the entire industry and human health.

Objective: To achieve high throughput and high detection rate of circulating tumor cells (CTCs) in human peripheral blood, and to provide efficient and accurate early screening for cancer patients.

Methods: A microfluidic chip with the integration of sorting, enrichment and detection was designed, and CTCs at the single cell level were detected by fluorescence detection system to obtain the number of CTCs in samples.

Results: The peripheral blood samples after lysed red blood cells were used for 6 experiments. When the injection rate reached 0.2 mL/h, CTCs could reach the best detection rate of 78.6%, and the correlation coefficient within the group was above 0.8.

Conclusion: CTCs detection system can achieve high detection rate and has good reliability, which can provide a reliable reference for clinical research in related fields.

With the encouragement of policies and the rapid development of the biopharmaceutical industry, the number of software as medical device (SaMD) registration applications in Shanghai has continued to increase in recent years, and this paper summarizes the GMP nonconformities found in the field inspection of SaMD in Shanghai from 2020 to 2023, and the results show that nearly 70% of the problems were found in the software development process. Through in-depth analysis, this paper proposes the corresponding countermeasures for the problems found in the five most common stages such as software requirements, software design, software testing, software defect management and software configuration management, combined with the characteristics of software development. These suggested measures have certain reference significance for medical device software development and quality control personnel, and technical reviewer and inspectors.

Objective: To select high-quality and cost-effective dural (spinal) membrane repair materials, in order to reduce the cost of consumables procurement, save medical insurance funds, and optimize hospital operation and management.

Methods: Taking the BS06B disease group (spinal cord and spinal canal surgery without extremely severe or severe complications and comorbidities, mainly diagnosed as congenital tethered cord syndrome) as an example, a retrospective analysis was conducted on the relevant data of surgical treatment for congenital tethered cord syndrome conducted in our hospital from January 2021 to June 2023. Safety and efficacy indicators in clinical application (incidence of postoperative epidural hemorrhage, incidence of postoperative purulent cerebrospinal meningitis, incidence of cerebrospinal fluid leakage, surgical duration, and postoperative hospital stay) were compared.

Results: There was no difference in safety and effectiveness between different brands of dura mater repair materials.

Conclusion: For the repair of small incisions in dura mater surgery, high-quality and cost-effective dura mater repair materials can be selected to reduce hospital costs and control expenses for the disease group.