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Sampling inspection by attributes is one of the most popular means for quality control of medical devices, and has widespread application in the process of production and supervision. GB/T 2828 series standards list different types of sampling procedures for inspection by attributes. This study introduced GB/T 2828 series standards and how to design and index the sampling schemes under different scenarios. At the same time, it also provided suggestions on how to balance accuracy and economy, which can provide guidance the application of medical devices manufactures and regulatory departments.As a special kind of in vitro diagnostic devices(IVDs), laboratory developed tests(LDTs) are of great significance to the development of clinical laboratories. This study aims to explore the regulatory requirements ideas of LDTs. By introducing the development of LDTs and the changing of regulatory requirements in the United States, combing the current regulatory framework and discussing relevant ideas in the regulatory requirements of LDTs.The pathological mechanism of wound healing is complicated and affected by multiple factors. Modern wound dressings are widely used in the clinical management of wound healing and have achieved good therapeutic effects. Clinically, wounds are often caused by different etiologies. However, there are few reviews focus on the selection of reasonable dressings for different types of wounds. This study mainly focuses on the characteristics of commonly used wound dressings and summarizes the characteristics of the most commonly used wound dressings in clinical practice and their effects. The advantages and disadvantages of pathology wounds diabetic foot ulcers, pressure injuries, burns, and leg ulcers are reviewed. This study aims to provide references for the development and clinical selection of wound dressings for scientific researchers and first-line nursing staff who are engaged in wound dressings.Magnetic anchoring technology provides a new development opportunity for current minimally invasive surgery. The magnetic anchoring abdominal video system based on this technology can effectively improve the operability and minimally invasiveness of single-port laparoscopic surgery. The development history of magnetically anchored abdominal video system was reviewed, and the design features and deficiencies of various types of magnetically anchored video devices were compared and analyzed. The evolution characteristics of the magnetic anchored video system are explained from minimally invasive and intelligent perspectives, and the challenges and opportunities of magnetic anchored video system are summarized and prospected.At present, heavy ion is an ideal radiation for cancer treatment, and carbon ion is used in the treatment of many kinds of cancer due to its higher relative biological effect value. In 2019, Wuwei heavy ion center built the first medical heavy ion accelerator-carbon ion radiotherapy system in China, and obtained the registration license from the National Medical Products Administration, and officially received cancer patients in March 2020. This study introduced the development and application of the first carbon ion radiotherapy system in China.
To develop a new type of puncture needle for indwelling needle, which can overcome the performance problems of the existing puncture needle, reduce producing cost, and enhance clinical operability.
In this design, solid needle thread is used to replace the traditional hollow pipe thread, three cutting edges are used to replace the existing two cutting edges, and the shaft edge form (the needle tip is on the needle thread's axis) is used to replace the original back blade or edge blade; the slot on the side of the solid core wire is used to replace the hollow and side hole on the traditional pipe. Finally, a new solid core puncture needle is formed by a section of solid core steel wire with a spiral groove, the cross-section of which is a circular slotted needle with a triangular shape at one end. Through the comparative analysis of stiffness mutation and puncture force in the experiment, the characteristics and advantages of new puncture needle are reflected.
The new solid core needle can meet the need of puncture in the course of treatment, and can avoid the potential risk caused by the rigidity mutation of the needle used in the traditional indwelling needle, at the same time, it also has the space to reduce the demand of needle diameter, that means it has the potential to develop smaller needle products.
The new type of trocar puncture needle, from hollow to solid core, can not only meet the basic requirements of puncture and observation of blood return, but also can avoid the risk of traditional puncture needle due to stiffness mutation, the utility model also has the advantages of better performance (less puncture force) and larger expansion space.
The new type of trocar puncture needle, from hollow to solid core, can not only meet the basic requirements of puncture and observation of blood return, but also can avoid the risk of traditional puncture needle due to stiffness mutation, the utility model also has the advantages of better performance (less puncture force) and larger expansion space.The precision of optical positioning system is one of the most important factors which affects the precision of navigation guided surgery. In this study, an efficient and low-cost tool and its algorithm were proposed to evaluate the accuracy of optical positioning system based on the ablation scenario of liver cancer, and two validation experiments were designed. Experimental results show that the tool and its algorithm can evaluate the accuracy of the current positioning system accurately and efficiently.
Develop an intelligent equipment that can perform multiple modes of functional exercise on the knee joint, and can accurately measure and control strength, angle, angular velocity, time, frequency and so on.
Using geared motors, magnetic powder brakes and synchronous belt wheel sets and other mechanical structure and transmission technology combined with sophisticated mechanical design methods, the knee joint multiple functional exercise methods are cleverly integrated; a highly reliable PLC is used as the control core; the resistance torque out-put by the equipment is accurately controlled by adjusting the size of the exciting current; the angle sensor is used to accurately measure the rotation angle around the axis; and the error of each parameter index and the actual measured value is controlled within 5%.
The developed prototype has a compact structure and a simple and convenient method of use. Based on the control of joint parameters such as resistance, the expected goal is achieved.
The equipment can carry out diversified, accurate and automatic rehabilitation treatment for knee joint diseases, and has certain social and economic benefits.
The equipment can carry out diversified, accurate and automatic rehabilitation treatment for knee joint diseases, and has certain social and economic benefits.In view of the high recognition error rate and long scanning time in the existing hospital scanning technology, a new hospital operating room scanning system is designed based on personal digital assistant (PDA). The PDA scanning device adopts PIC16F877A microcontroller of 8 bit for wireless transmission through RFID and bluetooth technology, the code scanning efficiency is greatly improved. In addition, in order to improve the accuracy of image analysis, this study also adopts the energy driven sampling classification algorithm (EDS-CA) to properly preprocess the medical data information received through PDA scanning, then constructs a function classifier, and improves the image processing efficiency according to the EDS-CA reduction process. The experimental results show that the average accuracy of the code scanning system designed in this study is 95%, which proves that PDA code scanning has good performance.
To design a series of geometric indexes, which can improve the correlation between geometric parameters and dosimetric parameters.
48 cases of upper abdomen were selected. Manual and automatic segmentation were performed for two organs at risk, which were stomach and duodenum. Three overlapping structures, which were the overlaps with target expanded by 5 mm, 10 mm and 20 mm, were generated for each organ at risk. The geometric parameters of overlapping structures were calculated. The relationship between these geometric parameters and the dosimetric parameters of organs was investigated.
When the geometric parameters of overlapping structures related to the target expand 5 mm, 10 mm and 20 mm were larger than 0.4, 0.6 and 0.8 respectively, the maximum dose differences of manual and automatic segmentation were less than 3 Gy. For the case with no overlaps between the organs and the target expansions, the overlap structure corresponding to target expanding 20 mm were recommended for safety considerations.
For organs at risk in the upper abdomen, the overlapping geometric parameters were closely related to the maximum dose of organs. Overlapping geometric parameters could predict whether the difference of maximum dose caused by automaticsegmentation was clinically acceptable or not.
For organs at risk in the upper abdomen, the overlapping geometric parameters were closely related to the maximum dose of organs. Overlapping geometric parameters could predict whether the difference of maximum dose caused by automaticsegmentation was clinically acceptable or not.In order to facilitate doctors to better obtain cardiovascular images by using intravascular ultrasound imaging system and make a more accurate diagnosis, a digital coordinate conversion method of intravascular ultrasound imaging system based on CORDIC algorithm is proposed, it converts polar coordinates into rectangular coordinates through angular rotation and orientation calculation. The experimental simulation test is carried out on the platform of intravascular ultrasound imaging system by FPGA. Experimental simulation shows that, CORDIC algorithm can effectively output sine and cosine values, compared with the traditional table finding method, this algorithm has faster speed, stronger real-time performance and needs less hardware resources. It is more suitable for intravascular ultrasound imaging system.
Non-contact continuous blood pressure monitoring is significant in vital sign monitoring. Frequency modulated continuous wave (FMCW) radar is suitable for non-contact wave signal extraction. A heartbeat-guided blood pressure monitoring algorithm using FMCW radar is proposed.
The target heart rate is detected and pulse wave signal is extracted based on FMCW reflected signals. The variational mode decomposition (VMD) is introduced to alleviate the interferences of human breath and slight body movements. The pulse wave signal is extracted based on target heart rate. Blood pressure related features of pure pulse waveform are extracted to obtain blood pressure based on its estimation model.
Experiments are conducted indoor among 15 participants sitting in a nature state. The average accuracy of diastolic blood pressure (DBP) is 94.3% and that of systolic blood pressure is 94.4%.
The experimental results demonstrate the robustness and effectiveness of the proposed algorithm, which makes it possible to further achieve long-term real-time non-contact blood pressure monitoring.
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