Interpretation and reflection on the Measures for the Administration of Standards for Medicinal Products / 中国药房

In July 2023， the National Medical Products Administration issued the Measures for the Administration of Standards for Medicinal Products （hereinafter referred to as the Measures）. This article interprets the main content of the Measures， and analyzes its shortcomings as unclear definition of the drug standard code and the goals of drug standard information construction. It is recommended that the national drug regulatory department promptly apply to the standardization authority for the confirmation of the drug standard code “YB” letter， and the drug standard code and numbering rules would be included in the next round of amendments to the Measures. It is necessary to clarify the construction goals of the information system for drug standards at the same time， and build a national drug standard data-sharing platform based on the basic framework of user interface layer， computing processing layer， and data storage layer. Digital drug standards will be free， and access and download services for the public will be provided.

Registros de enfermagem referentes à inserção de cateteres nasogástricos e nasoenterais: não conformidades e sub-registro / Nursing records regarding the insertion of nasogastric and nasoenteral catheters: nonconformities and sub-recording / Registros de enfermería respecto a la inserción de sondas nasogástricas y nasoenterales: no conformidades y subregistros

Objetivo: O registro dos dados referentes a Terapia Nutricional Enteral (TNE) é importante para assegurar o procedimento e comunicação sistemática da assistência. Com o estudo, objetivou-se analisar os registros de enfermagem referentes à inserção de cateteres nasogástricos (CNG) e nasoenterais (CNE) considerando o sub-registro e não conformidades encontradas em prontuários e durante observação dos pacientes. Métodos: estudo observacional, transversal com abordagem quantitativa, mediante a aplicação de instrumento para coleta de dados de pacientes internados em um Hospital Universitário no Pará entre agosto de 2019 a julho de 2020. Resultados: Foram identificadas 191 inserções de cateteres por enfermeiros, sendo 43 (22,52%) reinserções sub-registradas e 148 (77,48%) apresentaram não conformidades. Discussão: O sub-registro e as não conformidades interferem na qualidade da assistência de enfermagem, fragilizam as ações de segurança do paciente, além de apresentarem repercussões legais. Conclusão: Os dados apresentados neste artigo foram primordiais para a detecção de lacunas na assistência de enfermagem. (AU)

Objective: The recording of data referring to Enteral Nutrition Therapy (ENT) is important to ensure the procedure and systematic communication of care. The objective was to analyze the nursing records regarding the insertion of nasogastric (CNG) and nasoenteral (CNE) catheters, considering the under-recording and non-conformities found in medical records and during patient observation. Methods: observational, cross-sectional study with a quantitative approach, through the application of an instrument to collect data from patients admitted to a University Hospital in Pará between August 2019 and July 2020. Results: 191 insertions of catheters by nurses were identified, of which 43 (22.52%) underreported reinsertion and 148 (77.48%) presented non-conformities. Discussion: Under-registration and non-compliance interfere with the quality of nursing care, weaken patient safety actions, in addition to having legal repercussions. Conclusion: The data presented in this article were essential for the detection of gaps in nursing care. (AU)

Objetivo: El registro de los datos referentes a la Terapia de Nutrición Enteral (ENT) es importante para garantizar el procedimiento y la comunicación sistemática de los cuidados. El objetivo fue analizar los registros de enfermería con respecto a la inserción de catéteres nasogástricos (GNC) y nasoenterales (CNE), considerando el subregistro y las no conformidades encontradas en los registros médicos y durante la observación de los pacientes. Métodos: estudio observacional, transversal con abordaje cuantitativo, mediante la aplicación de un instrumento para recolectar datos de pacientes internados en un Hospital Universitario de Pará entre agosto de 2019 y julio de 2020. Resultados: fueron identificadas 191 inserciones de catéteres por enfermeros, de de los cuales 43 (22,52%) subreportaron reinserción y 148 (77,48%) presentaron no conformidades. Discusión: El subregistro y el incumplimiento interfieren en la calidad de la atención de enfermería, debilitan las acciones de seguridad del paciente, además de tener repercusiones legales. Conclusión: Los datos presentados en este artículo fueron esenciales para la detección de lagunas en el cuidado de enfermería. (AU)

Epidemiological model for the construction of scenarios of the dissemination of COVID-19 in Codó-MA / Modelo epidemiológico para construção de cenários da disseminação da COVID-19 em Codó-MA / Modelo epidemiológico para la construcción de escenarios de la diseminación del COVID-19 en Codó-MA

Background and objectives: due to the increase in the number of cases of the new coronavirus in the city of Codó-MA, there was a need to carry out a study on the spread of COVID-19 in the municipality in order to have a better knowledge and understanding of the problem. A study was carried out on the spread of COVID-19 in the city of Codó-MA, comparing the quantitative data on the number of cases in 2020 and 2021 between May and July and using the epidemiological model Susceptible-Infectious-Isolated-Recovered (SIQR). Methods: we collected daily data from the epidemiological bulletins made available by the Municipal Health Department of Codó (SEMUS-Codó), we chose the SIQR compartmental model to carry out the simulations, we assumed hypotheses and estimated the parameters in order to design the scenarios. We simulated scenarios such as social distancing of healthy individuals and social isolation of infected individuals. Results: in early 2020, cases increased more frequently than in early 2021, and approximately 20% of those infected were in social isolation. According to projections, more than 80% of cases of COVID-19 were not accounted for in Codó. In 2021, there was greater underreporting than in 2020, approximately 82% and 85%, respectively. Conclusion: from the results, the authors conclude that the social isolation of those infected is a more efficient method to contain an epidemic than the total blockade of the population and that the high number of underreported cases is because most of these cases are asymptomatic.(AU)

Justificativa e objetivos: devido ao aumento do número de casos do novo coronavírus na cidade de Codó-MA, viu-se a necessidade para fazer um estudo sobre a propagação da COVID-19 no município para a ter melhor conhecimento e entendimento do problema. Foi realizado um estudo sobre a disseminação da COVID-19 na cidade de Codó-MA, sendo comparados os dados quantitativos dos números de casos nos anos de 2020 e 2021 entre os meses de maio e julho e utilizando o modelo epidemiológico Suscetíveis-Infecciosos-Isolados-Recuperados (SIQR). Métodos: coletamos os dados diários dos boletins epidemiológicos disponibilizados pela Secretaria Municipal de Saúde de Codó (SEMUS- Codó), escolhemos o modelo compartimental SIQR para a realização das simulações, supomos hipóteses e estimamos os parâmetros para podermos projetar os cenários. Simulamos cenários, tais como distanciamento social dos indivíduos sadios e isolamento social dos indivíduos infectados. Resultados: no início de 2020, os casos aumentaram com mais frequência do que no início de 2021, e aproximadamente 20% dos infectados estavam em isolamento social. De acordo com as projeções, mais de 80% dos casos de COVID-19 não foram contabilizados em Codó. Em 2021, houve maior subnotificação do que em 2020, aproximadamente 82% e 85%, respectivamente. Conclusão: a partir dos resultados, os autores concluem que o isolamento social dos infectados é um método mais eficiente para conter uma epidemia do que o bloqueio total da população e que o alto número de casos subnotificados são porque a maioria desses casos são assintomáticos.(AU)

Antecedentes y objetivos debido al incremento en el número de casos del nuevo coronavirus en la ciudad de Codó-MA, surgió la necesidad de realizar un estudio sobre la propagación del COVID-19 en el municipio con el fin de tener un mejor conocimiento y comprensión de el problema. Se realizó un estudio sobre la propagación del COVID-19 en la ciudad de Codó-MA, comparando datos cuantitativos del número de casos en 2020 y 2021 entre mayo y julio y utilizando el modelo epidemiológico Susceptible-Infeccioso-Aislado-Recuperado (SIQR). Métodos: recolectamos datos diarios de los boletines epidemiológicos que pone a disposición la Secretaría Municipal de Salud de Codó (SEMUS-Codó), elegimos el modelo compartimental SIQR para realizar las simulaciones, asumimos hipótesis y estimamos los parámetros para poder diseñar los escenarios. Simulamos escenarios como el distanciamiento social de personas sanas y el aislamiento social de personas infectadas. Resultados: a principios de 2020, los casos aumentaron con más frecuencia que a principios de 2021, y aproximadamente el 20% de los infectados se encontraban en aislamiento social. Según proyecciones, en Codó no se contabilizaron más del 80% de los casos de COVID-19. En 2021 hubo mayor subregistro que en 2020, aproximadamente 82% y 85%, respectivamente. Conclusión: de los resultados, los autores concluyen que el aislamiento social de los contagiados es un método más eficiente para contener una epidemia que el bloqueo total de la población y que el alto número de casos subregistrados se debe a que la mayoría de estos casos son asintomáticos.(AU)

Long-term trend analysis of liver cancer survival rate in Qidong region, Jiangsu Province, 1972-2019 / 中华肝脏病杂志

Objective: To analyze the incidence and survival rate of liver cancer cases in the entire population in the Qidong region from 1972 to 2019, so as to provide a basis for prognosis evaluation, prevention, and treatment. Methods: The observed survival rate (OSR) and relative survival rate (RSR) of 34 805 cases of liver cancer in the entire Qidong region population from 1972 to 2019 were calculated using Hakulinen's method with SURV3.01 software. Hakulinen's likelihood ratio test was used for statistical analysis. Age-standardized relative survival (ARS) was calculated using the International Cancer Survival Standard. The Joinpoint regression analysis was performed with Joinpoint 4.7.0.0 software to calculate the average annual percentage change (AAPC) of the liver cancer survival rate. Results: 1-ASR increased from 13.80% in 1972-1977 to 50.20% in 2014-2019, while 5-ASR increased from 1.27% in 1972-1977 to 27.64% in 2014-2019. The upward trend of RSR over eight periods was statistically significant (χ (2) = 3045.29, P < 0.001). Among them, male 5-ASR was 0.90%, 1.80%, 2.33%, 4.92%, 5.43%, 7.05%, 10.78%, and 27.78%, and female 5-ASR was 2.33%, 1.51%, 3.35%, 3.92%, 3.84%, 7.18%, 11.45%, and 29.84%, respectively. There was a statistically significant difference in RSR between males and females (χ (2) = 45.68, P < 0.001). The 5-RSR for each age group of 25-34 years old, 35-44 years old, 45-54 years old, 55-64 years old, 65-74 years old, and 75 years old were 4.92%, 5.29%, 8.17%, 11.70%, 11.63%, and 9.60%, respectively. There were statistically significant differences in RSR among different age groups (χ (2) = 501.29, P < 0.001). The AAPC in Qidong region from 1972 to 2019 for 1-ARS, 3-ASR, and 5-ARS were 5.26% (t = 12.35, P < 0.001), 8.10% (t = 15.99, P < 0.001), and 8.96 % (t = 16.06, P < 0.001), respectively. The upward trend was statistically significant in all cases. The AAPC of 5-ARS was 9.82% in males (t = 14.14, P < 0.001), and 8.79% in females (t = 11.48, P < 0.001), and the upward trend was statistically significant in both. The AAPC of 25-34 years old, 35-44 years old, 45-54 years old, 55-64 years old, 65-74 years old, and 75 years old were 5.37% (t = 5.26, P = 0.002), 5.22% (t = 5.66, P = 0.001), 7.20% (t = 6.88, P < 0.001), 10.00% (t = 12.58, P < 0.001), 9.96% (t = 7.34, P < 0.001) and 8.83% (t = 3.51, P = 0.013), and the upward trend was statistically significant. Conclusion: The overall survival rate of registered cases of liver cancer in the Qidong region's entire population has greatly improved, but there is still much room for improvement. Hence, constant attention should be paid to the study on preventing and treating liver cancer.

Non-drug rehabilitation for gait abnormality of Parkinson's disease: a review based on ClinicalTrials.gov / 中国康复理论与实践

ObjectiveTo investigate the current trend of non-drug therapy for gait abnormality of Parkinson's disease. MethodsThe clinical trials about non-drug therapy for gait abnormality of Parkinson's disease were retrieved from the clinical trial registration platform ClinicalTrials.gov, from inception to October 25th, 2022. The records were screened by two researchers independently, and the registration time, registration count, sample sizes, interventions, primary outcome measurements and study design, etc., were summarized and analyzed, according to the PICOS principle. ResultsA total of 218 eligible records were included. The registration count increased in recently years. Almost all of the trials (93.6%) were with a relatively small sample size less than 100, mainly 21 to 30 cases. The major intervention approach was the neuromodulation technique, however, virtual reality and robot-assisted gait training were coming to use in recent years. The primary outcome measurements were the clinical scales, the questionnaires and the exercise examinations. Randomized parallel controlled trials were the most (111, 50.9%). ConclusionThe number of non-drug therapy for gait abnormality of Parkinson's disease increased year by year. The new technologies such as virtual reality and robot-assisted gait training may be used more in the future.

Analysis of the incentive effect of the patent linkage system on the application of generic drugs in China and suggestions for countermeasures / 中国药房

OBJECTIVE To optimize the system of patent linkage system and provide a reference for encouraging generic drugs to apply for listing. METHODS On the basis of literature research， combined with the author’s work experience， the situation of generic drug application and patent challenge were analyzed comparatively after the implementation of the patent linkage system in China. Based on the patent linkage system， the reasons for the insufficient incentive for the challenge of generic drug patents in China were analyzed； corresponding countermeasures and suggestions were proposed. RESULTS & CONCLUSIONS The patent linkage system in China was implemented in 2021， but due to the implementation of the system being still in its initial stage， the relevant documents for practical guidance are not yet complete， and the supporting incentive mechanism is not yet sound， resulting in a weak willingness of generic pharmaceutical enterprises to initiate patent challenges. It is suggested that China can further improve the patent linkage system by improving the patent information registration platform of generic drugs， developing professional drug patent agencies， and establishing the patent common challenges platform of the first generic drug， in order to incentivize Chinese generic drug enterprises to increase innovation motivation， challenge original research drug patents， and apply for listing， achieving the effect of suppressing drug prices and benefiting the people through full competition.

Development status of international transplantation pregnancy registration and its enlightenment for China / 中华器官移植杂志

With the continuous improvements of survival rate and quality-of-life for organ transplant recipients, the issue of pregnancy in organ transplant recipients is receiving greater attention from transplant specialists and obstetricians.Currently there are three major global registries related to transplant pregnancy, namely The United Kingdom Obstetric Surveillance System (UKOSS), The Australian and New Zealand Dialysis and Transplant Registry (ANZDATA) and The International Transplant Pregnancy Registry International (TPRI). Among them, TPRI is the most comprehensive and longest running system with a focus on the impact of pregnancy on transplant recipients and the impact of immunosuppressants on fertility and pregnancy outcomes.As the second largest organ transplant country in the world, China also has high expectations for pregnancy and fertility among transplant recipients.Therefore it is imperative to establish a pregnancy and childbirth registration office for organ transplantation in China, standardize the recording of relevant population data and conduct researches for formulating scientific guidance, providing reliable medical consultations and services for patients with pregnancy needs after organ transplantation in China.

Research progress and future prospect of hernia and abdominal wall surgery in China / 中华消化外科杂志

In recent years, due to the increasing population of ageing and obesity, the incidence rate of hernia is increasing year by year, which has become a social problem that needs to be focused. Although starting late, the hernia and abdominal wall surgery has developed rapidly in recent years in China, and many remarkable achievements have been made. The development of hernia and abdominal wall surgery is inseparable from the progress of medical technology, the continuous innovation of materials, the improvement of perioperative management concept and the improvement of registration and follow-up system. The authors investigate the relevant research at home and abroad in recent years, and summarize and prospect the materials science, the daytime surgery and the registration and follow-up system, in order to provide reference for the future development of hernia and abdominal wall surgery.

Analysis of Taijiquan-related clinical trial registration characteristics and reporting quality / 国际中医中药杂志

Objective:To analyze the registration characteristics and reporting quality of Taijiquan-related clinical trials.Methods:A database search of the China Clinical Trials Registry (ChiCTR) and ClinicalTrials.gov was performed by computer to collect basic information, study content, interventions, and other registration information of Taijiquan-related clinical trials from inception to June 30, 2022. The WHO TRDS was used to evaluate the registration quality of clinical trials.Results:Totally 381 Taijiquan-related clinical trials were incorporated, of which 241 (63.25%) were prospective registration and 140 (36.75%) were retrospective registration. The quantity of Taijiquan-related clinical trial registrations generally showed an increasing trend, reaching a peak in 2020 (14.70%). The number of clinical trials registered in Shanghai accounted for the most (9.97%). The largest contributor to the registered trials was Fujian University of Traditional Chinese Medicine (4.46%). 55.12% of registered studies were funded by hospitals and universities. The registered studies were most focused on cognitive impairment. 74.54% of the studies adopted randomized parallel controls, and the sample size was mainly between 20 and 200 (80.31%), and the age of the subjects was concentrated above 39 years (53.28%). The average report completion rate of WHO TRDS items was 86.90%.Conclusions:Presently, the development trend of clinical trials related to Taijiquan is relatively promising. However, imbalances exist in some aspects, for instance distribution of registration areas and institutions, funding allocation, and population of subjects. The description of some registration items is missing or not comprehensive, so corresponding measures are required to improve the quality of clinical trial design and to optimize registration details.

Study on African herbal medicine registration management measures and TCM registration strategy in Africa / 国际中医中药杂志

African herbal medicine is widely utilized with a long history. Most African countries have legalized herbal medicine and established a registration and listing mechanism. The present study firstly described the historical exchange and modern trade of TCM between China and Africa, and briefly described the herbal medicine registration management system of African countries from the regulations and guidelines of herbal medicine management and registration management institutions. Then it compared and analyzed the differences of registration systems in African countries from the following aspects: application materials, registration path, quality control and production, effectiveness evidence and food supplements, as well as summarizing the common points of African herbal medicine registration management. The registration strategy of TCM includes assessing the risk of registered investment, building a multilateral and diversified cooperation network between China and Africa, adhering to integrity and innovation, and promoting the international development of TCM, so as to form a standardized registration path of TCM in Africa and expand the TCM market in Africa.

Textual research on ancient and modern literature and analysis on research hot spots of classical prescription Shenling baizhu powder / 中国药房

OBJECTIVE To provide reference for the clinical application and further research and development of Shenling baizhu powder. METHODS Using the methods of textual research and bibliometrics， the key information such as the composition， dose， processing and usage of Shenling baizhu powder in ancient and modern literature were systematically summarized and sorted out， and the number of publications， keywords， and other contents of modern literature were visually analyzed. RESULTS & CONCLUSIONS Shenling baizhu powder was first collected in Taiping Huimin Hejiju Fang （abbreviated “Jufang”）， the composition of core drugs and most widely used dose ratio in previous generations were the same as those in Jufang， basically focusing on powder making and being taken after mixed with liquid； the dosage was concentrated on 2-3 qian； the function and application of it had been expanded to a certain extent compared with Jufang； its clinical application had gradually extended from internal medicine to surgery， gynecology， pediatrics， ophthalmology， dermatology， etc.， covering all aspects of the disease caused by spleen deficiency in general； the composition mechanism revolved around “strengthening the spleen， replenishing qi and removing dampness”； the recommended prescription drugs were all selected from the corresponding varieties in the pharmacopoeia. Modern research mainly focuses on clinical practice， with traditional Chinese medicine or traditional Chinese and Western medicine combined with this formula as the main modified treatment for various intestinal diseases， diarrhea diseases， and lung diseases. The efficacy and application are the frontier hot spots today， and the mechanism of action has begun to be explored. The usage in the literature and the inclusion in the pharmacopoeia are inconsistent， and further research is needed.

Implementation of points-based household registration policy for voluntary blood donors in Nanjing / 中国输血杂志

【Objective】 To analyze the implementation effect of points-based household registration policy for blood donors in Nanjing, so as to provide reference for other provinces and cities to develop incentive policies for blood donation. 【Methods】 The basic demographic profile, registration situation and deferral reasons of blood donors who applied for points-based household registration from 2017 to 2021 were analyzed by Excel. 【Results】 1) A total of 388 blood donors applied for points-based household registration for blood donation from 2017 to 2021, accounting for 0.042% of the total blood donors in Nanjing (388/923 160), and 357 applications were approved, accounting for 0.039% (357/923 160). 2) The proportion of male applicants was higher than that of female applicants (55.15% vs 44.85%). Applicants aged 26~35 accounted for the largest, followed by applicants aged 36~45, and applicants aged 18~25 accounted for the least. The proportion of applicants in Jiangsu province(23.27%) was higher than that of applicants from other provinces. The top three occupations were employees, workers and jobless. In terms of education level, applicants with junior high school education or below accounted for the largest, followed by high school and secondary school (35.05% vs 29.38% vs 23.20%). The proportion of first-time blood donors was the highest (33.24%). Among the repeated blood donors, blood donors who donated blood 2~3 times were with the highest share (23.93%). Nineteen donors(4.90%) got more than 100 points. 3) A total of 31 blood donors were deferred from 2017 to 2021, accounting for 7.90% of the total applicants. Among them, 23 applicants donated in other cities than Nanjing, 5 applicants failed to provide valid blood donation certificates, and 3 applicants submitted irrelevant material. 【Conclusion】 The implementation of points-based household registration policy for voluntary blood donors in Nanjing helped blood donors who could not reach other points due to low education level and income to become registered permanent residence in Nanjing

Effects of X-ray volume imaging registration methods on position verification for radiotherapy in treatment of middle/lower-segment esophageal cancer / 中国辐射卫生

@#<b>Objective</b> To compare the set up errors derived from different registration methods of the X-ray volume imaging (XVI) system for radiotherapy in the treatment of middle/lower-segment esophageal cancer, and to provide a reference for radiation treatment of esophageal cancer. <b>Methods</b> We randomly selected 63 patients with middle/lower-segment esophageal cancer, and obtained their reconstructed XVI images at the first therapy to perform automatic registration with gray-value and bone registration methods. We acquired and compared the three translation errors (along <i>x</i> [left to right], <i>y</i> [head to feet], and <i>z</i> [front to back] axes) and three rotation errors (around the <i>x</i>, <i>y</i>, and <i>z</i> axes) derived from the two registration methods. <b>Results</b> Gray-value registration had significantly smaller translation errors along the <i>x</i> and <i>z</i> axes than bone registration (<i>x</i> azes <i>t</i> = −2.78, <i>z</i> azes <i>t</i> = −2.15, <i>P</i> < 0.05), but there was no significant difference along the <i>y</i> axes (<i>P</i> > 0.05). The rotation errors around the three axes were all smaller than 1°, and were smaller with gray-value registration than with bone registration, but without significant differences (<i>P</i> > 0.05). <b>Conclusion</b> We recommend gray-value registration for radiotherapy in the treatment of middle/lower-segment esophageal cancer. Manual verification or fine-tuning is recommended after automatic registration in clinical practice. Besides translation errors, rotation errors should also be paid attention to.

A Brief Discussion on the in Vitro Diagnostic Reagent Inspection Practice of Self-examination Management Regulations for Medical Device Registration / 中国医疗器械杂志

On October 21, 2021, the National Medical Products Administration issued and implemented the Self-examination Management Regulations for Medical Device Registration. The regulations clarify the specific requirements of the registration applicants in the process of self-examination, and put forward detailed requirements from the aspects of self-examination ability, self-examination report, declaration materials and responsibility requirements, so as to ensure the orderly development of the self-examination of medical device registration. Based on the actual verification work of in vitro diagnostic reagent, this study briefly discussed the understanding of the relevant contents of the regulations, aiming to provide some reference for enterprises and related supervision departments that have the requirement of registered self-examination.

Discussion on Key Control Points and Common Problems of Molecular Diagnostic Reagents in the Process of Design and Development / 中国医疗器械杂志

Design and development process of molecular diagnostic reagents is critical to quality management system of in vitro diagnostic reagent. Based on the technical characteristics of molecular diagnostic reagents, the study analyzed the concerned key control points and common problems in the process of design and development from the view of registration quality management system. It aimed at offering technical guidance on design and development process of molecular reagents and registration quality management system to enterprises, thus improving the product development efficiency, optimizing the quality management system, and increasing the efficiency and quality of registration and declaration.

Concerns of Technical Evaluation on Registration of Disposable Endoscopic Injection Needle / 中国医疗器械杂志

From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.

Analysis of Revision Content and Evaluation Attentions on Guidance for Registration of Metallic Bone Plate Internal Fixation System (Revised in 2021) / 中国医疗器械杂志

This study briefly introduces the revised content of Guidance for Registration of Metallic Bone Plate Internal Fixation System (Revised in 2021) compared to the original guidance, mainly including the principles of dividing registration unit, main performance indicators of standard specification, physical and mechanical performance research, and clinical evaluation. At the same time, in order to provide some references for the registration of metallic bone plate internal fixation system, this study analyzes the main concerns in the review process of these products based on the accumulation of experience combining with the current review requirements.

Discussion on the Authenticity Verification Method in the Verification of Medical Device Registration Quality Management System / 中国医疗器械杂志

Authenticity verification is a very important aspect of medical device registration quality management system verification of medical device. How to verify the authenticity of samples is a problem worth discussing. This study analyzes the methods of authenticity verification from the aspects of product retention sample, registration inspection report, traceability of records, hardware facilities and equipment. In order to provide reference for relevant supervisors and inspectors in the verification of registration quality management system.

Non-rigid registration for medical images based on deformable convolution and multi-scale feature focusing modules / 生物医学工程学杂志

Non-rigid registration plays an important role in medical image analysis. U-Net has been proven to be a hot research topic in medical image analysis and is widely used in medical image registration. However, existing registration models based on U-Net and its variants lack sufficient learning ability when dealing with complex deformations, and do not fully utilize multi-scale contextual information, resulting insufficient registration accuracy. To address this issue, a non-rigid registration algorithm for X-ray images based on deformable convolution and multi-scale feature focusing module was proposed. First, it used residual deformable convolution to replace the standard convolution of the original U-Net to enhance the expression ability of registration network for image geometric deformations. Then, stride convolution was used to replace the pooling operation of the downsampling operation to alleviate feature loss caused by continuous pooling. In addition, a multi-scale feature focusing module was introduced to the bridging layer in the encoding and decoding structure to improve the network model's ability of integrating global contextual information. Theoretical analysis and experimental results both showed that the proposed registration algorithm could focus on multi-scale contextual information, handle medical images with complex deformations, and improve the registration accuracy. It is suitable for non-rigid registration of chest X-ray images.

Multiresolution discrete optimization registration method of ultrasound and magnetic resonance images based on key points / 生物医学工程学杂志

The registration of preoperative magnetic resonance (MR) images and intraoperative ultrasound (US) images is very important in the planning of brain tumor surgery and during surgery. Considering that the two-modality images have different intensity range and resolution, and the US images are degraded by lots of speckle noises, a self-similarity context (SSC) descriptor based on local neighborhood information was adopted to define the similarity measure. The ultrasound images were considered as the reference, the corners were extracted as the key points using three-dimensional differential operators, and the dense displacement sampling discrete optimization algorithm was adopted for registration. The whole registration process was divided into two stages including the affine registration and the elastic registration. In the affine registration stage, the image was decomposed using multi-resolution scheme, and in the elastic registration stage, the displacement vectors of key points were regularized using the minimum convolution and mean field reasoning strategies. The registration experiment was performed on the preoperative MR images and intraoperative US images of 22 patients. The overall error after affine registration was (1.57 ± 0.30) mm, and the average computation time of each pair of images was only 1.36 s; while the overall error after elastic registration was further reduced to (1.40 ± 0.28) mm, and the average registration time was 1.53 s. The experimental results show that the proposed method has prominent registration accuracy and high computational efficiency.