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1.
Journal of Geriatric Cardiology ; (12): 577-585, 2023.
Article in English | WPRIM | ID: wpr-1010185

ABSTRACT

OBJECTIVE@#To develop and validate a user-friendly risk score for older mitral regurgitation (MR) patients, referred to as the Elder-MR score.@*METHODS@#The China Senile Valvular Heart Disease (China-DVD) Cohort Study functioned as the development cohort, while the China Valvular Heart Disease (China-VHD) Study was employed for external validation. We included patients aged 60 years and above receiving medical treatment for moderate or severe MR (2274 patients in the development cohort and 1929 patients in the validation cohort). Candidate predictors were chosen using Cox's proportional hazards model and stepwise selection with Akaike's information criterion.@*RESULTS@#Eight predictors were identified: age ≥ 75 years, body mass index < 20 kg/m2, NYHA class III/IV, secondary MR, anemia, estimated glomerular filtration rate < 60 mL/min per 1.73 m2, albumin < 35 g/L, and left ventricular ejection fraction < 60%. The model displayed satisfactory performance in predicting one-year mortality in both the development cohort (C-statistic = 0.73, 95% CI: 0.69-0.77, Brier score = 0.06) and the validation cohort (C-statistic = 0.73, 95% CI: 0.68-0.78, Brier score = 0.06). The Elder-MR score ranges from 0 to 15 points. At a one-year follow-up, each point increase in the Elder-MR score represents a 1.27-fold risk of death (HR = 1.27, 95% CI: 1.21-1.34, P < 0.001) in the development cohort and a 1.24-fold risk of death (HR = 1.24, 95% CI: 1.17-1.30, P < 0.001) in the validation cohort. Compared to EuroSCORE II, the Elder-MR score demonstrated superior predictive accuracy for one-year mortality in the validation cohort (C-statistic = 0.71 vs. 0.70, net reclassification improvement = 0.320, P < 0.01; integrated discrimination improvement = 0.029, P < 0.01).@*CONCLUSIONS@#The Elder-MR score may serve as an effective risk stratification tool to assist clinical decision-making in older MR patients.

2.
China Journal of Orthopaedics and Traumatology ; (12): 1106-1110, 2023.
Article in Chinese | WPRIM | ID: wpr-1009194

ABSTRACT

The correct alignment of the knee joint is considered to be one of the most influential factors in determining the long-term prognosis after total knee arthroplasty(TKA). In order to achieve the correct alignment goal, many different alignment concepts and surgical techniques have been established. For example, mechanical alignment(MA), kinematic alignment(KA) and functional alignment(FA) have their own characteristics. MA focuses on achieving neutral alignment of the limbs, parallel and equal bone gaps during stretching and flexion. KA aims to restore the patient 's natural joint line, make the joint level and angle normal and improve the physiological soft tissue balance, and strive to reproduce the normal knee function;among them, functional alignment(FA) developed with robot-assisted surgery technology is a relatively new alignment concept. It not only considers the alignment of the body, but also aims to achieve flexion and extension balance, while respecting the native soft tissue capsule. It not only restores the plane and slope of the in situ joint line accurately during the operation, but also takes into account the balance of soft tissue, which is a better alignment method. Therefore, it is of great significance to correctly construct the lower limb force line of patients, which is helpful to restore knee joint function, relieve pain symptoms and prolong the service life of prosthesi. However, compared with traditional TKA, the operation time of robot-assisted FA-TKA is prolonged, which means that the probability of postoperative infection will be greater. At present, most studies of FA technology report short-term results, and the long-term efficacy of patients is not clear. Therefore, long-term research results are needed to support the application of this technology. Therefore, the author makes a review on the research status of functional alignment.


Subject(s)
Humans , Arthroplasty, Replacement, Knee/methods , Robotics , Knee Joint/surgery , Osteoarthritis, Knee/surgery , Knee , Knee Prosthesis , Biomechanical Phenomena
3.
Chinese Journal of Medical Instrumentation ; (6): 326-331, 2022.
Article in Chinese | WPRIM | ID: wpr-928914

ABSTRACT

This study is based on the summary of the characteristics of quality variation of national medical device supervision and inspection in 2020. According to the results of the national medical device supervision and inspection through comparative analysis, this study puts forward suggestions on the medical device production and supervision measures for the post-marketing products, so as to further improve the level of the medical device and ensure the safety use of medical device.


Subject(s)
Marketing , Reference Standards
4.
Chinese Journal of Medical Instrumentation ; (6): 459-463, 2022.
Article in Chinese | WPRIM | ID: wpr-939767

ABSTRACT

OBJECTIVE@#This paper puts forward suggestions on the development of in vitro diagnostic reagents and supervision measures for the post-marketing products, so as to further improve the quality of in vitro diagnostic reagents and ensure the safety use of medical device.@*METHODS@#This paper summarizes the quality of in vitro diagnostic reagents and analyzes the causes of the problems, according to the results of the national medical device supervision and inspection in 2020.@*RESULTS@#The overall quality of in vitro diagnostic reagents for national medical device supervision and inspection in 2020 is stable and the unqualified detection rate is 1.6%. However, there are some problems. For example, the management of raw materials is unscientific, the faultiness in the preparation of reference materials, the understanding of standards is unthorough, and the management of instructions is unimportance.@*CONCLUSIONS@#It is suggested that manufacturers of in vitro diagnostic reagents should improve the binding force of the quality management system, strengthen the awareness of risk management, attach importance to communicate with regulatory authorities, study standards sufficiently and strengthen the management of instructions. It is also suggested that the regulatory authorities should strengthen supervision and inspection, and further complete the evaluation guidance and standard publicity and implementation.


Subject(s)
Indicators and Reagents , Marketing , Reference Standards
5.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 241-250, 2021.
Article in Chinese | WPRIM | ID: wpr-906197

ABSTRACT

Osteonecrosis of the femoral head (ONFH) is a serious orthopedic disease caused by many factors. It is difficult to cure clinically and has a poor prognosis, which poses a serious threat to human health. The pathogenesis of this disease is still unclear. The ONFH caused by different causes involves the disorder of a variety of metabolic pathways in vivo. Abnormal proliferation and differentiation of bone mesenchymal stem cells (BMSCs), imbalance of bone metabolism, and increased destruction of bone trabeculae caused by abnormal transduction of bone metabolism-related signaling pathways may be the important causes of ONFH. BMSCs are pluripotent stem cells with self-renewal and multidirectional differentiation ability, which have good regeneration rate. Improving the osteogenic and differentiation ability of BMSCs is the key to inhibit bone absorption and promote bone matrix reconstruction, which plays an important role in bone remodeling. In recent years, there are many studies on the prevention and treatment of ONFH in traditional Chinese medicine(TCM), and it has been found that a variety of single herbs, monomers and compounds can regulate the differentiation direction and process of BMSCs by targeting signal molecules, with great potential for bone defect repair and anti-femoral head necrosis activity. Nowadays, prevention and treatment of ONFH by regulating bone metabolism signaling pathways has become a hot research topic. In this paper, the mechanism and related signal transduction pathways of TCM in preventing and treating ONFH were reviewed to explore some mechanisms of alleviating the rate of bone loss, promoting bone formation, and repairing bone defects, so as to provide reference for further research on the prevention and treatment of ONFH by TCM. The related clinical application studies also provided specific targets for gene-assisted therapy of ONFH.

6.
Chinese Journal of Medical Instrumentation ; (6): 85-89, 2021.
Article in Chinese | WPRIM | ID: wpr-880429

ABSTRACT

Summarize the quality status and variety quality change characteristics of the sampling products through the Summary and analysis, according to the results of the national medical device supervision and inspection in 2019. Put forward suggestions on the development of the medical device industry and supervisory measures. Thereby, further improve the level of the medical device and ensure the safety use of medical device.


Subject(s)
Equipment and Supplies , Industry , Reference Standards
7.
Chinese Pharmacological Bulletin ; (12): 844-851, 2021.
Article in Chinese | WPRIM | ID: wpr-1014446

ABSTRACT

Aim To investigate the effect of fibrinogen-isomeric protein 1 (FGL1) on the invasion and migration ability of docetaxel induced lung adenocarcinoma cells and the related mechanism. Methods Gene expression of FGL1 in tumors was obtained from TCGA database, and the Kaplan Meier Plotter database was used to analyze the sample information in the GEO database and draw the survival curve. The PC-9 and A549 of human lung adenocarcinoma cells were selected as the research object. FGL1 expression was knocked down by small interfering RNA (siRNA). Transwell method and cell scratch test were employed to detect cell invasion and migration; Western blot was applied to detect the expression level of E-cadherin and N-cadherin proteins. Results Compared with normal tissues, FGL1 expression was significantly up-regulated in lung adenocarcinoma. Survival analysis showed that the overall survival of patients with high FGL1 expression was shorter than that of patients with low expression. The migration and invasion ability of PC-9 and A549 cells significantly decreased after knockdown FGL1 expression. Under the same doze of docetaxel, decreased expression of FGL1 significantly inhibited the invasion and migration ability of lung adenocarcinoma PC-9 and A549 cells. FGL1 silencing combined with docetaxel significantly down-regulated N-cadherin protein expression and up-regulated E-cadherin protein expression in lung adenocarcinoma cells. Conclusions FGL1 is highly expressed in lung adenocarcinoma and is related to patient survival and prognosis. FGL1 can enhance the ability of docetaxel to inhibit the invasion and migration of lung adenocarcinoma PC-9 and A549 cells by blocking the EMT process.

8.
Braz. J. Pharm. Sci. (Online) ; 56: e00222, 2020. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1089183

ABSTRACT

A series of 2,3-dioxoindolin-N-phenylacetamide derivatives was evaluated for inhibitory activity against CDC25B and PTP1B enzymes. Most of the derivatives showed inhibitory activity against CDC25B (IC50 = 3.2-23.2 µg/mL) and PTP1B (IC50 = 2.9-21.4 µg/mL). Compound 2h showed the most inhibitory activity in vitro with IC50 values of 3.2 and 2.9 µg/mL against CDC25B and PTP1B, respectively, compared with the reference drugs Na3VO4 (IC50 = 2.7 µg/mL) and oleanolic acid (IC50 = 2.3 µg/mL). The results of selectivity experiments showed that the 2,3-dioxoindolin-N-phenylacetamide derivatives were selective inhibitors against CDC25B and PTP1B. Enzyme kinetic experiments demonstrated that compound 2h was a specific inhibitor with the typical characteristics of a mixed inhibitor. In cytotoxic activity assays compound 2h had potent activity against A549, HeLa, and HCT116 cell lines. In addition, compound 2h showed potent tumor inhibitory activity in a colo205 xenograft model in vivo.

9.
Braz. J. Pharm. Sci. (Online) ; 56: e17721, 2020. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1089201

ABSTRACT

In the present study, a series of novel 5,7-diisoprenyloxyflavone derivatives were designed, synthesized, and evaluated for their antibacterial activity. Most of these compounds displayed significant antibacterial effects against Gram-positive bacteria, especially against strains of multidrug-resistant clinical isolates. Compounds 4c, 4g, 4i, 4j, 4k, 4l, 4n, 4q and 4t showed high levels of antimicrobial activity against Staphylococcus aureus RN4220 with minimum inhibitory concentrations of 4.0-20 µM. Compound 4k showed the most potent activity among these compounds against all multidrug-resistant clinical isolates tested. Unfortunately, none of the compounds were active against Gram-negative bacteria at the doses of 24-164 µM.

10.
Chinese Medical Journal ; (24): 1304-1311, 2020.
Article in English | WPRIM | ID: wpr-827612

ABSTRACT

BACKGROUND@#Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as erlotinib and gefitinib, are widely used to treat non-small cell lung cancer (NSCLC). However, acquired resistance is unavoidable, impairing the anti-tumor effects of EGFR-TKIs. It is reported that histone deacetylase (HDAC) inhibitors could enhance the anti-tumor effects of other antineoplastic agents and radiotherapy. However, whether the HDAC inhibitor suberoylanilide hydroxamic acid (SAHA) can overcome erlotinib-acquired resistance is not fully clear.@*METHODS@#An erlotinib-resistant PC-9/ER cell line was established through cell maintenance in a series of erlotinib-containing cultures. NSCLC cells were co-cultured with SAHA, erlotinib, or their combination, and then the viability of cells was measured by the 3-(4,5-Dimethyl thiazol-2-yl)-2,5-diphenyl tetrazolium bromide assay and apoptosis was determined by flow cytometry and western blotting. Finally, the expression of phosphatase and tensin homolog deleted on chromosome 10 (PTEN) was assessed by western blotting.@*RESULTS@#The half-maximal inhibitory concentration of parental PC-9 cells was significantly lower than the established erlotinib-acquired resistant PC-9/ER cell line. PC-9/ER cells demonstrated reduced expression of PTEN compared with PC-9 and H1975 cells, and the combination of SAHA and erlotinib significantly inhibited cell growth and increased apoptosis in both PC-9/ER and H1975 cells. Furthermore, treating PC-9/ER cells with SAHA or SAHA combined with erlotinib significantly upregulated the expression of PTEN mRNA and protein compared with erlotinib treatment alone.@*CONCLUSIONS@#PTEN deletion is closely related to acquired resistance to EGFR-TKIs, and treatment with the combination of SAHA and erlotinib showed a greater inhibitory effect on NSCLC cells than single-drug therapy. SAHA enhances the suppressive effects of erlotinib in lung cancer cells, increasing cellular apoptosis and PTEN expression. SAHA can be a potential adjuvant to erlotinib treatment, and thus, can improve the efficacy of NSCLC therapy.

11.
Chinese Pharmacological Bulletin ; (12): 687-691, 2020.
Article in Chinese | WPRIM | ID: wpr-856974

ABSTRACT

Aim To investigate the effect of fibrinogenlike protein 1 (FGL1)) silencing on docetaxel sensitivity in human lung adenocarcinoma PC-9 cells. Methods Western blot was used to detect the expression of FGL1 protein in human normal bronchial epithelial cell line BEAS-2B and human lung adenocarcinoma cell line PC-9. The FGL1 gene in PC-9 cell line was silenced by siRNA. CCK-8 assay was used to detect the inhibitory effect of silencing FGL1 on PC-9 cell proliferation and its effect on docetaxel sensitivity. Results Compared with BEAS-2B cell line, FGL1 was highly expressed in PC-9 cell line, and the relative expression of FGL1 protein was 6. 5 times that of BEAS-2B cell line with statistically significant difference (P <0. 01). Silencing FGL1 by transfection with FGLlsiRNA could enhance the inhibitory effect of docetaxel on PC-9 cells. Compared with FGLlsiNC group, the IC50value of PC-9 cells in FGL1siRNA group was significantly reduced with statistically significant difference (P < 0. 01). Conclusions Specific silencing of FGL1 gene could inhibit the expression of FGL1 in human lung adenocarcinoma cell PC-9, inhibit the proliferation of PC-9 cells and increase the sensitivity to docetaxel.

12.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 204-211, 2019.
Article in Chinese | WPRIM | ID: wpr-801919

ABSTRACT

Bupleuri Radix is a traditional Chinese medicine commonly used in clinical practice, which has the effects of relieving fever, relieving liver and depression, and promoting Yangqi. At present, the varieties of Bupleuri Radix are relatively chaotic, and the processing in the production areas is relatively extensive. In the processing of Bupleuri Radix, the processed products contained in the 2015 edition of Chinese Pharmacopoeia are raw products and vinegar-processed products. In addition, the specifications on Chinese medicine processing in various provinces and cities contain many processing methods, such as stir-frying with wine, stir-frying with honey, processed with turtle blood, etc. However, there are great differences in processing specifications among provinces and cities, and the processing methods lack clear process parameters, so the quality of Bupleuri Radix decoction pieces produced on these basis is uneven, which affects the clinical application of the decoction pieces. By consulting ancient books and relevant literature, the authors conduct textual research on the varieties of Bupleuri Radix, and systematically summarized the processing methods and processing methods in the producing area, so as to provide reference for the establishment of processing technology specifications and quality standards of Bupleuri Radix decoction pieces.

13.
International Journal of Laboratory Medicine ; (12): 257-259,265, 2019.
Article in Chinese | WPRIM | ID: wpr-742900

ABSTRACT

Objective To investigate the incidence of leukopenia in superficial healthy population and its correlation with age and sex.Methods A total of 40 031 healthy subjects, including 23 393 males and 16 638 females, were selected from January to July, 2018.Their blood routine tests were performed to analyze the age, sex, neutropenia of leukopenia patients.Results The prevalence of leukopenia was 1.22% (490/40 031), 0.37% (151/40 031) in males, 0.85% (339/40 031) in females.The incidence in females was higher, with statistical significance (P<0.05).Age:the average age of males was higher.There was no difference between the incidence of leukopenia in the population aged less than 60 years and over 60 years.There was no significant difference in lymphocyte and monocyte counts between men and women with leukopenia (P>0.05), but there was significant difference in WBC and NEU counts (P<0.05).Neutropenia was found in 206 leukopenia patients, accounting for 42.04% (206/490), and thrombocytopenia was found in 21 patients, accounting for4.29% (21/490), and anemia was found in 71 patients, accounting for 14.49% (71/490).Conclusion The incidence of leukopenia is 1.22%in the apparently healthy population.The incidence of leukopenia in females is higher than that in males.Leukopenia is more severe in women than in men, neutropenia is more severe too.

14.
Chinese Traditional and Herbal Drugs ; (24): 2848-2855, 2019.
Article in Chinese | WPRIM | ID: wpr-851053

ABSTRACT

Objective: To study the correlation between the apparent color of the samples and the important variable components of HPLC fingerprint of rice-processed Codonopsis Radix (rpCR) in processing and its quality transfer law, and lay the foundation for revealing the processing principle of rpCR. Methods: This experiment was based on the experience of the process of rpCR and the apparent color change of traditional processed slices, the visual analyzer was used to analyze the change of apparent color of rpCR from different process time. HPLC fingerprint was used to evaluate the dynamic changes of chemical constituents of rpCR in processing. Then, the multivariate statistical method was used to analyze the correlation between the apparent color and the important variable components of the HPLC fingerprint. Results: In the processing of rpCR, the total color value (E*) of sample powder showed a downward trend, the apparent color of the samples changed from light yellowish brown to dark yellow; The proportions of the 10 chemical components varied greatly, corresponding to peaks of 7, 9, 10, 2, 3, 1, 20, 15, 6, and 4 in HPLC fingerprint, among them peak 4 was confirmed to be 5-hydroxymethyl-2-furaldehyde; Components 1, 3 and 4 were highly significantly and negatively relevant with the change of total color value Eab*, and peak 2 was highly significantly and positively correlated with the change of total color value Eab*, while peak 6 and peak 15 were positively relevant with the change of total color value Eab*. Conclusion: Compounds 1, 2, 3, 4, 6, and 15 were the components with obvious changes in process of rpCR, which were significantly correlated with the change of color and could be used as chemical markers for the monitoring processing and quality control of rpCR.

15.
Chinese Acupuncture & Moxibustion ; (12): 1063-1066, 2019.
Article in Chinese | WPRIM | ID: wpr-776212

ABSTRACT

OBJECTIVE@#To observe the therapeutic effect of pre-acupuncture at Neiguan (PC 6) and Zusanli (ST 36) on exercise-induced fatigue.@*METHODS@#A total of 50 subjects were divided into an observation group and a control group by random number table method, 25 cases in each one. In the observation group, acupuncture was applied at Neiguan (PC 6) and Zusanli (ST 36) before exercise, once a day, consecutive 5-day treatment was required. In the control group, there was no intervention. The subjective fatigue perception score, serum levels of lactate and lactate dehydrogenase, heart rate and oxygen saturation before and after exercise were observed in the two groups.@*RESULTS@#Compared before exercise, the subjective fatigue perception scores, serum levels of lactate and lactate dehydrogenase and heart rates after exercise were increased in the two groups (0.05).@*CONCLUSION@#Pre-acupuncture at Neiguan (PC 6) and Zusanli (ST 36) can effectively reduce the subjective fatigue perception score,serum levels of lactate and lactate dehydrogenase and heart rate to improve exercise-induced fatigue.


Subject(s)
Humans , Acupuncture Points , Acupuncture Therapy , Case-Control Studies , Exercise , Physiology , Fatigue , Therapeutics , Heart Rate
16.
China Journal of Chinese Materia Medica ; (24): 2792-2798, 2019.
Article in Chinese | WPRIM | ID: wpr-773258

ABSTRACT

In this experiment,the gradation analysis method was used to evaluate the quality of different pieces of Gardeniae Fructus through the extraction rate difference and the difference analysis of the main components in the extract. In this experiment cold-dip and hot-dip methods were used to compare the yield of Gardeniae Fructus extract and the content of chemical constituents with water,25%,50%,75% and 95% ethanol fractions. By weighted calculation,the optimal extraction method of Gardeniae Fructus was determined,and this was verified by practical application. RESULTS:: showed that for the water-soluble extract,cold dip method was better than the hot dip method; and for alcohol-soluble extract,75% ethanol under cold dip method was best. The verification results showed that water-soluble extracts under cold dip methods could be used to significantly distinguish the raw Gardeniae Fructus( GF) and processed( stir-baked) GF( GFP) collected from the market. Meanwhile,this method could be also used to distinguish the same batch of GF,GFP and carbonized GF( GFC) with significant differences,respectively( P<0. 05). Ethanol-soluble extract can be used to clearly distinguish GFP and GFC pieces in the same batch( P<0. 05). The results of content determination showed that the variation coefficient of components in GF processed products was higher than that in extracts,and the content of hydroxygeniposide was the most significant component between GF and its processed products. It is suggested that the method of water-soluble extract of GF and the determination of the content of gardoside should be combined together to evaluate the quality of GF and its heat processed products.


Subject(s)
Drugs, Chinese Herbal , Fruit , Chemistry , Gardenia , Chemistry , Plant Extracts
17.
China Journal of Chinese Materia Medica ; (24): 1814-1821, 2019.
Article in Chinese | WPRIM | ID: wpr-773162

ABSTRACT

Commercially available japonica rice and indica rice with different trade names were collected,and then based on the method of rice stir-frying,their many indexes were evaluated,for example the physical and chemical properties such as appearance color,grain type,broken kernel ratio,length-width ratio,1 000-grain weight,specific heat capacity,moisture content,amylose content,and protein content. The discriminant function analysis was used to determine the effective factors affecting the quality of rice as excipients. The results showed that two types of rice could be distinguished by rice color parameter a*,grain parameter circularity,1 000-grain weight and amylose content. These four effective factors can be used as the quality evaluation indexes for fried rice as excipients.Protein is one of the main components of rice,and its content affects the quality of rice. There is a significant difference in the protein content between japonica rice and indica rice. Therefore,protein content should be used as one of the evaluation indexes for rice quality. After comprehensive consideration,it is suggested that the red-green value a*shall not be less than 0. 50; the circularity not less than 53. 0,the 1 000-grain weight not less than 16. 0 g,the amylose content not less than 12. 0% and the protein content not less than4. 0% in the japonica rice; the red-green value a*shall not be lower than-1. 0,the circularity not less than 41. 0,the 1 000-grain weight not less than 13. 0 g,the amylose content not less than 9. 0% and the protein content not less than 3. 5% in the indica rice. In this study,the quality evaluation standards for rice as excipients( japonica rice,indica rice) were supplemented and improved,laying foundation for the development of quality standards for rice as excipients with the rice stir-frying method.


Subject(s)
Amylose , Cooking , Excipients , Food Quality , Hot Temperature , Oryza , Chemistry
18.
West China Journal of Stomatology ; (6): 309-313, 2019.
Article in Chinese | WPRIM | ID: wpr-772655

ABSTRACT

The polarity of ameloblasts and odontoblasts is crucial for their differentiation and function. Polarity-related molecules play an important role in this process. This review summarizes the process of polarity formation of ameloblasts and odontoblasts and their related regulators.


Subject(s)
Ameloblasts , Cell Differentiation , Odontoblasts
19.
Chinese Journal of Medical Instrumentation ; (6): 202-204, 2019.
Article in Chinese | WPRIM | ID: wpr-772527

ABSTRACT

This article introduces the process and principles of variety selection for medical device supervision and inspection, and it analyzes the reason and consideration of the variety selection data of national medical device supervision and inspection from 2017 to 2019, it also put forward a collection of selected varieties for reference in the future by sorting out the classified catalogue of medical devices and diagnostic reagents.


Subject(s)
Equipment Safety
20.
Chinese Journal of Medical Instrumentation ; (6): 209-213, 2019.
Article in Chinese | WPRIM | ID: wpr-772525

ABSTRACT

This paper reviews the quality and safety risk points of medical devices found in the sampling inspection of national medical device supervision in recent years. These risk points are summarized into quality management system, product technical requirements, national standards and industry standards, etc. Several specific risk scenarios are further summarized. Based on the above efforts, a more comprehensive risk point system is constructed. Then it is illustrated with typical examples. In view of the existing problems, the corresponding suggestions are put forward to the production enterprises and supervision departments respectively.


Subject(s)
Equipment Safety , Equipment and Supplies , Industry , Reference Standards
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