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OBJECTIVE@#Discuss the working ideas of the dynamic adjustment mechanism of medical device classification in the United States, and provide reference for the construction of medical device related mechanisms in China.@*METHODS@#Collect and interpret the documents of regulatory background, procedures and orders of the dynamic adjustment mechanism of the medical device classification in the United States, and summarize the overall situation and specific cases of the medical device classification adjustment under this mechanism in recent years.@*RESULTS@#The US work idea of the medical device classification dynamic adjustment mechanism is based on the latest valid scientific evidence, conducting risk analysis and identification, and determining the corresponding measures.@*CONCLUSIONS@#During the adjustment process, industry stakeholders have repeatedly discussed and achieved final agreement. Its procedures and working ideas can be used as a reference for China's work.
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China , United States , United States Food and Drug AdministrationABSTRACT
This article introduces the significance of packaging for the implementation of Unique Device Identification System (UDI system) and some key terms associated with it. It is further supported by analyzing the important role it plays in building a successful UDI system. This article provides a reference for the related stakeholders to meet the requirement and implement UDI system.
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The purpose of UDI-PI and related international regulations/guidelines is analyzed. The application practice for the registrant/filing applicant to determine the composition of UDI is given. The article provides reference for the related stakeholders to implement UDI system.
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Equipment and SuppliesABSTRACT
Facing the new situation of national green development, energy conservation and environmental protection, this study systematically expounds the energy consumption management of medical electrical equipment in USA, Europe and China, and puts forward suggestions on green development of medical electrical equipment in China.
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Electricity , Energy-Generating Resources , Equipment and SuppliesABSTRACT
A detailed analysis on re-classification procedure of medical devices from Food and Drug Administration.The experience on classification procedures,the work-flow of risk reanalysis and regulatory categories reassessment of listed products,as well as launching a comprehensive evaluation and downgrading of listed high-risk products were explored in recent years.Based on the analysis on classification procedures and supervision of medical device products in the USA,and combined with the current situation of classification of medical devices in China,some suggestions were put forward on the current classification mode of medical devices so as to improve the quality and efficiency of classified management of medical devices in China.
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China , Equipment Safety , Equipment and Supplies , United States , United States Food and Drug AdministrationABSTRACT
The information-based management of medical device standards is of great significance for promoting the development of the medical device standardization. Here we analyzed the important role of the information-based management of medical device standards in the delicacy management of the whole process of establishing and modifying medical device standards, introduced its present situation and upgrade of information-based management system of medical device standards, and put forward work ideas and suggestions for it.
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Equipment and Supplies , Reference Standards , Information Management , Reference Standards , Reference StandardsABSTRACT
Based on the developing situation of Computer Aided Diagnosis/Detection (CAD) software, considering the domestic and international regulation of CAD software, according to current Medical Device Classification Catalog and related laws of China Food and Drug Administration (CFDA), this paper investigated and analyzed the classification of CAD software, and provided technical suggestion on classifying principle of CAD software applying Artificial Intelligence (AI) or other advanced technology from medical device regulation scope, for the reference of regulatory and technical departments.
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Artificial Intelligence , China , Diagnosis, Computer-Assisted , Radiographic Image Interpretation, Computer-Assisted , SoftwareABSTRACT
Objective To explore the effect of kangfuxin liquid topical treatment on open wound of postoperative perianal abscess.Methods200 cases of patients with open wound abscess surgery in our hospital from February 2014 to September 2016 were randomly divided into control group and experimental group,with 100 cases in each group.The control group was given conventional treatment, the experimental group were treated by kangfuxin liquid.The relevant therapeutic indicators and clinical healing time between two groups were compared.ResultsThe effective rate of the treatment group was 93.0%, which was significantly higher than that of the control group (85.0%), the difference was statistically significant(P<0.05).The granulation growth period of the experimental group was (5.14±1.41) days, and the average healing time was (15.21±2.49) days.Which were significantly shorter than those of the control group[(7.45±1.32) days, (21.16±2.69) days], and the differences were Statistical differences (P<0.05).ConclusionTo improve the treatment effect to a great extent open wound infection of kangfuxin liquid in treatment of perianal abscess after surgery, shorten the healing time, improve the patient's symptoms, with further clinical promotion and application significance.
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To explore the application value of low-dose CT in lung cancer after operation in a short-term review by comparing conventional and low-dose CT. Methods:In 83 cases of lung cancer during the immediate postoperative period review, 50 cases (group A) underwent conventional CT scanning, whereas 33 cases (group B) underwent low-dose CT scanning. All CT scans were scored on the basis of image quality and clinical needs. The radiation dose indexes CTDIvol and DLP were recorded for each case. A comparison of the score and radiation dose between the two groups helped determine the existence of significant differences. Results:The average image quality scores of the two groups were 3.705±0.314 and 3.311±0.442, those for clinical demand were 2.670±0.373 and 2.561±0.410, those for CTDIvol were (19.248±1.532) mGy and (10.138±1.113) mGy, and those for DLP were (170.180±19.259) mGy*cm and (99.061±14.504) mGy*cm. The two groups exhibited significant differences in image quality, CTDIvol, and DLP but revealed no significant dissimilarity in clinical demand. Conclusion:Low-dose CT completely meets the clinical requirements for short-term follow-up after resection of lung cancer and significant reduction in radiation dose.
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Objective To explore clinical efficacy of compound sulfamethoxazole combined with conventional atomization in treatment of bronchial tuberculosis.Methods 190 cases were selected from January 2012 to October 2013 who diagnosised bronchial tuberculosis treated in minda hospital affiliated of Hubei institute for Nationalities,then the patiens were randomly divided into two groups(n=95 ),the control group underwent conventional spray treatment,the observation group row treatment on the basis of atomization,while giving sulfamethoxazole treatment,observation and comparison of two groups clinical outcomes and adverse reactions. Result After continuous treatment for 4~6 months in the observation group therapy effective rate of 70.5%,total effective rate was 89.5%in the control group significant efficiency and total efficiency of 48.4%and 76.8%,respectively,two groups of significant efficiency and total efficiency,there were significant differences(P<0.05 );bacterial turn negative time indicator on the observation group and the control group were respectively(2.6 ±0.9)months and(4.2 ±1.1)months,there was significant difference(P<0.05);adverse reactions in observation group and control group was 7.4% and 11.6%,respectively,which compared no significant difference.Conclusion Application of compound sulfamethoxazole combined with conventional atomization in treatment of bronchial tuberculosis,has quickly and significantly effect,and bacterial clearance time is short,with low adverse reactions,safety and reliable.
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For the preparation of implementing IEC 60601-1 Ed. 3.1 in advance, this paper analyzes the main difference between IEC 60601-1 Ed. 3.1 and GB 9706.1-2007, and discusses the possible influence to medical device designing and testing.
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Equipment Design , Reference Standards , Equipment and Supplies , Reference StandardsABSTRACT
This paper introduced the medical device classification in China and USA. Through the comparison between the two systems, several problems in Chinese classification system were exposed. To the end, some suggestions were proposed referred to the classification system of USA.
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China , Device Approval , Reference Standards , Equipment and Supplies , Classification , United StatesABSTRACT
Conclude some specific problems in drafting the industry standards of medical devices which are adopted to international standards. Provide relevant suggestion and recommendation in accordance to GB/T 1.1-2009 and GB/T 20000.2-2009, some preliminary suggestions were accordingly proposed.
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Device Approval , Reference Standards , International CooperationABSTRACT
This paper discussed some specific issues in the preparation of medical device standards. On the basis of GB/T 1.1-2009, some preliminary suggestions were accordingly proposed.
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Equipment and Supplies , Reference Standards , Quality ControlABSTRACT
Objective To investigate the early nursing intervention on recovery of upper limb edema after radical mastectomy, and subjective comfort of patients and satisfaction degree with the service quality of nursing staff. Methods 70 patients according to different methods of nursing intervention were randomly divided into the control group and the observation group with 35 patients in each group. The observation group was given comprehensive care, including psychological care, raising affected limb, strengthen the training arm function, conducting various forms of aerobic motion, pressure gloves and massage, hot packs, physical therapy, the use of elastic bandages, guidance and other aspects of hospital care. The control group only received routine care. The nursing effect, subjective comfort degree, satisfaction degree with the service quality, time of edema alleviation and disappearance and hospitalization time of two groups were compared. Results Compared with the control group, nursing effect of the observation group was better,subjective comfort of patients and the satisfaction degree with the quality of service significantly improved,and the time of edema alleviation and hospitalization time was significantly shorter, the difference was statistically significant. Conclusions Early implementation of nursing interventions for patients with limb swelling after radical operation of breast cancer can improve patients satisfaction degree, promote the recovery of upper limb edema, reduce hospital stay.
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This paper discussed the possible influence of the transformation and implementation of IEC60601-1 3rd edition in China, and accordingly proposed some preliminary suggestions.
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China , Equipment and Supplies , Reference Standards , Reference StandardsABSTRACT
<p><b>OBJECTIVE</b>To improve the diagnosis and treatment of testicular torsion (or spermatic cord torsion), and reduce its misdiagnosis and mistreatment.</p><p><b>METHODS</b>One hundred and thirteen misdiagnosed clinical cases of testicular torsion from 1994 to 2004 were reviewed and analysed.</p><p><b>RESULTS</b>The error rate of initial diagnosis was 84.3%, among which 81 cases (71.7%) were misdiagnosed as acute epididymitis or testis, 10 (8.8%) as hydrocele of the tunica vaginalis, and 7 (6.2%) as acute enteritis. The lengths of time between the income and diagnosis of the disease varied from 2 hours to 2 months, averaging 6.3 days. Hand replacement succeeded in 3 cases, surgical examination was carried out in 92, resection of the testis or epididymis was performed in 64, testis atrophy occurred in 26, and the total testis impairment rate was 79.6%.</p><p><b>CONCLUSION</b>The key to the reduction of misdiagnosis is to improve the diagnostic methods, which can be achieved by the combined use of case history, physical signs and color ultrasonography. Surgical examination of the scrotum is the best option for both the diagnosis and the treatment of testicular torsion.</p>
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Adolescent , Adult , Aged , Child , Child, Preschool , Humans , Infant , Male , Middle Aged , Diagnostic Errors , Epididymitis , Diagnosis , Orchitis , Diagnosis , Retrospective Studies , Spermatic Cord Torsion , DiagnosisABSTRACT
Objective The studies on tissue culture and cytological observations of leaf explants of Curculigo orchioides were conducted in order to provide the basis for the rapid propagation of C. orchioides. Methods Young leaf explants of C. orchioides were cultured on MS basal media. Differences in the callus induction and plantlet regeneration rate were observed by different light treatment as well as chemical factors like different phytohormones, casein hydrolysate (CH), and activated charcoal (AC) concentrations. Paraffin method was used to cytological observation. Results For callus induction of leaf explants of C. orchioides, dark treatment gave better results compared to light treatment; among the media tested, the suitable phytohormone combinations were 2.0 mg/L 2, 4-D or 6-BA 1.5 mg/L+2, 4-D 2.5 mg/L, and 300 mg/L CH+0.2% AC was good for plantlet regeneration from leaf explants. The callus from leaf explants mainly originated from midrib. The parenchyma cells near epicuticle of midrib firstly were initiated to division. Then the parenchyma cells of vascular bundle sheath and mesophyll cells on each side of vascular bundle were also divided to form callus. The buds developed on the peripheral parts of the calli, but the roots developed in the regions deep within the calli. Conclusion Tissue culture of young leaf explants of C. orchioides can make the propagation of C. orchioides rapid.
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Objective To observe the effect of ShenQi Wuweizi Tablet (Tablet composed of pilose asiabell root, astragalus root, and schisandra fruit) on anxiety before college entrance examination.Methods Totally 227 patients were randomized into a treatment group (113 cases, treated with Shenqi Wuweizi Tablet, 3 tablets each time and 3 time a day), and a control group (114 cases, treated with alprazolam, 0.4 mg each time and 3 times a day). The treatment course was 6 weeks for both groups. Before treatment and at the end of the 1st, 2nd, 4th and 6th week of treatment, the clinical effect was assessed with Hamilton Anxiety Scale (HAMA) and Clinical Global Impression (CGI), and Self-Rating Anxiety Scale (SAS). And at the same time, the untoward reactions was also observed.Results At the end of the 1st week of treatment, the HAMA score was significantly decreased in the control group (P
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Objective To evaluate the effect of mining waste water on drinking water quality and tumor mortality of villagers. Methods Analyse quality of drinking water sampled from well which only supply water to a family which the well belongs to and survey the death reasons of whole population in the polluted area and the control area. Results Mining waste water discharged by a mine contaminated the nearby river and impacted the drinking water quality of the nearby village also. Compared with the control, the concentration of lead, arsenic and mercury in drinking water of polluted area was much higher. The 5,year total mortality in polluted area and in the control was 3.09% and 1.55% respectively. Tumor mortality in polluted area was 50%, esophagus cancer mortality was 54.24%. Tumor mortality in the control area was 20% only and most tumors were liver cancer. Conclusion The adverse effect of mining waste water on drinking water quality and human health in polluted area has been seen.