1.Investigation on epidemic foci of paragonimiasis in eastern part of Zhenghe County,Fujian Province
Benxiang LIN ; Huanwang WEI ; Yousong LI ; Shiqing WU ; Fanzhen KONG ; Zhijin FAN ; Baogui TANG ; Cai CHEN
Chinese Journal of Schistosomiasis Control 2016;28(4):418-421
Objective To investigate the species and hosts of Paragonimus and its infection rate in eastern part of Zhenghe County,Fujian Province,so as to determine the local foci of Paragonimus. Methods The snails,crabs and stools of wild cats were collected for the examinations of cercariae,metacercariae and eggs of Paragonimus. The geographical and environmental conditions of the areas were also investigated. Results A total of 4 890 Pseudobythinella jianouensis snails and 1 035 Semisul?cospira liberlina snails were examined,and the cercariae of Paragonimus were only found in P. jianouensis,with an infection rate of 0.10%(5/4 890). Bottapotamon zhengheensis sp. nov. as the second intermediate host of P. skrjabini,were examined, and the infection rate was 85.29%(29/34)and the average numbers of metacercariae per crab and per gram of crab tissues were 3.85 and 0.62,respectively. Thirty?six Sinopotamun fujianensis crabs,as the second intermediate host of P. westermani,were examined,and the infection rate was 38.89%(14/36)and the average numbers of metacercariae per crab and per gram of crab tissues were 6.43 and 0.03,respectively. The eggs of Paragonimus were detected in 1 of 2 muck specimens of wild cats. Conclu?sion The data suggest that there is a focus of middle?to?high level of infection caused by P. westermani and P. skrjabini in the eastern part of Zhenghe County.
2.Analysis of Technical Evaluation for Current Regulation of 3D Printed Customized Medical Device.
Chinese Journal of Medical Instrumentation 2018;42(4):279-281
This paper summarizes the current research status of 3D printed customized medical devices regulations in US and EU. Based on the discussion of 3D printed customized medical devices in the US and the European Union, some thoughts are put forward from design, manufacturing, testing and other aspects.
Equipment and Supplies
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European Union
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Printing, Three-Dimensional
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United States
3.Analysis of Field Inspection Issues and Some Suggestions for Software as Medical Device
Yiqiang YANG ; Zhijin FAN ; Shuting GUO
Chinese Journal of Medical Instrumentation 2024;48(3):346-351
With the encouragement of policies and the rapid development of the biopharmaceutical industry,the number of software as medical device(SaMD)registration applications in Shanghai has continued to increase in recent years,and this paper summarizes the GMP nonconformities found in the field inspection of SaMD in Shanghai from 2020 to 2023,and the results show that nearly 70%of the problems were found in the software development process.Through in-depth analysis,this paper proposes the corresponding countermeasures for the problems found in the five most common stages such as software requirements,software design,software testing,software defect management and software configuration management,combined with the characteristics of software development.These suggested measures have certain reference significance for medical device software development and quality control personnel,and technical reviewer and inspectors.