Analysis and Improvement Suggestions on Change of Medical Devices Licensing Items / 中国医疗器械杂志

Based on the statistics of 350 technical evaluations of changes in licensing items of class Ⅱ passive and active medical devices completed in Henan province from July 2017 to November 2018, this paper summarized and analysed the common problems and requirements listed in the correction notifications of the technical evaluation, and put forward relevant countermeasures or suggestions, with a view to further speeding up the evaluation and approval of medical devices.

Study of epidemic area on Tsutsugamushi disease in Taizhou from 2013 to 2014 / 中华预防医学杂志

Objective@#To study the epidemiological characteristics of tsutsugamushi disease, and to confirm the existence of the disease's epidemic foci in Taizhou.@*Methods@#From 2013 to 2014, Dongxing town hospital and Xingqiao town hospital were selected as specimen collection sites in Jingjiang city. Blood samples (5 ml) were collected from 40 patients with acute tsutsugamushi disease. A total of 59 rodents were captured with cage night method in the survey sites at 5, 7, 9, 10, and 11 months in 2013, from which, the spleen, liver, and kidney specimens were selected. Chigger mites were captured by small blackboard method and from the ears of the captured rodents. A total of 226 small blackboards were laid, 27 mites were captured, and the samples were grounded into suspension. Nested-polymerase chain reaction and cell and tissue culture techniques were used to test the specimen from the probable patients, host animals and chigger mites.@*Results@#Among the 40 acute tsutsugamushi disease blood samples, 29 were found to meet the test requirements, 17 were positive for orientia tsutsugamushi nucleic acid with 59% of the positive rate, and 1 stran orientia tsutsugamushi was isolated. 59 rats were captured and the density of mice was 5.5%. Among them, there were 26 Mus musculus (2.4%), 18 Rattus flavipectus (1.7%) and 15 Smelly shrew (density 1.4%). 1 Smelly shrew was tested positive for orientia tsutsugamushi nucleic acid, and the negative results were found in the other rodent specimens. 27 Chigge mites were collected by small blackboard method and the density of mites was 0.12 for each blackboard, among which 3 larvae and 24 nymphs were found. 33 Chigger mites were collected from the ears of 3 Smelly shrew, and the density of the mite was 11 per mouse. All the captured Chigger mites were identified as Leptotrombidium scutellare and 1 group of specimens of Chigger mites from the external environment were positive for orientia tsutsugamushi nucleic acid.@*Conclusion@#There was a high density of mice in the epidemic area from May to November and the species of the chigger mites were Chigger mites in Taizhou. The nucleic acid of the oriental tsutsugamushi was detected in the patients with acute scrub typhus, rodents and vectors. According to the above-mentioned results, it was considered that the scrub typhus epidemic area of Taizhou city has the natural foci of scrub typhus.