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.

Study of the risk factors for syncope in children with orthostatic intolerance / 临床儿科杂志

ObjectiveTo investigate the risk factors for syncope in children with orthostatic intolerance (OI).Methods The clinical data from 136 children with OI were retrospectively analyzed. The children were divided into syncope group and non-syncope group based on the existence of syncope. Results Among the 136 children, 77 children (56.62%) had syncope and 59 children (43.38%) did not have syncope. The differences in BMI, prevalence of inducement of prolonged standing, prevalence of accompanied symptoms of blurred vision/ blacking out, cold sweating and pallor, prevalence of the history of motion sickness and blood flow velocity of MCA were statistically significant between two groups (P<0.05). Conclusions Children with OI who has low BMI, inducement of prolonged standing, accompanied symptoms of blurred vision/ blacking out, cold sweating and pallor, the history of motion sickness, and fast blood flow velocity of MCA, are prone to syncope.