Medical devices may revolutionize healthcare delivery but can lead to serious adverse events for treated patients and users. While reporting of adverse events related to medical devices is an essential starting point for post-market surveillance, underreporting of medical device adverse events is a global problem. Korea introduced a voluntary medical device adverse event reporting system in 2010, called the Medical Device Safety Information Monitoring Center, which has led to an increase in adverse event reports. For 10 years, the Medical Device Safety Information Monitoring Center has analyzed medical device adverse events systematically and has provided active feedback to the manufacturers and education on safe use. Recently, the Medical Device Safety Information Monitoring Center contributed to harmonization of international medical device vigilance through the sharing of adverse events. This experience of Korea might contribute to improvements in medical device vigilance, which is a critical prerequisite for improving medical device policies and regulations. 相似文献
Common carotid intima-media thickness (cIMT) is an index of subclinical atherosclerosis that is associated with ischemic stroke and coronary artery disease (CAD). We undertook a cross-sectional epigenome-wide association study (EWAS) of measures of cIMT in 6400 individuals. Mendelian randomization analysis was applied to investigate the potential causal role of DNA methylation in the link between atherosclerotic cardiovascular risk factors and cIMT or clinical cardiovascular disease. The CpG site cg05575921 was associated with cIMT (beta?=??0.0264, p value?=?3.5?×?10–8) in the discovery panel and was replicated in replication panel (beta?=??0.07, p value?=?0.005). This CpG is located at chr5:81649347 in the intron 3 of the aryl hydrocarbon receptor repressor gene (AHRR). Our results indicate that DNA methylation at cg05575921 might be in the pathway between smoking, cIMT and stroke. Moreover, in a region-based analysis, 34 differentially methylated regions (DMRs) were identified of which a DMR upstream of ALOX12 showed the strongest association with cIMT (p value?=?1.4?×?10–13). In conclusion, our study suggests that DNA methylation may play a role in the link between cardiovascular risk factors, cIMT and clinical cardiovascular disease.
ObjectiveTo check incidence of Asymptomatic Leishmania donovani reporting to Armed Forces Institute of Transfusion Rawalpindi.Material and MethodsTwo thousand (n = 2000) consecutive healthy voluntary blood donors were tested for 18 s rRNA by Real time Polymerase chain reaction. One thousand (n = 1000) subject’s permanent resident of Azad Kashmir along with a thousand (n = 1000) healthy voluntary blood donors from rest of Pakistan were included. The study was carried out over a period of three months Jun – Aug 2020.ResultsTotal of 2000 blood donors were enrolled in the study, all were males with age ranging from 16 to 60 years. Stratification based on residence, 1000 (50 %) resided in the Azad kashmir, 349 (17.45 %) were from Islamabad and Rawalpindi, 541 (27.05 %) from Punjab mainly residing in Lahore and Multan, 110 (5.5 %) were from other cities of Pakistan. Grouping on the basis of age, 55.25 % ( n = 1105) of the donors were 16–25 years old, 19.45 % ( n = 389) were in age range of 26–40 years old, 15.55 % ( n = 311) were 41–50 years old and 9.75 % ( n = 195) 51–60 years old. No donor was diagnosed as an asymptomatic carrier.ConclusionScreening of blood donors for Leishmania donovani is not recommended. 相似文献