ABSTRACT
Risk management of medical devices covers the whole life cycle of medical devices, which is of great significance to the life safety and health condition of patients. The existing risk management of medical devices, especially the risk analysis in the research and development stage, often becomes a mere formality. The special risks faced by the research and development products in the clinical application scenarios are not well addressed. This study proves the necessity and importance of the combination of risk analysis and clinical application in the research and development stage of medical devices by the analysis of several special hazard sources in the process of clinical application of portable emergency ventilator.
Subject(s)
Humans , Home Care Services , Risk Management , Ventilators, MechanicalABSTRACT
Objective To analyze the effect of special risk exposures during periconception period on birth defects of newborns.Methods From Jul.to Dec.2013,the multi-stage stratified random sampling method was adopted.Women of childbearing age between 15 and 49 who were pregnant during 2010 to 2013 in Shaanxi Province were selected as study subjects for investigation on special risk factors exposed during periconception period.The Logistic regression model was adopted to analyze the association between newborns' birth defects and special risk exposures.Results The study included 30 010 women of childbearing age and 29 550 newborns with 572 (193.57/ 10 000) cases of birth defects.After adjusting for demographic factors,the risk factors for birth defects were drinking [OR=2.29,95％ CI (1.22,4.29)] and passive smoking [OR=1.25,95％ CI (1.02,1.53)] during periconception.There was a higher risk of birth defects when exposure to medicine [OR =1.64,95％ CI (1.04,2.61)],pesticides [OR =2.41,95％ CI (1.09,5.35)],biological risk factors [OR-1.64,95％ CI (1.05,2.56)],physical risk factors [OR=1.15,95％ CI (1.13,2.34)] and chemical risk factors [OR =2.36,95％ CI (1.36,4.11)] 3 months both before and after pregnancy.Similarly,after adjusting for demographic factors and behaviors,we found that birth defects were related to antibiotics,salicylates,and antitussive,which could increase the risk of birth defects (P＜0.05).Conclusion Exposure to passive smoking and drinking during periconception and exposure to medicines and pesticides,as well as biological,physical and chemical risk factors 3 months before and after pregnancy could increase the risk of birth defects in newborns.