Postmarketing safety of biologics and biological devices

Background contextRegardless of study design, the approval process of biologics and biological devices cannot identify every possible safety concern. Postmarketing safety surveillance can provide information based on real-world use of medical products in heterogeneous populations and is critical for identifying potentially serious adverse events, events that are too rare to be detected during premarketing studies, late complications, and events involving individuals or uses that were not evaluated in clinical trials.PurposeTo review why adverse event reporting is important and how the information is used, with emphasis on the points that are most applicable for surgeons and other spine professionals.MethodsThis is an overview of postmarketing safety surveillance.ResultsReview of adverse event reports has resulted in safety notifications, label changes, and publications regarding the safety of biologics and biological devices, such as the risk of airway compromise after the use of recombinant human bone morphogenetic protein in cervical spine fusion, the occurrence of a fatal air embolism after the use of a fibrin sealant that had been applied with a spray device, and infections after allograft transplantation of human tissues.ConclusionsIn light of the rapid development of new biologics, postmarketing surveillance is imperative for ensuring that these products are as safe as possible. By reporting adverse events, surgeons and other health care professionals play a key role in improving and refining our understanding of the safety of biologics.     

改革开放以来医疗保障行政管理体制的变迁

改革开放以来，中国医疗保障行政管理职能和机构设置不断调整，形成了不同的医疗保障行政管理体制，改革朝着更加科学、更为规范的方向发展。但是，当前医疗保障行政管理体制还没有调整到位，主要是医疗保障制度由不同的部门分割管理，造成了重复建设、本位主义、社会不公、难以适应人口流动等诸多许多问题。下一步应在政府职能转变的前提下，统筹卫生服务和医疗保障职能，建立健康保障大部门体制。     

通过FTIR与DSC分析医疗器械包装材料成分特性

介绍了医疗器械塑料包装材料的特性，通过FTIR和DSC简单快捷的分析了包装材料聚乙烯与聚丙烯的成分及聚合度，为以后相关医疗器械包装材料的残留单体及添加剂等有害物质分析确认提供参考。     

医学新生儿童期心理虐待与创造力、认知偏差的调查分析

目的:了解海南医学新生的儿童心理虐待状况;比较不同创造力、认知偏差类型的学生的儿童期心理虐待差异。方法:方便取样,采用儿童心理虐待量表、卡特尔多项人格量表-创造力、认知偏差问卷对365名自愿参与的海南省某医学院临床医学专业2014级新生进行测量,对数据进行t检验和方差分析。结果:男生的恐吓、贬损、干涉、纵容维度得分高于女生(t=2.38,2.17,2.40,2.72;P均0.05);独生子女医学新生的忽视维度得分低于非独生子女者,而干涉维度得分高于后者(t=-3.82,2.17;P均0.05);单亲家庭医学新生的忽视和贬损维度得分高于非单亲学生(t=2.80,3.24;P均0.05)。不同创造力等级的医学新生在儿童心理虐待得分上的差异无统计学意义。不同认知偏差类型的医学新生在贬损、干涉维度得分上的差异均有统计学意义(F=10.92,13.54;P均0.001)。结论:不同性别、是否独生、是否单亲的医学新生在儿童期遭受的心理虐待不一样;不同创造力的医学新生在儿童期遭受的心理虐待无差异;不同认知偏差类型的医学新生在童年期遭受的贬损和干涉高于其他类型者。