Standalone medical device software: The evolving regulatory framework

Abstract

The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software—sometimes referred to as ‘software as a medical device’. To aid the reader’s comprehension of an often complex area, six case studies are outlined and discussed before the paper continues to provide detail of how software with a medical purpose in its own right can potentially be classified as a medical device. The reader is provided an appreciation of how to go about classifying such software and references to support the developer new to the field in locating detailed regulatory support documents and contact points for advice.     

基于网络用户搜索行为的医疗器械关键词分析

基于百度指数关键词检索频度分析，选取9个医疗器械相关关键词，分析关键词的大众关注度与媒体关注度，以及关键词检索人群属性，如性别、年龄、职业和地区等的分布情况，并据此提出具有针对性的意见。     

医学生实习带教体会

实习是这些医学生迈向医师岗位所必需经历的阶段和重要环节。更好地安排、组织好实习带教工作,具有重要的现实意义和需求。本文就长期实习带教的经历,分享体会,以期对医学生实习带教具有帮助。     

Timeline for maximal subjective outcome improvement following total ankle arthroplasty

BackgroundMaximal medical improvement (MMI) establishes the timepoint when patients no longer experience clinically significant improvements following surgery. The purpose of this investigation is to establish when patients achieve MMI following total ankle arthroplasty (TAA) through the use of patient reported outcome measures (PROMs).MethodsA systematic review to identify studies on TAA which reported consecutive PROMs for two years postoperatively was performed. Pooled analysis was done at 6 months, 12 months, and 24 months. Clinically significant improvement was defined as improvement between time intervals exceeding the minimal clinically important difference.ResultsTwelve studies and 1514 patients met inclusion criteria. Clinically significant improvement was seen up to 6 months postoperatively in both the American Orthopaedic Foot and Ankle Society Ankle Hindfoot Score and Visual Analog Scale scoring systems. The Short Musculoskeletal Function Assessment Dysfunction and Bother subsections showed maximal clinically significant improvement by 1 year postoperatively.ConclusionFollowing TAA, MMI is seen by one year postoperatively. Physicians may allocate the majority of resources within the first year when most of the improvement is perceived. This data may help inform preoperative counseling as it establishes a timeline for MMI.Level of evidenceIV.     

From formalin to thiel embalming: What changes? One anatomy department's experiences

In 2009, the Centre for Anatomy and Human Identification started Thiel embalming on a small scale to assess (i) the suitability for our current teaching in which long‐lasting dissection courses are key, (ii) the potential for new collaborations and activities, and (iii) the practical implications of changing our embalming method from formalin to Thiel. Twenty six Thiel‐embalmed cadavers have been used for dissection by staff and students on a taught MSc course, as a model for clinical and surgical training, and increasingly as a model for evaluation of new medical devices and procedures. Our experiences with dissection were mostly positive especially for teaching the musculoskeletal system. Internal organs handle differently from formalin‐fixed organs and dissection manuals need to be adjusted to reflect this. Durability of the cadavers was not an issue, though changes are seen over time due to gradual fluid loss. We have started new collaborations related to postgraduate anatomy teaching and advanced training in surgical and clinical skills. In general, feedback is very positive and demand for cadavers outstrips our current limited supply. Thiel‐embalmed cadavers were found to provide a unique opportunity for evaluation of medical products especially in areas where no suitable alternative model is available, and without the complications associated with clinical testing. This has resulted in new collaborations and research projects. As a result Thiel‐embalmed cadavers are used for longer and for more activities than formalin cadavers: this requires changes in our procedures and staff roles. Clin. Anat. 26:564–571, 2013. © 2013 Wiley Periodicals, Inc.     

加强医疗设备安全使用管理应把握的几个环节

针对临床科室人员在使用仪器设备时普遍存在的重使用、轻管理的现象,阐述了应从建立健全组织机构、明确安全管理重点以及严格落实制度措施等方面加强医疗设备安全使用管理,切实提高医疗设备安全使用管理水平,促进医院综合水平和社会效益的双提高。     

各类医用电气设备标准间电气安全指标的差异

本文统计了各类医用电气设备标准，分析了各标准间电气安全指标的差异，以指导临床工程师在不同医用电气设备的安全测试、维修或预防性维护丁作中采用合适的电气安全标准。     

病案首页签字管理

病案首页和病案记录及时签字,确保病案内容资料完整、正确、规范,才能及时归档,容易查找,不易丢失病案。经过各级医师审签确认后的病案资料,方可为医疗、科研、教学、社会保险、法律部门、医院管理、经济方面提供内容正确的病案信息。通过人性化管理和为签字医师提供满意的服务,可以督促各科主任和临床医师及时完成病案首页审核签字工作,以达到加强病案首页签字的监控管理。     

军队医院等级评审中医学装备管理部门的作用探讨

分析了医学装备管理现状以及等级评审对设备管理部门的作用要求,指出了如何发挥医院装备管理的作用,从院部领导高度重视、迎评工作组织严密、强化标准学习、修订各项规章制度等方面重点阐述了等级医院评审中的实践经验与体会,以期为医学装备管理部门提供参考.