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991.
《Journal of medical engineering & technology》2013,37(7):441-447
AbstractThe 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. 相似文献
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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。 相似文献
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Avinesh Agarwalla Anirudh K. Gowd Elizabeth A. Cody Phillip K. Johnson Kaisen Yao James A. Nunley Nirav H. Amin Joseph N. Liu 《Foot and Ankle Surgery》2021,27(3):305-310
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. 相似文献
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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. 相似文献
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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. 相似文献