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Practical Improvements for Medical Device Evaluation.

作者信息

Kramer Daniel B, Yeh Robert W

机构信息

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

出版信息

JAMA. 2017 Jul 25;318(4):332-334. doi: 10.1001/jama.2017.8976.

DOI:10.1001/jama.2017.8976
PMID:28742887
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6150452/
Abstract
摘要

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Power Morcellators, Postmarketing Surveillance, and the US Food and Drug Administration.动力组织粉碎器、上市后监测与美国食品药品监督管理局
JAMA. 2017 Jul 25;318(4):325-326. doi: 10.1001/jama.2017.7704.
2
Monitoring Medical Devices: Missed Warning Signs Within Existing Data.监测医疗设备：现有数据中的警示信号遗漏
JAMA. 2017 Jul 25;318(4):327-328. doi: 10.1001/jama.2017.6584.
3
Registry-Based Prospective, Active Surveillance of Medical-Device Safety.基于注册的医疗设备安全性前瞻性主动监测
N Engl J Med. 2017 Feb 9;376(6):526-535. doi: 10.1056/NEJMoa1516333. Epub 2017 Jan 25.
4
Need for a National Evaluation System for Health Technology.对卫生技术国家评估系统的需求。
JAMA. 2016 Sep 20;316(11):1153-4. doi: 10.1001/jama.2016.8708.
5
Relationship Between Femoral Vascular Closure Devices and Short-Term Mortality From 271 845 Percutaneous Coronary Intervention Procedures Performed in the United Kingdom Between 2006 and 2011: A Propensity Score-Corrected Analysis From the British Cardiovascular Intervention Society.2006年至2011年在英国进行的271845例经皮冠状动脉介入治疗中股动脉血管闭合装置与短期死亡率的关系：来自英国心血管介入学会的倾向评分校正分析
Circ Cardiovasc Interv. 2016 Jun;9(6). doi: 10.1161/CIRCINTERVENTIONS.116.003560.
6
Effectiveness of Arterial Closure Devices for Preventing Complications With Percutaneous Coronary Intervention: An Instrumental Variable Analysis.动脉闭合装置预防经皮冠状动脉介入治疗并发症的有效性：一项工具变量分析。
Circ Cardiovasc Interv. 2016 Apr;9(4):e003464. doi: 10.1161/CIRCINTERVENTIONS.115.003464.
7
N-of-1 Policymaking--Tragedy, Trade-offs, and the Demise of Morcellation.单病例决策制定——悲剧、权衡与粉碎术的衰落
N Engl J Med. 2016 Mar 10;374(10):986-90. doi: 10.1056/NEJMms1516161.
8
Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.2010 年和 2011 年 FDA 上市前批准的高风险治疗性医疗器械全产品生命周期临床试验特点。
JAMA. 2015 Aug 11;314(6):604-12. doi: 10.1001/jama.2015.8761.
9
Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies.评估美国食品和药物管理局批准后设备的安全性和有效性：FDA 强制要求的上市后研究。
JAMA Intern Med. 2014 Nov;174(11):1773-9. doi: 10.1001/jamainternmed.2014.4194.
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Postmarket surveillance of medical devices: a comparison of strategies in the US, EU, Japan, and China.医疗器械上市后监测：美国、欧盟、日本和中国的策略比较。
PLoS Med. 2013;10(9):e1001519. doi: 10.1371/journal.pmed.1001519. Epub 2013 Sep 24.