Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators
Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators
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DOI：
10.1001/jama.286.7.793
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发表时间：
2001-08-15
影响因子：
120.7
通讯作者：
Epstein, LM
中科院分区：
文献类型：
--
作者：
Maisel, WH;Sweeney, MO;Epstein, LM
背景 起搏器和植入式心律转复除颤器 (ICD) 发生器意外故障有时需要美国食品和药物管理局 (FDA) 召回。尽管装置植入越来越频繁，但起搏器和 ICD 召回以及安全警报（建议）仍然缺乏特征。 目标 确定美国的起搏器和 ICD 发生器建议率，确定这些比率的趋势，并检查其临床和财务影响。对 1990 年 1 月至 2000 年 12 月期间发布的每周 FDA 执法报告进行设计和设置分析，以确定美国涉及起搏器或 ICD 发生器的所有建议。涉及导线故障的召回和安全警报不包括在内。 主要结果指标 1990-2000 年美国受到 FDA 召回或安全警报的起搏器和 ICD 发生器的数量； 1990-2000 年美国起搏器和 ICD 年度咨询率；结果 在研究期间，发布了 52 份建议（中位数[25% 和 75%]，每年 4 份[4 和 7]），涉及 408500 个起搏器和 114645 个 ICD（总共 523 145 个设备）。硬件故障（35 条建议影响 280641 台设备）和计算机错误（10 条建议影响 216533 台设备）占设备召回的 95%。植入式心律转复除颤器比起搏器被召回的频率更高（平均 [SD]，每 100 人年 16.4 [1.6] 次建议 vs 6.7 [0.8] 次建议；P
Context Unanticipated pacemaker and implantable cardioverter-defibrillator (ICD) generator malfunctions sometimes warrant recall by the US Food and Drug Administration (FDA). Despite increasingly frequent device implantation, pacemaker and ICD recalls and safety alerts (advisories) remain poorly characterized.Objectives To determine pacemaker and ICD generator advisory rates in the United States, to identify trends in these rates, and to examine their clinical and financial implications.Design and Setting Analysis of weekly FDA Enforcement Reports issued between January 1990 and December 2000 to identify all advisories involving pacemaker or ICD generators in the United States. Recalls and safety alerts involving lead malfunctions were not included.Main Outcome Measures Number of pacemakers and ICD generators in the United States subject to FDA recall or safety alert in 1990-2000; annual pacemaker and ICD advisory rates in the United States in 1990-2000; and estimated cost of device advisories.Results During the study period, 52 advisories (median [25th and 75th percentiles], 4 [4 and 7] per year) involving 408500 pacemakers and 114645 ICDs (523 145 total devices) were issued. Hardware malfunctions (35 advisories affecting 280641 devices) and computer errors (10 advisories affecting 216533 devices) accounted for 95 % of device recalls. Implantable cardioverter-clefibrillators were recalled more frequently than pacemakers (mean [SD], 16.4 [1.6] vs 6.7 [0.8] advisories per 100 person-years; P