Rome Benjamin N, Kramer Daniel B, Kesselheim Aaron S
Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, 1620 Tremont St., Suite 3030, Boston, MA, 02120, USA,
Curr Cardiol Rep. 2014;16(6):489. doi: 10.1007/s11886-014-0489-0.
Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls-most notably related to underperforming ICD leads-have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a "least burdensome" approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative.
自1976年以来，美国食品药品监督管理局（FDA）一直采用上市前批准（PMA）程序来批准高风险医疗器械，包括植入式心脏除颤器（ICD）、冠状动脉支架和人工心脏瓣膜。尽管最近的召回事件——最引人注目的是与性能不佳的ICD导线相关的召回——引发了人们对医生和患者是否有时应该对通过该途径批准的器械更加谨慎的担忧，但PMA程序仍被广泛视为对器械安全性和有效性的严格评估。FDA必须采用“负担最小”的方法来批准新的医疗器械，并且许多广泛使用的器械型号已作为现有PMA批准器械的补充获得批准，临床测试有限。最高法院最近的一项裁决使得因不安全的PMA批准器械而受到伤害的患者很难在法庭上寻求损害赔偿。使用高风险医疗器械的心脏病专家应该意识到，FDA对新器械的批准依赖于不同程度的证据，并不一定表明其比现有型号更有效。临床医生和患者参与上市后监测和比较有效性研究仍然至关重要。
