Feldman Mitchell D, Petersen Amy J, Karliner Leah S, Tice Jeffrey A
Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA 94143-0320, USA.
J Gen Intern Med. 2008 Jan;23 Suppl 1(Suppl 1):57-63. doi: 10.1007/s11606-007-0275-4.
The global medical technology industry brings thousands of devices to market every year. However, significant gaps persist in the scientific literature, in the medical device approval process, and in the realm of postmarketing surveillance. Although thousands of drugs obtain approval only after review in randomized controlled trials, relatively few new medical devices are subject to comparable scrutiny.
To improve health outcomes, we must enhance our scrutiny of medical devices, and, without simply deferring to the Food and Drug Administration, we must ask ourselves: Who is responsible for evaluating the safety and effectiveness of medical devices?
Technology assessments by independent organizations are a part of the solution to this challenge and may motivate further research focused on patient outcomes.
全球医疗技术行业每年都有数千种设备推向市场。然而，科学文献、医疗器械审批流程以及上市后监测领域仍存在重大差距。尽管数千种药物仅在经过随机对照试验审查后才获得批准，但相对较少的新型医疗器械受到类似的严格审查。
为改善健康结果，我们必须加强对医疗器械的审查，而且，在不单纯依赖食品药品监督管理局的情况下，我们必须自问：谁负责评估医疗器械的安全性和有效性？
独立组织进行的技术评估是应对这一挑战的部分解决方案，并且可能促使开展更多关注患者结局的研究。
