Herndon James H, Hwang Raymond, Bozic K J
Department of Orthopaedic Surgery, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, USA.
Eur Spine J. 2007 Aug;16(8):1293-302. doi: 10.1007/s00586-007-0369-z. Epub 2007 Apr 11.
New technology is one of the primary drivers for increased healthcare costs in the United States. Both physician and industry play important roles in the development, adoption, utilization and choice of new technologies. The Federal Drug Administration regulates new drugs and new medical devices, but healthcare technology assessment remains limited. Healthcare technology assessment originated in federal agencies; today it is decentralized with increasing private sector efforts. Innovation is left to free market forces, including direct to consumer marketing and consumer choice. But to be fair to the consumer, he/she must have free knowledge of all the risks and benefits of a new technology in order to make an informed choice. Physicians, institutions and industry need to work together by providing proven, safe, clinically effective and cost effective new technologies, which require valid pre-market clinical trials and post-market continued surveillance with national and international registries allowing full transparency of new products to the consumer--the patient.
新技术是美国医疗成本上升的主要驱动因素之一。医生和行业在新技术的开发、采用、利用和选择中都发挥着重要作用。联邦药物管理局对新药和新医疗设备进行监管，但医疗技术评估仍然有限。医疗技术评估起源于联邦机构；如今，随着私营部门的努力不断增加，它已分散化。创新留给了自由市场力量，包括直接面向消费者的营销和消费者选择。但为了公平对待消费者，他/她必须充分了解新技术的所有风险和益处，以便做出明智的选择。医生、机构和行业需要共同努力，提供经过验证的、安全的、临床有效的和具有成本效益的新技术，这需要有效的上市前临床试验和上市后通过国家和国际注册机构进行持续监测，以使新产品对消费者——患者完全透明。
