McGivney W T
Science and Technology Department, American Medical Association, Chicago, IL 60610.
J Nucl Med. 1991 Apr;32(4):660-4.
Regulatory and economic hurdles to the introduction and the diffusion of expensive new medical instrumentation have changed substantially over the past decade. The process of diffusion has been slowed by the introduction of new hurdles and by the gradual shift in their relative importance. FDA approval, affirmative coverage decisions, and the setting of appropriate levels of reimbursement greatly influence the diffusion and utilization of major new technologies. Positron emission tomography (PET) is not an exception. This paper examines the mechanics of these hurdles and their impact on the availability of PET.
在过去十年中,昂贵的新型医疗仪器的引进和推广所面临的监管和经济障碍已发生了重大变化。新障碍的出现以及它们相对重要性的逐渐转变减缓了推广进程。美国食品药品监督管理局(FDA)的批准、肯定性承保决定以及适当报销水平的设定,对重大新技术的推广和使用有极大影响。正电子发射断层扫描(PET)也不例外。本文探讨了这些障碍的作用机制及其对PET可用性的影响。