Reitz Bruce A
Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA 94305-5407, USA.
Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2006:123-7. doi: 10.1053/j.pcsu.2006.02.018.
Long-term ventricular assist devices for adults have advanced far more than have suitable devices for neonates and infants. The difficulties of design and construction of miniaturized blood pumping systems and the high costs associated with developing, testing, and approval of such devices has been prohibitive. Still, there is an important clinical need for such devices as the availability of donor hearts for this age group has been especially limited. Recently, several pneumatic pulsatile pumps have been developed based on the adult experience, and the issues of regulatory approval are now assuming greater importance for these devices. This chapter reviews the current system for medical device classification and the approval processes in the United States and in Europe. This system is continually evolving, with dedicated and knowledgeable professionals charged with assuring the efficacy, safety, appropriate labeling, and continuing surveillance of approved devices. Pediatric cardiac surgeons involved in transplantation and assist devices need to be aware of the regulatory issues, and work with manufacturers and governmental agencies to make sure that successful devices are available as soon as possible for their patients.
用于成人的长期心室辅助装置的发展远比适用于新生儿和婴儿的装置先进得多。小型化血泵系统的设计和制造困难，以及开发、测试和批准此类装置的高昂成本令人望而却步。尽管如此，由于该年龄组供体心脏的可用性特别有限，临床上对此类装置仍有重要需求。最近，基于成人经验开发了几种气动搏动泵，现在这些装置的监管批准问题变得更加重要。本章回顾了美国和欧洲当前的医疗器械分类系统和批准程序。该系统在不断发展，有专业且知识渊博的专业人员负责确保已批准装置的有效性、安全性、适当标签以及持续监测。参与移植和辅助装置的小儿心脏外科医生需要了解监管问题，并与制造商和政府机构合作，以确保尽快为他们的患者提供成功的装置。
