关于一次性高值医用产品复用的探讨

Discussion on reprocessing expensive single use medical devices

现代医疗中,许多疾病的治疗都应用到复杂的、高值的一次性医疗器械。以心脏类疾病的治疗为例,导管介入治疗、电消融治疗以及起搏器的应用等延长了病人的生命,改善了病人的生活质量。但此类器械的成本一直很高,在医疗费用不断上涨、各国医疗体系都面临巨大的医疗成本压力的现状下,许多国家的医疗机构在最近的十几年里一直尝试对这些被标记为一次性使用的高值的医疗器械或产品的重复利用,并逐渐形成了较为成熟的一次性医疗器械复用的德国和美国的两大模式。综述了一次性医疗器械复用在欧美的发展,特别是对涉及到高值一次性医用产品复用所涉及的技术问题、伦理问题以及政策法律问题进行了探讨。

Modern medical treatments use complex and high-value single-use medical devices. For example, varies catheters like pereutaneous transluminal coronary angioplasty （PTCA）, electrophysiology （EP） and pacemakers are utilized in cardiology. The prices of many single-use medical devices are still very high. Advanced technologies have been developed to reprocess the single-use devices which reduced the high costs in the heahhcare system. In the last 30 years, many countries practice the reprocessing of single-use medical devices. German and United States are the leading countries with two regulation models. This article reviewed the development of reprocessing practices in the United States and EU. The technical, ethical and legal issues of reprocessing have been discussed in details.