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透析器复用

Authors
Doug Schram, MD
William L Henrich, MD, MACP
Thomas A Golper, MD
Section Editor
Steve J Schwab, MD
Deputy Editor
Alice M Sheridan, MD
Translators
袁亮, 主治医师

引言

血液透析器的复用始于1964年[1]。从那时起，对成本控制的重视、昂贵但更高效透析膜的研发及再处理技术的改善使美国出现了较高的透析器复用率。根据美国疾病预防控制中心(Centers for Disease Control, CDC)1992年的年度报告，接受调查的美国长期血液透析机构中有72%常规复用透析器，涉及78%的血液透析患者[2]。

透析器的复用率随后大幅度下降。例如在2005年里，仅有约40%的美国透析机构被认为会复用透析器[3]。

其中部分原因是费森尤斯医药用品公司(北美)为终止复用而大量生产优惠价格的透析器，这些产品的性能特点与常用的复用型透析器相似。费森尤斯医药用品公司还收购了肾脏治疗组，这些事件都显著降低了美国透析器的复用率[4]。

为确保透析器再处理过程的安全性和有效性，各种指南应运而生。美国医疗仪器促进协会(Association for the Advancement of Medical Instrumentation, AAMI)发布了关于透析器再处理技术的推荐[5]。美国保健财务管理局(Health Care Financing Administration, HCFA)要求所有再处理透析器的透析中心都要遵守AAMI指南，并将此作为报销条件[6]。各市、郡或州立卫生机构也可实施其他规定。

美国食品药品监督管理局(Food and Drug Administration, FDA)的标签规定血液透析器仅供一次性使用。发现美国普遍存在透析器复用后，FDA于1996年要求制造商标注可多次使用的透析器，并提供证明透析器在多次使用中仍能保持性能的数据，以支持这一声明。

                 

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Literature review current through: 2017-06 . | This topic last updated: 2016-06-20.
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