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透析器最佳实践:一次性使用还是重复使用?

Dialyzer best practice: single use or reuse?

作者信息

Lacson Eduardo, Lazarus J Michael

机构信息

Fresenius Medical Care-North America, Lexington, Massachusetts 02421, USA.

出版信息

Semin Dial. 2006 Mar-Apr;19(2):120-8. doi: 10.1111/j.1525-139X.2006.00137.x.

Abstract

Outcome studies have shown either no additional risk or a small additional risk for hospitalization and mortality associated with reprocessing dialyzers. Although the risks from reprocessing dialyzers have yet to be fully elucidated, reuse can be done safely if it is performed in full compliance with the standards of Association for the Advancement of Medical Instrumentation (AAMI). Like most industrial processes, however, complete control of the reuse process in a clinical environment and full compliance with regulations at all times is difficult. Potential errors and breakdowns in the reuse process are continuing concerns. The quality controls for reprocessing of dialyzers are not equal to the rigor of the manufacturing process under the purview of the U.S. Food and Drug Administration (FDA). Therefore, if one were to determine "best practice," single use is preferable to reuse of dialyzers based on medical criteria and risk assessment. The long-term and cumulative effects of exposure to reuse reagents are unknown and there is no compelling medical indication for reprocessing of dialyzers. The major impediment when deciding to convert from reuse to single use of dialyzers is economic. The experience in Fresenius Medical Care-North America (FMCNA) facilities demonstrates that converting from a practice of reuse to single use is achievable. However, the overall economic impact of conversion to single use is provider specific. The dominance of reuse has been negated of late by a major shift in practice toward single use. Physicians and patients should be well informed in making decisions regarding the practice of single use versus reuse of dialyzers.

摘要

结果研究表明,与复用透析器相关的住院和死亡风险要么没有额外增加,要么仅略有增加。尽管复用透析器的风险尚未完全阐明,但如果完全按照美国医疗仪器促进协会(AAMI)的标准进行复用,那么可以安全地进行。然而,与大多数工业流程一样,在临床环境中完全控制复用过程并始终完全遵守规定是困难的。复用过程中的潜在错误和故障仍然令人担忧。透析器复用的质量控制不如美国食品药品监督管理局(FDA)管辖下的制造过程严格。因此,如果要确定“最佳做法”,基于医学标准和风险评估,一次性使用优于复用透析器。接触复用试剂的长期和累积影响尚不清楚,并且没有令人信服的医学指征支持透析器复用。决定从复用改为一次性使用透析器时的主要障碍是经济因素。费森尤斯医疗北美公司(FMCNA)设施的经验表明,从复用做法转变为一次性使用是可行的。然而,转为一次性使用的总体经济影响因供应商而异。最近,由于实践中向一次性使用的重大转变,复用的主导地位已被否定。在就透析器一次性使用与复用的做法做出决策时,医生和患者应充分了解相关信息。

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