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[远程透析单元中透析液生产的风险控制]

[Risk control of dialysis fluids production in a teledialysis unit].

作者信息

Letournel Claire, Babinet François, Allard Bénédicte, Montecot Vincent

机构信息

Centre hospitalier François-Dunan, boulevard Port-en-Bessin, BP 4216, 97500 Saint-Pierre-et-Miquelon, France.

Expansion des Centres d'hémodialyse de l'Ouest, 72000 Le Mans, France.

出版信息

Nephrol Ther. 2019 Mar;15(1):51-58. doi: 10.1016/j.nephro.2018.08.002. Epub 2019 Jan 14.

Abstract

OBJECTIVE

The "Centre Hospitalier Francois Dunan" is located on an isolated island and ensures patients care in hemodialysis thanks to telemedicine support. Many research studies have demonstrated the importance of hemodialysis fluids composition to reduce morbidity in patients on chronic hemodialysis. The aim of this study was to identify the risks inherent in the production of dialysis fluids in a particular context, in order to set up an improvement action plan to improve risk control on the production of dialysis fluids.

METHODS

The risk analysis was conducted with the FMECA methodology (Failure Mode, Effects and Criticality Analysis) by a multi professional work group. Three types of risk have been reviewed: technical risks that may impact the production of hemodialysis fluids, health risks linked with chemical composition and health risks due to microbiological contamination of hemodialysis fluids.

RESULTS

The work group, in close cooperation with the expert staff of the dialysis center providing telemedicine assistance, has developed an action plan in order to improve the control of the main risks brought to light by the risk analysis.

CONCLUSION

The exhaustive analysis of the risks and their prioritisation have permitted to establish a relevant action plan in this improving quality of dialysis fluids approach. The risk control of dialysis fluids is necessary for the security of dialysis sessions for patients, even more when these sessions are realized by telemedicine in Saint-Pierre-et-Miquelon.

摘要

目的

“弗朗索瓦·迪南中心医院”位于一个孤岛,借助远程医疗支持为患者提供血液透析护理。许多研究表明,血液透析液成分对于降低慢性血液透析患者的发病率至关重要。本研究的目的是确定在特定背景下透析液生产中固有的风险,以便制定一项改进行动计划,以改善透析液生产中的风险控制。

方法

由一个多专业工作小组采用FMECA方法(失效模式、影响及危害性分析)进行风险分析。审查了三种类型的风险:可能影响血液透析液生产的技术风险、与化学成分相关的健康风险以及血液透析液微生物污染导致的健康风险。

结果

该工作小组与提供远程医疗援助的透析中心专家人员密切合作,制定了一项行动计划,以改善对风险分析中发现的主要风险的控制。

结论

对风险的详尽分析及其优先级排序有助于在这种提高透析液质量的方法中制定相关的行动计划。透析液的风险控制对于患者透析治疗的安全性是必要的,在圣皮埃尔和密克隆群岛通过远程医疗进行透析治疗时更是如此。

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