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用于预防腹膜透析相关腹膜炎的非接触式连接系统的设计与概念验证评估

Design and proof-of-concept evaluation of a touchless connector system for preventing peritoneal dialysis-associated peritonitis.

作者信息

Yekinni Ibrahim O, Viker Tom, Hunter Ryan, Tucker Aaron, Elfering Sarah, Rheault Michelle N, Erdman Arthur

机构信息

Bakken Medical Devices Center, University of Minnesota, Minnesota, USA.

Cerovations LLC, Minnesota, USA.

出版信息

BMJ Innov. 2022 Apr;8(2):98-104. doi: 10.1136/bmjinnov-2021-000845. Epub 2022 Jan 28.

Abstract

INTRODUCTION

In this paper, we describe the design of a touchless peritoneal dialysis connector system and how we evaluated its potential for preventing peritoneal dialysis-associated peritonitis, in comparison to the standard of care. The unique feature of this system is an enclosure within which patients can connect and disconnect for therapy, protecting their peritoneal catheters from touch or aerosols.

METHODS

We simulated a worst-case contamination scenario by spraying 40mL of a standardized inoculum [ 1×10 colony-forming units (CFU) per milliliter] of test organisms, ATCC1228 and ATCC39327, while test participants made mock connections for therapy. We then compared the incidence of fluid path contamination by test organisms in the touchless connector system and the standard of care. 4 participants were recruited to perform a total of 56 tests, divided in a 1:1 ratio between both systems. Peritoneal dialysis fluid sample from each test was collected and maintained at body temperature (37° C) for 16 hours before being plated on Luria Bertani agar, Mannitol Salts Agar and Pseudomonas isolation agar for enumeration.

RESULTS

No contamination was observed in test samples from the touchless connector system, compared to 65%, 75% and 70% incidence contamination for the standard of care on Luria Bertani agar, Mannitol Salts Agar and Pseudomonas isolation agar respectively.

CONCLUSION

Results show that the touchless connector system can prevent fluid path contamination even in heavy bacterial exposures and may help reduce peritoneal dialysis-associated peritonitis risks from inadvertent contamination with further development.

摘要

引言

在本文中,我们描述了一种非接触式腹膜透析连接系统的设计,以及与护理标准相比,我们如何评估其预防腹膜透析相关腹膜炎的潜力。该系统的独特之处在于有一个外壳,患者可以在其中连接和断开进行治疗,保护其腹膜导管免受触摸或气溶胶影响。

方法

我们通过喷洒40毫升标准化接种物(每毫升含1×10个菌落形成单位(CFU))的测试微生物ATCC1228和ATCC39327来模拟最坏情况下的污染场景,同时测试参与者进行模拟治疗连接。然后,我们比较了非接触式连接系统和护理标准中测试微生物导致的液体通路污染发生率。招募了4名参与者进行总共56次测试,两个系统按1:1比例分配。每次测试的腹膜透析液样本在37°C体温下收集并保存16小时,然后接种在Luria Bertani琼脂、甘露醇盐琼脂和假单胞菌分离琼脂上进行计数。

结果

非接触式连接系统的测试样本中未观察到污染,而护理标准在Luria Bertani琼脂、甘露醇盐琼脂和假单胞菌分离琼脂上的污染发生率分别为65%、75%和70%。

结论

结果表明,非接触式连接系统即使在大量细菌暴露的情况下也能防止液体通路污染,随着进一步发展,可能有助于降低因意外污染导致的腹膜透析相关腹膜炎风险。

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