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室温储存的部件中塑料管材焊缝的无菌性。

Sterility of plastic tubing welds in components stored at room temperature.

作者信息

AuBuchon J P, Pickard C, Herschel L

机构信息

Department of Pathology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.

出版信息

Transfusion. 1995 Apr;35(4):303-7. doi: 10.1046/j.1537-2995.1995.35495216078.x.

DOI:10.1046/j.1537-2995.1995.35495216078.x
PMID:7701547
Abstract

BACKGROUND

The ability of a sterile connecting device to maintain sterility when being used to weld tubing of a blood component to be stored at room temperature, such as a platelet unit, has not been adequately documented, nor has it been determined when the tubing to be welded is filled with liquid.

STUDY DESIGN AND METHODS

The sterility of sterile connecting device welds of polyvinylchloride tubing were challenged after intentional contamination of the exterior of the tubing with both gram-positive and gram-negative organisms (4 x 10(4) to 3 x 10(6) colony-forming units/mL). Welding (n = 244) was performed with the contaminated area either being wet or having been allowed to dry. At the time of the welding, the tubing segments were either empty or filled with liquid (either aliquots of white cell-reduced apheresis platelets or bacteriologic growth medium). After the welding, the liquid was passed across the weld and held in the attached transfer pack for 5 to 7 days at room temperature.

RESULTS

Two welds were found to be incomplete and leaky, and both of the units involved had positive cultures. One transfer pack had inadvertently been contaminated at the time of its initial, postweld culture by a bacterium other than the one used in the experiment. Aside from these three nonevaluable units, all of the welds were sterile when cultured after the packs were held for 5 to 7 days.

CONCLUSION

This study documents the ability of the sterile connecting device to maintain a closed system in the welding of blood component units to be maintained at room temperature. All welds should be closely inspected at the time of completion to detect leaks that may lead to contamination.

摘要

背景

一种无菌连接装置在用于焊接待在室温下储存的血液成分(如血小板单位)的管路时,其保持无菌的能力尚未得到充分记录,而且当待焊接的管路充满液体时也未进行过相关测定。

研究设计与方法

在用革兰氏阳性菌和革兰氏阴性菌(4×10⁴至3×10⁶菌落形成单位/毫升)有意污染聚氯乙烯管路外部后,对无菌连接装置焊接处的无菌性进行了挑战。焊接(n = 244)时,污染区域要么是湿的,要么已使其干燥。焊接时,管段要么是空的,要么充满液体(白细胞去除单采血小板的等分试样或细菌学生长培养基)。焊接后,使液体通过焊接处并在连接的转移包中于室温下保存5至7天。

结果

发现有两个焊接处不完整且有渗漏,涉及的两个单位培养结果均为阳性。一个转移包在其最初的焊接后培养时意外被实验所用细菌以外的一种细菌污染。除了这三个无评估价值的单位外,在转移包保存5至7天后培养时,所有焊接处均无菌。

结论

本研究记录了无菌连接装置在焊接待在室温下保存的血液成分单位时维持封闭系统的能力。所有焊接处完成时都应仔细检查,以检测可能导致污染的渗漏情况。

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