人体组织库采用微生物质量控制技术

C. Corsi, Katia Carmen Gabriel Scarpelini, Rodolfo Leandro Bento, Alan Vinicius Assunção-Luiz, Flávio Luís Garcia, Luís Gustavo Gazoni Martins
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引用次数: 0

摘要

巴西卫生部 2017 年 9 月 28 日颁布的第 4 号综合法令规定了人体组织库(bancos de tecidos humanos [BTH])在环境(ISO 5 级处理室)和产品(需氧、厌氧和真菌病原体培养)微生物控制方面的服务评估要求,以确保组织移植的无害性。目标:重点介绍一家 BTH 在过去 5 年中采用的分布式组织微生物控制技术,以及应用和使用这些技术所取得的成果。方法:采用标准操作程序(SOP),事先确定收集、检测和房间清洁的方法和频率。在所有采集和处理过程中,都从组织中提取了微生物培养物。在组织处理过程中,将处理人员手套上和处理室中的指纹样本播种到血琼脂平板上。处理室每周使用双胍和季铵进行清洁。处理台用无菌的 70% 酒精消毒,微生物环境控制由一家合格的外包公司每 6 个月进行一次。结果:在分析期间,这些技术在 46 个(96%)案例中证明是有效的,仅在两个(4%)处理和采集的样本中发现了污染。有效性和结果均已记录在案。结论有效的生物质量控制方法是理所当然的,但也可以加以改进,因此有必要为服务质量和移植组织的安全制定安全协议。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Use of Microbiological Quality Control Techniques Adopted in a Human Tissue Bank
The Brazilian Ministry of Health’s Consolidation Ordinance No. 4 of September 28, 2017, provides the requisites for the evaluation of services for human tissue banks (bancos de tecidos humanos [BTH]) in terms of the microbiological control of environments (ISO 5 classification processing room) and products (culture for aerobic, anaerobic, and fungal pathogens), with a view to guaranteeing harmlessness in tissue transplants. Objectives: To highlight the techniques for microbiological control of distributed tissues adopted by a BTH over 5 years, as well as the results obtained from the application and use of these techniques. Methods: Using standard operating procedures (SOPs), the methodology, and frequency of collections, tests and room cleaning were established in advance. Microbiological cultures were taken from the tissues during all the collections and processing. During tissue processing, fingerprint samples on the processor’s gloves and in the processing room were seeded on blood agar plates. The processing room was cleaned weekly with biguanide and quaternary ammonium. The processing bench was sanitized with sterile 70% alcohol and the microbiological environmental control was carried out every 6 months by a qualified outsourced company. Results: In the period analyzed, the techniques proved effective in 46 (96%) cases, with contamination identified in only two (4%) processed and collected samples. The effectiveness and results were documented. Conclusion: Effective biological quality control methods are legitimately required, but they can be improved, raising the need to develop safe protocols for the quality of services and the safety of transplanted tissues.
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