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在圣保罗内陆的一家公立医院中实施人类多组织库的挑战:在质量管理体系的光照下。

Challenges of Implementing a Human Multi-Tissue Bank in a Public Hospital in the Interior of São Paulo: Under the Light of the Quality Management System.

机构信息

Human Multi-tissue Bank of Hospital das Clínicas, State University of Campinas - UNICAMP, São Paulo, Brazil.

Human Multi-tissue Bank of Hospital das Clínicas, State University of Campinas - UNICAMP, São Paulo, Brazil.

出版信息

Transplant Proc. 2024 Jun;56(5):1041-1047. doi: 10.1016/j.transproceed.2024.01.007. Epub 2024 Feb 19.

DOI:10.1016/j.transproceed.2024.01.007
PMID:38378340
Abstract

BACKGROUND

Human multi-tissue banks (HMTB) are important health institutions specialized in the capture, processing, and distribution of human tissues for transplants and research, aiming for safety and quality in the supply of their products, intended for reconstructive surgeries and injury repair, in addition to contributing to the advancement of research developed in regenerative medicine. This study aims to report and share the experience of implementing an HMTB, as well as creating an institution's own quality management system.

METHODS

This is a descriptive study, an experience report type, which identifies historical aspects of an HMTB's actions in the 5 years of implementing and operating the service.

RESULTS

Initially, a musculoskeletal tissue bank was established in collaboration with the Department of Orthopedics at the State University of Campinas, São Paulo, Brazil, in June 2018. In 2023, through a management model and associated technologies, the banks of human musculoskeletal and ocular tissues at the institution established the HC-UNICAMP Human Multi-tissue Bank.

CONCLUSIONS

The implementation of the HMTB with modern and technological infrastructure, associated with the development and operation of the quality management system, allowed us to provide excellent organization of work processes, as well as obtain the necessary health license to begin activities. It is believed that this report can be an important source of information and recommendations applicable to the implementation of other human HMTBs.

摘要

背景

人类多组织库(HMTB)是专门从事人体组织采集、处理和分配的重要健康机构,旨在确保其产品供应的安全性和质量,这些产品用于重建手术和损伤修复,同时也为再生医学领域的研究进展做出贡献。本研究旨在报告和分享建立 HMTB 的经验,以及创建机构自身质量管理体系的经验。

方法

这是一项描述性研究,属于经验报告类型,确定了 HMTB 在实施和运营服务的 5 年内的历史行动方面。

结果

最初,于 2018 年 6 月与巴西圣保罗州立大学骨科系合作建立了一个肌肉骨骼组织库。2023 年,通过管理模式和相关技术,该机构的人类肌肉骨骼和眼部组织库建立了 HC-UNICAMP 人类多组织库。

结论

通过现代化和技术基础设施的 HMTB 实施,以及质量管理体系的开发和运行,使我们能够提供出色的工作流程组织,同时获得开展活动所需的必要卫生许可证。相信本报告可以为其他人类 HMTB 的实施提供重要的信息来源和建议。

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Transplant Proc. 2024 Jun;56(5):1041-1047. doi: 10.1016/j.transproceed.2024.01.007. Epub 2024 Feb 19.
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