Validation of Musculoskeletal Tissue Capture from a Living Donor: Experience from a Multi-tissue Bank

ABSTRACT

Introduction:

The harvesting of musculoskeletal tissues is essential to ensure the supply of biological products of human origin with safety and clinical efficacy. The harvesting stage must undergo a validation process to guarantee the quality of the tissues.

Objectives:

This article describes the experience of a public human multi-tissue bank (HMTB) in validating the harvesting of musculoskeletal tissue (femoral head) from a living donor.

Methods:

This involves evaluating and adapting a harvesting protocol to promote excellence in the quality of tissues distributed for therapeutic and research purposes. To this end, a technical visit was carried out at another tissue bank, and meetings were held with the orthopedic service team to present and discuss the process flow. Donor screening was done by applying forms evaluating the selection and exclusion criteria. After acceptance, through the consent form, the donor’s serological tests were requested and collected. The harvesting kit, control of the temperature thermal transport box, and collecting microbiological material from the piece at the time of removal were validated. The validated harvested tissue underwent macroscopic, radiological, and microbiological evaluations to consider the process valid. The forms and other documents in the medical record were audited by the institution’s health quality and safety center. Process mapping was also carried out, targeting risks and opportunities for improvement.

Results:

The harvesting protocol was validated as foreseen in the action plan. The harvesting technique was performed sterilely in the operating room. Microbiological and serological analyses showed negative results, and the tissue was considered macroscopically viable. After the audit, the documentation was deemed adequate to comply with current legislation (Resolução da Diretoria Colegiada – RDC Nº 707, of July 1, 2022), and the mapping of processes guaranteed the security of harvesting and provided opportunities for improvement.

Conclusion:

A protocol for capturing musculoskeletal tissues in the reference service is presented, with the validation process being replicable through a fundamental tool to ensure harmlessness and safety in tissue harvesting.

Descriptors
Tissue donation; Tissue transplantation; Biological Quality Control; Harmless Products; Human Tissue Bank