AUTHOR=Navarro Aurora , Len Oscar , Muñiz-Diaz Eduardo , Vives Corrons Joan-Lluis , Dominguez-Gil Beatriz , Vilarrodona Anna , Tort Jaume TITLE=The value of organ and tissue biovigilance: a cross-sectional analysis JOURNAL=Frontiers in Transplantation VOLUME=3 YEAR=2024 URL=https://www.frontiersin.org/journals/transplantation/articles/10.3389/frtra.2024.1307946 DOI=10.3389/frtra.2024.1307946 ISSN=2813-2440 ABSTRACT=Introduction

Biovigilance (BV) systems aim to improve the quality and safety of tissues and organs for transplantation. This study describes the Catalan BV system and analyzes its utility.

Methods

It is a retrospective analysis of notifications on serious adverse events (SAEs) and reactions (SARs) since the implementation of the BV system (2008 for tissues and 2016 for organs) until 2020. Variables are presented to describe the most common critical steps of the pathway and complications associated with the quality and safety of tissues and organs.

Results

A total of 154 and 125 notifications were reported to the Tissue and the Organ BV systems, respectively. Most SAEs were related to unexpected donor diseases and implemented actions were assured on those deemed preventable. Regarding SARs, donor-transmitted infections and malignancies (only organs) were the most common, followed by graft failure (tissues) and process-related (organs). The incidence of SAEs and SARs related to tissue was 3.44‰ and 0.22‰, respectively. The corresponding figures for organs were 31.48‰ and 8.8‰, respectively.

Discussion

The analysis of the notifications to the Catalan BV systems has provided useful information about existing risks associated with the quality and safety of tissues and organs, and enabled the implementation of actions targeted to diminish risks and mitigate damage.